Feature

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

In April, a group of more than a dozen cardiologists at St. Louis Heart and Vascular (SLHV) lost their privileges at SSM Health, an eight-hospital system in St. Louis.

The physicians did not lose their privileges because of a clinical failure. Rather, it was because of SSM’s decision to enter into an exclusive contract with another set of cardiologists.

“The current situation is economically untenable for us,” said Harvey Serota, MD, founder and medical director of SLHV. “This is an existential threat to the practice.”

Because of the exclusive contract, many of SLHV’s patients are now being redirected to SSM-contracted cardiologists. Volume for the group’s new $15 million catheterization lab has plummeted. SLHV is suing SSM to restore its privileges, claiming lack of due process, restraint of trade, interference with its business, and breach of contract.

Losing privileges because a hospital seeks to increase their profits is becoming all too familiar for many independent specialists in fields such as cardiology, orthopedic surgery, and urology, as the hospitals that hosted them become their competitors and forge exclusive contracts with opposing groups.

What can these doctors do if they’re shut out? File a lawsuit, as SLHV has done? Demand a hearing before the medical staff and try to resolve the problem? Or simply give up their privileges and move on?

Unfortunately, none of these approaches offer a quick or certain solution, and each comes with risks.

Generally, courts have upheld hospitals’ use of exclusive contracts, which is also known as economic credentialing, says Barry F. Rosen, a health law attorney at Gordon Feinblatt, in Baltimore.

“Courts have long recognized exclusive contracts, and challenges by excluded doctors usually fail,” he says.

However, Mr. Rosen can cite several examples in which excluded doctors launched legal challenges that prevailed, owing to nuances in the law. The legal field in this area is tangled, and it varies by state.
 

Can hospitals make exclusive deals?

Hospitals have long used exclusive contracts for hospital-based specialists – anesthesiologists, radiologists, pathologists, emergency physicians, and hospitalists. They say that restricting patients to one group of anesthesiologists or radiologists enhances operational efficiency and that these contracts do not disrupt patients, because patients have no ties to hospital-based physicians. Such contracts are often more profitable for the hospital because of the negotiated rates.

Exclusive contracts in other specialties, however, are less accepted because they involve markedly different strategies and have different effects. In such cases, the hospital is no longer simply enhancing operational efficiency but is competing with physicians on staff, and the arrangement can disrupt the care of patients of the excluded doctors.

In the courts, these concerns might form the basis of an antitrust action or a claim of tortious interference with physicians’ ability to provide care for their patients, but neither claim is easy to win, Mr. Rosen says.

In antitrust cases, “the issue is not whether the excluded doctor was injured but whether the action harmed competition,” Mr. Rosen says. “Will the exclusion lead to higher prices?”

In the case of interference with patient care, “you will always find interference by one entity in the affairs of another,” he says, “but tortious interference applies to situations where something nefarious is going on, such as the other side was out to destroy your business and create a monopoly.”

Hospitals may try to restrict the privileges of physicians who invest in competing facilities such as cath labs and ambulatory surgery centers (ASCs), says Gregory Mertz, managing director of Physician Strategies Group, a consultancy in Virginia Beach.

“However, any revenge that a hospital might take against the doctors who started an ASC would usually not be publicly admitted,” Mr. Mertz says. “Revenge would be exacted in subtle ways.”

In the St. Louis situation, SSM did not cite SLHV’s cath lab as a reason for its exclusive contract. SSM stated in court documents that the decision was based on the recommendations of an expert panel. Furthermore, SSM said the board created the panel in response to a state report that cited the limited experience of some SLHV cardiologists in treating a rare type of heart attack.

Mr. Mertz says the board’s interest in the state’s concern and then its forming the special panel lent a great deal of legitimacy to SSM’s decision to start an exclusive contract. “SSM can show evidence that the board’s decision was based on a clinical matter and not on trying to squeeze out the cardiologists,” he says.

In SLHV’s defense, Dr. Serota says the practice offered to stop taking calls for the type of heart attack that was cited, but the hospital did not respond to its offer. He says SSM should have consulted the hospital’s medical staff to address the state’s concern and to create the exclusive contract, because these decisions involved clinical issues that the medical staff understands better than the board.

The law, however, does not require a hospital board to consult with its medical staff, says Alice G. Gosfield, a health care attorney in Philadelphia. “The board has ultimate legal control of everything in the hospital,” she says. However, the board often delegates certain functions to the medical staff in the hospital bylaws, and depending on the wording of the bylaws, it is still possible that the board violated the bylaws, Ms. Gosfield adds.
 

Can excluded physicians get peer review?

Can the hospital medical staff help restore the privileges of excluded physicians? Don’t these physicians have the right to peer review – a hearing before the medical staff?

Indeed, the Joint Commission, which accredits hospitals, states that the hospital must have “mechanisms, including a fair hearing and appeal process, for addressing adverse decisions for existing medical staff members and other individuals holding clinical privileges for renewal, revocation, or revision of clinical privileges.”

However, excluded physicians may not have a right to a hearing if they have not been fully stripped of privileges. SSM discontinued adult cardiology privileges for SLHV doctors but retained some doctors’ internal medicine privileges. Dr. Serota says internal medicine privileges are useless to cardiologists, but because the doctors’ privileges had not been fully removed, they cannot ask for a hearing.

More fundamentally, exclusive contracts are not a good fit for peer review. Mr. Rosen says the hearings were designed to review the physicians’ clinical competence or behavior, but excluded physicians do not have these problems. About all the hearing could focus on is the hospital’s policy, which the board would not want to allow. To avoid this, “the hospital might rule out a hearing as contrary to the intent of the bylaws,” Mr. Rosen says.

Furthermore, even if peer review goes forward, “what the medical staff decides is only advisory, and the hospital board makes the final decision,” Mr. Rosen says. He notes that the doctor could challenge the decision in court, but the hospital might still prevail.
 

Excluded physicians sometimes prevail

Although it is rare for excluded physicians to win a lawsuit against their hospital, it does happen, says Michael R. Callahan, health lawyer at Katten Muchin Rosenman, in Chicago.

Mr. Callahan cites a 2010 decision by the Arkansas Supreme Court that stopped the state’s largest health system from denying physicians’ privileges. Among other things, the hospital was found to have tortiously interfered with the physicians’ contracts with patients.

In a 2007 decision, a West Virginia court ruled that hospitals that have a mission to serve the public cannot exclude physicians for nonquality issues. In addition, some states, such as Texas, limit the economic factors that can be considered when credentialing decisions are made. Other states, such as Ohio, give hospitals a great deal of leeway to alter credentialing.

Dr. Serota is optimistic about his Missouri lawsuit. Although the judge in the case did not immediately grant SLHV’s request for restoration of privileges while the case proceeds, she did grant expedited discovery – allowing SLHV to obtain documents from SSM that could strengthen the doctors’ case – and she agreed to a hearing on SLHV’s request for a temporary restoration of privileges.

Ms. Gosfield says Dr. Serota’s optimism seems justified, but she adds that such cases cost a lot of money and that they may still not be winnable.

Often plaintiffs can settle lawsuits before they go to trial, but Mr. Callahan says hospitals are loath to restore privileges in a settlement because they don’t want to undermine an exclusivity deal. “The exclusive group expects a certain volume, which can’t be reached if the competing doctors are allowed back in,” he says.
 

Many physicians don’t challenge the exclusion

Quite often, excluded doctors decide not to challenge the decision. For example, Dr. Serota says groups of orthopedic surgeons and urologists have decided not to challenge similar decisions by SSM. “They wanted to move on,” he says.

Mr. Callahan says many excluded doctors also don’t even ask for a hearing. “They expect that the hospital’s decision will be upheld,” he says.

This was the case for Devendra K. Amin, MD, an independent cardiologist in Easton, Pa. Dr. Amin has not had any hospital privileges since July 2020. Even though he is board certified in interventional cardiology, which involves catheterization, Dr. Amin says he cannot perform these procedures because they can only be performed in a hospital in the area.

In the 1990s, Dr. Amin says, he had invasive cardiology privileges at five hospitals, but then those hospitals consolidated, and the remaining ones started constricting his privileges. First he could no longer work in the emergency department, then he could no longer read echocardiograms and interpret stress test results, because that work was assigned exclusively to employed doctors, he says.

Then the one remaining hospital announced that privileges would only be available to physicians by invitation, and he was not invited. Dr. Amin says he could have regained general cardiology privileges if he had accepted employment at the hospital, but he did not want to do this. A recruiter and the head of the cardiology section at the hospital even took him out to dinner 2 years ago to discuss employment, but there was a stipulation that the hospital would not agree to.

“I wanted to get back my interventional privileges back,” Dr. Amin says, “but they told me that would not be possible because they had an exclusive contract with a group.”

Dr. Amin says that now, he can only work as a general cardiologist with reduced volume. He says primary care physicians in the local hospital systems only refer to cardiologists within their systems. “When these patients do come to me, it is only because they specifically requested to see me,” Dr. Amin says.

He does not want to challenge the decisions regarding privileging. “Look, I am 68 years old,” Dr. Amin says. “I’m not retiring yet, but I don’t want to get into a battle with a hospital that has very deep pockets. I’m not a confrontational person to begin with, and I don’t want to spend the next 10 years of my life in litigation.”
 

Diverging expectations

The law on exclusive contracts does not provide easy answers for excluded doctors, and often it defies physicians’ conception of their own role in the hospital.

Many physicians expect the hospital to be a haven where they can do their work without being cut out by a competitor. This view is reinforced by organizations such as the American Medical Association.

The AMA Council on Medical Service states that privileges “can only be abridged upon recommendation of the medical staff and only for reason related to professional competence, adherence to standards of care, and other parameters agreed to by the medical staff.”

But the courts don’t tend to agree with that position. “Hospitals have a fiduciary duty to protect their own financial interests,” Mr. Callahan says. “This may involve anything that furthers the hospital’s mission to provide high-quality health care services to its patient community.”

At the same time, however, there are plenty of instances in which courts have ruled that exclusive contracts had gone too far. But usually it takes a lawyer experienced in these cases to know what those exceptions are.

A version of this article first appeared on Medscape.com.

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

A version of this article first appeared on Medscape.com.

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

A version of this article first appeared on Medscape.com.

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

A version of this article first appeared on Medscape.com.

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

A version of this article first appeared on WebMD.com.

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

A version of this article first appeared on WebMD.com.

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

A version of this article first appeared on WebMD.com.

“One of the most important considerations before switching HIV patients to injectable long-acting cabotegravir/rilpivirine [CAB/RPV LA; Cabenuva, ViiV Healthcare] is for the patient and the clinician to arrive at this decision together,” Elliot DeHaan, MD, told this news organization. “This therapy is not necessarily for everyone.”

Dr. DeHaan is lead author of the newly released clinical guideline from the New York State Department of Health AIDS Institute for use of CAB/RPV LA as replacement antiretroviral therapy (ART) in virally suppressed adults with HIV. He explained that the guidance expands upon Health & Human Services’ Feb. 24 CAB/RPV LA recommendations, highlighting some of the most important clinical and patient considerations necessary to implement injectable ART. “There are a lot of things that need to be laid out beforehand,” he said.
 

Gaining consensus

Approved by the FDA in late January 2021, CAB/RPV LA is considered an optimization strategy for individuals with HIV whose virus is suppressed by oral ART and who might prefer monthly injections to daily oral therapy. While there are various reasons why patients might wish to switch to a long-acting injectable, one of the primary concerns is adherence. Of note, the guidance points to phase 3 clinical study findings that suggest high levels (86%-91%) of patient satisfaction with CAB/RPV LA, which portends a promising future for this therapeutic approach.

With regard to patient preference, recommendations focus on the need to thoroughly discuss several critical requisites with potential candidates, including a 4-week lead-in daily oral ART course (CAB [Vocabria] 30 mg, RPV [Edurant] 25 mg) before initiating a loading dose. Patients should be advised of the potential for development of resistance should dosing be interrupted for any reason (CAB and RPV have extended half-lives ranging from mean 5.6 to 11.5 weeks for CAB and 13 to 28 weeks for RPV), as well as the need to return to oral bridging therapy if subsequent injections are not administered within the 7-day window period. If the maintenance dose is delayed beyond 2 months, a loading dose and restart is necessary.

CAB/RPV LA therapy is administered into opposing gluteal muscles (CAB into one gluteus medius and RPV into the contralateral gluteus medius), and injection-site pain beginning 1 day post-injection and lasting 3-4 days is common. In phase 3 clinical trials, as many as 83% of patients experienced adverse effects (AEs), which also include nodules, induration, and swelling at the injection sites. Fortunately, 99% of AEs were of mild to moderate severity. While pain tends to decline over several injections, Dr. DeHaan said that it’s an important part of the initial discussion about switching therapies.
 

Other considerations

Prior resistance testing, ART treatment history, and/or baseline genotypic resistance testing that includes both reverse transcriptase and integrase genes should be reviewed or conducted before initiating treatment. K103 mutations alone are not considered exclusionary. Virologic failures (defined as two consecutive plasma HIV-1 RNA measurements greater than 200 copies/mL), while rare, were reported in 13 clinical trial participants. Recent data suggest that patients who developed resistance despite adherence had at least two of three factors: a body mass index greater than 30 kg/m², the HIV-1 subtype A6/A1, and the presence of proviral RPV RAMS.

CAB/RPV LA does not treat hepatitis B (HBV) coinfections, reinforcing the need for concurrent oral HBV therapy.

And there’s a paucity of data on the safety and efficacy of CAB/RPV in children and adolescents, or during pregnancy/lactation, precluding its use in those patient populations.
 

Clinical, institutional considerations

Adaptation of CAB/RPV LA as ART requires specific clinical institutional planning, especially in light of current pandemic-related resource and staffing limitations. Monthly dosing must be done within a 7-day window and requires preparations akin to initial loading doses. In addition to pharmacy resources and onsite storage requirements, the guidance points to patient scheduling and reminder systems, access (patient transportation, work constraints, parking), and most importantly, contingency plans for care (including oral bridging therapy) should a clinic be forced to shut down for any reason. Additional factors include billing protocols, insurance or third party authorizations, and provision of counseling and education training.

“Given that this is a completely new way of thinking among providers, we’re all learning together,” said David Koren, PharmD, MPH, a clinical pharmacy specialist in infectious diseases at Temple University, Philadelphia. “The guidelines provide a nice framework for taking the next step to operationalize these processes into practice, taking into account that barriers to implementation are still unknown.” Dr. Koren was not involved in the development of the guidelines.

Dr. DeHaan has disclosed no relevant financial relationships. Dr. Koren disclosed serving on a prior Advisory Panel for ViiV Healthcare US.

A version of this article first appeared on Medscape.com.

“One of the most important considerations before switching HIV patients to injectable long-acting cabotegravir/rilpivirine [CAB/RPV LA; Cabenuva, ViiV Healthcare] is for the patient and the clinician to arrive at this decision together,” Elliot DeHaan, MD, told this news organization. “This therapy is not necessarily for everyone.”

Dr. DeHaan is lead author of the newly released clinical guideline from the New York State Department of Health AIDS Institute for use of CAB/RPV LA as replacement antiretroviral therapy (ART) in virally suppressed adults with HIV. He explained that the guidance expands upon Health & Human Services’ Feb. 24 CAB/RPV LA recommendations, highlighting some of the most important clinical and patient considerations necessary to implement injectable ART. “There are a lot of things that need to be laid out beforehand,” he said.
 

Gaining consensus

Approved by the FDA in late January 2021, CAB/RPV LA is considered an optimization strategy for individuals with HIV whose virus is suppressed by oral ART and who might prefer monthly injections to daily oral therapy. While there are various reasons why patients might wish to switch to a long-acting injectable, one of the primary concerns is adherence. Of note, the guidance points to phase 3 clinical study findings that suggest high levels (86%-91%) of patient satisfaction with CAB/RPV LA, which portends a promising future for this therapeutic approach.

With regard to patient preference, recommendations focus on the need to thoroughly discuss several critical requisites with potential candidates, including a 4-week lead-in daily oral ART course (CAB [Vocabria] 30 mg, RPV [Edurant] 25 mg) before initiating a loading dose. Patients should be advised of the potential for development of resistance should dosing be interrupted for any reason (CAB and RPV have extended half-lives ranging from mean 5.6 to 11.5 weeks for CAB and 13 to 28 weeks for RPV), as well as the need to return to oral bridging therapy if subsequent injections are not administered within the 7-day window period. If the maintenance dose is delayed beyond 2 months, a loading dose and restart is necessary.

CAB/RPV LA therapy is administered into opposing gluteal muscles (CAB into one gluteus medius and RPV into the contralateral gluteus medius), and injection-site pain beginning 1 day post-injection and lasting 3-4 days is common. In phase 3 clinical trials, as many as 83% of patients experienced adverse effects (AEs), which also include nodules, induration, and swelling at the injection sites. Fortunately, 99% of AEs were of mild to moderate severity. While pain tends to decline over several injections, Dr. DeHaan said that it’s an important part of the initial discussion about switching therapies.
 

Other considerations

Prior resistance testing, ART treatment history, and/or baseline genotypic resistance testing that includes both reverse transcriptase and integrase genes should be reviewed or conducted before initiating treatment. K103 mutations alone are not considered exclusionary. Virologic failures (defined as two consecutive plasma HIV-1 RNA measurements greater than 200 copies/mL), while rare, were reported in 13 clinical trial participants. Recent data suggest that patients who developed resistance despite adherence had at least two of three factors: a body mass index greater than 30 kg/m², the HIV-1 subtype A6/A1, and the presence of proviral RPV RAMS.

CAB/RPV LA does not treat hepatitis B (HBV) coinfections, reinforcing the need for concurrent oral HBV therapy.

And there’s a paucity of data on the safety and efficacy of CAB/RPV in children and adolescents, or during pregnancy/lactation, precluding its use in those patient populations.
 

Clinical, institutional considerations

Adaptation of CAB/RPV LA as ART requires specific clinical institutional planning, especially in light of current pandemic-related resource and staffing limitations. Monthly dosing must be done within a 7-day window and requires preparations akin to initial loading doses. In addition to pharmacy resources and onsite storage requirements, the guidance points to patient scheduling and reminder systems, access (patient transportation, work constraints, parking), and most importantly, contingency plans for care (including oral bridging therapy) should a clinic be forced to shut down for any reason. Additional factors include billing protocols, insurance or third party authorizations, and provision of counseling and education training.

“Given that this is a completely new way of thinking among providers, we’re all learning together,” said David Koren, PharmD, MPH, a clinical pharmacy specialist in infectious diseases at Temple University, Philadelphia. “The guidelines provide a nice framework for taking the next step to operationalize these processes into practice, taking into account that barriers to implementation are still unknown.” Dr. Koren was not involved in the development of the guidelines.

Dr. DeHaan has disclosed no relevant financial relationships. Dr. Koren disclosed serving on a prior Advisory Panel for ViiV Healthcare US.

A version of this article first appeared on Medscape.com.

“One of the most important considerations before switching HIV patients to injectable long-acting cabotegravir/rilpivirine [CAB/RPV LA; Cabenuva, ViiV Healthcare] is for the patient and the clinician to arrive at this decision together,” Elliot DeHaan, MD, told this news organization. “This therapy is not necessarily for everyone.”

Dr. DeHaan is lead author of the newly released clinical guideline from the New York State Department of Health AIDS Institute for use of CAB/RPV LA as replacement antiretroviral therapy (ART) in virally suppressed adults with HIV. He explained that the guidance expands upon Health & Human Services’ Feb. 24 CAB/RPV LA recommendations, highlighting some of the most important clinical and patient considerations necessary to implement injectable ART. “There are a lot of things that need to be laid out beforehand,” he said.
 

Gaining consensus

Approved by the FDA in late January 2021, CAB/RPV LA is considered an optimization strategy for individuals with HIV whose virus is suppressed by oral ART and who might prefer monthly injections to daily oral therapy. While there are various reasons why patients might wish to switch to a long-acting injectable, one of the primary concerns is adherence. Of note, the guidance points to phase 3 clinical study findings that suggest high levels (86%-91%) of patient satisfaction with CAB/RPV LA, which portends a promising future for this therapeutic approach.

With regard to patient preference, recommendations focus on the need to thoroughly discuss several critical requisites with potential candidates, including a 4-week lead-in daily oral ART course (CAB [Vocabria] 30 mg, RPV [Edurant] 25 mg) before initiating a loading dose. Patients should be advised of the potential for development of resistance should dosing be interrupted for any reason (CAB and RPV have extended half-lives ranging from mean 5.6 to 11.5 weeks for CAB and 13 to 28 weeks for RPV), as well as the need to return to oral bridging therapy if subsequent injections are not administered within the 7-day window period. If the maintenance dose is delayed beyond 2 months, a loading dose and restart is necessary.

CAB/RPV LA therapy is administered into opposing gluteal muscles (CAB into one gluteus medius and RPV into the contralateral gluteus medius), and injection-site pain beginning 1 day post-injection and lasting 3-4 days is common. In phase 3 clinical trials, as many as 83% of patients experienced adverse effects (AEs), which also include nodules, induration, and swelling at the injection sites. Fortunately, 99% of AEs were of mild to moderate severity. While pain tends to decline over several injections, Dr. DeHaan said that it’s an important part of the initial discussion about switching therapies.
 

Other considerations

Prior resistance testing, ART treatment history, and/or baseline genotypic resistance testing that includes both reverse transcriptase and integrase genes should be reviewed or conducted before initiating treatment. K103 mutations alone are not considered exclusionary. Virologic failures (defined as two consecutive plasma HIV-1 RNA measurements greater than 200 copies/mL), while rare, were reported in 13 clinical trial participants. Recent data suggest that patients who developed resistance despite adherence had at least two of three factors: a body mass index greater than 30 kg/m², the HIV-1 subtype A6/A1, and the presence of proviral RPV RAMS.

CAB/RPV LA does not treat hepatitis B (HBV) coinfections, reinforcing the need for concurrent oral HBV therapy.

And there’s a paucity of data on the safety and efficacy of CAB/RPV in children and adolescents, or during pregnancy/lactation, precluding its use in those patient populations.
 

Clinical, institutional considerations

Adaptation of CAB/RPV LA as ART requires specific clinical institutional planning, especially in light of current pandemic-related resource and staffing limitations. Monthly dosing must be done within a 7-day window and requires preparations akin to initial loading doses. In addition to pharmacy resources and onsite storage requirements, the guidance points to patient scheduling and reminder systems, access (patient transportation, work constraints, parking), and most importantly, contingency plans for care (including oral bridging therapy) should a clinic be forced to shut down for any reason. Additional factors include billing protocols, insurance or third party authorizations, and provision of counseling and education training.

“Given that this is a completely new way of thinking among providers, we’re all learning together,” said David Koren, PharmD, MPH, a clinical pharmacy specialist in infectious diseases at Temple University, Philadelphia. “The guidelines provide a nice framework for taking the next step to operationalize these processes into practice, taking into account that barriers to implementation are still unknown.” Dr. Koren was not involved in the development of the guidelines.

Dr. DeHaan has disclosed no relevant financial relationships. Dr. Koren disclosed serving on a prior Advisory Panel for ViiV Healthcare US.

A version of this article first appeared on Medscape.com.

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.

So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.

Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”

What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.

Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.

When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”

But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.

As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.

The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.

Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.

The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.

For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.

When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.

Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.

“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”

In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”

“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.

That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.

In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.

Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”

The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”

The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.

Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
 

Warning signs

In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.

A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.

The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.

The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.

The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.

For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.

But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.

Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.

Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.

For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.

The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.

Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.

Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”

The 15-day deadline passed, and the FDA never penalized the company.

The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.

But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.

Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.

Again, the inspection report said the company “promised to correct” the issues.

“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”

By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.

One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
 

“A no-brainer”

When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.

For a while, she felt invulnerable with the HVAD on her heart.

Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.

Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.

Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.

“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”

Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.

Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.

But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.

She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.

Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.

Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.

As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.

Nothing changed, and panic crept into the voice on the phone.

An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.

Still nothing.

Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.

Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.

She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.

She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.

Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
 

Company-led oversight

If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.

By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.

Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.

Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.

Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.

Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.

In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.

But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.

In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.

In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.

The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.

In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”

The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.

Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.

“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”

Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”

HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.

A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.

Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.

A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
 

Rewards, not penalties

As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.

With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.

In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.

HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.

Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.

According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.

Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.

“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”

Leadership proceeded with human testing anyway, the suit alleges.

Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.

HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.

None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.

In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.

“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”

Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.

Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.

“Slipped Through The Cracks”

After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.

It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.

“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”

Her doctor later told her she must have “slipped through the cracks,” she said.

The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.

But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.

Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”

She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”

When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.

Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.

There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.

Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.

Winkler and an attorney for the other family said they could not comment on their settlements.

Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.

“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
 

“Run its course”

Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.

She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.

They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.

Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.

Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.

But her new pump had problems soon after the surgery.

The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.

Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.

Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.

Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”

This article first appeared on Propublica.

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.

So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.

Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”

What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.

Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.

When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”

But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.

As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.

The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.

Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.

The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.

For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.

When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.

Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.

“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”

In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”

“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.

That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.

In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.

Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”

The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”

The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.

Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
 

Warning signs

In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.

A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.

The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.

The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.

The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.

For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.

But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.

Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.

Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.

For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.

The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.

Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.

Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”

The 15-day deadline passed, and the FDA never penalized the company.

The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.

But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.

Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.

Again, the inspection report said the company “promised to correct” the issues.

“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”

By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.

One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
 

“A no-brainer”

When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.

For a while, she felt invulnerable with the HVAD on her heart.

Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.

Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.

Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.

“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”

Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.

Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.

But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.

She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.

Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.

Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.

As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.

Nothing changed, and panic crept into the voice on the phone.

An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.

Still nothing.

Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.

Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.

She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.

She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.

Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
 

Company-led oversight

If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.

By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.

Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.

Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.

Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.

Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.

In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.

But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.

In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.

In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.

The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.

In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”

The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.

Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.

“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”

Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”

HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.

A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.

Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.

A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
 

Rewards, not penalties

As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.

With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.

In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.

HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.

Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.

According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.

Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.

“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”

Leadership proceeded with human testing anyway, the suit alleges.

Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.

HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.

None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.

In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.

“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”

Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.

Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.

“Slipped Through The Cracks”

After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.

It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.

“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”

Her doctor later told her she must have “slipped through the cracks,” she said.

The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.

But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.

Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”

She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”

When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.

Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.

There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.

Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.

Winkler and an attorney for the other family said they could not comment on their settlements.

Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.

“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
 

“Run its course”

Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.

She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.

They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.

Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.

Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.

But her new pump had problems soon after the surgery.

The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.

Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.

Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.

Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”

This article first appeared on Propublica.

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.

So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.

Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”

What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.

Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.

When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”

But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.

As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.

The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.

Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.

The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.

For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.

When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.

Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.

“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”

In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”

“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.

That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.

In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.

Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”

The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”

The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.

Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
 

Warning signs

In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.

A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.

The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.

The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.

The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.

For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.

But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.

Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.

Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.

For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.

The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.

Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.

Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”

The 15-day deadline passed, and the FDA never penalized the company.

The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.

But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.

Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.

Again, the inspection report said the company “promised to correct” the issues.

“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”

By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.

One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
 

“A no-brainer”

When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.

For a while, she felt invulnerable with the HVAD on her heart.

Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.

Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.

Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.

“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”

Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.

Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.

But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.

She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.

Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.

Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.

As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.

Nothing changed, and panic crept into the voice on the phone.

An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.

Still nothing.

Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.

Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.

She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.

She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.

Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
 

Company-led oversight

If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.

By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.

Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.

Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.

Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.

Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.

In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.

But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.

In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.

In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.

The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.

In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”

The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.

Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.

“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”

Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”

HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.

A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.

Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.

A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
 

Rewards, not penalties

As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.

With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.

In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.

HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.

Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.

According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.

Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.

“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”

Leadership proceeded with human testing anyway, the suit alleges.

Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.

HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.

None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.

In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.

“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”

Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.

Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.

“Slipped Through The Cracks”

After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.

It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.

“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”

Her doctor later told her she must have “slipped through the cracks,” she said.

The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.

But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.

Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”

She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”

When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.

Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.

There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.

Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.

Winkler and an attorney for the other family said they could not comment on their settlements.

Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.

“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
 

“Run its course”

Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.

She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.

They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.

Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.

Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.

But her new pump had problems soon after the surgery.

The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.

Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.

Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.

Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”

This article first appeared on Propublica.

The World Health Organization is calling on wealthy nations to wait to give their citizens booster doses of COVID-19 vaccines until at least the end of September to give more people in other countries a chance to get a first dose of these lifesaving shots.

WHO Director-General Tedros Ghebreyesus, PhD, said that more than 80% of the 4 billion vaccine doses given around the world had been distributed to high-income countries, though they represent less than half the world’s population.

“I understand the concern of all governments to protect their people from the Delta variant,” Dr. Ghebreyesus said. “But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected.”

So far, high-income countries have given about 100 vaccine doses for every 100 people, while low-income countries have given just 1.5 doses for every 100 people.

“Which means, in some of the most vulnerable countries in the world with the weakest health systems, health care workers are working without protection. … the older populations remain at high risk,” said Bruce Aylward, MD, the WHO’s senior adviser on organizational change.

But not everyone agrees.

Leana Wen, MD, a visiting professor at the Milken Institute School of Public Health at George Washington University, Washington, said there are doses already in the United States that won’t last long enough to be sent elsewhere.

“Yes, we need to get vaccines to the world (which also includes helping with distribution, not just supply), but there are doses expiring here in the U.S.,” she said on Twitter. “Why not allow those immunosuppressed to receive them?”

Israel became the first country to start giving some residents booster shots on Sunday, offering extra doses to seniors who are more than 5 months past their last vaccinations. On Monday, Germany announced it would also give booster doses to vulnerable patients, such as nursing home residents, beginning in September.

Dr. Aylward said the moratorium was all about “trying to put a hold on those policies until and unless we get the rest of the world caught up.”

He said it’s clear from the emergence of variant after variant that if we don’t stop the transmission of the virus around the world, the pandemic will continue to put pressure on the vaccines, making them less and less effective.

“We cannot get out of it unless the whole world gets out of it together,” Dr. Aylward said.

“We need an urgent reversal, from the majority of vaccines going to high-income countries, to the majority going to low-income countries,” Dr. Ghebreyesus said, asking leaders of high-income countries to wait on distributing booster doses until at least 10% of the world’s population is vaccinated.

“To make that happen, we need everyone’s cooperation, especially the handful of countries and companies that control the global supply of vaccines,” he said.

A version of this article first appeared on WebMD.com.

The World Health Organization is calling on wealthy nations to wait to give their citizens booster doses of COVID-19 vaccines until at least the end of September to give more people in other countries a chance to get a first dose of these lifesaving shots.

WHO Director-General Tedros Ghebreyesus, PhD, said that more than 80% of the 4 billion vaccine doses given around the world had been distributed to high-income countries, though they represent less than half the world’s population.

“I understand the concern of all governments to protect their people from the Delta variant,” Dr. Ghebreyesus said. “But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected.”

So far, high-income countries have given about 100 vaccine doses for every 100 people, while low-income countries have given just 1.5 doses for every 100 people.

“Which means, in some of the most vulnerable countries in the world with the weakest health systems, health care workers are working without protection. … the older populations remain at high risk,” said Bruce Aylward, MD, the WHO’s senior adviser on organizational change.

But not everyone agrees.

Leana Wen, MD, a visiting professor at the Milken Institute School of Public Health at George Washington University, Washington, said there are doses already in the United States that won’t last long enough to be sent elsewhere.

“Yes, we need to get vaccines to the world (which also includes helping with distribution, not just supply), but there are doses expiring here in the U.S.,” she said on Twitter. “Why not allow those immunosuppressed to receive them?”

Israel became the first country to start giving some residents booster shots on Sunday, offering extra doses to seniors who are more than 5 months past their last vaccinations. On Monday, Germany announced it would also give booster doses to vulnerable patients, such as nursing home residents, beginning in September.

Dr. Aylward said the moratorium was all about “trying to put a hold on those policies until and unless we get the rest of the world caught up.”

He said it’s clear from the emergence of variant after variant that if we don’t stop the transmission of the virus around the world, the pandemic will continue to put pressure on the vaccines, making them less and less effective.

“We cannot get out of it unless the whole world gets out of it together,” Dr. Aylward said.

“We need an urgent reversal, from the majority of vaccines going to high-income countries, to the majority going to low-income countries,” Dr. Ghebreyesus said, asking leaders of high-income countries to wait on distributing booster doses until at least 10% of the world’s population is vaccinated.

“To make that happen, we need everyone’s cooperation, especially the handful of countries and companies that control the global supply of vaccines,” he said.

A version of this article first appeared on WebMD.com.

The World Health Organization is calling on wealthy nations to wait to give their citizens booster doses of COVID-19 vaccines until at least the end of September to give more people in other countries a chance to get a first dose of these lifesaving shots.

WHO Director-General Tedros Ghebreyesus, PhD, said that more than 80% of the 4 billion vaccine doses given around the world had been distributed to high-income countries, though they represent less than half the world’s population.

“I understand the concern of all governments to protect their people from the Delta variant,” Dr. Ghebreyesus said. “But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected.”

So far, high-income countries have given about 100 vaccine doses for every 100 people, while low-income countries have given just 1.5 doses for every 100 people.

“Which means, in some of the most vulnerable countries in the world with the weakest health systems, health care workers are working without protection. … the older populations remain at high risk,” said Bruce Aylward, MD, the WHO’s senior adviser on organizational change.

But not everyone agrees.

Leana Wen, MD, a visiting professor at the Milken Institute School of Public Health at George Washington University, Washington, said there are doses already in the United States that won’t last long enough to be sent elsewhere.

“Yes, we need to get vaccines to the world (which also includes helping with distribution, not just supply), but there are doses expiring here in the U.S.,” she said on Twitter. “Why not allow those immunosuppressed to receive them?”

Israel became the first country to start giving some residents booster shots on Sunday, offering extra doses to seniors who are more than 5 months past their last vaccinations. On Monday, Germany announced it would also give booster doses to vulnerable patients, such as nursing home residents, beginning in September.

Dr. Aylward said the moratorium was all about “trying to put a hold on those policies until and unless we get the rest of the world caught up.”

He said it’s clear from the emergence of variant after variant that if we don’t stop the transmission of the virus around the world, the pandemic will continue to put pressure on the vaccines, making them less and less effective.

“We cannot get out of it unless the whole world gets out of it together,” Dr. Aylward said.

“We need an urgent reversal, from the majority of vaccines going to high-income countries, to the majority going to low-income countries,” Dr. Ghebreyesus said, asking leaders of high-income countries to wait on distributing booster doses until at least 10% of the world’s population is vaccinated.

“To make that happen, we need everyone’s cooperation, especially the handful of countries and companies that control the global supply of vaccines,” he said.

A version of this article first appeared on WebMD.com.

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

A version of this article first appeared on WebMD.com.

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

A version of this article first appeared on WebMD.com.

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

A version of this article first appeared on WebMD.com.

America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.

The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.

And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.

So, how about an economic argument? Get a COVID shot to protect your wallet.

Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”

Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.

In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.

More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.

For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.

A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.

But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.

The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.

The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.

Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.

That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.

Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.

KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.

But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.

The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.

And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.

So, how about an economic argument? Get a COVID shot to protect your wallet.

Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”

Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.

In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.

More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.

For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.

A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.

But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.

The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.

The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.

Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.

That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.

Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.

KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.

But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.

The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.

And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.

So, how about an economic argument? Get a COVID shot to protect your wallet.

Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”

Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.

In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.

More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.

For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.

A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.

But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.

The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.

The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.

Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.

That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.

Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.

KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.

But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

After SARS-CoV-2 spread at a sleepaway camp in Georgia last summer, researchers described the efficient spread and high attack rates at camp.

In a report published online in The New England Journal of Medicine, researchers found that campers spread COVID to household members after returning home – but transmission was more likely from some than others. Distancing and masking helped reduce the risk.

Victoria T. Chu, MD, MPH, with the Centers for Disease Control and Prevention, Atlanta, and colleagues with the agency and the Georgia Department of Health followed up with 224 camp attendees, aged 7 to 19 years, who had evidence of SARS-CoV-2 infection on laboratory testing.

These index patients – 88% of whom had symptoms – had 526 household contacts, mainly parents and siblings. Of 377 household contacts who underwent testing, 46 (12%) tested positive. Another two cases in household contacts were identified using clinical and epidemiologic criteria.
 

Family members hospitalized

Of the 41 adult household contacts who were infected, four (about 10%) were hospitalized. Their hospital stays ranged from 5 to 11 days. Of the seven infected household contacts who were younger than 18 years, none were hospitalized.

The four hospitalized adults were parents and grandparents aged 45 to 80 years, Dr. Chu said. Two of the four had underlying conditions. None of the household contacts died.

In an adjusted analysis, campers who had practiced physical distancing were less likely to transmit the virus at home, compared with those who had not practiced physical distancing (adjusted odds ratio, 0.4). Household members who had had close or direct contact with the index patients were more than 5 times more likely to become infected, compared with family members with minimal or no contact, analyses showed.

“This retrospective study showed that the efficient transmission of SARS-CoV-2 from school-age children and adolescents to household members led to the hospitalization of adults with secondary cases of COVID-19,” the researchers write. “In households in which transmission occurred, half the household contacts were infected.”

The secondary attack rates in this report may be an underestimate because testing was voluntary and participants reported the results themselves, the authors note. It is possible that infected household contacts spread the virus further, but this study did not address that question, Dr. Chu said.

For the study, investigators interviewed all camp attendees and their parents or guardians by phone between July 17, 2020 and Aug. 24, 2020, to collect information about demographic and clinical characteristics, SARS-CoV-2 testing, and preventive measures. The researchers’ analysis excluded households in which illness onset in a household contact occurred before or less than 2 days after a camper became sick.

About a third of the index patients began to have symptoms while still at camp. These campers may have been less infectious by the time they got home, compared with those whose symptoms started after they returned.

Two-thirds of the index patients adopted physical distancing at home, which “probably reduced the transmission of SARS-CoV-2 in the household,” Dr. Chu and colleagues wrote.

“Children who have had a known COVID-19 exposure should quarantine and obtain testing if they develop symptoms within the 14 days of returning home,” Dr. Chu advised. “If a child develops COVID-19, the child should be cared for and monitored using the proper combination of physical distancing, isolation when feasible, and mask use to prevent household transmission as much as possible. In addition, any person over the age of 12 is now eligible for vaccination in the United States. If eligible, children attending camp and their family members should get vaccinated to protect themselves and others, as vaccinations are our most effective public health prevention strategy.”
 

Mitigation can help

Another report regarding four overnight camps in Maine – in which three campers tested positive after they arrived last summer – shows that “aggressive mitigation strategies can be effective” in limiting transmission of the virus, William T. Basco Jr., MD, writes in a commentary for this news organization.

This summer, a range of factors, including vaccination rates at the camp, may influence transmission dynamics, Dr. Chu said in an interview. In July, the Associated Press reported outbreaks tied to summer camps in several states.

“Transmission dynamics will probably vary from summer camp to summer camp depending on many factors, such as vaccination rates of camp attendees, the mitigation measures in place, and the number of individual introductions during camp,” Dr. Chu said. “We would expect that a camp with a low vaccination rate among attendees and no enforcement of mitigation measures” still may experience a large outbreak.

“On the other hand, a large proportion of vaccinated individuals and appropriate implementation of multiple mitigation measures, such as wearing masks, may be quite effective at keeping their transmission rates low,” Dr. Chu added. “For camps with younger children who are not currently eligible for vaccination, implementing layered prevention strategies (e.g., mask use, physical distancing, and encouraging outdoor activities when feasible) is important to prevent transmission.”

Although COVID-19 transmission from children to adults, potentially leading to hospitalization, is not a new phenomenon, “data on the extent of transmission driven by children and adolescents in different settings are still quite sparse,” Dr. Chu said. “A better understanding of their impact on household and community transmission to help guide public health recommendations is particularly important, as most children are still not eligible for vaccination, and in-person schools will be reopening this fall.”

A version of this article first appeared on Medscape.com.

After SARS-CoV-2 spread at a sleepaway camp in Georgia last summer, researchers described the efficient spread and high attack rates at camp.

In a report published online in The New England Journal of Medicine, researchers found that campers spread COVID to household members after returning home – but transmission was more likely from some than others. Distancing and masking helped reduce the risk.

Victoria T. Chu, MD, MPH, with the Centers for Disease Control and Prevention, Atlanta, and colleagues with the agency and the Georgia Department of Health followed up with 224 camp attendees, aged 7 to 19 years, who had evidence of SARS-CoV-2 infection on laboratory testing.

These index patients – 88% of whom had symptoms – had 526 household contacts, mainly parents and siblings. Of 377 household contacts who underwent testing, 46 (12%) tested positive. Another two cases in household contacts were identified using clinical and epidemiologic criteria.
 

Family members hospitalized

Of the 41 adult household contacts who were infected, four (about 10%) were hospitalized. Their hospital stays ranged from 5 to 11 days. Of the seven infected household contacts who were younger than 18 years, none were hospitalized.

The four hospitalized adults were parents and grandparents aged 45 to 80 years, Dr. Chu said. Two of the four had underlying conditions. None of the household contacts died.

In an adjusted analysis, campers who had practiced physical distancing were less likely to transmit the virus at home, compared with those who had not practiced physical distancing (adjusted odds ratio, 0.4). Household members who had had close or direct contact with the index patients were more than 5 times more likely to become infected, compared with family members with minimal or no contact, analyses showed.

“This retrospective study showed that the efficient transmission of SARS-CoV-2 from school-age children and adolescents to household members led to the hospitalization of adults with secondary cases of COVID-19,” the researchers write. “In households in which transmission occurred, half the household contacts were infected.”

The secondary attack rates in this report may be an underestimate because testing was voluntary and participants reported the results themselves, the authors note. It is possible that infected household contacts spread the virus further, but this study did not address that question, Dr. Chu said.

For the study, investigators interviewed all camp attendees and their parents or guardians by phone between July 17, 2020 and Aug. 24, 2020, to collect information about demographic and clinical characteristics, SARS-CoV-2 testing, and preventive measures. The researchers’ analysis excluded households in which illness onset in a household contact occurred before or less than 2 days after a camper became sick.

About a third of the index patients began to have symptoms while still at camp. These campers may have been less infectious by the time they got home, compared with those whose symptoms started after they returned.

Two-thirds of the index patients adopted physical distancing at home, which “probably reduced the transmission of SARS-CoV-2 in the household,” Dr. Chu and colleagues wrote.

“Children who have had a known COVID-19 exposure should quarantine and obtain testing if they develop symptoms within the 14 days of returning home,” Dr. Chu advised. “If a child develops COVID-19, the child should be cared for and monitored using the proper combination of physical distancing, isolation when feasible, and mask use to prevent household transmission as much as possible. In addition, any person over the age of 12 is now eligible for vaccination in the United States. If eligible, children attending camp and their family members should get vaccinated to protect themselves and others, as vaccinations are our most effective public health prevention strategy.”
 

Mitigation can help

Another report regarding four overnight camps in Maine – in which three campers tested positive after they arrived last summer – shows that “aggressive mitigation strategies can be effective” in limiting transmission of the virus, William T. Basco Jr., MD, writes in a commentary for this news organization.

This summer, a range of factors, including vaccination rates at the camp, may influence transmission dynamics, Dr. Chu said in an interview. In July, the Associated Press reported outbreaks tied to summer camps in several states.

“Transmission dynamics will probably vary from summer camp to summer camp depending on many factors, such as vaccination rates of camp attendees, the mitigation measures in place, and the number of individual introductions during camp,” Dr. Chu said. “We would expect that a camp with a low vaccination rate among attendees and no enforcement of mitigation measures” still may experience a large outbreak.

“On the other hand, a large proportion of vaccinated individuals and appropriate implementation of multiple mitigation measures, such as wearing masks, may be quite effective at keeping their transmission rates low,” Dr. Chu added. “For camps with younger children who are not currently eligible for vaccination, implementing layered prevention strategies (e.g., mask use, physical distancing, and encouraging outdoor activities when feasible) is important to prevent transmission.”

Although COVID-19 transmission from children to adults, potentially leading to hospitalization, is not a new phenomenon, “data on the extent of transmission driven by children and adolescents in different settings are still quite sparse,” Dr. Chu said. “A better understanding of their impact on household and community transmission to help guide public health recommendations is particularly important, as most children are still not eligible for vaccination, and in-person schools will be reopening this fall.”

A version of this article first appeared on Medscape.com.

After SARS-CoV-2 spread at a sleepaway camp in Georgia last summer, researchers described the efficient spread and high attack rates at camp.

In a report published online in The New England Journal of Medicine, researchers found that campers spread COVID to household members after returning home – but transmission was more likely from some than others. Distancing and masking helped reduce the risk.

Victoria T. Chu, MD, MPH, with the Centers for Disease Control and Prevention, Atlanta, and colleagues with the agency and the Georgia Department of Health followed up with 224 camp attendees, aged 7 to 19 years, who had evidence of SARS-CoV-2 infection on laboratory testing.

These index patients – 88% of whom had symptoms – had 526 household contacts, mainly parents and siblings. Of 377 household contacts who underwent testing, 46 (12%) tested positive. Another two cases in household contacts were identified using clinical and epidemiologic criteria.
 

Family members hospitalized

Of the 41 adult household contacts who were infected, four (about 10%) were hospitalized. Their hospital stays ranged from 5 to 11 days. Of the seven infected household contacts who were younger than 18 years, none were hospitalized.

The four hospitalized adults were parents and grandparents aged 45 to 80 years, Dr. Chu said. Two of the four had underlying conditions. None of the household contacts died.

In an adjusted analysis, campers who had practiced physical distancing were less likely to transmit the virus at home, compared with those who had not practiced physical distancing (adjusted odds ratio, 0.4). Household members who had had close or direct contact with the index patients were more than 5 times more likely to become infected, compared with family members with minimal or no contact, analyses showed.

“This retrospective study showed that the efficient transmission of SARS-CoV-2 from school-age children and adolescents to household members led to the hospitalization of adults with secondary cases of COVID-19,” the researchers write. “In households in which transmission occurred, half the household contacts were infected.”

The secondary attack rates in this report may be an underestimate because testing was voluntary and participants reported the results themselves, the authors note. It is possible that infected household contacts spread the virus further, but this study did not address that question, Dr. Chu said.

For the study, investigators interviewed all camp attendees and their parents or guardians by phone between July 17, 2020 and Aug. 24, 2020, to collect information about demographic and clinical characteristics, SARS-CoV-2 testing, and preventive measures. The researchers’ analysis excluded households in which illness onset in a household contact occurred before or less than 2 days after a camper became sick.

About a third of the index patients began to have symptoms while still at camp. These campers may have been less infectious by the time they got home, compared with those whose symptoms started after they returned.

Two-thirds of the index patients adopted physical distancing at home, which “probably reduced the transmission of SARS-CoV-2 in the household,” Dr. Chu and colleagues wrote.

“Children who have had a known COVID-19 exposure should quarantine and obtain testing if they develop symptoms within the 14 days of returning home,” Dr. Chu advised. “If a child develops COVID-19, the child should be cared for and monitored using the proper combination of physical distancing, isolation when feasible, and mask use to prevent household transmission as much as possible. In addition, any person over the age of 12 is now eligible for vaccination in the United States. If eligible, children attending camp and their family members should get vaccinated to protect themselves and others, as vaccinations are our most effective public health prevention strategy.”
 

Mitigation can help

Another report regarding four overnight camps in Maine – in which three campers tested positive after they arrived last summer – shows that “aggressive mitigation strategies can be effective” in limiting transmission of the virus, William T. Basco Jr., MD, writes in a commentary for this news organization.

This summer, a range of factors, including vaccination rates at the camp, may influence transmission dynamics, Dr. Chu said in an interview. In July, the Associated Press reported outbreaks tied to summer camps in several states.

“Transmission dynamics will probably vary from summer camp to summer camp depending on many factors, such as vaccination rates of camp attendees, the mitigation measures in place, and the number of individual introductions during camp,” Dr. Chu said. “We would expect that a camp with a low vaccination rate among attendees and no enforcement of mitigation measures” still may experience a large outbreak.

“On the other hand, a large proportion of vaccinated individuals and appropriate implementation of multiple mitigation measures, such as wearing masks, may be quite effective at keeping their transmission rates low,” Dr. Chu added. “For camps with younger children who are not currently eligible for vaccination, implementing layered prevention strategies (e.g., mask use, physical distancing, and encouraging outdoor activities when feasible) is important to prevent transmission.”

Although COVID-19 transmission from children to adults, potentially leading to hospitalization, is not a new phenomenon, “data on the extent of transmission driven by children and adolescents in different settings are still quite sparse,” Dr. Chu said. “A better understanding of their impact on household and community transmission to help guide public health recommendations is particularly important, as most children are still not eligible for vaccination, and in-person schools will be reopening this fall.”

A version of this article first appeared on Medscape.com.

Millions of Americans have been languishing for weeks in the oppressive heat and humidity of a merciless summer. Deadly heat has already taken the lives of hundreds in the Pacific Northwest alone, with numbers likely to grow as the full impact of heat-related deaths eventually comes to light.

In the final week of July, the National Weather Service issued excessive heat warnings for 17 states, stretching from the West Coast, across the Midwest, down south into Louisiana and Georgia. Temperatures 10° to 15° F above average threaten the lives and livelihoods of people all across the country.

After a scorching heat wave in late June, residents of the Pacific Northwest are once again likely to see triple-digit temperatures in the coming days. With the heat, hospitals may face another surge of people with heat-related illnesses.

Erika Moseson, MD, a lung and intensive care specialist, witnessed firsthand the life-threatening impacts of soaring temperatures. She happened to be running her 10-bed intensive care unit in a suburban hospital in Gresham, Ore., about 15 miles east of Portland, the weekend of June 26. Within 12 hours, almost half her ICU beds were filled with people found unconscious on the street, in the bushes, or in their own beds, all because their body’s defenses had become overwhelmed by heat.

“It was unidentified person after unidentified person, coming in, same story, temperatures through the roof, comatose,” Dr. Moseson recalled. Young people in their 20s with muscle breakdown markers through the roof, a sign of rhabdomyolysis; people with no other medical problems that would have put them in a high-risk category.

As a lifelong Oregonian, she’d never seen anything like this before. “We’re all trained for it. I know what happens to you if you have heatstroke, I know how to treat it,” she trailed off, still finding it hard to believe. Still reeling from the number of cases in just a few hours. Still shocked that this happened on what’s supposed to be the cooler, rainforest side of Oregon.

Among those she treated and resuscitated, the memory of a patient that she lost continues to gnaw at her.

“I’ve gone back to it day after day since it happened,” she reflected.

Adults, in their 50s, living at home with their children. Just 1 hour prior, they’d all said goodnight. Then 1 hour later, when a child came to check in, both parents were unconscious.

Dr. Moseson shared how her team tried everything in their power for 18 hours to save the parent that was brought to her ICU. But like hundreds of others who went through the heat wave that weekend, her patient didn’t survive.

It was too late. From Dr. Moseson’s experience, it’s what happens “if you’re cooking a human.”
 

How heat kills

Regardless of where we live on the planet, humans maintain a consistent internal temperature around 98° F for our systems to function properly. 

Our bodies have an entire temperature-regulating system to balance heat gain with heat loss so we don’t stray too far from our ideal range. The hypothalamus functions as the thermostat, communicating with heat sensors in our skin, muscles, and spinal cord. Based on signals about our core body temperature, our nervous system makes many decisions for us – opening up blood vessels in the peripheral parts of our body, pushing more blood toward the skin, and activating sweat glands to produce more sweat.  

Sweat is one of the most powerful tools we have to maintain a safe internal temperature. Of course, there are some things under our control, such as removing clothing, drinking more water, and finding shade (or preferably air conditioning). But beyond that, it’s our ability to sweat that keeps us cool. When sweat evaporates into the air, heat from our skin goes with it, cooling us off.

Over time, our sweat response can work better as we get used to warmer environments, a process that’s known as acclimatization. Over the period of a few days to weeks, the sweat glands of acclimated people can start making sweat at lower temperatures, produce more sweat, and absorb more salt back into our system, all to make us more efficient “sweaters.”

While someone who’s not used to the heat may only produce 1 liter of sweat per hour, people who have become acclimated can produce 2-3 liters every hour, allowing evaporation to eliminate more than two times the amount of heat.   

Because the process of acclimatization can take some time, typically it’s the first throes of summer, or heat waves in places where people don’t typically see high temperatures, that are the most deadly. And of course, the right infrastructure, like access to air conditioning, also plays a large role in limiting heat-related death and hospitalization.

A 2019 study showed that heat-related hospitalizations peak at different temperatures in different places. For example, hospitalizations typically peak in Texas when the temperature hits 105° F. But they might be highest in the Pacific Northwest at just 81° F.

Even with acclimatization, there are limits to how much our bodies can adapt to heat. When the humidity goes up past 75%, there’s already so much moisture in the air that heat loss through evaporation no longer occurs.

It’s this connection between heat and humidity that can be deadly. This is why the heat index (a measure that takes into account temperature and relative humidity) and wet bulb globe temperature (a measure commonly used by the military and competitive athletes that takes into account temperature, humidity, wind speed, sun angle, and cloud cover) are both better at showing how dangerous the heat may be for our health, compared to temperature alone.

Kristie L. Ebi, PhD, a professor in the Center for Health and the Global Environment at the University of Washington, Seattle, has been studying the effects of heat and other climate-sensitive conditions on health for over 20 years. She stresses that it’s not just the recorded temperatures, but the prolonged exposure that kills.

If you never get a chance to bring down that core body temperature, if your internal temperatures stay above the range where your cells and your organs can work well for a long time, that’s when you can have the most dangerous effects of heat.

“It depends then on your age, your fitness, your individual physiology, underlying medical conditions, to how quickly that could affect the functioning of those organs. There’s lots of variability in there,” Dr. Ebi said.

Our hearts take on the brunt of the early response, working harder to pump blood toward the skin. Water and salt loss through our skin can start to cause electrolyte changes that can cause heat cramps and heat exhaustion. We feel tired, nauseated, dizzy. With enough water loss, we may become dehydrated, limiting the blood flow to our brains, causing us to pass out.

These early signs are like a car’s check engine light – systems are already being damaged, but resting, refueling, and, most importantly, turning off the heat are critical steps to prevent fatal injury.

If hazardous heat exposure continues and our internal temperatures continue to rise, nerves stop talking to each other, the proteins in our body unfold and lose their shape, and the cells of our organs disintegrate. This in turn sets off a fire alarm in our blood vessels, where a variety of chemical messengers, including “heat-shock proteins,” are released. The release of these inflammatory proteins, coupled with the loss of blood flow, eventually leads to the death of cells throughout the body, from the brain, to the heart, the muscles, and the kidneys.

This process is referred to as heatstroke. In essence, we melt from the inside.

At a certain point, this cascade can’t be reversed. Just like when you cool a melting block of ice, the parts that have melted will not go back to their original shape. It’s a similar process in our bodies, so delays in cooling and treatment can lead to death rates as high as 80%.

On the outside, we see people who look confused and disoriented, with hot skin and rapid breathing, and they may eventually become unconscious. Core body temperatures over 105° F clinch the diagnosis, but at the first sign of feeling unwell, cooling should be started.

There is no fancier or more effective treatment than that: Cool right away. In emergency rooms in Washington State, doctors used body bags filled with ice and water to cool victims of the heat wave in late June.

“It was all from heat ... that’s the thing, you feel so idiotic ... you’re like, ‘I’ve given you ice’ ... you bring their temperature down. But it’s already set off this cascade that you can’t stop,” Dr. Moseson said.

By the time Dr. Moseson’s patient made it to her, cooling with ice was just the beginning of the attempts to resuscitate and revive. The patient was already showing evidence of a process causing widespread bleeding and clotting, known as disseminated intravascular coagulation, along with damage to the heart and failing kidneys. Over 18 hours, her team cooled the patient, flooded the blood vessels with fluids and blood products, attempted to start dialysis, and inserted a breathing tube – all of the technology that is used to save people from serious cardiovascular collapse from other conditions. But nothing could reverse the melting that had already occurred.

Deaths from heat are 100% preventable. Until they’re not.
 

No respite

As Dr. Ebi says, the key to preventing heat-related death is to cool down enough to stabilize our internal cells and proteins before the irreversible cascade begins.

But for close to 80% of Americans who live in urban areas, temperatures can be even higher and more intolerable compared to surrounding areas because of the way we’ve designed our cities. In effect, we have unintentionally created hot zones called “urban heat islands.”

Jeremy Hoffman, PhD, chief scientist for the Science Museum of Virginia, explains that things like bricks, asphalt, and parking lots absorb more of the sun’s energy throughout the day and then emit that back into the air as heat throughout the afternoon and into the evening. This raises the air and surface temperatures in cities, relative to rural areas. When temperatures don’t cool enough at night, there’s no way to recover from the day’s heat. You start the next day still depleted, with less reserve to face the heat of a new day.

When you dig even deeper, it turns out that even within the same city, there are huge “thermal inequities,” as Dr. Hoffman calls them. In a 2019 study, he found that wealthier parts of cities had more natural spaces such as parks and tree-lined streets, compared to areas that had been intentionally “redlined,” or systematically deprived of investment. This pattern repeats itself in over 100 urban areas across the country and translates to huge temperature differences on the order of 10-20 degrees Fahrenheit within the same city, at the exact same time during a heat wave.

“In some ways, the way that we’ve decided to plan and build our cities physically turns up the thermostat by several tens of degrees during heat waves in particular neighborhoods,” Dr. Hoffman said.

Dr. Hoffman’s work showed that the city of Portland (where the death toll from the heat wave in late June was the highest) had some of the most intense differences between formerly redlined vs. tree-lined areas out of the more than 100 cities that he studied.  

“Watching it play out, I was really concerned, not only as a climate scientist, but as a human. Understanding the urban heat island effect and the extreme nature of the inequity in our cities, thermally and otherwise, once you start to really recognize it, you can’t forget it.”
 

The most vulnerable

When it comes to identifying and protecting the people most vulnerable to heat stress and heat-related death, there is an ever-growing list of those most at risk. Unfortunately, very few recognize when they themselves are at risk, often until it’s too late.

According to Linda McCauley, PhD, dean of the Emory University School of Nursing in Atlanta, “the scope of who is vulnerable is quickly increasing.”

For example, we’re used to recognizing that pregnant women and young children are at risk. Public health campaigns have long advised us not to leave young children and pets in hot cars. We know that adolescents who play sports during hot summer months are at high risk for heat-related events and even death.

In Georgia, a 15-year-old boy collapsed and died after his first day back at football practice when the heat index was 105° F on July 26, even as it appears that all protocols for heat safety were being followed.

We recognize that outdoor workers face devastating consequences from prolonged exertion in the heat and must have safer working conditions.

The elderly and those with long-term medical and mental health conditions are also more vulnerable to heat. The elderly may not have the same warning signs and may not recognize that they are dehydrated until it is too late. In addition, their sweating mechanism weakens, and they may be taking medicines that interfere with their ability to regulate their temperature.

Poverty and inadequate housing are risk factors, especially for those in urban heat islands. For many people, their housing does not have enough cooling to protect them, and they can’t safely get themselves to cooling shelters.

These patterns for the most vulnerable fit for the majority of deaths in Oregon during the late June heat wave. Most victims were older, lived alone, and didn’t have air conditioning. But with climate change, the predictions are that temperatures will go higher and heat waves will last longer.

“There’s probably very few people today that are ‘immune’ to the effects of heat-related stress with climate change. All of us can be put in situations where we are susceptible,” Dr. McCauley said.

Dr. Moseson agreed. Many of her patients fit none of these risk categories – she treated people with no health problems in their 20s in her ICU, and the patient she lost would not traditionally have been thought of as high risk. That 50-something patient had no long-standing medical problems, and lived with family in a newly renovated suburban home that had air conditioning. The only problem was that the air conditioner had broken and there had been no rush to fix it based on past experience with Oregon summers.
 

Preventing heat deaths

Protecting ourselves and our families means monitoring the “simple things.” The first three rules are to make sure we’re drinking plenty of water – this means drinking whether we feel thirsty or not. If we’re not in an air-conditioned place, we’ve got to look for shade. And we need to take regular rest breaks.

Inside a home without air conditioning, placing ice in front of a fan to cool the air can work, but realistically, if you are in a place without air conditioning and the temperatures are approaching 90° F, it’s safest to find another place to stay, if possible.

For those playing sports, there are usually 1-week to 2-week protocols that allow for acclimatization when the season begins – this means starting slowly, without gear, and ramping up activity. Still, parents and coaches should watch advanced weather reports to make sure it’s safe to practice outside.

How we dress can also help us, so light clothing is key. And if we’re able to schedule activities for times when it is cooler, that can also protect us from overheating.

If anyone shows early signs of heat stress, removing clothing, cooling their bodies with cold water, and getting them out of the heat is critical. Any evidence of heatstroke is an emergency, and 911 should be called without delay. The faster the core temperature can be dropped, the better the chances for recovery.

On the level of communities, access to natural air conditioning in the form of healthy tree canopies, and trees at bus stops to provide shade can help a lot. According to Dr. Hoffman, these investments help almost right away. Reimagining our cities to remove the “hot zones” that we have created is another key to protecting ourselves as our climate changes.
 

Reaching our limits in a changing climate

Already, we are seeing more intense, more frequent, and longer-lasting heat waves throughout the country and across the globe.

Dr. Ebi, a coauthor of a recently released scientific analysis that found that the late June Pacific Northwest heat wave would have been virtually impossible without climate change, herself lived through the scorching temperatures in Seattle. Her work shows that the changing climate is killing us right now.

We are approaching a time where extreme temperatures and humidity will make it almost impossible for people to be outside in many parts of the world. Researchers have found that periods of extreme humid heat have more than doubled since 1979, and some places have already had wet-bulb temperatures at the limits of what scientists think humans can tolerate under ideal conditions, meaning for people in perfect health, completely unclothed, in gale-force winds, performing no activity. Obviously that’s less than ideal for most of us and helps explain why thousands of people die at temperatures much lower than our upper limit.

Dr. Ebi pointed out that the good news is that many local communities with a long history of managing high temperatures have a lot of knowledge to share with regions that are newly dealing with these conditions. This includes how local areas develop early warning and response systems with specific action plans.

But, she cautions, it’s going to take a lot of coordination and a lot of behavior change to stabilize the earth’s climate, understand our weak points, and protect our health.

For Dr. Moseson, this reality has hit home.

“I already spent the year being terrified that I as an ICU doctor was going to be the one who gave my mom COVID. Finally I’m vaccinated, she’s vaccinated. Now I’ve watched someone die because they don’t have AC. And my parents, they’re old-school Oregonians, they don’t have AC.”

A version of this article originally appeared on WebMD.com.

Millions of Americans have been languishing for weeks in the oppressive heat and humidity of a merciless summer. Deadly heat has already taken the lives of hundreds in the Pacific Northwest alone, with numbers likely to grow as the full impact of heat-related deaths eventually comes to light.

In the final week of July, the National Weather Service issued excessive heat warnings for 17 states, stretching from the West Coast, across the Midwest, down south into Louisiana and Georgia. Temperatures 10° to 15° F above average threaten the lives and livelihoods of people all across the country.

After a scorching heat wave in late June, residents of the Pacific Northwest are once again likely to see triple-digit temperatures in the coming days. With the heat, hospitals may face another surge of people with heat-related illnesses.

Erika Moseson, MD, a lung and intensive care specialist, witnessed firsthand the life-threatening impacts of soaring temperatures. She happened to be running her 10-bed intensive care unit in a suburban hospital in Gresham, Ore., about 15 miles east of Portland, the weekend of June 26. Within 12 hours, almost half her ICU beds were filled with people found unconscious on the street, in the bushes, or in their own beds, all because their body’s defenses had become overwhelmed by heat.

“It was unidentified person after unidentified person, coming in, same story, temperatures through the roof, comatose,” Dr. Moseson recalled. Young people in their 20s with muscle breakdown markers through the roof, a sign of rhabdomyolysis; people with no other medical problems that would have put them in a high-risk category.

As a lifelong Oregonian, she’d never seen anything like this before. “We’re all trained for it. I know what happens to you if you have heatstroke, I know how to treat it,” she trailed off, still finding it hard to believe. Still reeling from the number of cases in just a few hours. Still shocked that this happened on what’s supposed to be the cooler, rainforest side of Oregon.

Among those she treated and resuscitated, the memory of a patient that she lost continues to gnaw at her.

“I’ve gone back to it day after day since it happened,” she reflected.

Adults, in their 50s, living at home with their children. Just 1 hour prior, they’d all said goodnight. Then 1 hour later, when a child came to check in, both parents were unconscious.

Dr. Moseson shared how her team tried everything in their power for 18 hours to save the parent that was brought to her ICU. But like hundreds of others who went through the heat wave that weekend, her patient didn’t survive.

It was too late. From Dr. Moseson’s experience, it’s what happens “if you’re cooking a human.”
 

How heat kills

Regardless of where we live on the planet, humans maintain a consistent internal temperature around 98° F for our systems to function properly. 

Our bodies have an entire temperature-regulating system to balance heat gain with heat loss so we don’t stray too far from our ideal range. The hypothalamus functions as the thermostat, communicating with heat sensors in our skin, muscles, and spinal cord. Based on signals about our core body temperature, our nervous system makes many decisions for us – opening up blood vessels in the peripheral parts of our body, pushing more blood toward the skin, and activating sweat glands to produce more sweat.  

Sweat is one of the most powerful tools we have to maintain a safe internal temperature. Of course, there are some things under our control, such as removing clothing, drinking more water, and finding shade (or preferably air conditioning). But beyond that, it’s our ability to sweat that keeps us cool. When sweat evaporates into the air, heat from our skin goes with it, cooling us off.

Over time, our sweat response can work better as we get used to warmer environments, a process that’s known as acclimatization. Over the period of a few days to weeks, the sweat glands of acclimated people can start making sweat at lower temperatures, produce more sweat, and absorb more salt back into our system, all to make us more efficient “sweaters.”

While someone who’s not used to the heat may only produce 1 liter of sweat per hour, people who have become acclimated can produce 2-3 liters every hour, allowing evaporation to eliminate more than two times the amount of heat.   

Because the process of acclimatization can take some time, typically it’s the first throes of summer, or heat waves in places where people don’t typically see high temperatures, that are the most deadly. And of course, the right infrastructure, like access to air conditioning, also plays a large role in limiting heat-related death and hospitalization.

A 2019 study showed that heat-related hospitalizations peak at different temperatures in different places. For example, hospitalizations typically peak in Texas when the temperature hits 105° F. But they might be highest in the Pacific Northwest at just 81° F.

Even with acclimatization, there are limits to how much our bodies can adapt to heat. When the humidity goes up past 75%, there’s already so much moisture in the air that heat loss through evaporation no longer occurs.

It’s this connection between heat and humidity that can be deadly. This is why the heat index (a measure that takes into account temperature and relative humidity) and wet bulb globe temperature (a measure commonly used by the military and competitive athletes that takes into account temperature, humidity, wind speed, sun angle, and cloud cover) are both better at showing how dangerous the heat may be for our health, compared to temperature alone.

Kristie L. Ebi, PhD, a professor in the Center for Health and the Global Environment at the University of Washington, Seattle, has been studying the effects of heat and other climate-sensitive conditions on health for over 20 years. She stresses that it’s not just the recorded temperatures, but the prolonged exposure that kills.

If you never get a chance to bring down that core body temperature, if your internal temperatures stay above the range where your cells and your organs can work well for a long time, that’s when you can have the most dangerous effects of heat.

“It depends then on your age, your fitness, your individual physiology, underlying medical conditions, to how quickly that could affect the functioning of those organs. There’s lots of variability in there,” Dr. Ebi said.

Our hearts take on the brunt of the early response, working harder to pump blood toward the skin. Water and salt loss through our skin can start to cause electrolyte changes that can cause heat cramps and heat exhaustion. We feel tired, nauseated, dizzy. With enough water loss, we may become dehydrated, limiting the blood flow to our brains, causing us to pass out.

These early signs are like a car’s check engine light – systems are already being damaged, but resting, refueling, and, most importantly, turning off the heat are critical steps to prevent fatal injury.

If hazardous heat exposure continues and our internal temperatures continue to rise, nerves stop talking to each other, the proteins in our body unfold and lose their shape, and the cells of our organs disintegrate. This in turn sets off a fire alarm in our blood vessels, where a variety of chemical messengers, including “heat-shock proteins,” are released. The release of these inflammatory proteins, coupled with the loss of blood flow, eventually leads to the death of cells throughout the body, from the brain, to the heart, the muscles, and the kidneys.

This process is referred to as heatstroke. In essence, we melt from the inside.

At a certain point, this cascade can’t be reversed. Just like when you cool a melting block of ice, the parts that have melted will not go back to their original shape. It’s a similar process in our bodies, so delays in cooling and treatment can lead to death rates as high as 80%.

On the outside, we see people who look confused and disoriented, with hot skin and rapid breathing, and they may eventually become unconscious. Core body temperatures over 105° F clinch the diagnosis, but at the first sign of feeling unwell, cooling should be started.

There is no fancier or more effective treatment than that: Cool right away. In emergency rooms in Washington State, doctors used body bags filled with ice and water to cool victims of the heat wave in late June.

“It was all from heat ... that’s the thing, you feel so idiotic ... you’re like, ‘I’ve given you ice’ ... you bring their temperature down. But it’s already set off this cascade that you can’t stop,” Dr. Moseson said.

By the time Dr. Moseson’s patient made it to her, cooling with ice was just the beginning of the attempts to resuscitate and revive. The patient was already showing evidence of a process causing widespread bleeding and clotting, known as disseminated intravascular coagulation, along with damage to the heart and failing kidneys. Over 18 hours, her team cooled the patient, flooded the blood vessels with fluids and blood products, attempted to start dialysis, and inserted a breathing tube – all of the technology that is used to save people from serious cardiovascular collapse from other conditions. But nothing could reverse the melting that had already occurred.

Deaths from heat are 100% preventable. Until they’re not.
 

No respite

As Dr. Ebi says, the key to preventing heat-related death is to cool down enough to stabilize our internal cells and proteins before the irreversible cascade begins.

But for close to 80% of Americans who live in urban areas, temperatures can be even higher and more intolerable compared to surrounding areas because of the way we’ve designed our cities. In effect, we have unintentionally created hot zones called “urban heat islands.”

Jeremy Hoffman, PhD, chief scientist for the Science Museum of Virginia, explains that things like bricks, asphalt, and parking lots absorb more of the sun’s energy throughout the day and then emit that back into the air as heat throughout the afternoon and into the evening. This raises the air and surface temperatures in cities, relative to rural areas. When temperatures don’t cool enough at night, there’s no way to recover from the day’s heat. You start the next day still depleted, with less reserve to face the heat of a new day.

When you dig even deeper, it turns out that even within the same city, there are huge “thermal inequities,” as Dr. Hoffman calls them. In a 2019 study, he found that wealthier parts of cities had more natural spaces such as parks and tree-lined streets, compared to areas that had been intentionally “redlined,” or systematically deprived of investment. This pattern repeats itself in over 100 urban areas across the country and translates to huge temperature differences on the order of 10-20 degrees Fahrenheit within the same city, at the exact same time during a heat wave.

“In some ways, the way that we’ve decided to plan and build our cities physically turns up the thermostat by several tens of degrees during heat waves in particular neighborhoods,” Dr. Hoffman said.

Dr. Hoffman’s work showed that the city of Portland (where the death toll from the heat wave in late June was the highest) had some of the most intense differences between formerly redlined vs. tree-lined areas out of the more than 100 cities that he studied.  

“Watching it play out, I was really concerned, not only as a climate scientist, but as a human. Understanding the urban heat island effect and the extreme nature of the inequity in our cities, thermally and otherwise, once you start to really recognize it, you can’t forget it.”
 

The most vulnerable

When it comes to identifying and protecting the people most vulnerable to heat stress and heat-related death, there is an ever-growing list of those most at risk. Unfortunately, very few recognize when they themselves are at risk, often until it’s too late.

According to Linda McCauley, PhD, dean of the Emory University School of Nursing in Atlanta, “the scope of who is vulnerable is quickly increasing.”

For example, we’re used to recognizing that pregnant women and young children are at risk. Public health campaigns have long advised us not to leave young children and pets in hot cars. We know that adolescents who play sports during hot summer months are at high risk for heat-related events and even death.

In Georgia, a 15-year-old boy collapsed and died after his first day back at football practice when the heat index was 105° F on July 26, even as it appears that all protocols for heat safety were being followed.

We recognize that outdoor workers face devastating consequences from prolonged exertion in the heat and must have safer working conditions.

The elderly and those with long-term medical and mental health conditions are also more vulnerable to heat. The elderly may not have the same warning signs and may not recognize that they are dehydrated until it is too late. In addition, their sweating mechanism weakens, and they may be taking medicines that interfere with their ability to regulate their temperature.

Poverty and inadequate housing are risk factors, especially for those in urban heat islands. For many people, their housing does not have enough cooling to protect them, and they can’t safely get themselves to cooling shelters.

These patterns for the most vulnerable fit for the majority of deaths in Oregon during the late June heat wave. Most victims were older, lived alone, and didn’t have air conditioning. But with climate change, the predictions are that temperatures will go higher and heat waves will last longer.

“There’s probably very few people today that are ‘immune’ to the effects of heat-related stress with climate change. All of us can be put in situations where we are susceptible,” Dr. McCauley said.

Dr. Moseson agreed. Many of her patients fit none of these risk categories – she treated people with no health problems in their 20s in her ICU, and the patient she lost would not traditionally have been thought of as high risk. That 50-something patient had no long-standing medical problems, and lived with family in a newly renovated suburban home that had air conditioning. The only problem was that the air conditioner had broken and there had been no rush to fix it based on past experience with Oregon summers.
 

Preventing heat deaths

Protecting ourselves and our families means monitoring the “simple things.” The first three rules are to make sure we’re drinking plenty of water – this means drinking whether we feel thirsty or not. If we’re not in an air-conditioned place, we’ve got to look for shade. And we need to take regular rest breaks.

Inside a home without air conditioning, placing ice in front of a fan to cool the air can work, but realistically, if you are in a place without air conditioning and the temperatures are approaching 90° F, it’s safest to find another place to stay, if possible.

For those playing sports, there are usually 1-week to 2-week protocols that allow for acclimatization when the season begins – this means starting slowly, without gear, and ramping up activity. Still, parents and coaches should watch advanced weather reports to make sure it’s safe to practice outside.

How we dress can also help us, so light clothing is key. And if we’re able to schedule activities for times when it is cooler, that can also protect us from overheating.

If anyone shows early signs of heat stress, removing clothing, cooling their bodies with cold water, and getting them out of the heat is critical. Any evidence of heatstroke is an emergency, and 911 should be called without delay. The faster the core temperature can be dropped, the better the chances for recovery.

On the level of communities, access to natural air conditioning in the form of healthy tree canopies, and trees at bus stops to provide shade can help a lot. According to Dr. Hoffman, these investments help almost right away. Reimagining our cities to remove the “hot zones” that we have created is another key to protecting ourselves as our climate changes.
 

Reaching our limits in a changing climate

Already, we are seeing more intense, more frequent, and longer-lasting heat waves throughout the country and across the globe.

Dr. Ebi, a coauthor of a recently released scientific analysis that found that the late June Pacific Northwest heat wave would have been virtually impossible without climate change, herself lived through the scorching temperatures in Seattle. Her work shows that the changing climate is killing us right now.

We are approaching a time where extreme temperatures and humidity will make it almost impossible for people to be outside in many parts of the world. Researchers have found that periods of extreme humid heat have more than doubled since 1979, and some places have already had wet-bulb temperatures at the limits of what scientists think humans can tolerate under ideal conditions, meaning for people in perfect health, completely unclothed, in gale-force winds, performing no activity. Obviously that’s less than ideal for most of us and helps explain why thousands of people die at temperatures much lower than our upper limit.

Dr. Ebi pointed out that the good news is that many local communities with a long history of managing high temperatures have a lot of knowledge to share with regions that are newly dealing with these conditions. This includes how local areas develop early warning and response systems with specific action plans.

But, she cautions, it’s going to take a lot of coordination and a lot of behavior change to stabilize the earth’s climate, understand our weak points, and protect our health.

For Dr. Moseson, this reality has hit home.

“I already spent the year being terrified that I as an ICU doctor was going to be the one who gave my mom COVID. Finally I’m vaccinated, she’s vaccinated. Now I’ve watched someone die because they don’t have AC. And my parents, they’re old-school Oregonians, they don’t have AC.”

A version of this article originally appeared on WebMD.com.

Millions of Americans have been languishing for weeks in the oppressive heat and humidity of a merciless summer. Deadly heat has already taken the lives of hundreds in the Pacific Northwest alone, with numbers likely to grow as the full impact of heat-related deaths eventually comes to light.

In the final week of July, the National Weather Service issued excessive heat warnings for 17 states, stretching from the West Coast, across the Midwest, down south into Louisiana and Georgia. Temperatures 10° to 15° F above average threaten the lives and livelihoods of people all across the country.

After a scorching heat wave in late June, residents of the Pacific Northwest are once again likely to see triple-digit temperatures in the coming days. With the heat, hospitals may face another surge of people with heat-related illnesses.

Erika Moseson, MD, a lung and intensive care specialist, witnessed firsthand the life-threatening impacts of soaring temperatures. She happened to be running her 10-bed intensive care unit in a suburban hospital in Gresham, Ore., about 15 miles east of Portland, the weekend of June 26. Within 12 hours, almost half her ICU beds were filled with people found unconscious on the street, in the bushes, or in their own beds, all because their body’s defenses had become overwhelmed by heat.

“It was unidentified person after unidentified person, coming in, same story, temperatures through the roof, comatose,” Dr. Moseson recalled. Young people in their 20s with muscle breakdown markers through the roof, a sign of rhabdomyolysis; people with no other medical problems that would have put them in a high-risk category.

As a lifelong Oregonian, she’d never seen anything like this before. “We’re all trained for it. I know what happens to you if you have heatstroke, I know how to treat it,” she trailed off, still finding it hard to believe. Still reeling from the number of cases in just a few hours. Still shocked that this happened on what’s supposed to be the cooler, rainforest side of Oregon.

Among those she treated and resuscitated, the memory of a patient that she lost continues to gnaw at her.

“I’ve gone back to it day after day since it happened,” she reflected.

Adults, in their 50s, living at home with their children. Just 1 hour prior, they’d all said goodnight. Then 1 hour later, when a child came to check in, both parents were unconscious.

Dr. Moseson shared how her team tried everything in their power for 18 hours to save the parent that was brought to her ICU. But like hundreds of others who went through the heat wave that weekend, her patient didn’t survive.

It was too late. From Dr. Moseson’s experience, it’s what happens “if you’re cooking a human.”
 

How heat kills

Regardless of where we live on the planet, humans maintain a consistent internal temperature around 98° F for our systems to function properly. 

Our bodies have an entire temperature-regulating system to balance heat gain with heat loss so we don’t stray too far from our ideal range. The hypothalamus functions as the thermostat, communicating with heat sensors in our skin, muscles, and spinal cord. Based on signals about our core body temperature, our nervous system makes many decisions for us – opening up blood vessels in the peripheral parts of our body, pushing more blood toward the skin, and activating sweat glands to produce more sweat.  

Sweat is one of the most powerful tools we have to maintain a safe internal temperature. Of course, there are some things under our control, such as removing clothing, drinking more water, and finding shade (or preferably air conditioning). But beyond that, it’s our ability to sweat that keeps us cool. When sweat evaporates into the air, heat from our skin goes with it, cooling us off.

Over time, our sweat response can work better as we get used to warmer environments, a process that’s known as acclimatization. Over the period of a few days to weeks, the sweat glands of acclimated people can start making sweat at lower temperatures, produce more sweat, and absorb more salt back into our system, all to make us more efficient “sweaters.”

While someone who’s not used to the heat may only produce 1 liter of sweat per hour, people who have become acclimated can produce 2-3 liters every hour, allowing evaporation to eliminate more than two times the amount of heat.   

Because the process of acclimatization can take some time, typically it’s the first throes of summer, or heat waves in places where people don’t typically see high temperatures, that are the most deadly. And of course, the right infrastructure, like access to air conditioning, also plays a large role in limiting heat-related death and hospitalization.

A 2019 study showed that heat-related hospitalizations peak at different temperatures in different places. For example, hospitalizations typically peak in Texas when the temperature hits 105° F. But they might be highest in the Pacific Northwest at just 81° F.

Even with acclimatization, there are limits to how much our bodies can adapt to heat. When the humidity goes up past 75%, there’s already so much moisture in the air that heat loss through evaporation no longer occurs.

It’s this connection between heat and humidity that can be deadly. This is why the heat index (a measure that takes into account temperature and relative humidity) and wet bulb globe temperature (a measure commonly used by the military and competitive athletes that takes into account temperature, humidity, wind speed, sun angle, and cloud cover) are both better at showing how dangerous the heat may be for our health, compared to temperature alone.

Kristie L. Ebi, PhD, a professor in the Center for Health and the Global Environment at the University of Washington, Seattle, has been studying the effects of heat and other climate-sensitive conditions on health for over 20 years. She stresses that it’s not just the recorded temperatures, but the prolonged exposure that kills.

If you never get a chance to bring down that core body temperature, if your internal temperatures stay above the range where your cells and your organs can work well for a long time, that’s when you can have the most dangerous effects of heat.

“It depends then on your age, your fitness, your individual physiology, underlying medical conditions, to how quickly that could affect the functioning of those organs. There’s lots of variability in there,” Dr. Ebi said.

Our hearts take on the brunt of the early response, working harder to pump blood toward the skin. Water and salt loss through our skin can start to cause electrolyte changes that can cause heat cramps and heat exhaustion. We feel tired, nauseated, dizzy. With enough water loss, we may become dehydrated, limiting the blood flow to our brains, causing us to pass out.

These early signs are like a car’s check engine light – systems are already being damaged, but resting, refueling, and, most importantly, turning off the heat are critical steps to prevent fatal injury.

If hazardous heat exposure continues and our internal temperatures continue to rise, nerves stop talking to each other, the proteins in our body unfold and lose their shape, and the cells of our organs disintegrate. This in turn sets off a fire alarm in our blood vessels, where a variety of chemical messengers, including “heat-shock proteins,” are released. The release of these inflammatory proteins, coupled with the loss of blood flow, eventually leads to the death of cells throughout the body, from the brain, to the heart, the muscles, and the kidneys.

This process is referred to as heatstroke. In essence, we melt from the inside.

At a certain point, this cascade can’t be reversed. Just like when you cool a melting block of ice, the parts that have melted will not go back to their original shape. It’s a similar process in our bodies, so delays in cooling and treatment can lead to death rates as high as 80%.

On the outside, we see people who look confused and disoriented, with hot skin and rapid breathing, and they may eventually become unconscious. Core body temperatures over 105° F clinch the diagnosis, but at the first sign of feeling unwell, cooling should be started.

There is no fancier or more effective treatment than that: Cool right away. In emergency rooms in Washington State, doctors used body bags filled with ice and water to cool victims of the heat wave in late June.

“It was all from heat ... that’s the thing, you feel so idiotic ... you’re like, ‘I’ve given you ice’ ... you bring their temperature down. But it’s already set off this cascade that you can’t stop,” Dr. Moseson said.

By the time Dr. Moseson’s patient made it to her, cooling with ice was just the beginning of the attempts to resuscitate and revive. The patient was already showing evidence of a process causing widespread bleeding and clotting, known as disseminated intravascular coagulation, along with damage to the heart and failing kidneys. Over 18 hours, her team cooled the patient, flooded the blood vessels with fluids and blood products, attempted to start dialysis, and inserted a breathing tube – all of the technology that is used to save people from serious cardiovascular collapse from other conditions. But nothing could reverse the melting that had already occurred.

Deaths from heat are 100% preventable. Until they’re not.
 

No respite

As Dr. Ebi says, the key to preventing heat-related death is to cool down enough to stabilize our internal cells and proteins before the irreversible cascade begins.

But for close to 80% of Americans who live in urban areas, temperatures can be even higher and more intolerable compared to surrounding areas because of the way we’ve designed our cities. In effect, we have unintentionally created hot zones called “urban heat islands.”

Jeremy Hoffman, PhD, chief scientist for the Science Museum of Virginia, explains that things like bricks, asphalt, and parking lots absorb more of the sun’s energy throughout the day and then emit that back into the air as heat throughout the afternoon and into the evening. This raises the air and surface temperatures in cities, relative to rural areas. When temperatures don’t cool enough at night, there’s no way to recover from the day’s heat. You start the next day still depleted, with less reserve to face the heat of a new day.

When you dig even deeper, it turns out that even within the same city, there are huge “thermal inequities,” as Dr. Hoffman calls them. In a 2019 study, he found that wealthier parts of cities had more natural spaces such as parks and tree-lined streets, compared to areas that had been intentionally “redlined,” or systematically deprived of investment. This pattern repeats itself in over 100 urban areas across the country and translates to huge temperature differences on the order of 10-20 degrees Fahrenheit within the same city, at the exact same time during a heat wave.

“In some ways, the way that we’ve decided to plan and build our cities physically turns up the thermostat by several tens of degrees during heat waves in particular neighborhoods,” Dr. Hoffman said.

Dr. Hoffman’s work showed that the city of Portland (where the death toll from the heat wave in late June was the highest) had some of the most intense differences between formerly redlined vs. tree-lined areas out of the more than 100 cities that he studied.  

“Watching it play out, I was really concerned, not only as a climate scientist, but as a human. Understanding the urban heat island effect and the extreme nature of the inequity in our cities, thermally and otherwise, once you start to really recognize it, you can’t forget it.”
 

The most vulnerable

When it comes to identifying and protecting the people most vulnerable to heat stress and heat-related death, there is an ever-growing list of those most at risk. Unfortunately, very few recognize when they themselves are at risk, often until it’s too late.

According to Linda McCauley, PhD, dean of the Emory University School of Nursing in Atlanta, “the scope of who is vulnerable is quickly increasing.”

For example, we’re used to recognizing that pregnant women and young children are at risk. Public health campaigns have long advised us not to leave young children and pets in hot cars. We know that adolescents who play sports during hot summer months are at high risk for heat-related events and even death.

In Georgia, a 15-year-old boy collapsed and died after his first day back at football practice when the heat index was 105° F on July 26, even as it appears that all protocols for heat safety were being followed.

We recognize that outdoor workers face devastating consequences from prolonged exertion in the heat and must have safer working conditions.

The elderly and those with long-term medical and mental health conditions are also more vulnerable to heat. The elderly may not have the same warning signs and may not recognize that they are dehydrated until it is too late. In addition, their sweating mechanism weakens, and they may be taking medicines that interfere with their ability to regulate their temperature.

Poverty and inadequate housing are risk factors, especially for those in urban heat islands. For many people, their housing does not have enough cooling to protect them, and they can’t safely get themselves to cooling shelters.

These patterns for the most vulnerable fit for the majority of deaths in Oregon during the late June heat wave. Most victims were older, lived alone, and didn’t have air conditioning. But with climate change, the predictions are that temperatures will go higher and heat waves will last longer.

“There’s probably very few people today that are ‘immune’ to the effects of heat-related stress with climate change. All of us can be put in situations where we are susceptible,” Dr. McCauley said.

Dr. Moseson agreed. Many of her patients fit none of these risk categories – she treated people with no health problems in their 20s in her ICU, and the patient she lost would not traditionally have been thought of as high risk. That 50-something patient had no long-standing medical problems, and lived with family in a newly renovated suburban home that had air conditioning. The only problem was that the air conditioner had broken and there had been no rush to fix it based on past experience with Oregon summers.
 

Preventing heat deaths

Protecting ourselves and our families means monitoring the “simple things.” The first three rules are to make sure we’re drinking plenty of water – this means drinking whether we feel thirsty or not. If we’re not in an air-conditioned place, we’ve got to look for shade. And we need to take regular rest breaks.

Inside a home without air conditioning, placing ice in front of a fan to cool the air can work, but realistically, if you are in a place without air conditioning and the temperatures are approaching 90° F, it’s safest to find another place to stay, if possible.

For those playing sports, there are usually 1-week to 2-week protocols that allow for acclimatization when the season begins – this means starting slowly, without gear, and ramping up activity. Still, parents and coaches should watch advanced weather reports to make sure it’s safe to practice outside.

How we dress can also help us, so light clothing is key. And if we’re able to schedule activities for times when it is cooler, that can also protect us from overheating.

If anyone shows early signs of heat stress, removing clothing, cooling their bodies with cold water, and getting them out of the heat is critical. Any evidence of heatstroke is an emergency, and 911 should be called without delay. The faster the core temperature can be dropped, the better the chances for recovery.

On the level of communities, access to natural air conditioning in the form of healthy tree canopies, and trees at bus stops to provide shade can help a lot. According to Dr. Hoffman, these investments help almost right away. Reimagining our cities to remove the “hot zones” that we have created is another key to protecting ourselves as our climate changes.
 

Reaching our limits in a changing climate

Already, we are seeing more intense, more frequent, and longer-lasting heat waves throughout the country and across the globe.

Dr. Ebi, a coauthor of a recently released scientific analysis that found that the late June Pacific Northwest heat wave would have been virtually impossible without climate change, herself lived through the scorching temperatures in Seattle. Her work shows that the changing climate is killing us right now.

We are approaching a time where extreme temperatures and humidity will make it almost impossible for people to be outside in many parts of the world. Researchers have found that periods of extreme humid heat have more than doubled since 1979, and some places have already had wet-bulb temperatures at the limits of what scientists think humans can tolerate under ideal conditions, meaning for people in perfect health, completely unclothed, in gale-force winds, performing no activity. Obviously that’s less than ideal for most of us and helps explain why thousands of people die at temperatures much lower than our upper limit.

Dr. Ebi pointed out that the good news is that many local communities with a long history of managing high temperatures have a lot of knowledge to share with regions that are newly dealing with these conditions. This includes how local areas develop early warning and response systems with specific action plans.

But, she cautions, it’s going to take a lot of coordination and a lot of behavior change to stabilize the earth’s climate, understand our weak points, and protect our health.

For Dr. Moseson, this reality has hit home.

“I already spent the year being terrified that I as an ICU doctor was going to be the one who gave my mom COVID. Finally I’m vaccinated, she’s vaccinated. Now I’ve watched someone die because they don’t have AC. And my parents, they’re old-school Oregonians, they don’t have AC.”

A version of this article originally appeared on WebMD.com.