MDedge Infectious Disease

It was a 95° F day in July 2015, and emergency physician Martin Maag, MD, was driving down Bee Ridge Road, a busy seven-lane thoroughfare in Sarasota, Fla., on his way home from a family dinner. To distance himself from a truck blowing black smoke, Dr. Maag says he had just passed some vehicles, when a motorcycle flew past him in the turning lane and the passenger flipped him off.

“I started laughing because I knew we were coming up to a red light,” said Dr. Maag. “When we pulled up to the light, I put my window down and said: ‘Hey, you ought to be a little more careful about who you’re flipping off! You never know who it might be and what they might do.’ ”

The female passenger cursed at Dr. Maag, and the two traded profanities. The male driver then told Dr. Maag: “Get out of the car, old man,” according to Dr. Maag. Fuming, Dr. Maag got out of his black Tesla, and the two men met in the middle of the street.

“As soon as I got close enough to see him, I could tell he really looked young,” Dr. Maag recalls. “I said: ‘You’re like 12 years old. I’m going to end up beating your ass and then I’m going to go to jail. Go get on your bike, and ride home to your mom.’ I don’t remember what he said to me, but I spun around and said: ‘If you want to act like a man, meet me up the street in a parking lot and let’s have at it like men.’ ”

The motorcyclist got back on his white Suzuki and sped off, and Dr. Maag followed. Both vehicles went racing down the road, swerving between cars, and reaching speeds of 100 miles per hour, Dr. Maag said. At one point, Dr. Maag says he drove in front of the motorcyclist to slow him down, and the motorcycle clipped the back of his car. No one was seriously hurt, but soon Dr. Maag was in the back of a police cruiser headed to jail.

Dr. Maag wishes he could take back his actions that summer day 6 years ago. Those few minutes of fury have had lasting effects on the doctor’s life. The incident resulted in criminal charges, a jail sentence, thousands of dollars in legal fees, and a 3-year departure from emergency medicine. Although Dr. Maag did not lose his medical license as a result of the incident, the physician’s Medicare billing privileges were suspended because of a federal provision that ties some felonies to enrollment revocations.

Dr. Maag, 61, shared his story with this news organization to warn other physicians about the wide-ranging career ramifications that can happen as a result of offenses unrelated to medicine. 

“Every doctor, every health professional needs to know that there are a lot of consequences that go with our actions outside of work,” he said. “In my situation, what happened had nothing to do with medicine, it had nothing to do with patients, it had nothing to do my professional demeanor. But yet it affected my entire career, and I lost the ability to practice emergency medicine for 3 years. Three years for any doctor is a long time. Three years for emergency medicine is a lifetime.”
 

The physician ends up in jail

After the collision, Dr. Maag pulled over in a parking lot and dialed 911. Several passing motorists did the same. It appeared the biker was trying to get away, and Dr. Maag was concerned about the damage to his Tesla, he said. 

When police arrived, they heard very different accounts of what happened. The motorcyclist and his girlfriend claimed Dr. Maag was the aggressor during the altercation, and that he deliberately tried to hit them with his vehicle. Two witnesses at the scene said they had watched Dr. Maag pursue the motorcycle in his vehicle, and that they believed he crossed into their lane intentionally to strike the motorcycle, according to police reports.

“[The motorcyclist] stated that the vehicle struck his right foot when it hit the motorcycle and that he was able to keep his balance and not lay the bike down,” Sarasota County Deputy C. Moore wrote in his report. “The motorcycle was damaged on the right side near [his] foot, verifying his story. Both victims were adamant that the defendant actually and intentionally struck the motorcycle with his car due to the previous altercation.”

Dr. Maag told officers the motorcyclist had initiated the confrontation. He acknowledged racing after the biker, but said it was the motorcyclist who hit his vehicle. In an interview, Dr. Maag disputed the witnesses’ accounts, saying that one of the witnesses was without a car and made claims to police that were impossible from her distance. 

In the end, the officer believed the motorcyclist, writing in his report that the damage to the Tesla was consistent with the biker’s version of events. Dr. Maag was handcuffed and taken to the Sarasota County Jail.

“I was in shock,” he said. “When we got to the jail, they got me booked in and fingerprinted. I sat down and said [to an officer]: ‘So, when do I get to bond out?’ The guy started laughing and said: ‘You’re not going anywhere. You’re spending the night in jail, my friend.’ He said: ‘Your charge is one step below murder.’”
 

‘I like to drive fast’

Aside from speeding tickets, Dr. Maag said he had never been in serious trouble with the law before.

The husband and father of two has practiced emergency medicine for more 15 years, and his license has remained in good standing. Florida Department of Health records show Dr. Maag’s medical license as clear and active with no discipline cases or public complaints on file.

“I did my best for every patient that came through that door,” he said. “There were a lot of people who didn’t like my personality. I’ve said many times: ‘I’m not here to be liked. I’m here to take care of people and provide the best care possible.’ ” 

Sarasota County records show that Dr. Maag has received traffic citations in the past for careless driving, unlawful speed, and failure to stop at a red light, among others. He admits to having a “lead foot,” but says he had never before been involved in a road rage incident.

“I’m not going to lie, I like to drive fast,” he said. “I like that feeling. It just seems to slow everything down for me, the faster I’m going.”

After being booked into jail that July evening in 2015, Dr. Maag called his wife to explain what happened.

“She said, ‘I can’t believe you’ve done this. I’ve told you a million times, don’t worry about how other people drive. Keep your mouth shut,’” he recalled. “I asked her to call my work and let them know I wouldn’t be coming in the next day. Until that happened, I had never missed a day of work since becoming a physician.”

After an anxious night in his jail cell, Dr. Maag lined up with the other inmates the next morning for his bond hearing. His charges included felony, aggravated battery, and felony aggravated assault with a deadly weapon. A prosecutor recommended Dr. Maag’s bond be set at $1 million, which a judge lowered to $500,000.

Michael Fayard, a criminal defense attorney who represented Dr. Maag in the case, said even with the reduction, $500,000 was an outrageous bond for such a case.

“The prosecutor’s arguments to the judge were that he was a physician driving a Tesla,” Mr. Fayard said. “That was his exact argument for charging him a higher bond. It shouldn’t have been that high. I argued he was not a flight risk. He didn’t even have a passport.”

The Florida State Attorney’s Office did not return messages seeking comment about the case.

Dr. Maag spent 2 more nights in jail while he and his wife came up with $50,000 in cash, in accordance with the 10% bond rule. In the meantime, the government put a lien on their house. A circuit court judge later agreed the bond was excessive, according to Mr. Fayard, but by that time, the $50,000 was paid and Dr. Maag was released.
 

New evidence lowers charges 

Dr. Maag ultimately accepted a plea deal from the prosecutor’s office and pled no contest to one count of felony criminal mischief and one count of misdemeanor reckless driving. In return, the state dropped the two more serious felonies. A no-contest plea is not considered an admission of guilt.

Mr. Fayard said his investigation into the road rage victim unearthed evidence that poked holes in the motorcyclist’s credibility, and that contributed to the plea offer.

“We found tons of evidence about the kid being a hot-rodding rider on his motorcycle, videos of him traveling 140 miles an hour, popping wheelies, and darting in and out of traffic,” he said. “There was a lot of mitigation that came up during the course of the investigation.”

The plea deal was a favorable result for Dr. Maag considering his original charges, Mr. Fayard said. He added that the criminal case could have ended much differently.

“Given the facts of this case and given the fact that there were no serious injuries, we supported the state’s decision to accept our mitigation and come out with the sentence that they did,” Mr. Fayard said. “If there would have been injuries, the outcome would have likely been much worse for Dr. Maag.”

With the plea agreement reached, Dr. Maag faced his next consequence – jail time. He was sentenced to 60 days in jail, a $1,000 fine, 12 months of probation, and 8 months of house arrest. Unlike his first jail stay, Dr. Maag said the second, longer stint behind bars was more relaxing. 

“It was the first time since I had become an emergency physician that I remember my dreams,” he recalled. “I had nothing to worry about, nothing to do. All I had to do was get up and eat. Every now and then, I would mop the floors because I’m kind of a clean freak, and I would talk to guys and that was it. It wasn’t bad at all.”

Dr. Maag told no one that he was a doctor because he didn’t want to be treated differently. The anonymity led to interesting tidbits from other inmates about the best pill mills in the area for example, how to make crack cocaine, and selling items for drugs. On his last day in jail, the other inmates learned from his discharge paperwork that Dr. Maag was a physician.

“One of the corrections officers said: ‘You’re a doctor? We’ve never had a doctor in here before!’” Dr. Maag remembers. “He said: ‘What did a doctor do to get into jail?’ I said: ‘Do you really want to know?’ ”

About the time that Dr. Maag was released from jail, the Florida Board of Medicine learned of his charges and began reviewing his case. Mr. Fayard presented the same facts to the board and argued for Dr. Maag to keep his license, emphasizing the offenses in which he was convicted were significantly less severe than the original felonies charged. The board agreed to dismiss the case. 

“The probable cause panel for the board of medicine considered the complaint that has been filed against your client in the above referenced case,” Peter Delia, then-assistant general counsel for the Florida Department of Health, wrote in a letter dated April 27, 2016. “After careful review of all information and evidence obtained in this case, the panel determined that probable cause of a violation does not exist and directed this case to be closed.”
 

A short-lived celebration

Once home, Dr. Maag was on house arrest, but he was granted permission to travel for work. He continued to practice emergency medicine. After several months, authorities dropped the house arrest, and a judge canceled his probation early. It appeared the road rage incident was finally behind him. 

But a year later, in 2018, the doctor received a letter from the Centers for Medicare & Medicaid Services informing him that because of his charges, his Medicare number had been revoked in November 2015.

“It took them 3 years to find me and tell me, even though I never moved,” he said. “Medicare said because I never reported this, they were hitting me up with falsification of documentation because I had signed other Medicare paperwork saying I had never been barred from Medicare, because I didn’t know that I was.”

Dr. Maag hired a different attorney to help him fight the 3-year enrollment ban. He requested reconsideration from CMS, but a hearing officer in October 2017 upheld the revocation. Because his privileges had been revoked in 2015, Dr. Maag’s practice group had to return all money billed by Dr. Maag to Medicare over the 3-year period, which totaled about $190,000.

A CMS spokeswoman declined to comment about Dr. Maag’s case, referring a reporter for this news organization to an administrative law judge’s decision that summarizes the agency’s findings.

According to the summary, in separate reconsidered determinations, the CMS hearing officer concluded that the revocation was proper under section 424.535(a)(3). The regulation, enacted in 2011, allows CMS to revoke billing privileges if a provider was convicted of a federal or state felony within the preceding 10 years that the agency determines is detrimental to the Medicare program and its beneficiaries.

The hearing officer reasoned that Dr. Maag “had been convicted of a felony that is akin to assault and, even if it were not, his actions showed a reckless disregard for the safety of others.” She concluded also that CMS could appropriately revoke Dr. Maag’s Medicare enrollment because he did not report his felony conviction within 30 days as required.

Dr. Maag went through several phases of fighting the revocation, including an appeal to the Department of Health & Human Services Departmental Appeals Board. He argued that his plea was a no-contest plea, which is not considered an admission of guilt. Dr. Maag and his attorney provided CMS a 15-page paper about his background, education, career accomplishments, and patient care history. They emphasized that Dr. Maag had never harmed or threatened a patient, and that his offense had nothing to do with his practice.

In February 2021, Judge Carolyn Cozad Hughes, an administrative law judge with CMS, upheld the 3-year revocation. In her decision, she wrote that for purposes of revocation under CMS law, “convicted” means that a judgment of conviction has been entered by a federal, state, or local court regardless of whether the judgment of conviction has been expunged or otherwise removed. She disagreed with Dr. Maag’s contention that his was a crime against property and, therefore, not akin to any of the felony offenses enumerated under the revocation section, which are crimes against persons.

“Even disregarding the allegations contained in the probable cause affidavit, Petitioner cannot escape the undisputed fact, established by his conviction and his own admissions, that the ‘property’ he so ‘willfully and maliciously’ damaged was a motorcycle traveling at a high rate of speed, and, that two young people were sitting atop that motorcycle,” Judge Hughes wrote. “Moreover, as part of the same conduct, he was charged – and convicted – of misdemeanor reckless driving with ‘willful and wanton disregard for the safety of persons or property.’ Thus, even accepting Petitioner’s description of the events, he unquestionably showed no regard for the safety of the young people on that motorcycle.”

Judge Hughes noted that, although Dr. Maag’s crimes may not be among those specified in the regulation, CMS has broad authority to determine which felonies are detrimental to the best interests of the program and its beneficiaries.
 

A new career path

Unable to practice emergency medicine and beset with debt, Dr. Maag spiraled into a dark depression. His family had to start using retirement money that he was saving for the future care of his son, who has autism.

“I was suicidal,” he said. “There were two times that I came very close to going out to the woods by my house and hanging myself. All I wanted was to have everything go away. My wife saved my life.”

Slowly, Dr. Maag climbed out of the despondency and began considering new career options. After working and training briefly in hair restoration, Dr. Maag became a hair transplant specialist and opened his own hair restoration practice. It was a way to practice and help patients without having to accept Medicare. Today, he is the founder of Honest Hair Restoration in Bradenton, Fla.

Hair restoration is not the type of medicine that he “was designed to do,” Dr. Maag said, but he has embraced its advantages, such as learning about the business aspects of medicine and having a slower-paced work life. The business, which opened in 2019, is doing well and growing steadily.

Earlier this month, Dr. Maag learned CMS had reinstated his Medicare billing privileges. If an opportunity arises to go back into emergency medicine or urgent care, he is open to the possibilities, he said, but he plans to continue hair restoration for now. He hopes the lessons learned from his road rage incident may help others in similar circumstances.

“If I could go back to that very moment, I would’ve just kept my window up and I wouldn’t have said anything,” Dr. Maag said. “I would’ve kept my mouth shut and gone on about my day. Would I have loved it to have never happened? Yeah, and I’d probably be starting my retirement now. Am I stronger now? Well, I’m probably a hell of a lot wiser. But when all is said and done, I don’t want anybody feeling sorry for me. It was all my doing and I have to live with the consequences.”

Mr. Fayard, the attorney, says the case is a cautionary tale for doctors.

“No one is really above the law,” he said. “There aren’t two legal systems. You can’t just pay a little money and be done. At every level, serious charges have serious ramifications for everyone involved. Law enforcement and judges are not going to care of you’re a physician and you commit a crime. But physicians have a lot more on the line than many others. They can lose their ability to practice.”

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

It was a 95° F day in July 2015, and emergency physician Martin Maag, MD, was driving down Bee Ridge Road, a busy seven-lane thoroughfare in Sarasota, Fla., on his way home from a family dinner. To distance himself from a truck blowing black smoke, Dr. Maag says he had just passed some vehicles, when a motorcycle flew past him in the turning lane and the passenger flipped him off.

“I started laughing because I knew we were coming up to a red light,” said Dr. Maag. “When we pulled up to the light, I put my window down and said: ‘Hey, you ought to be a little more careful about who you’re flipping off! You never know who it might be and what they might do.’ ”

The female passenger cursed at Dr. Maag, and the two traded profanities. The male driver then told Dr. Maag: “Get out of the car, old man,” according to Dr. Maag. Fuming, Dr. Maag got out of his black Tesla, and the two men met in the middle of the street.

“As soon as I got close enough to see him, I could tell he really looked young,” Dr. Maag recalls. “I said: ‘You’re like 12 years old. I’m going to end up beating your ass and then I’m going to go to jail. Go get on your bike, and ride home to your mom.’ I don’t remember what he said to me, but I spun around and said: ‘If you want to act like a man, meet me up the street in a parking lot and let’s have at it like men.’ ”

The motorcyclist got back on his white Suzuki and sped off, and Dr. Maag followed. Both vehicles went racing down the road, swerving between cars, and reaching speeds of 100 miles per hour, Dr. Maag said. At one point, Dr. Maag says he drove in front of the motorcyclist to slow him down, and the motorcycle clipped the back of his car. No one was seriously hurt, but soon Dr. Maag was in the back of a police cruiser headed to jail.

Dr. Maag wishes he could take back his actions that summer day 6 years ago. Those few minutes of fury have had lasting effects on the doctor’s life. The incident resulted in criminal charges, a jail sentence, thousands of dollars in legal fees, and a 3-year departure from emergency medicine. Although Dr. Maag did not lose his medical license as a result of the incident, the physician’s Medicare billing privileges were suspended because of a federal provision that ties some felonies to enrollment revocations.

Dr. Maag, 61, shared his story with this news organization to warn other physicians about the wide-ranging career ramifications that can happen as a result of offenses unrelated to medicine. 

“Every doctor, every health professional needs to know that there are a lot of consequences that go with our actions outside of work,” he said. “In my situation, what happened had nothing to do with medicine, it had nothing to do with patients, it had nothing to do my professional demeanor. But yet it affected my entire career, and I lost the ability to practice emergency medicine for 3 years. Three years for any doctor is a long time. Three years for emergency medicine is a lifetime.”
 

The physician ends up in jail

After the collision, Dr. Maag pulled over in a parking lot and dialed 911. Several passing motorists did the same. It appeared the biker was trying to get away, and Dr. Maag was concerned about the damage to his Tesla, he said. 

When police arrived, they heard very different accounts of what happened. The motorcyclist and his girlfriend claimed Dr. Maag was the aggressor during the altercation, and that he deliberately tried to hit them with his vehicle. Two witnesses at the scene said they had watched Dr. Maag pursue the motorcycle in his vehicle, and that they believed he crossed into their lane intentionally to strike the motorcycle, according to police reports.

“[The motorcyclist] stated that the vehicle struck his right foot when it hit the motorcycle and that he was able to keep his balance and not lay the bike down,” Sarasota County Deputy C. Moore wrote in his report. “The motorcycle was damaged on the right side near [his] foot, verifying his story. Both victims were adamant that the defendant actually and intentionally struck the motorcycle with his car due to the previous altercation.”

Dr. Maag told officers the motorcyclist had initiated the confrontation. He acknowledged racing after the biker, but said it was the motorcyclist who hit his vehicle. In an interview, Dr. Maag disputed the witnesses’ accounts, saying that one of the witnesses was without a car and made claims to police that were impossible from her distance. 

In the end, the officer believed the motorcyclist, writing in his report that the damage to the Tesla was consistent with the biker’s version of events. Dr. Maag was handcuffed and taken to the Sarasota County Jail.

“I was in shock,” he said. “When we got to the jail, they got me booked in and fingerprinted. I sat down and said [to an officer]: ‘So, when do I get to bond out?’ The guy started laughing and said: ‘You’re not going anywhere. You’re spending the night in jail, my friend.’ He said: ‘Your charge is one step below murder.’”
 

‘I like to drive fast’

Aside from speeding tickets, Dr. Maag said he had never been in serious trouble with the law before.

The husband and father of two has practiced emergency medicine for more 15 years, and his license has remained in good standing. Florida Department of Health records show Dr. Maag’s medical license as clear and active with no discipline cases or public complaints on file.

“I did my best for every patient that came through that door,” he said. “There were a lot of people who didn’t like my personality. I’ve said many times: ‘I’m not here to be liked. I’m here to take care of people and provide the best care possible.’ ” 

Sarasota County records show that Dr. Maag has received traffic citations in the past for careless driving, unlawful speed, and failure to stop at a red light, among others. He admits to having a “lead foot,” but says he had never before been involved in a road rage incident.

“I’m not going to lie, I like to drive fast,” he said. “I like that feeling. It just seems to slow everything down for me, the faster I’m going.”

After being booked into jail that July evening in 2015, Dr. Maag called his wife to explain what happened.

“She said, ‘I can’t believe you’ve done this. I’ve told you a million times, don’t worry about how other people drive. Keep your mouth shut,’” he recalled. “I asked her to call my work and let them know I wouldn’t be coming in the next day. Until that happened, I had never missed a day of work since becoming a physician.”

After an anxious night in his jail cell, Dr. Maag lined up with the other inmates the next morning for his bond hearing. His charges included felony, aggravated battery, and felony aggravated assault with a deadly weapon. A prosecutor recommended Dr. Maag’s bond be set at $1 million, which a judge lowered to $500,000.

Michael Fayard, a criminal defense attorney who represented Dr. Maag in the case, said even with the reduction, $500,000 was an outrageous bond for such a case.

“The prosecutor’s arguments to the judge were that he was a physician driving a Tesla,” Mr. Fayard said. “That was his exact argument for charging him a higher bond. It shouldn’t have been that high. I argued he was not a flight risk. He didn’t even have a passport.”

The Florida State Attorney’s Office did not return messages seeking comment about the case.

Dr. Maag spent 2 more nights in jail while he and his wife came up with $50,000 in cash, in accordance with the 10% bond rule. In the meantime, the government put a lien on their house. A circuit court judge later agreed the bond was excessive, according to Mr. Fayard, but by that time, the $50,000 was paid and Dr. Maag was released.
 

New evidence lowers charges 

Dr. Maag ultimately accepted a plea deal from the prosecutor’s office and pled no contest to one count of felony criminal mischief and one count of misdemeanor reckless driving. In return, the state dropped the two more serious felonies. A no-contest plea is not considered an admission of guilt.

Mr. Fayard said his investigation into the road rage victim unearthed evidence that poked holes in the motorcyclist’s credibility, and that contributed to the plea offer.

“We found tons of evidence about the kid being a hot-rodding rider on his motorcycle, videos of him traveling 140 miles an hour, popping wheelies, and darting in and out of traffic,” he said. “There was a lot of mitigation that came up during the course of the investigation.”

The plea deal was a favorable result for Dr. Maag considering his original charges, Mr. Fayard said. He added that the criminal case could have ended much differently.

“Given the facts of this case and given the fact that there were no serious injuries, we supported the state’s decision to accept our mitigation and come out with the sentence that they did,” Mr. Fayard said. “If there would have been injuries, the outcome would have likely been much worse for Dr. Maag.”

With the plea agreement reached, Dr. Maag faced his next consequence – jail time. He was sentenced to 60 days in jail, a $1,000 fine, 12 months of probation, and 8 months of house arrest. Unlike his first jail stay, Dr. Maag said the second, longer stint behind bars was more relaxing. 

“It was the first time since I had become an emergency physician that I remember my dreams,” he recalled. “I had nothing to worry about, nothing to do. All I had to do was get up and eat. Every now and then, I would mop the floors because I’m kind of a clean freak, and I would talk to guys and that was it. It wasn’t bad at all.”

Dr. Maag told no one that he was a doctor because he didn’t want to be treated differently. The anonymity led to interesting tidbits from other inmates about the best pill mills in the area for example, how to make crack cocaine, and selling items for drugs. On his last day in jail, the other inmates learned from his discharge paperwork that Dr. Maag was a physician.

“One of the corrections officers said: ‘You’re a doctor? We’ve never had a doctor in here before!’” Dr. Maag remembers. “He said: ‘What did a doctor do to get into jail?’ I said: ‘Do you really want to know?’ ”

About the time that Dr. Maag was released from jail, the Florida Board of Medicine learned of his charges and began reviewing his case. Mr. Fayard presented the same facts to the board and argued for Dr. Maag to keep his license, emphasizing the offenses in which he was convicted were significantly less severe than the original felonies charged. The board agreed to dismiss the case. 

“The probable cause panel for the board of medicine considered the complaint that has been filed against your client in the above referenced case,” Peter Delia, then-assistant general counsel for the Florida Department of Health, wrote in a letter dated April 27, 2016. “After careful review of all information and evidence obtained in this case, the panel determined that probable cause of a violation does not exist and directed this case to be closed.”
 

A short-lived celebration

Once home, Dr. Maag was on house arrest, but he was granted permission to travel for work. He continued to practice emergency medicine. After several months, authorities dropped the house arrest, and a judge canceled his probation early. It appeared the road rage incident was finally behind him. 

But a year later, in 2018, the doctor received a letter from the Centers for Medicare & Medicaid Services informing him that because of his charges, his Medicare number had been revoked in November 2015.

“It took them 3 years to find me and tell me, even though I never moved,” he said. “Medicare said because I never reported this, they were hitting me up with falsification of documentation because I had signed other Medicare paperwork saying I had never been barred from Medicare, because I didn’t know that I was.”

Dr. Maag hired a different attorney to help him fight the 3-year enrollment ban. He requested reconsideration from CMS, but a hearing officer in October 2017 upheld the revocation. Because his privileges had been revoked in 2015, Dr. Maag’s practice group had to return all money billed by Dr. Maag to Medicare over the 3-year period, which totaled about $190,000.

A CMS spokeswoman declined to comment about Dr. Maag’s case, referring a reporter for this news organization to an administrative law judge’s decision that summarizes the agency’s findings.

According to the summary, in separate reconsidered determinations, the CMS hearing officer concluded that the revocation was proper under section 424.535(a)(3). The regulation, enacted in 2011, allows CMS to revoke billing privileges if a provider was convicted of a federal or state felony within the preceding 10 years that the agency determines is detrimental to the Medicare program and its beneficiaries.

The hearing officer reasoned that Dr. Maag “had been convicted of a felony that is akin to assault and, even if it were not, his actions showed a reckless disregard for the safety of others.” She concluded also that CMS could appropriately revoke Dr. Maag’s Medicare enrollment because he did not report his felony conviction within 30 days as required.

Dr. Maag went through several phases of fighting the revocation, including an appeal to the Department of Health & Human Services Departmental Appeals Board. He argued that his plea was a no-contest plea, which is not considered an admission of guilt. Dr. Maag and his attorney provided CMS a 15-page paper about his background, education, career accomplishments, and patient care history. They emphasized that Dr. Maag had never harmed or threatened a patient, and that his offense had nothing to do with his practice.

In February 2021, Judge Carolyn Cozad Hughes, an administrative law judge with CMS, upheld the 3-year revocation. In her decision, she wrote that for purposes of revocation under CMS law, “convicted” means that a judgment of conviction has been entered by a federal, state, or local court regardless of whether the judgment of conviction has been expunged or otherwise removed. She disagreed with Dr. Maag’s contention that his was a crime against property and, therefore, not akin to any of the felony offenses enumerated under the revocation section, which are crimes against persons.

“Even disregarding the allegations contained in the probable cause affidavit, Petitioner cannot escape the undisputed fact, established by his conviction and his own admissions, that the ‘property’ he so ‘willfully and maliciously’ damaged was a motorcycle traveling at a high rate of speed, and, that two young people were sitting atop that motorcycle,” Judge Hughes wrote. “Moreover, as part of the same conduct, he was charged – and convicted – of misdemeanor reckless driving with ‘willful and wanton disregard for the safety of persons or property.’ Thus, even accepting Petitioner’s description of the events, he unquestionably showed no regard for the safety of the young people on that motorcycle.”

Judge Hughes noted that, although Dr. Maag’s crimes may not be among those specified in the regulation, CMS has broad authority to determine which felonies are detrimental to the best interests of the program and its beneficiaries.
 

A new career path

Unable to practice emergency medicine and beset with debt, Dr. Maag spiraled into a dark depression. His family had to start using retirement money that he was saving for the future care of his son, who has autism.

“I was suicidal,” he said. “There were two times that I came very close to going out to the woods by my house and hanging myself. All I wanted was to have everything go away. My wife saved my life.”

Slowly, Dr. Maag climbed out of the despondency and began considering new career options. After working and training briefly in hair restoration, Dr. Maag became a hair transplant specialist and opened his own hair restoration practice. It was a way to practice and help patients without having to accept Medicare. Today, he is the founder of Honest Hair Restoration in Bradenton, Fla.

Hair restoration is not the type of medicine that he “was designed to do,” Dr. Maag said, but he has embraced its advantages, such as learning about the business aspects of medicine and having a slower-paced work life. The business, which opened in 2019, is doing well and growing steadily.

Earlier this month, Dr. Maag learned CMS had reinstated his Medicare billing privileges. If an opportunity arises to go back into emergency medicine or urgent care, he is open to the possibilities, he said, but he plans to continue hair restoration for now. He hopes the lessons learned from his road rage incident may help others in similar circumstances.

“If I could go back to that very moment, I would’ve just kept my window up and I wouldn’t have said anything,” Dr. Maag said. “I would’ve kept my mouth shut and gone on about my day. Would I have loved it to have never happened? Yeah, and I’d probably be starting my retirement now. Am I stronger now? Well, I’m probably a hell of a lot wiser. But when all is said and done, I don’t want anybody feeling sorry for me. It was all my doing and I have to live with the consequences.”

Mr. Fayard, the attorney, says the case is a cautionary tale for doctors.

“No one is really above the law,” he said. “There aren’t two legal systems. You can’t just pay a little money and be done. At every level, serious charges have serious ramifications for everyone involved. Law enforcement and judges are not going to care of you’re a physician and you commit a crime. But physicians have a lot more on the line than many others. They can lose their ability to practice.”

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

It was a 95° F day in July 2015, and emergency physician Martin Maag, MD, was driving down Bee Ridge Road, a busy seven-lane thoroughfare in Sarasota, Fla., on his way home from a family dinner. To distance himself from a truck blowing black smoke, Dr. Maag says he had just passed some vehicles, when a motorcycle flew past him in the turning lane and the passenger flipped him off.

“I started laughing because I knew we were coming up to a red light,” said Dr. Maag. “When we pulled up to the light, I put my window down and said: ‘Hey, you ought to be a little more careful about who you’re flipping off! You never know who it might be and what they might do.’ ”

The female passenger cursed at Dr. Maag, and the two traded profanities. The male driver then told Dr. Maag: “Get out of the car, old man,” according to Dr. Maag. Fuming, Dr. Maag got out of his black Tesla, and the two men met in the middle of the street.

“As soon as I got close enough to see him, I could tell he really looked young,” Dr. Maag recalls. “I said: ‘You’re like 12 years old. I’m going to end up beating your ass and then I’m going to go to jail. Go get on your bike, and ride home to your mom.’ I don’t remember what he said to me, but I spun around and said: ‘If you want to act like a man, meet me up the street in a parking lot and let’s have at it like men.’ ”

The motorcyclist got back on his white Suzuki and sped off, and Dr. Maag followed. Both vehicles went racing down the road, swerving between cars, and reaching speeds of 100 miles per hour, Dr. Maag said. At one point, Dr. Maag says he drove in front of the motorcyclist to slow him down, and the motorcycle clipped the back of his car. No one was seriously hurt, but soon Dr. Maag was in the back of a police cruiser headed to jail.

Dr. Maag wishes he could take back his actions that summer day 6 years ago. Those few minutes of fury have had lasting effects on the doctor’s life. The incident resulted in criminal charges, a jail sentence, thousands of dollars in legal fees, and a 3-year departure from emergency medicine. Although Dr. Maag did not lose his medical license as a result of the incident, the physician’s Medicare billing privileges were suspended because of a federal provision that ties some felonies to enrollment revocations.

Dr. Maag, 61, shared his story with this news organization to warn other physicians about the wide-ranging career ramifications that can happen as a result of offenses unrelated to medicine. 

“Every doctor, every health professional needs to know that there are a lot of consequences that go with our actions outside of work,” he said. “In my situation, what happened had nothing to do with medicine, it had nothing to do with patients, it had nothing to do my professional demeanor. But yet it affected my entire career, and I lost the ability to practice emergency medicine for 3 years. Three years for any doctor is a long time. Three years for emergency medicine is a lifetime.”
 

The physician ends up in jail

After the collision, Dr. Maag pulled over in a parking lot and dialed 911. Several passing motorists did the same. It appeared the biker was trying to get away, and Dr. Maag was concerned about the damage to his Tesla, he said. 

When police arrived, they heard very different accounts of what happened. The motorcyclist and his girlfriend claimed Dr. Maag was the aggressor during the altercation, and that he deliberately tried to hit them with his vehicle. Two witnesses at the scene said they had watched Dr. Maag pursue the motorcycle in his vehicle, and that they believed he crossed into their lane intentionally to strike the motorcycle, according to police reports.

“[The motorcyclist] stated that the vehicle struck his right foot when it hit the motorcycle and that he was able to keep his balance and not lay the bike down,” Sarasota County Deputy C. Moore wrote in his report. “The motorcycle was damaged on the right side near [his] foot, verifying his story. Both victims were adamant that the defendant actually and intentionally struck the motorcycle with his car due to the previous altercation.”

Dr. Maag told officers the motorcyclist had initiated the confrontation. He acknowledged racing after the biker, but said it was the motorcyclist who hit his vehicle. In an interview, Dr. Maag disputed the witnesses’ accounts, saying that one of the witnesses was without a car and made claims to police that were impossible from her distance. 

In the end, the officer believed the motorcyclist, writing in his report that the damage to the Tesla was consistent with the biker’s version of events. Dr. Maag was handcuffed and taken to the Sarasota County Jail.

“I was in shock,” he said. “When we got to the jail, they got me booked in and fingerprinted. I sat down and said [to an officer]: ‘So, when do I get to bond out?’ The guy started laughing and said: ‘You’re not going anywhere. You’re spending the night in jail, my friend.’ He said: ‘Your charge is one step below murder.’”
 

‘I like to drive fast’

Aside from speeding tickets, Dr. Maag said he had never been in serious trouble with the law before.

The husband and father of two has practiced emergency medicine for more 15 years, and his license has remained in good standing. Florida Department of Health records show Dr. Maag’s medical license as clear and active with no discipline cases or public complaints on file.

“I did my best for every patient that came through that door,” he said. “There were a lot of people who didn’t like my personality. I’ve said many times: ‘I’m not here to be liked. I’m here to take care of people and provide the best care possible.’ ” 

Sarasota County records show that Dr. Maag has received traffic citations in the past for careless driving, unlawful speed, and failure to stop at a red light, among others. He admits to having a “lead foot,” but says he had never before been involved in a road rage incident.

“I’m not going to lie, I like to drive fast,” he said. “I like that feeling. It just seems to slow everything down for me, the faster I’m going.”

After being booked into jail that July evening in 2015, Dr. Maag called his wife to explain what happened.

“She said, ‘I can’t believe you’ve done this. I’ve told you a million times, don’t worry about how other people drive. Keep your mouth shut,’” he recalled. “I asked her to call my work and let them know I wouldn’t be coming in the next day. Until that happened, I had never missed a day of work since becoming a physician.”

After an anxious night in his jail cell, Dr. Maag lined up with the other inmates the next morning for his bond hearing. His charges included felony, aggravated battery, and felony aggravated assault with a deadly weapon. A prosecutor recommended Dr. Maag’s bond be set at $1 million, which a judge lowered to $500,000.

Michael Fayard, a criminal defense attorney who represented Dr. Maag in the case, said even with the reduction, $500,000 was an outrageous bond for such a case.

“The prosecutor’s arguments to the judge were that he was a physician driving a Tesla,” Mr. Fayard said. “That was his exact argument for charging him a higher bond. It shouldn’t have been that high. I argued he was not a flight risk. He didn’t even have a passport.”

The Florida State Attorney’s Office did not return messages seeking comment about the case.

Dr. Maag spent 2 more nights in jail while he and his wife came up with $50,000 in cash, in accordance with the 10% bond rule. In the meantime, the government put a lien on their house. A circuit court judge later agreed the bond was excessive, according to Mr. Fayard, but by that time, the $50,000 was paid and Dr. Maag was released.
 

New evidence lowers charges 

Dr. Maag ultimately accepted a plea deal from the prosecutor’s office and pled no contest to one count of felony criminal mischief and one count of misdemeanor reckless driving. In return, the state dropped the two more serious felonies. A no-contest plea is not considered an admission of guilt.

Mr. Fayard said his investigation into the road rage victim unearthed evidence that poked holes in the motorcyclist’s credibility, and that contributed to the plea offer.

“We found tons of evidence about the kid being a hot-rodding rider on his motorcycle, videos of him traveling 140 miles an hour, popping wheelies, and darting in and out of traffic,” he said. “There was a lot of mitigation that came up during the course of the investigation.”

The plea deal was a favorable result for Dr. Maag considering his original charges, Mr. Fayard said. He added that the criminal case could have ended much differently.

“Given the facts of this case and given the fact that there were no serious injuries, we supported the state’s decision to accept our mitigation and come out with the sentence that they did,” Mr. Fayard said. “If there would have been injuries, the outcome would have likely been much worse for Dr. Maag.”

With the plea agreement reached, Dr. Maag faced his next consequence – jail time. He was sentenced to 60 days in jail, a $1,000 fine, 12 months of probation, and 8 months of house arrest. Unlike his first jail stay, Dr. Maag said the second, longer stint behind bars was more relaxing. 

“It was the first time since I had become an emergency physician that I remember my dreams,” he recalled. “I had nothing to worry about, nothing to do. All I had to do was get up and eat. Every now and then, I would mop the floors because I’m kind of a clean freak, and I would talk to guys and that was it. It wasn’t bad at all.”

Dr. Maag told no one that he was a doctor because he didn’t want to be treated differently. The anonymity led to interesting tidbits from other inmates about the best pill mills in the area for example, how to make crack cocaine, and selling items for drugs. On his last day in jail, the other inmates learned from his discharge paperwork that Dr. Maag was a physician.

“One of the corrections officers said: ‘You’re a doctor? We’ve never had a doctor in here before!’” Dr. Maag remembers. “He said: ‘What did a doctor do to get into jail?’ I said: ‘Do you really want to know?’ ”

About the time that Dr. Maag was released from jail, the Florida Board of Medicine learned of his charges and began reviewing his case. Mr. Fayard presented the same facts to the board and argued for Dr. Maag to keep his license, emphasizing the offenses in which he was convicted were significantly less severe than the original felonies charged. The board agreed to dismiss the case. 

“The probable cause panel for the board of medicine considered the complaint that has been filed against your client in the above referenced case,” Peter Delia, then-assistant general counsel for the Florida Department of Health, wrote in a letter dated April 27, 2016. “After careful review of all information and evidence obtained in this case, the panel determined that probable cause of a violation does not exist and directed this case to be closed.”
 

A short-lived celebration

Once home, Dr. Maag was on house arrest, but he was granted permission to travel for work. He continued to practice emergency medicine. After several months, authorities dropped the house arrest, and a judge canceled his probation early. It appeared the road rage incident was finally behind him. 

But a year later, in 2018, the doctor received a letter from the Centers for Medicare & Medicaid Services informing him that because of his charges, his Medicare number had been revoked in November 2015.

“It took them 3 years to find me and tell me, even though I never moved,” he said. “Medicare said because I never reported this, they were hitting me up with falsification of documentation because I had signed other Medicare paperwork saying I had never been barred from Medicare, because I didn’t know that I was.”

Dr. Maag hired a different attorney to help him fight the 3-year enrollment ban. He requested reconsideration from CMS, but a hearing officer in October 2017 upheld the revocation. Because his privileges had been revoked in 2015, Dr. Maag’s practice group had to return all money billed by Dr. Maag to Medicare over the 3-year period, which totaled about $190,000.

A CMS spokeswoman declined to comment about Dr. Maag’s case, referring a reporter for this news organization to an administrative law judge’s decision that summarizes the agency’s findings.

According to the summary, in separate reconsidered determinations, the CMS hearing officer concluded that the revocation was proper under section 424.535(a)(3). The regulation, enacted in 2011, allows CMS to revoke billing privileges if a provider was convicted of a federal or state felony within the preceding 10 years that the agency determines is detrimental to the Medicare program and its beneficiaries.

The hearing officer reasoned that Dr. Maag “had been convicted of a felony that is akin to assault and, even if it were not, his actions showed a reckless disregard for the safety of others.” She concluded also that CMS could appropriately revoke Dr. Maag’s Medicare enrollment because he did not report his felony conviction within 30 days as required.

Dr. Maag went through several phases of fighting the revocation, including an appeal to the Department of Health & Human Services Departmental Appeals Board. He argued that his plea was a no-contest plea, which is not considered an admission of guilt. Dr. Maag and his attorney provided CMS a 15-page paper about his background, education, career accomplishments, and patient care history. They emphasized that Dr. Maag had never harmed or threatened a patient, and that his offense had nothing to do with his practice.

In February 2021, Judge Carolyn Cozad Hughes, an administrative law judge with CMS, upheld the 3-year revocation. In her decision, she wrote that for purposes of revocation under CMS law, “convicted” means that a judgment of conviction has been entered by a federal, state, or local court regardless of whether the judgment of conviction has been expunged or otherwise removed. She disagreed with Dr. Maag’s contention that his was a crime against property and, therefore, not akin to any of the felony offenses enumerated under the revocation section, which are crimes against persons.

“Even disregarding the allegations contained in the probable cause affidavit, Petitioner cannot escape the undisputed fact, established by his conviction and his own admissions, that the ‘property’ he so ‘willfully and maliciously’ damaged was a motorcycle traveling at a high rate of speed, and, that two young people were sitting atop that motorcycle,” Judge Hughes wrote. “Moreover, as part of the same conduct, he was charged – and convicted – of misdemeanor reckless driving with ‘willful and wanton disregard for the safety of persons or property.’ Thus, even accepting Petitioner’s description of the events, he unquestionably showed no regard for the safety of the young people on that motorcycle.”

Judge Hughes noted that, although Dr. Maag’s crimes may not be among those specified in the regulation, CMS has broad authority to determine which felonies are detrimental to the best interests of the program and its beneficiaries.
 

A new career path

Unable to practice emergency medicine and beset with debt, Dr. Maag spiraled into a dark depression. His family had to start using retirement money that he was saving for the future care of his son, who has autism.

“I was suicidal,” he said. “There were two times that I came very close to going out to the woods by my house and hanging myself. All I wanted was to have everything go away. My wife saved my life.”

Slowly, Dr. Maag climbed out of the despondency and began considering new career options. After working and training briefly in hair restoration, Dr. Maag became a hair transplant specialist and opened his own hair restoration practice. It was a way to practice and help patients without having to accept Medicare. Today, he is the founder of Honest Hair Restoration in Bradenton, Fla.

Hair restoration is not the type of medicine that he “was designed to do,” Dr. Maag said, but he has embraced its advantages, such as learning about the business aspects of medicine and having a slower-paced work life. The business, which opened in 2019, is doing well and growing steadily.

Earlier this month, Dr. Maag learned CMS had reinstated his Medicare billing privileges. If an opportunity arises to go back into emergency medicine or urgent care, he is open to the possibilities, he said, but he plans to continue hair restoration for now. He hopes the lessons learned from his road rage incident may help others in similar circumstances.

“If I could go back to that very moment, I would’ve just kept my window up and I wouldn’t have said anything,” Dr. Maag said. “I would’ve kept my mouth shut and gone on about my day. Would I have loved it to have never happened? Yeah, and I’d probably be starting my retirement now. Am I stronger now? Well, I’m probably a hell of a lot wiser. But when all is said and done, I don’t want anybody feeling sorry for me. It was all my doing and I have to live with the consequences.”

Mr. Fayard, the attorney, says the case is a cautionary tale for doctors.

“No one is really above the law,” he said. “There aren’t two legal systems. You can’t just pay a little money and be done. At every level, serious charges have serious ramifications for everyone involved. Law enforcement and judges are not going to care of you’re a physician and you commit a crime. But physicians have a lot more on the line than many others. They can lose their ability to practice.”

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

In May 2020, two major scientific journals published and subsequently retracted studies that relied on data provided by the now-disgraced data analytics company Surgisphere.

One of the studies, published in The Lancet, reported an association between the antimalarial drugs hydroxychloroquine and chloroquine and increased in-hospital mortality and cardiac arrhythmias in patients with COVID-19. The second study, which appeared in the New England Journal of Medicine, described an association between underlying cardiovascular disease, but not related drug therapy, with increased mortality in COVID-19 patients.

The retractions in June 2020 followed an open letter to each publication penned by scientists, ethicists, and clinicians who flagged serious methodological and ethical anomalies in the data used in the studies.

On the 1-year anniversary, researchers and journal editors spoke about what was learned to reduce the risk of something like this happening again.

“The Surgisphere incident served as a wake-up call for everyone involved with scientific research to make sure that data have integrity and are robust,” Sunil Rao, MD, professor of medicine, Duke University Health System, Durham, N.C., and editor-in-chief of Circulation: Cardiovascular Interventions, said in an interview.

“I’m sure this isn’t going to be the last incident of this nature, and we have to be vigilant about new datasets or datasets that we haven’t heard of as having a track record of publication,” Dr. Rao said.
 

Spotlight on authors

The editors of the Lancet Group responded to the “wake-up call” with a statement, Learning From a Retraction, which announced changes to reduce the risks of research and publication misconduct.

The changes affect multiple phases of the publication process. For example, the declaration form that authors must sign “will require that more than one author has directly accessed and verified the data reported in the manuscript.” Additionally, when a research article is the result of an academic and commercial partnership – as was the case in the two retracted studies – “one of the authors named as having accessed and verified data must be from the academic team.”

This was particularly important because it appears that the academic coauthors of the retracted studies did not have access to the data provided by Surgisphere, a private commercial entity.

Mandeep R. Mehra, MD, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, who was the lead author of both studies, declined to be interviewed for this article. In a letter to the New England Journal of Medicine editors requesting that the article be retracted, he wrote: “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article.”

In a similar communication with The Lancet, Dr. Mehra wrote even more pointedly that, in light of the refusal of Surgisphere to make the data available to the third-party auditor, “we can no longer vouch for the veracity of the primary data sources.”

“It is very disturbing that the authors were willing to put their names on a paper without ever seeing and verifying the data,” Mario Malički, MD, PhD, a postdoctoral researcher at METRICS at Stanford (Calif.) University, said in an interview. “Saying that they could ‘no longer vouch’ suggests that at one point they could vouch for it. Most likely they took its existence and veracity entirely on trust.”

Dr. Malički pointed out that one of the four criteria of the International Committee of Medical Journal Editors for being an author on a study is the “agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.”

The new policies put forth by The Lancet are “encouraging,” but perhaps do not go far enough. “Every author, not only one or two authors, should personally take responsibility for the integrity of data,” he stated.

Many journals “adhere to ICMJE rules in principle and have checkboxes for authors to confirm that they guarantee the veracity of the data.” However, they “do not have the resources to verify the authors’ statements.”

Ideally, “it is the institutions where the researchers work that should guarantee the veracity of the raw data – but I do not know any university or institute that does this,” he said.
 

No ‘good-housekeeping’ seal

For articles based on large, real-world datasets, the Lancet Group will now require that editors ensure that at least one peer reviewer is “knowledgeable about the details of the dataset being reported and can understand its strengths and limitations in relation to the question being addressed.”

For studies that use “very large datasets,” the editors are now required to ensure that, in addition to a statistical peer review, a review from an “expert in data science” is obtained. Reviewers will also be explicitly asked if they have “concerns about research integrity or publication ethics regarding the manuscript they are reviewing.”

Although these changes are encouraging, Harlan Krumholz, MD, professor of medicine (cardiology), Yale University, New Haven, Conn., is not convinced that they are realistic.

Dr. Krumholz, who is also the founder and director of the Yale New Haven Hospital Center for Outcome Research and Evaluation, said in an interview that “large, real-world datasets” are of two varieties. Datasets drawn from publicly available sources, such as Medicare or Medicaid health records, are utterly transparent.

By contrast, Surgisphere was a privately owned database, and “it is not unusual for privately owned databases to have proprietary data from multiple sources that the company may choose to keep confidential,” Dr. Krumholz said.

He noted that several large datasets are widely used for research purposes, such as IBM, Optum, and Komodo – a data analytics company that recently entered into partnership with a fourth company, PicnicHealth.

These companies receive deidentified electronic health records from health systems and insurers nationwide. Komodo boasts “real-time and longitudinal data on more than 325 million patients, representing more than 65 billion clinical encounters with 15 million new encounters added daily.”

“One has to raise an eyebrow – how were these data acquired? And, given that the U.S. has a population of around 328 million people, is it really plausible that a single company has health records of almost the entire U.S. population?” Dr. Krumholz commented. (A spokesperson for Komodo said in an interview that the company has records on 325 million U.S. patients.)

This is “an issue across the board with ‘real-world evidence,’ which is that it’s like the ‘Wild West’ – the transparencies of private databases are less than optimal and there are no common standards to help us move forward,” Dr. Krumholz said, noting that there is “no external authority overseeing, validating, or auditing these databases. In the end, we are trusting the companies.”

Although the Food and Drug Administration has laid out a framework for how real-world data and real-world evidence can be used to advance scientific research, the FDA does not oversee the databases.

“Thus, there is no ‘good housekeeping seal’ that a peer reviewer or author would be in a position to evaluate,” Dr. Krumholz said. “No journal can do an audit of these types of private databases, so ultimately, it boils down to trust.”

Nevertheless, there were red flags with Surgisphere, Dr. Rao pointed out. Unlike more established and widely used databases, the Surgisphere database had been catapulted from relative obscurity onto center stage, which should have given researchers pause.
 

AI-assisted peer review

A series of investigative reports by The Guardian raised questions about Sapan Desai, the CEO of Surgisphere, including the fact that hospitals purporting to have contributed data to Surgisphere had never heard of the company.

However, peer reviewers are not expected to be investigative reporters, explained Dr. Malički.

“In an ideal world, editors and peer reviewers would have a chance to look at raw data or would have a certificate from the academic institution the authors are affiliated with that the data have been inspected by the institution, but in the real world, of course, this does not happen,” he said.

Artificial intelligence software is being developed and deployed to assist in the peer review process, Dr. Malički noted. In July 2020, Frontiers Science News debuted its Artificial Intelligence Review Assistant to help editors, reviewers, and authors evaluate the quality of a manuscript. The program can make up to 20 recommendations, including “the assessment of language quality, the detection of plagiarism, and identification of potential conflicts of interest.” The program is now in use in all 103 journals published by Frontiers. Preliminary software is also available to detect statistical errors.

Another system under development is FAIRware, an initiative of the Research on Research Institute in partnership with the Stanford Center for Biomedical Informatics Research. The partnership’s goal is to “develop an automated online tool (or suite of tools) to help researchers ensure that the datasets they produce are ‘FAIR’ at the point of creation,” said Dr. Malički, referring to the findability, accessibility, interoperability, and reusability (FAIR) guiding principles for data management. The principles aim to increase the ability of machines to automatically find and use the data, as well as to support its reuse by individuals.

He added that these advanced tools cannot replace human reviewers, who will “likely always be a necessary quality check in the process.”
 

Greater transparency needed

Another limitation of peer review is the reviewers themselves, according to Dr. Malički. “It’s a step in the right direction that The Lancet is now requesting a peer reviewer with expertise in big datasets, but it does not go far enough to increase accountability of peer reviewers,” he said.

Dr. Malički is the co–editor-in-chief of the journal Research Integrity and Peer Review , which has “an open and transparent review process – meaning that we reveal the names of the reviewers to the public and we publish the full review report alongside the paper.” The publication also allows the authors to make public the original version they sent.

Dr. Malički cited several advantages to transparent peer review, particularly the increased accountability that results from placing potential conflicts of interest under the microscope.

As for the concern that identifying the reviewers might soften the review process, “there is little evidence to substantiate that concern,” he added.

Dr. Malički emphasized that making reviews public “is not a problem – people voice strong opinions at conferences and elsewhere. The question remains, who gets to decide if the criticism has been adequately addressed, so that the findings of the study still stand?”

He acknowledged that, “as in politics and on many social platforms, rage, hatred, and personal attacks divert the discussion from the topic at hand, which is why a good moderator is needed.”

A journal editor or a moderator at a scientific conference may be tasked with “stopping all talk not directly related to the topic.”
 

Widening the circle of scrutiny

Dr. Malički added: “A published paper should not be considered the ‘final word,’ even if it has gone through peer review and is published in a reputable journal. The peer-review process means that a limited number of people have seen the study.”

Once the study is published, “the whole world gets to see it and criticize it, and that widens the circle of scrutiny.”

One classic way to raise concerns about a study post publication is to write a letter to the journal editor. But there is no guarantee that the letter will be published or the authors notified of the feedback.

Dr. Malički encourages readers to use PubPeer, an online forum in which members of the public can post comments on scientific studies and articles.

Once a comment is posted, the authors are alerted. “There is no ‘police department’ that forces authors to acknowledge comments or forces journal editors to take action, but at least PubPeer guarantees that readers’ messages will reach the authors and – depending on how many people raise similar issues – the comments can lead to errata or even full retractions,” he said.

PubPeer was key in pointing out errors in a suspect study from France (which did not involve Surgisphere) that supported the use of hydroxychloroquine in COVID-19.
 

A message to policy makers

High stakes are involved in ensuring the integrity of scientific publications: The French government revoked a decree that allowed hospitals to prescribe hydroxychloroquine for certain COVID-19 patients.

After the Surgisphere Lancet article, the World Health Organization temporarily halted enrollment in the hydroxychloroquine component of the Solidarity international randomized trial of medications to treat COVID-19.

Similarly, the U.K. Medicines and Healthcare Products Regulatory Agency instructed the organizers of COPCOV, an international trial of the use of hydroxychloroquine as prophylaxis against COVID-19, to suspend recruitment of patients. The SOLIDARITY trial briefly resumed, but that arm of the trial was ultimately suspended after a preliminary analysis suggested that hydroxychloroquine provided no benefit for patients with COVID-19.

Dr. Malički emphasized that governments and organizations should not “blindly trust journal articles” and make policy decisions based exclusively on study findings in published journals – even with the current improvements in the peer review process – without having their own experts conduct a thorough review of the data.

“If you are not willing to do your own due diligence, then at least be brave enough and say transparently why you are making this policy, or any other changes, and clearly state if your decision is based primarily or solely on the fact that ‘X’ study was published in ‘Y’ journal,” he stated.

Dr. Rao believes that the most important take-home message of the Surgisphere scandal is “that we should be skeptical and do our own due diligence about the kinds of data published – a responsibility that applies to all of us, whether we are investigators, editors at journals, the press, scientists, and readers.”

Dr. Rao reported being on the steering committee of the National Heart, Lung, and Blood Institute–sponsored MINT trial and the Bayer-sponsored PACIFIC AMI trial. Dr. Malički reports being a postdoc at METRICS Stanford in the past 3 years. Dr. Krumholz received expenses and/or personal fees from UnitedHealth, Element Science, Aetna, Facebook, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, Martin/Baughman Law Firm, F-Prime, and the National Center for Cardiovascular Diseases in Beijing. He is an owner of Refactor Health and HugoHealth and had grants and/or contracts from the Centers for Medicare & Medicaid Services, the FDA, Johnson & Johnson, and the Shenzhen Center for Health Information.

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

In May 2020, two major scientific journals published and subsequently retracted studies that relied on data provided by the now-disgraced data analytics company Surgisphere.

One of the studies, published in The Lancet, reported an association between the antimalarial drugs hydroxychloroquine and chloroquine and increased in-hospital mortality and cardiac arrhythmias in patients with COVID-19. The second study, which appeared in the New England Journal of Medicine, described an association between underlying cardiovascular disease, but not related drug therapy, with increased mortality in COVID-19 patients.

The retractions in June 2020 followed an open letter to each publication penned by scientists, ethicists, and clinicians who flagged serious methodological and ethical anomalies in the data used in the studies.

On the 1-year anniversary, researchers and journal editors spoke about what was learned to reduce the risk of something like this happening again.

“The Surgisphere incident served as a wake-up call for everyone involved with scientific research to make sure that data have integrity and are robust,” Sunil Rao, MD, professor of medicine, Duke University Health System, Durham, N.C., and editor-in-chief of Circulation: Cardiovascular Interventions, said in an interview.

“I’m sure this isn’t going to be the last incident of this nature, and we have to be vigilant about new datasets or datasets that we haven’t heard of as having a track record of publication,” Dr. Rao said.
 

Spotlight on authors

The editors of the Lancet Group responded to the “wake-up call” with a statement, Learning From a Retraction, which announced changes to reduce the risks of research and publication misconduct.

The changes affect multiple phases of the publication process. For example, the declaration form that authors must sign “will require that more than one author has directly accessed and verified the data reported in the manuscript.” Additionally, when a research article is the result of an academic and commercial partnership – as was the case in the two retracted studies – “one of the authors named as having accessed and verified data must be from the academic team.”

This was particularly important because it appears that the academic coauthors of the retracted studies did not have access to the data provided by Surgisphere, a private commercial entity.

Mandeep R. Mehra, MD, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, who was the lead author of both studies, declined to be interviewed for this article. In a letter to the New England Journal of Medicine editors requesting that the article be retracted, he wrote: “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article.”

In a similar communication with The Lancet, Dr. Mehra wrote even more pointedly that, in light of the refusal of Surgisphere to make the data available to the third-party auditor, “we can no longer vouch for the veracity of the primary data sources.”

“It is very disturbing that the authors were willing to put their names on a paper without ever seeing and verifying the data,” Mario Malički, MD, PhD, a postdoctoral researcher at METRICS at Stanford (Calif.) University, said in an interview. “Saying that they could ‘no longer vouch’ suggests that at one point they could vouch for it. Most likely they took its existence and veracity entirely on trust.”

Dr. Malički pointed out that one of the four criteria of the International Committee of Medical Journal Editors for being an author on a study is the “agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.”

The new policies put forth by The Lancet are “encouraging,” but perhaps do not go far enough. “Every author, not only one or two authors, should personally take responsibility for the integrity of data,” he stated.

Many journals “adhere to ICMJE rules in principle and have checkboxes for authors to confirm that they guarantee the veracity of the data.” However, they “do not have the resources to verify the authors’ statements.”

Ideally, “it is the institutions where the researchers work that should guarantee the veracity of the raw data – but I do not know any university or institute that does this,” he said.
 

No ‘good-housekeeping’ seal

For articles based on large, real-world datasets, the Lancet Group will now require that editors ensure that at least one peer reviewer is “knowledgeable about the details of the dataset being reported and can understand its strengths and limitations in relation to the question being addressed.”

For studies that use “very large datasets,” the editors are now required to ensure that, in addition to a statistical peer review, a review from an “expert in data science” is obtained. Reviewers will also be explicitly asked if they have “concerns about research integrity or publication ethics regarding the manuscript they are reviewing.”

Although these changes are encouraging, Harlan Krumholz, MD, professor of medicine (cardiology), Yale University, New Haven, Conn., is not convinced that they are realistic.

Dr. Krumholz, who is also the founder and director of the Yale New Haven Hospital Center for Outcome Research and Evaluation, said in an interview that “large, real-world datasets” are of two varieties. Datasets drawn from publicly available sources, such as Medicare or Medicaid health records, are utterly transparent.

By contrast, Surgisphere was a privately owned database, and “it is not unusual for privately owned databases to have proprietary data from multiple sources that the company may choose to keep confidential,” Dr. Krumholz said.

He noted that several large datasets are widely used for research purposes, such as IBM, Optum, and Komodo – a data analytics company that recently entered into partnership with a fourth company, PicnicHealth.

These companies receive deidentified electronic health records from health systems and insurers nationwide. Komodo boasts “real-time and longitudinal data on more than 325 million patients, representing more than 65 billion clinical encounters with 15 million new encounters added daily.”

“One has to raise an eyebrow – how were these data acquired? And, given that the U.S. has a population of around 328 million people, is it really plausible that a single company has health records of almost the entire U.S. population?” Dr. Krumholz commented. (A spokesperson for Komodo said in an interview that the company has records on 325 million U.S. patients.)

This is “an issue across the board with ‘real-world evidence,’ which is that it’s like the ‘Wild West’ – the transparencies of private databases are less than optimal and there are no common standards to help us move forward,” Dr. Krumholz said, noting that there is “no external authority overseeing, validating, or auditing these databases. In the end, we are trusting the companies.”

Although the Food and Drug Administration has laid out a framework for how real-world data and real-world evidence can be used to advance scientific research, the FDA does not oversee the databases.

“Thus, there is no ‘good housekeeping seal’ that a peer reviewer or author would be in a position to evaluate,” Dr. Krumholz said. “No journal can do an audit of these types of private databases, so ultimately, it boils down to trust.”

Nevertheless, there were red flags with Surgisphere, Dr. Rao pointed out. Unlike more established and widely used databases, the Surgisphere database had been catapulted from relative obscurity onto center stage, which should have given researchers pause.
 

AI-assisted peer review

A series of investigative reports by The Guardian raised questions about Sapan Desai, the CEO of Surgisphere, including the fact that hospitals purporting to have contributed data to Surgisphere had never heard of the company.

However, peer reviewers are not expected to be investigative reporters, explained Dr. Malički.

“In an ideal world, editors and peer reviewers would have a chance to look at raw data or would have a certificate from the academic institution the authors are affiliated with that the data have been inspected by the institution, but in the real world, of course, this does not happen,” he said.

Artificial intelligence software is being developed and deployed to assist in the peer review process, Dr. Malički noted. In July 2020, Frontiers Science News debuted its Artificial Intelligence Review Assistant to help editors, reviewers, and authors evaluate the quality of a manuscript. The program can make up to 20 recommendations, including “the assessment of language quality, the detection of plagiarism, and identification of potential conflicts of interest.” The program is now in use in all 103 journals published by Frontiers. Preliminary software is also available to detect statistical errors.

Another system under development is FAIRware, an initiative of the Research on Research Institute in partnership with the Stanford Center for Biomedical Informatics Research. The partnership’s goal is to “develop an automated online tool (or suite of tools) to help researchers ensure that the datasets they produce are ‘FAIR’ at the point of creation,” said Dr. Malički, referring to the findability, accessibility, interoperability, and reusability (FAIR) guiding principles for data management. The principles aim to increase the ability of machines to automatically find and use the data, as well as to support its reuse by individuals.

He added that these advanced tools cannot replace human reviewers, who will “likely always be a necessary quality check in the process.”
 

Greater transparency needed

Another limitation of peer review is the reviewers themselves, according to Dr. Malički. “It’s a step in the right direction that The Lancet is now requesting a peer reviewer with expertise in big datasets, but it does not go far enough to increase accountability of peer reviewers,” he said.

Dr. Malički is the co–editor-in-chief of the journal Research Integrity and Peer Review , which has “an open and transparent review process – meaning that we reveal the names of the reviewers to the public and we publish the full review report alongside the paper.” The publication also allows the authors to make public the original version they sent.

Dr. Malički cited several advantages to transparent peer review, particularly the increased accountability that results from placing potential conflicts of interest under the microscope.

As for the concern that identifying the reviewers might soften the review process, “there is little evidence to substantiate that concern,” he added.

Dr. Malički emphasized that making reviews public “is not a problem – people voice strong opinions at conferences and elsewhere. The question remains, who gets to decide if the criticism has been adequately addressed, so that the findings of the study still stand?”

He acknowledged that, “as in politics and on many social platforms, rage, hatred, and personal attacks divert the discussion from the topic at hand, which is why a good moderator is needed.”

A journal editor or a moderator at a scientific conference may be tasked with “stopping all talk not directly related to the topic.”
 

Widening the circle of scrutiny

Dr. Malički added: “A published paper should not be considered the ‘final word,’ even if it has gone through peer review and is published in a reputable journal. The peer-review process means that a limited number of people have seen the study.”

Once the study is published, “the whole world gets to see it and criticize it, and that widens the circle of scrutiny.”

One classic way to raise concerns about a study post publication is to write a letter to the journal editor. But there is no guarantee that the letter will be published or the authors notified of the feedback.

Dr. Malički encourages readers to use PubPeer, an online forum in which members of the public can post comments on scientific studies and articles.

Once a comment is posted, the authors are alerted. “There is no ‘police department’ that forces authors to acknowledge comments or forces journal editors to take action, but at least PubPeer guarantees that readers’ messages will reach the authors and – depending on how many people raise similar issues – the comments can lead to errata or even full retractions,” he said.

PubPeer was key in pointing out errors in a suspect study from France (which did not involve Surgisphere) that supported the use of hydroxychloroquine in COVID-19.
 

A message to policy makers

High stakes are involved in ensuring the integrity of scientific publications: The French government revoked a decree that allowed hospitals to prescribe hydroxychloroquine for certain COVID-19 patients.

After the Surgisphere Lancet article, the World Health Organization temporarily halted enrollment in the hydroxychloroquine component of the Solidarity international randomized trial of medications to treat COVID-19.

Similarly, the U.K. Medicines and Healthcare Products Regulatory Agency instructed the organizers of COPCOV, an international trial of the use of hydroxychloroquine as prophylaxis against COVID-19, to suspend recruitment of patients. The SOLIDARITY trial briefly resumed, but that arm of the trial was ultimately suspended after a preliminary analysis suggested that hydroxychloroquine provided no benefit for patients with COVID-19.

Dr. Malički emphasized that governments and organizations should not “blindly trust journal articles” and make policy decisions based exclusively on study findings in published journals – even with the current improvements in the peer review process – without having their own experts conduct a thorough review of the data.

“If you are not willing to do your own due diligence, then at least be brave enough and say transparently why you are making this policy, or any other changes, and clearly state if your decision is based primarily or solely on the fact that ‘X’ study was published in ‘Y’ journal,” he stated.

Dr. Rao believes that the most important take-home message of the Surgisphere scandal is “that we should be skeptical and do our own due diligence about the kinds of data published – a responsibility that applies to all of us, whether we are investigators, editors at journals, the press, scientists, and readers.”

Dr. Rao reported being on the steering committee of the National Heart, Lung, and Blood Institute–sponsored MINT trial and the Bayer-sponsored PACIFIC AMI trial. Dr. Malički reports being a postdoc at METRICS Stanford in the past 3 years. Dr. Krumholz received expenses and/or personal fees from UnitedHealth, Element Science, Aetna, Facebook, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, Martin/Baughman Law Firm, F-Prime, and the National Center for Cardiovascular Diseases in Beijing. He is an owner of Refactor Health and HugoHealth and had grants and/or contracts from the Centers for Medicare & Medicaid Services, the FDA, Johnson & Johnson, and the Shenzhen Center for Health Information.

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

In May 2020, two major scientific journals published and subsequently retracted studies that relied on data provided by the now-disgraced data analytics company Surgisphere.

One of the studies, published in The Lancet, reported an association between the antimalarial drugs hydroxychloroquine and chloroquine and increased in-hospital mortality and cardiac arrhythmias in patients with COVID-19. The second study, which appeared in the New England Journal of Medicine, described an association between underlying cardiovascular disease, but not related drug therapy, with increased mortality in COVID-19 patients.

The retractions in June 2020 followed an open letter to each publication penned by scientists, ethicists, and clinicians who flagged serious methodological and ethical anomalies in the data used in the studies.

On the 1-year anniversary, researchers and journal editors spoke about what was learned to reduce the risk of something like this happening again.

“The Surgisphere incident served as a wake-up call for everyone involved with scientific research to make sure that data have integrity and are robust,” Sunil Rao, MD, professor of medicine, Duke University Health System, Durham, N.C., and editor-in-chief of Circulation: Cardiovascular Interventions, said in an interview.

“I’m sure this isn’t going to be the last incident of this nature, and we have to be vigilant about new datasets or datasets that we haven’t heard of as having a track record of publication,” Dr. Rao said.
 

Spotlight on authors

The editors of the Lancet Group responded to the “wake-up call” with a statement, Learning From a Retraction, which announced changes to reduce the risks of research and publication misconduct.

The changes affect multiple phases of the publication process. For example, the declaration form that authors must sign “will require that more than one author has directly accessed and verified the data reported in the manuscript.” Additionally, when a research article is the result of an academic and commercial partnership – as was the case in the two retracted studies – “one of the authors named as having accessed and verified data must be from the academic team.”

This was particularly important because it appears that the academic coauthors of the retracted studies did not have access to the data provided by Surgisphere, a private commercial entity.

Mandeep R. Mehra, MD, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, who was the lead author of both studies, declined to be interviewed for this article. In a letter to the New England Journal of Medicine editors requesting that the article be retracted, he wrote: “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article.”

In a similar communication with The Lancet, Dr. Mehra wrote even more pointedly that, in light of the refusal of Surgisphere to make the data available to the third-party auditor, “we can no longer vouch for the veracity of the primary data sources.”

“It is very disturbing that the authors were willing to put their names on a paper without ever seeing and verifying the data,” Mario Malički, MD, PhD, a postdoctoral researcher at METRICS at Stanford (Calif.) University, said in an interview. “Saying that they could ‘no longer vouch’ suggests that at one point they could vouch for it. Most likely they took its existence and veracity entirely on trust.”

Dr. Malički pointed out that one of the four criteria of the International Committee of Medical Journal Editors for being an author on a study is the “agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.”

The new policies put forth by The Lancet are “encouraging,” but perhaps do not go far enough. “Every author, not only one or two authors, should personally take responsibility for the integrity of data,” he stated.

Many journals “adhere to ICMJE rules in principle and have checkboxes for authors to confirm that they guarantee the veracity of the data.” However, they “do not have the resources to verify the authors’ statements.”

Ideally, “it is the institutions where the researchers work that should guarantee the veracity of the raw data – but I do not know any university or institute that does this,” he said.
 

No ‘good-housekeeping’ seal

For articles based on large, real-world datasets, the Lancet Group will now require that editors ensure that at least one peer reviewer is “knowledgeable about the details of the dataset being reported and can understand its strengths and limitations in relation to the question being addressed.”

For studies that use “very large datasets,” the editors are now required to ensure that, in addition to a statistical peer review, a review from an “expert in data science” is obtained. Reviewers will also be explicitly asked if they have “concerns about research integrity or publication ethics regarding the manuscript they are reviewing.”

Although these changes are encouraging, Harlan Krumholz, MD, professor of medicine (cardiology), Yale University, New Haven, Conn., is not convinced that they are realistic.

Dr. Krumholz, who is also the founder and director of the Yale New Haven Hospital Center for Outcome Research and Evaluation, said in an interview that “large, real-world datasets” are of two varieties. Datasets drawn from publicly available sources, such as Medicare or Medicaid health records, are utterly transparent.

By contrast, Surgisphere was a privately owned database, and “it is not unusual for privately owned databases to have proprietary data from multiple sources that the company may choose to keep confidential,” Dr. Krumholz said.

He noted that several large datasets are widely used for research purposes, such as IBM, Optum, and Komodo – a data analytics company that recently entered into partnership with a fourth company, PicnicHealth.

These companies receive deidentified electronic health records from health systems and insurers nationwide. Komodo boasts “real-time and longitudinal data on more than 325 million patients, representing more than 65 billion clinical encounters with 15 million new encounters added daily.”

“One has to raise an eyebrow – how were these data acquired? And, given that the U.S. has a population of around 328 million people, is it really plausible that a single company has health records of almost the entire U.S. population?” Dr. Krumholz commented. (A spokesperson for Komodo said in an interview that the company has records on 325 million U.S. patients.)

This is “an issue across the board with ‘real-world evidence,’ which is that it’s like the ‘Wild West’ – the transparencies of private databases are less than optimal and there are no common standards to help us move forward,” Dr. Krumholz said, noting that there is “no external authority overseeing, validating, or auditing these databases. In the end, we are trusting the companies.”

Although the Food and Drug Administration has laid out a framework for how real-world data and real-world evidence can be used to advance scientific research, the FDA does not oversee the databases.

“Thus, there is no ‘good housekeeping seal’ that a peer reviewer or author would be in a position to evaluate,” Dr. Krumholz said. “No journal can do an audit of these types of private databases, so ultimately, it boils down to trust.”

Nevertheless, there were red flags with Surgisphere, Dr. Rao pointed out. Unlike more established and widely used databases, the Surgisphere database had been catapulted from relative obscurity onto center stage, which should have given researchers pause.
 

AI-assisted peer review

A series of investigative reports by The Guardian raised questions about Sapan Desai, the CEO of Surgisphere, including the fact that hospitals purporting to have contributed data to Surgisphere had never heard of the company.

However, peer reviewers are not expected to be investigative reporters, explained Dr. Malički.

“In an ideal world, editors and peer reviewers would have a chance to look at raw data or would have a certificate from the academic institution the authors are affiliated with that the data have been inspected by the institution, but in the real world, of course, this does not happen,” he said.

Artificial intelligence software is being developed and deployed to assist in the peer review process, Dr. Malički noted. In July 2020, Frontiers Science News debuted its Artificial Intelligence Review Assistant to help editors, reviewers, and authors evaluate the quality of a manuscript. The program can make up to 20 recommendations, including “the assessment of language quality, the detection of plagiarism, and identification of potential conflicts of interest.” The program is now in use in all 103 journals published by Frontiers. Preliminary software is also available to detect statistical errors.

Another system under development is FAIRware, an initiative of the Research on Research Institute in partnership with the Stanford Center for Biomedical Informatics Research. The partnership’s goal is to “develop an automated online tool (or suite of tools) to help researchers ensure that the datasets they produce are ‘FAIR’ at the point of creation,” said Dr. Malički, referring to the findability, accessibility, interoperability, and reusability (FAIR) guiding principles for data management. The principles aim to increase the ability of machines to automatically find and use the data, as well as to support its reuse by individuals.

He added that these advanced tools cannot replace human reviewers, who will “likely always be a necessary quality check in the process.”
 

Greater transparency needed

Another limitation of peer review is the reviewers themselves, according to Dr. Malički. “It’s a step in the right direction that The Lancet is now requesting a peer reviewer with expertise in big datasets, but it does not go far enough to increase accountability of peer reviewers,” he said.

Dr. Malički is the co–editor-in-chief of the journal Research Integrity and Peer Review , which has “an open and transparent review process – meaning that we reveal the names of the reviewers to the public and we publish the full review report alongside the paper.” The publication also allows the authors to make public the original version they sent.

Dr. Malički cited several advantages to transparent peer review, particularly the increased accountability that results from placing potential conflicts of interest under the microscope.

As for the concern that identifying the reviewers might soften the review process, “there is little evidence to substantiate that concern,” he added.

Dr. Malički emphasized that making reviews public “is not a problem – people voice strong opinions at conferences and elsewhere. The question remains, who gets to decide if the criticism has been adequately addressed, so that the findings of the study still stand?”

He acknowledged that, “as in politics and on many social platforms, rage, hatred, and personal attacks divert the discussion from the topic at hand, which is why a good moderator is needed.”

A journal editor or a moderator at a scientific conference may be tasked with “stopping all talk not directly related to the topic.”
 

Widening the circle of scrutiny

Dr. Malički added: “A published paper should not be considered the ‘final word,’ even if it has gone through peer review and is published in a reputable journal. The peer-review process means that a limited number of people have seen the study.”

Once the study is published, “the whole world gets to see it and criticize it, and that widens the circle of scrutiny.”

One classic way to raise concerns about a study post publication is to write a letter to the journal editor. But there is no guarantee that the letter will be published or the authors notified of the feedback.

Dr. Malički encourages readers to use PubPeer, an online forum in which members of the public can post comments on scientific studies and articles.

Once a comment is posted, the authors are alerted. “There is no ‘police department’ that forces authors to acknowledge comments or forces journal editors to take action, but at least PubPeer guarantees that readers’ messages will reach the authors and – depending on how many people raise similar issues – the comments can lead to errata or even full retractions,” he said.

PubPeer was key in pointing out errors in a suspect study from France (which did not involve Surgisphere) that supported the use of hydroxychloroquine in COVID-19.
 

A message to policy makers

High stakes are involved in ensuring the integrity of scientific publications: The French government revoked a decree that allowed hospitals to prescribe hydroxychloroquine for certain COVID-19 patients.

After the Surgisphere Lancet article, the World Health Organization temporarily halted enrollment in the hydroxychloroquine component of the Solidarity international randomized trial of medications to treat COVID-19.

Similarly, the U.K. Medicines and Healthcare Products Regulatory Agency instructed the organizers of COPCOV, an international trial of the use of hydroxychloroquine as prophylaxis against COVID-19, to suspend recruitment of patients. The SOLIDARITY trial briefly resumed, but that arm of the trial was ultimately suspended after a preliminary analysis suggested that hydroxychloroquine provided no benefit for patients with COVID-19.

Dr. Malički emphasized that governments and organizations should not “blindly trust journal articles” and make policy decisions based exclusively on study findings in published journals – even with the current improvements in the peer review process – without having their own experts conduct a thorough review of the data.

“If you are not willing to do your own due diligence, then at least be brave enough and say transparently why you are making this policy, or any other changes, and clearly state if your decision is based primarily or solely on the fact that ‘X’ study was published in ‘Y’ journal,” he stated.

Dr. Rao believes that the most important take-home message of the Surgisphere scandal is “that we should be skeptical and do our own due diligence about the kinds of data published – a responsibility that applies to all of us, whether we are investigators, editors at journals, the press, scientists, and readers.”

Dr. Rao reported being on the steering committee of the National Heart, Lung, and Blood Institute–sponsored MINT trial and the Bayer-sponsored PACIFIC AMI trial. Dr. Malički reports being a postdoc at METRICS Stanford in the past 3 years. Dr. Krumholz received expenses and/or personal fees from UnitedHealth, Element Science, Aetna, Facebook, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, Martin/Baughman Law Firm, F-Prime, and the National Center for Cardiovascular Diseases in Beijing. He is an owner of Refactor Health and HugoHealth and had grants and/or contracts from the Centers for Medicare & Medicaid Services, the FDA, Johnson & Johnson, and the Shenzhen Center for Health Information.

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

As doctors struggled through several surges of COVID-19 infections, most of what we learned was acquired through real-life experience. While many treatment options were promoted, most flat-out failed to be real therapeutics at all. Now that we have a safe and effective vaccine, we can prevent many infections from this virus. However, we are still left to manage the many post-COVID symptoms our patients continue to suffer with.

Symptoms following infection can last for months and range widely from “brain fog,” fatigue, dyspnea, chest pain, generalized weakness, depression, and a host of others. Patients may experience one or all of these symptoms, and there is currently no good way to predict who will go on to become a COVID “long hauler”.

Following the example of being educated by COVID as it happened, the same is true for managing post-COVID symptoms. The medical community still has a poor understanding of why some people develop it and there are few evidence-based studies to support any treatment modalities.

Earlier this month, the Centers for Disease Control and Prevention issued a set of clinical guidelines addressing treatment of post-COVID symptoms, which they define as “new, recurring, or ongoing symptoms more than 4 weeks after infection, sometimes after initial symptom recovery.” It is important to note that these symptoms can occur in any degree of sickness during the acute infection, including in those who were asymptomatic. Even the actual name of this post-COVID syndrome is still being developed, with several other names being used for it as well.

While the guidelines are quite extensive, the actual clinical recommendations are still vague. For example, it is advised to let the patient know that post-COVID symptoms are still not well understood. While it is important to be transparent with patients, this does little to reassure them. Patients look to doctors, especially their primary care physicians, to guide them on the best treatment paths. Yet, we currently have none for post-COVID syndrome.

It is also advised to treat the patients’ symptoms and help improve functioning. For many diseases, doctors like to get to the root cause of the problem. Treating a symptom often masks an underlying condition. It may make the patient feel better and improve what they are capable of doing, which is important, but it also fails to unmask the real problem. It is also important to note that symptoms can be out of proportion to clinical findings and should not be dismissed: we just don’t have the answers yet.

One helpful recommendation is having a patient keep a diary of their symptoms. This will help both the patient and doctor learn what may be triggering factors. If it is, for example, exertion that induces breathlessness, perhaps the patient can gradually increase their level of activity to minimize symptoms. Additionally, a “comprehensive rehabilitation program” is also advised and this can greatly assist addressing all the issues a patient is experiencing, physically and medically.

It is also advised that management of underlying medical conditions be optimized. While this is very important, it is not something specific to post-COVID syndrome: All patients should have their underlying medical conditions well controlled. It might be that the patient is paying more attention to their overall health, which is a good thing. However, this does not necessarily reduce the current symptoms a patient is experiencing.

The CDC makes a good attempt to offer guidance in the frustrating management of post-COVID syndrome. However, their clinical guidelines fail to offer specific management tools specific to treating post-COVID patients. The recommendations offered are more helpful to health in general. The fact that more specific recommendations are lacking is simply caused by the lack of knowledge of this condition at present. As more research is conducted and more knowledge obtained, new guidelines should become more detailed.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.

As doctors struggled through several surges of COVID-19 infections, most of what we learned was acquired through real-life experience. While many treatment options were promoted, most flat-out failed to be real therapeutics at all. Now that we have a safe and effective vaccine, we can prevent many infections from this virus. However, we are still left to manage the many post-COVID symptoms our patients continue to suffer with.

Symptoms following infection can last for months and range widely from “brain fog,” fatigue, dyspnea, chest pain, generalized weakness, depression, and a host of others. Patients may experience one or all of these symptoms, and there is currently no good way to predict who will go on to become a COVID “long hauler”.

Following the example of being educated by COVID as it happened, the same is true for managing post-COVID symptoms. The medical community still has a poor understanding of why some people develop it and there are few evidence-based studies to support any treatment modalities.

Earlier this month, the Centers for Disease Control and Prevention issued a set of clinical guidelines addressing treatment of post-COVID symptoms, which they define as “new, recurring, or ongoing symptoms more than 4 weeks after infection, sometimes after initial symptom recovery.” It is important to note that these symptoms can occur in any degree of sickness during the acute infection, including in those who were asymptomatic. Even the actual name of this post-COVID syndrome is still being developed, with several other names being used for it as well.

While the guidelines are quite extensive, the actual clinical recommendations are still vague. For example, it is advised to let the patient know that post-COVID symptoms are still not well understood. While it is important to be transparent with patients, this does little to reassure them. Patients look to doctors, especially their primary care physicians, to guide them on the best treatment paths. Yet, we currently have none for post-COVID syndrome.

It is also advised to treat the patients’ symptoms and help improve functioning. For many diseases, doctors like to get to the root cause of the problem. Treating a symptom often masks an underlying condition. It may make the patient feel better and improve what they are capable of doing, which is important, but it also fails to unmask the real problem. It is also important to note that symptoms can be out of proportion to clinical findings and should not be dismissed: we just don’t have the answers yet.

One helpful recommendation is having a patient keep a diary of their symptoms. This will help both the patient and doctor learn what may be triggering factors. If it is, for example, exertion that induces breathlessness, perhaps the patient can gradually increase their level of activity to minimize symptoms. Additionally, a “comprehensive rehabilitation program” is also advised and this can greatly assist addressing all the issues a patient is experiencing, physically and medically.

It is also advised that management of underlying medical conditions be optimized. While this is very important, it is not something specific to post-COVID syndrome: All patients should have their underlying medical conditions well controlled. It might be that the patient is paying more attention to their overall health, which is a good thing. However, this does not necessarily reduce the current symptoms a patient is experiencing.

The CDC makes a good attempt to offer guidance in the frustrating management of post-COVID syndrome. However, their clinical guidelines fail to offer specific management tools specific to treating post-COVID patients. The recommendations offered are more helpful to health in general. The fact that more specific recommendations are lacking is simply caused by the lack of knowledge of this condition at present. As more research is conducted and more knowledge obtained, new guidelines should become more detailed.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.

As doctors struggled through several surges of COVID-19 infections, most of what we learned was acquired through real-life experience. While many treatment options were promoted, most flat-out failed to be real therapeutics at all. Now that we have a safe and effective vaccine, we can prevent many infections from this virus. However, we are still left to manage the many post-COVID symptoms our patients continue to suffer with.

Symptoms following infection can last for months and range widely from “brain fog,” fatigue, dyspnea, chest pain, generalized weakness, depression, and a host of others. Patients may experience one or all of these symptoms, and there is currently no good way to predict who will go on to become a COVID “long hauler”.

Following the example of being educated by COVID as it happened, the same is true for managing post-COVID symptoms. The medical community still has a poor understanding of why some people develop it and there are few evidence-based studies to support any treatment modalities.

Earlier this month, the Centers for Disease Control and Prevention issued a set of clinical guidelines addressing treatment of post-COVID symptoms, which they define as “new, recurring, or ongoing symptoms more than 4 weeks after infection, sometimes after initial symptom recovery.” It is important to note that these symptoms can occur in any degree of sickness during the acute infection, including in those who were asymptomatic. Even the actual name of this post-COVID syndrome is still being developed, with several other names being used for it as well.

While the guidelines are quite extensive, the actual clinical recommendations are still vague. For example, it is advised to let the patient know that post-COVID symptoms are still not well understood. While it is important to be transparent with patients, this does little to reassure them. Patients look to doctors, especially their primary care physicians, to guide them on the best treatment paths. Yet, we currently have none for post-COVID syndrome.

It is also advised to treat the patients’ symptoms and help improve functioning. For many diseases, doctors like to get to the root cause of the problem. Treating a symptom often masks an underlying condition. It may make the patient feel better and improve what they are capable of doing, which is important, but it also fails to unmask the real problem. It is also important to note that symptoms can be out of proportion to clinical findings and should not be dismissed: we just don’t have the answers yet.

One helpful recommendation is having a patient keep a diary of their symptoms. This will help both the patient and doctor learn what may be triggering factors. If it is, for example, exertion that induces breathlessness, perhaps the patient can gradually increase their level of activity to minimize symptoms. Additionally, a “comprehensive rehabilitation program” is also advised and this can greatly assist addressing all the issues a patient is experiencing, physically and medically.

It is also advised that management of underlying medical conditions be optimized. While this is very important, it is not something specific to post-COVID syndrome: All patients should have their underlying medical conditions well controlled. It might be that the patient is paying more attention to their overall health, which is a good thing. However, this does not necessarily reduce the current symptoms a patient is experiencing.

The CDC makes a good attempt to offer guidance in the frustrating management of post-COVID syndrome. However, their clinical guidelines fail to offer specific management tools specific to treating post-COVID patients. The recommendations offered are more helpful to health in general. The fact that more specific recommendations are lacking is simply caused by the lack of knowledge of this condition at present. As more research is conducted and more knowledge obtained, new guidelines should become more detailed.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at fpnews@mdedge.com.

Key clinical point: Antibiotic resistance increased with longer hospital stays; vancomycin resistance increased among enterococci, and ceftriaxone and carbapenem resistance among Enterobacterales.

Major finding: A total of 183 community-associated coinfections were identified in COVID-19 patients who met criteria for infection (6%); hospital-acquired infections occurred in 350 patients (12%). Of the hospital-acquired infections, 57% were caused by gram-negative bacteria and 19% were caused by fungi.  

Study details: The data come from 3,028 adults with COVID-19 diagnosed between March 2, 2020, and May 31, 2020, who were hospitalized for at least 24 hours; 516 patients of 899 with positive cultures met criteria for infection.

Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose.

Source: Kubin CJ et al. Open Forum Infect Dis. 2021 May 5. doi: 10.1093/ofid/ofab201.

Key clinical point: Antibiotic resistance increased with longer hospital stays; vancomycin resistance increased among enterococci, and ceftriaxone and carbapenem resistance among Enterobacterales.

Major finding: A total of 183 community-associated coinfections were identified in COVID-19 patients who met criteria for infection (6%); hospital-acquired infections occurred in 350 patients (12%). Of the hospital-acquired infections, 57% were caused by gram-negative bacteria and 19% were caused by fungi.  

Study details: The data come from 3,028 adults with COVID-19 diagnosed between March 2, 2020, and May 31, 2020, who were hospitalized for at least 24 hours; 516 patients of 899 with positive cultures met criteria for infection.

Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose.

Source: Kubin CJ et al. Open Forum Infect Dis. 2021 May 5. doi: 10.1093/ofid/ofab201.

Key clinical point: Antibiotic resistance increased with longer hospital stays; vancomycin resistance increased among enterococci, and ceftriaxone and carbapenem resistance among Enterobacterales.

Major finding: A total of 183 community-associated coinfections were identified in COVID-19 patients who met criteria for infection (6%); hospital-acquired infections occurred in 350 patients (12%). Of the hospital-acquired infections, 57% were caused by gram-negative bacteria and 19% were caused by fungi.  

Study details: The data come from 3,028 adults with COVID-19 diagnosed between March 2, 2020, and May 31, 2020, who were hospitalized for at least 24 hours; 516 patients of 899 with positive cultures met criteria for infection.

Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose.

Source: Kubin CJ et al. Open Forum Infect Dis. 2021 May 5. doi: 10.1093/ofid/ofab201.

Key clinical point: More than half of hospitalized COVID-19 patients developed at least one superinfection, including 75 cases of ventilator-associated pneumonia and 57 systemic infections. Overall, bacterial infections, age, and the highest Sequential Organ Failure Assessment score were independently associated with ICU mortality or 28-day mortality.

Major finding: The most common pathogens behind cases of ventilator-associated pneumonia were Pseudomonas aeruginosa (34.7%) and Stenotrophomonas maltophilia (18.7%). Bloodstream infections occurred in 16 cases, and fungal infections occurred in 41 cases.

Study details: The data come from a retrospective analysis of prospectively collected data from 92 adults with COVID-19 who were admitted to a single ICU between February 21, 2020, and May 6, 2020.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Signorini L et al. Crit Care Explor. 2021 Jun 11. doi: 10.1097/CCE.0000000000000430.

Key clinical point: More than half of hospitalized COVID-19 patients developed at least one superinfection, including 75 cases of ventilator-associated pneumonia and 57 systemic infections. Overall, bacterial infections, age, and the highest Sequential Organ Failure Assessment score were independently associated with ICU mortality or 28-day mortality.

Major finding: The most common pathogens behind cases of ventilator-associated pneumonia were Pseudomonas aeruginosa (34.7%) and Stenotrophomonas maltophilia (18.7%). Bloodstream infections occurred in 16 cases, and fungal infections occurred in 41 cases.

Study details: The data come from a retrospective analysis of prospectively collected data from 92 adults with COVID-19 who were admitted to a single ICU between February 21, 2020, and May 6, 2020.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Signorini L et al. Crit Care Explor. 2021 Jun 11. doi: 10.1097/CCE.0000000000000430.

Key clinical point: More than half of hospitalized COVID-19 patients developed at least one superinfection, including 75 cases of ventilator-associated pneumonia and 57 systemic infections. Overall, bacterial infections, age, and the highest Sequential Organ Failure Assessment score were independently associated with ICU mortality or 28-day mortality.

Major finding: The most common pathogens behind cases of ventilator-associated pneumonia were Pseudomonas aeruginosa (34.7%) and Stenotrophomonas maltophilia (18.7%). Bloodstream infections occurred in 16 cases, and fungal infections occurred in 41 cases.

Study details: The data come from a retrospective analysis of prospectively collected data from 92 adults with COVID-19 who were admitted to a single ICU between February 21, 2020, and May 6, 2020.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Signorini L et al. Crit Care Explor. 2021 Jun 11. doi: 10.1097/CCE.0000000000000430.

Key clinical point: Candida albicans showed the strongest exoenzyme activity compared to non-albicans isolates in oral cavity samples from adults with diabetes.

Major finding:  Candida albicans isolates showed 97.3%, 100%, and 77.3% exoenzyme activity for phospholipase, hemolysin, and esterase, respectively. Differences in activity between albicans and non-albicans isolates were significant for phospholipase and hemolysin, but did not reach significance for esterase.

Study details: The data come from 108 Candida species including 75 Candida albicans and 33 non-albicans taken from diabetes patients’ oral cavity samples.

Disclosures: The study was supported by the Deputy of Research and Technology of Shiraz University of Medical Sciences, Shiraz, Iran. The study was part of the MD thesis of coauthor Mehdi Ghaderian Jahromi. The researchers had no financial conflicts to disclose.

Source: Nouraei H et al. Biomed Res Int. 2021 May 26. doi: 10.1155/2021/9982744.

Key clinical point: Candida albicans showed the strongest exoenzyme activity compared to non-albicans isolates in oral cavity samples from adults with diabetes.

Major finding:  Candida albicans isolates showed 97.3%, 100%, and 77.3% exoenzyme activity for phospholipase, hemolysin, and esterase, respectively. Differences in activity between albicans and non-albicans isolates were significant for phospholipase and hemolysin, but did not reach significance for esterase.

Study details: The data come from 108 Candida species including 75 Candida albicans and 33 non-albicans taken from diabetes patients’ oral cavity samples.

Disclosures: The study was supported by the Deputy of Research and Technology of Shiraz University of Medical Sciences, Shiraz, Iran. The study was part of the MD thesis of coauthor Mehdi Ghaderian Jahromi. The researchers had no financial conflicts to disclose.

Source: Nouraei H et al. Biomed Res Int. 2021 May 26. doi: 10.1155/2021/9982744.

Key clinical point: Candida albicans showed the strongest exoenzyme activity compared to non-albicans isolates in oral cavity samples from adults with diabetes.

Major finding:  Candida albicans isolates showed 97.3%, 100%, and 77.3% exoenzyme activity for phospholipase, hemolysin, and esterase, respectively. Differences in activity between albicans and non-albicans isolates were significant for phospholipase and hemolysin, but did not reach significance for esterase.

Study details: The data come from 108 Candida species including 75 Candida albicans and 33 non-albicans taken from diabetes patients’ oral cavity samples.

Disclosures: The study was supported by the Deputy of Research and Technology of Shiraz University of Medical Sciences, Shiraz, Iran. The study was part of the MD thesis of coauthor Mehdi Ghaderian Jahromi. The researchers had no financial conflicts to disclose.

Source: Nouraei H et al. Biomed Res Int. 2021 May 26. doi: 10.1155/2021/9982744.

Key clinical point: Fungal or bacterial bloodstream infections were common in children within 5 years of liver or kidney transplants; the overall incidence in the first year post-transplant was 1.91 per 100 recipients per month.

Major finding:  A total of 29 of 85 children who underwent liver or kidney transplants developed bacterial or fungal bloodstream infections within 5 years of their transplants with 16 different pathogens; the most common were Enterococcus faecium, Candida albicans, Escherichia coli, and Klebsiella pneumoniae.

Study details: The data come from a prospective study of 85 pediatric patients who underwent liver and kidney transplants between 2010 and 2017; the total follow-up was 390 person-years.

Disclosures: The study was supported by the Novo Nordic Foundation, the Independent Research Fund (FSS), the Danish National Research Foundation (DNRF), and the Research Foundation of Rigshospitalet; several coauthors also disclosed support from these organizations, as well as from Gilead and Merck.

Source: Møller DL et al. BMC Infect Dis. 2021 Jun 8. doi: 10.1186/s12879-021-06224-2.

Key clinical point: Fungal or bacterial bloodstream infections were common in children within 5 years of liver or kidney transplants; the overall incidence in the first year post-transplant was 1.91 per 100 recipients per month.

Major finding:  A total of 29 of 85 children who underwent liver or kidney transplants developed bacterial or fungal bloodstream infections within 5 years of their transplants with 16 different pathogens; the most common were Enterococcus faecium, Candida albicans, Escherichia coli, and Klebsiella pneumoniae.

Study details: The data come from a prospective study of 85 pediatric patients who underwent liver and kidney transplants between 2010 and 2017; the total follow-up was 390 person-years.

Disclosures: The study was supported by the Novo Nordic Foundation, the Independent Research Fund (FSS), the Danish National Research Foundation (DNRF), and the Research Foundation of Rigshospitalet; several coauthors also disclosed support from these organizations, as well as from Gilead and Merck.

Source: Møller DL et al. BMC Infect Dis. 2021 Jun 8. doi: 10.1186/s12879-021-06224-2.

Key clinical point: Fungal or bacterial bloodstream infections were common in children within 5 years of liver or kidney transplants; the overall incidence in the first year post-transplant was 1.91 per 100 recipients per month.

Major finding:  A total of 29 of 85 children who underwent liver or kidney transplants developed bacterial or fungal bloodstream infections within 5 years of their transplants with 16 different pathogens; the most common were Enterococcus faecium, Candida albicans, Escherichia coli, and Klebsiella pneumoniae.

Study details: The data come from a prospective study of 85 pediatric patients who underwent liver and kidney transplants between 2010 and 2017; the total follow-up was 390 person-years.

Disclosures: The study was supported by the Novo Nordic Foundation, the Independent Research Fund (FSS), the Danish National Research Foundation (DNRF), and the Research Foundation of Rigshospitalet; several coauthors also disclosed support from these organizations, as well as from Gilead and Merck.

Source: Møller DL et al. BMC Infect Dis. 2021 Jun 8. doi: 10.1186/s12879-021-06224-2.

Key clinical point: Mucormycosis cases surged after the appearance of COVID-19, but adjunct surgery in COVID-19 patients with mucormycosis improved clinical outcomes.

Major finding:  The mortality rate among 99 COVID-19 patients with mucormycosis was 34%. However, 81% of the patients underwent adjunct surgery, which significantly improved outcomes (P < 0.001).

Study details: The data come from 30 case series and case reports totaling 99 patients with COVID-19-associated mucormycosis (CAM). Glucocorticoids, a known risk factor for CAM, were used in 85% of the patients, and the average time from COVID-19 diagnosis to CAM diagnosis was 15 days.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pal R et al. Mycoses. 2021 Jun 16. doi: 10.1111/myc.13338.

Key clinical point: Mucormycosis cases surged after the appearance of COVID-19, but adjunct surgery in COVID-19 patients with mucormycosis improved clinical outcomes.

Major finding:  The mortality rate among 99 COVID-19 patients with mucormycosis was 34%. However, 81% of the patients underwent adjunct surgery, which significantly improved outcomes (P < 0.001).

Study details: The data come from 30 case series and case reports totaling 99 patients with COVID-19-associated mucormycosis (CAM). Glucocorticoids, a known risk factor for CAM, were used in 85% of the patients, and the average time from COVID-19 diagnosis to CAM diagnosis was 15 days.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pal R et al. Mycoses. 2021 Jun 16. doi: 10.1111/myc.13338.

Key clinical point: Mucormycosis cases surged after the appearance of COVID-19, but adjunct surgery in COVID-19 patients with mucormycosis improved clinical outcomes.

Major finding:  The mortality rate among 99 COVID-19 patients with mucormycosis was 34%. However, 81% of the patients underwent adjunct surgery, which significantly improved outcomes (P < 0.001).

Study details: The data come from 30 case series and case reports totaling 99 patients with COVID-19-associated mucormycosis (CAM). Glucocorticoids, a known risk factor for CAM, were used in 85% of the patients, and the average time from COVID-19 diagnosis to CAM diagnosis was 15 days.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pal R et al. Mycoses. 2021 Jun 16. doi: 10.1111/myc.13338.

Newly updated COVID-19 vaccination guidance from the American College of Rheumatology offers detailed insight into how clinicians should proceed with use, timing, and prioritization of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases (RMDs).

“The task force advised health care providers to avoid being overly dogmatic in following these recommendations,” Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, and colleagues wrote. “The attempt to optimize vaccine response in relation to the use and timing of immunosuppressive medications should not compromise a willing patient’s ability to undergo vaccination in a timely manner and risk a missed vaccination opportunity.” The guidelines were published in Arthritis & Rheumatology.

To review the published literature and determine the safety and efficacy of the available COVID-19 vaccines for patients with RMDs, a task force made up of nine rheumatologists/immunologists, two infectious disease specialists, and two public health physicians was formed. The ACR COVID-19 Vaccine Guidance Task Force considered vaccine clinical trial data and overall COVID-19 risk and outcomes among RMD patients, along with the immunogenicity of other vaccines in patients on immunomodulatory therapies and the safety profile of non-COVID vaccines in RMD patients.

Using a 9-point numeric scoring system, the task force developed 74 draft guidance statements that were rated with a median score of 7, 8, or 9. Consensus was deemed strong for 16 of the statements and moderate for the remaining 58.

Of the general considerations related to COVID-19 vaccination, the only statement to achieve strong consensus called for the rheumatology health care provider to take responsibility for assessing their patients’ COVID-19 vaccination status. Other notable statements asserted that patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at higher risk for hospitalized COVID-19, compared with the general population, and should be prioritized for vaccination accordingly, even though a risk for disease flare or worsening exists and the expected vaccine response for patients on systemic immunomodulatory therapies is “likely to be blunted in its magnitude and duration.”
 

Takeaway advice

When asked about a top-line takeaway for rheumatologists, Dr. Curtis replied: “Make sure that your patients are getting vaccinated. Even though the vaccine in patients with compromised immune systems might not work quite as well and might not last quite as long, they still should get vaccinated. And vaccine hesitancy is a real thing.”

Citing unpublished survey data, he estimated that roughly 25% of people with rheumatic conditions remain unvaccinated, and more than half of them said they had no vaccination plans. “That’s a pretty important message when up to a quarter of your higher-risk people take a pass,” he said. “You’d expect it to be better in people at risk who are on steroids or immune medications. That’s something rheumatologists can help with the most.”

Regarding vaccine use, the task force strongly recommended that RMD patients be offered COVID-19 vaccinations consistent with the emergency use authorization’s current age restrictions and/or Food and Drug Administration approval. They also strongly recommended patients with AIIRDs receive the second dose of a multidose vaccine, even if the first dose led to nonserious adverse events, and that health care providers avoid ordering lab testing to assess COVID-19 immunity in vaccinated and unvaccinated patients.

The issues around testing for immunity are ample, Dr. Curtis said. For starters, “there are different antibodies, and one of them wouldn’t be expected to go up after vaccination.” And even if you are testing for the correct antibodies, “now I get a number. Is my number high enough that says that I’m protected? That’s what clinicians want, that’s what patients want. Unfortunately, we don’t have that test. There’s an antibody test; you can test against the spike protein and get a number, but whether that number has clinical relevance that says you’re protected, and how much, and for how long, we definitely don’t have that information. You could be falsely reassured or falsely alarmed by the results.”

This statement, he added, has been particularly divisive. “A bunch of rheumatologists have said to me: ‘Look, we’re doing this routinely for our patients.’ My rejoinder was: ‘That’s great to know; what’s the evidence base for what you’re doing there? Because I haven’t read that paper.’ I fully acknowledge that, in groups of patients on certain therapies, the antibody response seems somewhat lower. But doctors don’t treat groups of patients; we treat patients one at a time. And I want to know how to help the patient in front of me, and I want to know what to tell him or her if I get the results of an antibody test.”

Finally, the task force emphasized that all AIIRD patients should receive the COVID-19 vaccinations, exempting only those with life-threatening disease, and they stated no preference for one COVID-19 vaccine over the other.
 

Vaccine choice

“Should you prefer one vaccine or vaccine platform to another? That’s been incredibly controversial,” Dr. Curtis said. Though the efficacy of the mRNA vaccines is often cited at 90%, compared with the roughly 60%-70% efficacy of the Johnson and & Johnson single-dose vaccine, “they’re not head-to-head studies. They weren’t done in the same countries; they weren’t done with the same viral variants. They’re not being evaluated under similar conditions; it’s not fair to hold them up and say: ‘Apples to apples, this one is better than that one.’ ”

“On the other hand,” he added, “if you were choosing, which would you want? If you are given a choice, you’re probably going to have a preference. The downside for a public health group – this group, which is trying to help rheumatologists and their patients make prudent decisions in light of very imperfect and evolving evidence – is that most people don’t have a choice. So if you send the message that one vaccine might be better than another, if that makes people wait for the one that supposedly might be better, you’ve probably done something bad. They’re delaying for what may be a marginal reason, and some vaccine protection is better than no vaccine protection.”

Regarding vaccination timing in patients who are on immunomodulatory therapies, the task force strongly recommended not delaying or adjusting the timing for anyone on hydroxychloroquine, sulfasalazine, leflunomide, apremilast, or intravenous immunoglobulin. They moderately recommended the same for patients on numerous drugs, including methotrexate, tumor necrosis factor inhibitors, Janus kinase inhibitors, abatacept, and glucocorticoids. Patients on rituximab with a low COVID-19 risk were recommended to schedule their vaccination so that the vaccine series is initiated roughly 4 weeks before their next scheduled rituximab cycle.

Regarding the use and timing of immunomodulatory therapies in relation to vaccination, they strongly recommended no modifications for patients on hydroxychloroquine, apremilast, intravenous immunoglobulin, or glucocorticoids. They also moderately recommended no modifications for patients on numerous drugs, including sulfasalazine, leflunomide, azathioprine, oral cyclophosphamide, and TNF inhibitors.

Regarding limitations, the researchers noted that there is no direct evidence about COVID-19 vaccine safety and efficacy yet in this subset of patients. They also acknowledged that they did not follow the rigorous methodology typically used by the ACR in developing formal clinical practice guidelines, calling it an “expected limitation” given the need to issue timely and potentially lifesaving guidance for the rheumatology community.

The authors acknowledged several potential conflicts of interest, including receiving consulting fees, speaking fees, and research grants from various pharmaceutical companies.

Newly updated COVID-19 vaccination guidance from the American College of Rheumatology offers detailed insight into how clinicians should proceed with use, timing, and prioritization of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases (RMDs).

“The task force advised health care providers to avoid being overly dogmatic in following these recommendations,” Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, and colleagues wrote. “The attempt to optimize vaccine response in relation to the use and timing of immunosuppressive medications should not compromise a willing patient’s ability to undergo vaccination in a timely manner and risk a missed vaccination opportunity.” The guidelines were published in Arthritis & Rheumatology.

To review the published literature and determine the safety and efficacy of the available COVID-19 vaccines for patients with RMDs, a task force made up of nine rheumatologists/immunologists, two infectious disease specialists, and two public health physicians was formed. The ACR COVID-19 Vaccine Guidance Task Force considered vaccine clinical trial data and overall COVID-19 risk and outcomes among RMD patients, along with the immunogenicity of other vaccines in patients on immunomodulatory therapies and the safety profile of non-COVID vaccines in RMD patients.

Using a 9-point numeric scoring system, the task force developed 74 draft guidance statements that were rated with a median score of 7, 8, or 9. Consensus was deemed strong for 16 of the statements and moderate for the remaining 58.

Of the general considerations related to COVID-19 vaccination, the only statement to achieve strong consensus called for the rheumatology health care provider to take responsibility for assessing their patients’ COVID-19 vaccination status. Other notable statements asserted that patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at higher risk for hospitalized COVID-19, compared with the general population, and should be prioritized for vaccination accordingly, even though a risk for disease flare or worsening exists and the expected vaccine response for patients on systemic immunomodulatory therapies is “likely to be blunted in its magnitude and duration.”
 

Takeaway advice

When asked about a top-line takeaway for rheumatologists, Dr. Curtis replied: “Make sure that your patients are getting vaccinated. Even though the vaccine in patients with compromised immune systems might not work quite as well and might not last quite as long, they still should get vaccinated. And vaccine hesitancy is a real thing.”

Citing unpublished survey data, he estimated that roughly 25% of people with rheumatic conditions remain unvaccinated, and more than half of them said they had no vaccination plans. “That’s a pretty important message when up to a quarter of your higher-risk people take a pass,” he said. “You’d expect it to be better in people at risk who are on steroids or immune medications. That’s something rheumatologists can help with the most.”

Regarding vaccine use, the task force strongly recommended that RMD patients be offered COVID-19 vaccinations consistent with the emergency use authorization’s current age restrictions and/or Food and Drug Administration approval. They also strongly recommended patients with AIIRDs receive the second dose of a multidose vaccine, even if the first dose led to nonserious adverse events, and that health care providers avoid ordering lab testing to assess COVID-19 immunity in vaccinated and unvaccinated patients.

The issues around testing for immunity are ample, Dr. Curtis said. For starters, “there are different antibodies, and one of them wouldn’t be expected to go up after vaccination.” And even if you are testing for the correct antibodies, “now I get a number. Is my number high enough that says that I’m protected? That’s what clinicians want, that’s what patients want. Unfortunately, we don’t have that test. There’s an antibody test; you can test against the spike protein and get a number, but whether that number has clinical relevance that says you’re protected, and how much, and for how long, we definitely don’t have that information. You could be falsely reassured or falsely alarmed by the results.”

This statement, he added, has been particularly divisive. “A bunch of rheumatologists have said to me: ‘Look, we’re doing this routinely for our patients.’ My rejoinder was: ‘That’s great to know; what’s the evidence base for what you’re doing there? Because I haven’t read that paper.’ I fully acknowledge that, in groups of patients on certain therapies, the antibody response seems somewhat lower. But doctors don’t treat groups of patients; we treat patients one at a time. And I want to know how to help the patient in front of me, and I want to know what to tell him or her if I get the results of an antibody test.”

Finally, the task force emphasized that all AIIRD patients should receive the COVID-19 vaccinations, exempting only those with life-threatening disease, and they stated no preference for one COVID-19 vaccine over the other.
 

Vaccine choice

“Should you prefer one vaccine or vaccine platform to another? That’s been incredibly controversial,” Dr. Curtis said. Though the efficacy of the mRNA vaccines is often cited at 90%, compared with the roughly 60%-70% efficacy of the Johnson and & Johnson single-dose vaccine, “they’re not head-to-head studies. They weren’t done in the same countries; they weren’t done with the same viral variants. They’re not being evaluated under similar conditions; it’s not fair to hold them up and say: ‘Apples to apples, this one is better than that one.’ ”

“On the other hand,” he added, “if you were choosing, which would you want? If you are given a choice, you’re probably going to have a preference. The downside for a public health group – this group, which is trying to help rheumatologists and their patients make prudent decisions in light of very imperfect and evolving evidence – is that most people don’t have a choice. So if you send the message that one vaccine might be better than another, if that makes people wait for the one that supposedly might be better, you’ve probably done something bad. They’re delaying for what may be a marginal reason, and some vaccine protection is better than no vaccine protection.”

Regarding vaccination timing in patients who are on immunomodulatory therapies, the task force strongly recommended not delaying or adjusting the timing for anyone on hydroxychloroquine, sulfasalazine, leflunomide, apremilast, or intravenous immunoglobulin. They moderately recommended the same for patients on numerous drugs, including methotrexate, tumor necrosis factor inhibitors, Janus kinase inhibitors, abatacept, and glucocorticoids. Patients on rituximab with a low COVID-19 risk were recommended to schedule their vaccination so that the vaccine series is initiated roughly 4 weeks before their next scheduled rituximab cycle.

Regarding the use and timing of immunomodulatory therapies in relation to vaccination, they strongly recommended no modifications for patients on hydroxychloroquine, apremilast, intravenous immunoglobulin, or glucocorticoids. They also moderately recommended no modifications for patients on numerous drugs, including sulfasalazine, leflunomide, azathioprine, oral cyclophosphamide, and TNF inhibitors.

Regarding limitations, the researchers noted that there is no direct evidence about COVID-19 vaccine safety and efficacy yet in this subset of patients. They also acknowledged that they did not follow the rigorous methodology typically used by the ACR in developing formal clinical practice guidelines, calling it an “expected limitation” given the need to issue timely and potentially lifesaving guidance for the rheumatology community.

The authors acknowledged several potential conflicts of interest, including receiving consulting fees, speaking fees, and research grants from various pharmaceutical companies.

Newly updated COVID-19 vaccination guidance from the American College of Rheumatology offers detailed insight into how clinicians should proceed with use, timing, and prioritization of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases (RMDs).

“The task force advised health care providers to avoid being overly dogmatic in following these recommendations,” Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, and colleagues wrote. “The attempt to optimize vaccine response in relation to the use and timing of immunosuppressive medications should not compromise a willing patient’s ability to undergo vaccination in a timely manner and risk a missed vaccination opportunity.” The guidelines were published in Arthritis & Rheumatology.

To review the published literature and determine the safety and efficacy of the available COVID-19 vaccines for patients with RMDs, a task force made up of nine rheumatologists/immunologists, two infectious disease specialists, and two public health physicians was formed. The ACR COVID-19 Vaccine Guidance Task Force considered vaccine clinical trial data and overall COVID-19 risk and outcomes among RMD patients, along with the immunogenicity of other vaccines in patients on immunomodulatory therapies and the safety profile of non-COVID vaccines in RMD patients.

Using a 9-point numeric scoring system, the task force developed 74 draft guidance statements that were rated with a median score of 7, 8, or 9. Consensus was deemed strong for 16 of the statements and moderate for the remaining 58.

Of the general considerations related to COVID-19 vaccination, the only statement to achieve strong consensus called for the rheumatology health care provider to take responsibility for assessing their patients’ COVID-19 vaccination status. Other notable statements asserted that patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at higher risk for hospitalized COVID-19, compared with the general population, and should be prioritized for vaccination accordingly, even though a risk for disease flare or worsening exists and the expected vaccine response for patients on systemic immunomodulatory therapies is “likely to be blunted in its magnitude and duration.”
 

Takeaway advice

When asked about a top-line takeaway for rheumatologists, Dr. Curtis replied: “Make sure that your patients are getting vaccinated. Even though the vaccine in patients with compromised immune systems might not work quite as well and might not last quite as long, they still should get vaccinated. And vaccine hesitancy is a real thing.”

Citing unpublished survey data, he estimated that roughly 25% of people with rheumatic conditions remain unvaccinated, and more than half of them said they had no vaccination plans. “That’s a pretty important message when up to a quarter of your higher-risk people take a pass,” he said. “You’d expect it to be better in people at risk who are on steroids or immune medications. That’s something rheumatologists can help with the most.”

Regarding vaccine use, the task force strongly recommended that RMD patients be offered COVID-19 vaccinations consistent with the emergency use authorization’s current age restrictions and/or Food and Drug Administration approval. They also strongly recommended patients with AIIRDs receive the second dose of a multidose vaccine, even if the first dose led to nonserious adverse events, and that health care providers avoid ordering lab testing to assess COVID-19 immunity in vaccinated and unvaccinated patients.

The issues around testing for immunity are ample, Dr. Curtis said. For starters, “there are different antibodies, and one of them wouldn’t be expected to go up after vaccination.” And even if you are testing for the correct antibodies, “now I get a number. Is my number high enough that says that I’m protected? That’s what clinicians want, that’s what patients want. Unfortunately, we don’t have that test. There’s an antibody test; you can test against the spike protein and get a number, but whether that number has clinical relevance that says you’re protected, and how much, and for how long, we definitely don’t have that information. You could be falsely reassured or falsely alarmed by the results.”

This statement, he added, has been particularly divisive. “A bunch of rheumatologists have said to me: ‘Look, we’re doing this routinely for our patients.’ My rejoinder was: ‘That’s great to know; what’s the evidence base for what you’re doing there? Because I haven’t read that paper.’ I fully acknowledge that, in groups of patients on certain therapies, the antibody response seems somewhat lower. But doctors don’t treat groups of patients; we treat patients one at a time. And I want to know how to help the patient in front of me, and I want to know what to tell him or her if I get the results of an antibody test.”

Finally, the task force emphasized that all AIIRD patients should receive the COVID-19 vaccinations, exempting only those with life-threatening disease, and they stated no preference for one COVID-19 vaccine over the other.
 

Vaccine choice

“Should you prefer one vaccine or vaccine platform to another? That’s been incredibly controversial,” Dr. Curtis said. Though the efficacy of the mRNA vaccines is often cited at 90%, compared with the roughly 60%-70% efficacy of the Johnson and & Johnson single-dose vaccine, “they’re not head-to-head studies. They weren’t done in the same countries; they weren’t done with the same viral variants. They’re not being evaluated under similar conditions; it’s not fair to hold them up and say: ‘Apples to apples, this one is better than that one.’ ”

“On the other hand,” he added, “if you were choosing, which would you want? If you are given a choice, you’re probably going to have a preference. The downside for a public health group – this group, which is trying to help rheumatologists and their patients make prudent decisions in light of very imperfect and evolving evidence – is that most people don’t have a choice. So if you send the message that one vaccine might be better than another, if that makes people wait for the one that supposedly might be better, you’ve probably done something bad. They’re delaying for what may be a marginal reason, and some vaccine protection is better than no vaccine protection.”

Regarding vaccination timing in patients who are on immunomodulatory therapies, the task force strongly recommended not delaying or adjusting the timing for anyone on hydroxychloroquine, sulfasalazine, leflunomide, apremilast, or intravenous immunoglobulin. They moderately recommended the same for patients on numerous drugs, including methotrexate, tumor necrosis factor inhibitors, Janus kinase inhibitors, abatacept, and glucocorticoids. Patients on rituximab with a low COVID-19 risk were recommended to schedule their vaccination so that the vaccine series is initiated roughly 4 weeks before their next scheduled rituximab cycle.

Regarding the use and timing of immunomodulatory therapies in relation to vaccination, they strongly recommended no modifications for patients on hydroxychloroquine, apremilast, intravenous immunoglobulin, or glucocorticoids. They also moderately recommended no modifications for patients on numerous drugs, including sulfasalazine, leflunomide, azathioprine, oral cyclophosphamide, and TNF inhibitors.

Regarding limitations, the researchers noted that there is no direct evidence about COVID-19 vaccine safety and efficacy yet in this subset of patients. They also acknowledged that they did not follow the rigorous methodology typically used by the ACR in developing formal clinical practice guidelines, calling it an “expected limitation” given the need to issue timely and potentially lifesaving guidance for the rheumatology community.

The authors acknowledged several potential conflicts of interest, including receiving consulting fees, speaking fees, and research grants from various pharmaceutical companies.

The Food and Drug Administration is adding a warning to mRNA COVID-19 vaccines’ fact sheets as medical experts continue to investigate cases of heart inflammation, which are rare but are more likely to occur in young men and teen boys.

Doran Fink, MD, PhD, deputy director of the FDA’s division of vaccines and related products applications, told a Centers for Disease Control and Prevention expert panel on June 23 that the FDA is finalizing language on a warning statement for health care providers, vaccine recipients, and parents or caregivers of teens.

The incidents are more likely to follow the second dose of the Pfizer or Moderna vaccine, with chest pain and other symptoms occurring within several days to a week, the warning will note.

“Based on limited follow-up, most cases appear to have been associated with resolution of symptoms, but limited information is available about potential long-term sequelae,” Dr. Fink said, describing the statement to the Advisory Committee on Immunization Practices, independent experts who advise the CDC.

“Symptoms suggestive of myocarditis or pericarditis should result in vaccine recipients seeking medical attention,” he said.
 

Benefits outweigh risks

Although no formal vote occurred after the meeting, the ACIP members delivered a strong endorsement for continuing to vaccinate 12- to 29-year-olds with the Pfizer and Moderna vaccines despite the warning.

“To me it’s clear, based on current information, that the benefits of vaccine clearly outweigh the risks,” said ACIP member Veronica McNally, president and CEO of the Franny Strong Foundation in Bloomfield, Mich., a sentiment echoed by other members.

As ACIP was meeting, leaders of the nation’s major physician, nurse, and public health associations issued a statement supporting continued vaccination: “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination.

“Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

ACIP heard the evidence behind that claim. According to the Vaccine Safety Datalink, which contains data from more than 12 million medical records, myocarditis or pericarditis occurs in 12- to 39-year-olds at a rate of 8 per 1 million after the second Pfizer dose and 19.8 per 1 million after the second Moderna dose.

The CDC continues to investigate the link between the mRNA vaccines and heart inflammation, including any differences between the vaccines.

Most of the symptoms resolved quickly, said Tom Shimabukuro, deputy director of CDC’s Immunization Safety Office. Of 323 cases analyzed by the CDC, 309 were hospitalized, 295 were discharged, and 218, or 79%, had recovered from symptoms.

“Most postvaccine myocarditis has been responding to minimal treatment,” pediatric cardiologist Matthew Oster, MD, MPH, from Children’s Healthcare of Atlanta, told the panel.
 

COVID ‘risks are higher’

Overall, the CDC has reported 2,767 COVID-19 deaths among people aged 12-29 years, and there have been 4,018 reported cases of the COVID-linked inflammatory disorder MIS-C since the beginning of the pandemic.

That amounts to 1 MIS-C case in every 3,200 COVID infections – 36% of them among teens aged 12-20 years and 62% among children who are Hispanic or Black and non-Hispanic, according to a CDC presentation.

The CDC estimated that every 1 million second-dose COVID vaccines administered to 12- to 17-year-old boys could prevent 5,700 cases of COVID-19, 215 hospitalizations, 71 ICU admissions, and 2 deaths. There could also be 56-69 myocarditis cases.

The emergence of new variants in the United States and the skewed pattern of vaccination around the country also may increase the risk to unvaccinated young people, noted Grace Lee, MD, MPH, chair of the ACIP’s COVID-19 Vaccine Safety Technical Subgroup and a pediatric infectious disease physician at Stanford (Calif.) Children’s Health.

“If you’re in an area with low vaccination, the risks are higher,” she said. “The benefits [of the vaccine] are going to be far, far greater than any risk.”

Individuals, parents, and their clinicians should consider the full scope of risk when making decisions about vaccination, she said.

As the pandemic evolves, medical experts have to balance the known risks and benefits while they gather more information, said William Schaffner, MD, an infectious disease physician at Vanderbilt University, Nashville, Tenn., and medical director of the National Foundation for Infectious Diseases.

“The story is not over,” Dr. Schaffner said in an interview. “Clearly, we are still working in the face of a pandemic, so there’s urgency to continue vaccinating. But they would like to know more about the long-term consequences of the myocarditis.”
 

Booster possibilities

Meanwhile, ACIP began conversations on the parameters for a possible vaccine booster. For now, there are simply questions: Would a third vaccine help the immunocompromised gain protection? Should people get a different type of vaccine – mRNA versus adenovirus vector – for their booster? Most important, how long do antibodies last?

“Prior to going around giving everyone boosters, we really need to improve the overall vaccination coverage,” said Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University. “That will protect everyone.”

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

The Food and Drug Administration is adding a warning to mRNA COVID-19 vaccines’ fact sheets as medical experts continue to investigate cases of heart inflammation, which are rare but are more likely to occur in young men and teen boys.

Doran Fink, MD, PhD, deputy director of the FDA’s division of vaccines and related products applications, told a Centers for Disease Control and Prevention expert panel on June 23 that the FDA is finalizing language on a warning statement for health care providers, vaccine recipients, and parents or caregivers of teens.

The incidents are more likely to follow the second dose of the Pfizer or Moderna vaccine, with chest pain and other symptoms occurring within several days to a week, the warning will note.

“Based on limited follow-up, most cases appear to have been associated with resolution of symptoms, but limited information is available about potential long-term sequelae,” Dr. Fink said, describing the statement to the Advisory Committee on Immunization Practices, independent experts who advise the CDC.

“Symptoms suggestive of myocarditis or pericarditis should result in vaccine recipients seeking medical attention,” he said.
 

Benefits outweigh risks

Although no formal vote occurred after the meeting, the ACIP members delivered a strong endorsement for continuing to vaccinate 12- to 29-year-olds with the Pfizer and Moderna vaccines despite the warning.

“To me it’s clear, based on current information, that the benefits of vaccine clearly outweigh the risks,” said ACIP member Veronica McNally, president and CEO of the Franny Strong Foundation in Bloomfield, Mich., a sentiment echoed by other members.

As ACIP was meeting, leaders of the nation’s major physician, nurse, and public health associations issued a statement supporting continued vaccination: “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination.

“Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

ACIP heard the evidence behind that claim. According to the Vaccine Safety Datalink, which contains data from more than 12 million medical records, myocarditis or pericarditis occurs in 12- to 39-year-olds at a rate of 8 per 1 million after the second Pfizer dose and 19.8 per 1 million after the second Moderna dose.

The CDC continues to investigate the link between the mRNA vaccines and heart inflammation, including any differences between the vaccines.

Most of the symptoms resolved quickly, said Tom Shimabukuro, deputy director of CDC’s Immunization Safety Office. Of 323 cases analyzed by the CDC, 309 were hospitalized, 295 were discharged, and 218, or 79%, had recovered from symptoms.

“Most postvaccine myocarditis has been responding to minimal treatment,” pediatric cardiologist Matthew Oster, MD, MPH, from Children’s Healthcare of Atlanta, told the panel.
 

COVID ‘risks are higher’

Overall, the CDC has reported 2,767 COVID-19 deaths among people aged 12-29 years, and there have been 4,018 reported cases of the COVID-linked inflammatory disorder MIS-C since the beginning of the pandemic.

That amounts to 1 MIS-C case in every 3,200 COVID infections – 36% of them among teens aged 12-20 years and 62% among children who are Hispanic or Black and non-Hispanic, according to a CDC presentation.

The CDC estimated that every 1 million second-dose COVID vaccines administered to 12- to 17-year-old boys could prevent 5,700 cases of COVID-19, 215 hospitalizations, 71 ICU admissions, and 2 deaths. There could also be 56-69 myocarditis cases.

The emergence of new variants in the United States and the skewed pattern of vaccination around the country also may increase the risk to unvaccinated young people, noted Grace Lee, MD, MPH, chair of the ACIP’s COVID-19 Vaccine Safety Technical Subgroup and a pediatric infectious disease physician at Stanford (Calif.) Children’s Health.

“If you’re in an area with low vaccination, the risks are higher,” she said. “The benefits [of the vaccine] are going to be far, far greater than any risk.”

Individuals, parents, and their clinicians should consider the full scope of risk when making decisions about vaccination, she said.

As the pandemic evolves, medical experts have to balance the known risks and benefits while they gather more information, said William Schaffner, MD, an infectious disease physician at Vanderbilt University, Nashville, Tenn., and medical director of the National Foundation for Infectious Diseases.

“The story is not over,” Dr. Schaffner said in an interview. “Clearly, we are still working in the face of a pandemic, so there’s urgency to continue vaccinating. But they would like to know more about the long-term consequences of the myocarditis.”
 

Booster possibilities

Meanwhile, ACIP began conversations on the parameters for a possible vaccine booster. For now, there are simply questions: Would a third vaccine help the immunocompromised gain protection? Should people get a different type of vaccine – mRNA versus adenovirus vector – for their booster? Most important, how long do antibodies last?

“Prior to going around giving everyone boosters, we really need to improve the overall vaccination coverage,” said Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University. “That will protect everyone.”

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

The Food and Drug Administration is adding a warning to mRNA COVID-19 vaccines’ fact sheets as medical experts continue to investigate cases of heart inflammation, which are rare but are more likely to occur in young men and teen boys.

Doran Fink, MD, PhD, deputy director of the FDA’s division of vaccines and related products applications, told a Centers for Disease Control and Prevention expert panel on June 23 that the FDA is finalizing language on a warning statement for health care providers, vaccine recipients, and parents or caregivers of teens.

The incidents are more likely to follow the second dose of the Pfizer or Moderna vaccine, with chest pain and other symptoms occurring within several days to a week, the warning will note.

“Based on limited follow-up, most cases appear to have been associated with resolution of symptoms, but limited information is available about potential long-term sequelae,” Dr. Fink said, describing the statement to the Advisory Committee on Immunization Practices, independent experts who advise the CDC.

“Symptoms suggestive of myocarditis or pericarditis should result in vaccine recipients seeking medical attention,” he said.
 

Benefits outweigh risks

Although no formal vote occurred after the meeting, the ACIP members delivered a strong endorsement for continuing to vaccinate 12- to 29-year-olds with the Pfizer and Moderna vaccines despite the warning.

“To me it’s clear, based on current information, that the benefits of vaccine clearly outweigh the risks,” said ACIP member Veronica McNally, president and CEO of the Franny Strong Foundation in Bloomfield, Mich., a sentiment echoed by other members.

As ACIP was meeting, leaders of the nation’s major physician, nurse, and public health associations issued a statement supporting continued vaccination: “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination.

“Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

ACIP heard the evidence behind that claim. According to the Vaccine Safety Datalink, which contains data from more than 12 million medical records, myocarditis or pericarditis occurs in 12- to 39-year-olds at a rate of 8 per 1 million after the second Pfizer dose and 19.8 per 1 million after the second Moderna dose.

The CDC continues to investigate the link between the mRNA vaccines and heart inflammation, including any differences between the vaccines.

Most of the symptoms resolved quickly, said Tom Shimabukuro, deputy director of CDC’s Immunization Safety Office. Of 323 cases analyzed by the CDC, 309 were hospitalized, 295 were discharged, and 218, or 79%, had recovered from symptoms.

“Most postvaccine myocarditis has been responding to minimal treatment,” pediatric cardiologist Matthew Oster, MD, MPH, from Children’s Healthcare of Atlanta, told the panel.
 

COVID ‘risks are higher’

Overall, the CDC has reported 2,767 COVID-19 deaths among people aged 12-29 years, and there have been 4,018 reported cases of the COVID-linked inflammatory disorder MIS-C since the beginning of the pandemic.

That amounts to 1 MIS-C case in every 3,200 COVID infections – 36% of them among teens aged 12-20 years and 62% among children who are Hispanic or Black and non-Hispanic, according to a CDC presentation.

The CDC estimated that every 1 million second-dose COVID vaccines administered to 12- to 17-year-old boys could prevent 5,700 cases of COVID-19, 215 hospitalizations, 71 ICU admissions, and 2 deaths. There could also be 56-69 myocarditis cases.

The emergence of new variants in the United States and the skewed pattern of vaccination around the country also may increase the risk to unvaccinated young people, noted Grace Lee, MD, MPH, chair of the ACIP’s COVID-19 Vaccine Safety Technical Subgroup and a pediatric infectious disease physician at Stanford (Calif.) Children’s Health.

“If you’re in an area with low vaccination, the risks are higher,” she said. “The benefits [of the vaccine] are going to be far, far greater than any risk.”

Individuals, parents, and their clinicians should consider the full scope of risk when making decisions about vaccination, she said.

As the pandemic evolves, medical experts have to balance the known risks and benefits while they gather more information, said William Schaffner, MD, an infectious disease physician at Vanderbilt University, Nashville, Tenn., and medical director of the National Foundation for Infectious Diseases.

“The story is not over,” Dr. Schaffner said in an interview. “Clearly, we are still working in the face of a pandemic, so there’s urgency to continue vaccinating. But they would like to know more about the long-term consequences of the myocarditis.”
 

Booster possibilities

Meanwhile, ACIP began conversations on the parameters for a possible vaccine booster. For now, there are simply questions: Would a third vaccine help the immunocompromised gain protection? Should people get a different type of vaccine – mRNA versus adenovirus vector – for their booster? Most important, how long do antibodies last?

“Prior to going around giving everyone boosters, we really need to improve the overall vaccination coverage,” said Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University. “That will protect everyone.”

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