Feature

Mt. Sinai Hospital in New York, was No. 1 this year in geriatric care, according to rankings by U.S. News & World Report. The Cleveland Clinic in Ohio, and the Mayo Clinic in Rochester, Minn., followed.

Rounding out the top 10 hospitals in caring for patients older than age 75 were (4) UCLA Medical Center, Los Angeles; (5) NYU Langone Hospitals in New York; (6) Johns Hopkins Hospital in Baltimore; (7) New York–Presbyterian Hospital–Columbia and Cornell, New York; (8) Northwestern Memorial Hospital, Chicago; (9) UCSF Medical Center, San Francisco; and (10) Cedars-Sinai Medical Center, Los Angeles.

Those were followed by (11) Keck Medical Center of USC, Los Angeles; (12) University of Michigan Hospitals–Michigan Medicine, Ann Arbor; (13) UC San Diego Health–Jacobs Medical Center, San Diego; (14) Massachusetts General Hospital, Boston; (15) Stanford Health Care–Stanford Hospital, Palo Alto, Calif.; (16) Rush University Medical Center, Chicago; (17) Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia; (18) Brigham and Women’s Hospital, Boston; (19) Barnes-Jewish Hospital, St. Louis, Mo.; (tied for 19) UPMC Presbyterian Shadyside, Pittsburgh.

Data for the 2021-2022 edition of the “Best Hospitals” were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

U.S. News also investigated racial disparities in health care and debuted health equity measures alongside each hospital’s rankings. Among other aspects of health equity, the new measures examine whether the patients each hospital treated reflect the racial and ethnic diversity of its community.

Ben Harder, managing editor and chief of health analysis, said in a statement, “At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery, and common heart procedures. Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents.”

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again No. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release. The Cleveland Clinic ranked No. 2, followed by UCLA Medical Center at No. 3.

In other top specialties, the University of Texas MD Anderson Cancer Center in Houston ranked No. 1 in cancer; the Cleveland Clinic is No. 1 in cardiology and heart surgery; and the Hospital for Special Surgery in New York is No. 1 in orthopedics.

A full list of rankings is available on the website.

In 12 of the 15 specialty areas, including geriatrics, rankings are derived from data sources such as Medicare. In the other three specialties – ophthalmology, psychiatry, and rheumatology – ranking is determined by expert opinion based on responses from 3 years of surveys of physician specialists who were asked to name the hospitals to which they would likely refer their sickest patients.

This year’s analysis adds seven new procedures and conditions: Heart attack, stroke, pneumonia, diabetes, kidney failure, hip fracture, and back surgery (spinal fusion).

The expanded list will help patients, in consultation with their physicians, choose their hospital on the basis of the specific type of care they need with consideration of distance to a facility and insurance coverage.

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

Mt. Sinai Hospital in New York, was No. 1 this year in geriatric care, according to rankings by U.S. News & World Report. The Cleveland Clinic in Ohio, and the Mayo Clinic in Rochester, Minn., followed.

Rounding out the top 10 hospitals in caring for patients older than age 75 were (4) UCLA Medical Center, Los Angeles; (5) NYU Langone Hospitals in New York; (6) Johns Hopkins Hospital in Baltimore; (7) New York–Presbyterian Hospital–Columbia and Cornell, New York; (8) Northwestern Memorial Hospital, Chicago; (9) UCSF Medical Center, San Francisco; and (10) Cedars-Sinai Medical Center, Los Angeles.

Those were followed by (11) Keck Medical Center of USC, Los Angeles; (12) University of Michigan Hospitals–Michigan Medicine, Ann Arbor; (13) UC San Diego Health–Jacobs Medical Center, San Diego; (14) Massachusetts General Hospital, Boston; (15) Stanford Health Care–Stanford Hospital, Palo Alto, Calif.; (16) Rush University Medical Center, Chicago; (17) Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia; (18) Brigham and Women’s Hospital, Boston; (19) Barnes-Jewish Hospital, St. Louis, Mo.; (tied for 19) UPMC Presbyterian Shadyside, Pittsburgh.

Data for the 2021-2022 edition of the “Best Hospitals” were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

U.S. News also investigated racial disparities in health care and debuted health equity measures alongside each hospital’s rankings. Among other aspects of health equity, the new measures examine whether the patients each hospital treated reflect the racial and ethnic diversity of its community.

Ben Harder, managing editor and chief of health analysis, said in a statement, “At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery, and common heart procedures. Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents.”

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again No. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release. The Cleveland Clinic ranked No. 2, followed by UCLA Medical Center at No. 3.

In other top specialties, the University of Texas MD Anderson Cancer Center in Houston ranked No. 1 in cancer; the Cleveland Clinic is No. 1 in cardiology and heart surgery; and the Hospital for Special Surgery in New York is No. 1 in orthopedics.

A full list of rankings is available on the website.

In 12 of the 15 specialty areas, including geriatrics, rankings are derived from data sources such as Medicare. In the other three specialties – ophthalmology, psychiatry, and rheumatology – ranking is determined by expert opinion based on responses from 3 years of surveys of physician specialists who were asked to name the hospitals to which they would likely refer their sickest patients.

This year’s analysis adds seven new procedures and conditions: Heart attack, stroke, pneumonia, diabetes, kidney failure, hip fracture, and back surgery (spinal fusion).

The expanded list will help patients, in consultation with their physicians, choose their hospital on the basis of the specific type of care they need with consideration of distance to a facility and insurance coverage.

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

Mt. Sinai Hospital in New York, was No. 1 this year in geriatric care, according to rankings by U.S. News & World Report. The Cleveland Clinic in Ohio, and the Mayo Clinic in Rochester, Minn., followed.

Rounding out the top 10 hospitals in caring for patients older than age 75 were (4) UCLA Medical Center, Los Angeles; (5) NYU Langone Hospitals in New York; (6) Johns Hopkins Hospital in Baltimore; (7) New York–Presbyterian Hospital–Columbia and Cornell, New York; (8) Northwestern Memorial Hospital, Chicago; (9) UCSF Medical Center, San Francisco; and (10) Cedars-Sinai Medical Center, Los Angeles.

Those were followed by (11) Keck Medical Center of USC, Los Angeles; (12) University of Michigan Hospitals–Michigan Medicine, Ann Arbor; (13) UC San Diego Health–Jacobs Medical Center, San Diego; (14) Massachusetts General Hospital, Boston; (15) Stanford Health Care–Stanford Hospital, Palo Alto, Calif.; (16) Rush University Medical Center, Chicago; (17) Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia; (18) Brigham and Women’s Hospital, Boston; (19) Barnes-Jewish Hospital, St. Louis, Mo.; (tied for 19) UPMC Presbyterian Shadyside, Pittsburgh.

Data for the 2021-2022 edition of the “Best Hospitals” were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

U.S. News also investigated racial disparities in health care and debuted health equity measures alongside each hospital’s rankings. Among other aspects of health equity, the new measures examine whether the patients each hospital treated reflect the racial and ethnic diversity of its community.

Ben Harder, managing editor and chief of health analysis, said in a statement, “At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery, and common heart procedures. Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents.”

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again No. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release. The Cleveland Clinic ranked No. 2, followed by UCLA Medical Center at No. 3.

In other top specialties, the University of Texas MD Anderson Cancer Center in Houston ranked No. 1 in cancer; the Cleveland Clinic is No. 1 in cardiology and heart surgery; and the Hospital for Special Surgery in New York is No. 1 in orthopedics.

A full list of rankings is available on the website.

In 12 of the 15 specialty areas, including geriatrics, rankings are derived from data sources such as Medicare. In the other three specialties – ophthalmology, psychiatry, and rheumatology – ranking is determined by expert opinion based on responses from 3 years of surveys of physician specialists who were asked to name the hospitals to which they would likely refer their sickest patients.

This year’s analysis adds seven new procedures and conditions: Heart attack, stroke, pneumonia, diabetes, kidney failure, hip fracture, and back surgery (spinal fusion).

The expanded list will help patients, in consultation with their physicians, choose their hospital on the basis of the specific type of care they need with consideration of distance to a facility and insurance coverage.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

Mark Nelson, PharmD, recalls the anguish when a major pharmacy benefit manager (PBM) moved all veteran patients with prostate cancer at his facility from an effective medication to a pricier alternative therapy. “All of these patients were stable on their therapy and were extremely distraught about their medications being changed,” said Dr. Nelson, CEO of Northwest Medical Specialties in Washington State. While there was no clinical reason to change the medication, “our oncologists had no choice other than to comply,” he said.

Niyazz/ThinkStock

It’s unclear why a PBM would switch to a more expensive medication that has no additional clinical benefit, he continued. “Why upset so many veterans? For what reason? We were not given a reason despite our very vocal protest.”

Angus B. Worthing, MD, sees these scenarios unfold every day in his rheumatology practice in the Washington, D.C., area. “In my clinic with 25 doctors, we have three full-time people that only handle PBMs,” he said in an interview. He and others in the medical community, as well as many states, have been pushing back on what they see as efforts by PBMs to raise drug prices and collect the profits at the expense of patients.

PCMA’s challenges against PBM law

The Pharmaceutical Care Management Association (PCMA), a trade group that represents PBMs, has sued at least a half dozen states on their ability to regulate PBMs. However, a landmark case in late 2020 (Pharmaceutical Care Management Association v. Rutledge) set a new precedent. Reversing a lower appeals court decision, the Supreme Court unanimously ruled in favor of allowing states to put in place fair regulation of these entities.

Dr. Worthing and others hope that the medical community and states can leverage this ruling in another lawsuit PCMA brought against North Dakota (PCMA v. Wehbi). PCMA filed this lawsuit in 2017, which challenges two statutes on PBM regulation. The group has issued similar legal challenges in Maine, the District of Columbia, Iowa, Oklahoma, and Arkansas with the Rutledge case.

“PBMs have become massive profit centers while (ironically) increasing patients’ out-of-pocket costs, interfering with doctor-patient relationships, and impairing patient access to appropriate treatment,” according to an amicus brief filed by The Alliance for Transparent & Affordable Prescriptions (ATAP), the Community Oncology Alliance (COA), and American Pharmacies, supporting North Dakota in the Wehbi case.

This is to ensure the case represents the voices of physicians, patients, nurses, and other stakeholders, and underscores PBM abuses, said Dr. Worthing, vice president of ATAP. He also serves as the American College of Rheumatology’s representative on ATAP’s Executive Committee.

PCMA did not respond to requests for comment. Its CEO and president, J.C. Scott, emphasizes that PBMs have a long track record of reducing drug costs for patients and plan sponsors. In 2021, PCMA released 21 policy solutions, a set of industry principles and a three-part policy platform, all with an aim to bring down costs and increase access to pharmaceutical care, according to the organization.

PCMA estimates that the strategies in its platform (updating Medicare Part D, accelerating value-based care, and eliminating anticompetitive ‘pay for delay’ agreements) would save the federal government a maximum of $398.7 billion over 10 years.

According to Wendy Hemmen, senior director with Texas Oncology in Dallas, PBMs do their own unique calculations to arrive at their cost reductions. “Essentially in a PBM, they use things that make their story. Numbers reported to plan sponsors and to the public are not audited and are usually in terms of percentages or a per member per month. Data points are moved around, dropped, or reclassified to make the story that the PBM needs to tell,” Ms. Hemmen said.


 

Amicus briefs dispute ERISA connection

North Dakota legislation prohibits PBMs from charging copays to patients that exceed the cost of a drug. It also prohibits gag clause provisions that restrict what pharmacists may discuss with patients. PBMs may charge fees based on performance metrics, but they must use nationally recognized metrics. Fees must be disclosed at the point of sale.

In its legal challenges, PCMA has asserted that state laws violate the preemption clause in the Employee Retirement Income Security Act (ERISA). “Federal preemption allows employers flexibility to administer innovative benefit plans in an environment of increasing health care costs. The court’s decision in Rutledge v. PCMA will either uphold or threaten these federal protections,” PCMA asserted in a statement issued in March 2020.

ATAP’s amicus brief, and another one filed by 34 attorneys general that supports the North Dakota statute to regulate PBMs, counter that this isn’t the case.

“First, PBM regulation (in its common and standard form) does not reference ERISA itself. These laws leave all plans on equal footing; they do not single out ERISA plans for preferred or disfavored coverage, and they do not change the playing field for ERISA plans alone ... Second, PBM regulation does not have any prohibited connection with ERISA plans,” noted authors in the ATAP brief.

PCMA has also included Medicare preemption in its arguments against PBM regulation. This is meritless, wrote the state attorneys general. “Medicare preempts state laws only if a Medicare ‘standard’ particularly addresses the subject of state regulation. Because the challenged North Dakota laws do not dictate plan benefits or conflict with a Medicare standard, they are not preempted.”

The auctioning of medications

PBMs in theory could use their market power to drive down costs by extracting discounts from drug makers and pharmacies. In reality, they retain any price concessions and discounts for themselves, ATAP’s brief continued.

A system that PBMs have put into place, called step therapy, is essentially an auction for the preferred spot that will be authorized and covered, Dr. Worthing explained.

PBMs create formularies through this auction. The highest rebate to the PBM earns the top spot in the auction and becomes the preferred drug. “That highest bid gets paid for by passing the cost along to patients and insurance plans, and PBMs pocket the profits. This provides an incentive for pharmaceutical manufacturers to raise prices,” he said.

Dr. Worthing has seen these practices trickle down and affect his patients. “Frequently, the medication I prescribe based on what’s best for the patient based on their disease activity, values, and medical history is often not covered because a different drug or portfolio of drugs has earned the top spot in step therapy. This is an extremely frustrating and cumbersome process that not only delays access to treatments but also provides an incentive for higher drug prices,” he said.

There are other ways in which PBMs get in the way of care, said Ms. Hemmen, whose facility serves complex-care oncology patients.

“PBMs force scripts out of higher-quality pharmacies that preserve unfragmented care. They incentivize plan sponsors to put programs into place that take away patient choice, fragment care, and drive scripts to their own owned pharmacies,” she said.
 

Rutledge case sets precedent

In the Rutledge case, PCMA had challenged an Arkansas law that forbid PBMs from paying local pharmacies at a lower rate than what the pharmacies were reimbursed to fill prescriptions. Although the 8th Circuit Court of Appeals agreed with PCMA, the Supreme Court ruled in favor of Arkansas in late 2020.

The appeals court also backed PCMA in PCMA v. Wehbi. However, the Supreme Court vacated this decision and remanded it back to the appeals court, asking for a reconsideration in wake of the outcome in Rutledge v. PCMA.

PCMA has argued that Rutledge was a narrow decision, limited to state laws that regulate PBM reimbursements, and that Rutledge has no bearing on North Dakota law.

While it’s unfortunate that PCMA is trying to delay implementation of sensible regulations, “a lot of us are happy that this issue is coming to light,” Dr. Worthing said. “As a rheumatologist and health policy advocate, exposing drug middlemen is the most important bipartisan issue in the country today because it gets at the core of making sure that sick people get access to the medications they need and reducing the budget of insurance carriers, hospitals, and the federal budget.”

The ATAP brief noted that 28 state attorneys general have filed suit against PBMs, “securing settlements compelling PBMs to correct deceptive trade practices.”

Many people at the state and local level were waiting for the Supreme Court to decide on Rutledge before enacting legislation and sensible regulations, and now they can go ahead and do it, said Dr. Worthing. “I expect to see this across the country as states look at budgets, and as patients bring personal stories to light. We look forward to states passing these kinds of laws to regulate PBMs.”

The ACR doesn’t anticipate a ruling in the Wehbi case until the spring of 2022.

Recent laws passed around PBMs and the pharmacy benefit are a good first step in holding PBMs accountable for quality of care and honoring patient choice, Ms. Hemmen said. The laws also begin to address the fiscal manipulations PBMs use to gain advantage and direct scripts to their own coffers, she added. However, this may not have enough teeth. “These state laws are coming from a provider perspective, and they don’t anticipate what PBMs will do in response. The PBMs are going to work around it.”

Mark Nelson, PharmD, recalls the anguish when a major pharmacy benefit manager (PBM) moved all veteran patients with prostate cancer at his facility from an effective medication to a pricier alternative therapy. “All of these patients were stable on their therapy and were extremely distraught about their medications being changed,” said Dr. Nelson, CEO of Northwest Medical Specialties in Washington State. While there was no clinical reason to change the medication, “our oncologists had no choice other than to comply,” he said.

Niyazz/ThinkStock

It’s unclear why a PBM would switch to a more expensive medication that has no additional clinical benefit, he continued. “Why upset so many veterans? For what reason? We were not given a reason despite our very vocal protest.”

Angus B. Worthing, MD, sees these scenarios unfold every day in his rheumatology practice in the Washington, D.C., area. “In my clinic with 25 doctors, we have three full-time people that only handle PBMs,” he said in an interview. He and others in the medical community, as well as many states, have been pushing back on what they see as efforts by PBMs to raise drug prices and collect the profits at the expense of patients.

PCMA’s challenges against PBM law

The Pharmaceutical Care Management Association (PCMA), a trade group that represents PBMs, has sued at least a half dozen states on their ability to regulate PBMs. However, a landmark case in late 2020 (Pharmaceutical Care Management Association v. Rutledge) set a new precedent. Reversing a lower appeals court decision, the Supreme Court unanimously ruled in favor of allowing states to put in place fair regulation of these entities.

Dr. Worthing and others hope that the medical community and states can leverage this ruling in another lawsuit PCMA brought against North Dakota (PCMA v. Wehbi). PCMA filed this lawsuit in 2017, which challenges two statutes on PBM regulation. The group has issued similar legal challenges in Maine, the District of Columbia, Iowa, Oklahoma, and Arkansas with the Rutledge case.

“PBMs have become massive profit centers while (ironically) increasing patients’ out-of-pocket costs, interfering with doctor-patient relationships, and impairing patient access to appropriate treatment,” according to an amicus brief filed by The Alliance for Transparent & Affordable Prescriptions (ATAP), the Community Oncology Alliance (COA), and American Pharmacies, supporting North Dakota in the Wehbi case.

This is to ensure the case represents the voices of physicians, patients, nurses, and other stakeholders, and underscores PBM abuses, said Dr. Worthing, vice president of ATAP. He also serves as the American College of Rheumatology’s representative on ATAP’s Executive Committee.

PCMA did not respond to requests for comment. Its CEO and president, J.C. Scott, emphasizes that PBMs have a long track record of reducing drug costs for patients and plan sponsors. In 2021, PCMA released 21 policy solutions, a set of industry principles and a three-part policy platform, all with an aim to bring down costs and increase access to pharmaceutical care, according to the organization.

PCMA estimates that the strategies in its platform (updating Medicare Part D, accelerating value-based care, and eliminating anticompetitive ‘pay for delay’ agreements) would save the federal government a maximum of $398.7 billion over 10 years.

According to Wendy Hemmen, senior director with Texas Oncology in Dallas, PBMs do their own unique calculations to arrive at their cost reductions. “Essentially in a PBM, they use things that make their story. Numbers reported to plan sponsors and to the public are not audited and are usually in terms of percentages or a per member per month. Data points are moved around, dropped, or reclassified to make the story that the PBM needs to tell,” Ms. Hemmen said.


 

Amicus briefs dispute ERISA connection

North Dakota legislation prohibits PBMs from charging copays to patients that exceed the cost of a drug. It also prohibits gag clause provisions that restrict what pharmacists may discuss with patients. PBMs may charge fees based on performance metrics, but they must use nationally recognized metrics. Fees must be disclosed at the point of sale.

In its legal challenges, PCMA has asserted that state laws violate the preemption clause in the Employee Retirement Income Security Act (ERISA). “Federal preemption allows employers flexibility to administer innovative benefit plans in an environment of increasing health care costs. The court’s decision in Rutledge v. PCMA will either uphold or threaten these federal protections,” PCMA asserted in a statement issued in March 2020.

ATAP’s amicus brief, and another one filed by 34 attorneys general that supports the North Dakota statute to regulate PBMs, counter that this isn’t the case.

“First, PBM regulation (in its common and standard form) does not reference ERISA itself. These laws leave all plans on equal footing; they do not single out ERISA plans for preferred or disfavored coverage, and they do not change the playing field for ERISA plans alone ... Second, PBM regulation does not have any prohibited connection with ERISA plans,” noted authors in the ATAP brief.

PCMA has also included Medicare preemption in its arguments against PBM regulation. This is meritless, wrote the state attorneys general. “Medicare preempts state laws only if a Medicare ‘standard’ particularly addresses the subject of state regulation. Because the challenged North Dakota laws do not dictate plan benefits or conflict with a Medicare standard, they are not preempted.”

The auctioning of medications

PBMs in theory could use their market power to drive down costs by extracting discounts from drug makers and pharmacies. In reality, they retain any price concessions and discounts for themselves, ATAP’s brief continued.

A system that PBMs have put into place, called step therapy, is essentially an auction for the preferred spot that will be authorized and covered, Dr. Worthing explained.

PBMs create formularies through this auction. The highest rebate to the PBM earns the top spot in the auction and becomes the preferred drug. “That highest bid gets paid for by passing the cost along to patients and insurance plans, and PBMs pocket the profits. This provides an incentive for pharmaceutical manufacturers to raise prices,” he said.

Dr. Worthing has seen these practices trickle down and affect his patients. “Frequently, the medication I prescribe based on what’s best for the patient based on their disease activity, values, and medical history is often not covered because a different drug or portfolio of drugs has earned the top spot in step therapy. This is an extremely frustrating and cumbersome process that not only delays access to treatments but also provides an incentive for higher drug prices,” he said.

There are other ways in which PBMs get in the way of care, said Ms. Hemmen, whose facility serves complex-care oncology patients.

“PBMs force scripts out of higher-quality pharmacies that preserve unfragmented care. They incentivize plan sponsors to put programs into place that take away patient choice, fragment care, and drive scripts to their own owned pharmacies,” she said.
 

Rutledge case sets precedent

In the Rutledge case, PCMA had challenged an Arkansas law that forbid PBMs from paying local pharmacies at a lower rate than what the pharmacies were reimbursed to fill prescriptions. Although the 8th Circuit Court of Appeals agreed with PCMA, the Supreme Court ruled in favor of Arkansas in late 2020.

The appeals court also backed PCMA in PCMA v. Wehbi. However, the Supreme Court vacated this decision and remanded it back to the appeals court, asking for a reconsideration in wake of the outcome in Rutledge v. PCMA.

PCMA has argued that Rutledge was a narrow decision, limited to state laws that regulate PBM reimbursements, and that Rutledge has no bearing on North Dakota law.

While it’s unfortunate that PCMA is trying to delay implementation of sensible regulations, “a lot of us are happy that this issue is coming to light,” Dr. Worthing said. “As a rheumatologist and health policy advocate, exposing drug middlemen is the most important bipartisan issue in the country today because it gets at the core of making sure that sick people get access to the medications they need and reducing the budget of insurance carriers, hospitals, and the federal budget.”

The ATAP brief noted that 28 state attorneys general have filed suit against PBMs, “securing settlements compelling PBMs to correct deceptive trade practices.”

Many people at the state and local level were waiting for the Supreme Court to decide on Rutledge before enacting legislation and sensible regulations, and now they can go ahead and do it, said Dr. Worthing. “I expect to see this across the country as states look at budgets, and as patients bring personal stories to light. We look forward to states passing these kinds of laws to regulate PBMs.”

The ACR doesn’t anticipate a ruling in the Wehbi case until the spring of 2022.

Recent laws passed around PBMs and the pharmacy benefit are a good first step in holding PBMs accountable for quality of care and honoring patient choice, Ms. Hemmen said. The laws also begin to address the fiscal manipulations PBMs use to gain advantage and direct scripts to their own coffers, she added. However, this may not have enough teeth. “These state laws are coming from a provider perspective, and they don’t anticipate what PBMs will do in response. The PBMs are going to work around it.”

Mark Nelson, PharmD, recalls the anguish when a major pharmacy benefit manager (PBM) moved all veteran patients with prostate cancer at his facility from an effective medication to a pricier alternative therapy. “All of these patients were stable on their therapy and were extremely distraught about their medications being changed,” said Dr. Nelson, CEO of Northwest Medical Specialties in Washington State. While there was no clinical reason to change the medication, “our oncologists had no choice other than to comply,” he said.

Niyazz/ThinkStock

It’s unclear why a PBM would switch to a more expensive medication that has no additional clinical benefit, he continued. “Why upset so many veterans? For what reason? We were not given a reason despite our very vocal protest.”

Angus B. Worthing, MD, sees these scenarios unfold every day in his rheumatology practice in the Washington, D.C., area. “In my clinic with 25 doctors, we have three full-time people that only handle PBMs,” he said in an interview. He and others in the medical community, as well as many states, have been pushing back on what they see as efforts by PBMs to raise drug prices and collect the profits at the expense of patients.

PCMA’s challenges against PBM law

The Pharmaceutical Care Management Association (PCMA), a trade group that represents PBMs, has sued at least a half dozen states on their ability to regulate PBMs. However, a landmark case in late 2020 (Pharmaceutical Care Management Association v. Rutledge) set a new precedent. Reversing a lower appeals court decision, the Supreme Court unanimously ruled in favor of allowing states to put in place fair regulation of these entities.

Dr. Worthing and others hope that the medical community and states can leverage this ruling in another lawsuit PCMA brought against North Dakota (PCMA v. Wehbi). PCMA filed this lawsuit in 2017, which challenges two statutes on PBM regulation. The group has issued similar legal challenges in Maine, the District of Columbia, Iowa, Oklahoma, and Arkansas with the Rutledge case.

“PBMs have become massive profit centers while (ironically) increasing patients’ out-of-pocket costs, interfering with doctor-patient relationships, and impairing patient access to appropriate treatment,” according to an amicus brief filed by The Alliance for Transparent & Affordable Prescriptions (ATAP), the Community Oncology Alliance (COA), and American Pharmacies, supporting North Dakota in the Wehbi case.

This is to ensure the case represents the voices of physicians, patients, nurses, and other stakeholders, and underscores PBM abuses, said Dr. Worthing, vice president of ATAP. He also serves as the American College of Rheumatology’s representative on ATAP’s Executive Committee.

PCMA did not respond to requests for comment. Its CEO and president, J.C. Scott, emphasizes that PBMs have a long track record of reducing drug costs for patients and plan sponsors. In 2021, PCMA released 21 policy solutions, a set of industry principles and a three-part policy platform, all with an aim to bring down costs and increase access to pharmaceutical care, according to the organization.

PCMA estimates that the strategies in its platform (updating Medicare Part D, accelerating value-based care, and eliminating anticompetitive ‘pay for delay’ agreements) would save the federal government a maximum of $398.7 billion over 10 years.

According to Wendy Hemmen, senior director with Texas Oncology in Dallas, PBMs do their own unique calculations to arrive at their cost reductions. “Essentially in a PBM, they use things that make their story. Numbers reported to plan sponsors and to the public are not audited and are usually in terms of percentages or a per member per month. Data points are moved around, dropped, or reclassified to make the story that the PBM needs to tell,” Ms. Hemmen said.


 

Amicus briefs dispute ERISA connection

North Dakota legislation prohibits PBMs from charging copays to patients that exceed the cost of a drug. It also prohibits gag clause provisions that restrict what pharmacists may discuss with patients. PBMs may charge fees based on performance metrics, but they must use nationally recognized metrics. Fees must be disclosed at the point of sale.

In its legal challenges, PCMA has asserted that state laws violate the preemption clause in the Employee Retirement Income Security Act (ERISA). “Federal preemption allows employers flexibility to administer innovative benefit plans in an environment of increasing health care costs. The court’s decision in Rutledge v. PCMA will either uphold or threaten these federal protections,” PCMA asserted in a statement issued in March 2020.

ATAP’s amicus brief, and another one filed by 34 attorneys general that supports the North Dakota statute to regulate PBMs, counter that this isn’t the case.

“First, PBM regulation (in its common and standard form) does not reference ERISA itself. These laws leave all plans on equal footing; they do not single out ERISA plans for preferred or disfavored coverage, and they do not change the playing field for ERISA plans alone ... Second, PBM regulation does not have any prohibited connection with ERISA plans,” noted authors in the ATAP brief.

PCMA has also included Medicare preemption in its arguments against PBM regulation. This is meritless, wrote the state attorneys general. “Medicare preempts state laws only if a Medicare ‘standard’ particularly addresses the subject of state regulation. Because the challenged North Dakota laws do not dictate plan benefits or conflict with a Medicare standard, they are not preempted.”

The auctioning of medications

PBMs in theory could use their market power to drive down costs by extracting discounts from drug makers and pharmacies. In reality, they retain any price concessions and discounts for themselves, ATAP’s brief continued.

A system that PBMs have put into place, called step therapy, is essentially an auction for the preferred spot that will be authorized and covered, Dr. Worthing explained.

PBMs create formularies through this auction. The highest rebate to the PBM earns the top spot in the auction and becomes the preferred drug. “That highest bid gets paid for by passing the cost along to patients and insurance plans, and PBMs pocket the profits. This provides an incentive for pharmaceutical manufacturers to raise prices,” he said.

Dr. Worthing has seen these practices trickle down and affect his patients. “Frequently, the medication I prescribe based on what’s best for the patient based on their disease activity, values, and medical history is often not covered because a different drug or portfolio of drugs has earned the top spot in step therapy. This is an extremely frustrating and cumbersome process that not only delays access to treatments but also provides an incentive for higher drug prices,” he said.

There are other ways in which PBMs get in the way of care, said Ms. Hemmen, whose facility serves complex-care oncology patients.

“PBMs force scripts out of higher-quality pharmacies that preserve unfragmented care. They incentivize plan sponsors to put programs into place that take away patient choice, fragment care, and drive scripts to their own owned pharmacies,” she said.
 

Rutledge case sets precedent

In the Rutledge case, PCMA had challenged an Arkansas law that forbid PBMs from paying local pharmacies at a lower rate than what the pharmacies were reimbursed to fill prescriptions. Although the 8th Circuit Court of Appeals agreed with PCMA, the Supreme Court ruled in favor of Arkansas in late 2020.

The appeals court also backed PCMA in PCMA v. Wehbi. However, the Supreme Court vacated this decision and remanded it back to the appeals court, asking for a reconsideration in wake of the outcome in Rutledge v. PCMA.

PCMA has argued that Rutledge was a narrow decision, limited to state laws that regulate PBM reimbursements, and that Rutledge has no bearing on North Dakota law.

While it’s unfortunate that PCMA is trying to delay implementation of sensible regulations, “a lot of us are happy that this issue is coming to light,” Dr. Worthing said. “As a rheumatologist and health policy advocate, exposing drug middlemen is the most important bipartisan issue in the country today because it gets at the core of making sure that sick people get access to the medications they need and reducing the budget of insurance carriers, hospitals, and the federal budget.”

The ATAP brief noted that 28 state attorneys general have filed suit against PBMs, “securing settlements compelling PBMs to correct deceptive trade practices.”

Many people at the state and local level were waiting for the Supreme Court to decide on Rutledge before enacting legislation and sensible regulations, and now they can go ahead and do it, said Dr. Worthing. “I expect to see this across the country as states look at budgets, and as patients bring personal stories to light. We look forward to states passing these kinds of laws to regulate PBMs.”

The ACR doesn’t anticipate a ruling in the Wehbi case until the spring of 2022.

Recent laws passed around PBMs and the pharmacy benefit are a good first step in holding PBMs accountable for quality of care and honoring patient choice, Ms. Hemmen said. The laws also begin to address the fiscal manipulations PBMs use to gain advantage and direct scripts to their own coffers, she added. However, this may not have enough teeth. “These state laws are coming from a provider perspective, and they don’t anticipate what PBMs will do in response. The PBMs are going to work around it.”

A multidisciplinary panel of U.S. experts released a “Call to Action” for improved screening, diagnosis, and treatment of patients with nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) on July 26, an effort organized by the American Gastroenterological Association in collaboration with seven other U.S. medical organizations including several endocrinology groups.

The published statement, “Preparing for the NASH Epidemic: A Call to Action,” proposes several urgent steps for the U.S. clinical community to provide better-focused and better-coordinated care for patients at risk for developing or having NAFLD or NASH, particularly among “emerging” at-risk cohorts such as patients with diabetes and obesity. It appears in the journals Gastroenterology, Diabetes Care, Metabolism: Clinical and Experimental, and Obesity.

The statement’s central pitch is that improvements in care won’t be possible unless the several medical specialties that deal with affected or at-risk patients stop working “in separate silos,” and instead create “a collective action plan,” and also organize multidisciplinary teams that “integrate primary care, hepatology, obesity medicine, endocrinology, and diabetology via well-defined care pathways.”

“The overarching goal” is a “unified, international public health response to NAFLD and NASH,” said the statement, which stemmed from a conference held in July 2020 that included representatives from not only the lead gastroenterology group but also the American Diabetes Association, the American Association for the Study of Liver Diseases, the American Association of Clinical Endocrinologists, The Endocrine Society, The American Academy of Family Physicians, The Obesity Society, and the American College of Osteopathic Family Physicians.

The statement cites sobering prevalence numbers, with estimates that NAFLD exists in more than half the patients with type 2 diabetes, while NASH affects about a third, rates that translate into many millions of affected Americans, given recent estimates that the U.S. prevalence of type 2 diabetes exceeds 30 million people. And the numbers continue to rise along with increases in the prevalence of obesity and type 2 diabetes.

“It’s an enormously common disease, and there are not enough gastroenterologists, to say nothing of hepatologists, to care for every patient with NAFLD,” said Anna Mae Diehl, MD, a gastroenterologist and professor at Duke University in Durham, N.C., who was not involved with the conference nor in writing the statement.

Clinical care pathways coming soon

Another key part of this initiative is development of clinical care pathways that will have “careful explication of each step in screening, diagnosis, and treatment,” and will be designed to inform the practice of primary care physicians (PCPs) as well as clinicians from the various specialties that deal with these patients.

The clinical care pathways are on track to come out later in 2021, said Fasiha Kanwal, MD, a professor and chief of gastroenterology at Baylor College of Medicine in Houston, and lead author on the Call to Action document.

“The Pathways will include practical recommendations about whom to screen and when to refer, and the criteria primary care physicians can use for diagnosis and risk stratification,” Dr. Kanwal said in an interview. “Patients can benefit from a standardized approach.”

The new document also includes results from a recent survey about NAFLD and NASH management completed by 751 U.S. physicians, including 401 (53%) primary care physicians, 175 gastroenterologists, (23%) and 175 endocrinologists (23%; percentages total 99% because of rounding).

The results showed “significant gaps in knowledge about whom to screen and how to diagnose and treat patients at high risk for NASH,” concluded the statement’s authors. Barely more than a third of the respondents knew that almost all patients with severe obesity likely have NAFLD, and fewer than half the endocrinologists and the primary care physicians appreciated that NAFLD is very common among patients with type 2 diabetes.
 

‘Understanding of NAFLD is not there’

“I applaud this effort that calls attention to an emerging public health problem. This paper and survey are great ideas. The findings are not surprising, but they’re important,” said Dr. Diehl said in an interview. “Much more needs to be done” including changes in social behavior and government policies.

“The public’s understanding of NAFLD is not there,” and many physicians also have an incomplete understanding of NAFLD and more serious stages of metabolic liver disease. “Physicians know that patients with obesity are at risk for heart disease, diabetes, and stroke, but they may not always be aware that these patients can also have cirrhosis,” noted Dr. Diehl, who published in 2019 a call to action for NAFLD of her own with some associates.

“My referrals are fueled by primary care physicians who recognize patients with significant liver disease. It would be great to outline recommended practice; I have no doubt that providers will embrace this,” as well as the broader concept of multidisciplinary teams, another focus of the statement. Dr. Diehl cited the “Cancer Center model,” where an oncologist takes primary responsibility for caring for a cancer patient while coordinating care with other specialists, an approach facilitated by EMRs that allow seamless data and chart sharing and something that many health systems have either already adopted or are moving toward.

She said the NASH Call to Action may help catalyze broader application of this model to many more patients with NAFLD or NASH, and noted that some U.S. centers already use this approach – including Dr. Diehl’s program at Duke – which brings together her gastroenterology colleagues with cardiologists, radiologists, endocrinologists, and bariatric surgeons. But she noted that for most patients with metabolic liver disease, the hub clinician needs to be a PCP, especially for patients with earlier-stage disease, because the number of affected patients is so huge.

“Key steps toward establishing such teams include establishing protocols for risk stratification and referral, definition of roles and responsibilities, and buy-in from institutions and payers. Clearly a lot of work needs to occur to get to these multidisciplinary teams,” said Dr. Kanwal.

Ralph A. DeFronzo, MD, professor and deputy director of the Texas Diabetes Institute at UT Health San Antonio, who was not involved with the conference or statement, had a different take on what the future of NASH and NAFLD care may look like.

“Endocrinologists, hepatologists, and obesity experts will work within their individual specialties to diagnose and manage NASH,” he said in an interview. But he acknowledged that “an integrated effort by specialists would be important” to help “primary care physicians who are less familiar with the disease.”
 

Controversy over pioglitazone?

Dr. DeFronzo endorsed development of clinical care pathways as “important,” but also as a potential source of “controversy, especially with respect to treatment.”

The Call to Action statement cites lifestyle-based therapies, such as an appropriate diet; regular, moderate exercise; and elimination when possible of obesogenic medications as cornerstone interventions for patients with NAFLD or early-stage NASH, interventions that can be prescribed by PCPs. For patients with NASH and stage 2 or worse fibrosis, the statement endorses liver-directed pharmacotherapy. While noting that no agents currently carry a Food and Drug Administration–approved indication for treating NASH, the statement cites evidence that 800 IU/day of vitamin E improves steatosis in patients with NASH but not type 2 diabetes.

For patients with type 2 diabetes, the statement notes that results from five randomized trials indicated that pioglitazone could reverse steatohepatitis, findings that led to its recommendation in guidelines from a modest circle of medical groups, including the American Association for the Study of Liver Diseases and the European Association for the Study of Diabetes. However, the 2021 Standards of Medical Care in Diabetes from the American Diabetes Association gives these agents limited endorsement, saying: “Pioglitazone, vitamin E treatment, and liraglutide treatment of biopsy-proven nonalcoholic steatohepatitis have each been shown to improve liver histology, but effects on longer-term clinical outcomes are not known.”

“The strongest evidence by far is for pioglitazone for treating NAFLD and NASH,” said Dr. DeFronzo, a vocal proponent of the drug for this indication. But he added that “hepatologists don’t feel comfortable with drugs from the thiazolidinedione class,” which includes pioglitazone.

“We don’t yet know how to optimally configure the health system for NAFLD and NASH to make it more efficient and helpful to patients, but models exist, and the approach is evolving,” said Dr. Diehl.

Dr. Diehl and Dr. Kanwal had no relevant disclosures. Dr. DeFronzo has been a speaker on behalf of AstraZeneca and Novo Nordisk, has been an adviser to AstraZeneca, Boehringer Ingelheim, Intarcia, and Janssen, and has received research funding from AstraZeneca, Janssen and Merck.

mzoler@mdedge.com

A multidisciplinary panel of U.S. experts released a “Call to Action” for improved screening, diagnosis, and treatment of patients with nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) on July 26, an effort organized by the American Gastroenterological Association in collaboration with seven other U.S. medical organizations including several endocrinology groups.

The published statement, “Preparing for the NASH Epidemic: A Call to Action,” proposes several urgent steps for the U.S. clinical community to provide better-focused and better-coordinated care for patients at risk for developing or having NAFLD or NASH, particularly among “emerging” at-risk cohorts such as patients with diabetes and obesity. It appears in the journals Gastroenterology, Diabetes Care, Metabolism: Clinical and Experimental, and Obesity.

The statement’s central pitch is that improvements in care won’t be possible unless the several medical specialties that deal with affected or at-risk patients stop working “in separate silos,” and instead create “a collective action plan,” and also organize multidisciplinary teams that “integrate primary care, hepatology, obesity medicine, endocrinology, and diabetology via well-defined care pathways.”

“The overarching goal” is a “unified, international public health response to NAFLD and NASH,” said the statement, which stemmed from a conference held in July 2020 that included representatives from not only the lead gastroenterology group but also the American Diabetes Association, the American Association for the Study of Liver Diseases, the American Association of Clinical Endocrinologists, The Endocrine Society, The American Academy of Family Physicians, The Obesity Society, and the American College of Osteopathic Family Physicians.

The statement cites sobering prevalence numbers, with estimates that NAFLD exists in more than half the patients with type 2 diabetes, while NASH affects about a third, rates that translate into many millions of affected Americans, given recent estimates that the U.S. prevalence of type 2 diabetes exceeds 30 million people. And the numbers continue to rise along with increases in the prevalence of obesity and type 2 diabetes.

“It’s an enormously common disease, and there are not enough gastroenterologists, to say nothing of hepatologists, to care for every patient with NAFLD,” said Anna Mae Diehl, MD, a gastroenterologist and professor at Duke University in Durham, N.C., who was not involved with the conference nor in writing the statement.

Clinical care pathways coming soon

Another key part of this initiative is development of clinical care pathways that will have “careful explication of each step in screening, diagnosis, and treatment,” and will be designed to inform the practice of primary care physicians (PCPs) as well as clinicians from the various specialties that deal with these patients.

The clinical care pathways are on track to come out later in 2021, said Fasiha Kanwal, MD, a professor and chief of gastroenterology at Baylor College of Medicine in Houston, and lead author on the Call to Action document.

“The Pathways will include practical recommendations about whom to screen and when to refer, and the criteria primary care physicians can use for diagnosis and risk stratification,” Dr. Kanwal said in an interview. “Patients can benefit from a standardized approach.”

The new document also includes results from a recent survey about NAFLD and NASH management completed by 751 U.S. physicians, including 401 (53%) primary care physicians, 175 gastroenterologists, (23%) and 175 endocrinologists (23%; percentages total 99% because of rounding).

The results showed “significant gaps in knowledge about whom to screen and how to diagnose and treat patients at high risk for NASH,” concluded the statement’s authors. Barely more than a third of the respondents knew that almost all patients with severe obesity likely have NAFLD, and fewer than half the endocrinologists and the primary care physicians appreciated that NAFLD is very common among patients with type 2 diabetes.
 

‘Understanding of NAFLD is not there’

“I applaud this effort that calls attention to an emerging public health problem. This paper and survey are great ideas. The findings are not surprising, but they’re important,” said Dr. Diehl said in an interview. “Much more needs to be done” including changes in social behavior and government policies.

“The public’s understanding of NAFLD is not there,” and many physicians also have an incomplete understanding of NAFLD and more serious stages of metabolic liver disease. “Physicians know that patients with obesity are at risk for heart disease, diabetes, and stroke, but they may not always be aware that these patients can also have cirrhosis,” noted Dr. Diehl, who published in 2019 a call to action for NAFLD of her own with some associates.

“My referrals are fueled by primary care physicians who recognize patients with significant liver disease. It would be great to outline recommended practice; I have no doubt that providers will embrace this,” as well as the broader concept of multidisciplinary teams, another focus of the statement. Dr. Diehl cited the “Cancer Center model,” where an oncologist takes primary responsibility for caring for a cancer patient while coordinating care with other specialists, an approach facilitated by EMRs that allow seamless data and chart sharing and something that many health systems have either already adopted or are moving toward.

She said the NASH Call to Action may help catalyze broader application of this model to many more patients with NAFLD or NASH, and noted that some U.S. centers already use this approach – including Dr. Diehl’s program at Duke – which brings together her gastroenterology colleagues with cardiologists, radiologists, endocrinologists, and bariatric surgeons. But she noted that for most patients with metabolic liver disease, the hub clinician needs to be a PCP, especially for patients with earlier-stage disease, because the number of affected patients is so huge.

“Key steps toward establishing such teams include establishing protocols for risk stratification and referral, definition of roles and responsibilities, and buy-in from institutions and payers. Clearly a lot of work needs to occur to get to these multidisciplinary teams,” said Dr. Kanwal.

Ralph A. DeFronzo, MD, professor and deputy director of the Texas Diabetes Institute at UT Health San Antonio, who was not involved with the conference or statement, had a different take on what the future of NASH and NAFLD care may look like.

“Endocrinologists, hepatologists, and obesity experts will work within their individual specialties to diagnose and manage NASH,” he said in an interview. But he acknowledged that “an integrated effort by specialists would be important” to help “primary care physicians who are less familiar with the disease.”
 

Controversy over pioglitazone?

Dr. DeFronzo endorsed development of clinical care pathways as “important,” but also as a potential source of “controversy, especially with respect to treatment.”

The Call to Action statement cites lifestyle-based therapies, such as an appropriate diet; regular, moderate exercise; and elimination when possible of obesogenic medications as cornerstone interventions for patients with NAFLD or early-stage NASH, interventions that can be prescribed by PCPs. For patients with NASH and stage 2 or worse fibrosis, the statement endorses liver-directed pharmacotherapy. While noting that no agents currently carry a Food and Drug Administration–approved indication for treating NASH, the statement cites evidence that 800 IU/day of vitamin E improves steatosis in patients with NASH but not type 2 diabetes.

For patients with type 2 diabetes, the statement notes that results from five randomized trials indicated that pioglitazone could reverse steatohepatitis, findings that led to its recommendation in guidelines from a modest circle of medical groups, including the American Association for the Study of Liver Diseases and the European Association for the Study of Diabetes. However, the 2021 Standards of Medical Care in Diabetes from the American Diabetes Association gives these agents limited endorsement, saying: “Pioglitazone, vitamin E treatment, and liraglutide treatment of biopsy-proven nonalcoholic steatohepatitis have each been shown to improve liver histology, but effects on longer-term clinical outcomes are not known.”

“The strongest evidence by far is for pioglitazone for treating NAFLD and NASH,” said Dr. DeFronzo, a vocal proponent of the drug for this indication. But he added that “hepatologists don’t feel comfortable with drugs from the thiazolidinedione class,” which includes pioglitazone.

“We don’t yet know how to optimally configure the health system for NAFLD and NASH to make it more efficient and helpful to patients, but models exist, and the approach is evolving,” said Dr. Diehl.

Dr. Diehl and Dr. Kanwal had no relevant disclosures. Dr. DeFronzo has been a speaker on behalf of AstraZeneca and Novo Nordisk, has been an adviser to AstraZeneca, Boehringer Ingelheim, Intarcia, and Janssen, and has received research funding from AstraZeneca, Janssen and Merck.

mzoler@mdedge.com

A multidisciplinary panel of U.S. experts released a “Call to Action” for improved screening, diagnosis, and treatment of patients with nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) on July 26, an effort organized by the American Gastroenterological Association in collaboration with seven other U.S. medical organizations including several endocrinology groups.

The published statement, “Preparing for the NASH Epidemic: A Call to Action,” proposes several urgent steps for the U.S. clinical community to provide better-focused and better-coordinated care for patients at risk for developing or having NAFLD or NASH, particularly among “emerging” at-risk cohorts such as patients with diabetes and obesity. It appears in the journals Gastroenterology, Diabetes Care, Metabolism: Clinical and Experimental, and Obesity.

The statement’s central pitch is that improvements in care won’t be possible unless the several medical specialties that deal with affected or at-risk patients stop working “in separate silos,” and instead create “a collective action plan,” and also organize multidisciplinary teams that “integrate primary care, hepatology, obesity medicine, endocrinology, and diabetology via well-defined care pathways.”

“The overarching goal” is a “unified, international public health response to NAFLD and NASH,” said the statement, which stemmed from a conference held in July 2020 that included representatives from not only the lead gastroenterology group but also the American Diabetes Association, the American Association for the Study of Liver Diseases, the American Association of Clinical Endocrinologists, The Endocrine Society, The American Academy of Family Physicians, The Obesity Society, and the American College of Osteopathic Family Physicians.

The statement cites sobering prevalence numbers, with estimates that NAFLD exists in more than half the patients with type 2 diabetes, while NASH affects about a third, rates that translate into many millions of affected Americans, given recent estimates that the U.S. prevalence of type 2 diabetes exceeds 30 million people. And the numbers continue to rise along with increases in the prevalence of obesity and type 2 diabetes.

“It’s an enormously common disease, and there are not enough gastroenterologists, to say nothing of hepatologists, to care for every patient with NAFLD,” said Anna Mae Diehl, MD, a gastroenterologist and professor at Duke University in Durham, N.C., who was not involved with the conference nor in writing the statement.

Clinical care pathways coming soon

Another key part of this initiative is development of clinical care pathways that will have “careful explication of each step in screening, diagnosis, and treatment,” and will be designed to inform the practice of primary care physicians (PCPs) as well as clinicians from the various specialties that deal with these patients.

The clinical care pathways are on track to come out later in 2021, said Fasiha Kanwal, MD, a professor and chief of gastroenterology at Baylor College of Medicine in Houston, and lead author on the Call to Action document.

“The Pathways will include practical recommendations about whom to screen and when to refer, and the criteria primary care physicians can use for diagnosis and risk stratification,” Dr. Kanwal said in an interview. “Patients can benefit from a standardized approach.”

The new document also includes results from a recent survey about NAFLD and NASH management completed by 751 U.S. physicians, including 401 (53%) primary care physicians, 175 gastroenterologists, (23%) and 175 endocrinologists (23%; percentages total 99% because of rounding).

The results showed “significant gaps in knowledge about whom to screen and how to diagnose and treat patients at high risk for NASH,” concluded the statement’s authors. Barely more than a third of the respondents knew that almost all patients with severe obesity likely have NAFLD, and fewer than half the endocrinologists and the primary care physicians appreciated that NAFLD is very common among patients with type 2 diabetes.
 

‘Understanding of NAFLD is not there’

“I applaud this effort that calls attention to an emerging public health problem. This paper and survey are great ideas. The findings are not surprising, but they’re important,” said Dr. Diehl said in an interview. “Much more needs to be done” including changes in social behavior and government policies.

“The public’s understanding of NAFLD is not there,” and many physicians also have an incomplete understanding of NAFLD and more serious stages of metabolic liver disease. “Physicians know that patients with obesity are at risk for heart disease, diabetes, and stroke, but they may not always be aware that these patients can also have cirrhosis,” noted Dr. Diehl, who published in 2019 a call to action for NAFLD of her own with some associates.

“My referrals are fueled by primary care physicians who recognize patients with significant liver disease. It would be great to outline recommended practice; I have no doubt that providers will embrace this,” as well as the broader concept of multidisciplinary teams, another focus of the statement. Dr. Diehl cited the “Cancer Center model,” where an oncologist takes primary responsibility for caring for a cancer patient while coordinating care with other specialists, an approach facilitated by EMRs that allow seamless data and chart sharing and something that many health systems have either already adopted or are moving toward.

She said the NASH Call to Action may help catalyze broader application of this model to many more patients with NAFLD or NASH, and noted that some U.S. centers already use this approach – including Dr. Diehl’s program at Duke – which brings together her gastroenterology colleagues with cardiologists, radiologists, endocrinologists, and bariatric surgeons. But she noted that for most patients with metabolic liver disease, the hub clinician needs to be a PCP, especially for patients with earlier-stage disease, because the number of affected patients is so huge.

“Key steps toward establishing such teams include establishing protocols for risk stratification and referral, definition of roles and responsibilities, and buy-in from institutions and payers. Clearly a lot of work needs to occur to get to these multidisciplinary teams,” said Dr. Kanwal.

Ralph A. DeFronzo, MD, professor and deputy director of the Texas Diabetes Institute at UT Health San Antonio, who was not involved with the conference or statement, had a different take on what the future of NASH and NAFLD care may look like.

“Endocrinologists, hepatologists, and obesity experts will work within their individual specialties to diagnose and manage NASH,” he said in an interview. But he acknowledged that “an integrated effort by specialists would be important” to help “primary care physicians who are less familiar with the disease.”
 

Controversy over pioglitazone?

Dr. DeFronzo endorsed development of clinical care pathways as “important,” but also as a potential source of “controversy, especially with respect to treatment.”

The Call to Action statement cites lifestyle-based therapies, such as an appropriate diet; regular, moderate exercise; and elimination when possible of obesogenic medications as cornerstone interventions for patients with NAFLD or early-stage NASH, interventions that can be prescribed by PCPs. For patients with NASH and stage 2 or worse fibrosis, the statement endorses liver-directed pharmacotherapy. While noting that no agents currently carry a Food and Drug Administration–approved indication for treating NASH, the statement cites evidence that 800 IU/day of vitamin E improves steatosis in patients with NASH but not type 2 diabetes.

For patients with type 2 diabetes, the statement notes that results from five randomized trials indicated that pioglitazone could reverse steatohepatitis, findings that led to its recommendation in guidelines from a modest circle of medical groups, including the American Association for the Study of Liver Diseases and the European Association for the Study of Diabetes. However, the 2021 Standards of Medical Care in Diabetes from the American Diabetes Association gives these agents limited endorsement, saying: “Pioglitazone, vitamin E treatment, and liraglutide treatment of biopsy-proven nonalcoholic steatohepatitis have each been shown to improve liver histology, but effects on longer-term clinical outcomes are not known.”

“The strongest evidence by far is for pioglitazone for treating NAFLD and NASH,” said Dr. DeFronzo, a vocal proponent of the drug for this indication. But he added that “hepatologists don’t feel comfortable with drugs from the thiazolidinedione class,” which includes pioglitazone.

“We don’t yet know how to optimally configure the health system for NAFLD and NASH to make it more efficient and helpful to patients, but models exist, and the approach is evolving,” said Dr. Diehl.

Dr. Diehl and Dr. Kanwal had no relevant disclosures. Dr. DeFronzo has been a speaker on behalf of AstraZeneca and Novo Nordisk, has been an adviser to AstraZeneca, Boehringer Ingelheim, Intarcia, and Janssen, and has received research funding from AstraZeneca, Janssen and Merck.

mzoler@mdedge.com

COVID-19’s ever-changing trajectory has led to a notable rise in anxiety-related disorders in the United States. The average share of U.S. adults reporting symptoms of anxiety and or depressive disorder rose from 11% in 2019 to more than 41% in January 2021, according to a report from the Kaiser Family Foundation.

With the arrival of vaccines, Elspeth Cameron Ritchie, MD, MPH, chair of psychiatry at Medstar Washington (D.C.) Hospital Center, has noticed a shift in patients’ fears and concerns. In an interview, she explained how anxiety in patients has evolved along with the pandemic. She also offered strategies for gaining control, engaging with community, and managing anxiety.
 

Question: When you see patients at this point in the pandemic, what do you ask them?

Answer: I ask them how the pandemic has affected them. Responses have changed over time. In the beginning, I saw a lot of fear, dread of the unknown, a lot of frustration about being in lockdown. As the vaccines have come in and taken hold, there is both a sense of relief, but still a lot of anxiety. Part of that is we’re getting different messages and very much changing messages over time. One day, we were still in a lockdown mode, and then a week later, we were told: If you’re vaccinated, take off your masks and do whatever you want to do. Then there’s the people who are unvaccinated, and we’re also seeing the Delta variant taking hold in the rest of the world. There’s a lot of anxiety, fear, and some depression, although that’s gotten better with the vaccine.

Q: How do we distinguish between reasonable or rational anxiety and excessive or irrational anxiety?

A: There’s not a bright line between them. What’s rational for one person is not rational for another. What we’ve seen is a spectrum. A rational anxiety is: “I’m not ready to go to a party.” Irrational represents all these crazy theories that are made up, such as putting a microchip into your arm with the vaccine so that the government can track you.

Q: How do you talk to these people thinking irrational thoughts?

A: You must listen to them and not just shut them down. Work with them. Many people with irrational thoughts, or believe in conspiracy theories, may not want to go near a psychiatrist. But there’s also the patients in the psychiatric ward who believe COVID doesn’t exist and there’s government plots. Like any other delusional material, we work with this by talking to these patients and using medication as appropriate.

Q: Do you support prescribing medication for those patients who continue to experience anxiety that is irrational?

A: Patients based in inpatient psychiatry are usually delusional. The medication we usually prescribe for these patients is antipsychotics. If it’s an outpatient who’s anxious about COVID, but has rational anxiety, we usually use antidepressants or antianxiety agents such as Zoloft, Paxil, or Lexapro.

Q: What other strategies can psychiatrists share with patients?

A: What I’ve seen throughout COVID is often an overwhelming sense of dread and inability to control the situation. I tell patients to do things they can control. You can go out and get exercise. Especially during the winter, I recommend that people take a walk and get some sunshine.

It also helps with anxiety to reach out and help someone else. Is there a neighbor you’re concerned about? By and large, this is something many communities have done well. The challenge is we’ve been avoiding each other physically for a long time. So, some of the standard ways of helping each other out, like volunteering at a food bank, have been a little problematic. But there are ways to have minimal people on staff to reduce exposure.

One thing I recommend with any type of anxiety is to learn how to control your breathing. Take breaths through the nose several times a day and teach yourself how to slow down. Another thing that helps many people is contact with animals – especially horses, dogs, and cats. You may not be able to adopt an animal, but you could work at a rescue shelter or other facilities. People can benefit from the nonverbal cues of an animal. A friend of mine got a shelter cat. It sleeps with her and licks her when she feels anxious.

Meditation and yoga are also useful. This is not for everyone, but it’s a way to turn down the level of “buzz” or anxiety. Don’t overdo it on caffeine or other things that increase anxiety. I would stay away from illicit drugs, as they increase anxiety.
 

Q: What do you say to patients to give them a sense of hope?

A: A lot of people aren’t ready to return to normal; they want to keep the social isolation, the masks, the working from home. We need to show patients what they have control over to minimize their own risk. For example, if they want to wear a mask, then they should wear one. Patients also really like the option of telehealth appointments.

Another way to cope is to identify what’s better about the way things are now and concentrate on those improvements. Here in Maryland, the traffic is so much better in the morning than it once was. There are things I don’t miss, like going to the airport and waiting 5 hours for a flight.
 

Q: What advice can you give psychiatrists who are experiencing anxiety?

A: We must manage our own anxiety so we can help our patients. Strategies I’ve mentioned are also helpful to psychiatrists or other health care professionals (such as) taking a walk, getting exercise, controlling what you can control. For me, it’s getting dressed, going to work, seeing patients. Having a daily structure, a routine, is important. Many people struggled with this at first. They were working from home and didn’t get much done; they did too much videogaming. It helps to set regular appointments if you’re working from home.

Pre-COVID, many of us got a lot out of our professional meetings. We saw friends there. Now they’re either canceled or we’re doing them virtually, which isn’t the same thing. I think our profession could do a better job of reaching out to each other. We’re used to seeing each other once or twice a year at conventions. I’ve since found it hard to reach out to my colleagues via email. And everyone is tired of Zoom.

If they’re local, ask them to do a safe outdoor activity, a happy hour, a walk. If they’re not, maybe engage with them through a postcard or a phone call.

My colleagues and I go for walks at lunch. There’s a fishpond nearby and we talk to the fish and get a little silly. We sometimes take fish nets with us. People ask what the fish nets are for and we’ll say, “we’re chasing COVID away.”

Dr. Ritchie reported no conflicts of interest.

COVID-19’s ever-changing trajectory has led to a notable rise in anxiety-related disorders in the United States. The average share of U.S. adults reporting symptoms of anxiety and or depressive disorder rose from 11% in 2019 to more than 41% in January 2021, according to a report from the Kaiser Family Foundation.

With the arrival of vaccines, Elspeth Cameron Ritchie, MD, MPH, chair of psychiatry at Medstar Washington (D.C.) Hospital Center, has noticed a shift in patients’ fears and concerns. In an interview, she explained how anxiety in patients has evolved along with the pandemic. She also offered strategies for gaining control, engaging with community, and managing anxiety.
 

Question: When you see patients at this point in the pandemic, what do you ask them?

Answer: I ask them how the pandemic has affected them. Responses have changed over time. In the beginning, I saw a lot of fear, dread of the unknown, a lot of frustration about being in lockdown. As the vaccines have come in and taken hold, there is both a sense of relief, but still a lot of anxiety. Part of that is we’re getting different messages and very much changing messages over time. One day, we were still in a lockdown mode, and then a week later, we were told: If you’re vaccinated, take off your masks and do whatever you want to do. Then there’s the people who are unvaccinated, and we’re also seeing the Delta variant taking hold in the rest of the world. There’s a lot of anxiety, fear, and some depression, although that’s gotten better with the vaccine.

Q: How do we distinguish between reasonable or rational anxiety and excessive or irrational anxiety?

A: There’s not a bright line between them. What’s rational for one person is not rational for another. What we’ve seen is a spectrum. A rational anxiety is: “I’m not ready to go to a party.” Irrational represents all these crazy theories that are made up, such as putting a microchip into your arm with the vaccine so that the government can track you.

Q: How do you talk to these people thinking irrational thoughts?

A: You must listen to them and not just shut them down. Work with them. Many people with irrational thoughts, or believe in conspiracy theories, may not want to go near a psychiatrist. But there’s also the patients in the psychiatric ward who believe COVID doesn’t exist and there’s government plots. Like any other delusional material, we work with this by talking to these patients and using medication as appropriate.

Q: Do you support prescribing medication for those patients who continue to experience anxiety that is irrational?

A: Patients based in inpatient psychiatry are usually delusional. The medication we usually prescribe for these patients is antipsychotics. If it’s an outpatient who’s anxious about COVID, but has rational anxiety, we usually use antidepressants or antianxiety agents such as Zoloft, Paxil, or Lexapro.

Q: What other strategies can psychiatrists share with patients?

A: What I’ve seen throughout COVID is often an overwhelming sense of dread and inability to control the situation. I tell patients to do things they can control. You can go out and get exercise. Especially during the winter, I recommend that people take a walk and get some sunshine.

It also helps with anxiety to reach out and help someone else. Is there a neighbor you’re concerned about? By and large, this is something many communities have done well. The challenge is we’ve been avoiding each other physically for a long time. So, some of the standard ways of helping each other out, like volunteering at a food bank, have been a little problematic. But there are ways to have minimal people on staff to reduce exposure.

One thing I recommend with any type of anxiety is to learn how to control your breathing. Take breaths through the nose several times a day and teach yourself how to slow down. Another thing that helps many people is contact with animals – especially horses, dogs, and cats. You may not be able to adopt an animal, but you could work at a rescue shelter or other facilities. People can benefit from the nonverbal cues of an animal. A friend of mine got a shelter cat. It sleeps with her and licks her when she feels anxious.

Meditation and yoga are also useful. This is not for everyone, but it’s a way to turn down the level of “buzz” or anxiety. Don’t overdo it on caffeine or other things that increase anxiety. I would stay away from illicit drugs, as they increase anxiety.
 

Q: What do you say to patients to give them a sense of hope?

A: A lot of people aren’t ready to return to normal; they want to keep the social isolation, the masks, the working from home. We need to show patients what they have control over to minimize their own risk. For example, if they want to wear a mask, then they should wear one. Patients also really like the option of telehealth appointments.

Another way to cope is to identify what’s better about the way things are now and concentrate on those improvements. Here in Maryland, the traffic is so much better in the morning than it once was. There are things I don’t miss, like going to the airport and waiting 5 hours for a flight.
 

Q: What advice can you give psychiatrists who are experiencing anxiety?

A: We must manage our own anxiety so we can help our patients. Strategies I’ve mentioned are also helpful to psychiatrists or other health care professionals (such as) taking a walk, getting exercise, controlling what you can control. For me, it’s getting dressed, going to work, seeing patients. Having a daily structure, a routine, is important. Many people struggled with this at first. They were working from home and didn’t get much done; they did too much videogaming. It helps to set regular appointments if you’re working from home.

Pre-COVID, many of us got a lot out of our professional meetings. We saw friends there. Now they’re either canceled or we’re doing them virtually, which isn’t the same thing. I think our profession could do a better job of reaching out to each other. We’re used to seeing each other once or twice a year at conventions. I’ve since found it hard to reach out to my colleagues via email. And everyone is tired of Zoom.

If they’re local, ask them to do a safe outdoor activity, a happy hour, a walk. If they’re not, maybe engage with them through a postcard or a phone call.

My colleagues and I go for walks at lunch. There’s a fishpond nearby and we talk to the fish and get a little silly. We sometimes take fish nets with us. People ask what the fish nets are for and we’ll say, “we’re chasing COVID away.”

Dr. Ritchie reported no conflicts of interest.

COVID-19’s ever-changing trajectory has led to a notable rise in anxiety-related disorders in the United States. The average share of U.S. adults reporting symptoms of anxiety and or depressive disorder rose from 11% in 2019 to more than 41% in January 2021, according to a report from the Kaiser Family Foundation.

With the arrival of vaccines, Elspeth Cameron Ritchie, MD, MPH, chair of psychiatry at Medstar Washington (D.C.) Hospital Center, has noticed a shift in patients’ fears and concerns. In an interview, she explained how anxiety in patients has evolved along with the pandemic. She also offered strategies for gaining control, engaging with community, and managing anxiety.
 

Question: When you see patients at this point in the pandemic, what do you ask them?

Answer: I ask them how the pandemic has affected them. Responses have changed over time. In the beginning, I saw a lot of fear, dread of the unknown, a lot of frustration about being in lockdown. As the vaccines have come in and taken hold, there is both a sense of relief, but still a lot of anxiety. Part of that is we’re getting different messages and very much changing messages over time. One day, we were still in a lockdown mode, and then a week later, we were told: If you’re vaccinated, take off your masks and do whatever you want to do. Then there’s the people who are unvaccinated, and we’re also seeing the Delta variant taking hold in the rest of the world. There’s a lot of anxiety, fear, and some depression, although that’s gotten better with the vaccine.

Q: How do we distinguish between reasonable or rational anxiety and excessive or irrational anxiety?

A: There’s not a bright line between them. What’s rational for one person is not rational for another. What we’ve seen is a spectrum. A rational anxiety is: “I’m not ready to go to a party.” Irrational represents all these crazy theories that are made up, such as putting a microchip into your arm with the vaccine so that the government can track you.

Q: How do you talk to these people thinking irrational thoughts?

A: You must listen to them and not just shut them down. Work with them. Many people with irrational thoughts, or believe in conspiracy theories, may not want to go near a psychiatrist. But there’s also the patients in the psychiatric ward who believe COVID doesn’t exist and there’s government plots. Like any other delusional material, we work with this by talking to these patients and using medication as appropriate.

Q: Do you support prescribing medication for those patients who continue to experience anxiety that is irrational?

A: Patients based in inpatient psychiatry are usually delusional. The medication we usually prescribe for these patients is antipsychotics. If it’s an outpatient who’s anxious about COVID, but has rational anxiety, we usually use antidepressants or antianxiety agents such as Zoloft, Paxil, or Lexapro.

Q: What other strategies can psychiatrists share with patients?

A: What I’ve seen throughout COVID is often an overwhelming sense of dread and inability to control the situation. I tell patients to do things they can control. You can go out and get exercise. Especially during the winter, I recommend that people take a walk and get some sunshine.

It also helps with anxiety to reach out and help someone else. Is there a neighbor you’re concerned about? By and large, this is something many communities have done well. The challenge is we’ve been avoiding each other physically for a long time. So, some of the standard ways of helping each other out, like volunteering at a food bank, have been a little problematic. But there are ways to have minimal people on staff to reduce exposure.

One thing I recommend with any type of anxiety is to learn how to control your breathing. Take breaths through the nose several times a day and teach yourself how to slow down. Another thing that helps many people is contact with animals – especially horses, dogs, and cats. You may not be able to adopt an animal, but you could work at a rescue shelter or other facilities. People can benefit from the nonverbal cues of an animal. A friend of mine got a shelter cat. It sleeps with her and licks her when she feels anxious.

Meditation and yoga are also useful. This is not for everyone, but it’s a way to turn down the level of “buzz” or anxiety. Don’t overdo it on caffeine or other things that increase anxiety. I would stay away from illicit drugs, as they increase anxiety.
 

Q: What do you say to patients to give them a sense of hope?

A: A lot of people aren’t ready to return to normal; they want to keep the social isolation, the masks, the working from home. We need to show patients what they have control over to minimize their own risk. For example, if they want to wear a mask, then they should wear one. Patients also really like the option of telehealth appointments.

Another way to cope is to identify what’s better about the way things are now and concentrate on those improvements. Here in Maryland, the traffic is so much better in the morning than it once was. There are things I don’t miss, like going to the airport and waiting 5 hours for a flight.
 

Q: What advice can you give psychiatrists who are experiencing anxiety?

A: We must manage our own anxiety so we can help our patients. Strategies I’ve mentioned are also helpful to psychiatrists or other health care professionals (such as) taking a walk, getting exercise, controlling what you can control. For me, it’s getting dressed, going to work, seeing patients. Having a daily structure, a routine, is important. Many people struggled with this at first. They were working from home and didn’t get much done; they did too much videogaming. It helps to set regular appointments if you’re working from home.

Pre-COVID, many of us got a lot out of our professional meetings. We saw friends there. Now they’re either canceled or we’re doing them virtually, which isn’t the same thing. I think our profession could do a better job of reaching out to each other. We’re used to seeing each other once or twice a year at conventions. I’ve since found it hard to reach out to my colleagues via email. And everyone is tired of Zoom.

If they’re local, ask them to do a safe outdoor activity, a happy hour, a walk. If they’re not, maybe engage with them through a postcard or a phone call.

My colleagues and I go for walks at lunch. There’s a fishpond nearby and we talk to the fish and get a little silly. We sometimes take fish nets with us. People ask what the fish nets are for and we’ll say, “we’re chasing COVID away.”

Dr. Ritchie reported no conflicts of interest.

The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe and effective in one sense but simply not needed – at least for now?

Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.

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

The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe and effective in one sense but simply not needed – at least for now?

Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.

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

The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe and effective in one sense but simply not needed – at least for now?

Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.

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

Family medicine has evolved in many ways since its inception in 1969, especially in terms of the people who are practicing it, but it still needs more diversity to represent the faces of patients.

The specialty has been on the path to a racially diverse workforce over the past few decades. Since family medicine is a discipline where doctors look not just at individual patients, but also at the health of the community, some family physicians see working in their specialty as a way to integrate public health with medicine to curb health inequities.

Maria Harsha Wusu, MD, MSEd, is an example of such a family physician.

Dr. Wusu, who is Black and of Japanese descent, chose to practice family medicine to address health in communities of color “which we know in the United States experience health inequities due to structural racism,” she said in an interview.

“It’s a discipline where you look at the health of the entire family and the community and you really look at the environmental, the political, the historical factors that are influencing the health of the community,” explained Dr. Wusu, who is currently the director of health equity at Morehouse School of Medicine, Atlanta. Family physicians are not just asking: “Does a patient have hypertension?” but also whether a patient has access to healthy food, green space and other things.

While the field of family medicine is more diverse in the 21st century than it was at its beginning, Dr. Wusu, who completed her residency in 2016, still faced challenges to achieving her goal of helping communities of color. These specifically stemmed from a lack of diversity among the people in the places where she studied to become a doctor and family physician.

There were moments when Dr. Wusu felt isolated while in medical school and residency, because so few students and faculty members she saw looked like her.

Plus, studies have shown that a racially and ethnically diverse physician workforce is necessary to address health inequities. Research published in 2018 in the Journal of Health Care for the Poor and Underserved, for example, found that underrepresented physicians are more likely to practice in underserved areas than their White peers.

“I went to medical school at a historically White institution, and so there were very few people who identified as what we would say are underrepresented minorities in medicine,” Dr. Wusu explained. “There are issues with both implicit and explicit racism, which I think could be echoed by colleagues across the country that are additional challenges that I think medical students, particularly students of color, experience during what is an already kind of challenging time of medical school and the rigorous training of residency.”

Ada Stewart, MD, FAAFP, president of the American Academy of Family Physicians, echoed Dr. Wusu’s medical school experience. Dr. Stewart, who finished her residency in 2003, said that, out of the 120 students in her graduating medical class, only 10 were Black.

Marginalized groups are still underrepresented in residences. According to data compiled by the Association of American Medical Colleges, only 9.3% of Black people, 10% of Latino, and 0.3% of Native Hawaiian or other Pacific Islanders are residents in family medicine residency programs in 2019-2020. Meanwhile, White residents make up 50.8% of the residency program.

“We really need to do all that we can to increase diversity within our medical schools and residencies,” Dr. Stewart said.

In regards to gender, there has been an increasing number of women in the family medicine specialty. A 2021 study found that the proportion of female physicians in family medicine has grown from 33.9% 2010 to 41.9% in 2020.

“There’s still room for growth and we have to change the system and those structures that created these problems,” noted Dr. Stewart.
 

The social responsibility of family medicine

The family medicine specialty was born during an era of protest of social change, alongside the Civil Rights Movement, the peace movement, and counterculture protests. In April 1966, 3 years before American Boards approved family practice as a new specialty; the National Commission on Community Health stated that every person should have a personal physician who is the “central point for the integration and continuity of all medical services to his patient.” They also said such physicians should be aware of the “many and varied social, emotional and environmental factors that influence the health of his patient and family.”

While the diversity of family medicine specialty has significantly increased since its beginnings, it continues to lag behind the general U.S. population. A 2018 study published in the Journal of the American Board of Family Medicine, which aggregated data from 1987 to 2017, found that the proportion of Black and Latino board certified family physicians increased from 1.3% to 7.8% and 2.3% to 9.1%, respectively, in 30 years.

A 2014 study included 2 decades worth of data from the U.S. Census and the Association of American Medical Colleges to examine trends in racial and ethnic composition among family medicine residents. The U.S. population increased from 9% to 17% for Latinos, 11.7% to 12.2% for Blacks/African Americans, and 0.87% to 0.89% for Native Americans from 1990 to 2012. Meanwhile, minority representation in family residencies increased 4.9% to 9.4% for Hispanics/Latinos, from 4.2% to 7.9% for Blacks/African Americans, and from 0.7% to 0.9% for Native Americans.

Furthermore, 13.4% of the U.S. population is Black and 18.5% of the population is Latino, while only 7.8% of family medicine residents in 2019 were Black and 9.1% of family medicine residents were Latino, according to a recent study published in Family Medicine.
 

Recruiting a diverse physician workforce

The AAFP has launched a few initiatives to increase diversity within the specialty. In 2017, the AAFP established the Center for Diversity and Health Equity, a center to address social determinants of health. The EveryONE Project, an initiative that’s part of the AAFP’s center, offers members education and resources to promote workforce diversity. Some of those resources include “The Ladder Program,” an initiative founded by an AAFP member which involves monthly meetings and events for students as young as 9 years old to introduce them to medicine at a young age.

“You can’t see what you don’t see,” noted Dr. Stewart, who is the first Black, female president of the AAFP, and the fourth woman in the role. “I really have seen how important it is to be a mentor and to be out there so that individuals who look like me can see that they too can become a family physician and be that member of their community.”

In addition to The Ladder Program, some other resources aimed at increasing diversity among family physicians include Tour for Diversity in Medicine and the Doctors Back to School Program.

The Tour for Diversity in Medicine involves a team of physicians, other clinicians and students hosting events nationwide for minority students to help them see a path to medicine and other health professions. Meanwhile, the AAFP’s Doctors Back to School Program involves family physicians visiting children at schools, clubs, community organizations, and other places to raise childhood awareness of family medicine and help them see their own potential in health care careers.

Dr. Stewart said these programs have been successful in increasing underrepresented groups.

“We are trying to see how best to measure their success,” the AAFP president said. “Looking at the high numbers of individuals who chose the specialty of family medicine last year is what I would deem a success.”

Dr. Wusu also believes outreach to children in elementary schools is important when it comes to increasing diversity in the family medicine specialty.

One organization that’s proving such outreach is the Student National Medical Association, a branch of the National Medical Association, which is a professional organization of Black physicians. This group’s initiative, the Health Professions Recruitment Exposure Programs, exposes teens to science-related activities while introducing them to careers in health professions. Another SMNA program, called Youth Science Enrichment Program, targets elementary and junior high school students.

Dr. Wusu led a 2019 project that focused on creating a more diverse family medicine residency program by developing and implementing a strategic plan for diversity recruitment, which involved increasing outreach to marginalized groups and revising interviews to minimize bias. In a paper published on the results of the initiative, Dr. Wusu and coauthors noted that, between 2014 and 2017, the total number of underrepresented minority applicants to the Boston Medical Center Family Medicine Residency Program increased by 80%. Before the intervention, the percentage of applicants who were part of an underrepresented group ranged from 0% to 20%. During the intervention, that range jumped to 25% to 50%, according to the paper.

While Dr. Wusu considers these programs to be beneficial for the specialty, she doesn’t believe they should be done in isolation. There should also be efforts to tackle lack of opportunities and structural racism.

“With any inequity, you have to address it on multiple levels,” Dr. Wusu explained. “It’s great that there has been recognition for a need for diversity in family medicine, but my hope is that the call for equity would reach beyond that.”
 

Fostering an inclusive environment

While family medicine has come a long way with regards to increasing the amount of underrepresented groups in its specialty, Stephen Richmond, MD, MPH, believes there also needs to be a focus on the infrastructure of support to help retain these physicians.

“The problem of diversity within family medicine and largely in other specialties cannot be summed up simply as a matter of poor representation. We must do be better to understand the lived experience of physicians of color, in particular Black physicians, once they arrive in the medical professional environment. Doing so will help institutions to provide that infrastructure of support – including antiracism policies and practices – that will enhance wellness and representation,” said Dr. Richmond, clinical assistant professor of medicine in the division of primary care and population health at Stanford (Calif.) University.

Dr. Wusu also suggested establishing an explicitly antiracist environment. This can be done in multiple ways, including by holding programs that acknowledge the impact of structural racism on both the patients, medical students and faculty, and by educating staff about the history of racism, she said.

Dr. Stewart and Dr. Wusu think the specialty has improved in its representation of minorities, but that it has a “long way to go.”

“I think family medicine is really one of the more inclusive specialties. I mean, it has higher numbers of Black and Brown residents and physicians than other specialties,” Dr. Wusu said. “We still have a very long way to go to be at numbers that match the general population. But I think, in that way, family medicine is a place where a lot of Black and Brown physicians can find a home.”
 

Family medicine has evolved in many ways since its inception in 1969, especially in terms of the people who are practicing it, but it still needs more diversity to represent the faces of patients.

The specialty has been on the path to a racially diverse workforce over the past few decades. Since family medicine is a discipline where doctors look not just at individual patients, but also at the health of the community, some family physicians see working in their specialty as a way to integrate public health with medicine to curb health inequities.

Maria Harsha Wusu, MD, MSEd, is an example of such a family physician.

Dr. Wusu, who is Black and of Japanese descent, chose to practice family medicine to address health in communities of color “which we know in the United States experience health inequities due to structural racism,” she said in an interview.

“It’s a discipline where you look at the health of the entire family and the community and you really look at the environmental, the political, the historical factors that are influencing the health of the community,” explained Dr. Wusu, who is currently the director of health equity at Morehouse School of Medicine, Atlanta. Family physicians are not just asking: “Does a patient have hypertension?” but also whether a patient has access to healthy food, green space and other things.

While the field of family medicine is more diverse in the 21st century than it was at its beginning, Dr. Wusu, who completed her residency in 2016, still faced challenges to achieving her goal of helping communities of color. These specifically stemmed from a lack of diversity among the people in the places where she studied to become a doctor and family physician.

There were moments when Dr. Wusu felt isolated while in medical school and residency, because so few students and faculty members she saw looked like her.

Plus, studies have shown that a racially and ethnically diverse physician workforce is necessary to address health inequities. Research published in 2018 in the Journal of Health Care for the Poor and Underserved, for example, found that underrepresented physicians are more likely to practice in underserved areas than their White peers.

“I went to medical school at a historically White institution, and so there were very few people who identified as what we would say are underrepresented minorities in medicine,” Dr. Wusu explained. “There are issues with both implicit and explicit racism, which I think could be echoed by colleagues across the country that are additional challenges that I think medical students, particularly students of color, experience during what is an already kind of challenging time of medical school and the rigorous training of residency.”

Ada Stewart, MD, FAAFP, president of the American Academy of Family Physicians, echoed Dr. Wusu’s medical school experience. Dr. Stewart, who finished her residency in 2003, said that, out of the 120 students in her graduating medical class, only 10 were Black.

Marginalized groups are still underrepresented in residences. According to data compiled by the Association of American Medical Colleges, only 9.3% of Black people, 10% of Latino, and 0.3% of Native Hawaiian or other Pacific Islanders are residents in family medicine residency programs in 2019-2020. Meanwhile, White residents make up 50.8% of the residency program.

“We really need to do all that we can to increase diversity within our medical schools and residencies,” Dr. Stewart said.

In regards to gender, there has been an increasing number of women in the family medicine specialty. A 2021 study found that the proportion of female physicians in family medicine has grown from 33.9% 2010 to 41.9% in 2020.

“There’s still room for growth and we have to change the system and those structures that created these problems,” noted Dr. Stewart.
 

The social responsibility of family medicine

The family medicine specialty was born during an era of protest of social change, alongside the Civil Rights Movement, the peace movement, and counterculture protests. In April 1966, 3 years before American Boards approved family practice as a new specialty; the National Commission on Community Health stated that every person should have a personal physician who is the “central point for the integration and continuity of all medical services to his patient.” They also said such physicians should be aware of the “many and varied social, emotional and environmental factors that influence the health of his patient and family.”

While the diversity of family medicine specialty has significantly increased since its beginnings, it continues to lag behind the general U.S. population. A 2018 study published in the Journal of the American Board of Family Medicine, which aggregated data from 1987 to 2017, found that the proportion of Black and Latino board certified family physicians increased from 1.3% to 7.8% and 2.3% to 9.1%, respectively, in 30 years.

A 2014 study included 2 decades worth of data from the U.S. Census and the Association of American Medical Colleges to examine trends in racial and ethnic composition among family medicine residents. The U.S. population increased from 9% to 17% for Latinos, 11.7% to 12.2% for Blacks/African Americans, and 0.87% to 0.89% for Native Americans from 1990 to 2012. Meanwhile, minority representation in family residencies increased 4.9% to 9.4% for Hispanics/Latinos, from 4.2% to 7.9% for Blacks/African Americans, and from 0.7% to 0.9% for Native Americans.

Furthermore, 13.4% of the U.S. population is Black and 18.5% of the population is Latino, while only 7.8% of family medicine residents in 2019 were Black and 9.1% of family medicine residents were Latino, according to a recent study published in Family Medicine.
 

Recruiting a diverse physician workforce

The AAFP has launched a few initiatives to increase diversity within the specialty. In 2017, the AAFP established the Center for Diversity and Health Equity, a center to address social determinants of health. The EveryONE Project, an initiative that’s part of the AAFP’s center, offers members education and resources to promote workforce diversity. Some of those resources include “The Ladder Program,” an initiative founded by an AAFP member which involves monthly meetings and events for students as young as 9 years old to introduce them to medicine at a young age.

“You can’t see what you don’t see,” noted Dr. Stewart, who is the first Black, female president of the AAFP, and the fourth woman in the role. “I really have seen how important it is to be a mentor and to be out there so that individuals who look like me can see that they too can become a family physician and be that member of their community.”

In addition to The Ladder Program, some other resources aimed at increasing diversity among family physicians include Tour for Diversity in Medicine and the Doctors Back to School Program.

The Tour for Diversity in Medicine involves a team of physicians, other clinicians and students hosting events nationwide for minority students to help them see a path to medicine and other health professions. Meanwhile, the AAFP’s Doctors Back to School Program involves family physicians visiting children at schools, clubs, community organizations, and other places to raise childhood awareness of family medicine and help them see their own potential in health care careers.

Dr. Stewart said these programs have been successful in increasing underrepresented groups.

“We are trying to see how best to measure their success,” the AAFP president said. “Looking at the high numbers of individuals who chose the specialty of family medicine last year is what I would deem a success.”

Dr. Wusu also believes outreach to children in elementary schools is important when it comes to increasing diversity in the family medicine specialty.

One organization that’s proving such outreach is the Student National Medical Association, a branch of the National Medical Association, which is a professional organization of Black physicians. This group’s initiative, the Health Professions Recruitment Exposure Programs, exposes teens to science-related activities while introducing them to careers in health professions. Another SMNA program, called Youth Science Enrichment Program, targets elementary and junior high school students.

Dr. Wusu led a 2019 project that focused on creating a more diverse family medicine residency program by developing and implementing a strategic plan for diversity recruitment, which involved increasing outreach to marginalized groups and revising interviews to minimize bias. In a paper published on the results of the initiative, Dr. Wusu and coauthors noted that, between 2014 and 2017, the total number of underrepresented minority applicants to the Boston Medical Center Family Medicine Residency Program increased by 80%. Before the intervention, the percentage of applicants who were part of an underrepresented group ranged from 0% to 20%. During the intervention, that range jumped to 25% to 50%, according to the paper.

While Dr. Wusu considers these programs to be beneficial for the specialty, she doesn’t believe they should be done in isolation. There should also be efforts to tackle lack of opportunities and structural racism.

“With any inequity, you have to address it on multiple levels,” Dr. Wusu explained. “It’s great that there has been recognition for a need for diversity in family medicine, but my hope is that the call for equity would reach beyond that.”
 

Fostering an inclusive environment

While family medicine has come a long way with regards to increasing the amount of underrepresented groups in its specialty, Stephen Richmond, MD, MPH, believes there also needs to be a focus on the infrastructure of support to help retain these physicians.

“The problem of diversity within family medicine and largely in other specialties cannot be summed up simply as a matter of poor representation. We must do be better to understand the lived experience of physicians of color, in particular Black physicians, once they arrive in the medical professional environment. Doing so will help institutions to provide that infrastructure of support – including antiracism policies and practices – that will enhance wellness and representation,” said Dr. Richmond, clinical assistant professor of medicine in the division of primary care and population health at Stanford (Calif.) University.

Dr. Wusu also suggested establishing an explicitly antiracist environment. This can be done in multiple ways, including by holding programs that acknowledge the impact of structural racism on both the patients, medical students and faculty, and by educating staff about the history of racism, she said.

Dr. Stewart and Dr. Wusu think the specialty has improved in its representation of minorities, but that it has a “long way to go.”

“I think family medicine is really one of the more inclusive specialties. I mean, it has higher numbers of Black and Brown residents and physicians than other specialties,” Dr. Wusu said. “We still have a very long way to go to be at numbers that match the general population. But I think, in that way, family medicine is a place where a lot of Black and Brown physicians can find a home.”
 

Family medicine has evolved in many ways since its inception in 1969, especially in terms of the people who are practicing it, but it still needs more diversity to represent the faces of patients.

The specialty has been on the path to a racially diverse workforce over the past few decades. Since family medicine is a discipline where doctors look not just at individual patients, but also at the health of the community, some family physicians see working in their specialty as a way to integrate public health with medicine to curb health inequities.

Maria Harsha Wusu, MD, MSEd, is an example of such a family physician.

Dr. Wusu, who is Black and of Japanese descent, chose to practice family medicine to address health in communities of color “which we know in the United States experience health inequities due to structural racism,” she said in an interview.

“It’s a discipline where you look at the health of the entire family and the community and you really look at the environmental, the political, the historical factors that are influencing the health of the community,” explained Dr. Wusu, who is currently the director of health equity at Morehouse School of Medicine, Atlanta. Family physicians are not just asking: “Does a patient have hypertension?” but also whether a patient has access to healthy food, green space and other things.

While the field of family medicine is more diverse in the 21st century than it was at its beginning, Dr. Wusu, who completed her residency in 2016, still faced challenges to achieving her goal of helping communities of color. These specifically stemmed from a lack of diversity among the people in the places where she studied to become a doctor and family physician.

There were moments when Dr. Wusu felt isolated while in medical school and residency, because so few students and faculty members she saw looked like her.

Plus, studies have shown that a racially and ethnically diverse physician workforce is necessary to address health inequities. Research published in 2018 in the Journal of Health Care for the Poor and Underserved, for example, found that underrepresented physicians are more likely to practice in underserved areas than their White peers.

“I went to medical school at a historically White institution, and so there were very few people who identified as what we would say are underrepresented minorities in medicine,” Dr. Wusu explained. “There are issues with both implicit and explicit racism, which I think could be echoed by colleagues across the country that are additional challenges that I think medical students, particularly students of color, experience during what is an already kind of challenging time of medical school and the rigorous training of residency.”

Ada Stewart, MD, FAAFP, president of the American Academy of Family Physicians, echoed Dr. Wusu’s medical school experience. Dr. Stewart, who finished her residency in 2003, said that, out of the 120 students in her graduating medical class, only 10 were Black.

Marginalized groups are still underrepresented in residences. According to data compiled by the Association of American Medical Colleges, only 9.3% of Black people, 10% of Latino, and 0.3% of Native Hawaiian or other Pacific Islanders are residents in family medicine residency programs in 2019-2020. Meanwhile, White residents make up 50.8% of the residency program.

“We really need to do all that we can to increase diversity within our medical schools and residencies,” Dr. Stewart said.

In regards to gender, there has been an increasing number of women in the family medicine specialty. A 2021 study found that the proportion of female physicians in family medicine has grown from 33.9% 2010 to 41.9% in 2020.

“There’s still room for growth and we have to change the system and those structures that created these problems,” noted Dr. Stewart.
 

The social responsibility of family medicine

The family medicine specialty was born during an era of protest of social change, alongside the Civil Rights Movement, the peace movement, and counterculture protests. In April 1966, 3 years before American Boards approved family practice as a new specialty; the National Commission on Community Health stated that every person should have a personal physician who is the “central point for the integration and continuity of all medical services to his patient.” They also said such physicians should be aware of the “many and varied social, emotional and environmental factors that influence the health of his patient and family.”

While the diversity of family medicine specialty has significantly increased since its beginnings, it continues to lag behind the general U.S. population. A 2018 study published in the Journal of the American Board of Family Medicine, which aggregated data from 1987 to 2017, found that the proportion of Black and Latino board certified family physicians increased from 1.3% to 7.8% and 2.3% to 9.1%, respectively, in 30 years.

A 2014 study included 2 decades worth of data from the U.S. Census and the Association of American Medical Colleges to examine trends in racial and ethnic composition among family medicine residents. The U.S. population increased from 9% to 17% for Latinos, 11.7% to 12.2% for Blacks/African Americans, and 0.87% to 0.89% for Native Americans from 1990 to 2012. Meanwhile, minority representation in family residencies increased 4.9% to 9.4% for Hispanics/Latinos, from 4.2% to 7.9% for Blacks/African Americans, and from 0.7% to 0.9% for Native Americans.

Furthermore, 13.4% of the U.S. population is Black and 18.5% of the population is Latino, while only 7.8% of family medicine residents in 2019 were Black and 9.1% of family medicine residents were Latino, according to a recent study published in Family Medicine.
 

Recruiting a diverse physician workforce

The AAFP has launched a few initiatives to increase diversity within the specialty. In 2017, the AAFP established the Center for Diversity and Health Equity, a center to address social determinants of health. The EveryONE Project, an initiative that’s part of the AAFP’s center, offers members education and resources to promote workforce diversity. Some of those resources include “The Ladder Program,” an initiative founded by an AAFP member which involves monthly meetings and events for students as young as 9 years old to introduce them to medicine at a young age.

“You can’t see what you don’t see,” noted Dr. Stewart, who is the first Black, female president of the AAFP, and the fourth woman in the role. “I really have seen how important it is to be a mentor and to be out there so that individuals who look like me can see that they too can become a family physician and be that member of their community.”

In addition to The Ladder Program, some other resources aimed at increasing diversity among family physicians include Tour for Diversity in Medicine and the Doctors Back to School Program.

The Tour for Diversity in Medicine involves a team of physicians, other clinicians and students hosting events nationwide for minority students to help them see a path to medicine and other health professions. Meanwhile, the AAFP’s Doctors Back to School Program involves family physicians visiting children at schools, clubs, community organizations, and other places to raise childhood awareness of family medicine and help them see their own potential in health care careers.

Dr. Stewart said these programs have been successful in increasing underrepresented groups.

“We are trying to see how best to measure their success,” the AAFP president said. “Looking at the high numbers of individuals who chose the specialty of family medicine last year is what I would deem a success.”

Dr. Wusu also believes outreach to children in elementary schools is important when it comes to increasing diversity in the family medicine specialty.

One organization that’s proving such outreach is the Student National Medical Association, a branch of the National Medical Association, which is a professional organization of Black physicians. This group’s initiative, the Health Professions Recruitment Exposure Programs, exposes teens to science-related activities while introducing them to careers in health professions. Another SMNA program, called Youth Science Enrichment Program, targets elementary and junior high school students.

Dr. Wusu led a 2019 project that focused on creating a more diverse family medicine residency program by developing and implementing a strategic plan for diversity recruitment, which involved increasing outreach to marginalized groups and revising interviews to minimize bias. In a paper published on the results of the initiative, Dr. Wusu and coauthors noted that, between 2014 and 2017, the total number of underrepresented minority applicants to the Boston Medical Center Family Medicine Residency Program increased by 80%. Before the intervention, the percentage of applicants who were part of an underrepresented group ranged from 0% to 20%. During the intervention, that range jumped to 25% to 50%, according to the paper.

While Dr. Wusu considers these programs to be beneficial for the specialty, she doesn’t believe they should be done in isolation. There should also be efforts to tackle lack of opportunities and structural racism.

“With any inequity, you have to address it on multiple levels,” Dr. Wusu explained. “It’s great that there has been recognition for a need for diversity in family medicine, but my hope is that the call for equity would reach beyond that.”
 

Fostering an inclusive environment

While family medicine has come a long way with regards to increasing the amount of underrepresented groups in its specialty, Stephen Richmond, MD, MPH, believes there also needs to be a focus on the infrastructure of support to help retain these physicians.

“The problem of diversity within family medicine and largely in other specialties cannot be summed up simply as a matter of poor representation. We must do be better to understand the lived experience of physicians of color, in particular Black physicians, once they arrive in the medical professional environment. Doing so will help institutions to provide that infrastructure of support – including antiracism policies and practices – that will enhance wellness and representation,” said Dr. Richmond, clinical assistant professor of medicine in the division of primary care and population health at Stanford (Calif.) University.

Dr. Wusu also suggested establishing an explicitly antiracist environment. This can be done in multiple ways, including by holding programs that acknowledge the impact of structural racism on both the patients, medical students and faculty, and by educating staff about the history of racism, she said.

Dr. Stewart and Dr. Wusu think the specialty has improved in its representation of minorities, but that it has a “long way to go.”

“I think family medicine is really one of the more inclusive specialties. I mean, it has higher numbers of Black and Brown residents and physicians than other specialties,” Dr. Wusu said. “We still have a very long way to go to be at numbers that match the general population. But I think, in that way, family medicine is a place where a lot of Black and Brown physicians can find a home.”
 

I dream of alien abductions

There he goes! It’s lunchtime and your colleague Tom is going on and on again about that time he was abducted by aliens. It sounds ridiculous, but he does make some convincing arguments. Tom thinks it was real, but could it have all just been in his head?

Engin Akyurt/Pixabay

Lucid dreaming may help explain alleged alien abductions. During a lucid dream, people know that they’re dreaming, and can also have some control over how the dreams play out. During some dream states, a person can feel intense sensations, such as terror and paralysis, so it’s no wonder these dreams feel so real.

In a recent study, scientists encouraged 152 participants who had self-identified as lucid dreamers to dream about aliens. Many (75%) of the participants were able to dream about alien encounters, and 15% “achieved relatively realistic experiences,” the investigators reported.

So cut Tom some slack. He’s not crazy, he might just have lucid dreaming privileges. Tell him he should dream about something more fun, like a vacation in the Bahamas.
 

Follow your heart: Drink more coffee

It seems like the world is divided into coffee drinkers and non–coffee drinkers. Then there’s decaf and regular drinkers. Whichever camp you fall into, know this: The widespread belief that caffeine consumption has an effect on your heart is all beans.

s-photo/iStockphoto.com

In what is the largest investigation of its kind, researchers from the University of California, San Francisco, looked into whether drinking caffeinated coffee was linked to a risk for heart arrhythmia. They also researched whether patients with genetic variants that affect their metabolism could change that association. Almost 400,000 people with a mean age of 56 years participated in the study. More than half of the participants were women.

The investigators analyzed the participants’ self-reported coffee consumption using a technique called Mendelian randomization to leverage genetic data with the participants’ relationship with caffeine, making it an even field and not relying on the participant consumption self-reporting for outcomes as in previous studies.

What they found, after the 4-year follow up, was nothing short of myth busting.

“We found no evidence that caffeine consumption leads to a greater risk of arrhythmias,” said senior and corresponding author Gregory Marcus, MD. “Our population-based study provides reassurance that common prohibitions against caffeine to reduce arrhythmia risk are likely unwarranted.”

There was no evidence of a heightened risk of arrhythmias in participants who were genetically predisposed to metabolize caffeine differently from those who were not. And, there was a 3% reduction of arrhythmias in patients who consumed higher amounts of coffee.

We are not lobbying for Big Caffeine, but this study adds to the reported health benefits linked to coffee, which already include reduced risk for cancer, diabetes, and Parkinson’s disease, with an added bonus of anti-inflammatory benefits. So, the next time you’re hesitant to pour that second cup of Joe, just go for it. Your heart can take it.
 

Bored? Feeling down? Don’t play Candy Crush

Now hang on, aren’t those the perfect times to play video games? If there’s nothing else to do, why not open Candy Crush and mindlessly power through the levels?

pxfuel

Because, according to a study by a group of Canadian researchers, it’s actually the worst thing you can do. Well, maybe not literally, but it’s not helpful. Researchers recruited 60 Candy Crush players who were at various levels in the game. They had the participants play early levels that were far too easy or levels balanced with their gameplay abilities.

Players in the easy-level group got bored and quit far earlier than did those in the advanced-level group. The group playing to their abilities were able to access a “flow” state and focus all their attention on the game. While this is all well and good for their gaming performance, according to the researchers, it confirms the theory that playing to escape boredom or negative emotions is more likely to lead to addiction. As with all addictions, the temporary high can give way to a self-repeating loop, causing patients to ignore real life and deepen depression.

The researchers hope their findings will encourage game developers to “consider implementing responsible video gaming tools directly within their games.” Comedy gold. Perhaps Canadians’ idea of capitalism is a little different from that of those south of the border.
 

Hiccups and vaccine refusal

Tonight, LOTME News dives into the fetid cesspool that is international politics and comes out with … hiccups?

But first, a word from our sponsor, Fearless Boxing Club of South Etobicoke, Ontario.

Are you looking to flout public health restrictions? Do you want to spend time in an enclosed space with other people who haven’t gotten the COVID-19 vaccine? Do you “feel safer waiting until more research is done on the side effects being discovered right now”? (We are not making this up.)

Then join the Fearless Boxing Club, because we “will not be accepting any vaccinated members.” Our founders, Mohammed Abedeen and Krystal Glazier-Roscoe, are working hard to exclude “those who received the experimental COVID vaccine.” (Still not making it up.)

And now, back to the news.

Brazilian president Jair Bolsonaro was hospitalized recently for a severe case of hiccups that may have been related to a stab wound he received in 2018. [Nope, didn’t make that up, either.]

djedj/Pixabay

Mr. Bolsonaro had been hiccuping for 10 days, and was experiencing abdominal pain and difficulty speaking, when he entered the hospital on July 14. Since being stabbed while on the campaign trail, he has undergone several operations, which may have led to the partial intestinal obstruction that caused his latest symptoms.

His medical team advised Mr. Bolsonaro to go on a diet to aid his recovery, but when he was released on July 18 he said, “I hope in 10 days I’ll be eating barbecued ribs.” (Maybe this is all just a lucid dream. Probably shouldn’t have had ribs right before bed.)

I dream of alien abductions

There he goes! It’s lunchtime and your colleague Tom is going on and on again about that time he was abducted by aliens. It sounds ridiculous, but he does make some convincing arguments. Tom thinks it was real, but could it have all just been in his head?

Engin Akyurt/Pixabay

Lucid dreaming may help explain alleged alien abductions. During a lucid dream, people know that they’re dreaming, and can also have some control over how the dreams play out. During some dream states, a person can feel intense sensations, such as terror and paralysis, so it’s no wonder these dreams feel so real.

In a recent study, scientists encouraged 152 participants who had self-identified as lucid dreamers to dream about aliens. Many (75%) of the participants were able to dream about alien encounters, and 15% “achieved relatively realistic experiences,” the investigators reported.

So cut Tom some slack. He’s not crazy, he might just have lucid dreaming privileges. Tell him he should dream about something more fun, like a vacation in the Bahamas.
 

Follow your heart: Drink more coffee

It seems like the world is divided into coffee drinkers and non–coffee drinkers. Then there’s decaf and regular drinkers. Whichever camp you fall into, know this: The widespread belief that caffeine consumption has an effect on your heart is all beans.

s-photo/iStockphoto.com

In what is the largest investigation of its kind, researchers from the University of California, San Francisco, looked into whether drinking caffeinated coffee was linked to a risk for heart arrhythmia. They also researched whether patients with genetic variants that affect their metabolism could change that association. Almost 400,000 people with a mean age of 56 years participated in the study. More than half of the participants were women.

The investigators analyzed the participants’ self-reported coffee consumption using a technique called Mendelian randomization to leverage genetic data with the participants’ relationship with caffeine, making it an even field and not relying on the participant consumption self-reporting for outcomes as in previous studies.

What they found, after the 4-year follow up, was nothing short of myth busting.

“We found no evidence that caffeine consumption leads to a greater risk of arrhythmias,” said senior and corresponding author Gregory Marcus, MD. “Our population-based study provides reassurance that common prohibitions against caffeine to reduce arrhythmia risk are likely unwarranted.”

There was no evidence of a heightened risk of arrhythmias in participants who were genetically predisposed to metabolize caffeine differently from those who were not. And, there was a 3% reduction of arrhythmias in patients who consumed higher amounts of coffee.

We are not lobbying for Big Caffeine, but this study adds to the reported health benefits linked to coffee, which already include reduced risk for cancer, diabetes, and Parkinson’s disease, with an added bonus of anti-inflammatory benefits. So, the next time you’re hesitant to pour that second cup of Joe, just go for it. Your heart can take it.
 

Bored? Feeling down? Don’t play Candy Crush

Now hang on, aren’t those the perfect times to play video games? If there’s nothing else to do, why not open Candy Crush and mindlessly power through the levels?

pxfuel

Because, according to a study by a group of Canadian researchers, it’s actually the worst thing you can do. Well, maybe not literally, but it’s not helpful. Researchers recruited 60 Candy Crush players who were at various levels in the game. They had the participants play early levels that were far too easy or levels balanced with their gameplay abilities.

Players in the easy-level group got bored and quit far earlier than did those in the advanced-level group. The group playing to their abilities were able to access a “flow” state and focus all their attention on the game. While this is all well and good for their gaming performance, according to the researchers, it confirms the theory that playing to escape boredom or negative emotions is more likely to lead to addiction. As with all addictions, the temporary high can give way to a self-repeating loop, causing patients to ignore real life and deepen depression.

The researchers hope their findings will encourage game developers to “consider implementing responsible video gaming tools directly within their games.” Comedy gold. Perhaps Canadians’ idea of capitalism is a little different from that of those south of the border.
 

Hiccups and vaccine refusal

Tonight, LOTME News dives into the fetid cesspool that is international politics and comes out with … hiccups?

But first, a word from our sponsor, Fearless Boxing Club of South Etobicoke, Ontario.

Are you looking to flout public health restrictions? Do you want to spend time in an enclosed space with other people who haven’t gotten the COVID-19 vaccine? Do you “feel safer waiting until more research is done on the side effects being discovered right now”? (We are not making this up.)

Then join the Fearless Boxing Club, because we “will not be accepting any vaccinated members.” Our founders, Mohammed Abedeen and Krystal Glazier-Roscoe, are working hard to exclude “those who received the experimental COVID vaccine.” (Still not making it up.)

And now, back to the news.

Brazilian president Jair Bolsonaro was hospitalized recently for a severe case of hiccups that may have been related to a stab wound he received in 2018. [Nope, didn’t make that up, either.]

djedj/Pixabay

Mr. Bolsonaro had been hiccuping for 10 days, and was experiencing abdominal pain and difficulty speaking, when he entered the hospital on July 14. Since being stabbed while on the campaign trail, he has undergone several operations, which may have led to the partial intestinal obstruction that caused his latest symptoms.

His medical team advised Mr. Bolsonaro to go on a diet to aid his recovery, but when he was released on July 18 he said, “I hope in 10 days I’ll be eating barbecued ribs.” (Maybe this is all just a lucid dream. Probably shouldn’t have had ribs right before bed.)

I dream of alien abductions

There he goes! It’s lunchtime and your colleague Tom is going on and on again about that time he was abducted by aliens. It sounds ridiculous, but he does make some convincing arguments. Tom thinks it was real, but could it have all just been in his head?

Engin Akyurt/Pixabay

Lucid dreaming may help explain alleged alien abductions. During a lucid dream, people know that they’re dreaming, and can also have some control over how the dreams play out. During some dream states, a person can feel intense sensations, such as terror and paralysis, so it’s no wonder these dreams feel so real.

In a recent study, scientists encouraged 152 participants who had self-identified as lucid dreamers to dream about aliens. Many (75%) of the participants were able to dream about alien encounters, and 15% “achieved relatively realistic experiences,” the investigators reported.

So cut Tom some slack. He’s not crazy, he might just have lucid dreaming privileges. Tell him he should dream about something more fun, like a vacation in the Bahamas.
 

Follow your heart: Drink more coffee

It seems like the world is divided into coffee drinkers and non–coffee drinkers. Then there’s decaf and regular drinkers. Whichever camp you fall into, know this: The widespread belief that caffeine consumption has an effect on your heart is all beans.

s-photo/iStockphoto.com

In what is the largest investigation of its kind, researchers from the University of California, San Francisco, looked into whether drinking caffeinated coffee was linked to a risk for heart arrhythmia. They also researched whether patients with genetic variants that affect their metabolism could change that association. Almost 400,000 people with a mean age of 56 years participated in the study. More than half of the participants were women.

The investigators analyzed the participants’ self-reported coffee consumption using a technique called Mendelian randomization to leverage genetic data with the participants’ relationship with caffeine, making it an even field and not relying on the participant consumption self-reporting for outcomes as in previous studies.

What they found, after the 4-year follow up, was nothing short of myth busting.

“We found no evidence that caffeine consumption leads to a greater risk of arrhythmias,” said senior and corresponding author Gregory Marcus, MD. “Our population-based study provides reassurance that common prohibitions against caffeine to reduce arrhythmia risk are likely unwarranted.”

There was no evidence of a heightened risk of arrhythmias in participants who were genetically predisposed to metabolize caffeine differently from those who were not. And, there was a 3% reduction of arrhythmias in patients who consumed higher amounts of coffee.

We are not lobbying for Big Caffeine, but this study adds to the reported health benefits linked to coffee, which already include reduced risk for cancer, diabetes, and Parkinson’s disease, with an added bonus of anti-inflammatory benefits. So, the next time you’re hesitant to pour that second cup of Joe, just go for it. Your heart can take it.
 

Bored? Feeling down? Don’t play Candy Crush

Now hang on, aren’t those the perfect times to play video games? If there’s nothing else to do, why not open Candy Crush and mindlessly power through the levels?

pxfuel

Because, according to a study by a group of Canadian researchers, it’s actually the worst thing you can do. Well, maybe not literally, but it’s not helpful. Researchers recruited 60 Candy Crush players who were at various levels in the game. They had the participants play early levels that were far too easy or levels balanced with their gameplay abilities.

Players in the easy-level group got bored and quit far earlier than did those in the advanced-level group. The group playing to their abilities were able to access a “flow” state and focus all their attention on the game. While this is all well and good for their gaming performance, according to the researchers, it confirms the theory that playing to escape boredom or negative emotions is more likely to lead to addiction. As with all addictions, the temporary high can give way to a self-repeating loop, causing patients to ignore real life and deepen depression.

The researchers hope their findings will encourage game developers to “consider implementing responsible video gaming tools directly within their games.” Comedy gold. Perhaps Canadians’ idea of capitalism is a little different from that of those south of the border.
 

Hiccups and vaccine refusal

Tonight, LOTME News dives into the fetid cesspool that is international politics and comes out with … hiccups?

But first, a word from our sponsor, Fearless Boxing Club of South Etobicoke, Ontario.

Are you looking to flout public health restrictions? Do you want to spend time in an enclosed space with other people who haven’t gotten the COVID-19 vaccine? Do you “feel safer waiting until more research is done on the side effects being discovered right now”? (We are not making this up.)

Then join the Fearless Boxing Club, because we “will not be accepting any vaccinated members.” Our founders, Mohammed Abedeen and Krystal Glazier-Roscoe, are working hard to exclude “those who received the experimental COVID vaccine.” (Still not making it up.)

And now, back to the news.

Brazilian president Jair Bolsonaro was hospitalized recently for a severe case of hiccups that may have been related to a stab wound he received in 2018. [Nope, didn’t make that up, either.]

djedj/Pixabay

Mr. Bolsonaro had been hiccuping for 10 days, and was experiencing abdominal pain and difficulty speaking, when he entered the hospital on July 14. Since being stabbed while on the campaign trail, he has undergone several operations, which may have led to the partial intestinal obstruction that caused his latest symptoms.

His medical team advised Mr. Bolsonaro to go on a diet to aid his recovery, but when he was released on July 18 he said, “I hope in 10 days I’ll be eating barbecued ribs.” (Maybe this is all just a lucid dream. Probably shouldn’t have had ribs right before bed.)

In combing the genome, scientists can use genetic clues to determine a person’s risk for psychiatric disease and even identify new drug targets. But the benefits of these discoveries will be limited to people of European descent.

Nearly 90% of participants in genome-wide association studies (GWASs), which search for gene variants linked to disease, are of European ancestry. This Eurocentric focus threatens to widen existing disparities in racial and ethnic mental health.

The significant downsides of genomics’ one-track mind

One obstacle hindering therapeutic advances in psychiatry is a shallow understanding of the mechanisms of disorders. “The biggest problem in terms of advancing research for mental health conditions is that we don’t understand the underlying biology,” says Laramie Duncan, PhD, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “Genetics is one of the best ways to systematically look for new clues about the underlying biology.”

At the advent of genomic research, scientists thought it best to study DNA from people of a single ancestry from one continent. “Researchers for a long time held the idea that it was going to be too complicated to include multiple ancestries in the first rounds of genetic analyses,” says Dr. Duncan.

Studying DNA from someone with ancestors from multiple parts of the world wasn’t compatible with methods used in the early days of GWASs. “Individual parts of a person’s DNA can be linked back to one region of the world or another, and most of our methods essentially assume that all of a person’s DNA came from one region of the world,” says Dr. Duncan.

Because many genes are usually involved in psychiatric disorders, scientists need large numbers of participants to detect uncommon, influential variants. Early research was concentrated in North America and Europe so that scientists could readily collect samples from people of European ancestry.

“It then went out of hand because it became routine practice to use only this one group, essentially White, European ancestry people,” says Karoline Kuchenbaecker, PhD, associate professor of psychiatry at University College London.

Yet findings from one population won’t necessarily translate to others. “And that’s exactly what has been shown,” says Dr. Teferra. Polygenic risk scores developed for schizophrenia from European samples, for example, perform poorly among people of African ancestry, although among Europeans, they are strongly effective at differentiating European individuals with and those without schizophrenia. Moreover, drugs that target a gene identified from studies in European populations may be harmful to other groups.

Studies drawn from a diverse pool of participants would benefit a wider swath of humanity. They would also allow scientists to discover small areas of overlap in genomes of different populations, which would help them close in on the true biology of diseases and ensure that “we’re all benefiting from more diverse data in genetics and psychiatric genetics,” says Dr. Kuchenbaecker.
 

New efforts aim at filling the gaps

Genomic studies are featuring more people of non-European ancestry, but most of that improvement comes from populations of Asian ancestry, not African, Latin American, or Indigenous ancestry.

Efforts to increase representation of persons of African ancestry have largely focused on African Americans; fewer efforts have extended to the African continent, home to the most genetically diverse populations. Even fewer have focused on mental health. “The little that was being done was on a very small scale,” says Karestan Koenen, PhD, a professor at Harvard School of Public Health, Boston.

With this in mind, researchers from institutions in Kenya, Uganda, South Africa, and Ethiopia partnered with researchers at the Broad Institute of the Massachusetts Institute of Technology and Harvard to conduct the largest GWAS of psychiatric disorders in Africa. Dr. Koenen leads the project, Neuropsychiatric Genetics of African Populations–Psychosis (NeuroGAP-Psychosis), which will analyze DNA from over 35,000 people of African ancestry in each of these four countries. Investigators will compare the half of participants who have no history of psychosis with the half with schizophrenia or bipolar disorder in the hopes of identifying the genetic determinants of psychosis.

“Then any potential intervention or therapeutics that will be developed will also be useful for Africans,” says Dr. Teferra, a NeuroGAP principal investigator. Because of the tremendous degree of genetic diversity among people on the continent, however, findings still might not translate to all African populations.

But correcting equity problems in genomics isn’t as simple as recruiting people with non-European backgrounds, especially if those people are unfamiliar with research or have been subject to scientific exploitation. “Special care needs to be taken to, first of all, provide information that’s appropriate [to participants], but also motivate people to take part and then find ways to keep these communities involved and understand what they’re interested in,” says Dr. Kuchenbaecker, who is not involved with NeuroGAP.

For NeuroGAP, the team needed to work with ethical committees at all of the institutions involved, ensure research materials were appropriate for each community’s cultural context, and gain the trust of local communities.

“One of the biggest criticisms within the scientific world is that people from more endowed countries just fly in, bully everyone, collect the data, and leave, with no credit to the local scientists or communities,” says NeuroGAP principal investigator Lukoye Atwoli, MMed, PhD, professor of psychiatry and dean of the Medical College, East Africa, at the Aga Khan University, Nairobi, Kenya. “That is one of the biggest pitfalls we had to grapple with.”

To address that concern, NeuroGAP is training local researchers and is providing them with requested resources so they can carry out similar studies in the future. “We will be looking to address a real need in the academic community and in clinical service delivery,” says Dr. Atwoli.

Dr. Kuchenbaecker says that NeuroGAP demonstrates features necessary for projects seeking to improve equity in psychiatric genomics. “What they’re doing right is recruiting really large numbers, recruiting from different African countries, and involving African investigators,” she says.

In the Americas, Janitza Montalvo-Ortiz, PhD, assistant professor in the Division of Genetics, department of psychiatry, Yale University, New Haven, Conn., and her colleagues are expanding psychiatric genomics projects in Latin America. She co-founded the Latin American Genomics Consortium in 2019, a network of scientists supporting psychiatric genomic research in the region. The consortium also involves the Neuropsychiatric Genetics in Mexican Populations project, which is similar to NeuroGAP and is also led by Dr. Koenan.

The study of Latin American populations is complicated, because genes in these populations reflect Indigenous American, European, and African ancestries. Even when investigators sampled DNA from Latin American individuals, that data often went unused. “Now with new methods emerging to allow us to properly analyze admixed populations in GWAS studies, we’re making efforts to compile different datasets scattered across different large-scale cohorts,” says Dr. Montalvo-Ortiz. “Our ultimate goal is to conduct the first large-scale LatinX GWAS of psychiatry,” she says.

With these projects, researchers hope that new psychiatric research will produce clinical advances for people historically left on the sidelines of genomic studies. By involving their communities in genomic research, “whatever is going to be developed will also benefit our community,” says Dr. Teferra. “We will not be left out.”

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

In combing the genome, scientists can use genetic clues to determine a person’s risk for psychiatric disease and even identify new drug targets. But the benefits of these discoveries will be limited to people of European descent.

Nearly 90% of participants in genome-wide association studies (GWASs), which search for gene variants linked to disease, are of European ancestry. This Eurocentric focus threatens to widen existing disparities in racial and ethnic mental health.

The significant downsides of genomics’ one-track mind

One obstacle hindering therapeutic advances in psychiatry is a shallow understanding of the mechanisms of disorders. “The biggest problem in terms of advancing research for mental health conditions is that we don’t understand the underlying biology,” says Laramie Duncan, PhD, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “Genetics is one of the best ways to systematically look for new clues about the underlying biology.”

At the advent of genomic research, scientists thought it best to study DNA from people of a single ancestry from one continent. “Researchers for a long time held the idea that it was going to be too complicated to include multiple ancestries in the first rounds of genetic analyses,” says Dr. Duncan.

Studying DNA from someone with ancestors from multiple parts of the world wasn’t compatible with methods used in the early days of GWASs. “Individual parts of a person’s DNA can be linked back to one region of the world or another, and most of our methods essentially assume that all of a person’s DNA came from one region of the world,” says Dr. Duncan.

Because many genes are usually involved in psychiatric disorders, scientists need large numbers of participants to detect uncommon, influential variants. Early research was concentrated in North America and Europe so that scientists could readily collect samples from people of European ancestry.

“It then went out of hand because it became routine practice to use only this one group, essentially White, European ancestry people,” says Karoline Kuchenbaecker, PhD, associate professor of psychiatry at University College London.

Yet findings from one population won’t necessarily translate to others. “And that’s exactly what has been shown,” says Dr. Teferra. Polygenic risk scores developed for schizophrenia from European samples, for example, perform poorly among people of African ancestry, although among Europeans, they are strongly effective at differentiating European individuals with and those without schizophrenia. Moreover, drugs that target a gene identified from studies in European populations may be harmful to other groups.

Studies drawn from a diverse pool of participants would benefit a wider swath of humanity. They would also allow scientists to discover small areas of overlap in genomes of different populations, which would help them close in on the true biology of diseases and ensure that “we’re all benefiting from more diverse data in genetics and psychiatric genetics,” says Dr. Kuchenbaecker.
 

New efforts aim at filling the gaps

Genomic studies are featuring more people of non-European ancestry, but most of that improvement comes from populations of Asian ancestry, not African, Latin American, or Indigenous ancestry.

Efforts to increase representation of persons of African ancestry have largely focused on African Americans; fewer efforts have extended to the African continent, home to the most genetically diverse populations. Even fewer have focused on mental health. “The little that was being done was on a very small scale,” says Karestan Koenen, PhD, a professor at Harvard School of Public Health, Boston.

With this in mind, researchers from institutions in Kenya, Uganda, South Africa, and Ethiopia partnered with researchers at the Broad Institute of the Massachusetts Institute of Technology and Harvard to conduct the largest GWAS of psychiatric disorders in Africa. Dr. Koenen leads the project, Neuropsychiatric Genetics of African Populations–Psychosis (NeuroGAP-Psychosis), which will analyze DNA from over 35,000 people of African ancestry in each of these four countries. Investigators will compare the half of participants who have no history of psychosis with the half with schizophrenia or bipolar disorder in the hopes of identifying the genetic determinants of psychosis.

“Then any potential intervention or therapeutics that will be developed will also be useful for Africans,” says Dr. Teferra, a NeuroGAP principal investigator. Because of the tremendous degree of genetic diversity among people on the continent, however, findings still might not translate to all African populations.

But correcting equity problems in genomics isn’t as simple as recruiting people with non-European backgrounds, especially if those people are unfamiliar with research or have been subject to scientific exploitation. “Special care needs to be taken to, first of all, provide information that’s appropriate [to participants], but also motivate people to take part and then find ways to keep these communities involved and understand what they’re interested in,” says Dr. Kuchenbaecker, who is not involved with NeuroGAP.

For NeuroGAP, the team needed to work with ethical committees at all of the institutions involved, ensure research materials were appropriate for each community’s cultural context, and gain the trust of local communities.

“One of the biggest criticisms within the scientific world is that people from more endowed countries just fly in, bully everyone, collect the data, and leave, with no credit to the local scientists or communities,” says NeuroGAP principal investigator Lukoye Atwoli, MMed, PhD, professor of psychiatry and dean of the Medical College, East Africa, at the Aga Khan University, Nairobi, Kenya. “That is one of the biggest pitfalls we had to grapple with.”

To address that concern, NeuroGAP is training local researchers and is providing them with requested resources so they can carry out similar studies in the future. “We will be looking to address a real need in the academic community and in clinical service delivery,” says Dr. Atwoli.

Dr. Kuchenbaecker says that NeuroGAP demonstrates features necessary for projects seeking to improve equity in psychiatric genomics. “What they’re doing right is recruiting really large numbers, recruiting from different African countries, and involving African investigators,” she says.

In the Americas, Janitza Montalvo-Ortiz, PhD, assistant professor in the Division of Genetics, department of psychiatry, Yale University, New Haven, Conn., and her colleagues are expanding psychiatric genomics projects in Latin America. She co-founded the Latin American Genomics Consortium in 2019, a network of scientists supporting psychiatric genomic research in the region. The consortium also involves the Neuropsychiatric Genetics in Mexican Populations project, which is similar to NeuroGAP and is also led by Dr. Koenan.

The study of Latin American populations is complicated, because genes in these populations reflect Indigenous American, European, and African ancestries. Even when investigators sampled DNA from Latin American individuals, that data often went unused. “Now with new methods emerging to allow us to properly analyze admixed populations in GWAS studies, we’re making efforts to compile different datasets scattered across different large-scale cohorts,” says Dr. Montalvo-Ortiz. “Our ultimate goal is to conduct the first large-scale LatinX GWAS of psychiatry,” she says.

With these projects, researchers hope that new psychiatric research will produce clinical advances for people historically left on the sidelines of genomic studies. By involving their communities in genomic research, “whatever is going to be developed will also benefit our community,” says Dr. Teferra. “We will not be left out.”

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

In combing the genome, scientists can use genetic clues to determine a person’s risk for psychiatric disease and even identify new drug targets. But the benefits of these discoveries will be limited to people of European descent.

Nearly 90% of participants in genome-wide association studies (GWASs), which search for gene variants linked to disease, are of European ancestry. This Eurocentric focus threatens to widen existing disparities in racial and ethnic mental health.

The significant downsides of genomics’ one-track mind

One obstacle hindering therapeutic advances in psychiatry is a shallow understanding of the mechanisms of disorders. “The biggest problem in terms of advancing research for mental health conditions is that we don’t understand the underlying biology,” says Laramie Duncan, PhD, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “Genetics is one of the best ways to systematically look for new clues about the underlying biology.”

At the advent of genomic research, scientists thought it best to study DNA from people of a single ancestry from one continent. “Researchers for a long time held the idea that it was going to be too complicated to include multiple ancestries in the first rounds of genetic analyses,” says Dr. Duncan.

Studying DNA from someone with ancestors from multiple parts of the world wasn’t compatible with methods used in the early days of GWASs. “Individual parts of a person’s DNA can be linked back to one region of the world or another, and most of our methods essentially assume that all of a person’s DNA came from one region of the world,” says Dr. Duncan.

Because many genes are usually involved in psychiatric disorders, scientists need large numbers of participants to detect uncommon, influential variants. Early research was concentrated in North America and Europe so that scientists could readily collect samples from people of European ancestry.

“It then went out of hand because it became routine practice to use only this one group, essentially White, European ancestry people,” says Karoline Kuchenbaecker, PhD, associate professor of psychiatry at University College London.

Yet findings from one population won’t necessarily translate to others. “And that’s exactly what has been shown,” says Dr. Teferra. Polygenic risk scores developed for schizophrenia from European samples, for example, perform poorly among people of African ancestry, although among Europeans, they are strongly effective at differentiating European individuals with and those without schizophrenia. Moreover, drugs that target a gene identified from studies in European populations may be harmful to other groups.

Studies drawn from a diverse pool of participants would benefit a wider swath of humanity. They would also allow scientists to discover small areas of overlap in genomes of different populations, which would help them close in on the true biology of diseases and ensure that “we’re all benefiting from more diverse data in genetics and psychiatric genetics,” says Dr. Kuchenbaecker.
 

New efforts aim at filling the gaps

Genomic studies are featuring more people of non-European ancestry, but most of that improvement comes from populations of Asian ancestry, not African, Latin American, or Indigenous ancestry.

Efforts to increase representation of persons of African ancestry have largely focused on African Americans; fewer efforts have extended to the African continent, home to the most genetically diverse populations. Even fewer have focused on mental health. “The little that was being done was on a very small scale,” says Karestan Koenen, PhD, a professor at Harvard School of Public Health, Boston.

With this in mind, researchers from institutions in Kenya, Uganda, South Africa, and Ethiopia partnered with researchers at the Broad Institute of the Massachusetts Institute of Technology and Harvard to conduct the largest GWAS of psychiatric disorders in Africa. Dr. Koenen leads the project, Neuropsychiatric Genetics of African Populations–Psychosis (NeuroGAP-Psychosis), which will analyze DNA from over 35,000 people of African ancestry in each of these four countries. Investigators will compare the half of participants who have no history of psychosis with the half with schizophrenia or bipolar disorder in the hopes of identifying the genetic determinants of psychosis.

“Then any potential intervention or therapeutics that will be developed will also be useful for Africans,” says Dr. Teferra, a NeuroGAP principal investigator. Because of the tremendous degree of genetic diversity among people on the continent, however, findings still might not translate to all African populations.

But correcting equity problems in genomics isn’t as simple as recruiting people with non-European backgrounds, especially if those people are unfamiliar with research or have been subject to scientific exploitation. “Special care needs to be taken to, first of all, provide information that’s appropriate [to participants], but also motivate people to take part and then find ways to keep these communities involved and understand what they’re interested in,” says Dr. Kuchenbaecker, who is not involved with NeuroGAP.

For NeuroGAP, the team needed to work with ethical committees at all of the institutions involved, ensure research materials were appropriate for each community’s cultural context, and gain the trust of local communities.

“One of the biggest criticisms within the scientific world is that people from more endowed countries just fly in, bully everyone, collect the data, and leave, with no credit to the local scientists or communities,” says NeuroGAP principal investigator Lukoye Atwoli, MMed, PhD, professor of psychiatry and dean of the Medical College, East Africa, at the Aga Khan University, Nairobi, Kenya. “That is one of the biggest pitfalls we had to grapple with.”

To address that concern, NeuroGAP is training local researchers and is providing them with requested resources so they can carry out similar studies in the future. “We will be looking to address a real need in the academic community and in clinical service delivery,” says Dr. Atwoli.

Dr. Kuchenbaecker says that NeuroGAP demonstrates features necessary for projects seeking to improve equity in psychiatric genomics. “What they’re doing right is recruiting really large numbers, recruiting from different African countries, and involving African investigators,” she says.

In the Americas, Janitza Montalvo-Ortiz, PhD, assistant professor in the Division of Genetics, department of psychiatry, Yale University, New Haven, Conn., and her colleagues are expanding psychiatric genomics projects in Latin America. She co-founded the Latin American Genomics Consortium in 2019, a network of scientists supporting psychiatric genomic research in the region. The consortium also involves the Neuropsychiatric Genetics in Mexican Populations project, which is similar to NeuroGAP and is also led by Dr. Koenan.

The study of Latin American populations is complicated, because genes in these populations reflect Indigenous American, European, and African ancestries. Even when investigators sampled DNA from Latin American individuals, that data often went unused. “Now with new methods emerging to allow us to properly analyze admixed populations in GWAS studies, we’re making efforts to compile different datasets scattered across different large-scale cohorts,” says Dr. Montalvo-Ortiz. “Our ultimate goal is to conduct the first large-scale LatinX GWAS of psychiatry,” she says.

With these projects, researchers hope that new psychiatric research will produce clinical advances for people historically left on the sidelines of genomic studies. By involving their communities in genomic research, “whatever is going to be developed will also benefit our community,” says Dr. Teferra. “We will not be left out.”

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