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About 60% of US physicians who served as panel and task force members for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) received more than $14 million in undisclosed industry funding, a new study shows.
Most payments were for food and beverages, travel, and consulting fees. But more than one third of contributors received compensation for services other than consulting, such as serving on a pharmaceutical company’s speakers bureau, which medical ethicists say is particularly problematic.
Often referred to as the bible of psychiatric disorders, the DSM-5-TR was released in 2022 by the American Psychiatric Association (APA) and includes changes that were made online since the DSM-5 was first published in 2013.
An APA spokesperson said that DSM-5-TR decision-makers were unable to participate if they had received more than $5000 in industry payments and that all 186 individuals who worked on the text revision were required to disclose all sources of income prior to their participation.
“The APA implemented and enforced a rigorous process for DSM-5-TR that required transparency by all contributors of their personal and professional interests, followed by an independent review to ensure that personal and professional interests did not bias any results,” the spokesperson said.
However, having industry funding did not preclude contributors’ participation, and investigators note that none of the disclosures were published in the manual or shared publicly.
“The point is not to point fingers at the APA or individual members of the APA but rather to provide hopefully a small piece of research data that would help the APA look at the larger systemic issue of conflicts of interest,” said the study’s lead investigator Lisa Cosgrove, PhD, professor of counseling and faculty fellow in the Applied Ethics Center at the University of Massachusetts Boston.
The findings were published online in The BMJ .
A Deep Dive
The work builds on the investigators’ earlier research into financial conflicts among DSM contributors. The lack of a centralized database of industry payments made the group›s prior studies far more complicated and time-consuming.
For this project, investigators drew on the Open Payments database, which launched in 2014. It collects and publishes data on payments by pharmaceutical and medical device companies to physicians and other healthcare professionals for research, meals, travel, gifts, speaking fees, and other expenses. The program was established as part of the Affordable Care Act and is run by the Centers for Medicare & Medicaid Services.
, just before work on the text revision began. Of the 168 individuals listed as contributors to the manual, 92 met the inclusion criteria of being a US-based physician with industry payments tracked in Open Payments.
Fifty-five of those physicians, or 59.8%, had financial ties to industry. The most common type of payment was for food and beverages (90.9%), travel (69.1%), and consulting (69.1%). Nineteen panel members received $1.8 million for “compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.”
The greatest proportion of compensation by category of payment was for research funding (71%).
Investigators found that every DSM-5-TR panel included at least one member with industry ties. The panels with the highest number of members with a recent history of industry funding were those for neurodevelopmental disorders; bipolar disorders; obsessive-compulsive disorders; neurocognitive disorders; medication induced movement disorders; and disruptive, impulse control, and conduct disorders. More than 70% of members on those panels had received industry funding.
The total payments received by all contributors was more than $14.2 million, with a range from just under $14 per physician to $2.7 million per physician. The researchers note that the percentage of panel members with industry support was similar between DSM-5-TR and DSM-5.
“What we also see that’s consistent with our 2016 study and 2012 study is the panels for which the members had the most financial ties to industry were those for which pharmaceutical interventions are the first line of therapy,” Dr. Cosgrove said.
No Public Disclosure
For DSM-5, the APA instituted a new disclosure policy for contributors and reported those disclosures on its website.
This time, the association spokesperson said that DSM-5-TR chairs and the DSM Steering Committee who reviewed all proposed changes were required to have no industry-related income above $5000 and that “in fact, many had no industry income.”
Other DSM-5-TR contributors had to submit “extensive” disclosure forms and report “any relationships they or close relations had with industry (very broadly defined) and sources of income,” the spokesperson added. They were also asked to report other nonfinancial interests that they or close relatives had that could potentially bias their work.
The APA’s standing Conflict of Interest Committee reviewed all disclosure forms and flagged those with disclosures that could impact content. Text written by individuals with flagged disclosures received additional review, the spokesperson said.
“If any possible bias was noted in the text content, such as for a potential commercial advantage with a diagnostic instrument, that content was deleted,” the spokesperson said.
However, the real sticking point for medical ethicists is that unlike with the DSM-5, the APA did not share DSM-5-TR contributors’ disclosures publicly.
Commenting on the research, Bernard Lo, MD, professor emeritus of medicine and director emeritus of the Program in Medical Ethics Emeritus at University of California, San Francisco, said that the lack of public disclosure is critical.
“Part of the report should be, ‘Here are the conflicts of interest reported by the members of the panel,’” said Dr. Lo, adding that publishing disclosures is standard in all of APA’s peer-reviewed journals. “Failure to do that in the DSM-5-TR is unacceptable from an ethical and transparency point of view.”
Loss of Public Trust?
In her previous research and in this new study, Dr. Cosgrove recommends the APA follow the 2011 report Clinical Practice Guidelines We Can Trust. Published by the Institute of Medicine (IOM, now called the National Academy of Medicine), that report updated and streamlined a 2009 conflicts of interest guideline, which Dr. Lo coauthored.
“The IOM recommends that the whole guideline development group be free of industry ties,” Dr. Cosgrove said. “At a minimum, the chair should not have ties and the majority of folks should not have ties to industry.”
Some have argued that banning all contributors with industry ties would shrink the expert pool that develops the DSM and other guidelines. Dr. Cosgrove disagrees with that assertion.
“There are hundreds of experts in all medical disciplines that do not have industry ties,” Dr. Cosgrove said. “The ‘most experts have industry ties’ is a spurious and unsupported argument.”
The APA also should ban contributors who receive industry funding as key opinion leaders, known as KOLs, such as members of pharmaceutical companies’ speakers bureaus, Dr. Lo said.
“Certain types of funding relationships with industry are more fraught with ethical problems,” including KOLs, who Dr. Lo said are “basically salespeople trying to increase sales of a product.”
“It really compromises their scientific objectivity and should exclude someone from any practice guideline body,” Dr. Lo said. “This failure to adequately address conflicts of interest doesn’t promote transparency and it doesn’t promote public trust in the diagnostic criteria.”
The Larger Issue
Removing financial conflicts of interest is a start, but it wouldn’t address the larger issue in medicine, said Allen Frances, MD, who chaired the DSM-4 task force and has been an outspoken critic of the DSM-5.
“The financial conflicts of interest may play a role with some people, I’m not denying that,” said Dr. Frances, a professor and chair emeritus of psychiatry at Duke University, Durham, North Carolina. “But that’s a much smaller problem than the fact that any individual from any professional association that has an intense interest in any given diagnosis will always be on the side of expanding that diagnosis and expanding the treatment for it.”
Though financial conflicts of interest can be addressed, Frances believes that professionals’ “intellectual and emotional conflicts” are much harder to overcome.
“People who spend their careers working on any diagnosis are terribly biased by virtue of their attachment to their work,” he said.
The solution is for guidelines in psychiatry and all medical fields to be developed by a truly multidisciplinary “neutral board” that includes broad representation of primary care physicians.
Specialists would be involved in the development of the guidelines but would not have a final say in what diagnoses or treatments are included or excluded.
“80% of psychiatric meds are prescribed by primary care doctors, not psychiatrists,” he said. “So, when you’re making a suggestion for a change in psychiatry, you’re making that suggestion primarily for primary care doctor and have to be thinking about, How will this change play in primary care, which the experts never do.”
The study was unfunded. Dr. Allen reported no relevant disclosures. Dr. Lo served as a paid member of the Takeda Pharmaceuticals Ethics Advisory Committee.
A version of this article appeared on Medscape.com.
About 60% of US physicians who served as panel and task force members for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) received more than $14 million in undisclosed industry funding, a new study shows.
Most payments were for food and beverages, travel, and consulting fees. But more than one third of contributors received compensation for services other than consulting, such as serving on a pharmaceutical company’s speakers bureau, which medical ethicists say is particularly problematic.
Often referred to as the bible of psychiatric disorders, the DSM-5-TR was released in 2022 by the American Psychiatric Association (APA) and includes changes that were made online since the DSM-5 was first published in 2013.
An APA spokesperson said that DSM-5-TR decision-makers were unable to participate if they had received more than $5000 in industry payments and that all 186 individuals who worked on the text revision were required to disclose all sources of income prior to their participation.
“The APA implemented and enforced a rigorous process for DSM-5-TR that required transparency by all contributors of their personal and professional interests, followed by an independent review to ensure that personal and professional interests did not bias any results,” the spokesperson said.
However, having industry funding did not preclude contributors’ participation, and investigators note that none of the disclosures were published in the manual or shared publicly.
“The point is not to point fingers at the APA or individual members of the APA but rather to provide hopefully a small piece of research data that would help the APA look at the larger systemic issue of conflicts of interest,” said the study’s lead investigator Lisa Cosgrove, PhD, professor of counseling and faculty fellow in the Applied Ethics Center at the University of Massachusetts Boston.
The findings were published online in The BMJ .
A Deep Dive
The work builds on the investigators’ earlier research into financial conflicts among DSM contributors. The lack of a centralized database of industry payments made the group›s prior studies far more complicated and time-consuming.
For this project, investigators drew on the Open Payments database, which launched in 2014. It collects and publishes data on payments by pharmaceutical and medical device companies to physicians and other healthcare professionals for research, meals, travel, gifts, speaking fees, and other expenses. The program was established as part of the Affordable Care Act and is run by the Centers for Medicare & Medicaid Services.
, just before work on the text revision began. Of the 168 individuals listed as contributors to the manual, 92 met the inclusion criteria of being a US-based physician with industry payments tracked in Open Payments.
Fifty-five of those physicians, or 59.8%, had financial ties to industry. The most common type of payment was for food and beverages (90.9%), travel (69.1%), and consulting (69.1%). Nineteen panel members received $1.8 million for “compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.”
The greatest proportion of compensation by category of payment was for research funding (71%).
Investigators found that every DSM-5-TR panel included at least one member with industry ties. The panels with the highest number of members with a recent history of industry funding were those for neurodevelopmental disorders; bipolar disorders; obsessive-compulsive disorders; neurocognitive disorders; medication induced movement disorders; and disruptive, impulse control, and conduct disorders. More than 70% of members on those panels had received industry funding.
The total payments received by all contributors was more than $14.2 million, with a range from just under $14 per physician to $2.7 million per physician. The researchers note that the percentage of panel members with industry support was similar between DSM-5-TR and DSM-5.
“What we also see that’s consistent with our 2016 study and 2012 study is the panels for which the members had the most financial ties to industry were those for which pharmaceutical interventions are the first line of therapy,” Dr. Cosgrove said.
No Public Disclosure
For DSM-5, the APA instituted a new disclosure policy for contributors and reported those disclosures on its website.
This time, the association spokesperson said that DSM-5-TR chairs and the DSM Steering Committee who reviewed all proposed changes were required to have no industry-related income above $5000 and that “in fact, many had no industry income.”
Other DSM-5-TR contributors had to submit “extensive” disclosure forms and report “any relationships they or close relations had with industry (very broadly defined) and sources of income,” the spokesperson added. They were also asked to report other nonfinancial interests that they or close relatives had that could potentially bias their work.
The APA’s standing Conflict of Interest Committee reviewed all disclosure forms and flagged those with disclosures that could impact content. Text written by individuals with flagged disclosures received additional review, the spokesperson said.
“If any possible bias was noted in the text content, such as for a potential commercial advantage with a diagnostic instrument, that content was deleted,” the spokesperson said.
However, the real sticking point for medical ethicists is that unlike with the DSM-5, the APA did not share DSM-5-TR contributors’ disclosures publicly.
Commenting on the research, Bernard Lo, MD, professor emeritus of medicine and director emeritus of the Program in Medical Ethics Emeritus at University of California, San Francisco, said that the lack of public disclosure is critical.
“Part of the report should be, ‘Here are the conflicts of interest reported by the members of the panel,’” said Dr. Lo, adding that publishing disclosures is standard in all of APA’s peer-reviewed journals. “Failure to do that in the DSM-5-TR is unacceptable from an ethical and transparency point of view.”
Loss of Public Trust?
In her previous research and in this new study, Dr. Cosgrove recommends the APA follow the 2011 report Clinical Practice Guidelines We Can Trust. Published by the Institute of Medicine (IOM, now called the National Academy of Medicine), that report updated and streamlined a 2009 conflicts of interest guideline, which Dr. Lo coauthored.
“The IOM recommends that the whole guideline development group be free of industry ties,” Dr. Cosgrove said. “At a minimum, the chair should not have ties and the majority of folks should not have ties to industry.”
Some have argued that banning all contributors with industry ties would shrink the expert pool that develops the DSM and other guidelines. Dr. Cosgrove disagrees with that assertion.
“There are hundreds of experts in all medical disciplines that do not have industry ties,” Dr. Cosgrove said. “The ‘most experts have industry ties’ is a spurious and unsupported argument.”
The APA also should ban contributors who receive industry funding as key opinion leaders, known as KOLs, such as members of pharmaceutical companies’ speakers bureaus, Dr. Lo said.
“Certain types of funding relationships with industry are more fraught with ethical problems,” including KOLs, who Dr. Lo said are “basically salespeople trying to increase sales of a product.”
“It really compromises their scientific objectivity and should exclude someone from any practice guideline body,” Dr. Lo said. “This failure to adequately address conflicts of interest doesn’t promote transparency and it doesn’t promote public trust in the diagnostic criteria.”
The Larger Issue
Removing financial conflicts of interest is a start, but it wouldn’t address the larger issue in medicine, said Allen Frances, MD, who chaired the DSM-4 task force and has been an outspoken critic of the DSM-5.
“The financial conflicts of interest may play a role with some people, I’m not denying that,” said Dr. Frances, a professor and chair emeritus of psychiatry at Duke University, Durham, North Carolina. “But that’s a much smaller problem than the fact that any individual from any professional association that has an intense interest in any given diagnosis will always be on the side of expanding that diagnosis and expanding the treatment for it.”
Though financial conflicts of interest can be addressed, Frances believes that professionals’ “intellectual and emotional conflicts” are much harder to overcome.
“People who spend their careers working on any diagnosis are terribly biased by virtue of their attachment to their work,” he said.
The solution is for guidelines in psychiatry and all medical fields to be developed by a truly multidisciplinary “neutral board” that includes broad representation of primary care physicians.
Specialists would be involved in the development of the guidelines but would not have a final say in what diagnoses or treatments are included or excluded.
“80% of psychiatric meds are prescribed by primary care doctors, not psychiatrists,” he said. “So, when you’re making a suggestion for a change in psychiatry, you’re making that suggestion primarily for primary care doctor and have to be thinking about, How will this change play in primary care, which the experts never do.”
The study was unfunded. Dr. Allen reported no relevant disclosures. Dr. Lo served as a paid member of the Takeda Pharmaceuticals Ethics Advisory Committee.
A version of this article appeared on Medscape.com.
About 60% of US physicians who served as panel and task force members for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) received more than $14 million in undisclosed industry funding, a new study shows.
Most payments were for food and beverages, travel, and consulting fees. But more than one third of contributors received compensation for services other than consulting, such as serving on a pharmaceutical company’s speakers bureau, which medical ethicists say is particularly problematic.
Often referred to as the bible of psychiatric disorders, the DSM-5-TR was released in 2022 by the American Psychiatric Association (APA) and includes changes that were made online since the DSM-5 was first published in 2013.
An APA spokesperson said that DSM-5-TR decision-makers were unable to participate if they had received more than $5000 in industry payments and that all 186 individuals who worked on the text revision were required to disclose all sources of income prior to their participation.
“The APA implemented and enforced a rigorous process for DSM-5-TR that required transparency by all contributors of their personal and professional interests, followed by an independent review to ensure that personal and professional interests did not bias any results,” the spokesperson said.
However, having industry funding did not preclude contributors’ participation, and investigators note that none of the disclosures were published in the manual or shared publicly.
“The point is not to point fingers at the APA or individual members of the APA but rather to provide hopefully a small piece of research data that would help the APA look at the larger systemic issue of conflicts of interest,” said the study’s lead investigator Lisa Cosgrove, PhD, professor of counseling and faculty fellow in the Applied Ethics Center at the University of Massachusetts Boston.
The findings were published online in The BMJ .
A Deep Dive
The work builds on the investigators’ earlier research into financial conflicts among DSM contributors. The lack of a centralized database of industry payments made the group›s prior studies far more complicated and time-consuming.
For this project, investigators drew on the Open Payments database, which launched in 2014. It collects and publishes data on payments by pharmaceutical and medical device companies to physicians and other healthcare professionals for research, meals, travel, gifts, speaking fees, and other expenses. The program was established as part of the Affordable Care Act and is run by the Centers for Medicare & Medicaid Services.
, just before work on the text revision began. Of the 168 individuals listed as contributors to the manual, 92 met the inclusion criteria of being a US-based physician with industry payments tracked in Open Payments.
Fifty-five of those physicians, or 59.8%, had financial ties to industry. The most common type of payment was for food and beverages (90.9%), travel (69.1%), and consulting (69.1%). Nineteen panel members received $1.8 million for “compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.”
The greatest proportion of compensation by category of payment was for research funding (71%).
Investigators found that every DSM-5-TR panel included at least one member with industry ties. The panels with the highest number of members with a recent history of industry funding were those for neurodevelopmental disorders; bipolar disorders; obsessive-compulsive disorders; neurocognitive disorders; medication induced movement disorders; and disruptive, impulse control, and conduct disorders. More than 70% of members on those panels had received industry funding.
The total payments received by all contributors was more than $14.2 million, with a range from just under $14 per physician to $2.7 million per physician. The researchers note that the percentage of panel members with industry support was similar between DSM-5-TR and DSM-5.
“What we also see that’s consistent with our 2016 study and 2012 study is the panels for which the members had the most financial ties to industry were those for which pharmaceutical interventions are the first line of therapy,” Dr. Cosgrove said.
No Public Disclosure
For DSM-5, the APA instituted a new disclosure policy for contributors and reported those disclosures on its website.
This time, the association spokesperson said that DSM-5-TR chairs and the DSM Steering Committee who reviewed all proposed changes were required to have no industry-related income above $5000 and that “in fact, many had no industry income.”
Other DSM-5-TR contributors had to submit “extensive” disclosure forms and report “any relationships they or close relations had with industry (very broadly defined) and sources of income,” the spokesperson added. They were also asked to report other nonfinancial interests that they or close relatives had that could potentially bias their work.
The APA’s standing Conflict of Interest Committee reviewed all disclosure forms and flagged those with disclosures that could impact content. Text written by individuals with flagged disclosures received additional review, the spokesperson said.
“If any possible bias was noted in the text content, such as for a potential commercial advantage with a diagnostic instrument, that content was deleted,” the spokesperson said.
However, the real sticking point for medical ethicists is that unlike with the DSM-5, the APA did not share DSM-5-TR contributors’ disclosures publicly.
Commenting on the research, Bernard Lo, MD, professor emeritus of medicine and director emeritus of the Program in Medical Ethics Emeritus at University of California, San Francisco, said that the lack of public disclosure is critical.
“Part of the report should be, ‘Here are the conflicts of interest reported by the members of the panel,’” said Dr. Lo, adding that publishing disclosures is standard in all of APA’s peer-reviewed journals. “Failure to do that in the DSM-5-TR is unacceptable from an ethical and transparency point of view.”
Loss of Public Trust?
In her previous research and in this new study, Dr. Cosgrove recommends the APA follow the 2011 report Clinical Practice Guidelines We Can Trust. Published by the Institute of Medicine (IOM, now called the National Academy of Medicine), that report updated and streamlined a 2009 conflicts of interest guideline, which Dr. Lo coauthored.
“The IOM recommends that the whole guideline development group be free of industry ties,” Dr. Cosgrove said. “At a minimum, the chair should not have ties and the majority of folks should not have ties to industry.”
Some have argued that banning all contributors with industry ties would shrink the expert pool that develops the DSM and other guidelines. Dr. Cosgrove disagrees with that assertion.
“There are hundreds of experts in all medical disciplines that do not have industry ties,” Dr. Cosgrove said. “The ‘most experts have industry ties’ is a spurious and unsupported argument.”
The APA also should ban contributors who receive industry funding as key opinion leaders, known as KOLs, such as members of pharmaceutical companies’ speakers bureaus, Dr. Lo said.
“Certain types of funding relationships with industry are more fraught with ethical problems,” including KOLs, who Dr. Lo said are “basically salespeople trying to increase sales of a product.”
“It really compromises their scientific objectivity and should exclude someone from any practice guideline body,” Dr. Lo said. “This failure to adequately address conflicts of interest doesn’t promote transparency and it doesn’t promote public trust in the diagnostic criteria.”
The Larger Issue
Removing financial conflicts of interest is a start, but it wouldn’t address the larger issue in medicine, said Allen Frances, MD, who chaired the DSM-4 task force and has been an outspoken critic of the DSM-5.
“The financial conflicts of interest may play a role with some people, I’m not denying that,” said Dr. Frances, a professor and chair emeritus of psychiatry at Duke University, Durham, North Carolina. “But that’s a much smaller problem than the fact that any individual from any professional association that has an intense interest in any given diagnosis will always be on the side of expanding that diagnosis and expanding the treatment for it.”
Though financial conflicts of interest can be addressed, Frances believes that professionals’ “intellectual and emotional conflicts” are much harder to overcome.
“People who spend their careers working on any diagnosis are terribly biased by virtue of their attachment to their work,” he said.
The solution is for guidelines in psychiatry and all medical fields to be developed by a truly multidisciplinary “neutral board” that includes broad representation of primary care physicians.
Specialists would be involved in the development of the guidelines but would not have a final say in what diagnoses or treatments are included or excluded.
“80% of psychiatric meds are prescribed by primary care doctors, not psychiatrists,” he said. “So, when you’re making a suggestion for a change in psychiatry, you’re making that suggestion primarily for primary care doctor and have to be thinking about, How will this change play in primary care, which the experts never do.”
The study was unfunded. Dr. Allen reported no relevant disclosures. Dr. Lo served as a paid member of the Takeda Pharmaceuticals Ethics Advisory Committee.
A version of this article appeared on Medscape.com.
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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Investigators analyzed industry payments made to DSM-5-TR contributors between 2016 and 2019</metaDescription> <articlePDF/> <teaserImage/> <teaser>Contributors to the DSM-5-TR received more than $14 million in undisclosed industry funding.</teaser> <title>DSM-5-TR Panel Members Received $14M in Undisclosed Industry Funding</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>cpn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">9</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">27442</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>DSM-5-TR Panel Members Received $14M in Undisclosed Industry Funding</title> <deck/> </itemMeta> <itemContent> <p>About 60% of US physicians who served as panel and task force members for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) received more than $14 million in undisclosed industry funding, a new study shows. </p> <p>Most payments were for food and beverages, travel, and consulting fees. But more than one third of contributors received compensation for services other than consulting, such as serving on a pharmaceutical company’s speakers bureau, which medical ethicists say is particularly problematic. <br/><br/>Often referred to as the bible of psychiatric disorders, the DSM-5-TR was <a href="https://www.medscape.com/viewarticle/969662">released in 2022</a> by the American Psychiatric Association (APA) and includes changes that were made online since the DSM-5 was first published in 2013.<br/><br/>An APA spokesperson said that DSM-5-TR decision-makers were unable to participate if they had received more than $5000 in industry payments and that all 186 individuals who worked on the text revision were required to disclose all sources of income prior to their participation. <br/><br/>“The APA implemented and enforced a rigorous process for DSM-5-TR that required transparency by all contributors of their personal and professional interests, followed by an independent review to ensure that personal and professional interests did not bias any results,” the spokesperson said.<br/><br/>However, having industry funding did not preclude contributors’ participation, and investigators note that none of the disclosures were published in the manual or shared publicly. <br/><br/>“The point is not to point fingers at the APA or individual members of the APA but rather to provide hopefully a small piece of research data that would help the APA look at the larger systemic issue of conflicts of interest,” said the study’s lead investigator Lisa Cosgrove, PhD, professor of counseling and faculty fellow in the Applied Ethics Center at the University of Massachusetts Boston. <br/><br/>The findings were <a href="https://www.bmj.com/content/384/bmj-2023-076902">published online</a> in <em>The BMJ</em> .</p> <h2>A Deep Dive</h2> <p>The work builds on the investigators’ <a href="https://www.medscape.com/viewarticle/760542">earlier research</a> into financial conflicts among DSM contributors. The lack of a centralized database of industry payments made the group›s prior studies far more complicated and time-consuming. </p> <p>For this project, investigators drew on the Open Payments database, which launched in 2014. It collects and publishes data on payments by pharmaceutical and medical device companies to physicians and other healthcare professionals for research, meals, travel, gifts, speaking fees, and other expenses. The program was established as part of the Affordable Care Act and is run by the Centers for Medicare & Medicaid Services. <br/><br/><span class="tag metaDescription">Investigators analyzed industry payments made to DSM-5-TR contributors between 2016 and 2019</span>, just before work on the text revision began. Of the 168 individuals listed as contributors to the manual, 92 met the inclusion criteria of being a US-based physician with industry payments tracked in Open Payments.<br/><br/>Fifty-five of those physicians, or 59.8%, had financial ties to industry. The most common type of payment was for food and beverages (90.9%), travel (69.1%), and consulting (69.1%). Nineteen panel members received $1.8 million for “compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.”<br/><br/>The greatest proportion of compensation by category of payment was for research funding (71%).<br/><br/>Investigators found that every DSM-5-TR panel included at least one member with industry ties. The panels with the highest number of members with a recent history of industry funding were those for neurodevelopmental disorders; bipolar disorders; obsessive-compulsive disorders; neurocognitive disorders; medication induced movement disorders; and disruptive, impulse control, and conduct disorders. More than 70% of members on those panels had received industry funding. <br/><br/>The total payments received by all contributors was more than $14.2 million, with a range from just under $14 per physician to $2.7 million per physician. The researchers note that the percentage of panel members with industry support was similar between DSM-5-TR and DSM-5.<br/><br/>“What we also see that’s consistent with our 2016 study and 2012 study is the panels for which the members had the most financial ties to industry were those for which pharmaceutical interventions are the first line of therapy,” Dr. Cosgrove said.</p> <h2>No Public Disclosure</h2> <p>For DSM-5, the APA instituted a new disclosure policy for contributors and reported those disclosures on its website. </p> <p>This time, the association spokesperson said that DSM-5-TR chairs and the DSM Steering Committee who reviewed all proposed changes were required to have no industry-related income above $5000 and that “in fact, many had no industry income.”<br/><br/>Other DSM-5-TR contributors had to submit “extensive” disclosure forms and report “any relationships they or close relations had with industry (very broadly defined) and sources of income,” the spokesperson added. They were also asked to report other nonfinancial interests that they or close relatives had that could potentially bias their work. <br/><br/>The APA’s standing Conflict of Interest Committee reviewed all disclosure forms and flagged those with disclosures that could impact content. Text written by individuals with flagged disclosures received additional review, the spokesperson said. <br/><br/>“If any possible bias was noted in the text content, such as for a potential commercial advantage with a diagnostic instrument, that content was deleted,” the spokesperson said.<br/><br/>However, the real sticking point for medical ethicists is that unlike with the DSM-5, the APA did not share DSM-5-TR contributors’ disclosures publicly. <br/><br/>Commenting on the research, Bernard Lo, MD, professor emeritus of medicine and director emeritus of the Program in Medical Ethics Emeritus at University of California, San Francisco, said that the lack of public disclosure is critical.<br/><br/>“Part of the report should be, ‘Here are the conflicts of interest reported by the members of the panel,’” said Dr. Lo, adding that publishing disclosures is standard in all of APA’s peer-reviewed journals. “Failure to do that in the DSM-5-TR is unacceptable from an ethical and transparency point of view.”</p> <h2>Loss of Public Trust?</h2> <p>In her previous research and in this new study, Dr. Cosgrove recommends the APA follow the 2011 report Clinical Practice Guidelines We Can Trust. Published by the Institute of Medicine (IOM, now called the National Academy of Medicine), that report updated and streamlined a <a href="https://nap.nationalacademies.org/catalog/12598/conflict-of-interest-in-medical-research-education-and-practice">2009 conflicts of interest guideline</a>, which Dr. Lo coauthored. </p> <p>“The IOM recommends that the whole guideline development group be free of industry ties,” Dr. Cosgrove said. “At a minimum, the chair should not have ties and the majority of folks should not have ties to industry.”<br/><br/>Some have argued that banning all contributors with industry ties would shrink the expert pool that develops the DSM and other guidelines. Dr. Cosgrove disagrees with that assertion.<br/><br/>“There are hundreds of experts in all medical disciplines that do not have industry ties,” Dr. Cosgrove said. “The ‘most experts have industry ties’ is a spurious and unsupported argument.”<br/><br/>The APA also should ban contributors who receive industry funding as key opinion leaders, known as KOLs, such as members of pharmaceutical companies’ speakers bureaus, Dr. Lo said. <br/><br/>“Certain types of funding relationships with industry are more fraught with ethical problems,” including KOLs, who Dr. Lo said are “basically salespeople trying to increase sales of a product.” <br/><br/>“It really compromises their scientific objectivity and should exclude someone from any practice guideline body,” Dr. Lo said. “This failure to adequately address conflicts of interest doesn’t promote transparency and it doesn’t promote public trust in the diagnostic criteria.”</p> <h2>The Larger Issue</h2> <p>Removing financial conflicts of interest is a start, but it wouldn’t address the larger issue in medicine, said Allen Frances, MD, who chaired the DSM-4 task force and has been an <a href="https://www.medscape.com/viewarticle/804378">outspoken critic</a> of the DSM-5. </p> <p>“The financial conflicts of interest may play a role with some people, I’m not denying that,” said Dr. Frances, a professor and chair emeritus of psychiatry at Duke University, Durham, North Carolina. “But that’s a much smaller problem than the fact that any individual from any professional association that has an intense interest in any given diagnosis will always be on the side of expanding that diagnosis and expanding the treatment for it.”<br/><br/>Though financial conflicts of interest can be addressed, Frances believes that professionals’ “intellectual and emotional conflicts” are much harder to overcome. <br/><br/>“People who spend their careers working on any diagnosis are terribly biased by virtue of their attachment to their work,” he said. <br/><br/>The solution is for guidelines in psychiatry and all medical fields to be developed by a truly multidisciplinary “neutral board” that includes broad representation of primary care physicians. <br/><br/>Specialists would be involved in the development of the guidelines but would not have a final say in what diagnoses or treatments are included or excluded. <br/><br/>“80% of psychiatric meds are prescribed by primary care doctors, not psychiatrists,” he said. “So, when you’re making a suggestion for a change in psychiatry, you’re making that suggestion primarily for primary care doctor and have to be thinking about, How will this change play in primary care, which the experts never do.”<br/><br/>The study was unfunded. Dr. Allen reported no relevant disclosures. Dr. Lo served as a paid member of the Takeda Pharmaceuticals Ethics Advisory Committee.<span class="end"/></p> <p> <em> <span class="Emphasis">A version of this article appeared on </span> <em><a href="https://www.medscape.com/viewarticle/dsm-5-panel-members-received-14m-undisclosed-industry-2024a10000pa">Medscape.com</a>.</em> </em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
FROM THE BMJ