Nemeroff, Seroquel, and ACCME
Roy Poses has discussed the atypical antipsychotic drug Seroquel (quetiapine) several times on this site, pointing out manipulation of clinical research results to enhance the appearance of efficacy, and suppression of studies with unfavorable results. I call this augmenting the marketed profile of the drug. Daniel Carlat has commented on published Seroquel data here and ClinPsych here.
AstraZeneca, the marketer of Seroquel, has also been busy with continuing medical education (CME) programs that augment Seroquel’s profile. Last December 8, one such program went on line, aired by the provider CME Outfitters. The program’s title was “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The corporate logo for CME Outfitters is Education with Integrity. I will allow readers to decide if the company is meeting its mission statement in this respect.
The key opinion leader engaged by CME Outfitters to discuss Seroquel and other atypical antipsychotic drugs was Charles Nemeroff of Emory University. He was joined by 2 KOLs-in-training, whom I will not name. The corporate sponsor that paid CME Outfitters and, indirectly, these presenters was AstraZeneca. I do not need to rehearse here the ethical issues that have surrounded Dr. Nemeroff for the past several years. Suffice it to say that, as a result of those issues, Dr. Nemeroff is no longer chair of the department of psychiatry at Emory University, he is no longer editor-in-chief of the ACNP journal Neuropsychopharmacology, he was removed from involvement with ongoing federally funded research grants at Emory University, and he was put on a short leash by the Emory administration.
On December 23, 2008 I filed a formal complaint about Dr. Nemeroff’s program with ACCME. My bill of particulars was lengthy, detailed, and backed up by extensive
materials. In due course, ACCME investigated the complaint and found that the program did violate ACCME standards. With respect to content, ACCME determined that Dr. Nemeroff’s program lacked sufficient information about possible adverse effects of treatment with atypical antipsychotic drugs; and failed to emphasize sufficiently the efficacy of alternative treatments. With respect to commercial bias, ACCME determined that bias existed as a result of the absence of contrasting therapy data, and through downplaying the drawbacks related to treatment with atypical antipsychotic drugs in depressed patients.
Following these findings by ACCME, the provider was notified of the violations in early September 2009, and the program was removed from the provider’s website. The sanitized statement of violations determined by ACCME does not capture the nuances of deceit, ineptitude, and deficient educational content in Dr. Nemeroff’s program. One remarkable example was Dr. Nemeroff’s citation of data, from one of his own publications, that were previously retracted. Did he think no one would notice?
A second example involved biased presentation of the sponsor’s data for Seroquel. Two doses of Seroquel (150 mg and 300 mg) were tested. Only the results for the 300 mg dose were statistically significant. Nevertheless, in the video presentation one of the junior presenters stated very clearly that there was “significant improvement in both response and remission with both doses” of Seroquel. That is a falsification of the scientific record. That falsification does not meet ACCME requirements for fair, balanced, truthful, and honest teaching. As moderator, Dr. Nemeroff was required to correct this false statement made by his junior assistant, but Dr. Nemeroff failed to do so.
The negative findings and sanction by ACCME against Dr. Nemeroff’s program are welcome, though I have to say it took ACCME an inordinately long time to complete their work. I also presented ACCME with several follow-on questions, which the Council is now considering. These are:
• Did ACCME notify the presenters that their program violated ACCME policies? If not, why not?
• Will CME credits be clawed back from physicians and other professionals who obtained credits through the noncompliant program? If not, why not? I believe this would be an effective form of negative feedback to the provider and the presenters.
• Does ACCME have a process to require the provider and presenters to ascertain whether any patients were injured as a result of the violations that created biased and deficient information in this program? If not, why not?
• Does ACCME require the provider to notify physicians and other professionals who completed the noncompliant program that the provider was sanctioned for violation of ACCME standards? If not, why not?
• Does ACCME require the provider to furnish corrective materials to such professionals in order to remedy the bias and incompetence to which they were subjected through violation of ACCME standards, and thereby to remove potential danger to future patients? If not, why not?
• Why did ACCME allow the noncompliant program to remain available long after the complaint was filed? I suggest that ACCME needs to place a hold on programs that are subject to active complaint. Had such a policy been in effect in December 2008, the violating program would not have been re-aired by the provider in early 2009, it would not have remained on-line for 9 months, and the damage to the continuing education community would have been contained.
• Will ACCME issue a public listing of sanctions it has enforced against providers and presenters? If not, why not? State medical boards do exactly that in relation to physicians and other professionals who violate standards of practice.
• Finally, I reminded ACCME that its primary constituents are patients, physicians and other professionals, not commercial or academic CME providers. It seems to me that ACCME was altogether too laissez-faire and dilatory in the way it handled this matter. At the time of my initial complaint last December, I requested expedited review precisely because additional airings of this violating program were scheduled.
The good news is that ACCME seems to have got the message that things need to change. As one of their officers wrote to me recently, “We sincerely appreciate the time and effort you have put into participating in our complaints and inquiries process. You have raised important issues that the ACCME will review and address.” I await their next communications on the remaining questions.
As for Dr. Nemeroff, he is yesterday’s news. The adverse findings by ACCME about his program serve as a reminder to corporate sponsors and CME companies that Dr. Nemeroff is so compromised by now that he has lost effectiveness as a front man for Pharma. Indeed, he is so toxic that he now glows in the dark.
Showing posts with label continuing medical education. Show all posts
Showing posts with label continuing medical education. Show all posts
Sunday, October 11, 2009
Friday, July 31, 2009
BLOGSCAN - More on Senate Hearings on Industry Funded CME
There has been considerable coverage of the remarkable hearings by the US Senate Special Committee on Aging on industry funded continuing medical education (CME). See reporting by Dr Daniel Carlat on the Carlat Psychiatry Blog, and by the Prescription Project on their Postscript Blog. See also the comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. Some key points were that the Senators failed to see why physicians cannot afford to pay for their own CME, and therefore must depend on corporate funding to support; and the Senators failed to buy the argument that medical progress vitally depends on health care corporations paying for and influencing the education physicians get.
Wednesday, July 29, 2009
BLOGSCAN - Live-Blogging Senate Hearing on Conflicts of Interest and Continuing Medical Education
Dr Daniel Carlat is live-blogging the US Senate Special Committee on Aging hearing on conflicts of interest and continuing medical education on the Carlat Psychiatry Blog, and so is Prof Margaret Soltan on the University Diaries.
Wednesday, March 25, 2009
BLOGSCAN - The Mysterious Disappearance of a Report Critical of Industry Funding of CME
On the Carlat Psychiatry Blog, Dr Daniel Carlat discussed the mysterious disappearance of a report by the AMA's Council on Ethical and Judicial Affairs (CEJA) which recommended the end of commercial funding of continuing medical education (CME). The report was tabled, and is now no longer available on the AMA web-site. (Although, it has not completely vanished off the webs. See the comments on Dr Carlat's post.) Meanwhile, the AMA has posted a series of "fact sheets" from their National Task Force on CME Provider/Industry Collaboration which seem notably friendly to "collaboration" among educators and industry.
Tuesday, January 27, 2009
Paying More for Worse Outcomes - the Wyeth/ DesignWrite/ University of Wisconsin Hormone Replacement Therapy Course as Microcosm
The Milwaukee Journal-Sentinel just published a remarkable investigative report about continuing medical education courses provided (after a fashion) by the University of Wisconsin. Here are the main points,
The course was created by a medical education and communications company (MECC), paid for by Wyeth
The course put hormone replacement therapy (HRT) for post-menopausal women in a very favorable light, at a time when results from a prominent randomized controlled trial sponsored by the Womens Health Initiative (WHI) had just become available, suggesting that HRT does more harm than good:
Some experts who reviewed the material thought that the "positive light" it placed on hormone replacement was very bright.
This is the second time that the University of Wisconsin medical school has received media attention for the cozy relationships with industry enjoyed by the school and its faculty members. We posted about some University of Wisconsin faculty's lucrative industry relationships, which they often did not fully disclose.
This, of course, is another story about how the web of conflicts of interest that now so enmesh academic medicine can enable stealth marketing, the disguising of marketing of commercial health care goods or services as medical education.
But because of the timing and subject matter of this course, this case has become a microcosm of much of what has gone wrong with US (and global) health care. Note this progression:
- Wyeth paid DesignWrite to design the course, which then paid the University of Wisconsin and its faculty to produce it. Thus considerable money flowed to the MECC and its employees, and to the university and its faculty. Ultimately, this came out of the pockets of patients or the public, adding to health care costs.
- The course they produced was viewed by numerous physicians. It is likely at least some were influenced by it to prescribe long-term HRT.
- Yet there is now (and there was in 2002) reason to believe that long-term HRT does more harm than good. A review in 2002 (see this link for summary, and links to the review) suggested that it produces increased risks of breast cancer, stroke, and pulmonary embolism which outweigh decreses in colorectal cancer and fracture. The WHI trial in JAMA had similar results (link here.)
- Therefore, more patients prescribed HRT by these physicians may have been harmed by it than were helped. Thus, the course not only added to health care costs, but likely worsened health care outcomes.
So in this case, deceptive practices presumably condoned by the leadership of a drug company, by the leadership of an academic medical institution, and by particular medical faculty, all of whom may have benefited personally by money spent to conduct these practices, likely did patients no good, and possibly did them serious harm. Deceptive practices and conflicts of interest resulted in increased health care costs and probably worse health care outcomes.
This suggests, as we have said before, that bad leadership of health care organizations causes these organizations to employ ethically questionable tactics, and these tactics in turn can systemically increase costs and worsen outcomes.
But up to now, there has been little public discussion of bad leadership and governance of health care organizations, the unethical tactics that bad leaders may employ, and how these tactics threaten physicians' professional values, and lead to bad outcomes for patients and society. Up to now, those interested in health care policy and health systems research have ignored these issues, which appear to be the herd of elephants in the health care living room.
But maybe if we improved the leadership and governance of health care organizations, and prevented the unethical practices they may employ, we could improve patient outcomes while actually controlling costs, improving access, and improving professional morale.
Of course, doing so would threaten many vested interests and fat wallets.
See also Dr Daniel Carlat's comments on the Carlat Psychiatry Blog, and Margaret Soltan's comments on University Diaries. Hat tip to PharmaGossip and the Schwitzer Health News blog.
The course was created by a medical education and communications company (MECC), paid for by Wyeth
The course material was developed largely by DesignWrite, a New Jersey-based firm paid by Wyeth.
The company is being investigated along with Wyeth by a U.S. senator looking into the practice of ghostwriting in scientific articles as a way to market hormone therapy drugs.
Together, Wyeth, DesignWrite and UW formed the Council on Hormone Education - the name of the educational organization stamped on course material for the class.
Thirty-four of the 40 council member physicians have financial ties to Wyeth, including the course director, Julie Fagan, a UW doctor and associate professor of medicine.
The course put hormone replacement therapy (HRT) for post-menopausal women in a very favorable light, at a time when results from a prominent randomized controlled trial sponsored by the Womens Health Initiative (WHI) had just become available, suggesting that HRT does more harm than good:
Rigorous studies involving thousands of women showed that hormone therapy increases the risk of heart disease, stroke, breast cancer, blood clots and dementia. They also showed quality-of-life benefits are short-lived.
In May 2002, a major clinical trial that was part of the Women's Health Initiative was suspended because medical investigators were worried they were subjecting women to too much risk.
In the fall of 2002, just months after the health initiative was stopped, the Council on Hormone Education launched its first UW hormone therapy medical education course.
'There were millions of women impacted by that information, and physicians and women really needed to have that information,' said Doug Petkus, spokesman for Wyeth. 'We felt we were providing a service to them by helping them . . . understand the significance.'
Over the next several years, Wyeth poured $12 million into the course.
According to the first newsletter published by the Council on Hormone Education, the goal of the course was 'to develop and disseminate balanced, accurate, timely and consistent information about hormone therapy' so doctors could "better serve women."
Other newsletters, which included patient handouts and multiple-choice exams in the back for physicians, urged doctors to consider the bonuses of hormone therapy.
For instance, in a newsletter titled 'Menopause and Quality of Life,' Wyeth-funded researcher JoAnn Pinkerton wrote: 'Undesirable skin changes associated with aging can have a deleterious impact on both physical and mental health. These changes include lines, wrinkles and dryness that affect Quality of Life.'
'American women attach to youthful, attractive skin,' she wrote, explaining that the age-induced changes are in large part the result of estrogen loss. There is no scientific consensus that estrogen supplements will reverse the aging process in skin.
The University of Virginia Health System doctor also suggested that depression, insomnia and mood issues could be the result of estrogen and other hormone imbalances.
Her conclusion: 'Hormone therapy treats menopausal symptoms more effectively than any other single agent.' And a physician must weigh those benefits against a woman's risk for 'coronary heart disease, deep vein thrombosis, pulmonary embolism, stroke, breast cancer, and gall bladder problems, which hormone therapy may be associated with.'
Fagan, the UW course director, defended the program, saying nothing in the course material was scientifically inaccurate. However, she said the material was presented in a 'more positive light' than she would have preferred.
Some experts who reviewed the material thought that the "positive light" it placed on hormone replacement was very bright.
The Journal Sentinel asked several doctors, including Jacques Rossouw, chief of the Women's Health Initiative branch of the National Institutes of Health, to review course material. The initiative is the largest clinical trial of hormone therapy drugs.
He said the views expressed in the course are not those of the general scientific community and are not suitable for a university medical education course.
'There is a history of this kind of thing from Wyeth,' Rossouw said. 'The materials regurgitate lines that I have heard and read many times, and I have come to believe (though I do not know) that this is part of an overall marketing strategy to the profession. It is not good science because it fails to strive for any kind of balance.'
Raymond Gibbons, a professor of medicine at the Mayo Clinic and former president of the American Heart Association, said he also found material relating to heart disease one-sided.
He noted that the materials inappropriately gave observational data equal weight to rigorously done, randomized clinical trials.
'It's a lot of post hoc analysis,' he said. 'I don't see the other side of the argument.'
This is the second time that the University of Wisconsin medical school has received media attention for the cozy relationships with industry enjoyed by the school and its faculty members. We posted about some University of Wisconsin faculty's lucrative industry relationships, which they often did not fully disclose.
This, of course, is another story about how the web of conflicts of interest that now so enmesh academic medicine can enable stealth marketing, the disguising of marketing of commercial health care goods or services as medical education.
But because of the timing and subject matter of this course, this case has become a microcosm of much of what has gone wrong with US (and global) health care. Note this progression:
- Wyeth paid DesignWrite to design the course, which then paid the University of Wisconsin and its faculty to produce it. Thus considerable money flowed to the MECC and its employees, and to the university and its faculty. Ultimately, this came out of the pockets of patients or the public, adding to health care costs.
- The course they produced was viewed by numerous physicians. It is likely at least some were influenced by it to prescribe long-term HRT.
- Yet there is now (and there was in 2002) reason to believe that long-term HRT does more harm than good. A review in 2002 (see this link for summary, and links to the review) suggested that it produces increased risks of breast cancer, stroke, and pulmonary embolism which outweigh decreses in colorectal cancer and fracture. The WHI trial in JAMA had similar results (link here.)
- Therefore, more patients prescribed HRT by these physicians may have been harmed by it than were helped. Thus, the course not only added to health care costs, but likely worsened health care outcomes.
So in this case, deceptive practices presumably condoned by the leadership of a drug company, by the leadership of an academic medical institution, and by particular medical faculty, all of whom may have benefited personally by money spent to conduct these practices, likely did patients no good, and possibly did them serious harm. Deceptive practices and conflicts of interest resulted in increased health care costs and probably worse health care outcomes.
This suggests, as we have said before, that bad leadership of health care organizations causes these organizations to employ ethically questionable tactics, and these tactics in turn can systemically increase costs and worsen outcomes.
But up to now, there has been little public discussion of bad leadership and governance of health care organizations, the unethical tactics that bad leaders may employ, and how these tactics threaten physicians' professional values, and lead to bad outcomes for patients and society. Up to now, those interested in health care policy and health systems research have ignored these issues, which appear to be the herd of elephants in the health care living room.
But maybe if we improved the leadership and governance of health care organizations, and prevented the unethical practices they may employ, we could improve patient outcomes while actually controlling costs, improving access, and improving professional morale.
Of course, doing so would threaten many vested interests and fat wallets.
See also Dr Daniel Carlat's comments on the Carlat Psychiatry Blog, and Margaret Soltan's comments on University Diaries. Hat tip to PharmaGossip and the Schwitzer Health News blog.
Wednesday, October 15, 2008
BLOGSCAN - An Industry Sponsored "Scholarly" CME Journal?
On the Carlat Psychiatry Blog, Dr Daniel Carlat discussed a new apparently scholarly peer-reviewed journal devoted to studies of continuing medical education. However, the journal seems to be funded by a group of pharmaceutical companies, published by a medical education and communications company (MECC), and edited by the Vice President of a for-profit medical education assessment company. A majority of the editorial board appear to work for the pharmaceutical industry, MECCs, and related businesses.
Thursday, October 2, 2008
Another Industry-Supported Physician Defends Industrial Support of Medical Societies
The President of the American College of Cardiology (ACC), W Douglas Weaver MD, has written a second editorial on relationships between the ACC and industry, continuing medical education, and conflicts of interest. In his first editorial [ Weaver WD. President's page: disclosures, transparency, and firewalls protect integrity. J Am Coll Cardiol 2008; 52(11): 964-965. Subscription required.] his major points were:
Major activities of the ACC require industry funding - "the Annual Scientific Session would not be possible in its current form if it were not for industry grants and fees from the Exposition."
"Firewalls" provided by the society prevent influence by industry on educational or scientific programs -
My comment is that is well and good, but it is possible for financial sponsors to exert subtle pressure that such firewalls would not prevent. Sponsors are likely to support educational activities which address topics which can fulfill marketing objectives. In particular, it is often in the interests of such sponsors to highlight, or exaggerate the prevalence of a disease which the sponsor's product can be used to diagnose or treat; to emphasize, or over-emphasize the importance of that disease; and to emphasize, or over-emphasize the benefits and deemphasize the harms of treating the disease. Presentations and publications which have such effects can help the sponsor's marketing objectives, without making crass, overt pitches for its products. It is likely that a professional society which needs substantial support from commercial sponsors will somehow end up providing educational and research presentations that help, or at least do not conflict with sponsors' marketing objectives. It is also likely that a society which needs such support will rarely provide presentations that are critical of these sponsors, their products, and their actions.
In a second article just out [Weaver WD. President's page: understanding the implications of conflict of interest issues. J Am Coll Cardiol 2008; 52(15): 1274-1275] Dr Weaver quantified the amount of support the ACC gets from industry, and again advocated such support as necessary:
My questions are how could a society which requires such a substantial proportion, 38% of funding from commercial sponsors ignore the preferences of the sponsors for particular topics and content areas? How could such a society dare to allow criticism of the sponsors, their products, or their activities? Knowing that the society is dependent on this level of support, could society leaders really hold industry representatives at arms' length? Knowing that industry supplies more than one-third of their salaries, would society staff really keep industry outside of some bureaucratic, but not concrete "firewall?"
Actually, it was not clear why so much external support was really necessary. The argument was not that the College could not continue its activities without the support. It was, instead, that the College would have to increase membership dues and meeting fees to do so. Perhaps College members would be willing to pay more to continue these activities to questions about industry influence on them? If College members, however, would not think that these activities are not worthy of their support via dues and fees, maybe these activities are not so important after all?
At the end of this first editorial, Dr Weaver declared:
I would urge him to reconsider that. I do not have sufficient time or resources to scrutinize all the activities of the College, but I would not be surprised if an impartial assessment might show that they may tend to emphasize clinical areas most of interest to the College's commercial sponsors, while perhaps slighting other areas that are not of interest to them, but are still important to patient care. They may also want to take a skeptical look to see if these activities really are fully balanced in their assessment of the harms and benefits of sponsors' products and activities.
For example, a while back, we posted about an ACC statement that patients taking ezetimibe for cholesterol reduction should continue to take the drug after a controversy about a study which failed to show that the drug had any benefits. At that time, ezetimibe had never been shown to have any clear benefits on clinical outcomes, that is, it had never been shown to decrease symptoms, improve function, prevent morbid events, or prolong life. So why would the ACC advocate that patients continue to take a drug which may do no good? Could it have to do with previous funding the society had received from a company that makes the drug?
Finally, I urge Dr Weaver to take to heart his vigorous defense of transparency and disclosure. As noted above, he has now written two editorials that defend the substantial industry funding his organization receives, and deny the possibility that the large infusion of money could possibly affect organizational decision making. Yet in these editorials he did not disclose any of his own relationships with industry, which appear to be not insubstantial.
Several papers which he authored in the last few years disclosed that he had apparently significant financial relationships with pharmaceutical companies.
So Dr Weaver seems to be another in a series of defenders of financial ties between physicians and medical societies and industry written by people who fail to disclose their own personal financial ties to industry. Perhaps having one's own cozy relationships with industry makes it hard to realize why people without such relationships may see them as a source of influence, if not outright bias. For other recent examples of stealth health policy advocacy, see this and this (which involved Dr Weaver's colleague, the editor of the JACC.)
I would submit that if medical societies want to avoid questions about their integrity, they ought to find ways to fund their activities through their members' dues and contributions, and without lavish contributions from industry, supposed "firewalls" notwithstanding.
Major activities of the ACC require industry funding - "the Annual Scientific Session would not be possible in its current form if it were not for industry grants and fees from the Exposition."
"Firewalls" provided by the society prevent influence by industry on educational or scientific programs -
Let me assure you that we have very strong firewalls around industry support.
As part of our firewall structure, the College has long-established policies that require strict segregation between the source of commercial support and the use of industry funding. The College adheres to internal and external policies that prohibit companies that provide support from exercising any influence or control over programmatic content, speaker/faculty selection, program format, planning, partnering arrangements, program evaluation methods, and related matters.
Most of the College's commercial support from pharmaceutical and medical device/equipment companies is used for a new or ongoing initiative. For example, the College may solicit support for an educational program on the management of patients with congenital heart disease. Commercial support, in cases such as this, is dedicated or directed to that special objective but with the contractual understanding by the supporter that they will have no influence on how the College uses the funds to support the objective. Unlike unrestricted educational or charitable grants, directed funds are restricted to the designated objective, but the College determines how to use them in accomplishing the objective.
My comment is that is well and good, but it is possible for financial sponsors to exert subtle pressure that such firewalls would not prevent. Sponsors are likely to support educational activities which address topics which can fulfill marketing objectives. In particular, it is often in the interests of such sponsors to highlight, or exaggerate the prevalence of a disease which the sponsor's product can be used to diagnose or treat; to emphasize, or over-emphasize the importance of that disease; and to emphasize, or over-emphasize the benefits and deemphasize the harms of treating the disease. Presentations and publications which have such effects can help the sponsor's marketing objectives, without making crass, overt pitches for its products. It is likely that a professional society which needs substantial support from commercial sponsors will somehow end up providing educational and research presentations that help, or at least do not conflict with sponsors' marketing objectives. It is also likely that a society which needs such support will rarely provide presentations that are critical of these sponsors, their products, and their actions.
In a second article just out [Weaver WD. President's page: understanding the implications of conflict of interest issues. J Am Coll Cardiol 2008; 52(15): 1274-1275] Dr Weaver quantified the amount of support the ACC gets from industry, and again advocated such support as necessary:
Many of you are probably aware that industry supports a broad array of College activities including professional education, quality programs, the Annual Scientific Session Expo, and digital products through educational and other types of grants. This support, which constitutes about 38% of the College's revenues, enables the College to provide programs that we would otherwise not be able to offer. In addition, without this support, the registration fees for the Annual Scientific Session and i2 Summit would have to be more than double their present amount, and member dues would have to increase significantly.
My questions are how could a society which requires such a substantial proportion, 38% of funding from commercial sponsors ignore the preferences of the sponsors for particular topics and content areas? How could such a society dare to allow criticism of the sponsors, their products, or their activities? Knowing that the society is dependent on this level of support, could society leaders really hold industry representatives at arms' length? Knowing that industry supplies more than one-third of their salaries, would society staff really keep industry outside of some bureaucratic, but not concrete "firewall?"
Actually, it was not clear why so much external support was really necessary. The argument was not that the College could not continue its activities without the support. It was, instead, that the College would have to increase membership dues and meeting fees to do so. Perhaps College members would be willing to pay more to continue these activities to questions about industry influence on them? If College members, however, would not think that these activities are not worthy of their support via dues and fees, maybe these activities are not so important after all?
At the end of this first editorial, Dr Weaver declared:
The College does everything possible to ensure that our scientific and educational activities are protected from conflict of interest. Disclosure, transparency, and secure firewalls between commercial support and program content and implementation enable us to use such funding for education and other programs aimed at improving the quality of care to patients without sacrificing our integrity.
I would urge him to reconsider that. I do not have sufficient time or resources to scrutinize all the activities of the College, but I would not be surprised if an impartial assessment might show that they may tend to emphasize clinical areas most of interest to the College's commercial sponsors, while perhaps slighting other areas that are not of interest to them, but are still important to patient care. They may also want to take a skeptical look to see if these activities really are fully balanced in their assessment of the harms and benefits of sponsors' products and activities.
For example, a while back, we posted about an ACC statement that patients taking ezetimibe for cholesterol reduction should continue to take the drug after a controversy about a study which failed to show that the drug had any benefits. At that time, ezetimibe had never been shown to have any clear benefits on clinical outcomes, that is, it had never been shown to decrease symptoms, improve function, prevent morbid events, or prolong life. So why would the ACC advocate that patients continue to take a drug which may do no good? Could it have to do with previous funding the society had received from a company that makes the drug?
Finally, I urge Dr Weaver to take to heart his vigorous defense of transparency and disclosure. As noted above, he has now written two editorials that defend the substantial industry funding his organization receives, and deny the possibility that the large infusion of money could possibly affect organizational decision making. Yet in these editorials he did not disclose any of his own relationships with industry, which appear to be not insubstantial.
Several papers which he authored in the last few years disclosed that he had apparently significant financial relationships with pharmaceutical companies.
- Mahaffey KW, Granger CB, Nicolau JC et al. Effect of pexelizumab, an anti-C5 complement antibody, as adjunctive therapy in fibrinolysis in acute myocardial infarction. Circ 2003; 108: 1176-1183. Subscription required. This disclosed "Drs Mahaffey, Granger, Nicolau, Ruzyllo, Weaver, Theroux, Hochman, and Armnstrong have received consultation fees and/or research grants from Procter & Gamble Pharmaceuticals and Alexion Pharmaceuticals."
- Hudson MP, Armstrong PW, Ruzyllo W et al. Effects of selective matrix metalloproteinase inhibitor (PG-116800) to prevent ventricular modeling after myocardial infarction: results of the PREMIER (prevention of myocardial infarction early remodeling) trial. J Am Coll Cardiol 2006; 48: 15-20. Subscription required. This disclosed "this study was funded by Procter & Gamble Pharmaceuticals...." Furthermore, "Drs Ruzyllo, Quinones, Theroux, and Weaver received consultancy fees for participating on PREMIER Trial Expert Panel."
- The APEX AMI Investigators. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA 2007; 297: 43-51. Dr Weaver was listed as a member of "authors and steering committee members." The paper disclosed "members of the Steering Committee received honoraria for their participation." "The study was jointly funded by Procter & Gamble and Alexion Pharmaceuticals."
- Prisant LM, Thomas KL, Lewis EF et al. Racial analysis of patients with myocardial infarction complicated by heart failure an/or left ventricular dysfunction treated with valsartan, captopril or both. J Am Coll Cardiol 2008; 51:1865-1871. Subscription required. It disclosed "all of the authors have received grant support or consulting fees from the sponsor of the VALIANT (VALsartin in Acute myocardial iNfarcTion) study, Novartis, as well as from multiple other manufacturers of cardiovascular drugs."
So Dr Weaver seems to be another in a series of defenders of financial ties between physicians and medical societies and industry written by people who fail to disclose their own personal financial ties to industry. Perhaps having one's own cozy relationships with industry makes it hard to realize why people without such relationships may see them as a source of influence, if not outright bias. For other recent examples of stealth health policy advocacy, see this and this (which involved Dr Weaver's colleague, the editor of the JACC.)
I would submit that if medical societies want to avoid questions about their integrity, they ought to find ways to fund their activities through their members' dues and contributions, and without lavish contributions from industry, supposed "firewalls" notwithstanding.
Thursday, September 11, 2008
Commercial Funding of CME, and Distinguishing Babies from Bathwater
There has been quite a bit of discussion lately about how industry funding influences continuing medical education. One of our industrious scouts pointed out one of the most recent entries in this discussion, an article on this subject by the Editor-in-Chief of the Journal of the American College of Cardiology, Dr Anthony N DeMaria [DeMaria AN. Continuing education, industry, and physicians. J Am Coll Cardiol 2008; 52: 1035-1036. Link here.]
Dr DeMaria confessed to "very mixed feelings" about the move to end commercial support of CME. He felt that such commercial support did some good.
Although he acknowledged that commercial support "sometimes appeared to primarily serve the interests of the supporters," he felt that full disclosure would allow physicians to be properly skeptical of that support.
Thus, he also felt that terminating commercial support would be bad.
First, note that this is yet another argument that physicians ought to be offended by the notion that they can be influenced by commercial relationships. I agree that maybe few physicians consciously alter their decisions and judgments according to their financial relationships with companies that have vested interests in selling health care products or services. But, common sense and experimental psychology suggests that such relationships can influence judgments and decisions even without conscious awareness of their effects.
Second, note that Dr DeMaria makes yet another argument that full disclosure can resolve conflicts of interest. However, there is also evidence from experimental psychology that disclosing conflicts may give people a license to further exaggerate their communication and actions in favor of their personal financial interests, and that recipients of disclosure may not know how to adjust for it adequately (see post here.)
I disagree with Dr DeMaria. I do not think the current approach, based on full disclosure as an adequate way to manage the conflicts caused by industry funded CME, and to manage conflicts of individual continuing medical educators, is adequate.
Finally, it appears that Dr DeMaria did not disclose his own financial relationships with commercial suppliers of health care goods and services. A bit of searching revealed that he serves or has served on medical advisory boards for CardioNet, Cardiodynamics International, and ResMed, on the scientific advisory board of BSP, and on the board of directors of Biosite. A disclosure for the American College of Cardiology ACCEL program also stated he has gotten modest (<$10,000) consulting fees or honoraria from "all echocardiography and ultrasound companies." He did not disclose these relationships in association with the article cited above, nor did he disclose them in conjunction with his role as editor-in-chief of the journal. A disclosure for a 2006 CME program included "Stock Options: Resmed, Biosite, Targe GW. Consulting Fees: Resmed, Targe GW, Vasomedical. Research Grants: Resmed, Acoufiant. Speaker: Acoufiant. Employment: Resmed. Ownership/Partnership: Resmed. Officer/Trustee: Resmed, Biosite. Receipt of Royalties: Resmed."
Although Dr DeMaria asserted that physicians are smart enough to recognize bias when they see it, it is not clear they could recognize the effect of financial relationships which are not disclosed to them at all. Dr DeMaria did not give his physician readers an opportunity to judge whether his defense of commercially sponsored CME might have been influenced by his own relationships with industry, nor did he give his readers an opportunity to judge whether his actions and writing as the editor in chief of a major medical journal were otherwise influenced by these relationships.
In my humble opinion, as I have said before, those who advocate particular health policy positions have the same obligation to disclose relevant conflicts of interest as do those who advocate particular approaches to clinical problems. Policy positions ought to be skeptically evaluated taking into account whether those expressing them stand to gain personally from what they advocate. Failure to adequately disclose conflicts of interest ought to inspire even more skepticism.
I fear much that today much of the health policy debate amounts to stealth health policy advocacy.
Furthermore, in my humble opinion, those who exercise editorial control over health care and medical journals have the same obligation to disclose relevant conflicts of interest as do authors of clinical research articles.
Finally, based on the experimental psychology study to which I alluded above, I doubt that even full disclosure of all conflicts in detail will allow adequate management of the conflicts of interest that now pervade medicine and health care.
Dr DeMaria confessed to "very mixed feelings" about the move to end commercial support of CME. He felt that such commercial support did some good.
This support has been estimated to amount to nearly $1 billion per year and has enabled us to have the breadth and depth of learning opportunities we currently enjoy.
Although he acknowledged that commercial support "sometimes appeared to primarily serve the interests of the supporters," he felt that full disclosure would allow physicians to be properly skeptical of that support.
I have a further, even more basic, reservation about the proposal to end commercial support for CME. Inherent in such an action is the idea that physicians are like sheep: easily led and without the ability to recognize biased or slanted information. I find this demeaning to the profession. In my experience, physicians are more skeptical than naïve; by nature they are not anxious to accept, but rather are waiting to be convinced. Given the competitive demands entailed in becoming a physician, we are likely intelligent enough to recognize bias when it is present.
Thus, he also felt that terminating commercial support would be bad.
I worry that termination of all commercial support is a major overreaction.
I view the proposal to eliminate all industrial support of medical education as throwing the baby out with the bath water. I agree that certified CME should be objective and free of all bias, and I am not naïve enough to think that this has been fully achieved. However, I think there are other ways to accomplish this goal, and that we have the structure in place to be successful in the ACCME, medical societies, and academic institutions. Tightening existing guidelines and greater diligence to adherence should be adequate. Equally important, I think physicians are intelligent, savvy, and independent enough to know bias when they see it, and to resist recommendations that are not based on firm data. Physicians may not be perfect, but in pursuing continuing education, we have set an example for other professions to follow. Industrial support has helped to make this possible; let's think long and hard before we upset the cart.
First, note that this is yet another argument that physicians ought to be offended by the notion that they can be influenced by commercial relationships. I agree that maybe few physicians consciously alter their decisions and judgments according to their financial relationships with companies that have vested interests in selling health care products or services. But, common sense and experimental psychology suggests that such relationships can influence judgments and decisions even without conscious awareness of their effects.
Second, note that Dr DeMaria makes yet another argument that full disclosure can resolve conflicts of interest. However, there is also evidence from experimental psychology that disclosing conflicts may give people a license to further exaggerate their communication and actions in favor of their personal financial interests, and that recipients of disclosure may not know how to adjust for it adequately (see post here.)
I disagree with Dr DeMaria. I do not think the current approach, based on full disclosure as an adequate way to manage the conflicts caused by industry funded CME, and to manage conflicts of individual continuing medical educators, is adequate.
Finally, it appears that Dr DeMaria did not disclose his own financial relationships with commercial suppliers of health care goods and services. A bit of searching revealed that he serves or has served on medical advisory boards for CardioNet, Cardiodynamics International, and ResMed, on the scientific advisory board of BSP, and on the board of directors of Biosite. A disclosure for the American College of Cardiology ACCEL program also stated he has gotten modest (<$10,000) consulting fees or honoraria from "all echocardiography and ultrasound companies." He did not disclose these relationships in association with the article cited above, nor did he disclose them in conjunction with his role as editor-in-chief of the journal. A disclosure for a 2006 CME program included "Stock Options: Resmed, Biosite, Targe GW. Consulting Fees: Resmed, Targe GW, Vasomedical. Research Grants: Resmed, Acoufiant. Speaker: Acoufiant. Employment: Resmed. Ownership/Partnership: Resmed. Officer/Trustee: Resmed, Biosite. Receipt of Royalties: Resmed."
Although Dr DeMaria asserted that physicians are smart enough to recognize bias when they see it, it is not clear they could recognize the effect of financial relationships which are not disclosed to them at all. Dr DeMaria did not give his physician readers an opportunity to judge whether his defense of commercially sponsored CME might have been influenced by his own relationships with industry, nor did he give his readers an opportunity to judge whether his actions and writing as the editor in chief of a major medical journal were otherwise influenced by these relationships.
In my humble opinion, as I have said before, those who advocate particular health policy positions have the same obligation to disclose relevant conflicts of interest as do those who advocate particular approaches to clinical problems. Policy positions ought to be skeptically evaluated taking into account whether those expressing them stand to gain personally from what they advocate. Failure to adequately disclose conflicts of interest ought to inspire even more skepticism.
I fear much that today much of the health policy debate amounts to stealth health policy advocacy.
Furthermore, in my humble opinion, those who exercise editorial control over health care and medical journals have the same obligation to disclose relevant conflicts of interest as do authors of clinical research articles.
Finally, based on the experimental psychology study to which I alluded above, I doubt that even full disclosure of all conflicts in detail will allow adequate management of the conflicts of interest that now pervade medicine and health care.
Wednesday, September 3, 2008
BLOGSCAN - More on the JAMA Commentaries on Physicians' Relationships with Industry
We recently blogged about Dr Marcia Angell's commentary about how the increasing influence of those with vested interests in selling products or services has "broken" the clinical research system. In the same issue of JAMA were two other commentaries. For further discussion of Dr Arnold Relman's call to end industry influence on continuing medical education, see this post by Dr Daniel Carlat in the Carlat Psychiatry Blog. For further discussion of all three JAMA commentaries, see this post by Merrill Goozner on the GoozNews blog.
Tuesday, August 26, 2008
BLOGSCAN - Stanford's CME Money Goes Into a Pool
On the Carlat Psychiatry Blog, Dr Daniel Carlat analyzed the new Stanford policy that would direct all commercial funds supporting continuing medical education (CME) into a single pool. As Dr Carlat pointed out, the devil may be in the details of this policy, which still allows connection of funding to some (admittedly broad) particular clinical categories. Furthermore, although the policy would apparently sever direct connections between funding from particular companies and particular CME courses, I do not see how it could prevent informal communications between commercial sponsors and academics that could shape the subject matter and content of these courses. Such communication is now easy since so many medical faculty already have financial relationships with specific drug, device, biotechnology or other health care corporations.
Monday, July 21, 2008
BLOGSCAN - Who Actually Organizes Medical Conferences and Continuing Medical Education?
On the Carlat Psychiatry Blog, Dr Daniel Carlat delved more into the role of medical education and communication companies (MECCs) in medical education. He found a MECC prospectus for a psychiatry conference ostensibly presented by a very prestigious medical school. In it, the MECC solicited "independently supported symposia," and offered to prepare for such symposia "enduring materials," which appear to be polished monographs, which can be read for CME credit. The charge to the sponsor for preparing such an article was a cool $103,000. Funny, I used to think that doctors and medical academics put together medical conferences and continuing medical education. But look through the section on "partner responsibilities" in the MECC's prospectus, and see how little there is for the prestigious academic institution to do, and how much is actually done by the MECC. How naive I was.
Friday, May 23, 2008
BLOGSCAN - On the Physician Payment Sunshine Act and CME Put on by MECCs
On the Carlat Psychiatry Blog, Dr Daniel Carlat discussed the Physician Payment Sunshine Act. This proposed legislation would mandate disclosure by drug companies of all payments over $500 made to physicians for speaking, consulting, travel, etc. Dr Carlat, however, noted an important loophole. The legislation would not cover payments made to medical education and communication companies (MECCs) to put on continuing medical education (CME) activities. Pharmaceutical, biotechnology and device companies often sponsor CME produced by MECCs. Such CME, even though it may be accredited, may be done more for marketing than educational purposes. But payments to physicians by MECCs made with money supplied by industry would not need to be disclosed according to the present form of the bill. Dr Carlat fears that the legislation, in its present form, may have the unintended consequence of promoting even more industry-sponsored (and industry-friendly) by MECC provided CME.
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