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
Monday, October 12, 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 02, 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 03, 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.
Tuesday, April 29, 2008
The AAMC Report on Medical Schools' Industry Relationships: A Glass Half Empty
The Association of American Medical Colleges (AAMC) just unveiled a report on relationships among academic medical institutions and the pharmaceutical, biotechnology, and device industry. The report was notable in its toughness in certain areas, laxity in others, and for what it did not mention, and what kinds of conflicts of interest it actually encouraged.
Where it was tough:
Where it was tough:
- It advocated banning "acceptance of any gifts from industry by physicians and other faculty, staff, students, and trainees...."
- It considered "industry supplied food and meals" as "personal gifts" which should be therefore banned (but see below).
- It advocated prohibiting "physicians, trainees, and students from directly accepting travel funds from industry." (But see below.)
- It advocated prohibiting "physicians, trainees, and students from allowing their professional presentations of any kind, oral or written, to be ghostwritten by any part, industry or otherwise."
Where it was lax
- It did not ban interactions among physicians, faculty, staff, students and trainees and pharmaceutical or device representatives (sales people), only restricting such interactions to "nonpatient care areas and nonpublic areas," "by appointment or invitation of the physicians." Furthermore, it suggested that "involvement of students and trainees in such individual meetings should occur only for educational purposes."
- It allowed "industry representatives who wish to provide educational information on their products" to do so "by invitation in faculty-supervised structured group settings"
- It allowed "access by device manufacturers' representatives" if they are "appropriately credentialed."
- It allowed participation in industry funded continuing medical education (CME) programs as long as they are accredited by the Accreditation Council for Continuing Medical Education (ACCME)
- It allowed industry-sponsored food and meals as long as they are part of ACCME accredited CME.
- It advocated that "participation by ... faculty in industry-sponsored speakers' bureaus" should be "strongly discouraged," but not prohibited.
- It allowed industry to reimburse travel "for legitimate reimbursement or contractual services."
What it encouraged:
- It acknowledged "the value of permitting academic medical center faculty to interact appropriately with industry." It deemed appropriate "faculty participation on industry boards of directors and scientific advisory boards," and faculty "services provided through professional service agreements and consulting contracts," as long as they are "in full compliance with the policies of the medical center and applicable law," and compensated according to "fair market value." It did not require, or even suggest disclosure of such financial relationships.
What it did not mention:
- Institutional conflicts of interest, in general.
- Industry manipulation or suppression of clinical research, and how contracts between academic medical institutions and industry allow such manipulation.
- Some specific kinds of financial relationships between faculty and industry, including faculty holding executive positions with or founding health care corporations, and faculty receiving royalty payments.
In my humble opinion, at best this report, which I suspect will be highly influential, is a glass half empty.
There is reason to ban gifts and food to trainees, and physicians. Such gifts imply the need for reciprocity, and hence may be influential beyond their monetary value. See our posts (here, here, and here) on how gifts are used for marketing purposes by pharmaceutical representatives.
Yet given the evidence (see posts above) that the goal of pharmaceutical (and biotechnology and device) representatives is to market product, not provide education, the report's allowance of "educational" activities by such representatives is at best disingenuous.
Furthermore, given the evidence that industry sponsored CME is likely to be biased in favor of the sponsoring companies' products and services (see posts here, and here, and numerous posts on the Carlat Psychiatry Blog and the Hooked: Ethics, Medicine and Pharma blog ), and the logic behind this assertion, the report's allowance of such "educational" activities is also at best disingenuous.
I believe that the report's failure to address the issue of manipulation and suppression of industry funded research is astonishing given how obvious such problems have become. (Try searching these topics on this blog, to begin with.)
Finally, the report's encouragement of certain often lucrative financial relationships (such as consulting, service on advisory committees, and service on boards of directors of health care corporations), while it ignored other lucrative relationships (service as a corporate executive, founding of health care corporations, and receipts of royalties) suggests cynicism and hypocrisy.
First, even though small gifts may have influence beyond their monetary value, very large payments are likely to be more influential. Even without empirical research, common sense suggests that a faculty member who receives tens of thousands of dollars for consulting or serving on an advisory committee or speakers' bureau is likely to look favorably on his or her corporate part-time employer, and its products or services. Furthermore, serving as an executive of a corporation, and particularly serving on the board of directors of a corporation should demand loyalty to the corporation, and such loyalty can be enforced in court. Surely such loyalty is likely to be much more powerful than warm feelings generated by the receipt of a free pizza.
If there is a reason to ban gifts of pens, coffee mugs, or pizza slices due to the concern that such gifts may influence trainees and physicians' behavior, there is more of a reason to ban service on speakers' bureaus and advisory committees, consulting contracts, and particularly service as company executives, and on boards of directors.
Otherwise, we may well see the spectacle of a the director of a health care corporation punishing a medical student for accepting a pen with that corporation's logo on it.
And a postscript - It appears that this report may be so ambivalent about conflicts of interest because several of its authors were affected by such conflicts. On the PharmaLot blog, Ed Silverman reported that three authors are on the boards of directors of large health care corporations, and three other authors had significant financial relationships with health care corporations. None of these relationships were disclosed in the report. The report did disclose that four other authors were not academics or medical college administrators, but CEOs of pharmaceutical or biotechnology corporations. Why the AAMC saw fit to ask such people, who are obviously likely to be more loyal to their corporations than to academic medicine, is a mystery yet to be solved.
Note, see somewhat more optimistic opinions about this report on the Carlat Psychiatry Blog and the Hooked: Ethics, Medicine and Pharma blog. Also, a New York Times editorial accused of the AAMC of "flinching" from banning service on speakers' bureaus, and industry supported CME, but did not mention the report's support of consulting, service on advisory committees and boards of directors, service as a corporate executive, etc. But I agree with its general conclusion, "Patients need to be assured that their doctors are prescribing what’s best for them, not what’s best for companies. "
ADDENDUM (30 April, 2008) - See also coverage in the Gooznews Blog, in which Merrill Goozner noted that the report "stopped short of calling for prohibiting faculty members from consulting or speaking on behalf of drug and device companies, or for eliminating industry’s role in financing continuing medical education (CME)." On the other hand, the Postscript blog by the Prescription Project noted the AAMC report without much comment.
ADDENDUM (30 April, 2008) - On theRetired Doc's Thoughts blog, Dr James Gaulte is also skeptical, "My non-insider take is that there will be a flurry of high profile (within the institutions at least) announcements of 'no more free lunches' and much self congratulation and talk of professionalism but somehow I doubt the faculty will give up the lucrative lecture gigs although a veneer of word smithed propriety and oversight will be grafted onto it."
Thursday, March 27, 2008
Smoked Out: Funding Lung Cancer Screening Research with Tobacco Money
A few weeks ago, we posted about conflicts of interest affecting a widely publicized study of using CT scans to screen for lung cancer. The study, basically a large case-series, was susceptible to multiple kinds of study bias that challenged its validity. Yet its authors used this limited and flawed data to strongly advocate such screening. Two lead study investigators, Dr Claudia Henschke and Dr David Yankelevitz of Weill Medical College of Cornell University, held multiple patents on technology used for the screening, and had licensed one patent to General Electric, a manufacturer of CT scans, and exchanged another for rights in a start-up manufacturer of lung biopsy devices. They did not disclose these conflicts in the articles they published describing study results, including one in the New England Journal of Medicine. We noted that perhaps these conflicts were related to the investigators' great enthusiasm for CT scan based lung cancer screening that went well beyond the data from their study.
Since then, the plot has thickened. A follow up article in the Cancer Letter(1) noted that the New England Journal of Medicine article which failed to disclose the authors' patents and licensing agreement also was a vehicle for continuing medical education (CME). Ethics rules for US CME require full disclosure of all authors' conflicts of interest. Futhermore, the authors had given multiple CME talks. Their disclosure of these conflicts was inconsistent across these talks. Thus, on the GoozNews blog, Merrill Goozner announced that "The Center for Science in the Public Interest later this week will ask the ACCME [Accreditation Council for Continuing Medical Education] to order all the CME providers where Henschke failed to disclose to send proper disclosures to anyone who participated in those activities."
Henschke and Yankelewitz wrote a letter to JAMA in which they acknowledged they had failed to disclose "potential conflicts of interest" in a previous JAMA article and letter.(2) The letter was rather defensive, in my humble opinion, declaring that "The license agreement was between General Electric and Cornell, the institution listed on the title page. A portion of the royalties are distributed to both of us and to the other co-inventors pursuant to Cornell policy, which in turn is consistent with the Bayh-Dole Act." The letter also asserted the authors' very narrow interpretation of conflicts of interest, "we believe that none of the patent applications or the license agreement played any role in the design of the study, interpretation of the data, or drafting of the publications in JAMA and therefore did not disclose them."
A recent AP article noted that even getting to Henschke and Yankelevitz to write this much was not easy.
But you ain't seen nothing yet.
This week, Gardiner Harris writing in the New York Times revealed that the same study which was reported in the New England Journal of Medicine article(3), was substantially funded by money from a tobacco company.
Moreover, Henschke and Yankelevitz could hardly deny knowing about this source of their funding. They were the ones running the foundation.
It turns out that the leadership of Weill Medical College of Cornell University were in on this.
The Cornell leadership denied that the intent was hiding tobacco money. On the other hand, the purpose of the foundation, other than to serve as a conduit for this money to the research project, was not exactly clear.
Note that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment seems quite obscure. It has no web-site. Its address and email address, as reported by SourceWatch, are for Dr Henschke's office. What it has done other than transfer tobacco money to the research project is unknown.
You just can't make this stuff up.
So we have yet another case which illustrates how pervasive is the web of conflicts of interest that entangles physicians, researchers, academic medical institutions, and industry. Moreover, the web increasingly appears to involve not only industries that make products meant to do patients more good than harm, that is drugs and medical devices, but also industries whose products have no medical use, and even now tobacco, certainly one of the major man-made health scourges.
So this case has actually produced some outrage. Per the New York Times article,
Also,
The case also illustrates the messiness of relationships among researchers, academic medical leaders, and industry. As Gardiner Harris wrote in the NY Times,
To illustrate Dr Kassirer's last point, a quick Google search revealed that Dr Gotto, in addition to being dean of the medical school, is a top leader of two pharmaceutical companies. He is on the board of directors of Aegerion Pharmaceuticals and of Arisaph Pharmaceuticals. So where do his interests lie? - promoting the integrity of the medical school, promoting more funding to the medical school, promoting the profits of these two companies, or promoting the interests of the power elite who simultaneously can run medical schools and run health care corporations? Who can tell?
And that is, as we have said before, the curse of conflicts of interest in health care. Conflicts lead to confused thought, speech, and action. One cannot tell what interests lie behind the speech and actions of the conflicted. So clinical research designed, implemented, analyzed, and discussed by the conflicted rather than leading to further clarity about how to care for patients, just leaves us in a fog of doubt.
But financial ties to various industries, regardless of the conflicts they produce, fuel academic medical institutions and universities who want their faculty to become "taxpayers" rather than teachers and researchers (see post here). Such funding may be one reason why administrators now outnumber faculty in higher educational institutions. Such funding fuels the imperial pretensions of their leadership (see post here). So the universities will not give up their conflicts without quite a fight. But it's time for that fight to start.
ADDENDUM (28 March, 2008) - See also comments by Merrill Goozner on Gooznews, and by Gary Schwitzer on the Schwitzer Health News Blog.
References
1. Goldberg P. NEJM says Henschke conflicts irrelevant; propriety of granting CME questioned. Cancer Letter 2008; 34: 1.
2. Henschke CI, Yankelevitz DF. Unreported financial disclosures. JAMA 2008. (Link here.)
3. The International Early Lung Cancer Action Program Investigators. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med 2006; 355: 1763-1771. (Link here.)
Since then, the plot has thickened. A follow up article in the Cancer Letter(1) noted that the New England Journal of Medicine article which failed to disclose the authors' patents and licensing agreement also was a vehicle for continuing medical education (CME). Ethics rules for US CME require full disclosure of all authors' conflicts of interest. Futhermore, the authors had given multiple CME talks. Their disclosure of these conflicts was inconsistent across these talks. Thus, on the GoozNews blog, Merrill Goozner announced that "The Center for Science in the Public Interest later this week will ask the ACCME [Accreditation Council for Continuing Medical Education] to order all the CME providers where Henschke failed to disclose to send proper disclosures to anyone who participated in those activities."
Henschke and Yankelewitz wrote a letter to JAMA in which they acknowledged they had failed to disclose "potential conflicts of interest" in a previous JAMA article and letter.(2) The letter was rather defensive, in my humble opinion, declaring that "The license agreement was between General Electric and Cornell, the institution listed on the title page. A portion of the royalties are distributed to both of us and to the other co-inventors pursuant to Cornell policy, which in turn is consistent with the Bayh-Dole Act." The letter also asserted the authors' very narrow interpretation of conflicts of interest, "we believe that none of the patent applications or the license agreement played any role in the design of the study, interpretation of the data, or drafting of the publications in JAMA and therefore did not disclose them."
A recent AP article noted that even getting to Henschke and Yankelevitz to write this much was not easy.
Dr. Catherine DeAngelis, editor in chief of JAMA, the Journal of the American Medical Association, said she contacted Henschke months ago after others pointed out patents not disclosed in a July 2006 study. DeAngelis said Henschke didn't believe the patents were relevant to the research and resisted disclosing them.
'We'd been working with Dr. Henschke trying to get her to write a letter of apology — which is our policy — and to take responsibility,' DeAngelis said. 'It was not easy to get her to do anything.'
But you ain't seen nothing yet.
This week, Gardiner Harris writing in the New York Times revealed that the same study which was reported in the New England Journal of Medicine article(3), was substantially funded by money from a tobacco company.
Small print at the end of the study, published in The New England Journal of Medicine, noted that it had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. A review of tax records by The New York Times shows that the foundation was underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands [Vector Group Ltd].
Moreover, Henschke and Yankelevitz could hardly deny knowing about this source of their funding. They were the ones running the foundation.
Dr. Henschke was the foundation president, and her longtime collaborator, Dr. David Yankelevitz, was its secretary-treasurer.
It turns out that the leadership of Weill Medical College of Cornell University were in on this.
Dr. Antonio Gotto, dean of Weill Cornell, and Arthur J. Mahon, vice chairman of the college board of overseers, were directors.
The Cornell leadership denied that the intent was hiding tobacco money. On the other hand, the purpose of the foundation, other than to serve as a conduit for this money to the research project, was not exactly clear.
In an e-mail message, Drs. Henschke and Yankelevitz wrote, 'It seems clear that you are trying to suggest that Cornell was trying to conceal this gift, which is entirely false.'
'The gift was announced publicly, the advocacy and public health community knew about it, it is quite easy to look it up on the Internet, its board has independent Cornell faculty on it, and it was fully disclosed to grant funding organizations,' they wrote, adding that the Vector grant represented a small part of the study’s overall cost. The foundation no longer accepts grants from tobacco companies, they wrote.
In the Vector press release, Dr. Henschke was quoted as saying that, thanks to the Vector grants, 'we have raised the initial funding needed to support this important research and data collection on the effectiveness of spiral CT screening.'
Dr. Gotto said in an interview that Dr. Henschke, Dr. Yankelevitz and another colleague set up the foundation initially without the university’s approval, which he said faculty members are allowed to do. He and Mr. Mahon joined the board some weeks or months after its creation to ensure that the Vector grants were handled correctly, he said.
'If we had been approached, we would not have set up the foundation,' Dr. Gotto said. 'We would have accepted the gift directly. We think we behaved honorably. There was no attempt to set up a foundation to hide tobacco money.'
Days earlier, Andrew Ben Ami, assistant secretary of the foundation, said in an interview he would not disclose the source of the charity’s financing at the request of the university.
In another interview before Dr. Gotto agreed to speak, Mr. Mahon, another foundation director, said he did not know the source of the funds.
Note that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment seems quite obscure. It has no web-site. Its address and email address, as reported by SourceWatch, are for Dr Henschke's office. What it has done other than transfer tobacco money to the research project is unknown.
You just can't make this stuff up.
So we have yet another case which illustrates how pervasive is the web of conflicts of interest that entangles physicians, researchers, academic medical institutions, and industry. Moreover, the web increasingly appears to involve not only industries that make products meant to do patients more good than harm, that is drugs and medical devices, but also industries whose products have no medical use, and even now tobacco, certainly one of the major man-made health scourges.
So this case has actually produced some outrage. Per the New York Times article,
Prominent cancer researchers and journal editors, told of the foundation by The Times, said they were stunned to learn of Dr. Henschke’s association with Liggett. Cigarette makers are so reviled among cancer advocates and researchers that any association with the industry can taint researchers and bar their work from being published.
'If you’re using blood money, you need to tell people you’re using blood money,' said Dr. Otis Brawley, chief medical officer of the American Cancer Society. The society gave Dr. Henschke more than $100,000 in grants from 2004 to 2007, money it would not have provided had it known of Liggett’s grants, Dr. Brawley said.
Also,
Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and the author of a book about conflicts of interest, said he believed that Weill Cornell had created the foundation to hide its receipt of money from a cigarette company. 'You have to ask yourself the question, ‘Why did the tobacco company want to support her research?’' Dr. Kassirer said. 'They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that’s outrageous.'
The case also illustrates the messiness of relationships among researchers, academic medical leaders, and industry. As Gardiner Harris wrote in the NY Times,
Universities are responsible for policing conflicts of interest and, in many cases, the required disclosures of their faculty. But Weill Cornell shared in the proceeds of Dr. Henschke’s patent and pending patents, and university officials were on the foundation board.
'We have a very strict oversight policy' for conflicts of interest, Dr. Gotto of Weill Cornell said. He dismissed any suggestion that the university could not police and benefit from faculty members’ financial deals.
But Dr. Kassirer said, 'The problem is that universities, because they’re so conflicted themselves, ignore the conflicts of interest of their faculty.'
To illustrate Dr Kassirer's last point, a quick Google search revealed that Dr Gotto, in addition to being dean of the medical school, is a top leader of two pharmaceutical companies. He is on the board of directors of Aegerion Pharmaceuticals and of Arisaph Pharmaceuticals. So where do his interests lie? - promoting the integrity of the medical school, promoting more funding to the medical school, promoting the profits of these two companies, or promoting the interests of the power elite who simultaneously can run medical schools and run health care corporations? Who can tell?
And that is, as we have said before, the curse of conflicts of interest in health care. Conflicts lead to confused thought, speech, and action. One cannot tell what interests lie behind the speech and actions of the conflicted. So clinical research designed, implemented, analyzed, and discussed by the conflicted rather than leading to further clarity about how to care for patients, just leaves us in a fog of doubt.
But financial ties to various industries, regardless of the conflicts they produce, fuel academic medical institutions and universities who want their faculty to become "taxpayers" rather than teachers and researchers (see post here). Such funding may be one reason why administrators now outnumber faculty in higher educational institutions. Such funding fuels the imperial pretensions of their leadership (see post here). So the universities will not give up their conflicts without quite a fight. But it's time for that fight to start.
ADDENDUM (28 March, 2008) - See also comments by Merrill Goozner on Gooznews, and by Gary Schwitzer on the Schwitzer Health News Blog.
References
1. Goldberg P. NEJM says Henschke conflicts irrelevant; propriety of granting CME questioned. Cancer Letter 2008; 34: 1.
2. Henschke CI, Yankelevitz DF. Unreported financial disclosures. JAMA 2008. (Link here.)
3. The International Early Lung Cancer Action Program Investigators. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med 2006; 355: 1763-1771. (Link here.)
Monday, February 11, 2008
BLOGSCAN - Contrasting Approaches to Commercial Funding of CME
On the Carlat Psychiatry Blog, Dr Daniel Carlat contrasted approaches to commercial funding of continuing medical education (CME) at two different academic medical centers. His earlier post noted that at Sloan-Kettering in New York, commercial funding of CME has been banned. On the other hand, his next post noted that at the Massachusetts General Hospital in Boston, the psychiatry department developed the "MGH Psychiatry Academy," to actively solicity big-time money from pharmaceutical companies. Whose programs will feature fancier venues, better food, and more high-tech graphics? Whose programs would you trust more?
Friday, February 08, 2008
What Are Those Consulting Fees and Speakers' Honoraria Really For?
Widely reported in the media were two large settlements reached by Merck & Co and federal prosecutors. As described by AP,
However, the settlement was not just about pricing.
Another AP report enlarged on this:
Clearly, this appears to be another in now a large series of cases in which prominent health care organizations settled charges of unethical, if not illegal behavior. The frequent appearance of such cases contributes to the impression that sleazy and unethical activities are more the rule than exception in health care, and that even the largest and formerly most reputable organizations are willing to go right up the line, and sometimes over it, in pursuit of more sales and more profits.
One feature of this case should be of particular concern to physicians and health care professionals. Drug, device, and biotechnology companies often loftily proclaim that all the money they spend to pay physicians as advisors, consultants, speakers, etc and to support myriad medical educational activities, goes to support of science and education. This case provides more evidence that consulting fees and speakers' honoraria may be meant as inducements to use and help market companies' products. Hence, at best, they are meant to support marketing, and at worst, they approach bribery.
Recall the recent case we discussed of a surgeon who admitted taking kickbacks from medical devices companies labelled as research grants and consulting fees.
Any physician of health care academic who accepts fees from commercial health care companies ought to consider whether the money is really supporting science or education, or is meant to pay for marketing or kickbacks for recommending the companies' products. In most cases, it may be hard to justify that the only purpose of the money is advancing science or education. Do physicians and other health care professionals really want to be regarded as part-time product marketers, or worse? Is the extra money really worth the shadow it throws on one's professionalism?
In Philadelphia, prosecutors said Merck agreed to pay $399 million for improper calculation of Medicaid rebates and bribing doctors. In New Orleans, prosecutors said the drugmaker agreed to pay $250 million for its rebate practices. With interest, that totals $671 million.The settlement is the third largest ever for health care fraud, behind a $900 million case involving hospital operator Tenet Healthcare Corp. and a $730 million case involving hospital chain HCA, according to the group Taxpayers Against Fraud.
Whitehouse Station, N.J.-based Merck said the settlements do not constitute an admission of any liability or wrongdoing.
'What we have here is a disagreement (over) the rules of the Medicaid rebate program,' said Merck spokesman Ronald Rogers. 'These civil settlements were the best and most appropriate way to resolve these lengthy investigations.'
However, the settlement was not just about pricing.
From 1997 to 2001, prosecutors said Merck had about 15 different programs used by its sales representatives to give doctors and other health professionals 'illegal kickbacks,' disguised as fees for training or consultation, to induce them to prescribe Merck drugs.
Another AP report enlarged on this:
Prosecutors ultimately alleged that Merck paid physicians, hospitals and others excess fees to run supposed educational programs, from lunches to speaking engagements to visiting professorships, in hopes they would favor their products.
Clearly, this appears to be another in now a large series of cases in which prominent health care organizations settled charges of unethical, if not illegal behavior. The frequent appearance of such cases contributes to the impression that sleazy and unethical activities are more the rule than exception in health care, and that even the largest and formerly most reputable organizations are willing to go right up the line, and sometimes over it, in pursuit of more sales and more profits.
One feature of this case should be of particular concern to physicians and health care professionals. Drug, device, and biotechnology companies often loftily proclaim that all the money they spend to pay physicians as advisors, consultants, speakers, etc and to support myriad medical educational activities, goes to support of science and education. This case provides more evidence that consulting fees and speakers' honoraria may be meant as inducements to use and help market companies' products. Hence, at best, they are meant to support marketing, and at worst, they approach bribery.
Recall the recent case we discussed of a surgeon who admitted taking kickbacks from medical devices companies labelled as research grants and consulting fees.
Any physician of health care academic who accepts fees from commercial health care companies ought to consider whether the money is really supporting science or education, or is meant to pay for marketing or kickbacks for recommending the companies' products. In most cases, it may be hard to justify that the only purpose of the money is advancing science or education. Do physicians and other health care professionals really want to be regarded as part-time product marketers, or worse? Is the extra money really worth the shadow it throws on one's professionalism?
Sunday, January 27, 2008
BLOGSCAN - CME Talks by "Hired Gun, MD"
On the Carlat Psychiatry Blog, Dr Daniel Carlat recounted the career of a "hired gun, MD" who earned an estimated $3 million total from honoraria giving pharma sponsored talks. Is this any way to provide continuing medical education? Would you trust a talk given by such a hired gun? Would you recognize a CME talk given by such a hired gun?
Wednesday, January 23, 2008
BLOGSCAN - Conflicts of Interest, CME, and MECCs
On the Carlat Psychiatry Blog, Dr Daniel Carlat reported an alternative take on the Macy Foundation report which called for the abolition of commercial funding of continuing medical education (CME). (See Dr Carlat's earlier post on this report here.)
In a seminar on medical ethics, Harvard University's Neurologist-in-Chief, Dr Martin Samuels, trashed the Macy report on the basis of, you guessed it, conflict of interest. He charged that one of the members of the conference that produced the Macy report was a top executive of UpToDate, a medical education and communication company (MECC) that makes its money by selling subscriptions, not from drug companies. Meanwhile, Dr Carlat also reported that Dr Samuels was praising yet another MECC, Pri-Med, for which he happens to direct a neurology course.
You can't tell the conflicts of interest without a scorecard. This story does seem to underline, in my humble opinion, the need to disclose all conflicts of interest, and the need to develop a structure for medical education (undergraduate, graduate, and continuing) that somehow avoids conflicts due to relationships with any organization, drug company, managed care organization, MECC, for-profit, not-for-profit, whatever that have vested interests other than discovering and disseminating the truth in a spirit of free enquiry (that is, the fundamental educational mission.)
We physicians also ought to remember the oaths we once swore, and stop trying to figure out clever deals to make more money on the side.
In a seminar on medical ethics, Harvard University's Neurologist-in-Chief, Dr Martin Samuels, trashed the Macy report on the basis of, you guessed it, conflict of interest. He charged that one of the members of the conference that produced the Macy report was a top executive of UpToDate, a medical education and communication company (MECC) that makes its money by selling subscriptions, not from drug companies. Meanwhile, Dr Carlat also reported that Dr Samuels was praising yet another MECC, Pri-Med, for which he happens to direct a neurology course.
You can't tell the conflicts of interest without a scorecard. This story does seem to underline, in my humble opinion, the need to disclose all conflicts of interest, and the need to develop a structure for medical education (undergraduate, graduate, and continuing) that somehow avoids conflicts due to relationships with any organization, drug company, managed care organization, MECC, for-profit, not-for-profit, whatever that have vested interests other than discovering and disseminating the truth in a spirit of free enquiry (that is, the fundamental educational mission.)
We physicians also ought to remember the oaths we once swore, and stop trying to figure out clever deals to make more money on the side.
Monday, January 14, 2008
BLOGSCAN - Macy Foundation Reports Suggests Ending Commercial Sponsorship of CME
Sunday, December 09, 2007
BLOGSCAN - "AIDS Pundits and Ties to Big Pharma"
On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody wrote about his discovery of a web-site entitled, "AIDS Pundits and Ties to Big Pharma," or by its more economic URL, www.shillfactor.net. The site catalogs, with a degree of sarcasm, the multitudinous financial ties to pharmaceutical manufacturers and biotechnology companies of some of the big wigs in the AIDS/ HIV research and academic world. Some of the individuals have truly amazing numbers of consulting jobs, leading the site writers to speculate how they ever have time to see patients or fulfill their academic responsibilities. The site contains pages for people who "control research," "vote on new drugs," "set treatment specs," "educate the field," "write and report," and ironically, "once were activists." The site is sponsored by Project THAMES, which stands for "transparency in HIV authorship, medical education and scientific investigation." Amazing.
Subscribe to:
Posts (Atom)