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.

[Source : Health Care Renewal]

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 wouldn’t be possible in its current form if it weren’t for industry allows 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’ve 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 wouldn’t prevent. Sponsors are apt 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-accentuate the importance of that disease; and to accentuate, or over-accentuate 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 don’t 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 wasn’t clear why so much external support was really necessary. The argument wasn’t 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 contintue 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 wouldn’t be surprised if an impartial assessment might show that they might 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 might 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 recommend that patients continue to take a drug which might 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 massive 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’d 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 allows 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.”

In addition, a current news articles in which Dr Weaver was interviewed also disclosed relationships with industry. This MedPage This day 2008 article disclosed “Dr Waver declared grant support from Proctor and Gamble and Schering-Plough and equity or stock interest in Acorn Cardiovascular.”

So Dr Weaver seems to be another in a series of defenders of financial ties between doctors 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 find their activities through their members’ dues and contributions, and without lavish contributions from industry, supposed “firewalls” notwithstanding.

[Source : Health Care Renewal]

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 current 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 doctors. J Am Coll Cardiol 2008; 52: 1035-1036. Link here.]

Dr DeMaria confessed to “very blended 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.

Even though he acknowledged that commercial support “sometimes appeared to primarily serve the interests of the supporters,” he felt that full disclosure would allow doctors to be properly skeptical of that support.

I’ve 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, doctors 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 doctor, 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’m 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’ve 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 doctors are intelligent, savvy, and independent enough to know bias when they see it, and to resist suggestions that are not based on firm data. Doctors 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 concur that maybe few physicians consciously modify 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 sufficient 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 said he has gotten modest (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 isn’t clear they could recognize the effect of financial relationships which are not disclosed to them at all. Dr DeMaria didn’t give his doctor 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 view, as I have said before, those who recommend particular health policy positions have the same obligation to disclose relevant conflicts of interest as do those who recommend 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 this day much of the health policy debate amounts to stealth health policy advocacy.

Furthermore, in my humble thought, 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.

[Source : Health Care Renewal]

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.

[Source : Health Care Renewal]

On the Carlat Psychiatry Blog, Dr Daniel Carlat examined 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 might 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 don’t 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.

[Source : Health Care Renewal]