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 -

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."
In addition, a recent news articles in which Dr Weaver was interviewed also disclosed relationships with industry. This MedPage Today 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 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.


Anonymous said...

Does he have a firewall in the middle of his brain?

Anonymous said...

Are you asking poor doctors to forego entitlements? One of the perks of their years of sacrifice is 'entree' to the party. That these poor individuals should have to 'pay their own way' is ridiculous.

(Sorry for the snark. Stereotyping requires painting with a broad brush. I KNOW there are responsible doctors who adhere to the Hippocratic Oath. But there ARE those who feel justified in feeding at the trough--be it public or industry.)

Anonymous said...

This conflict is exemplified in the exuberance for angioplasty and stenting as promoted in the ACC i2 Summit, "supported" by baloon and stent makers. Experts have said that more than one third of these procedures are not appropriate at the time they are done and joke about the ocular-cephalic-inflationary reflex in the cath lab. At no point have these procedures been proven to prevent heart attacks or death in patients who "electively" have it done. Hello!!

Anonymous said...

We have recently seen the capitulation of the drug firms regarding the retail, or general population drugs. This is highlighted by the recent cut in R&D jobs, laying off of drug reps in France, and the "redirection" of one drug companies corporate strategy, as found in the WSJ and on the WSJ Health Blog.

We then find this from the WSJ Health Blog: October 1, 2008, 9:35 am Medtronic, Boston Scientific Ordered to Pay J&J $1.2 Billion Posted by Jacob Goldstein regarding patent infringement. Medtronic makes the Oct. 2 WSJ with an article by David Armstrong highlighting questions concerning the $40M settlement and conflicts arising from the marriage of a Justice Dept. lawyer and a lawyer for Medtronic's defense firm.

The Oct. 3d WSJ article by Paul Glader Curing What Ails GE's Health Unit highlights it's new chief John Dineen and how he was chosen to head up GE's Health Unit due to his success at increasing profits at GE's locomotive unit. One of his first challenges is the 20% reduction in Medicare reimbursemnt for office scans. This made doctors and hospitals less likely to purchase the $1M machines.

One of the basic tenants of any sales organization is control. You control the message, messenger, and the possible responses. As pharma and the device manufactures have come under increasing scrutiny in their relationship with PCP's they have, and will, move their focus to areas where they may have more control. This would include the subspecialist.

With a smaller group they can use their tested methods of skewing the data, consulting fees, honorarium, unrestricted grants, and when all else fails, thinly disguised kick backs. Look for more of the medical societies to have increasing ties to industry and justify this as a means of reducing cost and improving "education."

In dealing with a smaller population it becomes easier to gain acceptability and also hide their activities. You are not going to turn me in if you are doing the same thing and what is the problem: We all are making money.

Now the public does not have to only worry about their doctor having a conflict, but doctors have to worry about the conflicts of the specialist the refer their patients too.

Steve Lucas