Identifying and Addressing Potential Conflict of Interest: A Professional Medical Organization’s Code of Ethics

I have read both Dr. Brody's well-articulated article and Dr. Helms' unconvincing rebuttal and apologia for the organizational ethics of AAFP with respect to the Coca-Cola connection.

Since the first edition of FamilyDoctor for the waiting room, I formally registered my objection to its advertising content. The response was unsatisfactory at the time, somewhat patronizing, and I now regret that I didn't terminate my membership then. I also registered my objections about Coca-Cola, and had a similar experience. I went ahead and paid my dues for the year in order to support my local chapter (Oregon), which I find to be on the leading edge in terms of corporate relationships. Despite the challenges it presents, for example, OAFP accepts no pharmaceutical company support for its conferences.

I'm proud to be in OAFP but I'm no longer proud of my AAFP membership, which I will not renew for 2011. I've been a member for over 25 years. I still appreciate the AAFP publications, policy updates, CME tracking, and more, but I'm too uncomfortable with the organizational ethics to defend my membership anymore, even to myself.

The so-called "Consumer Alliance," as has been pointed out, is actually a "Corporate Alliance." Thousands of corporations manufacturing products risky to population health are masquerading as good actors these days, and I believe we disregard that fact at our patients' peril.

Competing interests:   None declared

Partnerships between industry and medical organizations are 'liaisons dangereuses'. Full transparency is needed and the integrity, credibility and independence of the medical organization has absolutely to be safeguarded and visualized. To guarantee these needs a partnership with only one industrial enterprise (so called monosponsoring) - additionally to many other means - is to avoid following the guidelines of the Swiss academy of medical sciences, the Swiss medical society and the Swiss society of family doctors. Bruno Kissling

Competing interests:   None declared

A main theme in Dr. Brody’s excellent argument is that the Management Strategy is insufficient as a way of addressing the many ethical concerns that accompany the commercial funding of medical research and education.(1) Dr. Heim’s response to this criticism is that the AAFP is rigorously pursuing the Management Strategy.(2) I have no doubt that the AAFP's strategy is well-intentioned, but this response rather seems to miss the point of Dr. Brody’s criticism, which is that the Management Strategy does not work.

Why should we avoid conflicts of interest altogether, as opposed to merely managing them? One reason is that they lead to biased results. On this point, at least in medical research, the evidence is overwhelming: funding from the pharmaceutical industry distorts the results of clinical trials. (3, 4) Sponsored trials show a systematic bias in favour of the drug manufactured by the sponsoring company. This is a potentially serious ethical problem: it can lead to patients being prescribed drugs that are both less effective and more dangerous than available alternatives.

So we know that conflicts of interest produce biased results in clinical trials, and it seems likely that it produces biased educational material as well. Nevertheless, Dr. Heim and the AAFP think that conflicts of interest present no serious ethical problem. Perhaps this is because they believe that conflicts produce bias by leading individuals and institutions to succumb to temptation and knowingly abandon their ethical duties to patients in order to follow the money. If that were the case, the AAFP’s rigorous safeguards and public disclosure policies might well be effective. But such policies have been proven to be ineffective at combating bias.(5) In fact, there is even evidence that disclosure of conflict actually increases bias.(6)

The truth of the matter is that conflicts of interest do not result in bias by leading to fraud and a blatant disregard for patient safety. Rather, they create bias in much more subtle and hidden ways: they makes researchers more likely to design their studies and interpret the data in ways that ways that will favour the sponsor, more likely to present the data in ways that emphasize favourable and de-emphasize unfavourable points, more likely to fall victim to the confirmation bias, more prone to self-deception about whether their judgment is being clouded by commercial interests, and so on. Dr. Lesser’s comments above suggest one way in which this has already happened with the AAFP’s recommendations on sugary beverages.

Individuals caught in a conflict of interest can produce biased results while being unaware of that bias: no doubt most of them sincerely believe that their actions aim exclusively at scientific accuracy and patient safety. There is evidence that a gift as small as a pen from pharmaceutical sales reps can have significant impact on physician prescribing behaviour: when this is the case, it is reasonable to suppose that the physician is completely unaware of the bias the gift has introduced. (7)

If free pens can bias our judgment in hidden and subtle ways, then it is reasonable to suppose that large cheques from Coca-Cola can accomplish the same thing. We should not blame physicians and researchers who are placed in situations that make them fall victim to bias in ways of which they are unaware: this is one reason that Brody is right to say that conflicts of interest do not mean that unethical conduct has occurred. But we should blame institutions like the AAFP who decide to place themselves into such conflicts, knowing full well that it will undermine trust and is likely to lead to biased and unreliable educational material.

1. Brody, Howard. 2010. Professional Medical Organizations and Commercial Conflicts of Interest: Ethical Issues. Ann Fam Med 8, no. 4 (July 1): 354-358.

2. Heim, Lori. 2010. Identifying and Addressing Potential Conflict of Interest: A Professional Medical Organization's Code of Ethics. Ann Fam Med 8, no. 4 (July 1): 359-361.

3. Lexchin, Joel, Lisa A Bero, Benjamin Djulbegovic, and Otavio Clark. 2003. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ (Clinical research ed.) 326, no. 7400 (May): 1167-1170.

4. Sismondo, Sergio. 2008. Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemporary clinical trials 29, no. 2 (March): 109-113.

5. Doucet, Mathieu, and Sergio Sismondo. 2008. Evaluating solutions to sponsorship bias. Journal of Medical Ethics: Journal of the Institute of Medical Ethics. Vol 34, no. 8 (August): 627-630.

6. Cain, Daylian M., George Loewenstein, and Don A. Moore. 2005. The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest. The Journal of Legal Studies 34, no. 1 (January 1): 1-25.

7. Wazana, Ashley. 2000. Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift? JAMA 283, no. 3 (January 19): 373-380.

Competing interests:   None declared

As Dr.Heim states, the AAFP's FamilyDoctor.org website provides evidence on the link between sugary beverages and health outcomes. It is important to note the language on the website and compare it with another website.

The language on the AAFP's website states: "To avoid excess added sugar, you should know what foods and drinks are highest in added sugar. Sugary drinks, including soft drinks, sports drinks and fruit drinks, are the number 1 source of added sugar in the American diet."

This is a knowledge related tone. And comes from the assumption that if you give consumers the knowledge, they will connect it to the correct actions.

The Nutrition Department at the Harvard School of Public Health offered to have the AAFP to link to their site on beverages and health, in exchange for giving back the money to Coca Cola.

Harvard's site (http://www.hsph.harvard.edu/nutritionsource/healthy- drinks/) states the following (in bold letters at the top of the page): "1. Quit the sugar habit." On their other pages they state: "The Bottom Line: Skip Sugary Drinks and Go Easy on Diet Drinks". Their beverage guidelines, regarding sugary drinks, state "Ideally, zero drinks sweetened with sugar or high-fructose corn syrup, but up to a maximum of 8 ounces."

Notice the direct language of these recommendations, compared to the knowledge based arguments on the AAFP's site. I hope that this language was not made to satisfy Coca Cola, as Dr.Heim states. But, as Dr.Brody's asserts in his example of the judge with a conflict of interest, the public can never be assured. This is why conflicts of interest that appear to be wrong, are wrong.

This example shows how the arguments with this conflict of interest are based in language, communication, and ethics. They are complex arguments. The way to simplify them is by using powerful words. The AAFP has clearly succeeded in its name for the program: The Consumer Alliance Program. Their continued repetition of this term makes be believe that they are most interest in the PR aspects of this ethical question. If not, they would rename it the Corporate Alliance Program. This is what it actually is.

By law, a corporation's board must act in its stockholder's interests. Sponsoring a website that states "Quit the sugar habit," in large bold letters at the top of their main page (i.e. the Harvard website), would not be in Coca Cola's interest. Thus it appears Coca Cola is achieving its goals in sponsoring the AAFP. Despite the evidence, the AAFP's page does not state: "Avoid all sugary beverages, including soda." Hopefully the AAFP can recover and fight for its members' and patients' interest by ending this conflict of interest.

Competing interests:   Lenard Lesser is a member of the AAFP and writes a blog focused on prevention, food, and conflicts of interest.