Research and conflict of interest:
how “truthful” is corporate funded research

Dr. Olivieri and the HSC
August 1998 saw conflict of interest and truth in medical research intensely discussed, both in the popular media and in the medical literature. Although concerns brought forward were not new, the events that precipitated them allowed a renewed and deeper discussion among both researchers and the general public. Extensive coverage by Canada’s national media(1,2,3) explored the relationship between researcher Dr. Nancy Olivieri, Apotex Pharmaceuticals and the Hospital for Sick Children. What has emerged is a disturbing picture of a seemingly prestigious public institution which had gained community and global trust over the years, failing to defend honesty in research and the health and safety of its highly vulnerable clientele. By failing to support its researcher, Dr. Olivieri, committed to telling the truth in the interest of her patients’ health, the Hospital for Sick Children put the interests of patients at the mercy of the financial interests of the private, for-profit research sector, the pharmaceutical companies.
The Hospital For Sick Children is also the base for considerable research in the testing of infant feeding products and infant nutrition. Much of the funding for these activities come from the infant foods industry -- Mead Johnson, Ross Abbott, Heinz. Although it is recognized that such research is primarily aimed at improving the marketing of infant feeding products such as infant formulas and rationales for the fortification and early introduction of complementary foods, one cannot help but make analogies to the Olivieri case. The question remains, if this can happen to Dr. Olivieri, it can happen to researchers in infant nutrition as well. Do similar contracts exist between researcher and funder which allow no publication of negative data and no data to be published without the consent of the donor. How much information showing damage to artificially fed infants never makes it to the pages of medical journals? How censored is the information submitted to Health Canada for product approval protocols?

In the words of Canada’s Nobel prize winner, Dr. John Polanyi, “The purpose of research…is to uncover the truth. If this is to stand a chance of succeeding, it must be pursued openly…and be seen to be free from commercial and political influence. Universities and research hospitals were instituted to fulfill that function.”(4)

BMJ discusses conflict of interest
Also in August the British Medical Journal(5), both in an editorial and in a series of articles covered different aspects of conflict of interest in medical research. Citing research which looked at 70 articles on the safety of calcium channel antagonists, 23 studies were critical, 30 supportive and 17 neutral. Only two of the articles had disclosed the authors’ financial relationships to the manufacturers. Inquiries about financial relationships revealed that almost all supportive authors -- 96% -- had financial relationships with the manufacturers, compared to 60% of the neutral results and 37% of the critical results. Another interesting example was the funding sources reviewing the effects of passive smoking. Of 106 reviews, 37% concluded no harm, and the remainder that it was harmful. After doing regressional analysis controlling for a number of factors, the only factor associated with the review’s conclusion was whether the author was affiliated with the tobacco industry.

Infant feeding in conflict of interest
Infant feeding and conflict of interest is also discussed in the BMJ. Dr. Allan Lucas(6) a well-known researcher in infant nutrition, defends the importance of such research and these products. Since infant formulas are needed, he argues, in case of lactation failure, maternal death, or if a mother is HIV positive, the onus is on the infant formula industry to carry out high quality outcome studies. Nowhere does Lucas state how the independence of both the researcher and the truthfulness of the results can be assured as this may be an impossible end to achieve.

In contrast to the Lucas position, Pattie Rundall(7) of the UK based IBFAN group, Baby Milk Action, points out the importance of sponsorship to the industry’s need to market its product. These sponsorships affect not only our health, our environment but also whether people live or die. Further, she states that some scientists may argue that research is needed to improve the quality of the products, in the case of infant feeding products, the nutritional advantages of one “advantage” over another and the development of “niche” products have far less impact on global health compared with the “enormous benefits derived by infants if they have access to their mother’s milk”. Another ethical dilemma, she points out is that much of the moneys available to buy research comes from the profits of unethical marketing especially to the world’s poorest populations.

Companies, she says, have a particular need to offer sponsorship. Without it they would have a much harder time in silencing critics and create the image that they are responsible “corporate citizens” who can be trusted to regulate themselves.

Ms. Rundall raises a number of important questions: “How is it that scientists, who pride themselves on their academic rigour in the laboratory, so often seem to be so unaware of these issues? Why do so many fail to monitor the activities of their sponsors? Why are the bland corporate assurances that these products adhere to UN resolutions, believed by so many?”

References:
1. The Globe and Mail, A Doctor Takes on a Drug Company, August 13, 1998 BACK

2. The Globe and Mail, Sick Kids Plans External Review of Clinical Trials. August 21, 1998 BACK

3. The Globe and Mail, Researchers at Sick Kids Threaten to Leave. August 28, 1998 BACK

4. The Globe and Mail, letter to the editor, To tell the Truth. September 7, 1998 BACK

5. Smith, R. Beyond conflict of interest: Transparency is the key. 317:291-292, 1998 BACK

6. Lucas, A. Collaborative research with infant formula companies should not be censured. BMJ 317: 337-338, 1998 BACK

7. Rundall, P. How much research in infant feeding comes from unethical marketing? BMJ 317: 338-339, 1998 BACK