News - The Business of Medical Research

The Business of Medical Research
Funding by drug companies can pose problems for schools

By Jeffrey P. Kahn, Ph.D., M.P.H.
Director, Center for Bioethics
University of Minnesota

Monday, October 28, 2002

(CNN) -- The current issue of the New England Journal of Medicine contains a study of whether and how medical schools enforce guidelines to help reduce inappropriate influence by drug companies on medical research they fund.

What the authors found is disturbing for anyone who thinks medical research is immune from the kinds of biases seen recently in the business world.

Of more than 100 medical schools surveyed, less than 5 percent had rules that guaranteed researchers access to all research results, that established independent committees to oversee studies or that required that research results be allowed to be published.

Allowing companies so much say in how research is performed or reported isn't good for research subjects, patients or society. So how did we get to this point, and what can we do about it?

Restrictions on researchers

The problem is when drug companies fund research, they may limit what the researchers can do.

These restrictions introduce a conflict for researchers between making decisions based on science and agreeing to decision-making limits to get their research funded by the drug company.

These conditions can include veto by the company on the sharing or publication of study results, which is more likely to happen when the results aren't positive.

The problem is that negative findings could be useful in advancing medical research and treating patients, especially if the research shows that a particular product is harmful.

Preventing conflicts of interests

Numerous organizations and the federal government have issued guidelines regarding financial conflicts of interest for researchers -- what financial interests in the research are acceptable for investigators before it may bias their judgment.

The current issue is a twist on the same theme: Do researchers owe their commitment to the research whatever the results? Or do they owe their allegiance to the company that funds the research?

The International Committee of Medical Journal Editors helped answer that question by announcing that many leading medical journals would only publish articles submitted by researchers who could attest that they had control over the research data and what should be done with it. But as the current study shows, precious few medical schools actually require such conditions.

Who's minding the research shop?

Given these concerns, who is assuring that the results of research are not biased in the way it is collected or how it is reported?

Both researchers and universities depend on research funding, so it is difficult for them to govern themselves always, especially in a competitive research market. So rules must come from elsewhere.

The federal Office of Human Research Protections is a likely source, and the office has considered issuing guidelines on research conflicts of interests. But since the director just announced his resignation after less than two years on the job, it is unclear whether the office has the clout to do so.

Whether watched over by the government or not, universities need to protect their researchers by insisting that contracts with drug companies include provisions for appropriate access to research data, limits on restrictions that companies can impose on the use of the data and clear policies for who owns the data generated by the research.

Since so much medical research is performed in university settings, an agreement by the university community to live by such rules can create a standard that drug companies will respect.

We must do everything we can to avoid what is beginning to sound like the Enron-ization of medical research and to live by a commitment to making sure that what is produced is the best information research can provide rather than the best information money can buy.