TUESDAY, Jan. 21, 2003 (HealthDayNews) -- Big industry seems to be married to academia when it comes to biomedical research, according to a new study that says the relationship may need therapy if not legal intervention.
One quarter of biomedical investigators at academic institutions are affiliated with industry and about two-thirds of academic institutions have ownership stakes in enterprises that sponsor research undertaken at their institutions, says an article appearing in the Jan. 22/29 issue of the Journal of the American Medical Association.
The finding raises questions on whether such relationships are influencing what should be impartial scientific research.
"There are two main concerns here. One is innovation. Patients stand to benefit from innovation and progress in the medical area. We don't want to choke off innovation, because it is the only way we're going to bring science to patients," says Dr. Kevin Schulman, a professor of medicine at Duke University School of Medicine in Durham, N. C. "On the flip side, it's a question of the maturity of the relationships."
According to the study authors, industry's total investment in biomedical research and development almost doubled from about 32 percent in 1980 to 62 percent in 2000. At the same time, the federal government's participation fell. The passing of the Bayh-Dole Act of 1980 was largely responsible for encouraging ties between the industry and biomedical research sectors.
To assess the extent and nature of this apparent marriage over the past two decades, the study authors reviewed existing studies dealing with financial conflicts of interest in biomedical research and found some troubling trends.
Studies that were sponsored by industry, for instance, were more likely to come out with pro-industry conclusions. The imbalance could be
attributed to researchers choosing placebos as a comparison instead of
another therapy: It's easier for a treatment to look good compared to a
sugar pill or its equivalent.
Industry support also seemed to influence choice of research topics: If the subject was likely to become a commercial blockbuster, researchers were more likely to roll up their sleeves and delve into it.
Also, when financial interests were at stake, investigators appeared
more likely to delay publication of their results or to not share the
results with their colleagues. This could be interpreted as an effort to
keep the results proprietary until they could reach the market, the study says.
Experts are quick to point out that industry support of research is not itself a bad thing -- just that the relationship needs to be managed better and more consistently.
This is especially true when the research involves human subjects, which it frequently does.
The individuals in a study need to know they are
consenting to participate in a research project to further scientific
knowledge as opposed to helping a company bring a product to market.
Failure to make that distinction clear is unethical, says Schulman.
"When we're communicating health information, we don't require the level of independence that we do on financial statements, which are nowhere near as critical."
A process involving impartial "auditors" may be an option for biomedical research, Schulman says. "There's nothing wrong with innovation when it's handled responsibly and maturely and when there's [a] clear separation of interests," he says. "The problem right now is it's not clear that all the institutions have policies regarding [separation of interests] or that policies are consistent and disclosed to individual patients."
The lead author of the study, Dr. Cary P. Gross, an assistant professor
of medicine at Yale University School of Medicine, discloses in the JAMA article that he teamed with pharmaceutical giant AstraZeneca in what he called a "productive collaboration" on a survey of physicians.
"AstraZeneca guaranteed that I had access to the study data and controlled the decision to publish, and we formulated the research plan together," he says. "This was an excellent example of how we can collaborate with industry and ensure investigator independence."
The point is not to prohibit big business bucks from entering the
biomedical arena -- just to regulate them a little more, the experts say.
"Industry-sponsored research has led to numerous advances that would
have otherwise been impossible," Gross says. "We are not advocating a ban on industry-sponsored research. We think it is necessary, important and productive. However, we need to be mindful of the unintended consequences of having a substantial proportion of medical research being funded by industry."
More information
For more information on the Bayh-Dole Act, visit the Council on Governmental Relations.
Clinical trials information can be found at National Institutes of Health or Centerwatch.
