Bias has no home in medical research.
But as relationships between multi-billion dollar pharmaceutical companies and academic medical centers become dangerously intertwined, bias is now unavoidable, says Marcia Angell, M.D., former editor of The New England Journal of Medicine and Harvard Medical School lecturer. Angell doesn’t mince words when she speaks out against the increasing influence drug companies have in research performed at academic medical schools.
“There is simply no substitute for an unbiased investigator,” says Angell. “It’s often claimed that attempts to regulate conflicts of interest will slow medical advances, but the truth is that conflicts of interest distort medical research. Advances occur in spite of them – not because of them.”
Stifling Drug Development: Bayh-Dole Act of 1980
Before the 1980 enactment of the Bayh-Dole Act, discoveries made using federal funding were owned ipso facto by the federal government. Bayh-Dole changed the rules so that discoveries made with the help of federal funding could be owned by a university, small business, or non-profit institution, who in turn could sell their intellectual property and receive royalties. That meant that pharmaceutical companies could patent formulas, finish clinical trials and profit from discoveries made with public funding.
Although Bayh-Dole was billed as a way to move drug discoveries more quickly to the market, Angell asserts that it has had the opposite effect and is stifling independent drug development. “There is now very little innovative research in the modern pharmaceutical industry, despite its pretenses to the contrary,” says Angell. “Drug companies no longer have to do their own creative early-stage research. They can rely on universities and start-up companies for that and concentrate on late-stage development of drugs they’ve licensed in from other sources.”.
Selective Research Clouding Results
Angell believes that large pharmaceutical corporations are now setting the agenda in some academic centers. Researchers are focusing too much on targeted applied research and not enough effort is applied to determining causes, mechanisms and prevention of disease.
Instead of focusing on groundbreaking research, academic centers are instead enticed to perform commercial research that will increase revenues. For example, Angell cites that drug companies frequently contract with academic researchers to perform studies on “me-too drugs” that are designed to replace virtually identical drugs that are going off patent.
“Academic researchers are often little more than hired hands, supplying the human subjects and collecting data according to instructions by the company,” says Angell. “Often the sponsors keep the data and decide whether, when and where to submit the papers for publication.”
The evidence that drug company influence taints the results of research performed in academic centers is plentiful, says Angell. Industry sponsored trials are far more likely to be favorable to a sponsor’s products than NIH-funded research. Angell cites a recent survey of anti-depressant drug studies contracted by pharma that found that 37 of 38 studies with a positive result were published. However, 33 of 36 negative studies were either not published or were published in a form that conveyed a positive outcome..
Another example is the way that studies are designed. Instead of performing tests against an equal dose of a competitor’s drug, some studies will examine how a drug relates to a smaller dose of an existing drug. Some drug companies use other questionable tactics, such as testing a “me-too drug” against a placebo instead of a full-dose of an existing drug, resulting in duplicate drugs in the market. In fact, many drugs may perform little better than placebos, but there’s no way to know because the FDA will not release negative results without the company’s permission, she says.
Further complicating research and development, the pharmaceutical industry devotes large portions of its marketing budget to what it calls “education for doctors.” The reason for this designation is obvious, Angell says: “Doctors write the prescriptions, so they need to be won over.”
Academic Medical Centers Looking for a Way Out
Angell believes that a few institutional conflict-of-interest rules could preclude some of the most egregious offenses. But the rules now are highly variable, rather permissive and loosely enforced. Many universities have their own assorted deals with industry and are not in a moral position to object to their faculty acting in the same way, she says. A recent survey found two-thirds of academic medical centers hold equity interest in companies that sponsor research within the same institution. Another survey of medical school department chairs found two-thirds receive departmental income from drug companies and three-fifths receive personal income.
“Drug companies are not charities. They expect something in return for the money they spend on the medical profession and they evidently get it or they wouldn’t keep paying,” Angell said.
In order to establish a more professional ethics protocol, multiple reforms need to be made and several regulations need to come through congressional action and through the Food and Drug Administration, she says. However, the medical profession should also impose self-regulatory comprehensive reforms. Hospitals and doctors should only accept money from drug companies for studies and only if the medical centers are allowed to maintain complete control over the study design, results and publications. Also, all medical discoveries made by academic medical centers should be put into public domain or be made available for inexpensive licensure, Angell says.
“We’re so drenched in market ideology that any resistance is considered quixotic and odd. But academic medical centers are not supposed to be businesses. They now enjoy great public support and they jeopardize that support by continuing along the current path,” says Angell. “Conflicts of interest in medicine have serious consequences and we need to stop making excuses.”
How do you think academic medical centers and pharmaceutical companies should collaborate to drive medical innovation? Tell us what you think.
Angell spoke at a recent University of Utah School of Medicine lecture series. Watch the full lecture below.
Seth Bracken is a program manager for University of Utah Health Sciences.