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Health-Commerce Collision

Congress and the White House need to take steps to improve the credibility of medical research and reduce biased science.

April 28, 2003

Drug companies don't spend $30.3 billion each year on biomedical research just to improve the human condition. Profit is a powerful incentive and has led to breakthroughs including cancer therapies with fewer side effects and a class of drugs, statins, that lower cholesterol and often prevent heart attacks altogether.

The needs of public health and commerce collide, however, when a new drug is not provably better than a previous one -- or even worse, is no better than nonpharmaceutical therapies such as exercise and diet.

A spectacular example of this conflict is on display in this week's Journal of the American Medical Assn. It's an account of how Pharmacia Corp. pulled the plug on a study led by Dr. Henry R. Black, dean of research at Chicago's Rush-Presbyterian-St. Luke's Medical Center, after his study suggested that Pharmacia's pricey brand-name Covera was no better than two cheaper hypertension drugs at preventing heart- related complications of high blood pressure.

In an editorial in the same issue, JAMA's editors say they took the unusual step of publishing Black's incomplete study to highlight a practice they consider highly unethical. However, medical journals should not be the only protection consumers have against biased medical science.

Congress and the Bush administration should do at least two things to improve the credibility of medical research:

* Create a mandatory public "registry of research" that lets scientists keep tabs on all studies, whether they are in progress, aborted or completed, and lists who funds them. Yale medicine professor Cary Gross, who proposed the registry, points out that medical studies with "negative results" -- meaning they fail to prove that a brand-name drug is better than a competitor drug -- often are never published or disclosed.

* Establish a national institute of clinical research to test new drugs against older ones and grant its seal of approval only to those that prove superior.

Though the Food and Drug Administration lets new drugs on the market only after they are tested in clinical trials, it relies on the drug companies to fund the studies. As a result, it should be no surprise that, as Gross put it in an article that JAMA published in January, drug studies are often designed to "favor the sponsor's drug, sometimes by giving weak or inappropriate doses of a competitor's drug."

Politicians and public health officials also should consider a deeper problem raised in this week's JAMA: the medical establishment's tendency to slight nondrug-related solutions to pervasive public health problems. The magazine also reports that patients with not-yet-severe high blood pressure who stick to lifestyle changes such as eating better and spending more time at the gym reduce their cardiovascular disease risk at least as much as those who take hypertension drugs of any type.

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