Drug Studies' Gaps a Problem

Federal regulators at the Food and Drug Administration dictate which drugs can be sold in the U.S., but studies published in leading medical journals help decide which will be the most widely prescribed. Like reviews of Broadway plays, those studies are often excerpted or reprinted. They become part of drug companies' sales pitches aimed at doctors and, more recently, at patients.
A growing body of evidence has shown that studies paid for by drug companies are more likely to produce positive results for that company's products. But it is relatively rare that companies are accused of outright manipulation of data.
[Earlier this month], however, the New England Journal of Medicine accused researchers sponsored by drug-maker Merck of withholding information about the deaths of three patients in order to soft-pedal the risk of fatal heart attacks for patients taking Vioxx, the company's widely prescribed arthritis medicine.
It's a serious charge, because on the strength of such articles and ads aimed at patients, Vioxx became a blockbuster drug. It was pulled from the market late last year after long-term studies showed it did indeed increase the risk of heart attack and stroke. Merck is now facing thousands of civil suits. The first to be tried in federal court ended in a mistrial [last] week.
The company insists that it did nothing wrong. It said the deaths were reported to the Food and Drug Administration, which subsequently allowed Vioxx to be marketed.
The New England Journal claims researchers knew about the deaths more than four months before the article was published. The information originally was included in working drafts but was deleted two days before the article was sent to the New England Journal. Had the deaths been included in the original article, it would have shown a fatal heart attack rate five times greater among patients taking Vioxx than those taking a comparison drug.
By publishing lower rates, the authors were able to argue that the association between Vioxx use and heart problems was less clear.
The public health issue raised by these revelations goes well beyond Merck and Vioxx. Most pharmaceutical research is paid for by drug companies. Those companies have an enormous financial stake in the outcome, both in profits and potential liability. That's especially true now that drug companies can advertise directly to patients.
Medical journals must be able to rely on researchers to ensure that the data they report is complete and accurate. Doctors must be able to rely on medical journals to ensure they get the whole story about a drug's advantages and side effects. Last week's accusations provide more new evidence - if any more were needed - of the necessity for conservatism and healthy skepticism by doctors and patients eager for the next big thing.
Doctors must be able to rely on medical journals to ensure they get the whole story about a drug's advantages and side effects.