Caveat Emptor Is No Way to Monitor Drugs

Three times in the past nine months, the Food and Drug Administration ordered a recently approved new drug off the market because of lethal side effects. Last week, it removed the painkiller Duract, made by Wyeth-Ayerst, because of four deaths and eight liver transplants among its users.

Earlier in June, Posicor, a blood-pressure drug, was withdrawn because it could prove lethal in combination with other widely prescribed medications. And less than a year ago, the FDA removed the widely prescribed diet drug, Redux, often used in a combination known as “fen-phen.” Both drugs could produce heart valve problems.

In the past, it has been highly unusual for the FDA to remove a drug once the drug had won agency certification as safe and effective. In fact, this has happened only three other times in the past decade.

But the FDA’s approval of drugs that later turned out to have lethal side effects is the predictable result of an industry campaign, abetted by congressional Republicans, to speed up the approval process. This is part of a larger pattern in which the health and safety of the public are being sacrificed to the profit motive.

Drug companies, among the most profitable of all U.S. industries, have long criticized the FDA drug approval process. In recent years, that process has been expedited through a user-fee system, which has allowed the agency to hire additional personnel.

The industry and congressional Republicans promoted a further acceleration of the drug approval process, in “fast track” legislation signed last December that is just now taking effect. These needless deaths and injuries are the result of this drug approval stampede.

In the case of the two most recent recalls, Duract and Posicor, there was no good reason for this haste in approval (other than drug company profits) because neither was a breakthrough drug. Duract is a slight variation on some two dozen nonsteroidal anti-inflammatory agents already on the market. Likewise, Posicor is a close cousin to several drugs known as calcium-channel blockers, used to treat high-blood pressure.

Drug companies often vary a few molecules in a competitor’s drug, so they can patent it as something new. Sometimes, these variations yield benefits, but they do not justify sacrificing the FDA’s usual standards of safety.

Moreover, when the FDA approved both these drugs, it already had evidence of problems. The agency knew that Posicor produced abnormal electrocardiograms and dangerous lowering of heartbeat in some patients. The FDA’s expert advisory committee voted to approve it by only 5-3.

In the case of the painkiller Duract, which was originally promoted as a long-term arthritis drug, early trials showed that patients who took the drug for more than 10 days suffered potentially lethal liver damage. The FDA approved the drug, but only for treatments of less than 10 days. However, some patients and physicians ignored the warning.

Press accounts quoted FDA officials saying that the recall orders proved that the system worked. In fact, they proved that the system has been corrupted by industry pressure.

This corruption of the drug approval process in what has been America’s premier consumer safety agency is part of a larger debasement. Conflicts of interest are broadly seeping into the agency’s entire workings.

Traditionally, the process of conducting clinical trials for new drugs has been dominated by research universities, teaching hospitals and government scientists not on drug company payrolls. In recent years, more and more clinical investigations are being done by researchers on contract to drug companies and for-profit companies are displacing universities. There have been cases where a university-based review panel set high standards and a drug company simply found a more docile private contractor.

All of this, of course, creates a conflict of interest, since the reviewers have a financial stake in getting repeat business from the drug companies. And the FDA, under pressure from the industry and the Republican Congress, goes along with this erosion of standards.

Where billions of dollars of profits are at stake, the drug companies simply cannot be their own policeman. The FDA needs to be true to its own fine traditions, and Congress should work to restore some spine to the agency rather than joining the industry crusade to weaken it.