DATE: Saturday, September 20, 1997          TAG: 9709190015

SECTION: LOCAL                   PAGE: B8   EDITION: FINAL 
TYPE: Editorial 

                                            LENGTH:   56 lines

BETTER TO BE SAFETHE PUBLIC SHOULD CAREFULLY STUDY POSSIBLE SIDE EFFECTS OF ALLOWING THE FDA TO SPEED UP ITS APPROVAL TIME FOR PRESCRIPTION DRUGS.

Two powerful weight-loss drugs were pulled from the market last week because they are suspected of causing heart-valve disease. The drugs were fenfluramine and dexfenfluramine, known commercially as Pondimin and Redux.

This is a drug side-effect story of enormous proportions, when you consider the alarming number of Americans who have taken the drugs in the past several years - 50 million. How many of those face potentially serious side effects is unknown, but in one study, almost one third of users of the drugs showed heart-valve problems.

Both of these drugs were approved for use by the Food and Drug Administration about 20 years ago. They increased in popularity in recent years as doctors began prescribing the drugs in tandem with another weight-loss drug, phentermine, to produce a powerfully effectively diet cocktail nicknamed ``fen-phen.''

The FDA has been careful to point out that it never approved this combination of drugs.

This could be the first in a series of drug scares. In 1992 Congress passed the Prescription Drug User Fee Act, which allows for the speeded-up approval of drugs as long as the pharmaceutical companies pay for their own drug trials. This program is up for renewal, but it is so popular with the public and drug companies that it will almost certainly be extended.

As we see it, there are two inherent dangers in putting new drugs on the fast track to the public. The first is the possibility that drug trials might be tampered with since the very companies that stand to make money from the drugs' approval are involved with the testing. Secondly, speeded-up approval could fail to detect long-term problems with some drugs.

This 1992 law is just one example of Congressional determination to strip the FDA of power. Conservative critics of the FDA in Congress have chronically underfunded the agency and have then pointed to its slow action as an excuse to cut funding even further and to privatize some functions. Talk about self-fulfilling prophecies.

The FDA is the nation's premier consumer-protection agent. It is responsible for monitoring the safety of the foods we eat and the drugs we take. Reform may be needed, but safety can't be lost in the shuffle. Yet there is increasing pressure on the FDA - from across a spectrum that includes conservatives, drug companies and AIDS activists - to rush drugs to market.

Compounding the problem is an underfunded FDA monitoring program too burdened to spot serious side effects of drugs. According to an Associated Press story, the FDA relies mostly on physicians to voluntarily report side effects to the FDA's MedWatch agency. MedWatch workers are charged with tracking dangerous trends in drugs.

MedWatch has only four employees and an annual budget of $140,000.

This speeded up drug approval process, coupled with an anemic side-effect monitoring program is a scarier combination than the fen-phen cocktails.

We offer one word of warning: thalidomide.

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