Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: MONDAY, March 13, 1995 TAG: 9503130095
SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: METRO
SOURCE: ASSOCIATED PRESS
DATELINE: ROCKVILLE, MD. LENGTH: Medium
Dr. Susan Alpert hunched over the pages on her office floor - no table was big enough - and painstakingly looked for proof the medicine worked, that the manufacturer didn't finagle the science or hide side effects.
``People think, `Oh, an antibiotic's an antibiotic, what's to check?''' recalled Alpert, a veteran drug reviewer who now heads the FDA's medical device evaluation. ``It has to be done. You can't just put drugs out there and see what happens, because patients might get sicker or die.''
But critics accuse the FDA of holding medicine hostage, and they're demanding that Congress revamp, or even dismantle, the nation's oldest consumer protection agency.
``We all want safe, effective, carefully tested medicines,'' the Washington Legal Foundation argues in newspaper ads spearheading the attacks. ``But let's have them in our lifetime, not long after we've died in agony.''
Congress this spring will deliberate the charges in oversight hearings and already testy debate over FDA funding. The issue centers on critics' most basic question: How could the FDA possibly spend 11/2 years or more deliberating over a single new drug or medical device?
The FDA tracks every therapy from its first use in humans to the assembly line that produces it and even the wording on its sales container. ``That intensity of work takes a long time,'' Alpert said.
New drugs require at least 10 years and $360 million in research. The clock starts when scientists subject a new chemical to laboratory and animal tests.
The ovarian cancer drug Taxol, for instance, started lab tests in 1977. Scientists sought FDA permission to test Taxol in people in 1983, trials that spread over nine years as doctors gauged the drug's benefits and risks. Finally, Bristol-Myers Squibb had enough data to file its Taxol application, which the FDA approved five months later.
Armed with such trials, companies file 17,000 applications for new therapies - or new uses for existing ones - every year. FDA scientists then pull out the microscope. In its Baltimore lab, chemists recently tested a new long-acting ulcer medicine for hazardous byproducts that sometimes form on drug coatings. They timed a new generic painkiller to ensure it dissolved in blood as quickly as the name brand.
Back at headquarters, 1,034 reviewers comb company data to ensure the therapy works.
``The question is not whether a drug's safe, but safe for what?'' said Dr. Mack Lumpkin, deputy director of FDA's Center for Drugs. ``All drugs have some side effect. Are you willing to take risks from a drug if you don't know it's going to do you any good?''
The FDA spends an average of 13 to 19 months per drug. Simple medical devices take an average of four months, while complex ones can take more than 500 days.
Ideas to speed the process run the gamut. The medical device industry wants to privatize FDA, setting up government-accredited companies to approve products.
Drug companies, insisting they need a strong FDA to weed out quack competition, instead are discussing ways to loosen FDA restrictions on early human testing. And they want FDA reviewers to stop scrutinizing each patient and simply audit drug data, much as the IRS fights tax fraud.
Conservative think tanks would go further, allowing any medicine on the market and just labeling whether it's FDA-approved so patients can choose to risk taking it.
by CNB