WASHINGTON _ The FDA's stringent safety and efficacyrequirements have provided consumers better protection againstharmful drugs than the regulatory system used in Europe, accordingto a new study.

The Washington-based Public Citizen's Health Research Groupcompared the number of drugs first marketed in the U.S., France,Germany and the U.K. in 1970 or later and subsequently withdrawnbecause of safety problems. Of 56 drugs withdrawn in one or moreof the four countries by the end of 1992, 31 were withdrawn inFrance, 30 in Germany, 23 in the U.K. and nine in the U.S. (The totalexceeds 56 because some drugs were withdrawn in more than onecountry.)

Sidney Wolfe, director of the Public Citizen's Health ResearchGroup for 23 years, has been an outspoken critic of the FDA for laxdrug safety standards and of pharmaceutical companies forconcealing data about drug toxicities. His new study notes thatmanufacturers of three of the nine drugs withdrawn from the U.S.market later pleaded guilty to criminal charges of withholdingcritical data concerning deaths or serious injuries from the FDA.

"It is clear from this study that the more stringent drug safety andefficacy laws and regulations in the United States have saved manylives," Wolfe wrote. "The number of reported cases of deaths andinjuries which led to withdrawals in other countries of drugs neverapproved here is only the tip of the iceberg." That's because,according to Wolfe, only one in 10 adverse reactions are actuallyreported.

Public Citizen's findings are at odds with the prevailing mood inCongress and among policy analysts at a plethora of conservative,pro-free enterprise think tanks here. Many have hailed the Europeanmedical drug and device regulatory system as faster and moreefficient than the FDA's. A recent policy paper from the WashingtonLegal Foundation said there is no evidence that the FDA's lengthyregulatory reviews produce "any corresponding gain in safety" whencompared to the European model.

House Speaker Newt Gingrich (R-Ga.) is fond of brandishing thecardiopump, a cardiopulmonary resuscitation (CPR) device for heartattack victims approved in many European countries but not in theU.S., as an example of the FDA's sluggish approval process.However, the last two studies of the device in humans did notdemonstrate any benefit over conventional CPR. In 1993, the FDAhalted a clinical trial in part due to ethical concerns about testing theexperimental device on unconscious patients.

ICOS Corp. chairman and CEO George Rathmann recently assailedthe FDA for allowing a Hepatitis A vaccine to languish at the agencyfor 30 months. Meanwhile, it's been approved in 40 other countries."Not only is America falling behind Europe in approvals, we arelosing biotechnology jobs and research to countries abroad," hewrote in the Pharmaceutical Research and ManufacturersAssociation (PhRMA) annual report published last month.

PhRMA spokesman Steve Berchem told BioWorld that the PublicCitizen study results are "difficult to interpret" since the number ofdrugs withdrawn in each of the four countries was not compared tothe number of drugs approved. Obviously, countries that approvemore drugs might be expected to withdraw more drugs from themarket.

Berchem cited a study published in the journal ClinicalPharmacology and Therapeutics in May 1984 that compared drugapproval and withdrawal rates in the U.S. and U.K. between 1964and 1983. That study found that while more drugs were approved inthe U.K. than in the U.S., the number of withdrawals as a percent ofapprovals was comparable.

"There are things we can learn from the European model to improveour approval process here," said Berchem. "For example, in Europethey look at a summary of the clinical data instead of looking at asemi-truck-full of raw data. The data is reviewed by a panel ofoutside experts instead of a panel of inside bureaucrats." PhRMAhopes to release a white paper on FDA reform later this month andwill issue a response to the Public Citizen report next week.

Drugs Nixed In U.S. Caused Deaths Elsewhere

The Public Citizen study lists several drugs never approved in theU.S. that caused deaths in other countries. Clometacin, a nonsteroidalanti-inflammatory (NSAID) drug, was marketed and later withdrawnin France because of 130 reports of liver damage, including ninedeaths from hepatitis. Indomethacin-R, a timed-release NSAID, wasmarketed and later withdrawn in the U.K. and Germany because of717 adverse reaction reports, including 36 fatalities.

The biotechnology industry witnessed its own version of the U.S.-European approval differential with Centocor Inc.'s monoclonalantibody for sepsis, HA-1A. That drug was granted marketingauthorization in most European countries during 1991 on the basis ofa single Phase III clinical trial. By the end of 1992, annual sales inEurope had reached $22 million.

However, when the FDA learned that Centocor's analysis of its firstPhase III trial could have biased the results, it required the companyto conduct a second trial. That study was halted in early 1993 due toan unexpectedly high death rate among certain patients and Centocorimmediately withdrew the drug from the European market. It neverreceived FDA approval.

A recent poll of 1,000 randomly selected adults commissioned by theconservative, pro-business Citizens for a Sound EconomyFoundation revealed that a majority of Americans (61 percent)believe pharmaceutical and medical products are "more safe" in theU.S. than in other nations "like Canada, Japan, France or Germany."Experts challenged the results of that survey because it polledindividuals who are generally uninformed about the complexities ofthe drug approval process. n

-- Lisa Piercey Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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