WASHINGTON _ Readers of last Monday's Wall Street Journalcouldn't have helped but notice an advertisement featuring a pictureof tombstones with the grim headline, "If a murderer kills you, it'shomicide. If a drunk driver kills you, it's manslaughter. If the FDAkills you, it's just being cautious."

That dark message was followed by a block of text listing examplesof "lifesaving" drugs and devices stalled by FDA review. Samplecopy: "We all want safe and carefully tested medicines andtreatments. But let's have them in our lifetime . . . not long afterwe've died in agony from a disease." Running along the bottom ofthe ad is the tag line, "The problem with health care in America isthe FDA."

The ad, which has run twice in the Journal (the first time on Nov. 15)and twice in the Capitol Hill-based political magazine, the NationalJournal, was placed by The Washington Legal Foundation (WLF), anon-profit, conservative "pro-free enterprise" law firm and thinktank based here. The group, which has an annual budget of $3million (composed of donations from "over 100,000 individuals,"corporations and foundations), is a 17-year old organization that bothlitigates and publishes in its efforts to promote "de-regulation andlimited government."

According to Alan Slobodin, president of the WLF's legal studiesdivision, the ad is the centerpiece of WLF's new campaign toeducate the public and spark open debate about "the cost in lives,competitiveness and jobs of the FDA's lengthy, bureaucratic reviewprocess."

Although criticism of the FDA is certainly nothing new _ theagency is regularly attacked by public interest groups on the oppositeend of the political spectrum for colluding too closely with industryand failing to protect the public _ this concerted, anti-FDA adcampaign may be a first. "I'm not familiar with another campaignquite like this," FDA spokesman Jim O'Hara told BioWorld.

Some have suggested that repeated attacks from both sides of thepolitical fence may actually be the best litmus test of just how good ajob the FDA is doing. The agency must ensure the safety andefficacy of diverse products _ from mascara to potatoes to calciumblockers _ that constitute roughly 25 percent of the nation's grossdomestic product. It's a job fated to attract attention and critics.

Simple Attack _ Complex Issue

The recent WLF ad, however, may represent a particularly simplisticattack on the serious and complex challenge of regulating medicalproducts. Although it purports to educate, the ad contains flawed,selective reasoning, according to some experts.

Here's just one example: in its ad, WLF lists Chiron Corp.'s drug formetastatic kidney cancer, interleukin 2 (IL-2), as a lifesaving productarbitrarily withheld from dying patients by the FDA. "3,500 kidneycancer patients died during the three-and-a-half years it took theFDA to approve the drug Interleukin 2. It had already been approvedin nine European countries," states the ad.

"I don't think that's a fair example," Chiron spokesman Larry Kurtztold BioWorld. An FDA advisory committee did not recommendapproval of IL-2 in July 1990 due to serious questions about thepivotal study, according to Kurtz. That study was done at one site(the National Cancer Institute) in 100 patients and was led by anexpert in using the drug, Steve Rosenberg.

Although IL-2 produced an impressive 17 percent rate of partial andcomplete remissions in a deadly, untreatable disease, the drug alsokilled 4 percent of the patients who received it in the study. The FDApanel wanted three questions answered before recommendingapproval of IL-2: 1) Was the study reproducible outside of an expertsetting? 2) Could toxicity be reduced? 3) Could patient selection beclarified to reduce risks?

"Those were not unreasonable questions. A 4 percent drug-relateddeath rate is not a trivial matter to be glossed over," said Kurtz. Afterthe 1990 panel meeting, the IL-2 study was expanded to seven newsites and the results were reproduced, according to Kurtz. When newdata was presented to an FDA advisory committee in January 1992,panel members voted eight-to-one to recommend approval of IL-2and the FDA licensed the drug roughly three months later. Today,about 35 percent of the approximately 10,000 individuals who getkidney cancer each year receive IL-2. Some experts say toxicities aredown.

Slobodin said that the WLF's IL-2 reference in the ad is based on adata base search that produced "substantiated statements." Thereference listed for the IL-2 bullet point is an article in the May 3,1994 issue of Investor's Business Daily. "I'm not pretending to havea medical background," said Slobodin. "But I think it's reasonable toaccept the contention that the FDA delay in providing access to IL-2caused some people to die."

Examples Of `Needless Deaths'

Indeed, Slobodin is not alone in his criticism of the FDA's handlingof IL-2. President of the National Kidney Cancer Association,Eugene Schonfeld, told BioWorld that "IL-2 is one of the worstexamples of FDA regulation known to man."

Other examples of FDA delays that caused "needless deaths" listedin WLF's ad include:

* The seven-year approval process for the Alzheimer's drug tacrine."Nobody knows how many died," states the ad _ tacrine provides amoderate memory improvement but does not cure the disease.

* An alleged "year-and-a-half" delay in FDA approval of GenentechInc.'s clot buster. "The lives of more than 150,000 heart attackvictims may have been saved," states the ad.

* And numerous medical devices that have not yet received FDAapproval, such as a cardiac pump, a defibrillator, and a sensor padthat may aid women in locating lumps in their breasts.

The WLF's Slobodin said it's about time somebody took on theFDA. "We need an open, public debate about the role the FDA playsin this society," he explained.

The FDA's approach is flawed, according to Slobodin and variousWLF "backgrounders," because it is built on crippling "overcaution." "We have built a regulatory regime based on anunfortunate tragedy of 30 years ago [the Thalidomide debacle]," hecontends. "It's like the FDA is fighting the last war while the worldhas moved on to a whole new era of medicine."

FDA spokesman O'Hara was philosophical in the face of WLF'sassault: "They are entitled to their opinion and I'm sure thatnewspapers and magazines will continue to run their ads as long asthey keep paying the bills." n

-- Lisa Piercey Washington Editor

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

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