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Opinion Piece on Medical Officer's Opinions of the Drug Approval Process

Troubling Climate at FDA


This opinion piece, by Health Research Group Deputy Director Peter Lurie, M.D., M.P.H., and Director Sidney Wolfe, M.D.,  appeared in the Washington Post on December 30, 1998.

It's been a record-setting year at the Food and Drug Administration; The agency has been forced to remove three drugs from the market because of safety problems, more than in any similar period in in history. First Redux was removed for causing serious heart valve defects. Then off came Posicor, which caused life-threatening drug interactions and fatal heart problems, followed by Duract, which caused sometimes fatal liver damage. In all three cases, the drugs did not represent a significant advance in effectiveness over already-approved drugs. In all three cases, significant safety concerns existed prior to approval.

Egged on by its sponsors in the drug industry, Congress has systematically set about weakening a drug-approval process that for years ensured Americans the safest pharmaceutical supply in the world. But that is changing; these days Rezulin, one of 11 drugs available in the United States to treat diabetes, stays on the market with impractical requirements for 11 blood tests during the first year of use to prevent liver damage, while Britain has had the good sense to ban the drug. So far Rezulin has caused at least 33 deaths from liver failure.

The signs are that for many within the agency, morale is at a low point. One of FDA's medical officers - the physicians who actually review new drugs - was forced to turn to the letters page of The Post in August of this year to express his dissatisfaction with current agency drug review practices. He was threatened with dismissal as a result, although the agency backed off under pressure.

With this in mind, we decided to survey the medical officers to better understand conditions inside the agency. To protect the medical officers' confidentiality, we did not ask for their names or the names of the drugs they had reviewed. Fifty-three medical officers (31 percent) responded, which is more than respectable given the controversial subject matter.

The results were startling. Nineteen medical officers mentioned 27 drugs that had been approved by the FDA in the past three years even though the medical officer - the person most familiar with all the data on the drug - opposed approval. It is likely that had more medical officers responded, even more such drugs would have been mentioned.

Seventeen medical officers said that FDA's safety and efficacy standards had declined in the past three years, with only six saying they were higher. As one medical officer put it "In the last two years, I recommended that two drugs not be approved. They were both approved without consulting me. This never happened before. In one case, the drug did not meet the standards set up by the division, so they nullified the standards. "

Even free and unfettered discourse, a central ethic in science, is frequently abrogated in the current pro-industry environment at the agency. The medical officers described an array of inappropriate practices - including phone calls from sponsors, pressure from Congress and being prevented by their supervisors from presenting data critical of particular drugs to FDA advisory committees. How can these committees properly decide whether to recommend approving a drug when relevant data are being suppressed inside the agency?

While the changes to the drug laws enacted in 1992 and 1997 may have brought benefits for some people with life-threatening diseases such as AIDS or cancer, these drug industry-inspired and approved amendments will mostly serve to benefit the industry and its stockholders. Some changes in FDA approval processes predate the most recent of these legislative changes, but the climate within the agency has now shifted from a consumer-protective one to one in which success is measured in the terms favored by the industry. One medical officer stated that senior FDA officials "are mainly interested in counts of approvals and time to approval, and not quality."

Most of the new drugs being hurried onto the market in an effort to appease Congress and the drug industry offer no benefit over their predecessors. Some, like Redux, Posicor, Duract and perhaps many more, ultimately will have to be banned, but only after scores of Americans have been maimed or killed.

FDA officials repeatedly have asserted that speeded-up drug approvals and other changes at the agency have not compromised drug approval standards. But now many of those FDA physicians who know the drugs best have spoken, and they have painted a vastly different picture. It is time for Congress to admit that it has acted recklessly in pushing FDA to loosen drug approval standards, and to act expeditiously to force the agency to tighten them.

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