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Fen-phen case illustrates potential abuses

ACompanies under public scrutiny for illegal or unethical behavior want to deflect attention elsewhere. Often it isn’t that hard to do, because who really wants to believe the worst.

Better to believe that, in the case of health care above all, no company would knowingly withhold information from doctors about a harmful product. Even if they tried, we want to believe, Food and Drug Administration regulations would protect us.

Furthermore, the media -- treading very carefully these days when it comes to big companies with deep pockets -- often contributes to confusion by bending over backward to be fair.

In the case of American Home Products, the pharmaceuticals giant that marketed the infamous and potentially lethal part of the drug combination known as “fen-phen,” attention has been deflected to a fight among lawyers over settlement of a class action lawsuit, and to the possibility that medical problems linked to “fen-phen” are somehow vague or imagined.

Stay focused and don’t be fooled. Big figures will be thrown around in coming months. Staggering sums are at stake: a potential $3.75 billion class action settlement, and possibly millions more for former drug users who have opted out of the settlement because they plan to sue the company individually.

Fortunately, Redux (dexfenfluramine) and its chemical cousin Pondimin (fenfluramine) have been removed from the market, due to pressure from the FDA. The other half of the fen-phen combo, phentermine, has not been linked to medical problems.

Lawyers and sick people seeking huge court awards are easy targets for companies seeking to justify their actions. Recall, though, that it was federal health officials, not lawyers, who urged medical checkups for an estimated 1.2 million to 4.7 million fen-phen users.

Although the company insists that its behavior has been legal, ethical and proper, evidence brought forth in trials so far makes that claim extremely questionable.

The pharmaceutical company has been accused of hiding information from the FDA not only about the extent of heart valve damage linked to side effects of the drug, but also about the extent of primary pulmonary hypertension, a potentially fatal disease.

Further, the company paid to have articles written about obesity treatments -- favorable, naturally, to fen-phen -- and got two published in peer-reviewed medical journals under names of prominent researchers. Effectively, these articles, published in the American Journal of Medicine and Clinical Therapeutics, were advertisements veiled as scholarly research. Connections between authors and the drug company were not disclosed, though the medical journals require disclosure.

The place to focus attention and anger is on companies that manipulate the public trust. The alleged actions of American Home Products and its subsidiary, Wyeth-Ayerst Laboratories, have devastating implications for public health and for trust in medical professionals.

National Catholic Reporter, April 14, 2000