A Double Standard on Drugs?

By Claudia Wallis

Manufacturers are charged with abuses in the Third World

In the Philippines, chloramphenicol, a formidable antibiotic, is prescribed for infections ranging from flu to acne. The standard drug guide used by Filipino doctors does not carry warnings of a possible side effect: a deadly form of anemia.

In Kenya, doctors prescribe steroid hormones for use against such vague complaints as poor appetite, lack of stamina and listlessness. Taken continuously in very large doses, steroids have caused clitoral enlargement in young girls and beard growth and baldness in women.

In Indonesia, vendors sell clioquinol (brand name: Entero-Vioform) at roadside stands. The potent antidiarrheal drug was banned in Japan and withdrawn from the U.S. market ten years ago, after it was linked to cases of acute abdominal pain and, in some instances, brain damage and blindness.

These are among the scores of instances of mishandling cited by a major new study of drug promotion, sales, uses and abuses in Third World countries. The report was conducted over a period of eight years by Pharmacologist Milton Silverman of the University of California at San Francisco; his wife, U.C.S.F. Research Associate Mia Lydecker; and former HEW Assistant Secretary Dr. Philip Lee. Melodramatically titled Prescriptions for Death, the 172-page report diagnoses "an acute deficiency of social responsibility" on the part of the international pharmaceutical industry.

According to Silverman et al., the multinational drug companies practice a "blatant double standard" in selling products to poorer nations. Side-effect warnings that are disclosed in drug reference books in industrialized nations are sometimes left out of guides used in underdeveloped lands. Products that are outlawed or severely restricted in the Western world--clioquinol and aminopyrine, a fever and pain remedy linked to a serious blood ailment--are dumped in the unregulated markets of Southeast Asia. Many of these products are elaborately promoted. Clioquinol was touted on Indonesian television until the government banned all TV commercials last year. Other products, including vitamins and "tonics," are promoted as cures for malnutrition in such impoverished areas as Nigeria and Central America, although, as Silverman pointed out in an interview, "these people don't need vitamins, they need food."

The author of three earlier books condemning drugmakers, Silverman is a persistent gadfly, but an influential one. Among his targets are the biggest drug producers in the world. Switzerland's Ciba-Geigy, fourth in sales in the indus try, is accused in the report of dumping 30th clioquinol and aminopyrine. The West German giant Hoechst and E.R. Squibb and Sons, Inc., of Princeton, N.J., are charged with selling tetracycline in Southeast Asia without sufficient warnings that the antibiotic can discolor children's teeth. California-based Syntex Corp. is taken to task for failing to publish standard warnings on birth control pills sold in Singapore and Malaysia; Parke-Davis and Dow Chemical, for not publicizing the perils of chloramphenicol in Asian drug manuals.

Doctors in underdeveloped nations, Silverman says, are singularly dependent upon the data they receive from drug companies, through both salesmen and the data supplied to drug guide publishers. Medical journals are often unavailable or unaffordable, and physicians have little time for reading, since they may be seeing 30 patients an hour.

This dependency, often coupled with a lack of local government regulation, breeds corruption. Silverman says that in order to promote greater use of their products, some drug company representatives have bribed doctors and hospital administrators with cars or free university educations for their children. One Ciba-Geigy rep in the Philippines courted clients with pornographic films and prostitutes. More typical is the practice of distributing free drug samples to physicians, which the doctors then sell to patients for a profit. "It's the most effective incentive for overprescribing that I've seen," said Silverman. 'These people hand out toxic drugs as if they were popcorn."

Prescriptions for Death has elicited vigorous denials and rebuttals from the pharmaceutical industry. At a meeting in Washington this month of the International Federation of Pharmaceutical Manufacturers Associations (I.F.P.M.A.), pharmaceutical executives argued that the Silverman report had focused on isolated offenses and ignored the major obstacles that drug companies face in the Third World. Some of those problems: distributing drugs to patients who may live far from medical centers; keeping vaccines refrigerated in jungle outposts; teaching uneducated patients how to take medicines. Dow, Parke-Davis and Hoechst maintain they have uniform policies on drug information worldwide. Any abuses, they say, originate within the importing countries. Syntex and Squibb note that warnings for their products have been omitted by local drug manuals. "We are not responsible for what the guides will print," said a Squibb spokesman, "but we make all the information available."

Many firms say that they simply meet the drug standards set by importing countries. Ciba, for example, says it had permission from Asian governments to market aminopyrines. And, as far as labeling is concerned, "we would have a complete description if they required it," says West German Drug Industry Spokesman Helmut Kathe.

Yet few Third World nations are equipped to establish tough controls. In Kenya about 40% of government-purchased drugs wind up in the hands of thieves. Black markets and roadside outlets for stolen pills flourish in much of Africa and Asia. Even when controls exist, enforcement may fail. Philippines officials told a TIME reporter that clioquinol is no longer available, yet the reporter bought it (Ciba's Mexaform) at a major Manila drugstore. Parke-Davis' chloramphenicol and Upjohn's tetracycline were also available--no prescriptions requested, no warnings offered.

It will be years before most poor nations can solve these problems. Meanwhile, Silverman urges drugmakers to assume more responsibility. The signs are encouraging. Late last year the I.F.P.M.A. adopted a code of ethical standards in marketing; this spring it initiated a system to address complaints about abuses. Next month the U.S. industry launches an effort to upgrade Third World drug manuals. Silverman singles out Merck & Co. Eli Lilly & Co. and SmithKline Beckman for already showing responsibility in labeling and promotion. Says he: "You can tell the truth and still make a decent profit." --By Claudia Wallis. Reported by Nelly Sindayen/Manila and Dick Thompson/ San Francisco

With reporting by Nelly Sindayen, Dick Thompson

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