Dangerous Exports -- Drugs Banned In The U.S. Find Overseas Markets

Last of three parts

MEXICO CITY - The friendly woman behind the counter at the Villegas Pharmacy hands over a box of Winthrop's Conmel painkiller tablets. Though the label says a prescription is required, the clerk doesn't ask for one.

Even worse, Conmel is dipyrone, a drug banned 14 years ago by the U.S. Food and Drug Administration because it can cause a fatal blood disorder.

Yet, Winthrop and another American drug company, Carter-Wallace, still sell it abroad by using overseas subsidiaries not subject to tough American laws. While Winthrop warns consumers about the deadly side effect, it does not tell them the drug is banned in the United States. Carter-Wallace doesn't even warn consumers about the dangers.

Across town at the Federico Gomez Children's Hospital, Dr. Maria Guadalupe Rodriguez tries vainly to convince parents that the costly American drugs they buy to fight their babies' diarrhea are useless and often deadly.

Some of the drugs can paralyze a child's intestines. Others can destroy a child's ability to fight other infections. All fail to treat the worst enemy of a child with diarrhea: dehydration that kills about 4 million children under 5 in underdeveloped countries every year, the World Health Organization says. All these infants need, WHO says, is an inexpensive mixture of sugar, salt and water.

American drug companies thrive in countries like Mexico where drug regulations are weak or unenforced and untrained clerks sell prescription drugs.

The companies sell unsafe drugs that have been banned or withdrawn from sale in the United States. They promote products by exaggerating benefits and downplaying - or even leaving out - the risks, medical researchers, physicians and international health activists charge.

No one knows how many victims there are. Proof is hard to come by, health experts acknowledge. Official monitoring of drug side effects is almost nonexistent in underdeveloped nations. In rural areas, the dead are often buried at home, unnoticed by authorities.

A Mexican physician, Gloria Sayavedra, said she knows of deaths caused by dipyrone, a pain and fever-reducing drug, and by American anti-diarrheal products, but the families were too grief-stricken or afraid to complain.

Some health activists suggest a double standard is at work here: one for Americans, another for the other nations.

Spokesmen for drug companies, insisting their products are safe and their marketing practices proper, deny that. They want to sell their drugs everywhere to everyone - even drugs banned in the United States.

"We would sell (dipyrone) to our own countrymen . . . this is not a question of dumping," said Terry Kelley, a spokesman for Winthrop, the Eastman Kodak pharmaceutical subsidiary in New York City that sells dipyrone in more than 30 countries.

Says Peter Mansfield, an Australian doctor who heads a worldwide physicians' watchdog group that monitors the drug industry in developing nations: "With many drug companies, it's just one standard. They will do what they can get away with."

And the scarcity of trained inspectors and strict government oversight in many developing nations guarantees that drug companies can act with impunity.

In 1987, Mansfield's Medical Lobby for Appropriate Marketing (MaLAM) reported more than 450 alleged violations of the drug industry's voluntary code of conduct, which, among other things, calls on firms to limit claims for a drug to benefits that can be supported by scientific fact and to disclose side effects.

The industry group conceded that 168 advertisements broke the rules by failing to include basic information doctors need to evaluate a drug, such as its side effects. But Mansfield said the response was so slow that often the improper advertising had already stopped appearing, the damage done.

In the United States, FDA officials maintain strict controls over drug companies, including oversight of drugs exported from the United States.

American law prohibits the export of drugs banned in the United States, such as dipyrone.

But the federal government has no authority over drugs manufactured overseas by American multinational firms - and those products represent the bulk - 86 percent in 1985 - of foreign sales by U.S. firms.

In Kenya, more than 90 percent of the drugs sold by American companies were made outside U.S. borders. The label "Hecho en Mexico" - Made in Mexico - is on every drug package in that country, "even if they only put the pills in the bottle here," says Mexico's leading consumer advocate Arturo Lomeli.

"We advise and offer assistance to countries, but we don't tell them what drugs they should or shouldn't have," says Dr. Stuart Nightingale, associate FDA commissioner for health affairs.

And there's no reason the U.S. government should, drug companies argue.

Companies say their products are approved by health officials in foreign countries, who believe their benefits outweigh the risks.

"Many countries feel that the FDA is not the only regulatory agency that is capable of deciding these things," says Russell Durbin, a spokesman for Merck Sharp & Dohme.

Health experts counter that underdeveloped countries don't have the scientific and staff resources available in the United States to evaluate drug safety. A 1984 United Nations report noted a natural tendency to regard drugs as safe "until evidence of their damage comes to light." Unfortunately, the report added, few developing countries have any system for keeping track of side effects.

In any case, industry officials argue, they just sell the drugs. Doctors and pharmacists, who prescribe the drugs, bear responsibility, too.

But drug companies wield enormous influence in developing countries. For many overburdened doctors and poorly trained pharmacists, the source of information about drugs comes from company ads in medical journals or their salesmen, known in the trade as "detail men." In the United States, for every doctor there are three detail men. In Mexico, doctors are outnumbered ten to one.

To activists and international health professionals, one of the most appalling examples of legal but inappropriate marketing is the sale and promotion of anti-diarrheal drugs by drug companies. A worldwide market estimated at $438 million in 1984, it is undermining an international effort to wipe out the single greatest killer of children in the Third World, these observers say. In a new report, the WHO says flatly that "anti-diarrheal drugs . . . should never be used" in the treatment of acute diarrhea in children. "None has any proven practical value and some are dangerous."

"Medical professionals know that giving anti-diarrheals is not good, but the (drug) companies are pushing as hard as ever before. Maybe harder," says Dr. Shahida Haider, a professor of pediatrics in Lahore, Pakistan, where children under 5 suffer an estimated 90 million episodes of diarrhea every year. An estimated 228,000 children in that age group die.

In the last year, U.S. firms agreed to remove two products health professionals and activists considered two of the worst American offenders: Upjohn's Kaomycin, an antibiotic the company no longer sells in the United States, and Johnson & Johnson's anti-diarrhea drug Imodium.

But even though both companies agreed to take their drugs off the market - eventually - their responses illustrate the difficulty of ridding the Third World marketplace of useless and dangerous drugs.

Last November, following questions from MaLAM, Upjohn of Kalamazoo, Mich., agreed to withdraw Kaomycin worldwide, but not because they agreed with WHO that their product is harmful.

"We never agreed with that stance," company spokesman John Butler said. The product was "simply eclipsed" by oral rehydration therapy, the inexpensive mixture of sugar, salt and water.

Indeed, Upjohn marketers decided the company still needs 18 months to give doctors who have come to rely on Kaomycin "time to switch to an alternative therapy" - even though oral rehydration is widely available. Industry watchdog Mansfield suspects the company wants the time to sell off its existing stocks, a charge Butler denies.

Delays can have tragic consequences.

In December 1989, Pakistani pediatrician Tariq Bhutta asked Johnson & Johnson's local subsidiary to withdraw Imodium after he treated 19 babies whose intestines were paralyzed after their parents gave them Imodium drops. Six died in the hospital; four others were taken home to die.

To some, it was a situation comparable to the one Johnson & Johnson faced in the United States in 1982, when capsules of its painkiller Tylenol were found to have been contaminated by cyanide, killing seven people. The company immediately launched a nationwide recall, winning high praise from consumers and regulators alike.

But in Pakistan, Johnson & Johnson's subsidiary "dragged their feet," Bhutta said. "We could have moved faster," conceded Frank Barker, corporate vice president for public affairs at the firm's headquarters in New Brunswick, N.J.

And over the next six months, Bhutta continued to treat cases of Imodium poisonings. In February, a 4-week-old baby - born to a couple after 14 years of a childless marriage - died. "No one knows how many other children died elsewhere in Pakistan and other countries," said Mansfield. Johnson & Johnson said the Pakistan deaths were the first ever reported to the firm.

It wasn't until June 1990, a week after Britain's Yorkshire Television broadcast an expose about the situation in Pakistan, that Johnson & Johnson took decisive action.

The British expose was the key, company officials said. At headquarters, top Johnson & Johnson executives had gathered in board chairman Ralph Larsen's office to watch a tape of the show in "shock" and "stunned silence."

Said vice president Barker: "You don't see many programs where you actually see a child die on camera."