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SUNDAY REPORT

Lethal Drug Trade: Unsafe Medicines From Mexico

Back-room shops sell Latino immigrants dangerous remedies without warnings of sometimes fatal side effects.

May 23, 1999|TRACY WEBER | TIMES STAFF WRITER

Dipyrone sales in Germany, however, where Hoechst manufactures the drug, are tightly restricted. German health authorities banned all combination products made with dipyrone in 1990 and emphasized that pure dipyrone should only be used as a drug of last resort, primarily for tumor pain.

And publications worldwide continue to warn of its dangers. The Side Effects of Drugs Annual, a pharmacy reference, states that even taking into account the lowest risk estimates--more than 10 times lower than those recently seen in Sweden--it has been calculated that "22 cases of dipyrone-induced agranulocytosis would be seen daily, or over 7,000 cases annually worldwide."

Some health advocates and doctors contend that about 20% to 50% of those who contract agranulocytosis in developing countries die of the disease. Even at those low case estimates, 2,000 people a year could be dying from dipyrone, they say.

But Dr. Peter Mansfield, director of the Australia-based Medical Lobby for Appropriate Marketing, worries that the new data from Sweden suggest the death rate could be much higher.

"With agranulocytosis you need sophisticated intensive care," he said. "That's just not available in many developing countries" where the dipyrone is primarily sold.

Gasman finds the double standard galling: "There's no reason a drug that would not be good for Germans should be good for Mexicans. Why would a drug company produce things they are not allowed to sell in their own country?"

Lee, the former U.S. assistant secretary of HHS and the co-author of several books on the marketing of drugs to developing countries, said the answer is obvious. "Clearly, profit comes well ahead of the public interest," he said. "Clearly, they do it because they make 220 million bucks a year."

Side Effect Warnings Omitted

Nearly every time the Los Angeles task force bursts into a shop selling Mexican pharmaceuticals, Thompson sees stacks of chloramphenicol: liquids for babies, capsules, eye ointments, eardrops and glass ampules ready to crack open and inject.

And every time he shudders.

"In American medicine, we wouldn't use chloramphenicol unless it was the last resort," said Thompson, who has headed the Los Angeles Regional Drug Information Center for 30 years. "Because the lawyers will have you down at the courthouse the next day if you hurt someone."

The drug is a powerful, highly toxic antibiotic that is used only rarely in the United States and only under controlled situations. Its discovery in back-room clinics underscores the difference, doctors and pharmacists say, between its marketing in Mexico and the United States.

Nine companies sell the drug, alone or in combinations, in Mexico.

Even the drug's U.S. marketer acknowledges chloramphenicol's serious risks.

"It's such a dangerous drug," said Bill Smith, director of product information for Monarch Pharmaceuticals, which purchased the U.S. marketing rights to the brand Chloromycetin last year. "This is a last-ditch drug when nothing else will work."

Inexpensive and strong, chloramphenicol is best used to battle such scourges as typhoid fever or Rocky Mountain spotted fever. The FDA considers it so toxic that since 1961 it has required the drug's packaging to include a so-called "black box warning" detailing its risks.

This warning, which includes an italic emphasis, states that "serious and fatal blood [diseases] occur after chloramphenicol administration. . . . [It] must not be used when less potentially dangerous agents are effective. It must not be used to treat trivial infections(i.e. influenza, colds, throat infections). . . . "

Thompson said he hasn't found any package inserts detailing these adverse effects during sweeps of illegal pharmacies here.

"It's shocking every time I see this stuff," Thompson said. "It can stop your blood from being made."

Mexican health authorities say doctors are increasingly prescribing safer alternatives to the drug, but they have little control over people who buy the drug because it has worked for them in the past and they never consult a doctor.

Said one U.S. doctor: "In Mexico they will take it for strep throat. Frequently you will not see the [bone marrow] suppression right away. People will develop another infection and die, and they will not connect it."

The drug has had a controversial history in the United States. In the early 1970s, Parke-Davis, which first made the drug under the name Chloromycetin, paid out $400,000 to the family of a Long Beach woman who died after treatment with the drug. The state Supreme Court affirmed the jury's finding that the drug firm "negligently failed to provide adequate warning as to the dangers of Chloromycetin by 'watering down' its warnings" and so over-promoted the drug that doctors prescribed it when it was not justified.

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