We have seen that chloramphenicol is a drug which can have dangerous side-effects and which should only be used for a narrow range of life-threatening diseases, most...
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Smutek to uczucie, jak gdyby się tonęło, jak gdyby grzebano cię w ziemi.
For many years chloramphenicol has been promoted in the United States for only these limited indications. But Silverman found that in Mexico, Ecuador and Colombia, Parke-Davis promoted chloramphenicol for additional conditions many of which were far from life-threatening: tonsillitis, pharyngitis, bronchitis, urinary tract infections, ulcerative colitis, staphylococcus infections, streptococcus infections, eye infections, yaws, and gonorrhea.
In the United States, physicians are warned that use of chloramphenicol may result in serious or fatal aplastic anemia and other blood dyscrasias. Physicians in Mexico are given a similar warning in the promotional material for Parke-Davis' Chloromycetin, but no warnings are listed for the same product in Central America (Silverman, 1977: 159).
Worse, when Silverman appeared before the US Senate to discuss his findings, Senator Beall pointed out that the Italian labelling for Parke-Davis chloramphenicol said:
It is a very significant fact that Chloromycetin therapy is conspicuously devoid of side effects. The medication enjoys a high degree of tolerance with both adults and children. In the few cases where reactions have occurred, these are generally limited to mild nausea or diarrhea and only rarely does their gravity impose suspension of treatment (Subcommittee on Monopoly, 1976: 15359).
Dr Wegmar followed up with an even more remarkable revelation from Spain:
In 1973, the year after the tragic death of their daughter, Professor and Mrs. Zander travelled in Spain and brought home this poster which was on the drugstore counters, Chlorostrep, a product of Parke-Davis of Spain. The poster says, in effect, 'Don't allow diarrhea to interfere with your vacation. Take Chlorostrep at the first problem.' This drug is a combination of chloramphenicol and dihydroestreptomicine. As you may know, streptomycin, although not commonly in small doses, carries the risk of causing deafness. Thus, if you take this fine combination, you run the risk of becoming deaf before you die. And its usefulness for most causes of diarrhea commonly seen is negligible (Subcommittee on Monopoly, 1976: 15385-6).
The greatest tragedy of the overuse of chloramphenicol in the Third World was illustrated when in 1972-3 there was a typhoid fever epidemic in Mexico. Chloramphenicol is an invaluable treatment for typhoid fever. But many of the 100,000 victims of the Mexican outbreak could not be helped because the particular typhoid bacteria concerned had built up a resistance to chloramphenicol through long exposure. 20,000 typhoid victims died in the outbreak.
Another disturbing picture was painted by Silverman with respect to oral contraceptives marketed by Searle, Johnson and Johnson, Warner-Lambert and American Home Products:
In PDR [Physician's Desk Reference], all of these are described as indicated for only one use - contraception. In the Latin American countries, they are openly recommended for contraception, and also for the control of premenstrual tension,
menstrual pain, problems of the menopause, and a host of other conditions.
In the United States, physicians are warned of the possibility of many side-effects, especially thromboembolic changes that can lead to serious or fatal blood clots.
In Latin America, for all the products studied here, the risk of thromboembolic changes is ignored. No adverse reactions of any kind are given for the Searle product in Ecuador, Colombia, or Brazil for the Parke-Davis product in Central America, and for the Wyeth product in Ecuador, Colombia, or Brazil (Subcommittee on Monopoly, 1976: 15363-4).
Sandoz's powerful antipsychotic tranquilliser Mellaril was found to be promoted in Central America for a host of minor neurotic disorders not mentioned in US promotion. These additional indications included use for children with behavioural disorders, hostility reactions, inability to adapt in school, insomnia, sleep walking, bed-wetting and nail biting. Many adverse reactions of Mellaril were disclosed in the United States, a few in Mexico, but none in Central America, Colombia or Ecuador.
Silverman documents many many other examples. In some cases, trivial side-effects were described in great detail, while serious and potentially fatal reactions were not mentioned.
The industry defence was that they had not violated any local laws by their policies of disclosing as little as they could get away with. But Silverman points out that this was not always the case. In some of the Latin American countries there were relevant laws requiring the disclosure of hazards. It was simply that there were no resources for enforcing them. Further, Silverman points out, there is little realistic possibility of civil action against large pharmaceutical companies for damages in poor countries where there is no provision in law for class actions.