Bad medicine
a contraceptive that has been denied permission for clinical trials in the us as it is a suspected mutagen (substance that can change genetic material), is reportedly being tested with private American aid on thousands of women in India. The tests are being carried out in several government hospitals including Lady Hardinge Medical College, New Delhi.
The contraceptive in question is quinacrine, chemically known as '6-Chloro-9-(1-methyl-4-diethylamine) butylamino-2-methoxyacridine', a compound used as an antimalarial drug during the World War ii. It differs from the common chloroquine only marginally.
The controversy on the drug was kicked off in India following the recent premiere of a documentary film The Yellow Haze, produced by the Mass Communication Research Centre of the Jamia Milia Islamia University, New Delhi, which depicts clandestine trials of quinacrine that produces dubious results. Following this, on May 2, women's groups staged a protest in front of the Jain Medical Centre, New Delhi, one of the test centres.
In the late 1960s, Jaime Zipper of Santiago, Chile, discovered contraceptive properties in quinacrine. He formulated pellets designed to accommodate a Copper t intra-uterine device inserter. Once inserted, quinacrine would cause inflammation of the inner lining of the fallopian tubes, and eventually, the scar tissue would block the tubes, thus preventing pregnancy.
Although the first round of the toxicology trials of quinacrine sterilisation (qs) was done in 1983-84 in the us, the Food and Drugs Adminstration denied permission for the phase ii clinical trials on account of doubts on dosage and concern about the drug's ability to cause mutations. Later, the World Health Organization's (who) Research Programme in Human Reproduction Programme (hrp) demanded additional toxicology studies of qs, suspecting it to be carcinogenic. Meanwhile, clinical trials continued in 19 other countries, mostly in the developing world.
In the midst of an international debate, who / hrp expert Giuseppe Benagiano wrote a letter to the editor of The Lancet (Vol 342, June 4, 1994) explaining the hrp's opposition to qs on following grounds: 1) It needed additional toxicological studies before clinical trials; 2)concern about its mutagenecity and possible carcinogenic effects; 3) question of double standards. A Lancet edit also noted the barrage of criticism relating to an earlier report on over 30,000 cases of qs in Vietnam.
Although in the early 1990s, the Indian Council of Medical Research, after a limited trial on eight women, gave up qs because of "complications", still, there are enough takers of the drug in India. Here the drug is not available in pellet form; all materials like q-tablets and inserters are sent to various organisations from the International Federation for Family Health (iffh) in Oregon, us, a group propagating family planning in the developing world.
Pravin Kini of Contraceptive and Health Innovations Project in Bangalore and Ashi Sarin of the Government Medical College, Patiala, are some of the experts who have been promoting qs. Says J K Jain of the Jain Medical Centre, a former mp of the Bharatiya Janata Party and president of the iffh, "If the population of India is increasing fast, should not doctors find better contraceptive? We, doctors of India, could try to control this problem; neither the government, nor who has done so much." This zeal is shared by Jain's us counterparts as well.
Elton Kessel, secretary general of the iffh , brushing away hrp observations on the drug's failure to complete standard toxicity studies, wrote in a letter published by the iffh in July 1996: "The required in-vitro and in-vivo tests, including rodent carcinogenicity tests, have been successfully completed for oral administration of quinacrine and to repeat this and other further toxicology tests for intra-uterine administration is estimated to cost us $8 million. And it will take at least eight years to complete research
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