Ethics in research: IU Erythromycin

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This time it is intrauterine erythromycin!

Vijay

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(http://www.hindustantimes.com/news/181_537580,0008.htm)

Hindustan Times -- Sunday January 18 2004

Illegal tests done on 790 Indian women

Dinesh C Sharma

New Delhi, January 17

Indian women have once again been used as guinea pigs. Between August 1999

and October 2002, as many as 790 healthy women in West Bengal were illegally

administered the antibiotic erythromycin to test whether it would work as a

contraceptive. The tests were backed by a US outfit.

Erythromycin is normally taken orally to treat respiratory tract infections

like bronchitis. But the women were administered the drug as a

trans-cervical contraceptive ­ pellets of the drug were administered using

intra-uterine devices such as copper-T. This was done at two private clinics

in Kolkata and South 24 Parganas.

The two doctors involved in the trials are repeat offenders. Netai R.

Bairagi and Biral Chand Mullick were also involved in the illegal trials of

the anti-malarial drug quinacrine as a chemical sterilisation method in the

mid-nineties.

The drug was banned in India in 1998, following the Supreme Court's

intervention. The two doctors then began testing erythromycin on women. The

two have now revealed that they tested even tetracycline, another

antibiotic, as a trans-cervical contraceptive in the mid-eighties.

Medical experts are shocked. " This is illegal, unethical and amounts to

violation of human rights and the right to life, " says one.

Bairagi and Mullick say the tests have failed but argue that the drug

" appears to be safe " . But then why did they force the women to sign consent

forms that stated " in the opinion of the investigator the method was safe

but its efficacy was unknown " ?

The only animal study cited by the doctors was done in rats by an American

doctor working for the US-based Family Health International, which promotes

sterilisation by drugs like quinacrine and erythromycin.

The quinacrine trials were funded by American doctors Mumford and

Elton Kessel. The contact details in the paper published by Bairagi and

Mullick gives Mumford's phone and fax numbers in the US.

Contraception blues

• Tests: Erythromycin, an antibiotic, was used as contraceptive in women

• Results: Two Kolkata docs who did tests say trials failed. Women became

pregnant despite monthly doses

• Violation: No permission taken for trials. Nor was protocol of testing in

animals and humans followed

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