WHO Denies Company Male OC Claim

The World Health Organization has denied a Brazilian company's claim that it has backed Nofertil, a male contraceptive pill based on gossypol. Hebron SA of Brazil, which hopes to make the drug, said its approval studies were done in conjunction with the WHO, which it said had also approved the drug.

The WHO says it does not have a mandate for approving drugs for marketing and does not endorse products of any commercial company. It decided not to support clinical research into gossypol in 1981 after studying the available literature on its safety and the reversibility of its antifertility action. It did sponsor animal studies in the early 1980s, which revealed even at relatively low doses signs of toxicity in animals and concerns at lack of complete reversibility. There has since been "no basis for the WHO to reverse its 1981 decision," says the Organization.