Women Find Viagra’s Speedy OK Is Bitter Pill to Swallow

Female tempers are flaring. Thirty-four years after the birth control pill was first submitted for approval in Japan, the Ministry of Health finally made a decision this week: It approved Viagra, the best-selling anti-impotence drug, whose application was rushed through in a mere six months.

The pill remains banned.

“Am I the only person who is outraged by this total nonsense?” wrote Setsuko Ogawa in a Mainichi daily newspaper article attacking Japan’s pharmaceutical regulatory policy as hypocritical, male-centered and discriminatory.

“Why do they make everything convenient for men and strict for women?” parliament member Mizuho Fukushima asked.

“The drug that lets you get pregnant is approved, but the one that would prevent pregnancy is not,” she said, concluding: “The Japanese government will resort to anything possible in order to increase the birthrate.”

Fukushima said the outburst of female ire over Monday’s decision to approve Viagra could increase pressure on the authorities to also approve the pill this spring. However, she noted that a letter from 68 female lawmakers last year asking for a quick decision went nowhere.

Japan, with its wealthy and aging population, is expected to be a lucrative market for Viagra, which is made by New York-based Pfizer and is sold in about 40 countries. Japanese men had already been experimenting with the drug--perceived by many here as more of an aphrodisiac than an impotence remedy--leading to the death of an elderly man last year and to the arrest of an Osaka black-marketer.

The Health Ministry reportedly decided to approve Viagra quickly to avoid deaths among men popping the pills without medical supervision. The government has not yet decided whether national health insurance will pay for the drug.

A ministry official who asked not to be identified insisted that the six-month approval time for Viagra was not unprecedented; AIDS drugs also have been approved swiftly.

The official insisted that “male logic” and concern over Japan’s plummeting birthrate--now far below population replacement level--had nothing to do with the delay in approving the pill. He noted that there are women on the decision-making committee--although Fukushima reported that women make up three of the 24 members. The official cited fears that approving the oral contraceptive would lead to a decrease in condom use--70% of Japanese use condoms for contraception--and thus to an increase in HIV infection.

Most recently, the committee has been considering suggestions that hormone-laced urine from women on the pill might flow into Japan’s rivers and act as environmental endocrine-disrupters, leading to deformities in fish and potential human health problems.

In reality, hundreds of thousands of Japanese women are already on some form of oral contraceptive. An estimated 200,000 are taking a 1960s-vintage high hormone-dosage pill, which was approved only for the treatment of menstrual disorders in 1966 but is prescribed by doctors to women who want contraception, despite the side effects. Untold others obtain pills abroad.

Applications for approval of safer, low-dose pills have been pending at the Ministry of Health since 1990 with no action.

Yet the tide may be turning, judging from the headline, “Sexual Discrimination in Drugs? Viagra and the Pill,” in the Sankei newspaper, Japan’s most conservative daily.

The story begins with an account of a telephone call reportedly made last summer by a male lawmaker to a friend at the Ministry of Health, saying: “I’d like to try Viagra. Could you get some from the university that’s testing it?”

The article questioned the rationale for approving Viagra, a drug that has already been associated with 130 deaths, before the pill, which has been used for decades by hundreds of millions of women worldwide.