BY MICHAEL ZIELENZIGER
Mercury News Tokyo BureauTOKYO -- In a nation where men write the rules and women do the dishes, the Japanese Health Ministry's speedy decision Monday to approve the male impotence drug Viagra has infuriated women's groups.
Why, they protested, did the government approve the new drug in a record six months, when Japan remains one of the last industrialized nations to ban the low-dose oral contraceptive for women?
``Of course it's a double standard,'' complained Yoriko Ashino, deputy executive director of the Family Planning Federation of Japan, which has been crusading to get the safer version of the Pill legalized. ``We've been waiting 10 years to get the low-dose Pill approved and this Viagra medicine is being approved in just six months.''
``In my view, the basic reason for the delay for approving the Pill is discrimination against women,'' she said. ``Male bureaucrats and government officials do not want women to have control over their own fertility. It's a sexist system.''
Her criticism was echoed by a sales representative for one of the nine pharmaceutical companies that have doggedly -- but so far unsuccessfully -- attempted to get the low-dose oral contraceptive approved. ``The old men who run the parliament are dying to try this Viagra,'' she complained bitterly.
The Health Ministry said Monday that it had put approval of the impotence treatment on a ``fast track.'' It is the first time, ministry officials acknowledged, that research collected in clinical trials on patients abroad was used to win approval for a drug in Japan.
``We hope other drugs will also be approved more quickly in the future,'' said Toshiki Hirai, director of the agency's pharmaceutical licensing division.
Hirai said the agency was impelled to act because a large number of Japanese men were obtaining the drug illegally through the Internet. One travel agency even sponsored tours to Hawaii, where men can obtain Viagra prescriptions. Officials estimated that more than 6 million Japanese men may suffer from the types of sexual dysfunction that Viagra might help treat.
Still no decision on Pill
In a brief interview Monday, Hirai refused to discuss why Viagra was approved so quickly using data collected on foreign patients, while the low-dose Pill, used by women in more than 100 nations, is still banned in Japan. He said the country's Central Pharmaceutical Affairs Council, which screens drugs for approval, has yet to decide whether the Pill is safe.
But in an earlier conversation, Hirai's deputy Yasuhide Furusawa said ``social concerns'' remain a major stumbling block in legalizing the Pill.
``There is a significant concern that permitting use of the Pill will accelerate the spread of HIV'' by encouraging sexual promiscuity by women, Furusawa said.
Last year, it appeared the Health Ministry was finally going to approve the Pill, but new objections were raised that it was an ``endocrine disrupter'' and the urine of users might pollute the nation's ecosystem.
Might there be a double standard for men and women in Japan?
Furusawa squirmed in his chair, shuffled his papers and struggled to come up with an answer to that question. After a nearly a minute of silence he said ``Accidentally. Viagra has been offered at a time when we are looking at foreign data. During discussion of the Pill, we did not accept such foreign data.''
In a country with one of the world's lowest birth rates, condoms and abortion remain the two most common forms of contraception. In 1997, according to government data, there were 1.19 million live births and 338,000 abortions. Experts said that perhaps an additional 100,000 abortions were not reported.
While only one in five American couples use condoms as the primary means of contraception, surveys show that nearly four in five Japanese couples do. Because condom use is not wholly effective, an estimated one-third of all births in Japan are ``mistimed.''
Unlike in America, however, there has never been a taboo against abortion in Japan; even before modern times it was considered a suitable means of contraception, according to Dr. Kunio Kitamura, chief gynecologist for the Japan Family Planning Association. ``There is no country where a baby can be aborted as safely or as easily as in Japan,'' he said.
But abortion's impact is visible at hundreds of Buddhist temples across Japan. There, visitors find thousands of tiny stone statues of infants, known as mizuko jizo, or ``water babies.'' Women who have had abortions leave these small statues, often decorated with tiny mittens, shoes or hats, in remembrance of an unborn child.
Revenue-driven
Women's groups complain that Japan's gynecologists are among those who want to keep the contraceptive pill from being widely used. They said doctors are protecting their revenue from pregnancies money made either from women giving birth or having abortions.
But Kitamura welcomed the Health Ministry's approval of Viagra, saying it increases the likelihood that the low-dose Pill will finally be approved this year. ``I welcome the legalization of any drug that is safe and effective. I feel more confident now that the Pill will be approved soon.''
Viagra's approval was so quick that neither the government nor Pfizer, the drug's manufacturer, could say how much it will cost in Japan or whether it will be covered by national health insurance.
``They decide the price of the drug, not us,'' said Leslie R. Patterson, president and Chief Executive Officer of Pfizer Pharmaceuticals, at a news conference. Last week Pfizer reported it had sold $788 million worth of the blue tablets since receiving U.S. Food and Drug Administration approval in April. Company officials refused to estimate how much Viagra they might sell in Japan, the firm's second largest market.
Emiko Doi of the Mercury News Tokyo bureau contributed to this report.
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