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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (955)	10/23/1998 2:26:00 AM
From: Anthony Wong	Read Replies (2) \| Respond to of 1722

10/23 01:24 Quick nod seen for Viagra in Japan as pill languishes By Elaine Lies TOKYO, Oct 23 (Reuters) - If typical Japanese medical practices are any guide, Viagra shouldn't be in the hands of consumers here for decades. After all, the birth control pill still isn't available some 35 years after its Western debut. But the blockbuster anti-impotence medicine is likely to be available in Japan with unusual speed for a foreign drug, perhaps sometime early next year, industry sources said. And family planning activists are furious. "The whole thing is outrageous," said Kunio Kitamura, director of the Japan Family Planning Association. "There are real problems in a country that approves Viagra and won't approve the pill." Kitamura and others have struggled for years to bring the low-dose birth control pill to Japan. Japan remains the only industrialised country to prohibit the pill for contraceptive purposes. Low-dose contraceptives are banned altogether while high and medium-dose pills may only be legally prescribed for menstrual disorders. Condoms are the main form of birth control, leading to a thriving abortion industry and reluctance on the part of doctors to actively support the pill, some activists say. Opponents of the pill have also said its use would promote promiscuity, while heavy coverage of potential side effects has made most women shun it as a contraceptive choice. Most recently, concerns were raised that estrogen-tainted waste from women who use the pill will cause reproductive troubles in animals, a health ministry official said. Asked when the pill might be approved, he declined to give specific details but said: "It won't be anytime soon." But for Viagra, which on July 24 was submitted to the health ministry for approval by Pfizer Pharmaceuticals Inc, a division of U.S.-based Pfizer Inc the process appears to be moving along smoothly. "I'd say things are in the final stages," said Masafumi Shirai, an advisor at Hakujikai Memorial Hospital in Tokyo. "Definitely less than a year, and probably under six months," he added. The health ministry official declined to comment, citing ongoing discussions. A Pfizer spokesman also would not comment. But company president Henry McKinnell has been quoted as saying it hopes to offer the drug in Japan by the first half of 1999. Viagra advocates say it should be approved as soon as possible because it is already being bought and sold under the table and used without supervision, often dangerously - such as taking more than one at a time. One Japanese man has already died from using the drug. "Supposedly because of these risks, they'll shorten the pre-approval testing period," said Kitamura. Several doctors said data from initial Japanese tests agreed so completely with overseas tests that one stage of testing has, in fact, been omitted and the overseas data used. "There's pressure these days from other countries to make the Japanese pharmaceutical market more open and standards congruent with those abroad," Shirai said. But activists said the government remains curiously blind to foreign data regarding the pill. "We can say it is safe, because it's been thoroughly researched around the world. Probably few other drugs have been studied as much," said Midori Ashida, secretary of the Professional Women's Coalition for Sexuality and Health. The problem is that the pill is entangled with social and moral issues in official eyes, with the attitude that women who use the pill are "irresponsible" still lingering, she added. Yet no moral qualms have been raised about Viagra. "My patients are all very earnest," one doctor at a major Tokyo hospital said. "This is for a medical problem." Kitamura said that while impotence is certainly a serious disorder, there are no guarantees that people who use Viagra will confine their sexual activities to their marriages, raising the spectre of a rise in sexual diseases such as AIDS. But when the health ministry in 1992 dramatically reversed its decision to lift the ban on the pill, fears about the spread of AIDS were given as the reason. Even now, concern about AIDs and the pill remains high. "Proposals for legalising the pill have included requiring that women who take it have a number of tests, including those for sexual diseases, every three months," Ashida said. The tests, like the pill, would not be covered by insurance. Asked if Viagra users will face a similar system, the health ministry official said: "The effects of the drugs are different, so the same tests will not be required." moneynet.com@NEWS-P2&Index=0&HeadlineURL=../News/NewsHeadlines.asp&DISABLE_FORM=&NAVSVC=News\Company