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VIAGRA FEVER:
Impotence Drug Creates Gray Market

September 25, 1998

The new male impotence drug Viagra has already become one of the most famous pills in the world. In Japan, where the drug is not authorized, imports are flooding in as individuals place orders via the Internet and other routes, and men's magazines dwell on its effects in almost every issue. But the first Viagra-related death has already been confirmed in Japan. The Health and Welfare Ministry, however, has been reluctant to issue a specifically worded warning because the unapproved drug technically is not available in Japan. Nonetheless, its popularity shows no sign of waning; import agents are popping up everywhere, and demand is such that purchasing tours to the United States are being offered.

Over 1,000 Viagra Home Pages
Advertising and selling imported drugs that have not been approved as medicines within Japan is prohibited under Japanese law. But the import of drugs prescribed for up to a month for individual use does not come under the ban. Accordingly, the number of import agents using the Internet to solicit individual customers has ballooned. They are said to have set up over 1,000 home pages.

Usually, on receipt of an order import agents will send a simple questionnaire asking the applicant about his medical history. The questionnaire is sent back, in paper form or electronically, and is shown to a U.S. doctor by a middleman. The doctor writes out a prescription enabling the Viagra purchase to be made in America. There are even said to be some import agents who drop the prescription requirement. The current price, including commission and other costs, is 60,000 to 90,000 yen (444 to 667 U.S. dollars at 135 yen to the dollar) for a jar of 30 pills. The price has come down since the drug first became available, but it is still high compared with around 300 dollars a jar in the United States.

Viagra Tours
One travel agency offers Viagra-purchasing tours to Hawaii. Once in Hawaii, participants undergo a 15-minute examination by a Japanese doctor, get a prescription, and buy their pills from a pharmacy housed in the same building. The pills and examination together cost around 600 dollars. Since the five-day package includes three nights in Hawaii, there is plenty of time for shopping and sightseeing. But the round-trip flight, hotel accommodation, and guide service run to around 100,000 yen (741 dollars).

Also catering to Viagra users is one Japanese doctor resident in the United States who comes back to Japan every three or four months to see patients in a hotel room or similar premises and prescribe drugs not approved in Japan. He has recently seen a big rise in Viagra queries.

Health Ministry's Dilemma
In July 1998, Japan suffered its first Viagra-related death. The victim is thought to have obtained the drug from a friend and used it in conjunction with nitroglycerin, which he was taking for his angina--a deadly combination. The tragedy persuaded the Health Ministry to stop turning a blind eye to Viagra and to set up a home page describing its risks. But in order to avoid creating an impression of official approval for the drug, health officials gave the page the vague title, "Information on death following Viagra use."

In July 1998, Pfizer Pharmaceuticals Inc. applied for Health Ministry approval of the drug, developed by its U.S. parent Pfizer Inc., for use in Japan. With approval considered an "urgent necessity in view of the social ramifications," the Ministry loosened its requirements for clinical tests in Japan. It has allowed the Japanese subsidiary to use some data from clinical trials in the United States, expediting the application.

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Trends in JapanEdited by Japan Echo Inc. based on domestic Japanese news sources. Articles presented here are offered for reference purposes and do not necessarily represent the policy or views of the Japanese Government.

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