Team to decide on Viagra by November

By Stevie Emilia

JAKARTA (JP): The Indonesian government has apparently lost the battle against Viagra pill traders.

While the drug to overcome male erectile dysfunction is already on sale, albeit illegally, health ministry officials assisted by health experts are busy pooling ideas to determine if the drug should be allowed or banned.

Meanwhile, the U.S. drugs giant Pfizer Inc., which made a breakthrough with the introduction of the first impotence pill, is keeping a low profile.

The Ministry of Health's director general of food and drug supervision, Sampurno told The Jakarta Post that Pfizer representatives here proposed the registration of Viagra with his office about six months ago.

"Viagra is a strong medicine. At the moment, we're still evaluating its benefit and safety aspects. But if the drug is allowed to be sold here, it should be prescribed," he said.

The evaluation, he said, was conducted by a team of experts from among other places, the University of Indonesia.

"I haven't set a deadline when the evaluation should be completed, I don't want to interfere with the team's work," Sampurno said.

Under Indonesian law, every new drug has to be registered with the ministry before it can be prescribed by doctors or sold at drug stores.

"So, if there are ads offering Viagra, that's illegal," Sampurno said, asking the media not to publish such advertisements any more.

Viagra, he said, was aimed at only those who suffered from impotency.

"People can't use Viagra whenever they feel like it. It should be used under a doctor's supervision," Sampurno said.

Iwan Darmansjah, a member of the team, said it was working hard to analyze the pill before giving any recommendation to the ministry.

"Maybe this is the strictest evaluation (on a new drug) that we have ever conducted ... The evaluation might be completed by the end of October or early November," he told the Post on Saturday.

He said that, in his opinion, Viagra might be considered a 'recreational drug', but in a different category from Ecstasy, which is also considered a recreational drug.

Ecstasy, he said, was illegal and had not been officially tested by experts, while Viagra was offered to the public only after a great deal of research and strict controls.

But Iwan agreed that if the pill was approved, it would have to be issued under prescription.

"One can't be able to buy the pill just like that .... It should be prescribed as it can cause death," said Iwan, the head of the University of Indonesia's Clinical Trial Center and chairman of the ministry's drug safety and efficacy subcommittees.

Pfizer's local representative declined to comment on the new pill saying only that "Viagra was still under the ministry's evaluation."

AP reported in August that 69 Americans taking Viagra died between late March and July, with 46 of these cases linked to heart attacks and other cardiovascular incidents.

Of the 69 confirmed deaths, the cause was unknown for 21 patients, two had strokes and 46 had cardiovascular attacks, including 17 cardiac arrests. The median age among those who died, based on the ages provided for 55 of the patients, was 64.

The U.S. Food and Drug Administration, which approved the sales of Viagra in March, said in a posted summary that more than 3.6 million prescriptions for Viagra were dispensed between late March and July of this year.

DPA news agency quoted a Pfizer report written in March that the drug was tested on more than 4,000 men with a median age of 55. Viagra was shown to be effective for seven out of 10 men overall, including those whose problems were associated with diabetes, spinal cord injuries or psychological problems.

The company also said that possible side-effects include headaches or dizziness, and warned that patients who take nitrate medicine to treat angina (a heart condition) should not use Viagra.