Viagra hits the market with limitations

Viagra hits the market with limitations

By Stevie Emilia

JAKARTA (JP): After a three-month delay, the "wonder pill"
Viagra, as it frequently dubbed, will finally be sold here --
with several restrictions -- starting in August, at the price of
US$10 per tablet.

The drug can be prescribed by any doctor who has completed a
one-day training session on erectile dysfunction and its
prevention organized by the Indonesian Medical Association.

In March, the Ministry of Health's Director General of Drugs
and Food Supervision Sampurno approved Viagra's marketing here,
but it could only be prescribed by medical specialists, such as
urologists, internists, cardiologists and doctors working at
medical clinics specializing in impotency.

Sampurno said the new regulation was carefully made and he
dismissed speculation about possible abuse of the pills.

He explained the change was made following recommendations by
the medical association, saying that 80 percent of erectile
dysfunction cases were treated by general physicians and not
specialists.

The recommendation was then brought to the National Committee
of Drug Evaluation, which later agreed that general physicians
could prescribe the drug only after completing the training.

"Besides, the urologists themselves, only about 100 of them,
said that they could not handle those with erectile dysfunction
alone," Sampurno told The Jakarta Post by phone on Monday.

At present, it is estimated there are around six million
people suffering from erectile dysfunction across the country.

Sampurno said the ministry would also monitor the drug within
a six-month evaluation period to prevent any abuse.

Viagra, which restores a man's ability to respond naturally to
sexual stimulation, is a strong medicine only effective for those
suffering from impotency and is not recommended for people
suffering from certain diseases, such as hypertension, he added.

"Viagra is not to be used for fun. With the monitoring system,
we expect there will be no abuse of the pill," Sampurno said.

Viagra's local manufacturer, PT Pfizer Indonesia Tbk., is
required to prepare an information sheet on the drug, including
its side effects, for doctors and related medical workers. The
information sheet is approved by the Ministry of Health's
directorate general of drugs and food supervision.

Every month, the manufacturer is also required to report the
monitoring results of Viagra's side effects, supply and
distribution to the directorate general.

Apart from following the training, doctors should report any
findings of the drug's side effects to the ministry.

The first training session in Jakarta was held last Saturday
at the Hotel Mulia Senayan and was attended by around 1,200
doctors.

The medical association's chairman, Merdias Almatsier, said
the training program materials were prepared with guidance from
the Indonesian Erectile Dysfunction Advisory and Training
Council.

He added that other medical institutions could also hold
similar training courses after receiving accreditation from the
association. Accredited institutions will be able to train
doctors with materials and guidance provided by the association.

Merdias said the training was held with the serious intention
of preventing the abuse of the drug.

For instance, doctors were not allowed to simply register and
then be given certificates without completing the whole session,
he said.

"Doctors are required to follow the whole session," Merdias
said after opening the training program here. "By attending the
whole session, they will get clear information and treat those
with erectile dysfunction well and rationally."

The names of doctors participating in the training session
would then be delivered to the Ministry of Health before being
given to pharmacies that provide Viagra (sildenafil citrate).

After Jakarta, similar training sessions will be held this
month in Medan, Bandung, Semarang, Surabaya and Denpasar.

Every pharmacy is required to make a written request to the
distributor before being able to get the drug.

And under the ministry's regulation, pharmacists themselves
must personally give the drug to customers and provide them with
accurate information. The pharmacies are also required to record
all sales of Viagra.

Since its approval by the U.S. Food and Drug Administration in
March last year, more than 11 million Viagra prescriptions have
been written globally. It is now available in more than 70
countries.

But here, Viagra -- which works by increasing the blood flow
to the penis necessary for establishing and maintaining an
erection -- has been found in many places long before its
official marketing, at prices ranging between Rp 90,000 and Rp
125,000.

Pfizer acknowledged the situation and pledged to compete with
the illegal distributors.

"If the rupiah keeps strengthening, we can compete much
better," the company's pharmaceutical director Simon Tobing told
journalists during a press education forum last Thursday.

In Indonesia, Pfizer will provide 25 milligram and 50
milligram Viagra pills directly imported from the U.S., while
most illegal distributors sell 100 milligram pills. It will start
producing the drug here after evaluating the market's response.

Although the company regards Indonesia as a potential market,
in its initial marketing here the company does not expect to reap
a huge profit, but said it was focusing more on education
programs.

"Many (erectile dysfunction patients) do not have the
awareness to consult doctors about their problem yet," Simon
said.

"From about six million people suffering from erectile
dysfunction, only about 10 percent of them consult doctors.
Others live with their problem, while others try to find a
solution on their own," he added.

The company's marketing director, Noko Sumanto, says that
erectile dysfunction is now a well-known common medical
condition.

"It is no more a social stigma and there's no need to hide
yourself away... it's ok to talk about it."