Do the people suffering from ED really need Viagra?

JAKARTA (JP): Sex remains a touchy issue and is taboo for open discussion in some parts of society. Yet, regardless of the societal constraints, no subject is more controversial, and perpetual, than sexual vigor.

The contemporary controversy revolves around sildenafil, better known as Viagra, produced by the American medical giant Pfizer.

Although the invention of Viagra is a medical breakthrough, the recent vibes regarding the pill in reality just add a little more fuel to people's quest for the fountain of youth.

Accepted in Europe and approved by Food and Drug Administration (FDA) in the U.S., although the drug is clinically proven to cure certain causes of erectile dysfunction (ED), its safety is still questionable.

In Indonesia, study of Viagra has been conducted by a team of doctors led by Akmal Taher of the University of Indonesia. Together with their counterparts in Hongkong, Malaysia, the Philippines, Singapore and Thailand, the researchers have studied more than 400 volunteers.

The research, taking place between March and July this year, involved about 120 patients with ED, of which half were treated with Viagra while the rest used placebos.

According to Akmal, the research showed the efficacy of Viagra was 68 percent, while 27 percent of those taking placebos felt some kind of 'effect'.

According to Akmal, the average age of volunteers was 55 years. None of them died in the course of the test.

More than 120 deaths have been reported in the United States in connection with Viagra.

"There have been more than six million prescriptions issued worldwide. Among these, 200 deaths or more are possible. Yet, the patients' ages should be taken into consideration," said Akmal.

Akmal also questioned the statistics of deaths among Viagra users as released by the U.S. Food and Drugs Administration because the figures were produced without the consumers' medical backgrounds.

Although it is still not possible to conclude whether cardiovascular events are directly related to the use of Viagra and sexual activity, Pfizer has added information to the labeling of Viagra.

Issued in late November, the information addresses postmarketing reports of cardiovascular events such as heart attacks, sudden cardiac death and hypertension. It also advises against the treatment of Viagra on men with underlying cardiovascular problems and hypertension.

The information also cautions against the drug's use for patients with a certain medical history, since the groups were not studied in clinical trials. These groups comprise patients who have suffered cardiovascular problems over the past six months, have significantly high or low blood pressure, have a history of cardiac failure or coronary artery disease.

Patients with retinitis pigmantosa, an eye disorder, are also cautioned.

Although three percent of all patients reported visual disturbances, the Federal Aviation Administration's Federal Air Surgeons Medical bulletin has already cautioned pilots not to take Viagra six hours prior to their flight. The drug is suspected to impinge on the ability to distinguish between green and blue.

Pending authorization from the Ministry of Health, a black market for Viagra in Indonesia has been flourishing. Advertising in newspapers and equipped with cellular phones and e-mail addresses, the sellers will deliver the tablets directly to your house, even a single pill costing Rp 250,000 ($31).

In reality, causes of erectile dysfunction are not limited to the lack of production of cyclic guanosine monophosphate (cGMP), a substance that is needed to achieve erection, which Viagra helps to boost.

Experts say that to find the cause of ED, a proper evaluation consisting of medical, detailed sexual history, physical examination, psycho-social evaluation and basic laboratory studies needs to be conducted thoroughly.

According to Impotence Consens statement 1992 prepared by the National Institute of Health, USA, sexual history including practices and techniques "is needed to accurately define the patient's specific complaint and to distinguish between true erectile dysfunction, changes in sexual desire, and orgasmic or ejaculatory disturbances".

On the other hand, health factors such as hypertension, diabetes, smoking, coronary artery disease, peripheral vascular disorder, pelvic trauma or surgery may contribute to patient's erectile dysfunction.

Currently, there are four types of treatment for erectile dysfunction available according to the patient's need: external management, pharmaceutical treatment, surgery and psychotherapy.

External management consists of vacuum therapy--a suction device that creates an erection and then maintains it with a rubber ring. Although considered impractical-- the procedure has to be conducted prior to sexual intercourse, therefore it may interfere with the mood--in a clinic the device is used to test the patient's erection rigidity. Reports of side effects are minimal, yet mutual understanding by the patient's partner is needed.

Three types of pharmaceutical treatment are available. Oral medication such as Viagra, Yacon (yohimbe) or paxil is widely known, while the traditional medicine (jamu) has been used generation after generation in Indonesia.

Another method of pharmaceutical treatment is injection therapy. Through the discovery of Alprostadil, a synthetic formula that relaxes penile muscle through cGMP. Inserted through urethra, Muse is a less intimidating form of treatment using Alprostadil.

Surgery gives two solutions: implant of devices -- designed to provide long-term solutions to impotence -- and vascular surgery. Vascular surgery is performed to mend blocked or narrowed arteries.

Since not all erectile dysfunction is related to health conditions, psychotherapy and counseling is one treatment that is widely used -- sometimes concurrently with other treatments.