The New Straits Times, April 2, 2000
By Prof Dzulkifli Abdul Razak
AFTER two years in the global market, sildenafil, better known as Viagra, an icon drug of the Nineties, has become a real best-seller including via the Internet. Online pharmacies have been known to sell Viagra without prescription.
Last week, the US Customs Service reportedly shut down seven pharmacy websites in Thailand that sold prescription drugs to Americans illegally over the Internet.
Viagra is available in countries where sales are still not approved, for example Sri Lanka. It has already reported its first death related to the use the pill.
But the popularity of the little blue pill has brought tough competition. When it first went on sale in 1998, it inspired others to produce similar products including an array of home-grown anti-impotence remedies.
Names like "Viagrafrica", "Lovejet" were bandied around as possible competition. A French company announced that it would soon produce a "Super Viagra" for the market.
Even today there are many serious competitors in the pipeline. Last month, another drug developer was granted a US patent protection for "commercialising locally delivered phosphodiesterase (PDE) inhibitors".
PDE is the enzyme that Viagra inhibits to produce its effect. In other words, the new product while acting like Viagra, has the advantage of being marketed in the form of a topical cream, for instance.
In contrast with pills, the formulation of a topical or local drug delivery is expected to avoid many risks normally associated with oral or systematic drug administration.
Adverse reactions are still a major concern, although Viagra is generally approved for use even in heart patients (subject to proper medical examinations).
Recent findings from researchers at Cedars-Sinai Medical Center in Los Angeles, using data from the US Food and Drug Administration's post-marketing surveillance, reported 1,473 serious adverse events that were associated with Viagra.
Of these, 65 per cent were deaths, heart attacks, lethal or non-lethal arrhythmias. Death and heart attack accounted for 57 per cent of the serious complications.
The data included 3,700 men with erectile dysfunction and heart disease.
The researchers reported that only 12 per cent of the Viagra-associated deaths occurred in men who were using nitrates.
In 67 per cent Viagra-associated deaths, men had no diagnosis of heart disease.
They said that "although concomitant use of nitrates was associated with significant risk, most deaths occurred in patients not on... nitrates."
The researchers have concluded that further studies "are urgently needed to establish the safety of Viagra".
Meanwhile, some governments have refused to recognise the patent on Viagra due to the cost factor. In January, the Government of Colombia declined to give the manufacturer a patent, on the grounds that it had already obtained patents on Viagra's active ingredients for use in other drugs that have been earmarked for treatment of heart disease.
Instead, a local pharmaceutical firm has been given official blessing to begin selling a local version of Viagra.
Another local company is reportedly planning to introduce a third version of the drug. It "has all the same levels of quality and the same effects as Viagra", but costs just about half as much. The manufacturer of Viagra has vowed to take the Government to court.
The manufacturer has already done so in Australia in another context and lost.
It took Australia's Pharmaceutical Benefits Advisory Committee, (PBAC) to court last December (Poison Control, NST, Jan 16) to challenge the committee's decision not to subsidise the anti-impotency drug in the bid to save around A$45 million (RM112.5 million).
The manufacturer lobbied against the decision, forcing the Government to re-evaluate the pricing and listing of drugs on the nation"s Pharmaceutical Benefit Scheme (PBS).
Faced with protests from consumer, medical, and community groups, the Government later reconsidered its view. In fact, this was supported by a court ruling which dismissed with cost the manufacturer's plea to subsidise the drug.
On March 20, the judge found that "the Government's Pharmaceutical Benefits Advisory Committee was correct to take into account the large cost of the drug to taxpayers when it recommended against listing Viagra on the Pharmaceutical Benefits Scheme".
Evidence in the case revealed the manufacturer"s own figures showing that Viagra would add A$45 million to the PBS bill in the first year it was listed and A$64 million in the second year.
Other estimates of the possible costs of listing Viagra would equal the annual operating cost of a small Australian teaching hospital. The transcript makes it clear that the manufacturers failed to suggest satisfactory mechanisms for controlling these costs.
Viagra, legally available in Australia, costs $70 for four tablets. A PBS subsidy would have slashed the price to around A$20 for most patients and as low as A$3 for special users (healthcare card holders). The ruling, however, does not deny or prevent the company from re-applying for a subsidy on the PBS.
According to a professor of clinical pharmacology, Dr David Henry, even though if the ruling favours the manufacturer, the drug would not automatically have become available on the PBS.
The problems that arose with the previous submissions, namely the cost of the drug, must first be addressed.
As noted in a letter to the Australian press: the manufacturer "could show some goodwill and altruism and drop the price of the drug to where it is affordable to us Australians and to PBS."
This seems to be sound advice on behalf of the many users who need the drugs, especially in the Third World.
For Malaysians too drug pricing is an important issue. The Health Minister's call that the pharmaceutical industry "jointly draw up a standardised and transparent policy on the sale of drugs to doctors" (NST, Mar. 11), and by extension consumers, must be fully supported and complied with.
Aptly enough, Viagra is available in this country on April 1, widely recognised as April"s Fool Day. We need to be sure as far as drug pricing is concerned, we are not fooled.
