The New York Times.
September 23, 2002.
IN the four years since Bob Dole proclaimed the restorative wonders of Viagra, millions of men have filled millions of prescriptions to the delight, presumably, of millions of sexual partners. Now the drumbeat has begun for two similar medications that, if approved next year as expected, could offer new competition to one of the most famous pharmaceutical brands.
Viagra brought in an estimated $1.5 billion in worldwide sales for its maker, Pfizer, last year, a figure expected to rise to $1.7 billion this year, according to Dr. Leonard S. Yaffe, a pharmaceutical analyst for Banc of America Securities.
The potential market, though, could be much bigger: drug companies cite studies suggesting that 30 million American men may suffer from what used to be called impotence but is now referred to, with tactful precision, as erectile dysfunction. Fewer than a quarter are thought to have sought treatment.
For now, the pharmaceutical battle has been delayed. The makers of the new Viagra variants had each hoped to receive approval this year from the Food and Drug Administration to market their products. Several months ago, however, the agency asked both manufacturers to submit additional data, although neither the regulators nor the companies have publicly revealed the specific concerns prompting the request.
Despite the setback, the medical community expects the two drugs to be approved sometime next year. One is Cialis, from the Prozac-maker Eli Lilly and the biotechnology company Icos. The other is vardenafil, from a partnership of the pharmaceutical giants Bayer and GlaxoSmithKline.
While Viagra has won wide acceptance, it has not been free of problems or controversy. Some users complain of side effects like headaches and stomach upset. Doctors advise men with cardiovascular problems to use it cautiously, and those taking nitrates to treat heart conditions are warned against taking it at all.
Pfizer has repeatedly stated that the drug works only with sexual stimulation and should not be considered an aphrodisiac. But in the last year, public health authorities have become concerned by reports that some men, particularly in the gay community, view Viagra as a drug to take in combination with speed, Ecstasy and other party substances that can make it difficult to sustain erections. Because many Internet sites routinely sell Viagra without imposing even minimal, and legally required, controls, policing nonmedical use can be extremely difficult.
The drug has also faced more competition from a host of companies marketing vitamins, herbs and other supplements. They have persuaded many consumers that their products do the same thing — or better — for far less. According to the National Nutritional Foods Association, a trade group, sales of supplements promoting sexual health increased 50 percent last year to about $150 million.
LIKE Viagra, the new drugs being developed, vardenafil and Cialis, aim to increase the flow of blood to the penis by inhibiting an enzyme called PDE-5. Researchers say that the effects of Cialis, in particular, are longer-lasting than Viagra, which could make it both cheaper and more convenient to use but could also increase the possibility of negative interactions with other drugs.
In addition to these new PDE-5 inhibitors, a testosterone topical cream, AndroGel, has become increasingly popular since it was approved two years ago. It is indicated specifically, however, for men with low testosterone levels and can have potentially serious side effects, including increased risk of prostate problems in older men.
While analysts doubt that the delay will hurt the drugs’ prospects, some experts are questioning the numbers of men who are routinely cited by drug companies and urologists to be suffering from erectile dysfunction. ”I think those numbers are dramatically inflated,” said Michael Kimmel, a sociology professor at the State University of New York at Stony Brook. ”They’re designed to create a widespread frenzy of interest in this kind of therapeutic intervention. You were so drunk and couldn’t stand up and couldn’t get an erection? Take this pill.”
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