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The Rise of Viagra

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One fateful day in March of 1998, porn stars and old geezers everywhere joined hands and rejoiced, singing the gospel of Viagra and basking in its shimmering promises of renewed sexual bliss. It was on this day that the Federal Drug Administration, FDA, had approved Viagra, leading Pfizer Inc. to join the ranks of those who dominate the pharmaceutical world, while simultaneously leading to the formation of countless beleaguered old wives’ groups. The litany of bad late-night jokes aside, the medical community welcomed Viagra with open arms — impotence for some men, after all, was on par with castration.
In order to bring Viagra to the market, scientists had to pass a rigid hierarchy of FDA-approved tests to ensure the drug’s safety and efficacy. In the first phase of trials, after having shown early promise when tested on animals, the drug was given to a few dozen healthy volunteers to determine preliminary physiological repercussions, such as the side effects associated with increased doses.

When Viagra was deemed safe, it moved on to phase II, where the effectiveness of the drug was closely monitored in well-controlled studies involving hundreds of people. Finally, in phase III studies, performed on thousands of volunteers, scores of clinical trials were conducted to paint a clear picture of its overall potential benefits to the general population. Pending phase III clearance, untold of millions of dollars awaited the scientists and Pfizer Inc.

Carefully conducted clinical trials are integral to advancing medical knowledge. They are the fastest way to find new treatments for ravaging ailments like cancer and AIDS. Oftentimes, however, the trials introduce treatments or medications that are so cutting-edge that scientists may be unsure of potentially deleterious side effects. So an implicit agreement is forged between the doctor and volunteer. Having given his informed consent, a volunteer acknowledges that he understands the purpose, methodology and benefits and risks of the trial in which he will participate. The doctor must minimize the risks in the trial, and bring it to an abrupt halt should he detect even an inkling of adverse consequences above the acceptable risk inherent in any study involving humans.

In rare circumstances, however, you’ll have an ambitious physician who, in his quest to rescue the world from death’s grip, could err towards the side of risk. Or you could have a doctor performing a clinical trial who holds a disconcertingly keen interest in making sure a drug jumps through hoops as swiftly as possible, perhaps due to increased funding for other trials from a pharmaceutical conglomerate. In these cases of conflicting allegiances, the institution must stop the trial before something important such as patient safety is compromised.

Thus, every clinical trial in the United States is approved and monitored by an Institutional Review Board, IRB, which is composed of an independent committee of physicians and community members who ensure that a clinical trial is ethical, and, more importantly, that the rights and safety of the study participants are protected. With the voluminous amount of research occurring at the Medical School, it is not surprising that Stanford has three IRBs — one of which, I am a member of.

The IRB that approved the clinical trials involving Viagra must have done so with a smirk — and, if they were professors emeriti, perhaps also with a glimmer of hope. The scientific community was initially skeptical of a magical pill that could cure porn induced erectile dysfunction. Scientists believed that impotence stemmed from unresolved psychological issues. Such a thought was dispelled during an American Urological Association meeting, however, when a psychiatrist dropped his pants to demonstrate to skeptics once and for all that a penile injection of phenoxybenzamine — a compound found in Viagra — could cause an erection. There was a sudden burst of interest, and clinical trials came out of the works at a punishing pace.

In 1994, during phase II investigations, the drug worked so well that men fought relentlessly to get themselves into trials and refused to return unused pills. Even after the trials ended, Pfizer continued to dispense tablets out of compassion: Divorced men were sending poignant letters of how impotence had broken up their first marriage, and how they didn’t want it to happen again.

Since the FDA’s approval, 16 million people have used the pill to improve their sexual well-being. On its Web site, the FDA warns that a number of side effects have been reported for Viagra use, including heart attack, stroke, chest pain and increased blood pressure. These warnings should be seriously contemplated: A few years back, I remember reading that an older gentleman, after taking a double-dose of Viagra, croaked while in the middle of his performance.

I wasn’t sure if I felt more sympathy for the man or for his partner.

The FDA, additionally, lists two special notes: “Viagra can cause a rare but serious condition of prolonged erection (priapism). It is important to contact your health care provider immediately if your erection lasts longer than four hours.” And, understatedly: “Men for whom sexual activity is inadvisable may not be good candidates for natural Viagra.”

So there you have it. Important information straight from the venerable FDA, culled from studies published by the near slave labor of inadequately paid scientists and medical professors testing the safety and efficacy of the drug so that you, the consumer, could be sufficiently forewarned.

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