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How I helped Pfizer think about the ethics of Viagra 25 years ago

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TFive years ago, 75-year-old Bob Dole, a former Republican presidential candidate and United States Senator from Kansas, went on Larry King Live and pleaded sexually impotent.

That same year, he became an official pitcher for Viagra, which the Food and Drug Administration approved in late March 1998 for the treatment of erectile dysfunction although that now-common phrase hadn’t yet entered the lexicon. Pfizer was paying Dole to help remove the stigma and shame associated with the condition.

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In another ad, a couple dances with a focus on their wedding rings. The slogan of the ad was Let the Dance Begin. No mention of Viagra. But a clear message that if erectile dysfunction had left a marriage bed cold, Pfizer now had a solution.

Indirectly, I was partially responsible for both of these announcements. In late 1997, about six months before the FDA approved Viagra, I received a call from the head of the Pfizer Viagra team asking if I would be interested in doing a consult for them. He explained that they had a drug that he was going to sell but that it would probably also be ethically convoluted. I had never been contacted by a pharmaceutical company and I wasn’t sure what to say. I agreed to go to New York City from my office at the University of Pennsylvania in Philadelphia (there was no Zoom in those days) and meet him.

After clearing security at Pfizer headquarters, no mean feat, I was led into a generic conference room where the team was waiting. They explained that the company was developing a drug for angina and to reduce high blood pressure. It didn’t work for its intended purpose, but it had a noticeable side effect. In clinical trials, many men have reported having erections in the presence of young nurses conducting the trials. They had repeated the full process with young nurses on various groups of men in the UK with similar results. Their internal studies in Asia, they told me, showed similar results, with 80 percent of adult men reporting full or partial erections.

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It was all very interesting, but I can’t say exactly what they had in mind for me. The answer, it turned out, was that the company had little experience with reproductive or sexual issues. The executives were terrified that if they continued to develop this drug, they might get involved in all sorts of sex controversies. My job was to anticipate what those controversies might be and perhaps try to suggest remedies for them.

I had no idea how to run a consult. No professor of my PhD in philosophy had ever imagined such a request. I took the job, only asking that they pay for my travel and food expenses, no supplies, no pay. Not because I was ethically enlightened, I was just naïve about the profits the company was about to make. During my year there, Pfizers stock would have experienced a 30% gain. Sales hovered between $1.5 billion and $2 billion annually until 2017, when generic drugs became available.

My most important advice, which I think is evident in the hype, was that the pill had to target a disease. Helplessness was too vague a concept. A disease category would make it easier for men to get over the shame and seek help. Additionally, a medical condition would help deflect conservative moral criticisms that Pfizer was selling a sex pill and encouraged promiscuity. Shortly thereafter, popular understanding of erectile dysfunction arose, and Pfizer’s brilliant salesmen and advertisers envisioned Dole as its initial spokesperson. So I was a bit of a midwife to Dole’s astounding public admission.

I also urged the company to keep a close eye on post-approval side effects and deaths to discourage lawsuits. Pfizer’s lawyers had the same instinct, and the resulting close monitoring took the breath away from allegations of law firms claiming high heart attack rates among users.

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But I missed a couple of key things. For one thing, rates of venereal disease have increased among the elderly as some men who haven’t had sex in a long time have started dating prostitutes. I had thought specialists like urologists would be the prescribers, so Pfizer should focus educational efforts on them. Hardly. Very quickly almost all doctors were prescribing.

While I tried, I never got the company to address the need to make Viagra available in nursing homes where romances occur between people with and without mild dementia. Pfizer has offered no guidance on this, and to this day it remains an underexamined issue.

Nor had I really foreseen the cultural earthquake that drugs would produce. Consider these events reported by The Washington Post in the year following the approval:

In Taiwan, a politician gave out free Viagra as part of his campaign.

In the Philippines, nightclubs mixed crushed Viagra pills with gin or whiskey to create internet-advertised cocktails.

In France, a chef was arrested for serving his customers beef piccata in Viagra sauce with fig vinegar and fine herbs.

In Brazil, the mayor of a small town has promised to give out Viagra in a bid to boost the population and thus increase federal aid to his constituents.

In New York, a 63-year-old woman filed a lawsuit against her 70-year-old common-law husband, alleging that after using Viagra, he left her for another woman, telling her, “It’s time for me to become a stallion again.

In Israel, when the five-member Knesset’s scientific committee held a hearing on the drug, a witness circulated a sample box of eight Viagra pills. When the box returned, four pills were missing.

In Nevada, prostitutes at a brothel called Moonlight Bunny Ranch reported that Viagra was rejuvenating older customers: They pay more and stay longer.

All this madness finally subsided. But when competitors like Cialis entered the fray, advertisers ditched staid Bob Dole for much younger men, some of whom sprouted evil blue horns from their heads. There were ads during the Super Bowls, value cards for frequent users, and auto racing sponsorships. Today, the Internet makes a mockery of the old medical model by forgoing the effort of a real ED diagnosis replaced by a token doctor visit with approved pills in seconds.

However, when I think of this first bioethics consultation, I feel great pride.

Dole was right. A huge number of men have suffered in silence and shame due to sexual dysfunction. Releasing Viagra as a drug to treat a symptom of an underlying problem was reasonable, and deflating potential attacks on the importance of sex in human lives was a good thing. Much went off the ethical rails not long after Viagra became the most widely recognized product name in the world. But restoring sexual capacity to men who often suffered in guilty silence was a powerful moral good.

However, I think about those stock options that I could have had.

Just kidding. A type of.

Arthur L. Caplan is the Mitty Professor and head of the Division of Medical Ethics at NYU Grossman School of Medicine in New York City.


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