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How I helped Pfizer think through the ethics of Viagra - STAT

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

By Arthur L. CaplanMay 19, 2023

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Twenty-five years ago, 75-year-old Bob Dole — former Republican presidential candidate and U.S. senator from Kansas — went on “Larry King Live” and declared himself to be sexually impotent.

Later that year, he became an official pitchman for Viagra, which the Food and Drug Administration approved in late March 1998 for the treatment of erectile dysfunction — though that now-common phrase hadn’t yet made its way to 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 prominent focus on their wedding rings. The ad’s tagline 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 ads. Late in 1997, about six months before the FDA approved Viagra, I got a call from the head of the Pfizer Viagra team asking whether I might be interested in doing a consultation for them. He explained they had a drug that would sell but was also likely to prove ethically knotty. I had never been contacted by a pharmaceutical company and wasn’t quite sure what to say. I agreed to go up to New York City from my office at the University of Pennsylvania in Philadelphia (no Zoom in those days) and meet with him.

After I cleared security at Pfizer headquarters — no small achievement — I was led to a generic conference room where the team was waiting. They explained that the company had been developing a drug for angina and reducing high blood pressure. It didn’t work for its intended purposes, but it had a very remarkable side effect. In clinical trials, many men reported getting erections when in the presence of young female nurses carrying out the trial. They had repeated the trial complete with young nurses on various groups of men in the U.K. with similar results. Their in-house studies in Asia, they told me, showed similar results, with 80% of adult men reporting full or partial erections.

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This was all very interesting, but I couldn’t tell exactly what they had in mind for me. The answer, it turned out, was that the company had little experience with reproductive or sexual problems. Executives were terrified that if they proceeded to develop this drug, they might get caught up in all manner of controversy over sex. My job was to anticipate what those controversies might be and perhaps try to suggest remedies for them.

I had no idea how to manage a consult. No teacher in my philosophy doctorate program had ever envisioned such a request. I agreed to the job, requiring only that they pay my travel and food expenses, no stock, no pay. Not because I was ethically enlightened — I was just naive to the profits the company was about to rake in. During my year there, Pfizer’s stock would undergo a 30% gain. Sales hovered between $1.5 billion and $2 billion per year until 2017, when generics became available.

My most important advice, which I think is evident in the advertising campaign, was that the pill needed to target a disease. “Impotence” was too vague a concept. A disease category would make it easier for men to overcome their shame and look for help. Furthermore, a medical condition would help deflect conservative moral criticisms that Pfizer was selling a “sex” pill and encouraging promiscuity. Soon thereafter the popular understanding of “erectile dysfunction” was born, and the brilliant marketers and advertisers at Pfizer conceived of Dole as the initial spokesperson. Thus I was a bit of a midwife to Dole’s incredible public admission.

I also urged that the company keep a very close eye on post-approval side effects and deaths to deter lawsuits. Pfizer lawyers had the same instinct, and the resultant careful monitoring took the wind out of allegations from legal firms claiming high heart attack rates among users.

But I missed a couple of key things. For one, venereal disease rates went up among the elderly as some men who had not had sex for some time began visiting prostitutes. I had thought specialists like urologists would be the prescribers, so Pfizer should focus educational efforts on them. Hardly. Very quickly almost every doctor was prescribing.

Though I tried, I never convinced the company to address the need to make Viagra available in nursing homes where romance occurs among people with and without mild dementia. Pfizer offered no guidance about that, and it remains an under-examined issue to this day.

Nor did I really anticipate the cultural earthquake the drug would produce. Consider these events reported by the Washington Post in the year post-approval:

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

In the Philippines, nightclubs mixed crushed Viagra pills with gin or whiskey to create cocktails they advertised on the Internet.

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 promised to distribute Viagra in an effort to boost population and thereby increase federal aid to his constituents.

In New York, a 63-year-old woman filed a palimony suit against her 70-year-old common-law husband, claiming that after using Viagra, he’d left her for another woman, telling her, “It’s time for me to be a stud again.”

In Israel, when the Knesset’s five-member science committee held a hearing on the drug, a witness passed around a sample box of eight Viagra pills. When the box came back, four pills were missing.

In Nevada, prostitutes at a brothel called the Moonlight Bunny Ranch reported that Viagra was rejuvenating geriatric customers: “They’re paying more and staying longer.”

All of this craziness eventually quieted. But as competitors like Cialis entered the field, advertisers abandoned staid Bob Dole for much younger men, some of whom sprouted devilish blue horns out of their heads. There were ads during Super Bowls, frequent-user value cards, and car racing sponsorships. Today the internet makes a mockery of the old medical model by dispensing with the effort at a real diagnosis of ED replaced by a token doctor “visit” with pills approved in seconds.

Nevertheless, when I think of this early bioethics consultation, I feel a great deal of pride.

Dole was right. Huge numbers of men did suffer in silence and shame due to sexual dysfunction. Releasing Viagra as a medicine to treat a symptom of an underlying problem was sound, and deflating potential attacks on the importance of sex in human lives was a good thing. A lot went right 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 frequently suffered in guilty silence was a powerful moral good.

Still, I do think about those stock options I might have had.

Just kidding. Sort of.

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


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