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Launching Pfizer's Viagra

The Sunday Times

Sex drugs & rock 'n' roll

It's a bad news story about the giant insurers who are either refusing to pay or are rationing Viagra supplies. The chairman of the biggest, the 9m-member Kaiser Permanente, says that his company would need $100m a year if everyone's requests were met. A Viagra user appears and says he'll sue his insurer. A Pfizer consultant comes on and says that Kaiser's action is "incredible".

The company's worst nightmare is that European governments will take the same stance as Kaiser, but time is short and now comes the good news: "The Clamour for Viagra" segment. In Saudi Arabia, tablets cost $100 - ten times the US price. Japanese companies fly men to Hawaii. Doctors sell it on the Internet. Others, such as Goldstein, prescribe it to women, before any benefits are proved.

"It's irrational for Viagra to be used in women without any safety data," Padma-Nathan's soundbite slots in. "It's irrational to use a drug that is being used off-label without clinical research."

Pfizer's consultants provide both sides of the story. That strikes me as kind of smart.

*****

Padma-Nathan finds me a man called Bob Pollyea, who is shouting from the roof about how Viagra has given him back a sex life. Not literally from the roof, but he goes one better: he recounts his story for media. During the summer he appeared on NBC and, towards the end of July, when I call to see him, the BBC has just been in touch. He's passionate, articulate, good-looking, middle-class. He's just the kind of person to encourage European governments to make health services pay for the drug.

He lives with his wife, Sharlene, on West 4th Street in the heart of Los Angeles. They've a first floor condominium with big airy rooms, polished floors and a deck at the front. For my visit they nestle on a couch to praise Pfizer's remarkable blue diamond-shaped pill.

They met at university in 1955 and have been married for 41 years. Bob is 66 and grew up in Chicago; Sharlene is 61, a Californian. He retired as a psychology lecturer recently. She teaches business studies. They have two daughters and a squad of grandchildren. They seem to be in love.

Everything was fine until October 1994, when Bob had prostate cancer surgery. Though most of the nerves around the area were spared, he had a problem with sex after that. He could get erections, but lost them quickly. He couldn't see his lovemaking through. "You lose your self confidence," he tells me. "You feel less adequate."

Padma-Nathan helped during the operation, and 18 months back Bob went to see him to get a prescription for Caverject. This was the first licensed impotence medicine, manufactured by Upjohn and approved for sale in August 1995. Known generically as alprostidil, it's injected into the base of the penis and causes erections, without stimulation. "You have to leave your lovemaking, go to the refrigerator and inject yourself," Bob explains its biggest drawback. "Your partner is lying there thinking 'what's going on?'.

Then, on 27th March this year, Viagra got its license. It was approved by the US government's Food and Drug Administration (FDA) on a Friday, Bob went to Padma-Nathan the following Monday, got the prescription filled on Tuesday and tried it out with Sharlene on Wednesday.

"It's very natural," he says. "You take the pill. It's working in about 45 minutes. You get your erection as you did before. You have intercourse like you did as a young man. And in our case there were no side-effects."

The couple's bad news is that their medical insurer, Blue Cross of California, has issued an edict that rations them to only six 100mg tablets a month. And such is the change they report in Bob's erections that they aren't pleased about this restriction. He tells me that Padma-Nathan is lobbying government on this. Trying to get something done.

"Its renewed our relationship," Sharlene says. "We always had a loving relationship and a very good sex life. And now we've been able to have all that back. I think it's so amazing they could come up with something like this."

Padma-Nathan tells me that their are many such stories, bringing impotence out of the closet. But I wonder about the danger of relying on anecdotes: is the experience common or rare? Human interest trumps statistics. And the doctor wasn't telling me about any of his patients for whom Viagra failed to please.

Yet such failures are bound to be out there, as they are for any pharmaceutical product. And when I turn to the research - sponsored stuff, admittedly - it shows that the story of the drug's effectiveness can't be told through personal accounts. It also reveals that for many men who suffer from impotence, sadly, Viagra doesn't work.

I find the facts buried in a stack of reports that I obtain from the FDA. Agency staff analysed all Viagra's trials - including the material for Padma-Nathan's paper in the New England Journal of Medicine - and they came to the conclusion that the drug's effects are significant, but despite testimonials such as Bob and Sharlene's, it's by no means the answer for all.

The first trial in Padma-Nathan's paper starkly reveals its shortcomings. It involved 532 men, randomly allocated to get Viagra for 24 weeks in fixed doses of 25mg, 50mg, or 100mg, or alternatively a dummy, placebo, pill. Among volunteers on the "standard" 50mg dose, or 100mg like Bob's, only half (51%) of attempts at sexual intercourse were reported to be a success.

In the second study, of 329 men, the volunteers got Viagra or placebo for 12 weeks. In this case, however, they started on 50mg, but could vary the dose, if they wanted. The FDA's assessors reckon that fewer than half (47%) of attempts were successful among those on the drug.

A further, and maybe depressing, complication is that there was a big boost for sex among men whose pills had no active ingredient. In the first trial, nearly one quarter (24%) of attempts at sex were successful among those on placebo. In the second it was 13%. Figures in the paper suggest that between one quarter and one half of Viagra's benefits may have psychological roots.

These were short trials, but independent researchers suspect that such numbers might be right. "There's no doubt that this drug is very effective," Dr Ronald Lewis, head of urology at the Medical College of Georgia and president of the International Society of Impotence Research, tells me on the phone. "For patients who really do have impotence, I think when it's sorted out it's going to be about 40%-50% helped."

Pfizer, however, doesn't stress these results, but instead locks onto a measure which makes Viagra look a whole lot better. Despite FDA orders that the fairly objective "successful sex" measurement be the yardstick, the company prefers to use a more commercial and more subjective question about how hard or big the penis appears. On this scale, 74% of men on 50mg Viagra (and 24% on placebo) say that they experienced an "improvement in erection".

This is nearly three-quarters, a great headline figure, but redefining the goal is proving a double-edged sword for the company. Although men wanting a harder or larger penis is an infinitely more profitable market than men who have unsuccessful sex, wanting a harder or larger penis isn't exactly a medical complaint. And in the face of the fun-drug buzz around Viagra, insurers and governments are finding it easy to refuse to pay for it. Britain's gargantuan National Health Service, for instance, is determined to avoid coughing up.

Dealing with this dilemma needs more than anecdotes and, fortunately for Pfizer, there is help from science, which it deploys at every turn. First, there is the explosion in the incidence of impotence, as described in Padma-Nathan's slide show and based on the New England Journal of Medicine report. It points to what amounts to an impotence epidemic, which insurers and governments can't ignore.

Another forceful paper, published 15 months ago, unveils a new diagnostic tool. It's called the International Index of Erectile Function and using this, impotence is no longer judged a yes-or-no matter, but is placed on a sliding scale and becomes subjective like "improvement in erection". The index is based on a 15-point questionnaire, like you find in lifestyle magazines. "Over the last month," for instance, "when you attempted sexual intercourse how often was it satisfactory to you?" Again, this produces an increase in numbers. Through science, the market expands.

But if insurers and governments look carefully at this stuff, they may see what a small world it is. The terrifyingly high impotence figures can be traced through the footnotes to another journal paper, dated January 1994. It's co-authored by Dr Goldstein, Padma-Nathan's friend in Boston and is based on a mere 303 subjects, who are deemed by Goldstein to suffer from impotence even if they say that it's "minimal".

There's also credit due to two men involved in the widely-used erectile index. First, to Dr Raymond Rosen, a Pfizer consultant and New Jersey psychology professor. He's also one of the six authors of the New England Journal of Medicine paper. And second, Dr Osterloh, of Pfizer research in England, who led the team which developed Viagra.

The upshot of their efforts is to help shift the boundaries between those who think they're impotent and those who don't. It encourages doctors to write more prescriptions. And if a wave of anxiety is provoked around the globe about the hardness or size of erections, well apparently, in tests, 74% of men say their penis looks better on Viagra.

*****

It's a Monday evening. I'm now in New York, at the Downtown Holiday Inn. The television is tuned to NBC, where funnyman Jay Leno is starting his Tonight Show with fast-pace monologue gags. "It's so hot," he says, referring to the heat wave which currently grips the United States. "It's so hot," (two, three, four...) "men are taking Viagra just to get some shade."

Laughs, cheers. And he doesn't change the subject. NBC, a General Electric subsidiary, has sildenafil on the brain. "You see this new book? Viagra Nation?" (Two, three, four...) "I just hope it's not one of those pop-up books."

Launching Pfizer's Viagra
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This report is copyright, Brian Deer. No portion of this article on the launch of Pfizer's erectile dysfunction drug Viagra in 1998 may be copied, retransmitted, reposted, duplicated or otherwise used without the express permission of the author. Responses, information and other feedback are appreciated