Viagra's New Competition

Viagra's New Competition

WAY TO GO, VIAGRA. It's hard to believe you've been around more than five years. But what a half-decade it's been - from a gleam in some scientist's eye to one of the most recognizable brand names in the world, second only to Coca-Cola. What Prozac did to spread the word about depression, you've done for erectile dysfunction. You've made it socially acceptable to discuss ED in mixed company - heck, men are even talking to their doctors about Mr. Not-So-Reliable (though many will still fold their arms uncomfortably and avoid eye contact). Your staggering success, however, has also brought us worries - about popping pills for sexual recreation and the over-medicalization of sex, not to mention the possibility, albeit remote, of the user keeling over if he's weak of heart. You've spawned material for a generation of comedians - and sophomoric e-mail humour, such as:

Pfizer Corp. announced today that Viagra will soon be available in liquid form and will be marketed by Pepsi as a power beverage suitable for use as a mixer. It will now be possible for a man to pour himself a stiff one.

Obviously, we can no longer call this a soft drink.

Pepsi will market the new concoction under the name Mount & Do.

Your popularity induces profit envy. If U.S.-based Pfizer Inc. could sell $US1.7 billion worth of the little blue pill worldwide last year, other pharmaceutical manufacturers figure they can get a piece of the action. And so, Viagra, you now have not one but two new commercial bedfellows - a veritable ménage à trois. One is Levitra (pronounced luh-VEE-trah), jointly developed by Germany's Bayer Pharmaceuticals Corp. and GlaxoSmithKline Inc. in Britain. It won U.S. approval in August, and Health Canada has its efficacy and safety under review for its own go-ahead.

It takes about 60 minutes after ingesting either Viagra or Levitra for a man's chances of achieving an erection to improve. Both drugs allow increased blood flow into the penis. In both cases, the effects last roughly four hours. Some observers argue Levitra's similarity to Viagra will make it hard for it to emerge from the massive marketplace shadow cast by Viagra: 130 million prescriptions for more than 20 million men worldwide since 1998.

Enter the third contender, Cialis, the upstart with a reputation for bedroom stamina. Pronounced see-AL-iss, it has earned the nickname "le weekender" because it can be effective for up to 36 hours. Lilly ICOS - a joint venture between Eli Lilly and Co. and ICOS Corp., both U.S.-based - backs Cialis. It's available in more than 50 countries, including Canada since last month. It is expected to arrive in the U.S. in time for the new year.

And make no mistake about it - there's a war being waged for supremacy in the bedroom. The corporate parents of the three erection enhancers are prepared collectively to spend hundreds of millions of dollars a year in advertising to sway potential drug-assisted paramours. There's a huge untapped market, they say, of flaccid men who crave escape from the sexual frustration caused when erections go missing in action. With Pfizer, the world's largest pharmaceutical company, Lilly ICOS and Bayer-GlaxoSmithKline all determined to stiffen men's romantic resolve, a massive commercial thrust is underway to, um, free willy.

OK, OK. It's just too easy to poke fun. Recall the tittering after reports surfaced that U.S. soldiers had stumbled across a stash of Viagra while going through the belongings of Saddam's deceased sons, Uday, 39, and Qusay, 37. Septuagenarians with unreasonable expectations have become fair game, too. But Hugh Hefner fans take note. "If a 70-year-old man thinks he's going to take Viagra and have the erection he had when he was 17," says Sophie McCann, a Pfizer Canada spokeswoman, "he's going to be disappointed."

It's quite another thing, though, to overlook those in legitimate need. It is generally agreed that about three million Canadian men experience significant erectile dysfunction. According to Dr. Gerald Brock, former chairman of the Canadian Urological Association's guidelines committee, about 30 per cent of men aged between 40 and 70 have moderate to severe ED. Another 25 per cent endure a mild form. Brock, who at various times has conducted research and lectured on behalf of the makers of Viagra, Levitra and Cialis, says these drugs are not for everyone. "For a healthy 18-year-old man, it probably won't do anything at all," explains Brock. "On the other hand, for someone who's in his mid-40s and maybe notices that the erections aren't quite as hard, they probably will notice a significant improvement in how quickly they can get the erection, how long they can maintain it, and then how quickly they can regain a second erection after they ejaculate."

Then there are the men whose medical condition affects their ability to achieve erection. Prostate surgery, for instance, can damage the necessary nerves, and diabetes, along with some of the medication used to treat it, can lead to ED. "I started noticing that my erections would be there, but then they would all of a sudden drop," recalls Montreal photographer Karl Duarte of his experience after being diagnosed with diabetes about eight years ago. His doctor eventually prescribed Viagra and it has helped. But it's not, as Duarte, now 40, puts it, "a super-erection pill." In fact, as with all men, "without arousal, it doesn't work," he notes. "With it, it works really well sometimes, but not all the time."

THE ACTIVE INGREDIENT in Viagra is sildenafil, first developed as a heart drug. Levitra is the brand name for vardenafil, while Cialis is a pharmaceutical called tadalafil. All three chemicals do nothing for the libido, which is a function of testosterone levels. Instead, they inhibit an enzyme called phosphodiesterase-5 that normally interferes with the muscle relaxation and increased blood flow to the penis required for an erection. By handcuffing PDE5, these pills clear the way for an erection. In addition to a patent on sildenafil, Pfizer also holds one on the biological process that impedes PDE5. Lilly, Bayer and Pfizer are now suing each other over that patent on the mechanism.

As Duarte has found, and despite the common misconception, Viagra, Levitra and Cialis will not automatically give a man an erection. Just as toys require batteries, erections need sexual stimulation. Even then, the drugs don't work all the time; the efficacy depends on a man's age and physical problems. And while the drugs are effective for a number of hours, that does not mean that the user stays erect for that long, like some lascivious dowsing rod. What it means is that, when they work, an aroused man simply has a better chance of developing an erection during the time the drug remains effective. All three manufacturers, however, warn that in rare instances users may develop an erection that lasts more than four hours. If this happens, call a doctor. Fast. The risk is serious, irreversible damage to the penis.

The promise of enhanced sexual performance is bound to appeal to the adventurous. Plenty of bar cruisers and tripping ravers have popped Viagra to enhance their lovemaking - self-improvement of the biochemical kind. Curiosity attracted Geoff, 42, a Toronto-based freelance writer who'd rather not have his mother read this, so we aren't using his real name. Geoff obtained a single Viagra pill from a friend in the U.S. "I kind of laughed at first," says Geoff. "I said I didn't need it and he said he didn't need it either, although he had a really good time with it and that I might, too."

On a warm Saturday night last summer, Geoff swallowed the pill and waited an hour. The results, when he was ready to go for a test run, were mixed. "Viagra produces this massive erection that is just, like, unstoppable," he says. "But, I found the level of sensitivity was incredibly diminished and even the climax isn't as satisfactory." Geoff's conclusion: "If you're a normal healthy guy, it's superfluous, like gilding the lilly."

Some estimates suggest only one in 10 men with ED seeks help. The companies behind Viagra, Levitra and Cialis are determined to tap into that market. They could use the business. Pfizer's cholesterol-lowering pill, Lipitor, is the world's largest-selling drug, with US$8 billion in revenue in 2002, but its sales growth is flattening. Bayer has its own problems - in 2001, more than 30 patient deaths forced the German manufacturer to withdraw Baycol, an anti-cholesterol drug with US$578 million in revenue in 2000. And since 2001, generic drugs and other antidepressants have eaten into sales of Prozac, Eli Lilly's blockbuster medication.

So bring on the ad blitz. In the months leading up to Levitra's U.S. release, Pfizer employed a saturation campaign that included full-page ads in the New York Times and regular appearances behind home plate during the Major League Baseball playoffs in the fall. These days, Pfizer plasters "Viagra" on the boards at National Hockey League rinks. The company also uses Canadiens hockey legend Guy Lafleur to promote men's health issues and awareness of ED. And let's not forget Pfizer's TV commercial with the grinning, middle-aged suburbanites prancing to the sound of We Are the Champions.

In Canada, only two types of pharmaceutical ads are permitted by law. So-called "reminder ads" can raise awareness of, for instance, the dangers of high cholesterol, and are usually paid for by a company making drugs for the condition. Pharmaceutical companies may also plug the brand name of a drug - Viagra for example - then suggest you "ask your doctor," who's already had the sales pitch from a product rep.

Barbara Mintzes, an epidemiologist with the Centre for Health Services & Policy Research at the University of British Columbia, worries we've crossed a line. Mintzes, who tracks direct-to-consumer ads, says Health Canada's enforcement of the rules is inadequate. More than brand-name recognition is being promoted in the Viagra TV ad. "What message does the ad convey?" asks Mintzes. "Viagra works 100 per cent of the time; problems with sex are generally physical, not emotional or related to difficulties with relationships." Also possibly coming across, adds Mintzes, is "a recreational-use message - it makes sex better even if you don't have a problem."

Pfizer's marketing is as slick as the best beer ads. Gone is Viagra's original poster boy - one-time Republican presidential candidate Bob Dole. Pfizer ditched the aging Dole and reportedly paid US$14 million a season for the privilege of associating with Mark Martin, a popular, 40-something NASCAR driver who races with "Viagra" scrawled on his stock car. Gentlemen, rev your engines.

Not to be outdone, Bayer and GlaxoSmithKline signed "Iron" Mike Ditka, former National Football League coach of the Chicago Bears and New Orleans Saints, to pitch men's health (Ditka has ED and uses Levitra). They are the first pharmaceutical companies to sign a multi-year deal with the NFL. An ad during game broadcasts, watched on TV by 120 million fans each week, features a rugged looking man in his 40s failing to toss a football through a tire hanging from a tree (no sexual innuendo there). When he finally scores, er, makes the throw, an attractive, fawning woman joins him at his side. Cue the announcer: "Sometimes you need a little help staying in the zone. When it gets in the zone, it's good." Yeah, baby!

It's much the same for Lilly ICOS. The company wrote a big cheque to sponsor the 2003 America's Cup in New Zealand, giving itself prominence within the exclusive world of millionaire sailing, and blowing wind into Cialis sales.

Jo Ellins, a Ph.D. student at the University of Sussex in England, says Pfizer made the critical observation that male impotence is a self-diagnosed condition, "and hence they had to promote the diagnosis and their drug directly to men rather than doctors." Ellins, who is completing a doctorate on the medicalization of human behaviour, says that "whether this is encouraging men to use the drug who wouldn't otherwise, or indeed who don't really need it, is difficult to prove. But one thing is for sure - the men represented in their ad campaigns are getting younger and younger."

This orgy of marketing is exactly what worries Brian Cialis in Surrey, B.C. That's right, Brian Cialis. The family, quite understandably, isn't thrilled to have had to tell Eli Lilly they don't want their name used for erection medication. Alison Withey, an Eli Lilly Canada spokeswoman, says sorry, but a name change could delay getting the new treatment to market. Besides, it's not possible "to check any trademark against all surnames in existence globally."

Cialis wrote to Eli Lilly's chief executive officer, Sidney Taurel. "I asked, 'Why would you use my name, Cialis, to promote your erectile dysfunction drug when you have a name like taurus, the bull?" says Cialis. "Why didn't you use the name Taurel to promote your drug?" Russell Cialis, Brian's cousin in England, says the family is considering a lawsuit in North America. "It's brought a certain amount of notoriety, but everybody has said, 'Surely you've got them by the short and curlies.' I mean, you couldn't make this up."

Viagra in many ways was a godsend. Before the promise of a woody in a bottle came along, men and their partners had to endure vacuum pumps, penile implants and painful injections into the penis. Still, Viagra and its bulldozer marketing have led to an oversimplified understanding of sex, argues Barbara Marshall, a sociology professor at Trent University in Peterborough, Ont. "Where I'm critical of the whole enterprise is in what has become a gross over-medicalization of sexuality," says Marshall. "It kind of makes sex like going into a fast-food restaurant."

Marshall cites the Massachusetts Male Aging Study, a landmark report that came out in 1994. "It's true, as men age, they report more erectile difficulties," she points out. "But one of the things from that study that doesn't tend to get reported is that older men don't express more dissatisfaction with their sex life than younger men. In other words, their expectations are changing." But offer men youth in a tablet, and their expectations will undoubtedly rise.

It Could Have Been a Contender: Canadian product Uprima got hung up in marketing and approval problems

OH, WHAT might have been. In the early 1990s, with Viagra nowhere in sight, three researchers at Queen's University in Kingston, Ont., with a colleague in Chicago, raced to develop a made-in-Canada treatment for erectile dysfunction. Big money was at stake. Bottom line? Pfizer Inc. last year moved US$1.7 billion worth of Viagra, while the Kingston product, Uprima (pronounced you-PREE-ma), went nowhere. So what happened? Well, with Uprima caught up in marketing and approval problems, Pfizer's diamond-shaped blue pill hit the market first, and the rest is history. Viagra established a stranglehold on the market for erection medication, while Uprima is still not approved for sale in the lucrative U.S. market, or in Canada. It's been available in Europe since 2000, but Dr. Jeremy Heaton, one of the drug's co-inventors, acknowledges that very few people have heard of Uprima. "The goalposts," he says, "shifted hugely once Viagra hit."

Viagra and Uprima work in different ways. When swallowed, Viagra takes effect in 30 minutes or more, blocking an enzyme to make it easier for men to form an erection when sexually stimulated. Uprima, which is dissolved under the tongue, signals the central nervous system to release dopamine, a neurotransmitter in the brain required in the formation of an erection. On average, Uprima is effective in just 17 minutes. It doesn't have the desired effect as often as the little blue pill does. Still, if it had been available back in the pre-Viagra early 1990s as an easily administered drug to treat erectile dysfunction, it no doubt would have sold well.

Uprima's chemical name is apomorphine. It is injected to treat Parkinson's disease and, in higher-dose pills, to induce vomiting in overdose patients. Montreal scientists studying the substance in the 1970s reported that the dopamine it released played a role in erectile function. Heaton became involved in studying apomorphine in the late 1980s, and he and Uprima co-inventors Michael Adams, Dr. Alvaro Morales and researcher Ragab el Rashidy in Chicago developed a way to minimize its nauseating effects by delivering the drug through skin in the mouth.

Unfortunately for the Canadian trio, Viagra landed before they were ready in 1998, stealing Uprima's thunder. The drug is now available in almost 50 countries, and Heaton estimates its sales at what he calls a "bizarrely small" US$20 million a year. He blames Uprima's failure to break into the coveted North American market on the Illinois-based company licensed to make and sell it. It was a mistake, Heaton argues, to position Uprima as a Viagra competitor when the two are so different. Still, in a world where most drugs never get out of the lab, he and his colleagues at least achieved that much, even if the competition leaves them little room for growth. "It' not a very happy result at this point," says Heaton. "On the other hand, I think some people would say that we got further in the development path than you had any reason to expect."

In Search of the Woman's Viagra: Where are the prescription medicines to get women's embers glowing again?

YOU MIGHT say that what's good for the gander is good for the goose. If men can have their Viagra - and Levitra and Cialis, too - where are the prescription medicines to get women's embers glowing again? Since the late 1990s, researchers and drug companies have tried to make the case for what they have labelled female sexual dysfunction. Controversy persists over the legitimacy of FSD as a diagnosis, but London, Ont., urologist Dr. Gerald Brock is convinced it's a genuine condition. "I've seen women all the time," he says, "who describe a group of symptoms that really is very consistent."

In her dystopian novel Oryx and Crake, Margaret Atwood describes a pharmaceutical industry run amok that creates a pill she calls BlyssPluss. This tablet protects users from sexually transmitted diseases, boosts libido and sexual prowess, gives a sense of energy and well-being, all while prolonging youth. Atwood's vision taps into the real world's growing attachment to using pills to treat non-life-threatening conditions and, some say, ailments that don't really exist.

Journalist Ray Moynihan, writing in the British Medical Journal in January, critiqued industry efforts to convince physicians and the public that FSD is real. He noted a now widely cited 1999 University of Chicago research paper in the Journal of the American Medical Association. It maintained that fully 43 per cent of women 18 to 59 years old experienced sexual dysfunction. The women were asked if they'd had any of seven problems for two months or longer in the past year, including "a lack of desire for sex, anxiety about sexual performance, and difficulties with lubrication." Answer yes to one, and you have sexual dysfunction. "The JAMA article stated that its data were 'not equivalent to clinical diagnosis,'" Moynihan reported, "yet this caveat is regularly overlooked, and leading sex researchers have serious concerns about the figure's constant misuse."

Women certainly do have sexual problems, says sociologist Barbara Marshall of Trent University in Peterborough, Ont. But, she adds, there's a big difference between saying they have a problem and saying they have a disease. "And this is really what's happening with great gusto," says Marshall, "in a lot of the pharmaceutically driven research."

How is anyone to determine objectively if an experimental treatment has the desired effect in a woman? Pfizer is trying to figure that one out as it tests whether Viagra can increase blood flow in women and alleviate reported sexual dysfunction. "It's very difficult to prove," says Sophie McCann, a Pfizer Canada spokeswoman. "With a man, it's very easy to look at or even measure if he has an erection or no erection. When it comes to female sexual dysfunction, it's very difficult because you get into the subjective." Elsewhere in the pharmaceutical world, testing is underway with testosterone, antidepressants and Ritalin as efforts continue to medicalize female sexuality in a way that has proven so successful with men.

See also PHARMACEUTICAL INDUSTRY.

Maclean's December 15, 2003