Viagra Hits Canada

Bill Smith, a 55-year-old heavy-machine operator from Fredericton, knows these are his salad days revisited. As one of 500 Canadian men participating in the clinical trials of the impotency drug Viagra, he has been getting samples for two years. "They're free, so why not use them?" he says.

Viagra Hits Canada

Bill Smith, a 55-year-old heavy-machine operator from Fredericton, knows these are his salad days revisited. As one of 500 Canadian men participating in the clinical trials of the impotency drug Viagra, he has been getting samples for two years. "They're free, so why not use them?" he says. According to Smith, he now has sexual intercourse with his 38-year-old girlfriend four or five times a week. With Health Canada granting its approval last week for doctors to start prescribing Viagra, and with Smith's trial coming to a close this summer, he may have to slow down. "I don't imagine I'll be taking it every day if I have to pay for it," says Smith, considering the cost of roughly $15 per pill. "But I definitely will pay for it. It's a wonder drug."

It's not, however, totally free of controversy. Maclean's has learned that another Fredericton man taking part in the same clinical trial died of a heart attack, although his urologist, Dr. Allan Patrick, considers a connection with Viagra unlikely. "He didn't take Viagra on the same day," said Patrick, "so I suspect it's a non-issue." Perhaps, but when the man went to a hospital suffering from chest pains, he was given nitroglycerine - commonly administered to patients with heart problems - and died shortly after.

Pfizer Canada, the Montreal-based manufacturer of Viagra, will not comment on the case. Since Viagra's approval in the United States a year ago, the labels have cautioned against taking the drug in combination with any nitrate medication for heart problems. In November, Pfizer revised the labels to include further guidance for assessing cardiac risk. By then, U.S. authorities had recorded 130 fatal heart attacks among men taking Viagra. In Ottawa last week, Paul Roufail, head of Health Canada's medical review of Viagra, said he examined all of those deaths and concluded that "no cause and effect has been established with Viagra."

With the much-publicized little blue pill now cleared to arrive in Canadian drugstores by the end of the month, who will pick up the tab? Insurers, employers and governments must decide whether to budget for Viagra in their health-insurance plans, or deny coverage to an estimated three million men, most of them over age 40, who suffer from erectile dysfunction. The boom will end for pharmacies in Calais, Me., Lewiston, N.Y., Minot, N.D., Ferndale, Wash., and other border hamlets where prescription-toting Canadians flocked for the pill that the U.S. Food and Drug Administration approved last March. And many hopeful Canadians will have to face up to their urologists' sobering advice - Viagra is not for everyone with erectile problems.

Over the past year, the drug has become a phenomenon, with 60 million pills taken by seven million American men. Its popularity has spawned thousands of jokes and ripped the cover off a once-taboo topic. But it has also attracted entrepreneurs who sell the drug legally and illegally on the Internet, and mysterious operations offering Viagra to Canadian snowbirds in Florida and Arizona. Pfizer Canada has set aside a legal budget to prosecute anyone selling it inappropriately - mindful of what happened with the drug's release in Britain last summer. Within weeks, three per cent of patrons - including women - surveyed at three London nightclubs had experimented with the drug. "The only reservation I have [about the Canadian approval] is that people will fake symptoms to get a prescription," says Saskatoon urologist Dr. Peter Lau. "No one should be using it recreationally."

For Allard Gee and his wife, Joyce, two 58-year-olds who live in rural Gilmour, Ont., the drug is a marriage saver. Allard had lost his ability to get an erection after a lung operation in 1990. Joyce thought it would take a few months for her husband to regain his strength. Six years later, Joyce wondered: "Are we no longer in love with each other? Is the marriage on the way out?" Allard, at Joyce's urging, was accepted in Viagra trials in Kingston, Ont., and responded well to the drug. After what Joyce calls "a long spell when there was nothing," they began making love two or three times a week. "It was absolutely fantastic," she says. "We just got our whole life back."

Dr. Peter Pommerville, a urologist in Victoria, says any debate about funding Viagra should consider savings from money no longer spent on related problems. "How much do we pay for loss of self-esteem, depression, less productivity at the workplace?" he asks, not to mention the cost of stress, family breakups and suicides. But the B.C. government health plan has set the stage to reject Viagra from its list of covered drugs by turning down two other treatments for erectile dysfunction: Caverject, a drug injected into the penis, and Muse, a pellet inserted into the urethra. On the other hand, British Columbia does pay for silicone tube implants in the penis, which with surgery, hospital stay and examinations would cost the province, Pommerville says, about $15,000 per patient. Some of his patients choose that option, rather than the drugs, simply because it is free.

Approval by a provincial drug plan would allow virtually free access for those on social assistance - and for seniors, who are likely to be Viagra's primary users. In British Columbia, Saskatchewan and Quebec, provinces that offer drug coverage to citizens not otherwise covered by a plan, the approval could carry significant costs. In New Brunswick, Patrick says Viagra has no chance of being approved for the provincial drug plan. The province has already rejected his attempts to have Muse covered. "I know all too well the bottomless pit of demand for medications and the shrinking public purse," he says.

Drug industry insiders say Quebec is the most likely province to approve Viagra because it already covers Caverject. But approval in Quebec comes with a twist - any drug that the province includes must also be covered by private insurers. Approval by Quebec, says Jean Claude Bouchard of the Canadian Life and Health Insurance Association, would increase the cost of benefits packages by up to 2.5 per cent for large employers, and more for smaller companies.

But Barry Noble, national director of managed care for Toronto-based Manulife Financial, says his company is encouraging corporate clients to include Viagra. People with erectile dysfunction often have a parallel problem, such as diabetes. "If we're allowing medications to treat the illness," says Noble, "how can we not treat the complications of the illness?" Besides, he says, denying the drug to employees may lead to a human rights challenge. "To exclude it may be discriminating against males," he says. "If our clients don't want to cover Viagra, we suggest that they exclude from the drug plan the entire category of sexual dysfunction drugs," including medications such as estrogen for women.

Drug company sources expect any plans that do accept Viagra to set limits on their coverage. Tim Verbic, marketing development manager for Sun Life, says his company has suggested a cap of $1,200 - roughly 80 pills - per eligible employee and dependant each year. A limit, says Noble, "doesn't prevent them from buying more." In fact, no one involved in the issue expects costs to be a big factor for men who want access to the drug. Doctors who took part in trials across Canada say that even such side-effects as mild headaches, a blue tinge to their vision and facial flushing did not discourage men from taking the drug.

St. Catharines, Ont., physician Ron Casselman, who has written hundreds of prescriptions for his patients to fill at a pharmacy in Lewiston, N.Y., cautions against unreasonably high expectations. For starters, Canadian regulations will exclude thousands of men who are on nitrates for their heart problems. "Viagra is not the panacea, the elixir everyone thought it would be," says Casselman, who has found it ineffectual in older men who haven't had sex in years. "The gold standard is still injection therapy, but Viagra is a much-welcomed option. It shouldn't have taken so long for approval."

But Health Canada's delay in granting approval - almost a year after its U.S. introduction - may have saved lives, says Dr. Sidney Wolfe, co-founder of the Public Citizen's Health Research Group, an advocacy group based in Washington. The United States unwisely fast-tracked its approval, he says, meaning that Viagra was on sale there for eight months before Pfizer revised the labels. But Wolfe is disappointed that Health Canada did not follow Britain's lead and forbid doctors from prescribing it to anyone who has suffered a recent heart attack or stroke. Whatever the regulations, even Pfizer acknowledges the success of Viagra depends on co-operation between the physician and patient to make sure the drug is being used safely.

Could It Also Work For Women?

When it comes to Viagra, is what's good for the gander also good for the goose? Dr. Rosemary Basson, a Vancouver-based sexual medicine specialist, has spent four months studying the impact of the erectile dysfunction treatment on 14 women suffering from a lack of sexual arousal. Basson's research is part of an international study sponsored by the British arm of Viagra manufacturer, Pfizer Inc. Results have not yet been tabulated or made public, but Basson cautions against any expectation of a quick fix of a complex issue. Many aspects of a woman's arousal, she says, "have far more to do with non-medical factors, such as partner interaction, than with her medical status."

Viagra's popularity with men stems from its success in overcoming an inability to produce erections. Women, too, have erectile tissue that becomes engorged with blood in a state of arousal around the opening of the vagina, under the labia and in the clitoris. However, says Basson, "women are not particularly interested that you've changed the blood flow. So what? It may not increase their enjoyment, their sensation, their ability to become excited, to reach orgasm." But little research has been done on the topic, she says, because of the complexity of female arousal.

Maclean's March 22, 1999