The promise of Gardasil

I am skeptical of the motivations of the medical establishment and I tend to see conspiracies everywhere, especially antigay ones.

So when I learned that the federal government put up $300 million to inject all girls between the ages of nine and 13 with the newly developed human papilloma virus (HPV) vaccine, Gardasil, I was shocked and concerned.

HPV has been shown to cause most cases of cervical cancer. Gardasil is the first vaccine approved to prevent any kind of cancer. Health Canada reports that approximately 1,450 Canadian women will be diagnosed with invasive cervical cancer this year and approximately 420 of them will die from the disease. Many of those deaths could have been avoided by early detection through regular pap smears but despite education efforts most women who develop cervical cancer were not screened in the three years prior to their diagnoses.

Cervical cancer is not the only cancer linked to HPV. Anal cancer can be caused by HPV too. The incidence of anal cancer — not to be confused with colorectal cancer, which has not been linked to HPV — is still very low. Only about 1,900 (out of 150 million) men were diagnosed with anal cancer in the US in 2007. To add some perspective, the Canadian Institute for Health Information estimates that as many as 23,750 (out of 33 million) Canadians die every year due to medical errors by doctors, hospitals and pharmacists.

Even though anal cancer is rare, gay men are 17 times more likely to develop it than are heterosexual men. Statistics from the Seattle Men’s Clinic show that the incidence rate for anal cancer in gay and bisexual men is about the same as the rate of cervical cancer was in women before routine vaginal pap smears were widely used. The incidence of cervical cancer has decreased since the 1970s but the incidence of anal cancer in gay and bisexual men continues to rise.

These statistics seem to suggest that a vaccine, or perhaps an early screening process for HPV-related cancers, could help gay men. But let’s not even play the numbers game. The compassionate argument is certainly valid for men as well as women: If even one death from anal cancer can be prevented aren’t we obligated as a society to do so? Many gay men have HPV so why is the HPV vaccine only for women? What about us?

As I investigated I discovered that the reasons are not strictly scientific.

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Toronto Public Health (TPH) has offered Gardasil free to Grade 8 girls since September. I asked Susan Sperling, the TPH media contact, why the vaccine was not made available to gay men too. She said the federal government approved the vaccine only for use in women and that TPH has to administer it as instructed.

I asked Sperling if TPH is concerned about HPV and anal cancer in gay men. She said that Barbara Yaffee, acting medical officer, would get back to me on that; she never did. Instead I received an email message from Yaffee’s colleague, Rita Shahin, who wrote, “I think they are doing studies in Australia.”

When I inquired about something closer to home Shahin mentioned an anal dysplasia working group through the Ministry of Health but didn’t seem to know much about it. I believe that TPH is concerned about the health of gay men but don’t have a lot of ideas for action around HPV and anal cancer.

“HPV is also linked to other cancers in both men and women,” wrote Alain DesRoches, the media relations person for the Public Health Agency of Canada. “More research is needed to clearly define the extent of these linkages. Studies are also currently being done in males. The efficacy or effectiveness of the Gardasil vaccine in males is as yet unknown. Therefore the vaccine cannot be recommended for males by the National Advisory Committee on Immunization at this time. As further research becomes available these recommendations may change. Testing on women over 26 and men is ongoing.”

I was impressed by DesRoches’ goodwill but unimpressed by the lack of a specific action plan.

I found two Canadian studies, both involving Irving Salit. The first, which appears to be the anal dysplasia working group to which Shahin referred, is conducted by Jill Tinmouth of Sunnybrook Hospital. Tinmouth’s study focuses on discovering if anal pap smears are a practical way to diagnose precancerous lesions in the anus. Tinmouth assures me that there is proof of a link between HPV and anal cancer.

“Studies that have examined 400 specimens of anal cancer have found that close to 90 percent of them show the presence of HPV as compared to none in the control group,” she says.

Since pap smears — when women are willing and able to get them — have done so much to prevent cervical cancer, maybe gay men should have regular pap smears too. But Tinmouth says anal pap smears from male patients that are submitted for laboratory testing get returned marked “wrong gender.”

“If the government needs evidence that the pap smear prevents death from anal cancer that will take 20 years,” she says. “This is where advocacy from the gay community might come in to persuade the government that there are alternative criteria for accepting anal pap smears.”

Salit, head of the HIV clinic at Toronto General Hospital, is spearheading the second study, this one to determine the effectiveness of Gardasil for use in boys. Salit says the drug is now being tested on young gay men; preteens who have no sexual experience.

Salit says it will probably take at least three years simply to do the testing and another seven years until the drug is approved by Health Canada for use in boys.

Why doesn’t government seem to know much about this research? More importantly why doesn’t the gay community know about it? Does it care? Should it?

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Contacting Merck, the manufacturer of Gardasil, was easier said than done. I was told by various people at the company that those who might be able to answer my questions were unavailable until just after my deadline.

I mentioned that the HPV vaccine could be a critical issue for gay men. This seemed to have no effect. I finally received an email from Lise Gagnon, the assistant to Merck’s spokesperson, Sheila Murphy.

“We believe there is a strong public health rationale for male HPV vaccination,” she wrote. “Not only do males develop HPV diseases such as genital warts and cancers of the penis and anus but they also transmit HPV to their partners, male or female. Previous experience also shows that gender-neutral vaccinations result in more rapid and effective reduction in the burden of diseases. Gardasil is already being used for boys in over 40 countries including Argentina, Australia, Finland, France, Germany, Indonesia, Korea, Latvia, Mexico, Peru, Philippines, Slovakia and the United Kingdom.”

This was the first source to acknowledge that perhaps straight men ought to be vaccinated so they don’t pass HPV to women. Even more importantly for the gay cause, Merck seems to support Gardasil for all males.

Dr Keith Loukes of the Sherbourne Health Centre is pretty frank about Merck.

“Pharmaceutical companies are mainly into the vaccine to make a profit,” he says. “Physicians are recommending the vaccine for women because not a lot of women are getting pap smears.”

That is how the health establishment works. Discoveries are often made by researchers for drug companies. So choices about what will be researched and how are usually financially motivated. Doctors end up recommending solutions that are not necessarily the best simply because they are the only ones offered by the cash-driven corporations. When it comes to women and cervical cancer, for example, the cheapest, safest and most effective method for saving lives is education about the importance of pap smears. But there’s no money in that approach for drug companies. It’s no wonder Salit, who seems genuinely interested in the health of gay men, is involved with two studies: one the money-driven Gardasil study, the other a publicly funded screening project to study anal pap smears for men.

Loukes is clear about the economic imperatives of getting the vaccine for boys in Canada.

“In order for there to be a vaccine for boys there needs to be enough demand,” he says.

I asked Wilfred Steinberg, an obstetrician and gynecologist at St Michael’s Hospital, why research on men is so far behind research for women.

“Women were already going in for pap smears whereas men are not going in for the equivalent,” he says.

Aren’t there issues of sexual politics involved with the development of a vaccine and the implementation of anal pap smears for gay men?

“For a company to target a group on the basis of their sexual preference is politically tenuous, so they may not be in hurry to do that,” says Steinberg.

It makes sense. With the negative reaction in the gay community against the idea of AIDS as a gay disease, perhaps gay people think it is politically incorrect to link HPV and anal cancer with gay men. Steinberg urges us to ignore this squeamishness.

“Why haven’t gay men been advocating for a vaccine?” he asks. “We’ve been waiting for the gay community to come out and say we need to push this vaccine along. I’d like to see some political advocacy for it.

“It’s absolutely political,” says Steinberg. “If you speak to mothers and say, ‘Are you going to give your 12-year-old daughter the vaccine?’ She’ll say that her daughter is not going to have casual sex. Now what if you say you want to give it to her son? ‘Well he’s not going to have gay sex,’ the mother would say.”

Steinberg hit the nail on the head. The HPV vaccine is a huge political issue. What’s the real concern about little girls? It’s the same issue that hampers research on AIDS drugs, an AIDS vaccine and even safer sex.

In the barrage of statistics and information that I amassed to write this article one quote stood out for me. A statement from the US Centers for Disease Control and Prevention reads, “Most sexually active people will have HPV at some time in their lives.”

If you are sexually active then you are likely to have HPV. There are many kinds of HPV. Many are harmless, go away as quickly as they come and do not lead to cancer. What makes Gardasil controversial is that doctors will be giving it to innocent young ladies who are seen as sexually pure.

The Christian right — and some people who are just a little sexually conservative or merely straight — feel uncomfortable that safer sex, new drugs and an AIDS vaccine might facilitate free sexual fun. All those people who keep yelling about abstinence are really saying, “You wouldn’t need condoms for teenagers or HPV vaccines for little girls if sex was saved for monogamous, straight, married couples alone.”

This is the core political issue around this vaccine. The HPV vaccine has the capacity to be just as revolutionary for our entire society as an AIDS vaccine might be. Like AIDS, the issue of HPV forces people to confront issues of gender and sexuality. It forces parents to understand that not only are their little girls going to be sexually active but that their little boys might be sexually active and gay. If gay men were willing to take this issue head-on they might not only save lives but make sex everywhere easier and better.

It is clear to me, to certain doctors, to the various health agencies and to Merck that HPV is linked to anal cancer. It also seems likely that offering anal pap smears as well as cervical pap smears and vaccinating both boys and girls against HPV are wise, life-saving opportunities. But all the goodwill and scientific research in the world will not serve to propel governments and drug companies to move ahead with the HPV vaccine for men and anal pap smears unless gay people directly confront some of the political issues this scientific research raises.

This means admitting that, as gay men, we are sexually active and do enjoy sex for pleasure. This means that we might want to talk about something straight people don’t want to. After all, isn’t it a good idea to put an end to HPV simply because it’s no fun having anal warts?

Genital warts are not attractive or sexy. They discourage people from getting it on. They make sex difficult and dangerous. The HPV vaccine would not only save lives, it would make our sex lives happier and distinctly more pleasurable.

Gay men need to find the political will to get behind the HPV vaccine and behind anal pap smears for all men. How? We need to get our community health organizations involved with broad campaigns to lobby governments. We need to bring pressure to bear on all our politicians, especially gay ones like Kyle Rae and George Smitherman. It was our overt sexuality and honesty that helped so much in the battle against AIDS. We can fight for scientific breakthroughs and we can also fight — in our own special gay way — to change the way the world thinks about sex and sexuality, men and women.

It will not only help the fight against HPV, it will help the world.