Debating Gardasil in Canada

On Wednesday, September, 5, 2007, I was pleased to participate in a panel discussion on The Agenda with Steve Paikin on Ontario Public Television in Toronto, Canada. (You can view the debate by going to this page and selecting the tab that says "Gardasil, Morality and Medicare" and then clicking on "view video" to the right.)

Thanks to the wonders of video uplinks, I was brought in with 2 other remote guests from Ottawa and Montreal. The other three guests were in the Toronto studio. In addition to host Steve Paikin, the group was:

• Dr. David Butler-Jones, chief medical officer of Canada;
• Dr. Janet Dollin, family practice physician and president of Federation of Medical Women of Canada;
• Anne Rochon Ford, coordinator of Women and Health Protection, a national working group that undertakes research and advocacy work on women and pharmaceuticals;
• Dr. Joel Lexchin, an emergency physician at the University Health Network, a professor in the School of Health Policy and Management at York University, and an associate professor in the Department of Family and Community Medicine at the University of Toronto.
• Dr. Marc Steben, a family practitioner, and works at the National public health institute where he chairs the STI committee and he is a member of the HPV scientific group.
• and me, as the author of a four article series on the Politics and PR of Cervical Cancer.

The program spent the first twenty minutes or so talking with the newly appointed, and first ever, chief medical officer of Canada, Dr. David Butler-Jones. The need for a post overseeing public health in Canada was a result of the Severe Acute Respiratory Syndrome (SARS) epidemic in 2003, which was first recognized in Toronto in a woman who had recently returned from Hong Kong on February 23rd of that year. That initial case resulted in infection of 257 persons in several Greater Toronto Area. The interview with Dr. Butler-Jones touched on various aspects of public health in Canada, and touched at the end on prevention and particularly vaccines, which provided the segue to introduce the topic of Gardasil.

The panel was basically split between those that advocated for mass immunization against HPV and that didn't think the process had moved too quickly — Drs. Steben, Dollin, and Butler-Jones — and the rest of us, who had concerns and thought a yellow light approach was the most appropriate. As the sole non-Canadian on the panel, and as the only one not working directly in the health professions, I also had a different perspective to share.

The impetus for the panel was the start of mass vaccination of 8th grade girls in the province of Ontario at the start of the school year. In March 2007 the Canadian federal government announced CA$300million in funding to help provinces vaccinate their girls against HPV, and in August, the premier of Ontario announced a provincial investment of CA$117 million. But then, the August 27, 2007 cover story of Maclean's magazine announced, "Our Girls Aren't Guinea Pigs" and the public debate heated up significantly.

While most of us on the panel agreed that the Maclean's piece did not do the issue a service by focusing primarily on injection reactions, we differed on what we thought the real focus should be. Anne Rochon Ford laid out concerns about the speed with which this was approved, funded and implemented. In addition, she noted, as was very well addressed in the paper written by the Canadian Women's Health Network, that the objectives of this vaccination campaign is not even clear. Is it to eliminate HPV? Is it to eliminate cervical cancer? Will possible elimination of the strains covered by Gardasil increase occurence of other strains against which there is no vaccine? Without answering these questions, the start of a mass vaccination campaign seems ill-advised.

Dr. Steben asserted that those concerns "are not justified at all." But that was again going to the safety issue, not the other issues of Merck's inappropriate PR push and lobbying efforts, which I outlined at length in my four part series on The Politics and PR of Cervical Cancer.

Steve Paikin asked me to share with them how this has played out south of the border. I explained,

"My concern is that Merck has the only dog in the race right now. The big incentive to rush this is for Merck to make as much as possible. The next competitor, Cervarix by GlaxoSmithKline, probably won't be approved by the FDA and released in the U.S. until about a year from now, so Merck is extremely aware that they have a small window of opportunity to make as much money as possible. So here in the States, we've seen this 'education' campaign ... creating this culture of fear, and this sense of a crisis about HPV, so that when the vaccine was approved there was this sense of relief, like 'Oh! I've been so concerned about this and now there's the wonder drug.' And that was exactly what Merck planned on doing."

Anne Rochon Ford seconded that later in the program, stating that "There's a lot of hype, a lot of milking the public fear, and pain, and worry about getting cancer, and I think Merck has done a brilliant job of milking that vulnerability in the population." Paikin clarified that "milking" is really only used pejoratively, and Rochon Ford confirmed that was what she meant to say, and that she feels "Merck has exploited a very widespread human vulnerability around fear of getting cancer."

To further reinforce the point, I added, "I'm a woman, I identify as a feminist, and I'm the mother of a thirteen year old girl, so I'm coming at this, or it's coming at me, from several different angles. I find it very distasteful and disturbing how women and girls and their concerns about their health have really been manipulated for the profit margin of a pharmaceutical company."

Paikin followed up by asking me how the checks and balances worked in the States to provide a counter-balance to Merck's PR push. I responded, "Not very well. Merck, and other pharmaceutical companies, have very deep pockets, and the estimates are that they spend $2 in advertising and PR for every $1 on research and development. That means they are spending millions and billions of dollars promoting their products."

Anne Rochon FordAnne Rochon Ford made an excellent point that responsibility and concern for issues of sexual and reproductive health are so often laid at the feet of women and girls, that she is bothered that the vaccine was first developed for and is being implemented on girls, when boys and men are infected at equally high rates with HPV, and of course are able to infect female partners. While complimenting the public health workers for the amount of education and prevention work that they are able to do on small budgets, she strongly encouraged that boys be brought in on these issues much sooner and in much more meaningful ways. One of the areas she sees as lacking is education about healthy immune systems. This is particularly pertinent to this topic since the vast majority of HPV infections are actually cleared from the body without treatment because a healthy immune system is able to eliminate it.

Dr. Dollin's frequent refrain was that we need to keep our eye on the ball and that this is an important health advancement that she has been anxious to offer to her patients for years. She said she sees "devastated women." She said that she spends so much of her time dealing with abnormal Paps, and for 15 years she has been waiting for this vaccine. "If I now know there is a vaccine," she asked, "what am I supposed to tell my patients?" I countered that while I really appreciate her concern for her patients, "I think that if there is any blame in taking our eyes off the ball it lies predominantly with Merck because they don't seem to be content to let this run its course, and to have a large piece of whatever the eventual pie is, which will be in the billions of dollars of profits, they've really pushed this rush to vaccinate," including pushing for state mandates of the vaccine here in the U.S. I concluded, "They've really pushed the envelope. I think that if anyone has derailed what is probably one of the most promising women's health developments in decades, it's Merck. I really think the blame lies with Merck, and not with people that are questioning what speed it's going at , or other aspects of this issue."

Dr. Steben argued that each day a woman in Canada dies of cervical or vaginal cancer, and that this vaccine should be readily used to not only prevent those deaths, but the treatment of genital warts and abnormal Pap smears. He called the diagnostic tests and treatments, including colposcopies, as "traumatic." In fact, he said, "There is nothing more traumatic than an abnormal smear." It sounded a lot to me like the phrase in one of Merck's slick ads for Gardasil as part of the "One Less " campaign. A girl intones "I want to be one less family turned upside down by HPV." (They needed to show the One Less ad as part of the program, by the way, because Canada, like most of the world, does not allow direct to consumer advertising of drugs.)

Dr. Dollin expressed frustration that she has women in her office every day whose lives have been "devastated" by HPV. I shared that nearly 20 years ago I myself had an abnormal Pap smear, which was the result of mild to moderate cell dysplasia, and required a colposcopy for diagnosis and laser surgery for treatment. Fortunately, it was successful and I have had normal Paps since. But even with my own personal history, I still feel strongly that there are valid concerns that need to be addressed before mass vaccination is pushed forward.