Healthy Skepticism Library item: 9028

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Publication type: news

Picard A.
Scientific breakthrough or unproved fix?
The Globe and Mail (Toronto) 2007 Mar 26
http://www.theglobeandmail.com/servlet/story/RTGAM.20070326.wxhpv26/BNStory/specialScienceandHealth/home

Full text:

Hailed as an advance in cancer prevention, HPV vaccine sparks debates over funding and gender equality

When the family doctor recommended to Anna Janes that her 16-year-old daughter be vaccinated against human papillomavirus, which can cause cervical cancer, she did not hesitate for an instant.

“There was no question in my mind,” the suburban Toronto entrepreneur and the mother of two teens said.

“This vaccine prevents cancer. I couldn’t imagine who wouldn’t want their daughter protected.”

The vaccine, sold under the brand name Gardasil, has created a buzz in business, scientific and public-health circles because it has the potential to virtually wipe out cervical cancer.

“This is a big deal. There’s no denying it,” said Phil Branton, scientific director of the Institute for Cancer Research, one of the institutes in the Canadian Institutes of Health Research.

“This is a vaccine that prevents cancer or, more precisely, prevents the cause of cervical cancer.”

It also comes with a hefty price tag — a shelf price of more than $400 for the required three doses.

In Ms. Janes’s case, the shots were covered by private insurance, but she worried about her daughter’s classmates who might not get the new treatment because they were poor or uninsured.

“It seemed to me un-Canadian that this wasn’t being offered universally, to every girl.” Ms. Janes said.

That may soon change.

In last week’s federal budget, Finance Minister Jim Flaherty announced $300-million in funding to kick-start provincial programs that will likely see nine- and 10-year-old girls vaccinated against HPV, the world’s most common sexually transmitted infection.

The unexpected announcement has been greeted with a combination of praise, disbelief and disdain, and it has laid bare some furious debates among scientists, physicians, public-health officials, health educators and women’s groups, all of them magnified by the fact that discussions of HPV are always intertwined with hot-button issues such as teen sexuality, gender equality and cancer.

Scientists and medical specialists, for the most part, have hailed the vaccine as a major advance.

“This vaccine is the best thing to happen to women’s sexual health since the Pill,” said Diane Francoeur, a pediatric gynecologist at Ste-Justine Hospital in Montreal.

After all, the ongoing battle against HPV causes untold anxiety, starting with the annual ritual that many girls and women dread, the Pap test.

Add to this the embarrassment of genital warts, which signal HPV, or worries sparked by abnormal test results (up to one in four) and, of course, cancer itself.

In Canada, one woman a day dies of cervical cancer, and four others are diagnosed with the disease.

“I’m anxious to see this vaccine offered to every little girl. Nobody deserves the trauma this virus causes, or to get cervical cancer if we can prevent it,” Dr. Francoeur said.

But Madeline Boscoe, executive director of the Canadian Women’s Health Network, said enthusiasm for the vaccine is misplaced and its potential greatly overstated.

“I’m sure the government’s intentions are good, but it’s extremely premature to approve this vaccine and make it part of our repertoire of care,” she said.

The vaccine has not yet been shown to prevent cervical cancer — which is a slow-developing disease — but rather to prevent infection with a virus that can cause cancer.

“If this goes ahead, young girls will be unwitting subjects of a massive research experiment.”

Ms. Boscoe said that existing screening methods like Pap tests work well, but are grossly underfunded and not well targeted.

The result is that two in three women who develop cervical cancer have never had a Pap test, and most of them are from marginalized groups — largely refugees, immigrants, aboriginals, the poor, those with compromised immune systems — not well served by the current system and unlikely to benefit from the new vaccine.

“Every death from cervical cancer is a failure of public health,” Ms. Boscoe said.

“The answer is to invest in public health infrastructure, not some expensive, unproven, technological fix.”

Both those views — and many others that fall in between — derive from an analysis of the same research data.

HPV is so pervasive that virtually everyone will be infected at some point in their lifetime.

In most cases, the body’s immune system clears the virus, as it does a cold, but in a minority, it lingers and can cause cancer.

There are more than 150 types of HPV, about 40 of which can cause cancer; in addition to cervical cancer, HPV can cause penile, vulvar, anal, oral, pharyngeal, and head and neck cancers.

Scientific research has focused on a handful of strains of HPV. Types 16, 18 and 45 are, between them, responsible for 70 per cent of cancers of the anogenital tract; Types 6 and 11 account for about 90 per cent of genital warts.

Deborah Money, executive director of the Vancouver-based Women’s Health Research Institute, said the “wow moment” in vaccine research came in 2002 when a study showed that a vaccine reduced the risk of contracting HPV 16 by an eye-popping 99.7 per cent.

Then, in 2005, research showed that a vaccine targeting Types 6, 11, 16 and 18 was almost 100-per-cent effective. That is the current formulation of Gardasil, a product of Merck Frosst Canada Ltd. and, based on that research, it was approved for sale in Canada in mid-1996. (Cervarix, a vaccine from GlaxoSmithKline Inc., is expected to be approved later this year; it targets HPV Types 16, 18, 35 and 41.)

Critics note that research was conducted almost exclusively on young women 16 to 23, while the vaccine is now being promoted for use in girls as young as 9.

That is because a person must be immunized before becoming sexually active for it to be effective.

There are also questions about how long the vaccine will confer protection. “We don’t know the durability,” Dr. Money said, so booster shots may be required.

Another key scientific question is whether stopping transmission of known cancer-causing strains will actually stop cancer, or whether it will emerge over time that many other strains of HPV also cause cancer.

Despite the questions, Dr. Money still strongly supports vaccination, saying, “general primary prevention – vaccination to prevent infection that causes cancer – is always preferable to secondary prevention – Pap testing and treatment.”

Anne Rochon Ford, co-ordinator of Women and Health Protection, said she is troubled by the assumptions being made by scientists and policy makers.

“There are just so many unknowns,” she said.

“We don’t even know if this vaccine prevents cervical cancer, and we’re rushing ahead to spend hundreds of millions of health dollars.”

Ms. Rochon Ford said she is troubled by the vigorous lobbying of the vaccine manufacturer and the huge marketing campaign for Gardasil.

“People are being misled into thinking it’s a magic bullet.”

Further, Ms. Rochon Ford said, the hype surrounding the vaccine could leave women with a false sense of security and create a boomerang effect that results in even lower rates of Pap testing and more cervical cancer. (Already, up to 35 per cent of women are untested in some provinces and the untested account for the majority of cases of cervical cancer.)

If there is one matter that vaccine supporters and detractors agree on it is that screening for cervical cancer must continue for the foreseeable future, and be improved.

While some scientists have made bold claims that the vaccine will eradicate cervical cancer within a generation, the reality is that it will prevent, at best, 70 per cent of cases of such cancers (based on clinical trials) and, in the real world, that figure is likely to be significantly lower.

There are also three generations of women and men who have been exposed to HPV, and who could be vulnerable to cancer as a result.

Ian Gemmill, co-chairman of the Canadian Coalition for Immunization Awareness and Promotion, said those concerns should underscore that an education campaign needs to be an integral part of a HPV vaccination campaign.

“If we want this to work as a public-health measure, we have to provide information to the kids who will be vaccinated, to their parents, to health professionals and to the public,” he said.

Dr. Gemmill, who is also Ontario’s Medical Officer of Health for Kingston, Frontenac and Lennox and Addington Public Health (counties that are among the most conservative parts of the country), said he is not concerned about backlash of the kind that has occurred in the United States.

There, a vocal minority has opposed vaccination campaigns for preteen girls, arguing that they promote precocious sexual activity.

In a survey conducted by the Halifax-based Canadian Centre for Vaccinology, only 4 per cent of parents said they were worried that vaccination would lead to earlier sexual behaviour. (Their overwhelming concern was safety, followed by doubts about the necessity, and worry over cost.)

Dr. Gemmill noted that preteens are already vaccinated against hepatitis B and that Canadians are very supportive of vaccination overall.

“The biggest complaint I expect is that we’re not vaccinating enough children,” he said.

“Because, while $300-million seems like a lot of money, it won’t go as far as people think.”

Realistically, Dr. Gemmill said, that money should be enough to vaccinate two age groups, say nine- and 10-year-old girls, and then provinces will have to pick up the ball to keep programs going. And parents of slightly older children will likely be left to pay for the vaccines themselves.

Diane Cormier, an Ottawa caterer and cervical cancer survivor, said the investment is worth it, for individuals and for the state. She also stresses the need for more education, not just vaccines and Pap tests.

“I was 37 years old and I had never heard of HPV until they told me it caused my cancer,” Ms. Cormier said.

“I felt stupid and uninformed but I realize now that I’m not alone.”

Yet, she had religiously gone for annual gynecological exams, including a Pap test (in which cells are scraped off the cervix and tested for abnormalities that would indicate cancer).

Despite doing everything right, Ms. Cormier was diagnosed in August, 2004, with an aggressive form of cervical cancer.

She underwent a hysterectomy (removal of the uterus), then radiation, which destroyed her ovaries, and chemotherapy.

Today, Ms. Cormier is healthy, and has become an advocate for cervical cancer survivors (one of the few cancers that does not have its own support group) and a staunch supporter of vaccination.

“I would never, ever want anyone to go through what I did because of a stupid little virus. We should do whatever we can to protect people, including vaccination,” she said.

“If anybody is against this, I’ll take them for a visit to the cancer ward.”