HPV Vaccine

This fall BC joined the ranks of all the other Canadian provinces to offer the controversial human papillomavirus (HPV) vaccine to girls as young as nine. There’s been tremendous hype surrounding Gardasil, which protects against some of the strains of the virus that cause cervical cancer.

But just as vociferous as many doctors’ support of the vaccine is the fervent public opposition. Although many health professionals and drug-industry analysts say the vaccine has promise, they also say that there are still plenty of reasons to question Gardasil’s safety and benefits.

Fast-Tracking Approval

Gardasil, which is produced by pharmaceutical giant Merck Frosst, was fast-tracked for approval by Health Canada in March 2007. (The US approved it in 2006.) However, short-term safety studies are only wrapping up this month, and long-term safety studies will still take years.

Few are as familiar with Gardasil as Dr. Diane Harper, a professor of community and medicine at New Hampshire’s Dartmouth Medical School, who has been involved in the research and clinical trials of the vaccine. She’s not against it; in fact, she says it’s “100 percent effective” in females aged 16 to 24.

Caution and Concern

However, she has taken the bold stance of speaking out about its pitfalls. The fact that it’s being given to girls who still haven’t reached the double digits concerns her. Relatively few girls aged nine to 15 were enrolled in clinical trials of Gardasil, yet those in this age range represent a priority target population for mass vaccination.

“There is no way we can ethically do studies to prove efficacy in younger people,” Harper tells alive, adding that at age nine, immunological systems are still developing. “This is one of the age ranges we know least about.”

Although the vaccine is largely safe in older groups, Harper cautions that it’s early in the game, and crucial knowledge is still missing. Not surprisingly, Merck hasn’t invited Harper back for any future contracts. She says she’s even been denied jobs at various universities, which told her flat out that they’d be worried about what would happen to funding they receive from Merck if they were to hire her. But for Harper, it all comes down to being able to sleep at night.

“I have to be honest,” Harper says. “I see a lot of my colleagues who are not speaking out. They have to deal with their conscience, and I have to deal with mine.”

The Art of Disease Mongering

The frenzy around the vaccine has all the hallmarks of disease mongering, says Alan Cassels, a drug-policy analyst at the University of Victoria.

“It’s certainly the language of disease mongering: exaggeration of the prevalence to sell the cure,” says Cassels, who co-wrote the book Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All into Patients (Greystone Books, 2005).

Others point to Merck’s aggressive advertising campaign as a sign of hyping the disease. The Canadian Women’s Health Network (CWHN) has urged governments to mount public education campaigns to “quell the unfounded anxiety that has been instilled by marketers of the vaccine, that HPV represents a ‘new’ or ‘imminent’ threat.”

Calgary mother Susan Pederson won’t be vaccinating her two daughters. “I hate how it’s being marketed,” Pederson says. “There’s so much pressure. I’m so bothered by how people are being guilted into it … The drug is still in trials. I don’t want my daughters to be guinea pigs.”

Cervical Cancer by the Numbers

At a cost of about $400 for the three-dose vaccine, Gardasil protects against four strains of HPV, which cause about 70 percent of all cervical cancer cases. However, the virus often never reaches that stage. Rather, the body clears it out on its own, fuelling opponents’ argument that the vaccine isn’t crucial in the first place.

The statistics alone show that there is no cervical cancer epidemic in this country. According to the Canadian Cancer Agency, there were 1,300 new cases of cervical cancer in 2008, compared with 22,400 cases of breast cancer and 11,300 cases of lung cancer in women.

Nor is cervical cancer especially lethal. Last year lung cancer killed 9,200 women, and breast cancer killed 5,300; cervical cancer, meanwhile, took the lives of 380. Plus, cervical cancer can be detected in its early stages with regular Pap tests. Since the introduction of the Pap smear in the 1960s, mortality rates from cervical cancer have decreased by about 75 percent.

The Risks and the Benefits

Like any drug, there are risks and benefits, Harper notes. “In general, this is a really good thing. But there are caveats … The adverse events that have been reported are real; the interpretation of how much we should be concerned becomes the question of discussion. The occurrence of very severe and lethal side effects has not occurred in a statistically significant way. So, population-based health care deems that the vaccine is still very safe. But each of those side effects happened to real people.”

In the US adverse reactions are available for public viewing via the Vaccine Adverse Events Reporting System (VAERS). Although reactions reported to VAERS do not prove causation, they can provide early warning that a new vaccine may be causing serious health problems.

Harmless side effects of Gardasil include pain, redness, and swelling at the injection site. Others include fainting, vomiting, fever, difficulty breathing, headache, swollen glands, pancreatitis, and miscarriage.

There’s a risk of severe allergic reaction: a Canadian Medical Association Journal study found the rate of anaphylaxis to be five to 20 times higher with Gardasil than with other vaccines. There have also been reports of Guillain-Barr?yndrome, a neurological condition that causes muscle weakness.

Possible Deadly

According to VAERS, as of July 2008, 20 people who had received Gardasil had died.

VAERS lists reports such as the case of an 18-year-old female who had received her first dose of Gardasil and died that evening; her cause of death remains unknown. A 19-year-old with no medical history who was vaccinated with her first dose died in her sleep; no reason for death was detected in the autopsy.

Judicial Watch, a Washington, DC-based educational group that monitors government accountability, states that of the deaths in girls who had received the vaccine, 11 occurred less than a week after the shot was given, and seven occurred in less than two days. The most commonly diagnosed cause was blood clotting.

“The fact that blood clotting is responsible for almost a fourth of all deaths involving Gardasil is extremely concerning, especially since most birth control drugs increase one’s risk of developing blood clots,” Judicial Watch states. “The possibility that Gardasil may add to risk of blood clots is a serious issue that deserves attention.”

Merck Frosst is the same company that made the anti-inflammatory drug Vioxx, which, like Gardasil, got fast-track approval. Vioxx was later pulled from the market after thousands of adverse reactions, including heart attacks and strokes.

Gaps in Our Knowledge

The HPV vaccine has limitations. No one knows how long protection will last or whether people who receive it will need booster shots. Then there is the worry that women will feel invincible and won’t go for their Pap smears, which could result in boosting, not reducing, the cervical cancer rate.

It’s also not known how the vaccine will react if it’s given in conjunction with other shots, particularly those given to adolescents, such as protection from measles, mumps, and rubella. Also, no one knows whether the HPV vaccine will affect fertility. Merck’s fertility tests were conducted on rats.

Abby Lippman, an epidemiology professor at McGill University, headed a report published last year in the Canadian Medical Association Journal that cautioned about the many gaps in knowledge regarding Gardasil. “Individual girls and women, as well as policy-makers, can make truly informed decisions about vaccinations only when they have all the evidence, and today, there are more questions than answers,” the authors wrote.

Lippman and colleagues also referred to another study that found methodological weaknesses in the trial reports. “This situation is not unusual at this juncture in the development of new pharmaceutical products; however, it does caution against making overly optimistic descriptions of benefits and downplaying potential risks,” they stated.

The Effects of Lobbying

Meanwhile, there’s no denying the influence that a company such as Merck can have.

“While the word cancer invokes a wide range of emotions that can both influence and motivate parents, lawmakers, public health officials, pharmaceutical firms, and lobbyists; it is important to evaluate the facts against the claims of both slick marketing and sophisticated political pressure campaigns,” Judicial Watch says.

As of last summer, all of the reported HPV-vaccine trials for Gardasil and its potential competitor, Cervarix (Glaxo Smith Kline’s version, which at press time was yet to be approved), were fully or partially funded by the vaccine’s manufacturer.

Annual sales of the vaccine are predicted to reach $1.9 billion this year and $3 billion by 2012. The company has contributed approximately $12.5 million in corporate funds to political activities in the United States since 2002. Merck Canada has also donated money to Canadian political concerns. The Canadian government is now spending $300 million through its campaign to provide Gardasil to young girls.

The Canadian Women’s Health Network (CWHN) suggests that the federal government would be far wiser to spend that money ensuring that all women–particularly those who are poor, Aboriginal, and living in remote areas–have access to regular Pap smears.

Until long-term safety studies show reassuring results, groups such as the CWHN urge women and the parents of young girls to remain guarded about Gardasil. Parents should remember Merck’s Vioxx recall debacle and stand firm against the pressures of insistent advertising, governments, and doctors. Only time will tell if Gardasil is another Vioxx; until then, what are you willing to risk?