gardasil, vaccine

Doctors Caution Against Taking Gardasil Lightly

August 21, 2009 07:30 AM
by Anita Gutierrez-Folch
Doctors urge a weighing of the risks and benefits of the HPV vaccine, even though a recent study finds that it is as safe as most vaccines.

To Gardasil or Not to Gardasil

In the wake of a new study published in the Journal of the American Medical Association (JAMA) that vouches for the relative safety of Gardasil, a human papillomavirus vaccine, health experts continue to debate the benefits of a generalized application of the vaccine, Denise Mann writes for CNN.

Merck, the manufacturer, proclaims that “only a doctor or health care professional can decide if GARDASIL is right for you or your daughter,” but the lead researcher for the study urges parents to become active participants in the decision.

The Centers for Disease Control and Prevention ("CDC") added Gardasil to its routine vaccination schedule in 2007, recommending it for 11- or 12-year-old girls. Some physicians have previously opined that, because the effectiveness of Gardasil after five years has not been established, vaccinations should start at a later age.

The JAMA study notes that through the end of 2008, adverse side effects were reported in 12,424 cases, or 53.9 cases per 100,000 doses distributed.  This is comparable to other vaccines. The study also notes that 772 of the adverse effects reported are considered serious, including 32 deaths. Cases of fainting and blood clots, in particular, are unusually high for a vaccine. Adverse event reporting is inherently imperfect, because on the one hand, an adverse event after a vaccination does not prove that the vaccine caused the outcome, and on the other hand, many adverse events never get reported.

Lead researcher Dr. Barbara Slade, a medical officer at the CDC, says that the risks posed by Gardasil should “open the dialogue that people need to have with their physician about whether they need to get the vaccine.”

In the same issue of JAMA, Dr. Charlotte Haug of Norway publishes an editorial titled “The Risks and Benefits of HPV Vaccination.” She writes that HPV, in her opinion, “almost all HPV infections are cleared by the immune system … some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now.”

The CDC regularly reviews adverse event reports and updates its guidance on vaccines.  Based on its review of adverse events related to Gardasil through June 1, 2009, the CDC sees no medical patterns that suggest that Gardasil caused the adverse events reported, and it continues to recommend the vaccine.

Merck’s Marketing Push

Since the introduction of Gardasil in 2006, its manufacturer Merck & Co. has launched aggressive marketing campaigns. A report in JAMA accuses Merck of stressing the vaccine’s effectiveness while undermining its potential risks.

"By making this vaccine's target disease cervical cancer, the sexual transmission of HPV was minimized, [and] the threat of cervical cancer to all adolescents was maximized," Sheila M. Rothman and David J. Rothman from the College of Physicians and Surgeons wrote.

The Rothmans also criticized professional medical associations for accepting grants from Merck and then producing doctor education material that “did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits.”

In 2007, Texas legislators and lawmakers in other states considered making Gardasil a mandatory vaccine, and were met with fierce opposition from parents and others concerned that requiring a vaccine for an STD would complicate the idea of teaching abstinence to teens.

Even though Gardasil does have the ability to prevent cervical cancer, it does not protect against all types of HPV, and does not help those patients who have already contracted an HPV infection.

Abby Lippman, epidemiology professor at McGill University in Montreal, does not approve of a generalized recommendation of the vaccine until its true benefits and risks have been properly investigated.

"I am not alarmed about the safety, but we have to ask hard questions about the real benefits," she told CNN. "We don't know how long protection will last, and we won't know if the vaccine protects against cancer for a while. Doctors need to talk to parents and not say, 'Sign here on the dotted line.'"

In a similar vein, Dr. Haug opines in her editorial that “even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.”

Background: Gardasil: Medical Necessity or Marketing Success?

Related Topic: Merck Targets Gardasil Advertising to Older Women

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