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New Cervical Cancer Vaccine Should Not Be Mandatory

Posted by medconsumers on December 1, 2006

The new cervical cancer vaccine raises concerns that did not show up in the news coverage about its approval last summer. Usually mass vaccinations are advised for diseases with a high rate of death and/or disability, but cervical cancer doesn’t come close to meeting this criterion. And most important: Is it safe to vaccinate all girls for a disease that afflicts only 9,710 American women yearly and causes 3,700 deaths? The answer might be yes, if the vaccine is risk-free. But the nation’s leading vaccine safety organization raises some serious reservations.

Those reservations were ignored last summer when the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted to recommend that all 11- to 12-year-old girls receive the human papillomavirus (HPV) vaccine called Gardasil. This is a major step toward making the vaccine mandatory—at an age well before girls are likely to become sexually active.

Only one company, Merck, makes the HPV vaccine, which is given in three injections over six months and will cost $360. Merck says its trials proved Gardasil is “100% effective in preventing HPV infection in those who do not already have HPV with strains 16 and 18, which together cause about 70% of all cases of cervical cancer.”

These Merck-sponsored trials were submitted to the FDA, and Gardasil was approved. But Barbara Loe Fisher, an advocate for vaccine-safety studies and the president of the National Vaccine Information Center, questions the need for a cervical cancer vaccine given the availability of the Pap test, which she believes has greatly reduced the incidence of the disease. She also sees methodological flaws and major deficiencies in what has been reported to the public about HPV disease and the vaccine.

“Most people who have sex will have experience with HPV, but the majority will clear it from the body and go on to have healthy lives. Only a tiny percentage will have persistent HPV infection and will experience changes over a long period of time that will lead to cancer. On the list of cancers that kill, this is at the bottom,” she said, referring to U.S. women, as opposed to those in developing countries where cervical cancer deaths are far more common.

As a former member of the FDA Vaccines and Related Biologic Products Advisory Committee, Fisher has considerable experience analyzing the lengthy documents submitted by the vaccine companies to the FDA, as well as the agency’s own review of company-sponsored trials. Fisher’s safety concerns center on the type of placebo Merck used in the Gardasil trials. “A true placebo would be a saline solution—something that is innocuous and has no potential to cause a reaction on its own,” she said, referring to the injection given study participants who were assigned to the control group against which Gardasil was compared.

Instead, Merck used a solution that contained aluminum, Fisher explained, and neither the company nor the FDA has publicly disclosed the amount used in the solution. “Aluminum is used as an adjuvant in many vaccines to boost the potency of the vaccine,” she continued, “and though it has been in vaccines for decades, it has never been tested in clinical trials to see whether it is safe.

“We know from animal and human biological mechanism research that aluminum can cause inflammation and brain cell death. Putting it in the placebo [in a clinical trial] violates the principle of the scientific method when trying to ascertain truth,” said Fisher. “To make matters worse, aluminum is also in the Gardasil vaccine which makes it difficult to tell whether the many adverse events reported in the trials were due to the aluminum-containing placebo or the Gardasil,” she explained, referring to the well-documented fact that adverse events will show up in all clinical trial participants, even those given an inactive placebo.

Why would the FDA overlook this potential for confounding trial results? “The FDA has become partners with the vaccine manufacturers in fast-tracking these vaccines and in the process, the precautionary principle has been thrown out,” Fisher responded, adding that most health problems occurring in vaccine trials are often dismissed. “The companies tend to write them off as unassociated with the vaccine.”

Maryann Napoli, Center for Medical Consumers ©
December 2006

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