Experts Question the Safety of Gardasil

A recent release of documents from the Food and Drug Administration has some medical experts wondering if the vaccination approved to prevent cervical cancer does more harm than good.

Manufactured by Merck, the vaccination called Gardasil has been widely marketed for teenage girls to prevent the onset of human papillomavirus, or HPV, which may lead to cervical cancer. However, FDA records reveal that since the vaccination’s approval in June 2006, it has been associated with 47 deaths, 142 life-threatening incidents, and 6,732 other adverse medical reactions.

Judicial Watch, a government watchdog group, petitioned the FDA to release the documents detailing the problems even as the federal agency considers marketing the vaccination to adult women between the ages of 27 to 45.

A recent study published in the New England Journal of Medicine spells out the problems with the vaccine.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” said Dr. Charlotte Haug.

She says a number of unanswered questions about the future consequences of the preventative medicine cast doubt on the success of plans for large-scale vaccination programs. The study explains that the clinical trials that gained FDA approval for the vaccine were performed almost exclusively on 11 and 12 year old girls and virtually no long-term studies have been performed in the rush to get the perceived cancer-fighter on the market.

The American College of Pediatrics has joined the New England Journal of Medicine in publicly opposing mandatory vaccination, but that has not stopped lawmakers in 41 states from introducing legislation to require the vaccine or to spend taxpayer dollars educating the public on its perceived benefits.

Some states are even considering mandatory vaccinations for girls entering the sixth grade. Judicial Watch hopes the release of more public information about the documented side effects will get policymakers to think again.

"The FDA adverse event reports on the HPV vaccine read like a catalog of horrors,” said Tom Fitton, president of Judicial Watch. “Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports."
Fitton says it may not be appropriate to mandate the vaccine for young girls – or to recommend it for use by adult women.

In her book, The Secret History of the War on Cancer, Dr. Devra Davis also questions the appropriateness of marketing the HPV vaccination to adults.

Davis says early detection in the form of an annual pap smear may be the best defense against cancer. And, even those individuals who have been vaccinated still need to be screened on a regular basis.

According to Dr. Shobha Krishnan of Columbia University, the vaccine is recommended for 11 and 12 year old girls specifically before they become sexually active. She explains this is at the center of the ethical controversy over the vaccination because the viruses that cause the targeted cervical cancers are spread only through sexual contact. Since the vaccine can only help prevent, but cannot cure cancer, Krishnan says that vaccinating older teens and women may not be effective if they are already sexually active.

But, the controversy over HPV vaccinations does not end there.

Despite widespread marketing efforts, the vaccination is still in the testing phase with a final report due in September. It was initially fast-tracked by the FDA, becoming the most expensive vaccination ever to gain federal recommendation, yet the jury is still out on its potential for good or ill.

According to analysis by Judicial Watch, Gardasil is only a preventative or prophylactic inoculation; it cannot cure HPV or treat an infection. Some studies seem to indicate that Gardasil is only effective for a period of two to three years after vaccination. And, while it is meant to prevent cancer by preventing HPV, it is only made for use against four of thirty strains of the disease. Further, the vaccine has not been evaluated for its own ability to cause cancer.

Of the 47 deaths documented by the FDA, all occurred with women under the age of 23, but the largest number of them were much younger ranging in age from 11 to 16. Most of the deaths cite an “unknown” cause of death. Seizures, cardiac arrest, arrhythmia and blood clots were the most commonly named causes. Most often the deaths occurred within 20 days of the inoculation, but some happened within a week.

The FDA tracks the reported instances of Gardasil reactions in a national database called the Vaccination Adverse Effect Reporting System. Even so, Judicial Watch had to file two Freedom of Information requests and a legal complaint before the information was made public.

(from A Woman's View, July 2009)