Tuesday, October 21, 2008

GARDASIL DEATHS, ADVERSE REACTIONS SHOULD GET YOUNG WOMEN TO THINK TWICE!

The fast-track approach to getting the cervical cancer protection drug Gardasil® through the approval process may be on its way to haunting both the drug maker Merck & Co., and the approving agency, the U.S. Food and Drug Administration (FDA). It was recently revealed that at least 18 women have died in the past 2 years after receiving injections of the drug.

Gardasil is aimed at preventing the cancer-causing risks of the Genital Human Papillomavirus (HPV), which is considered to be the most common sexually transmitted disease in the world. Of the 30-some known strains of the virus, many are not harmful and go away on their own. Fifteen known strands of the virus can lead to cancer, with two of them causing the most cases. The drug Gardasil is aimed at protecting woman from only four of these known viruses.

The FDA approved Gardasil in June of 2006 after only 6 months of review. Typically, new drugs are reviewed for at least 10 months, but cancer drugs are often put on this fast-track approval process. Gardasil received unanimous approval from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and full FDA approval followed soon after.

Since then, it is reported that some 8 million young women between the ages of 9 and 26 have been injected. Three separate doses of the drug are given over a 6 month period at $120 each for a total of $360.

Now it has been learned by the watchdog group Judicial Watch that there have been 8,864 adverse reaction reports to the FDA since Gardasil was approved. These include the 18 deaths, 140 “serious” complications (27 considered life threatening), as well as 45 spontaneous abortions or miscarriages, plus cases of neurological disorders and blood clots.

As these issues come to light, parents and young women will have decisions to make regarding the advertised benefits of the drug versus a growing number of adverse reaction reports. “Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children,” said Tom Fitton, president of Judicial Watch.

This seems sage advice given the fact that Merck is advertising this drug by alleging to protect women from cancer, and while it does not even know if Gardasil itself might cause cancer! A report to the FDA on Merck’s testing protocol said this: “Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity.” In plain language this means, that they don’t know if Gardasil causes cancer or genetic damage to the cells that can cause cancer.

Merck also doesn’t know for sure how Gardasil will react when given in conjunction with any one of the common teenage vaccines. One in particular is the Menactra® vaccine for meningitis. Some very severe reactions to this vaccine alone are part of the 8,864 reports.

DR. CRAIG’S COMMENTS: Think twice, do your own research, and then think twice again before putting substances like Gardasil into your body. Your doctor may be doing what they “think is right”, but that does not mean that it is your best, or healthiest option! Clearly, the pharmaceutical industry’s influence on the American Medical Association is strong, and warrants a little skepticism on your part. We must take responsibility for our own health. Be proactive and educated - there is no better way than this!

Speak up and educate others,

Dr. Craig