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 month, 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.
Additionally, while Merck says that Gardasil should not be given to pregnant woman, they have not studied the potential for adverse effects on nursing mothers and breastfed babies.
Finally, there is no information known on how this drug will affect the future fertility of women currently taking it as well as the fertility of the next generation. Basically, this will only become known after 20 to 30 years when the women who are being experimented on now have additional adverse reactions with the future generations.
Questions have been raised as to whether a drug to protect young women against cancer is even a necessity. According to the American Cancer Society, cervical cancer deaths have decreased dramatically in the past several decades. Between 1955 and the early 1990s there has been a 74 percent decline in cervical deaths, which now continues to decline at a rate of 4 percent per year. The Society estimates that cervical cancer deaths in 2008 will be around 11,000. The majority of these occur in women in their 40s.
Considering all of this, here are some important items to weigh in making a decision to take Gardasil:
- Long-term effectiveness is an unknown, as is whether or not a booster shoot will be required in the future.
- It is still not really known if the drug will prevent cancer, cause future cancers, or if there will be other unforeseen consequences.
- Safety tests on the drug are not slated to be finished until September 2009.
It is also known that the major reason Merck was anxious to fast-track Gardasil to the market was to beat out rival drug maker GlaxoSmithKline’s Cervarix. Well, they won the race to the market, but at what price to the health and safety of the world’s young women? The results are starting to come in and many of them aren’t very pretty.