Within two weeks, over 100,000 sixth grade girls in Virginia schools will be required by state law to receive the controversial and costly vaccine Gardasil. Although the vaccine is touted to prevent cervical cancer caused by the sexually transmitted Human Papillomavirus (HPV), controversy has arisen over the number of deaths and disabilities occurring in healthy young girls after taking Gardasil.

    Pharmaceutical giant Merck, which brought the public Vioxx, has now turned its attention to women’s health. After only five years of testing, Merck has developed and marketed the HPV vaccine Gardasil.

     In some small amount of cases, HPV can cause cervical cancer, which is responsible for the death of 3,700 women in the US each year. However, Merck’s vaccine protects against only 4 out of around 100 known strains of HPV; two of which are responsible for 70% of cervical cancers. Cervical cancer is not by any means an epidemic, or even among the top-ten threats to an American woman’s health.

     While cancer in any form is devastating, the risk for cervical cancer is relatively low for most women, especially thanks to early detection through Pap tests.  The Center for Disease Control (CDC) says that most people who get HPV never know they have it, and the virus may disappear on its own.

Making a Merck Monopoly through State Power

     At the moment, Merck’s Gardasil, delivered in a series of three doses, is the only HPV vaccine on the market. Merck beat out rival GlaxoSmithKline (which is developing Cervarix, anticipated release in 2009) by fast-tracking the process through the Food and Drug Administration (FDA) in 2006.

     Merck then launched a massive marketing campaign to create hype about this virtually unknown cancer, and through various third party lobbyists, Merck successfully pressured over 20 state legislatures to consider making Gardasil among the mandatory school vaccines for girls ages 11-12. In Virginia, by October 1, the STD vaccine will take its place alongside contagious childhood diseases such as mumps, measles, and rubella (MMR).

     Virginia’s law allows Merck to monopolize the state market for Gardasil – neither the vaccine nor its booster is compatible with rival GSK Cervarix – and reap enormous profits from what critics call a massive new batch of guinea pigs. Gardasil costs an average $360-400 per girl, meaning that Virginia’s 100,000 11-12 year old girls (according to 2005 US Census Data) will earn Merck $36 million in this state alone for just one school year. Wall Street estimates Merck’s overall profits from Gardasil to soar into hundreds of millions annually and eventually into the billions.

Gardasil, the FDA, and the Vioxx Legacy

     Gardasil profits will help Merck recoup from lawsuits and lost revenue following the recall of the other Merck FDA approved drug: Vioxx. A 2004 FDA put the death toll at 28,000, however forthcoming FDA estimates are expected to range between 89,000-140,000 people in the US alone. In this case the death toll ran high on account of FDA reluctance to review the connection between heart complications and Vioxx.

     Merck’s connections in the FDA run deep. The FDA advisory panel on Gardasil included two former Merck employees who helped developed Gardasil. Dr. John Boslego was executive director of Biologics Clinical Research at Merck for ten years, and left the company just two months before the  FDA  approved Gardasil. Alan Shaw was part of Merck’s Vaccine and Biologics Research. Despite their close ties, the FDA ruled both free of any conflict of interest and able to credibly pass a judgment regarding the safety of Merck’s vaccine.

Deaths and Complications: 8,000 and Counting

     Gardasil has already managed to raise serious alarm over its effect on women’s health. Since its release into the public on June 2006, over 8,000 adverse reaction reports (including reports of seizures, paralysis, auto-immune disorders and death) have been filed for girls severely affected by Gardasil, according to the public watchdog group, Judicial Watch. Between 18-20 deaths – 11 within one week of vacinnation – have been reported among otherwise healthy girls after taking the HPV vaccine.
 
     Merck’s own website for Gardasil lists (currently known) side effects, and while some of these are harmless and common to most vaccines, others are serious and potentially fatal. Guillian-Barre Syndrome (GBS) is among these. According to CBS, The Kaiser Daily Health Policy Report, Judicial Watch and others, many girls have already started to show signs of these symptoms, with around 20 confirmed cases by June. Guillian-Barre is an auto-immune condition which can be contracted either by receiving vaccinations or undergoing surgery. It causes rapid muscle degeneration, and eventually paralysis. There is no known cure, and according to Merck and the National Institute of Neurological Disorders and Stroke (NINDS), there is no way to identify which women receiving vaccinations will be subject to this condition - or for that matter any sort of effect.

Poor Testing Base for Massive Gardasil Target Group

     Even more disturbing is the fact that for the age group of 9-15 year old girls – the targeted group for Gardasil – Merck observed fewer than 1,500 test subjects in this cohort over a period of less than five years. According to The Journal of the American Medical Association (JAMA), the doctor’s pitch to the young girls forced to be vaccinated might go something like this: “The three injections will probably protect you from an infection that you can get only from sexual contact, but research has not shown how long the protection will last or whether it might have rare bad effects on your health.”

     The cropping up of serious side effects seems to be a ghastly echo of Vioxx, as the FDA refuses to reconsider its decision to fast-track Gardasil on the US populace or consider any connection between the deaths and disabilities reported among healthy girls recently vaccinated with Gardasil. Neither have Gardasil’s long term effects upon recipients been documented, nor has its effect upon the fertility of these girls been seen.

Law Makes Taxpayers, not Merck, Pay Detrimental Consequences

     Instead Virginia is leading the way to exponentially expand the number of girls who receive Gardasil without consideration that the number of adverse effects also might exponentially increase.
 
     Gov. Tim Kaine in signing the bill making Gardasil compulsory for girls 11-12 effective October 1, 2008 said Virginia is now “going to be a model for other states to follow.” 

     Parents or guardians will have the opportunity to opt their daughters out of receiving the vaccine by giving “adequate reason.” However critics charge that in the first place, the public should have had the ability to “opt- in” to the vaccine rather than have to fight state law to make a healthy and informed choice for their daughters.

     If Gardasil goes the way of other products like Vioxx, Virginia taxpayers, not Merck, may find themselves footing the bill for adverse consequences. A 1986 US Federal law (National Childhood Vaccine Injury Act) is often invoked in civil courts to protect vaccine manufacturers from liability for the “unavoidable” adverse side effects caused by their vaccines. Ultimately only Merck is fully protected from any reaction to its own vacinne.