Texas might well be the first state to mandate a vaccine for a sexually transmitted disease.

Man on a mission

(Special from The Dallas Examiner, Member NNPA)Side-stepping the legislature, Governor Rick Perry recently mandated that all Texas schoolgirls entering the sixth grade receive vaccination for the Human Papillomavirus. That mandate is causing quite a stir, but Perry asserts that the mandate is necessary. “Requiring young girls to get vaccinated before they come in contact with HPV is responsible health and fiscal policy that has the potential to significantly reduce the cases of cervical cancer and mitigate future medical costs, “said Governor Perry.

Governor Perry also directed state health authorities to make the vaccine available free to girls 9 to 18 who are uninsured, enrolled in Medicaid or the Children’s Health Insurance Program or whose insurance does not cover vaccines. In addition, he ordered that Medicaid offer Gardasil to women ages 19 to 21 and Dallas County Health and Human Services has been prompt to respond to the Governor’s orders. DCJJS currently offers the Human Papillomavirus vaccine through its adult immunization clinic.

“DCHHS wants to provide the vaccine as a weapon against the deadly form of cancer”, said Zachary Thompson, DCHHS Director. “According to the Texas Cancer Registry, there were approximately 1,169 new cases and 391 deaths from cervical cancer in Texas in 2006. DCHHS is awaiting shipment of the HPV vaccine for children through the Texas Vaccine for Children program and will make a formal announcement when it becomes available.”

HPV infection in most cases is harmless

Many know that the vaccine has been tested for safeness and effectiveness against HPV. But what many do not know is that, according to the Center for Disease Control, HPV infection, in most cases, is harmless. In fact, 90 percent of infections are fought off by the bodies own immune system, rendering the infection inactive or causing it to dissolve on its own. But, there are other strains of HPV that are deemed as “high-risk” because the virus may, in rare cases, develop into persistent infecti9on that can progress to cervical cancer if left untreated (There are more than 100 known strains of HPV, 30 of these are sexually transmitted and are defined as genital HPV). It is estimated that fewer than 4000 Americans die from HPV related cervical cancer yearly. So why the need for an executive order which is used in times of crisis and emergency?

Justification

According to the Supreme Court: It is basic that no showing merely of a rational relationship to some colorable state interest would suffice (in reference to use of executive powers); in this highly sensitive constitutional area, “only the gravest abuses, endangering paramount interests, give occasion for permissible limitation,” Thomas v. Collins, 323 U.S. 516,530. Furthermore, Sherbert v. Verner (1963) posits that before executive powers can be used it must meet a three question litmus test which looks at the following questions: 1. government infringement with respect to its proposed action, 2. if the government has a compelling state interest which justifies government intervention and finally, 3. if compelling interests do not exist are there alternative means by which the government can achieve its goal and thus not burden the citizenry. The question is has the government determined this infection cannot be avoided by behavioral change and has chosen to shift the focus toward vaccination? And, if so, is mandatory vaccination against a disease that is largely sexually transmissible really the answer or is there a larger problem?

Adverse reactions reported during Gardasil’s testing phase

In initial clinical trials, Merk tested over 20,000 females, giving half of them placeboes and the other half Gardasil. The subjects were followed for approximately four years. More noteworthy, a little more than 1000 subjects, ages ranging from 9 to 16 years of age were a part of the trials and they were followed for only 18 months. Both in the placebo and in the vaccine groups, there are reports of adverse reactions. Gardasil’s own package insert sites as some of the adverse reactions reports of arthritis, headaches, dizziness, nausea, and pain at the injection site. Page 12 of the Merk package insert also cites 102 incidents of serious, adverse reactions such as headaches, dizziness, juvenile arthritis, gastroenteritis, appendicitis, pelvic inflammatory disease and includes 17 deaths out of 21,464 subjects. Merk concluded these deaths have nothing to do with their product. The test group was followed for a period of four years, raising doubts that as to whether Gardasil prevents anything, especially since the incubation period for the infection is about 20 years and usually presents in women in their late 30s and 40s. The only thing known with certainty is the short-term effects of this vaccine. Additionally, the study did not address carcinogens (any potentially cancer causing agent) or genotoxicity (a chemical or agent that causes damage to cellular DNA which can result in mutations or cancer).

The maker of Gardasil’s troubled past

Gardasil is made by Merk, a giant pharmaceutical manufacturer. Merk received licensing for Gardasil from the Food and Drug Administration in June of 2006, while the vaccine was still in clinical trials. In Gardasil’s own packing insert, it asserts that HPV types 16 and 18 are the cause for 70 percent of cervical cancer and Gardasil is reported to be affective against these implications for types 11 and 6. Merck’s package insert goes on to explain that women will continue to need regular cervical cancer screenings and that the vaccine may not protect everyone, raising questions as to whether this vaccine really is 100 percent effective. Merck is the same manufacturer of the drugs Fosomax and Vioxx, pharmaceutical nightmares for Merck and company that have left the company reeling from lawsuit settlements. It is estimated between 88,000 to 139,000 have suffered heart-attacks or strokes as a result of taking the drug Vioxx and more than 55,000 have died.
Merck continued to defend Vioxx even after it had been pulled from shelves, better than four years from when they knew there were problems.

Doesn’t FDA approval mean its safe?

According to The San Francisco Chronicle, Dr. David Graham, the scientist and 20 year FDA veteran, that blew the whistle on Merck & Co., said at a Senate hearing in 2004 that policies by the FDA had left the American public “virtually defenseless” against the kind of safety problems that led to Vioxx’ abrupt withdrawal in September 2004. Fox News.com reported that in his testimony, Graham said, “the FDA’s Office of New Drugs unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not. That rule does not protect consumers, Graham told the Senate committee. “What it does is it protects the drug,” he said. Additionally Graham told the Senate Finance Committee, “I would argue the FDA, as currently configured, is incapable of protecting America against another Vioxx.” According to Reuters, in the same hearing, Committee Chairman Charles Grassley, an Iowa Republican also raised concerns regarding the reliability of the FDA, saying he feared the FDA had become too intimately involved with drug companies and thought an independent office of drug safety might be need.

In an interview with CBS News Correspondent, Sharyl Attkinson, Dr. Graham characterized the FDA fostering as a work environment where supervisors intimidate employees when they bring attention to products that have questions with regard to safety. In the interview, he discussed problems not only with Vioxx and Fosomax, but also Bextra, Meridia, Crestor, Accutane, and Serevent. Were Gardasil to prove to be another Merck disaster, Governor Perry’s mandate requiring Gardasil to be offered under the vaccine for children’s law which will create total immunity from lawsuits from lawsuits from those who take Gardasil and experience adverse or even life threatening reactions. This is because the Federal Vaccine Liability program shields pharmaceuticals that develop vaccines.

One hand left to play, selling the public.

“We were first introduced to the Gardasil vaccine through what is commonly known as direct-to-consumer marketing.” says a mother with her young child in the background, in a Merck commercial. “O-N-E-L-E-S-S! I want to be one less, one less…”is chanted by children while skipping rope and playing. “Who wouldn’t want to vaccinate their children against cervical cancer?” It is a manufacturer’s way of first, raising awareness about its newest product and secondly, encouraging consumers, when visiting the doctor’s office, to ask for their product and to ask for it by name. If this were a game of poker, one might say it was the only hand that Merck had left to play if it were going to stay afloat financially. In a 2005 interview with Jim Lehrer of NPR, a representative from Merck Pharmaceuticals reported that because of financial hardships (largely attributed to trade mark expiration of Zocor, a cholesterol medication, and lawsuits from Fosomax and Vioxx), Merck, by 2008, would be closing seven manufacturing sites and laying off approximately 11 percent of its workforce. Ironically, 2008 is when the Governor’s mandate is to take affect. There is no word yet on whether sell of the Gardasil vaccine will off-set the financial disparities experienced by Merck & Co.

Gardasil is given in a series of three shots at $140.00 per shot ($420 in total). Some private doctors are already offering the vaccine, others are not stocking for reasons such as: too expensive to store and refrigerate or they have to charge a surcharge in case the insurance company does not pay. Gardasil is currently covered by some insurance companies, but others are waiting until there is more information about the drug (USA Today). But if the vaccine is indeed mandated under the Childhood Vaccination Program, this will guarantee profits for Merck both immediately and in the future as there is “sure to be a need for a booster. After all it is a vaccine,” said Dr. Edwards of the Texas Association of Ob-Gyns. This is a fact that has had little to no discussion in the public arena. Deputy Press Secretary for Governor Perry, Krista Moody, declined to respond to questions about the vaccine mandated by the Governor, stating, “I believe your attached questions should be directed to the CDC, FDA or Merck, as they relate to specifics for drug research and testing.” Both Christopher Loder, Media Relations Officer for Merck & Co. and Heidi Robello, FDR Media Relations agreed to answer questions presented to them in writing, but to date neither has responded.

Keeping it in perspective

The public is being told that the Gardasil vaccine should be hailed as a cure for cervical cancer, but this vaccination is not a cure for cancer. It is a vaccination purported to protect against two of over 100 different strains of HPV, with implications for two more. Furthermore, sexually active men and women, boys and girls can still continue to transmit other forms of HPV infections even after vaccination.