I support Bill Richardson's decision to veto Gardasil legislation

Yesterday Bill Richardson vetoed legislation that would have made Gardasil vaccination of 6 year-old girls compulsory. Here's the story :

"While everyone recognizes the benefits of this vaccine, there is insufficient time to educate parents, schools and health care providers," he said.

The measure would have taken effect June 15, requiring girls entering sixth grade this fall to be vaccinated against the human papillomavirus, or HPV, before they enter public or private school.

The bill would have allowed parents to opt out of the vaccination requirement.

Merck, the company that produces Gardasil, needed a homerun drug after the legal mess and PR nightmare of the Vioxx cases. The company lost a $235 million lawsuit for knowingly suppressing documentation about the potential lethal cardiovascular effects of Vioxx and for "tweaking" clinical studies evidence to support their false claims of safety.

The company knew as far back as 2000 the painkillers could kill people with cardiovascular problems but it took them a warning from the FDA, requests for new trials by American Heart Association, the National Stroke Association, the Arthritis Foundation and 4,000 lawsuits for the company to conduct another round of clinical trials that would further the minimum of testing they submitted to the FDA in order to get their drug approved.

On September 30, 2004 Merck finally pulled the drug off the market after the second round of trials did confirm Vioxx was not safe. In 2005 they lost the landmark Ernst v. Merck product liability case --which granted a record $253 million in damages to the plaintiff. The company's stock fell almost 8% minutes after the verdict and, given the drug accounted for 10% of the company's revenue, Merck has been losing since 2004 a record $2.5 billion annually in revenue.

To say Merck has been bullishly campaigning to make Gardasil vaccination mandatory, is to understate the desperation behind their pushing their economic interests as a public health issue. They need to offset some of those billions they've been losing since 2004.

Of course, don't tell that to some of my colleagues in the feminist blogosphere. They don't really want to discuss the issues surrounding the credibility of a company like Merck. Nor have they proceeded with caution over the FDAs enthusiastic support for the vaccine right on the heels of the agency's infamous campaign not to approve Plan B for over-the-counter use. How can they unquestioningly throw their support for mandatory vaccination when there is evidence that the FDA colludes with pharmaceutical companies to put out or suppress drugs either for economic or political reasons?

Bill Richardson is right to not push for this piece of legislation because, indeed, the general public has not had enough time to evaluate Gardasil and make educated decisions over it's safety. I am particularly concerned with the fact that after an incredibly detailed report submitted by the National Vaccine Information Center, not one legislature that has tried to push for mandatory vaccination has ever considered discussing their findings.

I am particularly troubled by the following points found in their Human Papilloma Virus Vaccine Safety |
Analysis of Vaccine Adverse Events Reporting System Reports: Adverse Reactions, Concerns and Implications :

4. Aside from Hepatitis B, Merck does not state that it is safe to simultaneously administer GARDASIL with any other vaccine. Considering that there are ongoing evaluations of a reported association between Menactra (meningococcal vaccine) and Guillain-Barre Syndrome, and Merck does not explicitly indicate that it is safe to administer to administer GARDASIL and Menactra simultaneously, consumers and clinicians should question whether administering both GARDASIL and Menactra at the same time is safe.

6. Most, if not all, of the reactions reported to VAERS were in response to the first of the three doses of GARDASIL. The Centers for Disease Control (CDC) Vaccine Information Sheet (VIS) developed for HPV vaccine states that severe reactions include "any unusual condition, such as a high fever or behavior changes. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness." [6] The CDC also states that "anyone who has ever had a life-threatening allergic reaction to yeast, to any other component of HPV vaccine, or to a previous dose of HPV vaccine should not get the vaccine." Which of the reactions reported to VAERS constitute a "life-threatening allergic reaction" and which, if any, of the children and young adults who experienced reactions should receive additional doses of vaccine?

At the October 2006 ACIP meeting, CDC staff stated that only "three serious reports were reported to VAERS after HPV vaccination in females 14 and 16 years of age. One of these patients had vasovagal syncope and was hospitalized overnight for observation." [7]CDC's summary of the first 76 VAERS reports suggests that CDC doesn't regard the remaining reports as "serious." CDC needs to clarify which of the reactions reported to VAERS constitute contraindications to further vaccination with GARDASIL and make this information available to the public and to prescribing physicians.

As a mother of a child who suffers from 17 allergy markers, most of which exploded after he got his first round of vaccination, I have to admit I am absolutely biased against any attempts by government or special interests in making any kind of vaccination mandatory. Especially after the radical changes in FDA drug approval that happened during the 1990's and of which I wrote when I first questioned the rush to Gardasil cheerleading in Somebody needs to smack the head of the FDA : How is Gardasil safe for minors but not Plan B?

Sure, the prospect of wiping out cervical cancer is exciting but it was never, ever, a reproductive rights issue. What has always been at the core of feminist issues is how the government colludes with big pharma in supressing affordable birth control measures --especially contraceptive drugs for men that would free many women like me from the hormonal havoc and damage wrecked by contraceptive medications.

I honestly find offensive how Merck has turned feminist organizations and bloggers into Gardasil cheerleaders for their marketing campaign. Which is why I approve of Richardson's prudent move. The people of New Mexico need more time to evaluate the findings of the National Vaccination Information Center and ensure this Gardasil product does not become the agent of future immunological nightmares.

But on a less dramatic level, if indeed evidence begins to build around the potential immunological and lethal problems with the vaccine, the state could open itself for a wave of liability lawsuits, far greater than the $253 million lost on account of Vioxx. Approving of the drug with little public evaluation could prove lethal to the future economy of New Mexico.

I really didn't intend to have so many Bill Richardson posts this week at culturekitchen but this is one issue that is near and dear to my heart. While working at Colgate-Palmolive 10 years ago, I learned too much about the shenanigans pharmaceutical companies engage in order to have their products approved.

Cow-towing to pharma money and bullying governors into irresponsible legislation, that ought not be the priority of any legislature. The most responsible thing legislatures could do is to ensure medical insurers pay for the vaccination. They could also empower product liability committees within their Public Health departments with the tools necessary to evaluate new drugs and even conduct testing if it means it will protect and enhance the quality of life of their citizens.

So Bill Richardson, you can quote this here feminist as saying your decision is the best one for New Mexicans.

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