I see that Sujatha has already published a post on Texas governor Rick Perry's order to make vaccination with Gardasil mandatory for 11-12 year girls in Texas. Many other states are considering a similar move. I nearly fell off my chair at the breakfast table yesterday morning when I read on the front page of the Houston Chronicle that Texas governor Rick Perry is at the forefront of this campaign.
The pros and cons of vaccinating girls with Gardasil are still under consideration. I don't think that the state of Texas or any other governmental agency ought to make the vaccine mandatory at this stage. Although the efficacy of the vaccine has proved to be nearly 100% in clinical trials, its long term effect on the health of women is not known. My own considered opinion is that the vaccine should be made freely available. Insurance should be required to pay. Those without insurance should be subsidized. But the decision to vaccinate (or not) should be left to parents, as of now. Many parents of young girls have naturally reacted with some alarm at Governor Perry's high handedness - some because of moral concerns(?) and others due to health related issues.
More than the debate over whether the vaccine should or should not be mandatory, the question that intrigued me was why our otherwise conservative and generally vacuous governor took this bold and drastic step which flies in the face of what his conservative base thinks of the vaccine. Halfway through the report, I got the answer that cleared up my fog of confusion - Perry's erstwhile chief of staff is now a lobbyist for Merck, the pharmaceutical company that manufactures Gardasil. Whoops! One sure fire way to boost sales and ensure an undying cash cow for a drug manufacturer is to make a pharmaceutical product mandatory. And here I was, puzzled and pleasantly surprised that Governor Goodhair had suddenly become a champion of women's health and had acted solely on an uncharacteristic progressive impulse of ensuring their well being. Silly me!
Acting on an issue that is stirring controversy in the Legislature, Gov. Rick Perry on Friday made Texas the first state to require girls to get a new vaccine for a sexually transmitted virus that causes cervical cancer.
The executive order, which would apply to all girls entering sixth grade next year, prompted surprise and relief from one lawmaker who didn't think her bill requiring the same would have passed. But it so angered many social conservatives who have consistently backed Perry that they suggested money and political ties to the vaccine's manufacturer were behind the decision.
Perry's office insisted that protecting girls ages 11 and 12 against the human papilloma virus was a public health issue, not politics.
"Requiring young girls to get vaccinated before they come into contact with HPV is responsible health and fiscal policy that has the potential to significantly reduce cases of cervical cancer and mitigate future medical costs," Perry said in a press release.
"This is 'follow the money' if I've ever seen it," said Cathie Adams, president of Texas Eagle Forum.
"There's no health emergency for cervical cancer. The only emergency is in the Merck board room," said Dawn Richardson of Parents Requesting Open Vaccine Education, a vaccine information group.
The vaccine, known as Gardasil, is manufacturered by Merck and was approved by the Food and Drug Administration in June. It is only effective if administered before infection; the Centers for Disease Control and Prevention recommends it for females ages 11 to 26.
Big push by Merck
Mike Toomey, former chief of staff to Perry, is a lobbyist for Merck. The pharmaceutical company has donated $6,000 to Perry since 2005 and $38,000 to legislative leaders and lawmakers. Merck spokesman Ray Kerins downplayed the company's role in Perry's order, saying "we're working in all 50 states to achieve the widest vaccination possible...."
By the way, why is the vaccine being aimed only at girls? Gardasil is a vaccine against the human papilloma virus (HPV), not cervical cancer. Although only girls are at risk of developing cervical cancer when infected with HPV, boys too get infected by the virus and can spread it to their sexual partners. Should yet another onerous burden of responsible sexual behavior be borne just by young women? The report on Gardasil says:
....A recent study found that 90 percent of cervical cancer cases could be eliminated if boys and girls got the vaccine. If only girls get it, just more than three quarters of cases would be eliminated. (italics mine)
The Facts About GARDASIL
1) GARDASIL is a vaccine for 4 strains of the human papillomavirus (HPV), two strains that are strongly associated (and probably cause) genital warts and two strains that are typically associated (and may cause) cervical cancer. About 90% of people with genital warts show exposure to one of the two HPV strains strongly suspected to cause genital warts. About 70% of women with cervical cancer show exposure to one of the other two HPV strains that the vaccine is designed to confer resistance to.
2) HPV is a sexually communicable (not an infectious) virus. When you consider all strains of HPV, over 70% of sexually active males and females have been exposed. A condom helps a lot (70% less likely to get it), but has not been shown to stop transmission in all cases (only one study of 82 college girls who self-reported about condom use has been done). For the vast majority of women, exposure to HPV strains (even the four “bad ones” protected for in GARDASIL) results in no known health complications of any kind.
3) Cervical cancer is not a deadly nor prevalent cancer in the US or any other first world nation. Cervical cancer rates have declined sharply over the last 30 years and are still declining. Cervical cancer accounts for less than 1% of of all female cancer cases and deaths in the US. Cervical cancer is typically very treatable and the prognosis for a healthy outcome is good. The typical exceptions to this case are old women, women who are already unhealthy and women who don’t get pap smears until after the cancer has existed for many years.
4) Merck’s clinical studies for GARDASIL were problematic in several ways. Only 20,541 women were used (half got the “placebo”) and their health was followed up for only four years at maximum and typically 1-3 years only. More critically, only 1,121 of these subjects were less than 16. The younger subjects were only followed up for a maximum of 18 months. Furthermore, less than 10% of these subjects received true placebo injections. The others were given injections containing an aluminum salt adjuvant (vaccine enhancer) that is also a component of GARDASIL. This is scientifically preposterous, especially when you consider that similar alum adjuvants are suspected to be responsible for Gulf War disease and other possible vaccination related complications.
5) Both the “placebo” groups and the vaccination groups reported a myriad of short term and medium term health problems over the course of their evaluations. The majority of both groups reported minor health complications near the injection site or near the time of the injection. Among the vaccination group, reports of such complications were slightly higher. The small sample that was given a real placebo reported far fewer complications — as in less than half. Furthermore, most if not all longer term complications were written off as not being potentially vaccine caused for all subjects.
6) Because the pool of test subjects was so small and the rates of cervical cancer are so low, NOT A SINGLE CONTROL SUBJECT ACTUALLY CONTRACTED CERVICAL CANCER IN ANY WAY, SHAPE OR FORM — MUCH LESS DIED OF IT. Instead, this vaccine’s supposed efficacy is based on the fact that the vaccinated group ended up with far fewer cases (5 vs. about 200) of genital warts and “precancerous lesions” (dysplasias) than the alum injected “control” subjects.
7) Because the tests included just four years of follow up at most, the long term effects and efficacy of this vaccine are completely unknown for anyone. All but the shortest term effects are completely unknown for little girls. Considering the tiny size of youngster study, the data about the shortest terms side effects for girls are also dubious.
8) GARDASIL is the most expensive vaccine ever marketed. It requires three vaccinations at $120 a pop for a total price tag of $360. It is expected to be Merck’s biggest cash cow of this and the next decade.
These are simply the facts of the situation as presented by Merck and the FDA.
Posted by: stickdog | February 04, 2007 at 04:17 PM
It is only labeled for use in women because it has only been tested on women. Women have the most incentive to pay for and take such a vaccine, so it was surely more profitable this way.
Posted by: Michael | February 07, 2007 at 10:27 AM
Check this link:
" Merck is bankrolling efforts to pass state laws requiring the Gardasil vaccine for girls across the country, funneling money through Women in Government, an advocacy group made up of female state legislators nationwide. Perry has ties to both.
One of the drug company's three lobbyists in Texas is Mike Toomey, Perry's former chief of staff. His current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director of Women in Government."
This has 'conflict of interest' plastered all over it.
Posted by: Sujatha | February 09, 2007 at 12:30 PM