TEXAS TO REQUIRE POORLY TESTED VACCINE
[The tests on this vaccine have been mainly on older girls and women, have been short term and were sponsored by Merck]
RALPH BLUMENTHAL, NY TIMES - Texas on Friday became the first state to require all 11- and 12-year-old girls entering the sixth grade to be vaccinated against a sexually transmitted virus that causes cervical cancer.
GREGORY LOPES, WASHINGTON TIMES - The National Vaccine Information Center yesterday warned state officials to investigate the safety of a breakthrough cancer vaccine as Texas became the first state to make the vaccine mandatory for school-age girls. Negative side effects of Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that causes cervical cancer, are being reported in the District of Columbia and 20 states, including Virginia. The reactions range from loss of consciousness to seizures. "Young girls are experiencing severe headaches, dizziness, temporary loss of vision and some girls have lost consciousness during what appear to be seizures," said Vicky Debold, health policy analyst for the National Vaccine Information Center. . .
Merck began marketing Gardasil last year after the Food and Drug Administration approved it for females ages 9 to 26. The vaccine is the first of its kind to build immunity against two strains of HPV, which lead to 70 percent of cervical cancer cases in the United States. . .
Its side effects were reported to the Vaccine Adverse Event Reporting System, a federal reporting system for consumers to notify federal regulators of bad reactions to medications. The adverse events began being reported in July 2006, when an advisory panel to the Centers for Disease Control and Prevention recommended girls ages 11 and 12 receive the series of shots.
The types of side effects reported are not cause for alarm, according to the American Cancer Society. "We have not been informed of an instance that would call into question the overall safety of the vaccine," said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society, adding that about 70 similar events had been known in October 2006. . .
Clayton Young, an obstetrician/gynecologist in Texas, objects to Merck's claim that Gardasil will prevent cervical cancer. "There is no proof Gardasil will stop cervical cancer," he said. "They haven't been studying it long enough to make that claim.". . .
Gardasil is delivered in three separate injections that cost $120 to $150 per injection. Blue Cross Blue Shield, an omnipresent health insurer in the Mid-Atlantic region, covers the vaccine for girls in the federally recommended age groups. Merck revenue from Gardasil reached $155 million for the fourth quarter of 2006 and $255 million for the entire year.
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Suppose, contrary to the evidence here, that the vaccine is safe and effective. Something I've never seen explained is why only girls are supposed to be vaccinated for this virus. As a sexually transmitted disease, one should see a nearly equal benefit from vaccinnating males as well (and further, perhaps a wider age range).
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.
The answer to my question as to why males aren't included can be inferred from the Merck report: effectiveness was measured by occurrence of "cervical intraepithelial neoplasia" (CIN) of severity 2 and 3 (explained here) and occurrences of "adenocarcinoma in situ" (AIS) (precursor lesions). I infer that these cervical phenomena are unobservable in males. Genital warts were monitored, and that would be universally observable. One is also left to wonder why Polymerase Chain Reaction (PCR), which apparently more directly detects presence of a specific virus, wasn't used past the 1 month following the last dose, and which would prima facie be sex-neutral.
The cost here, in time, money, and side effects, does indeed seem disproportionate to the good attained. Were stickdog to be more dispassionate and structured in their risk analysis, that disproportion might be even clearer.
Re: Texas To Require Poorly Tested Vaccine
Makes sense in the post-911 world: the USA has settled for a poorly tested ex-governor of Texas. "Oh the humanity!" (Or lack thereof...)
More info on Gardasil and HPV infection from the National Vaccine Information Center.
http://www.909shot.com/Diseases/
HPV/HPVHOME.htm
Since Gardasil is really about making money for Merck, I'm actually quite surprised they haven't decided to pursue making it compulsory for all middle school children.
IMO this suggests that Merck couldn't prove any benefit to males, and had to carefully design tests and manipulate data to get positive results for females.
I imagine Gov. Goodhair (as Molly I. loved to call him) thought this would be a good way to deal with all the criticism he and his evil predecessor have received for destroying the healthcare programs for poverty strciken children in of Texas. It seems to be backfiring a little.
Of course, It's also good for Merck who paid for the Gov's inauguration and contributed to his campaign.
Thanks for the nice post!
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