Follow the Money: There's a push to require Gardasil, the vaccine against the sexually transmitted human papilloma virus, for school children. The push, as these public health vaccine programs so often are, is being orchestrated by the vaccine manufacturer:
With at least 18 states debating whether to require Merck's Gardasil vaccine, Merck has funneled money through Women in Government, an advocacy group made up of female state legislators. A top official in Merck's vaccine division sits on the group's business council.
....Merck spokeswoman Janet Skidmore would not say how much the firm is spending on lobbyists or how much it gave to Women in Government. It could make billions if Gardasil -- at $360 for a three-shot regimen -- were mandatory.
"Cervical cancer is of particular interest to our members because it represents the first opportunity that we have to actually eliminate a cancer," Women in Government President Susan Crosby said.
Well, it's not the first. That's the same talking point they used to mandate Hepatitis B vaccination, which is now required for public school entry in many states, even though school children carry a very low risk of giving Hepatitis B to each other. (As compared to say, measles or mumps, or diphtheria.)
This issue is obviously very important to Merck:
A mandatory vaccine against a sexually transmitted disease could be a tough sell in the Lone Star State and other conservative strongholds, where schools preach abstinence and parents' rights are sacrosanct.
But Merck has doubled its spending on lobbyists in Texas this year, to between $150,000 and $250,000, as lawmakers consider the vaccine bill for girls entering the sixth grade.
Also, the drugmaker has hired one of the state's most powerful lobbyists, Mike Toomey, who once served as Republican Gov. Rick Perry's chief of staff and can influence conservatives who see him as one of their own.
"What we support are approaches that achieve high immunization rates," said Skidmore, the Merck spokeswoman. "We're talking about cervical cancer here, the second-leading cancer among women worldwide."
The important word there is worldwide - as in Third Worldwide. In the United States, it doesn't make the top ten. But of course, Merck isn't aggressively marketing (or donating) its expensive vaccine to the Third World or to the various international bodies and aid-groups whose mission it is to help the Third World. They're concentrating on where the money is. posted by Sydney on
1/31/2007 08:43:00 AM
The issue here is simply about legislating a specific company's product. Sex, medical need, lower health cost are all strawmen being used in this argument.
The reality here is that if this succeeds, regardless of the merits of the product, we will see other companies using the same technique to assure themselves of sales. Pharma has already used supposed consumer groups to demand legislation of it's drugs. This frontal attack will only increase this type of pressure on legislators and local agencies.
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.