Feb 3, 2007

Texas Republican orders HPV vaccine

Rick Perry, GOP governor of Texas, has written an executive order requiring HPV vaccination for middle school girls.
Beginning in September 2008, girls entering the sixth grade — meaning, generally, girls 11 and 12 — will have to receive Gardasil, Merck's new vaccine against strains of the human papillomavirus (HPV).

Perry also directed state health authorities to make the vaccine available free to girls 9 to 18 who are uninsured or whose insurance does not cover vaccines. In addition, he ordered that Medicaid offer Gardasil to women 19 to 21....

Perry, a conservative Christian who opposes abortion and embryonic stem-cell research, counts on the religious right for his political base. But he has said the cervical-cancer vaccine is no different from the one that protects children against polio.

"The HPV vaccine provides us with an incredible opportunity to effectively target and prevent cervical cancer," Perry said.

The shots will cost the state $50 million the first year.
A cynic might accuse Perry of sitting safely in the pocket of Merck, which stands to gain millions from the new policy--but then, why would Perry spend so much political capital by risking the anger of his supporters?

On the other side, conservative opponents sound pretty foolish:
Cathie Adams, who heads the Texas Eagle Forum, said she was "very sad" Perry issued the order and warned that state health officials and Merck are usurping the role traditionally played by parents.

"I am absolutely opposed that Merck and the state government are planning to inject young girls with a cancer-causing virus," Adams said.

Scientists, however, say the HPV vaccine uses particles that look like the virus on the outside but aren't infectious. The particles trick the body into thinking it has been infected, prompting the development of immunity to the virus.
Nothing like principled distortion of the facts.

Texas allows a faith-based or philosophical objection to vaccination. According to the CDC, approximately 80% of women over the age of 50 carry the virus.

Update: Be sure to read the comments for reader stickdog's skeptical questions. Also, check out Eugene Volokh's examination of mandatory HPV vaccination from a libertarian perspective.


stickdog said...

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.

Jim Anderson said...

stickdog, as a commentator on your site pointed out, some documentation would be good. Certainly would throw a lot more water on the "Perry saves lives" fire on some blogs.

Jim Anderson said...

Poking around on Merck's site, I see that "Only a doctor or healthcare professional can decide if GARDASIL is right for you or your daughter." I guess they'll have to start calling him Dr. Rick.

Jim Anderson said...

I should also point out that this medical professional is a lot more optimistic about the vaccine's prospects.

stickdog said...

There are two sides to every discussion, of course. This vaccine does appear to confer some benefits. If I were a sexually active woman who disliked condoms and liked to have multiple sex partners who had not yet been exposed to any of the four strains of HPV that this vaccine protects against, I just might sign myself up.

But that’s not the same thing as making this vaccine MANDATORY for a preteen population it was not rigorously tested on a scant 8 months after its initial rush job FDA approval.

Aside from all the known risks of all vaccines, the unknown risks of this three shot regimen for preteens along with their other vaccine load, and the unknown long term risks of this vaccine for all populations, we have to look at cost vs. benefit.

7861 of the placebo subjects contracted 83 cases of HPV 6-, 11-, 16-, 18-related dysplasias during the testing period compared compared to 4 cases among the 7858 subjects who were given GARDASIL. That’s after counting out every subject with any prior exposure to these strains. This includes 42 of the less serious HPV 6-, 11- related low grade dysplasias.

Merck has published no data for how many non-HPV 6-, 11-, 16-, 18-related dysplasias were contracted by these subjects over these periods, but some practitioners have commented that they expect the vaccine to protect against 40%-50% of all dysplasias.

In terms of every possible kind of dysplasia for which this vaccine confers protection, Merck’s own clinical evidence suggests that this vaccine saved about 10 patients out of each 1000 injected from the painful process of having these dysplasias treated (over the entire course of follow ups which ranged from 18 months to 4 years). Note that the populations for these studies were not preteens but women at the height of their sexual activity. Further note that since the vaccine uses virus-like particles (a new vaccine technology) and is only about five years in testing now, there is no guarantee that it has any long term efficacy.

Of course, the pre-teen population is so less sexually active (and when active, so much less likely to be active with a previously contaminated partner) that I think it would be conservative to estimate that preteens are 5 times less likely to contract HPV dysplasias than the 16 to 26 year olds who were tested by Merck. So instead of saving 10 women per 1000 from painful treatments for HPV dysplasias, this vaccine would save perhaps 2 girls per 1000 from these procedures among the much younger population that Merck and Merck’s politicians are targeting for mandatory vaccination.

Do we really want to pursue a public policy that costs $360,000 to vaccinate every 1000 girls while exposing each and every one of these thousand girls to the known adverse short term and largely unknown long terms side effects of three injections of a new vaccine just to save two of the more sexually active of these kids from having to have their dysplasias treated conventionally? What kind of a risk and cost vs. benefit trade off is that?

Note that nowhere are we discussing actual incidences of cervical cancer because there is no clinical evidence whatsoever that GARDASIL reduces cervical cancer rates, and even if we place our hope in the the fact that it might, cervical cancer is simply not a meaningful health risk for any girl in the target vaccination population who is getting an annual pap smear.

My source is Merck via the FDA

Also see: NY Times Op-Ed

Jim Anderson said...

stickdog, your questions are valid, and I'm becoming more skeptical of the prudence of Perry's action by the second. The more I read, the more it doesn't add up.

However, one more thing: condoms don't entirely protect against HPV. As the NY times editorialist grants, they reduce risk of infection by about 50%.

Eilebug said...

They said Vioxx was safe. This is the SAME company. The vaccine is also extremely expensive. No monetary help was negotiated by Gov. Perry.