Friday, February 09, 2007

More on the HPV Vaccine

I originally posted about Texas governor Rick Perry issuing an executive order mandating that 11- and 12-year-old girls be vaccinated with the new genital human papillomavirus vaccine. My main focus at that point was whether this should be a government function (and if so, should it be done by executive order, as opposed to going through the legislative process)?

Now, I'm more concerned with the process by which the vaccine was approved and the effects such a vaccine might have.

According to this column by Barbara Simpson, the vaccine was originally approved by the FDA back in June 2006, and pharmaceutical giant Merck has been lobbying states heavily since. At $360 a pop for the three-shot series, that's a lot of money for Merck.

The vaccine treats viruses that cause roughly 70% of all cervical cancers and genital warts. That leaves another 30% not covered by this vaccine. Hopefully, girls, their parents, and young women will be smart enough (and be informed by their doctors) that they still need yearly Pap smears even with this vaccine.

But more than just the fact that the vaccine only works on 70% of the viruses, I'm concerned about potential side effects. Because the dirt is always in the side effects that the pharmaceuticals never want to talk about.

Simpson cites that

in just six months, 82 cases reported to the government, involving neurologic symptoms, joint pain, fever and Guillain-Barre syndrome...

Fewer than 2,000 people were involved in the testing of Gardasil – with 102 adverse reactions, including juvenile, rheumatoid and regular arthritis, and 17 deaths, which were said to be unrelated.

So, our children would be forced to be injected with three doses of a vaccine that could cause serious side effects and we don't know the long term safety or efficacy.

Before anyone objects that this article comes from World Net Daily, I also found concerns raised here. This site raised a lot of questions.
--What are the various ingredients used in this vaccine?

--What are its possible interactions with medications, e.g., psychoactive drugs, antihypertensives, HRT, cholesterol-lowering agents?

--Are there any side effects seen in subsets of patients with medical conditions such as diabetes, attention deficit hyperactivity disorder (ADHD), seizure disorders, allergies and sensitivities (e.g., to yeast), and above all, the immunosuppressed?

--Is it really safe for preteens? The FDA has approved use of the vaccine for females between the ages of nine and 26. In Merck’s trials, however, only 250 nine-year-old girls and boys were tested with Gardasil. Where did these kids come from? The other question we ask ourselves is, "Would I volunteer my nine-year-old daughter to test a vaccine against a sexually transmitted disease?"

--How long will protection last? Will boosters be needed? Or worse, will elimination of just four out of over 100 viral strains create a niche for other strains to fill?

--“Who really needs it?” Isn’t there a greater call for an inexpensive vaccine in developing countries than for mandating an expensive one in American school systems?

One of the things this article points out is that Pap smears and yearly exams are far less expensive and more accurate for detecting cancers. Since the vaccine isn't a substitute for these measures, is it really in the public interest for the government to mandate that people spend this money?

Some of the numbers are problematic. For example, Simpson talks about "only 2,000" people tested with the vaccine before approval. The Woman to Woman site discusses "27,000 girls and women" tested. And I also found this site, which says that "20,541 women" were tested, but of that number, "only 1,121 subjects were under 16," and they were only followed for about 18 months. I think it is generally safe to say about 20,000 subjects were used and they were followed for anywhere from one to four years. That's not a long time to predict long-term effects on a vaccine given to your nine-year-old.

The question truly becomes is the benefit worth subjecting your nine-year-old daughter to the risks? According to Amanda, only parents who would rather their daughters die from cancer than admit they'll have sex one day would be ambivalent about this vaccine. But then, we've had so much evidence of where Amanda's head is over the last two weeks that we really can discount anything she says these days.

For more arguments against the vaccine, see this post at a site I probably would never visit otherwise. ;)

Cross-posted at Common Sense Political Thought.