There was an intriguing little comment exchange about my last posting, on freerepublic.com, a news site with a libertarian slant. One reader asked,
“Who is David Gumpert. What’s his racket?”
Another person answered: “From the blog, it looks like he is seriously anti-vaccination.”
I guess when you raise questions about ingrained practices, you are automatically “anti”. (I did answer this individual by linking to an earlier commentary about not wanting to take sides.) Unfortunately, when it comes to vaccination, you almost can’t help but want to question, and with each new vaccine, the questions seem to increase.
I was in the car a lot today, and heard an interview on NPR of a Columbia University professor of public health, James Colgrove, about the cervical cancer vaccine, which he’s been following very closely. When you listen to the interview, you have to shudder at the lack of questioning that goes on before needles are stuck into the arms of young people.
Colgrove doesn’t seem to be “pro” or “anti” vaccination, though reading between the lines, I suspect he is a defender of the public health establishment. (As someone who lives in a glass house, I guess I shouldn’t throw stones.)
Anyway…the NPR interview is about the HPV Vaccine for cervical cancer. It turns out that even as the vaccine is being administered, scientific investigators are coming up with “new data,” says Colgrove. Among the new data is information about the vaccine’s effectiveness against two viruses strongly implicated in cervical cancer. “When you look at the entire pool of women, efficacy is only 44%,” says Colgrove.
Hmmm. And that 44% is only for two strains of virus. There’s a third strain of virus implicated in cervical cancer, he says, and, “It’s not really known what the contribution of this other strain is to cancer.” It could be a lot or it could be a little, and it’s not defeated by the vaccine.
His conclusion? There is “a lot that is still not known about what will be the public health impact of this vaccine.”
Even the public health authorities are at odds on what to do. The Centers for Disease Control (CDC) is recommending the vaccine for all girls ages 11 to 26. The National Cancer Society is recommending vaccination for all girls 11 to 18, but not for those 19 to 26. That’s certainly reassuring.
One thing we do know for sure, though, is that it costs $360 for the recommended three-dose series of vaccinations. Unfortunately, that one clear fact leads to a couple of other unknowns, says Colgrove—for instance, “how parents will pay.” Another unknown is whether the same immunity might be achieved with two shots instead of three shots.
And then there are the areas not even covered by Colgrove: possible side effects from the three shots, and whether there’s been any exploration as to whether it’s possible to build up natural immunity to the viruses in question.
If you aren’t feeling all warm and fuzzy about this joint venture between Merck and the CDC, neither are lots of other people. The one encouraging development in all this is that enough parents are asking enough questions that some of the state legislative proposals mandating the vaccination of young girls are being pulled back. The Texas order has been rescinded. Right now, Virginia is the only state that has made vaccination mandatory. It’s interesting how parents’s intuition can cut right through the smoke and mirrors put up by public officials.
The interview is worth listening to if you hold any illusions at all that the public authorities who mandate things like vaccination (and pasteurization) are demanding complete data and full consideration of public health risks before promoting mass inoculations of healthy individuals.
One other thing from the professor: “You have to maintain the trust of the public or you have lost everything.” Yes, you definitely don’t want the masses turning against you.
First, whether or not GARDASIL has any efficacy beyond 5 years is completely unknown.
Second, GARDASIL’s efficacy against all high grade cervical lesions caused by all dangerous, cancer associated HPV strains — even among the sub-population who tested negative for both HPV 16 and 18 before the experiment began — is disappointingly small (6% to 27% depending on the study and the sub-population).
In both the FUTURE I & the FUTURE II studies, Merck declined to release GARDASIL’s overall efficacy against all high grade cervical lesions caused by all dangerous, cancer associated HPV strains for the the sub-populations of subjects who tested negative for any and all HPV exposure when the experiments began. Therefore, we are currently left to wishfully assume a higher than 27% efficacy for this sub-population based solely on FUTURE II’s published results for the slightly larger sub-population that had not been exposed to either HPV 16 or 18 when the experiment began. Nor did Merck supply a breakdown by dysplasia grade for this sub-population, leaving open the possibility that most of GARDASIL’s "effectiveness" came against lower grade 2 dysplasias.
The use of a highly pharmacologically alum adjuvant as the sole "placebo" in both the FUTURE I & FUTURE II studies makes it impossible to accurately assess the overall risks of vaccination vs. non-vaccination in the real world. Furthermore, the fact that GARDASIL has been studied for safety in just a few hundred pre-teens (again using an alum injection as the "placebo") is highly problematic.
If HPV itself were a domestic health crisis, the analysis would be different. If the actual health risks of injecting preteens vs. the risks of not injecting were well quantified, the analysis would be different. If HPV were highly contagious without prolonged skin to skin contact, the analysis would be different. If GARDASIL were free, the analysis would be different. But as it stands, we are looking at a vaccine with a clinical effectiveness of no more than 30% against all high grade cervical lesions over a three year period. Even if we assume that HPV 16 and 18 directly cause cervical cancer, that the prevalence and carcinogenicity of current HPV strains won’t change over time or in response to the limited immunity that GARDASIL confers, that vaccinated women will continue to get Pap smears at least as frequently as unvaccinated women currently do and that there will be no other improvements in tests or therapies for unvaccinated women, we are looking at saving no more than 1000 lives a year 20 to 40 years down the road, about half of which could be saved simply by assuring that all women receive regular Pap smears. That’s if we vaccinate every 9 to 12 year female in the US over the next 20 years at a cost of well over 20 billion dollars. Furthermore, with only a 6% to 30% efficacy, it is now 100% clear that GARDASIL can not be utilized to save lives in any reasonably cost effective manner by allowing medical policy makers to delay the onset or reduce the frequency of recommended Pap smears.
Finally, even though we don’t have any decent quantitative numbers concerning GARDASIL’s safety (especially on a pre-teen population), we must consider that vaccines in general are not 100% safe. They can cause juvenile arthritis, Guillain-Barre syndrome and other major complications (such as temporary paralysis, fainting, and persistent pain, swelling and itching) in a small subset of the population. Vaccines are not like other medicines in that they are given to a lot of healthy people who would not otherwise contract any disease with or without vaccination. So vaccines must be reasonably effective for their benefits to outweigh their associated risks.