The HPV Game
March 13th, 2007 at 6:45 am
The HPV vaccine showdown continues anew this morning. The early card is Houston Democratic Rep. Jessica Farrar’s 8:30 a.m. press conference to promote the mandatory use of the vaccine. That’s followed by the main event, a House debate over HB 1098, which would, basically, keep anyone in Texas, whether governor, legislator, or official, from making the vaccine a requirement for school.
All eyes will be on the debate, since the tone it takes and the facts it abuses will be the only thing in doubt. Dennis Bonnen (R-Angleton) the bill’s sponsor, has claimed for weeks to have the support of 90+ legislators, and there’s no reason to doubt him. My guess is that conservative lawmakers, more than anything, just want to see this mandate go away, since they really can’t win: after all, even standing for family values, or against Merck pay-for-play (eyes roll here), or for individual rights, or against government-sponsored health care, or whatever, it stills leaves you pretty much on the side of helping out cancer.
I would feel much more comfortable about vaccine opponents’ peaens to families being allowed to choose to receive the vaccine if there was a counter-proposal somewhere, anywhere, to drastically increase it’s availability — paying to have state contractors come to schools to deliver voluntary vaccination doses, similar to scoliosis checks, is one option, off the top of my head.
Instead, those most adamantly opposed to the vaccine have decided to attack the science behind it. Going into tomorrow’s debate, it’s good to get back to square one. Namely, all the existing evidence indicates this vaccine is both safe and effective. That’s why the FDA approved it and why expert organizatios like the Center for Disease Control readily endorse it. Because the vaccine is so new, there are limitations to how long the vaccine has been studied and how many women it has been tested on. It is these limitations that make doctors cautious to endorse a mandate of the vaccine, even though almost all support a voluntary program. It is also these limitations that prevent Merck from making definitive claims about the vaccine’s ability to reduce cancer rates or the length of time a dose of the vaccine will be effective. It is, obviously, an impossibility to test whether a vaccine that is only about 10 years old will last for 20 years.
But it is these limitations that opponents of the mandate seek to exploit. They say we don’t know what could happen in the future, we don’t know all of the possible side effects, we don’t know how long the vaccine will last, we don’t know what happens when pregnant women receive the vaccine, and so on. Based on these fears they claim that Merck has essentially paid off politicians to bankroll a grand medical experiment. But a lack of definitive data proving the safety and efficacy of the vaccine is not evidence of ineffectiveness or potential dangers. It is only proof that more testing is needed.
In just one example, take Rep. Bonnen’s favorite from the committee hearing on his bill, teens who don’t know they are pregnant accidentally receiving the vaccine. This uncertainty about a tiny subset of 11- and 12-year old girls is enough to justify prohibiting a mandate altogether, according to Bonnen. After all, even Merck warns against pregnant women receiving the vaccine.
The rebuttal from the CDC: “The vaccine is not recommended for pregnant women. There has been limited research looking at vaccine safety for pregnant women and their unborn babies. So far, studies suggest that the vaccine has not caused health problems during pregnancy, nor has it caused health problems for the infant– but more research is still needed. For now, pregnant women should complete their pregnancy before getting the vaccine.”
Again, the problem here is that opponents are attacking the vaccine with no supporting medical evidence, only fears of hypothetical unknowns. Ideally the debate would be a political discussion about the mechanics of a mandate. The vaccine is far from perfect. It is expensive, and because HPV-related diseases take years to develop, there will be a lag of possibly decades before the state sees any significant return on an investment in the vaccine.
All of these are fair reasons to question a statewide mandate, even as the governor’s office raises serious concerns about adoption if the vaccine is optional. Even if HPV is unique, both for what it treats and when it is administered, it is a near certainty that the rate of vaccination will be many times higher if it is mandatory with an opt-out policy, especially among low-income women who have the least access to pap tests and other medical care that is so vital to catching and treating cervical cancer, dysplasia, and all of the other diseases related to these strains of HPV.
Because of all this, the HPV vaccine seems like an issue ripe for compromise, if only lawmakers would drop the either/or premise and look for the best way to make sure the vaccine was as accessible as possible. Instead, we get a philosophical debate masquerading as a medical diagnosis.
March 14th, 2007 at 4:26 pm
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 virus. It is not contagious without prolonged skin to skin contact. 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.
For a more complete discussion on GARDASIL with sources, click on my name.