Gardasil: Conservative Group Trumpets Side Effects
18 CommentsBy Ed Silverman // October 9th, 2007 // 8:42 am
Judicial Watch, which bills itself as a conservative public interest group that “advocates high standards of ethics and morality in our nation’s public life,” is again making news by releasing FDA side effect reports showing an increase in adverse events attributed to Merck’s HPV vaccine. The group did the same thing last May, so it’s not surprising the tally rose, given that Gardasil has been more widely administered since then.
Nonetheless, Judicial Watch says that, after obtaining the info through a Freedom of Information Act request, the FDA received 1,824 adverse reaction reports, including as many as eight deaths. Previously, the group received 1,637 such reports and notes that a total of 11 deaths are now among the side effect reports to the agency. You can read the reports by visiting the group’s web site.
“In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls,†says Tom Fitton of Judicial Watch, which is also suing the FDA for not responding to the entire FOIA request. “These adverse reaction reports suggest the vaccine not only causes serious side effects, but might even be fatal.â€
This is, essentially, another front in the battle against Gardasil. By issuing such press releases, Judicial Watch not only caters to its core constituency - social conservatives who worry the HPV vaccine will be seen as a green light to premarital sex among teenagers - but also plays on the concerns of parents who are undecided whether to vaccine adolescent girls (Gardasil isn’t yet approved for teenage boys) and question mandated vaccination.
Even some Gardasil researchers question mandates, while the CDC has lined up solidly behind vaccination, in general. The challenge for Merck, which of course wants to boost sales, is to find a way to promote Gardasil without appearing heavy-handed or sleazy, which happened earier this year when a lobbying campaign was disclosed. Fighting reports of death, however, may not be easy.
Doug Bremner
Since HPV is so ubiquitous it is uncommon for HPV
to progress to cervical cancer. Cervical cancer kills 4000 women per year, only 1/10th the death rate of breast cancer, for example. If you do the numbers, that means that about 0.002% of women infected with HPV die each year from
HPV-induced cervical cancer—not a very impressive number. There certainly is no medical necessity to mandate Gardasil vaccines, or flu shots for that matter. The CDC is making recommendations that are not backed up by science.
Reality
Doug,
What is the cutpoint for annual deathrate for diseases we should care about and treat? Other things with death rates approximating cervical cancer include asthma, pancreatic cancer, ovarian cancer, Parkinsons, hep C. Should we stop research in these areas?
On a less snarky note, while “only” 4000 will die per year, 10-14,000 are diagnosed each year. Those who don’t die from it will still need to undergo surgery, chemo, and/or radiation therapy, which carry with them a large morbidity burden. Not to mention that the vaccine prevents HPV infection itself for those subtypes. That’s the science the CDC is using.
This is about being able to prevent morbidity and mortality. To deem it unworthy because not enough people die annually from it is woefully shortsighted and misguided.
Melody
Reality–
Is your “interpretation” intentionally obtuse? I believe Doug was commenting on the issue of MANDATORY vaccination . . . and you have reframed this as “stopping research.” I didn’t see that Doug advocated the termination of research . . . or prevention (with Gardisil) if desired. You obviously belong to the school of “black or white” with no middle ground for those who like gray.
Lisa Van S
Reality,
Would anyone like a Female perspective on this issue?…
Reality
Lisa,
I don’t think anyone’s ever stopped you from voicing your opinion ;-).
However, I was merely responding to Doug’s assertion that the death rate from cervical cancer isn’t sufficiently high enough to warrant treatment. Whether it should be mandated, I’m not sure, but I’m leaning toward “no”.
Lisa Van S
Reality,
Your’e becoming a man of “Wisdom”
Personally I wouldnt get this vaccine,why,because its just been recently approved and its safety profile isnt clear to me.
Secondly,I have a problem with these types of vaccines being federally mandated…Whatever happened to a Woman’s right to choose.If a woman has the right to choose to have an abortion,she should also have the right to refuse a vaccine.
And lets not forget how women get HPV…from man.
Advice I have given my 19 year old son….
No Glove,..No Love…
Reality
Lisa,
I think your opinions are perfectly valid, but not necessarily restricted to a woman’s point of view. The full safety profile of any drug may not be known for years, or even decades. And as I stated, I’m not thrilled with mandating a vaccine for something not highly contagious (e.g., measles) or rapidly lethal (e.g. tetanus).
And where did the man get the HPV? Presumably you were being funny, but at this point, with HPV being so prevalent, everyone’s giving it to everybody else.
The bigger problem here is that conservative groups are not really against this for side effects or anything remotely scientific. It’s about sex. Period. If this were a vaccine to prevent breast cancer, it would be a non-issue.
Hank
We discussed the Gardasil case in a course of mine last spring, just when all the WIG/Merck/Texas stuff was hitting the fan.
The public health and political economy here are obviously tangled up. But one of the women in my class raised an issue easy to miss. Even if one survives a CC dx - as the majority of women doin the “developed” world (but not by as high a _percentage_ as those dx’d with breast cancer - the tx can be horrific. Yes, it’s great to be a “survivor.” But when we talk about prevention, we should include the casualties as well as the deaths.
Adriana
What would the nonvaccinated HPV death rate be in the age group of girls who died from adverse vaccine reaction?
Doug Bremner
My point was that the science is not so open and shut that the federal or state governments should not be mandating this vaccine. Since the long term effects are not known people should be able to choose for themselves. There was a clear conflict of interest in the events that led to the state of Texas mandating the vaccine. Tell me I am wrong but by my calculations about .1% of women will die from HPV related cervical cancer, which means it costs $350,000 to save a life from cervical cancer. You can argue about how much a life is worth, but it is irresponsible to say that there should be no limit on how much we should spend to save a single life, since that is where we got into the health care financial mess we are in now.
Reality
Doug,
I was speaking more generally. As I wrote several times, I pretty much not in favor of mandating. However, as I and others noted, there’s both morbidity and mortality involved here, so to simplify it as it simply isn’t worth it to save so few lives leaves out the issue of associated personal and community disease burden.
So let’s rephrase, is is worth $300 (or less) per parent who chooses to vaccinate his/her daughter before she is sexually active in order to prevent acquiring and further spreading HPV, and risking cervical cancer and any associated medical issues?
Doug Bremner
That’s a personal choice. I wouldn’t say that it is absolutely not worth it.
Flu vaccine is another matter. The only group where it has been shown to save lives is older people with COPD. Nevertheless the CDC recommends for all
Doug Bremner
the CDC recommends for all under 6 and over 50. The problem is that there are many strains of flu and the vaccine targets only one, and you need the shots every year cause the viruses keep training. The experts in the literature are actually saying not to use it, although noone seems to listen to them. Quoting epidemiologist Tom Jefferson below:
“The optimistic and confident tone of some predictions of viral circulation and of the impact of inactivated vaccines, which are at odds with the evidence, is striking. The reasons are probably complex and may involve a ‘messy blend of truth conflicts and conflicts of interest making it difficult to separate factual disputes from value disputes’ or a manifestation of optimism bias (an unwarranted belief in the efficacy of interventions)â€
Jefferson, T. Influenza vaccination: policy versus evidence. British Medical Journal. 2007;333:912-915
Reality
Doug,
But I wasn’t talking about the flu vaccine. Nonetheless, your point regarding it is well taken, and to me, reinforces the strength and purpose of the HPV vaccines. Whereas the flu vaccine is an annual guessing game, the HPV vaccines are multivalent and specifically target those strains most likely to cause lesions.
Darrel Crain
Another couple of issues come to mind regarding the HPV vaccine. Will we see “replacement disease” such as that we are seeing with prevnar, inadvertently selecting other HPV strains not covered by the vaccine that may prove more virulent? Another problem with mass vaccination in general is the ever-increasing toxic burden resulting from common vaccine ingredients such as aluminum phosphate. In light of runaway chronic degenerative disease in this country, every toxic input known to be immunogenic and carcinogenic should be viewed as a potential contributor.
Doug Bremner
that’s a good point about the viral strain selection.
Shannon
This drug is all about “money”…Merck and the govt. (FDA) settled a tax issue……this was a fast track drug with flaws in the trials…..We do not know the long term effects…….. especially when it comes to “children”….
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[...] has been the focus of side effect issues. Twice last year, a conservative group, Judicial Watch, trumpeted side-effect reports obtained from the FDA that showed thousands of adverse reactions and [...]