Merck’s Gardasil Should Not Be Mandatory: Report
15 CommentsBy Ed Silverman // November 11th, 2008 // 3:33 pm
A trio of academics is joining the debate over the notion requiring girls to be vaccinated with Merck’s Gardasil is not a good idea. And in a recent issue of the Journal of Law, Medicine & Ethics, Gail Javitt of Johns Hopkins’s Berman Institute of Bioethics, Deena Berkowitz of George Washington University School of Medicine and Lawrence Gostin of Georgetown University Law Center offer five reasons….
The long-term safety and effectiveness is unknown; historical justifications for mandated vaccination have not been met; in the absence of historical justification, the government risks public backlash by mandating vaccination; mandatory vaccination for girls - and not boys - may violate constitutional principles of equality and due process; and there are unresolved economic concerns over Gardasil’s cost and insurance coverage. They go on to write…
“While the emergence of an HPV vaccine reflects a potentially significant public health advance, the vaccine raises several concerns. First, the long-term safety and effectiveness of the vaccine are unclear, and serious adverse events reported shortly after the vaccine’s approval raise questions about its short-term safety as well. In light of unanswered safety questions, the vaccine should be rolled out slowly, with risks carefully balanced against benefits in individual cases. Second, the legal and ethical justifications that have historically supported state-mandated vaccination do not support mandating HPV vaccine.
“Specifically, HPV does not threaten an imminent and significant risk to the health of others. Mandating HPV would therefore constitute an expansion of the state’s authority to interfere with individual and parental autonomy.
“Engaging in such expansion in the absence of robust public discussion runs the risk of creating a public backlash that may undermine the goal of widespread HPV vaccine coverage and lead to public distrust of established childhood vaccine programs for other diseases. Third, the current sex-based HPV vaccination mandates present constitutional concerns because they require only girls to be vaccinated. Such concerns could lead to costly and protracted legal challenges.
“Finally, vaccination mandates will place economic burdens on federal and state governments and individual practitioners that may have a negative impact on the provision of other health services. In light of these potentially adverse public health, economic, and societal consequences, we believe that it is premature for states to add HPV to the list of state-mandated vaccines.”
Meanwhile, you may recall that the Centers for Disease Control and Prevention last month declared that Gardasil is not likely the cause of numerous adverse events. The CDC look-see followed disclosures twice last year by Judicial Watch, a conservative group, about side-effect reports showing thousands of adverse reactions and several deaths.
Separately, a recent study in the New England Journal of Medicine found the vaccine, which is approved for girls and young women ages 9 to 26, isn’t cost effectiveness for those older than 18. The benefit depends on how long Gardasil’s protection will last, although Merck contends the vaccine is cost effective for women through age 24. Gardasil costs about $360 for a three-dose regimen.
Hat tip to the WSJ Health blog
Nathan
It seems to me that this report is a wasted effort. Is there anyone who IS actually advocating for manditory use based on the present data?
I’ve been a strong supporter of this vaccine — I’m going to give it to my two girls — but manditory use is a little crazy given the short period of time that this has been on the market.
Val
Actually, Nathan, yes.
It’s required for women immigrating to the US. And the state of Texas tried to mandate it, but could not because of public backlash.
Gardasil has been associated with 27 deaths so far (at last check, it may be more now). And that is deaths of young women with no pre-existing conditions — they just don’t wake up.
If one has already been in contact with any form of HP virus, it could make the infection worse — and I don’t mean just the sexually transmitted ones.
Furthermore, most people don’t need it. HPV is normally removed from the body naturally over 90% of the time. In other words, coming in contact with the virus is far from a guarantee of cancer.
In addition, Merck’s aggressive and manipulative marketing of Gardasil is highly suspect. If it were really so beneficial, Merck wouldn’t need to scare the public into taking it — we’d be begging for it!
To me, the risks of this “vaccine” are greater than the potential benefits.
I’ll definitely be “one less” to fall for Merck’s advertising.
Remember Vioxx?
Val
Can’t edit a post…I’d like to say that “some” of these women just don’t wake up. Don’t want to give the impression that all women who died after taking Gardasil did so in the same way.
Nathan
Val writes: “Furthermore, most people don’t need it. HPV is normally removed from the body naturally over 90% of the time. In other words, coming in contact with the virus is far from a guarantee of cancer.”
I’ll use an analogy from another thread on this site:
“Furthermore, most people don’t need airbags. Auto accidents is don’t cause bodily harm over 90% of the time. In other words, getting in an auto accident is far from a guarantee of harm.”
Nathan
Val writes: “If one has already been in contact with any form of HP virus, it could make the infection worse”
Hence, it is marketed only to preteens.
“If it were really so beneficial…we’d be begging for it!”
Are you sure? How would anyone be aware that it is so beneficial?
“To me, the risks of this “vaccine” are greater than the potential benefits.”
1) I don’t know why you put vaccine in quotes. It IS a vaccine. Do you doubt it?
2) This is your opinion. The FDA and many, many, MANY doctors think otherwise. No one is forcing anyone to take this vaccine.
Jan
Hopefully nobody reading this article will make any health care decisions based on inaccurate editorial internet blogs or Val’s non-factual comments. If anyone cares to get REAL information about the safety, efficacy and necessity of this vaccine- from REAL experts on the subject- check out the following sites:
http://www.cdc.gov/vaccinesafety/vaers/FDA_and_CDC_Information.htm
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm?s_cid=rr5602a1_e
Ed Silverman
Hi Jan,
With all due respect, I was not offering an editorial about the vaccine. I was reporting that the essay had been written by these three academics in that journal. Please read my post carefully and you’ll hopefully notice that I did not endorse any position, one way or the other.
My reason for posting about this was straightforward and simple - Gardasil has been controversial for various reasons, including the issue of mandatory vaccination. Their piece spelled out, in some detail, reasons why they believe it to be problematic. I saw this as another opportunity to provide information and discussion.
And please note that I also included a link to my previous post about the CDC declaring Gardasil to be safe. The link is in green letters in the graph that mentions the CDC making its announcement last month. And in that earlier post, you will then find a link to the same CDC statement you included in your comment. Why did I include the link to the earlier post? So people could find that info and decide for themselves, or at least have more info to mull over.
Again, there was no editorializing in this post, at least from me.
I hope this helps,
ed
Justice in MI
Brief note: Several states were on the verge of making HPV vaccination mandatory only a couple of years ago. Here, in Michigan, it was basically a legislative fluke that delayed it = the bill had already passed.
Soon afterward, the stories about the intensity of promotion, publicly and not so publicly, came out. The combination of social conservatives, many of whom were already opposed, and industry skeptics - plus some questioning voices within the CDC - put mandating on hold.
laurie
” If anyone cares to get REAL information about the safety, efficacy and necessity of this vaccine- from REAL experts on the subject- check out the following sites”
An informed consumer will read everything they possibly can from multiple sources.
From your one link:
“The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety.”
This statement highlights the possibility of safety risks not yet confirmed.
Mysterius
@laurie: Read widely, but don’t necessarily treat every source with equal weight. Merck obviously has financial motive, but the vaccine’s critics may have hidden social motives as well. Not necessarily, but keep it in mind.
As for your quote, there may be risks yet to be uncovered, but shouldn’t the commitment to further study alleviate concern?
If the manufacturer is truly worried about side-effects, then would it not be more reluctant to commit to further study?
Jason
It’s amazing to me that people are so quick to jump to a “quick cure” and not consider the potential long term effects of a drug or vaccine. Especially when it comes to a disease that can only be contracted thru sexual contact. Try teaching your children about sexual safety and using protection. Don’t get me wrong, it is improtant to protect yourself and your children, but let’s be honest, the pharmaceutical companies have produced drugs that the FDA and CDC have given their stamp of approval on, but years later have actually found those drugs to be harmful. What about all of the vaccines that contained Mercury? Is it just coincidence that Autism rates spiked along with those mandatory vaccines. The FDA will tell you that there is no correlation, do you believe that to be true. The below information is straight from a Merck website. Correct me if I’m wrong, but if your child is not sexually active, then they really can’t contract HPV. I don’t live in a cave either, and I know kids are sexually active, but to mandate giving a shot to a child at the age of 8, just to prevent against something they may never even come in contact with. You may want to think about that for a while, and also really ask yourself, when a drug company reports data from a study, how was that study designed?
HPV Transmission—Who Gets it?
Human papillomavirus (HPV) affects both females and males. HPV transmission can happen with any kind of sexual, genital contact with someone who has HPV—intercourse isn’t necessary.
Many people who have HPV don’t even know it, since the virus often has no signs or symptoms. That means HPV transmission can happen without anyone knowing it.
There are about 6 million new cases of genital HPV* in the United States each year. It’s estimated that 74% of them occur in 15- to 24-year-olds.
laurie
“As for your quote, there may be risks yet to be uncovered, but shouldn’t the commitment to further study alleviate concern?”
Further studies would be great…if they are done. But the fact remains that there are some identified problems with this vaccine that raise some red flags. I would not be vaccinating a young child of mine until those longer term studies are completed and the true risks/benefits identified.
Scott
“NO VACCINE IS SAFE” There might be so called benefits, but since polio was on the decrease BEFORE the vaccine was given to the public, the flu shot causes one to get the flu, we are told that MMR could kill your child if you don’t vaccinate them, and then since the vaccines can cause the disease, if your child gets the mumps now it just becomes an “oh well” they will get over it and be ok! Do you see this is russian-roullette with your child’s life. Every chemical or substance in vaccines are toxic and always have some negative effect on the body. Are your doctors given that right to decide or influence which children have harmful side effects or actually die?
And for LONG TERM studies, when will drug/vaccine studies tell us if they work or not??? They know that the drugs don’t work when the bodies pile up! And that is a quote from YOUR GOVERNMENT agencies that determine what it takes to keep your family healthy. If they knew what is best, the U.S would be the healthiest country, no cancer, no HD, no autism, ADHD, autoimmune disorders, etc………. But instead we get 1.1 million deaths by living in the medical model!!!! Do the opposite of the masses if you want to escape this trap!
amanda
there are many different stains of hpv but we are only talking about the sexually transmitted strains. is not a typical sexually transmitted disease. certain strains cause genital warts which are unsightly, yet harmless. others cause precancerous cells that are detected in a pap smear. the majority of women who test precancerous in a pap smear rid thier body of the hpv on their own. a greater number of women are contracting and ridding the hpv as well in between their gynecological visits never knowing they had it. we are not talking about a STD in the usual sense such as chlamydia or hiv.
a very, very small number of women who come in contact with hpv will go on to develop cancer. i wonder what percentage of these women were also on time with their yearly exams.
the bottom line is-
the overwhelming majority of the population will be exposed to hpv some time in thier lifetime. the overwhelming majority will rid their body of hpv on its own.
hpv is not a highly contagious communicable disease.
hpv is completely preventable by using condoms
hpv is highly treatable by getting timely pap smears.
hpv has not been fully tested in long term studies esp regarding reproduction.
hpv in itself is harmless. the vaccine is for hpv. how can you demand a vaccine for something that is harmless. could it cause cancer way down the road? well, there is a small chance of that, yes. but the virus being vaccinated against is not dangerous. how can you require this?
hpv mandated for girls would be questionable demanding vaccination for one sex. now a new study is saying males might gain protection against genital warts from gardisil. that should be interesting to follow as mandating a shot for a relatively harmless disease would go against everything the cdc claims for mandating vaccines, however, it would take the stress off of the gender discrimination issue. hmmmm
look, whether you are pro or against vaccines, i have to think we can all agree, the government MANDATING young girls to get a vaccine for something that is NOT a disease in which her health or the general publics health is at immediate risk is crossing the line. this makes us question the entire integrity of the vaccine program. aside from all this, why does the government and health care community instead focus on prevention thru condom use or abstinence, along with promoting timely pap smears, maybe offering them twice a year to at risk women?
DS
Oh, that’s grand! A woman here linked to the CDC page to tell the “entire truth”!!! Thank you, I needed a laugh for the day!