Tuesday, August 23, 2011

Gardasil’s Adverse Effects: The Institue of Medicine Reports


On Thursday August 25 at 1:00 PM the Institute of Medicine’s Ellen Wright Clayton (Chair of the committee) plus S. Claiborne Johnston and Douglas Barrett (members of the committee) will host an audio webcast to discuss the committee’s new report, Adverse Effects of Vaccines: Evidence and Causality . The report will be released at 11 AM on August 25 and can then be downloaded at www.iom.edu/vaccineadverseeffects.

The report is not just about Gardasil—it’s about all vaccines covered by the Vaccine Injury Compensation Program, including the chickenpox, flu, Hepatitis A and B, meningococcal, tetanus, MMR, pertussis, diphtheria, tetanus, etc. It will review the “epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines…the committee will author a consensus report with conclusions on the evidence bearing on causality and the evidence regarding the biological mechanisms that underlie specific theories for how a specific vaccine is related to a specific adverse event.”

Want to take part?

Email your comment to vaccinesafety@nas.edu, but bear in mind that any comment and identifying info you give, including your name, email address, and physical address, will be included in the Public Access File.

Register to take part in the audio webcast at www.nationalacademies.org; you’ll also find a link to the report there after 11 AM and will be able to email questions to the committee during the webcast via a link.

Download the report at 11 AM and make a note of any questions you might have. Should be interesting.


Natalie said...

Will you be able to listen to it later? I am busy during that time. :(

Anonymous said...

I recently read a series of posts on another blog supporting "science based" medicine and in support of gardasil. Most of it was not very informative or interesting to me and went on too many tangents unrelated to my issues (i don't particularly care that it protects against an STD, i'm more concerned with the side effects and whether it has been tested in a large enough population for me to know whether to administer to my young teenage daughter). However, one of the commenters summarized his own pro-vaccine position in response to someone named "Laura" as follows:

Laura, I get that you are terrified of Gardasil. It has an aluminum adjuvant (which has decades worth of safe use in humans in the U.S.). It might cause a serious allergic reaction (which is easily managed with an epipen and so, under normal circumstances, is a relative non-issue). You think that girls have died from the vaccine (despite the FDA having investigated the reports and found no connection at all). It makes money for its manufacturer (why shouldn't it? Doesn't the car you drive make money for the company that made it? What about the food you eat; doesn't that profit the companies and farmers involved in their production? Do you get paid for the work you produce, or should you just do it out of the goodness of your heart?).

Now, when the vaccine was first approved, I was a bit wary of it myself. There's always some uncertainty as to how a medical product will behave once it is used in the real world, far from the pristine and well-controlled world of clinical trials. But Gardasil has been around for quite a while, now. It has certainly been used in a large enough group of people for unexpected and rarer side effects to be noted. Yet we haven't seen them.

As to efficacy, it is still too early to tell how well it will prevent cancer, but data suggests that so far it's working pretty well at preventing infection with the 4 strains for which it was designed to grant immunity. Time will tell the ultimate power of the vaccine to prevent certain types of cancer.

If you really take a look at reliable information about the vaccine, you would see that it is safe (in a relative sense; nothing is 100% safe). I'm curious to know where your fear started. What first made you so afraid of the vaccine?

There was no response back from "Laura" to this comment, but I am curious if you can respond since I have found much more informative information here to begin with. Thank you.

Kristin Johns said...

There is a certain breed of knee-jerk scientist that is so busy ‘debunking’ anyone who questions science (aka ‘what we know so far’) that s/he forgets to be genuinely thoughtful. I find them about as interesting and useful as people who are knee-jerk supporters of anti-Western medicine thought. Thankfully, there are other scientists who are thoughtful, compassionate, and curious in this world.

In terms of the aluminum adjuvant used in Gardasil, I wrote about it here. http://www.gardasilhpv.com/2010/04/gardasil-and-aluminum-vaccine-adjuvants.html. It is distressing that there has not been, to my knowledge, more discussion of Dr Shaw’s studies, pro or con. It would be cool if someone proved a fault in the two studies. It would be cool if someone tried.

A serious allergic reaction controlled with an Epi pen is ‘a relative non-issue’? Words fail me. Clearly the writer does not have children and has never witnessed a child in a situation that has to be controlled with an Epi Pen. It’s terrifying.

In terms of money, sure, companies need to make a profit and also cover the cost of drugs that prove worthless. We all understand that. There is a huge difference, however, between marketing a car and marketing a drug that is also recommended by your physician and even required by the state. And when profits overcome scruples—as clearly happened with Merck’s marketing of Vioxx—we should all be concerned. Death and serious health problems are not ‘a relative non-issue.’

The FDA is not God. Nor is it immune to industry pressure (witness the ban on labeling milk as rBGH-free etc.). It makes mistakes sometimes. It’s human. And sometimes it just doesn’t have enough information that doesn’t come from manufacturer-sponsored trials, and, let’s face it, is the taxpayer really going to foot the bill for those?

Sometimes, too, effects are not easily isolated in infinitely complex human beings. We’ve been getting vaccines, not just Gardasil, for years…and the rate of autoimmune disease has been climbing. Could the cumulative effect of vaccines be part of the problem? No-one really knows. It’s like a friend who wasn’t allergic to lobster and wasn’t allergic to wine, but when he had wine AND lobster together, he suffered a near-fatal allergic reaction. Right now, vaccines are the best weapons we’ve got for some things, but that doesn’t mean we shouldn’t ask questions very seriously.

Sometimes you have to put your faith in science/medicine/vaccines. As I’ve written elsewhere in this blog, I’ve put my faith in the meningitis and polio vaccines, because the risk/reward ratio makes it sensible to do so. For OUR family, the risk/reward ratio for Gardasil doesn’t make it sensible to do so. I prefer to put my trust in a decent diet rich in vegetables and fruits, no smoking, educating my daughters about STDs and the multiplier effect, and regular exams, which (thank God) are available to us.

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Linda Thomas said...

I understood that the report is not just about Gardasil—it’s about all vaccines covered by the Vaccine Injury Compensation Program, including the chickenpox, flu, Hepatitis A and B, meningococcal, tetanus, MMR, pertussis, diphtheria, tetanus, etc. My attitude to vaccination you can read at blog post https://blog.payoneer.com/freelancers/industry-tips-fl/the-freelancers-dilemma-charge-by-the-project-or-by-the-hour/ . I appreciate if you will write your opinion too.

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