Vaccination Rates For Merck’s Gardasil Are Low
32 CommentsBy Ed Silverman // June 2nd, 2010 // 10:53 am
Only 34 percent of teenage girls ages 13 to 17 received Merck’s Gardasil human papillomavirus vaccine, which public health officials endorsed to prevent cervical cancer. Although vaccination rates remain low, the results indicate an increase from earlier studies showing only about 25 percent of teenage girls were vaccinated, according to a co-author of the study.
“The good news is that the vaccination rate is increasing,” study co-author Sandi Pruitt of the University of Washington School of Medicine tells us. “The bad news is this is just the first dose of a three-dose vaccine.” Although the study did not examine the reasons for the persistently low vaccination rates, she speculated that cost, awareness and social conservatism may contribute. The study appears in the American Journal of Preventive Medicine (here’s the abstract).
Gardasil prevents four strains of HPV, two of which are found in about 70 percent of all women with cervical cancer. However, the Merck vaccine has been controversial – the drugmaker lobbied states surreptiously for mandatory vaccination (see here and here); the price tag is high; side effect concerns continue to generate publicity (see this), and some remain skittish the vaccine offers a green light for teenage sex.
The study analyzed data from 1,709 girls in 274 counties of six states and the info came from a 2008 national telephone survey. Interestingly, more than 70 percent of the girls were white, and almost 75 percent had health insurance. Girls in states with higher poverty rates were less likely to get vaccinated, but higher poverty rates in individual counties within those states and lower family income levels made it more likely a girl would be vaccinated. “There’s not a lot of national surveillance data yet, but it varied across greographc areas,” says Pruitt. “We need to keep an eye open.” (You can read more here).
Pharma Conduct Guy
Considering the relatively short length of time the vaccine has been available, 33% is actually a relatively high percentage for vaccination.
patrons99
Could it be that vaccination rates remain low because the public has safety concerns re: Merck’s Gardasil?
R. Boyce made a comment relevant to the HPV vaccines in another thread, which I’ll quote in part here:
“How could VAERS play in here? What if a drug or vaccine is showing a majority of adverse events in the VAERS system, then clearly there is argument for giving the FDA the ability to recall something like this. Gardasil is now showing 23% of the ENTIRE database … should the FDA really have its hands tied with not being able to react? Something has to be done …”
http://www.pharmalot.com/2010/05/should-the-fda-have-mandatory-recall-powers/#comment-505195
Condor
I guess I disagree, PCG. . . . its been approved since 2006 — June of 2006, so four full years on, here — and 2 in 3 are declining it.
Just another perspective: I see it the other way.
Namaste
rohit
relatedly, do people here know about health advocates in India campaigning against this vaccine because of its reported–and severe–’side ‘ effects.
http://samawomenshealth.wordpress.com/2010/04/08/memorandum-to-the-health-minister-on-world-health-day-opposing-hpv-vaccinations/
patrons99
Here’s an additional perspective from the Skeptic’s Health Journal Club, an article titled “Gardasil is a Bad Idea”, Parts I and II, on May 24, 2010 and May 26, 2010, respectively.
http://healthjournalclub.blogspot.com/2010/05/gardasil-is-bad-idea.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+TheskepticsHealthJournalClub+%28The+%28Skeptic%27s%29+Health+Journal+Club%29&utm_content=Yahoo!+Mail
http://healthjournalclub.blogspot.com/2010/05/gardasil-is-bad-idea-part-ii.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+TheskepticsHealthJournalClub+%28The+%28Skeptic%27s%29+Health+Journal+Club%29&utm_content=Yahoo!+Mail
Stephanie
I would never get this vaccine nor have my children receive it. Way too much risk and not enough benefit. It is not effective against ALL strains of HPV and I think the others have given links to the many side effects/ risk.
No thank you Merck!
M. Black
They may as well say “50 percent at a time, it is effective 100
percent of the time.”
What I just love is the fact that once these two companies are coming well out of the closet because 1) they they are economically better shape, and 2) a drawn out white collar pointing finger session will ensue, as the public slowly forgets it’s relevancy.
MB
patrons99
rohit – Thank you for the link. In many respects, health advocates in India are ahead of the curve compared to health advocates in the U.S.
I think that we’d all agree that death is a pretty severe side effect. As for putative cancer prevention, without any long term data, that’s simply “wishful thinking”.
Personally, I think these two paragraphs are particularly important for the world to know, in that questions as to proper informed consent and compliance with the Nuremberg Code and Declaration of Helinski, may be at issue.
“Although, the nomenclature suggests otherwise, the secrecy regarding the non-transparent selection criteria of the area, the girls and the aim of the project has raised undeniable fears that this is a Phase IV clinical trial being carried out under the guise of a ‘demonstration project’ Moreover, there is an inexcusable lack of clarity with regards to the role and accountability of international agencies such as PATH and Bill and Melinda Gates Foundation that appear to be funding this project. It is beyond doubt the worst case of human rights violation, where young healthy girls have to die for being part of a state-endorsed experiment, initiated by a profit making private company.”
“This constitutes shocking criminal negligence on the part of the authorities, who have provided permission and support to this programme within the public health system. We need immediate government intervention to prevent this. No NGO should be given such permission for clinical trials/ demonstration projects, regardless of which vaccine or drug is being administered. Financial support from the industry or from an international organization should not be the criteria to introduce any vaccine, whether in a pilot project or in the universal immunization programme.”
Justice in MI
Erratum?
As far as I can determine, the author, Pruitt, is not at the University of Washington but at Washington University in St. Louis.
What I have not yet tracked is whether Merck funding was involved in the study.
Justice in MI
“No fınancial disclosures were reported by the authors of this paper.”
from the journal.
patrons99
@ rohit 3:10 PM -
Here’s another particularly relevant paragraph from your link. The article, titled “Memorandum to the Health Minister on World Health Day Opposing HPV Vaccinations” posted on April 8, 2010, is a VERY worthwhile read.
“Consent and information, reserved for only a few, is a farce and was based on provision of wrong information. Many of the girls were told that the vaccine would prevent uterine cancer and would provide life-long protection. This information is factually incorrect and provides the recipient with a false sense of security against the “dreaded” disease. As per the claims by the pharmaceutical companies themselves, the vaccine only protects against infections caused by 2 types of HPV virus (of the 13 high risk strains of HPV) that are associated with a higher risk of cancer of the cervix. Moreover, once again as claimed by the companies themselves, the protection by the vaccines is understood to last for only 4.5 years with Gardasil and 7 years with Cervarix, while, the need for a booster has not yet been established. There are reports in developed countries that this number too is an over estimation and the protection in fact may not last for more than 3-5 years.”
patrons99
JiM – “No fınancial disclosures were reported by the authors of this paper.”
From the Jim Dryden article of June 1, 2010, titled “A third of young girls get HPV vaccine to prevent cervical cancer”, it states,
“The study was funded in part by Pruitt’s postdoctoral fellowship through the Alvin J. Siteman Cancer Center’s Prevention and Control Program.”
AJPM offers CME. I’ve not had the opportunity to try it out. I’ll get back to you after I do. It’s important to know the veracity and funding sources of CME sites.
http://www.ajpm-online.net/edboard
http://www.ajpm-online.net/cme/home
http://www.ifpi2010.com/
Here’s AJPM’s author disclosure requirements:
* Conflict of interest statement: Include a statement from each of the authors disclosing all funding sources that supported their work as well as all institutional and corporate affiliations. Also include a publishable statement disclosing any commercial associations, current and over the past 5 years, that might pose a conflict of interest. These include but are not limited to consultancies, including those for investment companies; stock or other equity ownership; stock options; patent licensing arrangements; and payments for conducting or publicizing the study.
In addition, authors are required to disclose similar associations with companies that make a competing product. If the authors have competing or conflicting interests that cannot be disclosed in publishable statements, authors should list them in the comments section of EES (ees.elsevier.com/ajpm/).
When no competing interests are present, this should be indicated in the publishable disclosure statement (e.g., “No financial disclosures were reported by the authors of this paper.”).
Example of disclosure statements that should appear on the title page:
(Author 1 name) owns stock in _____ company.
(Author 2 name) has no financial disclosures.
(Author 3 name) has no financial disclosures.
(Author 4 name) has received consulting fees from ______, a company that manufactures a competing product to the one discussed in this paper.
patrons99
Here’s the relevant summary from Part I of the “Gardasil is a Bad Idea” article, link provided above:
“…there has never been an effective preventive “cancer vaccine” before, this would be an astonishing breakthrough. There is zero clinical evidence that Gardasil prevents cervical cancer. At best, Gardasil can only have an effect on 70% of the viruses associated with the development of cervical cancer. There is zero evidence of a long term induction of immunity by Gardasil to HPV. Oh and the HHS is a business partner in the scheme.”
Sooo…please say it ain’t so…HHS is a business partner in the scheme. Is that outrageous, or what!!!
patrons99
I apologize for the difficultly I had identifying the author of the “Gardasil is a Bad Idea” article from their website (healthjournalclub.blogspot.com), but I’ve identified the author. The author is an ex-FDAer by the name of Paul D. Maher, MD, MPH. I’d like to thank Dr Maher for a VERY thoughtful article.
To quote Jennifer Corbett Dooren,
“Vaccine safety should be a national conversation, outside of the autism world, which has been branded by our government and media from coast to coast as “crazy people.”
http://www.ageofautism.com/2010/05/wall-street-journal-reports-on-wasting-disease-pig-virus-dna-in-paul-offit-merck-rotateq-vaccine.html
I hope that I’ve given proper attribution to Ms Dooren.
Sincerely, “Crazy” Person
vince
Perhaps parents realize that the vaccine may cause severe side effects ; that even many in the established medical community admit no one really knows if this vaccine will prevent any deaths. That cervical cancer is largely preventable with current methods. That the medical industry acts much like the banking and oil industries .
karen a haack
If only I had known the horrible side effects.
I allowed my daughters pediatritian to poison her.
She is so incredibly ill still two years later and all the doctors won’t admit that this vaccine injured her. I hate to see her pain and suffering. I have known people with cervical cancer. They were never this sick. I could only pray that something is done before more girls are injured.
Norma Gonzalez
This vaccine is POISON!! I also trusted the doctors and allowed them to vaccinate my daughter, she has been sick for a year now since receiving the first shot. VAERS reports that only 8% of side effects are serious but they are mistaken. When a young girl suffers almost daily from: Nausea, Dizziness, Stomach Pain, Tremors, Muscle Weakness, Severe Fatigue, Hair Loss, Memory Loss, Headache, Neck Pain, Back Pain,Seizures, Vomiting,and Depression because of beings sick, doctors not believing that Gardasil is responsible, not getting answers or relief for her condition and finally living in fear of what the future holds, THAT IS SERIOUS!! Parents, do the research for yourself before saying yes to GARDASIL.
Stephany
I’ve written about Gardasil a few times:
http://bipolarsoupkitchen-stephany.blogspot.com/search/label/Merck
It’s all about profit, and competition with Cervarix soon enough.
In my opinion, as a woman, and the mother of 3 daughters, I would not have any one of us get the vaccine, it’s far too new, for long term effects to be known, there are no guarantees it works, and there ARE side effects such as death and convulsions coming into reports.
Especially intrusive were the discussions of making this a required vaccine for certain age groups. This is not measles or chicken pox, or tetanus—this is a viral cancer topic based on sexual activity.
So to enforce (force) women, of any age to have the vaccine required for school entry, etc. is unethical and crosses over into personal privacy issues as well as assuming sexual activity will take place.
Choices as with any drug should be of most importance in this case.
Of course, I always take time to look into the connect the dots, who did the study, who got paid to promote the drug and who wants to profit—when these things come up—and it always seems to be the dirty data all for profit stuff that makes me shake my head.
Consumer safety with regard to Gardasil? It’s a marketing profit maker!
28 deaths in 2008
Stephany
btw rat poison is an ingredient:
http://www.naturalnews.com/024872.html
Stephany
http://healthguide.howstuffworks.com/sodium-borate-poisoning-dictionary.htm
Sodium Borate poisoning
Jan Henderson
I see there are lots of links already to information on the extremely unfortunate side-effects of Gardsil, but here’s another one. There’s a four-part series by Norma Erickson in the San Francisco Examiner called “How did Gardasil pass FDA review?” Her point is that 463 new medical conditions occurred in a trial population of 20,118 healthy young women (including 37 deaths), that the new medical conditions are not listed in the adverse site reactions section of the prescribing information packet, some of the new medical conditions are quite rare, and that the deaths alone should have prompted the FDA to investigate further.
Not being a pharma person myself, I don’t quite appreciate the significance of this statement: “Why was Merck allowed to list their AAHS control group [containing the vaccine adjuvant] and the saline placebo control group separately under adverse site reactions, and allowed to combine them under new medical conditions?” I don’t know if this is unusual or standard procedure, but I assume it will mean something to readers of Pharmalot, to whom I am extremely grateful for the education I receive here.
Here are the links:
http://www.examiner.com/x-40801-Vaccines-Examiner~y2010m5d21-How-did-Gardasil-pass-FDA-review
http://www.examiner.com/x-40801-Vaccines-Examiner~y2010m5d22-Part-2-How-did-Gardasil-pass-FDA-review
http://www.examiner.com/x-40801-Vaccines-Examiner~y2010m5d26-Part-3-How-did-Gardasil-pass-FDA-review
http://www.examiner.com/x-40801-Vaccines-Examiner~y2010m6d2-Part-4-How-did-Gardasil-pass-FDA-review?cid=examiner-email
Rosemary Mathis
Go to the http://WWW.TRUTHABOUTGARDASIL.ORG and you will know why girls are not getting the Gardasil vaccine. Don’t let this happen to your child. Investigate before you vaccinate.
patrons99
Jan – Thanks so much for the links to the Norma Erickson series of articles.
“463 new medical conditions occurring in a population of 20,118 young healthy women–is that not unusual?”
Hmmm. Let me think about that. Let’s just throw caution to the wind. Who needs a Precautionary Principle? What’s more let’s go even further…we’ll mandate the jab!
“Any reasonable person would ask why the saline placebo group and the AAHs control group were combined in the ‘new medical conditions’ section and the ‘common systemic’ reactions section.”
Hmmm. Let me think about that too. Where is Inspector Closeau when you need him? “The crooks never sleep and neither does Clouseau.”
“Was it, perhaps, to lead people to believe the vaccine was just as safe as their ‘control solution’? After all, by combining these two ‘control’ groups, Merck was able to show the same percentage of ‘new medical conditions’ for both the vaccine and the control groups.”
Hmmm. Let me think about for about a nanosecond. Would Merck ever be guilty of JUNK science? The question should be rephrased. What would Merck not do to get a new vaccine approved?
See an article titled “A License to Kill? Part 2: who Guards Gardasil’s Guardians?” by Mark Blaxill on May 12, 2010.
http://www.ageofautism.com/2010/05/a-license-to-kill-part-2-who-guards-gardasils-guardians.html
“If the FDA trial standards were truly to enforce a high standard of safety, they would require the comparison of Gardasil’s safety profile to a true saline placebo. But Merck performed no such analysis and CBER permitted them to apply a lesser safety standard of safety analysis. As a result, CBER issued its BLA approval without any idea whatsoever of the true risks of Gardasil. Not surprisingly, most of the comparisons between adverse outcomes for those receiving doses of Gardasil and those exposed to an aluminum adjuvant “placebo” showed little evidence of injury risk from Gardasil.
Unfortunately, the conclusion that Gardasil was therefore safe was horribly wrong.”
Josh
Stephany…..warfarin was used as a rat poison ….now used extensively as an anticoagulant.
patrons99
Here’s the definition of a true optimist: someone who believes that Merck would voluntarily recall Gardasil, or any “innoculation”, for safety reasons.
Look at the JUNK science upon which its approval was based! But hey, Bill Gates believes that it’s safe and effective…for the whole world! That’s good enough for me. How about you? Come on, get on the band wagon! Let’s mandate it. Just look at the market opportunity ($$$).
Bottom line as to any “innoculation”: organomercurials and aluminum adjuvants are neurotoxins, pure and simple. This reality will not ever change.
Again, the usual disclaimer: this comment is opinion, not medical advice.
Stephany
And then it makes us take a look at the FDA who approves this JUNK, and others when reports are so damning at times; ie SAPHRIS, the report one year earlier was SO full of dangers and it still got approved! I digress and brought up an antipsychotic again.
Jeanne
My eighteen year old daughter was seriously injured by the Gardasil vaccination in June of 2007. She had unexplained paralysis which couldn’t be determined by Mayo. Not until June of 2009 did we put the link together. How many other girls are also suffering, unaware of the cause?
Stephany
48 page VAERS doc
http://www.judicialwatch.org/files/documents/2009/vaersdeathsALL_20090616.pdf
Very sobering, and sad, especially considering the ages….
patrons99
Here’s the link to an article titled “9 Questions That Stump Every Pro-Vaccine Advocate and Their Claims” on October 28, 2009, by David Mihalovic ND (naturopathic medical doctor).
http://www.imcv.info/vaccination/articles/9-questions-that-stump-every-pro-vaccine-advocate-and-their-claims.html
Whether you agree with his viewpoint or not, the article does make some points that warrant public discussion. Now!
exrep
I launched it and sold it-
DON”T TAKE IT OR GIVE IT TO YOUR DAUGHTER!
adgal
I’d be willing to bet money that the vaccination rates are directly proportionate to DTC ad impressions. I don’t see the commercials running anymore. No ‘One less’ = no vaccine!
Human Health
(Human Papillomavirus Quadrivalent)(Types 6, 11, 16, 18) Vaccine, Recombinant) prevented 91 percent of cases of persistent infection, low-grade cervical abnormalities, and pre-cancers, and external genital lesions caused by HPV types 6, 11, 16 and 18 compared with placebo in women aged 24 through 45, according to new data presented today at the 24th International Papillomavirus Conference (IPC) in Beijing, China.
“Women remain at significant risk for acquiring HPV infections and developing HPV-related diseases throughout their lifetime,” said Eliav Barr M.D., executive director of Biologics Clinical Research and head of the HPV Vaccine Program, Merck Research Laboratories. “These data build on the clinical program for GARDASIL and will help us to understand the potential benefit that GARDASIL may have in women through age 45.”