Merck’s Gardasil: A Risky and Unnecessary Vaccine

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people – it created a sense of panic that says you have to have this vaccine now.”- Dr. Diane Harper, professor of medicine at Dartmouth Medical School and a principal investigator on the clinical trial of Gardasil, to The New York Times

An editorial accompanying a study published by The New England Journal of Medicine (“Human Papillomavirus Vaccination - Reasons for Caution”) by Charlotte J. Haug, M.D., Ph.D), questioned the “lack of sufficient evidence of an effective vaccine against cervical cancer.”

An article on the marketing of Merck’s (MRK) Gardasil vaccine in The New York Times describes how the company managed to get “an obscure killer confined mostly to poor nations to the West’s disease of the moment.”

Merck is forecasting sales could top $2 billion this year.

According to the government’s Centers For Disease Control and Prevention [CDC] website,

 

11,892 women in the U.S. were told that they had cervical cancer in 2004, and 3,850 women died from the disease. It is estimated that more than $2 billion is spent on the treatment of cervical cancer per year in the U.S.” Scrolling further down the CDC’s web page shows statistical trends that “suggest that cervical cancer incidence and mortality continue to decrease significantly overall.

 

These statistics are from 2004 – two years before the FDA approved Merck’s Gardasil vaccine.

Cervical cancer is caused by the human papillomavirus [HPV] virus. As Merck’s Gardasil Patient Information sheet states:

 

There are more than 100 HPV types; Gardasil helps protect against 4 types (6, 11, 16, and 18). These 4 types have been selected for Gardasil because they cause approximately 70% of cervical cancers and 90% of genital warts.

 

Most of the population has contracted the HPV virus but their immune system has been able to combat it on its own. The sure way for women to avoid HPV erupting into genital warts or cervical cancer is to live a life of celibacy. Since this is not acceptable way of life for most of the population, the next best thing is to keep your sexual partners to a minimum and know their sexual health history. The more partners a woman has been with, the more important it becomes to have regular gynecological exams and Pap tests. Cervical cancer can be treated if detected early enough.

Considering that genital warts and cervical cancer rates are decreasing in the West because it can be prevented/treated by women taking charge of their health through appropriate behavior and preventative health care, why should the US government be spending over $1 billion on administering the Gardasil vaccine to girls? What’s even worse than that is 24 states are proposing to mandate that middle school girls get the Gardasil vaccine.

How Merck got politicians and parents to put Gardasil up there in importance with vaccines for such deadly diseases as polio and smallpox, explains why Gardasil was named “Brand of the Year” by Pharma Executive Magazine, and won the 2008 Pharmaceutical Advertising and Marketing Excellence awards.

According to The New York Times, Merck paid hundreds of doctors and nurses $4,500 for each 50 minute talk performed on Gardasil over Merck-sponsored meals. Many even got paid just to attend “advisory board” meetings on the vaccine. Despite the vaccine’s questionable effectiveness for young women in their late teens and early twenties, Gardasil has got promoted from college campuses to ads airing before “Sex and the City” at movie theaters. Merck pays Cornerstone Government Affairs to lobby Congress and the CDC for more federal money for vaccines.

Virginia will become the only state requiring girls get Gardasil to go to school, unless parents opt out. Governor Kaine signed the legislation after Merck said it would spend $57 million to expand its Elkton plant that makes the vaccine. $193 million more was pledged by Merck after the governor signed the bill, with the state providing a $1.5 million grant (on top of a $700,000 grant from an agency that is part of the executive branch). Lieutenant governor Bolling is an active participant in the “Ending Cervical Cancer in Our Lifetime” campaign of the NLGA, financed by Merck and GlaxoSmithKline (GSK), who has a competing vaccine awaiting FDA approval. Mandatory Gardasil for school girls in Texas was signed by the governor and overturned by the legislature after the governor’s former chief of staff was hired by Merck and contributed $6,000 to Governor Perry and $38,000 to other state legislators.

Gardasil retails between $400 to $1,000 for the series of three shots. Gardasil was studied in clinical trials for five years, and as The New England Journal of Medicine article states, “the overall effect of the vaccines on cervical cancer remains unknown.” There are more questions than answers available about Gardasil’s long term effectiveness. To quote a Gardasil ad: “The duration of protection has not been established.” Clinical trials were conducted on 16-24 year old women, not the 11-12 year old girls who the CDC and FDA view as the ideal target, so how it will affect them is still unknown. In some girls in the trials, the vaccine’s immunity was gone after three years.

According to the medical journal, “published reports of trials show an increasing trend of precancerous cervical lesions caused by HPV serotypes other than HPV-16 and HPV-18.”

More time and more trials will be needed to confirm this. The other concern is if other more virulent HPV strains emerge after heavy use of the vaccination.

The CDC’s voluntary Vaccine Adverse Events Reporting System has logged 6,667 US reports on Gardasil from its June 8, 2006 FDA approval to June 30, 2008. Reports ranging from pain and soreness at the injection site, to nausea and fainting were most commonly reported. Cases of paralysis and 17 US deaths were reported, but the CDC/FDA could not determine if Gardasil was the cause. Gardasil is being given to many girls who are not even menstruating yet; no one knows if these girls’ future fertility/babies will be adversely affected.

The purpose of vaccines prior to Gardasil has been to protect the person receiving the shot from the disease and to protect the community from a contagion spreading. HPV doesn’t spread through airborne or casual contact, and through early detection, is treatable. Policymakers should not be wasting money on a vaccine with little to possibly even a detrimental return when there are so many serious health needs that go unmet in America. I urge parents and young women to look beyond the slick ads and do some serious research on this. When medical providers and politicians tout Gardasil, investigate their vested interest.

Merck has already applied to the FDA to market Gardasil to women 26 to 45, and boys are next. Merck and its shareholders are desperately depending on it.

Previous Merck Posts: “Merck’s Lower Numbers”, “Merck’s Ghost Story”, and “Merck & Schering-Plough: More Nails in Vytorin’s Coffin”

No Disclosures

Comments

[Pamela8:]

I am shocked and appalled that the NY assembly has a bill in commitee that would allow young girls to get the HPV vaccine WITHOUT parental knowlege or consent assembly.state.ny.us/l...

2008 Aug 22 04:54 AM

[Truth19486:]

Pamela8, why are you shocked? Some states allow young girls to get abortions without parental consent...
More fear-reporting.... GARDASIL is 100% effective at preventing 70% of the cervical cancers and 90% of the genital warts in the general population. Meanwhile, the accuracy of the Pap Smear test is horribly bad and only finds the cancer AFTER you ALREADY HAVE IT. My wife routinely has to go back for second tests after initial "inconclusive" or "abnormal" results. We pray that the results of the second tests never come back positive. Only 17 deaths have been "reported" (NOT "proven") from GARDASIL, yet 10 women DIE EACH DAY EVERY YEAR from cervical cancer. As for our family, my 19 year old daughter got all three shots because of my wife's history with cervical problems, and we all sleep VERY well at night now because of GARDASIL....

2008 Aug 22 08:57 AM

[upndown1313:]

Pamela, don't understand the title of your article, or are you just short Merck and want to jump on the Merck bashing bandwagon. Do you think a parent whose daughter has cervical cancer would say the vaccine is risky and unnecessary? It seems to me, for a vaccine that was tested very safe and 100% effective in a clinical setting , it would be risky not to get the vaccine. Both my daughters received the vaccine, and when it is approved for boys, my son will get it too. I would say, to others, why take the chance with your child's health by not eliminating one type of cancer. In my view, this is both risky and unnecessary.

2008 Aug 22 09:18 AM

[mtcook:]

For years everyone has been saying that Pharma should come up with a cure for cancer. First of all if you need to "cure" something you already have it! A vaccine will prevent you from getting it. I hear people complaining about the cost. Top end $360 I have not idea where they got the $1000 price. Its has very good health care coverage, because most insurance companies know that it is a lot cheaper to get a shot than it is to CURE CANCER!!!!

2008 Aug 22 09:28 AM

[Tao:]

I like to wait a year or two before taking a shot or medicine that is new.

It saves a lot of distress and worry.

2008 Aug 22 10:47 AM

[Tao:]

I like to wait a year or two before taking new medicine or new shots.

That saves me a lot of stress.

2008 Aug 22 10:48 AM

[BKpseudo:]

This article is completely one sided and writer obviously has a bad taste in their mouth about either 1) Merck, 2) HPV, 3) vaccines. Or they have nothing better to write about. The first vaccine to PREVENT cancer should be honored and never bashed. How can you base your entire argument on speculation, where Merck bases their entire argument on facts. And writer, if you are going to make such irresponsible claims, you should state your name. One day ... you may end up with HPV and will look back on this article with shame.

- Frustrated

2008 Aug 22 06:27 PM

[thedivot:]

There should be nothing wrong with hearing both sides of the story - that's the best way to make informed decisions. If this drug helps prevent some kinds of cancer, we should all be for it. Do the drug companies exaggerate claims and do whatever they can (crooked or not) to make their drugs blockbusters? Absolutely. But we must all look beyond the hype and judge if the drug has value. This one certainly appears to.

2008 Aug 24 08:44 AM

[laurent_kabila:]

Your blog is terribly ill-informed and biased. Gardasil will prevent cervical cancer in most girls and young women. It is a triumph of medicine, as another pointed out, because we can for the first time prevent a cancer rather than try to treat it (at great cost). Whether you are personally afraid of cervical cancer or not, don't bias uneducated parents into withholding a vaccine from their innocent daughters.
The adverse event statistics you rattle off fail to mention that they occurred on a background of 16 million doses (from the same Times article), so the vaccine is completely adverse event free in...click click...99.9996% of patients. Pretty good for anything, let alone a vaccine that prevents cancer.
It seems that you are short Merck and are simply trying to manipulate the market (SEC violation?), although there are veiled references to abstinence and lifestyle choices in your blog that also may lead one to believe you are opposed to the vaccines "morality" as is the Christian Right. Why don't you come clean about who you are and why you believe your own drivel.

2008 Aug 25 02:50 PM

[Bonnie:]

Guardasil is a dangerous drug that has long-term, potential issues for young women. The fact that this company would try to entice mothers with guilt and young women with jewelry in order to sell their questionable product. For further, detailed information, please go to www.vaproject.org. by Prairie Collaborative for Immunization Safety that produced a high quality report to the State of Illinois stating why it would be totally inappropriate for Guardasil to be young women to be forced to take this vaccine. The article is entitled "What is wrong with the HPV vaccine mandate in Illinois?

Here is just a sampling of the report which is startling:

1. Merck has funded most HPV vaccine clinical trials and the majority authorship of published papers suggests considerable potential for extensive reporting bias. Over 40% of study co-authors are Merck employees and 81% had received money from Merck in some manner.
Of the 69 listed co-authors, 81% had financial connections to Merck, 42% were actual Merck employees, presumably holding stock/options and therefore were positioned to financially benefit from their own favorable reporting. In four of five papers a co-author was actually a Gardasil patent holder.

2. The HPV vaccine suffers a significant adverse reaction rate (90%) as reported in published trials and also in VAERS. There are no long-term safety studies yet over 500 REPORTS OF VACCINE FAILURES or ADVERSE REACTIONS have already been reported to the FDA. Gardasil contains a large quantity of a neurotoxin, ALUMINUM at doses that are KNOWN to cause NEUROLOGICAL DAMAGE in animals.

3. Nearly all cervical cancer deaths are preventable by a simple PAP TEST and appropriate FOLLOW-UP.

4. NOT ALL cervical cancers are related to HPV. Since the vaccine currently targets ONLY FOUR (4) HPV viruses that are known, prevention of all cases of HPV-related cancer is HIGHLY UNLIKELY.

5. This novel type of vaccine even possesses the POTENTIAL TO WORSEN cervical cancer. If HPV virus types compete to colonize the cervix, then the prevalence of competing strains not targeted by the vaccine, COULD INCREASE! If these virus types are more aggressive, cervical cancer could STILL DEVELOP OR WORSE DEVELOP INTO A MORE LETHAL FORM!

6. The actual Guardasil vaccine package insert assures that Merck’s HPV vaccine FAILED TO DETECT ADVERSE OUTCOMES, including REPRODUCTIVE HARM, in experimental animal studies. Unfortunately, HPV is only pathogenic to HUMANS and the applicability of animal studies is PROBLEMATIC, IN THE LEAST...AND INAPPROPRIATE AT BEST!!!

7. there were a disproportionately large percentage of complications reported in women ≤ 16-years old (38%), representing a subgroup that was the least evaluated in Merck’s safety studies. Frequently reported events included syncope/fainting (62), seizures (6), hypesthesia/paresthesi... (34), and Guillain-Barre Syndrome (5).

8. The concentration of aluminum in Gardasil is 25 mg/L or 18,000 times higher than what the FDA considers safe in injectable products. ALUMINUM has been shown to cause BEHAVIOR and MEMORY IMPAIRMENT associated with DEATH IN MOTOR NEURONS in animals at doses of 10-11 micrograms/kg. The Gardasil immunization series will expose 11 year-old girls to approximately 17 micrograms/kg, doses above that known to be NEUROTOXIC in animals Reports of neurological events following immunization with Gardasil are therefore not surprising if not predictable.

9. Four years prior this problem was foreshadowed in a Congressional investigation reviewing conflicts of interest among healthcare agencies that reported too close of ties between FDA and CDC advisory committee members and the drug industry.[18] This included the placement of patent holders on advisory committees who were allowed to vote in approval for their own vaccine. Four of six members of a 1999 FDA advisory who approved Vioxx were granted waivers from the conflict-of-interest rule.

10. Despite reporting adverse events in 90% of vaccine recipients (approximately 40% were systemic reactions), they minimized the significance by reporting similar reaction rates in placebo groups that had inappropriately RECEIVED HIGH DOSES OF ALUMINUM rather than conventional SALINE.

AND LAST, BUT CERTAINLY NOT THE LEAST.....

11. Financial pressures against the pharmaceutical giant are now even greater. Besides facing up to a $10 billion in legal losses from Vioxx they now anticipate a nearly $6 billion tax charge as the result of multiple tax reporting violations.[16] Is a company that already has spent millions of dollars on an advertising campaign for Gardasil capable of telling the truth when they are more financially desperate today than ever before? It has been estimated that HPV mandates could generate as much as $5 billion annually for Merck, who now has little liability in vaccine injuries that may ensue thanks to the CDC’s decision to distribute Gardasil through the Vaccine for Children Program. Any Gardasil-related legal claims will be addressed in the no-fault system of the U.S. Court of Federal Claims rather than state and federal courts. Thus, taxpayers and consumers will pay for children’s injuries, not Merck. Limited liability further undermines Merck’s motivation to be forthright about vaccine problems.

THIS IS THE PERFECT EXAMPLE OF WHAT HAS BEEN TAKING PLACE WITH OTHER VACCINES SUCH AS THE MMR WHICH HAS MERCURY (THIMEROSAL), IN IT AND HAS CAUSED PROBLEMS FOR BABIES AND CHILDREN RECEIVING THEM AS, BUT NOT LIMITED TO: AUTISM AND ITS MANY VARIATIONS AND LEVELS, ADD/ADHD, THYROID PROBLEMS AND TREMENDOUS WEIGHT GAIN WHICH CONTRIBUTES TO MANY OTHER HEALTH PROBLEMS IN CHILDREN, AND A MULTITUDE OF NEUROLOGICAL PROBLEMS DEVASTATING MILLIONS OF OUR CHILDREN FOREVER!!!

THANK YOU FOR POSTING THIS ISSUE ON YOUR BLOG AND I HOPE THAT MANY PARENTS WILL GO TO THE ABOVE LISTED WEBSITE AND READ FOR THEMSELVES THE ENTIRE REPORT AND SEE THAT THERE IS STILL MUCH RESEARCH TO BE DONE ABOUT THIS PHARMACEUTICAL PRODUCT, THAT MONEY IS THE ROOT OF THE HASTE AND THE EVIL INVOLVED IN PROMOTING IT ON A MASSIVE SCALE WITH SOME STATES AS TEXAS MANDATING ALL YOUNG WOMEN BE FORCED TO RECEIVE THIS VACCINATION, AND THAT WHEN IS AMERICA GOING TO STAND UP AND FIGHT FOR OUR RIGHTS TO PREVENT GOVERNMENTAL AGENCIES, THAT WE PAY FOR AS TAXPAYERS, WHO ARE SUPPOSE TO PROTECT US AT ALL COST, TO COMPROMISE THEMSELVES FOR MONEY, AND COMPROMISE OUR CHILDREN WHO ARE THE FUTURE OF OUR COUNTRY AND THEIR HEALTH!!! BE WISE AND BE AWARE AMERICANS...AS THE OLD ADAGE STATES, "ALL THAT GLITTERS IS NOT GOLD" OR IN RELATION TO THESE MIRACLE PRODUCTS, "ALL THAT SOME SAY IS A MIRACLE PREVENTIVE DRUG...MAY NOT BE ONE AT ALL, BUT A TOXIN IMPAIRING AND DEBILITATING OUR CHILDREN FOR MONEY!!!"

2008 Aug 30 11:17 AM

[Truth19486:]

Bonnie: Pap smears may help avoid deaths, but by the time a Pap smear comes back positive, you already HAVE cancer. Getting the vaccine will PREVENT you getting one of the four HP viruses that cause over 90% of all HPV cases (proven). And the Aluminum level is 18,000 times the FDA's safe limit? Come on, get real -- yeah, the FDA would have approved it if that were true. So we're to trust your medical analysis versus the years of published reasearch on the subject by qualified experts?

2008 Sep 02 03:56 PM

[HSIAlert:]

Important Video on the Potential Dangers of Gardasil

Please take a few minutes and watch this important video on the potential dangers --and limited benefits--of the Gardasil vaccine and consider sharing it with others. At least thirty two girls have already died, yet some are still pushing for mandatory vaccinations.

www.youtube.com/watch?...

Please share this with anyone you know who may be considering the vaccine for their daughters or themselves.

Thank you so much!

May 01 09:13 AM