Debate over Gardasil

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Registered: 06-16-2009
Debate over Gardasil
Thu, 03-04-2010 - 10:36pm

HPV Vaccine: Debate Over Benefits, Marketing, and New Adverse Event Data

Zosia Chustecka

Authors and Disclosures

August 18, 2009 — The benefit of vaccinating against human papilloma virus (HPV) to prevent cervical cancer is questioned in an editorial in the Journal of the American Medical Association.

"The theory behind the vaccine is sound: if HPV infection can be prevented, cancer will not occur," writes editorialist Charlotte Haug, MD, PhD, from the Journal of the Norwegian Medical Association. "But in practice, the issue is more complex."

HPV is the most prevalent sexually transmitted infection, "but the virus does not appear to be very harmful because almost all HPV infections are cleared by the immune system," she explains. In a few women, the HPV infection persists, and some women may develop precancerous cervical lesions and eventually cancer, Dr. Haug writes, "but it is currently impossible to predict in which women this will occur."

"The net benefit of the HPV vaccine to a woman is uncertain," Dr. Haug comments. "Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened ."

Dr. Haug has spoken out against HPV vaccination previously. Last year, she urged caution over widespread vaccination programs in an editorial in the New England Journal of Medicine (2008;359:861–862), as reported by Medscape Oncology at the time.

This latest editorial accompanies 2 articles published in the same issue of JAMA. One of the articles is critical of the marketing of the HPV vaccine Gardasil (Merck & Co) in the United States, and the other details adverse events that have been reported with the vaccine since it was launched there in 2006.

Dr. Haug comments that, in view of the uncertain benefit from the HPV vaccine, "only a small risk of harmful effects from the vaccine" is acceptable.

The balance between the risks and benefits of HPV vaccination should rest only on medical and scientific evidence, Dr. Haug states.

However, she warns that this balance is "easily skewed" if other matters weigh in; for example, profit for a company or gains for physicians — issues that are explored in the article on marketing.

"The balance will also tilt if adverse events are not calculated correctly," Dr. Haug comments, and her editorial points out limitations of the system used for collecting adverse event reports, detailed in the other article.

Criticism of Gardasil Marketing

The article discussing the marketing of Gardasil in the United States was authored by Sheila Rothman, PhD, from sociomedical sciences and David Rothman, PhD, from social medicine, both at the Columbia College of Physicians and Surgeons, New York City.

Merck & Co promoted Gardasil primarily to "guard" against cervical cancer, rather than promoting it as a vaccine against HPV viruses or sexually transmitted diseases, the authors note. (The vaccine is active against 4 virus subtypes: HPV-6, HPV-11, HPV-16, and HPV-18; HPV-16 and HPV-18 are responsible for about 70% of cervical cancers worldwide and can also cause other anogenital cancers, whereas HPV-6 and HPV-11 are the most common causes of genital warts).

The marketing was so successful that in its first year, Gardasil was named in the industry journal Pharmaceutical Executive as the "brand of the year" for building a "market out of thin air," the authors point out.

"By making this vaccine's target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to all adolescents maximized, and the subpopulations most at risk practically ignored," they write.

"Rather than concentrating on populations in geographical areas with excess cervical cancer mortality, including African Americans in the South, Latinos along the Texas-Mexico border, and whites in Appalachia, the marketing campaign posited that every girl was at equal risk," Dr. Rothman and Dr. Rothman write.

"That these arguments were delivered by professional medical associations (PMAs) is cause for concern," they add. Merck & Co funded activities at the American College of Obstetricians and Gynecologists, the American Society for Colposcopy and Cervical Pathology, the Society for Gynecologic Oncologists, and the American College Health Association.

Among the company-funded activities were speaker lecture kits and education resource panels, with sample answers to patient questions, as well sample press releases and sample letters to parents and students explaining why they should have the vaccine. The authors detail specific instances in which the message being promulgated by PMAs was influenced by Merck & Co.

Approached for comment, Diane Harper, MD, from the University of Missouri- Kansas City School of Medicine, Kansas City, Missouri, commented to Medscape Oncology that the PMAs "must confess to both their memberships and to the women whose health they serve that they were overtly exuberant in their hopefulness for vaccination and are guilty of presenting essentially only the information that Merck wanted presented."

She added, "In order to move on from this mistake, PMAs need to work with researcher clinicians to develop informed consents that include detailed risks and benefits of vaccination and screening." Dr. Harper also said that, now that serious adverse events have been documented, full disclosure of benefits and risks must be presented in all educational lectures.

Dr. Harper is professor and vice-chair, Obstetrics and Gynecology, Community and Family Medicine and Informatics and Personalized Medicine, and she conducted the phase 2 and phase 3 trials for Gardasil, authoring their publications. She has spoken out previously about the HPV vaccine and its marketing, and to Medscape Oncology, she expressed her concern over how the message about the need for regular cervical smears was overshadowed by "aggressive and inappropriate promotion of the vaccine."

Dr. Harper also commented that nowhere in any of the information about Gardasil has it been pointed out that in developed countries such as the United States, which have Papanicolaou (Pap) screening programs in place, the HPV vaccine will do little to decrease the already very small cancer rate but mostly will allow screening intervals to be extended safely.

Also approached by Medscape Oncology for comment, Maurie Markman, MD, professor of gynecologic medical oncology at the M.D. Anderson Cancer Center, Houston, Texas, questioned the credibility of the article on marketing, which is published as a "special communication." The authors are social scientists, he points out, and they "quote opinions from editorials as if they equate to facts." He emphasized the need to distinguish opinion from data and pointed out that there was no reference to any of the extensive peer-reviewed research articles on the HPV vaccine, which have accumulated data from thousands of patients.

Dr. Markman said he cannot comment directly about the claims made in the article, but added that he would be concerned if there were any truth to the idea that PMAs were not acting appropriately.

However, he strongly disagreed with one of the main points made in the article — the implied criticism of Merck & Co for promoting the vaccine for the prevention of cervical cancer. "I can't say how strongly I disagree with this — in fact, I am appalled," Dr. Markman told Medscape Oncology.

This vaccine does prevent cervical cancer, he emphasized, on the basis of all the data that are available, and "you cannot get better studies or a better strategy," he added. He acknowledges that there is no proof, as yet, but "it will take another 30 years or so to have that proof, and in the meantime, thousands of women will have died from cervical cancer."

"This paper is opinion masquerading as data," Dr. Markman said, and he added that it was "potentially harmful, as it may make people who have already received the vaccine think that they made a mistake."

(In fact, Gardasil is licensed for the prevention of cancer and is only the second vaccine to have this indication, point out the authors from the other article, all of who are from either the Centers for Disease Control and Prevention or the US Food and Drug Administration. The first was the hepatitis B vaccine against liver cancer, which is also marketed by Merck & Co. Dr. Rothman and Dr. Rothman suggest that the company learned valuable lessons in the marketing of this first vaccine, which helped it make the marketing of Gardasil so successful.)

Dr. Harper says that HPV vaccination has a role to play in the prevention of cervical cancer. However, she emphasizes the need for regular cervical smears and points out that even women who are vaccinated need to have regular smears, as otherwise they are still at risk for developing cancer. In addition, women who do not receive the vaccine can still protect themselves equally well by undergoing regular Pap tests.

HPV vaccination will prevent more cervical cancers in populations that do not have access to cervical cancer screening, she continued. Some developing countries without screening have an incidence of cervical cancer that is 5 to 12 times higher than that seen in the United States. Because the death rate from cervical cancer is so much higher in these populations, they may also tolerate a high rate of serious adverse events, including death, that have been associated with Gardasil, Dr. Harper commented.

However, in the United States, the usefulness of the vaccine is to increase the chance that a woman's next Pap test will be normal, Dr. Harper commented. Women must still have Pap tests after vaccination, and vaccination alone in the United States will only incrementally reduce the rate of cervical cancer, with its greatest benefit being to increase the screening interval between screens, and hence being a cost-saving device, she added. In fact, if women who are vaccinated stop going for Pap smears, the incidence rate for cervical cancer would increase, she said.

In the United States, the death rate from cervical cancer (3/100,000 women by statistics from the CDC) is at present similar to the rate of reported serious adverse events from Gardasil (3.4/100,000 doses distributed), Dr. Harper pointed out. "This is a sobering reality," she commented. "Would a parent accept such a rate of serious adverse events if the same cancer prevention can occur with continued Pap screening? Is there any acceptable level of risk of serious adverse events, including death, to prevent genital warts?" she asked, referring to one of the vaccine's other benefits.

Latest Adverse Event Data

The latest data on adverse events with Gardasil, published in the same issue of the journal, comes from the US Vaccine Adverse Event Reporting System (VAERS). In total, 12,424 adverse events after immunization were reported to in United States between June 2006 and December 2008, during which an estimated 23 million doses had been distributed (with a course of 3 doses per person recommended). This represents a reporting rate of 53.9 reports per 100,000 doses distributed.

Of these, 772 reports (6.2% of the total) were described as serious, including 32 reports of death.

The authors, headed by Barbara Slade, MD, from the CDC, comment that most of the rates of adverse events after immunization were "not greater than the background rates compared with other vaccines," with the exception of syncope and venous thromboembolic events, which were higher for the HPV vaccine.

These 2 events, syncope and thromboembolic events, were also reported for the HPV vaccine at a higher rate during this postlicensure period than they had been in clinical trials before marketing, the authors note.

Syncope or syncope vasovagal was mentioned in 1896 reports, and dizziness was mentioned in 1572 and nausea in 1164 reports. The reporting rate was 8.2 cases per 100,000 doses distributed. The majority (>90% – 95%) of these reports were classified as nonserious, the authors note. However, some of the reports mentioned falls, and some of these led to fractures, concussions, hemorrhages, and lacerations.

Venous thromboembolic events were mentioned in 56 reports, giving a reporting rate of 0.2 cases per 100,000 doses distributed. Of these, 19 cases involved pulmonary embolism, and 4 of these resulted in death.

Other adverse events included local site reactions (reporting rate, 7.5 cases per 100,000 doses distributed), headache (4.1 cases per 100,000 doses distributed), hypersensitivity reactions (3.1 cases per 100,000 doses distributed), urticaria (2.6 cases per 100,000 doses distributed), autoimmune reactions (0.2 cases per 100,000 doses distributed), Guillain-Barré syndrome (0.2 cases per 100,000 doses distributed), anaphylaxis (0.1 cases per 100,000 doses distributed), death (0.1 cases per 100,000 doses distributed), transverse myelitis (0.04 cases per 100,000 doses distributed), pancreatitis (0.04 cases per 100,000 doses distributed), and motor neuron disease (0.009).

Dr. Markman commented to Medscape Oncology that he saw nothing very new or surprising in this article and said that the surveillance shows that the vaccine is "generally quite safe."

Dr. Harper agreed that "HPV vaccination is generally safe for most girls or women," but she also commented that the adverse events reported are "quite significant."

However, Dr. Harper was critical of the system in which the reports were collected. "VAERS, by all accounts, is an inadequate reporting system whose function in this form is biased towards not showing causality," she said. The definition of the denominator (those exposed to the vaccine) is very broad — if this figure was divided by 3 for women who received all 3 doses, then the reporting rate would be increased, she added.

"If a statistical association is shown with this level of inaccuracy, then it is truly there," Dr. Harper commented. "But conversely, if no statistical association is seen, one cannot conclude that there is no association."

This point is also made by Dr. Haug in her editorial. She points out limitations of the VAERS reporting system, which the authors themselves emphasize by saying that the "data must be interpreted cautiously and cannot generally be used to infer causal association." Dr. Haug, however, adds that "these limitations work both ways: it is also difficult to conclude that a serious event is not caused by the vaccine."

Dr. Harper also highlighted another concern about the VAERS data. The majority of the reports (68%) were submitted by the manufacturer (Merck & Co), which the authors say compares with a rate of 40% from manufacturers of other vaccines. But for nearly 90% of these reports, Merck & Co would not provide the CDC with any follow-up information to investigate possible statistical causality link. As the authors pointed out in the article, this is unusual behavior for a pharmaceutical company, Dr. Harper comments. During the same reporting period, manufacturers reported only 14.5% of the adverse events associated with Menactra (a meningitis vaccine from sanofi pasteur) and only 7.5% of the adverse events associated with Adacel (a tetanus, diphtheria, and acellular pertussis booster vaccine from sanofi pasteur), she points out.

"Why would Merck make a concentrated effort at reporting nearly 70% of the adverse events for Gardasil if they did not want to control the information?" Dr. Harper comments. "Legislation needs to be enacted to require adverse events reported to pharma to include medical and contact information for potential follow-up by the CDC."

The editorialist and the authors of both articles have disclosed no relevant financial relationships. Dr. Harper reports having received honoraria from Merck & Co and GlaxoSmithKline, and institutions at which she has worked have received funding from both companies to support clinical trials on HPV vaccines. Dr. Markman reports having received grants for educational activities from Eli Lilly and serving as an advisor or consultant for Genentech, Celgene Corporation, Tibotec, and Boehringer Ingelheim.

JAMA. 2009;302:750–757, 795–796, 781–786.



iVillage Member
Registered: 04-09-2008
Tue, 03-09-2010 - 10:28am

If I understand you correctly, it would seem to me that 'lack of safety precautions' (only) would fall into one of the other categories (HPV/STD's).

Perhaps what they are stating is the natural vs synthetic hormones (possibly creating an overload or possibly fighting against each other); that is just a guess.


iVillage Member
Registered: 01-21-2010
Tue, 03-09-2010 - 11:46am
Kids may also be thinking that wearing a condom is protection enough but from what I have been reading, it's not. I once thought it was but penetration has nothing to do with it.
iVillage Member
Registered: 01-21-2010
Tue, 03-09-2010 - 12:57pm

Just found this in my in-box.


It appears that megadose folic acid eliminates cervical dysplasia (a cervical cancer precursor) which is associated with (and thought to be a result of) HPV-16. At least, folic acid eliminated dysplasia in three different woman that were patients of my private practice--all with severe dysplasia and having had cone biopsies. All three had completely normal PAP tests after 3 months on 20-40,000 micrograms of folic acid taken orally in concert with a broad spectrum nutritional supplement program.

Now that we are fortifying foods with folic acid for prevention of neural tube defects (e.g. spina bifida), I believe we will see a reduction in cervical cancer incidence. If Gardasil remains on the market, which I doubt, the "powers that be" will credit Gardasil with folic acid fortification results!

Good Morning Everyone!

It has been a rough few weeks! :) Projects are finishing up so that means I can stop being a recluse ;0)

I have some absolutely huge news. Some activists I work with have been compiling information on the adverse reactions to Gardasil. The FDA has officially requested a meeting with them to view the data they have amassed. The meeting is scheduled for the 12th and they will be releasing documents then. I am going to see if they will allow me to release the digital versions online. In any matter, this is HUGE because schools are trying to mandate this vaccine for every boy in girl in the country!

P.S. We interviewed Leslie Botha and posted it on the bottom of the article...

Christina England
Throughout history there have been strong women debating big issues and changing history, amongst them are Joan of Arc, Emrneline Pankhurst and Amelia Earhart. On the 12th March 2010 in an extraordinary move, six strong, brave women of the world will come forward to present their research, documents and findings involving probably the most controversial vaccine of all times Gardasil to the FDA. What they have uncovered does not make easy reading.
Calling themselves ‘Little Women with Big Voices’ they have been formally invited by the FDA to present their information. The women making the presentation on behalf of the parents whose daughters have died or have been injured by the HPV vaccines are: Karen Maynor; mother of the late Megan Hild, New Mexico; Rosemary Mathis: whose daughter Lauren was adversely injured, North Carolina; Freda Birrell; political activist and lobbyist, Scotland and the United Kingdom; Leslie Carol Botha; broadcast journalist, Colorado; Cynthia Janak: research analyst, Illinois; and Janny Stokvis: research analyst, Netherlands.
The press release released today, Monday 8th 2010 says
“Over 17,500 adverse reactions and 64 deaths have been reported to VAERS (estimated 1 to 10% of the population reporting). The National Vaccine Information Center (NVIC) has posted 272 VAERS reports of abnormal pap tests post-vaccination. Reports of deaths and injuries are now coming in from the United States, New Zealand, Australia, United Kingdom, France, Germany, Spain and India.
Birrell has compiled 40 pages of reports of deaths and injuries from the above countries for the FDA. Stokvis and Mathis have compiled data of vaccine injuries and deaths from VAERS. Botha is presenting studies on menstrual cycle evaluation to prevent vaccine injury – and the impact of aluminium on the endocrine system. Janak has researched vaccine ingredients and believes that she has found the reason as to why “healthy” girls have been injured or have died suddenly and unexpectedly within days weeks, months or potentially years after vaccination.”
According to Botha, it has been an amazing effort to mobilize a group of mothers and concerned women internationally to address the dangers of the HPV vaccines. A colleague of Botha’s, publicist Bobbi Cowan from Los Angeles joined the ranks providing here expertise in organizing a national media campaign. A press release was written and the group of six plus Stephen Tunley from Australia, whose daughter was injured by the vaccine, raised $600 to buy a major news release list through a professional news wire service. According to Botha, the group of ‘Little Women’ is now playing on the same marketing level as Merck and GSK. “They will be shocked at our savvy, expertise and determination to get our message out to the media and to the public.”
The presentation will be presented by the women to the FDA, on Friday, March 12 in the form of a power point presentation which will include 54 slides. Each member in the group will receive a file containing with over 236 pages of research, data and parental concerns. As soon as the presentation is over the data will be released to the public and media.

I have been told that the information contained in file will send shock waves around the world. There have been problems with this vaccine from the onset. Over the four years that Gardasil has been in use, the media has reported deaths, cases of Guillian Barre Syndrome, paralysis, seizures, blindness, problems with menstrual cycles, miscarriage and yet still this vaccine has been given to our children and women. Warnings have not been heeded and the problems have continued. This vaccine has now approved for use in males.
Merck has stated over and over that this vaccine is safe, the FDA and CDC have stated this vaccine is safe. This has been taken from the Merck website
“How safe is GARDASIL?
The safety of a vaccine is an important part of its story.
The common side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Fainting can happen after getting GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask you to sit or lie down for 15 minutes after you get GARDASIL. Some people who faint might shake or become stiff. This may require evaluation or treatment by your health care professional.
The Centers for Disease Control and Prevention (CDC) and the FDA have reviewed all the safety information available to them. Based on data available to them as of May 2009, the CDC and FDA determined that GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks. In August 2009, the CDC reaffirmed its continued recommendation for vaccination with GARDASIL in females. In October 2009, the FDA approved the use of GARDASIL in boys and young men ages 9 to 26 to protect against 90% of genital warts cases.
For more information on GARDASIL, talk to your doctor or health care professional.”
Karen Maynor one of the women involved in the presentation has told me her daughter Megan died after using this vaccine. Megan’s story along with the many others is included on the website The Truth About Gardasil a site dedicated to the girls who have lost their lives to Gardasil a vaccine manufactured by Merck to help protect women against cervical cancer.
‘Truth About Gardasil’ was designed to remember the girls who have lost their lives but also to alert the public to the dangers of Gardasil. The mission statement is firm stating “This website is dedicated to the girls whose lives have been taken way too early because of this vaccine. It is also dedicated to their families who continue on in this fight. We must unite to get this vaccine off the market, together we CAN make a difference!”
In a recent interview with journalist Marcia G. Yerman, Huffington Post , Expert Dr Diane Harper outlines these issues when speaking about the pros and cons of Gardasil.
Harms of HPV Vaccination:
• Duration of efficacy is key to the entire question. If duration is at least fifteen years, then vaccinating 11-year-old girls will protect them until they are 26 and will prevent some pre-cancers, but postpone most cancers. If duration of efficacy is less than fifteen years, then no cancers are prevented, only postponed.
• Safety: There is at least one verified case of auto-immune initiated motor neuron disease declared triggered by Gardasil [presented by neurologists at the 2009 American Neurological Association meeting in Baltimore, Maryland). There are serious adverse events, including death, associated with Gardasil use.
• No population benefit in reduction of cervical cancer incidence in the United States with HPV vaccination as long as screening continues.
• Incidence rate of cervical cancer in the United States based on screening is 7/100,000 women per year.
• Incidence rate of cervical cancer if women are only vaccinated with Gardasil is 14/100,000 per year (twice the rate of cervical cancer if young women vaccinated with Gardasil do not seek Pap testing at 21 years and the rest of their life).
• Incidence rate of cervical cancer with Cervarix vaccination is 9/100,000 per year– better than with Gardasil, but still more than with screening alone.
• Incidence of cervical cancer without screening and without vaccination is nearly 90/100,000 per year. The combination of HPV vaccine and screening in the U.S. will not decrease the incidence of cervical cancer to any measurable degree at the population level. Those women who do not participate in Pap screening, and who are vaccinated, will have some personal benefit for five years for Gardasil and 7.4 years for Cervarix (maybe longer), but they will not affect the population rates.
Boosters for Gardasil after antibodies wane makes the cost of vaccination escalate significantly, and cause implementation challenges to reach those women who might want to be revaccinated.”
Slightly different to what Merck are saying don’t you agree?
Jeffry John Aufderheide from agrees that he feels that it is big bucks that is driving the vaccine saying :-
“In general, many are becoming wise to the fact that young women are being monetized with the cervical cancer vaccines. At $130.27per vaccine, Gardasil is the most expensive on the market. What we know from the documents made available is the Gardasil vaccine has been one gigantic experiment. The FDA is now between a rock and a hard place. Do they continue protecting the brand of corporations or will management recognize a moral responsibility to protect these young women from an experimental product?”
The USA Government seem to have few concerns about Gardasil and have pushed for its use.
The Republican Governor Rick Perry has been reported to have pushed for all girls in Texas to be vaccinated at 11 – 12 signing an executive order requiring this to be mandatory for entry to 6th grade.
A critical look at a new and controversial vaccine by Ralph W. Moss, PhD says
“Despite vocal opposition from some religious groups and worried parents, on February 2, 2007, the Republican governor of Texas Rick Perry signed an executive order requiring all 11- and 12-year-old Texas schoolgirls to be vaccinated with Gardasil. This is a newly approved vaccine, manufactured by the pharmaceutical giant, Merck, Inc. It is designed to prevent infection with four strains of the human papillomavirus (HPV): types 6 and 11, which cause genital warts, and types 16 and 18, which are among the 30 or more strains that are capable of causing cervical cancer.
By signing this executive order, Gov. Perry bypassed the Texas legislature, and thereby avoided an open political debate on this controversial issue. Grassroots opposition in the Texas legislature may yet reverse this unilateral decision (see below). But at this writing the order stands: any girl who wants to enter sixth grade next September in the Lone Star State will have to show proof that she has received three Gardasil injections before school begins.”
Of course if you trace Mr Perry’s activities the usual conflicts of interest emerge. He has been reported to have links to Merck including the following as reported in Rick Perry’s Ties With Merck Run Deep –
“One of the drug company’s three lobbyists in Texas is Mike Toomey, his (Perry’s) former chief of staff. His current chief of staff’s mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government.
Toomey was expected to be able to woo conservative legislators concerned about the requirement stepping on parent’s rights and about signalling tacit approval of sexual activity to young girls. Delisi, as head of the House public health committee, which likely would have considered legislation filed by a Democratic member, also would have helped ease conservative opposition.
Perry also received $6,000 from Merck’s political action committee during his re-election campaign.”
Another report Larry describes Perry as snarky, scheming, and slimy.
However, from my research into vaccines this seems to be the usual dodgy pattern when you study the wheeling and dealing that goes on behind the scenes of the Governments we trust and it is easy to see why. It benefits Merck hugely to get officials on side if you consider the fact that every child vaccinated with Gardasil is worth $360 to Merck. If this vaccine becomes mandatory throughout the USA it is a nice little earner for the drug giants.
If the drug companies and Governments were honest with the public it would not take brave women of the world prepared to take risks to expose and uncover the truth. The truth would already be there and so to would our trust.