Merck’s HPV Gardasil Vaccine: Risks, Benefits, Marketing – JAMA

original link: www.ahrp.org

What possible risk/ benefit standard can justify giving an inadequately studied vaccine whose risks include serious, permanent adverse effects–including death– to millions of girls and women–who will likely never get cervical cancer? Two reports in the Journal of the American Medical Association (JAMA) [1][2] and an editorial written by Dr. Charlotte Haug, the editor-in-chief of the Journal of the Norwegian Medical Association, have re-ignited a debate about the rationale of encouraging–in some instances mandating–mass inoculation of women and girls (as young as 11) with the human papillomavirus (HPV) vaccine.

Below, Dr. Haug raises fundamental medical questions that need to be considered before adopting an invasive medical treatment whose documented risks–including 32 post-vaccination deaths–outweigh the evidence of potential benefits for the populations being targeted for “preventive treatment.”

“Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.”

Why then is the target population for Merck’s Gardasil HPV vaccine, girls and young women in the US and other industrialized countries who are LEAST at risk of dying from cervical cancer? They are least at risk because they are protected by regular PAP screens that identify early signs which are effectively treatable.

Below, CBS reporter, Sharyl Attkisson, interviewed Dr. Diane Harper, the principle investigator who helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck.

However, Merck’s aggressive marketing of the vaccine for populations least at risk, and its dissemination of disinformation about the vaccine’s benefits, have led Dr. Harper to publicly criticize the vaccine that she helped get approved. Indeed, Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; THERE IS NO DATA SHOWING THAT THE GARDASIL VACCINE REMAINS EFFECTIVE BEYOND FIVE YEARS.

She also questions the wisdom of the Centers for Disease Control and Prevention (CDC) recommendation encouraging girls as young as 11-years old to be given a series of shots:

“If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit. The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.”

Dr. Harper also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.

FACTS about HPV:

There are more than 100 different types of HPV and at least 15 of them are oncogenic (potentially cancerous).
The current vaccines target only 2 oncogenic strains: HPV-16 and HPV-18.
The relationship between infection at a young age and development of cancer 20 to 40 years later is not known.
HPV is the most prevalent sexually transmitted infection, with an estimated 79% infection rate over a lifetime.
The virus does not appear to be very harmful because almost all HPV infections are cleared by the immune system.
In a few women, infection persists and some women may develop precancerous cervical lesions and eventually cervical cancer.
It is currently impossible to predict in which women this will occur and why.
Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now.
The vaccine’s effectiveness is confirmed for only five years.
The true risk /benefit of the vaccine can be determined only through clinical trials and long-term follow-up.

In other words, every girl being vaccinated with the HPV vaccine is a human guinea pig in an uncontrolled medical experiment.

The JAMA editorial notes: “When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit.” Gardasil’s risks are borne by the girls and women vaccinated: its benefit clearly goes to Merck.

A report by Drs. Sheila Rothman and David Rothman in the same issue of JAMA, documents how Merck resorted to corrupt practices in the promotion of Gardasil, much as it had done in the marketing of Vioxx. [1]

The authors expose Merck’s covert payments to professional medical associations who sponsored marketing events at which commercial propaganda masqueraded as “educational” material. Merck not only bankrolled professional medical associations, the company provided ready-made presentations, slide sets, e-mails, and letters endorsing the vaccine–which were disseminated under the auspices of influential medical associations.

Among the influential professional medical associations who helped Merck promote Gardasil–having essentially sold their integrity for cash:

The Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, and American College Health Association.

All of these organizations helped Merck sell the vaccine with unsubstantiated claims, and helped Merck influence decisions about vaccine policy. None mentioned Merck funding.

As Rothman and Rothman point out:

“Marketing this HPV vaccine as an anticancer vaccine appears to have enabled its manufacturer to circumvent possible parental and public unease with an antidote to sexually transmitted diseases. But in doing so, the company bypassed public health officials who would have spearheaded a risk-sensitive vaccination campaign…. So too, this manufacturer understandably wanted as many adolescents as possible to be vaccinated. But the pursuit of this goal was neither cost-effective nor equitable.”

“It meant rather than concentrating on populations in geographic areas with excess cervical cancer mortality, including African Americans in the South, Latinos along the Texas-Mexico border, and whites in Appalachia–i.e., populations that cannot afford the $300 price tag of the vaccine–Merck’s marketing campaign targeted those least likely to die from cervical cancer, thanks to regular PAP tests. Merck’s aggressive propaganda FALSELY claimed that every girl was at equal risk:

“Your daughter could become 1 less life affected by cervical cancer.”

“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.”

That is a consequential disservice to girls and young women.

The fact that professional medical associations participated in this charade validates critics who charge that professional American medical associations are not to be trusted–they have betrayed the public trust by selling their integrity to industry.

The second report in the same issue of JAMA, by Barbara Slade and colleagues from the U.S. Centers for Disease Control, addresses Gardasil-linked adverse events reported to the US national database, AERS, which comprise only an estimated 1% to 10% of actual adverse events. [2]

Between June 1, 2006, through December 31, 2008 VAERS received 12 424 reports of AEFIs following qHPV distribution, a rate of 53.9 reports per 100 000 doses distributed.
772 reports (6.2% of all reports) described serious AE following inocularion, including 32 reports of death.
The reporting rates per 100 000 qHPV doses distributed were 8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache;
3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barré syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease.
Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods.

The authors acknowledge: “there was disproportional reporting of syncope and venous thromboembolic events,” but they soft-peddle the significance of these (admittedly) underreported findings:
“the significance of these findings must be tempered with the limitations (possible underreporting) of a passive reporting system.”

What possible risk/benefit standard can justify giving an inadequately studied vaccine whose risks include serious, permanent adverse effects–including death– to millions of girls and women–who will likely never get cervical cancer?