JAMA: HPV and Cervical Cancer Treatment Gardasil – Choosing to Ignore the Facts
Cervical Cancer is a serious disease and the second leading cause of cancer death in women world wide. In the US it is treatable. The American Cancer Society estimates that in 2009, about 11,270 cases of invasive cervical cancer will be diagnosed in the United States. Some researchers estimate that non-invasive cervical cancer (carcinoma in situ) is about 4 times more common than invasive cervical cancer.
Cervical cancer occurs most often in Hispanic women; the rate is over twice that in non-Hispanic white women. African-American women develop this cancer about 50% more often than non-Hispanic white women.
But cervical cancer which is caused by a sexually transmitted virus (HPV) is now largely preventable with the vaccine Gardisil developed by Merck.
In this weeks, JAMA there are two articles on Gardisil the first titled: Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine is authored by physicians and researchers from the US Centers for Disease Control and Prevention and the Food and Drug Administration that research article points out that Gardisil is safe and effective in preventing HPV.
“We feel confident recommending people get the vaccine; the benefits still outweigh the risks,” “This is the most complete picture we have.” said Dr. Barbara A. Slade, the study’s first author and medical officer with the Centers for Disease Control and Prevention.
But ignoring evidence even from the CDC and the FDA Catherine De Angelis, MD Editor and Chief of JAMA issued another “Special Communications” (special communications is JAMA code for anything the editor wants it to be selected by the editor bypassing traditional channels, lately focused on anti industry articles) this time taking a blow at Gardasil, Merck’s new vaccine against 4 types of human papillomavirus (HPV).
The recent Shelia and David Rothman, PhD (sociologists, not cancer researchers with the Institute of Medicine as a Profession) Special Communication in JAMA published suggests that there are “critical and unresolved questions … [concerning the] manufacturer’s decision to market its HPV vaccine primarily as an anticancer vaccine.” JAMA authors then asked the following:
· Is the vaccine being targeted to adolescents at greatest risk and who stand to benefit?
· Do professional medical associations (PMAs) that received funding from the company provide members with unbiased educational materials and balanced recommendations?
· Did the PMAs ensure that marketing strategies did not compromise clinical recommendations?
· Was the design and implementation of vaccine policy for adolescents consistent with scientific knowledge?
Interestingly, JAMA itself acknowledges that “the new vaccine against 4 types of HPV … appears to be a cost-effective intervention with the potential to enhance both adolescent health and the quality of their adult lives.” So the problem does not appear to be with the science of the medicine, rather “the messages and the methods by which the vaccine was marketed.”
In other words, JAMA believes that the means (the development of an HPV vaccine) used to accomplish the end (Gardisil), are somehow “unethical” because industry was involved. Regardless of the fact that without industry this “cost-effective intervention…that will enhance adolescent health and quality of their adult lives” would not exist, JAMA continued to discredit the manufacturers.
JAMA further claimed that “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the subpopulations most at risk practically ignored.” Another claim by JAMA is that the vaccine manufacturer which provided educational grants to (PMAs) “did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits.”
JAMA goes on to further describe that Gardasil was “promoted primarily to “guard” not against HPV viruses or sexually transmitted diseases but against cervical cancer.” The article somehow tries to correlate this promotion with enabling “its manufacturer to circumvent possible parental and public unease with an antidote to sexually transmitted diseases.” The drug was approved by the FDA, and went through all the clinical trials and research necessary, what more do parents need?
Continuing through the article, the authors assert that Merck only concentrated 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
PMA’s
In order to further the goal of treating patients and finding effective treatments for cervical cancer, Merck funded established Professional Medical Associations (PMAs) such as the American Society for Colposcopy and Cervical Pathology (ASCCP).
Instead of looking at these educational grants neutrally for what they provided to research and academia, JAMA asserted that the American Society for Colposcopy and Cervical Pathology (ASCCP) “perceived the vaccine promotion as an opportunity to turn a potential financial liability into an asset.”
Somehow JAMA interpreted ASCCP’s prediction about the need for new practitioners to educate about HPV and cervical disease as a risk. Moreover, the educational grants allowed the ASCCP to create an “Educate the Educators” program, training members to promote vaccine use, especially in “smaller and mid-sized communities that lack clinicians who have expertise in this area.” What is so unethical and wrong with that? Is this not what CME is supposed to do meet the unmet needs of communities? I would venture to say that these programs would receive commendation for such targeted actions, reaching physicians and patients with the greatest need.
In fact, the ASCCP also “arranged opportunities for CME accredited courses through “grand rounds, in-service opportunities, patient education forums, risk management and quality improvement meetings, and professional association society meetings.” With statistics like “worldwide, cervical cancer as the fifth leading cause of cancer death in women, 473,000 cases of cervical cancer, and 253,500 deaths per year” why would
JAMA even try to question such a breakthrough?
ASCCP materials also advocate for physicians to help in “convincing states and federal agencies to pay for the vaccine, convincing insurance to pay for it [and] encouraging state mandates for use.” What else more could JAMA want in order to help patients with an effective treatment?
Surprisingly, JAMA did get one thing right in this article: “Professional medical associations are obligated to provide members with evidence-based data so they can present relevant risks and benefits to their patients.” That is exactly what Merck and the CME providers they support have done, and continue to do.
About the Authors
One colleague noted that it is almost impossible for the article in JAMA to have been peer reviewed prior to publication, because the bias was so pervasive throughout the commentaries (they tried to make it to look like research but in reality it was nothing but pure commentary).
This article is pure David Rothman, PhD Director of Columbia University’s – Institute of Medicine as a Profession, who has received closed to $10 million from George Soros and his Open Society Institute to discredit the pharmaceutical and device industry, he is the lead author of this past springs JAMA published paper calling for an end of all relationships between industry and Professional Medical Associations (PMA’s).
In addition, David is the founder of the Prescription Project whose total goal is the same to eliminate “conflicts of Interest” code for all interest and relationships between industry and healthcare providers. He lives in a world were all drugs and devices are for the betterment of man and should be given away free of charge.
Fortunately the press did not follow the religious zealot line that Rothman portrayed and focused on the benefit that young women receive from getting the vaccine. This even includes the NY Times plus a plethora of other news papers. (Sorry but science sells and propaganda does not) But you keep ignoring the truth David, you must or your funding will dry up.
ASCCP Response
In response to the article, ASCCP issued a press release asserting that their “mission of ASCCP is to improve clinician competence and patient outcomes through provider education.” As a result, the organization endeavored into the research of an HPV vaccine because of the “widespread ignorance about HPV and its role in cervical oncogenesis.” Therefore, ASCCP wanted to educate clinicians about HPV vaccines, and in order to do so effectively and efficiently, accepted funds from a variety of sources, including HPV vaccine manufacturers.
The reason ASCCP accepted such funds from industry is because “funding for this purpose has not been available through government or nonprofit sources.” How else does JAMA expect physicians to cure the world’s second highest killing disease for women?
Specifically, ASCCP noted that although “the current prevention system based on Pap testing, colposcopy and destruction of precursors is effective, it remains expensive, intrusive, insensitive and nonspecific.” Moreover, they noted that “because it cannot be determined which women with CIN are fated to develop cancer, it results in overtreatment of thousands of women each year, with consequent cost, procedure-related injury, and perinatal morbidity resulting from cervical compromise.” That is why ASCCP accepted funds to develop a more effective treatment, and why “industry representatives played no role in the development or content of ASCCP educational materials.”
ASCCP also wrote a asserting the following points:
- The Food and Drug Administration (FDA) has approved HPV vaccination as safe and effective, reflecting the opinion of cervical cancer experts—which Rothman and Rothman are not—that vaccination will decrease the burden, not only of cervical cancer, but also of precancer, with fewer abnormal Pap tests, colposcopies, and cervical treatments.
- Materials were peer reviewed and financial support disclosed.
- While the authors argued that ASCCP failed to emphasize vaccination of high-risk populations, some 80% of sexually active women will acquire HPV, though most clear infection, so all women are at risk. Cervical cancer rates are highest in unscreened women. ASCCP has supported efforts to protect these women, including education of clinicians who serve them, collaboration with government agencies, and primary prevention through HPV vaccination.
- ASCCP supports a dialogue to advance efforts to provide vaccine to low income, immigrant, and minority women at greatest risk. Some controversial aspects of vaccination, including “catch-up” vaccination for sexually experienced women, were evaluated and approved by the FDA and subsequently adopted by the Advisory Committee on Immunization Practices (ACIP); ASCCP reported and explained ACIP positions in its educational materials but did not influence their adoption.
- ASCCP will continue to use income from a variety of sources including industry to support our mission of improving the lives of women through education about HPV, conventional screening and treatment, and HPV vaccination.
In the end, ASCCP put it best: “it is unethical to deny a generation of women access to HPV vaccination while waiting to demonstrate a decline in cervical cancer rates.” We should praise these entities for their breakthroughs with industry, and Americans should all appreciate the lives they will save.
If you have a choice who do you believe anti industry zealots David and Shelia Rothman or the researchers at the FDA and CDC? My money goes on the CDC and FDA, I would encourage everyone else to do the same and get your daughters vaccinated. I certainly will.
Thomas Sullivan, Author of Policy and Medicine is the President of Rockpointe
In 2005 – 2006 Rockpointe/Potomac Center for Medical Education produced CME activities on HPV and Cervical Cancer supported by Merck US Human Health. We are confident our efforts have contributed to lives saved by educating health professionals on preventing cervical cancer in women.