This is an abbreviated version of an August, 2009 article in PolicyMed.com:
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 Appalachia.” According to JAMA, Merck did this so they could market to consumers “that every girl was at equal risk” and that “Your daughter could become 1 less life affected by cervical cancer.”
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.
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