October 25, 2010
by Ed Silverman
Taking a direct approach with the FDA is all the rage these days. For instance, aggrieved investors recently created an online petition to implore the FDA to investigate staffers for their input into a recent panel meeting for the Arena Pharmaceutical diet pill (see this). And now several parents, who formed a non-profit to protest widespread use of Merck’s Gardasil vaccine for HPV, have written the agency to demand that approval be rescinded.
In its letter, SANE Vax argues that the FDA permitted Merck to use “an inappropriate primary endpoint and unreliable HPV genotyping methods” evaluating efficacy. You can read the letter here to learn more, but basically the group maintains that less serious cervical lesions were permitted as an endpoint and they cite National Cancer Institute reports to bolster their contention this was an erroneous decision.
“The FDA has approved a vaccine which is being marketed as a cancer vaccine, when in fact it has only been proven to prevent ‘not a true biologic entity,’ in the words of the NCI, the inventor of the current HPV vaccine technology and the co-developer of Gardasil,” SANE Vax writes to FDA commish Margaret Hamburg. “The situation is exacerbated because the FDA and the NCI have not attempted to encourage development of a reliable HPV genotyping method for post-license monitoring of the effects of Gardasil vaccination on the epidemiology of HPV infections in the American population.”