The FDA continues to spark controversy over Merck’s Gardasil vaccine, as they ignore scientific principles to grant approval for extended use as a preventative for anal cancer and anal intraepithelial neoplasm. The SaneVax Team wants to know why.
December 30, 2010
FOR IMMEDIATE RELEASE
PRLog (Press Release) – Dec 29, 2010 – Wednesday, December 22, 2010, Merck announced the FDA had granted permission for Gardasil to be used in the prevention of anal cancer in the male and female population, ages 9 through 26.
The SaneVax team finds this situation appalling, to say the least. After having studied the information Merck presented to the FDA Vaccines and Related Biologics Committee (VRBPAC) to secure this extended use, we cannot sit idly by and let medical consumers around the world accept these ‘facts’ at face value.
First, let it be said that any Advisory Committee Open Meetings to review applications for extended use are supposed to be public. The FDA has yet to publish the minutes from the meeting where they agreed to expand Gardasil’s use to include AIN and anal cancer.
Second, medical consumers need to know the real threat anal cancer presents. According to the National Cancer Institute, an estimated 5,260 people will be diagnosed with anal cancer in 2010 (United States). 720 fatalities due to anal cancer are anticipated. The average age at diagnosis is 60. The data presented in a 1996 study indicates you are over 10 times more likely to die from an overdose of over-the-counter pain medications, such as aspirin, than you are to die of anal cancer. Merck made no mention of these facts anywhere in the documentation they presented to the FDA.
SaneVax wants to know, “In what universe does this make a convincing argument for vaccinating people ages 9 to 26?”
In addition, Merck once again blatantly chose a double standard to set the endpoints for efficacy analysis to suit different purposes within the same document. On one hand, they quoted the authoritative National Cancer Institute (NCI) opinion that high-grade AIN 2/3 is a premalignant lesion in order to justify using reversible and poorly defined precancerous histological changes as the endpoint for evaluating Gardasil’s potential to prevent anal cancer.
On the other hand, when it came to ‘judging’ the real efficacy of Gardasil against premalignant lesions, they suddenly switched to using AIN of any grade, not necessarily high grade 2/3, as the determining factor. This is a gross deception because, as Merck should have known, AIN grade 1, and grade 2, lesions are frequently self-reversing and do not lead to cancer at all.
Furthermore, Merck stated HPV infection is the key in pathogenesis of anal cancer. In their selection of MSM (males who have sex with males) study subjects, Merck emphasized that key exclusion criteria included a history of HPV-related disease or infection. However, potential subjects were only examined for ‘visible signs’ of HPV infection; not screened via PCR, or tested for seropositivity prior to enrollment.
On the other hand, under Disease Endpoint Adjudication, it was required that at least one of HPV types 6, 11, 16 or 18 detected be confirmed by Thinsection PCR. Since no PCR testing was performed at the time of enrollment, a high percentage of study subjects already infected with HPV, but without ‘visible signs,’ might have been assigned to the placebo group, thus giving the vaccine group an artificially high appearance of efficacy.
Since there was no PCR-based common denominator established at the outset of the clinical trial, efficacy results based on PCR endpoint analysis should not be accepted as valid.
For confirmation of type-specific HPV infections during the trials, Merck did not use an FDA-approved genotyping method, or, the reliable HPV DNA short target sequences genotyping recommended by the NCI. Because of this choice, no one knows how many subjects began the trials with prior exposure to vaccine-relevant HPV; nor does anyone know for sure how many subjects were infected by any vaccine-relevant HPV at the end of the trials.
One additional problem is HPV types 6 and 11 are classified as low risk, meaning they are not normally associated with any type of cancer. Even so, Merck included 19 cases of AIN related to these two low-risk HPV genotypes to demonstrate the ‘efficacy’ of Gardasil against anal cancer.
SaneVax believes perhaps it is time the FDA stop claiming they are a “science-based, science-driven regulatory agency responsible for the safety, efficacy and security of drugs and medical devices.”
When it comes to the safety, efficacy and security of FDA approved vaccines medical consumers are apparently on their own.
Visit https://sanevax.org/pdf/VRBPAC-gardasil-2010-anal-cancer.pdf for the documentation Merck submitted to the FDA
Visit http://www.cancer.gov/cancertopics/types/anal for information on anal cancer
Visit http://drugwarfacts.org/cms/?q=node/30 for information on pain medication fatalities
Visit http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm181509.htm for information on HPV testing
# # #
One cannot help but wonder if the FDA has studied the data presented by Merck extremely superficially with intention.
There are numerous statements in which the actual formulation in the documentation submitted by Merck to FDA is provoking. Here are but a few:
On page 8: “The favorable safety profile of GARDASIL continues to be supported by clinical trials data, postlicensure studies, and surveillance systems”.
The fact is that the profile is NOT a favorable safety one – if the interest of patients is taken into consideration; and regarding clinical trials, results will not be presented unless they are favorable to Merck.
On page 9 we read:” Finally, based on the clinical trials experience to date, there is no evidence that the efficacy of GARDASIL® is gender- or sexual-behavior dependent”.
– Based on clinical trials to date? The protocols for clinical trials should not be, but unfortunately are drawn up by the pharmaceutical industry itself.
Regarding gender, not even within the female gender has there been a serious study comparing efficacy regarding prepubertal and older girls. Is hormonal stability a none-issue?
Page 12: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection”.
This may well be discussed. Absolutely ALL vaccines may cause infection.
An additional issue is that GARDASIL may cause a new infection due to replacement, a normal phenomenon in virology where the virus strains which are removed by the vaccine are replaced by more aggressive and possibly more carcenogenic strains.
“Administration of GARDASIL® has been generally well tolerated in all populations in which it has been evaluated”.
It is known that GARDASIL is NOT well tolerated – and the methods of evaluation leave much to be desired.
“Overall, the postlicensure experience with GARDASIL® collected through passive reporting of spontaneous adverse experiences to Merck & Co., Inc. has confirmed the favorable safety profile of the vaccine”.
We note that the package insert for Gardasil publishes Merck as the first name to contact regarding adverse events and the telephone number is given. If one reports an adverse event to Merck, what are the risks for it not to be documented correctly? What exactly would ensure that Merck would be positive towards documenting serious adverse events? The answer is: nothing at all.
Manufacturers should not be permitted to be involved in reporting adverse events for their products.
Page 62 Regarding safety:
“Study subjects recorded temperature values and injection-site adverse experiences for 5 days (Days 1 through 5 post-vaccination), and systemic adverse experiences and any other medications administered for 15 days (Days 1 through 15 postvaccination)”
It is completely unacceptable that this study lasted for 15 days only. Many adverse events occur long after this time.
Is FDA really unaware of all this?