JAMA questions Gardasil Safety
consumer injury lawyer | Monday, August 31st, 2009 | No Comments »In 2006, the FDA licensed Gardasil and approved its use for females ages 9 to 26. Unfortunately, it is not safe to base decisions regarding receipt of the Gardasil vaccine on FDA approval alone. The FDA has proven time and time again that it is simply incapable of fully protecting the public’s health. As a result, we must turn to independent studies of vaccine injury. This information is vital in getting a view of the true picture of vaccine safety.
The latest articles published in the Journal of American Medical Association (JAMA) are confirmation that there are more questions than answers available when it comes to the safety of Gardasil.
Merck relies on unreliable VAERS as proof of Safety
VAERS is a voluntary reporting system operated by the FDA and the CDC that allows physicians, patients, manufacturers, and others to report various reactions resulting from the administration of the vaccines. According to Merck, the manufacturer of Gardasil, over 23 million doses of the Gardasil vaccine have been administered in the United States. Out of those 23 million doses, 12,424 adverse reactions have been reported. JAMA states that only about 6.2% of the 12,424 reports are considered serious.
Unfortunately, the VAERS reporting system is rife with flaws and that information obtained from VAERS must be treated in a manner consistent with an imperfect system. Specifically, reports often lack information needed to make an accurate evaluation. There is also a notable concern of underreporting adverse reactions. Interestingly, it must be noted that 68% of the 12,424 reports were authored by Merck.
Merck’s focused marketing on Doctors to Increase Recommendations
Merck’s “1 Less” campaign, directed at every adolescent-aged female instead of those populations at greatest risk, combined with the generous education grants for PMAs (professional medical associations), made with the primary goal of obtaining physician encouragement of Gardasil vaccinations, proved successful. According to JAMA, sales of Gardasil in 2008 were $1.4 billion worldwide. The relationship between PMAs and Merck raises questions concerning Merck’s aggressive anticancer campaign’s influence on the responsibilities PMAs owe as impartial advocates for vaccinations.
According to JAMA, there are justifiable concerns surrounding the influence Merck’s marketing campaign has had on relationships with PMAs, in addition to the problems associated with reporting adverse effects by way of VAERS. The combination of Merck’s marketing campaign and underreporting of adverse effects in VAERS (never mind that Merck authored a majority of the adverse event reports) is a receipe for a public health disaster.
