Tuesday, March 30, 2010

Gardasil: 49 US deaths reported to VAERS/ Washington Examiner

From the Washington Examiner
Cervical cancer accounts for less than 1 percent of all cancer deaths, so it was somewhat surprising when the U.S. Food and Drug Administration fast-tracked approval of Gardasil, a Merck vaccine targeting the human papilloma virus (HPV) that causes the disease, in 2006.
As of Jan. 31, 2010, 49 unexplained deaths following Gardasil injections have been reported to the Centers for Disease Control and Prevention's Vaccine Adverse Event Reporting System (http://vaers.hhs.gov/index). By contrast, 52 deaths are attributed to unintended acceleration in Toyotas, which triggered a $2 billion recall.
These are 49 deaths in healthy teens and young women, not the elderly.  These deaths cannot be balanced against lives saved by the HPV vaccine, because all those who receive it still have to have regular PAP tests.  For women who receive yearly PAPs, the death rate from cervical cancer approaches zero.

Why get PAPs once you are vaccinated?  Doesn't the vaccine prevent HPV infections?  The answer is that it does, sometimes.
  • It doesn't prevent infections from all HPV strains that can cause cancer.  
  • The vaccine effect is temporary, but we don't know exactly how long it will last.
  • No vaccine works 100% of the time, and how well this one works remains to be seen.  For example, the best flu vaccines provide immunity in at most 70% of recipients.
How did FDA respond to this information?  It approved the vaccine for boys as young as age nine to prevent venereal warts due to HPV!

Understandably, FDA can claim it approved this vaccine to prevent cancer in women; this is the first cancer vaccine approved in the US.  Getting it licensed  made a splash!  It also gave industry encouragement that FDA would look favorably upon other cancer vaccines in development.

But giving approval to this vaccine in boys, to prevent warts, when it appears to cause some healthy kids to die inexplicably--where is the logic in that??

1 comment:

Anonymous said...

Hi Dr. Nass,

I have not followed much on Gardasil and don’t know if it is effective or if it is safe.

What I do know is that it worked very well for the former Director of the CDC Julie Gerberding.

She is now the President of Merck’s Vaccines division and of course they are the makers of Gardasil.