Merck applies for FDA approval to use the dangerous HPV vaccine in boys
Merck applies for FDA approval to use the dangerous HPV vaccine in boys
Let’s say you’re a drug maker. And let’s say you produce a drug that becomes a huge bestseller. But your drug turns out to have a deadly side effect – it increases the risk of fatal heart attacks. And worse, court documents reveal that you were apparently aware of this dangerous potential before the drug went to market.
So you get sued. But not just sued – it’s like the Tyrannosaurus rex of class action lawsuits. Finally, you throw in the towel and agree to pay nearly $5 billion to settle out of court.
Five BILLION. That’s a tough hit, even for a drug company.
So how to you bounce back from that?
Faced with the situation described above, executives for Merck (makers of the deadly Vioxx) are trying to wring every last dime out of Gardasil – the dangerous and expensive HPV vaccine for girls and young women.
As I’ve noted in previous e-Alerts, the FDA has received more than 9,700 adverse event reports for Gardasil, including 580 severe reactions such as seizures and convulsions. Those totals (compiled in August 2008) include 25 deaths.
But rather than proceed with caution, Merck is pouring on the steam, seeking FDA approval of Gardasil for the prevention of genital warts in boys and young men, ages 9 through 26. And even though the vaccine is said to be ineffective when given to those who have already become sexually active, Merck has also asked the FDA to approve the vaccine for older women.
According to Medical News Today, some estimates put the 2008 worldwide sales of Gardasil at more than $1.5 billion. That’s not too bad, unless you’ve just written a check for nearly $5 billion to make a catastrophic mistake go away.
I wonder how much the Gardasil cash cow will end up costing Merck in years to come?
Source:
“A Double Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of 5-Loxin for Treatment of Osteoarthritis of the Knee” Arthritis Research and Therapy, Vol. 10, No. 4, 7/30/08, arthritis-research.com
