Two former Merck virologists, Joan Wlochowski and Stephen Krahlin, have
filed a whistleblower complaint against Merck accusing it of overstating
the effectiveness of its vaccine for rubella, mumps, and measles and,
as a result, causing the US government, which bought about four million
doses of MMR vaccines that were misbranded and mislabeled every year for
at least 10 years, to be defrauded. They also contend that Merck’s
inaccurate claims about the vaccine’s effectiveness played a role
in causing, rather than preventing, two recent mumps outbreaks. The Qui
tam lawsuit, which was recently unsealed, was filed in 2010. Merck is
denying any wrongdoing.
According to the whistleblower complaint, as far back as the late 1990′s,
Merck manipulated the outcomes of clinical lab trials so that it could
say that MMR-II, which is the combined mumps vaccine, was 95% effective.
Krahlin and Wlochowski claim that the company did this so it could keep
its exclusive license to make the vaccine in the US. Rather than reformulate
the vaccine to enhance its effectiveness, Merck is accused of modifying
its testing technique so it would end up with the results that were desired.
The whistleblowers said that if the vaccine had tested under 95% effective,
the drug maker might have lost its monopoly to sell it in this country.
Krahlin and Wlochowski contend that as a result, the US government ended
up paying hundreds of millions of dollars for a vaccine that wasn’t
as effective as it was touted to be, while millions of children were deprived
of the full immunization protection that they needed. They said that they
actually witnessed the fraud and were asked to take part in this inaccurate
testing, called “Protocol 007.” They believe that Merck’s
failed vaccine is a reason why mumps still exists when it could/should
have been eradicated.
In April, the US government told a federal judge that it wasn’t
going to get involved in the whistleblower’s False Claims lawsuit
but that it might do so in the future.
Whistleblower Lawsuits
Unfortunately, there are companies and individuals that defraud our federal
and state governments every year, costing the nation and taxpayers billions
of dollars. Citizen whistleblowers can expose such fraud, involving false
claims submitted to the government for payment, by filing a lawsuit under
the False Claims Act. Whistleblowers may be entitled to up to 30% of what
the government recovers.
Merck Whistleblower Suit A Boon to Vaccine Foes Even As It Stresses Importance
of Vaccines, Forbes, June 27, 2012
Class Says Merck Lied About Mumps Vaccine, Courthouse News, June 27, 2012
