Friday, October 10, 2014

What Whistleblowers Tell Us About Vaccine Safety and Effectiveness

HPV-Vaccine_5

In 2010, two Merck virologists filed a federal lawsuit under the False Claims Act against their former employer, alleging the vaccine maker lied about the effectiveness of their mumps vaccine (which is part of the trivalent measles, mumps, and rubella (MMR) vaccine).
The whistleblowers, Stephen Krahling and Joan Wlochowski, claimed they witnessed “firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings.”
They charged that Merck used improper testing techniques; manipulated testing methodology; abandoned undesirable test results; falsified test data; and failed to adequately investigate and report the diminished efficacy of its mumps vaccine.
They also claim Merck falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling; falsely certified the accuracy of applications filed with the FDA; falsely certified compliance with the terms of the CDC purchase contract; and mislabeled, misbranded and falsely certified its mumps vaccine, among other violations.
Merck allegedly falsified the data to hide the fact that the mumps vaccine in the MMR shot has significantly declined in effectiveness.1
By artificially inflating the mumps vaccine efficacy, Merck was able to continue selling MMR vaccine in the US and maintain its monopoly over the mumps vaccine market in the US and other nations that purchase Merck’s MMR vaccine.
This is the main point of contention of a second class-action lawsuit, filed by Chatom Primary Care2 in 2012.
US District Court Judge C. Darnell Jones has now given both of these lawsuits the green light to proceed.34
Also noteworthy is the fact that the Department of Justice (DOJ) has gone on record disputing Merck’s apparently false assertions that DOJ previously investigated the issue and declined to join in the lawsuit because it found no wrongdoing by Merck.

Court Documents by Department of Justice Contradict Merck Statements