February 5, 2015
By Mark Terry, BioSpace.com Breaking News Staff
More details have surfaced this week about a former Merck & Co. virologist, Stephen Krahling, who has accused the company of falsifying data related to its MMR vaccine.
In 2010, two Merck virologists, Stephen Krahling and Joan Wlochowski, filed a suit against the company, accusing it of falsifying its mumps vaccine test results in order to achieve an efficacy rate of 95 percent. According to their accusations, Merck added animal antibodies to a blood sample to give the impression of increased antibodies.
The suit alleged, “Without demonstrating that its mumps vaccine continued to be 95 percent effective, Merck would lose its exclusive license to manufacture and sell its MMRII vaccine. And if Merck lost the license for MMRII, Merck would also be unable to secure U.S. Food and Drug Administration (FDA) approval for its ProQuad vaccine. So, Merck set out to conduct testing of its mumps vaccine that would guarantee an efficacy rate of 95 percent or higher. It did this through manipulating its testing procedures and falsifying the test results.”
Closer reading of the suit also alleges that numerous executives at the company were aware of the falsification of testing data, specifically Krahling’s human resources representative, Bob Suter, as well as various scientists. The suit says, “Krahling told Suter that he was going to report the activity to the FDA. Suter told him he wouldu go to jail if he contacted the FDA and offered to set up a private meeting with Emini [then company VP of the Vaccine Research Division] where Krahling could discuss his concerns.”
The original suit was filed Aug. 10, 2010. In 2012, a related lawsuit was filed by two physicians and a clinic, U.S. v. Merck and Chaatom v. Merck. The two cases were handled together. The second case claimed violation of the Sherman Act, for monopolistic, anti-competitive behavior results from the fraud, as well as violations of various state laws.
Merck filed a motion to dismiss the charges. On Sept. 5, 2014, the court rejected the motion to dismiss. It did, however, eliminate charges of breach of contract and unjust enrichment claims.
Merck has an exclusive license with the U.S. government to make the mumps vaccine. The company brings in revenue of approximately $1 billion annually on sales of childhood vaccines.
The whistleblower lawsuit was unsealed in June 2012. Krahling and Wlochowski are being represented by Gordon Schnell of Constantine Cannon, Joel Meredith of Meredith & Narine and Jeffrey Keller of Keller Grover. Merck is represented by Eric Sitarchuk and Lisa Dykstra of Morgan Lewis & Bockius and Dino Sangiamo and Sally Bryan of Venable.
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