Merck, the sole manufacturer licensed by the Food and Drug Administration to sell the mumps vaccine in the United States, is being sued by former employees for allegedly deliberately falsifying mumps vaccine efficacy studies, according to recently unsealed court documents.
According to the documents, the case focuses on Merck’s efforts for more than a decade to defraud the United States by selling a mumps vaccine that is mislabeled, misbranded, adulterated and falsely certified as having an inflated efficacy rate.
The 2 whistleblowers named in the documents are Stephen A. Krahling and Joan Wlochowski. Mr. Krahling was employed by Merck from 1999 to 2001 as a virologist in Merck’s vaccine division located in West Point, Pennsylvania. Ms. Wlochowski was employed by Merck from January 2001 to August 2002 also as a virologist in Merck’s vaccine division in West Point, Pennsylvania.
Defendant Merck is headquartered in New Jersey with its vaccine division based in West Point, Pennsylvania. Merck is one of the largest pharmaceutical companies in the world with annual revenues exceeding $20 billion. Merck is also a leading seller of childhood vaccines and currently markets in the U.S. vaccines for 12 of the 17 diseases for which the CDC currently recommends vaccination.
According to the court filings, during their employment at Merck, Krahling and Wlochowski both witnessed firsthand, and were asked to directly participate in, fraud in a clinical trial relating to the efficacy of Merck’s mumps vaccine.
The court filings also claim that in an effort to maintain its exclusive license to sell the vaccine and its monopoly of the U.S. market for mumps vaccine, Merck has fraudulently represented and continues to falsely represent in its labeling and elsewhere that its mumps vaccine has an efficacy rate of 95 percent or higher. This is the efficacy rate on which Merck’s original government approval for the vaccine was based more than forty years ago. In truth, Merck knows and has taken affirmative steps to conceal – such as by using improper testing techniques, falsifying test data in a clinical trial, and violating multiple duties of government disclosure – that the efficacy rate of Merck’s mumps vaccine is, and has been since at least 1999, significantly lower than this 95 percent rate.
The court documents discuss who is actually being hurt by this alleged selfish behavior by Merck. They state, “[a]s the single largest purchaser of childhood vaccines {accounting for more than 50 percent of all vaccine purchases}, the United States is by far the largest financial victim of Merck’s fraud. But the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection against mumps. And while this is a disease the CDC targeted to eradicate by now, the failure in Merck’s vaccine has allowed this disease to linger with significant outbreaks continuing to occur.”
What I want to know is this? If in fact all of this is true as stated, how in the world is it that we are supposed to trust that the vaccinations and the medications that are required and recommended by federal regulators, such as the FDA & CDC are safe and necessary when their manufacturers are bold face lying to the government in order to keep the money rolling in and the product rolling out?
