Merck Won’t Disclose Mumps Vaccine Efficacy, Say Scientists Accusing Company Of Falsifying Tests

Mumps vaccine manufacturer Merck & Co. Inc. is accused in a court filing of refusing to respond to a discovery request asking for the efficacy of the mumps vaccine as a percentage, reports say. Two of Merck’s former scientists, now whistleblowers, accuse Merck of deliberately falsifying tests in order to make the mumps component of its MMRII vaccine appear more effective than it actually is.

The scientists, Stephen Krahling and Joan Wlochowski, are represented by attorneys at Constantine Cannon, and those attorneys have now “asked U.S. Magistrate Judge Lynne Sitarski of the Eastern District of Pennsylvania to compel Merck to respond to their discovery request,” according to Reuters. They say that Merck refuses to answer the question and gives the excuse that it cannot run a new clinical trial in order to be able to state the efficacy in a different way. Instead, the company is using a “cut-and-paste” method of disclosure, repeating the efficacy results in the exact same way the data was depicted a half century ago.

“Merck should not be permitted to raise as one of its principal defenses that its vaccine has a high efficacy, which is accurately represented on the product’s label, but then refuse to answer what it claims that efficacy actually is,” the letter to the U.S. Magistrate stated. The whistleblowers’ lawsuit was filed in 2010 and asserted that Merck deliberately skewed the efficacy tests by actually adding animal antibodies to the blood samples that were to be tested. The scientists assert that, because of this falsification, Merck has been able to declare that the mumps vaccine is 95 percent effective and in doing so, keep any competing vaccine manufacturers away from the market.

That claim led to an antitrust class action against Merck by purchasers of the mumps vaccine. Both lawsuits are reportedly coordinated now before U.S. District Judge C. Darnell Jones and Magistrate Judge Sitarski.

While Merck asserts the efficacy of the mumps vaccine, the public has watched as the NHL battled a massive mumps outbreak last year. Matt McCarthy, assistant professor of medicine at Weill Cornell Medical Center, claimed, at the time, that the problem with the NHL was that the players had gone too long since their last MMR vaccination. Once believed to be a one-time jab, the MMR schedule eventually was changed to a two-dose schedule when evidence of waning-immunity became transparent. McCarthy explained in an editorial article at the time.

“Throwing a wrench into all of this is that some players with the disease recently did receive a booster. The Penguins claim Crosby was vaccinated against mumps in February; he had antibodies in his system, just not enough. And that’s what makes this so challenging for the NHL (or any concentrated workplace). There isn’t a simple blood test to confirm with 100 percent certainty that a hockey player (or any person) is truly immune to mumps. That’s because the optimal level of antibody to protect from the virus is unknown. NHL teams assumed players were immune when, in fact, they were not.”

Now, Canada’s public health officials are reporting that in Guelph, Ontario, all students from the two high schools involved in a very recent mumps outbreak had been vaccinated according to the schedule, and it’s unknown where the cases of mumps originated from.

“There have been six laboratory-confirmed cases of mumps in students that attend Bishop MacDonnell and Our Lady of Lourdes High Schools in Guelph. In all cases the students had received the recommended two doses of the MMR vaccine.”

“It is possible that there are a few individuals who either did not develop immunity to disease, or that immunity has declined over time,” Dr. Nicole Mercer said, but news of the whistleblowers’ lawsuit raises big questions from the public noticing a pattern.

Just weeks ago, there was a reported mumps outbreak at the University of Texas among vaccinated college students, according to Forbes. What do you think? Do you think that Merck actually falsified the efficacy tests in order to gain control of the mumps vaccine market with its MMRII?

[Photo via Drugwatch]