Two former Merck scientists, who filed a whistleblower lawsuit accusing the drug maker of falsifying data about its mumps vaccine, say the company is refusing to answer a key question about effectiveness of the product, according to court documents.
Specifically, the scientists complain that Merck is being evasive about the actual effectiveness rate, an issue that is at the heart of their 2010 lawsuit. As noted previously, the former virologists charged the drug maker knew its vaccine was less effective than the purported 95% level, and alleged senior management was aware and also oversaw testing that concealed the actual effectiveness.
The scientists, Stephen Krahling and Joan Wlochowski, charged that, by deliberately concealing information about efficacy, Merck precluded potential rivals from the market. This was based on a presumption that the U.S. government would not create additional contracts for new vaccine products while the Merck vaccine had a 95% efficacy rate, according to court documents.
Rather than answer questions, Merck has taken an “evasive approach in its blanket refusal” to provide information effectiveness, according to a letter that an attorney for the scientists wrote last week to a federal court in Philadelphia overseeing the case. Instead, the letter says the drug maker cited data from nearly 50 years ago, when the vaccine was introduced, and that it is not possible to conduct new trials.
“Either Merck knows the current efficacy of its mumps vaccine, or it does not,” the attorney writes. “Whichever the case, 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.”
For its part, Merck has argued the lawsuit is without merit. A spokeswoman sent us a note to say the drug maker believes “the information we provided to the plaintiffs was appropriate, given the way the… requests were framed and the complex scientific concepts involved. We’ll soon file a legal response with the court explaining these points in greater detail.”
The lawsuit has gained attention because it comes at a time of ongoing controversy over vaccine safety, in general, and resistance by some parents to having their children vaccinated. The issue was highlighted again last year after a measles outbreak at Disneyland in California, where 147 people were infected, prompting push back against religious exemptions for vaccination.
The mumps vaccine is a sizeable product for Merck, which reported that sales reached $721 million last year, when including both the MMR II vaccine – which is mumps, measles and rubella – and the ProQuad vaccine, a combination product that is also used to thwart chickenpox, according to a filing with the U.S. Securities and Exchange Commission (see page 49).
The federal government, by the way, declined to intervene – or join – the whistleblower lawsuit. We should note that several physicians later filed a lawsuit seeking class action status and charged the vaccine was mislabeled and was not the product for which the government or other purchasers paid, which meant that Merck violated the False Claims Act, according to court documents.
Meanwhile, the U.S. Centers for Disease Control and Prevention notes that mumps is no longer common in the U.S., although the number of cases has been rising. Last year, 1,151 people in the U.S. were reported to have had mumps, according to the agency. This was, in part, due to outbreaks at universities. Two years ago, the number of reported cases reached 438 people.