Vaccines in the news – an on-going series: Merck

Lawsuit Claims Mumps Vaccine Less Effective than Believed:

Two Merck researchers blow the whistle on fraudulent research data

By Dr. Bob Sears – TACA Physician Advisory member

Merck Pharmaceuticals, the makers of the MMR II vaccine which protects against measles, mumps, and rubella, is under fire with claims that the mumps portion of their MMR vaccine does not work as well as claimed, and that Merck falsified test procedures to make the vaccine appear more effective than it really was.

Stephen Krahling and Joan Wlochowski, two virologists who worked for Merck Pharmaceuticals between 1999 and 2002, claim that they “witnessed firsthand the improper testing and data falsification in which Merck engaged to conceal what Merck know about the vaccine’s diminished efficacy” and that “Merck management pressured them to participate in the fraud and subsequent cover-up when [the researchers] objected and tried to stop it,” according to the lawsuit. The plaintiffs claim that Merck attempted to defraud the U.S. government by using the false data to sell the vaccine to the government and help retain their patent on the product.

According to the Merck MMR II vaccine product insert, the vaccine is 96% effective in preventing mumps infection. However, recent United States outbreaks of the disease (6500 cases in the Midwest in 2006 and 5000 cases near the East coast in 2009) have called the vaccine’s efficacy into question. The two researchers claim that Merck “has taken affirmative steps to conceal – such as by using improper testing techniques [and] falsifying test data in a clinical trial – that the efficacy rate of Merck’s mumps vaccine is significantly lower than this 95% rate.”

What does this mean for parents who are deciding about the MMR vaccine, and for those children who have already had the shot and are relying on it for disease protection? First, I have to say that at this point these are simply allegations. We don’t yet know the truth or accuracy of these claims against Merck. BUT if it turns out to be true, this will further shake an already-waning consumer confidence in Merck’s vaccines and pharmaceuticals.

We do know that immunity from the MMR vaccine wanes over time; we expect that young adults become susceptible to the disease in their late teens or early twenties (the age groups most largely affected by the outbreaks). So, this finding, if true, doesn’t really impact the mumps susceptibility of adults, because that wanes regardless of the vaccine’s initial efficacy. But what about kids? The truth is mumps is a largely harmless disease for children. It typically causes fever, sore throat, and swollen glands in the cheeks that can leave kids feeling sick for several days. But it is virtually never fatal in children, and complications (such as meningitis and sterility) are extremely rare in kids. So, even if the vaccine is less effective than Merck claims, I don’t think that this greater disease susceptibility will put kids at risk.

But it certainly does annoy . . . no . . . anger me that a company would stoop so low in the name of profit (if, that is, these accusations are accurate). I don’t want to hang the accused before they are proven guilty and will wait for the findings after a full investigation.  If the charges are proven to be true, I don’t think parents may be so forgiving to know their child received the faulty vaccine, incurred the risk but not the reward of immunity. That issue will have to be addressed in many ways following the conclusion of this case.

Dr. Bob Sears

Author:  The Vaccine Book, The Autism Book

To read more about related stories please read TACA’s on-going series: Vaccine in the news

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