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Questionable MMR Data Buried as Measles Outbreak Spurs Need for Vaccine
The recent outbreak of measles originating at Disneyland has brought to light a False Claims Act complaint against vaccine manufacturer Merck & Co., according to a report posted on the BioSpace website.
Two virologists who worked at Merck, Dr. Stephen Krahling and Dr. Joan Wlochowski, filed a suit that was unsealed in 2010 accusing the company of falsifying its mumps vaccine test results to reach an efficacy rate of 95%. According to the scientists, Merck added animal antibodies to a blood sample to give the impression of increased antibodies.
Specifically, the suit stated: “In an effort to maintain its Food and Drug Administration (FDA) approval and exclusive license to sell the vaccine, Merck has used improper testing techniques and falsified test data to fabricate a vaccine efficacy rate of 95 percent or higher. This is the efficacy threshold on which the FDA insists for its licensing and approval of the vaccine. In truth, the efficacy rate of Merck’s mumps vaccine is, and has been since at least 1999, significantly lower than this requisite threshold.”
The first court case, United States v. Merck & Co., is based on Krahling and Wlochowski’s accusations.
There is, however, a second court case, Chatom Primary Care v. Merck & Co., that uses the same evidence. This is a class action lawsuit filed “against Merck for unlawfully monopolizing the U.S. market for mumps vaccine by engaging in a decade-long scheme to falsify and misrepresent the true efficacy of its vaccine.”
There is also a third whistleblower –– a scientist at the Centers for Disease Control and Prevention (CDC), Dr. William Thompson –– who participated in a study of a measles, mumps, and rubella (MMR) vaccine in 2004. In what is likely to be a controversial case, Thompson has stated that the CDC covered up data suggesting high rates of autism in African-American boys who received the MMR vaccination. The CDC and the study’s lead author, Dr. Frank DeStefano, say they stand by the original study results. DeStefano says, however, that he will review his notes.
The Disneyland measles outbreak has reached 87 cases so far, BioSpace reports. Most of those infected were not vaccinated, in some cases because they were children under the age of 12 months. Six of the cases involved individuals who received the vaccine.
The CDC has indicated that the MMR vaccine is 97% effective. More complete effectiveness requires two doses. With a single dose, 5% to 7% of people don’t achieve an effective antibody response for protection.
“And even with two doses, you can get some failure, whether it’s because the initial response isn’t perfect, or because the response waned in some people,” said Dr. Greg Wallace, leader of the measles, mumps, rubella, and polio team at the CDC.
The MMR vaccine manufactured by Merck is the same vaccine, or part of the vaccine, currently implicated in the fraud lawsuits.
Source: BioSpace; January 27, 2015.