Misconduct & Financial Incentives

Merck Has Some Explaining to Do Over Its MMR Vaccine Claims

Captured 2023-04-02
Document Highlights

The staff of representative Bill Posey (R-Fla) — a longstanding critic of the CDC interested in an alleged link between vaccines and autism — is now reviewing some 1,000 documents that [a] CDC whistleblower turned over to them.

Merck, the pharmaceutical giant, is facing a slew of controversies over its Measles-Mumps-Rubella (MMR) vaccine following numerous allegations of wrongdoing from different parties in the medical field, including two former Merck scientists-turned-whistleblowers.

The first court case… stems from claims by two former Merck scientists that Merck “fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act].”

According to the whistleblowers’ court documents, Merck’s misconduct was far-ranging:
It “failed to disclose that its mumps vaccine was not as effective as Merck represented,
(ii) used improper testing techniques,
(iii) manipulated testing methodology,
(iv) abandoned undesirable test results,
(v) falsified test data,
(vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine,
(vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling,
(viii) falsely certified the accuracy of applications filed with the FDA,
(ix) falsely certified compliance with the terms of the CDC purchase contract,
(x) engaged in the fraud and concealment describe herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine,
(xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and
(xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government was purchasing.”

These fraudulent activities, say the whistleblowers, were designed to produce test results that would meet the FDA’s requirement that the mumps vaccine was 95 per cent effective.

[T]he whistleblowers had plausible grounds on all of the claims lodged against Merck.

Merck expected [mumps] outbreaks to occur and, as predicted, they did -­ mumps epidemics occurred in 2006 in a highly vaccinated population and again in 2009-2010).

The third whistleblower — a senior CDC scientist named William Thompson — only indirectly blew the whistle on Merck. He more blew it on himself and colleagues at the CDC who participated in a 2004 study involving the MMR vaccine.

Here, the allegations involve a cover-up of data pointing to high rates of autism in African-American boys after they were vaccinated with MMR.