“Merck accused of stonewalling in mumps vaccine antitrust lawsuit,” a Reuters article by Brendan Pierson published Thursday, appears to be the first time a mainstream media outlet has covered explosive accusations that Merck falsified test results on its mumps vaccine. Today, the Wall Street Journal followed suit with coverage of its own, “Lawsuit Claims Merck Overstated Mumps Vaccine Effectiveness,” an article by Jon Kamp.
The court case, United States v. Merck & Co., stems from claims by two former Merck scientists, Stephen Krahling and Joan Wlochowski, 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% effective. In an earlier ruling, the court dismissed Merck’s objections to the case proceeding, finding the whistleblowers had plausible grounds on all of the claims lodged against Merck.
The Reuters article, in addition to describing the alleged fraud, focuses on a recent development in the case — Merck’s refusal to produce documentation on the vaccine’s efficacy — as well as describing a proposed anti-trust action stemming from the mumps allegation. The Wall Street Journal article, in contrast, is oddly preoccupied with assuring the public that the vaccine in question — MMR II, a combination vaccine for measles, mumps and rubella — is safe, a matter not before the court. To that end, the WSJ quotes Merck at length as well as citing assurances by the Centers for Disease Control.
Better late than never. Both Reuters (@Reuters) and Wall Street Journal (@WSJ) deserve credit for finally giving the public a heads-up on a court case filed in 2010 involving allegations of hundreds of million of dollars in fraudulent sales. Only Reuters’ Brendan Pierson (@brenpiers) deserves kudos, however, for his fact-based piece. The article by WSJ’s Jon Kamp (@jon_kamp) is less meritorious, dwelling on the tangential issue of the vaccine’s safety and also accepting the vaccine’s safety claims at face value, unbalanced by comment from scientists with an opposing perspective. (Reuters made an unsuccessful)attempt to obtain a comment from Merck).