At its core, the 55-page whistleblower lawsuit unsealed Friday in U.S. District Court in Philadelphia makes one stunning allegation – that pharmaceutical giant Merck traded children’s health to protect monopoly profits, and engaged in a systematic, elaborate, and ongoing fraud to do so.
If the charges – which Merck denies – are true, a 12-month-old child getting a recommended shot containing the mumps vaccine at their pediatrician’s office this morning would not be adequately protected from the disease, and could face serious health complications down the road as a result.
The alleged fraud: a multi-year effort to hide the fact that the mumps vaccine is no longer anywhere near as effective as Merck claims. The project was widely known and approved within the company’s vaccine division and even had a name, Protocol 007, according to the two former Merck scientists who filed the suit more than two years ago under the federal whistleblower statute. Virologists Stephen A. Krahling and Joan A. Wlochowski claim they witnessed the fraud firsthand when they worked at the Merck vaccine laboratory in West Point, Pennsylvania, between 1999 and 2002, and were pressured to participate.
They describe a supervisor manually changing test results that showed the vaccine wasn’t working; hurriedly destroying garbage-bags full of evidence to keep the fraud from being exposed; and lying to FDA regulators who came to the lab after being alerted by the whistleblowers. A top Merck vaccine official told Krahling the matter was a “business decision,” the suit says, and he was twice told the company would make sure he went to jail if he told federal regulators the truth.
The alleged fraud occurred because, in order to maintain its license for the mumps-measles-rubella vaccine, known as the MMRII, Merck needed to show that the mumps vaccine was still as potent as when originally approved in 1967 as a single vaccine, able to induce immunity in 95 percent of those vaccinated. That number, according to vaccine authorities, is crucial because it leads to “herd immunity,” protective against outbreaks even among unvaccinated people. The problem with the mumps vaccine lay in the fact that by the late 1990s, after decades of producing it with the original strain of mumps virus, the vaccine’s effectiveness had steadily declined, the suit says.
Merck is the only company licensed in the United States to produce the individual mumps vaccine, as well as the MMRII and a newer shot called the MMRV or ProQuad, which also contains the chickenpox vaccine. That gives Merck an effective monopoly on the product line, which by our estimate has brought the company as much as $10 billion in business since 2000. The complaint conservatively estimates MMRII purchases by the Centers for Disease Control and Prevention at $750 million.
If tests showed the mumps vaccine is ineffective -- or far less so than promised -- the door would be opened to any number of adverse events for Merck, from federal regulators pulling the licenses for all of its mumps-vaccine-containing products, to intensified competition from other manufacturers if they became aware of the problem.
What’s more, weak efficacy could be triggering real-time, real-world health problems here and abroad, where a version of the MMRII is also used. Mumps outbreaks unexpectedly occurred in the United States in 2006 and in 2009-10, reflecting the three-year cycle in which younger children become exposed. A total of 6,500 cases were reported in a highly vaccinated population in the Midwest in 2006, according to the suit, and another 5,000 cases in 2009; in the years leading up to the first outbreak, the annual average had been 265 cases.
If that pattern holds true, another outbreak might be due as early as this summer.
Additionally, poor vaccine efficacy has the effect of pushing some cases of mumps to a later age, when mumps is a more dangerous disease that can induce sterility in males. One intriguing implication is that no vaccine at all might have been better than the one Merck currently produces.
The suit claims that as a result of the fraud, the U.S. government has been cheated out of millions of dollars paid by the CDC to buy the vaccine for its immunization program. It says the agency, and other government bodies, were wrongly deprived of the knowledge they needed to make proper use of taxpayer money and sound medical decisions. (The CDC predicted several years ago that mumps would be eradicated in the United States by 2010, an outcome predicated on the idea that the vaccine worked.)
The suit describes Merck’s allegedly no-holds-barred effort to protect its market position. “Merck set out to conduct testing of its mumps vaccine that would support its original efficacy finding. In performing this testing, Merck’s objective was to report efficacy of 95 percent or higher regardless of the vaccine’s true efficacy. The only way Merck could accomplish this was through manipulating its testing procedures and falsifying the test results. … Krahling and Wlochowski participated on the Merck team that conducted this testing and witnessed firsthand the fraud in which Merck engaged to reach its desired results. Merck internally referred to the testing as Protocol 007.”