By Dan Olmsted and Mark Blaxill
In a blow to Merck’s hopes for a quick legal victory, the U.S. Justice Department is urging a federal judge not to dismiss a whistleblower lawsuit over the company’s mumps vaccine just because the department has not – yet – sided with the whistleblowers.
“The United States remains a real party in interest in this suit under the False Claims Act, with a strong interest in the outcome, even though it has not intervened in the case,” according to the statement, filed May 20 in federal court in Philadelphia and co-signed by an acting assistant attorney general. It pointedly noted the government is “allowed to intervene later.”
The whistleblower suit was unsealed in federal district court in Philadelphia a year ago, soon after the Justice Department, which had been studying the allegations for more than a year, declined to intervene. As we reported then, the alleged fraud was a multi-year effort to hide the fact that the mumps vaccine is no longer anywhere near as effective as Merck claims.
At stake: Hundreds of millions of dollars in government payments to Merck, and potentially billions in penalties from the company if the whistleblowers prevail in court. Merck could even lose its license to manufacture the vaccine.
The fraud was dubbed Protocol 007 and widely known and approved within the company’s vaccine division, according to the two former Merck scientists who filed the suit 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 frantically changing test results that showed the mumps vaccine wasn’t working; 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.
Merck says the suit is without merit, and filed a motion to dismiss the case, in part because the Justice Department has not intervened. It even used that fact in its public statements about the case.
“Merck--which stressed that none of these allegations relate to the safety of its product--said the lawsuit is ‘completely without merit’, and that it plans to ‘vigorously defend itself,’” the Wall Street Journal reported last June. “The Whitehouse Station, N.J., drug maker also noted that the U.S. Department of Justice has thus far declined to participate in the case after its own two-year probe.”
But the Justice Department’s new statement noted, “The Government’s decision not to intervene should not be interpreted as a comment on the merits of the plaintiff’s claims.”
“Moreover,” the statement said, “even if the Government initially declines to intervene in a [whistleblower’s suit], the government maintains a degree of control over the litigation and is allowed to intervene later by showing good cause.”
The Justice Department’s continued interest in the case sets up a possible face-off between government departments. The Food and Drug Administration approved the mumps-measles-rubella vaccine, the MMRII, and the Centers for Disease Control and Prevention recommends the vaccine and spends hundreds of millions of dollars to procure it for mass immunization. It is the only immunization for any of the three vaccines manufactured for use in the United States.
Those agencies may have an interest in the smooth functioning of the vaccine program, and no appetite for reviewing a drug the FDA approved and monitors and the CDC recommends. The Justice Department, however, is charged with preventing fraud and making sure the whistleblower statute enacted by Congress is enforced.
It’s plausible that the long period during which the Justice Department studied the allegations, followed by the decision not to intervene, followed by the new “statement of interest,” reflects tension among these entities that might need to be refereed at a high level of the Executive Branch.
Meanwhile, the National Institutes of Health, like the FDA and CDC part of the Department of Health and Human Services, appears to have tipped its hand over concern about the mumps vaccine. As we reported, just as the whistleblower suit was unsealed last year, health officials awarded almost $2 million to a research team at the University of Georgia.
The goal: Find a much better mumps vaccine, in a hurry. “The fact that outbreaks had occurred in populations with over 95% coverage of two-dose [mumps] vaccine strongly suggests that the current vaccine is not effective,” according to project information filed by Biao He, a researcher at the University of Georgia who received the $1.8 million grant.
We also noted that scattered mumps outbreaks this year – possibly underreported by the CDC – are reinforcing longstanding concern that Merck’s mumps vaccine is failing far more often than it should. The outbreaks appear to be following a three-to-four-year cycle in which a new cohort of immunologically susceptible persons is exposed but lacks full vaccine protection.
The current outbreak appears centered in college-age students. While mumps is generally benign when contracted in childhood, it can be much more serious when caught later. In males it can be excruciatingly painful and even lead to sterility.
If vaccine failures are involved in the current outbreak, that would undercut Merck’s statement that there is no safety issue involved with the alleged fraud.
Dan Olmsted is Editor and Mark Blaxill Editor at Large of Age of Autism. They are co-authors of The Age of Autism – Mercury, Medicine, and a Man-made Epidemic, published in 2010 by Thomas Dunne Books.