Protocol 007: Merck Denies Fraud, But Feds Seek New Mumps Vaccine as Cases Spread
Posted May 01 2013 12:00am
By Dan Olmsted and Mark Blaxill
Scattered mumps outbreaks – possibly underreported by the CDC – are reinforcing longstanding concern that Merck’s mumps vaccine is failing far more often than it should.
The outbreaks come as Merck defends itself in federal court against a whistleblower lawsuit filed last year claiming it faked data to mask the low efficacy of the mumps component of its MMRII vaccine. Within the company, according to the suit, the effort was known as Protocol 007.
In a filing earlier this year, Merck denied wrongdoing and said it stands by its claim that the vaccine is 96 percent effective. It asked the judge to dismiss the claim and pointedly noted that U.S. Justice Department officials have so far not joined on the whistleblower's behalf -- a move that often spells the difference in court.
But the government seems anxious despite Merck’s reassurances – just as the whistleblower suit was unsealed, Age of Autism has learned, 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.
According to a recent filing by the whistleblowers: "The government has not joined in Merck's current motion [to dismiss the case] and has made no decision on the current Complaint. Instead, it has taken a 'wait and see' approach requesting that it be served with all pleadings, motions and court orders in this case,
and that its consent be obtained before the case is settled, dismissed or discontinued.
"While the Department of Justice has chosen to sit on the sidelines of this case for
now, both the FDA and its sister agency, the National Institute of Health, have since the complaint was filed begun to take steps to address the failure of Merck's mumps vaccine. The
FDA has initiated its own study to determine the vaccine's efficacy, acknowledging that the
recent mumps outbreak 'indicat[es] lower vaccine efficacy than previously estimated.' The
NIH has gone even further. It is funding the University of Georgia to develop a new mumps
vaccine because the recent outbreaks 'strongly suggest that the current vaccine is not
Merck continues to state that its mumps vaccine is highly effective, as shown in this ad filed with the court by the whistleblowers; it claims 96 percent efficacy for the mumps portion of the MMRII -- in other words, 96 out of 100 people who get the shot are protected from the mumps virus:
Merck could face billions in punitive damages or even lose its license to manufacture the vaccine if it were convicted of defrauding the government, which has spent hundreds of millions of dollars to buy the MMR II for mass vaccination campaigns. At the very least, a new MMR vaccine based on a different mumps component would cut into the market share of Merck's MMRII. The shot is a mainstay of the recommended childhood vaccination schedule -- and of company profits.
Also at risk is the health of anyone who comes down with mumps at a later age than the disease usually occurs in childhood. When contracted early it is usually benign, but caught later it can be far more serious. In males it can be excruciatingly painful and even lead to sterility.
As we predicted a year ago based on the three-to-four year cycle of infection, recent mumps outbreaks have occurred in several states, notably Massachusetts, Maryland, and Virginia. The cycle was identified by scientist Gustavo Dayan, who wrote in 2008, “In the pre-vaccine era, mumps activity followed three year cycles, so the current low activity rate may be transient while another critical mass of susceptible persons accrues.”
A table from the May 3 Morbidity and Mortality Weekly Report, the CDC’s notifiable diseases tracking publication, clearly shows a spike in mumps cases in Virginia and Maryland, but contains no confirmed case reports at all from the Massachusetts cluster that was just reported at Boston College. We know they are missing a case in the Midwest.
Overall, the numbers are up by more than 60 percent so far in 2013, a figure consistent with a spike but not a major epidemic. The situation in the South Atlantic region shows a bigger discontinuity, with more than 80 cases reported this year, tenfold the number for all of 2012.
WTOP in Washington reported May 3: “The college years seem to be a prime time for coming down with the mumps. This spring, outbreaks of mumps have been reported at three universities in Virginia: the University of Richmond, Virginia Commonwealth University and James Madison University. Cases have also been reported at Loyola University in Baltimore.
“'The outbreaks at area college campuses are part of a national pattern,’ says Dr. David Hyun, an infectious disease specialist at Children's National Medical Center. 'The outbreaks that we have seen in the past few years tend to come from college students,' he says, adding the prime age for mumps now seems to be 15 to 24.
“No one is exactly sure why. But Hyun says the mumps vaccine could be losing its effectiveness over time.”
That, of course, is consistent with the claims in the whistleblower suit, which was unsealed in U.S. District Court in Philadelphia last June. 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. Project 007 was 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 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. 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 more than $10 billion in business since 2000. The complaint conservatively estimates MMRII purchases by the Centers for Disease Control and Prevention at $750 million.
We noted that 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.
That three-year cycle could be repeating itself, judging from the recent reports in Virginia, Maryland, and Massachusetts. Despite the fact the CDC surveillance data is not showing large numbers, one possibility is the surveillance is actually missing a surge in mumps cases, many of which are not reported to health authorities.
The CDC acknowledges the difficulty of confirming mumps outbreaks in heavily vaccinated populations, stating that "persons with a history of mumps vaccination may not have detectable mumps ... antibody." (An Age of Autism reader who was vaccinated during childhood with MMRII, two weeks after spending time in one of the cluster areas reported to us the characteristic symptoms of mumps. By then, thousands of miles away from the cluster, this reader simply chose to stay at home sick and did not report the condition, seek testing or medical treatment.)
The whistleblower case is now subject to the usual blizzard of motions in federal court, with Merck demanding that the case be dismissed. The Justice Department has so far not joined the lawsuit on the whistleblower’s behalf, but that remains a possibility.
Merck has filed a motion to have the case dismissed; the whistleblowers, called "relators" in the suit, responded with a document explaining what they believe is at stake:
"This case involves Merck's efforts to conceal from the government and the public that
Merck's forty-five year old mumps vaccine no longer provides adequate immunization. Relators
know this because they were virologists in the Merck lab at the center of this fraudulent
campaign. They were even pressured by their superiors to participate in the scheme, which
included, among other things, falsifying test data; destroying evidence; lying to the FDA; and
most importantly, continuously hiding from the government and the public over the course of a
decade -- including through two unprecedented mumps outbreaks -- the significantly diminished
efficacy of the vaccine.
"Relators know this not only because of their eyewitness account of the activity. They
also know it because the Merck executives that led the campaign admitted it to them. They
admitted that Merck's vaccine had significantly degraded through Merck's repeated passaging of
it for what is now approaching five decades, to make more and more vaccine for the millions of
children that take it every year. They admitted that this degradation would eventually lead to the
reemergence of mumps outbreaks, which it has. Worst of all, they admitted that Merck engaged
in this fraud and deception as a 'business decision' necessary to ensure that Merck maintained its
exclusive license to sell the vaccine in the U.S. "
Shortly after the suit was filed, the government seemed to focus on the vaccine's effectiveness, as reflected in the $1.8 million grant to the University of Georgia, announced just days before the lawsuit was unsealed “Mumps may seem like a disease of a bygone era to many people in the U.S. who, thanks to immunization programs, have been spared the fever, aches and characteristic swollen jawline of the once common viral infection,” according to the university news agency.
“Biao He, a University professor of infectious diseases and a Georgia Research Alliance distinguished investigator in the College of Veterinary Medicine, worries that a new strain of the virus is spreading, and it could lead to the widespread reintroduction of mumps.
“Now, thanks in part to a $1.8 million grant from the National Institutes of Health, He and his team are working on a new vaccine to stop it.” -- Dan Olmsted is Editor and Mark Blaxill is Editor at Large of AgeOfAutism.com. They are co-authors of The Age of Autism – Mercury, Medicine, and a Man-made Epidemic, published in 2010 by Thomas Dunne Books.