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“Protocol 007”: Merck Scientists Accuse Company of Mumps Vaccine Fraud that May Be Endangering Public Health Today

Merck-buildingAs mumps or "mumps like illness" is in the news, we're re-running this post from Dan Olmsted and Mark Blaxill from 2012. Here we are, 7 years later - 9 years after Krahling and Wlochowski originally launched the suit. Merck is more powerful than ever and vaccine mandates are racing across the nation like wildfires.

From June, 2012.

By Dan Olmsted and Mark Blaxill

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.”

The suit says testing began in 1999, led by Senior Investigator David Krah and his second-in-command, Mary Yagodich. Merck’s Executive Director of Vaccine Research, Alan Shaw, approved the testing methodology, the suit says. Krahling said he complained about the fraud to Emilio Emini, Vice President of Merck’s Vaccine Research Division, and brought “actual testing samples and plaque counting sheets to demonstrate to Emini the fraudulent data that Krah was directing. Emini agreed that Krah had falsified the data,” the suit said, but defended some aspects of the work.

“Emini promised to conduct an ‘internal audit’ of the mumps testing. … Emini ordered Krahling not to call the FDA. Immediately after the meeting [a Human Resources representative] approached Krahling and again threatened that he would be put in jail if he contacted the FDA.” Shortly thereafter, Krahling was transferred to another lab, and soon left the company; Wlochowski was also transferred and left the next year. (In 2005, Emini became Executive Vice President of Vaccine Research and Development at Wyeth Pharmaceuticals. He is now Senior Vice President and Chief Scientific Officer of Vaccine Research at Pfizer.)

The suit describes how Merck scientists allegedly engaged in a number of techniques in order to claim that the vaccine remained effective, from essentially testing the vaccine against itself – using the weakened vaccine virus rather than the more virulent “wild” type to which children are exposed in the real world -- to adding animal antibodies that increased potency in lab tests; to, when all else failed, simply changing the data accurately recorded by Krahling, Wlochowski, and other virologists.

While many of the details of the alleged fraud are technical, one internal Merck document clearly describes the nature of the mission, according to the suit. It was titled: “Objective: Identify a mumps neutralization assay format [testing procedure] that permits measurement of a greater than or equal to 95% seroconversion rate in MMRII vaccines.”

Merck responded Friday that the suit is “completely without merit” and said the company will “vigorously defend” itself – presumably by quickly filing a motion to have the suit dismissed. Merck pointedly noted that, to date, the U.S. Department of Justice has not joined the suit.

Under the federal whistleblower statute, anyone can bring a whistleblower suit alleging that a business they worked for defrauded the United States government and, by extension, taxpayers. Such a suit remains sealed while the company has a chance to review it, and Department of Justice (DOJ) attorneys decide whether to join as plaintiffs, throwing the government’s weight behind the whistleblower’s claim that it was defrauded.

In this case the DOJ did not reach its decision on whether to join as a plaintiff quickly or definitively. The lengthy period between the filing of the suit by Krah and Wlochowski, on April 27, 2010, and the department’s decision not to intervene for the time being, on April 27, 2012, required the DOJ to request multiple six-month extensions, according to the civil docket for the case, filed in the Eastern District of Pennsylvania. In its statement declining to intervene, the department asked that if either side wants to settle or dismiss the case, “the court solicit the written consent of the United States before ruling or granting its approval.”

The mumps component of the combination measles-mumps-rubella (MMR) vaccine has long been a source of controversy.  Merck was first to market in the category introducing a vaccine named MMR in 1971, using a strain of mumps taken from the throat of a Merck scientist’s daughter named “Jeryl Lynn.” (In 1979, Merck replaced the MMR’s rubella component due to safety concerns and named the reformulated vaccine MMRII). Starting in 1986, the first serious competitors to Merck’s vaccine began to emerge based on a different mumps component: the so-called Urabe strain, which was first licensed by Japan’s Biken Institute in 1979. Urabe-based vaccines were licensed in countries all over the world, including Canada, Japan, and the United Kingdom, to name just a few. For many years, however, Merck was able maintained its advantage in the category by outpacing the performance of Urabe-based MMR vaccines.

Merck’s main advantage came from its superior safety reputation. One of the most troublesome adverse events for MMR vaccines, aseptic meningitis, is a serious and potentially fatal side effect of vaccination. According to a major textbook on vaccines, “the Urabe strain has been linked with aseptic meningitis wherever adverse reactions have been studied.” By contrast, according to another review cited in the complaint, “aseptic meningitis, the Achilles heel of mumps vaccines, has never been documented to be caused by Jeryl Lynn.” In country after country, introduction of Urabe-based MMR vaccines have spawned outbreaks of aseptic meningitis and prompted withdrawal of the suspect MMR vaccine. In several of these cases, Merck’s MMRII has been the primary beneficiary.

Some researchers have argued, however, that the superior safety profile of MMRII comes at the expense of reduced efficacy. According to the authors above, “a mathematical model using the Urabe or Jeryl Lynn strains, suggested that … the greater apparent safety … associated with the Jeryl Lynn strain is offset by the potentially greater effectiveness associated with the Urabe strain.”

In light of these competitive threats to its highly successful MMRII franchise, it’s not surprising that asking Merck scientists to oversee testing of the efficacy of its own mumps vaccine would create a conflict of interest, not to mention an incentive to cheat on the test, if the underlying efficacy of the vaccine was weak.

The DOJ’s decision also points to another unavoidable but potentially troubling conflict of interest – the department is part of the same Executive Branch of government as the FDA and CDC. Under the Department of Health and Human Services, the FDA and CDC approve, recommend, and monitor vaccines, and they have repeatedly certified mumps-containing vaccines as effective. Allowing an alleged fraud to go on under their noses, involving a vaccine to which they are strongly committed, might not be something they would care to acknoweldge.

The fate of the lawsuit notwithstanding, serious new questions about children’s health are now in the public domain. It will be worth watching whether regulators or legislators here or abroad ask Merck for convincing, current evidence that the mumps vaccine is working as promised, and that the public's health remains protected.

--

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.

Comments

Patrick Hayden

Tests by an independent research center should be required for a goverment contract. Its to easy for a company to make falsified documents that includes billions. Childrens safety is first and foremost....corruption exists in the FDA and CDC time to clean house

Morag

A template of organisational behavioural tendencies apparent?
Merchantile "barra boys" would not see,would not listen ,did not act .
Vioxx was over Prescribed by Doctors in the UK / The BMJ
https/www.bmj.com/rapid response /2011/10 - 25 Nov 2004 .
Despite Warning Drug Giant Took Long Path To Vioxx Recall
https/www.nytimes.com -14 Nov 2004
Do they eat Marmite or not?
How do they stir their tea, clockwise or anti-clockwise?
Flavour mix up prevention strategy ! ma darlin ,please keep "Your Marmite " on a seperate shelf fom "Ma Bovril" in the kitchen cupboard !
Health and Safety Regulation continues to work without a full set of teacups and saucers in it's own teacups and saucers cupboards ? With too many lackeys and not enough high-tea place settings for them !
"The lackeys of lackeys always have been and always will be a hundred times worse than the servant of a servant!" Georgina Gunn MacDonald
High-Tea Menu -Not available -Factory Farmed Salmon and Trout or Humble Pie which never has been and never will be on the menu !

annie

OK, i'm not done....there is no greater example of America's RELIGIOUS devotion to the practice of vaccination than this. There is no question of this practice. It is nothing but pure, it is nothing but safe, it is nothing but absolutely necessary.

Piss off, you fascist pricks!

annie

When the education of children is contingent upon what is injected into them, and when what is injected into them garners profit, we have reached a fascist state. Nothing should ever jeopardize the education of a child.

Shelley Tzorfas

People are in an uproar in the US now because of the news uncovering a ring of wealthy people manipulating test scores to get their children into high end elite colleges and universities. Even bogus athletic enterprises were established in area like soccer and rowing. "Rowing, what's that some high school kids asked?" This hurt some high achieving high school kids who could not bribe entrance committees and their families as well as some non profit charities. Compare that to this case where a vaccine maker manipulates their own test results to-allegedly make it appear as if the MMR is still effective? This lawsuit based on possible fraud occurred nearly 10 years ago and instead of taking action for children's safety they have been part of a race to force more vaccines and take away parents ability to say no or intellectually consider the outcomes. Imagine if Tikata tested their own products for our government and declared that there is no such thing as a negative result despite people dying from the deployment of airbags? Don't worry about the potential cases of Meningitis as a result of an MMR vaccine. Don't worry because Vaccine Maker's have Meningitis shots now required for school and University students. See-One Vaccine Solves Another Vaccine!

annie

Justice denied.

Benedetta

7 years later

The insight of Dan and Mark

Bob Moffit

The SWAMP is expert at eliminating "Whistleblowers" ... to the point of making them magically disappear. It has become increasingly impossible to pursue justice when the entire justice process is corrupt .. from the corporations themselves, entire industries, federal regulatory agencies, courts, politicians, media, academia, public health careerist bureaucrats, on and on.

How many times have whistleblowers "disappeared' without ANY investigation .. let alone prosecution .. for the CRIMINAL ALLEGATIONS THESE WHISTLEBLOWERS HAVE HAD THE COURAGE TO COME FORWARD .. THEREBY RISKING THEIR PROFESSIONAL REPUTATIONS AND CAREERS?

It has been SEVEN YEARS AND COUNTING since Merck's whistleblowers came forth .. a little less since Dr Thompson exposed the CRIMES committed by the highest levels of the CDC regarding the significant increased risk of autism to minority children .. and … NOTHING HAS BEEN RESOLVED.

How do these SWAMP creatures sleep at night?

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