Protocol 007: Feds Urge Judge Not to Dismiss Mumps Vaccine Suit
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.
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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.
Late August (Tuesday, August 20, 2013) Hilary Butler did write on the case : http://www.beyondconformity.co.nz/hilarys-desk/mercks-illegal-mmr-smokescreen-continues
Posted by: Fièvre | September 11, 2013 at 11:30 AM
Dan, would it be possible to read the Justice Department's news release on its own website ( I can't find it)?
Posted by: Fièvre | June 09, 2013 at 01:00 PM
I'll be curious to see whether the "new" mumps vaccine is merely a stand-alone booster version of what's in MMRII, or if it will be reformulated to be free of human DNA and other adventitious contaminants. It seems like a convenient opportunity to slyly make needed changes without ever having to openly address the last 20 years of FDA's appalling lack of safety oversight of the current schedule. Thank God for whistleblowers, and let's hope that this incident underscores the need for INDEPENDENT POST-LICENSURE MONITORING of long-term vaccine safety and efficacy, free from manufacturer interference.
Posted by: Garbo | June 07, 2013 at 02:08 PM
The package insert from Merck’s website at http://www.merck.com/product/usa/pi_circulars/a/afluria/afluria_pi.pdf states that “The multi-dose [flu vaccine] presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.”
But 24.5 micrograms is the same weight of mercury as a half cup of D009 hazardous waste mercury. And if this is not injected into the bodies of children and pregnant women it must be sent to an approved hazardous waste disposal facility because it is classified as too toxic to flush down the toilet or place into municipal trash.
And look at this quote from the 6-24-11 interview with Julie Gerberding at http://www.xconomy.com/national/2011/06/24/mercks-julie-gerberding-former-cdc-director-on-the-future-of-vaccines/
“The old model would say ‘we just need to give people better information. If they have the facts, they’ll make the right choice.’ The new model is that it’s not a left-brain decision for many parents—this is a right-brain, heartfelt decision.”
Thus Julie presents us with a newspeak version of informed consent—that is to say no informed consent.
This is the nonsense that George Orwell warned us about.
Posted by: Jim Thompson | June 07, 2013 at 06:08 AM
These scientists that worked at Merck are now blowing the whistle by alleging scientific fraud at Merck and witnessing the changing of “test results that showed the mumps vaccine wasn’t working.”
So look at how Julie Gerberding said the integrity of science at Merck “is as strong as it was when I was working for the CDC.
“... At Merck (NYSE: MRK), she has been learning the ins and outs of a $5-billion-a-year operation that makes 14 of the 17 vaccines the CDC recommends for children, and nine of the 10 recommended for adults…
X [Timmerman]: What’s life been like for you in industry?
JG [Julie Gerberding]: I love it. The biggest surprise for me is working in a company where the passion and the commitment to science and integrity of science is as strong as it was when I was working for the CDC.”
See Luke Timmerman, “Merck’s Julie Gerberding, Former CDC Director, on the Future of Vaccines,” 6-24-11 at http://www.xconomy.com/national/2011/06/24/mercks-julie-gerberding-former-cdc-director-on-the-future-of-vaccines/
Posted by: Jim Thompson | June 07, 2013 at 05:39 AM
Extract:-
Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2)
"Main results
We included five randomised controlled trials (RCTs), one controlled clinical trial (CCT), 27 cohort studies, 17 case-control studies, five time-series trials, one case cross-over trial, two ecological studies, six self controlled case series studies involving in all about 14,700,000 children and assessing effectiveness and safety of MMR vaccine. Based on the available evidence, one MMR vaccine dose is at least 95% effective in preventing clinical measles and 92% effective in preventing secondary cases among household contacts.
Effectiveness of at least one dose of MMR in preventing clinical mumps in children is estimated to be between 69% and 81% for the vaccine prepared with Jeryl Lynn mumps strain and between 70% and 75% for the vaccine containing the Urabe strain. Vaccination with MMR containing the Urabe strain has demonstrated to be 73% effective in preventing secondary mumps cases.
Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children and adolescents was estimated to be between 64% to 66% for one dose and 83% to 88% for two vaccine doses. We did not identify any studies assessing the effectiveness of MMR in preventing rubella."
This review was written in 2011, AFTER the GMC guilty verdicts on Dr Wakefield and his two clinician colleagues, and BEFORE Professor Walker-Smith's High Court exoneration.
The reported Jeryl Lynn mumps vaccine efficacy is a disgrace,(64% to 66% for one dose and 83% to 88% for two vaccine doses). It seems NOTHING was done by the WHO and individual world governments, to warn parents about the poor immunisation efficacy of the Jeryl Lynn Mumps MMR component, and this Cochrane review was published more than 2 years ago. This is a disgrace!!
Posted by: Jenny Allan | June 07, 2013 at 02:57 AM
I have just transcribed an extract from a UK Joint Committee on Vaccination and Immunisation report from the Secretariat (David Salisbury), dated 1 November 1991:
"Clearly, despite far less Jeryl Lynn containing vaccine having been used, this product is less reactogenic. With an alternative vaccine available it is reasonable to question the continues use of the Urabe strain vaccines. Yet the Jeryl Lynn vaccine is not without problems. It has been poorly promoted by the manufacturer and has been unpopular on the grounds of causing pain at the injection site. Furthermore, the restrictions on the vaccines' "time out of the fridge" has limited its distribution, despite manufacturers having evidence of its long term stability at ambient temperatures. It does appear, however, that there are ground to believe that Urabe vaccines are more immunogenic. When the evidence from the literature which compares immunogenicity of the two vaccine types is combined, there is a tendency, which is not significant, that confirms the increased immunogenicty of Urabe strains. This is borne out by recently available information from Sweden that shows very poor mumps sero-conversion, of the order of 70%, using the Jeryl Lynn strain. If this of importance, if mumps elimination can be achieved with a less immunogenic but less reactogenic vaccine, there will be larger numbers of non-immune vaccinated individuals. The susceptible cohort size would increase and should virus circulation be reduced not eliminated, or importation of mumps virus occur in the future, the susceptible population, amongst who epidemics could occur, would be older and liable to the more serious sequelae of mumps infection..."
Presumably "not significant" should read "not insignificant", but of course it was always known that introducing mumps vaccine would increase the risk to the population from the disease, even among promoters of vaccine dogma, and they were struggling with consequences only three years after MMR was introduced in the UK.
Posted by: John Stone | June 06, 2013 at 06:49 PM
Oh, boy -- another rushed vaccine for the masses.
Is that better than a fraudulently tested vaccine?
Posted by: nhokkanen | June 06, 2013 at 04:44 PM
Are they holding up the mandated U.S. MMR market to the highest bidder? As this administration has, it's being said, gone after more whistle-blowers than any in history, this position is perhaps as endorsed as things get for a whistle-blower today?
But individuals, daily, are taking the risk of this vaccine likely without mumps protection and this drags out getting the truth (though I assume we mostly have it) to the public. I hope the NVICP does not shield manufacturers for efficacy issues as well.
Though IMO, the whole recommendation of mumps vaccine in infancy, then kindergarten, and then essentially needed ever after is the first irresponsible act.
Posted by: Jeannette Bishop | June 06, 2013 at 02:43 PM
Just to canibalise a comment that I made under one of Andy's broadcasts a month ago:
Of course, it was also an issue with the abandoned Urabe version over Jeryl Lynn that it was thought to be more immunogenic as well as unfortunately being more reactive (Tomljenovic p.8)
http://www.ecomed.org.uk/wp-content/uploads/2011/09/3-tomljenovic.pdf
Which may further show how inherently problematic vaccinating against mumps is. The Tomljenovic paper mentions that Elizabeth Miller's lab was supposed to be investigating this issue while a decision was being made about the future of the Urabe vaccine, though I can't find what conclusion was reached if any.
And, of course, it is actually harmful if mumps vaccine only postpones mumps to an age when it is more hazardous, and using a weaker strain made this even more likely.
Posted by: John Stone | June 06, 2013 at 02:42 PM
The whistleblowers "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."
The conduct described in this statement is evidence of a corporate CRIMINAL CONSPIRACY .. and .. is unrelated to whether or not the Mumps vaccine works or not.
"The Justice Department, however, is charged with preventing fraud and making sure the whistleblower statute enacted by Congress is enforced."
The question whether or not Merck "lied" about the efficiency of the mumps vaccine is only one part of this travesty .. the other part is the Justice Department deliberately ignoring evidence that Merck personnel "lied" to federal regulators.
What kind of federal regulation do we have in the US if corporate personnel can "lie to federal regulators" (FDA, EPA, SEC, IRA, etc) without penalty?
Posted by: Bob Moffitt | June 06, 2013 at 02:25 PM
Big trouble that would make the MMR a fraud also ...as we have all said all along ..vaccines don't work...
MMR RIP
Posted by: IAngus Files | June 06, 2013 at 11:45 AM
To support families of vaccine-injured children and demand accountability for those being responsible for the tragedies, please visit the link below right now and sign the petition to ‘Lift the ban shielding drug companies from lawsuits for vaccine-related injuries or deaths.’
http://www.thepetitionsite.com/383/907/145/lift-the-ban-shielding-drug-companies-from-lawsuits-for-vaccine-related-injuries-or-deaths/
Posted by: White Rose | June 06, 2013 at 10:16 AM
I'm watching this one closely. I hate that they've taken choices away from parents to vaccinate for single illnesses. I was just reading about chicken pox and how shingles has risen since the introduction of that vaccine. It seems like I hear of a shingles case all the time now- even in young. We have messed with nature too much- maybe getting some of these illnesses younger really is better.
Posted by: Jen | June 06, 2013 at 10:12 AM
Not sure what is going on here?
Nader coined he word whistleblower back in the 70s and in 1986 the law was modernized - cobwebs brushed off from back in the Civil War Days.
Boy; if anyone had any real power back then that would be the year to program the DeLorean to go back to.
Same year Congress decided to protect the Vaccine Manufacturers and set up laws to protect them - calling it the silly name: the Vaccine Injury Compensation Court.
Same year - I watched my son react to two vaccine twice, and my daughter react to her's.
What a year.
So according to law - see if I have this right?
The Justice Department is to make sure that whistle blower cases - are not dismissed?
Well what happens if they are?
It seems that when it comes to vaccines there is a constant clash with laws that have been set up - and the laws have continued to yield.
Posted by: Benedetta | June 06, 2013 at 09:12 AM
Vaccines ....rotten to the very core !
Vaccines = Muck = Merck
Posted by: White Rose | June 06, 2013 at 07:37 AM