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Hilary's Desk

Former Merck Scientists File Suit Against Merck Under the False Claims Act

Hilary Butler - Saturday, June 23, 2012

On April 27, 2012, a formal complaint was filed in the Eastern Pennsylvania District Court accusing Merck of a longstanding scheme to mislead and defraud Government health authorities worldwide. Two of Merck’s former employees have accused the pharmaceutical giant of marketing multivalent MMR vaccines under false pretenses. According to the complaint, these vaccines have been mislabeled, misbranded, adulterated and falsely certified as having a 95% efficacy rate.

Before the lawsuit was filed, 21 doctors added their voices to other groups of doctors who are calling for MMR vaccines to be used as a regular booster every 4 – 8 years, in order to control mumps outbreaks. These doctors all assume that the mumps component of all MMR vaccines have the 95 – 98% efficacy promised by Merck.


However, the court documents filed by two Merck virologists meticulously detail how Merck ostensibly manipulated test results for decades in order to create a false 95% efficacy rate for the mumps component of their multivalent MMR vaccines.

The former Merck virologists contend that the multivalent mumps component has a vastly reduced efficacy which is directly responsible for mumps outbreaks during the last decade which prompted international calls for MMR booster shots every 4 – 8 years.

Virologists Stephen Krahling and Joan Wlochowski describe how Merck had to recertify the mumps component in 2000, to comply with regulatory requirements in order for the mumps component to be included in two new multivalent MMR vaccines. The usual test, which had certified the mumps component’s efficacy in the 60’s, failed when used in 2000. They claim the results were so low Merck decided to change its own test protocol by testing the vaccine against the weakened mumps vaccine virus instead of the wild (naturally circulating) mumps virus which they used in the past.

When that modification didn’t result in the desired 95% efficacy figure, Merck’s executive directors of vaccine research, Drs Alan Shaw and Emilio Emini, instructed Drs David Krah and Mary Yagodich to implement a vast array of modifications to testing procedures, then, allegedly pressured both Krahling and Wlochowski to participate.

When these modifications also failed to demonstrate the desired 95% efficacy rate, it is alleged that Drs Shaw and Emini, instructed Drs Krah and Yagovich to abandon “gold standard” testing, and implement a new procedure, supposedly with the agreement of FDA, which included adding rabbit antibodies to human blood samples, taken both pre and post vaccination.(The rabbit antibodies were more fully discussed in the first court documents dated August 2010.)

By combining the very low levels of human antibodies with animal antibodies in test samples, a much higher total level of virus neutralization was obtained than could occur from human antibodies alone. The human antibody levels alone would never protect in the real world against wild mumps. But after adding animal antibodies, the human blood samples which had previously failed under the old “gold standard” testing were retested using the “enhanced” protocols and passed with flying colors. New ‘enhanced’ tests showed 100% efficacy, not against wild mumps virus, but against the mumps vaccine virus.

However, combining the animal and human antibodies led to a new problem. In some of the tests more than 80% of pre-vaccine blood samples now showed up as immune. Usually, the highest number of pre-vaccine immune results any scientist could expect is 10%. Further manipulations of the animal antibody levels failed to bring the pre-vaccine blood test results down to the expected 10% levels. According to the complaint, Merck then implemented additional ‘creative’ strategies to show a lack of seroconversion in immune samples in an attempt to reduce the pre-vax level to the expected 10% because had the FDA seen the high numbers of “immune” pre-vaccine samples they would have easily detected the fraudulent test procedures.

Krahling and Wlochowski worked with the same team conducting these tests, but were outraged at what they deemed to be gross scientific deception and fraudulent practices.

When Krahling and Wlochowski attempted to stop what they saw as, “wholesale fabrication of test data to reach its preordained 95% efficacy threshold,” Merck made various attempts to prevent them, including threatening to jail Krahling should he inform the FDA.

Despite these efforts, Krahling made numerous calls to FDA. These calls remained unanswered until Krahling reported to the FDA that Dr. Krah had removed and/or destroyed Krahling’s evidence.

An FDA agent then came and interviewed Dr. Krah, who apparently told the agent whatever was necessary to allay their concerns, a conversation which Krahling heard. The agent made no attempt to interview any other personnel, check any facilities, laboratory notebooks, or samples to corroborate what had been reported to them.

The lawsuit claims that to this day, Merck has consistently misrepresented the potency by simply quoting the 40 year old data from the pre-MMR monovalent mumps vaccine, thereby misrepresenting the efficacy of four multivalent vaccines: MMR, MMRII, Europe’s MMRvaxpro, and ProQuad, which is MMR plus chickenpox.

According to the two whistleblowers, not only have all the multivalent MMR vaccines been sold under false pretenses, but, as a result of this LACK OF EFFICACY, there have been numerous mumps outbreaks worldwide prompting calls for regular MMR boosters throughout life.

These mumps outbreaks were predicted by Merck’s Dr Krah in 2001, yet Merck allegedly ‘willfully’ withheld this information from multiple governments while consistently claiming there was no need for a new mumps component.

Several questions need to be asked:

 

“If the mumps component is actually 95% effective, as stated, would experts be calling for lifelong boosters every 4 – 8 years?”

Answer:  That puzzles me because scientists have known, since 2000, that the mumps vaccine is far less effective than 95%.  Harling 05 from the UK stated that blood samples taking during an outbreak in 1998/1999 gave the MMR vaccine a mumps efficacy of 69%.

Vyse 06 had this mumps vaccine efficacy graph in their study:

Light gray above, is decent immunity.  So that equates to about 67% efficacy. One reason that Merck knew they could get away with a low efficacy is that mumps disease is much less infectious than measles (Barsky 09) and a very high rate of subclinical infections, and therefore outbreaks are far more unlikely than if measles vaccines had a similarly low efficacy.

Dayan 08 reported a mumps resurgence, at a time when he was working with CDC. Dayan questioned whether a more effective vaccine was needed. 

Of note, is that Dayan was headhunted by Sanofi Pasteur not long after that. Any further research on this by Dayan is unlikely, because Sanofi Pasteur is partnered with Merck in the manufacture of MMRvaxpro, which contains the same defective mumps vaccine component.

Dr Julie Gerberding was head of CDC at the same time as Dayan, and stated: "We have absolutely no information to suggest that there is any problem with the [mumps] vaccine." (Page 29)

After her steadfast loyalty to Merck's mumps vaccine, and fast-tracking Merck's Gardasil vaccine, Dr Gerberding accepted the position of Head of Merck's Vaccine Division, when her tenure at the CDC was curtailed.

Merck states 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 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."

Presumably Merck will defend themselves publicly in a trial, rather than try to bury their alleged sins under a "motion to dismiss" the case, to stop the public watching Merck defend themselves under cross examination.

However, Merck's comment that nothing in the case speaks to the issue of the mumps vaccine safety is not correct. 

After all, the vaccine suposedly worked way back in the 1960s when it was first released.

What changed? According to Krah, the virus mutated every year with repeated passages. If the testing done in the 1960s no longer accurately characterizes the vaccine's efficacy because of the virus' mutation, how can Merck then say those same tests show that the current vaccine, made with a different vaccine virus, is safe?

If the vaccine virus is different today, shouldn't that mandate new safety tests today?

Merck cites the fact that the US Department of Justice has so far declined to participate, as if that adds validity to its claim that the vaccine is okay, and the case has no merit.  But the USA government is a huge entity that encompasses lots of different agencies.

It is more accurate to say the Department of Justice didn't join the case. Why?

The whistleblowers have lawyers who are pressing the case.  Those lawyers have the whistleblowers for a client.

Why didn't the D of J, join with the whistleblowers? 

Well, who are is the Department of Justice's clients?

Two of them would be the FDA and the CDC.

This case goes way deeper than Merck's fraudulent tests. 

It also extends to people in the FDA who allegedly authorised and approved those tests in the first place, and staff in the CDC who defended a vaccine, when they already had scientific indictors which showed there were problems with the Mumps vaccine.

There is no way those people could join with the whistleblowers, because to do so would mean they would have to account for their inaction, or actions, whichever way you look at it.

Dr Gerberding would also hold the uncomfortable position of being on both sides of the fence if D of J joined the suit.  A house divided against itself cannot stand.

Merck can't claim that the D of J not joining the case, means that the case isn't valid, therefore is some sort of pious victory for Merck. 

The Department of Justice declining to join the whistleblowers case, could also be seen as a silent acknowledgement that they know that to do so would bring a group of their own, right into the whisteblower's firing line.

Therefore, to the Department of Justice, not joining the case... and expedient silence about why... is golden.  Or yellow.

 

 

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