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

By Hilary Butler, Contributing Author from New Zealand

On April 27, 2012, a formal complaint was filed in the Eastern Pennsylvania Federal 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[1] 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^[2] 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, in order 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.

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,[3] 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 animal antibodies to human blood samples taken both pre and post vaccination[4].

By combining the very low levels of human antibodies with animal antibodies, 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 Drs Krahling and Wlochowski attempted to stop what they saw as, “wholesale fabrication of test data to reach its preordained 95% efficacy threshold,” Merck allegedly made various attempts to prevent them, including threatening to jail Dr. Krahling should he inform the FDA.

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

An FDA agent then came and interviewed Dr. Krah, who apparently told the agent whatever was necessary to allay their concerns. The agent made no attempt[5] 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[6] in 2001, yet Merck allegedly ‘willfully’ withheld this information from multiple governments[7] while consistently claiming there was no need for a new mumps component.^[8]

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

Has Merck turned over a new leaf since the recent Vioxx Scandal? Do they still put profit before people? Read the complaint, follow the court case, examine the evidence, and decide for yourself.