This is a legal filing by former Merck virologists who claim they were pressured by Merck management to participate in fraud by falsifying Merck’s mumps vaccine efficacy rate in clinical trials. This filing claims that the mumps vaccine efficacy rate is significantly lower than the 95% that Merck has misrepresented to the government and the public. The mumps vaccine is a component of MMR. – The Refusers

Free-Market Analysis: With the Supreme Court’s decision to validate major parts of “Obamacare,” the paradigm of Western medicine is more firmly enshrined than ever, and thus the behavior of its component parts is even more important.

What has happened under the current system is that certain drugs are enshrined as “approved” medical treatments and assigned various prices the government will pay. But what if the drugs themselves are not actually efficacious or have considerable side effects?

Many pharmaceutical drugs actually may have side effects and certainly in the case of pharmaceutical giant Merck there are major questions as to the viability of some of the drugs it markets and the conditions under which regulatory conclusions were delivered.

Now Merck is reportedly involved in another tranche of litigation – aimed at the company’s falsifying of vaccine data. It seems to be a significant lawsuit and may be worse than the last big case that involved Merck’s horrible drug Vioxx.

Former Merck virologists filed this lawsuit, recently unsealed, claiming they had basically been forced to participate in fraud by falsifying Merck’s mumps vaccine efficacy rate in clinical trials.

Commentary on the filing was posted at The Refusers website, along with the entire filing itself. The post notes that the mumps vaccine efficacy rate is “significantly lower than the 95% that Merck has misrepresented to the government and the public.” Merck denies the charges.

What this may portend, were the charges to be found true, is that the vaccine’s efficacy may fall below the threshold at which herd immunity is produced. This would lead to one of two possible conclusions: Either more children are at risk for mumps given the potential ineffectiveness of the vaccine, or vaccines such as this one don’t make a substantial difference, anway.

The Vioxx promotion was especially horrible. While Merck executives managed to escape being personally accountable, there is little doubt that the flawed and deadly nature of the drug was known in advance of its public presentation. Here’s an “AllGov” summary of the Vioxx troubles and subsequent litigation:

Despite knowing that Vioxx was potentially lethal, Merck put it on the market in 1999. Although a Food and Drug Administration study showed that perhaps 55,000 Americans died from heart attacks and strokes after using Vioxx, other sources indicated that upwards of 500,000 people—almost all of them older adults—may have died from the drug, which produced lawsuit after lawsuit against Merck. The company wound up settling for $4.85 billion …

Lawyer Peter Gordon, called the decision “a victory for justice,” and added that Merck displayed absolute contempt for Australians when the drugmaker failed to include them in a US settlement. Merck … made no admission of guilt and was also criticized in the UK.

The issues are, of course, much bigger than any one case. Thanks to increasing availability of electronic information, what we call the Internet Reformation, more and more people are skeptical about pharmaceutical drugs in general. In the meantime, homeopathy, acupuncture and naturopathy are making inroads. The idea that one can treat a disease by disguising or attacking the symptoms is being increasingly questioned.

The vaccine issue is especially important. We’ve written numerous articles on the issue as we began to discover that at least for some, there seemed to be manifold side-effects as regards vaccines. Just Google “Dr. Andrew Wakefield” and “Daily Bell” for more on the issue.

It turns out that vaccines, at least in the past, may not have been fully vetted for efficacy for ethical reasons, supposedly. Meanwhile, there is a significant and evolving ‘Net-based literature on problems that people have undergone from receiving vaccines, especially children.

Dr. Wakefield was pilloried for making an indirect linkage between vaccines and austism, (and ultimately lost his medical ilcense) but there certainly seems to be evidence along these lines no matter how Big Pharma attempts to conceal it.

What is clear to anyone who studies the issue with an open mind is that Big Pharma is an exceptionally important element of the power elite’s world-spanning agenda. Pharmaceutical medicines are defended aggressively no matter how many problems they cause. The elites are surely determined to control every life-supporting resource, food, water, energy, etc. Medicines are an important part of the strategy.

It must be what we call a power elite dominant social theme, the idea that only pharmaceutical mediciines can effectively confront modern sicknesses. In fact, the whole concept of developing synthetic cures from natural sources such as the Amazon jungle is likely flawed.

When one creates synthetic substances to take the place of natural ones, trouble is surely in the offing. It is done because natural plants are not patentable. Thus the difficulties of the pharmaceutical industry are introduced by the necessity of making the sector, in aggregate, a going concern.

Because so many hundreds of billions – trillions of dollars – are at stake, the industry aggressively defends itself and has a history of threatening whistleblowers and others who would confront unethical practices. Yet from what we can tell, potential falsification of results of drugs that do not provide the requisite results may be a kind of business-as-usual.

Merck, as one of the biggest pharma conglomerates, is also one of the most aggressive. Another Big Pharma entity, Roche, has been investigated fairly recently for by the European Medicines Agency for ignoring 80,000 adverse reactions, including 15,161 deaths.

Conclusion: Nationalizing health care, as Obamacare does, will not change the fundamental realities of Western medicine – realities that are increasingly disturbing.

Below is language from the introduction of the lawsuit filed filed April 27, 2012 at the US District Court for the Eastern District of Pennsylvania.

Introduction …

1. This case is about Merck’s efforts for more than a decade to defraud the United States through Merck’s ongoing scheme to sell the government a mumps vaccine that is mislabeled, misbranded, adulterated and falsely certified as having an efficacy rate that is significantly higher than it actually is.

2. Specifically, in an effort to maintain its exclusive license to sell the vaccine and its monopoly of the U.S. market for mumps vaccine, Merck has fraudulently represented and continues to falsely represent in its labeling and elsewhere that its mumps vaccine has an efficacy rate of 95 percent or higher. This is the efficacy rate on which Merck’s original government approval for the vaccine was based more than forty years ago, In truth, Merck knows and has taken affirmative steps to conceal – such as by using improper testing techniques, falsifying test data in a clinical trial, and violating multiple duties of government disclosure – that the efficacy rate of Merck’s mumps vaccine is, and has been since at least 1999. significantly lower than this 95 percent rate.

3. Relators Krahling and Wlochowski were employed as virologists in the Merck lab that performed this fraudulent efficacy testing. They witnessed firsthand the improper testing and data falsification in which Merck engaged to conceal what Merck knew about the vaccine’s diminished efficacy. In fact, their Merck superiors and senior management pressured them to participate in the fraud and subsequent coverup when Relators objected to and tried to stop it.

4. As, a result of Merck’s fraudulent scheme, the United States has over the last decade paid Merck hundreds of millions of dollars for a vaccine that does not provide the efficacy Merck claims it provides and does not provide the public with adequate immunization. Had Merck complied with its multiple duties of disclosure and reported what it knew of the vaccine’s diminished efficacy – rather than engage in fraud and concealment — that information would have affected (or surely had the potential to affect, which is all the law requires) the government’s decision to purchase the vaccine. However, since the government was not fully informed, it did not have the opportunity to consider its options, including not purchasing the vaccine from Merck, paying less, requiring a labeling change, requiring additional testing, or prioritizing development and approval of a new vaccine from Merck or another manufacturer.

5, Merck’s failure to disclose what it knew about the diminished efficacy of its mumps vaccine has caused the government to purchase mislabeled, misbranded, adulterated and falsely certified vaccines in violation of Merck’s contract with the Centers for Disease Control(“CDC’”) and in violation of the law.

6. As the single largest purchaser of childhood vaccines {accounting for more than 50 percent of all vaccine purchases}, the United States is by far the largest financial victim of Merck’s fraud. But the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection against mumps. And while this is a disease the CDC targeted to eradicate by now, the failure in Merck’s vaccine has allowed this disease to linger with significant outbreaks continuing to occur.

7. Relators bring this case on behalf of the United States to recover the funds that the government spent for this fraudulently mislabeled, misbranded, adulterated and falsely certified vaccine, and for all associated penalties. They also bring this case to stop Merck from continuing with its scheme to misrepresent the true efficacy of its mumps vaccine and require Merck to comply with its reporting, labeling and testing obligations under its contract with the CDC and under this country’s vaccine regulatory regime.

PARTIES

8. Relator Stephen A. Krahling is a citizen of the United States and a resident of Pennsylvania. He was employed by Merck from 1999 to 2001 as a virologist in Merck’s vaccine division located in West Point, Pennsylvania. During his employment at Merck, Krahling witnessed firsthand, and was asked to directly participate in, fraud in a clinical trial relating to the efficacy of Merck’s mumps vaccine.

9, Relator Joan Wlochowski is a citizen of the United States and a resident of Connecticut. She was employed by Merck from January 2001 to August 2002 as a virologist in Merck’s vaccine division in West Point, Pennsylvania. During her employment there, Wlochowski also witnessed firsthand, and was asked to directly participate in, fraud in a clinical trial relating to the efficacy of Merck’s mumps vaccine.

10, Defendant Merck is headquartered in New Jersey with its vaccine division based in West Point, Pennsylvania. Merck is one of the largest pharmaceutical companies in the world with annual revenues exceeding $20 billion. Merck is also a leading seller of childhood vaccines and currently markets in the U.S. vaccines for 12 of the 17 diseases for which the CDC currently recommends vaccination.

11. Merck is the sole manufacturer licensed by the Food and Drug Administration (“FDA”) to sell mumps vaccine in the United States, Merck’s mumps vaccine, together with Merck’s vaccines against measles and rubella are sold as MMRII Merck annually sells more than 7.6 million doses of the vaccine in the U.S. for which it derives hundreds of millions of dollars of revenue. The US purchases approximately 4 million of these doses annually, Merck also has a license in the U.S. to sell ProQuad, a quadravalent vaccine containing MMRII vaccine and chickenpox vaccine. Under a license from the European Medicines Agency (“EMA”), Merck also sells mumps vaccine in Europe as a part of the trivalent MMRVaxpro and the quadrivalent ProQuad through Sanofi Pasteur MSD, a joint venture with the vaccine division of the Sanofi Aventis Group. ProQuad has been sold intermittently in the U.S. and Europe from its approval in 2005 until 2010.

Published on The Daily Bell June 29, 2012.

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