Children's Health Defense
For decades, Merck misrepresented the efficacy of its mumps vaccine, marketing an “adulterated” drug without proven efficacy to millions of American children, according to a recently released expert report by Dr. David Kessler, former head of the U.S. Food and Drug Administration (FDA).
The report — posted in two documents and marked “highly confidential,” for “attorneys’ eyes only” — provides over 800 pages of Kessler’s opinion and analysis about the history and severity of Merck’s regulatory violations over decades, beginning in the late 1990s.
By 1998, regulatory labeling review had revealed that the mumps component of Merck’s measles, mumps rubella vaccine, MMRII, did not maintain the stated potency over its shelf-life, in violation of FDA regulations.
Rather than recalling the vaccine or attempting to develop a different formula, the company spent years trying to develop new and more sensitive ways to test the existing vaccine that would show high efficacy results, so it would still be in compliance with regulatory requirements and allow Merck to maintain its exclusive license.
Merck did this even though its existing data showed the vaccine was significantly less effective than claimed, Kessler wrote.
To temporarily make the drug meet Merck’s efficacy claims while the company developed tests, Merck increased the dosage of virus present in the vaccine — with the FDA’s knowledge — although the higher dosage was never tested in clinical trials for either safety or efficacy.
The company did not inform the vaccine recipients, providers or purchasers — including the Centers for Disease Control and Prevention (CDC), which purchased the drug through its Vaccines for Children Program — that its vaccine was out of compliance.
Merck’s actions, Kessler wrote, had important “public health significance.”
According to the report, starting in 2006 and recurring since then, there has been a resurgence of mumps outbreaks in the U.S. The largest outbreak in 2017 affected more than 10,000 people in 46 states.
The vast majority of the people infected in all of the outbreaks received the recommended two-dose regime of Merck’s MMR vaccine, the report says.
“In my opinion, with regard to children immunized in the United States with vaccines manufactured from 1998-2007, no one can determine which of the children, who are now young adults, were immunized from the lots of MMRII for which Merck did not have adequate assurances of the potency,” Kessler wrote.
Krahling v. Merck
Kessler’s report was made public as part of the Krahling et al. v. Merck and Co. Inc trial. On July 9, the 3rd Circuit U.S. Court of Appeals in Philadelphia heard oral arguments in the case.
The case involves former Merck virologists Stephen Krahling and Joan Wlochowski, who became whistleblowers in the early 2000s after alleging upper management tried to get them to falsify data in the tests the company was conducting to show its mumps vaccine maintained high efficacy.
In 2010, Krahling and Wlochowski sued Merck under the False Claims Act, alleging the company falsified data and fraudulently marketed its MMRII vaccine, which was “mislabeled, misbranded, adulterated and falsely certified as having an efficacy rate that is significantly higher than it actually is.”
U.S. District Judge Chad Kenney in July 2023 dismissed the case without ruling on whether there was any fraud. The court found that the alleged misrepresentations were not material to the CDC’s decision to buy the vaccine from Merck.
In other words, the court ruled that even if the fraud allegations were true and Merck had defrauded the U.S. government, physicians and vaccine recipients, the fraud wasn’t a factor in the government’s decision to purchase the vaccines. The plaintiffs couldn’t show that the false claims influenced the government’s decision.
After the July 2023 decision, documents, including the Kessler report, were unsealed and recently made available.
In last week’s oral arguments, plaintiffs’ attorneys argued the appeals court should overturn the dismissal, especially given the revelations in the Kessler report, including that a leading figure in U.S. public health — who was also the architect of the Biden administration’s COVID-19 mass vaccination campaign — determined the fraud and the violations were severe.
Merck disputed the Kessler report in documents the company submitted to the court, the attorneys said.
The fraud
Under the National Childhood Vaccine Injury Act of 1986, vaccine manufacturers are required by law to ensure their vaccines are “safe and effective” and have labeling that is “not false or misleading.”
Companies must update any changes regarding efficacy, duration of protection or other similar issues. Periodically the FDA reviews the labels. In 1996, the agency started reviewing the Merck MMRII vaccine label, Kessler wrote. The agency first licensed the vaccine in 1978.
The vaccines are “live attenuated viruses,” meaning they contain a small amount of live mumps virus that is weakened to reduce its virulence, so the vaccine elicits an immune response, but does not make the recipient sick.
A live attenuated vaccine’s “potency” is the concentration of live virus in a single dose.
Merck’s vaccines were approved at a specific potency, listed on the label. Label potency is set based on the vaccine’s potency when it is first produced — which must be informed by safety data that ensures a vaccine is safe at the release potency — and by how much potency is lost during a vaccine’s shelf life.
Merck’s label claimed the potency of the MMRII vaccine was “20,000 TCID50,” which is the potency clinical trials showed protected against mumps. “TCID50” is a measure of the number of viral particles in a vaccine.
However, by 1998 it was clear that potency did not hold up over the two-year shelf life…
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