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Best of Dan Olmsted: Mumps Vaccine on Trial

AofA Red Logo Ayumi YamadaNOTE: Dan wrote this post in 2016.

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By Dan Olmsted Mumps can't play

If you’ve been wondering what’s up with the suit filed by two whistleblowers against Merck for allegedly hiding the fact that the mumps vaccine doesn’t work – well, so have we.

Now a timeline has emerged, although you might need a telescope to see its further reaches. An Amended Scheduling Order was released this month that extends deadlines even longer: “dispositive motions” to be filed by December 20, 2017 – basically two years from now; “motions involving class certification” by May 3, 2018. That looks like the earliest a trial could start, and it’s not hard to see the whole thing going into 2019, if not a new decade entirely.

This for an allegedly blatant fraud against taxpayers that occurred last decade – in 1999!

A key date appears to be October 31 of next year, when a status report from both sides is due on whether “the parties would consent to alternative dispute resolution” – in other words, I believe, to settling out of court.

Backed by a major California law firm that knows how to write powerful briefs and has a lot of material to work with, the whistleblowers – Stephen A. Krahling and Joan A. Wlochowski – haven’t budged. Attempts by Merck to get the suit thrown out on all kinds of grounds (such as, unbelievably, that the FDA knew about it and didn’t care, so why should anyone else!) failed in federal court in Philadelphia.

Discovery of documents must also be completed by that October  date. Discovery – the delivery of relevant material that might help make a case – is exactly what private firms of all kinds dread, and one reason you see so many settlements where terms are not disclosed, nobody admits any wrongdoing and the whole thing goes away. The big firms pay millions to defend themselves, so what’s a few more million out of billions in profits to buy someone off? Most people can’t resist the temptation given that they could lose everything in court.

That’s why getting to discovery in this lawsuit is the crux of the matter – it’s so rare, and there’s so much at stake. That includes billions in potential penalties for Merck if it’s found the firm defrauded the government, which pays hundreds of millions a year for the MMR – the mumps, measles, and rubella shot. Merck has the only license to manufacture any of the MMR components in the United States, and in the worst outcome for Merck it could lose that lucrative monopoly entirely.

There is no discovery allowed in the so-called “vaccine court” that has so far thwarted thousands of parents who claimed their child’s autism was due to the MMR, the mercury in some vaccinations, or a combination of both. The judges who threw out all the cases ridiculed the families for having no evidence to that effect, a Catch-22 if ever there was one.

So while it seems like bad news that this case is stretching so far into the future, the fact that it is still headed for daylight is kind of a miracle. If it makes it all the way, you have to wonder what a jury will make of some of the Merck documents already disclosed – such as the one in which a Merck official told subordinates that their job was to show that the mumps vaccine met federal licensing standards, when it clearly did not. To bridge the gap, according to the suit:

“Merck set out to conduct testing of its mumps vaccine that would support its original efficacy finding. In performing this testing, Merck’s objective was to report efficacy of 95 percent or higher regardless of the vaccine’s true efficacy. The only way Merck could accomplish this was through manipulating its testing procedures and falsifying the test results. … Krahling and Wlochowski participated on the Merck team that conducted this testing and witnessed firsthand the fraud in which Merck engaged to reach its desired results. Merck internally referred to the testing as Protocol 007.”

Naming a secret project after a British spy with a license to kill might have seemed amusing inside Merck; perhaps not so much in an American courtroom.

It is also worth pointing out that lawsuits like this are typically long slogs, but sometimes pay off big-time. An example is close at hand: For instance, Merck just paid $830 million to settle a lawsuit with shareholders over the painkiller Vioxx. That drug was pulled from the market 11 years ago, in 2004; since then, the company pleaded guilty to a misdemeanor for violating drug laws; paid $900 million; and settled 50,000 lawsuits by patients in 2007 for nearly $5 billion.

Before it settled, Merck engaged in a tobacco-style scorched earth policy of fighting every individual claim of harm or death from the drug, denying all, even after it became clear that thousands of people had died from heart attacks and strokes and Merck had been, shall we say, not forthcoming about the implications of its own studies of the drug’s safety. (The master of that approach, its chief lawyer, was rewarded with the chairmanship of the company.)

You may remember the heavy marketing of the drug – skater Peggy Fleming in a TV ad holding her sore ankle, hardly the appropriate audience for a heavy-duty painkiller. That pill-popping approach to a compound not much better, and far more dangerous, than aspirin mirrors the mumps vaccine hype: According to research Mark Blaxill and I have done, the vaccine is unnecessary, given the mildness of most mumps infections in early children. Now, thanks to the vaccine, outbreaks are showing up more and more in adolescents and young adults, in whom it can cause sterility and other complication.

That’s because, according to the whistleblowers, it doesn’t even work.

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Dan Olmsted is Editor of Age of Autism.

Comments

Bob Moffit

AND THE BAND PLAYS ON AND ON .. ON AND ON … ON AND ON ….

Recent "60 Minutes" with whistleblower .. Dr David Kessler the FDA's former commissioner .. on the FDA's decision to allow OxyContin and other opioids to be broadly marketed for chronic pain patients. According to Kessler .. "the rigorous kind of scientific evidence that the agency should be relying on is not there".

As bad as Vioxx proved to be … opioid drug addiction is causing tens of thousands of deaths a YEAR .. yet .. the FDA has never been held to account for allowing opioids to be "broadly marketed for chronic pain patients".

AND THE BAND PLAYS ON AND ON .. ON AND ON …..

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