Merck Engaged in Blatant Scientific Fraud with Vytorin Cholesterol Study?

It’s no surprise these days to hear about a pharmaceutical company committing scientific fraud and distorting clinical trials to get the results they want, but it’s unusual to see it done as blatantly and arrogantly as what you’re about to see here.

In June, 2002, Merck and Shering-Plough began a cholesterol study called “ENHANCE” to test the effectiveness of their blockbuster drug Vytorin ($3 billion in sales so far). The trial concluded in 2006, and the final results are still not available. Why? Because the companies are sitting on the data, trying to figure out how to manipulate the results enough to make them look good!

The trial was attempting to measure the reduction of arterial plaque in the carotid arteries, and this reduction was measured by a high-tech ultrasound imaging technique called intravascular ultrasound. The measurements from the study were murky and unreliable. Some were “biologically implausible,” meaning the images were showing things that could not possibly exist in a human body. So instead of doing the scientifically correct thing and ditching the study results, they decided to do something arrogant (and scientifically invalid): They changed the definition of what the study was measuring, after the fact!

In other words, they decided to cherry pick the data they wanted to use by redefining the goal of the study after it was complete. This is such a blatant violation of scientific principles that it would earn you an “F” if you tried to pull this stunt in a high school chemistry class.

Upon hearing about this utterly non-scientific alteration of the trial goals, the medical community expressed outrage. Big Pharma critics leapt at the opportunity to point out how drug-company-funded clinical trials are little more than junk science designed to distort findings and produce the results desired by the study sponsor. Even Congress got in on the act, announcing an investigation of Merck for its apparent attempt to commit scientific fraud with Vytorin study results.

By the way, the FDA doesn’t require medical studies to be non-fraudulent. The agency is happy to accept fraudulent studies from Big Pharma — and it has done so for decades! When it comes to pharmaceuticals, the point of conducting studies is not to discover the scientifically-validated truth about a particular drug’s effects on the human body, but rather to provide a sufficient amount of pseudoscientific cover to allow the FDA to approve the drug and proclaim it to be both safe and effective. It’s all about sales, after all, and if a little science needs to be “redefined” along the way to earn another billion dollars a year in the marketplace, then that’s easy to accomplish.

So now, instead of measuring three points along the carotid artery where plaque typically accumulates, the Vyrotin ENHANCE study will retroactively select just one point. And guess what? Merck gets to choose which point!

I sure would like to use this system the next time I got to Vegas. I’ll just place my bet on the roulette wheel after the spinning stops! Or maybe I’ll go to the poker table, have the dealer toss me ten cards, and then I’ll decide which five cards I want to be in my hand! It sure would be nice to be able to cherry pick the results I want to “count” after the fact, wouldn’t it?

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