Drug that causes patients to bleed to death was approved under questionable circumstances by Obama FDA nominee

Monday, December 21, 2015 by: L.J. Devon, Staff Writer
Tags: Robert Califf, Xarelto, false test results

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(NaturalNews) Meet Robert Califf. He was recently appointed as Deputy Commissioner for Medical Products and Tobacco at the FDA, by the Obama administration. This is the same guy who worked at the Duke Institute for Clinical Research, where he co-chaired the executive committee for the clinical trials of the pharmaceutical blood-thinning drug, Xarelto.

Xarelto is an FDA-approved drug that has caused numerous heart patients to bleed to death. A staggering 2,000 lawsuits have now been filed in the US because the drug is causing people to bleed profusely. However, drugs just like these continue to be accepted as medicine under the careful watch of the FDA's Robert Califf.

European investigators are now finding out that Califf's clinical trials to approve Xarelto took advantage of recalled devices that produce misleading test results.

Since 2011, Xarelto has been marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Interestingly enough, the FDA's Robert Califf, who set up the clinical trial to approve Xarelto, also received an $87,500 payment from Johnson & Johnson in 2012. The conflict of interest is apparent.

Pharmaceuticals not based on sound science

Most pharmaceutical drugs aren't validated and approved based on sound science. They are often approved because drug companies pay the approval process off, using large sums of cash to directly influence how these dangerous drugs come to market. Drug companies infiltrate the government regulatory agencies and basically become the government, getting their way even when their products cause people to bleed to death.

It's how medical science works in the USA, and hardly anyone is held accountable for the lives that are taken due to "medicine." Drug company insiders are instead given top positions in the government. That's exactly what President Obama did, nominating Califf to a top FDA position, even after he helped to "design and oversee" the clinical trial used to unsafely fast-track Xarelto to market, using recalled testing equipment.

Xarelto comes under investigation as patients bleed to death

The clinical trial and approval process Califf designed for Xarelto is now under investigation by European regulators. The drug is supposed to thin the blood of heart patients, but it's also putting them "at greater risk of harm from stroke and/or bleeding," as reported by The Washington Free Beacon.

Many scientists rebuked its approval in 2011, and the FDA official who gave it the green light even then had concerns over the drug's safety. In a November 2011 memo, FDA Deputy Division Director Stephen M. Grant said, "The decision [to approve the drug] was made difficult by the limitations in the design and conduct," referring to the clinical trial set up by Robert Califf. [Emphasis added]

The Project on Government Oversight reports, "The FDA approved Xarelto in 2011 over the objections of the primary FDA scientists assigned to study its safety and effectiveness. The report by the reviewers argued that patients could be 'at greater risk of harm from stroke and/or bleeding' if they took Xarelto than if they were treated skillfully with Warfarin, a blood thinner that has been on the market since the 1950s."

According to the current European investigation, Robert Califf set up the clinical trial using blood testing devices from the INRatio product line that were under FDA recall notice at the time. The investigation determined that the faulty devices used in the approval process delivered false test results. An FDA warning letter cautioned that the devices may produce misleading test results that "cause severe or life-threatening injuries, including death." [Emphasis added]

Sources include:

Freebeacon.com