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article imageOp-Ed: Watchdog group takes FDA to task over Pradaxa approval

By Karen Graham     Oct 18, 2015 in Health
A watchdog group said on Thursday the FDA was “lax” and “permissive” in its approval of a blood-thinner designed to prevent clots and strokes in patients with a heart condition that affects millions of Americans.
The Project on Government Oversight (POGO), in a new investigation, says the Food and Drug Administration (FDA) made questionable calls in its efforts to accommodate German drugmaker Boehringer Ingelheim, the manufacturer of the anticoagulant drug, Pradaxa, according to the Washington Post.
As reported in AllGov, the investigation by POGO includes assertions the FDA approved the drug Pradaxa for the U.S. market after a review committee of experts with financial ties to the drug industry, including Boehringer Ingelheim, gave its blessing for its approval.
Needless to say, Pradaxa doesn't have a glowing history, by any means. Approved by the FDA in 2010, Pradaxa has been responsible for numerous cases of uncontrolled bleeding. Unlike Warfarin, the blood-thinner it is supposed to replace, there was no antidote to stop the bleeding.
Boehringer Ingelheim ended up facing around 4,000 lawsuits in state and federal courts and eventually agreed to pay $650 million in damages because the drug manufacturer failed to sufficiently warn people that the medication
caused life-threatening and sometimes fatal bleeding.
In the review of the FDA approval process, POGO describes in detail the "panel of expert's" ties to the pharmaceutical industry, and the substantial amount of compensation a few of them received.
Dr. Darren McGuire, a Texas cardiologist was on the committee approving Pradaxa. Three years later, he disclosed in a medical journal he had received “personal fees from Boehringer Ingelheim.” He also said he had received money from other drug companies, too. But AllGov describes Boehringer Ingelheim as McGuire's "sugar daddy," paying McGuire between $75,000 and $134,994 over a three-year period, based on his financial disclosure form.
Dr. Sanjay Kaul, a medical professor at UCLA and cardiologist at Cedars-Sinai Medical Center also received payments from Boehringer Ingelheim. In 2013, he received $21,000, and in 2014, he received an additional $75,000. The watchdog group based its report on interviews conducted with participants and researchers, as well as reviewing hundreds of pages of documents.
Here's an interesting side-story
The FDA and Boehringer Ingelheim both knew Pradaxa could more than likely cause uncontrolled bleeding, that's fairly obvious from the number of lawsuits. So the drug manufacturer came up with a drug that's supposed to reverse the effects of Pradaxa, and the FDA approved it under its accelerated approval program, which is used to review drugs for serious or unmet medical conditions based on preliminary studies.
Funded by Boehringer Ingelheim, Idarucizumab (Praxbind), an antibody fragment, was developed to reverse the anticoagulant effects of dabigatran (Pradaxa). It is an injectable medicine that reverses the effects of Pradaxa. To let you know how fast it was approved, clinical studies involved only 90 patients, with the results showing that Idarucizumab normalized the test results in 88 to 98% of the patients, according to the clinical study report.
The news of the FDA's seemingly lax investigation and review of Pradaxa causes some concern over the approval of the "female viagra" drug, Addyi that went on sale yesterday in selected pharmacies across the nation. With the number of warnings accompanying Addyi, and the questionable clinical studies and lack of real proof it is any better than a placebo, it leaves one to wonder how much the "experts" got paid this time.
This opinion article was written by an independent writer. The opinions and views expressed herein are those of the author and are not necessarily intended to reflect those of DigitalJournal.com
More about pradaxa, FDA approval, Boehringer Ingelheim, Lawsuits, Blood thinner
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