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FDA: Protecting Consumers or Helping Cronies Capitalize on Human Suffering?

In a shocking override of its own scientific advisors, the FDA approved an experimental drug, Sarepta Therapeutics' eteplirsen, for the treatment of Duchenne Muscular Dystrophy. DMD is a rare, degenerative disease that strikes boys and usually takes their lives before they reach the age of 30.

The Wall Street Journal reports that a panel of advisors concluded by more than a 2-to-1 margin that the manufacturer's study, conducted on only 12 subjects and without a control group, failed to demonstrate that the drug provided any real benefit for patients. Dr. Janet Woodcock, Director of the FDAs Center for Drug Evaluation & Research, justified overriding the panel of medical experts to grant the fast-track approval, not because early studies demonstrated that the drug is effective, but because there are "no [other] treatment options" for DMD. The FDA has recently rejected 3 other drugs intended to treat this illness. 

The Duke University Science & Policy Blog reports that FDA Chief Scientist Dr. Luciana Borio reviewed a formal complaint filed by a member of the evaluation team. She noted Dr. Woodcock's early and substantial interference in the process, stating

Dr. Woodcock made clear from her position at the top that she was pushing for a particular outcome from the very early stages.  ~Dr. Luciana Borio, FDA Chief Scientist

Two staffers are expected to leave the FDA in the wake of the tainted decision-making process, which Dr. Borio described as driven not by science, but “pressures exerted by outside forces." She concluded, "we fear that those actions could have chilled scientific debate and reduced the level of participation by the review team.”

Why would the FDA, a completely taxpayer-funded entity created for no other purpose than to safeguard the health and safety of Americans, clear the field of competition and then lower the bar to fast-track a drug for which no scientific evidence of efficacy exists? A drug, incidentally, that is forecast to cost approximately $300,000 to treat the average patient for a single year. Could financial interests have played a part in this decision? 

Its stock price more than doubling within a few days of the approval, Sarepta is now being described by analysts as "one of the most attractive takover targets in biopharma." Barron's reports that Sarepta received a voucher provided by the FDA for a fast-track drug review. Ostensibly intended to allow Sarepta to quickly buttress its weak experimental results with more scientifically-sound data, Sarepta is expected to instead sell the voucher on the open market for a cool quarter-million dollars or more. Because when you've got a government-protected monopoly, why rush back to regulators for a decision that could only hurt you? And why does the FDA permit such a thing to be bought and sold to begin with? These are people's lives we're talking about, not bypassing a long line at an amusement park.

Sarepta has spent nearly a million dollars on lobbying. The pharmaceutical industry spends more money lobbying Washington than any other industry in the United States: over 50% more than the next highest spender, the insurance industry (two of the most heavily-regulated industries in the United States, incidentally). Time magazine reported last year that Dr. Robert Califf, the FDA Commissioner who dismissed the concerns of the panel and approved Woodcock's decision, himself has six-figure ties to Big Pharma. Diana Zuckerman, President of the National Center for Health Research, says such ties “should be of great concern.” While describing Dr. Califf as “a very accomplished, smart physician who’s been an important name in the field,” she goes on to say that his "interdependent relationships" call into question his ability to remain an objective advocate whose sole concern is for the health of the American people. Zuckerman cites multiple National Institutes of Health studies that suggest that the medical products industry uses such ties to influence the behavior and decision-making of doctors and researchers, even when the scientists don’t realize it.

If you think there may be more to this than innocent coincidence, that it's time to put an end to the shadowy connection between money and regulatory agency favoritism, sign the on-line petition at COSaction.com. And use the buttons below to share with your friends on social media. Because the FDA was created to help us, not Big Pharma.

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