16 October 2013

Patients Hurt by Biased Research

Yes, this goes without saying. The actions of our pharmaceutical manufacturers is almost criminal, no it is criminal. I say this because once the drug is approved for one use; the drug reps are promoting it heavily for “off-label” uses. Then they get FDA approval for these “off-label” uses and doctors happily promote their use and even have the philosophy that more is better.

This blog by Dr. Kenneth Lin, carefully lays out how pharmaceutical manufacturers convince doctors to overuse many drugs often to the harm of patients. He uses two common drugs that this has happened to, anemia drugs (Epogen, Procrit, and Aranesp, which mimic the actions of the hormone erythropoietin) and the diabetes drug rosiglitazone (Avandia). These two drugs were featured in recent articles by Peter Whoriskey in the Washington Post. The anemia drugs were developed to spare dialysis patients with severe anemia the inconvenience and risks associated with periodic blood transfusions.

Whoriskey also found that pharmaceutical companies moved aggressively to put these drugs into use in a far greater patient population, including those less likely to benefit from them.

The trouble would arise as the drug makers won FDA approval for vastly expanded uses, pushing it in larger doses, for milder anemia and for patients with a wider array of illnesses. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. The size of average doses would more than triple. And over the next five years, the FDA would approve it to treat anemia in patients with cancer and AIDS, as well as those getting hip and knee surgery.”

Doctors became motivated to give more doses of these drugs because the pharmaceutical companies were offering greater incentives, estimated between $100,000 and $300,000 annually for an oncologist. This created a seductive atmosphere and caused doctors to think if some of the drug was good, more had to be better. No checks were done and over prescribing continued.

Not until 14 years later did an independent researcher obtain access to the complete study report from the FDA and conclude that the NEJM authors had used statistical slight-of-hand to obscure an increased risk of heart attacks and death in the normal-hematocrit group. In the meantime, lobbyists working for the drug manufacturers successfully blocked efforts by Medicare administrators to stop paying for the higher (harmful) doses.”

This was the same tactic used by Glaxo Smith Kline in their promotion of Avandia and the manufacturer successfully stalled regulatory action in the US for three years, during which thousands of new patients were prescribed the drug.

This leads to the conclusion that the role of FDA members were to blame and let huge conflicts of interest stand in the way of protecting the public. The system of rotation from FDA to the pharmaceutical industry and them back to the FDA needs to stop and this should be outlawed with severe penalties for employees that do this. The next issue is passing a law that pays the salary of the FDA employees and pays for the supplies and operations to prevent pharmaceutical companies from having to kick in large sums of money to pay for the approval of their drugs. This practice also needs to be against the law with larger fines levied. These fines should be large enough to prevent companies from bribing FDA officials.

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