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Gouging the Gouty

 

this story originally appeared in The Urban News

Those paying the bills for treating people who suffer from gout, a common form of arthritis, will experience a flare-up of financial pain this year. The price of colchicine tablets, a mainstay of treatment, is going from $.10 to $5.00/per pill.

The reason for this fifty-fold price increase spotlights yet another area of dysfunction (for patients) in the American healthcare system.

Colchicine preparations have been successfully treating gout for at least 2,000 years. The purified drug was first produced in 1820. Since then doctors have accumulated vast clinical experience with using it safely. However, because colchicine predated federal rules for safety and effectiveness testing, the Food and Drug Administration (FDA) never approved it.

In 2006 the agency began a serious push to bring old unapproved medicines into compliance with modern requirements. Rather than conduct the necessary research with tax dollars, the FDA offered drug manufacturers a sweetheart deal. In return for doing the tests, a company could corner the market on a newly approved old drug for a period of years.

One privately held company, URL Pharma, has a business plan to take advantage of this situation. In 2006, URL won FDA approval to exclusively market the ancient malaria and leg cramp drug, quinine sulfate. The price of URL’s approved form, Qualaquin®, was set five times higher than existing generics. URL then sued competing manufacturers to stop them from producing quinine sulfate.

URL is taking the same approach with its newly FDA approved brand of colchicine, Colcrys®. But why settle for charging five times more per pill when you can get fifty times the former price? URL’s arrangement with the FDA allows it three years of exclusive marketing rights for Colcrys® in the treatment of acute gout. For the rarer Familial Mediterranean Fever, URL has the market to itself for seven years. Again, other generic manufacturers must cease production or face a URL lawsuit.

The American College of Rheumatology complained to the FDA about the new cost of colchicine. The doctors were told that the agency “regretted the price increase” but stood by the need to evaluate old medicines by modern standards. The FDA said other generic manufacturers could re-enter the market by researching colchicine for other indications, such as the treatment of chronic gout. (Presumably, such a company could also charge prices exorbitant by historic standards.)

But for this FDA policy—started under Bush and continued by Obama—colchicine would still cost a dime instead of a five dollar bill. It’s easy to wish gout on the FDA brain trust that either didn’t see this price gouge coming or didn’t care. (URL’s research did produce a few new findings with limited clinical impact.)

The bigger picture isn’t so simple. Boneheaded bureaucracy is a serious problem, but so is our system of developing and testing medicines. Had tax money funded the colchicine studies, the drug would have remained cheap. Instead, patients and taxpayers are directly or indirectly on the hook to URL Pharma for years.

Colcrys® is only one example of the drawbacks of relying on the free market for drug testing. Scandals involving manufacturer suppression of evidence about severe and potentially fatal side effects for pricy new drugs have become commonplace. GlaxoSmithKline’s diabetes drug Avandia® is currently under federal scrutiny. Eli Lily & Co. paid out billions in federal fines and lawsuit verdicts for concealing serious side effects of its lucrative antipsychotic drug, Zyprexa®, and promoting it for unapproved uses. In 2004, after revelations that Vioxx® patients were at increased risk for heart attack and stroke, Merck withdrew the popular anti-inflammatory drug. The list goes on.

The FDA may be in need of a brain and muscle transplant but, as long as greed drives corporate behavior, the public needs a regulatory cop on the beat. Sorry as it is, the FDA and congressional oversight committees are the only protection we have from drug companies that value the welfare of profits above patients.

—Michael Hopping
copyright © 2010 all rights reserved

 

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