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From the Townsend Letter
June 2011

Taxing the Sick: the Colchicine Story
by Alan R. Gaby, MD

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Colchicine is an anti-inflammatory drug derived from the autumn crocus plant. It has been used successfully for more than 100 years for the acute treatment of gout. It is also an effective treatment for familial Mediterranean fever, a condition that affects about 100,000 people worldwide. In addition, colchicine has been used to treat symptoms associated with herniated discs, and it has been reported to prolong life markedly in patients with cirrhosis of the liver. Colchicine has been widely available as a prescription drug since the 19th century.

Until recently, the cost of a colchicine tablet was 9 cents. However, in 2010, the price was abruptly increased more than 50-fold, and a single tablet now costs about $5.50. State Medicaid programs paid a total of about $1 million for colchicine prescriptions in 2007. Today those same prescriptions would cost more than $50 million. Not surprisingly, the dramatic price increase has also created a financial hardship for the many people without health insurance who depend on the drug.

This obscene price increase was the result of apparently unintended consequences of federal law, which authorizes the US Food and Drug Administration (FDA) to grant market exclusivity for 3 years for any FDA-approved new indication for a drug. Since colchicine was in widespread use before the FDA even existed, the drug had never been officially approved but, rather, had been "grandfathered" in. Beginning in 2007, URL Pharma (a small pharmaceutical company) conducted pharmacokinetic studies on colchicine, which were followed by a one-week double-blind trial in patients with acute gout. Based on this research, the FDA approved URL Pharma's colchicine product (Colcrys) for the treatment of gout. Because this was a "new indication" for colchicine (it had never been officially approved), URL Pharma was now the only company allowed to sell colchicine to gout patients. At the same time, under the Orphan Drug Act, the company was granted a 7-year use patent for the treatment of familial Mediterranean fever. After the FDA approved URL Pharma's version of colchicine, the company filed a lawsuit to prevent other companies from selling the drug, while at the same time raising the price to the aforementioned obscene level.

So, what was it that made this objectionable event possible? Congress had previously passed the Waxman–Hatch Act and the Orphan Drug Act, which were designed to offer incentives for drug companies to conduct research. These laws granted various periods of market exclusivity to pharmaceutical companies that performed the research needed to obtain FDA approval. However, in the case of colchicine, the research conducted by URL Pharma provided virtually no new information about the safety, efficacy, dosage, or administration of the drug. Furthermore, the financial windfall that resulted from the company's newfound monopoly appeared to be out of proportion to the relatively modest cost of the research that it had conducted.

In the end, there are no winners, other than URL Pharma. Patients who need colchicine (and their insurance companies) are now the victims of a game of legal extortion. The public receives nothing in return for the much higher price that it is now being forced to pay. If the FDA believed that it was so important to conduct additional research on colchicine (which ultimately just confirmed what we already knew about the drug), the agency should have petitioned Congress or the National Institutes of Health to fund such research.

Representatives of the FDA have argued that it is not their fault that colchicine is now so expensive. They point out that, since URL Pharma was the first company to submit the appropriate data and to be granted approval for colchicine, federal law requires that the company be given a monopoly. While those points are true, the FDA should have known that inviting the drug industry to compete for monopoly control over an inexpensive, old drug was going to send the price into orbit. If they had thought about it, they might have realized that it would have been best to allow colchicine to remain as a grandfathered drug. But apparently they did not think about it (or did not care), and people has again been harmed by an agency whose supposed reason for existence is to protect the public.



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