The curious case of colchicine

This story demonstrates the concept of “unintended consequences” very clearly.Please note that potentially there is the possibility of scores of future stories like this if this part of drug research policy is not changed. Aspirin is one of the possibilities.first an intro courtesy of the WSJ: credit for the photo also goes to WSJ

…A common gout drug, colchicine, has been around for so long that pre-dated the FDA and until last year, it had never been approved by the agency. As part of a push by the FDA to bring such drugs under its umbrella, a company called URL Pharma commissioned studies to show that colchicine was safe and effective, and last summer the FDA approved the company’s version and gave URL three years of marketing exclusivity for the drug.

Here come the unintended consequences. While the FDA says it hoped there wouldn’t be a significant run-up in the price of colchicine — sold as Colcrys by URL — the retail cost has soared to more than $5 a bill from the previous pennies a tablet. URL Pharma also sued five makers of manufacturers of colchicine, saying they have been illegally marketing their colchicine products since Colcrys’s approval….

more via With FDA approval, a gout drug now costs $5 instead of pennies

Now an editorial from NEJM, which concludes with the suggestion that publicly financed drug research might be better:

from the New England Journal of Medicine:

After the FDA approved Colcrys, the manufacturer brought a lawsuit seeking to remove any other versions of colchicine from the market and raised the price by a factor of more than 50, from $0.09 per pill to $4.85 per pill.4 These increased prices directly affect the availability of the drug to patients with gout or FMF who have long been using colchicine safely in an evidence-based manner. Exclusivity can also affect health care delivery more broadly. According to the Centers for Medicare and Medicaid Services, state Medicaid programs filled about 100,000 prescriptions of colchicine in 2007 and paid approximately $1 million for the drug. Use of the new brand-name colchicine could add as much as $50 million per year to these insurance programs’ budgets at a time when they are addressing the rising costs of health care by reducing some services or raising eligibility thresholds.

The colchicine case demonstrates some important limitations of our current system for rewarding innovation in the pharmaceutical market. Incentive programs like those enacted by the Waxman–Hatch Act and the Orphan Drug Act offer market exclusivity to encourage drug research, but these rewards are not calibrated to the quality or value of the information produced. Although the goals underlying the development of Colcrys were sound — few would argue against the need to comply with FDA requirements and the need to ensure the safety and efficacy of all prescription drugs — and the manufacturer seems to have followed FDA guidance, the reward appears to be out of proportion to the level of investment. More important, there is no evidence of any meaningful improvement to the public health. We believe that when creating and implementing incentives for private investment in drug research, policymakers should seek to avoid policies that can lead to such outcomes. An alternative solution, probably much less expensive, would be for the FDA or the National Institutes of Health to fund trials that address outstanding questions related to widely available drugs such as colchicine.

via Incentives for Drug Development — The Curious Case of Colchicine | Health Care Reform Center.


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