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Colchicine: Comment on “The Colchicine Debacle”

Colchicine: Comment on “The Colchicine Debacle” The US drug approval system has 2 important goals: getting safe and effective drugs rapidly to patients and rewarding innovation in the pharmaceutical industry by offering market exclusivity for new drugs. Unfortunately, there are weaknesses in our current system, as illustrated by this article concerning colchicine. Offering market exclusivity in the 21st century for a drug that has been used for the treatment of gout since the 18th century, with randomized control trials confirming this benefit from the 1980s, is not in the public service. A system that allows a drug that has been used for gout for centuries to be classified as a new discovery, with a price increase of 500% and generics forced off the market, is not in our patients' interest. Patients have little recourse unless regulations are changed to avoid allowing centuries-old drugs to become a profit-making vehicle for industry at the expense of access to patients. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Colchicine: Comment on “The Colchicine Debacle”

JAMA Internal Medicine , Volume 173 (3) – Feb 11, 2013

Colchicine: Comment on “The Colchicine Debacle”

Abstract

The US drug approval system has 2 important goals: getting safe and effective drugs rapidly to patients and rewarding innovation in the pharmaceutical industry by offering market exclusivity for new drugs. Unfortunately, there are weaknesses in our current system, as illustrated by this article concerning colchicine. Offering market exclusivity in the 21st century for a drug that has been used for the treatment of gout since the 18th century, with randomized control trials confirming this...
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Publisher
American Medical Association
Copyright
Copyright © 2013 American Medical Association. All Rights Reserved.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2013.3093
Publisher site
See Article on Publisher Site

Abstract

The US drug approval system has 2 important goals: getting safe and effective drugs rapidly to patients and rewarding innovation in the pharmaceutical industry by offering market exclusivity for new drugs. Unfortunately, there are weaknesses in our current system, as illustrated by this article concerning colchicine. Offering market exclusivity in the 21st century for a drug that has been used for the treatment of gout since the 18th century, with randomized control trials confirming this benefit from the 1980s, is not in the public service. A system that allows a drug that has been used for gout for centuries to be classified as a new discovery, with a price increase of 500% and generics forced off the market, is not in our patients' interest. Patients have little recourse unless regulations are changed to avoid allowing centuries-old drugs to become a profit-making vehicle for industry at the expense of access to patients.

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Feb 11, 2013

Keywords: colchicine

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