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Maui News Gets it Wrong on Unapproved Drugs

In an op-ed over the holiday season (Government Protecting Us, December 27, 2010), the Maui News Editorial Board incorrectly argues that the Food and Drug Administration’s (FDA’s) decision to grant exclusivity to the drug company that makes Colcyrs (the only FDA-approved version of colchicine, an anti-gout drug) constitutes “outrageous waste — if not fraud.”

Although Maui News’s larger frustration with health care costs is correct in a larger sense, it’s worth pointing out the larger reasoning and giving readers the full story.

The FDA’s mission is to ensure that medicines actually work as intended and are safe, with minimal and known side effects. As part of this responsibility, the FDA launched the Unapproved Drugs Initiative, designed to identify and remove from the market drugs that have never been proven to be safe and effective. This rigorous approval process is what makes the US medical system arguably the most advanced in the history of humankind.

In the case of colchicine, that’s a drug that has been available for generations in both injectable and oral tablet form for generations; however, it was never FDA-approved until recently, when one version was finally determined by the FDA to be safe and effective. As our collective understanding of science and health has improved over the years, it was determined that the non FDA-approved versions of colchicine were to blame for deaths and other serious side effects.  Moreover, without the rigorous review process required to obtain FDA approval, the correct dosage regimen and insights regarding drug-to-drug interactions would have not been discovered, further putting patients at risk.  FDA is performing its proper role in protecting patient safety by ensuring that there is a safe and effective gout medication for patients to rely on, without the higher likelihood of health-related, even fatal, side effects.

Although the editorial correctly noted that this raised the price of FDA-approved colchicine as compared to illegal unapproved and potentially unsafe versions, it did not note that the manufacturer has made a patient assistance program available to patients to provide the drug for free or a greatly reduced cost based on income eligibility. (This information is also available at LegitScript’s home page, where Internet users can search for patient assistance programs.NeedyMeds.org is also a great source for this information.) More to the point, the editorial incorrectly suggests that all versions of  colchicine are equally safe and effective. The science clearly establishes that this is not the case, and taking an illegal unapproved version of the drug may cause adverse side effects and even death.

High health care costs are an important and difficult issue. But in discussing prescription drug prices, the paper’s readership (as well as the public at large) deserve to be informed about the safety risks of using unapproved prescription drugs, too – not indirectly encouraged to use unapproved versions that may put patient health at risk.