Docs in drug dispute must remember to put patient safety first

Jim Martin Chairman, 60 Plus Association
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Seniors depend largely on the medical expertise provided to them by their physicians. We have little choice but to trust that they are helping us make good health decisions, and most importantly, putting safety first.

That is why I was surprised by a recent report in the Wall Street Journal on a dispute over whether or not unapproved colchicine medications should be prescribed to patients for the treatment of gout flares despite the availability of approved ones.

Unapproved drugs have never been tested for proper dosage, regimen and possible interactions with other medications. Accounting for two percent of the total drug marketplace in the United States, they have been associated with countless injuries and hundreds of deaths. Advocating for the use of an unapproved drug despite the availability of a tested, approved medication for the same purpose is nothing less than irresponsible.

The FDA understands the dangers posed by unapproved drugs. Since the announcement of their “Unapproved Drugs Initiative,” in which the agency committed to removing unapproved drugs from America’s pharmacies, they have successfully cleared over 500 untested products from the market.  That’s a good start to this problem.

In recent months they have been active, sending warning letters to manufacturers of untested nitroglycerine and morphine products. In addition, the agency cracked down on OSR#1, an untested children’s autism therapy drug which fails to warn users of potential side effects that could include “abnormalities of the pancreas.”

Your local pharmacy is a safer place due to the FDA’s efforts, and we at the 60 Plus Association have formally encouraged the FDA to continue their work to enforce the Unapproved Drugs Initiative and pick up the pace because there is no time to waste when it comes to patient safety.

The responsibility to protect patients from avoidable deaths does not lie only with the FDA, however.  Manufacturers and distributors must also stop supplying unapproved drugs to patients. And doctors, who often prescribe untested drugs unknowingly, must make sure they are prescribing approved drugs whenever possible, keeping in mind that safety comes first when it comes to treating patients.

If we are to provide Americans with the safest drug marketplace possible, this is a lesson that all who are involved in providing drugs to the patients of America will need to understand.

Mr. Martin is Chairman of the 60 Plus Association, formed in 1992 as a non-partisan seniors’ advocacy group with a free-enterprise, limited government, lower taxes mission and a strict adherence to the Constitution. www.60plus.org.