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January 04, 2006

Risk & Reward

How each individual reacts to medications can be puzzling. Any one anti-depressant may only work well for half of those who take it. Fortunately, there are many choices for anti-depressants so doctors can find a medication that does work for a patient. That wasn't the case a few decades ago.

Ralph Nader's group, Public Citizen, has been campaigning the FDA for years to ban various medications because they feel the risks are too high. They, and other groups , have focused their attention on drugs that are used to treat mental disorders in children and teenagers. Many feel that such drugs should not be prescribed (or at least prescribed much less).

Users of Permoline (Cylert) are now victims to this campaigning as the FDA has pulled Permoline from the market. Permaline was originally released as a treatment for ADHD, however it has found to be useful in the treatment of fatigue in M.S. and Narcolepsy.

One victim is Teresa Nielsen Hayden of the Making Light blog. Permoline has been the only drug that has worked against her Narcolepsy. Now she nothing to help her with her disease.

So what was the FDA's reason for pulling Permoline from the market? Some people taking Permoline developed liver problems (and many people didn't). Originally, to address this, the FDA issued a "black box" warning asking to doctors to regularly check the livers of patients taking this medication and to stop use of the medication if a problem developed.

Teresa Nielsen Hayden's liver is fine, she had been regularly tested. However, her narcolepsy isn't. Now she has no options. Since narcolepsy is a "rare" disease, similar in numbers to Huntington's Disease, they don't have as much influence with the FDA as Public Citizen.

It's a crying shame.

Hat tip to Glenn Reynolds.

Posted by Dave at January 4, 2006 07:01 AM

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