The FDA is preparing to put warning labels on epilepsy drugs, including Topiramate (marketed as Topamax), Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon), Pregabalin (marketed as Lyrica), and Zonisamide (marketed as Zonegran) that will notify users about the increased risk for suicidal behavior. Sales of the affected drugs, widely used for nonepilepsy problems such as migraines, topped $8 billion last year.
Russell Katz, director the FDA's neuropharmacological drug division, said, "Everything points in the direction of an increase in what we call suicidality."
In January the FDA announced that a review of 199 studies comparing 11 epilepsy drugs to placebos found that patients taking the drugs had about twice the risk of suicidal behavior compared with patients taking a placebo. With almost 44,000 patients in the studies, four people taking antiepileptic drugs committed suicide while none of the patients receiving a placebo did.
Some epilepsy drug makers like Pfizer and Abbot Laboratories have contested the FDA's decision to place warning labels on the drugs, claiming that the risks for suicidal behavior are minimal and that the labels will negatively impact company revenues.
Isn't it about time we all wake up and realize drugs are for profit? In April of 2006, Forbes Magazine released their study of the pharmaceutical industry and concluded that drug companies have traded in their "cure finding research labs" for "market research labs" to find more profitable markets for their existing drugs.
Two outstanding performers and poster children for remarketing for high-profit have been the anti-convulsive drug Topamax and the Parkinson's drug Requip. Topamax went from being one of 11 epilepsy drugs in a market of 900,000 to being the only one in a market of 30,000,000 by a simple FDA application that allowed it to be sold as a migraine drug. Its approval also prevented it from going generic. Five stars may hang on the door of the financial genius who came up with that idea. Too bad they don't get points deducted for the side effects that can mess up a person.
Whereas Requip originally developed for Parkinson's disease, found much higher profitability in keeping restless legs still and became an over-night winner with first year sales of $500,000,000. Considering that "restless leg syndrome" is a phantom disease most likely caused by a lack of vitamin D and iron, that move should have produced some outstanding bonuses. Today it stands as one of the greatest "switch disease" drugs in terms of how to make money through promotion. Who hasn't seen it on TV and on plaque cards in the doctor's office?
At the end of the day many things can be used for other purposes and a drug invented for one thing may turn out to be better for another, like a heart drug that may grow hair in some cases where the bald spot is located in a circular formation on the upper portion of the back of the head for example. But does that mean that drugs that have many known and rather extreme side effects should be used to treat problems that can be helped by other more effective means? You have to be the judge of that.
Perhaps we need to investigate what our doctor prescribes before we fill the prescription. After all it is your body and your brain that are affected.
More information on the use of Topamax for migraines can be found at http://topamax-migraine-alternative.com.
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