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Lotronex - Another Pharmaceutical Backfire

© Adelle Vancil Tilton

Imagine for a moment that you suffer from a non-fatal, but yet severe illness which causes not only physical problems but embarrassment as well. Imagine that you have suffered from it for years. Then, suddenly the Food and Drug Administration approves a new medication which promises to give you the relief you've sought for years.

You begin taking the medicine, as prescribed and following all of the manufacturers instructions, and lo and behold your symptoms subside and you begin to feel better. Doesn't this scenario sound good? Wouldn't you welcome this relief? This is exactly the way patients who took Glaxo Wellcome's new drug for irritable bowel syndrome, Lotronex felt. Their symptoms disappeared and the frequent trips to the bathroom stopped.

Then the unspeakable happened. The same Food and Drug Administration published information that the drug was dangerous. It ordered the manufacturer to include a warning, written in plain, simple English to the patients who took the drug about the potentially harmful effects of it, and how to recognize them. As you read the information, you make a startling discovery. The relief you found is an exact description of the symptoms that indicate a potentially fatal side-effect. As you read the above link to the Physician Information paperwork distributed by the company, you might have noticed that nowhere was this "plain, simple English" version for the patient. Despite an extensive search, this was not located on the company's website, days after the order was made by the FDA. In fact, no mention of the problems was found on the company site. If it is there, it is written in such a way that to the average person, it is impossible to locate and therefore it does no good to have it.

As I created this example, I tried to imagine how this hypothetical patient might feel. Finding relief and then finding that the relief might be a fatal flaw in the drug. How could this happen? What can be done to stop it from happening again?

Some experts have advised the Food and Drug Administration to spend more time evaluating pharmaceuticals which are intended to treat non-fatal illnesses and less time in the evaluation of those designed for patients who will die without some sort of treatment. By a longer time of evaluation, cases such as that of Lotronex might be discovered before the drug was placed on the market, and therefore lives could be saved by finding the problems and correcting them before distribution. To me this sounds reasonable. For example, the FDA is notorious for taking "forever" to approve treatments for HIV or AIDS. Even though the AIDS patient is considered terminal, a potential treatment can not be used because of administrative delays. On the other hand, drugs for less serious illnesses are rushed through and then recalled because harmful effects are discovered, after the drug is in use by the public.