Public Outcry for FDA Reform

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High-profile, deadly and previously undisclosed side-effects of mass-marketed prescription medications like Vioxx and Avandia have consumer watchdog groups, medical professionals and the public at large wondering if the U.S. Food and Drug Administration can stem the tide of "bad medicine." Most people think of the FDA as the gatekeepers of our country's food and medical supplies - there to prevent any harm from befalling us, responsible for making sure that only the highest quality products hit the marketplace. Unfortunately, in its quest to be better, the FDA may have hindered its own effectiveness.

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The FDA's rigorous testing and regulatory procedures are at cross purposes sometimes.

Obviously, a goal of the FDA is to get new medications, particularly those attempting to stave off terminal illnesses like heart disease or certain cancers, onto the market quickly. That altruistic purpose - speeding treatment to ailing patients - can be a double-edged sword, though, resulting in inadequate investigational trials that do not disclose harmful side effects.

Comprehensive clinical trials involve thousands of patients and regularly last for years.

Both the drug manufacturers and the FDA have a vested interest in ensuring patient safety, so the process of having a medication certified and put into the stream of commerce is a long and arduous one. Shortening that process for any reason can mean that proper steps were not taken to fully investigate the effects that the medication has not just on the illness, but on the entire body.

Drugs that are designed for one distinct purpose - like Vioxx (used to treat arthritis pain) and Avandia (to minimize the effects of diabetes) - can severely impact a seemingly unrelated body part, so studies must account for the fact that 99 percent of readily available prescription medications are not localized in nature.

Is the FDA Even Listening?

It has recently come to light that the FDA's reputation for dragging its feet when responding to complaints about unexpected side effects being linked to a medication - even when the information comes from its own experts - is likely a well-deserved one.

FDA staffers tried to warn the agency about issues with both Vioxx and Avandia by communicating their concerns up the internal chain of command, but to no avail. Some blame this on the fact that the FDA's complex operating structure has complaints going to the Center for Drug Evaluation and Research - the same organization that performs the quality assurance testing in the first place.

What may initially appear to be a wonder drug that will save the world could end up doing much more harm than good. The FDA is the eyes and ears of hundreds of millions of patients and doctors around the country - they must learn that in order to properly police the marketplace, they must first police themselves.

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