Why Do I Love Drug Regulation? Simple: It Keeps Us Safe
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that drugs be tested for safety during pregnancy before they can be approved. Kelsey received an award from President John F. Kennedy for her actions, and in 2010 an annual award was established in her name at the FDA (with Kelsey being the first recipient). Incidentally, thalidomide was more recently developed into an effective treatment for multiple myeloma and for treating lesions in leprosy patients. Its use is now very carefully controlled to keep it away from pregnant women.
Many of you reading this are probably thinking, “These stories are all from years ago. What does this have to do with modern medicine? No one is selling snake oil these days. The only drugs on the market now are those that have been approved by the FDA.”
Unfortunately, this simply isn’t true. In 2006, the FDA started the Unapproved Drugs Initiative to remove unapproved prescription drugs from the market, which are mostly medicines used for coughs, colds, and allergies. The goal is to eliminate prescription medicines that have not been evaluated by the FDA for “safety, effectiveness, or quality” and which are being sold illegally. Efforts to have these drugs yanked off the market are continuing, and the list is surprisingly lengthy, with hundreds of unapproved medicines on it.
Diethylene glycol made a return visit to the annals of medical infamy in 2007 when The New York Times reported it was discovered as a counterfeit substitute for glycerin in cold medicines imported into Central America from China. It also turned up in medicines given in China and in Bangladesh. Once again, hundreds of innocent people died. This was not an industrial accident. Laboratory reports and licenses were forged in order to deceive pharmaceutical manufacturers into buying the counterfeit glycerin.
Not all problematic drugs are made by third world manufacturers. It was discovered in the late 1980s that several generic drug manufacturers had submitted falsified data on applications for their generic medicines. One approach they took to gain approvals: substitute the branded drug for testing in place of the generic drug they were planning on manufacturing. The investigation led to the suspension or recall of dozens of drugs.
Drugs that don’t work are not necessarily harmless. There are three problems associated with them. First, they may actually be toxic and injure you. Second, taking a worthless drug, even if it does no harm, may inhibit you from taking a drug that might actually provide you with some benefit. Finally, even if the drug you are taking is harmless, you are wasting money that could be used to enhance your well being in any number of ways.
Many people are familiar with the first three stages of drug approval in which a drug must clear hurdles of safety and efficacy. In some cases, drug companies are granted accelerated approval for their cancer drugs in exchange for a promise that they will complete follow-up studies to ensure that these medicines actually work. Unfortunately, pharma companies are often either late in doing these confirmatory studies, or they don’t do them at all. A 2005 study showed that follow-up data was submitted in only 9 cases out of 26 accelerated approvals for cancer drugs, some of which were shown to have serious side effects after they were approved for sale. And when drug companies do generate the data, it sometimes shows that the drug does not have a survival benefit. This happened with AstraZeneca’s non-small cell lung cancer drug gefitinib (Iressa), which led the FDA to restrict access to this medicine in 2005.
Takeda Pharmaceuticals recently announced that it is pulling its drug serrapeptase (Dazen) off the market after selling it for 40 years in Japan. The reason? Tests of the drug in 2009 revealed that it was completely ineffective; there was no difference in … Next Page »