Newer isn’t always better
According to news reports, Donald Light, a sociologist and professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, says that newer isn’t always better when it comes to drugs and that “fatal flaws” exist in the process of testing new drugs that may put consumers at risk of serious injury or death. In a study conducted by Light that will be presented at a future American Sociological Association meeting, he alleges that out of every seven new drugs that comes on the market, only one is superior to a similar existing drug and that two of the seven result in serious side effects which may lead the FDA to issue black box or other warnings or even to withdraw the drugs from the market altogether.
Why the process doesn’t work
According to Light’s study, there are two reasons why the process doesn’t work. The first is that clinical trials of drugs are compared to placebos instead of a similar, existing product, so as long as a drug works better than the placebo, it is considered “effective.” The second is that many drug manufactures conduct their clinical trials in ways that will “minimize” any adverse effects, such as not conducting trials for an appropriate amount of time to discover the drug’s true side effects. Light’s conclusions seem to agree with other studies.
The FDA bases much of its decision on whether to approve a drug on the clinical trials conducted by the manufacturer itself. Critics of the FDA’s procedures say that drug companies understand that the FDA is understaffed and under funded to adequately direct the process – especially with the staggering number of new drugs that seek approval every year.
Consumers pay the price
Unfortunately, consumers end up paying the price for the information not gathered before a drug is approved for use and many feel as though drug companies should be ultimately responsible for their products regardless of the FDA’s requirements or actions. If you’ve been injured due to a drug, contact a lawyer whose practice focuses in this area of the law to discuss your situation free of charge. There is no obligation and the consultation is strictly confidential. To contact one of our experienced lawyers, please click here. We may be able to help.