The FDA’s system for approving drugs is fatally flawed. So is the process that the FDA uses to make vital information about approved drugs available to doctors. As a result of these two broken approaches, every year thousands of Americans suffer serious personal injuries and wrongful deaths from the side effects of prescription medications.
The biggest and most obvious problem with the system is that it lacks impartiality. Many consumers probably believe that some branch of the United States government conducts thorough, rigorous, and unbiased tests on every drug before granting approval, but that’s not how the system works. Instead, pharmaceutical companies do their own testing on their own products, and they then submit their results to their friends at the FDA.
As the track record for this system clearly shows, many drugs that should never have received FDA approval have harmed and killed the people who have turned to them for help. Vioxx and Bextra are 2 bad examples.
Vioxx, a painkiller from Merck, was on the market for just 5 years before thousands of reports of heart attacks and strokes led to its withdrawal from the market. Bextra, a non-steroidal anti-inflammatory, lasted only 3 ½ years before the same sorts of cardiovascular problems caused the FDA to ask Pfizer to remove it from the market. If the system of testing and approval worked properly and if impartial researchers conducted the studies, those dangerous drugs never would have been allowed to harm people.
That’s the first flaw in the system, but it’s not the only one. In addition to doing their own testing, the pharmaceutical companies write the information on the labels that come in the packages. These labels are the primary source of information about a drug for the doctors who will prescribe it, and the labels frequently fail to provide doctors with all the information that they need in order to make the best decisions for their patients.
The label may tell the truth, but not the whole truth, and the part of the study that the label leaves out will never be something that will help to increase sales of the drug.
A good example is the label on Lunesta, which is supposed to help people sleep longer and better. Reporters for the New England Journal of Medicine analyzed important information from the studies on Lunesta that did not appear on the label. According to the report, that missing information showed that “On average, Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness or functioning.”
So, the benefits of taking Lunesta are minimal, but that information is not on the label, and many other drugs have received approval with similarly unimpressive credentials.
In 2008, Donald Light, a sociologist and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, delivered a paper called “Institutional Foundations of the Vioxx Disaster” to the American Sociological Association. In his paper, he warned that “Drug disasters are literally built into the current system of drug testing and approvals in the United States.”
Light’s analysis found that only one in seven new drugs is better than existing drugs, but two in every seven new medicines have such serious side effects that they lead to personal injuries, wrongful deaths, and FDA actions such as Black Box warnings, adverse reaction warnings, and outright withdrawals of drugs that the FDA itself had approved.
This entire system needs to change. The FDA must do a much better job of reviewing drugs and of getting all the information from trials to the doctors who write the prescriptions. If the drug companies would act in the best interests of their customers, doctors would know all the facts about the drugs that they prescribe, but that’s not how the system works. The drug companies use the system to their advantage, and consumers suffer and die.
Regardless of what the FDA requires, pharmaceutical companies have an obligation to keep dangerous drugs off the market and to provide doctors with all the information that they need to make the right choices for their patients. If you have suffered a personal injury because of a dangerous drug or because a drug company chose not to tell the whole truth on a label, call us to find out if we can help. We are specialists in drug litigation and have the record to prove it.
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Onward,
Richard Alexander
