Drug Companies Play Fast and Loose With FDA Rules
By Gerri Elder
Some evidence recently presented at the annual meeting of the American Sociological Association has raised some eyebrows.
According to a report by Pharmalot, the research presented at the 2008 meeting in early August showed that Americans are being recklessly used as human experiments with FDA-approved drugs. It was revealed that people in the United States who take prescription medications are likely to experience nasty side effects due to flaws in testing and marketing procedures.
Thanks to FDA preemption, patients who are injured by drugs that have been approved by the FDA are usually not able to file personal injury lawsuits against the drug manufacturer. The evidence examined at the American Sociological Association meeting seems to indicate that drug companies are taking full advantage of this protection.
Donald Light, a sociologist and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, spoke at the meeting. Light said that disasters resulting from the use of prescription drugs are expected. This is because the expectation of injuries and deaths is built into the current system of drug testing and FDA approvals.
Additionally, according to Light, it's only getting worse. Recent changes in the FDA approval process have served to increase the proportion of new drugs that carry risks for serious injuries, illnesses and deaths.
Although research and reviews have concluded that one out of seven new drugs is an improvement over existing medications, there is a flip side. Two out of every seven new drugs carry the risk of serious side effects. These side effects have been proven to be serious enough to warrant Black Box warnings by the FDA, adverse reaction warnings, and in some cases even a complete withdrawal of the defective drug from the market.
Based on the information that is currently available, Light draws the conclusion that new drugs approved by the FDA are twice more likely to cause injuries to patients than to provide superior benefits over existing drugs.
Vioxx - A True Drug Disaster
The prescription drug Vioxx was a prime example that Light used in his presentation. Light referred to Vioxx as the worst drug disaster in history.
The FDA estimated that 32,000 patients who were treated with Vioxx suffered heart attacks, strokes and sudden death as a result of the defective drug. However, Light says that there were 953,000 cardiac events in the United States associated with the use of Vioxx and as many as 1.9 million worldwide.
More Startling Facts about Prescription Drugs and the FDA
According to Light, Vioxx is far from the first dangerous drug that was approved by the FDA. He says that since the 1950s, drug companies have repeatedly discredited or denied serious injuries and complications associated with prescription drugs and continued selling them. Light's presentation asserted that drug testing meets only minimal requirements and is unsystematic and biased.
Light also alleges that when certain drugs were banned in the West, the drug companies continued to market the same defective drugs in Africa, Asia and Latin America without warnings about the dangerous side effects.
Light's thesis contends that the testing, approval, marketing and regulation of prescription drugs routinely cause injury and death to patients.
Other Points Highlighted At The Meeting:
- Prescription drug side effects are the 4th leading cause of death and are responsible for 1.5 million hospitalizations each year in the United States.
- Approximately 4 million hospitalizations worldwide are the result of prescription drug side effects.
- Adverse event reports to the FDA tripled from 1995 to 2005.
Skewing the Results of Drug Trials
Light's presentation also alleged that drug companies design drug trials to deliberately skew the results. According to Light, in order to minimize evidence of toxic side effects, samplings are routinely taken from a population of people that are healthier than the typical patients who will actually be treated with the drug after FDA approval.
During these drug trials, people who are elderly, indigent or who have multiple health problems are purposefully excluded. The trials are also only run long enough to determine the main effects of the drug, but not the long-term side effects that may occur.
FDA approvals are based on this limited and biased data, and therefore drugs that may have dangerous side effects are sometimes approved.
Safety reviews on new drugs are now conducted faster than ever. As a result, the number of Black Box Warnings of potentially serious side effects or withdrawals of drugs on the market has tripled.
Light says that the harm-benefit ratio of prescription drugs is worsening due to these speedy safety reviews and relaxed rules that now allow drug companies to market drugs for uses that have not been approved by the FDA.