Drug Approval System in U.S. Built on "Disasters"
As reports of defective drugs and the tragic injuries, illnesses and deaths of using these drugs continue unabated, it's beginning to become crystal clear that something is wrong at a basic level with the drug system in America.
The fact that consumers have legal recourse in the form of defective drug lawsuits is a clear benefit given by the U.S. legal system, but the fact that so many of these consumers have to turn to the law for redress suggests that more should be done prior to ensure drug safety prior to going on the market.
However, nowhere was this need for fundamental change presented so bluntly than in a research presentation at the 2008 American Sociological Association meeting in early August.
The presentation by Donald Light, a sociologist and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, painted a brutal picture of the FDA approval system, describing the vetting process as deeply flawed and leaving consumers as helpless guinea pigs in drug company experiments.
As Light memorably put it in his presentation, "Drug disasters are literally built into the current system."
As Light's presentation concludes, the expectation of injuries and deaths is built into the current drug testing system.
Many experts point to the fact that one out of seven new drugs is an improvement over existing medications; yet Light points out that the flipside of that improvement is that two out of every seven new drugs carry the risk of serious side effects. (The "serious" side effect would be one that results in Black Box warnings by the FDA, adverse reaction warnings, and even a complete withdrawal of the defective drug from the market in some cases.)
Overall, reports of defective drugs tripled from the decade spanning 1995 to 2005.
Vioxx: The Defective Model in Action
Light centered his presentation on what he called the worst drug disaster in the FDA's history: Vioxx.
Building upon FDA estimates, which put the number of patients treated with Vioxx who suffered heart attacks, strokes and sudden death at 32,000, Light claims in fact that 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.
Light concluded that Vioxx was simply "a pain pill that no one needed," despite claims of its effectiveness in patients with gastrointestinal problems.
In fact, Light quotes a statement from the editors of the New England Journal of Medicine indicating that Vioxx caused one death for every gastrointestinal bleeding incident prevented.
More Startling Facts about Prescription Drugs and the FDA
But even though Vioxx is the centerpiece of his argument, Light acknowledges that Vioxx is just the latest in a pattern of behavior intended to downplay serious side effects and potential defects.
Since the 1950s, drug companies have repeatedly discredited or denied research linking up-and-coming drugs to serious side effects.
And, according to Light's research, when a drug is banned in the West, drug companies will continue to market the same defective drugs in Africa, Asia and Latin America with inadequate warnings or no warnings at all.
This accounts for the fact that Vioxx resulted in more than one million more cardiac events outside of the United States despite domestic reports of side effects.
Skewing the Results of Drug Trials
However, the most controversial piece of Light's presentation is his charge that drug companies deliberately skew trials on new drugs to push them through the approval process. For example, in order to minimize evidence of toxic side effects, samplings are taken from a population of people who are healthier than the typical patients who will actually be treated with the drug after FDA approval.
As a result, when the drugs are used by those with weaker constitutions, such as chronically ill individuals and the elderly, any tendency towards side effects is magnified, resulting in more damaging side effects.
Furthermore, long-term side effects are often undetected by the short-term trials required by the FDA.
FDA Complicity in the Broken Drug System
While drug companies receive the brunt of Light's criticism, the FDA does not get a free pass according to Light's view on the system.
Safety reviews on new drugs are now conducted faster than ever, he claims. In the rush to bring new drugs to the market, the FDA has resorted to its Black Box warnings more than ever that alert consumers to potential dangers after the drugs have gone on the market.
In the background of Light's frank portrayal of a broken drug approval system is a major upcoming Supreme Court decision that will affect the drug approval process greatly.
In November, the Supreme Court will be ruling on the concept of preemption, which is the rule that FDA approval of a drug would be the final word on defective drug lawsuits. If the court rules in favor of preemption, it will mean that if a consumer has adverse effects with a drug that has been approved by the FDA, they will not be able to pursue a lawsuit through state laws.
Considering that the Supreme Court decided in favor of preemption for defective medical devices, the legal avenue for gaining compensation from drug companies for defective drugs seems to be closing in a hurry.
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