August 2008 ASA Meeting: Sociologist Donald Light Presents His Paper, "Institutional Foundations of the Vioxx Disaster"
(Posted by Tom Lamb at DrugInjuryWatch.com)
On August 3, 2008, at the American Sociological Association (ASA) annual meeting in Boston, Donald W. Light, PhD, MS, presented the paper, "Institutional Foundations of the Vioxx Disaster", in which this sociologist identified eight institutional foundations for likely future serious side-effect problems with some new prescription drugs approved by the FDA.
Dr. Light is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey.
According to an August 5, 2008 ScienceDaily online article, "Toxic Drugs, Toxic System: Sociologist Predicts Drug Disasters", Dr. Light's paper and presentation included these contentions:
- "Drug disasters are literally built into the current system of drug testing and approvals in the United States."
- "Recent changes in the system have only increased the proportion of new drugs with serious risks."
- "Speed-up reviews for safety have more than tripled the number of 'black box warnings' of side effects or withdrawals after drugs are on the market."
In more detail, from the August 5 ScienceDaily article:
According to Light, rather than using current approved drugs as benchmarks of efficacy, the existing testing system evaluates the effectiveness of new drugs based on their effects compared to placebos. Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the U.S. Food and Drug Administration (FDA), including black box warnings, adverse reaction warnings, or even withdrawal of the drug.
Based on this system, Light asserts that new drugs are twice as likely to harm patients as to provide them with benefits superior to existing drugs.
The current FDA drug approval picture depicted by Dr. Light certainly seems to me yet another compelling reason why any application of the federal preemption doctrine to prohibit product liability lawsuits involving prescription drugs is bad public policy.
What do you think: Should injured patients be prohibited from filing product liability lawsuits against pharmaceutical companies?