New England Journal of Medicine Urges the U.S. Supreme Court to be Skeptical

Peter Wetherall — Tue, 26 Aug 2008 20:33:01 GMT

Last week, physicians came to the aid of Plaintiff's lawyers, citizens of Clark County and the American consumer of prescription medication. The editors of the New England Journal of Medicine filed a "friend-of-the-court brief" in the case of Wyeth v. Levine. Readers will know the Wyeth v. Levine case is pending before the United States Supreme Court.

The New England Journal of Medicine wrote in the brief, that lawsuits can serve as "a vital deterrent" and protect consumers if drug companies don't disclose risks of their drugs. The New England Journal acknowledged that the FDA is often called the "gold standard" in drug evaluation, but the journal urged the Supreme Court justices to be skeptical. The editors stated "The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," The journal noted that discoveries made by plaintiff's lawyers through liability litigation serve an important function and that the "FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decision, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct." Many consumers recognize that importance of litigation for harmful drugs such as Vioxx, Chantix, Ketek, Reglan and Digoxin.

The editors joined 47 state attorneys general and two former FDA commissioners-David Kessler and Donald Kennedy in supporting Levine's position. The Bush Administration is supporting the position of Wyeth, and if this position is successful, the ability of a consumer to sue drug companies for harmful side effects will be non-existent.

Journal Editor, Dr. Jeffrey M. Drazen in an interview, stated that the FDA is overwhelmed in trying to keep up with drug safety problems, which can range from rare but serious side effects, to shortcomings in manufacturing plants oversees. He also said that the "court system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public.

Originally posted at InjuryBoard by Peter Wetherall

The FDA and the IRS

Peter Wetherall — Sun, 10 Aug 2008 21:17:17 GMT

Clark County residents, as well as every other American consumer of prescription drug products, should consider whether the FDA is too cozy with the industry it regulates particularly in light of the recent problems with CHANTIX, an anti-smoking pill.

The FDA depends the integrity of the data a drug company submits to determine whether the drug is safe. If the data the drug company submits is false, as is the case with KETEK, the American consumer is at great risk. (A nice analogy is this: the FDA is like the IRS. It is a self-reporting industry. If the drug company does not "report" the correct information to the FDA, then it is unlikely the FDA will discover the fraudulent reporting.)

Thanks to the diligent efforts of Rep. John Dingell (D. Mich) and Sen. Chuck Grassley (R. Iowa) and other like minded members of Congress, perhaps one day, this will change.

Originally posted at InjuryBoard by Peter Wetherall

Las Vegas Personal Injury Lawyer - Chantix

New England Journal of Medicine Urges the U.S. Supreme Court to be Skeptical

The FDA and the IRS