NEJM Editors Enter Supreme
Court Fray Over Drug Risks
FDA isn’t a reliable gatekeeper as it has
been given over to the industry it regulates

Alicia Mundy

In a first, the current and former editors of the New England Journal of Medicine have banded together and plunged into an escalating legal battle over how much FDA’s approval of drugs should shield their makers from liability claims under state laws. The influential doctors take the side of plaintiffs, arguing that lawsuits are a needed check to protect consumers from dangerous medicines.
A case called Wyeth v. Levine is on the docket at the Supreme Court in United States this fall, and the editors and four big-name contributors to the journal have filed a brief in support of the plaintiff, Vermont musician Diana Levine who lost an arm after an injection of the nausea drug Phenergan. She claims Wyeth failed to adequately warn of the drug’s risk and won a judgment of $6.8 million in a Vermont trial. The NEJM signers say it’s the first time that the full roster of current and former editors of the journal has come together on a court brief. Wyeth, the drug industry and the feds take the position that FDA’s rules should trump any state laws, and that the judgment of FDA experts shouldn’t be second-guessed. The case will test this legal doctrine, called preemption, for prescription drugs.
The NEJM posse points to a string of problems with drugs as evidence that second-guessing the FDA is good public policy. In particular, they cite 23 drugs withdrawn from the market since 1997, including Merck’s Vioxx, Wyeth’s Redux and Pfizer’s Rezulin. “These examples demonstrate that the FDA alone cannot be the guarantor of drug safety,” the brief says.
In a particularly interesting twist, former NEJM editor Marcia Angell, for years the bane of trial lawyers, signed the NEJM brief supporting the rights of plaintiffs to press their cases. Angell had famously denounced junk science invoked in liability suits over breast implants in a book called “Science on Trial.” Though, we have to point out she more recently wrote a book blasting drugmakers: “The Truth About the Drug Companies: How They Deceive Us And What To Do About It.”
Lawsuits, she told the Health Blog, are now the only deterrent against misbehavior by drug companies because the FDA isn’t a reliable gatekeeper. “The FDA has been given over to the industry it regulates,” Angell said. Companies are “putting drugs on the market with insufficient evidence of safety, and keeping them there even where clear evidence of risk emerges — and the FDA has not take decisive or fast action.”
FDA Commissioner Andrew von Eschenbach has said that his agency is independent and is working to respond faster to adverse information about drugs. But two former FDA Commissioners, David Kessler and Donald Kennedy, filed a separate amicus brief for Levine also criticizing the FDA, which they say cannot “police the market on its own.”
Another brief for Levine signed by a former FDA official questions FDA behavior involving Sanofi-Aventis’s Ketek and GlaxoSmithKline’s Avandia. Industry, consumer groups and tort lawyers have been in amicus madness the last month. The tort bar is helping underwrite several briefs for Levine. There are some unusual bedfellows. On Wyeth’s side, the American College of Emergency Physicians co-signed a brief by the Washington Legal Foundation, a well-funded pro-business group. WLF’s brief argues against the dangers of “over-warning” on drugs and food. The ER docs are concerned about the high costs of lawsuits.
Linda Lawrence, president of the 26,000-member ACEP, told the Health Blog, “Medical providers should be held to medical standards, not to what a jury says.” Some members of ACEP objected to joining WLF on the brief, but Lawrence says they don’t appreciate the facts in the case. “We’re following FDA guidelines but then we get dragged into these suits,” she said.
 

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