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JAMA Editors Support Patients in Upcoming Federal Preemption Case

Posted on October 27, 2008

Coming up next week is an issue that affects all Americans who take any kind of drug- virtually all of us.

The case is Wyeth v. Levine and it will be before the U.S. Supreme Court on November 3rd. Now a prestigious medical journal is taking the side of consumers, which puts them squarely against the pharmaceutical industry. That’s a rare position for doctors to take.

In this case, Diana Levine, 62, was given a Wyeth drug for a migraine after she was taken to an emergency room. The Wyeth drug was a secondary drug given to minimize nausea. Now Levine wishes she had opted for the nausea.

Wyeth’s label doesn’t warn against administering the drug as she received it, through something called an IV push. The drug turned her arm gangrenous then she lost much of her right arm, a terrible tragedy for a musician.

Wyeth was sued by Levine. She won in court, almost $7 million. Wyeth said, wait a minute and appealed. Levine won that too. Now Wyeth it taking the issue to the highest court in the land hoping for a favorable outcome.

Wyeth argues that since the warning label was approved by the FDA that the FDA has the final word on the label, its safety and efficacy, that state courts, in this case Vermont, shouldn’t be allowed to question the federal authority. In essence, the feds preempt state authority.

The endorsement from the medical community comes from the editors of the Journal of the American Medical Association (JAMA).

They say, in a nutshell that the government cannot possibly protect the public from the potential downsides of drugs that enter the market. Sometimes not enough testing has been done. Sometimes the results have been faked, or withheld from FDA regulators. The approval process is an “inexact and incomplete science” the doctors write.

“Given the current imperfect process for approval and the flawed postmarketing surveillance system, the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications.”

Given a subpoena and an order to submit documentation is the most likely way to find out what is really happening behind the boardroom doors.

“Thus, tort law serves in effect as a way to close regulatory gaps in the FDA premarketing approval process and to provide a mechanism for postmarketing surveillance. Moreover, litigation has been a rich source of information about how drug and device manufacturing companies behave, such as with off-label promotion, guest and ghost authorship, and reporting of safety findings.”

Without information gathered in court many of the behavior by drug companies would stay hidden.

Until the system for reviewing drugs improves, patients who are wronged need to be able to seek a remedy, a reimbursement for injury, and answers to the dangers of the drugs for the sake of others, in court.

Doctors too realize if they don’t stand beside the safety of their patients, they too could be on the hook for unsafe drugs.