No Redemption for Preemption

While Americans sit mesmerized by Sarah Palin clapping into the microphone and rambling on about Greek Columns while her daughter wipes down her youngest child's hair with her own spit, they are utterly unaware of yet another attempt by the Republican machine to steal even more of their civil rights and liberties. As if the "Patriot" Act wasn't enough, the war mongerers now want to take away your civil rights in the form of redress in the event that you or your family are damaged by dangerous prescription drugs. And while the fear mongerers are hyping the "War on Drugs" and making chemical attacks against Columbian farmers, they aren't drawing attention to the fact that three times as many people die from "legal" prescription medications every year as from illegal drugs, and that the government is getting ready to remove your right to have any recourse for the harm that is done to you by a pharmaceutical company.

That's right, "preemption" is coming soon to a theater near you. Preemption states that if a drug is approved by the FDA, that approval "preempts" the rights of citizens to litigate in state courts. The good people of Michigan have been living with this ludicrous law for the past decade. People from Michigan who had a heart attack on Vioxx lost their right to have their day in court. That is because preemption says that "if the FDA approved it it is OK," ignoring the fact that scientists have been saying that Vioxx causes heart attacks since 2000, and the FDA literally had to be beaten over the head before they came along six years later. Ditto for suicidality with antidepressants; it took a strong stance by the British organization for the regulation of prescription medications before the FDA "reopened" their files and changed their opinion on the issue. In the case of Levine v. Wyeth Pharmaceuticals, involving a musician who lost her right arm as a consequence of a medication administered to her for migraine headaches in an emergency room, the US Supreme Court will soon rule on whether FDA approval "preempts" the rights of citizens to receive any form of redress in state courts.

Prescription medications are often found to have dangerous side effects after they are approved by the FDA. That is because it takes time and the treatment of many patients before uncommon, but potentially dangerous, side effects come to light. Even members of the FDA don't want preemption; they see civil litigation as complementary to the FDA. Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, a law that allowed drug companies to pay a fee to the FDA to speed up the approval process, there has been a decline in the resources that the FDA has to monitor drugs after approval. That is because PDUFA requires a 3% yearly increase in the budget for new drug approval. Since Congress hasn't increased the FDA budget, that means the money went from monitoring approved drugs to approving new drugs.

Preemption isn't good for anyone except for the drug companies. And they are unable to come up with a coherent reason to be in favor of it, other than it will provide more money to develop "life saving drugs," and we've heard that malarkey before. If you are tired of the erosion of your rights as a US citizen, take action.

Doug Bremner MD is author of Before You Take That Pill

Comments

[minnilu]

Thank you, Dr. Bremner, for bringing this issue to the public’s attention. I am a member of ADDA, Americans for Drug and Device Accountability. We are a grassroots organization of healthcare professionals, academics, activists, and regular citizens concerned with the safety of our medicine, the health of the American public and the protection of civil rights.
Dear readers of this blog, please sign the on-line petition, “FDA Preemption = Bad Medicine,” and forward it on to every one you know. The petition can be accessed by clicking on “take action” at the end of Dr. Bremner’s piece.
Several notables have signed the petition, including Dr. Bremner and FDA scientist, Dr. David Graham. Additionally, the New England Journal of Medicine has come out against FDA preemption.
The Supreme Court will hear Levine v Wyeth this November. The consensus is Levine will lose. If FDA preemption is upheld, preemption will become the law of the land. Sadly, the American public has not been made aware of this situation. A disaster is about to happen, and we all know how difficult it is to have a Supreme Court precedent reversed. Please help. Please do it now.

[jadda]

Arianna,
Thank you for your enlightening post regarding FDA Preemption, and for including Dr. Bremner's superb article. Please sign the petition, and pass it on to everyone you know. We must all work together to inform the public of this spreading plague.

[Doug Bremner - Huffpost Blogger]

Thanks minnilu. Not to sound like sour grapes, but unfortunately this piece got a lot less "air time" (i.e showing up on the main page of the living section of the huffpost) than pieces about "finding yourself". Unfortunately most Americans don't think that this topic applies to them, but they will when they find themselves on the wrong side of a drug or device disaster, and then it will be too late, and they will be going up against a behemoth in the form of a deep pockets company. Please post information about your organization.