Wyeth v. Levine ruling could be major blow to healthcare consumers

People’s Pharmacy is an excellent syndicated column that you should definitely check out if you aren’t already reading it. If it’s not in your hometown paper, you can find them online here. The writers, Joe and Terry Graedon, have been impassioned advocates for healthcare consumers for more than 30 years.

(Here’s what the Graedons have to say about Canadian pharmacies, by the way: “The FDA won’t admit it, but buying drugs from legitimate Canadian pharmacies may be safer than buying from the drugstore down the block.”} I bring up the Graedons because their column recently reminded me about a very important issue that had fallen off my radar screen.

Today, the U.S. Supreme Court is scheduled to begin hearing arguments on Wyeth v. Levine, a case that could leave consumers powerless to get redress if they are injured (or worse) by medications that don’t work as promised. Washington oddsmakers predict the pro-business justices will rule in favor of the drugmaker Wyeth over Diana Levine (pictured). Here’s an excerpt of the Graedons’ column:

Does Food and Drug Administration approval guarantee safety? If the Supreme Court rules as expected, patients might have no legal recourse if they are harmed by an FDA-approved medicine. The case that will soon be decided by the Supreme Court involves a musician who was treated for a migraine. The medicine that was injected to stop her nausea was administered incorrectly. This led to gangrene of her arm and eventual amputation just below the elbow. The Vermont Supreme Court upheld a Superior Court finding that the drug company was negligent because it did not provide adequate warning about the injection process. The manufacturer maintains that the FDA approved the prescribing information that was used and therefore the drug company has no liability. In other words, FDA approval could get the pharmaceutical firm off the hook for any complications that might arise…This case could well set a precedent for all future pharmaceutical-related litigation. If FDA approval means that drug companies are not liable, then there will be no recourse if someone experiences a serious or even deadly adverse reaction.

Anyone who’s been watching the machinations of Big Pharma and the Bush Administration over the past decade already knows the following: — The FDA has had its staff and other resources dramatically slashed in the past eight years. — Not coincidentally, the FDA has been involved in more scandal for approving dangerous drugs than at any time since its formation. — The FDA is infested with Big Pharma lobbyists, further tying its hands to adequately regulate potentially dangerous medications.

In this environment, where Big Pharma is pushing drugs through the FDA with less resistance than ever, where staff is stretched thin and conflicts of interests are pervasive, do we really want to give Big Pharma a free pass if the FDA approves (as it inevitably will) another drug that turns out to be harmful? I sure don’t. FDA approval should be the floor, not the ceiling, when it comes to consumer protection. You can read more about the Levine case — and how we reached this point — here. If you’re not already familiar with the case, I’m guessing it will make your blood boil.

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