Latest Drugwonks' Blog
Volume 359:1977-1981 November 6, 2008 Number 19
The timing of an announcement will, IMHO, demonstrate how seriously the new administration views the FDA's role in both protecting and advancing the public health.
One prediction I will hazard to offer is that the next FDA Commissioner will not be Steve Nissen. He is widely disliked within the agency and is, as those in the know know, quite conflicted.
Barack Obama's election as President tells us a lot about what kind of ball player he was. The next four years will be a reflection of his leadership, his self-confidence and response to events. And nothing else. Now let's stop the thumb sucking and get down to business.
It’s Wednesday. I woke up. I shaved and drove to work. My EZPass still worked.
T
http://www.medicalchoiceforaz.com/about/
Here's a movement worth spreading nationwide...
Thank you Dr. Mill.
Remember Utilitarianism? It’s the philosophy based on the principle of utility -- that the moral worth of an action is solely determined by its contribution to overall utility. And the poster boy of the
i. that systematised value assessment would not simply serve the interests of a free-market competitive contest but might tend to be captured by regulatory agencies which have predominantly purchaser-side responsibilities; and
ii. that the need to satisfy pre-established criteria of value could in due course have profound effects on the dynamics of a private-industry innovation system.”
“At the root of its operations is a Benthamite approach to health benefits. For NICE, value equates to social utility, the optimisation of which informs all of its judgements. Some of NICE's decisions may seem cruel in human terms, and ill-advised in public relations terms, but there is an arid logic to them which can usually be seen at work.”
“NICE's decision to withhold approval of donepezil from patients with mild Alzheimer's disease, on the grounds that an insufficiently high percentage of patients would benefit, while the drug was approved for patients who had progressed beyond the mild stage, was widely ridiculed. Why, it was asked, do we not allow the drug to do some good when patients are still enjoying some quality of life, rather than restricting it to use when a poor and declining quality of life can be only marginally reversed?”
To view Mr. Jones' full commentary, click here.
Legal Side Effects
Diana Levine's story is gut-wrenching. It's also the sort of case that makes bad law, which is why Monday's Supreme Court oral argument in Wyeth v. Levine is important for consumers and drug development in America.
A professional guitarist who suffered from migraines, Ms. Levine went into a clinic in April 2000 for an injection of Phenergan, an antinausea drug produced by Wyeth Pharmaceuticals. The clinic administered the drug by what the label described as the "preferred" method -- "deep intramuscular injection." When that didn't help her symptoms, the clinic injected another dose directly into her arm -- a technique known as "IV push." As the label warned, this was dangerous. If Phenergan is accidentally injected into an artery instead of a vein, gangrene can quickly set in and lead to amputation. To avoid this, the drug's label described in detail how to administer an intravenous injection.
Even so, the worst happened. Gangrene set in and Ms. Levine lost her right hand and forearm. She sued the clinic, which settled the case. But then she sued Wyeth in Vermont state court. She argued that Wyeth should have warned health-care providers never to attempt IV-push injection because "other, safer methods" were available. She won, and the Vermont Supreme Court upheld the $6.7 million verdict.
In Wyeth v. Levine, the issue is whether a drug company that had sought and received all the necessary approvals from the Food and Drug Administration, and had labeled that drug in accordance with FDA requirements, can still be held liable under state law. This is not a case about whether a drug company concealed evidence or other misconduct. The FDA-approved label for the drug specifically warned against the risk that became Ms. Levine's reality.
But this case is not just about Ms. Levine. It is about a drug-approval system that balances the risks of treatments against the risk of not being treated at all. And a jury, faced with a single sympathetic plaintiff, is in no position to rule on the correctness of those FDA judgments. The Supreme Court ruled as much in February in Reigel v. Medtronic, a similar case involving medical devices. Justice Antonin Scalia argued for the 7-2 majority in Reigel that a jury "sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Though the tort bar lost that case, Ms. Levine's lawyers are arguing that the relevant federal devices statute explicitly mentions pre-emption, while the drug statute does not. But this is a red herring. As Ms. Levine's lawyer admitted at oral argument, the question in Wyeth is not whether any state-law tort claim was pre-empted by FDA regulation. The question is whether, in a case in which the FDA has made one determination about safety, a state jury should be permitted to come to another. As Justice Scalia put it yesterday, "If you're telling me the FDA acted . . . irresponsibly, then sue the FDA."
Chief Justice John Roberts asked former Solicitor General Seth Waxman, who argued the case for Wyeth, whether this case could be distinguished from Reigel on these grounds. Mr. Waxman's response goes to the heart of this case: "A jury was asked to look at the same information [that the FDA had] and conclude that the precise language that the . . . FDA required Wyeth to use rendered that drug unreasonably unsafe." In other words, the jury is being asked to look at a situation where the worst has happened, and the risks have been realized, and to decide whether the FDA made the right call. This would all but guarantee that the drug companies would be sued whenever a known risk becomes actual in a particular case.
The U.S. drug approval system is imperfect, and the FDA makes mistakes -- most of which involve blocking or slowing drug therapies that could save lives. Congress created that system and asks drug companies to spend some $1 billion per drug and wait years to gain approval. It amounts to double jeopardy to say, even if you do all those things right, and disclose all the known dangers and label the drug as ordered by the FDA, that you can still get sued if something goes wrong because someone else made a mistake.
If a known and disclosed medical risk can still lead to a law suit, drug companies can literally be sued for anything. No doubt there are trial lawyers and Democrats in Congress who would prefer it that way. But if we want state juries second-guessing the FDA at every turn, let's pass a law in broad daylight so everyone knows whom to blame when drug innovation stops cold.
From today’s New York Times:
Justices Weigh Effect of F.D.A. Approval of Drug Labels on Suits in State Courts
By ADAM LIPTAK
The case, Wyeth v. Levine, No. 06-1249, concerns an implied form of the doctrine of pre-emption, which bars state lawsuits from people injured by products that met federal safety standards. The drug law at issue in the case says nothing about pre-emption, and the question before the court was whether the Food and Drug Administration’s approval of drug labels should knock out state lawsuits contending that the labels did not contain adequate warnings.
A broad endorsement of implied pre-emption based on regulators’ actions rather than on statements in laws enacted by Congress could shut down countless injury suits in cases involving not only drugs but also motor vehicles, household products, chemicals and agricultural products.
Several justices appeared open to the idea that pre-emption could follow from the F.D.A.’s approval of a drug label — but only if drug companies remained subject to lawsuits if they failed to disclose new information about potential risks. There was much discussion of what information should be considered new.
Other justices seemed prepared to allow pre-emption — but only if the drug agency had considered the particular risk before approving the label.
Given the justices’ interest in those refinements, the court seemed unlikely to rule broadly on the larger issues in the case: whether the agency and other federal regulators set minimum safety standards that states are free to augment or whether they make judgments about the optimal balance between risks and benefits that states must follow.
In February, however, an eight-justice majority of the court ruled, in Riegel v. Medtronic, that suits concerning injuries caused by medical devices were pre-empted by a 1976 federal law. But the underlying law in Riegel required pre-emption, in so many words; in the jargon, it involved “express pre-emption.”
The plaintiff in the case argued on Monday, Diana Levine, lost her arm after being injected with a Wyeth drug, Phenergan. The drug is safe, Ms. Levine’s lawyers said, when administered by intramuscular injection or by intravenous drip. But they said that efforts to inject the drug directly into a vein carry enormous risks.
A
Ms. Levine settled with the clinic and sued Wyeth, saying the company should have added a warning telling doctors not to use the risky method.
Seth P. Waxman, a lawyer for Wyeth, said the company had provided “ample, lavish warnings” about the risks involved and left it to medical professionals to make the ultimate judgment about how to administer the drug.
Justices Samuel A. Alito Jr. and Ruth Bader Ginsburg both questioned the cost-benefit calculation that allowed the drug to be administered by IV push.
“On the benefit side of this you don’t have a life-saving drug, you have a drug that relieves nausea,” Justice Alito said. “On the risk side, you have the risk of gangrene.”
Justice Antonin Scalia said that what mattered was not whether the agency’s decision was sound but whether it had addressed the issue at all. “If you’re telling me the F.D.A. acted irresponsibly,” Justice Scalia told Ms. Levine’s lawyer, David C. Frederick, “then sue the F.D.A.”
Chief Justice John G. Roberts Jr. tried to boil down Mr. Frederick’s argument to a simple test. If the F.D.A had considered the risks involved in IV-push administration, Ms. Levine would lose; if the F.D.A. had not considered those risks, Ms. Levine would win.
Mr. Frederick said Ms. Levine would win under that analysis, saying the F.D.A. had never specifically compared the risks of methods of intravenous administration.
Mr. Waxman said he understood that “members of this court are concerned about applying a broad, vague or freewheeling analysis.” But Ms. Levine’s case, he added, is in the “heartland” of implied pre-emption, given that the jury had awarded damages for Wyeth’s failure to alter the very drug label the F.D.A. had approved.
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