Latest Drugwonks' Blog
As a result of this policy shift, patients are now lining up and demanding the government reimburse them for the out-of-pocket expenses they incurred buying these drugs privately.
Quite frankly, these patients have been grossly wronged by the NHS and they deserve to be compensated.
While NICE has reversed its policy on top-up payment, do bear in mind that Britons are obligated to sustain the expenses "associated with the extra drugs they buy." That includes scans, tests, use of NHS staff time, etc. In other words, patients are still being kicked while they're down by the NHS.
The more things change, more they remain the same.
November 5, 2008
Apart from the fact that he will be a dart board for the stunts and ethical questions dogging him that we already know about, there are even more serious problems -- even legal problems -- that could be raised at or before his confirmation hearing, problems that his lapdogs in the MSM have eagerly ignored. I can assure those who went after Scott Gottlieb for his "conflicts" and quoted Nissen approvingly in trashing Scott, the good doctor from Cleveland has a lot of, uh, adverse events he has failed to report.
2. Following the advice of the health care experts at the Hamilton Projects
I wrote about this before: The bright idea of Harvard's Joe Newhouse and Richard Frank: "To address the stresses on the federal budget, prices paid for drugs purchased on behalf of beneficiaries previously covered by Medicaid should be reduced to near their former Medicaid levels. To limit the ability of manufacturers to name their prices of therapeutically unique drugs, a standby mechanism for establishing temporary administered prices should be developed."
Meanwhile, this from the WSJ:
Cash-Poor Biotech Firms Cut Research, Seek Aid
By JEANNE WHALEN AND RON WINSLOW
http://online.wsj.com/article/SB122523819921178005.html?mod=googlenews_wsjVolume 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.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
