Hip Device Phaseout Followed F.D.A. Data Request
By BARRY MEIER
Johnson & Johnson executives decided in 2009 to phase out a hip implant and sell off its inventories for use in patients just weeks after the Food and Drug Administration asked the company in a letter for added safety data about the implant, administration documents and corporate records show.
At the same time, the agency told the company that blood tests of some patients who got the all-metal hip showed a “high concentration of metal ions” that it found “concerning,” according to the F.D.A. letter, obtained by The New York Times under the Freedom of Information Act.
Officials also wrote that reports from countries where the implant was then being used showed it was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated. By mid-2009, for example, data from Australia showed that the device was failing at high rates just a few years after implantation, rather than lasting 15 years as expected.
Single-Payer and the Supreme Court
When the Supreme Court begins its extraordinary three days of hearings on the constitutionality of the Affordable Care Act, one of the oddities will be an amicus brief challenging the act’s individual mandate from 50 doctors who support national health insurance. They point out the inconvenient truth that, contrary to the administration’s representations, the government did not need to require citizens to purchase insurance from private companies in order to meet its goals of serving the health-care needs of the populace. Congress could have enacted a single-payer law.
http://prospect.org/article/single-payer-and-supreme-court
Could This Be the End of Health Care Reform?
By EZEKIEL J. EMANUELEzekiel J. Emanuel on health policy and other topics.
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What if the Supreme Court declares unconstitutional the Affordable Care Act’s requirement that everyone buy health insurance? What if it strikes down all the act’s insurance provisions, including the requirement that insurance companies cover everyone, regardless of pre-existing illnesses? Would this totally put an end to the health care reforms we have passed in the last three years?
Absolutely not.
The essence of the case the Supreme Court will begin hearing on Monday is whether, invoking its powers in the commerce clause of the Constitution, Congress can require individuals to purchase health insurance or pay a penalty. I believe the mandate is constitutional, but no matter how the court rules, many health care reforms that were approved by Congress through the Affordable Care Act and other recent bills — like those to promote electronic health records, encourage coordinated care, reduce medical errors and cut costs — will proceed.
Implications Are Far-Reaching in States’ Challenge of Federal Health Care Law
By ROBERT PEAR
WASHINGTON — A major issue in the Supreme Court battle over the new health care law is whether Congress can force states to make a huge expansion of Medicaid, to add millions of low-income people to the rolls.
States say the federal law is unconstitutionally coercive because all their Medicaid money would be at risk if they flout the new requirement.
The states’ argument has implications that go far beyond health care. It raises questions about Congress’s ability to attach conditions to federal grants to the states for other purposes, like education,transportation, law enforcement and protection of the environment.
The implications for the health care overhaul are also enormous. The Congressional Budget Office says that about half of the people expected to gain coverage under the new law — 16 million of the 31 million people — will get it through Medicaid.
The Obama administration denies coercion and says the terms of the deal are exceedingly generous to states.
Steps Set for Livestock Antibiotic Ban
By GARDINER HARRIS
The Obama administration must warn drug makers that the government may soon ban agricultural uses of some popular antibiotics that many scientists say encourage the proliferation of dangerous infections and imperil public health, a federal magistrate judge ruled on Thursday.
The order, issued by Judge Theodore H. Katz of the Southern District of New York, effectively restarts a process that the Food and Drug Administration began 35 years ago, but never completed, intended to prevent penicillin and tetracycline, widely used antibiotics, from losing their effectiveness in humans because of their bulk use in animal feed to promote growth in chickens, pigs and cattle.
The order comes two months after the Obama administration announced restrictions on agricultural uses of cephalosporins, a critical class of antibiotics that includes drugs like Cefzil and Keflex, which are commonly used to treat pneumonia, strep throat and skin and urinary tract infections.
Siobhan DeLancey, an F.D.A. spokeswoman, would not say whether the government planned to appeal. “We are studying the opinion and considering appropriate next steps,” she said.
Mitt Romney names health advisory board - Nation - The Boston Globe
Republican presidential candidate Mitt Romney addressed supporters during a "Repeal & Replace Obamacare" campaign in Metairie, La., today.
WASHINGTON - On Friday, the two-year anniversary of President Obama’s health care law, Mitt Romney ramped up his criticism of the plan by calling it an “unfolding disaster,’’ while also announcing a new advisory board that would help guide the former Massachusetts governor’s health care policies.
“It was always a liberal pipe dream that a 2,700-page, multitrillion dollar federal takeover could actually address the very serious problems we face with health care,’’ Romney said in Metairie, La., with a “Repeal and Replace Obamacare’’ sign behind him. “Sadly, the law itself is fast becoming the national nightmare that I and other critics have always predicted.’’
Obamacare’s contract problem
By George F. Will,
On Monday the Supreme Court begins three days of oral arguments concerning possible — actually, probable and various — constitutional infirmities in Obamacare. The justices have received many amicus briefs, one of which merits special attention because of the elegant scholarship and logic with which it addresses an issue that has not been as central to the debate as it should be.
Hitherto, most attention has been given to whether Congress, under its constitutional power to regulate interstate commerce, may coerce individuals into engaging in commerce by buying health insurance. Now the Institute for Justice (IJ), a libertarian public interest law firm, has focused on this fact: The individual mandate is incompatible with centuries of contract law. This is so because a compulsory contract is an oxymoron.
The brief, the primary authors of which are the IJ’s Elizabeth Price Foley and Steve Simpson, says that Obamacare is the first time Congress has used its power to regulate commerce to produce a law “from which there is no escape.” And “coercing commercial transactions” — compelling individuals to sign contracts with insurance companies — “is antithetical to the foundational principle of mutual assent that permeated the common law of contracts at the time of the founding and continues to do so today.”
http://www.washingtonpost.com/opinions/obamacares-rewriting-of-contract-law/2012/03/23/gIQAVuFmWS_print.html
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