A.M. Vitals: Case Claiming Individual Mandate is Unconstitutional to Proceed

Case to Proceed: A federal judge says the assertion by 20 states that the health-care overhaul law’s individual coverage mandate is unconstitutional is “a plausible claim,” the WSJ reports. Judge Roger Vinson of U.S. District Court for the Northern District of Florida is permitting the states’ case to go forward. He was more skeptical about the claim that the expansion of Medicaid included in the bill is also unconstitutional, but permitted it to go forward as well. The case is likely to make it to the Supreme Court, the WSJ says.

Offering Suggestions: UnitedHealth Group suggests that to save money, health benefits for the nine million people eligible for both Medicare and Medicaid should be administered via managed-care plans, Bloomberg News reports. The insurer issued a report proposing several measures for Medicare and Medicaid it says can save $3.5 trillion over the next 25 years.

FDA Reversal: The FDA said it shouldn’t have allowed the Menaflex knee implant to reach the market because political influence affected the approval process, and is now revoking its approval of the device, the WSJ reports. As the paper wrote in 2009, the implant, made by ReGen Biologics, was approved following a lobbying campaign by four members of Congress — even after FDA staff questioned its safety and efficacy. ReGen says it’s weighing its options, which include an appeal of the decision.

Fighting Bacteria?: Chiquita Brands’ Fresh Express, which makes bagged salad mixes, says washing greens in a mixture of two organic acids — rather than the usual chlorine — is a more effective way to kill off potentially dangerous bacteria, the New York Times reports. The company will switch to the FreshRinse wash and will also license it to other producers; food-safety experts tell the NYT that without published data, it’s impossible to verify the wash’s effectiveness. Fresh Express has recalled packaged greens three times this year over bacterial contamination worries, the NYT says.

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A.M. Vitals: Case Claiming Individual Mandate is Unconstitutional to Proceed

Case to Proceed: A federal judge says the assertion by 20 states that the health-care overhaul law’s individual coverage mandate is unconstitutional is “a plausible claim,” the WSJ reports. Judge Roger Vinson of U.S. District Court for the Northern District of Florida is permitting the states’ case to go forward. He was more skeptical about the claim that the expansion of Medicaid included in the bill is also unconstitutional, but permitted it to go forward as well. The case is likely to make it to the Supreme Court, the WSJ says.

Offering Suggestions: UnitedHealth Group suggests that to save money, health benefits for the nine million people eligible for both Medicare and Medicaid should be administered via managed-care plans, Bloomberg News reports. The insurer issued a report proposing several measures for Medicare and Medicaid it says can save $3.5 trillion over the next 25 years.

FDA Reversal: The FDA said it shouldn’t have allowed the Menaflex knee implant to reach the market because political influence affected the approval process, and is now revoking its approval of the device, the WSJ reports. As the paper wrote in 2009, the implant, made by ReGen Biologics, was approved following a lobbying campaign by four members of Congress — even after FDA staff questioned its safety and efficacy. ReGen says it’s weighing its options, which include an appeal of the decision.

Fighting Bacteria?: Chiquita Brands’ Fresh Express, which makes bagged salad mixes, says washing greens in a mixture of two organic acids — rather than the usual chlorine — is a more effective way to kill off potentially dangerous bacteria, the New York Times reports. The company will switch to the FreshRinse wash and will also license it to other producers; food-safety experts tell the NYT that without published data, it’s impossible to verify the wash’s effectiveness. Fresh Express has recalled packaged greens three times this year over bacterial contamination worries, the NYT says.

Image: iStockphoto

View the original article here

A.M. Vitals: Case Claiming Individual Mandate is Unconstitutional to Proceed

Case to Proceed: A federal judge says the assertion by 20 states that the health-care overhaul law’s individual coverage mandate is unconstitutional is “a plausible claim,” the WSJ reports. Judge Roger Vinson of U.S. District Court for the Northern District of Florida is permitting the states’ case to go forward. He was more skeptical about the claim that the expansion of Medicaid included in the bill is also unconstitutional, but permitted it to go forward as well. The case is likely to make it to the Supreme Court, the WSJ says.

Offering Suggestions: UnitedHealth Group suggests that to save money, health benefits for the nine million people eligible for both Medicare and Medicaid should be administered via managed-care plans, Bloomberg News reports. The insurer issued a report proposing several measures for Medicare and Medicaid it says can save $3.5 trillion over the next 25 years.

FDA Reversal: The FDA said it shouldn’t have allowed the Menaflex knee implant to reach the market because political influence affected the approval process, and is now revoking its approval of the device, the WSJ reports. As the paper wrote in 2009, the implant, made by ReGen Biologics, was approved following a lobbying campaign by four members of Congress — even after FDA staff questioned its safety and efficacy. ReGen says it’s weighing its options, which include an appeal of the decision.

Fighting Bacteria?: Chiquita Brands’ Fresh Express, which makes bagged salad mixes, says washing greens in a mixture of two organic acids — rather than the usual chlorine — is a more effective way to kill off potentially dangerous bacteria, the New York Times reports. The company will switch to the FreshRinse wash and will also license it to other producers; food-safety experts tell the NYT that without published data, it’s impossible to verify the wash’s effectiveness. Fresh Express has recalled packaged greens three times this year over bacterial contamination worries, the NYT says.

Image: iStockphoto

View the original article here

A.M. Vitals: Jazz Pharma’s Fibromyalgia Drug Needs More Studies

FDA Says No: Jazz Pharmaceuticals said the FDA won’t approve its fibromyalgia drug in its current form and that the therapy needs more trials, Dow Jones Newswires reports. In August an FDA panel voted against recommending the drug — already available under the Xyrem brand name to treat narcolepsy, but distributed under heavy restrictions — in part because of its potential as a street drug. An illegal form of the medication is similar to the “date rape drug” GHB.

Jaundice Connection?: A study published in Pediatrics finds an association between jaundice in newborns and the development of autism, but doesn’t show that one causes the other, the Associated Press reports. The Danish study found a 9% incidence of jaundice among infants who went on to develop autism, compared to a 3% incidence among those who didn’t. Other studies have found no link.

Drug Pricing: Novartis has put a price tag on its newly-FDA-approved oral MS drug Gilenya: about $48,000 a year, the WSJ reports. The first oral therapy for the disease approved in the U.S. is more expensive than current therapies, which are delivered by injection or infusion and top out at about $40,000, the paper says.

Weighing ACOs: Accountable care organizations — providers teaming up to deliver more integrated care that is hopefully both better and cheaper — are the latest fad in health care, and various interests are trying to suss out their potential impact, Kaiser Health News reports. Because providers will be incentivized to hold down costs, medical-device makers, for example, are worried cheaper devices will be favored, regardless of what’s most appropriate for a given patient. Employers, meantime, are concerned that costs may rise as large providers increase market share, KHN says.

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A.M. Vitals: Novartis Aims to Accelerate Vaccine Production

Novartis’s Need for Speed: Novartis is partnering with Craig Venter’s Synthetic Genomic Vaccines in an effort to reduce the production cycle for flu vaccines from its current five to six months, the WSJ reports. Analysts say the Swiss drug maker could charge more for more speedily produced vaccines and could also grab a bigger piece of the global vaccine market, the paper says.

Sector Shrinkage: A full quarter of U.S. biotech companies were purchased or went out of business since the end of 2007, according to an industry official, Bloomberg News reports. An official from BIO, the trade group for biotechs, said 25% of the estimated 294 companies that remain have enough cash to fund operations for less than a year, compared to 45% at the end of 2008, BN reports.

Drug Combo Study: A new study finds that combining Plavix — the blood-thinner co-marketed by Sanofi-Aventis and Bristol-Myers Squibb — with heartburn pills such as AstraZeneca’s Nexium and Procter & Gamble’s Prilosec doesn’t increase the risk of heart problems, the WSJ reports. Researchers behind the 3,800-person study, published online in the New England Journal of Medicine, say there’s little reason for patients or doctors to worry about a drug interaction; the FDA, which warned about the issue on the basis of observational studies, says the study was too small to give a conclusive answer.

Boosting Protection: California will next year require secondary school students to get a booster shot of the whooping cough vaccine, the Los Angeles Times reports. The state hasn’t mandated a booster before, in part out of cost concerns — but that was before a whooping cough epidemic infected more than 5,000 people, killing nine babies, the paper says.

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A.M. Vitals: Genzyme to Explore ‘Alternatives’ to Sanofi Bid

Considering its Options: In an SEC filing, Genzyme said it will “probe and evaluate alternatives,” including “contacting third parties,” as it fends off a $18.5 billion, now-hostile bid from French drug maker Sanofi-Aventis, the WSJ reports. People familiar with the matter tell the paper the Boston biotech isn’t actively looking for a so-called white knight, but does want to “know what its options are.”

Going Up: Data from IMS Health show global prescription drug sales are expected to rise by as much as 7% to $880 billion next year, a faster rate of growth than seen this year, the Associated Press reports. Fueling the projected increase are new drugs with potentially large sales and greater demand in emerging economies, the AP says.

New Guidance: Draft guidance from the U.K.’s health-care costs arbiter, NICE, says it will now recommend the use of three Alzheimer’s drugs for mild forms of the disease, the WSJ reports. That’s a reversal of its previous stance on use of the drugs — Pfizer’s and Eisai’s Aricept, Shire’s Reminyl and Novartis’s Exelon — in that setting. NICE also recommended the use of another drug in more advanced cases of the disease.

No Guarantee: A survey conducted in Ohio finds that 13% of parents with health coverage say they still had to skip some care for their kids — such as seeing a specialist, filling a prescription or getting a lab test — because of the high cost, HealthDay reports. Families whose kids were covered by public insurance reported less difficulty in paying for recommended care, HealthDay says.

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View the original article here

A.M. Vitals: Novartis Aims to Accelerate Vaccine Production

Novartis’s Need for Speed: Novartis is partnering with Craig Venter’s Synthetic Genomic Vaccines in an effort to reduce the production cycle for flu vaccines from its current five to six months, the WSJ reports. Analysts say the Swiss drug maker could charge more for more speedily produced vaccines and could also grab a bigger piece of the global vaccine market, the paper says.

Sector Shrinkage: A full quarter of U.S. biotech companies were purchased or went out of business since the end of 2007, according to an industry official, Bloomberg News reports. An official from BIO, the trade group for biotechs, said 25% of the estimated 294 companies that remain have enough cash to fund operations for less than a year, compared to 45% at the end of 2008, BN reports.

Drug Combo Study: A new study finds that combining Plavix — the blood-thinner co-marketed by Sanofi-Aventis and Bristol-Myers Squibb — with heartburn pills such as AstraZeneca’s Nexium and Procter & Gamble’s Prilosec doesn’t increase the risk of heart problems, the WSJ reports. Researchers behind the 3,800-person study, published online in the New England Journal of Medicine, say there’s little reason for patients or doctors to worry about a drug interaction; the FDA, which warned about the issue on the basis of observational studies, says the study was too small to give a conclusive answer.

Boosting Protection: California will next year require secondary school students to get a booster shot of the whooping cough vaccine, the Los Angeles Times reports. The state hasn’t mandated a booster before, in part out of cost concerns — but that was before a whooping cough epidemic infected more than 5,000 people, killing nine babies, the paper says.

Image: iStockphoto

View the original article here