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CVS Sales Practice Set to Expire

December 18th, 2008 | No Comments | Source: kaisernetwork.org, Providence Journal

New York Attorney General Andrew Cuomo has filed a lawsuit against CVS Caremark after an investigation revealed it had since 2006 been selling expired products at 60% of its outlets in the state, according to the Providence Journal.

cvs CVS Sales Practice Set to ExpireOn the same day, the state announced it had settled similar claims against Rite Aid Corporation for approximately $1.3 million.

The suit will attempt to force Rhode Island-based CVS to pay a $500 fine for each violation, post signs that inform consumers about health risks of expired products, offer refunds for such products and pay a  quality assurance monitor to review the situation monthly.

Earlier this year, California and Pennsylvania lodged similar complaints against CVS, according to the suit.

In 2003, CVS dodged a similar charge by agreeing to cease and desist after an investigation in New York revealed it was selling expired OTC medications.

The “widespread nature of these violations indicates that CVS has not taken seriously its legal obligations or its responsibilities to its consumers vis-à-vis the sale of expired products,” according to the lawsuit.

Michael DeAngelis, a CVS spokesperson expressed disappointment that Cuomo had filed the suit. He indicated CVS had begun working with the AG’s office on the matter.

“We have a specific product-removal policy,” DeAngelis mentioned in an email to the Journal. “Over the last several months we retrained our employees to ensure compliance.”

CVS is the second largest drugstore chain in the US after Walgreen’s and ahead of Rite Aid.

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GE Brings Things to Health

December 2nd, 2008 | No Comments | Source: Healthcareitnews, kaisernetwork.org, Wall Street Journal

GE Healthcare has been in a funk for awhile and John Dineen, its new chief executive has been looking to make a splash.

ge GE Brings Things to HealthWhat better way than announce a 5-year, $200 million initiative to develop a national electronic health record system in conjunction with Mayo Clinic, Intermountain Healthcare, Montefiore and UCSF?

Company press releases tell us the system will help providers share medical records, improve the efficiency and quality of care and cut costs. Later iterations will facilitate evidence-based decision making and more informed patient decisions.

Good luck on that John, and we’ll check back in 5 years.

Meanwhile, 60% of GE Healthcare’s $17 billion annual revenue comes from diagnostic imaging which has been plagued by factory-production glitches and diminishing insurance payments, according to the Wall Street Journal.

As well, some customers complain GE’s machines are too complex and require too much training.

The imaging thing drove a 7% drop in GE Healthcare’s operating profit since January, 2007 and forced the unit to riff a few hundred employees last summer.

So why risk diverting attention from an ailing core business on a project that won’t contribute to the bottom line until the Big O is old enough to qualify for social security?

GE CEO Jeffrey Immelt figures ya’ gotta’ start somewhere and the field is too lucrative to pass up. “At the end of the day,” Immelt said in a press release, “Governments are going to spend money on things that drive productivity. Strategically, it’s a great place (to be) long term.”

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FDA Scientists Allege Misconduct

November 24th, 2008 | 1 Comment | Source: kaisernetwork.org, NY Times

In a letter to Congress, 8 FDA scientists accuse senior FDA officials of “serious misconduct” in squelching their opinions and approving ineffective and potentially unsafe medical devices.

The letter was sent a month ago and made public in redacted form last week. It says the scientists can prove that FDA managers “corrupted the scientific review of medical devices” by coercing experts to alter conclusions about certain devices, according to the New York Times.

fda FDA Scientists Allege MisconductThe scientists claim that top officials in the Center for Devices and Radiological Health told them they might be fired or given poor performance reviews if they did not alter their reports to hide unfavorable data and legal violations such as not obtaining informed consent from participants.

Public information on the matter does not specify which devices are being called into question.

“This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation,” according to the letter received by Congress.

The FDA scientists initially raised the matter with FDA Commissioner Andrew von Eschenbach in May. Eschenbach asked Assistant Commissioner William McConagha to investigate. The FDA scientists say McConagha concurred that the evidence was “’sufficient’ to justify curative and disciplinary actions” according to the letter received by Congress.

The matter was then referred to the CDRH Director who concluded there was no cause for disciplinary action. He told the FDA scientists to “move forward.”

Indeed they have.

 “These allegations are deeply concerning,” Representative John Dingell (D-Mich) told the New York Times. The chairman of the House Committee on Energy and Commerce added, “We intend to uncover whether any FDA activity has compromised the health and safety of American consumers.”

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