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Archive for January 16th, 2009

16
Jan

medications as risky as older ones for New anti-psychotic

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Newer anti-psychotic medications used to treat schizophrenia, dementia and other psychiatric disorders appear to double a patient’s risk of sudden heart failure, research published Thursday in the New England Journal of Medicine found.

The major study is the latest in recent months to show that these newer drugs, dubbed “atypical medications,” are not much safer than the older generation of “typical” treatments, as scientists had widely thought.

They said that now “limited data available” suggest the “electrophysiological effects” of both types of drugs are similar.

The new generation of drugs examined in the study — which also are significantly more expensive than their predecessors — include Johnson and Johnson’s Risperdal; AstraZeneca’s Seroqueland Eli Lilly’s Zyprexa.

The three drugs are among the top sellers in their class with more than 14.5 billion dollars in sales worldwide in 2007.

Some doctors have warned against these drugs being prescribed “off-label” or for conditions not approved by the US Food and Drug Administration .

They said that now “limited data available” suggest the “electrophysiological effects” of both types of drugs are similar.

The new generation of drugs examined in the study — which also are significantly more expensive than their predecessors — include Johnson and Johnson’s Risperdal; AstraZeneca’s Seroqueland Eli Lilly’s Zyprexa.

The three drugs are among the top sellers in their class with more than 14.5 billion dollars in sales worldwide in 2007.

Some doctors have warned against these drugs being prescribed “off-label” or for conditions not approved by the US Food and Drug Administration .

16
Jan

Medical devices escaped close review

The report comes as the FDA’s Center for Devices and Radiological Health is the subject of allegations that scientists were pressured to approve medical machinery against their professional judgment. Nine FDA scientists wrote the Obama transition team last week complaining that a “corrupted” review process is putting public health at risk.

The allegations are a separate matter from the concerns raised in Thursday’s report. But taken together, they probably will raise the level of congressional scrutiny over the FDA’s medical devices branch.

“GAO’s investigation confirms my concerns that the approval process for medical devices is woefully inadequate,” said Rep. Frank Pallone, who heads the House Energy and Commerce Committee’s health panel. “For years, Congress has required high-risk medical devices to undergo stringent premarket review, but GAO’s findings show that is simply not happening in every case.”

Pallone, D-N.J., said he intends to hold hearings on the FDA’s oversight of medical devices. The GAO did not look into whether any patients were harmed as a result of devices that got less government scrutiny.

The root of the problem seems to be that the FDA never fully carried out the intent of a decades-old change in the law.

Medical devices include everything from tongue depressors to silicone breast implants and pacemakers. In 1976, Congress set up a three-tiered classification system for devices.

Manufacturers of low-risk devices such as bandages and reading glasses could get cleared by notifying the FDA before going to market. High-risk devices such as pacemakers and heart valves would have to go through tighter scrutiny, and their manufacturers were required to provide evidence of safety and effectiveness. Devices classified as high-risk tended to be ones that are implanted in the body or could spell the difference between life and death.

The FDA acknowledged the problem, but has not set a timetable for resolving it. “In general, we agree with the conclusions and recommendations,” said spokeswoman Karen Riley. “We are considering legal and procedural options to accomplish this objective.”

The GAO report found that two-dozen distinct types of devices approved without close scrutiny, including metal hip joints, external defibrillators, and electrodes for pacemakers.

“It all adds up to less-than-rigorous device review, and it’s placing tens of thousands of Americans at risk,” said Peter Lurie, deputy director of Public Citizen‘s health research group.

16
Jan

Acquire Emageon to Health Systems Solutions

Stanford International Bank Ltd, a member of the Stanford Financial Group and HSS’ principal shareholder will fund the transaction with a total of $85 million. The residual amount will be utilized for growth initiatives and working capital. For the current transaction,  Jefferies  & Company and Sun Trust Robinson Humphrey will act as financial advisor for Emageon. The agreement, receiving unanimous approval from boards of directors of both companies, as well as Emageon’s Strategic Alternatives Committee, is subject to approval by Emageon’s majority stockholders and certain customary closing conditions.

Founded in 1997, Emageon is a leading provider of enterprise medical information technology systems for hospitals, healthcare networks and imaging facilities. The company delivers a family of multi-specialty, advanced visualization and infrastructure tools to enable enhanced patient care, automated imaging workflow capabilities and improved productivity, and provide better service to physicians. Its standards-based solutions are based on a unified Enterprise Content Management system that provides advanced visualization and infrastructure tools to facilitate clinical analysis and management of digital medical images, reports and associated clinical content. Emageon has bagged the 2007 Frost & Sullivan Technology Innovation Award.

Following the acquisition, Emageon will operate as a part of HSS group of companies, with the combined company having approximately 400 employees. Till the closing of the transaction, both companies will continue to operate independently, while maintaining sales and support operations. After the transaction is completed, HSS plans on applying for listing on the NASDAQ.

The current acquisition is regarded by industry watchers as a bold step by HSS, considering that Emageon is a much larger company than itself. HSS reported total revenues for the first half of 2008 to be $6.49 million compared to Emageon’s $37.4 million generated for the same time period.

HSS provides healthcare technologies and services for home health care, medical staffing, acute and post-acute facilities, and telehealth/telemedicine. The company’s offerings are grouped into three segments, namely technology solutions provided by subsidiary HSS Consultancy LLC, which provides high-end development and post-implementation support for complex projects; software segment, which develops, markets, sells and supports proprietary healthcare products; and consulting segment, created to provide performance analyses and professional services. HSS focuses on leveraging current and next-generation technologies to provide value-added products and services for improved clinical, operational and financial outcomes.