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Articles from 2006 In August

FDA Reexamines Patient Consent Rules

Recently, the agency has taken flack for two blood substitute studies--Northfield Laboratories' PolyHeme, a product used in trauma patients, and the U.S. Navy's request to use Biopure Corp.'s Hemopure without patient consent. FDA is drafting a guidance on emergency research and will hold a public hearing on the issue on October 11. The meeting will address the challenges of balancing emergency research with the protection of human subjects, along with providing suggestions for improving the process.  

Antitrust Win for J&J

The company stated that Ethicon offered discounts on sutures to hospitals that also purchased its trocars and clip appliers. William White, an antitrust lawyer who was quoted in the LA Times article, pointed out that companies who have monopolies walk a "very fine line," as what is legal for a nonmonopolist could be illegal for a monopolist. Applied Medical sued Johnson & Johnson three years ago for $54 million, which could have tripled under antitrust laws.

Patients See Benefits of Diabetes-Treatment Device, Even if Insurers Don't

While his experience wasn't perfect, it was a major improvement from his previous condition, so after the trial period finished, he decided to spend $350 per month for replacement sensors (which must be changed every three days) because insurance companies aren't covering that cost yet. Let's hope Medtronic and its competitors are going to provide them the data to make them change their minds.

Defective Infusion Pumps Seized

Alaris issued a recall on August 15; the seizure was made to ensure that pumps being stored at Alaris' San Diego facility are not distributed until the problem is fixed. More information is available on Cardinal's Web site. There have been quite a few problems with infusion pumps reported in recent years. This incident won't make FDA any less distrusting of the technology.

FDA to Collect Info on Third-Party Inspections

The public has until October 23, 2006 to comment as to whether the collection is necessary or burdensome, and to suggest ways to enhance the quality, utility, and clarity of the information to be collected. Comments can be submitted electronically. (Make sure to reference Docket No. 2006N-0326.) What FDA digs up is likely to determine whether the program survives the next version of MDUFMA.

Investor Turnover for Boston Scientific

New investors think that the firm's stock is at or near bottom and that its management is capable of fixing its problems -- and that perhaps these problems aren't as bad as they've been made out to be. Hence, value investors such as Wellington Management Co. (which has become the largest outside investor) and Primecap Management have snapped up the stock, as have hedge funds managed by firms like D.E. Shaw & Co. and Paulson & Co. And growth and "momentum" investors have bailed. Boston Scientific has a history of defying expectations and overcoming short-term obstacles. A lot of folks seem to be betting on its management to pull off such feats again. (Full disclosure: One of my best friends is an analyst for Wellington, and another is a manager for D.E. Shaw. I have never discussed Boston Scientific or any other device company with either of them.)

Nominate a Company for MD&DI's Medical Manufacturer of the Year

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Is High Healthcare Spending Necessarily Bad?

Food, shelter, and clothing don't account for as large a percentage of the average American's income as they used to. Hence, more can be spent on healthcare. And hence, perhaps policymakers should be encouraging medical device innovation, rather than fretting about its costs. Something has to drive the economy, why not healthcare?

J&J-Medtronic Deal?

But two or three years ago, no one believed Guidant was an acquisition target, either.

Angioplasties Overused in Ohio Town?

The Times (and our friend Reed Abelson, who always assumes the worst about industry's motives) slants the article to plant the idea in the reader's mind that something suspicious is going on here. Maybe something is -- but let's let the insurers investigate before jumping to any conclusions. Doctors tend to perform procedures in their comfort zone, regardless of motive.