NYTpg1: FDA Had Report of Short Circuit in Heart Devices (delayed release)

[DeepModem Mom]

F.D.A. Had Report of Short Circuit in Heart Devices
By BARRY MEIER
Published: September 12, 2005


Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corporation heart devices, the agency received a report from the company showing that some of those units were short-circuiting, agency records obtained by The New York Times show.

But the agency did not make that data public at the time because it treats the information it receives in such reports as confidential. While the agency has a policy of reviewing the reports within 90 days, it is unclear when regulators did so within that time frame or how they first interpreted the information.

As part of a lengthy annual report that Guidant submitted to the F.D.A. in February, the company disclosed data showing that one of its widely used defibrillators, the Ventak Prizm 2 DR, was short-circuiting at the rate of about one a month, a rate that some doctors say was troubling. A month later, a college student who had one of those units implanted in his chest died of sudden cardiac arrest.

In June, the F.D.A. issued an alert about the model, later updating it to say that the short circuits, while rare, posed a significant risk because they could render the device useless just when it was needed most. Defibrillators use jolts of electricity to stop erratic heart rhythms, which can be fatal.

Guidant, which knew about the model's flaw for three years but did not tell physicians about it until May, has recently found itself in the spotlight. But the disclosure that the F.D.A. also had data that might have alerted doctors is likely to increase scrutiny of the agency's policy of not releasing the information it requires heart device makers to submit, as well as how quickly it reviews such reports....


http://www.nytimes.com/2005/09/12/business/12fda.html

[UpInArms]

1. FDA knew of Guidant heart device failures -NYT

http://today.reuters.com/News/newsArticle.aspx?type=healthNews&storyID=2005-09-12T070606Z_01_HO225555_RTRIDST_0_HEALTH-GUIDANT-NYT-DC.XML

NEW YORK (Reuters) - Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corp. heart devices, a company report to the agency showed that some of those units were short-circuiting, The New York Times reported on Monday.

But the agency did not make that data public at the time because it treats the information it receives in such reports as confidential, the newspaper said, citing FDA records.

While the agency has a policy of reviewing the reports within 90 days, it is unclear whether regulators did so within that time frame or how they first interpreted the information, the Times said.

As part of a lengthy annual report that Guidant submitted to the FDA in February, the company disclosed data showing that one of its widely used defibrillators, the Ventak Prizm 2 DR, was short-circuiting at the rate of about one a month, a rate that some doctors say was troubling.

A month later, a college student who had one of those units implanted in his chest died of sudden cardiac arrest, the Times report said.

...more...

let's see who's running the FDA these days:

http://news-service.stanford.edu/news/2002/october2/fda-102.html

Stanford Report, October 1, 2002

Bush nominates Mark McClellan to head the FDA

excerpt:

Garber brushed aside concerns that McClellan has no experience in significant areas of FDA concern, such as what to do with tainted food and how to decide whether a drug is safe enough to be sold. "The FDA mandate is so broad that it makes tremendous sense to pick someone who can learn quickly and not be an expert in just one thing," he said.

But WAIT - there's more!

http://www.nationalview.org/newsletter/newsletter_030205.htm

Health Care



Mark McClellan, the brother of White house Press Secretary Scott McClellan (no nepotism there) and the administrator of the Centers for Medicare and Medicaid Services, told hospital administrators that he wants Medicare to adopt a concept called "pay-for-performance.'' The reasoning behind this is that he different organizations should be paid more or less depending on various factors.

One wonders what those factors are going to be. Are they going to involve patients' rights? Are the health care providers going to have to release private information, in much the same way that Kansas' Attorney General Phil Kline wants clinics to release patient information for intimidation purposes? Are the funds going to be doled out in relation to how many abortions a doctor or a health care facility provide?

...more...

[acmavm]

2. The only qualfication necessary for a high post in the current jerkoff

administration is to be related to someone in the administration, know someone of having attending college (or whatever) with someone in the administration, of donate money to the administration. But God help us, don't know anything about anything or get the position because of expertise.

We are the laughingstock of the world. What a bunch of dumbshits and crooks that are running everything.

[UpInArms]

3. Will the MSM out this buffoon for his lack of leadership ability?

I set the odds at: slim to none