Another Article on Faulty ICDs

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Helen
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Another Article on Faulty ICDs

Post by Helen » September 13th, 2005, 11:25 am

This article is from today's NY Times.. the last sentence gives a nice simple solution

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September 13, 2005
Regulating a Faulty Heart Device
The deplorable story of how a medical-device company sat on information about a flawed heart defibrillator while a hapless recipient died has now engulfed the Food and Drug Administration as complicit in the silence. A report by Barry Meier in The Times yesterday revealed that the agency received a report from the manufacturer detailing the flaws months before the F.D.A. issued a safety alert on the devices. By the time the agency acted, a college student relying on the implanted defibrillator to shock any erratic heart beats back to normal had died while mountain biking. His unit had short-circuited, just as the same model did earlier in about two dozen other patients.

What is disturbing is how long it took the company, the Guidant Corporation, and the regulators to get a meaningful warning to doctors and patients. The company is required to submit an annual report to the F.D.A. that includes data on how often, and why, its devices fail. As it turned out, the company waited until mid-February of this year to submit a report that covered the year from June 1, 2003, to May 31, 2004. The eight-month lag seems intolerably long for devices that can mean life or death. In previous years, Guidant had submitted reports within three months of the period covered.

The report revealed that 10 of the problematic devices suffered short circuits during the year. This was surely information of potentially great importance to doctors and patients. The student mountain biker died in March. Neither he nor his doctors were aware of the short-circuiting problem.

The regulators also appeared lethargic. The F.D.A. has a policy of reviewing the annual reports within 90 days, but it is unclear whether the regulators read Guidant's report by mid-May. There is no indication that the agency took any action in response to it. Only when The Times was about to publish an article on the flawed devices in late May did the company issue an alert to doctors, followed in June by an alert from the F.D.A.

The agency's excuse for not making the failure data public right away is too feeble to withstand scrutiny. Although F.D.A. officials have sometimes claimed that the annual reports are proprietary documents that must be kept confidential, they now acknowledge that the failure data itself is not confidential. The problem, they say, is that the failure data is included in a report that contains other proprietary information. It would be an inefficient use of time and resources, the agency says, to plow through hundreds of annual filings to determine what information could be released and what had to be kept confidential.

If that is the only problem, the solution is simple: require the companies to submit the failure data separately in a form that can be released immediately.

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Post by Shelby » September 13th, 2005, 12:10 pm

Thanks Helen, and yes, that's a simple, common-sense solution. Let's hope some real changes are made.
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don
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Post by don » September 13th, 2005, 6:50 pm

Hi Helen

Thank you for sharing that article with us.

Guidant has been castigated by everyone from patients to the news media and the FDA. Really it's like watching the news reports of hurricane Katrina. It's covered every day but there's nothing new to report. It's the same images of dirty water we saw yesterday, the day before, the day before, ad naseum.

There is a bright side. Most of the patients who have affected devices have either had them replaced or have made arrangements to do so. I suppose a few have even decided not to have them replaced. There will be problems. One I can think of is the person who doesn't have health insurance and can't affort the doctor and hospital bills. That will have to be worked out with Guidant and/or the legal system. I hope Guidant will be amenable to helping those people.

I have heard that some insurance companies are trying to recoup their expenses from Guidant. I don't know if they will be successful. That really doesn't have a great impact on us as patients. Those of us who have a lifetime limit on medical expenses might be interested in that effort.

Some patients have decided to sue Guidant. I don't know how successful that will be. I don't think it affects us as a BBS. We are about support, not law suits. Law suits are an individual decision.

Guidant may or may not be bought out. The company that had planned to buy Guidant has, to my knowledge, a good reputation for being straightforward with their patients. It will be interesting to see if the sale goes through as planned.

Guidant management will undoubtedly be replaced if the sale goes through. If it doesn't only time will tell if the corporate attitude has been adjusted by the adverse publicity. Guidant may fold, as Sultzer-Medica did after their artifical joints were found to be defective. Or Guidant may recover and become a viable player again.

The only thing that is sure to me is that as heart patients we don't need the added stress of being angry with Guidant. It's time to forgive. Forgiveness doesn't mean reconciliation. Forgiveness doesn't mean I will ever have a Guidant device in my chest (I won't). Forgiveness means that I won't give Guidant free rent in my mind any longer. My anger will not change their corporate structure one iota. My anger will only decrease my body's defenses against disease.

Namaste

don

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Helen
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Post by Helen » September 13th, 2005, 7:09 pm

Hi Don,, Don't get me wrong.. I am not at all angry or looking to sue or anything along those lines.. I had a Medtronic recalled and was very satisfied with their handling of the whole situation..

The reason I was putting the articles in here was to keep people up to date about the FDA and the policies about reporting defects ASAP... I think that is why I found this article helpful...as this article said, the simple solution is to have any problems with ICD's or any other medical device reported immediately to and from the FDA... and especially to our doctors.. to give them the opportunity to help us. Love, Helen

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