Tuesday, March 07, 2006

The Guidant recall (which we must not call a recall)

This was asked on Dr Helen's blog.

There has been a lot of news recently about cardiac pacemaker & defibrillator recalls. I would be curious to hear the cardiologist's perspective on
How much harm is generated by intense media buzz around devices that are extremely effective but have very low failure rates? Do patients that could benefit actually get scared away from life-saving therapy?
To what degree is the litigious environment in the US actually slowing innovation & hampering the standard of care? Especially in the medical device and pharma industries.

For a good timeline of the Guidant fiasco it's possbile to start with this article from the New York Times.

Reading the reports coming out of the USA, it appears that the problems were detected during post implantation reports by doctors of seven patient, who died suddenly. These devices were the Guidant's Intra-Cardiac Defibrillators, model Prizm 2DR, Contak Renewal 1 and 2. Five of the seven deaths involved the Contak models. The fault seemed to be short circuiting of the device when they should deliver life saving electrical shocks to terminate life-threatening arrhythmias.

These problems was discovered probably sometime in 2003. What was very upsetting was that Guidant knew about the problem, but refused to sound the alert, possibly because they were in deep discussion to merge with JnJ Cordis. Bad news of device recall at such a sensitive time may have resulted in loss of stock value to either company. The fact that the company placed share-holder's profits above patient safety is something that is not acceptable.

The company did very many things to try and allay the doctors fears, without resolving the problem or recalling the device. I believe the media term used is they tried to put a "spin" on things. This kept on happening until they literally had no choice as some of the doctors had gone to the press, and hard questions were being asked. At the time the news broke JnJ was in the midst of possible due diligence. Needless to say, there are many litigations are pending in the US courts as a result of these devices.

It is true that a strict and uncompromising FDA (or its equivalent) in any country will hinder medical development. A good FDA should have the best interests of the patient at heart. What we are seeing today is that many device companies are now using their latest devices in Europe first, where the regulatory body is more accommodating.

Any arguments in this area would be a fight to find balance between patient safety and getting device innovations of future treatments into the market rapidly. The FDA has the unenviable task of determining, perhaps sometimes arbitrarily, where this balance should lie.

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