The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
So when you read another story like this:
NEW YORK - 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.
In June, the FDA 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.
The newspaper quoted Dr. Daniel Schultz, the director of the FDA’s Center for Devices and Radiological Health, that it would tie up too many resources to review hundreds of filings the FDA receives each year and determine which data could be routinely released and what should be treated as confidential.
There was no immediate comment from Guidant.
The Times report said makers of defibrillators and pacemakers, which regulate heart rhythms, must file annual reports with the FDA that say how often, and why, their devices fail. The level of detail in these reports, which are submitted on paper, is far higher than is required for other medical devices because of their life-sustaining roles. Those filings also include much more data than the summaries that companies give to doctors.
You have to wonder if the oath they took as physcians is different than the one everyone else took. But then you have to wonder why Guidant didn't just take it upon themselves to issue the recall.
Lee Oukrop holds a high school senior portrait of his late son, Joshua, May 24 in Grand Rapids, Minn. Joshua had an implanted heart defibrillator made by Guidant Corp. and died on a bicycling trip in March after the device short-circuited.BTW - Cheney's defib was made by Medtronic, wonder if the story might have different if he had a Guidant defib installed.