Apparently the Food and Drug Administration endangered countless patients' lives when it stopped enforcing 30-year-old requirements that medical device makers meet federal lab standards before testing their products on humans. The report was by the non-profit Project on Government Oversight.
The rules cover studies on defibrillators, pacemakers, heart valves and coronary stents.
The repercussions of faulty defibrillators, pacemakers, heart valves and stents could be quite horrific if you consider that all of these devices are aimed at the smooth functioning of the heart.
This is another result of cutting back on regulatory agencies bending to corporate interests at the expense of the public. We saw the same dangerous result with the FDA fastracking big time drugs like Vioxx.
With Vioxx, there were alternatives (I always counsel my patients to wait at least 7 years after a new drug release), but with heart devices, there are very few alternatives, so their safety is paramount.
Thank goodness that there are watchdog groups out there.
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