"When many cures are offered for a disease, it means the disease is not curable" -Anton Chekhov
''Once you tell people there's a cure for something, the more likely they are to pressure doctors to prescribe it.'' -Robert Ehrlich, drug advertising executive.
"Opinions are like sphincters, everyone has one." - Chris Rangel
Self-Regulation Some readers think I’m being too hard on the medical device industry when I criticize their efforts to win the right to police themselves. They point out that the current system is very slow because there aren’t enough FDA inspectors and that self-policing works well in other industries. The medical device industry, however, is not like other industries. Their products are put into our bodies (artificial joints, artificial heart valves, stents, etc.) The consumer (i.e. patient) has no choice as to which product goes into his body. He trusts the physicians who in turn trust the companies to provide a safe product. Companies are in business to make a profit, not to benefit humanity. When profit, not service, is the prime motivation, the pressure to maximize the bottom line pervades the entire corporate culture. This is equally true of the firms that would be hired to do the inspecting. The temptation to avoid conflict and give favorable judgements to the companies that hire them to do the inspections would just be too great. Even small problems that were overlooked for this reason could have ultimately fatal consequences. If there’s a problem with the speed of inspections now, then a better solution would be to increase the budget of the FDA so they could hire more inspectors, not to turn inspections and standards over to the industry. posted by Sydney on
7/18/2002 07:29:00 AM
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