The Strategic Sourceror received the following clarification from Dr. Diana Zuckerman, President of the National Research Center for Women & Families Cancer Prevention and Treatment Fund, in regard to a statement attributed to her that was included in yesterday’s item concerning the growing pressure on the Food & Drug Administration to overhaul its medical device approval process:

“My quote about saving money, taken from my testimony before the Senate, was not specific to post-market surveillance. On the contrary, I was talking about the benefits of using higher standards for the approval of implanted medical devices such as artificial hips and heart valves.

“Currently, most hips and knees and many heart valves and other implants are cleared by FDA through the 510(k) process, which does not require:

1. clinical trials
2. inspections of manufacturing process
3. post-market clinical trials or epidemiological studies as a condition of approval

“My remarks about saving lives and money referred to improving standards on all three. Post-market studies are important, but the better way to save lives and save money is to have higher standards before devices are sold. Post-market studies will get products off the market faster, but won’t save nearly as much money, because the implants will still need to be replaced, and the surgery, hospitalization, and rehab that involves are the major expenses.

“The pressure on FDA to approve more quickly is coming from the companies that make the devices. It is not coming from public health experts or medical experts, many of whom are shocked when they learn that hips, knees, heart valves, and other life-saving and life-sustaining medical devices are not tested on humans in scientific studies prior to approval. The standards for the least important prescription drugs are much higher than those for the most important medical implants.”


Diana Zuckerman, Ph.D.
National Research Center for Women & Families
Cancer Prevention and Treatment Fund
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Thomas Derr

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