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On the way back from  yoga class, listening to my preferred WMFE 90.7 radio station, I was both surprised and alarmed by the NPR podcast of Fresh Air with Terry Gross of an interview  of the author of “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle To Survive It“,  Jeanne Lenzer.  Ms. Lenzer,  a medical journalist, warns that implanted medical devices are approved to be used with far less scrutiny and testing than pharmaceutical drugs. Many medical devices would be marketed without going through clinical trials. As a result, some have caused harm and even deaths. According to Ms. Lenzer, FDA does not require the medical device makers to report how many people are implanted with these devices, therefore it is hard to tell how often these devices have problems. “Walmart tracks heads of lettuce they have on a shelf at any given time. They know how many they have to replace. They can track those a lot better than we’re tracking medical devices implanted in people,” Lenzer says. Her new book is ‘The Danger Within Us.’  This radio interview is shared below:

Jeanne Lenzer, a former Physician Associate who had worked in emergency rooms for many years until she discovered that medical studies indicated the medical treatment that she and others have been using to treat chest pain was actually causing fatal heart rhythm. Her subsequent search for the cause of this problem led her to a career in medical journalism. For those of you who are thinking of getting medical devices, or who are medical students or medical professionals, I would highly recommend this book that helps to shed light on the deficiency in the requirements for the safety of medical devices to be implanted in human body.

In the book, one finds passage such as”Whereas the standard for approval of a new medicine calls for two randomized controlled clinical trials, only 5 percent of high-risk implanted cardiac devices have even partially met that standard.”

Ms. Lenzer further pointed out, through the eyes of Rudolf Virchow, the brilliant 19th century physician who once commented, “Medicine is a social science, and politics [is] nothing more than medicine on a grand scale.” that we cannot create a healthy society solely through the application of medical and scientific knowledge. We need to address challenging questions about access to information and distribution of resources. Answers to these questions would ultimately decide whether healthcare should be treated as a commodity or a common good.

Finally, it is important for government regulatory agency such as FDA to have consistent and rigorous policy with regard to any medical devices that will be implanted into human body.

For those of you who are contemplating having medical devices implanted, be sure to do your home work and read this book to help you in making the decision and asking the right questions.

Photographed, gathered, written, and posted by Windermere Sun-Susan Sun Nunamaker
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