The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It

Winston Churchill, after spending a decade warning the British Parliament & peopleabout the rise of Nazis in Germany, had to reach out to President Franklin D. Rooseveltto try to awaken the U.S. to the need to stop the subjugation of western civilization. Duringthis period, he observed of the U.S., that : “You can count on Americans to do the right thing,but only after they’ve tried everything else first.” The same might well be said of our currenthealthcare system. In recent years, a growing number of tomes have indicted a system that costs more thanother advanced economies and delivers worse care despite providing universal coverageinstead of our hit-or-miss coverage – Overdosed by Abramson, Overtreated by Brownlee,Ovediagnosed by Welch et al., Tracking Medicine by Wennberg & Ending Medical Reversalby Prasad. These texts marshal the case against our healthcare system but don’t quite closethe loop:- Why has our system allowed unexplained variation across sites and yet claimed “scientific” validity?- Why has “routine care”, when tested by the gold standard methodology (randomly-assigned, controlled clinical trials or “RCTs”) been found to be ineffective, or harmful to patients about half the time?- How do our practitioners recurrently fool themselves about the benefit/risk value of new therapies when 80% of what they have done has NOT been properly vetted by RCTs? The Danger Within Us tackles the safety and effectiveness of the arena of implanted devices.The semi-science that permits the acceptance of new therapies includes “clinical experience”and epidemiological correlations, but is mostly due to biomechanistic theories about normaland abnormal biology. For example, angioplasty of occluded arteries was, for decades, acceptedbecause “an open artery is better than a closed artery” and thus stent placement “must” preventheart attacks and deaths. Oops! After twelve smaller RCTs failed to find a heart attack/death rate benefit, a massive RCT called COURAGE documented the absence of any benefit.A procedure that cost $27-45K dollars per patient and was done for about 30 years with reassurancesto patients that it prevented heart attacks was actually all an illusion. Physicians and patients alikewere fooled by a placebo effect, and survivor bias – only those patients who didn’t die lived to testifythat angioplasty “saved my life”. The dead can’t tell us the truth! Lenzer does a yeoman’s job of educating us about the Vagus Nerve Stimulator (VNS) –a devicerampantly sold by a hucksterish CEO as a cure for pretty much anything that ails you (anxiety,depression, atrial fibrillation, autism, bulimia, fibromyalgia, heroin abuse, obesity, rheumatoidarthritis, tinnitus, heart failure, etc.). The dangers were minimized/denied, the lack of efficacywas suppressed and the biomechanistic rationale was enough to achieve widespread use andto make billions of dollars for the manufacturer. Lenzer also reviews the available clinical outcomedata on angioplasty, breast implants, pacemakers, defibrillators, surgical mesh, an implantedbirth control device, hip replacements, spinal implants, etc. If our healthcare system is ever to be to be cost-effective and maximally safe, the lessons Lenzerprovides must by heeded. The conjunction of a profit-driven free-market system with the clinicalsemi-science of modern American healthcare is not only bankrupting the country, it is killing thousands,and perhaps hundreds of thousands, of patients each year. Is this why we don’t live as long as otherOECD countries despite spending a trillion or two more? The healthcare system owes the public muchgreater scientific rigor. We should not be socializing the cost of inadequately tested and validatedtherapies. And we hould not be dying from our care.

After watching a Netflix documentary based on Ms Lenzer's book, I purchased her book and I'm not sorry. We are unaware that medical devices do not have to be approved by the FDA when the device is presented as a version of something that already exists. Thus, if hip replacements made of non-metal substances are being used, the introduction of the same devices made of metal is a shoo-in. Except that the metal involved can cause the breakdown of tissue, general health problems that doctors don't recognize as owing to the device, etc. This is just an example (metal replacements are not used now) of the complications arising from inadequate supervision. Just last week a news report about the damage caused by heart pumps used for people waiting for transplants came out in ProPublica. Read Ms. Lenzer's book as a precaution against devices that have not been adequately researched, tested, or which have not had any kind of approval by a competent institution. You won't be sorry.

This book is simply fantastic. It is an easy and fascinating read of how corrupt many organizations are in the USA. I have known Jerome Hoffman, MD, who is referenced here for many years and he is a leader in Emergency Medicine. I am an actively practicing emergency medicine physician of over 29 years and this book is a must read.Ms. Lenzer is an expert and has many articles published in the most respected medical journals, in the USA and abroad.I only wish there were more people out there like Ms. Lenzer and Dr. Hoffman who are trying to improve the medical care system by pointing out the flaws in medical studies and who are trying to do the 'right thing' for the American public without any reimbursement.

I have a VNS which is what is the main topic in this book. I know from personal experience that most of the things talked about are probably or certainly could be true.

As an epileptologist who is experienced in the use of VNS and the lives it has saved, I found Lenzer’s book to be hyperbolic. If VNS devices are truly causing massive amounts of people to experience cardiac arrhythmias, neurologists would have caught on by now. She could have used an example of a device actually found to cause widespread harm after FDA-approval that is clearly documented in the scientific literature. While some of her comments make it obvious she is not an experienced clinician in the realm of neurology, I do however think that she touches on some very real problems within the medical industrial complex. The book makes two very insightful points. The first is that scientific data on medical devices, although it should be scrutinized carefully before clinical implementation, is often not. This leads to premature, and sometimes, inappropriate approval and use of devices, some of which can cause serious harm. The second is that the FDA lacks necessary stringent guidelines on device approval, and FDA decisions are often influenced by the private medical device industry.

Good read that made me think about the FDA product approval process. Clearly, there is a concern about the main product highlighted in this book. My only hope is the book brings about more awareness for the safety of patients.

A good read. The author reviews the process used to approve medical devices in the US. Horror stories are highlighted and this IS NOT a well balanced review. There are many good companies, safe and effective medical devices and the regulatory process works in most cases. None-the-less, the downside of the approval and post marketing surveillance process has received insufficient attention. Targeted audience: consumers, health care providers and medical device professionals.

Highly recommend this to anyone who wants to learn more about how healthcare works.

A book to reflect and critically think about healthcare system and its efficiency, as well as regarding the responsibility of the different stakeholders (Regulatory Authorities, Manufactures, Academia and physicians) in offering safe and efficient medical devices, primarily designed to treat, preserve and save lives around the world.

great read

I have read "whistle blower" type books on health care and what this book out lined was an enlightening and frightful behind the scenes look at health care. It looks like the book was very thoroughly researched and kudos for the author. My problem is in the last chapter, What is to be done, one of the solutions she offers in a single payer health care system. She mentions several countries that have a single payer health care system including Canada. I worked in Canada's health care system for 25 years and watched it degrade over the years to the point that I don't even use it anymore despite that I involuntarily pay taxes to support it. She uses a few examples of France's health care system and it may very well be that the answer to safe and effective health care would be employing some of the French model, I would add the US should also look at Germany's health system as well. However to not include the dark side of single payer health care systems for a full and fair assessment of how to solve health care issues is doing a disservice to her readers. I feel so strongly the omission of the serious draw backs to single payer health that I only gave 2 stars and otherwise I would have been inclined to give this a 5 star rating. So I still strongly endorse this book for everything else that the author unveils of the dysfunction of the medical/industrial complex

Medical device regulation has less monitoring & less active control & enforcement than drugs regulation, despite some devices intended to be permantly implanted & used to sustain life or support organs. Many fail , with no patient safety alerts, although these adverse events are notified to the relevant bodies. Most Drs fail to report device failures. This book shines a light on the medical device industry & how it affects patients