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

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.

The information provided is easy to understand. Yet shocking. But it should open our eyes more to ask questions and not just jump to treatments. I’ll be sharing this book with my friends to pass around.

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.

Winston Churchill, after spending a decade warning the British Parliament & people about the rise of Nazis in Germany, had to reach out to President Franklin D. Roosevelt to try to awaken the U.S. to the need to stop the subjugation of western civilization. During this 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 current healthcare system. In recent years, a growing number of tomes have indicted a system that costs more than other advanced economies and delivers worse care despite providing universal coverage instead of our hit-or-miss coverage – Overdosed by Abramson, Overtreated by Brownlee, Ovediagnosed by Welch et al., Tracking Medicine by Wennberg & Ending Medical Reversal by Prasad. These texts marshal the case against our healthcare system but don’t quite close the 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 normal and abnormal biology. For example, angioplasty of occluded arteries was, for decades, accepted because “an open artery is better than a closed artery” and thus stent placement “must” prevent heart 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 reassurances to patients that it prevented heart attacks was actually all an illusion. Physicians and patients alike were fooled by a placebo effect, and survivor bias – only those patients who didn’t die lived to testify that 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 device rampantly 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, rheumatoid arthritis, tinnitus, heart failure, etc.). The dangers were minimized/denied, the lack of efficacy was suppressed and the biomechanistic rationale was enough to achieve widespread use and to make billions of dollars for the manufacturer. Lenzer also reviews the available clinical outcome data on angioplasty, breast implants, pacemakers, defibrillators, surgical mesh, an implanted birth control device, hip replacements, spinal implants, etc. If our healthcare system is ever to be to be cost-effective and maximally safe, the lessons Lenzer provides must by heeded. The conjunction of a profit-driven free-market system with the clinical semi-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 other OECD countries despite spending a trillion or two more? The healthcare system owes the public much greater scientific rigor. We should not be socializing the cost of inadequately tested and validated therapies. And we hould not be dying from our care.

If you want to understand why our healthcare system is so expensive and delivers such poor results, read this book. It’s an easy read and moves fast and explains so much. Everyone who uses the healthcare system needs to know these details to protect yourself. With medical error the number three cause of death, you might be saving your own life.

Well written and very engaging material! Every one in the US should read this book and be wary of medical devices and interventions that can be harmful and deadly. The author exposes the shocking corruption in the industry, the FDA and some of our lawmakers charged with protecting us from harm.

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 was eye opening for me. There is a lot of detailed examples along with the history of the medical device industry that is important to understand before you ever consider having anything implanted. As I read the book, I did my own research online. There is much we need to do to ensure that devices that cause public health risks never make it to market. I am sending copies of this book to may family and friends.

great read

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

we need very very mature people working in health care companies. read this to get responsibly about your and your friend's health.

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.

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