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

by Jeanne Lenzer

Medical interventions have become the third leading cause of death in America, killing more Americans each year than diabetes, murders, car accidents and AIDS combined.

An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc.

The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial.

The FDA lets device manufacturers decide whether to report serious complications or deaths that may have been caused by their products.

The average salary and compensation package for CEOs of the 18 publicly traded medical device companies in the U.S. was $1.3 million and $15.4 million respectively as of 2015.

In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment.

His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies.

In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a meticulously researched and propulsive read that will fill you with anger and indignation, a stirring call for reform, and a must-read for anyone who cares about the future of American healthcare.

Genres: Nonfiction, Medical, Health, Science, Medicine, Health Care, Audiobook

336 pages, Hardcover

First published December 12, 2017

Reviews

[terpkristin · Rating 3 out of 5]

It's hard to say I "liked" this book when the topic was so awful. This book shows how completely dysfunctional the US Food and Drug Administration is and how it got that way. It shows in gory detail why many of the things that we (patients and even most doctors) believe are "safe" because they're FDA approved are in fact under-regulated, under-tested, and issues go under-reported. It tells this horror story using an example of an actual case where a guy got a vagus nerve stimulator implanted and the near-death experience that he had. Further, one of the implants that was used on me is called out by name (which wasn't exactly a surprise, since I know there is a class-action lawsuit related to its use), which is never comforting. There was a good section of a chapter devoted to it. Long and short, medical implants don't require much to get an FDA seal of approval and issues with implants don't have to be reported in any meaningful, useful, or possibly truthful way. Drugs are only slightly better, due to the fact that the regulations for them was passed in the 50's or so.

Unless it's an emergency or a truly last resort, based on this book and until or unless things change, I'd avoid getting any implants...

[Ell · Rating 5 out of 5]

Wow! What a riveting read! The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It is written by a Physician Assistant, turned investigative journalist who worked in the medical field for over a decade. This book is deeply insightful and credible. Much has been written about the harm certain popular classes of pharmaceuticals may be causing, but rarely does one get a glimpse into the underbelly of the medical device industry in the USA. This book should not be confused with a suspicious all-encompassing disdain for the medical device industry. Quite the contrary! It offers an eye opening historical and objective view of what can and does go wrong, all the while maintaining that, of course much of it is lifesaving as well. Author Jeanne Lenzer does a formidable job at keeping the reader entirely engaged in what could have come off as rather dry content.

[Karl Worsham · Rating 4 out of 5]

This book is horrifying and excellent.

[Rachel Blakeman · Rating 3 out of 5]

This is going to be one of those books that people will love not because of the writing but because if fuels their outrage. As a concept this is a great topic but the actual book is tedious, repetitive and really poorly organized. It drifts all over the place with no sense of going forward. Listen to her "Fresh Air interview instead of reading this one.

[Khari · Rating 3 out of 5]

So.

I've got some thoughts.

This was a very interesting, thought-provoking book. Right up until the last chapter. Then it became a haranguing political diatribe that completely ignored all of the earlier points the book had implicitly been making, and ended with a blatantly manipulative emotional hook designed to make the reader identify even more with Vegan's (not sure how to spell it since I listened to the book) Davidic struggle with the Goliath that is the medical implant industry.

I had to actually stop listening to the book when I had 40 minutes left because it got so irritating and go clear out my brain with some Rammstein, Two Steps from Hell, and Era before I could continue.

…The above list reveals how odd my music tastes are...anyway.

I do not understand why people who are careful researchers and who caveat everything for 400 pages suddenly, in the last 50, throw out all such care and start spouting things that disagree with the entire premise before.

Let's look at a couple of them.

First, a good portion of the book talks about how a lot of the research that is put out by the medical industrial complex is garbage. It's designed, not to be scientific, but to make whatever medical intervention they are working on look amazing. In some cases they manufacture data to make something look more effective than it actually is, in others, they manipulate the data to make it look more effective than it actually is, in still others, the methodology itself is purposefully flawed to make it look more effective than it actually is. Hoffman, someone Lenzer quotes profusely, is an expert on such medical illusions and is basically making the point that things are always more complicated than they seem and that the human body and history and how those things interact are far more complex than we account for. One of the reasons that mortality rate for heart disease going down is not that we are better at treating heart disease, but we are better at detecting it and so the number of deaths, while remaining constant, are now making up a smaller portion of an ever-growing pie. It's not that we are decreasing heart disease mortality, we just know now how many people actually have heart disease. 20 deaths out of a 1000 has moved to 20 deaths out of 10,000 or a 100,000, but it's still 20 deaths. The other 999,998 people always had heart disease before, we just didn't know it. Those 20 people still die because of the severity of the disease, we haven't managed to ameliorate the severity at all.

So, the book is talking about bad research and how a tiny incremental change in something is enough to render it useless. The spinal fusion cage and it's growth factor for instance, it was approved by the FDA for the lower back, but move it up a couple of vertebrae and it becomes deadly. That's a pretty minor difference and it has a huge effect. She slams the makers of the VNS device because they are acting like a bunch of miracle pill peddlers by claiming that it is effective for treating basically everything, epilepsy, depression, bipolarity, thyroid problems, etc., justifiably so. It's highly unlikely that one device can treat so many different diseases when there are so many factors that go into the production of these problems. But then she forgets her own argument and comes out with 'we can solve all of the problems of the US medical industry if we just get rid of the wealth gap.' Simplistic much?!!?

We just spent 400 pages going over how broad stroke research and broad stroke interventions are bad, inefficient, and just plain don't work. And you come out with that!??! There wasn't even any justification! There were no studies mentioned! Just a bunch of anecdotes comparing Britain to the US! As if the only difference between the US and Britain is the presence of a universal health system!

I want to go shake this woman.

Let's ignore the substantially different diet. Let's ignore the substantially different lifestyle, you know, how not as large a portion of the population owns a car, requiring that they use some form of public transportation and their own legs to get around. Let's ignore those things that surely have an effect on health outcomes and just focus on...whether or not the British people like their health system.

Worse, it's anecdotal!!!! The woman had an entire chapter about how anecdotes are bad because they're cherry picked and subjective! One reason the VNS device got approved in the first place is because there were 5 patients who came to tell their stories and their subjective, cherry picked stories made the VNS look really good. So why are you doing the same thing? Could we please compare life span? Could we compare amount of money spent as a nation and on a per capita basis? Could we compare early detection of disease? Could we compare the availability of hospital beds and mortality rates of various diseases? Could we compare the availability of medications and the effects of rationing, if at all? How about wait times? How about time spent with the doctor? How about time spent waiting for ambulances? How about patient choice in how they are treated? How about complex surgery success rate? How about expertise of doctors? Could we talk about some of those?

I don't know how Britain and the US would compare on those, but I can guarantee that Britain wouldn't come out being golden on all of them. I'm sure there are problems with the National Health Service. It may actually be empirically and objectively better than the US system for all I know, but not because the people of Britain like it better. Please come up with a better argument and actually defend your position. Are there less deaths and complications from implanted devices in Britain than in the US? Even that little factoid would help make the argument a tiny bit stronger, but nope, nothing is said.

The last chapter was just so tacked on and the entire focus of the book shifted. It would have been fine if she was making the argument all the way through and then wrapped it up as a conclusion, but she didn't. She just switched direction right at the end and said a bunch of stuff that had very little to do with what she had been saying the rest of the time.

The second thing that really made me scratch my head was the insistence that there should be more government regulation on the medical industry. We spent chapters and chapters on how the FDA is essentially useless, corrupt, and not doing their job properly, and that's why we should give them more work to do and depend on them more.

Huh?

Lenzer really only proposed five reforms for the FDA: get rid of political appointees, make sure that every company submits at least two studies that compare the use of the proposed device with a medically treated control group, that some of the studies actually look at patient health outcomes instead of measuring surrogate markers, industry money be removed from the FDA and it only receive public funding, and that it be given more funding. I actually agree with all but the last of those reforms, but I'm not naïve enough to think that will actually stop the problem of shoddy research and FDA approval being given to things it shouldn't be, and that's because Lenzer has missed the actual number one problem that is leading to these issues.
It's not that industry exists and is seeking a profit. It's that the FDA accepts research from companies about the companies' own product.

This ignores everything that you are taught as a beginning baby chick researcher back in high school. Don't take anything Coca Cola says about Coca Cola without a huge grain of salt. A grain of salt bigger than the empire state building. They are biased. Inherently biased. And yet that's what the FDA is doing!

I'm really glad I read this book, I thought that the FDA and the NIH and the CDC ran their own studies. Nope. They fund studies. They give money to companies to research their own products. Who thought this was a good idea?

Why didn't Lenzer propose an independent research facility? The FDA gives it money to produce one study and the company produces one. They could even be the exact same design. I think that would go a long way towards keeping data manipulation shenanigans down to a manageable level. When a company knows that their work is going to be checked by another research team, it tends to keep them more honest. Having a system of checks and balances that expects people to do stupid things and builds in a way of detecting and stopping said inevitable corruption seems a lot better than just expecting that making a few more rules about who can work where is going to just fix all of the problems.

The final thing is I don't understand why people declare some things to be human rights. Like health care. It's not a human right, it's something you pay for. It's a product, a thing. A right is not a thing, it's a capacity. If you are going to declare that products are human rights, why not declare that food is a human right? That's more essential to a human being's prosperity than health care, but she doesn't seem to think that's necessary. Probably because most people seem to understand the idea that you have to work to eat. Food doesn't just appear out of nowhere. You either have to grow it, or hunt it, or pay someone else to do that for you. Every place that has declared food to be a human right has ended up facing starvation, so it doesn't work all that well. She doesn't make that mistake, but then she says the same thing for health care. I think that everyone should have the capacity to seek out health care, as in they shouldn't be denied health care on the basis of say color of skin, educational status, political viewpoint, or fitness level, but they should still have to pay for it. It's a product, it doesn't just exist like the air does, it's something that takes years of study for the provider to learn how to do. They deserve to be compensated for their labor.

I don't think Lenzer believes that health care providers shouldn't be compensated, but she does think that their compensation should be regulated, and that they shouldn't be paid on a per service basis like they are in the states. I actually agree with her there. The idea of service in the US is extremely weird. Why should the nurse popping in during her shift to make sure you are still breathing be something you have to pay for separately? That should just be a normal part of care. However, I don't think that can simply be fixed by making everyone salaried. I'm not that naïve.

I work in a salaried industry. We have our own host of problems, including the issue that when everyone receives the same recompense for their work regardless of the outcomes they produce you have a whole lot of people who just ride that system and do the minimum amount of work necessary to continue receiving that salary. Is that we want in our doctors?

[Hannah Willover · Rating 5 out of 5]

The American healthcare system is riddled with corrupt practices. The Danger Within Us comes from the lens of implanted medical devices and analyzes the FDA’s lack of oversight in the medical device industry. Capitalism allows these companies to prioritize profit over patient safety and pay off the FDA, government officials, researchers, publishers, and doctors to keep their devices on the market. It is tragic to hear the stories of people affected by this industry, but the book ends on a positive note with industry independent organizations for research, patient safety, and advocacy. Would recommend as an intriguing book club pick or a personal read, since we are all actively involved in our individual healthcare journeys.

[Evin Ashley · Rating 5 out of 5]

This book took me an incredibly long time to finish, because it was infuriating and not pleasant to read. Jeanne Lenzer is an incredible author, whose professional experience as a medical doctor and investigative journalist perfectly entwined to form this book.

Lenzer lays the foundation of how we arrived at our current U.S. healthcare landscape, which began about half a century ago with government policy to fund medical research, the marriage of private industry and public health, and academic incentives that result in biased research. This toxic private-public marriage isn't the result of one bad actor or conspiracy; rather it's an unchecked mutation of the negative aspects of human nature—greed and laziness. Greed and laziness have resulted in making the average American unhealthy today, afflicted with a variety of preventable illnesses.

The system that creates these health issues for Americans also avoids accountability in the name of profit. The evidence provided in this book illuminates how the FDA does not properly regulate medical devices that are implanted in Americans. We arguably have the most advanced scientific minds and medical training in the world, but priceless knowledge and the scientific rigor needed to protect it have been manipulated and silenced over the years by private greed and public laziness, resulting in this tragically ironic outcome.

"To protect the lofty goal of encouraging rigorous inquiry without fear or favor, we must insist that our colleges and universities once again function as centers that seek truth, not profit. That means we need to demand that Congress repeal the Bayh-Dole Act and truly insulate our academic centers from industry pressures." (p.277)

My uncle may have passed away from a faulty medical device, which also made this book harder to get through. Don't get a medical device installed in your body or the body of anyone you love, until the FDA has done its job to regulate these devices. If you or a loved one have a medical device in you, check what company made it and ask questions to be empowered. Read all the fine print, and advocate for change. On p. 284 of her book, Lenzer provides a list of advocacy organizations actively campaigning to solve for these avoidable and embarrassing problems we have today. The list is also published on her website, here: https://jeannelenzer.com/independent-....

[Desmond Brown · Rating 4 out of 5]

A bit sensational but well-researched and well-presented, this book brings much-needed attention to the issue of FDA evaluation of medical devices. She focuses on some of the well-publicized failures of the current system, but does not examine the alternatives to the current system in any meaningful detail. Her comments on the manipulation of research results to show favorable results for a device, and on the potential for financial incentives to undermine physician decision-making, are important for anyone who wants to understand the US healthcare system.

[Alexa · Rating 4 out of 5]

Horrifying topic, but engaging and well-researched book. Now I want to know if its release helped the fight against under-regulation, profiteering, and overtreatment. One can hope!

[Amanda Mc · Rating 3 out of 5]

3.5 stars.

This is well-researched book that addresses a major concern in the US healthcare system—the safety of medical devices and the lack of oversight and regulation about how they are approved and used. It doesn’t surprise me how often research is manipulated to show a desired outcome. This is a problem in most research, unfortunately. Of course I the field of medicine, there are real lives at stake and the consequences can be deadly Fegan’s story and those of the numerous other patients are heartbreaking and challenging to read.

As one might expect, there were some passages that were quite technical, so that could be a barrier for the casual reader. There is also a significant amount of repetition (some phrases were repeated almost word for word multiple times) that I found frustrating. There were also some structural issues that’s that interrupted the flow of the book.

Overall a compelling read with just a few flaws.

I received a copy of this book for free from Netgalley.

[Geoff · Rating 5 out of 5]

In short, an engaging, if enraging, book about the medical device industry--the shenanigans of for-profit companies that put devices on the marketplace with little or no oversight from regulators.

While much attention has been granted to issues in the drug industry (conflicts of interest, shoddy and compromised research on new drugs, high prices, lack of government bargaining power), this book brings to light similar problems with devices. Lenzer documents the degrading influence of the profit motive when it comes to the evaluation of medical devices as well as conflicts of interest within the FDA, including corporation-friendly administrators who ignore recommendations of FDA-appointed scientists. This is documented via the story of a man who was implanted with a dangerous device but unable to sue the device manufacturer or prompt any action from the FDA or Congress.

Definitely worth reading.

[Alicia · Rating 4 out of 5]

A chilling, well researched page turner of medical risk and wrongdoing by the medical implant industry that offers up a buffet of literary adjectives. Kafkaesque labyrinths of legal traps and dead ends; Orwellian creativity with definitions of "benefit", "significant", and "safety"; Faustian deals with the devil by researchers, doctors, the FDA, politicians, etc; Homeric determination of patients to seek justice and prevail though decades of an exhausting personal odyssey. Who says medical nonfiction is boring? :-)

[Cat · Rating 5 out of 5]

Pretty intense book. As a recipient of several medical devises, it gave me plenty of food for thought. I never realized the implants I have were never tested. I always assume the medical profession looks out for us, to some degree. I figured the implants were tested before use in humans. Scary. Oddly, I have wondered for years about the drugs we're given by our doctors.... Well researched and riveting read.

I received a Kindle ARC from Netgalley in exchange for a fair review.

[Melissa Rochelle · Rating 5 out of 5]

I hope none of my friends actually believe that the government is looking out for our well-being. "Safety" in the USA is entirely dependent on money. Who's going to give more to a Senator? Who's got the most lobbyists with the deepest pockets? Who's going to take someone out to Denny's?

Great read. If you wanted to learn more about the medical device industry after watching Bleeding Edge on Netflix, then this is the book for you!

[Ford · Rating 5 out of 5]

This book is about how the whole Health Care business needs a major overhaul. As someone with metal hips, do I need to be screened for cobalt in my blood? As a family that got clobbered by Obamacare, I am all on board with a single payer health system.

[Eric Xia · Rating 4 out of 5]

Written by a British Medical Journal reporter.

There's a big focus within this book on the vagus nerve stimulator, which is actually an embedded medical device used frequently to treat epileptic patients, very popular in the 1990s. I was not expecting so much of a narrow focus, but it was interesting to read about. What actually shocks me is are the statistical fallacies around the general rate of death for heart disease: if the pool of patients diagnosed with increasingly sensitive tests increases, and the rate of death from serious heart problems stays the same, then statistics like "we've gone from 35% to 5% fatality over the last thirty years" are clearly flawed. The book points out how anecdotes are flawed (although it itself is built around just a handful of VERY opinionated anecdotes), but it makes me wonder whether its actually ethically correct for my own case to be considered epilepsy. Theoretically, I don't have any identifiable condition except for a past history that would distinguish me from the general population, and if they count cases like mine towards the general pool of epileptic patients, is it really appropriate? Or is this new standard a dilution so that in ten years they will be able to say that serious cases of epilepsy have gone dramatically down?

The size of the incident pool matters JUST as much as the proportion affected, and this issue is core to the thesis of the book:

> Twelve years after the device was approved for epilepsy, the company hadn't collected death data for the five studies submitted as proof of safety and wouldn't release the death data it did collect outside of the studies. I informed the FDA, assuming that the company would get slammed by the regulator for failing to collect death data on a device approved only conditionally because of
the FDA's concerns about a "high rate of deaths." But the FDA continued to insist the device was safe. When I pressed the agency about this, it responded in an e-mail that it hadn't asked the company to count the number of deaths, instead it only required Cyberonics to "characterize mortality." I wondered: ***How does one characterize mortality without knowing whether anyone implanted with the device died?***

Other interesting parts include the history of the first biotech company Genentech, and the failure of their one trick "penincillin for the heart" tPa, against strepkinase, against ASPIRIN, to reduce overall mortality by any measurable amount (but costing x10 as much), that drug companies will routinely file in the SEC about their anticipated fine amounts for failure to disclose in the following year, the many stories about doctors getting paid for overtreatment:

> Biederman had almost single-handedly changed pediatric psychi-
atry by insisting that bipolar disorder could be diagnosed in children
as young as two years old, and his work was credited with a forty-
fold increase in pediatric bipolar disorder diagnoses. His academic
credentials at Harvard gave his recommendations credibility, and doctors and parents alike accepted his recommendations. An investigation by Senator Charles Crassly found that Biederman failed to disclose that he had received six milion in funding from fifteen drug companies between 20?? and 20?? and two of the companies, Eli Lily and Janssen Pharmaceuicals manufacture two of the antipsychotic drugs he recommended for bipolar disorder, together generating several billion dollars in revenue.

... and about the regulatory capture of the FDA.

[CatReader · Rating 3 out of 5]

As someone in healthcare, I appreciate a dose of healthy skepticism...however I found this book a bit too heavy-handed. Ms. Lenzer clearly demonstrates her biases in calling Mr. Fagan (the patient in the story's central, recurring vignette who was clearly harmed by his implanted vagus nerve stimulator) a hero and citing only negative examples of how medical device industries are bypassing proper scrutiny of their devices through bribery and regulatory loopholes. However, this does not mean that every medical device company is a bad actor and that every political appointee to the FDA is an unqualified crook. To cite another example in healthcare, Theranos was a blood testing technology company once valued at $9 billion dollars that was exposed several years ago as misrepresenting the capabilities of their technology and turning out thousands of incorrect blood test results that did demonstrably harm patients. In its 15-year history, Theranos filed dozens of patents but only 1 510K application seeking FDA-clearance-for-noninferiority for one single test they performed (an HSV-2 antibody test). The FDA (among other governing bodies) has oversight over laboratory testing, and Theranos was able to bypass much regulation by claiming their tests were laboratory-developing tests (LDTs), which for decades the FDA, while claiming oversight over, has deigned to not regulate (though various legislature to enforce regulation of LDTs has been in the works for over a decade). Similar to Ms. Lenzer's argument about medical devices and FDA loopholes, one could argue that because of Theranos' high profile demise and blatant abuse of FDA loopholes, all companies and laboratories that have LDTs must be up to no good and trying to profit off of testing that will hurt patients -- and this is blatantly false. The vast majority of laboratories and biotech companies pursuing LDTs are doing things the correct way, going through proper channels, and doing work that benefits patients. While I don't understand all of the nuances of the medical device industry as my area of practice is not in that arena, and I can attest to the pervasiveness of industry influence in most/all areas of healthcare, I would caution readers to take Ms. Lenzer's assertions with a grain of salt and realize that are multiple legitimate sides to every story.

[Sarah Ewald · Rating 5 out of 5]

I read this book because the author was featured on a Netflix documentary from a while back regarding medical devices gone wrong. The comment on the front of the book says "Disturbing and riveting" attributed to Marcia Angell, author of The Truth About the Drug Companies. That is such an apt comment. There is a lot of science in this book and sometimes it is hard to follow, but you certainly get the gist of it.
As the author looks at various devices and the various ways they have been ushered through the FDA approval processes, she follows Dennis Fegan. She tells his story from his childhood through the current timeline in the book (published in 2017) He has a thriving life until he is diagnosed with epilepsy. He sees specialist after specialist, until he visits one who wants to implant him with a device called the VNS, Vagus Nerve Stimulator. Approval for the device by the FDA was supported by cherry-picked studies and evidence put forth by its manufacturer. All was well until it wasn't. The 'cure' implanted by his doctor, almost killed him.

Ms. Lenzer tells of questionable relationships with device manufacturers and the FDA, oftentimes, FDA people end their careers working for the manufactures they did approvals for.
Like I said, there is a lot of science in this book, but after you read this, you will forever be wary of any specialist who advises an implant of any kind.

[E Garcia · Rating 4 out of 5]

The Danger Within Us by Jean Lenzer
This book touches upon life saving devices such as vagus nerve stimulator (VNS), pacemaker, stents, knee surgery and others. However, while devices may help most patients the truth is most lack FDA (food and drug administration) approval. Conflict of interest between doctors and device manufacture complicate the issues. Doctors are offerred financial rewards and gifts influencing medical decisions. Moreso clinical studies of devices or medications are inaccurate,  incomplete, and sometimes false. In some cases surgeries are unnecessary because it won't improve the patients health.

An example shared was of a man who suffers from epilepsy whose VNS almost killed him. Despite his efforts to expose the companies neglect his pleas went ignored. On a daily basis he would send emails to politicians and other allies. His effortless advocacy for himself and to bring awareness to others with similar health concerns left him to suffer two nervous breakdowns.

This book serves as a reminder of the profits made by ceo's health insurance and manufacturing companies. Also the FDA incompetence for failure to follow up on medical studies, enforce deadlines, or hold manufactures responsible for mistakes.

I learned that some of these medical devices are viewed or monitored through bluetooth base systems and it can be hacked. Unfortunately this is one more thing to worry about in health care.

[Timothy · Rating 3 out of 5]

It's hard to pick between three and four stars for this one, so call it a 3.5.

This book provides an informative and frightening look at how poorly regulated the medical device industry is. It deals with a lot of corruption, but it struck me as pretty even-handed in how it assigned responsibility for these problems. It's also just a good read if you want to learn more about how the regulatory environment in the US and how these devices impact the lives of regular people.

I did feel that the book was uneven. Parts of it were densely researched and featured quite a bit of investigative reporting, while others seemed to just be quoting the same five people ad nauseam. It also had some scope creep, as it drifted into talking about pharmaceuticals and eventually ended up with a long jeremiad about the need for public health initiatives and single-payer health insurance. Not a problem for me exactly, but I did feel by the end of the book that she strayed pretty far from the central narrative.

The writing is workmanlike, and while it wasn't especially beautiful I appreciated that the author didn't try to spice it up too much. When she was in her element, the book was incredibly compelling. I do think a lot of this content could have been cut, though.

[Kate · Rating 5 out of 5]

Wow -- this book was terrifying but it's probably one of the most important books out there in the market right now. The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It has been on my radar since I saw a review on NPR and I'm so glad I was able to get an early reviewer copy. This book is well researched, insightful, and the most horrifying book I've read about the dysfunction in the United States' healthcare system.

Having worked in the healthcare industry and suffering from a chronic illness, I've had more than my fair share of run-ins with the medical device industry. Even then, I had no idea just how corrupt the system really was. Learning that many medical devices are implanted with little or no testing is awful -- especially when I consider the fact that I was thinking about having an off-label device implanted myself!

The United States is at a pivotal moment. There is a lot of upheaval happening. Perhaps this book could stir the pot and lead to change in the current healthcare system. I know one thing: Everyone should read this book before considering medical device implants. Do your research. Know your risks. Be your own advocate. The healthcare industry won't help you there.

[Julie Capell · Rating 4 out of 5]

Surprising and disturbing revelations about the FDA process for the approval of implanted medical devices. The story focuses on the experience of one man who had a vagus nerve stimulator implanted to control his epileptic seizures (with disastrous results). One persons experience does not an argument make, but the author goes on to document thousands of deaths and lesser harms caused by implanted devices, including pacemakers and cardiac stents.

Most of us--myself included--presume such devices have extensive, thorough testing before being sold on the open market, but it turns out that is not the case. In fact, the FDA is in the pockets of the device makers (such as Medtronics). Many side effects, including deaths, that could possibly be linked to theses devices are never properly reported, much less investigated.

Yet another yawning chasm of horror awaiting the unwitting US health care consumer. Even doctors don't know what the real side effects are of the devices they are prescribing and implanting. Makes one want to stay as far away from the doctor as possible.

[Gabriel · Rating 5 out of 5]

I loved this book. A lot of truths.

The only thing I would add to this body of work is that, while everything the author writes aligns with my experience working in this field, I think the author would be surprised at how few people benefiting from this system/market, are aware of the reasons behind it. While there are certainly incredibly sophisticated organizations like AdvaMed, most people in medical devices are not aware of these important issues; They tend to truly believe in what they’re doing and chalk up their success to their own skills. This compounds the problems by limiting critical thinking and promoting groupthink.

As a public health economist, I think this book is the best summation of what I do for a living: I make sure that the medical device/pharma companies I work for don’t go down the paths described in this book.

I’m recommending this book to my entire team at work, my boss, and my legal counsel. There’s plenty of money to be made saving lives. There’s no reason to make money endangering lives.

[Paul · Rating 5 out of 5]

It should be required reading, especially for anyone contemplating having a medical device implanted. The medical device industry is further evidence of how far off track we have gone, when the agency that is supposed to be protecting consumers conspires with manufacturers to take away consumer rights. I got the book after watching "The Bleeding Edge," a documentary on the medical device industry that focuses on other devices than the vagus nerve stimulator that is the device at the center of this book. All I can say after reading the book is thank heavens for investigative journalists who bring these things to light (and for those in the medical profession who fight against the perverse incentives that our system has created).

[Brian Bigelow · Rating 5 out of 5]

The US has the most expensive medical system on the entire planet but I don't think we get a good value for the money. I've said this many times.
Only during the last couple of years have I had health insurance. Now I go see a doctor regularly. I do feel I'm treated like it's stated in the book. Kind of like being ran through a cattle chute.
One of my health issues is actinic keratoses. The first doctor who treated me used chemo. Sounds all good. The treatment costs totaled $140 for the chemo, another $80 for doctors visits.
My last treatment was freezing the keratoses for a copay of $40. I think the health insurer was billed $100. Single visit.

[Pooja Rao · Rating 4 out of 5]

The book's message deserves to reach a very wide audience - it’s the only book that I could find on the subject! It's deeply researched and packed with anecdotes.
I can’t help but contrast this with ‘Bad Pharma’ The styles are completely opposite. Where bad pharma relies on facts, science, and stats, this one is pure human storytelling. This book is an easy and engaging read, I wonder if some more numbers would have allowed a truer, less subjective picture. The author underestimates the intelligence and capability of her audience to digest information on a scale larger than a single patient.

[Samantha · Rating 5 out of 5]

Profound.

"Jeanne Lenzer is an award-winning independent medical investigative journalist." She herself worked in healthcare before doing this work.

Some of the last chapter was more opinion based. While I disagree with some of her thoughts, she does make great points. In a less corrupt system, they'd probably work, too.

You'll never look at things the same way again. That's a good thing though.

Every single claim and whistle blow moment is cited, sourced, and put in the last chunk of the book. That's why this is 5 stars. It isn't someone rambling about their thoughts.. It's fact. I highly recommend it.

[(IG:RemindMeToRead) · Rating 4 out of 5]

This book put a lot of what I love about the medical device industry in a new perspective. I feel a little radicalized to do better than the people before me with my future work. Seeing names of companies I really admired throughout college in this book disappointed me and then there wasn't a resolve for Fegan. The patient stories really touched me. I enjoyed that and I enjoyed learning more about the FDA and how the process of getting devices approved isn't ironclad for optimal safety as we'd like t o think. I'd love to read more from Jeanne Lenzer. My critique is that although this book felt well researched and I was actually entertained, it was a lot of information to connect before she went on to a next point. I wish the book was organized better because it felt like a lot of word salad at times.

[Gail GB · Rating 4 out of 5]

This is a 4.5 book and the reason not a 5 is that it was confusing in parts. I highly recommend the book which talks about profit over healthcare. Reading this particular book during the COVID-19 pandemic where states are opening too fast according to the top medical professionals, opening too soon as some states numbers are going up, and demonstrations across the country funded by industry is very disconcerting. Americans need to realize how big businesses affect us all.

[Tiffani Valentin · Rating 4 out of 5]

3.5 ⭐️ the info i learned in this book was honestly shocking. could not believe the FDA has the ability to do such unsafe things when it comes to these devices. really liked how this book highlighted the importance of societal factors in one's health and i also liked how dennis fagan's story unfolded throughout the novel. would definitely recommend to anyone who is in the healthcare field/who is interested in learning more about the FDA and the medical device industry