For many Americans, medical devices such as hip implants and pacemakers can improve and save lives.
The United States is the largest medical device market in the world, valued at $140 billion in 2015, according to the most recent estimates from the U.S. Department of Commerce.
But, the reality is that medical device manufacturers may not have adequately tested the products they sell. Even when they do tests, they may obscure results from the public or bury important safety information.
My guest on this episode of Drugwatch Podcast is award-winning investigative journalist Jeanne Lenzer. She has appeared in and written for media outlets and journals, including The New York Times, The Atlantic and the British Medical Journal (BMJ).
A former physician assistant, Lenzer questioned how much the public actually knew about the drugs and devices they received from doctors.
“What triggered my career into investigative journalism was finding out that some drugs were killing people and yet many doctors were unaware of those deaths,” she said. “And I was puzzled by this.”
In her new book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, Lenzer discusses corruption in the medical-device industry and how it affects patients.
The U.S. Food and Drug Administration did not begin regulating medical devices until the 1970s, long after it began approving drugs. The 510(k) premarket clearance process and the premarket approval (PMA) process are two methods the FDA uses to allow devices on the market.
According to Lenzer, both pathways have problems.
“The problem is that in many — if not most instances — the manufacturers of those devices, have never submitted safety and efficacy studies for those devices,” she said.
In the case of premarket approval (PMA) devices such as the vagus nerve stimulator or Essure birth control, a court ruling prevents patients from filing lawsuits against manufacturers, leaving them with no recourse.
In addition to shedding light on the problems with the industry, Lenzer provides consumers with some tips to take action and protect themselves.
Hi there and welcome to another episode of the Drug Watch Podcast. I'm your host Michele Llamas. And today, I've got a special guest with us. It's author and investigative journalist Jeanne Lenzer. And she just came out with a really amazing book that really shines a light on some of the darker areas of the medical-device industry. And the book is called The Danger Within Us, Americas Untested Unregulated Medical Device Industry and One Man's Battle to Survive it.
So welcome to the show Jeanne.
Thanks Michelle, good to be here.
So tell us a little bit about your professional background.
So I was working as a PA, a physician assistant, for many years. And I worked in practice and emergency medicine, and got frustrated with what I knew that doctors talked about among themselves and what the public knew about medicine.
Perfect. So then you segued into journalism after that. Did you kind of see a need for something like that to shine a light on some of the things that you learned?
Yeah. That was my goal when I left medicine was to help bring some of these problems to the forefront. There are doctors who've been talking for more than a decade now and even longer about the problems of profits over medicine and the research that comes out of that, and how it's often buried by it. So it was my concern is that there were a number of drugs that were being used that really there's very little evidence for their use. And in fact, many of them were unsafe. That's really what triggered my career into investigative journalism was finding out that some drugs were killing people and yet many doctors were unaware of those deaths. And I was puzzled by this. And I'll give on example.
Take Vioxx. Vioxx was sought by one FDA account to have caused more than 60,000 deaths from myocardial infarction, from heart attacks. And I couldn't figure out how is it that we as clinicians could be giving patients drugs that were unsafe and not be aware of the carnage we were causing. And it took a good while for me to learn the answer to that question. But it turns out that it's quite possible. Doctors only see ... maybe they have several thousand patients in their panel that they care for. And if an older man, say taking Vioxx, dies of a heart attack, we just assume, well he was old and he's gonna die of a heart attack.
It really takes unbiased study to understand when a device or a drug is safe and effective. And that just wasn't happening because virtually all research in the United States is either conducted entirely by industry, or in the case of much NIH, National Institutes of Health, research is actually partnered with industry. And I tracked some of the so-called independent research by NIH and found that the data from those studies were often off bounds to ... in fact, not just often. I'm gonna give you what happened when I wrote this one article in the New Republic about the problem. I tracked down several years' worth of studies that were funded by NIH. And I tried to figure out how many of those studies had their data released under the Sunshine and Data Act.
The Sunshine and Data Act says that data from publicly funded studies should be available to the public. That makes sense. And what I found, and the NIH has admitted in writing, was that "despite numerous requests for the data, none had ever been released."
That's another shocking thing there. Even when they say they're supposed to release things, they find ways not to or they probably just don't even mention it and they figure no one's ever gonna look for this. You mentioned that. I think a lot of people I know even try to do the Freedom of Information Act to get some stuff. But what they get back is severely ... it's redacted a lot of parts and it's blacked out. And so you're thinking, "Well, how much information am I really getting here?"
So you started with the drug issue. And you mentioned Vioxx, which is probably one of the best examples of how horrific a drug can be and such widespread injuries. But it's kind of downplayed in the media sometimes. You won't find anybody that really even knows about this. You decided to go digging in the medical device industry now, as opposed to drugs. How did the idea for The Danger Within Us come up?
I was writing for the British Medical Journal. I've written for the BMJ for many, many years. And a man named Dennis Fegan contacted me because he said that he had a device implanted that nearly killed him. And I get a lot of requests like these, so in order to decide whether I wanted to report on this story, I asked for supporting information, including his own medical record. And when I got his medical record, I was just shocked. I couldn't believe my eyes. He clearly was nearly killed by this device. And yet, the manufacturer would take no responsibility. And to make matters worse, the U.S. Supreme Court prevented him from filing suit against the manufacturer. And that's because of a Supreme Court ruling that says that people who've been harmed by devices that have been approved by their supposedly very stringent testing pathway called the Premarket Approval Process or PMA process, that they can't sue.
Well, this is particularly bizarre in the case of the device he was implanted with, a vagus nerve stimulator, because the device was only approved conditionally because the agency was so concerned about what they noted was a "high rate of death" among test subjects who were implanted with the device before the device won approval. So even though they were concerned about death rate, they were prevented ... he was prevented, as were many other people in the case of PMA-approved devices, from suing when it nearly killed him.
So you mentioned PMA here. It's really important to note that, for people listening, that medical devices are approved usually in a couple different ways, two main ways. So you mentioned the PMA, which in theory has a more stringent approval process, where they've actually gotta provide some studies, any kind of safety and efficacy studies. And then there's the other way to get through, which is more of a clearance than an approval, and it's called 510K.
So let's go a little bit into what the difference is between those things. And can you tell the listeners what devices usually fall in what category?
Sure. There's Class 1, which is the low risk devices like tongue depressors. Class 2, which are intermediate risk and includes many implants and hip devices, artificial knees, artificial hips, things like that. And Class 3 devices, which are considered to be high-risk devices that can cause serious injury or death, and those are things like implanted pacemakers, defibrillators, and deep-burn stimulators. They also include things like multiple or combined devices, which not only consist of a device, but of either a drug or a biologic product. So you have things like drug-eluting stents. These are stents that may be put in the coronary artery, that have drugs in them to keep the stents from clotting, and spine implants that have biologically active bone stimulators.
These things are usually things that are life-saving. Right? That's kind of the high risk are usually for serious type things that, like you said, pacemakers, heart stents, things like that.
That's the promise. Frequently, that's not the case. So let's back up and talk about 510K briefly. So 510K is the vast majority of devices. When all the manufacturer has to do ... almost skip to the Class 1 because class one, often many of those are simply registered. They don't even go through 510K, they just tell the FDA, "I've got a new tongue depressor. I'm putting it on the market." That's it. They register.
The 510K ... I'll back up even further. In 1976, the FDA was assigned the task of overseeing medical devices. So unlike drugs, which came under FDA's purview decades earlier, devices didn't come under the control of or the regulatory authority of the FDA until 1976. By then, there were lots of devices already on the market, implanted devices, artificial hips, pacemakers, et cetera. So what the FDA said was, "Okay. You guys are already all on the market. You can stay on the market and we're gonna divide you up into those three classes we just discussed. And the Class 3 devices will have to prove that you're safe after you're on the market."
The problem is that in many if not most instances, the manufacturers of those devices, have never submitted safety and efficacy studies for those devices. Studies showed that five years after devices were conditionally approved for the market, 40 percent had never submitted any data. And even when they do submit data ... I'll return to the story of Dennis Fegan and the vagus nerve stimulator. So that device was approved conditionally because of a high rate of death. When they did submit five studies that they said proved safety, not one of the studies included whether anybody died.
Wow, that's amazing.
When I called them up and said, "How can you prove this is safe? You don't have any data on death." And they admitted that they never "collected any data on death" for any of those five studies. And when I started kicking up a real fuss and I filed Freedom of Information Act requests with them, with the FDA, and said, this is insane. This was not approved fully because of concern about death. You were told to conduct post-market studies to see if this is safe. And yet, you didn't collect any death data.
And then they backed up and said, "Oh. Well, we did. We did. We collected it through the Social Security death index." And I said, "Oh, okay, Fine." I was writing for the British Medical Journal then. Then I said, "Please release those data to the British Medical Journal." And they refused.
So they don't collect the data. And when they do collect the data, they refuse to release it. And I've filed multiple Freedom of Information Act requests, never able to ... as you pointed out, dislodge any of those data.
So the crazy thing is now this is one example. So I know that when you were probably investigating and doing the research for the book, you probably found a bunch of different instances of this. I mean, this is shocking, since even at the highest rate of approval, that the PMA, which is supposed to be the most stringent, you still have these kind of issues here where things just simply slip through. And the FDA never follows up with manufacturers. Or actually, I think ... here's another thing. They don't actually have enforcement capabilities of a lot of these things because they're regulatory.
Someone just says, "Oh, you know what? Everything is a guidance. Not a mandate." It's just so shocking for anybody that is finding this out for the first time. So what other-
Well, it was shocking for me.
I gotta say. I was already very cynical about the pharmaceutical industry, and the nature of biased research before Dennis Fegan came to me. But I gotta say, after looking into devices and you're absolutely right, the VNS is just one example, but it really illustrates the problems that are industrywide. And in fact, at the beginning of my book, one of the things I say is that I tell the story of Dennis Fegan, and his story runs throughout the book, not because his story is the worst. It wasn't. But because it illustrates the problems from the conception of a device, how they're approved, how they're monitored or not monitored right through to the Supreme Court ruling and regulatory capture that allows this kind of stuff to keep happening.
So yeah, I did look at a number of other device problems, and hundreds of thousands of patients impacted by everything from the Sprint Fidelis lead wires that fractured and were implanted in hundreds of thousands of people. And then, what patients don't realize is that once a device is in them, it can be very hard to either turn them off or take them out. And in the case of the Sprint Fidelis leads, a study showed that 15 to 18 percent of patients, one in five patients, suffered serious adverse events or death when they tried to take the lead wires out, because they become so enmeshed in the tissue that removal of lead wires can be very dangerous.
And in fact in Dennis Fegan's case, he wanted his wires removed. The surgeon refused saying that it was just too dangerous to attempt.
And see, here's the thing, too. No one every says these things to patients before they get them implanted. I think if anybody told them and said, "Hey. You know what? There's a chance that if this thing messes up, we won't be able to take it out because you'll die if we try to take it out." I believe that happens in some other instances too like there's a lot of news about the IVC filters, which are the little cages, they look like little spider cages, that trap blood clots in the vein.
But they're these little metal things, and they stick 'em in there. And they're only supposed to be temporary in most cases. But what's happening is they're just left in there. And at any moment, they can fracture and travel in the bloodstream and go to the heart or the lungs. And a lot of people I've spoken to said that they're afraid. They want them out. But now, it's too late. Doctors can't take them out because they'll bleed out or it's too dangerous. So you mentioned that, too. So now people are left without any recourse. And then, you mentioned when a PMA device is approved through that way, they basically don't have any legal recourse because of the Supreme Court ruling.
And I like what you said about not notifying the patients. People have criticized me saying, "You're just lambasting the industry." But the main reason I focus on problems within the industry is because, first of all, patients need to know the truth. But secondly, I actually believe in mainstream science. There are devices that are life-saving and really improve people's lives. And to me, it's very distressing to see that people are left not knowing which devices they can trust and which devices might be deadly. And what I want see is a lot more honesty so patients can make their own decisions.
Yes. That's right.
There are devices that may pose a certain deadly risk, but patients will know when they're taking them. And we know I'm taking an aspirin or penicillin. And yet we know that people die on occasion of taking those drugs from allergic reactions or other problems. That should be the right of the patient to decide. But it has to be a right faced on actual fact, not on fantasy. And I can't imagine what would have happened if the FDA had actually required Cyberonics, the manufacturer of the VNS device, to be honest and tell patients, "By the way, this device was only approved conditionally because of concerns about a high rate of death. Would you like to be implanted with this device?"
There may have been some people who were so desperate that they would have said yes, and that's fine if that's their choice. But many people tell me they would never have had it implanted if they knew this information. So I think that's really the starting point is just simply saying the data need to be transparent and we need to let the public know the truth about these devices.
Like you mentioned there, that is actually the key to this whole thing, because you said medicine and medical devices, they're life-saving. We're certainly not anti-medicine. Right? Not anti-medical devices. However, again, the transparency has to be there. There's got to be clear warnings. And in some cases, I think patients probably should sign consent forms to prove that they know here's some of the things that could happen.
If they sign consent forms, those forms can't be created by industry.
Oh yeah. No, no. Definitely not.
They have such ways to distort information. In fact, I attended a B2B conference, a business-to-business conference, on medical devices where this muckety muck gave a lecture explaining basically how to conceal ... and in fact, the title of his talk was How To ... I don't know the word they used. They didn't use something as obvious as conceal, but How To Relay Information that you'd Rather Not Have the Public Know, or Have the FDA Know. That was it. And what they recommended was simply burying uncomfortable data way deep in a bunch of other data so that people don't notice it.
And then they also quoted this wonderful statement of "Never write what you can speak. Never speak what you can imply." Something like that.
Never imply what you can wink at. I mean it was just ... it's pretty amazing.
It was a course on how to be sneaky. That's pretty much what that was. Be creative. And "Oh, but we didn't lie. It's there." However, if the FDA regulators can't find it, then, oh well. It's as good as not there. And an interesting thing here too. So you've got industry providing all the data on their own devices to the FDA. The FDA does not actually conduct any of their own studies, which is something that people ought to know. All the data is not from the FDA. It's from industry.
Exactly. And they trust industry to supply them with that information, even though they know that very little of the harms ever make it into the FDA's database. So one study showed that only 1 percent of those serious adverse events made it into the FDA's database. So they have to sort of guess at what may be going on, which yet they don't demand that manufacturers submit data about how many of the devices are actually in people who are implanted with devices.
Oh yeah. That's a good point.
So we have no denominator. We have an unreliable numerator that maybe we should multiply by 100, but we don't really know. And again, if you have say 100 deaths in the database from a device that was implanted in 200 people, that's really worrying.
Yes. That's significant.
But if you have 100 deaths and you've got 2 million people implanted. Well, that's a different story. It's the kind of risk maybe many people are willing to take. But we don't have that information. So patients can't accurately determine what's going on, what their real risks are.
So now, after you found out all the things that you found out here. And you said you were already skeptical before you wrote the book. Did you learn anything that affirmed any of your beliefs or changed them about the medical-device industry?
I think it only increased my concern. The one thing that really sort of took me by surprise was that natural devices could do the same thing that drugs do. And that is mimic the very problem that's being created. I hadn't really thought about that. I had already become aware that with drugs, they frequently overshoot their target. So you give antidepressants to patients who are depressed and some people improve. Antidepressants are sort of like alcohol. In some people, they drink alcohol and you know they're gonna get in a fight. Other people, they drink alcohol and they just become super friendly. It has different effects on different people.
But overall, when you look at groups of people, there's actually an increase in suicidality among people who are given antidepressants. So you're targeting in a system that's already disordered, and when you give them a drug, it can only make things worse. Sometimes it makes things better. But it's also possible for it to make things worse so that you mimic the underlying disease. So people become more depressed, and doctors think, "Oh, it's the underlying depression." And then, they give them more drugs. I had no idea that that was true of devices as well.
They actually caused clots to aggregate on it and if those break off, then you're even more likely to develop a lung clot or a pulmonary embolism. And there's many other devices where, again, the same things happened. The vagus nerve stimulator, actually there was an increase in seizures among many of the patients, almost as many as had a decrease in seizures. And in fact, some patients had up to a 600 percent increase in their seizures once they were implanted with a device.
The last thing any of the clinicians question is the implant or the drug. Right? You're either too old, or you're, "Oh, you're getting worse. So now we've gotta up your dose or we've gotta give you a different implant or more implants." Crazy things like that. It's never, "Oh wait, could be a side effect of the thing that we just put in this poor person."
So with all of these things going on, all the stuff that you've learned here, what would you tell the average consumer now going into maybe looking into having a medical device or taking a new drugs perhaps that they've never taken before? What can you give them to help them, I guess, protect themselves from these kind of things?
Part of the reason I wrote this book was because I began to realize that there really was no individual answer to this problem. That's part of why I told the stories of just two people, in addition to many other people, but these two people in particular, about this problem that one can't figure it out individually. This is not a problem that we can solve for ourselves when we want … with an implant. So I tell the story of Dr. Tower and his hip implant that even with all his training, he can't tell.
And I told the story of a Medtronic executive who gets a Medtronic implant, and she suffers horrific consequences from that implant. So even the insiders can't necessarily tell which devices are safe or not safe because the science is so biased. We have to rely on what industry is telling us at this point. And so I wrote the book in part because I wanted people to realize that we need to make systemic changes in order for things to improve. We need transparency. We need independent research that isn't funded by industry. We need public funding of genuinely independent research. And we need to change our medical system so that profiteering isn't at the heart of what doctors are doing. So that surgeons aren't earning tens of millions of dollars, as they literally are, for implanting certain devices.
So you put somebody on a salary and you don't pay them more for doing more, and you don't pay more for doing less. The only consideration they should have is what's best for the patient. There are a couple things that patients could do individually. It's no guarantee of a good outcome. But in one example, that's the spine implants I mentioned. The FDA had actually issued a warning to doctors that they shouldn't implant that device in the necks of patients' spines because of deadly reactions. And that warning was simply ignored by a lot of doctors. But if patients knew to go to the FDA's database, they could have found that and found out that that was not recommended. And in that case, it was even a Medtronic executive who was unaware of that warning in the FDA's database. This is how hard the information is to unearth.
But I could recommend that they at least do that much.
All right. So definitely be an informed consumer. Do some research. See what's out there. Like you mentioned, check the FDA, which again, is notoriously difficult to navigate. And I do this all the time. And it's difficult for me. I can only imagine .. trying to find this stuff. But usually, if you search recalls, warnings, FDA warnings for such and such product ...
You're bound to at least hopefully find some kind of trail there. And the, this kind of opens a dialogue with your doctor right? Take that stuff to the doctor and say, "Hey, you know what?"
But unfortunately most doctors, again, have to rely on this research that's just unreliable.
You are right. You are right.
And there is one other thing I'd recommend is that patients should not be fooled by so-called patient groups online, because many, many of them are funded by the very manufacturers that are peddling the devices that will be used. And that can be very obscure. I've seen some patient websites that look like they're run independently by patients who are interested in their best interest. And it takes a lot of work to unearth their funding and find out that these are actually industry fronts. So be careful and do look for non-industry funded websites, and things like Consumer Reports and National Center for Health Research.
You would always wanna go to the consumer-based organizations versus the ... if you see again it's a big company that has anything to do with the product that's being sold. And when you say patient groups, are you talking about groups that are saying, "Oh, hey. This is how I cured. I got this hip implant and I love it." Are you talking about that kind of ...
And the names of some of these groups can be very misleading. It can be things like Citizens for Better Medicare.
I see what you mean.
And it turns out it's industry funded. So watch out. They use names. There's another group called Patients Like Me — industry funded.
Oh, hey. That's a big one, I believe. That's a big site.
Yeah. And they actually sell the data that patients put on their website. One of the things I'm doing at my website is opening up a page for people to find industry independent resources. And I have a list of industry independent experts for journalists that they can access. And I'm going to be putting up shortly the same list that I put in my book of all the industry independent patient groups.
So this is on jeannelenzer.com, then?
All right. So, I will make sure that that link is also within the story that accompanies this podcast. So if anybody needs any of that, I will put the links there.
Great. And the patient groups aren't up yet. But I encourage all patient groups who want be added to the list that I have in my book, to contact me, and I do make sure that these are industry independent.
Oh great. That's wonderful because I do know a lot of legitimate groups that would love to be there because they really are just there to help people. And this is usually after the fact, of course. You've got a lot of support groups that talk to people that have been injured by these things. So I think sometimes that's a better place to go because you can see here's all the stories about it.
And there's another resource I'd love to recommend. And that's Health News Review. They do excellent work on a number of devices and drugs. They are directed towards criticizing media reports or evaluating media reports. And they have an award rating in terms of how well or how poorly certain devices and drugs are reported. But they also give a lot of information. They're extremely good and have a number of physician writers that are involved in their website. And in terms of making changes, systemic changes that need to be made, policy changes, The Lown Institute and the Right Care Alliance, are groups that do a lot in that direction.
Okay. So if anybody's interested in trying to support any of that and try to affect change, those last two organizations would be good ones for people to look at, I guess.
All right. Well thank you so much for being on the show. You've said so much already that, I mean is mind blowing for a lot of people, I'm sure. You just assume the FDA is protecting us and really looking out for these things, but for various reasons, funding and what not, they're really just ... it's better than nothing, that's how I look at it. However, people really need to take a look at this. So, glad that you've shone a light on this. People really need to check the book out because it's gonna go into a lot more detail and really talk about these stories that you mentioned briefly here. So once again, everybody, the book is called The Danger Within Us, America's Untested Unregulated Medical Device Industry and One Man's Battle to Survive It.'
So thanks so much Jeanne. Pleasure having you on the show.
Thank you so very much for having me.
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