Do some surgical implants do more harm than good?(newyorker.com)
newyorker.com
Do some surgical implants do more harm than good?
https://www.newyorker.com/magazine/2020/04/20/do-some-surgical-implants-do-more-harm-than-good/
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> companies are always scheming, wicked villains
I believe the baseline assumption is that many people are trying to make a buck, and something like coronavirus is a great opportunity to scam people. Is that wrong?
I'll bet if I purchase ten coronavirus test kits "from the internet", at least 9 out of 10 will be bogus. In the absence of regulation, that would be 13 out of 10. There's a potential for truly massive scams: 7 billion people want something in tight supply, just announce you've got a test kit for $19.95, maybe mail people some pH test strips or nothing at all, and retire to your own private island. One of the reasons government exists is to protect the populace from threats to their health such as health scams.
I believe the baseline assumption is that many people are trying to make a buck, and something like coronavirus is a great opportunity to scam people. Is that wrong?
I'll bet if I purchase ten coronavirus test kits "from the internet", at least 9 out of 10 will be bogus. In the absence of regulation, that would be 13 out of 10. There's a potential for truly massive scams: 7 billion people want something in tight supply, just announce you've got a test kit for $19.95, maybe mail people some pH test strips or nothing at all, and retire to your own private island. One of the reasons government exists is to protect the populace from threats to their health such as health scams.
The way that most industries solve this problem is through accreditation and branding. If Apple made a test that was endorsed by Consumer Reports, you can bet good money that it's effective.
The FDA & CDC shipped their own tests that were bogus. What's worse: They threatened researchers who invented their own tests that worked.[1] Thanks to the government's incompetence, testing was delayed by a month in the US.
1. From https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...: Later that day, the investigators and Seattle health officials gathered with representatives of the C.D.C. and the F.D.A. to discuss what happened. The message from the federal government was blunt. “What they said on that phone call very clearly was cease and desist to Helen Chu,” Dr. Lindquist remembered. “Stop testing.”
The FDA & CDC shipped their own tests that were bogus. What's worse: They threatened researchers who invented their own tests that worked.[1] Thanks to the government's incompetence, testing was delayed by a month in the US.
1. From https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...: Later that day, the investigators and Seattle health officials gathered with representatives of the C.D.C. and the F.D.A. to discuss what happened. The message from the federal government was blunt. “What they said on that phone call very clearly was cease and desist to Helen Chu,” Dr. Lindquist remembered. “Stop testing.”
It is also not prudent to assume that regulators are always scheming, wicked villains, or power hungry idiots or whatever. For example, in your distillery link the FDA explains that incidents of kids eating hand sanitizer are up since the pandemic.
That's not a problem that should be solved by poisoning ("denaturing") the alcohol.
The article is a little bit confusing on the nature of denaturing.
Alcohol can be denatured by making it literally unsafe to drink (methanol, gasoline, etc), or by making it really unpalatable (denatonium benzoate, vinegar, etc), or both. The list of agents and formulae are here: https://www.law.cornell.edu/cfr/text/27/part-21
Balancing the safety effects of kids eating hand sanitizer vs. the safety effects of not having enough hand sanitizer is tough, but insisting on a bitterant doesn't strike me as totally indefensible.
Alcohol can be denatured by making it literally unsafe to drink (methanol, gasoline, etc), or by making it really unpalatable (denatonium benzoate, vinegar, etc), or both. The list of agents and formulae are here: https://www.law.cornell.edu/cfr/text/27/part-21
Balancing the safety effects of kids eating hand sanitizer vs. the safety effects of not having enough hand sanitizer is tough, but insisting on a bitterant doesn't strike me as totally indefensible.
Oh, ok. I guess bittering is reasonable.
Regulators don't need to be
> scheming, wicked villains, or power hungry idiots
to explain any of their recent misbehavior - perfectly banal explanations suffice. At the end of the day, our regulators will let people die invisibly if it means avoiding bad press because that's what they are incentivized to do.
> scheming, wicked villains, or power hungry idiots
to explain any of their recent misbehavior - perfectly banal explanations suffice. At the end of the day, our regulators will let people die invisibly if it means avoiding bad press because that's what they are incentivized to do.
> A registry is a plausible idea, but in general, this article seems to assume by default that regulators are always wise and benevolent
This article doesn't seem to say that regulators are wise and benevolent. It looked like the author was, in fact, troubled by the lack of regulation as cited here:
> The root of the problem, of course, is money. In medicine, progress is driven by innovation, and, in our society, innovation is driven by profit. “Among implant manufacturers,” Schneider writes, “market analysis drives research and consideration of device innovation.” The implantable-device industry is even more lucrative, for many companies, than the pharmaceutical industry is. At the largest companies, operating-profit margins are typically twenty-five per cent or higher. In 2014, the industry’s over-all estimated revenues totalled more than a hundred and thirty-six billion dollars.
> The financial incentives within this industry are one of the reasons that its lack of regulation is troubling.
This article doesn't seem to say that regulators are wise and benevolent. It looked like the author was, in fact, troubled by the lack of regulation as cited here:
> The root of the problem, of course, is money. In medicine, progress is driven by innovation, and, in our society, innovation is driven by profit. “Among implant manufacturers,” Schneider writes, “market analysis drives research and consideration of device innovation.” The implantable-device industry is even more lucrative, for many companies, than the pharmaceutical industry is. At the largest companies, operating-profit margins are typically twenty-five per cent or higher. In 2014, the industry’s over-all estimated revenues totalled more than a hundred and thirty-six billion dollars.
> The financial incentives within this industry are one of the reasons that its lack of regulation is troubling.
If you assume adding regulation makes things better without further argument/evidence, you are assuming regulators are wise and benevolent. (Regulators != Legislators.)
Why is Fitbit able to get a pulse oximeter in the market while Apple is not?
It's not clear if Fitbit's pulse oximeter update was ever shipped in the US. I can only find forum posts by disgruntled users who say they don't have it. I asked an acquaintance and he says he doesn't have the functionality despite owning a compatible device.
Amusingly, both Fitbit and Apple are part of the FDA's digital health software precertification pilot program[1], which is intended to streamline the approval process. If not for the FDA, both companies could have shipped this 3+ years ago. I'm sure the data would have saved quite a few lives.
1. https://www.fda.gov/medical-devices/digital-health/digital-h...
Amusingly, both Fitbit and Apple are part of the FDA's digital health software precertification pilot program[1], which is intended to streamline the approval process. If not for the FDA, both companies could have shipped this 3+ years ago. I'm sure the data would have saved quite a few lives.
1. https://www.fda.gov/medical-devices/digital-health/digital-h...
> Schneider writes, “It is more likely for Toyota to know about faulty exhaust pipes in a Prius than DePuy [medical device company] to understand how a new hip implant is performing in the United States.” A registry of implants would enable the F.D.A., doctors, and patients to access data on their risks and benefits over time, but the U.S. has no such registry, unlike Canada, Australia, New Zealand, Japan, and several countries in Europe. Schneider emphasizes how these systems provide “valuable information about the longevity of an implant when used in real-world conditions by all surgeons.” A registry prevents surgeons from “cherry-picking” to exclude cases that would sully papers about implants they may have designed, and protects against the gaming of data.
> Repeated efforts to implement a registry system in the United States have failed. The implant industry has a powerful lobby in Washington, and the courts and recent legislation have made regulatory oversight more feeble.
Wonder about the history of this. Which lobby groups are making it hard to build a registry?
> Repeated efforts to implement a registry system in the United States have failed. The implant industry has a powerful lobby in Washington, and the courts and recent legislation have made regulatory oversight more feeble.
Wonder about the history of this. Which lobby groups are making it hard to build a registry?
Because generally speaking:
1. People care about keeping medical information private.
2. Having people opt into making their medical information public would skew the data.
3. Your doctor can't be arsed to update a global registry every time you go to him for a checkup. In the long run, you have a relationship with your GP, not the surgeon who put the implant in.
4. And yeah, I assume the implant industry would like to have the aegis of the high trust people place in the medical profession, without having to do the hard work of earning that trust.
1. People care about keeping medical information private.
2. Having people opt into making their medical information public would skew the data.
3. Your doctor can't be arsed to update a global registry every time you go to him for a checkup. In the long run, you have a relationship with your GP, not the surgeon who put the implant in.
4. And yeah, I assume the implant industry would like to have the aegis of the high trust people place in the medical profession, without having to do the hard work of earning that trust.
5. They don't want to generate evidence that can be used in a class action lawsuit.
Feigned ignorance is a great defense.
Feigned ignorance is a great defense.
"... if a device was sold before 1976, an updated version can be released without new clinical trials, so long as the manufacturer deems it to be 'substantially equivalent' to the existing device. Thirty years after the 1976 legislation was passed, the F.D.A. had approved more than a thousand high-risk devices, only sixteen per cent of which had gone through rigorous clinical testing before sale."
Shades of Boeing here. Interesting.
Shades of Boeing here. Interesting.
It's not really shades of boeing, though I can see how it may look like that from the outside.
The problem is that a pre-market assessment (PMA) is a huge and expensive beast, if you require every device/implant/etc. to go through that it will definitely slow things down a lot and make them more expensive...
So the pre-market notification and de-novo paths were created to keep rigor in the system without adding years and millions to development costs of everything. For the most part it works fairly reasonably to balance these concerns.
There is already a classification system (I, II, III) which captures this and can force your device through a PMA if it is deemed high enough risk.
One could argue that class II is being used to much I suppose, but that is a very different issue than pointed at by boeing.
The problem is that a pre-market assessment (PMA) is a huge and expensive beast, if you require every device/implant/etc. to go through that it will definitely slow things down a lot and make them more expensive...
So the pre-market notification and de-novo paths were created to keep rigor in the system without adding years and millions to development costs of everything. For the most part it works fairly reasonably to balance these concerns.
There is already a classification system (I, II, III) which captures this and can force your device through a PMA if it is deemed high enough risk.
One could argue that class II is being used to much I suppose, but that is a very different issue than pointed at by boeing.
I must be missing something. That sounds almost exactly like the Boeing situation to me.
It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades.
How is that parallel to the Boeing situation? We know there was an engineering failure followed by a process failure wrt 737 max.
If we have similar evidence in devices (i.e. the process isn't working, or the developers are cutting corners, or both) that should certainly be addressed. But drawing that line with information such as this article seems a stretch, at best.
How is that parallel to the Boeing situation? We know there was an engineering failure followed by a process failure wrt 737 max.
If we have similar evidence in devices (i.e. the process isn't working, or the developers are cutting corners, or both) that should certainly be addressed. But drawing that line with information such as this article seems a stretch, at best.
Forgive me, but I also had the same thought as OP and honestly can't tell the difference between what you are describing and Boeing.
> It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades.
Just like the FAA and Boeing until it didn't?
> We know there was an engineering failure followed by a process failure wrt 737 max.
My reading of the situation was a process failure, a couple of engineering screw ups, and possibly user error.
> It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades.
Just like the FAA and Boeing until it didn't?
> We know there was an engineering failure followed by a process failure wrt 737 max.
My reading of the situation was a process failure, a couple of engineering screw ups, and possibly user error.
How are the both of you not included all regulatory oversight in the same bucket?
Could the FDA process become weaker to the point of a problem, sure. Is there any evidence that it currently is? I haven't seen any. Is this something they (the FDA and similar) should keep an eye on, absolutely
Honestly, I don't see how you are drawing the parallel. In what wad do you think the FDA is making the "same" mistake as the FAA did?
Could the FDA process become weaker to the point of a problem, sure. Is there any evidence that it currently is? I haven't seen any. Is this something they (the FDA and similar) should keep an eye on, absolutely
Honestly, I don't see how you are drawing the parallel. In what wad do you think the FDA is making the "same" mistake as the FAA did?
Ah, well, the FAA did not make Boeing go through recertification for the new "version" of the plane. Close enough. Same thing. Did it back then, should be alright. And so the safety process was not seen through on this new model.
Similarly, the FDA grandfathered in a bunch of devices and because they are "substantially equivalent," the FDA did not ask for recertification and the safety process was not gone through for these devices.
Similarly, the FDA grandfathered in a bunch of devices and because they are "substantially equivalent," the FDA did not ask for recertification and the safety process was not gone through for these devices.
What I am saying is I think that your last paragraph is a misunderstanding of what the 510(k) and de-novo pathways are, and that they are a safety process, which was and is followed.
If you argued that the V&V necessary for a 510(k) filing is insufficient, I would understand where you are coming from, and it could be interesting.
If you argued that a PMA is needed for all medical devices, I would understand the argument but probably disagree.
Your 'similarly' just isn't that similar, unless I've vastly misunderstood the FAA/Boeing case.
Again it's clear that the FDA could fall into a state where it's review and audit processes had the same sort of problems that the FAA exhibited with the 737max. But I don't see evidence at all that this has actually happened.
What do you think the substantively equivalent bar for a 510(k) allows a company to do?
Regulatory capture is a real risk for any regulatory oversight, but it is not synonymous with that regulatory oversight.
If you argued that the V&V necessary for a 510(k) filing is insufficient, I would understand where you are coming from, and it could be interesting.
If you argued that a PMA is needed for all medical devices, I would understand the argument but probably disagree.
Your 'similarly' just isn't that similar, unless I've vastly misunderstood the FAA/Boeing case.
Again it's clear that the FDA could fall into a state where it's review and audit processes had the same sort of problems that the FAA exhibited with the 737max. But I don't see evidence at all that this has actually happened.
What do you think the substantively equivalent bar for a 510(k) allows a company to do?
Regulatory capture is a real risk for any regulatory oversight, but it is not synonymous with that regulatory oversight.
> What I am saying is I think that your last paragraph is a misunderstanding of what the 510(k) and de-novo pathways are, and that they are a safety process, which was and is followed.
I don't think anyone in this chain has tried to claim that the 510(k) is not a safety process nor that it is not followed - merely that avoiding more rigorous testing and review of a new device by tying it to the safety rating of a previous device sounds exactly like what happened with boeing's 737 max, and secondly, that existing regulations incentivize bad outcomes whereby companies make more expensive/dangerous/worse products that get less testing.
> What do you think the substantively equivalent bar for a 510(k) allows a company to do?
Honestly, I have literally no idea, and have been trying to tease that information out of you. Specifically, how does that bar differ from the one that Boeing had to clear with the 737 Max took which took 5 years and a few billion dollars (I don't know how much of that was for compliance, but we can guess its at least 10s of millions).
This is literally the first article I found when I searched google:
https://www.medicaldesignandoutsourcing.com/boeings-737-max-...
I don't think anyone in this chain has tried to claim that the 510(k) is not a safety process nor that it is not followed - merely that avoiding more rigorous testing and review of a new device by tying it to the safety rating of a previous device sounds exactly like what happened with boeing's 737 max, and secondly, that existing regulations incentivize bad outcomes whereby companies make more expensive/dangerous/worse products that get less testing.
> What do you think the substantively equivalent bar for a 510(k) allows a company to do?
Honestly, I have literally no idea, and have been trying to tease that information out of you. Specifically, how does that bar differ from the one that Boeing had to clear with the 737 Max took which took 5 years and a few billion dollars (I don't know how much of that was for compliance, but we can guess its at least 10s of millions).
This is literally the first article I found when I searched google:
https://www.medicaldesignandoutsourcing.com/boeings-737-max-...
> and have been trying to tease that information out of you
I really didn't get that from your comments. I will try.
1st off I'm no expert in aerospace regulation or anything like it so perfectly happy to be wrong, but my assumption is this: The 737max issue arose because of a combination of two things. 1 the engineering standards at Boeing have been eroded (so they cut corners) and 2) the FAA has been subject to regulatory capture to the degree that they did not catch this (or did not/could not act effectively when they did). If I'm wrong here please advise.
Now I suspect there are a lot of differences in how broadly these things are applied so I will try and draw as close a parallel as I can. Imagine you and I have a med dev company and we are building a new version of a device X, call it X2, and we are using a self-predicated 510(k) to do it. When we file that we still have a full system V&V. We have a hazard analysis that can included everything for X, but must focus on any functional differences between X and X2, We run all our system trace & testing, produce he documentation, and file it with the FDA panel. Now if the panel don't like anything in the V&V (or the rest of the filing) they can ask use to support it better, and that includes the previously covered aspects. If they think the predicate is too much of a stretch they can kick it back. If we can't make them comfortable they can push it to refile with new methods or a to a full PMA (i.e. clinical trials) and force us to go the whole route (along with anyone else doing the same thing, they can't just target our company). We absolutely can propose pretty much anything to address the variations in our machine, but they don't have to accept any of them.
So I can see how we might pressure our engineers to cut corners, and we can see how we might paper it over to file. But I can't see the mechanism where the FDA fails to do it's part (or for that matter, how a clinical trial would have caught everything that might be missed that way).
Make sense?
Again, I'm not saying the FDA couldn't have such a problem, all regulatory bodies can. I just don't see evidence that it does have this problem. And the narrative that the creation of a 510(k) path was due to regulatory capture seems pretty weak, for what it's worth.
I really didn't get that from your comments. I will try.
1st off I'm no expert in aerospace regulation or anything like it so perfectly happy to be wrong, but my assumption is this: The 737max issue arose because of a combination of two things. 1 the engineering standards at Boeing have been eroded (so they cut corners) and 2) the FAA has been subject to regulatory capture to the degree that they did not catch this (or did not/could not act effectively when they did). If I'm wrong here please advise.
Now I suspect there are a lot of differences in how broadly these things are applied so I will try and draw as close a parallel as I can. Imagine you and I have a med dev company and we are building a new version of a device X, call it X2, and we are using a self-predicated 510(k) to do it. When we file that we still have a full system V&V. We have a hazard analysis that can included everything for X, but must focus on any functional differences between X and X2, We run all our system trace & testing, produce he documentation, and file it with the FDA panel. Now if the panel don't like anything in the V&V (or the rest of the filing) they can ask use to support it better, and that includes the previously covered aspects. If they think the predicate is too much of a stretch they can kick it back. If we can't make them comfortable they can push it to refile with new methods or a to a full PMA (i.e. clinical trials) and force us to go the whole route (along with anyone else doing the same thing, they can't just target our company). We absolutely can propose pretty much anything to address the variations in our machine, but they don't have to accept any of them.
So I can see how we might pressure our engineers to cut corners, and we can see how we might paper it over to file. But I can't see the mechanism where the FDA fails to do it's part (or for that matter, how a clinical trial would have caught everything that might be missed that way).
Make sense?
Again, I'm not saying the FDA couldn't have such a problem, all regulatory bodies can. I just don't see evidence that it does have this problem. And the narrative that the creation of a 510(k) path was due to regulatory capture seems pretty weak, for what it's worth.
The answer to any question of the form "Do some X interventions do more harm than good?" is always "Well yes, but is it a statistically significant amount?"
This is a set of anecdotes and editorializing about a very statistical kind of question.
This is a set of anecdotes and editorializing about a very statistical kind of question.
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Makes one wonder - in the absence of thorough regulation, why a third-party evaluator hasn't arisen to provide real risk analysis for patients regarding each device (the good device seal) - and I'm surprised insurance companies aren't more aggressive in ensuring that they aren't making the patients worse 9which would increase their insurance costs).
My theory is that insurance companies don’t try to save money as long as they can pass the cost to the patient or whoever pays the premiums. Otherwise I can’t explain the insanity of the charges hospitals are getting away with.
If your limited to a certain percentage of costs as your profits, you have an incentive to increase costs. Hospitals and insurance enter into an unholy pact to increase costs implicitly as a result.
Doesn't gaming the system to increase profits by increasing costs show malevolent motives which would not be fixed by removing profit restrictions? I mean if you're "evil" with regulations, why should I trust that removing regulations will make you "less evil"? It sounds like a crook asking you to remove the handcuffs.
Removing the profit regulations has less to do with enabling greed (which exists either way) than it does with aligning incentives.
The idea is that you want the insurance companies to profit from patients getting timely, cost-effective care, rather than incentivizing them to drive up costs and delays.
The idea is that you want the insurance companies to profit from patients getting timely, cost-effective care, rather than incentivizing them to drive up costs and delays.
Why would they not increase executive pay, raise prices and deliver worse service? Private industry is not perfect at utilizing resources or delivering great products all the time. You just assume they will deliver a better product, but their undermining of the current system shows that profit over patient outcome is already their top priority. Deregulate so the crooks are less crooked has blown up in our face before.
If you remove the profit regulations insurances will keep doing exactly what they are doing now while making more profit. The won’t pass savings to the patient unless forced to do so. Health care is just a very bad area to apply regular economics. As far as I know most countries have some kind of price control including the US with Medicare.
You are proposing a cost spiral due to greed; why doesn't this happen in every industry which provides 'essentials' but has no profit-limiting regulations?
Examples would be grocery stores, clothing, transportation, etc. You can say 'this one is different' about every single industry, but why does that difference matter?
Examples would be grocery stores, clothing, transportation, etc. You can say 'this one is different' about every single industry, but why does that difference matter?
The American healthcare industry is fascinating for a number of reasons. First, when insurance is involved you have the person seeking the service completely removed from the person paying for it - which almost always will result in overconsumption.
Then, you have life or death issues, which people won't apply their usual cost/benefit analysis. Do you need a new car? Depends, is it worth the added expense. Do you need brain surgery even if the chance of success is 4%? Will it possibly extend my life? Yes, no matter how much it costs.
Because in all these industries pricing is relatively clear, customers have some level of understanding of the product and they can choose between competitors. In US health care you have zero pricing information, the employer chooses insurance based on their needs, not the patient’s, and people are not in a position to judge the quality of procedures so they do what the doctor tells them. It’s not a functioning market and probably can’t be.
Employer-provided healthcare is a result of tax policy, so it is tough to blame that on insurance companies.
The average person understands much more about healthcare products than they do about transportation products. Your car is made up of >20k components, and extremely intricately designed. Understanding the factors that go into a reliable car requires a fairly advanced understanding of thermodynamics, metallurgy, fracture mechanics, electronics, software engineering, statistics, and manufacturing. Most healthcare is comparatively primitive.
If you're worried about the quality of procedures (as I am), it's a doctor/hospital issue, not an insurance issue. Doctors have very effectively avoided oversight, and they often cause huge problems for their patients. The leading cause of death in hospitals in medical error.
The average person understands much more about healthcare products than they do about transportation products. Your car is made up of >20k components, and extremely intricately designed. Understanding the factors that go into a reliable car requires a fairly advanced understanding of thermodynamics, metallurgy, fracture mechanics, electronics, software engineering, statistics, and manufacturing. Most healthcare is comparatively primitive.
If you're worried about the quality of procedures (as I am), it's a doctor/hospital issue, not an insurance issue. Doctors have very effectively avoided oversight, and they often cause huge problems for their patients. The leading cause of death in hospitals in medical error.
“Employer-provided healthcare is a result of tax policy, so it is tough to blame that on insurance companies.“
Agreed. However, they make a very good living off this and will fight to keep things that way.
When you buy a car, you know all competitors, their prices, there is ton of information about maintenance, durability and all other factors that may cost you money. In healthcare you get none of this.
I am not trying to single out one factor in health care. Insurers, providers, pharmaceuticals and the various middlemen are all guilty of making an excellent living off this insanely stupid system on the back of patients who suffer from it health wise and financially. Where it gets evil is the fact they lobby for keeping things that way by spreading a lot of misinformation.
Agreed. However, they make a very good living off this and will fight to keep things that way.
When you buy a car, you know all competitors, their prices, there is ton of information about maintenance, durability and all other factors that may cost you money. In healthcare you get none of this.
I am not trying to single out one factor in health care. Insurers, providers, pharmaceuticals and the various middlemen are all guilty of making an excellent living off this insanely stupid system on the back of patients who suffer from it health wise and financially. Where it gets evil is the fact they lobby for keeping things that way by spreading a lot of misinformation.
The ones making the real money in healthcare are the doctors and nurses, who have been very successful in restricting competition. Doctors and nurses in the USA (and to a lesser extent Canada) make far more money than they do almost anywhere else in the world (in either absolute or relative terms). Doctors have also been successful in preventing/avoiding tracking their results; some are much worse than others, but it is very tough to find out how good/bad they are.
Hospitals and clinics in some states have been very successful in reducing competition, to the extent that you often need permission from your competitors to open a new one. Hospitals have also avoided much scrutiny by avoiding cost-accounting, which is a very interesting tactic.
Pharmaceuticals and insurance companies are the bogey-men of the industry, but they're not as profitable as most imagine, and their high overheads are largely due to regulatory burden.
Hospitals and clinics in some states have been very successful in reducing competition, to the extent that you often need permission from your competitors to open a new one. Hospitals have also avoided much scrutiny by avoiding cost-accounting, which is a very interesting tactic.
Pharmaceuticals and insurance companies are the bogey-men of the industry, but they're not as profitable as most imagine, and their high overheads are largely due to regulatory burden.
You are making the mistake of singling out one participant. In the US health system all players are making “the real money”. The only exception is the patient.
How exactly would this work? Station someone on the sidewalk outside the hospital and interview people leaving the building? "Excuse me sir, have you received a medical implant today? We're interested in enrolling you in our study group which will take a good deal of your time and give you no benefit..."
More systematically: offer a "good housekeeping" seal. Presumably those who have good implants will cooperate and open their books so you can look at who they install to and outcomes. Being a reliable 3rd party, cooperating and getting a gold medal seal will help with sales.
1) For current patients, how will you get their data. I'm reluctant to give some places my email address; access to my complete medical records for the rest of my life is a giant stretch.
2) For future patients (or their doctors), how will you convince them that your recommendation is credible and not some kind of front for a specific manufacturer?
2) For future patients (or their doctors), how will you convince them that your recommendation is credible and not some kind of front for a specific manufacturer?
One obvious variable that is not mentioned in the article, and is a contributing factor to case outcomes, is surgical technique.
I work in the medical device industry and have observed (live, bedside), plenty of laparoscopic surgeries and have seen plenty of good surgeons and also many bad ones.
I'm not defending the medical devices (every company I've worked at has had recalls and devices fail, injuring people), but the reality is that the implant is only as good as it is placed.
I work in the medical device industry and have observed (live, bedside), plenty of laparoscopic surgeries and have seen plenty of good surgeons and also many bad ones.
I'm not defending the medical devices (every company I've worked at has had recalls and devices fail, injuring people), but the reality is that the implant is only as good as it is placed.
"""For much of Western history, however, surgery lay somewhat apart from the practice of medicine. Hippocrates was leery of it, writing, “He who wishes to be a surgeon should go to war”; the crude practices of the battlefield were, as Roy Porter put it in his classic history of medicine, “Blood and Guts” (2002),"the work of hand not head.” This suspicion bred an enduring medical division of labor, in which many healers viewed surgery as inferior. Well into the modern era, surgical procedures were the province of the barber, along with pulling teeth."""
Even now sometimes I wonder is surgery a science? Does it use the scientific method?
Even now sometimes I wonder is surgery a science? Does it use the scientific method?
Yes! It's common to run clinical trials comparing different types of implants, different surgical approaches, and even decisions on when/if to do the surgery at all.
On the other hand, they are relatively to run and interpret. For a drug trial, you can give everybody a fixed dose of a drug (X mg; Y mg/kg bodyweight) in a fixed way (pill, injection, etc). Surgery is a lot harder to standardize. Along with the patient-to-patient variability, there's also surgeon-to-surgeon variability. Different surgeons might be faster or slower, cut more (and get a better visualization of whatever they're doing) or less (reduced tissue damage). Moreover, the individual surgeons improve with practice and it sometimes takes a lot (e.g., 100-200 knee arthroscopies) to plateau, which makes it tricky to evaluate a totally new method.
This is a nice paper discussing some of the issues in more detail: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415901/
On the other hand, they are relatively to run and interpret. For a drug trial, you can give everybody a fixed dose of a drug (X mg; Y mg/kg bodyweight) in a fixed way (pill, injection, etc). Surgery is a lot harder to standardize. Along with the patient-to-patient variability, there's also surgeon-to-surgeon variability. Different surgeons might be faster or slower, cut more (and get a better visualization of whatever they're doing) or less (reduced tissue damage). Moreover, the individual surgeons improve with practice and it sometimes takes a lot (e.g., 100-200 knee arthroscopies) to plateau, which makes it tricky to evaluate a totally new method.
This is a nice paper discussing some of the issues in more detail: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415901/
I am not sure how much the scientific method applies to medicine in general. Medicine is a very diffuse subject.
But I work in medical devices and I know for sure that there isn’t much data available of how well a procedure works. There is no centralized database that tracks outcomes. Most surgeons view a surgery as success if the surgery as such went well. They don’t do much tracking of whether the patient is doing better so there is risk they will keep doing surgeries that don’t really work. The manufacturer gets some information but also not much.
There definitely should be a countrywide or even better worldwide database of outcomes.
But I work in medical devices and I know for sure that there isn’t much data available of how well a procedure works. There is no centralized database that tracks outcomes. Most surgeons view a surgery as success if the surgery as such went well. They don’t do much tracking of whether the patient is doing better so there is risk they will keep doing surgeries that don’t really work. The manufacturer gets some information but also not much.
There definitely should be a countrywide or even better worldwide database of outcomes.
There are many centralized databases in the US that track outcomes (e.g. https://www.sts.org/registries-research-center/sts-national-...).
I know for sure that my company doesn’t have great long term data about its own devices in the field and even less about competitors. Once implanted, most patients disappear.
The hospitals buying your devices probably do, depending on the device. Our long term data is incomplete because people can switch providers, but we actively monitor long term patient outcomes for a wide range of devices that we use.
But how do you get data from thousands of hospitals? I also assume hospitals don’t exchange much data. The data is just very fragmented.
A quote from George Eliot's Romola, sort of indicative of how a doctor in 1400s Italy viewed surgery with some contempt, maybe it is exaggerated a bit for effect:
"""" “It is but fitting that a great medicus like you,” said Nello, adjusting the cloth, “should be shaved by the same razor that has shaved the illustrious Antonio Benevieni, the greatest master of the chirurgic art.”
“The chirurgic art!” interrupted the doctor, with an air of contemptuous disgust. “Is it your Florentine fashion to put the masters of the science of medicine on a level with men who do carpentry on broken limbs, and sew up wounds like tailors, and carve away excrescences as a butcher trims meat? Via! A manual art, such as any artificer might learn, and which has been practised by simple barbers like yourself—on a level with the noble science of Hippocrates, Galen, and Avicenna, which penetrates into the occult influences of the stars and plants and gems!—a science locked up from the vulgar!”
"""
"""" “It is but fitting that a great medicus like you,” said Nello, adjusting the cloth, “should be shaved by the same razor that has shaved the illustrious Antonio Benevieni, the greatest master of the chirurgic art.”
“The chirurgic art!” interrupted the doctor, with an air of contemptuous disgust. “Is it your Florentine fashion to put the masters of the science of medicine on a level with men who do carpentry on broken limbs, and sew up wounds like tailors, and carve away excrescences as a butcher trims meat? Via! A manual art, such as any artificer might learn, and which has been practised by simple barbers like yourself—on a level with the noble science of Hippocrates, Galen, and Avicenna, which penetrates into the occult influences of the stars and plants and gems!—a science locked up from the vulgar!”
"""
Anyone who's seen TV commercials in the past several years ("Attention surgical mesh patch implant patients!") must be aware that the answer is "no".
Likewise for OTC and prescription drugs, cleaning products, garden products, pet foods, etc. Companies do not always have your best interests in mind. Class-action lawsuits are good at showing how bad they can be.
Likewise for OTC and prescription drugs, cleaning products, garden products, pet foods, etc. Companies do not always have your best interests in mind. Class-action lawsuits are good at showing how bad they can be.
Much of the risk in implants is not tied to concept or design, but rather execution. The final product has been distorted to some degree by market forces (cost/profitability, application domains, viable hosts), and this reflects, I believe, in the majority of harmful use cases that we observe.
My mother went in for a fusion on her spine and came out with MRSA and died from it. In this case the cure was worse than the disease.
Your situation is tragic and I'm saddened by the loss, but fatal infection is orthogonal to the subject of the article. MRSA infection is a procedural error not caused by the implant itself.
The article discusses infection risk. Infection risk is an inherent part of the total risk associated with any medical procedure. It is not separable -- you cannot use an implant if it is not implanted.
Sadly, horribly, that is now a risk with every major procedure - but at least it's a known risk that the patient can choose to accept when the underlying condition is not life threatening. Devices that don't work properly and haven't been properly reviewed by the FDA are risks the patient can't reasonably evaluate.
> Sadly, horribly, that is now a risk with every major procedure
Infection always has and likely always will be a risk when you open up a human. Evaluating, understanding, and measuring those risks is the only way we can begin to mitigate them.
On the bright side, recent medical technology has also brought us a lot of minimally or non-invasive procedures. Those generally have much lower (sometimes almost zero) risks of infection.
Infection always has and likely always will be a risk when you open up a human. Evaluating, understanding, and measuring those risks is the only way we can begin to mitigate them.
On the bright side, recent medical technology has also brought us a lot of minimally or non-invasive procedures. Those generally have much lower (sometimes almost zero) risks of infection.
MRSA is known to "hide" from the immune system on indwelling hardware. Often, part of the treatment for MRSA infection is to explant the hardware (source control). So even though MRSA infection is not a "device failure," having a device in place is a major factor in whether the body can clear the infection. Also, it's probably rare, but an implant can directly cause an infection if there's a flaw in the sterilization process the manufacturer uses.
"My mother went in for a fusion on her spine and came out with MRSA and died from it."
This tragic and inexcusable outcome is doubly so because even a "successful" implantation of a spinal fusion has, essentially, zero chance of improving pain or mobility outcomes[1] and patients would be much better off pursuing a moderate, graduated course of walking-as-physical-therapy.
I'm sorry that your mother died.
[1] https://en.wikipedia.org/wiki/Spinal_fusion#Effectiveness
This tragic and inexcusable outcome is doubly so because even a "successful" implantation of a spinal fusion has, essentially, zero chance of improving pain or mobility outcomes[1] and patients would be much better off pursuing a moderate, graduated course of walking-as-physical-therapy.
I'm sorry that your mother died.
[1] https://en.wikipedia.org/wiki/Spinal_fusion#Effectiveness
Surgery ruined my life and will be the cause of it's end. I was scared into having surgery I didn't need and told if I did not I would be crippled by middle age. Multiple opinions got multiple variations on what should be done but I was too young and inexperienced to know better. It stole everything from me and has caused so much physical and mental pain as I tried to survive it and society and people turned their backs on me. Then when I became the very thing I was told to fear in all ways...and there was no way out...I tried to end my life and even THAT was denied me and now its all worse.
People love to talk about "worth the risk and cost" etc when they have no TRUE idea what the risk and cost are. People love to justify, explain, defend those who do the damage and love to blame, demean, and ignore those who suffer it. Nice little just world package to feel safe and smart. I wish I had never gone to a doctor and I wish I had known the realities of medical mistake frequency and unneeded surgery instead of the whitewashed nonsense that is sold.
Even now...post suicide attempt...the system and people are just proving what I believed was true all along...but being correct doesn't bring me any solace or pain relief.
*I understand it's bad form to complain about voting...but when your life is so painful and full of invalidation by family, society, and "professionals" even a person pushing a button to further invalidate you hurts and just reinforces what you believe about ego and selfishness in others. Being "right" or in control is always more important than others to most people. I just cannot fathom the thinking of kicking someone who is down over their experience or a generalized comment. Even if I disagreed with someone I wouldn't do that.
People love to talk about "worth the risk and cost" etc when they have no TRUE idea what the risk and cost are. People love to justify, explain, defend those who do the damage and love to blame, demean, and ignore those who suffer it. Nice little just world package to feel safe and smart. I wish I had never gone to a doctor and I wish I had known the realities of medical mistake frequency and unneeded surgery instead of the whitewashed nonsense that is sold.
Even now...post suicide attempt...the system and people are just proving what I believed was true all along...but being correct doesn't bring me any solace or pain relief.
*I understand it's bad form to complain about voting...but when your life is so painful and full of invalidation by family, society, and "professionals" even a person pushing a button to further invalidate you hurts and just reinforces what you believe about ego and selfishness in others. Being "right" or in control is always more important than others to most people. I just cannot fathom the thinking of kicking someone who is down over their experience or a generalized comment. Even if I disagreed with someone I wouldn't do that.
> a person pushing a button to further invalidate you hurts
The problem with your post is that you have predicated it entirely on your personal experiences, while being unwilling to describe those experiences in detail. You have not told us, for example, what kind of surgery was performed, what the complications were, who "scared" you "into having surgery" (and how), or what the negative effects on your life were, specifically.
You are free to choose not to share this information -- nobody can fairly expect you to share such intimate and painful details. I realize that is very difficult. But without specifics, an account of your personal experiences does not contribute very much to the discussion.
The problem with your post is that you have predicated it entirely on your personal experiences, while being unwilling to describe those experiences in detail. You have not told us, for example, what kind of surgery was performed, what the complications were, who "scared" you "into having surgery" (and how), or what the negative effects on your life were, specifically.
You are free to choose not to share this information -- nobody can fairly expect you to share such intimate and painful details. I realize that is very difficult. But without specifics, an account of your personal experiences does not contribute very much to the discussion.
"The problem" is always the victim...never the people doing the victimization. This just reinforces that I said and believe. People don't see others as living, feeling humans. They are means to an end and if they don't "contribute to the discussion" in the way they want then they are invalidated. It's one thing to leave people be, it's another to actively push down irl or with voting. It's saying "you don't matter and what you say and do annoys/bothers/irritates me and I need to demonstrate that". I cannot understand such a selfish mindset. But it's my mistake for continuing to believe people are going to be different. Every psychologist etc I have seen has said that most people never grow past the ego driven, narcissistic child phase of emotional maturity, no matter how "intelligent" or "successful" they appear they just cannot have empathy or care about others as emotional beings like them.
If I laid out details...which I have done many times...those details would be ignored, picked apart, invalidated, twisted...and nothing good happens. Occasionally a good soul reaches out and offers support of some sort...but only once in my life has that ever been actionable and beyond "I understand and that sucks". I know it offends people...and I don't even care anymore...but most people are in it entirely for themselves as I have said. Everything they do and say is for their own emotional and physical need and even their seemingly good actions toward others is self serving. My mistake was believing the few mentors and good examples of loving human beings I have been fortunate to know were not unicorns and were just people I had to get out in the world and find. But unicorns they were/are. I learned after my suicide attempt how even when things are at their worst people will still punch down, betray, lie, abuse, cheat, and step on you for their own needs. They prevent people from opting out of life because that scares and angers them...but they refuse to do whats needed to allow those people in need to survive. They just keep you in a nice smoldering fire because that's best for them. But since I AM a feeling human being I cannot just accept it and suffer the fire...I get upset and lash out and speak out...and it just stokes the flames and I regret it. Cannot win...can only hurt.
If I laid out details...which I have done many times...those details would be ignored, picked apart, invalidated, twisted...and nothing good happens. Occasionally a good soul reaches out and offers support of some sort...but only once in my life has that ever been actionable and beyond "I understand and that sucks". I know it offends people...and I don't even care anymore...but most people are in it entirely for themselves as I have said. Everything they do and say is for their own emotional and physical need and even their seemingly good actions toward others is self serving. My mistake was believing the few mentors and good examples of loving human beings I have been fortunate to know were not unicorns and were just people I had to get out in the world and find. But unicorns they were/are. I learned after my suicide attempt how even when things are at their worst people will still punch down, betray, lie, abuse, cheat, and step on you for their own needs. They prevent people from opting out of life because that scares and angers them...but they refuse to do whats needed to allow those people in need to survive. They just keep you in a nice smoldering fire because that's best for them. But since I AM a feeling human being I cannot just accept it and suffer the fire...I get upset and lash out and speak out...and it just stokes the flames and I regret it. Cannot win...can only hurt.
>"The problem" is always the victim...never the people doing the victimization.
You are not being victimized. Your post was downvoted. It is not a big deal. Nothing bad happened to you here today.
>if they don't "contribute to the discussion" in the way they want then they are invalidated.
It is a community norm to downvote posts that do not contribute to the discussion. I like that norm. It's one of the reasons I choose to post here. If you don't like that rule, there may be other discussion boards more suited to you.
>If I laid out details...which I have done many times...those details would be ignored, picked apart, invalidated, twisted...and nothing good happens.
If you choose to assume, before you post anything, that you cannot expect the people here to be reasonable, then there is no reason to post here at all. Why would you expect people to believe you when you give no information, given that you do not expect them to believe you if you do give the information?
Nobody can do anything for you if you won't let them.
You are not being victimized. Your post was downvoted. It is not a big deal. Nothing bad happened to you here today.
>if they don't "contribute to the discussion" in the way they want then they are invalidated.
It is a community norm to downvote posts that do not contribute to the discussion. I like that norm. It's one of the reasons I choose to post here. If you don't like that rule, there may be other discussion boards more suited to you.
>If I laid out details...which I have done many times...those details would be ignored, picked apart, invalidated, twisted...and nothing good happens.
If you choose to assume, before you post anything, that you cannot expect the people here to be reasonable, then there is no reason to post here at all. Why would you expect people to believe you when you give no information, given that you do not expect them to believe you if you do give the information?
Nobody can do anything for you if you won't let them.
You cannot even see what you are doing and are proving my point perfectly. You invalidate and minimize what I say. You turn it into something lesser to dismiss. You excuse the things I say bother me. You say it's MY fault there is no help because I am not LETTING that help happen...which is ironically classic and well studied victim blaming.
I am done. I am not going to continue to go back and forth. No matter what I say or do there is reason to interrogate, invalidate, blame. Nothing is every enough for anyone and every answer leads to more questions and more positioning to dismiss. I know you don't agree...don't "believe"...it doesn't matter. For you this is an opportunity to win a debate or show you are smarter or better. That's what people do. My only mistake is beating my head against that same wall of human ego because I am in pain and want to make noise to relieve it.
I am done. I am not going to continue to go back and forth. No matter what I say or do there is reason to interrogate, invalidate, blame. Nothing is every enough for anyone and every answer leads to more questions and more positioning to dismiss. I know you don't agree...don't "believe"...it doesn't matter. For you this is an opportunity to win a debate or show you are smarter or better. That's what people do. My only mistake is beating my head against that same wall of human ego because I am in pain and want to make noise to relieve it.
https://www.politifact.com/factchecks/2020/mar/23/dan-crensh...
Distilleries have been trying to make hand sanitizer, but the FDA has made this much more difficult by requiring that the alcohol be denatured first:
https://abcnews.go.com/Politics/distillers-lawmakers-pressur...
Companies developed at-home coronavirus tests, but the FDA shut them down:
https://www.statnews.com/2020/03/21/fda-warns-new-home-coron...
(the FDA later approved one by LabCorp - at-home testing does in fact work - but this took almost a month, and AFAICT the original sellers still haven't been approved)
The Apple Watch has the ability to test blood oxygenation, which would be incredibly useful now, but it can't because that would be an illegal medical device:
https://www.city-journal.org/fda-blocks-apple-watch-blood-ox...