9 ms·

Many medical devices on the market have undergone no clinical testing

152 points by howsilly 9y ago

neonate 9y ago
http://archive.is/O6M10 http://archive.is/O6M10
mortenjorck 9y ago
There was an episode of Reveal awhile back about Essure, a permanent, implantable female contraceptive that, due to unforeseen nickel leakage, caused severe long-term reactions (and in some cases, even pregnancy) in a significant subset of its patients. Essure underwent clinical trials prior to FDA approval, but there was no control group, and its ~400 women studied for one year were compared against a long-term study of 10,000 tubal ligation patients. Reveal episode: https://soundcloud.com/thisisreveal/her-own-devices-is-a-contraceptive-implant-making-us-sick https://soundcloud.com/thisisreveal/her-own-devices-is-a-con... There's also a good Washington Post long-form on the subject: http://www.washingtonpost.com/sf/style/2017/07/26/essure/ http://www.washingtonpost.com/sf/style/2017/07/26/essure/
refurb 9y ago
This isn't really news for people familiar with medical device regulation. Depending on exactly what the new technology is, you can get approval based on a predicate device. Otherwise, your most basic medical devices (bladder catheters) would be crazy expensive as the manufacturer would need to run a clinic trial to test a piece of tubing.
- maxerickson 9y ago
  It seems pretty crazy that new alloys and materials for long term implants wouldn't have to do any bio-compatibility testing. I also wonder what the culture is like for orthopedic surgeons. What risks and benefits did the doctor-patient in the article perceive came with the particular implant?
  - seehafer 9y ago
    They would have to do biocomp testing. Every 510(k) requires an analysis of device compliance to ISO 10993, regardless of whether or not its predicate is preamendment. The premise of the article is alarmist and acts as if FDA requires no testing whatsoever, when the list of standards is as long as my arm: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=4508 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/cla... Now one could argue that biocomp testing, which is done on animal models for the most part, is insufficient for any implanted device. That's a fair argument and one worth having. But the linked op-ed is a polemic.
    - danvoell 9y ago
      Agreed. This article is pretty alarmist. I would ask the author to actually go through the process and report back. It's not for the weak of pocketbook or compliance.
  - tinokid 9y ago
    >I also wonder what the culture is like for orthopedic surgeons. It is among the worst specialties as far as being based on tradition/folklore/marketing. When you see one of their own being injured this badly you realize how wholeheartedly they buy into their own BS about "new innovations" that can "help" people.
godzillabrennus 9y ago
It costs $5 Billion Dollars now to bring a new drug to market. Can anyone blame companies for trying to find loopholes to that staggering fee? https://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/ https://www.forbes.com/sites/matthewherper/2013/08/11/how-th... We should be finding better ways to do clinical trials to help companies lower the cost. I'm glad there was a blockchain event in Miami recently about this. It's one of the most under discussed issues in tech/healthcare today.
- Alex3917 9y ago
  > It costs $5 Billion Dollars now to bring a new drug to market. It costs more like $35M. Look at the last 20 years of MAPS budgets.
  - stochastician 9y ago
    Could you point to where this number comes from more precisely? I'm incredibly curious, given that it is an order of magnitude different from what I've seen. For example, there's the Tufts study: http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014... which arrives at $2.6B. And if you are interested in keeping up with some of these studies from someone in the industry, I highly recommend Derek Lowe's blog -- he's a medicinal chemist. For example, http://blogs.sciencemag.org/pipeline/archives/2017/09/12/it-costs-more-than-this http://blogs.sciencemag.org/pipeline/archives/2017/09/12/it-...
    - deleted 9y ago
      [deleted]
    - aaavl2821 9y ago
      The tufts study is the definitive source I usually hear as well. But most of the $2.6B is cost of failed candidates. The actual cash costs of developing a successful drug are probably more like $100-200M minimum from start of lead optimization to FDA approval, based on the tufts data and also anecdotally if you track venture funding raised from companies that get drugs approved In some indications however one phase 3 study can be $300M+
dwyerm 9y ago
Yes, but resolving this might be a case where the cure is worse than the disease. Take Colchicine for example, which is one of the first medicines ever. It was cheap and plentiful, and thousands of people used it daily to help control gout. However, nobody ever actually did modern science on it. We all just assumed it was safe and effective, because it had been so for thousands of years. So, in 2006 the US FDA started the Unapproved Drugs Initiative. The US government said they would give an exclusive right to the drug to anyone who did the science. So, URL Pharma did a tiny bit of research to prove what generations of physicians already knew, and the US Government let them have the exclusive right to sell Colchicine. The price immediately went from pennies a pill to $3 and up. While I applaud the goal, it is far too easy to turn these well-meaning initiatives into cynical IP land-grabs that are distinctly anti-consumer. https://www.jwatch.org/jw201006100000001/2010/06/10/spotlight-colchicine-colcrys-controversy https://www.jwatch.org/jw201006100000001/2010/06/10/spotligh...
- c3534l 9y ago
  The problem is that in medicine, it's rarely the engineering that's valuable, it's knowing if it's safe and effective. I can see why that would rub people the wrong way, but it's also worrying that people were prescribing medicine based on tradition rather than science. Pennies to dollars for a period of time is better than pulling the drug off the market entirely until it was proven safe (which no one would have done).
  - MrLeap 9y ago
    Rather than issue an artificial monopoly, what if a "reward" to the company that "did the science" was capped at 2x their costs or X years, whichever comes first. Then it's public domain. Wouldn't that get SOMEBODY to take the nigh guaranteed investment? I think what rubs people the wrong way is the limitless profits that are guaranteed by government sanctioned monopoly for things that save people's lives. It's a strange perversion of the free market that benefits the wrong people disproportionately.
    - baddox 9y ago
Thriptic 9y ago
This is a silly piece and it misrepresents the space. For starters, the 510(k) pathway only applies to moderate risk class 2 devices. It's not like every device on the market prior to 1976 was automatically granted 510(k) status which is what this piece implies. Second, holding medical devices to the same safety standards as drugs is unnecessary. The reason drugs are held to a higher standard is because they present a high risk of acute injury and they are more novel. Most medical devices won't kill you suddenly if they are faulty, and the ones that can are class 3 devices which require a clinical trial component. Third, the 510(k) pathway exists because the safety risks for device classes are relatively similar whereas for drugs there can be high variability depending on structures. If you design a dental implant that is made of the same material, has a similar design, and has a similar purpose as a pre-existing device which has been shown to be safe, it will generally be safe to assume the new device will also be safe. Most new devices that cannot be shown to be similar to something already on the market are automatically deemed to be high risk and require a trial. Finally, you can't have your cake and eat it too. Want devices to be as safe as drugs? Apply the same safety standards and watch device costs skyrocket. Then nyt will be back to incorrectly blaming product manufacturers for sky high healthcare costs. The FDA is already in a position where they do not have the funding or manpower to even review all the 510(k)s they get every year. If you make every device submission a premarket approval (highest level of scrutiny + a clinical trial) then devices will never get approved in a timely fashion.
- ProAm 9y ago
  What happened in-regards to the device in the article? What class is it?
  - Thriptic 9y ago
    It was one of 19 devices that were class 3 (high risk) but granted 510(k) exemptions due to precedent. Ultimately all of these devices were intended to be transitioned to the higher standard pma approval process normally associated with class 3 devices, but were allowed to leverage moderate risk 510(k) pathways typically granted to class 2 devices until pma processes were developed for them. FDA was slow in orchestrating the change, and so this was allowed to continue until these safety concerns manifested, forcing FDA's hand. I was actually not aware that this had happened as by the time I entered this space almost all of the class 3 devices in question had transitioned to pma. To my knowledge there are very few devices left where this is still the case.
Tade0 9y ago
My father's last position before retirement was as a civil servant responsible for approving equipment for medical use. One of his last cases concerned a businessman who insisted, that a vacuum cleaner produced by his company should be certified as a medical device - ostensibly its use was to deliver drugs(via reverse action and inhalation). My father rejected this notion on the grounds that, among other things, it was impossible to control the dosage. Unfortunately once my father retired that man eventually found somebody who would give in to pressure. What I'm trying to say is that there's a decent amount of "medical" devices on the market that serve no such purpose so, a non-conformant artificial hip joint is only the tip of the iceberg.
wunderlust 9y ago
A recent episode[1] of Fresh Air (NPR) discussed medical implants. Pretty eye opening. [1] https://www.npr.org/2018/01/17/578562873/are-implanted-medical-devices-creating-a-danger-within-us https://www.npr.org/2018/01/17/578562873/are-implanted-medic...
pdkl95 9y ago
It's even worse if software is involved. Radio controlled heart implants that rely on security through obscurity is tragedy waiting to happen. I recommend Karen Sandler's talk about her own experiences with that kind of device. https://www.youtube.com/watch?v=qW1h1s_ojpM https://www.youtube.com/watch?v=qW1h1s_ojpM "Freedom in My Heart - Lessons from a Cyborg Lawyer"
fzeroracer 9y ago
Personally I would consider being even more strict on medical device testing. My mother who had a stroke about a decade ago was using a device designed to test the PT/INR levels of her blood. The stroke had made her body less capable of properly balancing her blood, so she has to constantly test her levels to ensure she doesn't suffer from either fatal bleeding or internal clotting. The device she was using had to be recalled after years of use because it could report a low value, causing her to over-balance her medication into dangerous levels. Not only that, but they chose not to inform my mother after the recall and made no efforts to fix the issue. Needless to say I was not pleased.
billfruit 9y ago
I hear that that's true of other things in medical practice as well. For eg: are surgical procedures validated by any kind of controlled clinical trails?
deleted 9y ago
[deleted]
gersh 9y ago
What is a medical device? Are we talking about things like thermometers, wheelchairs, and surgical knives. Is this saying you need a double-blind study for every new design of wheelchair?
- HeyLaughingBoy 9y ago
  Sometimes. No. Yes. No. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan... Sometimes the medical device is software. In fact, there are many software products on the markets whose makers don't even realize are unapproved medical devices. However, the FDA just doesn't have the manpower to investigate that on a wide scale.
bjd2385 9y ago
This sounds like individuals or groups of individuals covering their own rears instead of facing the problem for themselves. It's very difficult to see product defects from behind a desk. And it's impossible to recognize the personal complications and difficulties that arise for people on the receiving end while looking at statistics and financial reports.

152 points by howsilly 9y ago

http://archive.is/O6M10 http://archive.is/O6M10

There was an episode of Reveal awhile back about Essure, a permanent, implantable female contraceptive that, due to unforeseen nickel leakage, caused severe long-term reactions (and in some cases, even pregnancy) in a significant subset of its patients. Essure underwent clinical trials prior to FDA approval, but there was no control group, and its ~400 women studied for one year were compared against a long-term study of 10,000 tubal ligation patients. Reveal episode: https://soundcloud.com/thisisreveal/her-own-devices-is-a-contraceptive-implant-making-us-sick https://soundcloud.com/thisisreveal/her-own-devices-is-a-con... There's also a good Washington Post long-form on the subject: http://www.washingtonpost.com/sf/style/2017/07/26/essure/ http://www.washingtonpost.com/sf/style/2017/07/26/essure/

refurb 9y ago

This isn't really news for people familiar with medical device regulation. Depending on exactly what the new technology is, you can get approval based on a predicate device. Otherwise, your most basic medical devices (bladder catheters) would be crazy expensive as the manufacturer would need to run a clinic trial to test a piece of tubing.

maxerickson 9y ago
It seems pretty crazy that new alloys and materials for long term implants wouldn't have to do any bio-compatibility testing. I also wonder what the culture is like for orthopedic surgeons. What risks and benefits did the doctor-patient in the article perceive came with the particular implant?
- seehafer 9y ago
  They would have to do biocomp testing. Every 510(k) requires an analysis of device compliance to ISO 10993, regardless of whether or not its predicate is preamendment. The premise of the article is alarmist and acts as if FDA requires no testing whatsoever, when the list of standards is as long as my arm: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=4508 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/cla... Now one could argue that biocomp testing, which is done on animal models for the most part, is insufficient for any implanted device. That's a fair argument and one worth having. But the linked op-ed is a polemic.
  - danvoell 9y ago
    Agreed. This article is pretty alarmist. I would ask the author to actually go through the process and report back. It's not for the weak of pocketbook or compliance.
- tinokid 9y ago
  >I also wonder what the culture is like for orthopedic surgeons. It is among the worst specialties as far as being based on tradition/folklore/marketing. When you see one of their own being injured this badly you realize how wholeheartedly they buy into their own BS about "new innovations" that can "help" people.

godzillabrennus 9y ago

It costs $5 Billion Dollars now to bring a new drug to market. Can anyone blame companies for trying to find loopholes to that staggering fee? https://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/ https://www.forbes.com/sites/matthewherper/2013/08/11/how-th... We should be finding better ways to do clinical trials to help companies lower the cost. I'm glad there was a blockchain event in Miami recently about this. It's one of the most under discussed issues in tech/healthcare today.

Alex3917 9y ago
> It costs $5 Billion Dollars now to bring a new drug to market. It costs more like $35M. Look at the last 20 years of MAPS budgets.
- stochastician 9y ago
  Could you point to where this number comes from more precisely? I'm incredibly curious, given that it is an order of magnitude different from what I've seen. For example, there's the Tufts study: http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014... which arrives at $2.6B. And if you are interested in keeping up with some of these studies from someone in the industry, I highly recommend Derek Lowe's blog -- he's a medicinal chemist. For example, http://blogs.sciencemag.org/pipeline/archives/2017/09/12/it-costs-more-than-this http://blogs.sciencemag.org/pipeline/archives/2017/09/12/it-...
  - deleted 9y ago
    [deleted]
  - aaavl2821 9y ago
    The tufts study is the definitive source I usually hear as well. But most of the $2.6B is cost of failed candidates. The actual cash costs of developing a successful drug are probably more like $100-200M minimum from start of lead optimization to FDA approval, based on the tufts data and also anecdotally if you track venture funding raised from companies that get drugs approved In some indications however one phase 3 study can be $300M+

dwyerm 9y ago

Yes, but resolving this might be a case where the cure is worse than the disease. Take Colchicine for example, which is one of the first medicines ever. It was cheap and plentiful, and thousands of people used it daily to help control gout. However, nobody ever actually did modern science on it. We all just assumed it was safe and effective, because it had been so for thousands of years. So, in 2006 the US FDA started the Unapproved Drugs Initiative. The US government said they would give an exclusive right to the drug to anyone who did the science. So, URL Pharma did a tiny bit of research to prove what generations of physicians already knew, and the US Government let them have the exclusive right to sell Colchicine. The price immediately went from pennies a pill to $3 and up. While I applaud the goal, it is far too easy to turn these well-meaning initiatives into cynical IP land-grabs that are distinctly anti-consumer. https://www.jwatch.org/jw201006100000001/2010/06/10/spotlight-colchicine-colcrys-controversy https://www.jwatch.org/jw201006100000001/2010/06/10/spotligh...

c3534l 9y ago
The problem is that in medicine, it's rarely the engineering that's valuable, it's knowing if it's safe and effective. I can see why that would rub people the wrong way, but it's also worrying that people were prescribing medicine based on tradition rather than science. Pennies to dollars for a period of time is better than pulling the drug off the market entirely until it was proven safe (which no one would have done).
- MrLeap 9y ago
  Rather than issue an artificial monopoly, what if a "reward" to the company that "did the science" was capped at 2x their costs or X years, whichever comes first. Then it's public domain. Wouldn't that get SOMEBODY to take the nigh guaranteed investment? I think what rubs people the wrong way is the limitless profits that are guaranteed by government sanctioned monopoly for things that save people's lives. It's a strange perversion of the free market that benefits the wrong people disproportionately.
  - baddox 9y ago

Thriptic 9y ago

This is a silly piece and it misrepresents the space. For starters, the 510(k) pathway only applies to moderate risk class 2 devices. It's not like every device on the market prior to 1976 was automatically granted 510(k) status which is what this piece implies. Second, holding medical devices to the same safety standards as drugs is unnecessary. The reason drugs are held to a higher standard is because they present a high risk of acute injury and they are more novel. Most medical devices won't kill you suddenly if they are faulty, and the ones that can are class 3 devices which require a clinical trial component. Third, the 510(k) pathway exists because the safety risks for device classes are relatively similar whereas for drugs there can be high variability depending on structures. If you design a dental implant that is made of the same material, has a similar design, and has a similar purpose as a pre-existing device which has been shown to be safe, it will generally be safe to assume the new device will also be safe. Most new devices that cannot be shown to be similar to something already on the market are automatically deemed to be high risk and require a trial. Finally, you can't have your cake and eat it too. Want devices to be as safe as drugs? Apply the same safety standards and watch device costs skyrocket. Then nyt will be back to incorrectly blaming product manufacturers for sky high healthcare costs. The FDA is already in a position where they do not have the funding or manpower to even review all the 510(k)s they get every year. If you make every device submission a premarket approval (highest level of scrutiny + a clinical trial) then devices will never get approved in a timely fashion.

ProAm 9y ago
What happened in-regards to the device in the article? What class is it?
- Thriptic 9y ago
  It was one of 19 devices that were class 3 (high risk) but granted 510(k) exemptions due to precedent. Ultimately all of these devices were intended to be transitioned to the higher standard pma approval process normally associated with class 3 devices, but were allowed to leverage moderate risk 510(k) pathways typically granted to class 2 devices until pma processes were developed for them. FDA was slow in orchestrating the change, and so this was allowed to continue until these safety concerns manifested, forcing FDA's hand. I was actually not aware that this had happened as by the time I entered this space almost all of the class 3 devices in question had transitioned to pma. To my knowledge there are very few devices left where this is still the case.

Tade0 9y ago

My father's last position before retirement was as a civil servant responsible for approving equipment for medical use. One of his last cases concerned a businessman who insisted, that a vacuum cleaner produced by his company should be certified as a medical device - ostensibly its use was to deliver drugs(via reverse action and inhalation). My father rejected this notion on the grounds that, among other things, it was impossible to control the dosage. Unfortunately once my father retired that man eventually found somebody who would give in to pressure. What I'm trying to say is that there's a decent amount of "medical" devices on the market that serve no such purpose so, a non-conformant artificial hip joint is only the tip of the iceberg.

wunderlust 9y ago

A recent episode[1] of Fresh Air (NPR) discussed medical implants. Pretty eye opening. [1] https://www.npr.org/2018/01/17/578562873/are-implanted-medical-devices-creating-a-danger-within-us https://www.npr.org/2018/01/17/578562873/are-implanted-medic...

pdkl95 9y ago

It's even worse if software is involved. Radio controlled heart implants that rely on security through obscurity is tragedy waiting to happen. I recommend Karen Sandler's talk about her own experiences with that kind of device. https://www.youtube.com/watch?v=qW1h1s_ojpM https://www.youtube.com/watch?v=qW1h1s_ojpM "Freedom in My Heart - Lessons from a Cyborg Lawyer"

fzeroracer 9y ago

Personally I would consider being even more strict on medical device testing. My mother who had a stroke about a decade ago was using a device designed to test the PT/INR levels of her blood. The stroke had made her body less capable of properly balancing her blood, so she has to constantly test her levels to ensure she doesn't suffer from either fatal bleeding or internal clotting. The device she was using had to be recalled after years of use because it could report a low value, causing her to over-balance her medication into dangerous levels. Not only that, but they chose not to inform my mother after the recall and made no efforts to fix the issue. Needless to say I was not pleased.

billfruit 9y ago

I hear that that's true of other things in medical practice as well. For eg: are surgical procedures validated by any kind of controlled clinical trails?

deleted 9y ago

[deleted]

gersh 9y ago

What is a medical device? Are we talking about things like thermometers, wheelchairs, and surgical knives. Is this saying you need a double-blind study for every new design of wheelchair?

HeyLaughingBoy 9y ago
Sometimes. No. Yes. No. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan... Sometimes the medical device is software. In fact, there are many software products on the markets whose makers don't even realize are unapproved medical devices. However, the FDA just doesn't have the manpower to investigate that on a wide scale.

bjd2385 9y ago

This sounds like individuals or groups of individuals covering their own rears instead of facing the problem for themselves. It's very difficult to see product defects from behind a desk. And it's impossible to recognize the personal complications and difficulties that arise for people on the receiving end while looking at statistics and financial reports.