6 ms·

The FDA fails to adequately screen or monitor products

74 points by js2 8y ago

arkades 8y ago
Today must be an even-numbered day at the NYTimes. On odd-numbered days we scold the FDA for demanding too much data and investigation, and so taking too long to let products onto the market.
- ErikVandeWater 8y ago
  It can be both - The FDA is inefficient when it does test a product causing the costs to increase, and also doesn't screen every product as well as it should.
  - BurningFrog 8y ago
    It's also has separate legal frameworks for drugs and medical devices.
  - timtim51251 8y ago
    FDA doesn't test, drug companies do and then provide data. That's why they can cheat and lie as much as they do.
- unknownkadath 8y ago
  It should not be surprising that different writers have different priorities and opinions. Would it not be more suspicious if the paper's content were monotone and homogeneous?
  - jessedhillon 8y ago
    Yes, but today is an odd-numbered day at HN, so we scold the media for indecisiveness. Otherwise, it's for their consistent bias.
    - creato 8y ago
      It should not be surprising that different commenters have different priorities and opinions. Would it not be more suspicious if Hacker News' content were monotone and homogeneous?
      - Judgmentality 8y ago
        Yes, but today is an odd-numbered day at HN, so we become meta like reddit. Otherwise we scold them for their memes.
- Symmetry 8y ago
  We really need numerical estimates, even bad ones, of the number of lives saved versus cost for different levels of regulation in order to talk sensibly about all of this.
  - smt88 8y ago
    The CDC does an enormous amount of this already. They research problems, then research possible effects of regulation, and then they advocate for that regulation. They then measure the effects. One example is smokefree regulations[1] limiting people's exposure to tobacco. There are many nonprofits and other governmental organizations that are also researching these things heavily and providing estimates. Just because you haven't seen the numbers doesn't mean no one is crunching and publishing them. 1. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/secondhand_smoke/protection/improve_health/index.htm https://www.cdc.gov/tobacco/data_statistics/fact_sheets/seco...
  - ikeboy 8y ago
    Here you go http://www.fdareview.org/issues/theory-evidence-and-examples-of-fda-harm/ http://www.fdareview.org/issues/theory-evidence-and-examples...
    - mehrdadn 8y ago
      These all seem to be pre-2000?
- macspoofing 8y ago
  Thank you! There is a cost to process and bureaucracy. It is a balance between innovation and protecting the public. Like security and marketing, there is no end to how much regulation you can have because you can always regulate more. You can add more rules, more laws, more regulators, more auditors, etc. etc. etc.
ralph84 8y ago
They want a: > global medical device registry where patient outcomes for all medical devices are openly monitored A global open database of people’s most sensitive medical information, what could go wrong.
- cannonedhamster 8y ago
  You can measure outcomes without specifics of who was impacted. The doctor actually as a bulwark in this case and only provides the data specific to the devices as a report. I.e. we performed 175 hip replacement surgeries using x device. During that time there was a median issue rate of x percent. This is within x range of standard. This would have the added benefit of evaluating the medical professionals against similar circumstances especially if you factors in removing outliers that have a higher risk profile.
- macspoofing 8y ago
  That's a mess. How do you measure patient outcomes of, say, using a radiology software package (which is typically designated a Class 2 Medical Device)? By the way, every medical device will have a registry number that you can certainly use to browse for things like recall notices.
  - icegreentea2 8y ago
    I think that gets to the heart of one of the problems in the current system, which is that Class 2 is hilariously broad and the distinction between Class 2 and Class 3 is also little odd... For example, I actually had no idea that metal in plastic hip implants were Class 2. I think the fact that metal in plastic hip implants are Class 2, but metal on metal were shifted to Class 3 points to something being really off in how the system is implemented. Like I understand that metal in plastic has a long history of use and that in practice that means that they likely have lower risk (in the sense that there are probably less unknown unknowns and known unknowns). But it still feels a little weird, since it doesn't automatically reduce the risk of any specific product/implementation. (For context, compression socks designed to prevent blood pooling in the legs are also Class 2... but all other medical compression socks are Class 1).
awakeasleep 8y ago
Another example of a government agency that has been captured and lost the will to govern
- gumby 8y ago
  Congress has gradually eroded its authority. For example FDA can no longer do its own science but has to rely on the companies to do so. It has been stripped of any authority over so-called "natural" supplements so they can make unproven medical claims (e.g. "our homeopathic remedy will cure your cold") thanks to Oren Hatch being paid reelection dollars by Herbalife. Etc. Don't blame the agency, blame congress.
danielfoster 8y ago
It makes sense to rush new medical devices and drugs to market when there's no better option. For example the Reagan FDA removed the review process for new AIDs drugs during the 1980s epidemic. But the FDA should have scrutinized vaginal mesh more closely given that there are already so many effective forms of birth control. People also need to remember that you can't pick and choose regulations. I feel like many readers of this article will be rightfully appalled, but conversely also want to see increased medical use of psychedelics and marijuana despite a similar lack of research on long-term effects.
- astura 8y ago
  Transvaginal mesh is for pelvic organ prolapse, not some sort of birth control.
- headShrinker 8y ago
  > the Reagan FDA removed the review process for new AIDs drugs during the 1980s epidemic Just a quick historical correction: Reagan administration did no such thing. The FDA would not release potentially helpful drugs that were untested or unproven even as 100,000s of gay men lay dying in such a horrific way. Gay activists begged and pleaded while Reagan did literally nothing to help. He didn’t even mention the words gay or AIDS until 1986. The outbreak was in full bloom by 1983. Act Up was a grassroots organization designed in part to pressure the government to allow the use of drugs with limited track record. There was a modicum of success as AZT was approved in 1987 following Act Up protests on wall street were over 100 people were arrested I’m curious where you heard that Reagan fast tracked AZT and similar. Sadly, I wouldn’t be surprised if it was in some ‘legit’ history books. Source: “On March 24, 1987, 250 ACT UP members demonstrated at Wall Street and Broadway to demand greater access to experimental AIDS drugs and for a coordinated national policy to fight the disease.” https://en.m.wikipedia.org/wiki/ACT_UP https://en.m.wikipedia.org/wiki/ACT_UP
gist 8y ago
What really bothers me about this is a) The editorial board, when writing such an important piece, is not identified on the actual article other than 'the editorial board'. Sure you can find out who is on the board but you don't know what parts they played in the write up. I hate this convention. b) Chain of information custody issue. They cite this organization with a link to the page but there is nothing easily apparent on that page that would lead you to know how legit the actual underlying data (which they are quoting) is. At least on a quick check. https://www.icij.org/investigations/implant-files/ https://www.icij.org/investigations/implant-files/ It's almost as if it's a 'well we are the NY Times the paper of record so you can trust that we have thoroughly vetted all of this as well as how the actual data was compiled'. This is not to say there isn't an issue. But it's easy for a writer to sit back and take pot shots (and find something to support that pot shot) w/o the scope of the problem other than 'and big number of people are impacted'.
aheilbut 8y ago
The FDA regulates (or fails to regulate) many different classes of products (drugs, biologics, devices, human cell and tissue products, supplements, food, tobacco and nicotine products, etc). FDA's authority and its effectiveness is extremely variable across these classes. My sense is that the traditional drug and biologic drug parts still work reasonably well, but the biggest problems lately are coming from devices and from human cell and tissue products (and with products that are being pushed into those categories). A lot of this is due to the ways the laws have been written (due to lobbying and legislative capture), but some of it is undoubtedly a result of regulatory capture and incompetence.
tomohawk 8y ago
There's a few things that are problematic about this opinion piece. First off, many of the items being discussed are related to surgical treatments. It is very hard to impossible to do a double blind study of a surgical thing. What are you going to do? Open a bunch of people up and only do the actual treatment on half of them? I've heard of this being done in very rare situations, but the ethics of this are pretty edgy. Secondly, there appears to be a mischaracterization of women being disproportionately affected by things. This is a pretty complex topic, but lets balance out the offered information by pointing out that prostate cancer (men) kills more people than breast cancer (women) and receives a lot less funding https://www.telegraph.co.uk/news/2018/02/02/prostate-cancer-kills-people-breast-cancer-first-time-new-figures/ https://www.telegraph.co.uk/news/2018/02/02/prostate-cancer-... My personal experience with FDA regulation has been that they are being asked to do an impossible task, and not doing a great job of it. People close to me have been hugely (negatively) impacted by FDA decisions because they are going for a one size fits all solution for everything, and because they somehow fancy that they know more than doctors involved in a particular situation.
- anon1m0us 8y ago
  Doctors are biased too, that's the problem. Often times, knowing a lot about something will bias you even more because you fail to acknowledge or accept what you do NOT know or what conflicts with what you THINK you know.
  - tomohawk 8y ago
    Everybody's biased, and I've certainly met my share of biased doctors. If you have a specific complaint, each doctor brings their toolbag of golden hammers that they know about and rarely has the ability to look beyond it. It's one of the challenges of being a patient to wade through that. The FDA isn't really going to be very helpful with this, and they labor under the additional burden of being much more subject to politics. Sure, they may stop the obvious quackery, but remember that general anesthesia used to be considered quackery, as did prescribing antibiotics for stomach ulcers.

74 points by js2 8y ago

Today must be an even-numbered day at the NYTimes. On odd-numbered days we scold the FDA for demanding too much data and investigation, and so taking too long to let products onto the market.

ErikVandeWater 8y ago
It can be both - The FDA is inefficient when it does test a product causing the costs to increase, and also doesn't screen every product as well as it should.
- BurningFrog 8y ago
  It's also has separate legal frameworks for drugs and medical devices.
- timtim51251 8y ago
  FDA doesn't test, drug companies do and then provide data. That's why they can cheat and lie as much as they do.
unknownkadath 8y ago
It should not be surprising that different writers have different priorities and opinions. Would it not be more suspicious if the paper's content were monotone and homogeneous?
- jessedhillon 8y ago
  Yes, but today is an odd-numbered day at HN, so we scold the media for indecisiveness. Otherwise, it's for their consistent bias.
  - creato 8y ago
    It should not be surprising that different commenters have different priorities and opinions. Would it not be more suspicious if Hacker News' content were monotone and homogeneous?
    - Judgmentality 8y ago
      Yes, but today is an odd-numbered day at HN, so we become meta like reddit. Otherwise we scold them for their memes.
Symmetry 8y ago
We really need numerical estimates, even bad ones, of the number of lives saved versus cost for different levels of regulation in order to talk sensibly about all of this.
- smt88 8y ago
  The CDC does an enormous amount of this already. They research problems, then research possible effects of regulation, and then they advocate for that regulation. They then measure the effects. One example is smokefree regulations[1] limiting people's exposure to tobacco. There are many nonprofits and other governmental organizations that are also researching these things heavily and providing estimates. Just because you haven't seen the numbers doesn't mean no one is crunching and publishing them. 1. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/secondhand_smoke/protection/improve_health/index.htm https://www.cdc.gov/tobacco/data_statistics/fact_sheets/seco...
- ikeboy 8y ago
  Here you go http://www.fdareview.org/issues/theory-evidence-and-examples-of-fda-harm/ http://www.fdareview.org/issues/theory-evidence-and-examples...
  - mehrdadn 8y ago
    These all seem to be pre-2000?
macspoofing 8y ago
Thank you! There is a cost to process and bureaucracy. It is a balance between innovation and protecting the public. Like security and marketing, there is no end to how much regulation you can have because you can always regulate more. You can add more rules, more laws, more regulators, more auditors, etc. etc. etc.

ralph84 8y ago

They want a: > global medical device registry where patient outcomes for all medical devices are openly monitored A global open database of people’s most sensitive medical information, what could go wrong.

cannonedhamster 8y ago
You can measure outcomes without specifics of who was impacted. The doctor actually as a bulwark in this case and only provides the data specific to the devices as a report. I.e. we performed 175 hip replacement surgeries using x device. During that time there was a median issue rate of x percent. This is within x range of standard. This would have the added benefit of evaluating the medical professionals against similar circumstances especially if you factors in removing outliers that have a higher risk profile.
macspoofing 8y ago
That's a mess. How do you measure patient outcomes of, say, using a radiology software package (which is typically designated a Class 2 Medical Device)? By the way, every medical device will have a registry number that you can certainly use to browse for things like recall notices.
- icegreentea2 8y ago
  I think that gets to the heart of one of the problems in the current system, which is that Class 2 is hilariously broad and the distinction between Class 2 and Class 3 is also little odd... For example, I actually had no idea that metal in plastic hip implants were Class 2. I think the fact that metal in plastic hip implants are Class 2, but metal on metal were shifted to Class 3 points to something being really off in how the system is implemented. Like I understand that metal in plastic has a long history of use and that in practice that means that they likely have lower risk (in the sense that there are probably less unknown unknowns and known unknowns). But it still feels a little weird, since it doesn't automatically reduce the risk of any specific product/implementation. (For context, compression socks designed to prevent blood pooling in the legs are also Class 2... but all other medical compression socks are Class 1).

awakeasleep 8y ago

Another example of a government agency that has been captured and lost the will to govern

gumby 8y ago
Congress has gradually eroded its authority. For example FDA can no longer do its own science but has to rely on the companies to do so. It has been stripped of any authority over so-called "natural" supplements so they can make unproven medical claims (e.g. "our homeopathic remedy will cure your cold") thanks to Oren Hatch being paid reelection dollars by Herbalife. Etc. Don't blame the agency, blame congress.

danielfoster 8y ago

It makes sense to rush new medical devices and drugs to market when there's no better option. For example the Reagan FDA removed the review process for new AIDs drugs during the 1980s epidemic. But the FDA should have scrutinized vaginal mesh more closely given that there are already so many effective forms of birth control. People also need to remember that you can't pick and choose regulations. I feel like many readers of this article will be rightfully appalled, but conversely also want to see increased medical use of psychedelics and marijuana despite a similar lack of research on long-term effects.

astura 8y ago
Transvaginal mesh is for pelvic organ prolapse, not some sort of birth control.
headShrinker 8y ago
> the Reagan FDA removed the review process for new AIDs drugs during the 1980s epidemic Just a quick historical correction: Reagan administration did no such thing. The FDA would not release potentially helpful drugs that were untested or unproven even as 100,000s of gay men lay dying in such a horrific way. Gay activists begged and pleaded while Reagan did literally nothing to help. He didn’t even mention the words gay or AIDS until 1986. The outbreak was in full bloom by 1983. Act Up was a grassroots organization designed in part to pressure the government to allow the use of drugs with limited track record. There was a modicum of success as AZT was approved in 1987 following Act Up protests on wall street were over 100 people were arrested I’m curious where you heard that Reagan fast tracked AZT and similar. Sadly, I wouldn’t be surprised if it was in some ‘legit’ history books. Source: “On March 24, 1987, 250 ACT UP members demonstrated at Wall Street and Broadway to demand greater access to experimental AIDS drugs and for a coordinated national policy to fight the disease.” https://en.m.wikipedia.org/wiki/ACT_UP https://en.m.wikipedia.org/wiki/ACT_UP

gist 8y ago

What really bothers me about this is a) The editorial board, when writing such an important piece, is not identified on the actual article other than 'the editorial board'. Sure you can find out who is on the board but you don't know what parts they played in the write up. I hate this convention. b) Chain of information custody issue. They cite this organization with a link to the page but there is nothing easily apparent on that page that would lead you to know how legit the actual underlying data (which they are quoting) is. At least on a quick check. https://www.icij.org/investigations/implant-files/ https://www.icij.org/investigations/implant-files/ It's almost as if it's a 'well we are the NY Times the paper of record so you can trust that we have thoroughly vetted all of this as well as how the actual data was compiled'. This is not to say there isn't an issue. But it's easy for a writer to sit back and take pot shots (and find something to support that pot shot) w/o the scope of the problem other than 'and big number of people are impacted'.

aheilbut 8y ago

The FDA regulates (or fails to regulate) many different classes of products (drugs, biologics, devices, human cell and tissue products, supplements, food, tobacco and nicotine products, etc). FDA's authority and its effectiveness is extremely variable across these classes. My sense is that the traditional drug and biologic drug parts still work reasonably well, but the biggest problems lately are coming from devices and from human cell and tissue products (and with products that are being pushed into those categories). A lot of this is due to the ways the laws have been written (due to lobbying and legislative capture), but some of it is undoubtedly a result of regulatory capture and incompetence.

tomohawk 8y ago

There's a few things that are problematic about this opinion piece. First off, many of the items being discussed are related to surgical treatments. It is very hard to impossible to do a double blind study of a surgical thing. What are you going to do? Open a bunch of people up and only do the actual treatment on half of them? I've heard of this being done in very rare situations, but the ethics of this are pretty edgy. Secondly, there appears to be a mischaracterization of women being disproportionately affected by things. This is a pretty complex topic, but lets balance out the offered information by pointing out that prostate cancer (men) kills more people than breast cancer (women) and receives a lot less funding https://www.telegraph.co.uk/news/2018/02/02/prostate-cancer-kills-people-breast-cancer-first-time-new-figures/ https://www.telegraph.co.uk/news/2018/02/02/prostate-cancer-... My personal experience with FDA regulation has been that they are being asked to do an impossible task, and not doing a great job of it. People close to me have been hugely (negatively) impacted by FDA decisions because they are going for a one size fits all solution for everything, and because they somehow fancy that they know more than doctors involved in a particular situation.

anon1m0us 8y ago
Doctors are biased too, that's the problem. Often times, knowing a lot about something will bias you even more because you fail to acknowledge or accept what you do NOT know or what conflicts with what you THINK you know.
- tomohawk 8y ago
  Everybody's biased, and I've certainly met my share of biased doctors. If you have a specific complaint, each doctor brings their toolbag of golden hammers that they know about and rarely has the ability to look beyond it. It's one of the challenges of being a patient to wade through that. The FDA isn't really going to be very helpful with this, and they labor under the additional burden of being much more subject to politics. Sure, they may stop the obvious quackery, but remember that general anesthesia used to be considered quackery, as did prescribing antibiotics for stomach ulcers.