4 ms·

This isn't new. There was an article six years ago about a bioactive tattoo ink that could measure blood glucose levels non-invasively (after the tattoo was app

This isn't new. There was an article six years ago about a bioactive tattoo ink that could measure blood glucose levels non-invasively (after the tattoo was applied, of course). The measurement required a sensor attached to an I-Phone and the sensor was estimated to cost several hundred dollars, but it would allow for frequent glucose measurements without finger sticks. Not continuous like CGM devices, but less painful and significantly less expensive. So far as I know it still hasn't been approved by the FDA, and I don't know whether the developers are even still trying to get it approved. Google also developed a sensor incorporated into a contact lens that provided non-invasive, continuous glucose monitoring at about the same time. Same result; not approved (that I know of) and no indication that it ever will be.

QAPereo 9y ago
Unfortunately these companies/institutions have no experience with, and no concept of the challenges involved in approving a totally novel medical device in the US.
- wyager 9y ago
  And double unfortunately, approving a medical technology is vastly more expensive and slower than it needs to or should be. Existing medical approval policies are strongly motivated by political concerns (we're still reeling from thalidomide) rather than any rational social optimization policy. It's very easy to scare people into excessive conservatism (in the literal sense). http://www.fdareview.org/05_harm.php http://www.fdareview.org/05_harm.php
  - Retric 9y ago
    I hear that viewpoint frequently but their seems to be minimal support. The simple truth is for large numbers of medications the benefit is very minimal while the risks are huge. Also, if you look at the approval process costs are largely focused on how studies are done not the minimum requirements for data collection. PS: Remember, a very well funded group has a huge incentive to reduce costs in this area.
    - wyager 9y ago
      Did you look at the link I posted? There's a ton of high-quality evidence for what I said in the medical literature.
      - Retric 9y ago
        US is still just one country. You can collect data cheaply if you get approval in another country fist. However, the US approval process is fairly reasonable so this does not happen. And yes I read what you linked it over states it's case and has very poor support.
  - jfoutz 9y ago
    > we're still reeling from thalidomide Wasn't that one of the FDA's big victories? Perhaps you mean the FDA is far to powerful because of that win. I can see some argument for abandoning the efficacy requirement, and only going with "safe" but so few drugs actually do anything - isn't it something like a 95% attrition rate? only 1 in 50 actually have a measurable effect? Maybe the bar is too high. Seems like the bigger challenge, and far far greater win is just making testing cheaper.
    - wyager 9y ago
      It wasn't a victory at all; existing medical procedure failed to stop huge numbers of deformities. As a reactionary knee-jerk response, the US instated vastly overwrought medical restrictions.
    - serf 9y ago
      >Wasn't that one of the FDA's big victories? Perhaps you mean the FDA is far to powerful because of that win. depends who you ask. Milton Friedman used the thalidomide reaction as a case-book example of government meddling in the private sector where it needn't be, causing vast delay in possible new therapeutics, which basically created an unquantifiable loss of value due to us being unaware of "what could have been without bureaucratic delay". Friedman believed that if a company does sufficient harm to a population that the negative market signal will eventually destroy the 'bad-actor' company, without the need for anything like the FDA and the delays it imposes[0] I don't know whether or not he's right. [0]: https://www.youtube.com/watch?v=KUDV0YII6lk https://www.youtube.com/watch?v=KUDV0YII6lk

QAPereo 9y ago

Unfortunately these companies/institutions have no experience with, and no concept of the challenges involved in approving a totally novel medical device in the US.

wyager 9y ago
And double unfortunately, approving a medical technology is vastly more expensive and slower than it needs to or should be. Existing medical approval policies are strongly motivated by political concerns (we're still reeling from thalidomide) rather than any rational social optimization policy. It's very easy to scare people into excessive conservatism (in the literal sense). http://www.fdareview.org/05_harm.php http://www.fdareview.org/05_harm.php
- Retric 9y ago
  I hear that viewpoint frequently but their seems to be minimal support. The simple truth is for large numbers of medications the benefit is very minimal while the risks are huge. Also, if you look at the approval process costs are largely focused on how studies are done not the minimum requirements for data collection. PS: Remember, a very well funded group has a huge incentive to reduce costs in this area.
  - wyager 9y ago
    Did you look at the link I posted? There's a ton of high-quality evidence for what I said in the medical literature.
    - Retric 9y ago
      US is still just one country. You can collect data cheaply if you get approval in another country fist. However, the US approval process is fairly reasonable so this does not happen. And yes I read what you linked it over states it's case and has very poor support.
- jfoutz 9y ago
  > we're still reeling from thalidomide Wasn't that one of the FDA's big victories? Perhaps you mean the FDA is far to powerful because of that win. I can see some argument for abandoning the efficacy requirement, and only going with "safe" but so few drugs actually do anything - isn't it something like a 95% attrition rate? only 1 in 50 actually have a measurable effect? Maybe the bar is too high. Seems like the bigger challenge, and far far greater win is just making testing cheaper.
  - wyager 9y ago
    It wasn't a victory at all; existing medical procedure failed to stop huge numbers of deformities. As a reactionary knee-jerk response, the US instated vastly overwrought medical restrictions.
  - serf 9y ago
    >Wasn't that one of the FDA's big victories? Perhaps you mean the FDA is far to powerful because of that win. depends who you ask. Milton Friedman used the thalidomide reaction as a case-book example of government meddling in the private sector where it needn't be, causing vast delay in possible new therapeutics, which basically created an unquantifiable loss of value due to us being unaware of "what could have been without bureaucratic delay". Friedman believed that if a company does sufficient harm to a population that the negative market signal will eventually destroy the 'bad-actor' company, without the need for anything like the FDA and the delays it imposes[0] I don't know whether or not he's right. [0]: https://www.youtube.com/watch?v=KUDV0YII6lk https://www.youtube.com/watch?v=KUDV0YII6lk