7 ms·

>That road involves decades of trials and costs billions of dollars per approved drug. Only because we've had time as a luxury in the past. I imagine new varia

>That road involves decades of trials and costs billions of dollars per approved drug. Only because we've had time as a luxury in the past. I imagine new variants will get fast tracked. FDA bureaucrats hoping to lazy their way to retirement will be under a lot of pressure to actually get things done quickly when there's so much social need. No one wants to be the POTUS who didn't fast track life saving antibiotics if they're shown to be generally safe in early testing. The FDA is a government organization and as such is subject to the politics of our leadership and indirectly, the electorate. The FDA has a page about this process here: http://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm http://www.fda.gov/forpatients/approvals/fast/ucm20041766.ht... At least 774 drugs have gone this route: http://www.bmj.com/content/351/bmj.h4633 http://www.bmj.com/content/351/bmj.h4633

djschnei 10y ago
Am I the only one that would prefer that politics and lazy bureaucrats didn't have the ability to get in the way of my well being in the first place?
- nnf 10y ago
  No.
  - djschnei 10y ago
    Oh, good.
- iheartmemcache 10y ago
  It's not as easy as that. Take the meat/poultry/milk products industry. In the EU, legislators have done a net-good for humanity by aggressively issuing legislation restricting antibiotics and growth-hormones. This is widely accepted as good for humanity as evidenced in this seminal article[1]. The sword cuts both ways. [1] http://jac.oxfordjournals.org/content/53/1/28.full http://jac.oxfordjournals.org/content/53/1/28.full
  - ceejayoz 10y ago
    See also: vehicle safety features like airbags, seatbelts, crumple zones, child car seats, safety testing, etc. Collectively, they've helped drop car crash injuries and fatalities enormously.
    - djschnei 10y ago
      Because humans, without regulation, don't value vehicle safety. Gotcha. See also: https://en.wikipedia.org/wiki/Totalitarianism https://en.wikipedia.org/wiki/Totalitarianism
      - ceejayoz 10y ago
        > Because humans, without regulation, don't value vehicle safety. Gotcha. Basically. Humans are horrible at cost/benefit calculations on an abstract level that may not directly affect them for years or even ever on an individual scale. I've known people who won't wear seatbelts because someone they know got trapped by one in a freak accident, despite overwhelming statistical evidence that's a dumb approach. The industry also has a long history of fighting regulations that require safety features but make cars more expensive. http://www.nytimes.com/1986/07/20/weekinreview/the-give-and-take-on-seat-belt-rules.html http://www.nytimes.com/1986/07/20/weekinreview/the-give-and-... > Last month, Ford proposed weakening the transportation department's 1984 rule in exchange for faster introduction of air bags in its cars. The company offered to install the bags on the driver's side of a majority of its cars by the 1990 model year if the department would drop its requirement that the front seats of all cars be equipped by then with automatic or so-called passive belts, designed to restrain the passenger as the car door closes. http://blog.esurance.com/seat-belt-history/ http://blog.esurance.com/seat-belt-history/ > A Federal Motor Vehicle Safety Standard proposes that all vehicles made after January 1, 1973, include an automatic restraint system, i.e., air bags or automatic belts. The auto industry, knowing that it would have to increase production costs to meet the new standard, balks, leading to a decade of argument and delay. https://en.wikipedia.org/wiki/Unsafe_at_Any_Speed https://en.wikipedia.org/wiki/Unsafe_at_Any_Speed etc.
        10y ago
- ceejayoz 10y ago
  We tried that, for centuries. https://en.wikipedia.org/wiki/Snake_oil https://en.wikipedia.org/wiki/Snake_oil https://en.wikipedia.org/wiki/Medicine_show https://en.wikipedia.org/wiki/Medicine_show https://en.wikipedia.org/wiki/Patent_medicine https://en.wikipedia.org/wiki/Patent_medicine
  - djschnei 10y ago
    There is a huge difference between preventing fraud and what we have today, and you know that.
    - ceejayoz 10y ago
      The differences largely result from stuff like that fraud, ethics failures, and other issues we've run into in the past. Just like Bitcoiners rediscovered the reasons our financial system has the various moving parts it does, healthcare regulations tend to have good reasons behind them.
- coldtea 10y ago
  No, every snake oil merchant in the planet wants that too.
- jbigelow76 10y ago
  Theranos approves this message!
- baq 10y ago
  issues with trust re government? who would you suggest to trust then, because i assume free market businessmen aren't trustworthy either?
- matt4077 10y ago
  Sure. Would you like some Thalidomide with that? Oh! You never had a chance to get that in the US. (For those who don't know her: https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey was the filthy lazy bureaucrat we all wish we could be (i. e. heroic))
  - BurningFrog 10y ago
    Discussing FDA type regulation you need to consider both costs and benefits. As with everything else, of course. The Thalidomide argument points out the benefit: These regulations avoid releasing medications with bad side effects to the population. Nobody denies this is a good thing. The costs are more rarely discussed. I think these are the main ones 1. When approval of a medication is delayed 10 years, everyone who would have been cured/helped by it during that time pays. Often with their life. 2. The high cost of FDA level trials makes medication more expensive. It also makes some medications economically unviable, with similar costs as in 1. I'm not aware of any study trying to quantify these effects, but my wild guess/gut feel is that the costs are ~100 times bigger than the benefits. The PR problem is that victims of bad medications are seen. The Thalidomide sufferers became world famous. But the ~100k Americans who died while the FDA took 17 years extra to approve beta blockers had no idea why they died.
    - matt4077 10y ago
      Having worked a bit in the industry, changes in regulation aren't actually the main problem. There are two trends combining: some tightening of the rules, yes (although the 'hockey stick phase of regulatory interference' was after WW2) and, much more importantly, a complete collapse of research success. We're still basically following the process established in 192x (Bayer, sulfa drugs) of throwing any structure we can think of onto some essay, into some mice, then humans. Educated guesses have become more educated, but not much better. Regulation has only become a burden because we're chasing ever-decreasing improvements. Even placebo got better over the last decades, which may have doomed a few potential blockbusters. It's obviously a problem of the lower-hanging fruits having been picked, and not all is bleak (kicking HIVs butt these days). But a cell just happens to be 35mill lines of self-modifying, multi-layered, self-evaluating, quantum-effects-using complexity and we're far away from a rational, hypothesis-driven drug discovery process. Deregulation wouldn't actually help. While it is possibly attractive for a patient now, that comes at a certain and significant disadvantage for future patients: If you could sell everything you wanted, there'd be no incentive for studying efficacies – it'd just be random stuff that may work, competing in a dysfunctional marketplace. Dysfunctional because nobody would know anything. Even with the somewhat professional studies we have today, and even for professionals, it is a major undertaking to form a solid opinion on a drug. Throw in patients who have nothing to lose and it'd probably be worse than it ever was. It's not like experimental treatments aren't available today. Almost every cancer patient is enrolled in one or more trials, unless she immediately responds to existing drugs. Quite a few people have traveled to Asia for some stem cell snake oil (less money, nice tan, no improvement, life-threatening complications being the usual outcome).
- Mz 10y ago
  Sigh. I have read all your comments -- including the doozy "all...without fallible men" -- and I will suggest that: A) If you are incredibly savvy, you can already sidestep government regulation by pursuing remedies outside the scope of what they control. B) Most people are not that savvy and, unfortunately, need the protection provided by government regulation. C) There is zero means to remove the fallibility of "men" from the equation. (I am a woman. As much as I would love to joke that things would be so much better if women ruled the world, the reality is that the fallibility of humankind is inescapable. Also -- cough -- Theranos.) D) Antibiotic resistance is not due to lazy bureaucrats. It is due to lazy humans. It's lazy humans all the way down. They are hardly confined to government. E) Even in alternative med circles, you get social pressure and people with a profit motive and conflict of interest and on and on. F) The path to solve this will never catch on. It is too much work. It can be done now. The research into how to break up biofilms is already at a useful stage, if you are sufficiently motivated. G) Gosh, I wish you would step away from this discussion. You aren't adding any value here.

djschnei 10y ago

Am I the only one that would prefer that politics and lazy bureaucrats didn't have the ability to get in the way of my well being in the first place?

nnf 10y ago
No.
- djschnei 10y ago
  Oh, good.
iheartmemcache 10y ago
It's not as easy as that. Take the meat/poultry/milk products industry. In the EU, legislators have done a net-good for humanity by aggressively issuing legislation restricting antibiotics and growth-hormones. This is widely accepted as good for humanity as evidenced in this seminal article[1]. The sword cuts both ways. [1] http://jac.oxfordjournals.org/content/53/1/28.full http://jac.oxfordjournals.org/content/53/1/28.full
- ceejayoz 10y ago
  See also: vehicle safety features like airbags, seatbelts, crumple zones, child car seats, safety testing, etc. Collectively, they've helped drop car crash injuries and fatalities enormously.
  - djschnei 10y ago
    Because humans, without regulation, don't value vehicle safety. Gotcha. See also: https://en.wikipedia.org/wiki/Totalitarianism https://en.wikipedia.org/wiki/Totalitarianism
    - ceejayoz 10y ago
      > Because humans, without regulation, don't value vehicle safety. Gotcha. Basically. Humans are horrible at cost/benefit calculations on an abstract level that may not directly affect them for years or even ever on an individual scale. I've known people who won't wear seatbelts because someone they know got trapped by one in a freak accident, despite overwhelming statistical evidence that's a dumb approach. The industry also has a long history of fighting regulations that require safety features but make cars more expensive. http://www.nytimes.com/1986/07/20/weekinreview/the-give-and-take-on-seat-belt-rules.html http://www.nytimes.com/1986/07/20/weekinreview/the-give-and-... > Last month, Ford proposed weakening the transportation department's 1984 rule in exchange for faster introduction of air bags in its cars. The company offered to install the bags on the driver's side of a majority of its cars by the 1990 model year if the department would drop its requirement that the front seats of all cars be equipped by then with automatic or so-called passive belts, designed to restrain the passenger as the car door closes. http://blog.esurance.com/seat-belt-history/ http://blog.esurance.com/seat-belt-history/ > A Federal Motor Vehicle Safety Standard proposes that all vehicles made after January 1, 1973, include an automatic restraint system, i.e., air bags or automatic belts. The auto industry, knowing that it would have to increase production costs to meet the new standard, balks, leading to a decade of argument and delay. https://en.wikipedia.org/wiki/Unsafe_at_Any_Speed https://en.wikipedia.org/wiki/Unsafe_at_Any_Speed etc.
      - 10y ago
ceejayoz 10y ago
We tried that, for centuries. https://en.wikipedia.org/wiki/Snake_oil https://en.wikipedia.org/wiki/Snake_oil https://en.wikipedia.org/wiki/Medicine_show https://en.wikipedia.org/wiki/Medicine_show https://en.wikipedia.org/wiki/Patent_medicine https://en.wikipedia.org/wiki/Patent_medicine
- djschnei 10y ago
  There is a huge difference between preventing fraud and what we have today, and you know that.
  - ceejayoz 10y ago
    The differences largely result from stuff like that fraud, ethics failures, and other issues we've run into in the past. Just like Bitcoiners rediscovered the reasons our financial system has the various moving parts it does, healthcare regulations tend to have good reasons behind them.
coldtea 10y ago
No, every snake oil merchant in the planet wants that too.
jbigelow76 10y ago
Theranos approves this message!
baq 10y ago
issues with trust re government? who would you suggest to trust then, because i assume free market businessmen aren't trustworthy either?
matt4077 10y ago
Sure. Would you like some Thalidomide with that? Oh! You never had a chance to get that in the US. (For those who don't know her: https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey was the filthy lazy bureaucrat we all wish we could be (i. e. heroic))
- BurningFrog 10y ago
  Discussing FDA type regulation you need to consider both costs and benefits. As with everything else, of course. The Thalidomide argument points out the benefit: These regulations avoid releasing medications with bad side effects to the population. Nobody denies this is a good thing. The costs are more rarely discussed. I think these are the main ones 1. When approval of a medication is delayed 10 years, everyone who would have been cured/helped by it during that time pays. Often with their life. 2. The high cost of FDA level trials makes medication more expensive. It also makes some medications economically unviable, with similar costs as in 1. I'm not aware of any study trying to quantify these effects, but my wild guess/gut feel is that the costs are ~100 times bigger than the benefits. The PR problem is that victims of bad medications are seen. The Thalidomide sufferers became world famous. But the ~100k Americans who died while the FDA took 17 years extra to approve beta blockers had no idea why they died.
  - matt4077 10y ago
    Having worked a bit in the industry, changes in regulation aren't actually the main problem. There are two trends combining: some tightening of the rules, yes (although the 'hockey stick phase of regulatory interference' was after WW2) and, much more importantly, a complete collapse of research success. We're still basically following the process established in 192x (Bayer, sulfa drugs) of throwing any structure we can think of onto some essay, into some mice, then humans. Educated guesses have become more educated, but not much better. Regulation has only become a burden because we're chasing ever-decreasing improvements. Even placebo got better over the last decades, which may have doomed a few potential blockbusters. It's obviously a problem of the lower-hanging fruits having been picked, and not all is bleak (kicking HIVs butt these days). But a cell just happens to be 35mill lines of self-modifying, multi-layered, self-evaluating, quantum-effects-using complexity and we're far away from a rational, hypothesis-driven drug discovery process. Deregulation wouldn't actually help. While it is possibly attractive for a patient now, that comes at a certain and significant disadvantage for future patients: If you could sell everything you wanted, there'd be no incentive for studying efficacies – it'd just be random stuff that may work, competing in a dysfunctional marketplace. Dysfunctional because nobody would know anything. Even with the somewhat professional studies we have today, and even for professionals, it is a major undertaking to form a solid opinion on a drug. Throw in patients who have nothing to lose and it'd probably be worse than it ever was. It's not like experimental treatments aren't available today. Almost every cancer patient is enrolled in one or more trials, unless she immediately responds to existing drugs. Quite a few people have traveled to Asia for some stem cell snake oil (less money, nice tan, no improvement, life-threatening complications being the usual outcome).
Mz 10y ago
Sigh. I have read all your comments -- including the doozy "all...without fallible men" -- and I will suggest that: A) If you are incredibly savvy, you can already sidestep government regulation by pursuing remedies outside the scope of what they control. B) Most people are not that savvy and, unfortunately, need the protection provided by government regulation. C) There is zero means to remove the fallibility of "men" from the equation. (I am a woman. As much as I would love to joke that things would be so much better if women ruled the world, the reality is that the fallibility of humankind is inescapable. Also -- cough -- Theranos.) D) Antibiotic resistance is not due to lazy bureaucrats. It is due to lazy humans. It's lazy humans all the way down. They are hardly confined to government. E) Even in alternative med circles, you get social pressure and people with a profit motive and conflict of interest and on and on. F) The path to solve this will never catch on. It is too much work. It can be done now. The research into how to break up biofilms is already at a useful stage, if you are sufficiently motivated. G) Gosh, I wish you would step away from this discussion. You aren't adding any value here.