6 ms·

I think we have to face that the FDA is incompetent and corrupt. Getting a drug approved is more dependent on how much money you want to spend than on whether

by powera 12y ago

I think we have to face that the FDA is incompetent and corrupt. Getting a drug approved is more dependent on how much money you want to spend than on whether it works. Some drugs that may be effective are delayed for years and years ( http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-a-hopeful-drug-thats-out-of-reach/?_r=0 http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-... ) while other drugs that don't work are approved as being effective.

erkkie 12y ago
Most likely self-experimenting and community based "trials" are gonna be much more prevalent in the coming years, due to bio hacking opening up. Gonna be even trickier to regulate and navigate.
- ekianjo 12y ago
  Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. Plus, the public does not have access to the synthesis or new materials, and I doubt that people would actually inject themselves with drugs that have never been tested on animals in the first place.
  - erkkie 12y ago
    > Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. You might've misread me as condoning this, not at all, but I think it's inevitably gonna happen and in fact already is, if you dig around a little bit (all kinds of life extension forums out there, not to mention the current nootropics trends). You don't have to agree with or like things to see them coming you know. > Plus, the public does not have access to the synthesis or new materials You wouldn't believe how much is possible to do in a home lab and dna/rna based techniques are becoming more and more accessible as well.
    - ekianjo 12y ago
      > You wouldn't believe how much is possible to do in a home lab and dna/rna based techniques are becoming more and more accessible as well. Sure, but combine the lack of such equipment for most people with the fact that your experiments will have small n size (because of lack of pilot plant scale to do proper large batches of drugs) and the significance of the home trial drops to nil.
      - erkkie 12y ago
        That's to be seen, and it becomes an analytics problem to separate signal from noise more than anything else. For preview google about the current issues around people 3d printing their own dental braces (or prosthetics).
  - 1123581321 12y ago
    You're missing the big trend. In addition to the availability of DIY hardware and more ways for patients to find each other and communicate, other developed or developing countries are approving treatments before the FDA. The size of the US market still holds back medical research, but at some point in this century, the size of the "early adopter" markets with sufficient buying power will be big enough that it won't matter. Signed, one American Type 1 diabetic who is tired of the FDA letting us die by keeping the best tools out of our hands. P.S. If an analogy helps you, think about how music piracy ended up giving us Spotify, and how it had to come from Europe to break into the US market, and how it blocked Americans to avoid getting shut down in its early days. Or, think about how Jobs essentially tricked the labels into allowing iTunes. The traditional record label publishing model is analogous to the FDA's drug trial model. The FDA can make any number of arguments about how their method is more rigorous and beneficial, but at some point, newer methods of getting similar results are coming along, and at some point after that, those methods will be backed by a power with the resources and inclination to bring the benefits of rigor to the new methods without resorting to the old methods.
    - zaroth 12y ago
      Just got my son on a CGM last week. The receiver claims a range of 20 ft, but it won't pick him up from our bedroom a wall away. When the receiver fails, you silently lose the hypoglycemia alerts. I've already ordered a pack of Wixels to setup these throughout the house, backyard, and at his preschool: https://github.com/StephenBlackWasAlreadyTaken/wixel-DexDrip https://github.com/StephenBlackWasAlreadyTaken/wixel-DexDrip
      - 1123581321 12y ago
        That's a good solution. I'm getting a Dexcom pretty soon (relatively recently diagnosed.) It's a bit depressing to compare the speed of the Dexcom hacker community to the speed of Dexcom's FDA-approved software releases, but at least we aren't still stuck with Medtronic.
      - deleted 12y ago
        [deleted]
chris_va 12y ago
The oped piece you cited does not support your assertion that the "FDA is incompetent and corrupt". They may be, but that is a pretty hefty accusation and requires more evidence. Nor, honestly, does it support the "getting a drug approved is more dependent on how much money you want to spend than on whether it works" claim, or the "some drugs that may be effective are delayed for years and years". Developing a drug is an incredibly complex operation. The FDA requires evidence that a drug will not kill people before it will approve it, which means that most drugs need to be tested in thousands of people. That requires outsourcing clinical trials to hospitals, which are then paid per patient to take on the extra work. The original link cites corruption at the hospital level, which does seem like the weakest link in the system. The hospitals/doctors get paid based on getting patients through the trial protocol, or at least saying they did. Much of the cost born by pharmaceutical companies is actually auditing this process, to make sure it happens correctly. Just yelling about the FDA will not change the corruption practices of a hospital in China.
- chaostheory 12y ago
  > The original link cites corruption at the hospital level, which does seem like the weakest link in the system. If corruption stopped at the hospital there, then this wouldn't happen at the FDA: > As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.” Corruption goes beyond the hospital level and it extends into the FDA itself. > As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted.
Alex3917 12y ago
And this article doesn't even cover 95% of the problems with the FDA, many of which are as bad or worse. But on this topic, here is a good example that the article missed: http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9.html http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9... Basically the FDA ordered pharma companies bury the research showing that antidepressants were ineffective in children and could lead to suicide, because they were worried that parents would stop spending money on them.
- refurb 12y ago
  The FDA's actions in this case are understandable. Proving that CNS drugs work is a huge pain in the ass and the FDA knows this. There is a huge placebo effect (that is interestingly increasing over time) and the our tools to measure depression frankly suck (too subjective). Yes, a number of antidepressant trials failed to show efficacy. However, a few of the trials did show improvement. The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market. As for the suicide risk, again, there is data to suggest that antidepressants can increase the risk of suicide. However, that data isn't cut and dry. Over the last few years the FDA has actually loosened it's warning since the data is in question. Note that the FDA required all of these drugs to have a black box warning stating the risk of suicide (the most strict warning any drug can have). Producing and testing drugs does not result in a binary outcome (drug good/drug bad). What the FDA does is look at the risk/benefit and makes a decision on that. Frankly I think they do a pretty good job at it.
  - Alex3917 12y ago
    > The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market. I'm all for allowing patents to access unproven medicines, but why should the companies be allowed to run billion dollar marketing campaigns saying that they work?
- AdamMickiewicz 12y ago
  I'm sorry, I thought that FDA is there precisely to protect us from ineffective or dangerous drugs. Not to cover it up to protect the big pharma.

by powera 12y ago

erkkie 12y ago

Most likely self-experimenting and community based "trials" are gonna be much more prevalent in the coming years, due to bio hacking opening up. Gonna be even trickier to regulate and navigate.

ekianjo 12y ago
Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. Plus, the public does not have access to the synthesis or new materials, and I doubt that people would actually inject themselves with drugs that have never been tested on animals in the first place.
- erkkie 12y ago
  > Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. You might've misread me as condoning this, not at all, but I think it's inevitably gonna happen and in fact already is, if you dig around a little bit (all kinds of life extension forums out there, not to mention the current nootropics trends). You don't have to agree with or like things to see them coming you know. > Plus, the public does not have access to the synthesis or new materials You wouldn't believe how much is possible to do in a home lab and dna/rna based techniques are becoming more and more accessible as well.
  - ekianjo 12y ago
    > You wouldn't believe how much is possible to do in a home lab and dna/rna based techniques are becoming more and more accessible as well. Sure, but combine the lack of such equipment for most people with the fact that your experiments will have small n size (because of lack of pilot plant scale to do proper large batches of drugs) and the significance of the home trial drops to nil.
    - erkkie 12y ago
      That's to be seen, and it becomes an analytics problem to separate signal from noise more than anything else. For preview google about the current issues around people 3d printing their own dental braces (or prosthetics).
- 1123581321 12y ago
  You're missing the big trend. In addition to the availability of DIY hardware and more ways for patients to find each other and communicate, other developed or developing countries are approving treatments before the FDA. The size of the US market still holds back medical research, but at some point in this century, the size of the "early adopter" markets with sufficient buying power will be big enough that it won't matter. Signed, one American Type 1 diabetic who is tired of the FDA letting us die by keeping the best tools out of our hands. P.S. If an analogy helps you, think about how music piracy ended up giving us Spotify, and how it had to come from Europe to break into the US market, and how it blocked Americans to avoid getting shut down in its early days. Or, think about how Jobs essentially tricked the labels into allowing iTunes. The traditional record label publishing model is analogous to the FDA's drug trial model. The FDA can make any number of arguments about how their method is more rigorous and beneficial, but at some point, newer methods of getting similar results are coming along, and at some point after that, those methods will be backed by a power with the resources and inclination to bring the benefits of rigor to the new methods without resorting to the old methods.
  - zaroth 12y ago
    Just got my son on a CGM last week. The receiver claims a range of 20 ft, but it won't pick him up from our bedroom a wall away. When the receiver fails, you silently lose the hypoglycemia alerts. I've already ordered a pack of Wixels to setup these throughout the house, backyard, and at his preschool: https://github.com/StephenBlackWasAlreadyTaken/wixel-DexDrip https://github.com/StephenBlackWasAlreadyTaken/wixel-DexDrip
    - 1123581321 12y ago
      That's a good solution. I'm getting a Dexcom pretty soon (relatively recently diagnosed.) It's a bit depressing to compare the speed of the Dexcom hacker community to the speed of Dexcom's FDA-approved software releases, but at least we aren't still stuck with Medtronic.
    - deleted 12y ago
      [deleted]

chris_va 12y ago

The oped piece you cited does not support your assertion that the "FDA is incompetent and corrupt". They may be, but that is a pretty hefty accusation and requires more evidence. Nor, honestly, does it support the "getting a drug approved is more dependent on how much money you want to spend than on whether it works" claim, or the "some drugs that may be effective are delayed for years and years". Developing a drug is an incredibly complex operation. The FDA requires evidence that a drug will not kill people before it will approve it, which means that most drugs need to be tested in thousands of people. That requires outsourcing clinical trials to hospitals, which are then paid per patient to take on the extra work. The original link cites corruption at the hospital level, which does seem like the weakest link in the system. The hospitals/doctors get paid based on getting patients through the trial protocol, or at least saying they did. Much of the cost born by pharmaceutical companies is actually auditing this process, to make sure it happens correctly. Just yelling about the FDA will not change the corruption practices of a hospital in China.

chaostheory 12y ago
> The original link cites corruption at the hospital level, which does seem like the weakest link in the system. If corruption stopped at the hospital there, then this wouldn't happen at the FDA: > As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.” Corruption goes beyond the hospital level and it extends into the FDA itself. > As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted.

Alex3917 12y ago

And this article doesn't even cover 95% of the problems with the FDA, many of which are as bad or worse. But on this topic, here is a good example that the article missed: http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9.html http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9... Basically the FDA ordered pharma companies bury the research showing that antidepressants were ineffective in children and could lead to suicide, because they were worried that parents would stop spending money on them.

refurb 12y ago
The FDA's actions in this case are understandable. Proving that CNS drugs work is a huge pain in the ass and the FDA knows this. There is a huge placebo effect (that is interestingly increasing over time) and the our tools to measure depression frankly suck (too subjective). Yes, a number of antidepressant trials failed to show efficacy. However, a few of the trials did show improvement. The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market. As for the suicide risk, again, there is data to suggest that antidepressants can increase the risk of suicide. However, that data isn't cut and dry. Over the last few years the FDA has actually loosened it's warning since the data is in question. Note that the FDA required all of these drugs to have a black box warning stating the risk of suicide (the most strict warning any drug can have). Producing and testing drugs does not result in a binary outcome (drug good/drug bad). What the FDA does is look at the risk/benefit and makes a decision on that. Frankly I think they do a pretty good job at it.
- Alex3917 12y ago
  > The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market. I'm all for allowing patents to access unproven medicines, but why should the companies be allowed to run billion dollar marketing campaigns saying that they work?
AdamMickiewicz 12y ago
I'm sorry, I thought that FDA is there precisely to protect us from ineffective or dangerous drugs. Not to cover it up to protect the big pharma.