9 ms·

Where is the scrutiny over FDA’s role in the overdose epidemic?

147 points by colinprince 5y ago

pstuart 5y ago
And what about the DEA?
- Shank 5y ago
  The DEA was effectively stripped of its ability to issue "Immediate Suspension Orders" which were its most effective tool to combat drug diversion by stopping drug distributors with the passage of the "Ensuring Patient Access and Effective Drug Enforcement Act" in 2016 [0]. This is actually a key point in the HBO documentary "The Crime of the Century." > In April 2016, Congress enacted the Ensuring Patient Access and Effective Drug Enforcement Act of 2016, or the “Marino Bill,” which created a new standard of proof necessary for DEA to issue an ISO. Pursuant to 21 U.S.C. § 824(d)(2), in order to issue an ISO against a registrant, DEA must prove that the registrant’s conduct was an “imminent danger to the public health or safety” because the registrant failed to maintain effective controls against diversion, or to otherwise comply with the obligations of DEA registration, and there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance would occur unless there is an immediate suspension of the registration. [0] (This is from the 2019 DOJ OIG report). Separately, the same October 1, 2019 report from the DOJ OIG noted that the DEA was already decreasing use of ISOs (prior to the Marino Bill being passed), and authorized a 400% increase in oxycodone production from 2002 to 2013, and only reduced the production quota in 2017 [1]. [1]: https://oig.justice.gov/press/2019/2019-10-01.pdf https://oig.justice.gov/press/2019/2019-10-01.pdf [0]: https://oig.justice.gov/reports/2019/e1905.pdf https://oig.justice.gov/reports/2019/e1905.pdf
  - nradov 5y ago
    There are two sides to that issue. One of the reasons that Congress stripped the DEA of some authority was because they had occasionally abused that authority to harass and even prosecute some legitimate pain medicine doctors.
- ethbr0 5y ago
  The problem is that as a regulator, the FDA declares what constitutes legal use. Consequently, if they make over-prescribing legal, then it is. Similar problem with the EPA chemical safety division: https://news.ycombinator.com/item?id=28092336 https://news.ycombinator.com/item?id=28092336 The general problem is there's not enough basic funding to fund quality safety trials. Which are still run, but by the manufacturers themselves. What probably should happen is more pushback from agencies with downstream remits like the DEA once statistically durable negative effects are observed on the ground.
- stadium 5y ago
  Disband it and focus on harm reduction. Edit: Let the CDC focus on harm reduction. Read Maté's book, it completely changed my perspective. "In the Realm of Hungry Ghosts: Close Encounters with Addiction" https://g.co/kgs/iSPSHB https://g.co/kgs/iSPSHB
gillytech 5y ago
The FDA and any oversight groups will protect their own by remaining silent and they'll get away with it. Nobody will be jailed. The people have the power but they are so dispersed, distracted and lulled into inaction by the corn and games of our times. Cancel your Netflix account, cancel your cable and go volunteer if you want to make a difference.
- peterfield 5y ago
  https://www.google.com/search?q=spectorsoft+fda&oq=spectorsoft+fda&aqs=chrome..69i57j33i160.18906j0j7&sourceid=chrome&ie=UTF-8 https://www.google.com/search?q=spectorsoft+fda&oq=spectorso... You can volunteer here: www.tinyurl.com/openhealthtech
reedjosh 5y ago
My son is almost through Topical Steroid Withdrawal (TSW). In this case he was misdiagnosed as having Eczema, and put on topical steroids from about 2 months old. See http://www.red-skin-syndrome.com/ http://www.red-skin-syndrome.com/ https://www.itsan.org/ https://www.itsan.org/ And my favorite, a video that finally opened my eyes on the issue. https://m.youtube.com/watch?v=PpW4VV2bsD8&t=19s https://m.youtube.com/watch?v=PpW4VV2bsD8&t=19s My two year old son has been steroid free for just about three months now and is finally looking like a healthy young boy. We're both very happy and very angry. Had we not sought out our own solution we'd have him on yet stronger steroids today as that is the 'standard of care'. From my perspective, it's hard to put any faith in the FDA at all.
- AndrewBissell 5y ago
  On Twitter or Facebook this is where someone would link the New Yorker cartoon with the guy turning to his wife from the computer and saying, "look honey, I found something all the world's top scientists and doctors missed!" When my daughter was very young her doctors tried to give her an oral antibiotic for a little infected sore she had on her finger. At the time I was much more of a "just do what the doctors say!" type, but luckily my wife insisted we handle it on our own with topical antibiotics instead. Now, knowing more about all the harms caused by antibiotics I'm extremely grateful we didn't just slavishly follow the doctors' advice. In seriousness, good job looking out for your son.
  - reedjosh 5y ago
    Thank you. I really appreciate this. It's been rough losing faith in what is basically not just the medical establishment, but kinda also society writ large. I guess at least I can take comfort in the self confidence gained through experience, but now all I see is in question. Hopefully I can aim my new found confidence at solving some of the issues that now seem obvious to me.
  - mthoms 5y ago
    That’s not what that comic means.
  - 5y ago
peterfield 5y ago
That's indeed preposterous. Same thing for the Theranos scandal. Financial regulators have done better for the safety of the patients than the FDA! Other regulators in the world are worst sadly. The European framework is a mess - stuck in between 2 revisions of their dogma and in the hand of Notified Bodies which are running a private business of setting up the benchmark of safety and efficacy for health-tech, without any accountability mechanism in place. I could go for hours on that. Note that there are great people and initiative too (there's one coming up at the FDA on 14 OCT). These institutions are sadly not "fit" for the upcoming intelligence explosion. Everyone is asking for more regulation of AI but we need to learn how to be efficient at regulating fast!! https://youtu.be/tFxLoqbLj6I https://youtu.be/tFxLoqbLj6I
- threeseed 5y ago
  Theranos is interesting because they modelled themselves after the startup world. And in this world being less than truthful (fradulent ?) with customers and investors is not only accepted but often encouraged. YC itself has often promoted this "fake it until you make it" approach. As an example, Musk has promised robotaxis and FSD for years which if delivered would have a massive impact on Tesla's stock performance. And yet he has never been taken to task and likely never will.
  - onethought 5y ago
    But he's also clearly working towards delivering those things. This isn't Theranos-like at all. FSD is a real thing, and it's not a stretch to see it becoming Robo-taxis. What would you take him to task on? The timings? That's not a startup thing... every company has delays on timings: Apple, Boeing, Sony... the entire car industry....
  - fallingknife 5y ago
    Taken to task for what? Failing to predict the future?
  - burnished 5y ago
    Yeah! We were supposed to get full-self driving by now, the Jetsons promised!
PragmaticPulp 5y ago
I do agree that we should re-examine the nature of opioid prescribing, but at the same time I get worried when journalists start demonizing opioids altogether: > Yet it turns out the FDA never had reliable scientific evidence supporting the claim of safety and efficacy of opioids for chronic pain Opioids should be prescribed with great caution, but I don’t think you’ll find anyone well-versed in pain management who questions their utility in severe cases. The problem in the past wasn’t that opioids existed. It was that they were being prescribed far too liberally and the risks were being deliberately downplayed. We need more evidence and more regulation, but let’s not have the pendulum swing too far in the opposite direction. It’s already common to hear stories of pain patients being forced off of their stable opioid prescriptions because their doctors are concerned with keeping their numbers down. I look forward to the day that we have better medications for pain management with less abuse liability, but until then we need to work with what we have. Regulate and educate, yes, but demonizing the substances isn’t the solution. They have their place when used correctly.
- awesomeusername 5y ago
  Cannabinoids
  - qq4 5y ago
    Do you want to expand on this one word answer? Why do you think cannabinoids are a good substitute for opioids?
    - eurasiantiger 5y ago
      It might have something to do with the reports from US states that legal and widely available cannabis tends to curb opioid use. No, people won’t necessarily stop using opioids, but they will use much lower doses and not as often.
      - qq4 5y ago
        Anecdotally, all of the people I know struggling with opioid addiction were potheads beforehand. I think drug addicts will abuse whatever they can, regardless of available options.
randycupertino 5y ago
Having read Empire of Pain: the Secret History of the Sackler Dynasty by Patrick Radden Keefe, which heartbreaking and outraging- one of the biggest surprises for me in that book was how the Sacklers literally hired and FDA commissioner who approved their submission to come work for them: > Richard Sackler, in a sworn deposition, said that [FDA commissioner] Curtis Wright had actually started calling Purdue about a job before he even left the FDA. And then he left the FDA and got a $400k a year job at Purdue (in 1995 $$, so ~700k/year now). Incredibly outrageous how the Sacklers got away with a hand-slap and litigation shield after looting all assets Purdue and declaring bankruptcy. Highly recommend that book if anyone you know has struggled with addiction or if you just want a really gripping nonfiction read. I found it as well written and in-depth researched as Bad Blood by John Carreyrou.
- okhobb 5y ago
  The FDA's biggest (only?) obvious enormous win was with blocking https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide
  - randycupertino 5y ago
    So, I'm outing myself as a book nerd (read a lot during quarantine), but I also recently enjoyed The Poison Squad by Deborah Blum which covered the creation of the FDA during the end of the 19th century and a few of their first BIG wins were getting formaldehyde, borax, arsenic and lead out of milk, canned meats and other products on the market. I was surprised in that book of how much the F in the "Food and Drug Administration" was initially involved in enforcement. Nowadays we mostly think of them for regulating drugs and medical devices (or, at least, that's what I think of them as doing!) however initially a lot of their enforcement powers were to prevent fraudulent labeling and unsafe additives in supermarket foods. The part in the book where the US Army was feeding the troops fighting the Spanish American War canned beef embalmed with formaldehyde was rather disgusting: https://en.wikipedia.org/wiki/United_States_Army_beef_scandal https://en.wikipedia.org/wiki/United_States_Army_beef_scanda... Also, if you don't like reading here's a PBS documentary covering the same info in the book: https://www.pbs.org/wgbh/americanexperience/films/poison-squad/ https://www.pbs.org/wgbh/americanexperience/films/poison-squ...
encryptluks2 5y ago
But lets all trust them about vaccinations. There is no way these hierarchical government systems ripe for abuse and misinformation, usually lead by CEOs from the medical industry that have paid out billions due to previous lies, could ever mislead us again.
- nathanvanfleet 5y ago
  -
  - encryptluks2 5y ago
    Wow, no where did I mention Ivermectin but your knee-jerk reaction was that I somehow believed that was the answer. What is worse, suggesting that we should be leary of government agencies that are ripe for abuse or having a scripted NPC-lke response to people that question anything?
  - reedjosh 5y ago
    This whole meme is sick. Ivermectin is a noble prize winning drug for humans. Joe Rogan took a human dose prescribed by a human for a human. How are you outsourcing your thinking to this degree, yet so confidently responding condescendingly? BTW, Joe was better after a day...
    - AndrewBissell 5y ago
      I'm a big believer that ivermectin probably helps (especially after the gigantic astroturfed media freakout about it), but Rogan took so many things it's impossible to credit any one part of his cocktail. Always funny when liberals get their hopes up as soon as someone tests positive and then they're fine a day or two later though.
      - reedjosh 5y ago
        > Rogan took so many things it's impossible to credit any one part of his cocktail. Of course. I'm not saying that's what fixed him, mostly just that mocking someone for their stupidity in trying early treatment whom also recovered in above average time...
saul_goodman 5y ago
Perdue Pharma has been allowed to push "non-addictive narcotics" for over 20 years and the FDA barely feigns any resistance. But some folks find non-perfect but worth trialing effects from a couple drugs in combating a pandemic illness and they come out of the woodwork to fight that. When the UN accidentally brought Cholera to Haiti in 2010 the US actively discouraged disemination of that information: https://slate.com/news-and-politics/2016/04/what-caused-haitis-cholera-epidemic-the-cdcs-museum-knows-but-wont-say.html https://slate.com/news-and-politics/2016/04/what-caused-hait... Follow the money.
refurb 5y ago
As usual this over simplifies the problem and is incorrect when it comes to the FDA's role as a regulator. The FDA job is to ensure that approved drugs met a risk vs. benefit threshold. Once FDA approved, doctors can prescribe a drug for whatever they want. Bump your elbow? Doctor can prescribe Oxycontin for it, even if the FDA never approved it for that. Doctors are the gatekeepers for prescription drugs (along with pharmacists). Anyone who has done even a little bit of research knows the FDA was looking into the abuse of Oxycontin way back into the late 1990's. This issue wasn't ignored and the FDA issued multiple letters and updated product labels to inform doctors of the risk involved. I guess, what were the FDA's options? Pull Oxycontin from the market? That would cause harm as well since many patients benefited from it (and continue to do so). And as another comment mentioned, when it comes to controlled substances, that's the DEA's purview along with physician licensing organizations in each state. It was apparent those folks were asleep at the switch as multiple clinics had line ups out the door of cash paying customers who would fill a script and then turn around and sell it in the parking lot. And that went on for years. Not sure what the FDA should do in that case.
- handmodel 5y ago
  You are right about the current role. But I think the frustration with the FDA comes from their textbook following of the rules without any apparent concern for trade-offs beyond their immediate purview. Their algorithm for decision making is limited and that leads to uncreative decisions. My personal frustration with them has been their slowness to approve vaccines (and to do common sense things like offer boosters or lower doses for those who want them) because it goes against procedure written years ago for illnesses that are not time-dependent at all.
  - refurb 5y ago
    Your frustration is they "follow rules"? I mean their role was created by law and if they overstep it, it gets shut down. For example, the FDA can't say "we're not approving this drug because the price is too high". That's not in their mandate and if they did do it, they'd pretty quickly get sued and forced to approve the drug. And slowness in approving vaccines? The FDA was one of the first globally to approve the Covid vaccines (I think the UK was first). And nothing stops your doctor from giving you a vaccine booster right now. In fact, I believe many people are getting them. The FDA does not dictate how drugs can be used once approved - that's at a doctors discretion.
joshuaheard 5y ago
Two-thirds of opioid overdose deaths come from counterfeit tablets illegally laced with fentanyl. That is not the FDA's purview, but the DEA.
- gillytech 5y ago
  Where does that statistic come from? As far as I know there were several distributors for OxyContin that were investigated for turning a blind eye to highly suspicious volumes of the medication being funneled into the mid eastern states.
- ALittleLight 5y ago
  Did these users start their usage with "legit" tablets? Would they be using counterfeit opiods if the real thing weren't so widespread?
rpaddock 5y ago
Please watch the documentary "Pain Warriors" to see what is happening to people with Chronic Pain and the other side of the "Opioid Epidemic". "Pain Warriors" is NOT a warm and fuzzy movie to watch. It is five stories, two being suicides one of which was my late wife. It is also a good example of how today's Medical Establishment fails people. In Karen's case each doctor did what they thought was in her best interests, and I have no issue with any of them. Yet the system as a whole killed her. "Pain Warriors" can be watched for free on Amazon Prime, and TubiTV. It is also on iTunes, Google Play and Veimo for international viewers. We are in the process of applying to get it on Netflix. I receive no remuneration from the documentary. I'm simply trying to raise awareness of obscure conditions like Intracranial Hypotension due to Cerebrospinal Fluid (CSF) Leaks. As well as raise awareness of how broken the Medical Establishment can be if you have an obscure condition.
- thehappypm 5y ago
  I will watch it. I went through about a 2 year stint when, due to a series of injuries, I was in pain just about constantly. I broke my tailbone, had a stress fracture in my ankle, and suffered a lower back injury at the same time. No posture was painless for me -- lying down was OK, but sitting hurt my tailbone, standing hurt my back, walking hurt my ankles, biking hurt my tailbone. It was a very difficult thing to deal with. I'm better now (still have the back pain) but I understand what it's like to wake up every morning and just be in pain.
vt100 5y ago
The FDA is cracking down on the overdose epidemic for horse dewormer

147 points by colinprince 5y ago

pstuart 5y ago

And what about the DEA?

Shank 5y ago
The DEA was effectively stripped of its ability to issue "Immediate Suspension Orders" which were its most effective tool to combat drug diversion by stopping drug distributors with the passage of the "Ensuring Patient Access and Effective Drug Enforcement Act" in 2016 [0]. This is actually a key point in the HBO documentary "The Crime of the Century." > In April 2016, Congress enacted the Ensuring Patient Access and Effective Drug Enforcement Act of 2016, or the “Marino Bill,” which created a new standard of proof necessary for DEA to issue an ISO. Pursuant to 21 U.S.C. § 824(d)(2), in order to issue an ISO against a registrant, DEA must prove that the registrant’s conduct was an “imminent danger to the public health or safety” because the registrant failed to maintain effective controls against diversion, or to otherwise comply with the obligations of DEA registration, and there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance would occur unless there is an immediate suspension of the registration. [0] (This is from the 2019 DOJ OIG report). Separately, the same October 1, 2019 report from the DOJ OIG noted that the DEA was already decreasing use of ISOs (prior to the Marino Bill being passed), and authorized a 400% increase in oxycodone production from 2002 to 2013, and only reduced the production quota in 2017 [1]. [1]: https://oig.justice.gov/press/2019/2019-10-01.pdf https://oig.justice.gov/press/2019/2019-10-01.pdf [0]: https://oig.justice.gov/reports/2019/e1905.pdf https://oig.justice.gov/reports/2019/e1905.pdf
- nradov 5y ago
  There are two sides to that issue. One of the reasons that Congress stripped the DEA of some authority was because they had occasionally abused that authority to harass and even prosecute some legitimate pain medicine doctors.
ethbr0 5y ago
The problem is that as a regulator, the FDA declares what constitutes legal use. Consequently, if they make over-prescribing legal, then it is. Similar problem with the EPA chemical safety division: https://news.ycombinator.com/item?id=28092336 https://news.ycombinator.com/item?id=28092336 The general problem is there's not enough basic funding to fund quality safety trials. Which are still run, but by the manufacturers themselves. What probably should happen is more pushback from agencies with downstream remits like the DEA once statistically durable negative effects are observed on the ground.
stadium 5y ago
Disband it and focus on harm reduction. Edit: Let the CDC focus on harm reduction. Read Maté's book, it completely changed my perspective. "In the Realm of Hungry Ghosts: Close Encounters with Addiction" https://g.co/kgs/iSPSHB https://g.co/kgs/iSPSHB

gillytech 5y ago

The FDA and any oversight groups will protect their own by remaining silent and they'll get away with it. Nobody will be jailed. The people have the power but they are so dispersed, distracted and lulled into inaction by the corn and games of our times. Cancel your Netflix account, cancel your cable and go volunteer if you want to make a difference.

peterfield 5y ago
https://www.google.com/search?q=spectorsoft+fda&oq=spectorsoft+fda&aqs=chrome..69i57j33i160.18906j0j7&sourceid=chrome&ie=UTF-8 https://www.google.com/search?q=spectorsoft+fda&oq=spectorso... You can volunteer here: www.tinyurl.com/openhealthtech

reedjosh 5y ago

My son is almost through Topical Steroid Withdrawal (TSW). In this case he was misdiagnosed as having Eczema, and put on topical steroids from about 2 months old. See http://www.red-skin-syndrome.com/ http://www.red-skin-syndrome.com/ https://www.itsan.org/ https://www.itsan.org/ And my favorite, a video that finally opened my eyes on the issue. https://m.youtube.com/watch?v=PpW4VV2bsD8&t=19s https://m.youtube.com/watch?v=PpW4VV2bsD8&t=19s My two year old son has been steroid free for just about three months now and is finally looking like a healthy young boy. We're both very happy and very angry. Had we not sought out our own solution we'd have him on yet stronger steroids today as that is the 'standard of care'. From my perspective, it's hard to put any faith in the FDA at all.

AndrewBissell 5y ago
On Twitter or Facebook this is where someone would link the New Yorker cartoon with the guy turning to his wife from the computer and saying, "look honey, I found something all the world's top scientists and doctors missed!" When my daughter was very young her doctors tried to give her an oral antibiotic for a little infected sore she had on her finger. At the time I was much more of a "just do what the doctors say!" type, but luckily my wife insisted we handle it on our own with topical antibiotics instead. Now, knowing more about all the harms caused by antibiotics I'm extremely grateful we didn't just slavishly follow the doctors' advice. In seriousness, good job looking out for your son.
- reedjosh 5y ago
  Thank you. I really appreciate this. It's been rough losing faith in what is basically not just the medical establishment, but kinda also society writ large. I guess at least I can take comfort in the self confidence gained through experience, but now all I see is in question. Hopefully I can aim my new found confidence at solving some of the issues that now seem obvious to me.
- mthoms 5y ago
  That’s not what that comic means.
- 5y ago

peterfield 5y ago

That's indeed preposterous. Same thing for the Theranos scandal. Financial regulators have done better for the safety of the patients than the FDA! Other regulators in the world are worst sadly. The European framework is a mess - stuck in between 2 revisions of their dogma and in the hand of Notified Bodies which are running a private business of setting up the benchmark of safety and efficacy for health-tech, without any accountability mechanism in place. I could go for hours on that. Note that there are great people and initiative too (there's one coming up at the FDA on 14 OCT). These institutions are sadly not "fit" for the upcoming intelligence explosion. Everyone is asking for more regulation of AI but we need to learn how to be efficient at regulating fast!! https://youtu.be/tFxLoqbLj6I https://youtu.be/tFxLoqbLj6I

threeseed 5y ago
Theranos is interesting because they modelled themselves after the startup world. And in this world being less than truthful (fradulent ?) with customers and investors is not only accepted but often encouraged. YC itself has often promoted this "fake it until you make it" approach. As an example, Musk has promised robotaxis and FSD for years which if delivered would have a massive impact on Tesla's stock performance. And yet he has never been taken to task and likely never will.
- onethought 5y ago
  But he's also clearly working towards delivering those things. This isn't Theranos-like at all. FSD is a real thing, and it's not a stretch to see it becoming Robo-taxis. What would you take him to task on? The timings? That's not a startup thing... every company has delays on timings: Apple, Boeing, Sony... the entire car industry....
- fallingknife 5y ago
  Taken to task for what? Failing to predict the future?
- burnished 5y ago
  Yeah! We were supposed to get full-self driving by now, the Jetsons promised!

PragmaticPulp 5y ago

I do agree that we should re-examine the nature of opioid prescribing, but at the same time I get worried when journalists start demonizing opioids altogether: > Yet it turns out the FDA never had reliable scientific evidence supporting the claim of safety and efficacy of opioids for chronic pain Opioids should be prescribed with great caution, but I don’t think you’ll find anyone well-versed in pain management who questions their utility in severe cases. The problem in the past wasn’t that opioids existed. It was that they were being prescribed far too liberally and the risks were being deliberately downplayed. We need more evidence and more regulation, but let’s not have the pendulum swing too far in the opposite direction. It’s already common to hear stories of pain patients being forced off of their stable opioid prescriptions because their doctors are concerned with keeping their numbers down. I look forward to the day that we have better medications for pain management with less abuse liability, but until then we need to work with what we have. Regulate and educate, yes, but demonizing the substances isn’t the solution. They have their place when used correctly.

awesomeusername 5y ago
Cannabinoids
- qq4 5y ago
  Do you want to expand on this one word answer? Why do you think cannabinoids are a good substitute for opioids?
  - eurasiantiger 5y ago
    It might have something to do with the reports from US states that legal and widely available cannabis tends to curb opioid use. No, people won’t necessarily stop using opioids, but they will use much lower doses and not as often.
    - qq4 5y ago
      Anecdotally, all of the people I know struggling with opioid addiction were potheads beforehand. I think drug addicts will abuse whatever they can, regardless of available options.

randycupertino 5y ago

Having read Empire of Pain: the Secret History of the Sackler Dynasty by Patrick Radden Keefe, which heartbreaking and outraging- one of the biggest surprises for me in that book was how the Sacklers literally hired and FDA commissioner who approved their submission to come work for them: > Richard Sackler, in a sworn deposition, said that [FDA commissioner] Curtis Wright had actually started calling Purdue about a job before he even left the FDA. And then he left the FDA and got a $400k a year job at Purdue (in 1995 $$, so ~700k/year now). Incredibly outrageous how the Sacklers got away with a hand-slap and litigation shield after looting all assets Purdue and declaring bankruptcy. Highly recommend that book if anyone you know has struggled with addiction or if you just want a really gripping nonfiction read. I found it as well written and in-depth researched as Bad Blood by John Carreyrou.

okhobb 5y ago
The FDA's biggest (only?) obvious enormous win was with blocking https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide
- randycupertino 5y ago
  So, I'm outing myself as a book nerd (read a lot during quarantine), but I also recently enjoyed The Poison Squad by Deborah Blum which covered the creation of the FDA during the end of the 19th century and a few of their first BIG wins were getting formaldehyde, borax, arsenic and lead out of milk, canned meats and other products on the market. I was surprised in that book of how much the F in the "Food and Drug Administration" was initially involved in enforcement. Nowadays we mostly think of them for regulating drugs and medical devices (or, at least, that's what I think of them as doing!) however initially a lot of their enforcement powers were to prevent fraudulent labeling and unsafe additives in supermarket foods. The part in the book where the US Army was feeding the troops fighting the Spanish American War canned beef embalmed with formaldehyde was rather disgusting: https://en.wikipedia.org/wiki/United_States_Army_beef_scandal https://en.wikipedia.org/wiki/United_States_Army_beef_scanda... Also, if you don't like reading here's a PBS documentary covering the same info in the book: https://www.pbs.org/wgbh/americanexperience/films/poison-squad/ https://www.pbs.org/wgbh/americanexperience/films/poison-squ...

encryptluks2 5y ago

But lets all trust them about vaccinations. There is no way these hierarchical government systems ripe for abuse and misinformation, usually lead by CEOs from the medical industry that have paid out billions due to previous lies, could ever mislead us again.

nathanvanfleet 5y ago
-
- encryptluks2 5y ago
  Wow, no where did I mention Ivermectin but your knee-jerk reaction was that I somehow believed that was the answer. What is worse, suggesting that we should be leary of government agencies that are ripe for abuse or having a scripted NPC-lke response to people that question anything?
- reedjosh 5y ago
  This whole meme is sick. Ivermectin is a noble prize winning drug for humans. Joe Rogan took a human dose prescribed by a human for a human. How are you outsourcing your thinking to this degree, yet so confidently responding condescendingly? BTW, Joe was better after a day...
  - AndrewBissell 5y ago
    I'm a big believer that ivermectin probably helps (especially after the gigantic astroturfed media freakout about it), but Rogan took so many things it's impossible to credit any one part of his cocktail. Always funny when liberals get their hopes up as soon as someone tests positive and then they're fine a day or two later though.
    - reedjosh 5y ago
      > Rogan took so many things it's impossible to credit any one part of his cocktail. Of course. I'm not saying that's what fixed him, mostly just that mocking someone for their stupidity in trying early treatment whom also recovered in above average time...

saul_goodman 5y ago

Perdue Pharma has been allowed to push "non-addictive narcotics" for over 20 years and the FDA barely feigns any resistance. But some folks find non-perfect but worth trialing effects from a couple drugs in combating a pandemic illness and they come out of the woodwork to fight that. When the UN accidentally brought Cholera to Haiti in 2010 the US actively discouraged disemination of that information: https://slate.com/news-and-politics/2016/04/what-caused-haitis-cholera-epidemic-the-cdcs-museum-knows-but-wont-say.html https://slate.com/news-and-politics/2016/04/what-caused-hait... Follow the money.

refurb 5y ago

As usual this over simplifies the problem and is incorrect when it comes to the FDA's role as a regulator. The FDA job is to ensure that approved drugs met a risk vs. benefit threshold. Once FDA approved, doctors can prescribe a drug for whatever they want. Bump your elbow? Doctor can prescribe Oxycontin for it, even if the FDA never approved it for that. Doctors are the gatekeepers for prescription drugs (along with pharmacists). Anyone who has done even a little bit of research knows the FDA was looking into the abuse of Oxycontin way back into the late 1990's. This issue wasn't ignored and the FDA issued multiple letters and updated product labels to inform doctors of the risk involved. I guess, what were the FDA's options? Pull Oxycontin from the market? That would cause harm as well since many patients benefited from it (and continue to do so). And as another comment mentioned, when it comes to controlled substances, that's the DEA's purview along with physician licensing organizations in each state. It was apparent those folks were asleep at the switch as multiple clinics had line ups out the door of cash paying customers who would fill a script and then turn around and sell it in the parking lot. And that went on for years. Not sure what the FDA should do in that case.

handmodel 5y ago
You are right about the current role. But I think the frustration with the FDA comes from their textbook following of the rules without any apparent concern for trade-offs beyond their immediate purview. Their algorithm for decision making is limited and that leads to uncreative decisions. My personal frustration with them has been their slowness to approve vaccines (and to do common sense things like offer boosters or lower doses for those who want them) because it goes against procedure written years ago for illnesses that are not time-dependent at all.
- refurb 5y ago
  Your frustration is they "follow rules"? I mean their role was created by law and if they overstep it, it gets shut down. For example, the FDA can't say "we're not approving this drug because the price is too high". That's not in their mandate and if they did do it, they'd pretty quickly get sued and forced to approve the drug. And slowness in approving vaccines? The FDA was one of the first globally to approve the Covid vaccines (I think the UK was first). And nothing stops your doctor from giving you a vaccine booster right now. In fact, I believe many people are getting them. The FDA does not dictate how drugs can be used once approved - that's at a doctors discretion.

joshuaheard 5y ago

Two-thirds of opioid overdose deaths come from counterfeit tablets illegally laced with fentanyl. That is not the FDA's purview, but the DEA.

gillytech 5y ago
Where does that statistic come from? As far as I know there were several distributors for OxyContin that were investigated for turning a blind eye to highly suspicious volumes of the medication being funneled into the mid eastern states.
ALittleLight 5y ago
Did these users start their usage with "legit" tablets? Would they be using counterfeit opiods if the real thing weren't so widespread?

rpaddock 5y ago

Please watch the documentary "Pain Warriors" to see what is happening to people with Chronic Pain and the other side of the "Opioid Epidemic". "Pain Warriors" is NOT a warm and fuzzy movie to watch. It is five stories, two being suicides one of which was my late wife. It is also a good example of how today's Medical Establishment fails people. In Karen's case each doctor did what they thought was in her best interests, and I have no issue with any of them. Yet the system as a whole killed her. "Pain Warriors" can be watched for free on Amazon Prime, and TubiTV. It is also on iTunes, Google Play and Veimo for international viewers. We are in the process of applying to get it on Netflix. I receive no remuneration from the documentary. I'm simply trying to raise awareness of obscure conditions like Intracranial Hypotension due to Cerebrospinal Fluid (CSF) Leaks. As well as raise awareness of how broken the Medical Establishment can be if you have an obscure condition.

thehappypm 5y ago
I will watch it. I went through about a 2 year stint when, due to a series of injuries, I was in pain just about constantly. I broke my tailbone, had a stress fracture in my ankle, and suffered a lower back injury at the same time. No posture was painless for me -- lying down was OK, but sitting hurt my tailbone, standing hurt my back, walking hurt my ankles, biking hurt my tailbone. It was a very difficult thing to deal with. I'm better now (still have the back pain) but I understand what it's like to wake up every morning and just be in pain.

vt100 5y ago

The FDA is cracking down on the overdose epidemic for horse dewormer