Where is the scrutiny over FDA’s role in the overdose epidemic? | Hacker News Reader

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

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147 pointscolinprince113 comments

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.

The FDA's biggest (only?) obvious enormous win was with blocking https://en.wikipedia.org/wiki/Thalidomide

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_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-squ...

Off topic but do you have any other interesting recommendations for books you've recently read?

Oh boy, you're gonna release the Kraken here.

Nonfiction that reads like a thriller is my favorite genre.

The last book that truly surprised me for how good it was and had been sitting unread in my queue for a while because the descriptions didn't give it justice was Empty Mansions: Empty Mansions: The Mysterious Life of Huguette Clark and the Spending of a Great American Fortune by Bill Dedman. https://en.wikipedia.org/wiki/Empty_Mansions

It's basically like rise and fall of Sackler family 1.0 in dynastic wealth and all crazy things that happen to the next generations. Her dad was a mining baron who created the US' largest superfund site and bought himself a Montana Senate seat and then it gets more wild from there. Unlike the Sacklers, the daughter who does seem to have arrested development re: emotional maturity- she played with dolls and ordered customized artisanal dollhouses from Japan for 500k and up into her 80s - did have a very kind heart and gave large gifts to her staff, her relatives, friends, even the guy who came in to repair the TV in her hotel room got a $40k tip. At the end there is a giant fight over multiple versions of the will, allegations of elder abuse by both Doctors Hospital in NYC and her nurse, CPA and attorney and pursuit by the IRS for unpaid gift taxes of millions of dollars.

She lived such a long life that you basically get a tour through American history throughout the book because it starts in the Gilded Age and she lives to be 105 years old! Even at the end of the book the main character who seems easy to write off as a batty old rich lady sort of earns your respect because she doesn't let the hospital push her around too much and stands her ground to many predatory family members and other sharks circling for her estate and largess.

There are some tie ins with modern tech wealth as well- a few of the purchasers of her assets including her Stradivarius violin for $2.5 million is one of the original microsoft guys!

Def check out John Carreyrou's book about Theranos, Bad Blood if you haven't already. That's imo the GOAT of this genre.

The Smartest Guys in the Room about the rise and fall of Enron is AWESOME and truly outrageous, as is Nobody would Listen by Harry Markopolos is about the Bernie Maddof ponzi scheme.

Another long read but REALLY GOOD was The Rise and Fall of the Third Reich which has a sloooooow start (there are a few chapters off the bat about philosophy and the origins of various schools of political theory etc) but once the Beer Hall Putsch happens it really takes off. It was written by William Shirer, an American journalist who lived in Germany and stayed through from the end of WW1 through WWII.

Bloodlands: Europe Between Hitler and Stalin by Timothy Snyder was horrific reading and just gruesomely sad but also incredibly well researched and fascinating. I liked it so much I then when on an Ann Applebaum kick of Iron Curtain, Gulag and Red Famine, all of which were very good. If you were going to pick one of hers, I'd do Gulag.

John Kraukauer's Into Thin Air and Under the Banner of Heaven are excellent, as is Crisis in the Red Zone about the origins and spread of ebola in the Sierra Leon.

edit: Oh! Also Midnight in Chernobyl was amazing, especially great if you listen to it before or after watching the HBO show. It's a fantastic read even if you don't watch the show and I think is what kicked off my interest above in life in the Soviet bloc.

Red Notice by Bill Browder details his experience as a global investor during the economic transition and rise of the oligarchs in Russia under Putin and details so much of the corruption and fraud of the current regime. It was written in 2014 after Browder's partner was tortured and murdered and brought about the Magnitsky Act. All the more relevant today with Navalny's recent revelations and very good background for what is happening in Russia now.

Re: tech co books, I'd say STAY AWAY from Chaos Monkeys by Antonio Garcia Martinez - was awful and the author is just totally unlikeable douchebag. He's not particularly insightful and the whole book was poorly written, sparsely edited bloviating.

Dear Leader by Jang Jin-sung about his life as a Pyongyang party elite, defectation and escape from North Korea was fantastic, thrilling and actually read like a real life spy novel. Some of the portions where he gets close to the border and as he survives on the lam in the Chinese border adjacent countryside while being hunted are... heart pounding.

Nothing to Envy by Barbara Demick is also about life in North Korea but focuses less on the party elite and more on the suffering of the general population. Heart-wrenching, horrific, well-researched and depraved.

And the Band Played on by Randy Shilts about the origins and spread of HIV & AIDs is another fantastically written and educational medical themed nonfiction about the development of the AIDS epidemic and the world spread and US and world research responses. Several infuriating portions especially the disinformation campaigns by the blood bank industry and lobbyists once the supply was tainted with the virus.

Ugh... I have so many more, but this should get you started. Have fun and don't forget book reports are due in 5 weeks so get cracking :P

I'd also strongly recommend this book, which had multiple moments of utter disbelief. Keefe was able to obtain inside information from the Sackler family itself and from collaborators and Purdue employees. It's a great read.

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/ 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

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.

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.

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.

That’s not what that comic means.

That's what I find so frustrating about these comics and the general narrative about medical care and procedures.

Anyone who has had to deal with doctors regularly knows how little they should be trusted. There are those who will diagnose any chronic health issue as anxiety, those that prescribe life-destroying drugs for a scratch, those that dismiss patients with serious medical conditions as drug-seeking or "being whiny". That's only worsened by the widespread arrogance in the profession that makes them speak with unwavering confidence about things there is little certainty about. Good patient care can only be achieved when the family is well informed and ready to get involved and push back.

If you go on any disability forum, you'll find hundreds of testimonies to that effect.

There are loads of psychiatrists who will ask you what you want prescribed. I’m not too sure how they are different from drug dealers.

Reading a few articles on the internet doesn't make you well informed though. Certainly not well informed enough to accurately diagnose medical conditions. It's a doomed if you do, doomed if you don't situation.

I think the commenters point was not about people reading articles on the internet and feeling that they've got a better understanding than doctors. It's about medical professionals thinking that they are infallible.

Sure. And I think that that leads to people distrusting doctors, and trusting things they read on the internet.

So despite 12 years of elite education, doctors still prescribe Tylenol, even though current science says it basically does nothing except screw with your liver.

Chiropractic is bunk. Audiology is a tool of price gouging hearing aid cartels. Every doctor that played along with the Sackler playbook directly perpetuated the opioid crisis. Optometrists are a front for cartels of glasses and lens manufacturers.

Much of what is qualified as medicine is exploitative corporate fuckery.

Toxic incentives abound, but god forbid we question the integrity of the system.

There's a lot wrong with the institutional role of "doctor" in the US. Part of it is that there aren't enough of them. Part is that the institution is granted a veneer of authority over things it has no claim to (see: psychology.) Part is corporate pharmaceutical corruption and bad incentives.

There are many situations where self directed research is going to be much better than what you'll get from a brief visit with an overworked, irritated, often arrogant and egotistical doctor without intimate knowledge of your unique medical situation. It's infuriating to get those half-assed "best guess" diagnoses or prescriptions.

I would trust an earnest high schooler with Google over a doctor from, say, 1920, with almost any medical situation except actual surgery, and maybe not then. I trust my own understanding of scientific evidence and research over doctors from 1970 or maybe even later.

How much time is needed by modern, educated doctors to exceed the quality of advice gained by self directed, appropriately conducted research, using the best of what the internet has to offer?

Obviously the doctor's advice will exceed what the patient can accomplish on their own, given sufficient time. Absent sufficient time, a person spending 4 weeks researching online could, and probably frequently does, exceed the domain specific knowledge and assessment by a doctor making a 5 minute "best effort. "

It shouldn't be combative, and doctors should be willing to investigate information brought by patients from legitimate resources. The gap between "civilian" and doctors available information and education is not nearly as great as it once was.

Dismissing the situation as "don't believe what you read on the internet" is a shallow and ignorant stance. We have the sum total of human knowledge available to us via Wikipedia, specialist sites, forums, scihub,arxiv, and so on. Everything, including the good stuff, is online.

People can and do use rational, scientific thinking to engage with that information, and in that situation, the doctor's 12 years of education only means something if they can spend an appropriate amount of time acquiring evidence and information from the patient. There's not enough of them, so unless a situation is serious and demands immediate attention, doctors often won't be able to provide sufficient time to make their expertise relevant.

I don't dispute the problems with medicine you listed, although there are also good doctors out there, if you can find them. And sure, if you spend enough time researching something and can filter the facts from the misinformation on the internet then you might be able to do a better job than a doctor that spends less than an hour. But how much of the general population will put in that effort versus trusting the first thing that comes up in a Google search?

Now if you do your own research, and use that to improve your interaction with your doctor that is good. But replacing medical professionals with google searches can potentially be dangerous, at least for some conditions.

Absolutely, the biggest pitfall with self research is not knowing what set of unknowns you have to fill in the blanks for. The value of education is the deep context in which any particular fact will fit, so it takes a lot of effort to fill in a rational approximation of what a doctor can diagnose. 1 hour of a doctor's time could be worth months of effort on your own.

Someone with MS might have their doctor recommend against being vaccinated. Someone else with MS might be fine, but their two stories could lead people to radically different conclusions, when it's the unique particulars that validate the judgment of the doctors in question.

We need a better culture of scientific discourse in public, allowing for nuanced and depth without the pitfalls of fallacious thinking.

Hyperpartisan and sensational media amplify the feedback loop in ragebait meme propagation. Maybe there's a mathematical tool or theory in graphs or networking that could help identify and shut down the spread of argument and combative discourse - not particular ideas, but particular forms. Seemingly opposite facts and opinions can be true in parallel and it's dangerous to attempt to either validate or censor one side or the other.

The latest crusade on misinformation and "anti vax" views is an example of how spectacularly flawed tools of censorship and rightthink can be.

In my country we often joke about how hard it is to find that one "perfect" doctor - knows what he's doing and knows about his strengths and weaknesses, isnt too arrogant or unwilling to accept his own doubts on the diagnosis, experienced enough yet doesn't charge too much and whatever is prescribed seems to work magically for you.

Once you find someone like that, you're set. Not that one has to blindly follow that person, but it lifts a lot of stress off your head.

Edit: I am not from USA

The harms of antibiotics include an immense reduction in child mortality and morbidity from strep, persistent ear infections, meningitis, tuberculosis, pneumonia, gangrene, and the list goes on.

Yeah and our child had none of those things. When needed, oral antibiotics can be a lifesaver. When overprescribed they are wrecking people's gut biomes and causing all kinds of issues, some of which can persist for a lifetime.

I would agree you made a prudent choice but it does seem like a drop in the bucket as any kind of exposure to modern lifestyle in childhood correlates with similar issues of perturbed microbiome, autoimmune disease, reduced fertility, and metabolic syndrome. Exhaust particulate, herbicides, plasticizers, PCBs, heavy metals, and the like are universal.

Even the background level of 410ppm CO2 which a child can never escape is extremely unnatural.

I'm curious -- OTC antibiotic ointments are easy to get access to and downright obvious to use when there's a skin injury. Did you not try that before going to the doctor?

If I'm the doctor, the risk/reward for me is to overdo antibiotics and make sure to kill infections with them, if the parent has come so far as to come see me. It's risky to say "use an ointment" if there's even a slim chance it doesn't work.

Yes, we had tried those and also prescription mupirocin and none had worked by themselves. We wound up having to lance the infection on her finger daily and treat it with the mupirocin for a couple of weeks. Her whole hand was in a bandage for that time, and some of the doctors were telling us she might lose part of her finger if it wasn't treated.

I'm not sure I follow -- you tried topical antibiotics, it didn't work, you went to the doctor who recommended an oral antibiotic, you ignored that and tried a different topical antibiotic and it worked? What's your point exactly?

Your quarrel is not with the FDA. They approved topical steroids as safe and effective, which was correct. But the FDA generally can't control how physicians use those drugs. If a doctor misdiagnosed your son or prescribed improper treatment then you should file a complaint with your state medical licensing board.

Also, not to victim blame at all, but - any medicine, regardless of whether it's over the counter or not, needs to be discussed with a doctor.

That's why they literally have that label on everything you buy, and warning about using it on your own, either in the short- or long-term, depending on the specific medicine.

Just because people assume it's safe, doesn't mean it's safe, and is nobody's fault but their own for not reading the actual instructions and safety labels.

It's medicine, for Christ's sake, even if relatively benign looking. It has the intent on changing something about your body. Why do people think you can just go to the corner store and take whatever you want without actually thinking about it?

I think it's established that in the opioid crisis, all medication was prescribed by docters, for 2 important reasons:

1) pressure from patients (and sometimes the doctor themselves, too). What is wrong with drugs? I mean, we can all agree that there's a minority in society that doesn't see the problem here. There are plenty of medical people in that minority.

2) pain medication "cures" everything (cheaply!). Can't diagnose what's wrong? Opioids cure it! Not really sure if anything is wrong at all? Opioids make patient happy! Patient scared of treatment? Opioids cure the problem without the treatment! Patient can't pay for real treatment? Opioids cure it!

I'm not clear on what this has to do with the FDA? Would you want the tubes and boxes to have stronger warnings? Other than that it comes down to doctors giving appropriate diagnosis and protocol. There isn't really a scandal in terms of someone cashing out on the overprescription of lowish cost topicals .

I'd like for the FDA to either...

Not allow Hydrocortisone based ointments over the counter, and to include two week addiction warning labels.

Or...

I'd like them to get out of drug regulation at all so people aren't engendered with a false sense of safety and are allowed to make up their own minds without a rent seeking gatekeeper (doctors).

That said, I think, as you suggest, my problems may be more with the medical system and authority in general.

In Australia Topical Steroids are not over the counter. I'm always surprised by how many things I can get over the counter in the US. Here we need a Drs. prescription for pretty much anything stronger than a vitamin or mild painkiller.

Depending on the strength, Yes they are

Which ones?

Derm aid is a widely known trade name available in 0.5% or 1% hydrocort formulations on the shelf of any pharmacy you walk into

They absolutely are. I have some in my cupboard right now, including some quite strong ones (one of which is brand new to being OTC).

Could you name it?

Australia is becoming a nanny state so no big surprise you have to get permission to buy simple skin ointments.

I think it's safe to change "becoming" to "has become", it's no longer in transition.

That is absurd. 1% hydrocortisone sold over the counter is a useful medication for millions of people. The risk and abuse potential is extremely low. It isn't really addictive in the way opioids are. I'm sorry you had a bad experience but that's not a valid reason to change the system.

So, your preferred solution is that they either require a prescription for the specific drug you used (at a doctor's suggestion) that does not currently require a prescription -or- that they allow all drugs without a prescription because doctors cost money and are the worthless except that they can prescribe a drug?

Those seem to be contradictory things. I think you just want the doctor who (apparently) misled you to be punished. Which is reasonable and what malpractice suits are for. The FDA's job isn't to review every prescription written by every doctor.

If the packaging doesn't inform you of side effects from the medication then the doctor prescribing it should. The doctor can also limit refills to prevent overuse.

FYI - There are other side effects from long-term use of steroidal ointments.

I believe you meant to respond to someone else

TSW seems like it's not very well supported by data? I mean if you are treating a rash with a steroid, one shouldn't be surprised it comes back if stop using it?

That said, topical steroids beyond 1% hydrocortisone are powerful drugs that can have long-term side effects (thinning of skin). But on the flip-side, there are often no alternatives.

>TSW seems like it's not very well supported by data?

How would you design an ethical experiment to get said data?

Particularly considering the timespans involved.

Please review the following case study(s).

https://www.medicaljournals.se/acta/download/10.2340/0001555...

In some of the children it took over two years, but every child was left with normal skin or mildly itchy skin in their inner elbows or behind their knees.

Nothing like the dehibilitating steroid withdrawal these children and my son went through.

Your reference are case reports and even has this disclaimer "While TSW was considered the most likely diagnosis in these children, confirmation was not possible partly due to the fact diagnostic criteria for TSW did not exist when they were first assessed, and partly due to the inability to completely exclude all differential diagnoses".

And of course you can ethically confirm this data through a clinical trial. Enroll kids with specific diagnoses, treat half of them with steroids, half without and compare outcomes.

I'm not saying TSW doesn't exist, but the evidence for it doesn't look very conclusive.

I'm happy your son is doing better.

But the FDA isn't your parent, getting diagnoses are hard, and it's up to you and your doctor to decide what treatment is best, not the FDAs.

The FDA is just a big organization that regulates advertising, and what can be prescribed. Every drug has risks, and the only way to ensure the FDA doesn't approve drugs that will hurt people is to make sure they never approve any drugs.

In my 20s, I used to run through the woods fairly often, and a couple of times a year would get careless and get a rash from poison ivy. A topical steroid usually helped.

I'm sorry to hear about your son, though.

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.

Cannabinoids

Do you want to expand on this one word answer? Why do you think cannabinoids are a good substitute for opioids?

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.

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.

That is just simplistic labeling and stereotype. What were these individuals’ childhoods like and what was their outlook on life in general? Do you even know what their inner self was like?

Addiction usually starts from escapism, and the causality that drugs cause addiction is very far from true.

It is simplistic labeling, and I am generalizing from what I've seen. I agree it starts from escapism in many cases. From what I have witnessed it's escaping boredom and/or pain, two things that life has much of. It's a dangerous attitude (obviously).

I'm not arguing your second point, but suggest you consider that some drugs are more difficult to quit and are therefore more addictive than others. I'm arguing that people who have problems with drug addiction will likely add more legal drugs to their stack rather than curb use.

So, do you want to ban private car ownership, because some people are prone to speeding?

Do you also want to ban everything except heterosexual copulation for the sole purpose of procreation because there are sex addicts?

Shall we do away with video games, playing cards, dice and horses because some people have problems controlling their gaming and gambling behaviours?

How about making it illegal to own pets because some people neglect theirs? The same goes for having children.

Are we banning all food except reconstituted, fortified, protein—fat—carbohydrate sludge because some people have eating disorders?

I didn't say anything about bans or making things illegal. I don't mind too much that there are drug addicts, speeders, sex addicts and frivolous games.

I think you're letting emotion blind you since it seems you're not actually reading and understanding what I write.

I was trying to show by several analogies the faulty logic in ”some people have problem with X, therefore X must not be allowed for all people”.

Of course, your mentioning of polydrug use could be just a neutral observation, but why then use it as an argument?

... are not a panacea, and not a replacement for opioids for many, many uses.

I totally agree, but for a while there it was really out of control. In 2007 an oral surgeon gave me an opioid prescription after a tooth extraction! The pain was minor so I never took any but in retrospect that was just crazy. It's easy to see how many people got started on the path to addiction.

> 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.

The other problem is that addicts were either cut off and forced to, or found it substantially cheaper, to move on to street drugs laced with fentanol and poor quality control. Instead of being given sufficient rehab to get over their problem.

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.

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.

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.

https://www.google.com/search?q=spectorsoft+fda&oq=spectorso...

You can volunteer here: www.tinyurl.com/openhealthtech

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.

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.

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.

The FDA is making the rules that the only way to take a vaccine is by their approval. By FDA rules, there is no in-between of being illegal to administer and being recommended (aka no "up to you" zone)

Right now, for instance, they are conducting tests on a couple thousand 11 year olds even though we have data on millions of 12 year olds. Data from the 12 year olds will not be used to determine if it is safe for 11 year olds. If you are a parent of an 11 year old not only is the vaccine not recommended - you are now allowed to get it.

I am saying the FDA should allow more flexibility instead of demanding to be the arbiter of every decision. They want, however, to be the arbiter of every decision because it makes them more integral to the system.

If the FDA prematurely approved a vaccine which was later found to have serious side effects that would destroy public confidence in vaccines for generations. Be patient.

So here's the thing: the FDA has already given full approval to the vaccine. They've approved it. And yet, somehow we're still having this discussion about whether it's ok to give a third dose, after several months, despite good evidence that doing so would often be helpful. We can argue about the data, but a reasonable person, looking at the data, could come to the conclusion that there is good reason to give a third dose of a vaccine the FDA has already approved. So where's the ability of physicians to exercise their expert discretion? Why are we even having this discussion?

Contrast this with the opioid epidemic, where lives and communities were being destroyed wholesale. Why wouldn't it be appropriate for the FDA to step in and temporarily put greater restrictions on the medications? They regulated dispensation of pseudoephedrine and do all sorts of things. Why not do it with opioids? When there's actual serious harm, the FDA shouldn't do anything because the drug has some legitimate uses sometimes, but when there's evidence of very little harm, the FDA should leverage its complete authority to prevent it, despite evidence it might be of public health benefit?

I can give other examples of drugs where in the peer-reviewed literature there are review articles concluding that a medication is completely safe to be offered over-the-counter, but conclude that it shouldn't be so as to not establish a precedent.

The problem is this inconsistency: what real authority -- not legally inherited authority, but actual authority, in the sense of moral authority -- does the FDA have if it bans substances like cannabis, all the while allowing alcohol (which has much more serious consequences), letting an opioid crisis burn like wildfire, and then putting the hammer down on a third dose of a pharmaceutical it has already approved?

Think of it this way: is it any wonder there are so many vaccine skeptics when the FDA behaves as if a third dose of a vaccine it has already approved is so dangerous physicians shouldn't be allowed to use their discretion to prescribe it?

It's no surprise that there's such a crisis of skepticism about expertise in this country. The credentialing associated with the expertise is empty of meaning anymore, and it is constantly overstepping its role.

I'm not sure what you're complaining about. The FDA already authorized a third vaccine booster for immunocompromised people who want it.

https://www.fda.gov/news-events/press-announcements/coronavi...

The FDA never banned cannabis. That was done by Congress and the DEA.

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

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.

Did these users start their usage with "legit" tablets? Would they be using counterfeit opiods if the real thing weren't so widespread?

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

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.

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....

Taken to task for what? Failing to predict the future?

Yeah! We were supposed to get full-self driving by now, the Jetsons promised!

> yet he has never been taken to task and likely never will.

They are not comparable at all. Diagnostics is a life-or-death issue. Any "faking" employed there should automatically lead to a capital sentence for everyone involved. Look at how the Chinese dealt with the milk-powder adulteration scandal of 2008.

> Same thing for the Theranos scandal. Financial regulators have done better for the safety of the patients than the FDA!

I have no idea why you think that. The FDA looked into Theranos in 2014-2015 and by 2015 had shut down everything but their herpes test. In 2012, when they started signing deals, Theranos was still claiming they were only performing research and development, so the FDA wouldn't get involved then. If a big company wants to invest in your startup with promises of future delivery of healthcare, how is that the FDA's responsibility?

They have been "looking" since 2012 - and between 2012 and 2015 did - in effect - nothing else than looking. They did not shut down anything - Theranos pulled back when the FDA requested a change of classification from I to II. When you have the auditing power of the FDA, you should have the ability to do better than request a "change of classification" in 3 years when you have so much evidence of fraud.

https://www.washingtonpost.com/news/wonk/wp/2015/12/02/inter...

For the other point - the FDA has oversight into R&D when human are concerned - even if the requirements are not the same than for market clearance.

And what about the DEA?

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 [0]: https://oig.justice.gov/reports/2019/e1905.pdf

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.

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

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.

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

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

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.

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?

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...

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.

> 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...

Rogan was sick for 3 days and said that one of those days was really rough. Is that better than average for somebody who was vaccinated (as Rogan was) and took a giant cocktail of things, including monoclonal antibodies, which are proven to combat COVID?

As an aside, "whom" is incorrect there.

> "whom" is incorrect there.

I was describing what I was saying, and thus Rogan was not the subject of the sentence.

I'm all for pedantry though, so please do elucidate. :)

It's not the subject of the sentence, but "who" is a pronoun in nominative case because it is the subject of the appositive phrase. You wouldn't say "him also recovered", but "he also recovered" in any case. You use "whom" where "him" would make more sense and "who" where "he" would make more sense.

It's very pedantic, because it's the subject of a pronounal phrase which is itself an object in the sentence. Personally, I'm not a fan of "whom" in general. It's not technically necessary, can always be replaced with "who" in modern English, and I see it used incorrectly almost as often as correctly.

This sort of thing is easier for German speakers, who have to inflect all pronouns correctly for every part of speech. English speakers largely get who wrong because there are very few words in the language that make you have to keep track of more than primary subject and object. It's not their fault, really, it's just an archaic construct of English from when the language was more modal.

Thank you! I actually really do appreciate this. I'll review further.

I think people should outsource their thinking to those tasked with the job:

https://www.fda.gov/consumers/consumer-updates/why-you-shoul...

https://www.ema.europa.eu/en/news/ema-advises-against-use-iv...

Summary: Don't take ivermectine, no evidence it helps against Covid-19.

There is at least some limited evidence that ivermectin helps against COVID-19.

https://www.mdpi.com/1999-4915/13/6/989

That's why the NIH is sponsoring a large scale clinical trial. That should give us more reliable evidence one way or the other.

https://www.nih.gov/research-training/medical-research-initi...

There is conflicting low-quality evidence:

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD...

Until we get back the results from larger and better studies, people shouldn't say Ivermectin works.

> I think people should outsource their thinking to those tasked with the job ... Summary: Don't take ivermectine, no evidence it helps against Covid-19.

The Lancet: Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial https://www.thelancet.com/journals/eclinm/article/PIIS2589-5...

The Journal of Antibiotics: The mechanisms of action of Ivermectin against SARS-CoV-2: An evidence-based clinical review article https://www.nature.com/articles/s41429-021-00430-5

Mainichi: Dr. Satoshi Omura, Nobel Prize scholar: "Vaccines for prevention, ivermectin for treatment" https://weekly-economist.mainichi.jp/articles/20210712/se1/0...

New Microbes and New Infections: Ivermectin: a multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8383101/

WSJ: Why Is the FDA Attacking a Safe, Effective Drug? https://www.wsj.com/articles/fda-ivermectin-covid-19-coronav...

Sorry, but that is low quality evidence. The conclusion of the current evidence is inconclusive and mixed. Don't self-medicate.

And what's with the harping about the nobel price? How does this matter?

> I think people should outsource their thinking to those tasked with the job

A few decades ago most Americans would've said that was the Pope.

I'm with you on this. It's controversial to say, but logically obvious.

But there are facts on the ground. Hundreds of millions of people worldwide have been vaccinated.

And there are no widespread health concerns apart from a rare bloodclotting issue with Johnson & Johnson/AstraZeneca. None of which come close to the the complications and deaths that COVID has caused.

So clearly the government has been successful in this case.

There have been numerous concerns, it is just the people sharing their reactions are not taken seriously and demonized and lumped into an anti-vaccine group for even speaking up.

This is part of the systemic issues I'm referring to. Also, they usually only look at reactions for about 15 minutes after receiving the vaccine. Any reaction after that is assumed to be unrelated.

I'd also like to point out that numerous deaths that have been attributed to COVID-19 which apparently were not due to COVID. This is just one of many similar stories:

https://www.king5.com/article/news/health/coronavirus/washin...

From the story:

> Previously a COVID-19 death was counted if the coronavirus test came back positive.

> Four of those deaths were in King County and three were from Yakima. They included two suicides, three homicides and two overdose deaths, according to DOH.

I like how you mention that there’s numerous concerns of reactions yet link not a single one and then list a lot of unrelated points.

Weird pivot to an unrelated point, but I find it kind of funny that this article is essentially saying the opposite of what you're implying. They noticed these deaths weren't actually from the virus, so they fixed the data. All 7 data points out of however many thousand.

> So clearly the government has been successful in this case.

It's hard to tell when side-effect reporting is suppressed.

Currently OSHA is banned from reporting on vaccine side-effects. That means the government wants no accountability, despite promoting employer mandates.

OSHA is also advising employers not to record side-effect data:

https://www.laborandemploymentlawcounsel.com/2021/04/osha-ad...

This has nothing to do with hierarchical government systems (whatever that is and in contrast to what else), but all about corruption and fraud by corporations.

Most corporations just as most humans are driven by their ethics and internal processes to act inside the law. And it isn't easy to abuse/subvert the FDA's approval and monitoring processes as anyone can attest that ever received a FDA warning letter.

The ability of a government agency to withstand attempts of corruption in mind hinges more on the societies attitude towards corruption than the structure of the government organization.

It’s wild that anti-vax sentiment isn’t outlawed or penalized given that it’s getting pretty close to murder territory

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-hait...

Follow the money.

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