12 ms·

A Woman Who Stood Between America and a Generation of ‘Thalidomide Babies’

156 points by dcminter 6y ago

hprotagonist 6y ago
This explains about everything you need to know about the ethos of the FDA. It’s baked in at a really foundational level. As a biomedical person, i find the FDAs policies and procedures eminently sensible, perhaps especially when they chafe, and this is why. I do not envy them their jobs even the littlest bit, but I’m glad they’re around.
- k__ 6y ago
  How come, the US has an opiate crisis?
  - formerly_proven 6y ago
    A while ago I posed a similar question and the answers/downvotes made it clear to me why; Americans have a broken model of pain management. Americans think that opiates are necessary to manage the pain from most surgeries, back pain, headaches etc., so, they get opiates to do that, with the obvious and foreseeable catastrophic consequences.
    - zdragnar 6y ago
      A friend of mine was very briefly hooked. He had pretty serious leg surgery after an accident at an air force base, and the Veterans Affairs doctor basically wrote him out a prescription for a massive quantity of pills with the instructions to take as needed. So, naturally, he sat around with nothing to do during recovery but to play video games, drink beer and pop pills. Pain management is definitely not taken seriously enough by some doctors, and too many people are too trusting that their overworked doctors and nurses know better. Both myself and my wife also have chronic pain from past injuries (back pain mostly, plus some arthritis for me) but we manage with stretching, liberal amounts of tiger balm, and the occasional ibuprofin.
      - xxpor 6y ago
        I had relatively routine surgery last year that affected my kidneys. It took a few days to recover, and after a few days I wasn't getting any better so they sent me to the ER. I had Percocet that they prescribed me after the surgery, but the ER doctor wrote me a prescription for straight oxycodone because he was concerned that the acetaminophen in Percocet is sufficiently damaging to the kidneys that I really shouldn't be taking them. I have to be honest, I was really hesitant to fill that prescription. I did after a few hours when the pain got unbearable (at 1 in the morning, they filled it in 5 minutes which also makes me worried that pharmacy would be an easy robbery target...), and damn they did work quite well. I only needed them for 2 days, and I didn't get the sense of being high that I expected, and had no issues stopping them. I can't say I didn't wonder what would have happened if I needed them for a week or more, or if I had previously been addicted to opiates. It just seems hard to believe in modern times there's nothing in between NSAIDs/Tylenol and full on opioids for managing pain, especially for this sort of post-op temporary use case.
        freeone3000 6y ago
        Ibuprofen was already a huge step up from Paracematol, which is another step up from Aspirin. The fact that ibuprofen is also much better tolerated, has fewer side effects, and has to be dosed less often means you're taking the best non-opioid painkiller we know of as your first-line option.
        jorvi 6y ago
        > The fact that ibuprofen is also much better tolerated, has fewer side effects I'd much rather have the slight load on the liver that paracetemol has than the issues with the stomach that NSAIDs bring.
        freeone3000 6y ago
        Well, lucky for you, both (in fact, all three) are still available. But, as a statistical matter, Ibuprofen is safer. Not only because the liver is such a contentious point for drug elimination, including alcohol, but due to the ability to fix overdoses. Even with minor overdoses (such as mixing with alcohol), paracematol causes permanent liver damage, whereas stomach ulcers can be repaired. More than 100,000 people die annually from Paracematol overdoses. Ibuprofen is sold more, and has fewer than 16,000 deaths.
    - dbcurtis 6y ago
      There is a great Freakonomics podcast on the opiate crisis. If you want to get some food for thought about the American approach to pain management, how it is done elsewhere, and some background on the opiate crisis. (Looks like episodes 402 and 403, from a quick search.)
  - every 6y ago
    Regulatory capture can be a significant factor: https://en.wikipedia.org/wiki/Regulatory_capture https://en.wikipedia.org/wiki/Regulatory_capture
  - meekrohprocess 6y ago
    Many American regulatory institutions have crumbled in the past few decades, the FAA being a particularly jarring example. In some cases it seems like peoples' trust in those regulators may be fueled by nostalgia, but the FDA does seem like one of the few agencies that has retained some measure of independence. Looking at what has happened in this nation's other industries and institutions, only one crippling decades-long medical crisis doesn't seem all that bad.
    - bordercases 6y ago
      That's not an explanation for why the FDA has failed to address the regulatory aspects of the opioid crisis, but an argument for why we should discount or ignore that failure. At the very least – this is a non sequitur.
      - meekrohprocess 6y ago
        I disagree. Regulatory capture is a clear and present danger to the United States, and it is contributing to a breakdown in accountability across all sectors of the nation's economy and society. So I offered it as an explanation for why the FDA could be well-respected and reasonably functional, while the United States fails to address some acute public health issues. Things could be much worse; at least they don't turn a blind eye when huge sums of money are not involved. It's still very rare for a drug's approval to be pushed through via fraud, and there are a lot of diseases that need treating. They have a solid track record, even now.
    - Clewza313 6y ago
      There hasn't been a fatal crash of a US commercial airliner since 2009. Even for the 737 Max debacle Boeing deserves at least as much blame the FAA.
      - sofixa 6y ago
        The FAA are the ones responsible for stopping shit like the 737Max fiasco. Yes, Boeing did it, and many people there deserve to go to prison, but the FAA is supposed to be the guardrail ensuring they can't get away with it in the first place. It was an objective failure, and it has eroded the trust in them - point in case, most other aviation regulators did their own checks on the 737 Max before allowing it back to service, which usually doesn't happen ( EASA trusts FAA's ratings and vice versa).
  - xxpor 6y ago
    That's sort of a different situation. Thalidomide did what it was supposed to, but ended up having horrible unknown (at the time) side effects. The FDA correctly didn't approve it based on the lack of safety data. Opiates also do what they're supposed to, but the fact that they're addictive wasn't a mystery. They're safe if taken and prescribed as instructed. The failure is more on the DEA and other enforcement bodies for not dealing with the obvious prescription abuse. The FDA doesn't make controlled substance decisions.
    - maxerickson 6y ago
      There's lots of controversy about opiates being excessively addictive even when used 'on label'. I didn't find it with a bit of searching, but I remember an article about the 'extended release' aspect of Oxycontin tending to encourage addictive use patterns (because it didn't really work for 6 hours). Figuring that out wouldn't necessarily be an up front trial kind of thing though.
    - hilbert42 6y ago
      "The FDA doesn't make controlled substance decisions." It never spoke out either. Like Pontius Pilate, it washed its hands of the matter.
  - Scoundreller 6y ago
    The FDA only protects you against novel drugs. Once something is approved for something (or grandfathered!), it’s a free-for-all for prescribing and usually insurance coverage.
  - mhh__ 6y ago
    The FDA doesn't do that kind of regulation if I have read up on it correctly. That and opiates do what they say on the tin - it's more of a policy problem than a specific thing you can just FDA-away.
  - freeflight 6y ago
    That has way more to do with ease of access, due to over-prescription practices resulting from pharma lobbying, than FDA med approval.
  - rscho 6y ago
    The US opiate crisis has its roots deep in US healthcare culture and the blame lies on both sides of the doctor-patient fence. US docs used to prescribe opiates like candies, but US patients expect to feel no pain at all and are extremely aggressive legally speaking. Those two aspects go hand in hand. My 2c.
  - hilbert42 6y ago
    Exactly, the FDA was not only completely incompetent but indirectly responsible for the deaths of thousands. It should have pounced on Purdue at the very outset. Unlike much medical/drug research, knowledge about opioids and opioid addiction is well known. The FDA irresponsibly failed to act on a no-brainer.
- orangecat 6y ago
  On the other hand, it's likely that thousands of people will die due to the delay in approving the AstraZeneca vaccine. There are always tradeoffs, and it's not at all clear that the FDA is operating at the optimal level of caution.
- ghaff 6y ago
  It's also very easy, especially at the moment and with the benefit of hindsight, for people to be going that the FDA last March should have said "F it. Go out with whatever vaccines you think will work and see how it goes." Which is what a fair number of people believe (at least other than those who still feel testing was rushed).
  - Aerroon 6y ago
    My thinking on this was the exact opposite. Emergencies like this are precisely when you need these types of agencies the most, because you're talking about treatments that will be taken by a huge amount of people in a short timespan. Negative effects from treatment could end up as a catastrophe on their own. It's more important than ever to get it right.
    - Gibbon1 6y ago
      Also when I tried seeing what people that actually develop vaccines had to say. It sounded like crash programs to produce a vaccine would take a year before there was enough capacity to mass vaccinate people. And then six months to vaccinate everyone. The required trials didn't slow anything down because they were done in parallel. Also, some of the vaccines they developed for covid didn't work. A year ago people were somewhat dubious about mRNA vaccines because they'd never been tried before. And then previous vaccines attempts have also resulted in vaccines that make the infection worse. Or caused dangerous side effects. I don't think with vaccines there is this 'one neat trick' that professionals have overlooked somehow.
      - ghaff 6y ago
        And even six months into parallel speculative manufacturing and multiple vaccines approved or on track to be approved for emergency use, the US--in spite of vaccinating at one of the highest rates in the world--still needs to up its rate considerably to hit 50% of the population over the summer sometime. The idea that if the FDA had only washed its hands of the whole approval procedure thing in March, things would be fine now is just a complete fantasy.
- foobiekr 6y ago
  Well.. Thalidomide - in pregnancy - was replacing diethylstilbestrol, which was still in use in the US until 1971.
  - rscho 6y ago
    Yes, but cancer is much less spectacular than missing limbs. Especially when it occurs years later in the next generation.
  - refurb 6y ago
    No. Those two drugs were used for different things.
- ggreer 6y ago
  In total, Thalidomide caused around 2,000 deaths and 10,000 birth defects. Compare that to the 100,000 people that the FDA killed by not approving a single beta blocker sooner. The FDA waited until 1981 to let doctors prescribe Timolol to prevent heart attacks. Stunningly, the FDA bragged that approving Timolol would save up to 17,000 lives a year.[1] That same drug had been in use in Europe since the mid-70s, meaning that the FDA tacitly admitted to killing 100,000 people by forbidding its use in the US. Even the original beta blocker (propranolol) wasn't allowed to be used for angina or hypertension until 1978, 13 years after it had been approved in Europe. That delay likely killed more than 100,000 people. The FDA is also the reason why epi-pens are so expensive[2], why Martin Shkreli was able to jack up the price of Daraprim[3], why many drugs suffer from shortages[4], and why home testing for covid was delayed for so long[5]. And don't forget that covid community spread was discovered in February of 2020 only because researchers risked jail time by violating the FDA's prohibition on testing.[6] Yes, the FDA lets leaders avoid an occasional political snafu. But the organization kills far more people than it saves. 1. https://www.washingtonpost.com/archive/politics/1981/11/26/drug-approved-to-fight-second-heart-attacks/02938b37-8e6c-4ded-aa2c-ebef953ad1d6/ https://www.washingtonpost.com/archive/politics/1981/11/26/d... 2. https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-drugs-vs-chairs/ https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-d... 3. https://slatestarcodex.com/2015/09/24/the-problems-with-generic-medications-go-deeper-than-one-company/ https://slatestarcodex.com/2015/09/24/the-problems-with-gene... 4. https://slatestarcodex.com/2019/04/30/buspirone-shortage-in-healthcaristan-ssr/ https://slatestarcodex.com/2019/04/30/buspirone-shortage-in-... 5. https://www.nytimes.com/2020/05/15/us/coronavirus-testing-seattle-bill-gates.html https://www.nytimes.com/2020/05/15/us/coronavirus-testing-se... 6. https://www.nytimes.com/2020/03/10/us/coronavirus-testing-delays.html https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...
  - hprotagonist 6y ago
    So, defensive language aside, I think that the FDA has a point in its white paper. The reason we don’t have cures for a lot of diseases is not so much that pesky regulations keep great drugs from getting to the market. It’s that we don’t know enough – yep, even in 2015 – to make so many great drugs. https://blogs.sciencemag.org/pipeline/archives/2015/08/07/on-the-fda-drug-approvals-and-not-knowing-enough https://blogs.sciencemag.org/pipeline/archives/2015/08/07/on... Now, when I mentioned that we’d surely have killed off more people by doing drug research by the more direct routes, the reply is that we’ve been killing people off by moving too slowly as well. That’s a valid argument. But under the current system, we choose to have people die passively, through mechanisms of disease that are already operating, while under the full-speed-ahead approaches, we might lower that number by instead killing off some others in a more active manner. It’s typically human of us to choose the former strategy. The big questions are how many people would die in each category as we moved up and down the range between the two extremes, and what level of each casualty count we’d find “acceptable”. So while it’s not crazy to say that we should be less risk-averse, I think it is silly to say that the FDA is the only (or even main) thing holding us back. I think that this has a tendency to bring on both unnecessary anger directed at the agency, and raise unfulfillable hopes in regards to what the industry can do in the near term. Neither of those seem useful to me. https://blogs.sciencemag.org/pipeline/archives/2013/08/19/is_the_fda_the_problem https://blogs.sciencemag.org/pipeline/archives/2013/08/19/is... The replies to my comment here nicely delimit the cleft stick the FDA is in. You are on the "oh, god, just let them try it already! the FDA are stick in the mud beancounters just holding everyone back" side. A few others are on the "But this one time, they didn't pull Vioxx fast enough, and look at what it got us!!" side. For myself, I'm glad that 1. i don't have to walk that tightrope and 2. there are enough people to make an institution old enough to have memory that _do_ walk that tightrope. But i'm pretty sure that sanity is somewhere in the middle, case by case, agonizingly slow clinical trial by agonizingly slow clinical trial.
- refurb 6y ago
  As someone who works in the healthcare industry I agree. I think the FDA does a very good job all things considered. They have approved drugs that were desperately needed (Avastin for breast cancer) based on little evidence, only to later pull them when the data didn’t support approval. They appropriately balance risk versus benefit. And there is more at stake than most people realize. Approve a vaccine that isn’t safe and people will lose trust in general and will refuse any vaccine. Then what? Lots of Monday morning armchair drug regulators in this thread.
- mchusma 6y ago
  I think your position, and that of the FDA is based on emotion, and not any logical reasoning. The Thalidomide crisis cased a few thousand issues. The risk-benefit analysis clearly favored lifting the ban on COVID vaccines after successful phase 1 trials, in June 2020 or so. They decided they should be banned until further study, during a pandemic. The FDA was empowered explicitly by congress to take more aggressive action during such a time. They opted instead to ignore that mandate, and instead run things like normal, albeit with taking reasonable time to respond to a crisis. The deaths of 100,000 to 400,000 could be directly blamed on the simple fact that for most of this crisis, we had not 1 but approximately 8 vaccines that were all expected to be safe and work, and all turned out to be safe and to work. Vaccines candidates are not like Thalidomide, period. It's important for citizens to publically shame the FDA for their actions, and demand change from our elected officials.
  - mattkrause 6y ago
    It’s simply not true that all of the candidate vaccines worked. - The Sanofi-GSK one produced meh immune responses in the elderly, which is the population most at risk. (https://www.cbc.ca/news/health/sanofi-gsk-vaccine-covid19-trial-1.5837249 https://www.cbc.ca/news/health/sanofi-gsk-vaccine-covid19-tr...) - Merck/MSD abandoned TWO candidates, V590 and V591. https://www.merck.com/news/merck-discontinues-development-of-sars-cov-2-covid-19-vaccine-candidates-continues-development-of-two-investigational-therapeutic-candidates/ https://www.merck.com/news/merck-discontinues-development-of... - CSL/Queensland abandoned theirs because it interfered with HIV tests. https://www.csl.com/news/2020/20201211-update-on-the-university-of-queensland-covid-19-vaccine https://www.csl.com/news/2020/20201211-update-on-the-univers...
- hilbert42 6y ago
  "...i find the FDAs policies and procedures eminently sensible..." Damn shame the FDA was asleep at the wheel during the opioid epidemic! (It's a shame you've not bothered to justify that statement in the light of overwhelming evidence to the contrary.) The FDA did SFA to stop Purdue Pharma selling—sorry—pushing boxes of OxyContin to all and sundry as if they were kids lollipops despite the fact that it would have been aware of over a hundred or more years of solid medical evidence of the dangers of narcotics and narcotic addiction. The fact that any opioid narcotic that's capable of killing pain is addictive—and if not very carefully managed—very addictive is 101 medical/pharmacy knowledge. Even kids know the fact! Armed with this knowledge the FDA knew what Purdue was doing was completely unacceptable, so why didn't it act? https://www.theguardian.com/us-news/2019/jan/24/fda-opioids-big-pharma-prescriptions https://www.theguardian.com/us-news/2019/jan/24/fda-opioids-... The FDA still has a lot to answer for its negligence over the Purdue/Opioid crisis. Its ethics are nothing like they were in Frances Kelsey's day. — Later edit: Let me add Frances Kelsey was a true hero, she saved many kids from developing terrible deformities! Despite current criticism of the FDA by many including myself, we should never forget her contribution to medicine.
  - thereare5lights 6y ago
    Racism played a part in this too > If a doctor subscribes to stereotypes of what an addict looks like — nonwhite, from a low-income community — the physician may assume their white, middle-class patients are immune to addiction, he says. https://www.wbur.org/hereandnow/2020/01/03/bias-opioid-prescribing-black-americans https://www.wbur.org/hereandnow/2020/01/03/bias-opioid-presc...
    - hilbert42 6y ago
      Yeah, I'm not a bit surprised, but in my view there's an even deer systemic reason and we need to fix it. The overriding issue is that medicos, pharmacists and opioid drug manufacturers should know the dangers of opioids like the back of their hand. I'd even argue that such knowledge is almost a priori in the sense that the vast majority of medical professionals would have already known the essential details before they'd even entered training from the fact that it's common knowledge that opioids are very addictive and dangerous if not managed with considerable care. As I see it, just about everyone knows the multiple reasons behind the decades-old war on drugs by just about every government anywhere on the planet. Even if the way this war was and is still being conducted is ineffective and counterproductive (which, incidentally, is my view), one would have had to have been Sleeping Beauty and have slept though the past 100 years not to know that narcotic opioids, heroin, morphine, etc. along with stimulants, cocaine, methamphetamine, etc. are at the center of this war. (When I was a kid, drugs were never an issue as fortunately we kids never came across any—not even pot! That's to say, with respect to knowledge about drugs, we kids were about as naïve as it gets, nevertheless, even as a nine or ten year old, I'd heard of heroin and morphine and was very well aware of their dangers!) What I am saying is that the relationship between opioids and addiction is so well known—and that these facts are so central to medical and pharmacy training—that it's impossible for professionals not to know about such matters. Thus, the fact that everyone wasn't immediately up in arms and pointing to the problem and demanding that something be done about the problem is very strange indeed. I'd go so far as to say that it's a sociological phenomenon worthy of research. It's not just a matter of penalizing and disciplining the perpetrators but getting to the core of why it actually happened given that basic training, existing laws, dispensing protocols, FDA rules, FDA experience etc. any one of which should have been able to prevent the crisis but didn't.) (In my opinion, the opioid crisis has a similar ring it to what happened at Boeing with the 737 Max where once the notion critical systems engineering and attention to safety details was paramount and inculcated deep within every level of the organization and its work culture but which in recent times vanished. Clearly, we have to get to the heart of the problem and understand it before we can rectify it.)
- roenxi 6y ago
  From a "well what did you expect" perspective - delaying drugs and asking for more safety data is occasionally going to result in scary drugs getting caught and kept off the market. The problem is the flip side - when wonder drugs are delayed causing unnecessary pain and suffering - generates no human interest stories. The damage of increasing cost of drugs and delaying the rate of improvement because of delays in the approval process is also an unknown. The FDA is a process - every time something goes wrong, bureaucrats take heat and then tighten the standards. This process is going to be more conservative about approving drugs than is rational.
- marton78 6y ago
  As a European who had to deal with getting a medical devices approved both in the EU and in the US: mad respect for the FDA. There is lots of paperwork required on both sides, but the difference is who accompanies the project. In the EU it's bureaucracts with zero domain knowledge, in the US it's domain experts who asked the right questions and were strict, but also genuinely helpful.
- CryptoPunk 6y ago
  These are problems that would have been solved without the preemptive FDA ban on unapproved drugs. Society, as usual, over-reacted, and created a set of highly restrictive rules that have cost probably millions of lives over the subsequent decades. A much more sensible law in the aftermath of the drug scandals of the 1930s and 40s, that would have run a much much lower risk of having a myriad negative consequences, would have been a requirement to include on any drug, a disclosure of whether it is approved by the FDA. Non-approved drugs could have been required to include a warning that the FDA recommends a person not take the drug as it has not been verified to be effective or safe. This provides most of the benefits of the FDA's role as gatekeeper, without most of the harm done by heavily restricting a market and making it totally dependent on a single central authority. Providing consumers with the ability to ignore the warnings of the FDA would have acted as a lifeline/failsafe in cases where the FDA erred.
ficklepickle 6y ago
While this is great and all, the comments indicate that tons of doses circulated the USA as samples. There are two people in the comments claiming to be survivors from these samples. If this is true, then the article is incorrect. It appears that Americans were just denied compensation because the drug wasn't approved. I'm sure the harm would have been much greater had the FDA approved the medication. But it seems unfair to say they were no victims in the USA.
- xiphias2 6y ago
  The article reports that there were victims. Are we reading the same article?
  - potiuper 6y ago
    The title of the page implies there were no victims; there was "A Generation of 'Thalidomide Babies'" in the U.S. even though greatly limited.
- dcminter 6y ago
  The article itself states that samples were distributed and that "In the U.S., 17 cases of congenital deformities were reported"
LatteLazy 6y ago
From the Wikipedia article: >At the time of the drug's development, scientists did not believe any drug taken by a pregnant woman could pass across the placental barrier and harm the developing fetus https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide Wtf?
- rscho 6y ago
  Medicine used to be, and in substantial part still is, a disordered heap of hypotheses relying on practical experience and relayed by the stars of the field. There are plenty of strange examples throughout history. For example, we used to believe until not so long ago that infants couldn't feel pain (with all the 'interesting' consequences on practice you can imagine).
  - myself248 6y ago
    I'm less than convinced that anyone sincerely believed that. It seems more plausible that it's a lie they told themselves to paper over other cultural, profit, or institutional pressure.
    - rscho 6y ago
      Of course people believed strange things! As I said, the field is far from being hard science even today (am MD myself). What do you think "expert opinion" actually means? Well, just that... and the literature is full of such opinions driving many important guidelines for practice in the real world. As recently as 1999, it was commonly stated that babies could not feel pain until they were a year old.[0] [0] https://en.wikipedia.org/wiki/Pain_in_babies#%3A%7E%3Atext%3DAs_recently_as_1999%2C_it%2Ccertain_age_can_experience_pain.?wprov=sfla1 https://en.wikipedia.org/wiki/Pain_in_babies#%3A%7E%3Atext%3...
- burlesona 6y ago
  I mean, people think all kinds of things that seem plausible at the time and look crazy in hindsight to future generations. This is what progress looks like.
chosen1111 6y ago
I wonder what names she was called at the time for her refusal to go along with the established research from the pharmaceutical and medical community
tomcam 6y ago
Thalidomide babies were my age and not unknown where I grew up. Limb deformities differed: sometimes they had flipper-like appendages, sometimes shortened limbs. (FWIW while cruelty was extremely common back then I never saw a single case of anyone handicapped being made fun of. Nor did I ever witness any racist behavior in my racially integrated neighborhood.) There was a locally famous dude at the public pool who was kind of the coolest guy around. His legs stopped at knee length and he would pull himself up the high dive ladder, walk on his hands to the end of the diving board, and casually launch himself off the end perfectly every time. It was spectacular.
WalterBright 6y ago
On the other hand, there are costs with delaying approval. This is pretty obvious with the Covid vaccines, probably at least 200,000 on the dead side of the ledger. Another cost that's harder to quantify is the cost in lives and misery of drugs never developed because it's for an uncommon and there's no way to make back the money needed to pay for FDA approval.
- ip26 6y ago
  There are like 50+ COVID vaccines in development. Which one do you administer? Forget about side effects, half of them are probably duds! Can we afford to administer billions of vaccines that don’t even work?
  - WalterBright 6y ago
    With the agonizingly slow rollout of the current vaccine, we wouldn't be administering billions of vaccines without soon finding out if it is efficacious or not. > Can we afford Evidently we can afford to spend several trillion dollars and hundreds of thousands of deaths waiting 6 months for the vaccine trials.
  - JoshuaDavid 6y ago
    Yes? 10 billion vaccine doses that cost $100 each would be a trillion dollars. Which is somewhere between 7% and 25% of the total cost of COVID-19 to the US. The real question is whether we can afford to use our non-emergency drug approval process in a time of crisis. This time the answer is probably "yes, and it probably only cost a few tens of thousands of lives and a few trillion dollars" but if the disease in question had been Ebola instead of COVID I worry that we would have seen the same ineffective response that optimizes for minimizing liability instead of maximizing effectiveness.
    - ip26 6y ago
      The problem is not administering one vaccine. If you were pretty sure which one to use you could take a gamble- which is exactly what we have done with early auth of the Moderna and Pfizer! But If you don’t yet know which ones actually work yet, do you give everyone ten different experimental vaccines in one shot?
dcolkitt 6y ago
Let's be very clear. Covid is currently killing more Americans every three days than the total number of global birth defects attributed to Thalidomide over its entire life. The FDA refuses to approve AstraZeneca, despite the fact that it's approved in the UK, and doing so would prevent hundreds of thousands of American Covid deaths. The only answer the naysayers can give is to sputter and point at Thalidomide. So, I want all of us to be crystal clear. If they're wrong about AstraZeneca, then the type II errors of the FDA will cancel out the Thalidomide type I errors by three orders of magnitude. And hereby, no intellectual honest person should ever bring up Thalidomide again, unless explicitly qualifying the much large type II failure of not approving AstraZeneca. If you believe that AstraZeneca is the next Thalidomide, I want you to bet money on it. If you're willing to bet other people's lives, then you should be willing to bet your own money. I will accept any bet, up to $10,000, that the number of deaths attributable to AstraZeneca over the next two years will not exceed ten thousand deaths globally. (Far less than the number of Americans immediate approval would save). If you're not willing to bet money than AstraZeneca is the next Thalidomide, then stop insisting that the FDA let hundreds of thousands die by implicitly treating it that way.
- ianlevesque 6y ago
  We already have two other vaccines approved and being manufactured in large quantities. It’s not a zero to one situation.
- deleted 6y ago
  [deleted]
- tzs 6y ago
  > The FDA refuses to approve AstraZeneca. AstraZeneca has not applied to the FDA for an emergency use authorization. They are expected to apply soon.
  - streptomycin 6y ago
    That's because the FDA basically told them it would be rejected unless they spent months collecting more data. Similar situation with the Novavax vaccine, which seems to have even better results than the AstraZeneca one.
xyzelement 6y ago
I love stories of people thoughtfully doing their jobs and having huge life saving impact like this. I was saying to my wife on a recent drive, that there's some civil engineer somewhere who figured out you can embed those little light reflectors into highway lane markets, and some other engineer who figured out those perpendicular cuts in the asphalt that vibrate your car before you run off the road. Both of these probably naturally arose in the context of their work, and both of these things passively save hundreds of lives daily.
- Stratoscope 6y ago
  For the curious: https://en.wikipedia.org/wiki/Botts%27_dots https://en.wikipedia.org/wiki/Botts%27_dots (named after Elbert Dysart Botts) https://en.wikipedia.org/wiki/Raised_pavement_marker https://en.wikipedia.org/wiki/Raised_pavement_marker https://en.wikipedia.org/wiki/Rumble_strip https://en.wikipedia.org/wiki/Rumble_strip
- dingsbumps 6y ago
  I recently listened to an interesting episode about those reflectors on the 99 Percent Invisible podcast. This [1] is an associated article on their site that seems to have similar content to the episode I listened to. [1] https://99percentinvisible.org/article/decoding-cats-eyes-global-color-guide-reflective-road-markers/ https://99percentinvisible.org/article/decoding-cats-eyes-gl...
chefkoch 6y ago
And now Thalidomide is used in treating cancer and sold for over $200 a pill. Quite a nice markup for telling the patients not to get pregnant while on treatment.
- madaxe_again 6y ago
  Only one enantiomer caused birth defects - and a defect in the original manufacturing process created L- as well as D- chiral species. Pretty sure it no longer contains the problem enantiomer.
  - Metacelsus 6y ago
    The enantiomers can interconvert (racemize) within the body, so it's not that simple.
- eterm 6y ago
  It needn't cost that much, the UK's NHS is charged around $15/pill if I'm reading this right: https://bnf.nice.org.uk/medicinal-forms/thalidomide.html https://bnf.nice.org.uk/medicinal-forms/thalidomide.html Also worth noting that "Don't get pregnant" also extends to "don't get anyone else pregnant" since the side effects can pass from men to women too.
nojvek 6y ago
Also reminds me how people were blaming for FDA for vaccine delays including President Trump. It’s not a vaccine, until it’s proven safe. While FDA isn’t perfect they have stringent procedures to prove something is safe. The way FAA let Boeing ship planes that killed people, and lost their trust, same applies to FDA. If people die and have irreversible damage, it’s on their hands.

156 points by dcminter 6y ago

This explains about everything you need to know about the ethos of the FDA. It’s baked in at a really foundational level. As a biomedical person, i find the FDAs policies and procedures eminently sensible, perhaps especially when they chafe, and this is why. I do not envy them their jobs even the littlest bit, but I’m glad they’re around.

k__ 6y ago
How come, the US has an opiate crisis?
- formerly_proven 6y ago
  A while ago I posed a similar question and the answers/downvotes made it clear to me why; Americans have a broken model of pain management. Americans think that opiates are necessary to manage the pain from most surgeries, back pain, headaches etc., so, they get opiates to do that, with the obvious and foreseeable catastrophic consequences.
  - zdragnar 6y ago
    A friend of mine was very briefly hooked. He had pretty serious leg surgery after an accident at an air force base, and the Veterans Affairs doctor basically wrote him out a prescription for a massive quantity of pills with the instructions to take as needed. So, naturally, he sat around with nothing to do during recovery but to play video games, drink beer and pop pills. Pain management is definitely not taken seriously enough by some doctors, and too many people are too trusting that their overworked doctors and nurses know better. Both myself and my wife also have chronic pain from past injuries (back pain mostly, plus some arthritis for me) but we manage with stretching, liberal amounts of tiger balm, and the occasional ibuprofin.
    - xxpor 6y ago
      I had relatively routine surgery last year that affected my kidneys. It took a few days to recover, and after a few days I wasn't getting any better so they sent me to the ER. I had Percocet that they prescribed me after the surgery, but the ER doctor wrote me a prescription for straight oxycodone because he was concerned that the acetaminophen in Percocet is sufficiently damaging to the kidneys that I really shouldn't be taking them. I have to be honest, I was really hesitant to fill that prescription. I did after a few hours when the pain got unbearable (at 1 in the morning, they filled it in 5 minutes which also makes me worried that pharmacy would be an easy robbery target...), and damn they did work quite well. I only needed them for 2 days, and I didn't get the sense of being high that I expected, and had no issues stopping them. I can't say I didn't wonder what would have happened if I needed them for a week or more, or if I had previously been addicted to opiates. It just seems hard to believe in modern times there's nothing in between NSAIDs/Tylenol and full on opioids for managing pain, especially for this sort of post-op temporary use case.
      - freeone3000 6y ago
        Ibuprofen was already a huge step up from Paracematol, which is another step up from Aspirin. The fact that ibuprofen is also much better tolerated, has fewer side effects, and has to be dosed less often means you're taking the best non-opioid painkiller we know of as your first-line option.
        jorvi 6y ago
        > The fact that ibuprofen is also much better tolerated, has fewer side effects I'd much rather have the slight load on the liver that paracetemol has than the issues with the stomach that NSAIDs bring.
        freeone3000 6y ago
        Well, lucky for you, both (in fact, all three) are still available. But, as a statistical matter, Ibuprofen is safer. Not only because the liver is such a contentious point for drug elimination, including alcohol, but due to the ability to fix overdoses. Even with minor overdoses (such as mixing with alcohol), paracematol causes permanent liver damage, whereas stomach ulcers can be repaired. More than 100,000 people die annually from Paracematol overdoses. Ibuprofen is sold more, and has fewer than 16,000 deaths.
  - dbcurtis 6y ago
    There is a great Freakonomics podcast on the opiate crisis. If you want to get some food for thought about the American approach to pain management, how it is done elsewhere, and some background on the opiate crisis. (Looks like episodes 402 and 403, from a quick search.)
- every 6y ago
  Regulatory capture can be a significant factor: https://en.wikipedia.org/wiki/Regulatory_capture https://en.wikipedia.org/wiki/Regulatory_capture
- meekrohprocess 6y ago
  Many American regulatory institutions have crumbled in the past few decades, the FAA being a particularly jarring example. In some cases it seems like peoples' trust in those regulators may be fueled by nostalgia, but the FDA does seem like one of the few agencies that has retained some measure of independence. Looking at what has happened in this nation's other industries and institutions, only one crippling decades-long medical crisis doesn't seem all that bad.
  - bordercases 6y ago
    That's not an explanation for why the FDA has failed to address the regulatory aspects of the opioid crisis, but an argument for why we should discount or ignore that failure. At the very least – this is a non sequitur.
    - meekrohprocess 6y ago
      I disagree. Regulatory capture is a clear and present danger to the United States, and it is contributing to a breakdown in accountability across all sectors of the nation's economy and society. So I offered it as an explanation for why the FDA could be well-respected and reasonably functional, while the United States fails to address some acute public health issues. Things could be much worse; at least they don't turn a blind eye when huge sums of money are not involved. It's still very rare for a drug's approval to be pushed through via fraud, and there are a lot of diseases that need treating. They have a solid track record, even now.
  - Clewza313 6y ago
    There hasn't been a fatal crash of a US commercial airliner since 2009. Even for the 737 Max debacle Boeing deserves at least as much blame the FAA.
    - sofixa 6y ago
      The FAA are the ones responsible for stopping shit like the 737Max fiasco. Yes, Boeing did it, and many people there deserve to go to prison, but the FAA is supposed to be the guardrail ensuring they can't get away with it in the first place. It was an objective failure, and it has eroded the trust in them - point in case, most other aviation regulators did their own checks on the 737 Max before allowing it back to service, which usually doesn't happen ( EASA trusts FAA's ratings and vice versa).
- xxpor 6y ago
  That's sort of a different situation. Thalidomide did what it was supposed to, but ended up having horrible unknown (at the time) side effects. The FDA correctly didn't approve it based on the lack of safety data. Opiates also do what they're supposed to, but the fact that they're addictive wasn't a mystery. They're safe if taken and prescribed as instructed. The failure is more on the DEA and other enforcement bodies for not dealing with the obvious prescription abuse. The FDA doesn't make controlled substance decisions.
  - maxerickson 6y ago
    There's lots of controversy about opiates being excessively addictive even when used 'on label'. I didn't find it with a bit of searching, but I remember an article about the 'extended release' aspect of Oxycontin tending to encourage addictive use patterns (because it didn't really work for 6 hours). Figuring that out wouldn't necessarily be an up front trial kind of thing though.
  - hilbert42 6y ago
    "The FDA doesn't make controlled substance decisions." It never spoke out either. Like Pontius Pilate, it washed its hands of the matter.
- Scoundreller 6y ago
  The FDA only protects you against novel drugs. Once something is approved for something (or grandfathered!), it’s a free-for-all for prescribing and usually insurance coverage.
- mhh__ 6y ago
  The FDA doesn't do that kind of regulation if I have read up on it correctly. That and opiates do what they say on the tin - it's more of a policy problem than a specific thing you can just FDA-away.
- freeflight 6y ago
  That has way more to do with ease of access, due to over-prescription practices resulting from pharma lobbying, than FDA med approval.
- rscho 6y ago
  The US opiate crisis has its roots deep in US healthcare culture and the blame lies on both sides of the doctor-patient fence. US docs used to prescribe opiates like candies, but US patients expect to feel no pain at all and are extremely aggressive legally speaking. Those two aspects go hand in hand. My 2c.
- hilbert42 6y ago
  Exactly, the FDA was not only completely incompetent but indirectly responsible for the deaths of thousands. It should have pounced on Purdue at the very outset. Unlike much medical/drug research, knowledge about opioids and opioid addiction is well known. The FDA irresponsibly failed to act on a no-brainer.
orangecat 6y ago
On the other hand, it's likely that thousands of people will die due to the delay in approving the AstraZeneca vaccine. There are always tradeoffs, and it's not at all clear that the FDA is operating at the optimal level of caution.
ghaff 6y ago
It's also very easy, especially at the moment and with the benefit of hindsight, for people to be going that the FDA last March should have said "F it. Go out with whatever vaccines you think will work and see how it goes." Which is what a fair number of people believe (at least other than those who still feel testing was rushed).
- Aerroon 6y ago
  My thinking on this was the exact opposite. Emergencies like this are precisely when you need these types of agencies the most, because you're talking about treatments that will be taken by a huge amount of people in a short timespan. Negative effects from treatment could end up as a catastrophe on their own. It's more important than ever to get it right.
  - Gibbon1 6y ago
    Also when I tried seeing what people that actually develop vaccines had to say. It sounded like crash programs to produce a vaccine would take a year before there was enough capacity to mass vaccinate people. And then six months to vaccinate everyone. The required trials didn't slow anything down because they were done in parallel. Also, some of the vaccines they developed for covid didn't work. A year ago people were somewhat dubious about mRNA vaccines because they'd never been tried before. And then previous vaccines attempts have also resulted in vaccines that make the infection worse. Or caused dangerous side effects. I don't think with vaccines there is this 'one neat trick' that professionals have overlooked somehow.
    - ghaff 6y ago
      And even six months into parallel speculative manufacturing and multiple vaccines approved or on track to be approved for emergency use, the US--in spite of vaccinating at one of the highest rates in the world--still needs to up its rate considerably to hit 50% of the population over the summer sometime. The idea that if the FDA had only washed its hands of the whole approval procedure thing in March, things would be fine now is just a complete fantasy.
foobiekr 6y ago
Well.. Thalidomide - in pregnancy - was replacing diethylstilbestrol, which was still in use in the US until 1971.
- rscho 6y ago
  Yes, but cancer is much less spectacular than missing limbs. Especially when it occurs years later in the next generation.
- refurb 6y ago
  No. Those two drugs were used for different things.
ggreer 6y ago
In total, Thalidomide caused around 2,000 deaths and 10,000 birth defects. Compare that to the 100,000 people that the FDA killed by not approving a single beta blocker sooner. The FDA waited until 1981 to let doctors prescribe Timolol to prevent heart attacks. Stunningly, the FDA bragged that approving Timolol would save up to 17,000 lives a year.[1] That same drug had been in use in Europe since the mid-70s, meaning that the FDA tacitly admitted to killing 100,000 people by forbidding its use in the US. Even the original beta blocker (propranolol) wasn't allowed to be used for angina or hypertension until 1978, 13 years after it had been approved in Europe. That delay likely killed more than 100,000 people. The FDA is also the reason why epi-pens are so expensive[2], why Martin Shkreli was able to jack up the price of Daraprim[3], why many drugs suffer from shortages[4], and why home testing for covid was delayed for so long[5]. And don't forget that covid community spread was discovered in February of 2020 only because researchers risked jail time by violating the FDA's prohibition on testing.[6] Yes, the FDA lets leaders avoid an occasional political snafu. But the organization kills far more people than it saves. 1. https://www.washingtonpost.com/archive/politics/1981/11/26/drug-approved-to-fight-second-heart-attacks/02938b37-8e6c-4ded-aa2c-ebef953ad1d6/ https://www.washingtonpost.com/archive/politics/1981/11/26/d... 2. https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-drugs-vs-chairs/ https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-d... 3. https://slatestarcodex.com/2015/09/24/the-problems-with-generic-medications-go-deeper-than-one-company/ https://slatestarcodex.com/2015/09/24/the-problems-with-gene... 4. https://slatestarcodex.com/2019/04/30/buspirone-shortage-in-healthcaristan-ssr/ https://slatestarcodex.com/2019/04/30/buspirone-shortage-in-... 5. https://www.nytimes.com/2020/05/15/us/coronavirus-testing-seattle-bill-gates.html https://www.nytimes.com/2020/05/15/us/coronavirus-testing-se... 6. https://www.nytimes.com/2020/03/10/us/coronavirus-testing-delays.html https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...
- hprotagonist 6y ago
  So, defensive language aside, I think that the FDA has a point in its white paper. The reason we don’t have cures for a lot of diseases is not so much that pesky regulations keep great drugs from getting to the market. It’s that we don’t know enough – yep, even in 2015 – to make so many great drugs. https://blogs.sciencemag.org/pipeline/archives/2015/08/07/on-the-fda-drug-approvals-and-not-knowing-enough https://blogs.sciencemag.org/pipeline/archives/2015/08/07/on... Now, when I mentioned that we’d surely have killed off more people by doing drug research by the more direct routes, the reply is that we’ve been killing people off by moving too slowly as well. That’s a valid argument. But under the current system, we choose to have people die passively, through mechanisms of disease that are already operating, while under the full-speed-ahead approaches, we might lower that number by instead killing off some others in a more active manner. It’s typically human of us to choose the former strategy. The big questions are how many people would die in each category as we moved up and down the range between the two extremes, and what level of each casualty count we’d find “acceptable”. So while it’s not crazy to say that we should be less risk-averse, I think it is silly to say that the FDA is the only (or even main) thing holding us back. I think that this has a tendency to bring on both unnecessary anger directed at the agency, and raise unfulfillable hopes in regards to what the industry can do in the near term. Neither of those seem useful to me. https://blogs.sciencemag.org/pipeline/archives/2013/08/19/is_the_fda_the_problem https://blogs.sciencemag.org/pipeline/archives/2013/08/19/is... The replies to my comment here nicely delimit the cleft stick the FDA is in. You are on the "oh, god, just let them try it already! the FDA are stick in the mud beancounters just holding everyone back" side. A few others are on the "But this one time, they didn't pull Vioxx fast enough, and look at what it got us!!" side. For myself, I'm glad that 1. i don't have to walk that tightrope and 2. there are enough people to make an institution old enough to have memory that _do_ walk that tightrope. But i'm pretty sure that sanity is somewhere in the middle, case by case, agonizingly slow clinical trial by agonizingly slow clinical trial.
refurb 6y ago
As someone who works in the healthcare industry I agree. I think the FDA does a very good job all things considered. They have approved drugs that were desperately needed (Avastin for breast cancer) based on little evidence, only to later pull them when the data didn’t support approval. They appropriately balance risk versus benefit. And there is more at stake than most people realize. Approve a vaccine that isn’t safe and people will lose trust in general and will refuse any vaccine. Then what? Lots of Monday morning armchair drug regulators in this thread.
mchusma 6y ago
I think your position, and that of the FDA is based on emotion, and not any logical reasoning. The Thalidomide crisis cased a few thousand issues. The risk-benefit analysis clearly favored lifting the ban on COVID vaccines after successful phase 1 trials, in June 2020 or so. They decided they should be banned until further study, during a pandemic. The FDA was empowered explicitly by congress to take more aggressive action during such a time. They opted instead to ignore that mandate, and instead run things like normal, albeit with taking reasonable time to respond to a crisis. The deaths of 100,000 to 400,000 could be directly blamed on the simple fact that for most of this crisis, we had not 1 but approximately 8 vaccines that were all expected to be safe and work, and all turned out to be safe and to work. Vaccines candidates are not like Thalidomide, period. It's important for citizens to publically shame the FDA for their actions, and demand change from our elected officials.
- mattkrause 6y ago
  It’s simply not true that all of the candidate vaccines worked. - The Sanofi-GSK one produced meh immune responses in the elderly, which is the population most at risk. (https://www.cbc.ca/news/health/sanofi-gsk-vaccine-covid19-trial-1.5837249 https://www.cbc.ca/news/health/sanofi-gsk-vaccine-covid19-tr...) - Merck/MSD abandoned TWO candidates, V590 and V591. https://www.merck.com/news/merck-discontinues-development-of-sars-cov-2-covid-19-vaccine-candidates-continues-development-of-two-investigational-therapeutic-candidates/ https://www.merck.com/news/merck-discontinues-development-of... - CSL/Queensland abandoned theirs because it interfered with HIV tests. https://www.csl.com/news/2020/20201211-update-on-the-university-of-queensland-covid-19-vaccine https://www.csl.com/news/2020/20201211-update-on-the-univers...
hilbert42 6y ago
"...i find the FDAs policies and procedures eminently sensible..." Damn shame the FDA was asleep at the wheel during the opioid epidemic! (It's a shame you've not bothered to justify that statement in the light of overwhelming evidence to the contrary.) The FDA did SFA to stop Purdue Pharma selling—sorry—pushing boxes of OxyContin to all and sundry as if they were kids lollipops despite the fact that it would have been aware of over a hundred or more years of solid medical evidence of the dangers of narcotics and narcotic addiction. The fact that any opioid narcotic that's capable of killing pain is addictive—and if not very carefully managed—very addictive is 101 medical/pharmacy knowledge. Even kids know the fact! Armed with this knowledge the FDA knew what Purdue was doing was completely unacceptable, so why didn't it act? https://www.theguardian.com/us-news/2019/jan/24/fda-opioids-big-pharma-prescriptions https://www.theguardian.com/us-news/2019/jan/24/fda-opioids-... The FDA still has a lot to answer for its negligence over the Purdue/Opioid crisis. Its ethics are nothing like they were in Frances Kelsey's day. — Later edit: Let me add Frances Kelsey was a true hero, she saved many kids from developing terrible deformities! Despite current criticism of the FDA by many including myself, we should never forget her contribution to medicine.
- thereare5lights 6y ago
  Racism played a part in this too > If a doctor subscribes to stereotypes of what an addict looks like — nonwhite, from a low-income community — the physician may assume their white, middle-class patients are immune to addiction, he says. https://www.wbur.org/hereandnow/2020/01/03/bias-opioid-prescribing-black-americans https://www.wbur.org/hereandnow/2020/01/03/bias-opioid-presc...
  - hilbert42 6y ago
    Yeah, I'm not a bit surprised, but in my view there's an even deer systemic reason and we need to fix it. The overriding issue is that medicos, pharmacists and opioid drug manufacturers should know the dangers of opioids like the back of their hand. I'd even argue that such knowledge is almost a priori in the sense that the vast majority of medical professionals would have already known the essential details before they'd even entered training from the fact that it's common knowledge that opioids are very addictive and dangerous if not managed with considerable care. As I see it, just about everyone knows the multiple reasons behind the decades-old war on drugs by just about every government anywhere on the planet. Even if the way this war was and is still being conducted is ineffective and counterproductive (which, incidentally, is my view), one would have had to have been Sleeping Beauty and have slept though the past 100 years not to know that narcotic opioids, heroin, morphine, etc. along with stimulants, cocaine, methamphetamine, etc. are at the center of this war. (When I was a kid, drugs were never an issue as fortunately we kids never came across any—not even pot! That's to say, with respect to knowledge about drugs, we kids were about as naïve as it gets, nevertheless, even as a nine or ten year old, I'd heard of heroin and morphine and was very well aware of their dangers!) What I am saying is that the relationship between opioids and addiction is so well known—and that these facts are so central to medical and pharmacy training—that it's impossible for professionals not to know about such matters. Thus, the fact that everyone wasn't immediately up in arms and pointing to the problem and demanding that something be done about the problem is very strange indeed. I'd go so far as to say that it's a sociological phenomenon worthy of research. It's not just a matter of penalizing and disciplining the perpetrators but getting to the core of why it actually happened given that basic training, existing laws, dispensing protocols, FDA rules, FDA experience etc. any one of which should have been able to prevent the crisis but didn't.) (In my opinion, the opioid crisis has a similar ring it to what happened at Boeing with the 737 Max where once the notion critical systems engineering and attention to safety details was paramount and inculcated deep within every level of the organization and its work culture but which in recent times vanished. Clearly, we have to get to the heart of the problem and understand it before we can rectify it.)
roenxi 6y ago
From a "well what did you expect" perspective - delaying drugs and asking for more safety data is occasionally going to result in scary drugs getting caught and kept off the market. The problem is the flip side - when wonder drugs are delayed causing unnecessary pain and suffering - generates no human interest stories. The damage of increasing cost of drugs and delaying the rate of improvement because of delays in the approval process is also an unknown. The FDA is a process - every time something goes wrong, bureaucrats take heat and then tighten the standards. This process is going to be more conservative about approving drugs than is rational.
marton78 6y ago
As a European who had to deal with getting a medical devices approved both in the EU and in the US: mad respect for the FDA. There is lots of paperwork required on both sides, but the difference is who accompanies the project. In the EU it's bureaucracts with zero domain knowledge, in the US it's domain experts who asked the right questions and were strict, but also genuinely helpful.
CryptoPunk 6y ago
These are problems that would have been solved without the preemptive FDA ban on unapproved drugs. Society, as usual, over-reacted, and created a set of highly restrictive rules that have cost probably millions of lives over the subsequent decades. A much more sensible law in the aftermath of the drug scandals of the 1930s and 40s, that would have run a much much lower risk of having a myriad negative consequences, would have been a requirement to include on any drug, a disclosure of whether it is approved by the FDA. Non-approved drugs could have been required to include a warning that the FDA recommends a person not take the drug as it has not been verified to be effective or safe. This provides most of the benefits of the FDA's role as gatekeeper, without most of the harm done by heavily restricting a market and making it totally dependent on a single central authority. Providing consumers with the ability to ignore the warnings of the FDA would have acted as a lifeline/failsafe in cases where the FDA erred.

ficklepickle 6y ago

While this is great and all, the comments indicate that tons of doses circulated the USA as samples. There are two people in the comments claiming to be survivors from these samples. If this is true, then the article is incorrect. It appears that Americans were just denied compensation because the drug wasn't approved. I'm sure the harm would have been much greater had the FDA approved the medication. But it seems unfair to say they were no victims in the USA.

xiphias2 6y ago
The article reports that there were victims. Are we reading the same article?
- potiuper 6y ago
  The title of the page implies there were no victims; there was "A Generation of 'Thalidomide Babies'" in the U.S. even though greatly limited.
dcminter 6y ago
The article itself states that samples were distributed and that "In the U.S., 17 cases of congenital deformities were reported"

LatteLazy 6y ago

From the Wikipedia article: >At the time of the drug's development, scientists did not believe any drug taken by a pregnant woman could pass across the placental barrier and harm the developing fetus https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide Wtf?

rscho 6y ago
Medicine used to be, and in substantial part still is, a disordered heap of hypotheses relying on practical experience and relayed by the stars of the field. There are plenty of strange examples throughout history. For example, we used to believe until not so long ago that infants couldn't feel pain (with all the 'interesting' consequences on practice you can imagine).
- myself248 6y ago
  I'm less than convinced that anyone sincerely believed that. It seems more plausible that it's a lie they told themselves to paper over other cultural, profit, or institutional pressure.
  - rscho 6y ago
    Of course people believed strange things! As I said, the field is far from being hard science even today (am MD myself). What do you think "expert opinion" actually means? Well, just that... and the literature is full of such opinions driving many important guidelines for practice in the real world. As recently as 1999, it was commonly stated that babies could not feel pain until they were a year old.[0] [0] https://en.wikipedia.org/wiki/Pain_in_babies#%3A%7E%3Atext%3DAs_recently_as_1999%2C_it%2Ccertain_age_can_experience_pain.?wprov=sfla1 https://en.wikipedia.org/wiki/Pain_in_babies#%3A%7E%3Atext%3...
burlesona 6y ago
I mean, people think all kinds of things that seem plausible at the time and look crazy in hindsight to future generations. This is what progress looks like.

chosen1111 6y ago

I wonder what names she was called at the time for her refusal to go along with the established research from the pharmaceutical and medical community

tomcam 6y ago

Thalidomide babies were my age and not unknown where I grew up. Limb deformities differed: sometimes they had flipper-like appendages, sometimes shortened limbs. (FWIW while cruelty was extremely common back then I never saw a single case of anyone handicapped being made fun of. Nor did I ever witness any racist behavior in my racially integrated neighborhood.) There was a locally famous dude at the public pool who was kind of the coolest guy around. His legs stopped at knee length and he would pull himself up the high dive ladder, walk on his hands to the end of the diving board, and casually launch himself off the end perfectly every time. It was spectacular.

WalterBright 6y ago

On the other hand, there are costs with delaying approval. This is pretty obvious with the Covid vaccines, probably at least 200,000 on the dead side of the ledger. Another cost that's harder to quantify is the cost in lives and misery of drugs never developed because it's for an uncommon and there's no way to make back the money needed to pay for FDA approval.

ip26 6y ago
There are like 50+ COVID vaccines in development. Which one do you administer? Forget about side effects, half of them are probably duds! Can we afford to administer billions of vaccines that don’t even work?
- WalterBright 6y ago
  With the agonizingly slow rollout of the current vaccine, we wouldn't be administering billions of vaccines without soon finding out if it is efficacious or not. > Can we afford Evidently we can afford to spend several trillion dollars and hundreds of thousands of deaths waiting 6 months for the vaccine trials.
- JoshuaDavid 6y ago
  Yes? 10 billion vaccine doses that cost $100 each would be a trillion dollars. Which is somewhere between 7% and 25% of the total cost of COVID-19 to the US. The real question is whether we can afford to use our non-emergency drug approval process in a time of crisis. This time the answer is probably "yes, and it probably only cost a few tens of thousands of lives and a few trillion dollars" but if the disease in question had been Ebola instead of COVID I worry that we would have seen the same ineffective response that optimizes for minimizing liability instead of maximizing effectiveness.
  - ip26 6y ago
    The problem is not administering one vaccine. If you were pretty sure which one to use you could take a gamble- which is exactly what we have done with early auth of the Moderna and Pfizer! But If you don’t yet know which ones actually work yet, do you give everyone ten different experimental vaccines in one shot?

dcolkitt 6y ago

Let's be very clear. Covid is currently killing more Americans every three days than the total number of global birth defects attributed to Thalidomide over its entire life. The FDA refuses to approve AstraZeneca, despite the fact that it's approved in the UK, and doing so would prevent hundreds of thousands of American Covid deaths. The only answer the naysayers can give is to sputter and point at Thalidomide. So, I want all of us to be crystal clear. If they're wrong about AstraZeneca, then the type II errors of the FDA will cancel out the Thalidomide type I errors by three orders of magnitude. And hereby, no intellectual honest person should ever bring up Thalidomide again, unless explicitly qualifying the much large type II failure of not approving AstraZeneca. If you believe that AstraZeneca is the next Thalidomide, I want you to bet money on it. If you're willing to bet other people's lives, then you should be willing to bet your own money. I will accept any bet, up to $10,000, that the number of deaths attributable to AstraZeneca over the next two years will not exceed ten thousand deaths globally. (Far less than the number of Americans immediate approval would save). If you're not willing to bet money than AstraZeneca is the next Thalidomide, then stop insisting that the FDA let hundreds of thousands die by implicitly treating it that way.

ianlevesque 6y ago
We already have two other vaccines approved and being manufactured in large quantities. It’s not a zero to one situation.
deleted 6y ago
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tzs 6y ago
> The FDA refuses to approve AstraZeneca. AstraZeneca has not applied to the FDA for an emergency use authorization. They are expected to apply soon.
- streptomycin 6y ago
  That's because the FDA basically told them it would be rejected unless they spent months collecting more data. Similar situation with the Novavax vaccine, which seems to have even better results than the AstraZeneca one.

xyzelement 6y ago

I love stories of people thoughtfully doing their jobs and having huge life saving impact like this. I was saying to my wife on a recent drive, that there's some civil engineer somewhere who figured out you can embed those little light reflectors into highway lane markets, and some other engineer who figured out those perpendicular cuts in the asphalt that vibrate your car before you run off the road. Both of these probably naturally arose in the context of their work, and both of these things passively save hundreds of lives daily.

Stratoscope 6y ago
For the curious: https://en.wikipedia.org/wiki/Botts%27_dots https://en.wikipedia.org/wiki/Botts%27_dots (named after Elbert Dysart Botts) https://en.wikipedia.org/wiki/Raised_pavement_marker https://en.wikipedia.org/wiki/Raised_pavement_marker https://en.wikipedia.org/wiki/Rumble_strip https://en.wikipedia.org/wiki/Rumble_strip
dingsbumps 6y ago
I recently listened to an interesting episode about those reflectors on the 99 Percent Invisible podcast. This [1] is an associated article on their site that seems to have similar content to the episode I listened to. [1] https://99percentinvisible.org/article/decoding-cats-eyes-global-color-guide-reflective-road-markers/ https://99percentinvisible.org/article/decoding-cats-eyes-gl...

chefkoch 6y ago

And now Thalidomide is used in treating cancer and sold for over $200 a pill. Quite a nice markup for telling the patients not to get pregnant while on treatment.

madaxe_again 6y ago
Only one enantiomer caused birth defects - and a defect in the original manufacturing process created L- as well as D- chiral species. Pretty sure it no longer contains the problem enantiomer.
- Metacelsus 6y ago
  The enantiomers can interconvert (racemize) within the body, so it's not that simple.
eterm 6y ago
It needn't cost that much, the UK's NHS is charged around $15/pill if I'm reading this right: https://bnf.nice.org.uk/medicinal-forms/thalidomide.html https://bnf.nice.org.uk/medicinal-forms/thalidomide.html Also worth noting that "Don't get pregnant" also extends to "don't get anyone else pregnant" since the side effects can pass from men to women too.

nojvek 6y ago

Also reminds me how people were blaming for FDA for vaccine delays including President Trump. It’s not a vaccine, until it’s proven safe. While FDA isn’t perfect they have stringent procedures to prove something is safe. The way FAA let Boeing ship planes that killed people, and lost their trust, same applies to FDA. If people die and have irreversible damage, it’s on their hands.