15 ms·

Nearly 400 medical devices, procedures and practices found ineffective in study

274 points by EndXA 7y ago

asdf21 7y ago
Actual study: https://elifesciences.org/articles/45183 https://elifesciences.org/articles/45183 Seems to impact nearly all medical disciplines.. https://iiif.elifesciences.org/lax:45183%2Felife-45183-fig2-v1.tif/full/617,/0/default.webp https://iiif.elifesciences.org/lax:45183%2Felife-45183-fig2-...
EndXA 7y ago
Abstract: > The ability to identify medical reversals [practices that have been found, through randomized controlled trials, to be no better than a prior or lesser standard of care] and other low-value medical practices is an essential prerequisite for efforts to reduce spending on such practices. Through an analysis of more than 3000 randomized controlled trials (RCTs) published in three leading medical journals (the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine), we have identified 396 medical reversals. Most of the studies (92%) were conducted on populations in high-income countries, cardiovascular disease was the most common medical category (20%), and medication was the most common type of intervention (33%). The original study can be found here: https://doi.org/10.7554/eLife.45183.001 https://doi.org/10.7554/eLife.45183.001
- js2 7y ago
  Supplementary File 2 contains the full list of reversals: https://elifesciences.org/articles/45183/figures#supp2 https://elifesciences.org/articles/45183/figures#supp2 I don’t know if this is a permalink due to the hash parameter but I’ll try: https://elifesciences.org/download/aHR0cHM6Ly9jZG4uZWxpZmVzY2llbmNlcy5vcmcvYXJ0aWNsZXMvNDUxODMvZWxpZmUtNDUxODMtc3VwcDItdjEuZG9jeA==/elife-45183-supp2-v1.docx?_hash=X7MxyiHvN4wdoXByVuyzLJxV6%2FSJjil2sR5Sc1ETBzw%3D https://elifesciences.org/download/aHR0cHM6Ly9jZG4uZWxpZmVzY...
  - web007 7y ago
    The b64 of that crazy link directs you to https://cdn.elifesciences.org/articles/45183/elife-45183-supp2-v1.docx https://cdn.elifesciences.org/articles/45183/elife-45183-sup... - maybe slightly more permanent?
hirundo 7y ago
I think it's bad policy for the FDA to screen medicines not just for safety but also efficacy. From this study it appears to be frequently unjustified but it gives the drug a seal of approval that has a tendency to replace the judgement of doctors and patients. It's not that the FDA decision makers are corrupt or incompetent. These are wildly complex issues that nobody can get right consistently. Better not to conceal that with centralized decision making. Modern medicine can't even agree in broad strokes on the proper ratio of macronutrients for humans. We give them too much power when we uncritically accept their judgement on any given treatment. For me, prayer would have no effect. For others it could be a life saving intervention. The efficacy of a particular molecule for a particular patient isn't much easier than that to determine. Therefore decision making should be as decentral and computationally parallel as we can make it.
- rileymat2 7y ago
  It seems wrong to judge based on the number of false positives without weighing agianst all the snake oil they keep out.
- avar 7y ago
  Not screening for efficacy will result in both legitimate cancer medication and homeopathic medicine having an FDA stamp of approval. Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement, a tea or whatever. You just can't advertise that it's a drug.
  - kanzure 7y ago
    > Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement a tea or whatever. You just can't advertise that it's a drug. Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particular efficacy. https://www.technologyreview.com/s/603530/a-biohackers-plan-to-upgrade-dalmatians-ends-up-in-the-doghouse/ https://www.technologyreview.com/s/603530/a-biohackers-plan-... On another note, see the sensor pads story here: http://www.fdareview.org/devices.shtml http://www.fdareview.org/devices.shtml "We rarely get to try products that the FDA fails to approve, and we never get to try products that are never brought into existence because FDA rules and regulations have made research and development uneconomic. As a result, the public remains ignorant of the true costs of FDA power."
reallydude 7y ago
Challenging chemo: https://www.icnr.com/articles/ischemotherapyeffective.html https://www.icnr.com/articles/ischemotherapyeffective.html Australia has a study that's pretty damning. Is that one of these practices listed?
- OldFatCactus 7y ago
  the website you linked reads like homeopathic conspiratorial junk. I would be wary of anything they cite
  - reallydude 7y ago
    The papers cited (eg Morgan G, Ward R, Barton M. The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies. Clin Oncol (R Coll Radiol). 2004;16(8):549-60.) have been instrumental in removing Chemotherapy as the defacto treatment of many cancers in Australia. The science is definitive insofar as the inefficacy of the treatment. The pharmacological industry resistance to these findings is unsurprising.
  - DanBC 7y ago
    Here's information about the Cancer Drugs Fund which was used in England to provide access to newer forms of chemo. Most of it didn't work, and caused severe side effects. This is from the British Medical Association: https://www.bmj.com/content/357/bmj.j2097 https://www.bmj.com/content/357/bmj.j2097 This is from the Royal Society of Medicine: https://journals.sagepub.com/doi/full/10.1177/0141076818796802 https://journals.sagepub.com/doi/full/10.1177/01410768187968...
naringas 7y ago
while I have no doubt that the vast majority of vaccines work and are necessary, I believe that the efficacy of many of them should be put to the test. I believe that profit-motivated pharmaceutical companies have incentives to make new vaccines -- more sales, and if they're also cheap to make, more profit. this together with some corporate ethics, political regulators, and greedy humans and I think you can see where I'm going with this. note: I am not saying that they cause diseases, I am just advocating we review how truly necesary they all are. maybe not everybody needs the same set of vaccines? (thou I don't doubt there's a subset everyone needs) second note: unwritten rule of HN, do not question vaccines.
- rconti 7y ago
  third note: don't whine about being downvoted.
  - deleted 7y ago
    [deleted]
- delecti 7y ago
  What you're suggesting already exists. Nobody gets the smallbox vaccine anymore. People only get the rabies vaccine after exposure. There are a handful of vaccines you only need if you're traveling to certain international destinations [1]. The set of vaccines that everyone gets is already subset that everyone needs. And because of people expressing unfounded "skepticism" like this, we're getting outbreaks of diseases that were being kept at bay by the vaccines. [1] https://www.cdc.gov/features/vaccines-travel/index.html https://www.cdc.gov/features/vaccines-travel/index.html
- CathedralBorrow 7y ago
  > I am just advocating we review how truly necesary they all are. maybe not everybody needs the same set of vaccines? Is this something you believe no one has done so far?
- Mvandenbergh 7y ago
  The efficacy of vaccines is tested as part of the approval process, vaccines are not profit centres for anyone, I award you zero points and may God have mercy on your soul.
dannykwells 7y ago
Everyone yelling about how the FDA is corrupt or should only screen for safety are completely ignorant of history and basic facts. Medicine is not like trying out a new coding framework - in some cases, like cancer: i) There is no ability to "try it out for your self" - you are either all in or not ii) There are extreme risks to taking the drug (most cancer drugs are actually somewhat to extreme toxic...just less toxic than cancer) iii) You only get a few tries (since, you know, cancer will kill you). iv) People are very desperate and will try anything v) Data sharing is very very hard given the sensitivity of the information (patient data) - making it effectively impossible to have an open data exchange. (This is also due to the billions of dollars at stake on the pharma side). Try designing a system to overcome those challenges...and you will likely end up with a central governing body that looks like the FDA. Anything else you are going to get way way more drugs that don't work, which waste time and money and kill people, which endanger patient privacy, or which are not satisfactory to pharma or, ... The fact is, the FDA is full of many of the smartest and hardest working doctors and scientists in all of medicine. They take their jobs extremely seriously. They are far more careful and rigorous than most academic or even pharma-level researchers. Do they get it wrong? Yes, occasionally. Not frequently. Occasionally. But that also, is science. The FDA follows rigorous statistical procedures, but even p<0.05 (or <0.001) still means false positives can happen.
- gumby 7y ago
  This. Having been through the FDA process myself (though we didn't make it to NDA, sob) I have to say that dealing with the Agency was great. Tedious, but great, and nothing seemed stupid except some trivialities at the margin (e.g. certain formatting issues). Honestly the worst parts of dealing with them are direct consequences of people trying to game the system. We went out of our way to make sure nothing we did could give that impression and got excellent guidance and response.
  - bilbo0s 7y ago
    Same. Been through that process with a couple products from a medical imaging software startup. Extreme professionalism and competence was the lasting impression I got from my time interacting with them. We were making software that could be used in oncology for diagnosis, analysis, and treatment planning, so yeah, we got the regulatory proctology exam. But I wasn't annoyed at all. They were highly competent people who took their duty to protect the public from me seriously. I took no offense at all.
geggam 7y ago
Frankly, Me and most of America think the FDA approves things according to the highest bidder. This is one of the biggest contributing factors to the anti vax movement. | The trust in our govt and all govt agencies is simply gone.
- testpostpls 7y ago
  That really isn’t the truth though. What should be done?
  - geggam 7y ago
    Transparency, in all levels of government. And quit equating money to speech. Lobbying is legalized bribery and everyone knows it.
- avip 7y ago
  Highest bidder of what?
- ims 7y ago
  > Me and most of America think the FDA approves things according to the highest bidder. Why do you think this?
  - geggam 7y ago
    Here is one example https://ivn.us/2013/02/11/the-revolving-door-fda-and-the-monsanto-company/ https://ivn.us/2013/02/11/the-revolving-door-fda-and-the-mon...
    - ims 7y ago
      Revolving doors between regulators and industry can raise conflict of interest concerns, but this is not at all the same problem that you alluded to above.
      - geggam 7y ago
Moodles 7y ago
Last Week Tonight with John Oliver did a segment on this recently: https://youtu.be/-tIdzNlExrw https://youtu.be/-tIdzNlExrw
deleted 7y ago
[deleted]
hurrdurr2 7y ago
I do remember watching a documentary about medical devices where it describes a FDA loophole; if the device you are trying to introduce is similar to a previous already approved product then the scientific rigor involved is significantly less. I wonder if this has something to do with it.
manjana 7y ago
Can anyone comment on the validity of this publication? I'm sceptical towards the site given it's "flashy" title and I'm not well enough schooled in distinguishing good vs. bad publications.
ptah 7y ago
>to actively seek out independent, governmental and non-conflicted clinical research does this mean private sector pharma studies are to blame?
kevinalexbrown 7y ago
I read the original study. I have a few thoughts. My partner is a physician and I am an AI researcher working in medicine. I think a lot about doctors as machine learning models, and RCT results like loss terms in a complicated objective function. What is the best learning rate for updating physicians (our models) from the results of RCT's (part of our loss)? The authors reviewed all articles in three journals from (generally) between 2003-2017. They didn't, afaict (please point me if they did), review the time-to-correction (if any correction has been made). It takes some time before the results of an RCT end up in established practice. I'm actually surprised it's so small in many cases. It's not like there's a database where the results of every RCT are immediately updated and the physician model is retrained overnight on the new data. Even if there were, imagine if the learning rate (so to speak) were so high that every discipline immediately changed their published best practices on the basis of a single RCT? Here's a cautionary paragraph from one of the excellent reversal studies they use: Several limitations of the study warrant discussion. First, because we enrolled only 26% of eligible patients, our findings must be generalized cautiously. The most frequent reason that patients declined enrollment was a strong preference for one treatment or the other. Since patients' preferences may be associated with treatment outcome, our trial may be vulnerable to selection bias. Participating surgeons may not have referred potentially eligible patients because they were uncomfortable randomly assigning these patients to treatment; this form of selective enrollment may also create bias.26 Second, because the trial was conducted in academic referral centers, the findings should be generalized carefully to community settings. Third, we did not formally assess the fidelity of the physical therapists or surgeons to the standard intervention protocols. Finally, our study was not blinded, since our investigative group did not consider a sham comparison group feasible. [0] I'm less concerned about RCT to Best Practice time than from Best Practice to Typical Physician Practice time. There is a cascaded model connected to the 'complex RCT loss' and it's discipline published practice down to individual physician treating patients. Compressing the time from RCT to individual physician is fraught with difficulties, but could be improved. Finally, RCT is the gold standard, but it's not perfect and it doesn't always clearly translate to the individual physician's model of practice. Many best practices weren't established from RCT's either. And an inconclusive result from an RCT is not the same thing as proving that there's no difference in outcomes, but a proper statistician can chime in there. [0]https://www.nejm.org/doi/full/10.1056/NEJMoa1301408 https://www.nejm.org/doi/full/10.1056/NEJMoa1301408
program_whiz 7y ago
The majority of every invention / attempt will be wrong in any human pursuit. Just think, 400 useless apps or pieces of software are probably released DAILY to the itunes store. The only difference is the impact, but its still understandable. What if you had to write software that did the following: * Fixed a bug in an existing "legacy system", deployed remotely without your knowledge. You have no logs or debug information, but you can speculate on cause and try it in small simulated / test environments (e.g. rodents). By introducing this fix you would also be changing the system in unknown ways. * You only have a vague idea of how the code in the OS for this system works, your fix doesn't even change the code. Your only mechanism of change is injecting some foreign JS into a webform to cause ripple effects on the system for the user, meanwhile the system is setup to try to stop / avoid such "attacks" and will try to undo your fix if it can be detected by the system's "AI". * if your fix fails in production for even one user, you may lose millions and potentially go jail, that person may die. * You get one shot to release it to the public, after go-live it basically has to work or everything was for nothing. There is no "push this fix and everything gets better", even one small change is a complete restart (new molecule == new drug). * If you accidentally release any information about the users, or lose their data, you lose millions and potentially go to jail. * This software will take 10 years, a handful of scientists, a lab, some lawyers, lobbying, and a few billion dollars to make. * Every user using your software will be on an entirely unique stack, processing all kinds of data in tandem with your software, and will not follow directions. Some will even have lots of other bugs in the system that are unrelated to your fix.
- martindbp 7y ago
  Have you ever thought that maybe not everything has to be seen through the lens of software? Not trying to be snarky, but it's something I see so often here on HN and it kind of bugs me.
  - Duladian 7y ago
    It is much easier to relate to a known quantity than an unknown. I would say the vast majority of people here are either programmers or at least have enough knowledge in programming to relate to it.
peterwwillis 7y ago
Most comments here are only focusing on medical devices; this is about the practice of medicine, not shitty companies! In dentistry/endodontics it was believed for a long time that installing a post helped keep a crown and tooth intact for longer. But long term studies showed posts can actually reduce longevity. In another case, a study showed that a common type of knee surgery for pain is actually less helpful than a placebo surgery. The overarching problem is that it's (currently) very hard to evaluate the real effect of practicing medicine on large swaths of the population, and then using those results to change what doctors do. By getting doctors into a continuous improvement cycle, we could identify costly, useless practices, and improve health.
EvanAnderson 7y ago
I found this one from the table of reversals to be interesting: Article: Efficacy of infant simulator programmes to prevent teenage pregnancy: a school-based cluster randomised controlled trial in Western Australia Summary: The infant simulator is an example of persuasion technology or captology, where the use is intended to prevent teenage pregnancy.26 Their use is widespread in developed countries27 and is expanding into low-income and middle-income countries.28 However, in this study done in Australia, the infant simulator-based VIP program did not reduce teenage pregnancy. In fact, girls in the intervention group (n=1,267) were more likely to experience a birth (8% vs. 4%; HR=1.35; 95% CI=1.06-1.73; p=0.016) or an induced abortion (9% vs. 6%; HR=1.33 (1.00-1.78; p=0.049) than those in the control group (n=1,567) before they reached 20 years of age. This is a reversal of the practice of infant simulator programs to prevent teenage pregnancy. A school district I contract with purchased some of these "infant simulators" a few years ago. I shared spooky photos of them entombed in foam in their storage cases (evoking visions of racks of "hibernating" astronauts from sci-fi) with my wife. She made a general observation that she thought some fraction of teenage girls would feel encouraged to have a baby after time w/ the infant simulator. Guess there was some truth to that intuition after all.
- sp332 7y ago
  That would only explain part of the effect. It wouldn't explain why the number of abortions went up by 50%.
  - Qwertystop 7y ago
    Potentially, the subset of those girls who felt encouraged and then changed their minds.
  - ljf 7y ago
    I can't find the study now, but I read previously that even filling in a questionare asking about tennagers sexual history (or lack of) increases the chance of those teenagers having children and abortions. I assume at that in some level this seeds the idea of sex and babies in a group that might have not had that thought, opportunity or imputus otherwise.
jpmattia 7y ago
It's hard to see this headline as something other than a result of The Irreproducibility Crisis.
dang 7y ago
The study was discussed a few days ago at https://news.ycombinator.com/item?id=20164809 https://news.ycombinator.com/item?id=20164809
graycat 7y ago
Remember, in research it is easy to conclude that some treatment does no good -- just do sloppy statistics. E.g., collect some data, flip a coin, and report the results of the coin flip. That will work because the coin flip is, in probability, independent of everything else including the data and treatment. Well that's not the only way to do sloppy statistics -- just pick some measures that are relevant but not very good. And use a small sample size. E.g., there are some reports on how much data was needed by the Large Hadron Collider (LHC) to conclude that the Higgs Boson DOES exist -- the amount of data needed was beyond belief. Sooooo, anytime well short of that much data they could have conluded that the Higgs did not exist, that is, so far their data failed to show that it DID exist. Same for any treatment: If don't collect enough data, use poor measures, let the data get corrupted, etc., i.e., do sloppy work, then will fail to find where the treatment did work and conclude that it didn't.
chiefalchemist 7y ago
I wonder how many of these are still covered by insurance companies. You'd think they're in ideal (data collection) position to raise questions about what works and what doesn't. Certainly, the insurance cos have more incentive to raise red flags than Big Pharma.
- DoctorOetker 7y ago
  upvoted this, but what happens with conflicts of interest? for example, what if insurance companies insure both patients (to cover medical expenses) and doctors (to cover malpractice lawsuit costs)? insurance company houses and systems are typically set up such that the house will statistically win out (a supposed small tax that pays for running the paper work, and manpower within an insurance company). In such a setting, where insurance companies insure both doctors and patients, the net motivation is no longer defending what works, but increasing throughput of interactions...

274 points by EndXA 7y ago

Actual study: https://elifesciences.org/articles/45183 https://elifesciences.org/articles/45183 Seems to impact nearly all medical disciplines.. https://iiif.elifesciences.org/lax:45183%2Felife-45183-fig2-v1.tif/full/617,/0/default.webp https://iiif.elifesciences.org/lax:45183%2Felife-45183-fig2-...

EndXA 7y ago

Abstract: > The ability to identify medical reversals [practices that have been found, through randomized controlled trials, to be no better than a prior or lesser standard of care] and other low-value medical practices is an essential prerequisite for efforts to reduce spending on such practices. Through an analysis of more than 3000 randomized controlled trials (RCTs) published in three leading medical journals (the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine), we have identified 396 medical reversals. Most of the studies (92%) were conducted on populations in high-income countries, cardiovascular disease was the most common medical category (20%), and medication was the most common type of intervention (33%). The original study can be found here: https://doi.org/10.7554/eLife.45183.001 https://doi.org/10.7554/eLife.45183.001

js2 7y ago
Supplementary File 2 contains the full list of reversals: https://elifesciences.org/articles/45183/figures#supp2 https://elifesciences.org/articles/45183/figures#supp2 I don’t know if this is a permalink due to the hash parameter but I’ll try: https://elifesciences.org/download/aHR0cHM6Ly9jZG4uZWxpZmVzY2llbmNlcy5vcmcvYXJ0aWNsZXMvNDUxODMvZWxpZmUtNDUxODMtc3VwcDItdjEuZG9jeA==/elife-45183-supp2-v1.docx?_hash=X7MxyiHvN4wdoXByVuyzLJxV6%2FSJjil2sR5Sc1ETBzw%3D https://elifesciences.org/download/aHR0cHM6Ly9jZG4uZWxpZmVzY...
- web007 7y ago
  The b64 of that crazy link directs you to https://cdn.elifesciences.org/articles/45183/elife-45183-supp2-v1.docx https://cdn.elifesciences.org/articles/45183/elife-45183-sup... - maybe slightly more permanent?

hirundo 7y ago

I think it's bad policy for the FDA to screen medicines not just for safety but also efficacy. From this study it appears to be frequently unjustified but it gives the drug a seal of approval that has a tendency to replace the judgement of doctors and patients. It's not that the FDA decision makers are corrupt or incompetent. These are wildly complex issues that nobody can get right consistently. Better not to conceal that with centralized decision making. Modern medicine can't even agree in broad strokes on the proper ratio of macronutrients for humans. We give them too much power when we uncritically accept their judgement on any given treatment. For me, prayer would have no effect. For others it could be a life saving intervention. The efficacy of a particular molecule for a particular patient isn't much easier than that to determine. Therefore decision making should be as decentral and computationally parallel as we can make it.

rileymat2 7y ago
It seems wrong to judge based on the number of false positives without weighing agianst all the snake oil they keep out.
avar 7y ago
Not screening for efficacy will result in both legitimate cancer medication and homeopathic medicine having an FDA stamp of approval. Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement, a tea or whatever. You just can't advertise that it's a drug.
- kanzure 7y ago
  > Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement a tea or whatever. You just can't advertise that it's a drug. Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particular efficacy. https://www.technologyreview.com/s/603530/a-biohackers-plan-to-upgrade-dalmatians-ends-up-in-the-doghouse/ https://www.technologyreview.com/s/603530/a-biohackers-plan-... On another note, see the sensor pads story here: http://www.fdareview.org/devices.shtml http://www.fdareview.org/devices.shtml "We rarely get to try products that the FDA fails to approve, and we never get to try products that are never brought into existence because FDA rules and regulations have made research and development uneconomic. As a result, the public remains ignorant of the true costs of FDA power."

reallydude 7y ago

Challenging chemo: https://www.icnr.com/articles/ischemotherapyeffective.html https://www.icnr.com/articles/ischemotherapyeffective.html Australia has a study that's pretty damning. Is that one of these practices listed?

OldFatCactus 7y ago
the website you linked reads like homeopathic conspiratorial junk. I would be wary of anything they cite
- reallydude 7y ago
  The papers cited (eg Morgan G, Ward R, Barton M. The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies. Clin Oncol (R Coll Radiol). 2004;16(8):549-60.) have been instrumental in removing Chemotherapy as the defacto treatment of many cancers in Australia. The science is definitive insofar as the inefficacy of the treatment. The pharmacological industry resistance to these findings is unsurprising.
- DanBC 7y ago
  Here's information about the Cancer Drugs Fund which was used in England to provide access to newer forms of chemo. Most of it didn't work, and caused severe side effects. This is from the British Medical Association: https://www.bmj.com/content/357/bmj.j2097 https://www.bmj.com/content/357/bmj.j2097 This is from the Royal Society of Medicine: https://journals.sagepub.com/doi/full/10.1177/0141076818796802 https://journals.sagepub.com/doi/full/10.1177/01410768187968...

naringas 7y ago

while I have no doubt that the vast majority of vaccines work and are necessary, I believe that the efficacy of many of them should be put to the test. I believe that profit-motivated pharmaceutical companies have incentives to make new vaccines -- more sales, and if they're also cheap to make, more profit. this together with some corporate ethics, political regulators, and greedy humans and I think you can see where I'm going with this. note: I am not saying that they cause diseases, I am just advocating we review how truly necesary they all are. maybe not everybody needs the same set of vaccines? (thou I don't doubt there's a subset everyone needs) second note: unwritten rule of HN, do not question vaccines.

rconti 7y ago
third note: don't whine about being downvoted.
- deleted 7y ago
  [deleted]
delecti 7y ago
What you're suggesting already exists. Nobody gets the smallbox vaccine anymore. People only get the rabies vaccine after exposure. There are a handful of vaccines you only need if you're traveling to certain international destinations [1]. The set of vaccines that everyone gets is already subset that everyone needs. And because of people expressing unfounded "skepticism" like this, we're getting outbreaks of diseases that were being kept at bay by the vaccines. [1] https://www.cdc.gov/features/vaccines-travel/index.html https://www.cdc.gov/features/vaccines-travel/index.html
CathedralBorrow 7y ago
> I am just advocating we review how truly necesary they all are. maybe not everybody needs the same set of vaccines? Is this something you believe no one has done so far?
Mvandenbergh 7y ago
The efficacy of vaccines is tested as part of the approval process, vaccines are not profit centres for anyone, I award you zero points and may God have mercy on your soul.

dannykwells 7y ago

Everyone yelling about how the FDA is corrupt or should only screen for safety are completely ignorant of history and basic facts. Medicine is not like trying out a new coding framework - in some cases, like cancer: i) There is no ability to "try it out for your self" - you are either all in or not ii) There are extreme risks to taking the drug (most cancer drugs are actually somewhat to extreme toxic...just less toxic than cancer) iii) You only get a few tries (since, you know, cancer will kill you). iv) People are very desperate and will try anything v) Data sharing is very very hard given the sensitivity of the information (patient data) - making it effectively impossible to have an open data exchange. (This is also due to the billions of dollars at stake on the pharma side). Try designing a system to overcome those challenges...and you will likely end up with a central governing body that looks like the FDA. Anything else you are going to get way way more drugs that don't work, which waste time and money and kill people, which endanger patient privacy, or which are not satisfactory to pharma or, ... The fact is, the FDA is full of many of the smartest and hardest working doctors and scientists in all of medicine. They take their jobs extremely seriously. They are far more careful and rigorous than most academic or even pharma-level researchers. Do they get it wrong? Yes, occasionally. Not frequently. Occasionally. But that also, is science. The FDA follows rigorous statistical procedures, but even p<0.05 (or <0.001) still means false positives can happen.

gumby 7y ago
This. Having been through the FDA process myself (though we didn't make it to NDA, sob) I have to say that dealing with the Agency was great. Tedious, but great, and nothing seemed stupid except some trivialities at the margin (e.g. certain formatting issues). Honestly the worst parts of dealing with them are direct consequences of people trying to game the system. We went out of our way to make sure nothing we did could give that impression and got excellent guidance and response.
- bilbo0s 7y ago
  Same. Been through that process with a couple products from a medical imaging software startup. Extreme professionalism and competence was the lasting impression I got from my time interacting with them. We were making software that could be used in oncology for diagnosis, analysis, and treatment planning, so yeah, we got the regulatory proctology exam. But I wasn't annoyed at all. They were highly competent people who took their duty to protect the public from me seriously. I took no offense at all.

geggam 7y ago

Frankly, Me and most of America think the FDA approves things according to the highest bidder. This is one of the biggest contributing factors to the anti vax movement. | The trust in our govt and all govt agencies is simply gone.

testpostpls 7y ago
That really isn’t the truth though. What should be done?
- geggam 7y ago
  Transparency, in all levels of government. And quit equating money to speech. Lobbying is legalized bribery and everyone knows it.
avip 7y ago
Highest bidder of what?
ims 7y ago
> Me and most of America think the FDA approves things according to the highest bidder. Why do you think this?
- geggam 7y ago
  Here is one example https://ivn.us/2013/02/11/the-revolving-door-fda-and-the-monsanto-company/ https://ivn.us/2013/02/11/the-revolving-door-fda-and-the-mon...
  - ims 7y ago
    Revolving doors between regulators and industry can raise conflict of interest concerns, but this is not at all the same problem that you alluded to above.
    - geggam 7y ago

Moodles 7y ago

Last Week Tonight with John Oliver did a segment on this recently: https://youtu.be/-tIdzNlExrw https://youtu.be/-tIdzNlExrw

deleted 7y ago

[deleted]

hurrdurr2 7y ago

I do remember watching a documentary about medical devices where it describes a FDA loophole; if the device you are trying to introduce is similar to a previous already approved product then the scientific rigor involved is significantly less. I wonder if this has something to do with it.

manjana 7y ago

Can anyone comment on the validity of this publication? I'm sceptical towards the site given it's "flashy" title and I'm not well enough schooled in distinguishing good vs. bad publications.

ptah 7y ago

>to actively seek out independent, governmental and non-conflicted clinical research does this mean private sector pharma studies are to blame?

kevinalexbrown 7y ago

I read the original study. I have a few thoughts. My partner is a physician and I am an AI researcher working in medicine. I think a lot about doctors as machine learning models, and RCT results like loss terms in a complicated objective function. What is the best learning rate for updating physicians (our models) from the results of RCT's (part of our loss)? The authors reviewed all articles in three journals from (generally) between 2003-2017. They didn't, afaict (please point me if they did), review the time-to-correction (if any correction has been made). It takes some time before the results of an RCT end up in established practice. I'm actually surprised it's so small in many cases. It's not like there's a database where the results of every RCT are immediately updated and the physician model is retrained overnight on the new data. Even if there were, imagine if the learning rate (so to speak) were so high that every discipline immediately changed their published best practices on the basis of a single RCT? Here's a cautionary paragraph from one of the excellent reversal studies they use: Several limitations of the study warrant discussion. First, because we enrolled only 26% of eligible patients, our findings must be generalized cautiously. The most frequent reason that patients declined enrollment was a strong preference for one treatment or the other. Since patients' preferences may be associated with treatment outcome, our trial may be vulnerable to selection bias. Participating surgeons may not have referred potentially eligible patients because they were uncomfortable randomly assigning these patients to treatment; this form of selective enrollment may also create bias.26 Second, because the trial was conducted in academic referral centers, the findings should be generalized carefully to community settings. Third, we did not formally assess the fidelity of the physical therapists or surgeons to the standard intervention protocols. Finally, our study was not blinded, since our investigative group did not consider a sham comparison group feasible. [0] I'm less concerned about RCT to Best Practice time than from Best Practice to Typical Physician Practice time. There is a cascaded model connected to the 'complex RCT loss' and it's discipline published practice down to individual physician treating patients. Compressing the time from RCT to individual physician is fraught with difficulties, but could be improved. Finally, RCT is the gold standard, but it's not perfect and it doesn't always clearly translate to the individual physician's model of practice. Many best practices weren't established from RCT's either. And an inconclusive result from an RCT is not the same thing as proving that there's no difference in outcomes, but a proper statistician can chime in there. [0]https://www.nejm.org/doi/full/10.1056/NEJMoa1301408 https://www.nejm.org/doi/full/10.1056/NEJMoa1301408

program_whiz 7y ago

The majority of every invention / attempt will be wrong in any human pursuit. Just think, 400 useless apps or pieces of software are probably released DAILY to the itunes store. The only difference is the impact, but its still understandable. What if you had to write software that did the following: * Fixed a bug in an existing "legacy system", deployed remotely without your knowledge. You have no logs or debug information, but you can speculate on cause and try it in small simulated / test environments (e.g. rodents). By introducing this fix you would also be changing the system in unknown ways. * You only have a vague idea of how the code in the OS for this system works, your fix doesn't even change the code. Your only mechanism of change is injecting some foreign JS into a webform to cause ripple effects on the system for the user, meanwhile the system is setup to try to stop / avoid such "attacks" and will try to undo your fix if it can be detected by the system's "AI". * if your fix fails in production for even one user, you may lose millions and potentially go jail, that person may die. * You get one shot to release it to the public, after go-live it basically has to work or everything was for nothing. There is no "push this fix and everything gets better", even one small change is a complete restart (new molecule == new drug). * If you accidentally release any information about the users, or lose their data, you lose millions and potentially go to jail. * This software will take 10 years, a handful of scientists, a lab, some lawyers, lobbying, and a few billion dollars to make. * Every user using your software will be on an entirely unique stack, processing all kinds of data in tandem with your software, and will not follow directions. Some will even have lots of other bugs in the system that are unrelated to your fix.

martindbp 7y ago
Have you ever thought that maybe not everything has to be seen through the lens of software? Not trying to be snarky, but it's something I see so often here on HN and it kind of bugs me.
- Duladian 7y ago
  It is much easier to relate to a known quantity than an unknown. I would say the vast majority of people here are either programmers or at least have enough knowledge in programming to relate to it.

peterwwillis 7y ago

Most comments here are only focusing on medical devices; this is about the practice of medicine, not shitty companies! In dentistry/endodontics it was believed for a long time that installing a post helped keep a crown and tooth intact for longer. But long term studies showed posts can actually reduce longevity. In another case, a study showed that a common type of knee surgery for pain is actually less helpful than a placebo surgery. The overarching problem is that it's (currently) very hard to evaluate the real effect of practicing medicine on large swaths of the population, and then using those results to change what doctors do. By getting doctors into a continuous improvement cycle, we could identify costly, useless practices, and improve health.

EvanAnderson 7y ago

I found this one from the table of reversals to be interesting: Article: Efficacy of infant simulator programmes to prevent teenage pregnancy: a school-based cluster randomised controlled trial in Western Australia Summary: The infant simulator is an example of persuasion technology or captology, where the use is intended to prevent teenage pregnancy.26 Their use is widespread in developed countries27 and is expanding into low-income and middle-income countries.28 However, in this study done in Australia, the infant simulator-based VIP program did not reduce teenage pregnancy. In fact, girls in the intervention group (n=1,267) were more likely to experience a birth (8% vs. 4%; HR=1.35; 95% CI=1.06-1.73; p=0.016) or an induced abortion (9% vs. 6%; HR=1.33 (1.00-1.78; p=0.049) than those in the control group (n=1,567) before they reached 20 years of age. This is a reversal of the practice of infant simulator programs to prevent teenage pregnancy. A school district I contract with purchased some of these "infant simulators" a few years ago. I shared spooky photos of them entombed in foam in their storage cases (evoking visions of racks of "hibernating" astronauts from sci-fi) with my wife. She made a general observation that she thought some fraction of teenage girls would feel encouraged to have a baby after time w/ the infant simulator. Guess there was some truth to that intuition after all.

sp332 7y ago
That would only explain part of the effect. It wouldn't explain why the number of abortions went up by 50%.
- Qwertystop 7y ago
  Potentially, the subset of those girls who felt encouraged and then changed their minds.
- ljf 7y ago
  I can't find the study now, but I read previously that even filling in a questionare asking about tennagers sexual history (or lack of) increases the chance of those teenagers having children and abortions. I assume at that in some level this seeds the idea of sex and babies in a group that might have not had that thought, opportunity or imputus otherwise.

jpmattia 7y ago

It's hard to see this headline as something other than a result of The Irreproducibility Crisis.

dang 7y ago

The study was discussed a few days ago at https://news.ycombinator.com/item?id=20164809 https://news.ycombinator.com/item?id=20164809

graycat 7y ago

Remember, in research it is easy to conclude that some treatment does no good -- just do sloppy statistics. E.g., collect some data, flip a coin, and report the results of the coin flip. That will work because the coin flip is, in probability, independent of everything else including the data and treatment. Well that's not the only way to do sloppy statistics -- just pick some measures that are relevant but not very good. And use a small sample size. E.g., there are some reports on how much data was needed by the Large Hadron Collider (LHC) to conclude that the Higgs Boson DOES exist -- the amount of data needed was beyond belief. Sooooo, anytime well short of that much data they could have conluded that the Higgs did not exist, that is, so far their data failed to show that it DID exist. Same for any treatment: If don't collect enough data, use poor measures, let the data get corrupted, etc., i.e., do sloppy work, then will fail to find where the treatment did work and conclude that it didn't.

chiefalchemist 7y ago

I wonder how many of these are still covered by insurance companies. You'd think they're in ideal (data collection) position to raise questions about what works and what doesn't. Certainly, the insurance cos have more incentive to raise red flags than Big Pharma.

DoctorOetker 7y ago
upvoted this, but what happens with conflicts of interest? for example, what if insurance companies insure both patients (to cover medical expenses) and doctors (to cover malpractice lawsuit costs)? insurance company houses and systems are typically set up such that the house will statistically win out (a supposed small tax that pays for running the paper work, and manpower within an insurance company). In such a setting, where insurance companies insure both doctors and patients, the net motivation is no longer defending what works, but increasing throughput of interactions...