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FDA halts coronavirus testing program backed by Bill Gates
- LordOfWolves 6y agoBeyond the reliability of the tests, which has also been questioned of those by Abbot Labs (the same tests administered to the President), the FDA states they simply need further inquiry. Tests do not inject you with any form of matter or fluid. Why are we completely halting testing, even if it is only 1/3 correct? Just disclose that fact to the testee and/or use 3 tests for a statistically significant result. Does this reek of backdoor capitalism (corruption)?
- anonuser123456 6y agoDo you mean regulatory capture? I don't think so. More likely regulatory morass. FDA is still fighting the battle on thalidomide. But in the process, it's losing the war on many other fronts.
- ZitchDog 6y agoIt’s more likely they don’t want testing rolling out too quickly. It would appear as a new wave of infection and spook the all important Stock Markets.
- alistproducer2 6y agoDing, ding, ding we have a winner. This is the same FDA that stopped ethanol producers from making hand sanitizer, at the behest of the purell of course[0]. The feds have done practically nothing for the States making them compete each other for ppe and also confiscated shipments [1] while saying the national stock pile isn't for the States [2]. At this point I hope they just ignore the feds. We might be better off revisiting the articles of confederation at this point. Edit: adding sources 0: https://www.reuters.com/article/us-health-coronavirus-ethanol-sanitizer/u-s-calls-ingredients-in-some-ethanol-based-hand-sanitizers-unsafe-idUSKBN22C0LG https://www.reuters.com/article/us-health-coronavirus-ethano... 1: https://www.snopes.com/fact-check/trump-admin-seizing-ppe/ https://www.snopes.com/fact-check/trump-admin-seizing-ppe/ 2: https://www.politico.com/news/2020/04/03/strategic-national-stockpile-description-altered-after-kushners-remarks-163181 https://www.politico.com/news/2020/04/03/strategic-national-...
- social_quotient 6y agoAny sources for this handy?
- alistproducer2 6y agoUpdated to add sources
- social_quotient 6y agoTop notch - thx!
- greglindahl 6y ago[0] includes text like: > In one case, the FDA said it had found significant levels of the carcinogen acetaldehyde in ethanol supplied by a company for use in hand sanitizer, according to a recent email exchange seen by Reuters. Is anyone surprised that using fuel ethanol might not be a good idea for hand sanitizer?
- FireBeyond 6y agoThey also stopped distilleries from doing so. Unless the argument there is "you can ingest alcohol made in this facility, but not put it on your skin"...
- loeg 6y ago> Acetaldehyde occurs naturally in coffee, bread, and ripe fruit,[10] and is produced by plants. It is also produced by the partial oxidation of ethanol by the liver enzyme alcohol dehydrogenase Doesn't really sound like a problem in a topical solution like hand sanitizer given people ingest it regularly.
- greglindahl 6y agoThe quote said "significant levels" -- before dismissing it as "doesn't really sound like a problem", you might want to look a little harder.
- mrfusion 6y agoAny you can blame the media for jumping on positive increases and ignoring increased testing.
- taeric 6y agoI don't think you can just use three tests. Whatever caused the false positive is almost certainly a facet of the person you are testing, such that more testing of a single individual by the same test likely should be ignored. You could do independent tests, though, again it is complicated. The causal factor for the false positive is probably correlated between tests. Such that the math will be more complicated than just the inverse of any false positive rate. (Though, mayhap that is good enough.)
- didibus 6y agoSome statistician correct me if I'm wrong, but that doesn't work. You are assuming the likelihood of a test being wrong on the same individual is random every time it is taken. Which I don't think is something we know yet.
- tankenmate 6y agostatistically it depends on whether tests are independent; i.e. if the cause of the false positive is to do with the subject then using three tests won't help. if the cause of the false positive is entirely random then doing three tests will help improve the accuracy. if the correlation between false positive occurrence and the testing parameters are somewhat correlated then it may help but maybe not as much as you'd want.
- loeg 6y agoEven worse than that -- even if statistically independent, 3 instances of a 33% individual test chance of true positive does not mean 100% chance of a true positive result after 3 tests. Something like (1 - (1-33%)^3) gives you a 70% chance of true positive after 3 totally independent 1/3 change trials.
- specialp 6y agoEven the Abbott antibody test which is considered a good one is backed by a disturbingly small clinical study. The positive result pool had a sample size of around 75 people, and 1k negatives. I read the reagent insert for this. Then when labs are running this test, they have very poor correlation studies that are essentially useless. Everyone is trying to rush these tests out the door. I agree that they should start running them at scale, but all the data needs to be centralized and analyzed. They also need to bring in a lot of previously RNA tested positive COVID patients and see how many test positive. The problem with all these fragmented efforts with 100 different tests is that we never get the full picture or a good sample pool. I think the FDA does need to apply the brakes here a bit and get this going.
- rkagerer 6y agohttp://archive.is/O2x4U http://archive.is/O2x4U
- yalogin 6y agoI don't get it. From what I can gather they are not testing a new medicine or vaccine, this is purely testing. So there is no harm to patients at all. All they are trying to do is understand the pandemic and the virus. Why stop it? Correct me if I am missing something really obvious here, but I cannot help but think it could be politically motivated given that its bringing out dozens of previously undetected infected patients. I really hope its not the case but cannot stop thinking about it.
- TylerE 6y agoBecause Trump has come out and said too much testing is bad, because it might spook the almighty stock market. https://www.businessinsider.com/donald-trump-coronavirus-response-keep-stock-market-up-economy-2020-5 https://www.businessinsider.com/donald-trump-coronavirus-res...
- greglindahl 6y agoThere is harm to a patient if you tell them an incorrect test result.
- boulos 6y agoI think it’s more nuanced than that (see my other comment). If you have a false negative, then maybe they spread the disease more than they might have otherwise (unwittingly, but now with the “certainty” they don’t have it). If you have a false positive, the main downside is from people who think “great, I’ve had it / got it, I’ll be immune shortly”. So that’s the main risk to them.
- loeg 6y agoIn addition to the points raised above, a false positive could also have negative impacts on income (unpaid sick leave to self-quarantine). The false negative hypothesis is facile; even if you don't have it, you can still get it. Ignoring social distancing on that basis wouldn't be any more sensible than doing so without the test. To the extent that some people are just idiots, a false negative diagnosis does not change that.
- ZitchDog 6y agoIt’s become painfully obvious that the trump admin doesn’t want want testing rolling out too quickly. It would appear as a new wave of infection and spook the all important Stock Markets.
- coredog64 6y agoThe FDA has been a smelly dumpster fire for a long time, so I don’t think you can lay this particular issue on his doorstep.
- fzeroracer 6y agoThe FDA, much like other departments which exist as the long arm of the executive branch, depend on the president and whom the president appoints. I think it's fair to lay it directly on his doorstep considering the person running the FDA currently is someone he directly appointed.
- anonymouswacker 6y agoSo it was halted because the original requirement for this sort of testing program was for surveillance, not diagnosis. Washington's public health authorities chose to change its intention and purpose (to instead provide the results immediately to patients, also known as diagnoisis) while still expecting the FDA to approve it. This is just a case of one bureaucracy not being forthright with another one, and I don't see why the fact that Bill Gates "backs" it has anything to do with the program. Is Bill Gates somehow involved in this decision? Because one would hope that a private individual would not be have undue influence on public health organizations' decisions, especially when he has much of his wealth invested in the very industry that is likely to be affected by the results of this Coronavirus study. It's an overt conflict of interest.
- boomboomsubban 6y ago>I don't see why the fact that Bill Gates "backs" it has anything to do with the program I doubt the FDA's decision had anything to do with the Gates connection, but most study rejections don't get articles in the NYT. His backing is why it's "news," he spend/gives millions to the press to ensure it.
- anonymouswacker 6y agoYou're right. I wish NY Times were slightly above this practice, of including a polarizing celebrity with no relation to the story as if he is either A. an authority, or B. an actor in the narrative. This attracts both the audience who thinks Bill Gates' work is humanitarian, and those who think he is doing this for selfish (money/power/influence) reasons. It seems his only connection, from what I can tell, is proximity and endorsement, which are irrelevant, and only tangential to the story, which is already scant.
- FireBeyond 6y agoI disagree with that - at least in this instance. Perhaps in other situations, but if you're suggesting that a program between the major state and city health departments in Seattle (which was one of the earliest known COVID-19 cities) _about_ COVID-19 being halted would otherwise "not be news", I'm going to have to disagree. Edit: to say "halted".
- boulos 6y agoThis is pretty similar to the 23andme shutdown years ago, and for the same reason. The FDA regulates what kind of “medical advice” you are giving. From the article: > The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients. > “We had previously understood that SCAN was being conducted as a surveillance study,” the spokesperson said. ... > Dr. Topol said it would not make sense to have people swab their noses and then not give them their test results. > “To withhold that information from people is downright absurd,” Dr. Topol said. While I agree with the sentiment, the 23andme situation provides a useful counter balance: if you provide untrained people with inaccurate results, is that better or worse? In the 23andme case there was a worry that people might commit suicide or make massive life changes, if they discovered they had a potential terminal illness. Here, the 2x2 matrix of positive vs negative and true vs false, seems most dangerous on the false-positive side for people who believe it grants them freedom to do whatever they like. False negatives are dangerous for those who then feel certain they don’t have the disease currently and thus expose others unwittingly (but this is already likely!). So I dunno, I bet they’ll review this somewhat quickly (the group sent their FDA materials in a few weeks ago according to the article) particularly once they have a tighter estimate on the false positive and negative rates.
- adrr 6y agoPublic health is controlled by the state though. FDA shouldn’t have jurisdiction in preventing a state from taking actions to control an outbreak.
- loeg 6y agoThe FDA doesn't object to the surveillance study, just the part where SCAN actually give individual test results to study participants ("diagnosis"). Nevermind that the informed consent form has explicitly told study participants they might get their results ("diagnosis") since early March, after the last time the FDA "helped": https://pastebin.com/wj6fMnrw https://pastebin.com/wj6fMnrw
- mnm1 6y agoStealing PPE. Stopping legitimate test programs. What else is the federal government doing to actively hinder the pandemic response and kill people? Not to mention everything they are not doing.
- dragonwriter 6y ago> Stealing PPE. Stopping legitimate test programs. What else is the federal government doing to actively hinder the pandemic response and kill people? Using the Defense Production Act to order meat plants open (and thus prevent states from taking action to close them or make them safer if they are to remain open in the light of massive outbreaks at many of them.)
- dehrmann 6y agoWhat would happen if the King County health department ignored the FDA? Would the FDA have to sue? Could local official face federal charges?
- loeg 6y agoWhat I've gleaned from the Theranos saga is that the FDA has an office of criminal investigations and can refer cases to the DoJ for prosecution if there is a crime. I don't know if there would be a crime in that hypothetical scenario; Theranos was charged with wire fraud, and this is pretty clearly not wire fraud. I don't know if there's any recent historical precedent (since WWII) for researchers violating the FDA's notion of informed consent. It may be a type of negligence crime although I think the FDA has a pretty weak case for that.[1] [1]: https://www.encyclopedia.com/science/encyclopedias-almanacs-transcripts-and-maps/informed-consent-i-history-informed-consent https://www.encyclopedia.com/science/encyclopedias-almanacs-...
- aaomidi 6y agoOdd coincidence that Trump complains about testing too much and then a few days later FDA steps in and starts stopping testing programs.
- megiddo 6y agoThis whole thing is just making it painfully obvious that the best use of the FDA is as targets at a firing range. I think just lining them up and shooting them would result in fewer deaths than letting them continue to operate.
- deleted 6y ago[deleted]
- peace777 6y agoIf you want the truth you need to go to Amazing Polly on youtube. She has connected all of the dots behind the Pharmaceutical Industry and its corruption. Also if you want to find out how unsafe Bill Gates' Vaccines are go to Robert Kennedy Jnr's videos. You will be shocked how evil these bad people are who are dictating to us about our health etc.
- Jaxkr 6y agoReally didn’t expect to see vaccine conspiracy comments on Hacker News. Mods?
- lumberingjack 6y agoThey should shut that program down it's quite scary I'm fairly certain it's for data collection and surveillance not healthcare