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With a major pandemic sweeping the world, the standard process of clinical trials for drug approval has come under criticism as a needless source of bureaucracy and delay. Drug discovery chemist Derek Lowe in a blog post explains how clinical trials for drug approval work and the reasons behind the various requirements that the FDA and equivalent organisations around the world generally put in place before approving a new drug. He explains how most of these apparently pointless bureaucratic hurdles are actually there to help protect the integrity of the scientific process and ensure that the human subjects undergoing the trials are treated ethically. While a case can be made for relaxing some of these safeguards, especially in this time of pandemic, it is probably not a good idea to do so without at least understanding what these safeguards are for.
Determining how much of a pharmaceutical is needed to prepare for the trial. Ensuring your are actually preparing just that drug and not a polymorph. Proper laboratory and manufacturing practices to ensure the desired drug is actually prepared without impurities and contaminants. Preparing a plan for a drug trial. Demographics — age, gender, weight, current medications being taken. Getting a representative distribution of these as participants. And there's much more.
(Score: 1, Touché) by Anonymous Coward on Saturday May 02 2020, @09:24PM (3 children)
And then after the trials are complete and the FDA gives approval, you may inject the bleach in the lungs.
(Score: 1, Informative) by Anonymous Coward on Saturday May 02 2020, @11:12PM (2 children)
Only using the patented process of course.
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @01:35AM (1 child)
(Score: 2) by Muad'Dave on Monday May 04 2020, @12:48PM
Then why have they extended the patent 13 times, out to 2030 [qz.com]?
(Score: 4, Interesting) by Anonymous Coward on Saturday May 02 2020, @10:06PM (6 children)
saw a comment where someone asked the why of occupational regulations that seemed to not be needed because "wouldn't common sense keep that from happening", and the answer was "every regulation was because of at least one person's death". they don't seem so onerous in that light...
having personally witnessed a work accident (no death, just crushed fingers on both hands) due to someone's stupid behavior... and rumors of a former classmate screwing around with a nail gun, who nailed his head...
the biomedical world is full of stories from way back... 'mercury is bad, mkay?'
(Score: 0, Flamebait) by Ethanol-fueled on Saturday May 02 2020, @11:13PM (3 children)
Lemme guess, press brake? I've seen 2 different Mexicans lose 2 different fingers at 2 different employers with the same type machine. And then there was the one with the hydraulic shears where the instrument was deactivated but the shears were still pressurized. Nail gun stuff is pretty easy to do, heard about a framer who nailed his hand to a post, pulled the bitch out, threw on a bandage and went right back to work.
(Score: 0) by Anonymous Coward on Saturday May 02 2020, @11:26PM
If that happened at my workplace, 1/2 the building would clear out and go on sick leave for PTSD.
(Score: 2, Interesting) by Anonymous Coward on Sunday May 03 2020, @02:43AM
no. we were teens working at a greenhouse. It was a mundane job at a greenhouse. I was on one end of conveyer belt, filling 4" square pots with soil, putting the flats on the belt. the other two took the flats off and put them pn pallets. They got bored, and wanted to play chicken with the conveyer and their fingers, to see how close they could get their fingers before they got sucken in... well, one of them lost.
as they say, some things cannot be unseen.
another was a colleague who used to work at a sawmill on the green chain crew. one of his coworkers tried to stop a mistake he'd made... got both hands removed... that story was funny only for a sec until I saw the 1000-yd stare look in his eyes after he told it...
so, tell me again how bad working from home these days really is?
(Score: 0) by Anonymous Coward on Monday May 04 2020, @05:37PM
Your shitposting always seems to coincide with the POTUS getting in trouble. Is your world view really so fragile?
(Score: 1) by khallow on Sunday May 03 2020, @10:48AM
Or because someone got bribed (like a 70 year phone monopoly) or needed to look like they were doing something (most nuclear power regulation and modern airport security). They don't seem so onerous in that light, amirite?
(Score: 2) by toddestan on Sunday May 03 2020, @06:24PM
I would also assume like the occupational regulations a big part of it is to try to get large companies to do the right thing. Common sense can go a long way with stuff like heavy equipment, but there is also a conflict of interest when the people buying the equipment aren't the ones that have to use it, and for the ones that do it's either use it or look for another job.
With for profit drug companies, there is a huge amount of pressure to get that drug out on the market. I would assume that a lot of this stuff is so that when a drug company claims that some drug is safe and effective, that we have some assurance that is actually the case.
(Score: 5, Insightful) by aristarchus on Saturday May 02 2020, @10:17PM (13 children)
There is a reason clinical trials have to be so complicated. The primary one is that Pharma companies are greedy. They will fake results given the chance, because billions of dollars are at play! We have seen this among the investing class here on SoylentNews, with Sulla and others speculating on what stocks of what companies to buy.
Second, fear and paranoia. Sick people are easy marks, and "I told you I was sick" people even more so. They need to be protected from unscrupulous snake oil peddlers, Fox News, and the President of the United States, Impeached.
Third, emotional investment by researchers. Even Dr. Didier Raoult probably has an egoistic interest in his research being successful, and thus saving lives. Non-medical researchers are not so emotionally tied up in outcomes. Between the researchers wanting positive results, and the patients in a trial desiring positive results, a double whammy of confirmation bias ensues.
Conclusion, Clinical Trials are not overly complicated. Any one who says so is no doctor, is no medical professional, and probably is a anti-regulation Libertard-Republican looking to make big bucks off of death and dying, fear and paranoia.
(Score: 4, Interesting) by JoeMerchant on Saturday May 02 2020, @10:41PM (5 children)
My favorite "told you so" moment in an FDA application was when the data for a new product, patented and developed by a single M.D. who owned a majority stake in the company was all collected and analyzed by the same M.D. I advised the CEO in no uncertain terms: what you're trying to do here is a complete and total conflict of interest, there's no way they're going to approve this, response: "getting other doctors to collect and analyze the data is too expensive, we have to at least try to submit like this." Yeah, o.k. burn 6 months of development runway while you get your rejection. Oh, and burn another 90 days by failing to file an extension request by the deadline - kids these days (CEO was 27) think that bureaucrats are soft-touches like their parents, I guess they have to learn somehow.
🌻🌻 [google.com]
(Score: 4, Interesting) by anubi on Sunday May 03 2020, @01:03AM (1 child)
I've always felt that responding with exactly as you see it, not what you think they want to hear, is in the long run the best policy, even if in the short run you have to find another job.
Office politics is a bear that i have never successfully fought.
Clinical trials take so long for the same reason I take so long. I want to make damned sure I don't release half baked work. Trouble is a lot of executive-class people demand half-baked work in the interest of quarterly profit goals and bonuses.
You sound like the kind of guy who is satisfied with nothing less than the best, lots of A's, Dean's List, and so on...and did your own work, not copy someone else's. Simply because you did not trust it.
It took lots of time to do it this way, but there is a comfort in knowing it's done right. It's tough for people of this mindset to subordinate to someone else who prides themselves in making the quick buck by cheapening the product.
Anyone think Elon Musk or Bill Gates would have made a decent employee?
Anyway, that's a great post, seen from the inside, of how half-baked stuff makes it out if proper checks and balances are not in place.
My hope is they run the clinical verifications, do it right, and give it to me straight...regardless of the outcome or investor interests.
"Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
(Score: 2) by JoeMerchant on Sunday May 03 2020, @03:54AM
I work for a big place now, and that's their HR approved messaging "from the top down," and, they're not wrong... even though human nature tends to avoid the confrontation in bringing bad news.
Yes, and no. If I won a major lottery, I'd probably devolve into perfectionism because I enjoy it. Back in the real world, doing the most good for the most people usually involves knowing when to cut and run, accepting the minor flaws for the greater good. That same big company takes mistakes very seriously and really strives to avoid embarrassment (which is horrible for innovation, we end up expanding/innovating by acquisition 90% of the time), but... they also develop and refine policies to review product and accept "acceptable imperfections" in recognition of the fact that a product that never ships never does any good for anybody, and we make stuff that's complex enough that it's never perfect.
🌻🌻 [google.com]
(Score: 2, Interesting) by Anonymous Coward on Sunday May 03 2020, @05:29AM (2 children)
I ran into one of those. I did the blind statistical analysis on the equivalent of preregistered study. Crunch the numbers according to the scope. I got back an email requesting a particular "Tee Test." Now, a t-test of any kind would have been totally inappropriate, especially without being in the registered protocol without justification. I refuse, while copying the appropriate people to cover my ass, and rescind permission to my previous work.
Months later, I get a call. "Hello, AC. I'm $VERY_IMPORTANT_PERSON. So I'm looking at some stuff here and it looks ... Well ... I'll just put it this way, did you do analysis for $STUDY?" I told them I emailed them months ago about it. Situation diffused, they catch me up. Turns out the person redid the analysis and left out every single comparison measure except for the t-test they asked me about. Turns out that was the only comparison found with significant results if uncorrected. They then lied to cover their ass and tried to throw me and other collaborators under the bus. Ended up costing them everything once their reputation was shot.
I just laughed so hard when I got a copy of their work. Looked like they followed a walkthrough online of how to do the basics in R and put what that spit out into the document. Nobody cares about your descriptives for unused variables, variable Q-Q plots or the mean of ordinal, non-interval variables. Trying to baffle them with bullshit so they wouldn't notice the meat was missing, I guess. And it probably just ended up calling more attention to the fact it wasn't there.
(Score: 5, Informative) by rleigh on Sunday May 03 2020, @09:18AM (1 child)
I've seen this in academic research as well. I've seen people trying different statistical tests until they find one which is significant. Stuff like using U tests where a T test would be appropriate. "But you can't do that, your data is parametric and it's clearly not significant. Sorry, but your data is simply not showing what you want it to show". "Well, it's publishable if it's significant, and the U test shows significance". Shocking. And this was for medial research as well, so it would have potentially influenced clinical studies. It's no little wonder that so much published life sciences work is later retracted. It's marginal at best. At worst, it's fraudulent. But the pressure to publish is so great, too many people try to bend the rules. It's one of the reasons why I didn't succeed as an academic. I outright refused to publish incomplete or misrepresentative data, which didn't make me popular.
A friend of mine went to the US to work for the NIH on some postdoc. Couldn't reproduce the previous postdoc's research, but was supposed to continue that line of investigation. After spending months trying to reproduce their results, they basically found that they fabricated everything. They raised this, but the previous postdoc had gone on to a high profile position and start actual clinical trials based upon this fraud. He ended leaving academia; doing the right thing is a career-ending move. No results to show for that postdoc? Out. Doesn't matter that you're actually a good researcher. That person not only killed the career of at least one promising scientist, they actually started human clinical trials based upon a complete fabrication.
I've also worked for a pharma company on various drug screening assays. I would have so say, they were far more diligent about good experimental design and statistics than academics. They employed full time staff for data analysis and statistics, as well as scientists. The accuracy of the results determined which drugs would proceed further in the pipeline, so they genuinely cared about not picking a dud which would fail down the line. They had the opposite problem. Despite making better and more detailed experimental models for assays (high-content screening), drug performance in cell-based assays was not sufficiently predictive of behaviour in whole animals or human trials. A drug could kill cancer cells like no tomorrow on an assay plate, yet be ineffective (or toxic) in reality.
So based upon these experiences and observations, I'm happy that there is a high bar to meet. There's too much untrustworthy nonsense out there. The trial has to independently prove the safety and efficacy of the treatment. I'm sure that some of the red tape could be cut; not all of it is strictly necessary, and some of it is to raise the bar to competition, but that would need to be done very carefully to not remove some of the strictly necessary barriers.
(Score: 2) by JoeMerchant on Monday May 04 2020, @12:46AM
They know the value of C'ing their A's... a lot to lose when you're a Trillion dollar enterprise.
🌻🌻 [google.com]
(Score: -1, Flamebait) by Anonymous Coward on Saturday May 02 2020, @11:25PM (2 children)
They need to be protected from unscrupulous snake oil peddlers, Fox News, and the President of the United States, Impeached
Because, yeah...fuck having any hope. You should be WANTING this shit to work. Yet you seem to have a different attitude on it. Why is that? Did your bitch lose the 'in the bag election'?
You have to look no further than the current accusation against Biden. We went pretty damn quick from 'believe all women' to 'welllll acccchtuuuuly'. That pretty much proves all of this histrionics has zero to do with actual issues. It is 'wah wah wah we lost'. Throw whatever shit at anyone. Make sure it sticks.
Impeached
And exonerated. For 'hey that looks like a crime look into it'. Sure do not see anyone pissed off what Biden and his son were up to. Even *if* Trump did something wrong, so did they. But lets not talk about that. It was just as BS as the one they did against Clinton.
(Score: 0) by Anonymous Coward on Saturday May 02 2020, @11:29PM (1 child)
> You should be WANTING this shit to work.
You proved his point - you're all stakeholders in the outcome and can't be trusted.
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @12:34AM
Duh. That's why politics exists. We're all biased and is impossible to trust each other's motivations, so we have to conjuring's and try to figure out acceptable solutions.
(Score: 4, Interesting) by Anonymous Coward on Sunday May 03 2020, @01:26AM (3 children)
Greed is not solely tied to one side of the political spectrum. Big money is a powerful temptation to commit research misconduct regardless of political party.
Dr. Fauci has been promoting the results from one remdesivir clinical trial [statnews.com], saying there's clear-cut evidence that remdesivir works. It would be good to know whether or not he has any financial interest in Gilead. So far, I haven't been able to find this information.
There's good reason to question the results of this clinical trial. There are experimental design of one of the Gilead trials [statnews.com] of remdesivir. Leaked results from a trial in China showedno evidence that remdesivir is beneficial for coronavirus patients [statnews.com]. In the study Dr. Fauci is referencing, the standard for evaluating the efficacy of the drug was changed during the study [washingtonpost.com] from tracking the number of deaths or patients on ventilators to the mean recovery time. While a statistically significant difference was reported in mean recovery time, the difference in the death rate was not statistically significant. Scientists have raised concerns about approving the drug prior to releasing the data from the trial [qz.com] for other scientists to examine. Dr. Fauci chose to release the results early like he did [reuters.com] out of concerns about the results being leaked.
I hope remdesivir really does have efficacy at treating the coronavirus. But there are a lot of trials with questionable methodologies producing conflicting results about drugs like hydroxychloroquine and remdesivir. While some studies claimed that hydroxychloroquine is effective, a large study at the VA suggests it has no benefit in preventing patients from being placed on mechanical ventilators [medrxiv.org]. It's also worth noting that the standard in the VA study of whether patients are placed on mechanical ventilators is different from the standard in the remdesivir study.
My intuition is that Dr. Fauci was just excited about the first study showing a statistically significant positive result versus a placebo for treating the coronavirus. But the question about conflicts of interest is still valid. I'm a researcher in a different field, working in academia. Yesterday, I received a notification that a proposal I submitted a few months ago has been recommended for funding. Before my university processes the award, I'll need to fill out a form disclosing any potential conflicts of interest. And I'll be required to submit a new form every year disclosing any conflicts of interest. Scientists are expected to disclose possible conflicts of interest. Dr. Fauci has been a principal investigators on other awards and didn't have any relevant financial disclosures, but I couldn't find specific information if he has a financial interest with Gilead. Dr. Fauci is a fellow scientist and it's completely fair to ask scientists if they have conflicts of interest.
(Score: 5, Interesting) by Anonymous Coward on Sunday May 03 2020, @02:05AM (1 child)
Has Fauci been "pushing" this drug? I give him a lot of slack given the fine line he has to tread. He has to delicately caveat and temper false hope spouted out of the President, but do it in a way that doesn't embarrass him. Plus he is under tremendous pressure to "wrap all this up" and put a happy spin on everything.
By the way, I work in the Federal Government and every year I have to take an ethics training as well as file a financial disclosure form. Do you know how galling it is under this administration to sit through an ethics course and filling out my disclosure form when our "bosses" flagrantly ignore all of it without ANY repurcussions? It is pretty demoralizing, actually.
(Score: 5, Insightful) by hendrikboom on Sunday May 03 2020, @02:59AM
And that's how a culture of corruption gets established and propagates itself. By demoralizing the honest.
(Score: 1, Interesting) by Anonymous Coward on Sunday May 03 2020, @06:13AM
I've defended the new Remdesivir results. There are key differences in that study compared to many others, but we will have to see the actual preliminary results before anything can really be said. With that out of the way, changing the primary measures happens in studies, especially switch a primary and a secondary. Now, they are correct that this is usually very suspicious because it suggests blinding has been removed or something else fishy is going on, but the preliminary results should give a much better picture of who, when, where, why, and how it was changed.
In addition, there are key differences in this study, according to the public information on it that we have, and ones like the Chinese one in the Lancet. For example, there is a large disparity in group sizes, comorbidity ratios, and other characteristics in the Chinese study that would favor the placebo group. It also had a relatively low statistical power.
To me, this whole thing reeks as the NIAID and the government in general being desperate to come up with something now. The existence of a known mechanism and these preliminary results are an interesting indication that there may actually be something there and is a stark contrast to what came before. When used on patients that aren't nearly as sick, this could be a veritable "miracle drug" such as they can exist. But it is too easy to take shortcuts under political and other pressure. This could just as easily be an ineffective and expensive dud or turn out to net-harm healthier people due to side effects or iatrogenic adverse events.
(Score: 5, Insightful) by JoeMerchant on Saturday May 02 2020, @10:35PM (22 children)
There are some very good scientific/biological/statistical reasons why clinical trials are complicated, expensive, and long drawn out processes... however, there are also some straight up barrier to entry reasons behind it too. The "Big Pharma" can handle the cost and complexity, and smaller players can't; Big Pharma likes it that way and has goosed the scales a bit to keep their exclusive club as small as possible - after all: competition is bad for profits.
Double-blind (where appropriate) multi-stage (to reduce risks to study subjects) multi-population (because 140lb white women from Boston are NOT the same as 240lb Hawaiian men) are all important to ensure that we really know what a drug is going to do before "testing" it on hundreds of millions of people.
🌻🌻 [google.com]
(Score: -1, Troll) by Anonymous Coward on Saturday May 02 2020, @11:15PM (10 children)
Rubbish! Give it all of them and let herd immunity sort it out. That's the invisible hand taking your rectal temperature with its penis if you didn't notice.
(Score: 2, Interesting) by anubi on Sunday May 03 2020, @01:11AM (9 children)
You have a crude way of saying it, but invariably, herd immunity or tolerance will be the final outcome.
If it didn't, leprosy would have eventually wiped out the whole human race. Or that Covid19 would have completely wiped out those Chinese bats who supposedly gave it to us.
"Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
(Score: 2, Informative) by Anonymous Coward on Sunday May 03 2020, @03:18AM
leprosy takes 20+ years to start presenting symptoms. and it is relatively hard to get in the first place. it has never reached epidemic status, even though it is still endemic in some regions.
(Score: 3, Insightful) by JoeMerchant on Sunday May 03 2020, @04:07AM (7 children)
Part of why it spreads so well is that a very large percentage of us already have immunity/tolerance - it's turning most of the people it infects into "Typhoid Marys."
Latest numbers I've heard are 63,000 dead in the US, that's somewhere around 0.02% of the population, and I have a hard time believing that our present total infected level is less than 0.5%. In other words: I believe the overall death rate is pretty far below the 3.4% level that I've seen quoted. Which is fine, people wouldn't take it seriously if you told them the overall death rate after infection was 0.1%, and below age 70 was 0.01%, and the whole "curve flattening" thing wouldn't work.
🌻🌻 [google.com]
(Score: 1, Interesting) by Anonymous Coward on Sunday May 03 2020, @06:33AM (2 children)
Viruses usually evolve to be less lethal due to the selective pressures on them. Last I checked, the various clades already have drastically differing mortality rates. They are also not distributed geographically in an even fashion, which is part of the reason why death rates are so different. It wouldn't be too surprising if those less-lethal strains are dragging the overall mortality rate down. Either way, the phylogenetic analysis will be interesting.
(Score: 2) by hendrikboom on Sunday May 03 2020, @04:07PM (1 child)
We can hope that immunity against the less-lethal strains confers immunity against the more lethal strains.
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @08:40PM
It should. It is the major reason the Pandemic Flu disappeared.
(Score: 1, Informative) by Anonymous Coward on Sunday May 03 2020, @08:29AM (1 child)
(Score: 2) by JoeMerchant on Sunday May 03 2020, @12:37PM
Absolutely, and we should take measures to prevent that. Hell, we should also have taken stronger measures to prevent the million+ deaths caused by Gulf War II. It's just a shame that you have to lie to the general population to get them to react in an appropriate manner.
🌻🌻 [google.com]
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @11:46AM (1 child)
Seems to work here in Germany.
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @02:36PM
We know that Germany is reporting the underlying condition as the cause of death even if a person is infected, and that in the US we are reporting covid as the cause of death even if the person has an underlying condition. I spent some time yesterday trying to figure out Canada's death criteria but couldn't find it. Anyway, the point is, all these numbers being thrown around are just numbers and may not be all that comparable and whether Germany has or has not flattened the curve is hard to know.
(Score: 5, Insightful) by stormwyrm on Sunday May 03 2020, @02:44AM (6 children)
Numquam ponenda est pluralitas sine necessitate.
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @03:20AM (3 children)
be careful.
much of how we treat and know about hypothermia is from Mengele.
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @09:58AM (2 children)
(Score: 2) by driverless on Sunday May 03 2020, @12:34PM (1 child)
I don't think we'll ever really find out whether those studies were useful or not: Can you see the NEJM publishing a paper "Nazi Medical Research Was Actually Quite Useful In Some Cases"? Certainly after the war the Allies scrambled to get their hands on the Nazi study data, and former Unit 731 members were snapped up by the US, so there was obviously some use for it. "Totally unethical but now it's been done, may as well use it".
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @02:29PM
(Score: 2) by JoeMerchant on Sunday May 03 2020, @03:46AM
Barriers are good, and the scientific barriers should be higher than they are (or, alternately, an increased level of transparency on the already established scientific standards). What's not so good is that some of the barriers are costlier than they have to be to get the good science. Want to setup a new animal research lab? The requirements are beyond gratuitous, they're basically saying: "if you don't already have one, you're not going to get one."
🌻🌻 [google.com]
(Score: 2) by The Vocal Minority on Sunday May 03 2020, @05:17AM
Article was a good read - thanks for submitting this one.
(Score: 2) by driverless on Sunday May 03 2020, @08:01AM (3 children)
It's not just the obvious "hurr durr big pharma bad" that the previous thread degenerated into, there are so many things you need to control for that the tests end up being incredibly complicated and expensive. In particular as we've become aware of more and more things that can confound trials we've needed to add more and more mechanisms to deal with them. Look at what happens when you don't do it. As a well-known example, a certain Dr.Raoult in France, who doesn't believe in evolution, climate change, ..., and most importantly evidence-based medicine and who resigned from the editorial boards of several ASM journals after he was caught fudging experimental results in a journal paper, runs a... well, he called it a "trial" but one that met none of the requirements for a randomized controlled trial (RCT) - it's not just that he missed one of the requirements, he missed all of them - and the outcome was chaos. This is why there are stringent requirements for clinical trials, and why they tend to be really complex and expensive.
(Score: 2) by JoeMerchant on Sunday May 03 2020, @12:49PM (2 children)
In my opinion, the cure for most of these problems is transparency. When you get a "trial" run by another Raoult (and they are legion), with sufficient transparency in the process it can be called out for what it is, not only by competitors but also by watchdogs.
People complain that automation is taking away all of their jobs - I think there's a huge industry waiting to be born in "industrial monitoring" - just because it only takes 100 people to run an industry that supplies all the corn for a continent doesn't mean those 100 people are doing their jobs in a way that meets the needs, or wants, of the corn customers. I'm not saying the 10,000 people employed by the proposed continental corn monitoring congress should tell the corn producers how to do their jobs - not exactly - but they should be telling the customers / consumers how the job is being done and provide them with the option to source their corn from preferred suppliers. A billion corn consumers can easily afford the $1 per year it would take to pay 10,000 people $100K per year to diligently monitor and report on the corn manufacturing and supply channels, and each other. Same thing could/should be applied to pharma, energy, foods in general, etc.
🌻🌻 [google.com]
(Score: 2) by driverless on Sunday May 03 2020, @12:53PM (1 child)
In theory we're already doing this, it's called "taxes" and "government regulators", problem is that many of them have been captured by the industries they're supposed to be watching. It does work in some areas, e.g. water quality monitoring, and in some countries which take it seriously. Problem is that in the US too much government oversight is communism or socialism or something and so you can't have it.
(Score: 2) by JoeMerchant on Sunday May 03 2020, @01:32PM
In the med device industry, regulation is effectively forcing the companies to do it to themselves - what's lacking is transparency to the consumer level. The device companies employ legions of compliance officers who ensure legally compliant levels of documentation and traceability discoverable by regulator (government, or agencies mandated to exist by EU regulation) audit. What I'm proposing is greater transparency / exposure of this kind of information to the end users of the products - and shifting the reporting structure such that the "transparency officers" don't report to the same CEO who is bonused on quarterly profits.
As alluded to above, the EU regulators (ISO-9000 notified bodies and similar) are moving closer to this "monitoring by the people" model, but they still lack transparency to the consumers. Their scope of discovery is also tremendously restricted, the opposite of transparency. There's no reason that corporate internal financial details should be secret - following the money is often the most direct route to expose corruption.
🌻🌻 [google.com]
(Score: 4, Touché) by fadrian on Sunday May 03 2020, @01:30AM (17 children)
Everyone (at least of the Libertarian bent) knows that all of this is only meaningless governmental red tape. And it's keeping much needed medications from covid patients. Who needs all that science stuff, anyway, when you have true belief backed up by lack of evidence?
That is all.
(Score: 0, Troll) by Anonymous Coward on Sunday May 03 2020, @01:59AM (8 children)
You may cover your ass with however many layers of lawyerese you want. But in the end, it is your doing nothing, your dragging your feet, your obstruction, that costs people their lives. The maybe-possibly-by-long-shot-once-in-a-blue-moon chance of someone harmed by violating the protocols, versus hundreds, or thousands, or tens of thousands certainly dying while things that could save them, percolate through the bureaucracy or wither on the vine.
If you believe in any higher power, do you think that He is bound by the letter of mundane lawyering? Or maybe, just maybe, He will hold people responsible for the consequences of the decisions they make? And for the consequences of decisions they actively support?
(Score: 3, Insightful) by Anonymous Coward on Sunday May 03 2020, @10:51AM (4 children)
Current testing protocols may delay useful treatments, but they also catch a lot of non-useful or downright dangerous ones. Guess which ones are more common?
As to the higher power thing, there are too many stories about too many higher powers to take any of them seriously.
(Score: 2, Disagree) by khallow on Sunday May 03 2020, @11:19AM (3 children)
Nobody has proposed ignoring testing altogether.
People dying from the absence of useful treatments. By many orders of magnitude.
(Score: 0) by Anonymous Coward on Monday May 04 2020, @05:45PM (1 child)
"Nobody has proposed ignoring testing altogether."
Wow, khallow actually said something factually correct! But oh no, it looks like being technically true is less important than being effectively true. Tell me, didn't someone high up in the gov promise that anyone could get tested? Also, hasn't testing been the number one tool countries have successfully used to contain COVID?
I'll check back later after you've had a chance to look over the propaganda response predictions.
(Score: 1) by khallow on Monday May 04 2020, @06:36PM
And then you kept writing for some reason. Pro-tip: when you have nothing to say, then saying nothing is a good move.
(Score: 0) by Anonymous Coward on Saturday May 09 2020, @05:41AM
This is indeed true. But playing fast and loose with scientific testing as you seem to be proposing is not going to make those useful treatments get found more quickly, in fact they may make them harder to find. Relaxing standards of scientific rigour will instead encourage the proliferation of bogus treatments of questionable usefulness. If we do not demand reasonably good standards of scientific evidence of safety and effectiveness, and there are no short-cuts to to obtaining that, we might bury real treatments that actually work in mountains of bullshit.
(Score: 4, Insightful) by rleigh on Sunday May 03 2020, @12:27PM (2 children)
Are you aware of the number of drugs which fail to get through clinical trials? It's most of them. Only a small number make it through. The consequence of this dynamic, is that if you were to relax the stringency of the testing, you would allow more bad drugs through than good ones. That's not an acceptable tradeoff.
Is there more red tape and delay than absolutely necessary. I think that's pretty much a given with any bureaucratic system. But most of that "obstruction" and "delay" itself serves an important purpose: protecting lives from toxic or ineffective pharmaceuticals.
People might be complaining right now that various drugs aren't being fast-tracked. But they would complain even more if they got fast-tracked, and later on were found to cause all sorts of horrible side-effects and were less effective than no treatment at all.
(Score: 0, Flamebait) by khallow on Sunday May 03 2020, @12:30PM (1 child)
But they still might live longer and better on average. Bellyaching isn't everything.
(Score: 2) by rleigh on Sunday May 03 2020, @05:06PM
That is very much in doubt. Most drugs fail clinical trials, and the urge to fast track stuff through is not borne out of logical thinking. It's borne out of the desire to be seen to be doing something, anything, even when this is known to be a counterproductive course of action.
We already know this. It's simple probability based on existing success rates.
Look at the various drugs that have been proposed. I've read very mixed things about them. Some apparently raise the chance of dying, so rather than helping, they are hindering. The only way to be sure is independent trials, to definitively show one way or the other if there is a quantifiable benefit. To act without full information can be worse than not acting at all.
Some things can be potentially fast-tracked. Off-label use of existing, approved pharmaceuticals, is one means. The safety testing is already done, and doesn't need to be repeated. You need to prove that it provides a quantifiable benefit for a new purpose. But the toxicity and side-effects should be well established.
(Score: 1, Flamebait) by khallow on Sunday May 03 2020, @10:58AM (7 children)
(Score: 0, Troll) by Anonymous Coward on Sunday May 03 2020, @11:43AM (6 children)
Try injecting that Clorox. I'm sure it will help
I guess also you liked those Nazi experiments too. What is it, losing a few jews to improve the lives of the superior race?
https://en.wikipedia.org/wiki/Nazi_human_experimentation [wikipedia.org]
(Score: 1) by khallow on Sunday May 03 2020, @12:28PM (5 children)
(Score: 2) by MostCynical on Sunday May 03 2020, @08:59PM
$300 epipen?
Not [bloomberg.com] everywhere [corporatecrimereporter.com]
"I guess once you start doubting, there's no end to it." -Batou, Ghost in the Shell: Stand Alone Complex
(Score: 0) by Anonymous Coward on Monday May 04 2020, @02:24AM (3 children)
$300 epi-pens has nothing to do with trials. Epinephrine passed its trials decades ago. And patents on the early auto-injectors should have expired, since they date back to the early '80s.
(Score: 1) by khallow on Monday May 04 2020, @03:57AM (2 children)
Barrier to entry. [thehill.com] The cost of clinical trials and the FDA's regulatory maze go a long ways to making those prices possible. From the link:
(Score: 0) by Anonymous Coward on Monday May 04 2020, @04:00AM (1 child)
So why are those companies trying to develop new auto-injectors rather than use older ones that were already approved?
(Score: 1) by khallow on Monday May 04 2020, @05:38AM
(Score: 2) by All Your Lawn Are Belong To Us on Monday May 04 2020, @04:01PM
Laudanum
Banbar, and Any Number of BS Patent Medications
Sulfanilamide
Tuskeegee
Thalidomide
FenPhen
And quite possibly we can now add hydroxychloroquine in relation to COVID. Hopefully remdesevir will do better, although I've yet to digest the article in the summary saying it doesn't.
The latter two are still available in some circumstances, the point being that even after the laborious process of drug approval serious adverse effects can become known. Plus the basic idea that things become as they are because of reasons one can point to in the past. Just because it is difficult does not make it right, but nor does it make it wrong. Plus, as we've been seeing, there are routes available for more rapid approval for drugs when there is an ethical imperative to do so.
But hey, read for yourself the history: https://www.fda.gov/media/110437/download [fda.gov]
This sig for rent.