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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: 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