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Experts Decry Randomized Ebola Treatment Trials As Unethical, Impractical
New submitter Strangely Familiar writes "A letter in the Lancet calls for alternatives to randomized trials for Ebola treatments: "Leading health experts today urge the deployment of alternative trial designs to fast-track the evaluation of new Ebola treatments. In a letter to The Lancet, 17 senior health professionals and medical ethicists, from Africa, Europe, and USA, argue that although randomised controlled trials (RCTs) provide robust evidence in most circumstances, the lack of effective treatment options for Ebola, high mortality with the current standard of care, and the paucity of effective health care systems in the affected regions means that alternative trial designs need to be considered."
Seriously, starting to experiment with uncertain approaches in a time of crisis is about the most stupid thing that can be done. Stick to what is known to work, there is no time to come up with anything better. If something better had been found in centuries of research into medical methods, then it would be the standard-approach. There is nothing. There will not be anything new even if you debate that question to death now.
This continues the series of incompetence, misinformation, self-aggrandizement and general fuck-ups that have become the signature of the fight against Ebola this time.
Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.
the news increasingly censors any opinion that would be against socialism or popular accepted opinions
I find it incredible that in the 21st century Internet-connected Scandinavia, there are no independent contrarian news outlets.
Ezekiel 23:20
argue that although randomised controlled trials (RCTs) provide robust evidence in most circumstances, the lack of effective treatment options for Ebola, high mortality with the current standard of care, and the paucity of effective health care systems in the affected regions means that alternative trial designs need to be considered."
Translation:
Even though randomized trials are the gold standard for determining whether a treatment is effective or not, these places have shitty health care systems so we think should do something else now that we know is a bad idea even though it will be detrimental in the long run rather than engage in the hard work that will really solve the problem.
Conveniently these "alternative trial designs" are not detailed in any way. Doing something different for the sake of doing something different is rarely a good idea.
We use randomized trials for VERY good reasons. If we push a bunch of experimental treatments out there it's possible we may save some lives but it is more likely we will accomplish nothing and even worse we will learn nothing in the process. Yes some people are going to die from ebola while we develop treatments. This is the cold hard fact of medicine - we sacrifice some so that a greater number may benefit eventually. You can try taking shortcuts but the odds are very long against them working and even worse you run a high risk of sacrificing future patients on the altar of compassion.
I get that people are dying and my heart goes out to them. But we do things the way we do them for very good reasons and the middle of a (minor overblown) crisis is hardly the time to start throwing out what we know for a fact works.
Oh yeah, add that to the list of problems. There isn't enough ZMapp to give it to everyone, even if it were a good idea. Since you don't have enough for everyone, why on earth wouldn't you do a randomized trial?
"First they came for the slanderers and i said nothing."
But randomized trials were designed to be used in a certain set of circumstances. The question is whether these circumstances fall outside of what those would be applicable to and what would be the appropriate protocol if they're not. Being too rigid can be a bad thing but also things should not be done in a knee-jerk fashion.
Randomized trials worked just fine for syphilis.
The signatories to that letter in Lancet are willing to shoulder any monetary and/or criminal penalties that, in the future, come about because doctors and pharmaceutical makers haven't followed eatablished best practices in pursuit of effective Ebola treatments.
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I think you happen to have a very different idea as to what "censored" means than the rest of the world. But perhaps you simply meant "censured"...
Ezekiel 23:20
Any more meaningless generalities to contribute? The field is not static or rigid. The problem is just that generating and validating new drug-trial methods takes decades and cannot really be sped-up. The whole reason we have this gold-standard of randomized trials is that all else has failed. The worst was always the physician on the ground deciding about it, as they have a strong, well-known (and understandable) tendency to always favor their own patients and an inability to clearly see what is happening as a result. That is fine as it is, of course doctors should be strong allies to their patients and try whatever is possible if the patient wants that. It is also catastrophic when objective information about effectiveness or its absence of some treatment is critically needed. All this messing around that these people propose will in the end only cause more victims, potentially a lot more.
Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.
Honestly I don't want to wave a tin foil here, but you have to admit certain parties would benefit a lot from an eventual panic or a "wide spread" Ebola occurrence.
Context - what's actually on the rise in Scandinavia at the moment is Nazism. So far, the fight against it has been a rather ham-fisted attempt to suppress it in the news, rather than engaging it and letting people see for themselves what it is. OP apparently sympathises with the rise of the far right in his country.
Er, it happened in America too and you couldn't exactly describe them as socialist.
The Democrat Party is a socialist/populist organization. So while the mantra is by the people for the people, it's still very much authoritarian from the top down once placed in positions of power. This is nothing new.
Notice this is not liberal vs. conservatism as it is so much as rural vs urban. That hold true for all other european nations as well. Rural vs. Urban.
Life is not for the lazy.
IMO you've mistaken political correctness and socialism terms for something else. Your first point about media censoring an opinion is in fact related to political correctness but after that you have no clue. Think about yourself - please answer this sincerely - if you or somebody close to you had contradicted Ebola abroad of your country would you wish your country to help you or not? After all you've had paid for your country's medical care in your taxes - and this is by no means socialism. So how would it be? Would you wish your country to help you or your close one or just leave you to certain death abroad perhaps in some uncivilized African country?
I think you happen to have a very different idea as to what "censored" means than the rest of the world.
Many people that have kooky opinions think they are being censored when others don't take their ideas seriously.
OP apparently sympathises with the rise of the far right in his country.
You don't have to agree with someone to believe that they have a right to speak.
I didn't say he didn't have the right to speak. I was just framing his comments with a bit more context.
Having the right to speak is not the same as having the right to not be called an idiot.
Randomized trials are essential withholding potential treatment from some suffering patients, to satisfy some of the experimenters' goals.
So why not allow the experimental product to be administered outside of the trial, having only passed safety standards? That can provide solid evidence for a large category of illnesses (those that people are not known to recover from spontaneously).
Then, if some folks want more rigorous evidence of efficacy, they are welcome to find patients who accept to participate in the randomized trials. Maybe by compensating them in some way for the risk they are taking? (It's possible that nobody would accept such a deal, so what?)
Or maybe by modifying the protocol so that they get the treatment for sure if their condition worsens?
These comments are mine; I do not speak for my employer.
intentionally risking the infection of people in order to save your own ass is monumentally stupid. But people tend to act in ways of self preservation when the issue is pressed and you will see things like this often. It's no different than a criminal who rats on his buddies for a lesser term in prison or the conscripted soldier who flees to another country to avoid the conscription.
So aspirin, Pepto bismol, and hydrocodone or Vicodin will cover up most early symptoms of Ebola. I guess the issue is will the news coverage be such in ways that people in these infected countries think they can be cured by going to other countries. If so, expect a raid and looting on hospital clinics and people thinking their lives will be saved if they can only get to another country.
And this is not even touching the terrorism aspect of things. Imagine someone intentionally doing this knowing that their eventual symptoms will be discovered after it is already too late. Imagine if they worked at a food stall at a busy mall or subway or right outside the government offices or court rooms or something.
No, you cannot "easily calculate" the mathematics of an alternate approach. In a clinical trial, you _create_ the experimental conditions and that is the only reason that you know them and can do calculations. Sure, if you have all data, then modeling is easy. You will not even get reasonable approximations in the situation at hand. Remember that hospitals refuse treatment to sick and dying people because they are full? Remember that people there bury their dead themselves? Remember that conditions are bad enough that likely quite a few people die that would have survived with reasonable care? You are _not_ going to get any useful numbers unless you control the experimental situation. And you make a second mistake: Even in completely controlled clinical trials, you have to estimate uncertainty before you can do any modeling. That requires intuition and experience. This nos mostly not a mathematical problem.
Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.
Nothing is being tested without success in animal models. That's not a guarantee, but AFAIK viruses in humans replicate in basically the same way that they do in animals, so odds are reasonably good that they will, assuming that they don't kill the patients or cause other harm, unless the human body filters them out of the bloodstream more efficiently. I wouldn't expect physiological differences to play nearly the same role in treatment for a virus that they would play in (for example) treatments for cancer or Alzheimer's, though I suppose it depends on the method used to disrupt viral replication.
That's okay. The records in the test group are likely to be of poor quality, too, so it will balance out. :-D
But seriously, AFAIK, we have a pretty good idea of the CFR of people treated in hospitals/clinics/*. The real record problem is that lots of people avoid going to the hospitals, which means the total death rate may be grossly underestimated, and the total number of cases may also be grossly underestimated.
There's even a minute chance that 90% of people exposed don't get sick, and that the high CFR represents the fatality rate of the worst of the worst. The medical community is relatively certain that this is not the case, but there are no guarantees.
But none of that is really relevant, because they aren't talking about prophylactically treating the entire population; they're talking about treating people who are known to be sick with Ebola, and as previously noted, we have a pretty good idea of what the CFR is among that population.
Although that would have an effect on the spread of the disease, it is unlikely to have much of an effect on how likely the infected are to die, short of policies that force people to get treatment sooner (which can be controlled for trivially by comparing people in groups based on how bad their symptoms were when they arrived).
If it is effective in only part of the population, then yes, that's true. But chances are, you can do something resembling meta-analysis after the fact to obtain the same information, as long as your records are good enough, and if they aren't... well, again, they're not likely to be good enough with a slower, more methodical study in those countries, so I'm not sure what difference it makes. :-)
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And you can't really be sure without a control.
Is the fact that there are less dead people in the zmapp group vs the current untreated death rate not enough of a control for you?
You're talking about a zmapp group composed of people who are well fed their entire lives, of a different racial composition, and who received care in first world hospitals. Your control group is a bunch of people being given palliative care for the most part in tents and the like, most of which who probably have never been to a doctor otherwise in their entire lives.
No, that isn't a controlled experiment.
You people don't know shit about how medical studies work, there are only two outcomes with this virus, and that is dead vs not dead. It would be very easy to derive the P value of the zmapp treated group relative to the known death rate of the virus.
Anybody can load a pile of data into a statistics program and have that program output numbers. Those numbers only mean something if the data was any good. You can't do an uncontrolled experiment and get a real result out. Sure, you might use this kind of data to decide whether the expense of doing a controlled experiment is worthwhile, but on its own there are so many reasons that the results could turn out wrong they're nearly worthless.
Don't feel too bad though - lots of researchers do things just the way you describe, which is why the US spends all kinds of money on treatments that have little evidence supporting their effectiveness. While everybody likes to pick on drugs, the irony is that at least recently these tend to have quite a bit of rigor behind them. The real black magic are things like surgical treatments and the like.
Oh, and while you're doing your uncontrolled studies you should just try injecting patients with saline solution. I would expect it to have a noticeable impact on Ebola death rates - the placebo effect works on just about anything that has ever been tested.