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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."

10 of 193 comments (clear)

  1. Yea, best form a comitee to consider all options.. by gweihir · · Score: 4, Insightful

    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.
  2. Translation... by sjbe · · Score: 3, Insightful

    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.

    1. Re:Translation... by TWX · · Score: 2, Insightful

      Between the high mortality rate and the apparently high transmission rate, coupled with cultural structures that are making the likelihood of spreading the disease post-mortem exceedingly high, they're simply desperate to find anything that will stop it. It also means that for those that are infected, there's so little chance of survival with "traditional" treatments that they have very little to lose by trying something experimental. Even if a treatment gives them cancer, or HIV, or leaves them with something like chronic fatigue syndrome, they're still going to enjoy quality of life better than they would if they're dead.

      If there's any time to drop stages between reasoned research and application on human patients, this is it. Look at each and every patient as they're treated and attempt to monitor them after-the-fact.

      --
      Do not look into laser with remaining eye.
  3. Re:ZMapp by phantomfive · · Score: 3, Insightful

    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."
  4. Re:Yea, best form a comitee to consider all option by Richy_T · · Score: 4, Insightful

    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.

  5. Re:Yea, best form a comitee to consider all option by gweihir · · Score: 4, Insightful

    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.
  6. Re:Our PC society will be our demise! by beelsebob · · Score: 4, Insightful

    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.

  7. Re:Our PC society will be our demise! by ShanghaiBill · · Score: 3, Insightful

    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.

  8. Re:Our PC society will be our demise! by beelsebob · · Score: 3, Insightful

    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.

  9. Re:Yea, best form a comitee to consider all option by Rich0 · · Score: 3, Insightful

    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.