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Ebola Vaccine Trials Forcing Tough Choices
An anonymous reader writes: Medical researchers hope an experimental vaccine for Ebola can help protect against infection and slow the spread of the disease. Efficacy trials for the vaccine begin in a few months, and it's forcing some difficult decisions for health care officials. The first test will involve front line health care workers, who, as a group, are at the gravest risk of infection. But every trial needs a control group, and scientists are bitterly divided over whether the vaccine should be withheld from a portion of those putting their lives on the line to protect the rest of us. Development of the vaccine has been vastly accelerated already, due to the virus's spread and its mortality rate.
"The leading alternative is a design known as step-wedge, which essentially uses time to create a control group. In this design, researchers take advantage of the inescapable reality that large-scale trials can't give everyone the vaccine on the exact same date; they compare the rates of infection in people already vaccinated with those who have yet to receive the shots. Barney Graham, a virologist ... says "people are more comfortable" with the step-wedge design, because everyone in such a study would get the Ebola vaccine. But statistically speaking, this design makes it more difficult to determine the vaccine's worth, and it takes longer." NY Mag has a related story summarizing the treatments currently being used to fight Ebola.
"The leading alternative is a design known as step-wedge, which essentially uses time to create a control group. In this design, researchers take advantage of the inescapable reality that large-scale trials can't give everyone the vaccine on the exact same date; they compare the rates of infection in people already vaccinated with those who have yet to receive the shots. Barney Graham, a virologist ... says "people are more comfortable" with the step-wedge design, because everyone in such a study would get the Ebola vaccine. But statistically speaking, this design makes it more difficult to determine the vaccine's worth, and it takes longer." NY Mag has a related story summarizing the treatments currently being used to fight Ebola.
Funny that ebola has been in existence in the modern world since the 70s, yet only now this is coming to light. Oddly enough, this is perfectly timed with someone in the US getting infected.
"Shit, this is on OUR turf now!??! Better do something about it!"
This sig contains repetition and redundancy.
They known the mortality rate of ebola when untreated.
They can find out the mortality rate effect when vaccinated.
What does it matter if they can't measure the amount of the placebo effect in this particular case? Hell, if magic capsules of sugar help people with Ebola and the vaccine doesn't, then give them that.
The difficulty in determining the effectiveness of the vaccine when you give it to everyone is dependant on how effective it is. If it reduces the chances of exposure resulting in infection by 10%, then yes, it will be tough to show that it's not useless. However, if it reduces the chances by 90%, it will be quite obvious.
Experts: Ebola Vaccine At Least 50 White People Away
"Development of the vaccine has been vastly accelerated already, due to the virus's spread and its mortality rate." Ebola isn't new. What's new is that there's now a very real chance of the infection spreading to countries where white people live. Hence the "vastly accelerated" development.
Every year is the same, some rare and potential deadly desease has an outbreak and the big pharma companies have some experimental UNPROVEN cure.
The same happened H1N1, H5N1, SARS and all that crap that only made phamaceutical laboratories richer.
The question is, HOW THE FUCK DID THOSE VISITING WEST OF AFRICA BECOME INFECTED IN THE FIRST PLACE IF IT'S NOT AIRBORNE(transmitted through bodily fluids)? Either they ate animal meat that wasn't cooked properly or they went there primarily to have sex with people or animals who knows.
Until them, we should call it something along the lines of "hopefully dead ebola virus that we think might make you immune to live ebola".
If we call it that, then no one will complain about not getting it.
excitingthingstodo.blogspot.com
It's not impossible to know the impact, see regression discontinuity for an example. The issue is effectiveness. Do we want to save some people now and learn less, or save lots of people later but risk some now?
Your study is doomed already. Ask the researchers that tested AIDs drugs in the 80s. People will share pills in an attempt to be sure they got the right thing. They'll buy them on the black market. They'll join multiple studies and take herbal remedies. When death is on the line people will do what they need to do to survive, your study be damned. So just give the drug to them all and save your study work for when there isn't an epidemic going on.
According to the alert on CNN, he has just died from Ebola.
Taking guns away from the 99% gives the 1% 100% of the power.
The only objective is to keep them from dying, and we already know the death rate of ebola through empirical observation, so we don't need a control group.
By yet another secret executive order by Hunta Strong Man Barak Hussein Obama, all U.S. citizens returning to all U.S. airports from any foreign country will be arrested on entry, have their temperature taken by anus or penis thermometer and given an extensive questionnaire that will require three days quarantine at the airport at their own expense or face death by stationed U.S. Army units on site.
Obama yet again launches a war against his most hated of enemy, the legal U.S. citizens of the U.S.
Down with Beta! Down with Dice!
Need an un-vacinated control group. How about the continent of Africa. Enough people for your test group?
The conservatives seem to want to turtle and ban all travel from those nations ... which would, of course, be a death knell for any aide workers traveling there to help out. They seem to think that will prevent it from spreading when, in fact, that's just increasing the odds that ebola spreads more rapidly inside Africa and ensures that it becomes a global catastrophe. But that's pretty typical of conservative ideals. I'm still waiting on those 'trickle down' economics to get to me.
Some of the conservatives in the South are real dirtbags. It's really quite ridiculous.
Just inject the people who are already infected with Ebola, with the "vaccine". If they are all cured, then it passes.
People like you are so fucking obviously stupid. Being ignorant is OK, but stupidity is posting as if you knew anything.
Why in Sam Hill didn't you just Google before posting bullshit?
It little behooves the best of us to comment on the rest of us.
One problem with rushing a treatment to market (aside from the obvious side effects and toxicity risks) is that you sometimes end up with a treatment that works but you have no idea why it works. This has happened with some drugs in the past. We've started testing them and found that they worked really well. So we stopped the clinical trials early in order to rush the drug to market quickly for perfectly appropriate humanitarian reasons. After all if you have a drug that you know works then it's pretty cruel to withhold it from someone who would benefit. The problem is that sometimes we know a drug works before we know why or how it works.
Part of clinical trials is figuring out if a treatment will work. The other part which is sometimes even more important is figuring out why a treatment works so that we can build off that information in the future. If you skip or stop clinical trials early you sometimes end up losing this critical information. If we don't know why something works it's pretty hard to make further progress in developing even better treatments.
Development of the vaccine has been vastly accelerated already, due to the virus's spread and its mortality rate. No, development of the vaccine has been vastly accelerated already, due to WHITE PEOPLE GETTING SICK. When Ebola was only killing poor black people in Africa, no one gave a fuck. Now that rich white people are getting it, we'll have a vaccine within the year.
When death is on the line people will do what they need to do to survive, your study be damned.
They'll do what they THINK will help even if there is no evidence to back that up. Just because desperate people are being (understandably) irrational doesn't mean the rest of us should join them. We do things the way we do them because it works and because the alternatives result in much worse problems.
So just give the drug to them all and save your study work for when there isn't an epidemic going on.
There is always an epidemic going on somewhere. The value of these studies is that it saves many at the expense of a few. That is the cold hard fact of medicine. Some people are going to die/suffer so that others can live. Giving someone a treatment before we actually have proof does a disservice to later patients because we cannot learn what works and why. It also is right on the edge of being quackery. The vast majority of candidate treatments turn out to be ineffective or even outright harmful. There are sometimes good reasons to make exceptions to this policy but they are relatively few and far between.
Start gathering data on the front line ebola care-givers who are doing so right now, and then when the vaccine is ready, if all front line ebola caregivers choose to receive it, compare the data from before the vaccine to the data after the vaccine.
Of course, if the experimental vaccine is effective, then we should be keeping people from dying and we don't need a control group. But this is an unwarranted assumption: we don't know yet if the exerimental vaccine is effective -- this is what we are trying to determine, and we won't have the answer until after the experiment.
You say "we already know the death rate of ebola through empirical observation", but the death rate depends on many variables. For example, health-care workers probably have better habits than the average person, but they are exposed to Ebola more than the average person. Suppose after the vaccine we see a lower death rate. Are we sure this is due to the vaccine? Perhaps the workers who got the vaccine were from volunteers from Sweden, and Swedish people are more resistant to Ebola? The point of randomized trials is exactly to account for any known and unknown effects of this type by randomly choosing who gets the treatment and who doesn't among a reasonably uniform population. This way the people who get and don't get the treatment differ statistically only in the experimentally tested property, and we can have some confidence any observed effects are due to the treatment.
The only objective is to keep them from dying, and we already know the death rate of ebola through empirical observation, so we don't need a control group.
I disagree strongly with your framing of this issue. The objective is (or should be) to keep the LARGEST POSSIBLE number of people from dying. This means that we have to weigh the needs of the patients who are sick right now against the needs of future patients who will become infected. The demonstrated best way to learn if a treatment is effective, safe and to learn why is through controlled studies. Often this means we sacrifice some so that more may live in the future. While i'm not suggesting we don't do what we can for every patient it would be borderline suicidal to ignore proven best practices to save some now that will result in more deaths down the road.
Without a control group you might learn if a treatment is effective if the effect is sufficiently pronounced but you'll have little idea why. To understand why a treatment works you need to be able to control the variables between groups getting a treatment and those that are not and isolate those things that are different between them. A treatment that saves a patient today is much less valuable than one that saves hundreds tomorrow.
The solution to this is easy, it's just ones America's puritan's can't swallow. You send over terminally ill volunteers who have a short time to live anyways. You use them as the non-vaccinated group. If they contract Ebola, you allow them an assisted death (OH THE HORROR/THINK OF BABY JESUS). Everyone wins.
You can always do that research in the future.
So lives in the future are worth less than lives now? I could not disagree more. If we practiced what you suggest we would never do any studies because we would always be putting them off into the future. We use controlled studies because it is the best way to know if something works and just as importantly why it works. And yes this comes at the cost of some lives. We sacrifice some so that more may live in the future. If you can find a better way to do it then let us know and go collect your Nobel prize. Without controlled studies it is nearly impossible to figure out whether a treatment is effective or not.
Rushing a life-saving treatment to deployment is always ethical:
Not true. First off, we DO NOT KNOW if these treatments will work. Even if they do work we will not know why they worked. We might get lucky but odds are we will not. Giving an unproven treatment in the hope that it will work outside of a medical study is compassionate but ultimately self defeating because you learn nothing from it. If defy you to find a medical ethicist who would agree that rushing unproven candidate treatments into use is "always ethical". I assure you that they would say exactly the opposite.
people like to bitch about experimentation on humans and all the complications and side-effects and suffering you can cause, but this doesn't fucking apply when your human guinnea pigs are definitely going to die soon.
Riddle me this. You apply an unproven candidate treatment to a patient dying of ebola without that patient being part of a controlled study. How do you know whether or not the treatment worked? The answer is you don't. You literally have no way to know if the treatment is what saved that specific patient or if some unknown factor saved them. Not everyone who has ebola dies from it. So instead of taking the risk of the patient dying and learning something you have administered a treatment and learned absolutely nothing in the process. You don't know what saved that patient and in the process you have denied future patients the benefits of what could have been learned. THAT my friend is hugely unethical. There are damn good reasons why we do not do things that way.
There are some exceptions we make on occasion for compassionate reasons. We try an unproven treatment as a last ditch effort to save someone certain to die when nothing further can be learned. But patients infected with ebola do not fit that description. Many/most will die but not all. Forgoing the opportunity to learn something from their disease process in favor of quackery is highly unethical.
Thomas Eric Duncan has died of Ebola
The first vaccine to be used was developed in Canada.
This Ebola epidemic seems more like a marketing ploy where n+1 pharmaceutical companies are attempting to create a need for their fancy-schmancy snake oil. I remember from “back in the day”, reading that Ebola had a 100% mortality rate; once you’re infected, you’re as good as dead.
Well said. You also want to know if your vaccine causes a recipient to contract rapid onset brain cancer, or some other side effect that might be just as bad as the thing that you are trying to prevent/cure in the first place before you administer it to everyone. The Hippocratic oath contains a line about 'Do no harm'.
HA! I just wasted some of your bandwidth with a frivolous sig!
Vaccine trials first started in 2003. The current best candidate was first tried in a human in 2009 in Germany.
Famine, plague, war, or birth control. Choose. I guess you have.
-Malthus.
Too late. Game over.
The West will begin mining the harbors and cratering the airports so
nothing can leave. They will landmine the jungle. Anything that leaves
is sunk or shot. Snipers sans Frontieres. Quarantine with extreme
prejudice.
Civilization is a choice. Make it. Soon.
Or don't, and the population goes back to the under-billion level
before the West started feeding everyone... No more global warming
or traffic problems!
it has to be done this way.
Keep using your protocols, make the research a top priority.
The Kruger Dunning explains most post on
Well, none of the current or the older vaccines have been proven to work. Impossible.
The idea to produce vaccines the way they do it, is rather, lets say, .... questionable to say the least. Usually, they (who damn well know the vaccine doesn't work) introduce it once the outbreak has already peaked.
Try me and find out when polio hit hard and when did the vaccine come out.
If it works...yaay no more racism. And if it doesn't, well the US is a racist country.
spread by the CIA into the united states
abolish the CIA
The opposite possibility is also an issue.
The Vaccine could be 0% effective but other best practices for handling infected patients rolled out around the same time are 90% effective.
It would be difficult to distinguish between that and the Vaccine being 90% effective.
The main difference is that Ebola has a mortality rate close to 90%, whereas all those others have something like .1% mortality rates.
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The only objective is to keep them from dying, and we already know the death rate of ebola through empirical observation, so we don't need a control group.
What's the death rate through empirical observation?
Sure, it is tough, but without the control group all scientific basis for efficiency evaluation goes out the window. That leads to guesswork that routinely kills a lot more people later. That said, of course the control group should be as small as possible as it can be and still give scientifically sound results. It might also be a good idea to give the members or the control group preferential treatment when they get infected to offset the higher risk they are running. But there is no way to get around this requirement. It is essential and critical to the much-needed optimization of the vaccine, not only for improving effectiveness, but also for decreasing unintended side-effects. And for something like Ebola, these side-effects may well include death. Especially in that case a clear and accurate estimation of its benefits are needed.
There have been enough screw-ups with Ebola already. Let us not add a botched vaccine trial to the list.
Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.