Slashdot Mirror
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.
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.
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
They are doing more about it because of the scale of the current problem.
That scale is also the reason a person in the US got infected.
The scale is likely the result of a mutation in the virus, there's a much longer incubation time now.
Thank you, Bradley Manning, Edward Snowden and so many others, for courageously defending humanity, my freedom and more!
No, the rush to create a vaccine coinicdes with the latest outbreak, which has 10 times (and counting) the number of infected as the next largest outbreak. More importantly, all previous outbreaks were local and contained reasonably easily. This is the first time Ebola is getting away from us; in previous cases we had the option of containing it and letting it run its course, now it looks like that may no longer be enough.
And before this outbreak happened, research into vaccines was already taking place. Of course the urgency is somewhat higher now, since we may be looking at a global epidemic. This has nothing to do with ohmygodanAMERICANgotinfected.
If construction was anything like programming, an incorrectly fitted lock would bring down the entire building...
This latest outbreak has already infected more than in the entire history of the virus prior to it. There hasn't been a great deal of effort, because there simply hasn't been a great deal of need. It takes time for labs to spool up against an outbreak, and the fact that new treatments are coming down the pipeline right around the same time the virus starts spreading to other countries is purely coincidence.
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.
That scale is also the reason a person in the US got infected.
A clarification; No person in the US has gotten infected, as far as I know. The only US cases are those infected outside the US and then traveling to the US. There was a nurse in Spain that got infected from a patient, otherwise I don't think there are any known infections that happened outside of Africa.
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.
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!"
There is a causal relation driving this correlation, but it's not the one you cynically postulate. Both the appearance of someone in the US with the disease and the attempt to create a vaccine have been caused by the scale of the latest outbreak.
Note to ACs: I usually delete AC replies without reading them. If you want to talk to me, log in.
They known the mortality rate of ebola when untreated.
They can find out the mortality rate effect when vaccinated.
It isn't that simple. The situation on the ground is changing rapidly over time, so current rates are worthless as a point of comparison.
Compared to many diseases with which we're familiar, Ebola is rather difficult to transmit, given that someone needs to be in contact with the bodily fluids of an infected individual. As such, infection rates among the population of medical staff are highly dependent on the conditions of the environment. A properly maintained quarantine with medical professionals engaging in best practices should basically have a 0% infection rate, whereas the sorts of conditions they're seeing in Africa right now will see significantly higher infection rates among the medical staff, but even those rates can vary significantly from facility to facility depending on the facility's resources, the level of training of the staff and their assistants, and how cooperative the patients are. As those infection rates change, so too do the mortality rates. Moreover, as I mentioned, those rates are likely changing over time as new practices are put into place, training is improved, resources are improved thanks to new funding, or changes occur in the cultural awareness of the patients.
Which is all to say, you need some way to account for the changes to the mortality rate that are occurring for reasons besides the vaccine. Comparing future mortality rates against past rates doesn't do that. All that does is tell us that something has changed, but it doesn't tell us what changed. You need a control group in the same environment going through the same changes, with the only difference being that the test group is vaccinated. Anything else, and we'll have no way to isolate the efficacy of the vaccine or its lack thereof from the other changes occurring in the environment that are also affecting the outcome.
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.
Coincidence, maybe, but the fact that the vaccine was ready *almost as soon* as the first american was infected proves that the vaccine was in development for a *long time* before that happened.
What? Do people actually believe the TV shows they watch? Vaccines don't actually get developed over night.
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.
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 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.
Either they ate animal meat that wasn't cooked properly or they went there primarily to have sex with people or animals who knows.
Yes, because those are the ONLY two ways that people come in contact with fluids from animals. Thank God butchering is such a tidy process, animals don't bleed after you shoot them while on the hunt, and that people handling animals never get bitten, because if any of those were things that actually happened we might need to consider the possibility that there are other ways people could get infected, and we wouldn't want to do that!
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
What vaccine? There is no vaccine? All we have is antiviral drugs that are effectively antibody supplements. In previous outbreaks, people have been cured by receiving blood (and antibodies) from someone who has already successfully fought off the infection. The drugs are basically just an artificially manufactured form of that. You don't run large volume production of an experimental drug for a virus that only has small outbreaks every few years.
The first vaccine to be used was developed in Canada.