[waps]

And who pays for the, potentially unbounded fallout from that decision ?

Let's say this happens : http://en.wikipedia.org/wiki/Thalidomide

(First read about the advantages of the drug, then move to the crises. in particular the birth defects crisis)

And please don't just say that people knowingly took the risk, read the article first to see how that played out.

People won't accept the consequences of decisions made under duress (and this decision would be "death or we experiment on you". Decision to be made in an isolation camp, guarded by soldiers with guns), for obvious reasons, and this has been an accepted legal principle since a millenium before Jesus was born. You're suggesting just canceling it ? Really ?

What you're suggesting is a really, really, really, really bad idea.

[ekianjo]

Why? When you are going to die you should have the choice to go on a treatment which is untested. That's what people with AlS have been asking for YEARS and still cannot get because they have to follow the usual regulatory process.Cancer patients can get drugs as soon as Phase I, I don't see why we don't allow other patients who are in critical condition to try whatever is new out there. What do you have to lose?

[x0x0]

The death rate from the current ebola is approximately 50%. While that sucks, what patients have to lose is both a 50% chance of living and their right not to be a playground for medical experimentation.

edit: and just who vets the people/companies who get to offer drugs to desperately ill people? Does anybody with $1k to buy needles get to make a sign and advertise curative injections? I'm sure glibertarian idiots will say it was a freely made choice, but choices made while infected with ebola (or even scared of being so infected) aren't freely taken, not to mention the asymmetric information.

[crusso]

glibertarian idiots

Please avoid making personal attacks like this on HN.

As a mostly libertarian-minded person myself, the height of compassion is to allow dying people to reach out for any hope out there.

Cruelty would be to prevent people from attempting to save their own lives "for their own good"; especially when no alternative cure is being offered by the politicians and bureaucrats making such life-impinging decisions.

Yes, the quacks and charlatans will try to take advantage and they should specifically be combatted. That doesn't mean that people should not be able to make decisions about their own lives.

[ekianjo]

> edit: and just who vets the people/companies who get to offer drugs to desperately ill people?

Look at the scientists who were helping fight Ebola in Africa. When they discovered they were infected as well they had the chance to take a new treatment and they took it. And they recovered.

The question of who decides is important, I'm not saying it should be overlooked but the possibility is not even there for those who actually want to take it desperately. And no need to throw the "libertarian" word for everything you disagree with, we are talking about having choice here.

[krschultz]

And some of the people that were given the experimental drug in Africa died as well. Correlation does not equal causation.

We all love silver bullets and magic serums, but the real answer here is to get the basics right. There are major improvements that can happen in sanitation, medical care, keeping quarantines effective, proper handling of the dead, etc. A lot of major epidemics were stopped in the 1800s and early 1900s with these kind of things, Ebola can be fought in many ways without inventing a drug.

Solving the crisis on a large scale isn't really a "medical" challenge in the normal sense, it is about logistics and resources and public trust in government & doctors.

[ekianjo]

I'm not saying it's a silver bullet, and I never implied causation either on n=2, while it may be that they recovered because of that. Don't change the discussion. My point is, if you are dying from Ebola and you'd like to test a last treatment before all bets are off, why not accept it ?

I think that if you were yourself in such a situation, with any incurable disease, you'd see the world in a different way. It's always easy to talk about things that do not concern oneself directly. And again, right NOW, Cancer patients have that choice, so why not others?

[JoeAltmaier]

Its historically been where lots of abuse happened - quacks offering miracles; legitimate researchers overstating the hope and downplaying the suffering involved in 'new' treatments. So there's a lot of rules in place.

[ng12]

I would argue there are at least a few orders of magnitude between someone with morning sickness and someone who will almost definitely die of Ebola or T1 Diabetes.

It's a calculated risk, sure, but I don't think the Thalidomide example is particularly relevant.

[hueving]

>It's a calculated risk, sure, but I don't think the Thalidomide example is particularly relevant.

It's very relevant. It shows that people are too willing to take risks with major unknowns. Where do you make the cutoff with your drug experiments? Only people that are certain to die? People with high exposure risk? People that are having difficulties recovering? Any selection you pick there is completely arbitrary because you don't know the potential downsides to the experimental stuff you want to try.

[ghshephard]

"Where do you make the cutoff with your drug experiments? "

I don't know where you make the cutoff, but I'm comfortable saying that its somewhere below having a disease with a 50% mortality rate in under 14 days. I'm pretty much okay taking any risk at that point.

[DanBC]

What if the risk was survival but with locked-in syndrome and constant very high pain? Or survival but severely brain damaged - no ability to feed yourself; or talk; or understand the conversations of other people.

[ctdonath]

A risk? yes. But if that risk is significantly less than the other high-risk form of "severely brain damaged, unable to eat, talk, or understand" known as death, many would take it. Remember, the point is trying something that doctors & pharmacists believe has a sensible chance of actual _cure_ (perhaps with acceptable side effects better than death/dementia).

I don't understand the propensity of some to demean "hey, there's a serious immediate problem, let's do everything we can to help" with "but it might (with minuscule odds) go horribly wrong! therefore we can't let anyone do anything that's not established best-condition status quo!" With that mindset, it's a wonder such people ever drive to work (you might die in a horrible flaming carbecue!).

Statistical prioritization matters. Just because there isn't a perfect solution doesn't mean there isn't a better one.

[waps]

Experimental treatment obviously means unknown risk.

And of course the deal is going to be that you take full responsibility for the risk. In other words, if something like that happens, you get zero assistance, not even from any health insurance you already have.

> I don't understand the propensity of some to demean "hey, there's a serious immediate problem, let's do everything we can to help" with "but it might (with minuscule odds) go horribly wrong! therefore we can't let anyone do anything that's not established best-condition status quo!" With that mindset, it's a wonder such people ever drive to work (you might die in a horrible flaming carbecue!).

Short answer : because it's happened before.

I would also argue that given history, the risks of unknown treatments having major side effects are significant (let's say ~15-20%). The risks of major side effects on pregnancies and later offspring are even more significant (20-40%).

So those odds are not that minuscule and there are going to be victims.

Your attitude stems from the idea that seems to be propagated a lot these days : that science and therefore medicine can fix anything, any disease. That was almost true for a short period at the end of the 70s. In the 80s we found several diseases became fully resistant. Now the counter of completely incurable diseases is in the thirties, and rising fast. Old, well-known diseases are coming back, untreatable. Tuberculosis, pneumonia, dysentery ... all have MRSA variants. And that's ignoring a lot of viruses. Rabies, HIV, Hep C, MERS, Avian flu, Pig flu, ... all of which are essentially untreatable.

The point the CDC has been making for ~20 years now is that ~3 decades ago "net-"scientific advancement against infectious diseases stopped. There were advances, but diseases advanced at roughly the same pace. 2 decades ago we started losing ground and in the last decade we've been losing ground like never before.

And of course we're completely focusing on the wrong solution : don't use medicine anymore ! Great, but that ship has sailed, adaptation has happened and it's generally too late. There have been studies on how long these adaptations last, and how long we'd have to wait if we stopped treating ill people. The timeframe is in the centuries.

[tripzilch]

Or how about if you're fine, but your children will be born with disabilities.

[andygates]

What about preventative treatment? Say we have a prototype vaccine. Now you have to find the cutoff between a chance of getting a fairly deadly disease, and the chance of a vaccine not working or having nasty side effects. That's a much greyer area.

[Padding]

You didn't get the point of the argument.

What do you do when something with 51% mortality in 15 days comes up? And then something with 49% in 13 days .. where do you draw the line? And what do you do when people continue to cry out?

[barrkel]

The existence of a Sorites paradox doesn't mean that heaps and grains are not different things.

[ghshephard]

I got the point of the argument. And, I made it very clear that I don't know where to draw the line. All I know for sure, is that 50% mortality in 14 days comes below that line. Sign me up for an experimental treatment.

[narrator]

So you're suggesting that we let potentially hundreds of thousands of people die to prevent a potential tort lawsuit? Would you be ok if we shoot them if they try and leave the quarantine though to get an unapproved treatment? Do you see how crazy your logic is? The benefit of Thalidomide was that it prevented morning sickness and you're comparing that to treatment of a disease with a fatality rate of greater than 50%! You have no sense of proportion at all!

[lotsofmangos]

It seems reasonably proportionate not to suspend all regulations on drug testing. If you did that then the vitamin peddlers out to make a fast buck would swamp anything that might actually help. The amount of con artists massively outnumbers the amount of people with a cure for Ebola.

I agree that it may be an idea to look at trying some of the experimental treatments, however given there is a 50% chance of surviving with palliative care and that we know how to stop it spreading given the resources, I am not sure that turning the situation into an unregulated free-for-all for every quack looking to make their name will really help matters.

[cstross]

There are pros and cons for both sides of this argument.

The question is whether to suspend normal precautionary procedures during an extraordinary situation, not whether to ditch normal precautionary procedures which exist for very good reasons (see the Elixir Sulfanilamide disaster for why):

http://www.fda.gov/aboutfda/whatwedo/history/productregulati...

You're rightly concerned for the possible side-effects of using untested treatments on people during an emergency. But flip the question around: who's liable for not deploying an available experimental treatment that is later determined to work, but only after tens of thousands have died while it sits, unused, on the shelf due to lack of test data?

[ObviousScience]

> who's liable for not deploying an available experimental treatment that is later determined to work, but only after tens of thousands have died while it sits, unused, on the shelf due to lack of test data?

No one, that's exactly the point.

There's no way to sort out misdeeds, eg, fake cures from real attempts if we lift the normal trial and liability procedures. No one would use untrialed drugs if they had to take the full liability.

So the reality is that there is no good way to send only useful drugs there while skipping the filtering process.

If you're okay with some people being poisoned or lied to for money in the hope that some people will get a real drug, then we could make that work, but I'm not sure we want to go down that path.

[cstross]

There's no way to sort out misdeeds, eg, fake cures from real attempts if we lift the normal trial and liability procedures. No one would use untrialed drugs if they had to take the full liability.

I'm ready to assume that medics treating an emergency epidemic are unlikely to knowingly turn to quack remedies -- homeopathic or bogus ones -- as opposed to items like ZMapp, a monoclonal antibody treatment by a well-regulated pharmaceutical company that just happens not to have been approved for human clinical trials yet.

http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimenta...

Furthermore, let me add that conducting a randomized controlled clinical trial (for effectiveness and safety) when dealing with a pathogenic infection with a > 50% fatality rate is arguably unethical: you can collect data on clinical applications and apply a retrospective control sample of patients to determine whether it improved the outcome where it was used, but withholding a potentially effective treatment becomes extremely problematic under some circumstances -- the historic classic example was zidovudine for HIV, which was rushed through human trials into use in just 27 months because it was the first effective treatment for a then-100% fatal disease (HIV). (Some of the double-blind trials were short-circuited when it became apparent that continuing to alternate patients with placebo controls was likely to be injurious.)

http://en.wikipedia.org/wiki/Zidovudine

[Padding]

I fully agree with you. This is the rational decision to make, and the best one, considering the fallibility of humans.

At the same time though, we need to realize that this is primarily about protecting the health professionals and care givers, and only indirectly the sick. (The sick will of course indirectly profit from professionals being just that - professional, but only in the "long term".)

We should have no delusions about willingly letting people die, in the name of professionalism, just to have a clean concience and the ability to claim to have done nothing wrong.

[jcromartie]

This is not a proposal for developing general-purpose drugs. This is for developing emergency treatment for an acute viral outbreak emergency. If an anti-Ebola drug works, then it saves lives. If it doesn't work (or is dangerous) then it's still less dangerous than Ebola itself.