It's a Monoclonal antibody - those are some of the most expensive drugs there are (i.e. hard to make in bulk). Add to that how difficult it is to administer (keep frozen, thaw slowly).
We (appear to) have a way to stop the epidemic, yet we can't actually do it.
There is a lot more to stopping an epidemic than creating the drug. You also need to be able to administer the drug--and in some of the areas worst-hit by the current outbreak, residents are suspicious (or actively hostile) to medical teams.
Ebola transmits through direct contact with bodily fluids, which means that basic measures of sanitation and hygiene can go a long way toward slowing its spread. If those cannot be achieved, distributing an expensive, delicate drug is not likely to be achievable either.
Antibody drugs are being made in bulk without too much difficulty. There are a number of RA-specific drugs on the market that are doing well, and at least one of them is grown in 6000-litre fermenters. Yeah, there might be problems getting this set up and approved, but the technology's been in place for a decade or two.
To be fair, the ultra wealthy were already safe. It's pretty easy to avoid sick people (particularly sick people spewing blood) when you can just hang out on your island or on a large estate.
Or any room that lacks someone currently dying of Ebola or recently dead from Ebola. I'm pretty sure the only victims are caregivers and people who deal with the dead - it's not easy to catch.
While I understand that giving people experimental drugs is extraordinarily dangerous, it still saddens me that, in all likelihood, these guys only got the rules bent because they were doctors. Anybody else would likely not have had the option.
Doctors risk their lives. If and when they get ill during their work we should spare absolutely no expense to get them well again.
Also, if I were a doctor in a situation like that it would be good to know that my back is covered in case I do get ill. It would substantially increase the likelihood of me continuing to risk my life. If I saw other doctors around me being abandoned if they got ill then I might have second thoughts about staying in that line of work.
To be clear: I think it's _great_ that we went out of our way to get those doctors back to the US for treatment. If it would be resource-prohibitive to help everyone, I think it's important to help the helpers first, and we owe that to them.
But the issue with experimental drugs is not one of resource constraint. We _could_ give them to anybody who asks. It's not that we gave them to the doctors because they are more deserving, but rather because they are insiders to the system and thus can get strings pulled and rules bent.
The bending of the rules gwillen was referring to is not paying for expensive medication, it is allowing these doctors to take experimental drugs. The sad thing is not that these deserving doctors got the help they needed, but that if they were less deserving we would have forcibly prevented them from getting the help they needed, out of a misguided attempt to protect them.
To be fair, Nancy Writebol (one of the two who received that drug) isn't a doctor, though she did volunteer at ELWA Hospital. From what I read, her official job title is "Personnel Coordinator", and she is also a certified nursing assistant. She was also helping disinfect staff leaving the isolation ward.
Regardless, if we've only got a few doses of an experimental drug available, I think it's totally fair to give it to the folks who are putting their lives on the line to help treat hundreds of others.
So? I realize you're not saying anything negative, but let's remember that she was there in the middle of a terrifying epidemic, helping people.
I'm not particularly religious, nor am I a Christian, but I don't feel the outrage that so many others do online about missionaries. To the contrary, I have a deep appreciation for anyone helping people in the midst of medical emergencies, regardless of motivation.
Now, do I think that American Missionaries, or any ex-pats, should have priority medical care over others, particularly local medical staff? That's the real issue here. What were the criteria for finding patients?
> Now, do I think that American Missionaries, or any ex-pats, should have priority medical care over others, particularly local medical staff? That's the real issue here. What were the criteria for finding patients?
While I share the same general sentiment, and I don't know what laws the US has about quarantining people, I think the big factor to keep in mind here is that as American citizens, they have every right to return to the US -- they just happen to be returning for medical treatment. Whereas foreign nationals with infectious diseases (much less Ebola) could be turned away as a matter of routine.
Did you see that much outrage in my comment that you had to reply?
> Now, do I think that American Missionaries, or any ex-pats, should have priority medical care over others, particularly local medical staff? That's the real issue here. What were the criteria for finding patients?
I don't think any officials considered that. They have just airlifted her because she was helping the sick - i.e. she was more of a nurse than missionary.
I'm pretty sure she and the other doctor were airlifted because they were Americans. The other high-profile doctors who have caught the disease haven't been evacuated to the US for treatment, because they're Africans.
Medical missionaries are a real thing. "Missionary" is a pretty broad term, and "evangelization through works" is the focus of a lot of missionary work. Not all missionaries are involved in preaching as such, and even fewer are exclusively involved in such work.
I do partially agree with you, but it's at least worth noting that people in the medical field are much more likely to have the capacity to genuinely consent to the receipt of experimental drugs (in the sense of actually understanding what they're agreeing to).
We discussed this over lunch. Ebola's one of the (fortunately) few diseases that have a quick, negative outcome. So, faced with "death in hours or days", risk management is altered. So, taking something that might not work (die quick), kill you (die quick) or give you more than hours or days to live seems like a good gamble. Or at least not a bad one.
Dr's would probably better able to understand the risks and give informed consent - there is also a long history of Doctors experimenting on themselves.
instead of being saddened by it you should be happy that these are two lives spared for people who can go on to now help others. and it also will potentially accelerate the development of these drugs.
what would be truly sad is if we had the ability to save these people and we didn't do so because it would be bending the rules.
I think it is appropriate to be saddened because these people would not have been allowed to receive treatment if we did not bend the rules for them and at the same time be happy that these two lives were saved.
If they're doctors that contracted Ebola because they were deliberately putting themselves in harm's way treating other Ebola sufferers and plan to continue doing so after they recover?
"As doctors, trying an untested drug on patients is a very difficult choice since our first priority is to do no harm, and we would not be sure that the experimental treatment would do more harm than good."
Really? I don't think this is a difficult choice at all there's nothing worse than dying so at that point any experimental drug should be fair game with the patients consent.
We already know what will happen if they don't take anything so why not try something else instead of letting people die all the time.
They don't know that the patients will die. There is a survival rate of somewhere between 10-50%. The patient will likely die if you do nothing, but it isn't a certainty.
That said, I don't think there was anything wrong with giving it a go when they have pretty poor odds.
From what I was reading about this Ebola outbreak, most of the "survivor" percentages were from those who hadn't yet had the illness long enough to die or be certain they will live. There is a lot of uncertainty about the death rate for Ebola in a given outbreak, this one included.
As for using experimental drugs, there are certainly times when the probability of death may seem dramatically increased for one patient relative to the overall survival numbers. "Certainty" for a population is one thing, "certainty" for some patients can be more (but not entirely) clear.
There was a quote in an article yesterday, where a doctor at Emory basically said: our treatment strategy with Ebola is just to keep the patient alive long enough for the body's immune system to fight the disease. People don't die of the bleeding per se, but the fluid loss and organs going into shock: http://www.latimes.com/science/sciencenow/la-sci-sn-ebola-vi.... A doctor in that article estimates that the mortality rate with proper medical care is more like 45-55%.
So the proper base rate to consider for an experimental treatment with respect to U.S. persons is not the 90% mortality rate in Africa, but the ~50% mortality rate that might be expected of someone in a hospital here in the U.S.
Donald Rumsfeld, the CIA and victims of "extraordinary rendition" would like to disagree. (hint: waterboarding)
so at that point any experimental drug should be fair game with the patients consent.
The ethics of it are way more complicated than that. How would you like to take the risk of not only dying a horrible death, but having the pain magnified 10x due to a drug side effect? Or a drug that causes permanent brain damage to the point of vegetative state but saves your life?
Humans will always find inventive ways to torture other humans however if i had a choice between waterboarding and Ebola i will have to go with the one with higher chances of survival.
As far as drug side effects are concerned it's up to the patient really.
Risk brain damage or amplification of pain for the potential for a higher chance?
There's only so far you can go experimenting on animals before you just have to give people a chance to choose for themselves.
Once the drug has been proven to give you better odds without known severe side effects or it the likelihood of the side effects is very low then it's up to each individual person to decide even if these test were only done on animals before.
What is worse being given a choice or being prevented from choosing by a lot of read tape.
I agree it does not seem fair, although if they now use this drug more broadly for everyone who's infected, it would be worth the unfairness. I also think Sheik Umar Khan, who was Sierra Leone's head doctor on this, deserved a chance -- surprised he did not try a blood transfusion from a survivor.
and the fallout if an untested experimental drug, one that has not even reached clinical trials, killed a non white non American...
really there is no please your type. damned if we do, damned if we don't.
What saddens me, unlike the OP about Doctors getting it, is that far too many are looking to take offense or worse, take offense for someone else who may not actually be offended, for nearly any event which occurs.
Two people already volunteering to do work I bet over ninety nine percent of us here would never volunteer to do in a place we would certainly not volunteer to go to took a drug that just as likely could have not even worked, I am more than happy it worked out for them I am betting if allowed the will go back
When we have an experimental treatment for
which there are not enough doses for all
victims, medical personnel go to the front
of the line.
I could also support a policy that said:
When we have an experimental treatment which
has not been proven safe in humans, it may
only be given to those who have given
informed consent.
But what if someone told you that our actual policy is this:
When we have an experimental treatment it
is made available only to Americans and
Europeans, never Africans.
I could never support a policy like that. I would consider it deeply unethical. And if that is the policy being implemented, then there is something deeply wrong.
You are criticizing floody-berry's post, saying things like "there is no please [sic] your type". But in fact, floody-berry is providing actual evidence (albeit circumstantial) that the actual practice implements that third possibility. And if that is true, then I want to know about it -- because I want to change the behavior of my country.
From the perspective of society as a whole, the most important thing is whether or not this drug works. There are limited doses, it has potential to save many lives, but we need good data on it. That means we can't just take the handful of doses and use them willy-nilly, the patients need to be brought to a lab for observation (and to see what happens if given the best medical care available).
Given that the research for the drugs is happening in the US and the US's CDC is really responsible for all of it, that means the patients need to come to the US.
Given that there is not a snowballs chance in hell of a bringing a non-US citizen to the US when they are known to have Ebola (many didn't even want to let a US citizen back in), it has to be a US citizen.
The 3rd outcome is a result of multiple factors, not some insane racist conspiracy.
What "type" would that be, exactly? I agree the deciding factor is that they were white Americans. So obviously you must think I'm of some "type" who would be part of some "fallout" if it had killed a non-white non-American.
And you would be 100% wrong.
I'll accept your apology now.
Actually, scratch that, I won't. I don't want an apology from your type.
Gosh, all the crazies crawl our of the woodwork now...
Look, unless you have some actual proof, speculating that because they were white, that's why they got it is just conspiracy theory wackiness.
The drug company was an American company, perhaps for legal or whatever reasons, they thought it better to test on their own citizens first? And Shivetya has a point - if they had picked some random chump from Africa to use as their guinea pig and things had gone south, I bet there would be a s*itstorm of moral outrage that we'd used those poor foreigners as our test subjects.
As others have pointed out, one of the victims was a doctor, the other some type of nursing staff, who flew over to Africa from the US, of their own volition, to help look after Ebola victims. Have you done something like that recently?
If I was risking my life every day, to try to help Ebola victims, I'd want to think that I'd at least be covered.
I have neither their raw courage or medical skillset, but I tip my hat off to them.
I don't think we just begrudge that an American company was ok to use them as guinea pigs for an experimental drug that had never been tested in humans.
And hey, look, if these people get cured, maybe they'll head back over to Africa again, to continue helping people.
> Gosh, all the crazies crawl our of the woodwork now...
Please stop with the name-calling. We at Hacker News should be better than that.
> Look, unless you have some actual proof, speculating that because they were white, that's why they got it is just conspiracy theory wackiness.
No, it is speculation, but it is not "conspiracy theory wackiness". An extremely plausible theory is that these two received the drug while others did not because they were American. Your own posting suggests that. floody-berry posted three links to other health care professionals who happen to be African, who had died in this outbreak.
> As others have pointed out, one of the victims was a doctor, the other some type of nursing staff, who flew over to Africa from the US, of their own volition, to help look after Ebola victims. Have you done something like that recently?
>
> If I was risking my life every day, to try to help Ebola victims, I'd want to think that I'd at least be covered.
Indeed. So what about Dr. Sheik Humarr Khan? He was lauded by news services and governments around the world for the enormous difference he had made in the treatment of Ebola in Sierra Leone. I would want someone like him to be covered too.
But he wasn't. Why not? Is it, as you suggest, because the company decided "perhaps for legal or whatever reasons" (your words) that they should only provide the experimental drug for Americans? Because if so, I think that is TERRIBLE -- and I think that the laws (or "whatever reasons") should be changed. Because it is unethical to say that only American lives are important enough to save with an experimental treatment.
I suspect you perhaps didn't actually read my post that carefully.
As I pointed out, this was a drug from an American pharmaceutical company.
And the trial was overseen by the CDC, which last time I checked, was an American federal body.
So it's perfectly reasonable, whether for legal, jurisdictional, or whatever reasons, that they would pick American citizens as their first guinea pigs.
This has nothing to do with "only saving American lives". You could replace American with any other country, and it would probably be exactly the same.
For example - Bayer, a German drug company, has in tandem with the Bundesinstitut für risikobewertung decided to run a trial on two local volunteer. Would you be just as outraged then?
Yet, you seem to see this as some grand conspiracy to protect American lives...
Further, you seem to have completely overlooked the fact that we have American citizens flying over to Africa, and putting themselves at risk to look after Ebola victims.
I'm not even from America, and I don't really see the huge moral outrage here. The drugs hasn't even hit human clinical trials yet, so I don't see how you can even draw conclusions on who it might or might not be offered to.
And the type who has no clue what predominately white Americans spend on predominately black Africans to help them fight AIDS. It's 2014. You can drop the race baiting and nationalism.
Being American is a possible reason because the Americans tend to get more attention in America. White has nothing to do with it though. There is no evidence of that. Get over your hangups.
> Last week, several vials of an experimental drug serum called ZMAPP were transported to Liberia from the NIH in an effort to treat two American aid workers with Ebola.
And then the patients were put in a US plane with US staff and flown to a US hospital next to the US CDC, all paid for by a US charity. There they will be monitored by the US trained doctors, meanwhile feeding information back to the US based company that invented the drug, which is manufactured on US soil.
This has nothing to do with them being doctors and everything to do with them being American. Sorry, it's not an insane conspiracy, it's just the way the system works. You keep pointing it out - but we all already get it. There is a different standard when it comes to American vs non-Americans in the situation.
The important question is whether or not the drug works. Because if it does, you can bet your ass people are going to try and get as much as of it to the affected countries as possible. If we made a stockpile of the wonder drug and withheld it from Africa, then you would have a point. Until then, cross your fingers like the rest of us that this will work.
If the choice was between certain death and an experimental drug that might or might not work, I'd certainly choose the latter no matter how unsafe it could be.
Right now, the lethality of this outbreak of Ebola is around 60%, so an infection is definitely not certain death, particularly with the supportive care possible in the U.S.'s best hospitals.
When you've already dedicated yourself by traveling across the world to help people fight a highly-contagious disease, it makes sense that you'd be first in line to test a serum (which, while experimental, uses a method that has had great success in the past).
I'll just mention that although many mAbs have been tremendously successful in controlling various diseases (and being a staple of many lymphoma treatments used currently) there are indeed very good reasons for caution, see e.g. http://en.wikipedia.org/wiki/TGN1412#Clinical_trials
In this case this was a phase I trial. For those unfamiliar with trial design, phase I is not meant to assess the efficacy of the drug but just its safety in humans. It was provided at 1/500th of the maximum safe dose determined in macaques.
Isn't it a bit early to be declaring victory? Especially given the fact that this particular drug hasn't been used in humans before, I wouldn't say the patients are out of the woods yet.
No. The human immune system needs to interact with something that "looks" a lot like the actual virus to go through the process of developing antibodies. An antibody would need the ability to enter a functioning cell and to use the cell to create copies of itself. That is an unlikely thing.
Also, the rate of change of a virus means that antibodies for one strain may not be totally or even partially effective against a slightly different strain. (See flu, cold, etc.)
I'm guessing that this was a flood of antibodies that attach to the free virus in the body that block the spots on the virus that would enable the entry into healthy cells or hinder replication. The article indicates stopping infection of healthy cells, so I'm further guessing the former.
Evolution is an arms race. The tech hope would be the ability to quickly isolate, understand, and be able to generate vaccines or serums which would have extremely high probabilities of being safe and effective in humans without the long and complex trials needed to OK new treatments. By building better vaccines, we merely put selective pressure on pathogens.
As far as we know, these people could die in weeks to years of kidney or liver problems. They could develop neuro or muscular issues or cancer. This may have only saved them for now.
That takes a while, much much longer then how long it takes a mouse to react to a virus injected directly into its bloodstream. Human cells don't really enjoy growing outside the body.
Genetic alteration involves infecting a cell with a virus that cuts DNA and splices in its own (along with the correct antibody). You have the slight possibility that the virus cuts randomly, turning off some cancer-inhibitory pathways. B cells also have this really interesting maturation pathway where they splice their own DNA randomly in the process of becoming an antibody-producing cell.
Edit, to add: The B-cell maturation pathway is called V(D)J recombination. Cool stuff. It's how the immune system can create cells that respond to things it's never seen before. http://en.wikipedia.org/wiki/V(D)J_recombination
Thanks. It still seems like there must be some way to transfer what one individual's immune system has learned to another person. I'll have to read up on it some more.
"As doctors, trying an untested drug on
patients is a very difficult choice since
our first priority is to do no harm, and
we would not be sure that the experimental
treatment would do more harm than good."
Uh, we're talking about a virus with a 90% mortality rate. What are you afraid the drug might do? Kill them?
Damage their genome? So, they live but their children will have horrible deformations? Or they live but their bodies get damaged so bad that they are basically bound to bed and medical machines for the rest of their lives? Or ...
There are fates worse than death. And then ethics: Is it right to use patients who fear for their live as medical test subjects? Is it really an "informed consent" if a person who fears for its live gets promised a "possible cure", even if that cure could do ANYTHING? If someone tortured you and you started saying "I do everything, just stop it!" - would that be informed consent? Isn't Ebola a natural version of torture? And so on ...
It's easy to say "it worked! We cannot justify to not help those people who will die anyway", but there is NO guarantee that it will work a third time. It could dissolve the organs of the next person. And then it wouldn't sound so great anymore, would it?
It's easy to say "it worked! We cannot justify to not help those people who will die anyway", but there is NO guarantee that it will work a third time. It could dissolve the organs of the next person. And then it wouldn't sound so great anymore, would it?
Even if it dissolved the organs of the next 2 people it'd still be a better survival rate than Ebola itself (I understand this strain has a 60% mortality rate, not 90%), so yes, it would still be great.
Either way, this is a choice that the patient should make for themselves. It may be ethically dubious to offer experimental drugs to dying patients, but it is obviously and completely morally and ethically reprehensible to deny a possible cure to someone who is dying and wants to give the cure a try.
This is a poorly considered view of experimental treatments. Particularly in the case of aid work, experimentation on the patient population is not only unethical in every formalizable sense, it is quite likely to inculcate a sense of distrust in the treated (justifiably, and moreso if there are unanticipated side effects), making treatment and control of future outbreaks more difficult. A chance at life for a single patient may damage the chance for hundreds if not thousands of future patients.
I'm not advocating experimentation on the patient population. I'm just saying it is frankly unethical and immoral to withhold a potential cure from a patient with a very high chance of dying, when you have that potential cure at hand and they are making an informed choice that they want to give it a try.
I don't see how treating that one patient will prevent "treatment and control of future outbreaks", either.
> Damage their genome? So, they live but their children will have horrible deformations?
Unfounded assumption. I'd love to be given the opportunity to maybe live, and have to avoid reproducing, instead of being forced to consider possibilities that may have no basis in fact. If I'm days away from dying, and my only alternative is that I can take a magic pill that means I shouldn't have children, then I won't have children. It's not exactly a dilemma.
> Is it right to use patients who fear for their live as medical test subjects?
Is it right to give someone the opportunity to control their own destiny?
> Is it really an "informed consent" if a person who fears for its live gets promised a "possible cure", even if that cure could do ANYTHING?
The 'cure' showed some positive preliminary results in lab animals.
> It could dissolve the organs of the next person
Ebola doesn't literally liquefy your organs, but the virus destroys your liver and kidneys.
Unfounded assumption. I'd love to be given the opportunity to maybe live, and have to avoid reproducing, instead of being forced to consider possibilities that may have no basis in fact. If I'm days away from dying, and my only alternative is that I can take a magic pill that means I shouldn't have children, then I won't have children. It's not exactly a dilemma.
While I agree with your broad point, your reasoning here is facile because it assumes reliable foreknowledge. It's possible that you might not knoew that you shouldn't have children until after you've done so and things have turned out very badly; consider for example the administration of thalidomide during pregnancy, which turned out to produce horrific birth defects, or diethylstilberol, which turned out to cause tumors in the daughters of women who took it during pregnancy (a fact which was not discovered until many years after the drug was first administered).
Is it right to give someone the opportunity to control their own destiny?
Get it wrong and you may be doing the exact opposite, as possibility you seem to have overlooked. Good intentions are not automatically ethical, unless those intentions have a sound probabilistic basis. Tort law is full of stories about people who thought they were helping and who ultimately made things much, much worse.
Mortality rates for ebola outbreak vary by strand of virus between roughly 60% and 90%. This outbreak is so far on the lower end of the scale, so having a drug that reliably safes 30% and kills 70% would be a loss, whereas in other cases it might be a win. Untested drug, things can go wrong and you're giving it to people that are already in very bad shape.
Yes, but think about one specific person who found out she has it. Prognosis - 60% that you'll die if you don't try the drug. With such drugs there are just not enough statistics to come up with odds so early. So do you take it?
Yes but I doubt any drugs will kill 70% of people. In fact anything below a 60% death rate would be a net win, but certainly no-one is talking about such ridiculously high mortality rates from trial medications.
Within the realm of tested drugs, then sure, you won't find any with that mortality rate. But this drug had never been given to a human. There's no safe way to predict the exact effect it will have, and there is a realistic chance it could kill the intended recipient. This wasn't even trial medication, it hadn't reached that stage yet.
Anything could happen. Imagine the Virus will adapt to this cure and is now more worse than before and is faster and will spread now more easily by air (no one can say that this will not happen with this cure). Or to say it in a more satirical way: Have not you seen any Zombie movies... it all started this way. This is like playing roulette and you will not know what impact this cure has in a bigger and longer perspective (not looking at an individual).
Right, and we should go back to the Middle Ages, where people died from things like the common cold.
Or where diseases like polio left children crippled for the rest of their lives?
Or where diabetes sufferers went blind, or had bits of their legs fall off?
Ugh. This is as bad as arguing with the anti-vaccination crowd.
Look, pathogens will adapt. That's evolution - deal with it. But does that mean that as humans, blessed with our intellect and skills, we shouldn't try to improve our lot in life?
You are comparing apples with oranges. I'm definitely not anti-vaccination. But this serum is highly experimental and not widely available or even tested on humans. I even doubt that your FDA has the right to give an exception here. Who is responsible when something goes wrong or worse? Your FDA? For Liberia? Europe would e.g. never allow usage of this serum on humans (it's totally illegal) and there is a big reason to avoid that usage even if two individuals die. Would you say ok to every experimental serum which could cure and it is not well tested (for aids? for cancer?) ... and what about the 1600 Africans who are dying at this moment and are not US citizens?
They are Christian medical professionals who gave up well above average salaries in the United States to provide medical care to people who otherwise may not have had access to it.
I can't even begin to wrap my mind around you asking if they had the right to be there. They weren't there on vacation, they felt an obligation to assist those in need who they were uniquely qualified to help.
> I can't even begin to wrap my mind around you asking if they had the right to be there.
There's a pretty long and often controversial history around European & American missionaries in Africa (both purely religious missionaries and hybrid humanitarian/religious missionaries), so I can see the question coming up. However I believe in this case it was a sanctioned trip complying with local law and overseen by international medical organizations.
Samaritan's Purse was mentioned in the article. I did some volunteer construction work with them in Mississippi a year after Hurricane Katrina. We did mention we were a religious group when people asked but we didn't spend time proselytizing. We were there to help people regardless of their religious beliefs. Nothing was asked in return for our service.
I'm betting the Mapp Pharma, pharmaceutical company, paid for everything. After all, this represents an incredible opportunity for them to test their drug.
More importantly, they get public exposure and the government sponsor for their research will more likely resume this project. It was shelved due to budgetary reasons.
However, their project is not really going to be able to compete with companies like Tekmira who have begun human testing, having a much higher efficacy in Primates (and likely humans) and are simply further along.
Ebola would unlikely be a block buster drug for any company - however, it allows them to research technologies and systems for other, more profitable things.
We (appear to) have a way to stop the epidemic, yet we can't actually do it.