8 ms·

Experimental Drug Likely Saved Ebola Patients

123 points by codexjourneys 12y ago

ars 12y ago
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.
- gnu8 12y ago
  I think we can all rest easy knowing that the ultra wealthy are safe.
  - emidln 12y ago
    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.
    - DatBear 12y ago
      Or any estate, or literally anywhere that isn't Africa...
      - pessimizer 12y ago
        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.
  - stef25 12y ago
    And that the ones who refuse to listen to basic instructions will be less safe
  - gtCameron 12y ago
    Do you have an actual suggestion about what should have been done differently or are you just trolling people who have a deadly virus?
  - tomjen3 12y ago
    In this context anybody in the west is likely to be wealthy enough to get this drug. Of course if you living in Africa you are fucked, but what else is new.
- snowwrestler 12y ago
  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.
- jleyank 12y ago
  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.
gwillen 12y ago
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.
- Fuxy 12y ago
  "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.
  - deleted 12y ago
    [deleted]
  - shiven 12y ago
    there's nothing worse than dying 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?
    - Fuxy 12y ago
      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.
aaronbrethorst 12y ago
"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?
- sgift 12y ago
  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?
  - swombat 12y ago
    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.
    - mentalhealth 12y ago
userbinator 12y ago
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.
- sparkman55 12y ago
  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).
  - puzzlingcaptcha 12y ago
    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 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.
ck2 12y ago
I'm curious who foot the bill for all this. These people were "missionaries" - does that mean they were over there proselytizing? Did they have any right to be there?
- jnbiche 12y ago
  I'm betting the Mapp Pharma, pharmaceutical company, paid for everything. After all, this represents an incredible opportunity for them to test their drug.
  - deleted 12y ago
    [deleted]
  - nemo44x 12y ago
    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.
- deleted 12y ago
  [deleted]
- CharmingAF 12y ago
  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.
  - _delirium 12y ago
    > 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.
mrfusion 12y ago
Does these antibodies actually train the recipients immune system to produce more of them? Why or why not? Why can't we pursue a similar technology to treat the common cold, or MRSA for that matter?
- pistle 12y ago
  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.) http://cnx.org/content/m49785/latest/ http://cnx.org/content/m49785/latest/ 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.
  - mrfusion 12y ago
    Thanks. How about producing memory B cells from the patient's own stem cells, and genetically altering them to produce the correct antibody?
    - omegaworks 12y ago
      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 http://en.wikipedia.org/wiki/V(D)J_recombination
refurb 12y ago
For anyone interested, here is a good article on the science behind the drug: http://www.forbes.com/sites/davidkroll/2014/08/05/ebola-secret-serum-small-biopharma-the-army-and-big-tobacco/ http://www.forbes.com/sites/davidkroll/2014/08/05/ebola-secr... The antibodies are produced in tobacco plants on a farm owned by RJ Reynolds Tobacco.
- jmulho 12y ago
  > "This same tobacco species is one also used by Medicago USA for development of a pandemic influenza virus." I hope the above paragraph from the Forbes article was a typo.
Shivetya 12y ago
More description on how its created, and issues with this use. http://www.bloomberg.com/news/2014-08-05/ebola-drug-made-from-tobacco-plant-saves-u-s-aid-workers.html http://www.bloomberg.com/news/2014-08-05/ebola-drug-made-fro... Interesting they used tobacco plants in the process and how this drug is not scheduled for clinical trials until next year
krschultz 12y ago
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.

123 points by codexjourneys 12y ago

ars 12y ago

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.

gnu8 12y ago
I think we can all rest easy knowing that the ultra wealthy are safe.
- emidln 12y ago
  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.
  - DatBear 12y ago
    Or any estate, or literally anywhere that isn't Africa...
    - pessimizer 12y ago
      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.
- stef25 12y ago
  And that the ones who refuse to listen to basic instructions will be less safe
- gtCameron 12y ago
  Do you have an actual suggestion about what should have been done differently or are you just trolling people who have a deadly virus?
- tomjen3 12y ago
  In this context anybody in the west is likely to be wealthy enough to get this drug. Of course if you living in Africa you are fucked, but what else is new.
snowwrestler 12y ago
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.
jleyank 12y ago
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.

gwillen 12y ago

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.

Fuxy 12y ago
"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.
- deleted 12y ago
  [deleted]
- shiven 12y ago
  there's nothing worse than dying 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?
  - Fuxy 12y ago
    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.

aaronbrethorst 12y ago

"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?

sgift 12y ago
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?
- swombat 12y ago
  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.
  - mentalhealth 12y ago

userbinator 12y ago

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.

sparkman55 12y ago
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).
- puzzlingcaptcha 12y ago
  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 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.

ck2 12y ago

I'm curious who foot the bill for all this. These people were "missionaries" - does that mean they were over there proselytizing? Did they have any right to be there?

jnbiche 12y ago
I'm betting the Mapp Pharma, pharmaceutical company, paid for everything. After all, this represents an incredible opportunity for them to test their drug.
- deleted 12y ago
  [deleted]
- nemo44x 12y ago
  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.
deleted 12y ago
[deleted]
CharmingAF 12y ago
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.
- _delirium 12y ago
  > 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.

mrfusion 12y ago

Does these antibodies actually train the recipients immune system to produce more of them? Why or why not? Why can't we pursue a similar technology to treat the common cold, or MRSA for that matter?

pistle 12y ago
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.) http://cnx.org/content/m49785/latest/ http://cnx.org/content/m49785/latest/ 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.
- mrfusion 12y ago
  Thanks. How about producing memory B cells from the patient's own stem cells, and genetically altering them to produce the correct antibody?
  - omegaworks 12y ago
    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 http://en.wikipedia.org/wiki/V(D)J_recombination

refurb 12y ago

For anyone interested, here is a good article on the science behind the drug: http://www.forbes.com/sites/davidkroll/2014/08/05/ebola-secret-serum-small-biopharma-the-army-and-big-tobacco/ http://www.forbes.com/sites/davidkroll/2014/08/05/ebola-secr... The antibodies are produced in tobacco plants on a farm owned by RJ Reynolds Tobacco.

jmulho 12y ago
> "This same tobacco species is one also used by Medicago USA for development of a pandemic influenza virus." I hope the above paragraph from the Forbes article was a typo.

Shivetya 12y ago

More description on how its created, and issues with this use. http://www.bloomberg.com/news/2014-08-05/ebola-drug-made-from-tobacco-plant-saves-u-s-aid-workers.html http://www.bloomberg.com/news/2014-08-05/ebola-drug-made-fro... Interesting they used tobacco plants in the process and how this drug is not scheduled for clinical trials until next year

krschultz 12y ago

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.