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(Vox)   FDA recently halted testing of a successful Ebola treatment due to possible negative side effects. The side effects of Ebola meanwhile include a 90% death rate   (vox.com) divider line 59
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1835 clicks; posted to Geek » on 04 Aug 2014 at 7:21 AM (19 weeks ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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2014-08-04 04:39:24 AM  
Um ... that's not what the article said at all.  The FDA wants more information on what the drug is doing in the body before accepting larger scale trials.

It's not that they are seeing side effects, it's that they want to know what the drug does in the body before they start injecting a larger pool of test subjects.  This seems like a reasonable request and should be relatively easy for the drug company to comply with if they've been diligent with their science.
 
2014-08-04 07:13:25 AM  
Another case where if government was just a tad smaller we'd descend into Somalia, er, Sierra Leone.
 
2014-08-04 07:20:34 AM  
Fact 1) Ebola is scary
Fact 2) Big Gubmint Fedzillaregulatojobkillercrats are scary

Therefore by the transitive property of crapping-your-pants-in-terror-while-glued-to-Fox-News...

Fact 3) Obama wants us all to die of Ebola

/checkmate
 
2014-08-04 07:20:52 AM  
May cause anal leakage and increased thoughts of suicide... meanwhile Ebola causes everything leakage and death.

/Read an article... I don't need to read no stinking article.
 
2014-08-04 07:24:04 AM  
Zombies!!!
 
2014-08-04 07:30:05 AM  
Autism. Is it autism? I heard that autism and injections are linked. It's autism, right? Autism? Is it autism? Autism?!?
 
2014-08-04 07:35:31 AM  
They're just having trouble getting funding for a disease that only affects the poors.  Modern medicine, fark yeah.
 
2014-08-04 07:36:00 AM  
FTFA:  "But more recently the federal government has dealt TKM-Ebola a setback: the FDA  http://investor.tekmirapharm.com/releasedetail.cfm?ReleaseID=857714" style="box-sizing: border-box; -webkit-transition: all 100ms ease; transition: all 100ms ease; color: rgb(109, 152, 168); text-decoration: none; font-weight: 600; -webkit-font-smoothing: antialiased; font-family: 'Alright Sans', sans-serif; font-size: 15px; line-height: 22.5px; background-image: none !important; background-attachment: initial !important; background-color: rgb(241, 243, 242); background-size: initial !important; background-origin: initial !important; background-clip: initial !important; background-position: initial !important; background-repeat: initial !important;">halted the treatment's phase one trials at the start of July, requesting that Tekmira provide additional information about how the drug actually works, before the company begins giving trial subjects even larger dosages. That happens in Phase One trials to test how much the human body can handle. "

That seems reasonable to me.
 
2014-08-04 07:36:54 AM  
Personally I think we should all panic and just start injecting each other with whatever random fluids we have laying around.
 
2014-08-04 07:39:35 AM  
And bleeding your internal organs out of your arse.
 
2014-08-04 07:43:26 AM  
Just inject them with whatever? Is that the suggestion.

It's more like 50-90% death rate so doing the wrong thing can almost double your chances of dying.

Further being in phase 1, it would still be going through the trials stage
 
2014-08-04 07:46:27 AM  
You know you have issues with a drug when its side effects are potentially worse than Ebola.
 
2014-08-04 07:52:32 AM  

Teaser: And bleeding your internal organs out of your arse.


xbox360media.ign.com
 
2014-08-04 07:55:23 AM  
FDA recently halted testing of a successful Ebola treatment due to possible negative side effects. The side effects of Ebola meanwhile include a 50-90% death rate according to Wikipedia, and 25-90% according to some other site I read today.
 
2014-08-04 08:28:18 AM  

FuManchu7: Um ... that's not what the article said at all.  The FDA wants more information on what the drug is doing in the body before accepting larger scale trials.

It's not that they are seeing side effects, it's that they want to know what the drug does in the body before they start injecting a larger pool of test subjects.  This seems like a reasonable request and should be relatively easy for the drug company to comply with if they've been diligent with their science.


This.  Bad subby.
 
2014-08-04 08:30:59 AM  
"The Defense Department awarded it a contract for $140 million in 2010, after the vaccine proved completely effective in treating non-human primates in chimps. "
That's some freaky stuff right there...

"Correction: An earlier version of this article mistakenly identified TKM-Ebola as a vaccine. While it has been tested as an Ebola treatment, it is not a vaccine. "
I CAN SEE THROUGH TIME ITSELF.
Or they suck at writing and version control...
 
2014-08-04 08:34:36 AM  
Someone not reading what they submit?

Interesting quote tho, "12 villages in Guinea that might have Ebola but aren't safe for workers".

*MIGHT*? Granted, the numbers of infected healthcare workers doesn't inspire anything but fear, not knowing where the affected areas are, VERY scary.

Isolated areas will either die off or survive if they stay isolated.

/sadly, the whole thing only seems to prove that us 'mericans don't has us no monopoly on teh dumb
 
2014-08-04 08:34:52 AM  

PunGent: FuManchu7: Um ... that's not what the article said at all.  The FDA wants more information on what the drug is doing in the body before accepting larger scale trials.

It's not that they are seeing side effects, it's that they want to know what the drug does in the body before they start injecting a larger pool of test subjects.  This seems like a reasonable request and should be relatively easy for the drug company to comply with if they've been diligent with their science.

This.  Bad subby.


True but the FDA does make some interesting decisions sometimes.  Like the treatment for acne (Accutane, now pulled).  Yes acne can be socially difficult to handle and there may be rare cases where aggressive treatment is needed.  However, the side effects list that includes hallucinations, suicidal thoughts, stroke, heart attack, seizure, and hearing loss might be a little extreme to fight acne.  Ebola, maybe not so much.
 
2014-08-04 08:45:11 AM  
Wow, good thing people get to submit anonymously, because subby is a complete and utter moron who doesn't understand how FDA screening works or why it is set up that way.
 
2014-08-04 08:47:11 AM  

PunGent: FuManchu7: Um ... that's not what the article said at all.  The FDA wants more information on what the drug is doing in the body before accepting larger scale trials.

It's not that they are seeing side effects, it's that they want to know what the drug does in the body before they start injecting a larger pool of test subjects.  This seems like a reasonable request and should be relatively easy for the drug company to comply with if they've been diligent with their science.

This.  Bad subby.


It's unusual to fast track a drug and then stop it in Phase 1 like that. This suggests to me that there might have been a side effect or two limiting the dose that caused the fda to ask for more information to justify the risk. That could include asking the company to finish developing a test that gives a readout on how well the drug is doing it's thing in each patient.

So this isn't necessarily about being overly cautious . It could also be about getting data that would improve the clinical studies and possibly increase the chance that the drug will get a faster approval.

Pure speculation, but I wouldn't try to second guess the FDA without knowing more.
 
2014-08-04 08:47:20 AM  

Shakin_Haitian: Personally I think we should all panic and just start injecting each other with whatever random fluids we have laying around.


Subby? Is that you?
 
2014-08-04 09:10:29 AM  
I read somewhere that the survival rate for this outbreak has been about 40%
 
2014-08-04 09:18:52 AM  

Shakin_Haitian: Personally I think we should all panic and just start injecting each other with whatever random fluids we have laying around.


Sure! Don't expect me to cuddle afterwards though.
 
2014-08-04 09:22:58 AM  
The phase 1 tests are on healthy people. The FDA would like some indication of how many healthy people the company is going to kill in their trials.
 
2014-08-04 09:27:22 AM  

Plant Rights Activist: They're just having trouble getting funding for a disease that only affects the poors.  Modern medicine, fark yeah.


I'm sure they'd take your donation.
 
2014-08-04 09:27:58 AM  

Dinobot: Zombies!!!


Yeah! Now that's a side effect
 
2014-08-04 09:28:47 AM  
The fact that six out of seven primates were protected from Ebola with the treatment administered 30 minutes after the Ebola exposure might be more impressive if they had a comparison group. What is the Ebola infection and death rate among similar groups of primates who were not administered the treatment?
 
2014-08-04 09:36:03 AM  

draypresct: The phase 1 tests are on healthy people. The FDA would like some indication of how many healthy people the company is going to kill in their trials.


It's an Ebola treatment not a vaccine which means that people they're testing it on are already infected with Ebola. If my options are experimental drug that was promising in animal trials or sit there and hope I get better, I'd sure as hell want the drug.

It's like withholding drugs meant to cure terminal cancer because they might cause heart problems. You've already got Ebola, it's hard to imagine what possible side effects are worse than a 60-90% chance of death.
 
2014-08-04 09:40:38 AM  

ArcadianRefugee: FDA recently halted testing of a successful Ebola treatment due to possible negative side effects. The side effects of Ebola meanwhile include a 50-90% death rate according to Wikipedia, and 25-90% according to some other site I read today.


The 90% fatality rate is because the vast majority of cases of Ebola are being treated in these conditions:

www.nationalpost.com
Rather than these conditions:

i2.cdn.turner.com
 
2014-08-04 09:41:48 AM  

Plant Rights Activist: They're just having trouble getting funding for a disease that only affects the poors.  Modern medicine, fark yeah.


So modern medicine is the problem then, eh? I suppose you'd like to go back in time when medicine was under the purview of the church and leeches were the pinnacle of medical technology? Because, at least at that point, medical attention was free for everyone.
 
2014-08-04 09:49:11 AM  

To The Escape Zeppelin!: draypresct: The phase 1 tests are on healthy people. The FDA would like some indication of how many healthy people the company is going to kill in their trials.

It's an Ebola treatment not a vaccine which means that people they're testing it on are already infected with Ebola.


RTFA: For phase I, they are testing it on healthy people to see the effects of the drug on the human body.  They are testing it on healthy adults to see if adults can take the drug, NOT testing if the drug works.  If testing the drug will harm more people than the drug will save, the drug is halted.

It's a temporary hold anyway while the company compiles their data, it sounds like there may have been some adverse effects and they need to explain what happened.

Standard part of human research training is the discussion of the hypothetical: "There is a disease which kills 1% of children.  A vaccine has been developed, but phase I trials showed that reactions to the vaccine will kill 0.1% of those administered it.  Should the testing proceed?"

/Answer is easy when you save 10,000 for every 1, but not as easy if you save 10 for every 1.
 
2014-08-04 09:51:22 AM  
PhDemented:

Standard part of human research training is the discussion of the hypothetical: "There is a disease which kills 1% of children.  A vaccine has been developed, but phase I trials showed that reactions to the vaccine will kill 0.1% of those administered it.  Should the testing proceed?"

Other variant is: "There is a disease that permanently maims 10% of a group and kills 1%, and a treatment that cures 98% and kills 2%"

/Need to administer human research training to the new grad students this week
 
2014-08-04 09:53:56 AM  

dookdookdook: Fact 1) Ebola is scary
Fact 2) Big Gubmint Fedzillaregulatojobkillercrats are scary

Therefore by the transitive property of crapping-your-pants-in-terror-while-glued-to-Fox-News...

Fact 3) Obama wants us all to die of Ebola

/checkmate


I heard some angry woman on Fox News Saturday night who was trying to foment outrage about point #3 above. She went on about the Ebola patient being brought to the US and had a guest on to say he should have stayed in Africa. Of course, the whole thing is Obama's fault too.

/stuck in the car with my dad
//he's a Fox News fan and has discovered the conservative echo chamber on the internet
 
2014-08-04 09:56:03 AM  

To The Escape Zeppelin!: draypresct: The phase 1 tests are on healthy people. The FDA would like some indication of how many healthy people the company is going to kill in their trials.

It's an Ebola treatment not a vaccine which means that people they're testing it on are already infected with Ebola. If my options are experimental drug that was promising in animal trials or sit there and hope I get better, I'd sure as hell want the drug.


I don't think so. At least, that's not what the company implies with their description of the study.

In January 2014, Tekmira commenced a Phase I clinical trial using TKM-Ebola. The TKM-Ebola Phase I clinical trial is a randomized, single-blind, placebo-controlled study involving single ascending doses and multiple ascending doses of TKM-Ebola. The study will assess the safety, tolerability and pharmacokinetics of administering TKM-Ebola to healthy adult subjects.

It's like withholding drugs meant to cure terminal cancer because they might cause heart problems. You've already got Ebola, it's hard to imagine what possible side effects are worse than a 60-90% chance of death.


My personal bias is that I despise those who enroll desperate people in a study on a treatment that has very little chance for success and horrific side effects. The people enroll simply because they're willing to try anything, and the quacks can't lose because even if the subjects die in agony, they can blame it on the disease. These quacks enroll the patients as their front lines on the battle for their profits, telling the patients "if it weren't for the FDA, I could cure you" and turning them loose on the press in order to bypass the whole "does this actually work" process.

In reality, the FDA is perfectly fine with doctors administering a treatment to their consenting patients who won't benefit from conventional treatment (see "compassionate use") - they just can't market it (i.e. get money for it).
 
2014-08-04 10:01:30 AM  

cgraves67: Plant Rights Activist: They're just having trouble getting funding for a disease that only affects the poors.  Modern medicine, fark yeah.

So modern medicine is the problem then, eh? I suppose you'd like to go back in time when medicine was under the purview of the church and leeches were the pinnacle of medical technology? Because, at least at that point, medical attention was free for everyone.


I just don't imagine some of the great scientists like Louis Pasteur were thinking, "Damn, this vaccine will make me rich, biatch!" as their primary motivation
 
2014-08-04 10:03:09 AM  

ArcadianRefugee: FDA recently halted testing of a successful Ebola treatment due to possible negative side effects. The side effects of Ebola meanwhile include a 50-90% death rate according to Wikipedia, and 25-90% according to some other site I read today.


Ebola Bundibugyo is a weak strain of Ebolavirus. That's why the 25% fatality. Meanwhile Ebola Zaire, which is currently infecting W. Africa is the strain that had pushed the numbers up to a potential 90% fatality rate.

Thankfully it isn't living up to it's previously made reputation.
 
2014-08-04 10:20:50 AM  
If Ebola had even limited ability to be airborne(such as being able to survive in microscopic droplets), do you think that it would spread everywhere?

Do you guys think that it could still be potentially contained?
 
2014-08-04 10:23:37 AM  

AngryDragon: PunGent: FuManchu7: Um ... that's not what the article said at all.  The FDA wants more information on what the drug is doing in the body before accepting larger scale trials.

It's not that they are seeing side effects, it's that they want to know what the drug does in the body before they start injecting a larger pool of test subjects.  This seems like a reasonable request and should be relatively easy for the drug company to comply with if they've been diligent with their science.

This.  Bad subby.

True but the FDA does make some interesting decisions sometimes.  Like the treatment for acne (Accutane, now pulled).  Yes acne can be socially difficult to handle and there may be rare cases where aggressive treatment is needed.  However, the side effects list that includes hallucinations, suicidal thoughts, stroke, heart attack, seizure, and hearing loss might be a little extreme to fight acne.  Ebola, maybe not so much.


On the other hand, a drug that can cause strokes and heart attacks is not one that I'd call a "successful" Ebola treatment.
 
2014-08-04 10:32:13 AM  
Who wants to deal with 6 hour erections and enlarged sexual organs? Ebola is a walk in the park,  compared to this.
 
2014-08-04 10:33:16 AM  
Disapproves
img.fark.net
 
2014-08-04 10:33:31 AM  

Pick: Who wants to deal with 6 hour erections and enlarged sexual organs? Ebola is a walk in the park,  compared to this.


What drug does that!?!

/I'm asking for a friend.
 
2014-08-04 10:34:45 AM  

RexTalionis: ArcadianRefugee: FDA recently halted testing of a successful Ebola treatment due to possible negative side effects. The side effects of Ebola meanwhile include a 50-90% death rate according to Wikipedia, and 25-90% according to some other site I read today.

The 90% fatality rate is because the vast majority of cases of Ebola are being treated in these conditions:

[www.nationalpost.com image 620x465]
Rather than these conditions:

[i2.cdn.turner.com image 618x347]


Plus some Farker posted a link to an article that stated there rates of 15% of people having antibodies without ever reporting any symptoms. So it might really really kill some people but not bother some people.

Not that I would like to find out via personal experience.
 
2014-08-04 10:39:08 AM  

Sammichless: If Ebola had even limited ability to be airborne(such as being able to survive in microscopic droplets), do you think that it would spread everywhere?

Do you guys think that it could still be potentially contained?


Fuel air bomb the site from orbit, its the only way to be sure.
 
2014-08-04 11:01:10 AM  

xria: Sammichless: If Ebola had even limited ability to be airborne(such as being able to survive in microscopic droplets), do you think that it would spread everywhere?

Do you guys think that it could still be potentially contained?

Fuel air bomb the site from orbit, its the only way to be sure.


I was sorta thinking that.

I am referring to a 2 year old study on Ebola Zaire that showed that it may be able to do exactly this.

It is still not ever going to be a global pandemic..... Ebola spreads much too slowly.

But, I wonder if there is ANY hope of containing it to Africa if this turns out to be true.
 
2014-08-04 11:17:08 AM  
If I'm not mistaken the FDA doesn't have jurisdiction of the whole world. Plenty of other places to do research. Maybe rather than slam the FDA they focus on who is doing research and who is paying for it. Also technically not sucessful since it hasn't been tested, promissing would be a better term.
 
2014-08-04 11:43:47 AM  
Measles killed 110,000 people last year in countries that a few years ago had almost nonexistant mortality rates due to successful vaccination. Anti-vaxxers will kill hundreds more people this year than Ebola. Anti-vaxxers are an imminent danger to public health and it is time we start treating them as such. Do not let them send kids to school. If you work with an anti-vaxxer whose child is unvaccinated, they should be fired. They could carry a disease in that you could carry and spread to an unvaccinated infant who will die. Theme parks and airlines should request vaccination records for all children. It is time to isolate these people as much as possible. Let them know that we do not wish to share our civilization with them.
 
2014-08-04 11:47:25 AM  

Nabb1: Measles killed 110,000 people last year in countries that a few years ago had almost nonexistant mortality rates due to successful vaccination. Anti-vaxxers will kill hundreds more people this year than Ebola. Anti-vaxxers are an imminent danger to public health and it is time we start treating them as such. Do not let them send kids to school. If you work with an anti-vaxxer whose child is unvaccinated, they should be fired. They could carry a disease in that you could carry and spread to an unvaccinated infant who will die. Theme parks and airlines should request vaccination records for all children. It is time to isolate these people as much as possible. Let them know that we do not wish to share our civilization with them.


People are bad at judging risk. Hence people who are afraid to fly, but wouldn't hesitate to drive.
 
2014-08-04 12:23:42 PM  
From previous articles that I have read, they need to be extra cautious with any potential vaccine side effects because one of the major factors that doctors are facing over there is distrust from the locals.

So if they have a vaccine, and it's 99% effective but has visible side effects on 1% (random numbers) of the population... They're going to be fighting an uphill battle to treat anyone as they'd rather take their chances with Ebola than be exposed to potential mind controlling drugs of Western medicine.
 
2014-08-04 01:17:26 PM  

FuManchu7: Um ... that's not what the article said at all.  The FDA wants more information on what the drug is doing in the body before accepting larger scale trials.

It's not that they are seeing side effects, it's that they want to know what the drug does in the body before they start injecting a larger pool of test subjects.  This seems like a reasonable request and should be relatively easy for the drug company to comply with if they've been diligent with their science.


If I had ebola, I wouldn't give a shiat what it does in the body. It's not like my prognosis can get any worse. Just pump me full of whatever the most likely treatment is, and if I live, great.

Nabb1: Measles killed 110,000 people last year in countries that a few years ago had almost nonexistant mortality rates due to successful vaccination. Anti-vaxxers will kill hundreds more people this year than Ebola. Anti-vaxxers are an imminent danger to public health and it is time we start treating them as such. Do not let them send kids to school. If you work with an anti-vaxxer whose child is unvaccinated, they should be fired. They could carry a disease in that you could carry and spread to an unvaccinated infant who will die. Theme parks and airlines should request vaccination records for all children. It is time to isolate these people as much as possible. Let them know that we do not wish to share our civilization with them.


All that sounds goodish. Kind of a pain in the ass hauling vaccination records everywhere. As long as we never step over the "forcibly perform medical procedures on people" line.
 
2014-08-04 01:50:03 PM  

That Guy Jeff: FuManchu7: Um ... that's not what the article said at all.  The FDA wants more information on what the drug is doing in the body before accepting larger scale trials.

It's not that they are seeing side effects, it's that they want to know what the drug does in the body before they start injecting a larger pool of test subjects.  This seems like a reasonable request and should be relatively easy for the drug company to comply with if they've been diligent with their science.

If I had ebola, I wouldn't give a shiat what it does in the body. It's not like my prognosis can get any worse. Just pump me full of whatever the most likely treatment is, and if I live, great.


A seemingly less important side effect can kill you. If they think it's due to Ebola,  they might increase your treatment to try to halt the side effect. You're already weakened, and this one additional factor could be what puts you over the edge.

On the other hand, if that side effect is a known consequence of using the treatment, they can prepare for it.

As long as we never step over the "forcibly perform medical procedures on people" line.

Experimenting on people with a deadly disease sometimes comes pretty close to that line, IMO. There's a huge difference between giving an individual patient the best care for their condition & circumstances v. using unsupported claims to lure patients into a trial where their other treatments are discontinued because they might interfere with the results. It's very easy to persuade desperate patients and their families - just say you can give them a chance at a complete recovery.
 
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