It was cute to see the doctors on the stage during the press conference in their white coats
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Ebola coming to the US
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Compassionate use usually requires that some human testing/development has occurred. Typically it's done in cases where a drug is in Phase II (past "safety in healthy volunteers" which is generally speaking "Phase I") but not in broader studies (Phase III which tests dosing, side effects, etc. in the broader population and is completed just before FDA approval).
The reason is that in Phase II (and often PIII), there are fairly stringent eligibility criteria especially for very serious diseases. So people are often too sick to be included because they might die/have adverse events regardless of receiving the therapy. If that happens, it could raise questions about the therapy's efficacy/safety that are actually not drug related. Thus, studies are often NOT done on the sickest people with any disease. Compassionate use opens therapies up to people who may get extended life or better quality of life but do not qualify for the trials.
Honestly, it is rather poorly applied. Often it's somewhat arbitrary who gets compassionate use and who doesn't. People often campaign and beg and plead with the companies to get accepted. Companies are very wary because one bad outcome puts billions of dollars and years of work at risk for a single person vs. all the people who could eventually benefit (to say nothing of their profits...).
So anyway, this "compassionate use" isn't really the standard usage because the only testing so far wasn't even in humans.
I do a lot of biotech drug development work...sorry if that was more than anyone wanted to know.Married to a Urology Attending! (that is an understated exclamation point)
Mama to C (Jan 2012), D (Nov 2013), and R (April 2016). Consulting and homeschooling are my day jobs.
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Ebola coming to the US
T&S - Here is the World Health Organization's statement on the ethical use of experimental drugs lacking safety trials for this outbreak.
http://www.who.int/mediacentre/news/...ew-summary/en/
ETA: You're right, this really isn't "compassionate use" as the term is typically used. This is unprecedented and having defined the outbreak as an international threat may change recommendations.Last edited by scrub-jay; 08-21-2014, 03:03 PM.Wife to PGY4 & Mother of 3.
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It's here--the Dallas case was confirmed.
I really am not worried about it, though. I hope this is another case of survival being more likely in the US.
This hospital was DH's #2 pick for prelim year (we matched at #3). He's actually bummed he's not there because he thought it would be interesting to see how they deal with it. Not like they would have let an intern anywhere near itMarried to a newly minted Pediatric Rad, momma to a sweet girl and a bunch of (mostly) cute boy monsters.
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Originally posted by SoonerTexan View PostIt's here--the Dallas case was confirmed.
I really am not worried about it, though. I hope this is another case of survival being more likely in the US.
This hospital was DH's #2 pick for prelim year (we matched at #3). He's actually bummed he's not there because he thought it would be interesting to see how they deal with it. Not like they would have let an intern anywhere near it
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IMO: Mosquito-borne illnesses are scarier than Ebola, only because of how they are spread. You're much more likely to be bitten by an infected mosquito (West Nile, ChikV, Inf A, etc), especially in places like TX, than come into contact with bodily fluids expelled from a person infected with Ebola.
That EV68 isn't looking too hot, either...
Sent from my iPhone using TapatalkWife to Family Medicine attending, Mom to DS1 and DS2
Professional Relocation Specialist &
"The Official IMSN Enabler"
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More vaccines!! More vaccines for all! Seriously though, I don't think we're going to be able to get a handle on the Ebola in Liberia without a vaccine, the spread is just astronomical. And 13, I'm very concerned about the mosquito-borne illnesses and EV68 too.Wife to PGY4 & Mother of 3.
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Originally posted by Thirteen View PostIMO: Mosquito-borne illnesses are scarier than Ebola, only because of how they are spread. You're much more likely to be bitten by an infected mosquito (West Nile, ChikV, Inf A, etc), especially in places like TX, than come into contact with bodily fluids expelled from a person infected with Ebola.
That EV68 isn't looking too hot, either...
Sent from my iPhone using Tapatalk
The other scary thing is the dork of a governor we have. Could he not have been any more dramatic about the patient with Ebola announcement?Finally - we are finished with training! Hello real world!!
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Oops! Reports are coming out that the patient was sent home from the ER when he first started showing symptoms, despite telling a nurse his travel history & recent contact with an Ebola patient in Monrovia. Drs are saying it wasn't communicated to the medical team. He later exposed several school children who are now on home monitoring.Wife to PGY4 & Mother of 3.
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This was one of my fears when I started this thread. The US has saved every Ebola patient who has come here for treatment. Now, we have a Monrovian national who buys tickets here immediately after a known exposure to "visit family"? Maybe I'm cynical, but it sounds like medical tourism to me.Wife to PGY4 & Mother of 3.
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Meh, not worried. When the ID docs start to look concerned, I will worry then. For now, I would just hate to be the hospital's risk mgt, admin, & PR team. If they sent the guy home, what else are they sending back home. I'd be more worried about TB ya know.
When the CDC pays a visit, it is never a good thing.Finally - we are finished with training! Hello real world!!
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Originally posted by medpedspouse View PostMeh, not worried. When the ID docs start to look concerned, I will worry then. For now, I would just hate to be the hospital's risk mgt, admin, & PR team. If they sent the guy home, what else are they sending back home. I'd be more worried about TB ya know.
When the CDC pays a visit, it is never a good thing.Wife to PGY4 & Mother of 3.
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It's one of the more frou frou hospitals that is more known for its customer service than anything. Not bad and still pretty big, but my sister and I were discussing this tonight and if it were is, we would have gone to Baylor University Medical. More hard core but the ER isn't as much of mess as Parkland. Thank God he didn't go to Parkland...trying to track down all the potential exposure there would have been a nightmare.Married to a newly minted Pediatric Rad, momma to a sweet girl and a bunch of (mostly) cute boy monsters.
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