"Secret Serum" Used To Treat Americans With Ebola 390
mrspoonsi (2955715) writes with news that the two Americans infected with Ebola in Liberia and transported to Atlanta for treatment were given an experimental drug, and their conditions appear to be improving. From the article: While some people do fight off the disease on their own, in the case of the two Americans, an experimental serum may have saved their lives. As Dr. Kent Brantly and missionary Nancy Writebol waited in a Liberian hospital, someone from the National Institutes of Health reached out to Samaritan's Purse, one of the two North Carolina-based Christian relief groups the two were working with, and offered to have vials of an experimental drug called ZMapp sent to Liberia, according to CNN's unnamed source. Although the Food and Drug Administration does allow experimental drugs to occasionally be distributed in life-threatening circumstances without approval under the expanded access or "compassionate use" conditions. It's not yet clear whether that approval was granted in this case or not. ... Brantly, who had been sick for nine days already ... [received] the first dose ... within an hour, he was able to breathe better and a rash on his body started to fade. The next day he was able to shower without help before boarding the air ambulance that flew him to Atlanta.
"Secret" (Score:5, Informative)
It's only "secret" in the sense that almost all pharmaceutical research is completely ignored by the media.
If you dig around you'll find some articles about ZMAPP in no-name low-impact journals like PNAS and Science.
"Secret"
Re:Expert:Ebola Vaccine At Least 50 White People A (Score:0, Informative)
Funny? Insightful? Predicts the future?
Confused as to how to moderate this. Considering how right Onion was in the past on those issues...
(Those who don't know what I'm talking about: http://www.theonion.com/articl... [theonion.com]
Note the date).
Re:hmmmmm (Score:4, Informative)
Rashes are not bruises; most rashes are just dilated capillaries, often due to immune system activation. Of course, eventually, Ebola does cause bleeding from capillaries, but it may not have had progressed to that point. It's possible that a serum like this acts fairly quickly on a rash.
Re:ROI for drug development (Score:5, Informative)
Odds are the so-called "secret-serum" is called ZMapp manufactured by a small biotech company called Mapp Biopharmaceutical [mappbio.com]...
Odds are this treatment is an optimized cocktail combining the best components of MB-003 [mappbio.com] and ZMAb [defyrus.com] (both appear to be three-mouse monoclonal antibody produced by exposing mice to fragments of the Ebola virus and extracting antibodies from their blood)...
Odds are these particular antibodies are actually manufactured in a plants, specifically Nicotiana, not extracted from animal blood.
Odds are you could find this information on this internet in less than 1 minute w/o suggesting or consulting a poorly researched, highly politicized book written in alarmist form.
Unfortunately, odds are many people are unable to use the internet effectively...
Re:"Secret" (Score:4, Informative)
Roundup of Ebola drugs and vaccines in Science (Score:5, Informative)
Science magazine had a good article about the drugs being developed for Ebola. One drug, TKM-Ebola, is in Phase I trials, but the FDA put them on hold because they wanted to change the protocol to protect participants' safety.
One researcher, Erica Ollmann Saphire, said that, because of the high case fatality rate, if she were exposed to Ebola, "I'd run for the freezer and ask for forgiveness instead of permission." But in cases like this, they usually can get FDA permission, under compassionate use. One German researcher got a needlestick, and they rushed the VSV-vaccine to her. But those were individual cases, in western hospitals, and they can't give an untested drug to a population in Africa (although some American pharmaceutical companies have tried that, and it didn't go too well).
http://www.sciencemag.org/cont... [sciencemag.org]
Science 25 July 2014:
Vol. 345 no. 6195 pp. 364-365
DOI: 10.1126/science.345.6195.364
Infectious Diseases
Ebola drugs still stuck in lab
Martin Enserink
For you suckers who are stuck behind the paywall, it had a good table that summed it all up:
VACCINES
VSV-based vaccines. Profectus BioSciences; Public Health Agency of Canada
Adenovirus-based vaccines. At least three different labs/companies
DRUGS
TKM-Ebola (RNAi-based). Tekmira Pharmaceuticals Corp. In phase I trials, but the FDA put a hold
Nucleoside analog. U.S.Army Medical Research Institute of Infectious Diseases
Monoclonal antibodies. Many labs/companies
AVI-7537 (antisense-based). Sarepta Therapeutics.
Everybody who does clinical research knows that most of the drugs that work great in mice, work reasonably well in monkeys, passably well in Phase I trials, poorly in Phase II trials, and not at all in Phase III trials.
There were a few articles in the New England Journal of Medicine on the FDA's fast track approvals. They found that when the FDA started speeding up drug approvals, they started approving more drugs with life-threatening side effects that had to be withdrawn from the market.
Of course, if you're dying of a disease now, the calculus is different.
Secret, my ass (Score:5, Informative)
Mapp Biopharmaceutical have been publishing articles about their ebola research in scientific journals since 2011. They seem to be a very secretive at all.
Maybe CNN thinks it's a secret because it hasn't been covered in the mainstream press - TMZ and Entertainment Weekly have completely ignored the company.
Re:ROI for drug development (Score:5, Informative)
Here's a good, reliable page on Ebola, Reston variant: (this assumes you don't think Stanford is a cheesy school, or in on the vast conspiracy to supress all conspiracy theories, or whatever).
http://virus.stanford.edu/filo... [stanford.edu]
from this page
"twelve of the 186 people tested had serological evidence of infection with EBO-R. 22% of the workers at Ferlite Farms had positive IFAT (indirect fluorescent antibody test) titers, which was significantly higher than at the other three export facilities."
Those infection mumbers are low for a virus that normally attacks humans, like Ebola Marburg, in a setting with no precautions at all and lots of hosts, but the fact that humans have no significant symptoms from it says that the Reston variant virus does not colonize humans at all well, and so are at least marginal support for it being exceptionally likely to survive in the environment, compared to the more human lethal types. This just might indicate that Reston is airborne, but probably just indicates it survives a bit longer on surfaces or takes a little more exposure to some disinfectants to destroy than the commoner Ebola virus types. So you're halfway right about that - Reston is not presumed to have become air vectorable, it's just been raised as a possibility in discussion, and is still rated as less likely than some alternatives.
this particular shipment of nonhuman primates had a far larger number of deaths in Room F than would normally have been expected.
And there goes your record - Reston is deadly to simians, at least to cynomolgus macaques. Unless you want to stand on your obvious spelling error (yeah, it doesn't kill "semians" - I hear not even Kryptonite kills them), the poster you are "correcting" was correct.
Given a 25% accuracy rating and four spelling errors and two grammer errors in four sentences you would have a hard time persuading people to reject the conspiracy theory that Donald Trump's hairpiece is an Venusion Brainslug invader.
Re:..but we won't give any more doses to anyone el (Score:5, Informative)
To quote TFA:
"It is important to keep in mind that a large-scale provision of treatments and vaccines that are in very early stages of development has a series of scientific and ethical implications," the organization said in a statement.
Which means, we haven't figured (worked) out yet the costs and payment plans for this drug, so we aren't going to use it to help those people already suffering who otherwise have no chance of survival. Let's just say they are "expendable", in the name of commerce, of course.
If anyone believes that hogwash about ensuring safety and efficacy and yada yada...well the mighty dollar beats all that.
No, what it means is that if they inject somebody with a large therapeutic dose of a drug that has only been tested in mice, they're liable to have life-threatening adverse reactions, like anaphylactic shock from the mouse antibodies, and it's much easier to keep the adverse reactions from killing them in a state-of-the-art western hospital than it is in the field, where they have trouble maintaining refrigeration, and don't have x-ray machines (much less CAT scans), among many other problems.
I can't find the quote, but a researcher told Science that things work great in mice, well in monkeys, passably well in phase I trials, poorly in phase II trials, and not at all in phase III trials.
Actually, it's the pharmaceutical companies that want to speed up drug approvals in order to increase their profits, and the Clinton and Bush administrations gave them their wish. According to a few articles in the New England Journal of Medicine, every time the FDA sped up drug approvals, they wound up approving drugs that had fatal adverse effects and had to be withdrawn from the market, like that Merck COX inhibitor.
You can't make a baby in 1 month by getting 9 women pregnant.
Re:"Secret" (Score:4, Informative)
No, apparently the name of the coctail is "ZMapp"; "ZMAb" is one of the main constituents of "ZMapp":
http://www.mappbio.com/zmapinfo.pdf [mappbio.com]
Man, what's with those big-A little-a things - they're driving me crazy!
Re:If it bleeds, lt leads. (Score:5, Informative)
Flu deaths aren't nearly as sexy as hemmoraghic fever. Someone passing away while sweating and shivering is nothing compared to having your internals turn to goo. This scared the shit out of me, no matter how small of a scale ebola currently is: http://en.wikipedia.org/wiki/T... [wikipedia.org]
This. Ebola is a very destructive virus.
The thing with Ebola is the fatality rate, up to 90% in some cases. Influenza (flu) infects 10's of thousands in each country per year but will only kill a few thousand at most in the countries with the most limited health care systems (in western nations, it kills maybe a dozen) and these people usually die from complications caused by other illnesses or old age.
Most people fight off flu with a bit of bed rest and some chicken soup, no such luck for Ebola as it attacks . The current fatality rate for the current outbreak is 60%, with 1600 confirmed cases (880 deaths) and there are more suspected cases. Beyond this, Ebola remains infectious after death, so people handling corpses without protection can contract the virus.
My doctor scared the shit out of me with my Yellow Fever vaccination (which is still the old school style live vaccine) and that has a fatality rate of 3% (less than 1% if treated early) and the vaccine had an infection rate of 1 in 5,000,000.
Re:ROI for drug development (Score:2, Informative)
Wow, an actual insightful comment here.
The other kicker on this is the human trials component: in order for an experimental drug to be released for production and manufacture, it actually has to undergo human trials. Human trials consists of first characterizing the target patient's symptoms, which is a tricky balance: many patients don't show all the symptoms, and often times symptoms aren't exactly conclusive which could lead to a person sick with something else becoming a false negative response and screwing up the data. At the same time you need the patient inclusion/exclusion criteria to be broad enough so you can get enough patients to reach a statistical significance. The FDA doesn't even require a super high statistical significance, usually around 3 standard deviations, but that can be hard if you don't get enough patients.
Then, where do you get the patients? Ebola is a disease that comes and goes in big outbreaks. It's one thing to test on lab grown CDC samples or infected monkeys, but at some point you have to test on humans and see the results as nothing gives you an idea of human response to a drug than human trials. So where do you get those? If someone developed a drug for ebola it's likely on CDC samples, but it's never been tested on humans because an outbreak hadn't occured yet, which means it's impossible to have done human trials and know the full effect of the drug.
Clinical trials are simply not easy affairs, and definitely not as easy as the majority of the uneducated masses on Slashdot seem to think it is.
Re:Expert:Ebola Vaccine At Least 50 White People A (Score:5, Informative)
As a researcher in the pharma industry: You are an idiot.
Where can I find the tens to hundreds of millions in public money needed to fund clinicals for a single drug that will most likely not get approved? That money doesn't exist, and many promising drugs die because companies run out of money. So companies have to have major profits on the few drugs that succeed- you should think about it as if you were playing the lottery, but each ticket cost you 10+ mil. High risk-high reward.
Also, a lot of cost is added by FDA incompetence. Yes, they are needed. Yes, we need to make sure everything is safe to some reasonable statistical level. Unfortunately, old rules and test requirements are never removed, so a company has to do a barrage of tests on everything, of which 90% are redundant outdated tests that nobody uses anymore.
I don't really understand the hatred for drug companies. Why is it a problem to pay a few hundred bucks for a pill that will literally save your life, but not a problem to pay thousands for your car? We need new drugs to replace failing medicines, and cure untreatable diseases. If we want to solve the problem of these diseases, we need to give a reason for people to form companies in this area, and that isn't going to happen without an expectation to get the money spent back.
Re:hmmmmm (Score:5, Informative)
Okay, I'll feed the AC troll.
I'm not talking about "most rashes"; real physicians have words to describe different kinds of rashes. The word that describes the rash of Ebola is "purpura." The distinguishing feature of this kind of rash is that when you push on it, it doesn't stop looking like a bruise. That is because the blood isn't contained within blood vessels that can be pressurized and allow the blood to be pushed out of the way. Because IT'S A FUCKING BRUISE.
Once blood leaves the vasculature, it is broken down into a couple of proteins. Hemosiderin is taken up by white blood cells. Biliverdin turns your turds brown (eventually). They make your bruises turn "black and blue" and eventually yellow. This takes days and is the reason why purpuric rashes don't fade immediately in response to anything.
You are conflating "hives" and "purpura." Kindly pay tuition if you want to continue.
Re: Expert:Ebola Vaccine At Least 50 White People (Score:4, Informative)
Technically, aspirin is a generic name in the USA, plus Australia, France, India, Ireland, New Zealand, Pakistan, Jamaica, Colombia, the Philippines, South Africa, and the United Kingdom, because (no kidding) Germany lost World War 1. In countres where it is still trademarked, the word should be written with a capital A, as Aspirin, the way you used it. The correct way to write the trademarked Johnson and Johnson wound care product is Band-Aid, with the dash.
But surely, even if some of the ACs above are a bit confused, that's not because someone still spends money on marketing brand names like 'Band-Aids". Surely they don't spend anything much on them, Let's see, for 2012, Johnson and Johnson claimed consumer wound care products resulted in sales of about 1 Billion US dollars, even, out of about 67 billion totak. Total advertising was 2.3 billion, so if we assume consumer wound care doesn't get a disproportionate share, that's 'only' approximately 34 million dollars a year. I don't think I'd call that next to zero. I will leave researching the budget Bayer spends for advertising Aspirin to most of the world, and specifically Bayer brand Aspirin (as it's described in the US and some other nations to get around that pesky genericness) as an exercise for the reader, but I have done the math, and it's actually larger than for Band-Aids.
Re:Expert:Ebola Vaccine At Least 50 White People A (Score:4, Informative)
Most medical patents aren't American. America has more medical research than other single nation, but by capita many European countries does more research and holds more patents especially Switzerland and Denmark. As such those countries are also interested in seeing the patents protected, though they haven't allowed themselves to be nearly as abused as the American healthcare system.
Re:Expert:Ebola Vaccine At Least 50 White People A (Score:4, Informative)
Anytime something is "publicly funded" the cost shoot up.
Which is why the Canadian health care system costs half of that in the US, and gets the same outcomes with high consumer satisfaction.
http://www.openmedicine.ca/art... [openmedicine.ca]
Open Medicine, Vol 1, No 1 (2007)
Home > Vol 1, No 1 (2007) > Guyatt
Research
A systematic review of studies comparing health outcomes in Canada and the United States
Re:Expert:Ebola Vaccine At Least 50 White People A (Score:5, Informative)
Sorry, you are going to have to explain how "the rest of the world" buying a branded, 100% genuine, drug for a fraction of the US price drives up the price in the US. You also might give an example where patents are being ignored in those same markets.
Here's a recent example of a man being charged $3,766 for Zovirax cold sore cream in hospital. The same product could be bought in Walmart for $181.66 . UK price $7.
http://www.fosters.com/apps/pbcs.dll/article?AID=/20140728/GJNEWS_01/140729484 [fosters.com]
Drug prices in the US are entirely down to the insane US health system.
Re:Expert:Ebola Vaccine At Least 50 White People A (Score:5, Informative)
World's most profitable pharma company: Pfizer
2013 Net Sales: $51.6B
2013 Net Income (profit): $22B
Profit as a percent of sales: 42.7%
R&D as a percent of sales: 13.3%
World's most profitable automaker: Toyota
2013 Net Sales: $168B
2013 Net Income (profit): $16.2B
Profit as a percent of sales: 9.6%
R&D as a percent of sales: 4.1%
World's most profitable tech company: Apple
2013 Net Sales: $170B
2013 Net Income (profit): $37B
Profit as a percent of sales: 22%
R&D as a percent of sales: 2.6%
Re:Expert:Ebola Vaccine At Least 50 White People A (Score:4, Informative)
There is no reason American health programs can not do the same.
Actually there is a law against that."The 2003 Medicare law* prohibits Medicare from negotiating drug prices, setting prices or establishing a uniform list of covered drugs, known as a formulary."
*: full title "Medicare Prescription Drug, Improvement, and Modernization Act"
src: http://www.nytimes.com/2007/04... [nytimes.com]