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"Secret Serum" Used To Treat Americans With Ebola
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.
Their lives were forever changed. One developed incredible muscles, which he used to fight crime. The other's brain was equally enhanced, but her turned to a life of crime.
Given that Ebola is currently confined to Africa, and that a relatively small number of people have caught it (less than 4000)...and these outbreaks seem to only come along once every 20 years, where was the incentive for the drug company to create this drug? Was it good timing that it has something ready to go just now. Will each dose be prohibitively expensive to administer in Africa, or it remains to be seen if WHO will foot the bill to the tune of 10's of millions $$.
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"
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Experts: Ebola Vaccine At Least 50 White People Away
http://www.theonion.com/articl...
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The same reason the US funds a vast majority of drug research in general (at least as of now): It has the money, universities, companies, the property right protection, and other laws that enable people to spend decades working on something and then eventually getting a payday for it.
And much of the rest of the world piggy-backs on US research money and then demands that they get it at a discount or will just ignore the patents anyway. It is part of the reason drugs are so expensive in the US - the US subsidizes the rest of the world.
It would be great if there were 5 or 6 (or more) areas all working on the problems instead of very few. Europe certainly does some, but even with European contributions, their percentages are still quite small.
There's a lot of hype on this Ebola topic in the media.
Lets have some scale:
The population of Africa: 1 billion
http://worldpopulationreview.c...
Number of people to die of Ebola in the past year: 887
http://www.usatoday.com/story/...
The number of deaths in Liberia alone during the last flu outbreak: 5,561
http://www.worldlifeexpectancy...
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.
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...
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.
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.
The rest of the world does not "get US drugs at a discount." Rather, American consumers are forced to pay a lot more for each branded medication than anyone else in the world. It is illegal for us to even shop around for a better deal.
Bust those American patents, world. We need to get affordable medications out there for all.
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.
Cut the marketing budget and the executive salary/bonus overhead and set up publicly funded drug trials and the final costs would plummet (even counting the public money... profit and patent monopolies are massive inefficiencies in the drug "market").
Then you can afford to get back on your meds. Win-win!
If you want a vision of the future, imagine a youtube comments section scrolling - forever.
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...
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.
Calling someone a "hater" only means you can not rationally rebut their argument.
Moreover, the American government refuses to try and negotiate on price or bulk buy bargains. Australia subsidizes the cost of drugs, and negotiates aggressively on price with pharma companies since a drug on the PBS is guaranteed to ship huge quantities.
There is no reason American health programs can not do the same.
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.
Right, which is why medical treatment in the UK is so much cheaper (yes, even after you take into account taxes), than in the US.
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.
I don't really understand the hatred for drug companies.
Well, since you (sort of) asked... Americans pay an outrageous amount for health care and the largest institutional beneficiaries of that are the drug companies, being the only group with double digit profits (the other beneficiaries are high salaried individuals). Defenders of big pharma's high profits usually try to wave away complaints by saying that it's necessary to fund drug research, never mind that if the money was going to research than it wouldn't qualify as profits, but the largest allotment of drug company money goes to advertising useless drugs to people who don't need them - research averages less than 20% of pharma budgets.
Then there's the lobbying: the Medicare Modernization Act forbade the government from negotiating on the cost of drugs, ensuring that Medicare pays twice as much as other groups for common drugs. This was essentially a $200 billion gift the the pharmaceutical industry passed under the pretense of "avoiding socialism." The United States is the only country in the world which both allows drugs to be patented and does nothing to limit the cost of those drugs. And speaking of patents, we have the drug companies to blame for the death of every attempt to pass patent reform - they need strong and indiscriminate patents for foreign markets since many countries, the poorer ones in particular, need drugs but can't afford the licensing. It's funny, but the reason why we have all the problems with software patents doesn't really have anything to do with software.
Oh, and also there's the whole thing about killing people for profit. Remember Vioxx?
As another researcher in the pharma industry: reread your post. Your entire post is only highlighting how poor of a job pharmaceutical companies do at effectively bringing drugs to market, all while adding the inefficiency of a 20% profit margin. The emphasis on profit alone also leads to too great of a focus on evergreening and low risk projects.
I've worked in a university lab that brought two (while I was there) drugs from design, synthesis, and screening through animal testing for the cost of an R01 ($250k) each. I realize that the clinicals are more expensive, but even $10M/drug is pretty small change compared to posted phama expenses. It's the bloat above the $10M per drug that makes them so expensive.
Hatred for drug companies comes from the (at least perceived) extortionate nature of the business. People feel as if their health is held ransom for another person's profit. Hospitals share the same ill feelings. It's especially potent because the people who profit the most from the whole scheme are already obscenely wealthy. Buying a car doesn't have the same "life or death" aspect to it.
If you want a vision of the future, imagine a youtube comments section scrolling - forever.
The same people who develop drugs elsewhere in the developed world, that's who. Switzerland, for example, has a research-intensive pharma industry rivaling the US in size, and it prospers just fine without having to screw its citizens with fixed prices and special laws against shopping around.
What I want to see is a pharma industry that operates like that other industry that has a special need to invest such a large percentage of corporate operating budget into research and development - electronics. Somehow Intel manages to keep cranking out new processors at steadily increasing ratios of functionality to price, and yet still reap billions while its customers freely shop the world market for the best bargain. Why can't Pfizer do the same without having to wheedle special legal privileges from Washington?
It's also shit like taking colchicine, which has been cheap and generic for years, doing a little extra research (which arguably was useful) and then using that status to bump the price up by 15 times.
Those people taking the drug couldn't give a shit about the research - they take the pills, their gout gets better, that's their own personal research right there. What sticks in their craw is that their pills now cost $5 apiece.
That and the systematic hiding of research that is negative or equivocal, the deliberate creation of medicines that are just a couple of atoms different from an existing one, not because they'll be better but because they'll be on patent, etc, etc.
Big pharma does a lot of good, but it's kind of like picking gold coins out of a midden.
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
Drug prices in the US are entirely down to the insane US health system.
Actually what you see here is very well understood. You are seeing an inelastic market; that is if a drug or procedure will save you life, it does not matter of it costs $5 or $5000, you will find the money to pay for it. The reason why socialized healthcare drives costs down is because the government / the insurance company will bargain on your behalf. Since they are not the one who is going to die, they can not be extorted and can pit different drug makers against each other. Health care is one of the few areas where "the free market" does not work as naively expected.
Of course, this ignores the reaction of onlookers, who are given a clear message that they're worth nothing to their society, and as such don't owe it anything either. I wonder if a nation facing such a problem might turn to exaggerated forms of patriotism as a desperate attempt to win loyalty where none is deserved, such as making little kids swear their allegiance every morning?
Free market doesn't really seem to work anywhere anymore, seeing how economy is always in a crisis, unemployment has apparently become permanent fixture of it and even employed people can't afford the lifestyle of their parents without getting into debt.
Forget magic. Any technology distinguishable from divine power is insufficiently advanced.
Why is it a problem to pay a few hundred bucks for a pill that will literally save your life
Probably because most of the world can't afford that. In fact millions in the US can't afford that, especially if they need a long course of treatment. It's basically telling them "we have a cure, but you are too poor, sorry". Rightly or wrongly I can see why they find that upsetting.
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SJW, n: "Someone I don't like, and by the way I'm a fuckwit" - AC
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%
https://www.eff.org/https-everywhere