Leaked Documents Reveal Behind-the-Scenes Ebola Vaccine Issues 124
sciencehabit writes Extensive background documents from a meeting that took place today at the World Health Organization (WHO) have provided new details about exactly what it will take to test, produce, and bankroll Ebola vaccines, which could be a potential game changer in the epidemic. ScienceInsider obtained materials that vaccinemakers, governments, and WHO provided to the 100 or so participants at a meeting on 'access and financing' of Ebola vaccines. The documents put hard numbers on what until now have been somewhat fuzzy academic discussions. And they make clear to the attendees—who include representatives from governments, industry, philanthropies, and nongovernmental organizations—that although testing and production are moving forward at record speed, knotty issues remain.
So 1 x F35 = 60 million x vaccinations? (Score:5, Interesting)
If an F35 costs $337M* and "27 million doses of vaccine" would cost $151 million (half to produce and half to deliver as per TFA), then one F35 would be worth about 60 million doses of vaccine? * (https://medium.com/war-is-boring/how-much-does-an-f-35-actually-cost-21f95d239398)
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We could also redirect some of that 85 billion a month going to Wall Street right now.
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85B / 337M = 252.22 (ebola-cost-units-per-wall-street-month)
252.22 / 30 = 8.41 (ebola-cost-units-per-wall-street-day, assumes 30-day month)
1440 / 8.41 = 171.22 (wall-street-minutes-per-ebola-cost-unit)
171.22 / 60 = 2.85 (wall-street-hours-per-ebola-cost-unit)
Yeah. A whole whopping 2 hours and 51 minutes of it.
Wall Street needs to take a long, unpaid lunch, basically. That will provide a cure for Ebola. We'll even let them brag about it.
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Re:So 1 x F35 = 60 million x vaccinations? (Score:5, Insightful)
I really don't think debt should be transferable at all without consent of the debtor. I may take out a loan with a community bank reasoning that if I have trouble, they have a friendly reputation to maintain (let's face it, anyone can find themselves unable to pay a debt if bad things happen, no matter the intent). That doesn't mean I agreed to owe Snidely Whiplash and his robosigning minions money.
Let's apply a transitive test. I take out a loan after the bank examines every facet of my life for ability to pay. I then get a homeless man to accept my debt for a fifth of Jack. No problem, right? The bank will definitely not try to deny that the transfer happened and come after me, right?!?
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You can't just hand over debt like it was a fvcking coupon, it's legally binding, which is why you have to sign all the fvcking papers. To get the homeless pers
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Yes, and by the same token, I never accepted being in debt to Snidely. I don't get the opportunity to vet his character to make sure he is the sort of person I am willing to be indebted to. I never met him, he never gave me a dime. I am claiming the opposite of what you understood, that I should have the opportunity to vet the party my loan might be sold to.
As for credit, I was speaking primarily of mortgages (since those are the loans that are typically bought and sold. Few if any can afford to buy at leas
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The best advice I can give to all.
Stop living off credit
If you have to buy it on credit, it means you can't fvcken afford it.
If you can't buy it cash - Don't buy it
In most cases I agree. There is a caveat though: sometimes it is cheaper in the long run to buy something on credit than the alternative.
Example: I just bought an apartment with a mortgage. The alternative was to rent. However, houses are cheap to buy at the moment while renting is slowly going up. After careful calculation it turned out it was cheaper pay the mortgage to the apartment than to rent it.
An XBOX or PlayStation is not in that category. The alternative is free (not buy it) so it can't be cheaper
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Are you talking about $$ from private investors into private/public businesses?
Who is it to decide to take money from private individuals and companies in the US???
I don't mind the govt giving money...but I don't see it in the US constitution for the govt to start taking money from its citizens to do this type thing??
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The government has the power and the right to do as it wishes with its currency, but they have turned that power over to a bunch of counterfeiters in the name of "privatization", which means floating it on the commodities markets. The "gold standard" now is the petro-dollar. That is the global currency of today. No matter, it is trivial for them to divert the bits over to people developing a vaccine, they know exactly where to take them from. But... the power of derivatives prevails, and we all know who pay
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REally? Where exactly is THAT power listed in the constitution that enumerates the limited powers and responsibilities of the US Govt?
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Article 1 Section 8 clause 5:
The Congress shall have Power...To coin Money, regulate the Value thereof...
Spells it out pretty clearly, don't you think?. Is there anything else I can assist you with while I'm here?
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they have the power to print more money... that's about it. they don't have the power to confiscate it.
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It's not a "confiscation", it's a recovery of stolen goods acquired by fraud. And the power to regulate the value says it's all okay. They can just print new money and render the old worthless. This is one of those little things a government is authorized to do by default. And the fact that the law is there in black and white, on the supreme document of the land, makes it all the easier.
Not the money: politics (Score:5, Informative)
$151M or $337M is not such a large sum of money that the US, UK, or French government couldn't unilaterally pick it up. The issue is with the politics. Voters and politicians in a single country are more okay with joining an international effort than seeing that they're the only ones footing a big bill.
In this regard, the UK's strategy shows a lot of leadership combined with practical politics:
"As far as financing, the U.K. government contends that a “multi-donor club” should pay for the vaccine development in “the medium term.” But for now, the United Kingdom says it will “unilaterally” cover the costs for purchasing vaccines in Sierra Leone, and it asks the governments of the United States and France to make the same commitment for Liberia and Guinea, respectively."
It's a good play that let's the more xenophobic groups feel that the UK isn't propping up the whole world, but also allows hawks to see this as the UK exercising leadership/dominance internationally.
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If it lets us save lives, I can live with that.
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... what's there to destabilize?
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In my case, I would be more likely to die driving to the hospital for the vaccine, than I would be of Ebola.
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Every West African country I've been to, they won't let you in unless you've got an in-date vaccination certificate for Yellow Fever. That's every such country.
(They actually changed the required vaccine booklet for new issues to have a yellow cover, as a flag of the main disease they look for in it. My older one is grandfathered in though.)
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Oh, sorry, I disturbed your political posturing with a relevant question. I'll let you get back to grandstanding without reading the fucking article. Meanwhile, I've got friends in the area, trying to do their jobs. But don't let the real world disturb your political ranting.
The Cult Leader will solve the problem! (Score:1, Troll)
And yes, I know I will be moderated straight down to hell for this one.
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There's a rapid diagnostic test that is developed and can be at West African airport departure gates in less than three months if the FDA gets out of the way. I know, it's only nutters like the NPR health sciences correspondent going on about this - was Dr. Paul also saying crazy things like the government is making the situation worse? Instead, they should totally go ahead and implement a travel ban so people sneak into the country with ebola instead of coming through the airports.
Meanwhile nobody in th
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Instead, they should totally go ahead and implement a travel ban so people sneak into the country with ebola instead of coming through the airports.
How exactly is coming in through the airports with ebola, where you have a nice vector to spread the virus both nationally and internationally, superior to people sneaking into the country with ebola?
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The design purpose of these is not to test people arriving in western countries, but to test people suspected of infection in the outbreak countries, which is a far more effective way of keeping the disea
Re:The Cult Leader will solve the problem! (Score:5, Insightful)
I'm sure the world's most average Ob/Gyn [Ron Paul] - and most successful living American cult leader - is also a highly qualified expert on Ebola.
That sounds suspiciously like an ad-hominem argument. "Most average" Ob/Gyn? What does that even mean, other than to convey dark undertones?
Shouldn't we be debating the things he says? Shouldn't we be considering the merits of his argument, rather than his background?
Obama's Ebola czar (Ron Klain) is a lawyer and former chief-of-staff. Do you think *he's* qualified to tell us what we're doing wrong?
What the heck are you getting at? What's your purpose in posting this? Is there some way in which you gain by posting such drivel?
You're right about being modded down - your post does nothing to inform the discussion.
Re:The Cult Leader will solve the problem! (Score:5, Insightful)
That sounds suspiciously like an ad-hominem argument. "Most average" Ob/Gyn? What does that even mean, other than to convey dark undertones?
I am using that because his followers make a huge deal about the number of babies he has delivered. However considering how long he was a practicing Ob/Gyn, that number is actually not particularly impressive - particularly if he was the main or only practicing Ob for a moderately populated area.
Shouldn't we be considering the merits of his argument, rather than his background?
From what I have seen, so far all he has been saying is that we're doing it wrong. I haven't seen anything from him about how to do it right. Naturally, his followers jump all over it as gospel.
Obama's Ebola czar (Ron Klain) is a lawyer and former chief-of-staff. Do you think *he's* qualified to tell us what we're doing wrong?
The Ebola czar is supposed to help manage the response. Just as the Surgeon General does not perform surgeries while a member of the cabinet, the Ebola czar is just a manager.
What the heck are you getting at? What's your purpose in posting this?
My point is that there are a lot of people - including one particular cult leader / politician / retired physician - telling us that we're doing it wrong. I have not seen any of these people do anything other than bitch and moan about it being done wrong; I most certainly have not seen them propose anything other than what we are doing.
Hell any proposal for the government to do anything would be automatically rejected as "the wrong thing" by Ron Paul as he is against all forms of government spending, regardless of how many lives are at stake (excluding, of course, his own).
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Hell any proposal for the government to do anything would be automatically rejected as "the wrong thing" by Ron Paul as he is against all forms of government spending, regardless of how many lives are at stake (excluding, of course, his own).
So if he is against all government spending he should return his paychecks then.
Oh wait that is ok?
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Ebola czar is just a manager.
Exactly. And the man should have an idea of what he is managing, unless he's just handling lawsuits. I would give the benefit of the doubt to a real medical doctor. But, hey, troll on, dude.
Re:The Cult Leader will solve the problem! (Score:5, Funny)
It's kind of hilarious that a bunch of self-styled libertarians need to have a leader cult, isn't it?
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Liberty for him and those like him, but not for people whose concept of liberty involves not starving if you can't work, or not being discriminated against because they're part of some despised minority.
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An "average Ob/Gyn" is a fully qualified and licensed medical doctor and far better informed about Ebola than 99% of SlashDot users.
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No, see, you're supposed to make it *hard* for us to spot the cultists. Saying something stupid like that makes it too obvious.
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Holy shit you're a fucking moron.
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By that reasoning, I should listen to everything Dr. Oz says because he's a fully licensed and trained medical doctor (cardiologist), right?
Or maybe being in one medical field doesn't make you an expert in all medical fields?
(Even more so if you have a political agenda to advance and thus reason to ignore evidence that doesn't agree with your views.)
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Ron would certainly know more than the empty suit bureaurocrats you seem to idolize. By the way, most polled doctors argree a travel ban is a good idea.
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Summary (Score:5, Insightful)
And the ethics around live human trials are tricky, because some participants in the trial will die from ebola.
Which isn't surprising. If someone can think of alternative which delivers a better result, then I'm all ears. The framing of this as if the documents reveal some sort of 'scandal' is a bit troubling.
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Which isn't surprising. If someone can think of alternative which delivers a better result, then I'm all ears.
I'll give it a try. So many people are executed every year in various countries (even the US). Why not allocate them for research purposes? Instead of electrocuting someone, give him Ebola and try to cure him. You could even give them the option: Do you want a lethal ejection with 100% mortality or Ebola with treatment with projected 30% mortality?
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So you are suggesting that if a death row inmate agrees to be a guinea pig, then actually survives whatever nasties they are injected with, then they should be allowed to live?
Does your master plan include releasing the survivors from jail completely then? or just downgraded from death row to life in prison?
The alternative is they keep getting tested with nasties until they do eventualy die.
Which of these do you think is going to be an acceptable outcome to everyone?
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I'll put my statistician's hat on to answer your fucking stupid scenario.
Are the immune systems of overweight drug-addicted white guys living on a high fat diet directly comparable to the immune systems of subsistence farmers who work a 12-14 hour day and are significantly malnourished, and also have several types of intestinal worms and other chronic infections? (And malaria too, active o
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If someone can think of alternative which delivers a better result, then I'm all ears
Simple. Use a portion of the 24,000 doses (a few thousand?) to spot vaccinate anyone who's had close contact with someone with Ebola, say all immediate family members. Those peoople are arguably at risk or at greater risk than health care workers. That's how polio is being eradicated. The WHO comes in and vaccinates an entire community when a poliio case is detected.
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That's what you do if you already have a proven vaccine, yes.
But if you gave a hypothetical ebola vaccine to all 100-odd people in the US who'd plausibly been exposed by Duncan, you'd conclude it was 98% effective because only 2 infections resulted. Except you could've given them sugar pills and saline injections to the exact same effect.
Doing this doesn't tell you what trials need to tell you: "Does this vaccine/treatment have partial or complete preventative/curative powers without unreasonable side effec
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That's what you do if you already have a proven vaccine, yes.
And also what you should consider doing when you have a worldwide pandemic in a country that threatens to kill millions of people.
Doing this doesn't tell you what trials need to tell you:
That's why you do it with a small amount of the available vaccine. Note I said use a portion, not abandon the clinical trial. There's absolutely no reason why you can't use SOME of the vaccine to combait the disease. It might not work at all, but it's a decent
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OK, that's the first 100,000 doses of your 24,000 used. What are you going to do with the next -76,000 doses?
Most (not all) people in this area live in fairly extended families - mum, dad, several kids, one or several grandparents, maybe a cousin from the country. 6 to 8 per household might be a reasonable average.
Infections are running at a
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Actually the problems are the potential side effects of new vaccines, and not if it works or not...
If they're comfortable enough to give it to 10s of thousands of health care workers, who are wearing protective clothing, trained to deal with the exposure, and are highly monitored and controlled who they come into contact with, why wouldn't they give it to people at high risk of developing ebola?
If the risk is so high from the vaccine, then you sure as hell shouldn't expose 24,000 healthy people to it.
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Most of the high risk people will resist or outright refuse the vaccine, they don't trust healthcare workers and they especially don't trust 1st world healthcare workers and a lot firmly believe that drug companies are actively trying to poison them.
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The scandal is the financing, and legal issues, like patenting. This whole thing sounds like somebody is trying to drum up business, and create a distraction during election season. And if one company can't make enough, then others can take up the slack. Boeing didn't build all its airplanes during the war, GM and Ford helped, and made a pretty penny from it.
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Yeah, but clickety click. Click. Click. Race. Shock. Money. Lives. Click click. Life or death. Click. Choice. Kerching! We have a winner! Kerching!
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Properly designed and conducted double-blinded trials result in fewer deaths overall than badly conducted trials, if the drugs are any good. If the drugs are not any good (which is something you do not know until after you're at least part way int
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And the ethics around live human trials are tricky, because some participants in the trial will die from ebola.
At this point, there's no use for a control group. There's also no point in artificially introducing test subjects to the virus, since there are so many people at risk already. Inject everybody already infected with the vaccine/cure and see what happens. The likely worst case is that people die from side effects of the drug, but without the cure, most people are going to die from the disease anyway. The absolute but unlikely worst case is that one strain has mutated to the point where the cure is no longer
clinical trials. (Score:2)
I still emotionally struggle with the clinical trial approach of giving half the participants a placebo to see how many of them die vs. the ones who were given the drug under study... I understand that it's statistically necessary but that doesn't make it easier to digest.
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Yeah, I'd argue it doesn't need to be 50/50. Surely, assuming we could make enough vaccine for it, a 80/20 study would give us enough statistical significance, with less than half the number of needless deaths.
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What about:
80/20 - with the remaining 20% monitored more closely - with daily temperature readings - and if temperature spikes - take a blood sample, and give a high dose of vaccine. (or monitor everyones temperature, if blinding is a concern)
As I understood it - vacine - post infection is a moderately effective treatment
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We don't know that for this disease. It is the case for some diseases, but ... I'll spell it out : ...
W_E
D_O
N_O_T
K_N_O_W
T_H_A_T
And that is one of the things that we need to find out.
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If your study was 100 folks and you gave 80 the vaccine and 20 placebo, you would only have a sample size of 20 to test the null-effect (e.g. how many folks naturally get better w/o the new fangled vaccine to see if the vaccine statistically helped the 80 folks or not).
To increase the placebo sample size to the same statistically significant level (e.g, 50 folks) you would now have to give your untested vaccine which may have potential side effects to 200 people (+120 more folks). Which would be more ethic
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Yeah, but their study size is 12000, not 100.
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In situations like this, you usually see a study that tries to use a "time as a placebo group" mechanism. Essentially, you give the damn vaccine to everyone, and see how mortality rates compare against what was happening before the vaccine. Obviously this is a bit complicated by improved public health awareness, improved standards of care, improved procedures, etc. It definitely muddies the study up somewhat, but you can still g
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I'll translate that into statistician speak : more patients die than absolutely necessary.
I'm not trying to make you feel bad - it's just a nasty situation.
Try one of the standard psychological tests : there is a run-away train on a line running towards a car with a family of five children in a car stuck on the tracks ; there is a set of points (errr, EN_US : switch??) which you can use to divert the runaway train into a siding where it will impact a wheelchair
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It's easier to digest than potentially wasting money and resources (that could be used for alternative vaccines) and giving people false hope with something that ends up the same as a placebo.
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We desperately need a more ethical, and faster, approach to drug development than the double-blind trial. Build a supercomputer cluster that models the human body, and keep iteratively improving the model over time. Meanwhile, we use the model to directly assess the effects of new medications. Yes, developing such a model would be costly and at first risky. But compared to the ethics of giving half your population of ebola victims a placebo and watching them die in ways I wouldn't wish on anyone not working
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Said the guy who's completely unaware of the inner complexities of the human body.
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Can't we use some already known Ebola fataility rate, i.e. 50%? Then use this as a baseline to determine the effect of a vaccine without a placebo group, i.e. if vaccine A results in 90% survival, and vaccine B gives 55% survival, we can already draw some conclusions..
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Well, at least you have enough rational outlook to recognize it is necessary. Not doing this right will cause a lot more death and suffering.
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You don't, generally, give the patients a placebo ; you give them the standard treatment. Generally, you're not interested in comparing whether your new treatment is better than nothing ; you're interested in finding out if your new treatment is better than the standard treatment.
And as your results (deaths, or whatever other end
So... (Score:3)
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The doctors. At WHO.
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From WHENCE.
Summary reveals nothing (Score:2)
If there was ever a reason for @SavedYouAClick, this summary is it.
Money, money, money... (Score:2)
It seems that this all about the financial bottom line. I understand things cost money, but it would nice if there was, for once, more concern about human lives.
At the risk of sounding like a conspiracy theorist, I think this particular outbreak is being publicized to create FUD.
There have been outbreaks in the past that weren't nearly so well publicized. I think a few companies are close to having a cure/preventative and are using this FUD to get around a few regulations (we have a cure, but the rotten r
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Here is a link that seems to support my previous comments: http://www.msn.com/en-us/news/... [msn.com]
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Re:Money, money, money... (Score:4, Interesting)
It seems that this all about the financial bottom line. I understand things cost money, but it would nice if there was, for once, more concern about human lives.
Actually, it's not.
Glaxo Smith Klein has said that even if they relax the bio safety level 2 requirements for filling the vaccine vials, after a certain (short) point, they will be converting their production of other vaccines from such diseases as rotavirus, measles, mumps, and rubella.
At that point, we are talking about trading American lives to benefit Liberian lives.
Note that the NewLink vaccine donated by Canada has demonstrated Ebola-like symptoms in many of the people who've been inoculated in Phase I trials, so it's entirely possible Canada Health has been giving those people either the virus or a weakened strain of the virus, and is actually infecting people. Apart from that, they also have the fill rate problem that GSK was complaining about, which would short-sheet supplies of other vaccines.
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Hmmm, I wonder if, after vaccination with this (or one of the other in-development vaccines and treatments), the patient will then always return positive on the piss-in-a-pot type tests for Ebola which are also under development?
Of course, if they do return positive because of the vaccination
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Why? The attacking nation would of course have vacines for those of the preferred segments of their society.
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Why? The attacking nation would of course have vacines for those of the preferred segments of their society.
It mutates as it reproduces. It's like the rolling codes on your car alarm or garage door opener: vaccination against the previous code won't prevent you getting infected with the new one. This same effect is why you can have the cold or flu more than once in your life.
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Many diseases are not like that, and vaccines offer "cross protection" against mutated strains
Paul Allen just donated $100M to the cause (Score:2)
Colour me Suspicious (Score:2)
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I find it a bit suspicious that Africa has handled many Ebola outbreaks before this just fine. Sure there were deaths, it's Ebola, but they handled it. Now we have 20+ medical companies with untested human trials of Ebola vaccines/cures all rushing in to "save" the day by testing the drug on humans without a controlled environment and with no legal liability. If a survivor's next fetus grows a third eye and has an IQ of a sweet potato in a drought are they going to take responsibility? I doubt it. How about getting the right gear and help to the health workers instead of pumping them full of crap you could not test legally in your own country. Stop using Africa as a petri dish. Makes me wonder if they didn't start and help spread the epidemic in the first place. But then again maybe I have played/watched too much resident evil.
Proper help to the health workes would include vaccine. In an early phase, there won't be enough vaccine doses for the general population anyway, but currently health workers are at high risk and the number of doctors is dwindling. Not because they leave their posts, but because they die. If you have protective gear and practices that reduce the risk of infection by 99 %, that's still a high risk scenario if you are at a treatment center with multiple patient encounters a day. For any similar infection wher
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Maybe you have. (What's "resident evil"?) Unfortunately, this is not a game, and people are at risk. I've a colleague working in the area at the moment, and I'm due to be going back there in about April ; my neighbour's husband is worried about relatives who live in Ghana and his colleagues in Senegal.
I really think your concern about your conspiracy theories are a bit over-blown.