What if mega-rich people could buy places on clinical trials?
mosaicscience.com
mosaicscience.com
There are a number of medical treatments that have been proven safe to EMA (the European version of the FDA) standards, but were either mired for further years in the FDA approval process or were never approved at all due to the increased complexity and cost of the FDA approval process. Take a look at http://www.bioworld.com/content/ema-trounces-fda-2013-drug-a... to see the disparity.
The argument I always hear against allowing people to purchase drugs that haven't been officially approved by whatever agency has jurisdiction over the patient is "But what if some unscrupulous drug salesman bamboozles them into buying snake oil?". It seems to me that the existence of the FDA, EMA, and any number of other national and private certifying bodies is more than sufficient to allow people to make an informed decision for themselves.
I think that any argument for drug decriminalization or bodily sanctity can be applied in favor of allowing people to choose what drugs they wish to consume (even though some people will make unwise choices).
Whay would happen is the snake oil industry would get huge, and all accountability will be lost. The drug industry after all WAS unregulated in the past.
>* It seems to me that the existence of the FDA, EMA, and any number of other national and private certifying bodies is more than sufficient to allow people to make an informed decision for themselves.*
You'd be surprised. People already fall for all kind of BS "snake oil" remedies and magic pill solutions (not to mention stuff like homeopathy and aromatherapy, etc).
What would happen in that case will be that they would consider FDA some "bureucratic, antiquated" organization, that is "too slow" to respond to new drug needs etc. And of course all the propaganda from the snake oil salesmen will help in this.
Plus, remember the thamilomide baby situation back in the fifties? That would be a much more frequent occurence with non FDA approved drugs.
> Whay would happen is the snake oil industry would get huge, and all accountability will be lost. The drug industry after all WAS unregulated in the past.
This
That's fair. But is protecting these people from their own stupidity sufficient justification to possibly promote unnecessary suffering and prevent people from accessing needed/wanted medication?
I think a big question is whether this would get any worse. I think that it would, but I am not exceedingly confident about that.
They aren't. In the U.S. they are prevented from purchasing certain drugs without the advice and consent of a prescribing physician. The prescribing physician can be on-board for the use of non-FDA approved meds, it's just uncommon.
source : personal anecdote. I used 4-Aminopyridine[0] with the consent of my doctor within the US before clinical trials began as a 'research tool' for insights into a medical condition. It was dispensed by a medical chemistry lab under the consent of my physician, and paid for out of pocket.
This seems to be essentially false. I can find some evidence that unapproved drugs are prescribed in the US, but this is usually because A) the drug is grandfathered in or B) the doctor is breaking the law (intentionally or unintentionally).
http://www.fda.gov/drugs/guidancecomplianceregulatoryinforma...
http://en.wikipedia.org/wiki/New_Drug_Application
http://en.wikipedia.org/wiki/Investigational_New_Drug
http://en.wikipedia.org/wiki/Kefauver_Harris_Amendment
Also, the FDA approved 4-Aminopyridine in 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...
Without marketing and mass adoption is hard to fund the manufacturing process for a drug.
A carrot to get FDA approval for a drug can be that the drug maker is shielded from liability for side effects of the drug. (Of course, the shield wouldn't apply if the drug maker misrepresented the drug during the approval process, or did not make the drug correctly.)
If patients could just buy unapproved drugs directly, why would they sign up for a clinical trial where there is a good chance they get the placebo? Keep in mind that even if there are a lot of people taking a drug, it is incredibly difficult to see if it actually works without a randomized controlled trial.
And a big problem with clinical trials today is recruiting enough patients for the trial. It's difficult and expensive. If the pool of patients wanting to enter the trial was smaller, less trials would get run and we would learn less about which drugs actually work and which don't.
Two reasons. 1. They might be too poor to afford the drug. 2. The drug company has an incentive not to release the drug before being officially approved, for reasons of CYA and reputation.
If there's a rising proportion of mega-rich people in any given study, this could introduce significant sampling biases. Ethnicity, diet, lifestyle, gender - it all factors in and will have to be controlled for appropriately.
Another concern is that this could introduce incentives into the eco-system that detract from the primary goal that is to obtain a drug that would be effective for as many people as possible (setting aside drugs with specificity as a goal for a moment).
Imagine there's a drug A that happens to show very promising results on caucasians but not so much for africans, and a drug B that has more general effectiveness (hackneyed I know, but please bear with me). While a more impartial set of trials might have wound up selecting drug B (albeit after some passage of time), it's now possible drug A could get fast-tracked to market by virtue of being awash with funding from affluent volunteers while drug B never generates enough monetary interest to make it.
Still, and I realise I'm coming dangerously close to sounding like a tinfoil spouting "money corrupts" as I type this, I would still be wary about how introducing massive amounts of private donations of this sort might impact the process of bringing drugs to the market. For the moment, this sounds great as trials could now have a source of funding where there currently is none... but it seems to me that this would further exacerbate the problem with the pharma industry focusing on cash-cow meds. Things could get such that it would be more profitable to target an exotic ailment with wealthy backers than to target an affliction disproportionately affecting the plebes.
Not that I'm saying that we must not explore alternatives to the current policy of denying experimental drugs to terminal patients. I'm simply cautioning that we have limited resources and researchers, so we ought to be careful how policy changes influences their priorities over the years.
The other logical workaround would be to give the HNI donor a trail of the drug but not include (or interpret with caution) the results of that particular individual (which can be tough for rare diseases)
Of course, it would be ideal if resources were simply abundant and all these trials could be funded without giving special treatment to wealthy donors. But given that we don't live in that world, I would certainly rather see one wealthy donor and nine other individuals (for example) get access to a potentially life-saving therapy than to have them all die in the name of equality.
It's a shame that autocomplete can still elicit laughs.
I like to think about it in another way: If poor people were given preference in terms of going on drug trials, would the same groups be up in arms about the poor being used as guinea pigs for the rich?
> If poor people were given preference in terms of going
> on drug trials, would the same groups be up in arms
> about the poor being used as guinea pigs for the rich?
> What if the first doses of the drug — which had never
> been used in people and had not even finished the
> typical animal safety testing — had been given to
> African patients instead?
> “It would have been the front-page screaming headline:
> ‘Africans used as guinea pigs for American drug
> company’s medicine,’ ” said Dr. Salim S. Abdool Karim,
> director of Caprisa, an AIDS research center in South
> Africa.
https://www.google.com/search?tbm=nws&q=ebola+"Guinea+pigs"&...
That's already how most drugs are currently tested. We used to test new drugs on prisoners and conscientious objectors, now we just test them on the poor and indigent.
Why, why let ethics mess up a perfectly profitable business idea?
>Of course, it would be ideal if resources were simply abundant and all these trials could be funded without giving special treatment to wealthy donors.
I don't think it's about resources, it's about their distribution. Such trials CAN be funded "without giving special treatment to wealthy donors" -- we're spending trillions more giving special treatmeants to wealthy people,(such as bailouts).
I'm not going to argue the public policy motivation behind bailouts as we could go on quite a tangent there, but the fact is that many clinical trials go unfunded. Obviously money exists somewhere, and the government could unilaterally decide that it's more valuable to fund clinical research than to bail out failing companies (or buy F35s, or build schools, or whatever). Thus far they haven't done so. This plan, on the other hand, could actually start saving people's lives immediately.
Other group - deontologist believe in some rule or sets of rule and they might not be concerned with consenquences that much.
Famous trolley problem describe this idea nicely.
Obviously this is problem on its own.
Another issue is that the rich people likely wouldn't be happy with the chance that they're in the placebo group. So they probably would have to be guaranteed to get the real drug, outside of the actual trial.
If you look at the research done on disease prevalent in Rich population vs prevalent diseases in the poor -- you will see a clear pattern.
For example: There are significantly more resources (Time, People and Money) focused on Rare Genetic Diseases such as Cystic Fibrosis (a rare genetic disease in Caucasians) Vs resources to find cure for malaria or better medications (in spite of the growing problem of resistance)
Although many of the disease that are more common in poorer people are always linked to socio-economic issues and are not just a disease in themselves. From intestinal parasites to malaria.
But not providing adequate resources to all such disease can turn out to be a disaster -- like that happened with US ignoring Tuberculosis as a significant health problem and then subsequent re-emergence of TB due hiv and MDR (drug resistant) forms of TB
Similarly, because few people in these nations are affected by malaria, mostly because they had already been spent time and resources attacking it a century ago, they are more apt to spend money on problems that they are affected by.
This does not mean rich white people have bought up clinical trials and medical research. This is just a natural manifestation of economics.
I completely agree that blindness to larger issues can certainly cause huge problems, but your sentiment has little to do with the super rich buying themselves spots in medical trials.
I'd say that's an unfair, and loaded statement to make. "Bought up" is a very loaded term, and suggests bribery and denial of the thing being bought up from the "not-rich" by virtue of it all being taken by the "rich".
So, you say there is a "pattern", and that this is somehow the purposeful doing of the rich. With not any proof of wrong-doing, you jump to that conclusion. You don't even posit that maybe it's perhaps researchers go where there is funding, or maybe drug companies find it more profitable to treat diseases that affect the rich, whatever.
No. You blame the rich, for essentially having money and spending it on the things that affect them(if we can even make that causal link, but it's more likely indirect as per my alternate suggestions above). So in essence, what you're really bothered by is the fact that the rich don't share your views on what the rich should be spending their money on.
In a fair world we would allocate funds for medical research based on number of people suffering from illness and not their purchasing power -- but then the world isn't truly fair to everyone.
Imagine this were happening inside a country -- a large percentage of population with income below 60K suffered from an particular disease A and a very small chunk of people earning more than 120K suffered from a rare disease B. And everyone including the government decides to fund research on disease B -- won't that be unfair and unjust ??
Also with people shunning vaccines and emerging varied forms of resistance, Disease of the so called "Poor Developing Countries" might come back to haunt the "Rich"
Agreed, it's really impossible and on the same shelf as "Perpetual Motion". But, to be fair, when most people these days talk of fairness or just, they mostly refer to their own personal notions of those terms and what physical outcome represents them best. The end result is that the terms are basically meaningless, as no one can reconcile their personal definitions with a global/universal definition (if one even exists).
"[..]And everyone including the government decides to fund research on disease B -- won't that be unfair and unjust ??" I'd say that sucks for the "large percentage" of people you speak for. But, then again, a discussion of this hypothetical scenario would devolve to a discussion of politics, because their government is supposed to represent majority interest. i.e. That's the actual problem.
Those who can afford it would still set up their own labs and pay their own scientists. There is nothing wrong with that.
But the government should of course do things differently, I agree, which is why the health system including research should be run directly by the state (instead of being funded indirectly via insurance) and patents for pharmaceuticals should not be granted anymore.
Since the big companies involved currently spend most of their money on marketing (again paid for indirectly by insurance), this would also lower the total costs.
Sometimes those people selling the nonsense know it's nonsense and they're just outright crooks.
Often those people genuinely think they have a valid treatment and they're just being ignored because BIG PHARMA[1] or somesuch.
Diverting money from those sham treatments into carefully controlled trials seems to be beneficial.
[1] It's tricky to argue against some forms of WOO[2] because the behaviour of some pharma companies is so terrible. Only publishing results that show efficacy; fudging the compliance documentation; using dying cancer patients to campaign for changes in prescribing guidelines when the company knows the drug only adds maybe two weeks of poor quality life.
[2] Waste Of Oxygen - a useless stupid pointless treatment such as homeopathy.
Organizations like the FDA might not approve of people buying their way onto trials for pills that can induce a specific mental state in someone, but if one is in a research lab now working on something similar but with a device, there doesn't appear to be an FDA like organization (yet) that would shut PI's (or current corporations make and sell said devices commercially) down if some wealthy individual decides to fly up every couple of weeks so they can "play", despite the non-zero probability of inducing negative side effects from the states one is potentially trying to induce.
Kind of reminds me of in the late 1940's where x-rays machines were used fit shoes… only nearly 2 decades later the Nuclear Regulatory Commission was formed, where its predecessor was more in the business of enabling such endeavors.
It seems like people who have access to enough resources and are looking for ways to exchange resources for something they want will find a way if the perceived possibilities are in their field of awareness… no matter any ones understanding of such things.
tangent: If we're facing the lag "problem" with purely human behaviors and their externalities, humans approaching the endeavor for AI and AI augmented humans evokes the imagery of pounding ones fists in sand.
> Every year, an untold number of potential new drugs or interventions, any one of which might go on to improve thousands of lives, are thrown away without being tested in humans. It is a matter of funding, not science: there is not enough money in the public or private sector to run clinical trials on every exciting proposal that comes out of research labs.
Thinkable.org is a recently-launched crowdfunding platform for cutting-edge scientific research: http://thinkable.org/discover
Similar to the article's Dating Agency model, Thinkable does review the campaigns before listing them publicly: "Dr McNeil said Thinkable would only allowed researchers affiliated with accredited research organisations to use the site and any funds donated would be managed by the organisation to ensure they were used for research." [1]
Thinkable doesn't appear to allow you to buy early spots in the clinical trial queue, but it certainly seems that they want to ensure that important science research won't be lost between the cracks due to a lack of funding. A more democratic approach to funding scientific research, in contrast to the plutocratic approach discussed in the article.
[1] http://www.smh.com.au/technology/sci-tech/young-scientists-u...
Edit: I temporarily removed my point about Thinkable being a democratic approach, because in retrospect it seemed a trivial & obvious observation, until I saw that wyager had just replied to that point specifically!
Pedantically, it's a more market-oriented approach. A democratic approach would be if everyone got one vote (not proportional to how much money they were willing to risk), and voted on which drugs they thought should get funding, and the rest got nothing.
Forgive me, this is a personal pet peeve of mine :)
The difference between one-vote-per-person and a vote proportional to the amount of money you are willing to risk, is a significant one. So I suppose Thinkable is halfway between the plutocratic and democratic approaches?
As an aside (tangent to your comment about the rest getting nothing), I don't know what Thinkable does if a campaign doesn't reach its funding target: Whether the money is restored to the sponsors or the researchers simply have to work on a smaller budget (maybe once a minimal funding threshold is passed).
I know it will vary wildly from drug to drug, but, in general, does anyone know if it actually costs that much to manufacture a single dose?
Also, what if a rich, terminally sick person decides to break the law and manufacture a promising experimental drug for her own use in her basement? The chemical formula is in the published papers, after all. How many specialists would be needed in the conspiracy?
The cost lies in the development of the drug, plus the ten other drugs that didn't make it to market where R&D costs need to be recouped. And small scale production is naturally more labour-intensive.
It seems like no matter who you are, you have the commonality in death. I'm surprised more of the billionaires of the world aren't investing in curing it in all its myriad forms, considering their risk of succumbing to it at some point.
The dark side of course being that clinical trials become the fast lane for the rich to drugs that will save their lives but never reach the commoners cold. But if you got rid of the medicine patents, then once the drug hits market anyone can duplicate it.
Before they do that they better stop birth, because we would have some serious problems on our hands.
If you brought the bottom ~2 billion up to the median global living standard, the total human population would begin to contract due to the reduction in new births brought on by the higher standard of living. If you reach an income level on par with poor Eastern European nations ($10k to $15k), you start to see a decline or flattening in population.
With accidental deaths, and the huge drop in new births, it wouldn't take very long - relative to the new life expectancies - to cut the population of the planet in half.
If all people stopped dying at 65, and say lived to 400, the wealth accumulation would be substantial for most of the poorest (which currently reside in China and India). Their standard of living would skyrocket, as they'd have perhaps 300 good working years. Those 1.5+ billion poor living in China and India would also likely live long enough to see the conditions of the poor in said countries improve immensely. Not to mention the remarkable breakthroughs in technology / medicine that would occur during their lifetimes, a further multiplier lifting them up out of current levels of poverty.
1. Living longer doesn't mean your standard of living will rise. Even if you work longer, you will not necessarily accumulate significantly (or perhaps even any) more wealth. And if you are in poverty currently (ie, effectively earning nothing), multiplying that by another 300 years still leaves you with zero.
2. If there is any change to the accumulation patterns of money, I would suspect that either the rich would get (individually) richer -- or perhaps more money would be printed, thus de-valuing the existing money.
3. Being at the median global living standard does not guarantee that you will produce fewer children. For example, there are many people in Western countries who for religious reasons continue to produce large families. More time for them would presumably result in even larger families.
4. In fact, Africa is particularly interesting, because its birth rate is NOT dropping as fast as predicted due to economic development: http://www.economist.com/news/leaders/21598648-birth-rates-a...
2) I'm not sure what this means. We already have an inflation-controlled money supply, and the patterns of both acquiring and printing money has changed vastly over the past century or so.
3) That article tells you straight up that those parts of Africa are missing out on the important parts of economic development that lead to lower birth rates, namely physical safety and access to family planning.