If you're an American, every time you read a new article on Ketamine for depression your thought should be "Jeese, healthcare is screwed up". Pharma companies don't benefit from getting Ketamine approved (since it's no longer patent protected), so no one is putting it through FDA for depression. As a result insurance will never cover it (under the current model).
The reason this treatment isn't mainstream isn't because "the research is still out" (though that may still be). It's because there are no financial interests to get it over the hoops into the highly convoluted state that enables affordable medical care.
The very article you're commenting on directly contradicts what you're saying. Big pharma is actively running studies and trying to get this fast tracked for treatment in the US and Europe.
Granted the article is somewhat poor reporting because the title should read "esketamine" not ketamine.
Esketamine is the patentable isomer they're trying to use to enable this process of patenting + FDA so the drug companies can make a return. So the end result is a very expensive drug that insurance would pay for vs a cheap drug with 90% of the benefits that insurance won't pay for.
Yeah, this is basically a variation of the POTAXOR strategy [1]. Well, whatever it takes to get it into the hands of sick people! But I think it is a commentary on the system that it will take decades after we had good evidence for ketamine's effectiveness.
> Pharma companies don't benefit from getting Ketamine approved (since it's no longer patent protected), so no one is putting it through FDA for depression.
This is incorrect.
There are ongoing phase 3 clinical trials for nasally applied esketamine that will lead to FDA approval if succesfully reviewed. These trials are conducted worldwide and are very encouraging. The specific application seems to be patentable. First results should be available around 2019ish or 2020.
> What if racemic ketamine performs better than esketamine? We'll never know because they won't test that.
It's quite likely some public institutions (e.g., universities, public research labs, etc.) or other countries (e.g., in India, China) will test exactly that. It's also in their interest to pubblish the results. So we'll get to know the differences between racemic ketamine, esketamine and arketamine.
The question is if different variants will also be approved, which is much more expensive.
Do you have a source for that? You can get a patent on a new use for something that already exists if the new use is a non-obvious advance over the prior art.
What I do not understand from a market perspective is why insurers don't cooperate more to fund such research. If a treatment goes from 20k to 1k p.a. the benefits for insurers are clear. They could even fund such research in an equity-fashion, that way steering clear of anti-competition law and free-rider problems (just sell it to the non-cooperators for 20k).
That is an incentive to insurers only if they are paying the price or if the lower costs to a specific group of consumers increases their market share. Since most costs are passed on to the consumers and most consumers don't get to pick their insurance (in the U.S.) , the incentives aren't there.
Yes, healthcare sounds pretty screwed up. But even though ketamine for depression might never get FDA approved, I think it's still good that these positive effects are still being reported on. The fact that there are new articles on ketamine shows that there is still some interest.
And this interest isn't completely fruitless just because the pharma industry will never support it. Individuals (admittedly, only those who can afford it) can still try to benefit from e.g. off-license prescriptions.
Healthcare in the UK moves at a snail's pace. NICE requires a lot of evidence before they will permit new treatments. The bigger issue though are the "Daily Mail politics" of using drugs that can be abused - it's seen as politically toxic with a particular segment of voters. Take cannabis as an example - it was moved back to class B years ago, purely for political reasons. And as other nations are starting to use it therapeutically, we still seem light years away.
Generic pharma is still big business. And there's patents for novel ways to deliver the medication (e.g., Vyvanse and Concerta in the ADD stimulants space)
Getting a drug approved by the FDA is pretty expensive. Abolishing the FDA, thereby reducing the cost of introducing the drug, might be the real solution here.
I find public health inspectors also make it more expensive to run a restaurant. Perhaps the solution to their tight margins would be to abolish health inspections.
Well, it would be interesting to look at impartial cost/efficiency research regarding "health inspections". I routinely travel to countries where those inspections are just a pure formality, or completely non-existent - and, I must say, in most cases there's no trouble finding a good, safe place to eat.
Although I don't disagree with your point, that wasn't my point. My point is that these things have different aspects (some of which are arguably useful, some perhaps in your eyes less so or not) but removing them has serious consequences. It is easy to be against something (for example, paying taxes) but removing taxation has serious consequences which have to be accounted for.
Keeping them as they are also has serious consequences that are rarely examined, or even raised for consideration.
The public interest is for medical treatments to have the following qualities: safe, effective, affordable. The business interest for healthcare providers is for medical treatments to have the following property: profitable. Those interests only partially overlap.
It is possible to imagine many different institutional architectures that cater to the public's interests, and a large number of them are theoretically better than the actual results yielded from the FDA and the rest of the modern American health care system.
Thus, one of the consequences of maintaining the status quo is the foregone advantage of moving to a different and wholly incompatible system. That's the kind of argument only an economist could love, because it ties your brain up in knots trying to figure it out, and you can plausibly justify any prejudicial opinion you might care to support.
> Keeping them as they are also has serious consequences that are rarely examined, or even raised for consideration.
Yes, but the burden of proof lies with those who prefer an alternative. If you want to demonstrate an alternative is better, you need an honest and in depth comparison with the current. Just saying "the current sucks" isn't an argument.
I do agree it is difficult for drugs like ketamine, psilocybin, and MDMA(/MDA/MDE/etc) to get research funding, but that doesn't mean the current options are useless; we know they are useful, just not in every case. Nor does it mean that those mentioned drugs are better; we do not know.
> Yes, but the burden of proof lies with those who prefer an alternative. If you want to demonstrate an alternative is better, you need an honest and in depth comparison with the current. Just saying "the current sucks" isn't an argument.
That burden of proof lay originally with those that introduced, e.g., the FDA. We could go back to investigate whether we find that proof sufficient, if any was even provided, but your interpretation of the proof would perhaps be different than mine.
But decisions like creating an FDA are not based on proof, I would argue. It is based on other factors, especially on what can give government more power and what people will vote for. The average voter does not investigate any proof on the matter, but instead rely solely on gut feeling, for instance the feeling that drug companies are greedy enough to deliberately release drugs they know will harm people.
US government is not set up to A/B test the efficacy of its own agencies.
You can't set up an alternative to the FDA in order to test it, because the FDA is the supreme dictator over the regulatory domain, and you can't get around Mom saying "no" by asking Dad behind her back.
You can, however, look at the European pharmaceuticals regime, and note that an identical drug costs three times in the US the amount it costs in France.
Clearly, the FDA is not optimal. Equally clearly, we do not demand meta-studies proving that the FDA itself is safe and effective for its stated purpose.
Anarcho-capitalism largely depends on a belief that human nature is essentially good, and prone to spontaneous cooperation. It is also heavily dependent on reputation, which scales poorly, or on trustless technologies, which aren't yet mature.
I'm still anarchist in 2018, but I haven't been anywhere near the an-cap territory of it since around 2006. Sticking to a political dogma out in the libertarian hinterlands is really only good for pointlessly arguing with other libertarians on the Internet.
That can be fun sometimes, but it's not as entertaining as it used to be, what with everyone pointing at Twitler and saying "You see? This is exactly as (insert libertarian variant) predicted!"
Honest question: consumers are notoriously ill-informed, companies are good at propaganda and fake "clinical" evidence, and finding out if medicines ate effective AND safe is really complex.
How do you imagine abolishing the FDA would improve outcomes instead of increasing supplies (and marketing) of snake oil?
You know who is also good at propaganda? Government and state.
Can you prove that FDA improves the outcome? Is FDA somehow free from lobbying, or are the people working there consistently uninfluenced by certain counterproductive incentives? How could we go about ever proving that the absence or existence of a government agency has improved conditions overall? Sorry if this comes off as lecturing, but these are questions that I think should be asked and is not intended for you specifically.
In any case, you cannot take away that FDA approval likely costs millions of dollars and makes it more costly to introduce a drug. It is self-evident that making something more expensive to do reduces the incentive to do it (weighed against the potential profit).
> It is self-evident that making something more expensive to do reduces the incentive to do it (weighed against the potential profit).
No argument - but you didn't answer my questions at all other than to say "FDA is fallible!"
I can't prove the FDA is non-evil/non-fallible. I don't have numbers to share, so I'm going off of very fallible impressions. However, those impressions are that the FDA has done a better job of keeping crappy products off the market than a free-market world.
You complain about the opposite - good products being prevented because of lack of incentives. It's impossible to measure what hasn't happened, but do we have evidence that lack of incentive cause more harm than preventing crap/toxic/poisonous products that we have a recorded history of?
We have a solution today, a solution with problems, but a solution that I'm confident is better than the original problem. What is your basis to claim that removing the solution will in fact be better than the problem?
Same with Vitamin D, almost. If it were patent-protected, you'd probably get a big list of features promoted for an almost "miracle pill" that would probably cost a few dollars per pill.
But Vitamin D is not patent protected and it's dirt cheap, so not only does Big Pharma have no interest in promoting it, but it would rather you take much more dangerous drugs and much more expensive drugs to cure the same things Vitamin D does.
This is what a private healthcare system gets you, where profit is always a bigger priority than the well-being of the patient.
The reason this treatment isn't mainstream isn't because "the research is still out" (though that may still be). It's because there are no financial interests to get it over the hoops into the highly convoluted state that enables affordable medical care.