This is one of the reasons why I want presence of governmental entities in drug research. There is very little incentive for a private drug companies to show that an el-cheapo generic drug that has had centuries of use (in some form or the other) behind it, can counter some serious diseases. Yes new use can be patented, but its really impractical to enforce. Sort of like those allergy drugs and sleeping aids, same exact composition but placed in different aisles with different names and grossly different prices. As much as I love the market, sometimes it is either insufficient, or works way too slow for a human lifetime.
[Digression: We either need a quantum increase in life-span, or a market force catalyst that will speed up market dynamics few orders of magnitude, so that the consequence of a market intervention affects the same guy who made that intervention]
Back to aspirin, its really somewhat of a wonder-drug without a hype, if you can stomach it that is.
> There is very little incentive for a private drug companies to show...
Yes, but let's consider why:
1- Government regulation (patents) creates an artificial concept of property that prevents humanity at large from benefiting from scientific advances that could be much cheaper. The reasoning for patents is that they are a required incentive from companies to go through expensive tests. But guess what...
2- It's government regulation that makes the tests so expensive.
So the government tries to solve a problem, then creates a new problem, then tries to solve the new problem, then....
Every step seems reasonable and in the interest of the consumer, but the end result is still that a majority of people do not have access the the level of health care that is scientifically and technically possible, and not even close. But at least they are protected from a number of things. Maybe.
We demand a high level of scientific rigor to accept a medication, but we don't demand the same high level of scientific rigor to accept government meddling. We just take it at face value that the benefits of regulation outweigh the costs and this premise is never tested at large.
I don't know much about the regulations the government imposes on pharma companies, but I assume it's mostly to show that the new drug actually does something and is not dangerous.
I think those are reasonable. I don't want a few hundred people to die and their relatives to sue the company because it saved money on the safety checks before a drug is removed from the market. And I also don't want to go back to the time of snake oil salesmen traveling the country...
>Government regulation (patents) creates an artificial concept of property that prevents humanity at large from benefiting from scientific advances that could be much cheaper.
That regulation might be voted by government, but is lobbied for and pushed by the corporations. Like copyright is.
It's not inherent in government to have strong patent/copyright/etc regulation. In fact some of them that don't get pushed and attached diplomatically by more powerful governments working for private interests (like the US pressuring Sweden for the Pirate Bay etc).
>If the government cannot balance and resist those influences then this is an inherent flaw of the government.
Or merely of the way government is practiced at a certain place and time.
Nothing has to be "inherent", especially since the word "goverment" is a shortcuts for tons of different methods, practices and cultures of government.
> 2- It's government regulation that makes the tests so expensive.
Yes and no. You'll see numbers saying that each approved drug costs several billion, with most of that money going to clinical testing. The reason for that is that something like 90-95% of candidate drugs never make it through clinical testing. So if you add up the clinical testing costs for each of these failed drugs, and amortize them over the approved drugs, you get these astronomical costs.
But I'm not sure if the takeaway is the same as what you're saying. Would drug development be cheaper if these 90-95% of drugs that currently fail clinical testing made it onto the market? If you replaced the regulatory regime with the usual recourse of letting people sue for drugs that ended up being ineffective or harmful, then it probably wouldn't be any cheaper for the drug companies. And if you blocked the legal remedy, then you've just externalized the cost of ineffective or harmful drugs onto the public.
It's like a balloon: you can push all the air out of one side, and crow about how you've shrunk it down, but the air just goes to the other side. The fundamental issue is that drug development is intrinsically expensive: there's an expense to proving drugs safe and effective through clinical trials, there's an expense to allowing consumers to sue to recover for unsafe and ineffective drugs, and there's an expense in allowing unsafe and ineffective drugs to enter the market.
The problem is that in a first-world country, taking years off of someone's life is incredibly expensive, whether it happens because you sell a harmful drug, or because you sell an ineffective drug that precludes someone from taking an effective one. Let's say the social value of a human life is $1 million per decade. One source puts the cost of regulatory approval for 12 leading pharma companies from 1997-2011 at $57 billion per year on average (http://www.forbes.com/sites/aroy/2012/04/24/how-the-fda-stif...). What is that measured in person-decades? Only 57,000. Out of not just the 300 million people in the U.S., but the hundreds of millions if not billions of people around the world who piggy-back off of U.S. drug safety protocols.
I don't know the details of the testing regimen, but it seems to me that you're offering a false choice fallacy: that we must either do testing the way it's done today, or not do testing.
While I don't know what the alternative might be, it seems reasonable to assume that there are other levels of intermediate trade-off, where we're willing to accept somewhat higher risk for lesser expense (not to mention faster time-to-market).
There are an infinite number of intermediate points in the design space in which you trade off lower testing costs for higher risk. But what does "higher risk" mean? It means nothing other than costs borne by the public. And at $1 million per person-decade, those costs add up really quickly.
Those 90-95% of drugs that fail clinical testing have to go somewhere. Cheaper testing might mean that only 75% of drugs fail, and 25% end up in the market. Could this be more efficient overall? Maybe. Or it could be a lot less efficient, since 80% of those drugs are harmful or ineffective and would've failed more stringent testing!
It's not testing that makes drug development expensive. That's just the symptom. What makes drug development expensive is that the science doesn't exist to let us improve on that 90-95% number.
>2- It's government regulation that makes the tests so expensive.
Yes. I've heard that 80% of drug development costs go towards the elaborate testing required by regulations [0]. Perhaps we as a society agree that it is necessary to do all of that testing. However, it is important to acknowledge that the extra safety comes with a very high price tag.
"We demand a high level of scientific rigor to accept a medication, but we don't demand the same high level of scientific rigor to accept government meddling" that seems like fairly rational behavior right given one could be life threatening and one is a low level irritant that we feel like we can address at the next ballot box if we feel so strongly?
...and one is a low level irritant that we feel like we can address at the next ballot box if we feel so strongly?
But this is no longer true, for two reasons.
First, Congress has abdicated much of its power to regulatory agencies, which are where the actual regulations' details are determined. These bodies are not elected, so we can't vote them out. While it's true, in principle, that we could use the ballot to get Congress to claw back its power, or at least to influence the details, this would (a) take a really long time, and (b) is far too broad a brush to paint with. Being able to cast one vote every 2 years for my Representative, and one every six years for my Senator, is many orders of magnitude too gross a control to be able to influence specific regulations across the whole realm of governmental interest (suppose I hate the way the FDA is handling one thing, but love the way that the DOT is doing something else, etc.; how am I to influence all those factors with just two rare votes?)
Second, we're no longer able to determine with certainty what our government is doing, in order to exercise control over it as necessary. For example, just yesterday afternoon there was a story [1] on HN covering the government's efforts to actually rewrite the records of a court proceeding, so that we wouldn't know what had actually transpired in the court. And surely I don't need to go into detail about Snowden, FISA courts, National Security Letters, etc.
I was under the impression that the main point of government was to record and enforce property rights, which are, therefore, by definition artificial.
Hear hear, there are a lot of drugs in this position. c.f. Naltrexone 'low dose Naltrexone' and OGFr http://en.wikipedia.org/wiki/Met-enkephalin
The lack of research into these drugs leads to a lot on-line mis-information and patient-led self-experimentation. This can work for some, it has for me with LDN and Crohn's but can leave others confused, disappointed and frustrated, as well as putting doctors in an awkward position.
Is there a stomach which can handle aspirin regularly (even in small doses) without the risk of getting ulcers and bleeding?
If there is... where's the line to get one? :)
Just dissolve the tablet in a spoon of water. Will pass through the stomach fast enough. Also there are PPIs which can help with ulcer risk reduction... I mean, between cancer and aspirin...
How fast the aspirin passes through your stomach has no impact on ulceration and bleeding. It's not a contact effect, it's a systemic effect that reducing the stomach's ability to protect itself.
They do, but with such old generics, the profit per unit would really be peanuts compared to newer fad'ish drugs, regardless of whether they are more effective than their older kin. Dont have the numbers but I would guess the market price of generic aspirin would have reached the zone shade above its marginal cost by now. A company would spend only so much effort here. The effect is more pronounced for poor man's diseases and health care issues.
Which would in turn create a massive opportunity for companies like Bayer to undercut the market. The concept that the government would be more incentivized and thus more likely to discover novel uses for a product than it's sellers doesn't really make sense to me.
Really the big difference is that with the government their motivation will always (in theory, of course) be finding the best cure, whereas for businesses it could go either way. Sure, Bayer might have a great opportunity to undercut the market. Alternatively Bayer might have a less efficient but more-profitable drug which incentivates them away from stuff like this.
with the government their motivation will always (in theory, of course) be finding the best cure
Well, that ignores all of public choice theory. Under this model, the entities of government (the politicians, the regulators, the regulatory agencies) only have the incentive to ensure their own outcomes. That overlaps to a certain extent with finding the best cure, but it's far from synonymous.
Much as I love the market (I'm a Hayek groupie), I think there's a free rider problem here. Why would Bayer invest in improving the market for aspirin (paying for research, marketing, etc.) when the benefit of that investment would be enjoy by countless other generic makers, with Bayer reaping hardly any of it?
[Digression: We either need a quantum increase in life-span, or a market force catalyst that will speed up market dynamics few orders of magnitude, so that the consequence of a market intervention affects the same guy who made that intervention]
Back to aspirin, its really somewhat of a wonder-drug without a hype, if you can stomach it that is.