[debunked] Linus on drugs

[Alexander Terekhov]

--------
Name: Anil Maliyekkel (amaliy1@nospam.edu) 12/3/06

Linus Torvalds (torvalds@osdl.org) on 12/3/06 wrote:
---------------------------
>Do you think penicillin was invented because Alexander
>Fleming or St Mary's Hospital (where he was working) was
>looking to make a huge profit?

...

>Btw, penicillin is again a great example: not only was
>it discovered without any patent push what-so-ever, but:

This is a poor argument. If we relied on accidental discoveries to
advance medicine, we wouldn't have very many antibiotics today to treat
the multitude of antibiotic-resistant bacteria that have popped up since
the advent of penicillin (and other naturally produced antibiotics).

If you can't rely on nature to do all the hard work, you are going to
have to spend lots of money. And even when nature has done the hard
work, finding the results either depends on luck or spending lots of
money. The question is where does that money come from.


Name: Chung Leong (chernyshevsky@hotmail.com) 12/3/06

Linus Torvalds (torvalds@osdl.org) on 12/3/06 wrote:
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>That's a rather idiotic argument. It's sadly a very common
>one.

Since your position is that the system is distorted, it's only fair to
ask to what an undistorted system is and how it'd function.

>How do you think most drugs got invented historically?

I think most drugs used today were at some point under patent
protection. Can't find a survey that confirms this, but a cursory search
at the USPTO indicates that most drugs are covered by multiple patents.

>What kind of sad and dark world do you live in, that you
>believe that people only do things because they want to
>help "big pharma" make billions and billions of dollars?

It live in a world where researchers expect to make a salary, where
facility and equirpment cost money, where drug test volunteers are cared
for, and where consumers demand compensation if a drug turns out to be
unsafe. Even if an organization does not seek to make a profit, clearly
it has to avoid losses in order to continue operation.

>In other words, one of the most important drugs of modern
>times totally lays to waste your idiotic and unrealistic
>argument.

Why don't you bring up the paper, removeable-type, gun-powder, and
compass too. Those are important inventions. Better yet, lay waste to my
argument with the wheel.

>So. Try to back up your opinions with facts instead
>of trying to make the inane (and unsupportable) argument
>that patent protection rackets are the only way to make
>progress.

Let me just randomly picked a few drugs:

Cipro was patented.
Ibuprofen was patented.
Asprinin was patented.
AZT was patened.
Prozac was patented.
Ecstasy was patented.
Cortisone was patented.

>There is basically zero support for the notion that
>technical advances (in any area) depend on strong IP laws,
>and there are lots of examples where the biggest advances
>were done in the absense of strong IP rules.

IP protection channels resources to those making technical advances, who
can then perform more research to beget more advances. The logic is
simple enough.

Corporations aren't the only ones benefitting. The Bayh-Dole act has
been a huge boon to American universities. And the results show. The
Shanghai education ranking (which emphasizes research) is dominated by
American schools. This year's Nobel science prizes were swept by
Americans. Meanwhile, Europe is fretting about a brain-drain. 


Name: Anil Maliyekkel (amaliy1@nospam.edu) 12/4/06

Linus Torvalds (torvalds@osdl.org) on 12/3/06 wrote:
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>I've got news for that person: a lot of human
>advances are "accidents". The interesting thing is how
>those "accidents" just keep on happening to people who
>are interested in how things work, and they start looking
>at what the reason for the "accident" was. At that point,
>it's not an accident at all any more: it's how science
>gets done. Being "accidental" in no way changes that basic
>fact.

Yes accidents happen, but they don't happen at a fast enough pace. And
we can't rely on nature to provide us with all the solutions. The
multitude of beta-lactam drugs designed from knowledge gained from
studying penicillin and the few other naturally occuring drugs in the
same family and from studying the resistance bacterial mechanisms to
those drugs were obviously not accidental creations. They were mostly
created by researchers working for companies or academic institutions
interested in product development or building IP portfolios.

>Btw, of the drugs you mention, at least a couple weren't
>done by commercial companies at all, which totally moots
>your point. At least AZT was from a University with US
>government funding, for example. IOW, even when patented,
>important drugs were not discovered because of
>any patent, but because of very simple and direct needs:
>people paying for it because of basic science and health
>reasons.

>So I don't think you have a very strong case to say that
>patents "drive" the industry.
>
>Linus

AZT was synthesized in the 1960s as a cancer drug by researchers at a US
university funded by the NIH, but was not effective and was highly
toxic. AZT was identified as an HIV drug by a team of scientists working
at the NCI and Burroughs Wellcome, and the clinical trial was
subsequently run by that phamaceutical company.


Name: rwessel (robertwessel@yahoo.com) 12/4/06

Dean Kent (dkent@realworldtech.com) on 12/4/06 wrote:
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>What you (and others) are doing is claiming a causal relationship between 
>development
>of various inventions and patents. What Linus is doing is saying that there is
>no definite evidence to indicate that these inventions would not have been 
>developed
>even without patents. In fact, history has shown that very smart people tend to
>create new things simply for the joy of it, or because they are somehow 
>compelled to.

I'm quite sure that somebody someplace will continue to poke at stuff,
and discover a new and useful drug.

Unfortunately that accomplishes precisely *nothing* without tens or
hundreds of millions in investment to get it past the regulators.
Pasteur might have discovered penicillin on his own, but he didn't need
to get it approved by the FDA.

>Whether it would be slower or not is a question that can be debated, and one 
>might
>be able to present a very convincing argument that the money involved has 
>provided
>the resources to speed up the research and development. OTOH, Linus has also 
>presented
>an alternative argument that is just as convincing by using x86. One cannot 
>seriously
>claim that Intel and AMD have not poured billions of dollars into research for 
>a
>product that neither one has a monopoly on.

No he hasn't. This is a strawman, and a bad one. Intel and AMD are not
pouring billions into x86 development, they're pouring billions into
Pentium, Core, Athlon, Xeon, Duron, Opteron, etc. development. Why
shouldn't Intel, after the P4/Prescott fiasco, simply have done a quick
micrograph reverse engineering and respin of an Opteron on their
semiconductor excellent process and sold it as a Pentium 5? Not that
doing so wouldn't have been hard, but it would certainly have been
*much* less expensive than what they spent on Core. Why hasn't AMD
replaced their CPUs with a Core Duo clone?

If you used the same strawman on drug companies, you'd be trying to
argue that nobody would invest in a new high blood pressure drug unless
they had a monopoly on high blood pressure drugs. Clearly false. GSK may
have a patent (and monopoly) on one high blood pressure drug, and
Novartis another. But GSK can't start selling Diovan.

At least I agree with Linus that something like an ISA should not be
patentable.


Name: Chung Leong (chernyshevsky@hotmail.com) 12/4/06

Linus Torvalds (torvalds@osdl.org) on 12/3/06 wrote:
---------------------------
>What you claimed was that without patents, there would
>not exist any drug market. You're basically claiming that
>the drugs you mention wouldn't even exist without
>patents, and I don't think you have any data what-so-ever
>to back up that ludicrous claim.

A common problem in social science is the impossibility of conducting
controlled-test. Economists, for instance, can't divide a country into
equal halves and implement one set of policies in one and another set in
the other. Then how do they know, say, the Soviet system in the US
wouldn't lead to dramatic improvement in the life of its citizens? There
has never been an Soviet Republic of America after all. What we can do
is draw conclusions from other countries' experience. but
cross-comparing the situation in different countries we can eliminate
cultural phenomenons as factors (e.g. that communist secret police isn't
a merely holdover from Tsarist time) and arrive at fairly firm
conclusion that, yes, the Soviet system is pretty rotten.

We can do the same analysis in regards to patents. The drugs I mentioned
were all invented in countries with strong patent laws (mostly in
America, a couple were from pre-war Germany, I think). Name any drug and
that will likely be true. Why did the West (the US in particular)
dominate the field? Why weren't drugs invented in Soviet Russia, India,
or China? Basic science weren't lacking in these countries. Nor were
medical personnel Their pharmaceutical sectors were fully capable of
syntheticizing drugs invented in the West. The possibility for new drugs
to be developed certainly existed in these countries.

India in particular deserves our attention. Prior to the country joining
the WTO in 2005, patents on drugs weren't respected. So drug firms just
busied themselves making cheap copies of western drugs. Now that the law
has been changed, investment is pouring into drug R&D. A lot of it comes
from western firms eager to take advantage of the lower wages. But local
firms are opening research centers too. The same thing is happening in
China (to a lesser extent, because rule of law is still weak there).
Novartis recently announced that it's going to spend $100 million to
build a research center in Shanghai.

>My counter-claim was not that patents don't exist (they
>obviously do), but I wanted to point out that a lot of
>drugs came to be even without them, and despite
>them. In other words, there's no real reason to believe
>that patents (in the current form, at least) actually help
>us get better drugs.

One is not a lot. I can give your another: deer testicles. The Chinese
think that they cures impotent. There's no patent on them.

>Btw, of the drugs you mention, at least a couple weren't
>done by commercial companies at all, which totally moots
>your point. At least AZT was from a University with US
>government funding, for example. IOW, even when patented,
>important drugs were not discovered because of
>any patent, but because of very simple and direct needs:
>people paying for it because of basic science and health
>reasons.

Ummm, as I was saying, universities can obtain patents on federally
funded research. Exactly what motivates researchers I don't know as I
can't read minds. But it can't be denied that patent income allows more
research projects to go ahead. Rather than an expense that has to be
balanced against teaching, they can be seen as investments that pay for
themselves.


Name: Tom W (twerges@hotmail.com) 12/4/06

Linus Torvalds (torvalds@osdl.org) on 12/3/06 wrote:
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>Chung Leong (chernyshevsky@hotmail.com) on 12/3/06 wrote:
>>
>>That's a strange way to argue it. You're speaking as
>>though there's a "normal" market in which new drugs
>>without patent protection would be developed. Let say
>>we remove this market distortion. Can you explain how
>>the economics of developing a drug that could be
>>immediately copied by others?
>
>That's a rather idiotic argument. It's sadly a very common
>one.
>
>How do you think most drugs got invented historically?

The vast majority of drugs now in use were invented by corporate
research laboratories. The motivation was revenues that would allow
those corporations to recoup the costs of developing and testing the
drugs.

You can find a list of the 200 most-prescribed _generic_ drugs here:
http://www.rxlist.com/top200.htm

You'll notice that virtually all generic drugs were patented originally.
And that list is only the _generic_ drugs--all of the brand-name drugs
are under patent.

>In other words, your whole argument is not only totally
>stupid and scary, it's also provably irrelevant.
>Most of the drugs people use today are actually not even
>protected by patents, and were invented totally without
>any of those protections.

That assertion is false, as I documented above. Almost all the drugs
people use today are (or were) protected by patents.

>Do you think penicillin was invented because Alexander
>Fleming or St Mary's Hospital (where he was working) was
>looking to make a huge profit?
>
>...Btw, penicillin is again a great example: not only was
>it discovered without any patent push what-so-ever, but:
>what pushed it to be developed was actually World War
>II.
>
>...In other words, one of the most important drugs of modern
>times totally lays to waste your idiotic and unrealistic
>argument.

You've provided only a single example of a modern drug developed without
patent, out of thousands of drugs currently available.

The question is not whether _any_ drug has ever been developed without
patent--clearly, several have. Nobody is suggesting we prohibit
non-patent discovery. The question is whether _all_ (or most) of the
drugs now available would have been developed without patent, and
whether the patent system is on net balance a benefit to society.

I, for one, do not believe that we would all be better off if our drug
choices were reduced to penicillin, baking soda, and morphine. In fact,
many of us would be dead.

>It's sad how people seem to believe - despite all evidence
>to the contrary - that somehow patents are "required" to
>make people even want to develop drugs.

At present, bringing a drug to market requires subjecting the drug to
safety tests which currently take 9 years, generate more than 100,000
pages in documentation, and cost over $800 million. That is the minimum
requirement for FDA approval of a drug.

I doubt very much that the hurdle would be overcome in the absence of
anticipated revenues. For example, in the course of my career, I've
gotten to know a few of the vast army of employees which conduct drug
trials, and I don't believe any of them would conduct those trials if
their job didn't require it. Few of them were passionately devoted to
collecting detailed statistics about every possible side-effect that
every test candidate may have experienced. Few of them were passionately
devoted to compiling enormous binders of data as the FDA requires.

Given the current hurdles of drug development, I doubt very much that a
"gentlemen scientist" or a hobbyist could now bring even a single drug
to market. In fact I doubt that even a small group of extremely
motivated people could do it.


Name: rwessel (robertwessel@yahoo.com) 12/4/06

Linus Torvalds (torvalds@osdl.org) on 12/2/06 wrote:
---------------------------
>rwessel (robertwessel@yahoo.com) on 12/1/06 wrote:
>>
>>In effect, U.S. drug consumers are subsidizing drug
>>development for the rest of the world. While I don't feel
>>so bad about cheap drugs for poor countries, it really
>>irks me that many very wealthy countries are freeloading
>>here.
>
>I call bullshit on that one.
>
>"freeloading" is not what they are doing. If it didn't
>make sense to make those drugs with prices that aren't
>monopolistic (or are regulated), drug companies wouldn't
>do it.

Which I certainly acknowledged (read the sentence immediately preceding
what you quoted). As far as I know, in essentially all cases the
price-controlled drugs are being sold at a reasonable profit over their
manufacturing (and other on-going) costs. The "freeloading" applies to
recovery of R&D expenses.

And sure, there are all sorts of really annoying distortions in the
market, not least of which is that "best" is often equated with "most
profitable", which often results in a slew of "me-to" drugs, but central
research planning doesn't have all that bright a history either. And
many of the reality distortions come from the patient/legal side of
things - a drug that is a tiny bit more effective than its predecessor
is hugely preferred, no matter the expense (especially if you’re not
paying that expanse), since failure to use it will likely get you sued
for providing sub-standard care. In the "real" world, if airplane
manufacturer "B" builds an airplane with lower operating costs than an
equivalent model from manufacturer "A", they'll be able to charge a
premium, but only one rationally supportable by the cost savings over
the life of the aircraft (the airlines being fairly rational and
hardnosed about that sort of thing).

And certainly I think there are plenty of reforms needed in the IP
regimes of the world.

But you avoid the basic question:

What motivates me to blow nine figures on getting a new drug to market,
if a generic maker can start selling the same drug five minutes later at
a price that need only recoup manufacturing costs?

Again, for most drugs, manufacturing costs are inconsequential, or
nearly so, as is the difficulty in setting up a "clone" manufacturing
line.

Nor would I ever suggest all drug research would stop. Certainly not,
but it would largely stop at places intending to make a profit from the
activity. Lots of interesting stuff comes out of government and
university labs, but then what? Who decides when you go ahead and pay
for the endless trials and safety studies? Perhaps some bureaucrat in
the central research planning department?

You've at least acknowledged that those of us in the closed-source end
of the software industry have a right to exist and to take a swing at
things with our business model (and mind you, I really appreciate that -
a few of the OSS zealots appear to want to deny that we have the right
to exist at all, and you may know who I mean. ;-) ).

I know that *I* find the prospect of charging customers thousands of
times the cost of a replicated CD is what keeps me paying programmer's
salaries. Something I can only do because of IP protection. (See, I've
dragging this thread back to computing!)

Why is that OK, and not the same by a drug company? Is it more than the
usual disdain (How *dare* you make money off people being sick! You
immoral b******!) for the notion of making a profit in health care?

As near as I can tell, the potential for profit motivates people to
invest *a lot*. That's a good thing, in my book. Tell me again how I'm
motivated to spend $100m if I have no payback.
--------

regards,
alexander.