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patents and Pharma, another downside | 397 comments | Create New Account
Comments belong to whoever posts them. Please notify us of inappropriate comments.
Not necessarily true
Authored by: Anonymous on Saturday, November 17 2012 @ 01:08 PM EST

Drug development costs are only a small portion of the cost of a new (or
modified) drug.

The biggest cost is usually safety testing. And safety testing is one of the
biggest problems, because companies currently do this themselves, and
several companies have been caught playing games with the results
(check out what happened with Pfizer and the pain drug Celebrex, a drug I
know well because I've been on it for years).

If the safety testing was taken away from the Pharma companies, and
instead done on a publicly funded model, it would lower development costs
dramatically, and reduce both the reason and means for cheating.

I think that Mike Masnick of TechDirt is one of the people who has covered
this. Today's a bad day (I feel like amputating my left leg), my concentration
is shot, and I can't remember where I read about the issue.

Oh, and another minor point - a lot of drugs are developed from natural
substances (I.e. Penicillin and bread mold). Development costs come down
to testing only in cases like that. Also for some reason Pharma companies
are allowed to advertise in the United States (the only first world country
that I believe allows this). Make advertising illegal like everywhere else, and

again costs drop.

There's probably points that I'm missing. Maybe tomorrow will be better.

Wayne
http://madhatter.ca

[ Reply to This | Parent | # ]

The difference with software is you can do it at home in your bedroom......
Authored by: tiger99 on Saturday, November 17 2012 @ 02:07 PM EST
Yes, exactly like writing a book, which is adequately protected by copyright,
which few argue against. (Excessively long term protection in the US is argued
against, as we all know.) Somehow, software became the only thing, as far as I
can tell, which is protected in some countries by both software and patents, and
that is just plain wrong. Either that, or books should be patented too, and just
imagine the outcry that would cause amongst authors! It would be impossible,
especially in fiction, to avoid incorporating features of someone else's plot by
accident, which is, simplistically, the same as the software problem.

[ Reply to This | Parent | # ]

Something very wrong with this picture
Authored by: Anonymous on Saturday, November 17 2012 @ 04:14 PM EST
OK, maybe it is appropriate for a company to have rights over the product so
that they can get their development costs back. Let's consider that.

Do those companies disclose their development costs? No.
Do those companies cease their monopoly after recouping development costs? No.

Therefore the current system cannot perform the service you're claiming it's
good for.


My wife is a kidney transplant patient. We eagerly awaited one of her
anti-rejection drug's patent expiration, thinking it might lower our monthly
expenses. The patent expired - but the company came out with a newer version,
and told doctors, insurance companies, and pharmacists that the makers of the
generic hadn't shown the generic to be "safe" or "absorbed
bioidentically" to the original. Well, in spite of this being false (the
testing was actually more thorough than the original, safety was better, and
absorption was inside the margins of error of the patented product's tests) our
insurance won't cover the generic and the doctor won't prescribe it.

So, we need to pay the pharma company the extortion-price for another 17 years.
For what? Development? No, the new drug is actually the primary metabolite of
the old one - if you swallow the original patent product, the first thing your
body does is convert it into a slightly less complex molecule; this was found
during development of the original drug, there was *no* further development work
necessary. So - maybe for testing? Hah. I got to read the tests. 1 single
clinical study, 4 weeks, 4 healthy male subjects, 2 doses a day. If my wife were
the *only* person taking this drug, we paid off the testing costs in under a
year.

The problem with pharma is that it's one of those "indistinguishable from
magic" technologies - and you have to remember, for most of the population,
software is the same.

The real reason pharma products cost so much is the regulatory environment. It
doesn't make their products safer, it just means there are specific processes to
bribe the system when their products do maim or kill people, and *those* are the
costs the patent system defrays.

Is it worth it?

[ Reply to This | Parent | # ]

Patents actually make some sense in the pharma world.
Authored by: Wol on Saturday, November 17 2012 @ 06:51 PM EST
Actually, I believe the evidence is that they don't!

Scrap patents there - the regulatory regime messes it up anyway. What we need is
a sort of copyright - a company pushes a product through testing, and then the
competition can't copy it for a few years.

Or, as Wayne suggested, a public testing setup. Although I gather in the US
there's a massive problem doing studies because patients and doctors have this
nasty habit of collaborating to try and make sure they get the active drug and
not the placebo - to the extend that people the study says are taking the
placebo are actually getting hold of the test drug. NOT good! (Especially where
there really is NOT good evidence that the drug actually works!)

Surely it's not beyond the wit of man to test drugs for safety then roll them
out in a controlled study at a teaching hospital to test for efficacy. If they
work, the consultants will see that and start using them.

By the way, I think drug advertising occurs in the UK as well. I don't know -
I'd love to get hold of copies of The Lancet - but I certainly get the
impression doctors are influenced by advertising ...

Cheers,
Wol

[ Reply to This | Parent | # ]

Apparently the benefits of patents for Pharma have been overstated
Authored by: Anonymous on Saturday, November 17 2012 @ 11:48 PM EST
The other thing that's really offensive about patents is that they
protect the wrong thing. There's a lot of software out there that
*couldn't* be developed by one individual in their bedroom, because
it takes a lot of work to build it and get it right. But all that
patents protect is the basic idea, which is somewhere around 0.1-1%
of the work by my estimate.

In contrast, the difficulty in pharmaceuticals *is* figuring out the
basic idea -- and verifying that it's safe, but competitors get to
free-ride on that too. It is (by my understanding, anyway) much
easier to reproduce a drug by analyzing it than to reproduce a
complex software system.

At more length:

Fundamentally, a software program is nothing but a very long and
precise description of exactly what is to happen. Going from a vague
idea to a working product requires dealing with a huge number of
individually trivial details in order to build that description.
Think about Apple's attempt at building map software: it's obvious
what the end goal is (Google Maps), yet even with huge amounts of
effort they were not able to build a satisfactory system of their
own. And that's just one example. Look at how much work was dumped
into trying to get OpenOffice to mimic Microsoft Office. Look at
Amazon's attempts to build a mobile operating system. Look at
Google's attempts to build their own Facebook. Look at Microsoft's
attempts to do, well, anything.

All of that work is left out of a patent. It *has* to be, because if
every small point of design and implementation was covered, the
patent would be enormous and would cover only the particular system
the patentee built -- thus rendering it useless for crippling the
competition.

[ Reply to This | Parent | # ]

Pharma is a highly regulated industry - it doesn't work like other products
Authored by: artp on Sunday, November 18 2012 @ 01:16 AM EST
Back in the early 90s, Durk Jager, the CEO of Procter &
Gamble, tried to switch markets and get into the
pharmaceutical arena. He failed miserably and the value of
P&G dropped by over 50%. There are some VERY long lead times
in Pharma between investment and sales. At the time, P&G HAD
been about #26 or 27 on the Fortune 500 list. If P&G can't
afford to get into a new market, then what are patents
really protecting?

A lot of time and expense comes from the clinical trials. A
lot of time. Sometimes the patent expires before the trials
are done. So perhaps the system is broken. Patents do not
help in that situation. The regulatory climate is
unfavorable to patents, yet everybody keeps saying that we
need them. The regulatory climate also protects the
established players from new competition. Handy, isn't it?

Others have pointed out how drugs tend to be replaced once
the patent expires. Nobody wants to make generic drugs -
except in Third World countries, who somehow think that
saving lives with cheaper drugs is a good idea. This is an
intentional subversion of the FDA process to prop up
profits.

I would also like to find out just what pharma companies
really spend on basic research. Like other process
companies, the cycle of development goes from the lab to a
development project to a pilot project to test market to
full production. Most companies focus on the last few steps.
In Pharma, a lot of basic research is done outside the
pharma companies. Universities and teaching hospitals also
do basic research, and publish in professional journals. I'm
betting that most of the pharma industry's research is
actually focused on developing a manufacturing process, and
figuring out how to keep a product covered by patent until
eternity expires.

I am not a medical researcher, but I have some practical
experience with validation of systems for FDA requirements
on pharmaceutical, cosmetic and food products - i.e. are we
making what we told the FDA we are making in the manner that
was approved. Validation is SUPPOSED to keep us safe, but it
has become a problem with getting drugs to market. We are
not safe, either. The number of companies who have made such
huge mistakes that the FDA is running their QA departments
would shock you.

Validation and patents are not compatible. Validation really
needs to take its time. Patents really want to rush to
market. If the primary goal is safety, I'd vote for an
effective FDA process (versus what we have now) instead of
patent protection.

---
Userfriendly on WGA server outage:
When you're chained to an oar you don't think you should go down when the galley
sinks ?

[ Reply to This | Parent | # ]

Apparently the benefits of patents for Pharma have been overstated
Authored by: Anonymous on Monday, November 19 2012 @ 05:17 AM EST
"He said that the purpose, in the minds of legislators,
for patent law is jobs."

Silly me, I thought the purpose of Patents was to promote the progress of
science and the useful arts.

Either that or to give the old boys club another big stick to use against
newcomers.


But you say it's all about the jobs. Care to give an example of patents
providing jobs for anyone except lawyers?

Because I still haven't seen anyone give an example of the patent system working
as advertised.

[ Reply to This | Parent | # ]

patents and Pharma, another downside
Authored by: hAckz0r on Monday, November 19 2012 @ 12:39 PM EST
There is one side effect of the Pharma Patents in that ir really hurts the general public. The Big-Pharma companies will not put a product to market 'unless' the have assurance of total dominance in the market for that product. They will not waste any time working on simple or natural remedies without having any guaranteed benefits to their bottom line. They do not consider the 'benefits to society' at all, and patents were created to benefit society, but in this case it actually does the opposite. As a minor investor in this pharma industry I generally know what they are working on, when I care to know.

Think about Aspirin. If aspirin was discovered today you would never see in on the store shelves from a source you could trust. Maybe in a health food store which is not allowed to even tell you what the benefit of the product is. They are barred by law in asserting potential benefits, and therefore they stay in obscurity even when they are 'known' by bonafide medical studies to be beneficial with low risk. The pharma industry now sells enough Aspirin derivative products to be well worth the initial investment of testing due to the massive numbers of people that currently buy the products, but the desired economic situation, due to the lack of a solid patent, would kill the product before it even got started. Are we thus saying that the Aspirin industry is non-profitable? Obviously they are still selling a LOT of derivatives of the base formula, and improving on it as we go forward (e.g. ibuprofen).

A case in point in today's Market; One soluble component of Cinnamon was discovered by a University of Maryland research study to be significantly more effective than any pharma drug currently (at the time) prescribed drug for Diabetes type II. This was about 15 years ago if my memory serves me correctly. Because there is no hope for a 'total lock on the market' for such a pharma based product nobody is going to spend one dime of commercial money on bringing it to market. A synthesized product is both feasible and volume economical, but nobody will give it the time of day because they would rather sell a small quantity of a patented product, for a high price, rather than a low profit product in high volumes. Remember, billions of ageing people world wide would benefit from such a low cost drug, but you will never see it lableed properly on the store shelf, as safe as it is. The lack of patentability has killed the product before it even got started. Only research organizations like U of MD, with very small research budgets, can even think to do the necessary research needed to move the potential product forward.

Keep in mind that most all pharma products start by testing natural substances. Its just that the more common substances, that will likely not get patents assigned, will never see the light of day. This is a very sad state of affairs for everyone. Those people who use unapproved products from health-food-stores, that are legally barred by law from listing potential benefits, are making bad decisions for their health when other remedies would really work but haven not been fully studied due merely to the lack of patentability, not economics.

U of MD: Diabetes Complimentary Medicine research
Sorry, I don't have a direct link to the initial Cinnamon research papers handy. The above is a general reference to show that they do consider it proven to be beneficial.

---
The Investors IP Law: The future health of a Corporation is measured as the inverse of the number of IP lawsuits they are currently litigating.

[ Reply to This | Parent | # ]

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