[geeks] Drug prices [was Re: nVidia 8800GT for Apple Mac Pro]

[Geoffrey S. Mendelson]

On Fri, May 23, 2008 at 08:27:25AM -0500, Lionel Peterson wrote:

> Theft is theft, and most countries (I believe - I'm leaving
> wiggle-room here...) honor each other's patents and intellectual
> property rights. Of course, there are also countries that don't.

No, none at all. There is the patent cooperation treaty, which allows
you to get a patent in one country based upon a patent approval in another.
However, you have one year from the date of filing the first patent application
to file the PCT applications. 

There are some countries without patents at all or have not signed the
PCT, AFAIK several middle east Kingdoms, and some where they are totally
ignored. :-)

If you don't file an orginal patent application or a PCT application,
you have declared your intention not to seek patent protection in that
country. 

PCT applications are (relativly) cheap and can be in English, so most
companies file U.S. provisonal applications, then U.S. regular applications
then PCT applications. 

However the time from patent application to FDA approval for sale is
about 10 years and several million dollars of expense. The patent to
marketed drug ratio is about 100:1.

> The best thing I've heard about Pharma's innovating with another's
> product was the Indian (I think, could be wrong) Pharma that took what
> was a complex regimine of multiple pills at multiple times a day,
> reformulated and combined the drugs and made one pill you take at
> regular intervals (i.e. twice a day you take one pill, not several
> different ones, each at different intervals). The Major Pharmas
> couldn't/wouldn't do it, since they'd have to run extensive multi,
> multi-million dollar drug trials to reprove efficacy, cross-license
> drugs from several manufacturers, etc. The issue this solved was that
> many patients in developing countries were having a hard time stickinig
> to complex drug regimens for AIDs treatments.

 
> Still wrong, but they provided a benefit.

It depends. If a company, or country licensed the drugs or they are off
patent, it would be perfectly legal. 

The problem you percieve is one of tarrifs and border protection, not of
patents. The whole FDA approval system (or any foreign equivalent) falls
apart when residents of a country can import unapproved drugs. 

I don't know much about Canada, and Israel is the largest manufacturer
of generic drugs in the world, including many sold in the U.S., but India
and China have little or no quality control, etc. Even if an approved
drug was manufactured under license there, there is no way of ascertaining
that it fits the U.S. standards for saftey and efficacy by a person ordering
from a website.

Then there is the big problem of counterfit drugs. I read that a drug I was
taking was found to be a counterfit sold/distrubted in the Palestinian
Authority and had to double check to make sure the pills I had were
"real". The counterfit had none of the active ingredient.

I bought mine directly from my HMO, so it was traceable back to the 
manufacturer if need be. 

Since the drug was exhorbinately expensive, and I took it for a whole year,
I can imagine someone without health insurance trying to buy it at a discount
mail order. 

I'm speculating here, but since there are no pharmaceutical companies operating
in the PA, I think you can reasonably expect the originals came from somewhere
else.



> If you starve a Pharma of cash, you stifle innovation and you reduce
> the number of new companies that enter the market (why go into Pharma if
> your work product will be stolen?). Amazingly, many people think new
> drug compund "fall out of the sky" - it is a very expensive process to
> develop a new drug, or even get approval for a new use of an existing
> drug.

Any of you ever seen a NDA (new drug application)? It's the final step in
a very long and expensive process to get approval to sell a drug in the U.S.

I worked on several in the 1990's and they were around 350,000 pages. 
Yes, people actually read every page.

A UK NDS (new drug submission) was about 60k pages, as the supporting
documents were not provided until asked for.

Canada would accept either an NDA or an NDS.

Russia accepts among other things a certification that the drug was 
approved for sale in the U.S. 

Singapore has been know to accept stolen NDA's with the original company
name still on the everything except the cover. 

I don't know about other countries.

> Personally, I'd like to see Pharma's be prevented from advertising
> drugs to consumers here in teh US. That just makes no sense to me - your
> Doctor wants to prescribe compound A, but you convince him that you want
> compound B because you like the ad they ran in Time Magazine? WTF?

That's because doctors are awfully ignorant of the latest drugs and their
uses, side effects, etc. In the U.S. the one they prescibe is either the
top of the list provided by their employer or the latest one that a salesman
pitched to them.

Geoff. 

-- 
Geoffrey S. Mendelson, Jerusalem, Israel gsm at mendelson.com  N3OWJ/4X1GM