Clinical Trials and Pharmaceuticals

http://tinyurl.com/5zgndn
A recent archived discussion about clinical testing and pharmaceuticals.

[Excerpts

"…..I have one question which has been troubling me. All these
hundreds of research units have been advancing steadily on THEIR Pca
front. Is their a Commander in Chief anywhere? Is anybody able to
coordinate all these different, fast-moving, penetrating thrusts?'….
I added: "Is there a computer team in a research clinic somewhere
analysing links between all the discoveries - so that Monty doesn't
waste time charging at the gaps already made by Patton?'

Rosbif was supportive and expanded my analogy powerfully into three
dimensions: He wrote in reply (June 19):

>'I imagine researchers as a system of tunnelers, the holy-grail is
> believed to be in a particular direction and they're all digging towards

>a vague compass point. Some are probably digging in the opposite
> direction, but if the world is round they could get there too.
> Some might intersect, meet, compare their disparate notes, others
>may find themselves digging only inches away from parallel tunnels
>and could pool resources .but…"

Alan, replied to my post (June 19):
Big snip:

>'I work as a computer programmer at NCI ' (the U.S.National Cancer
Institute).

This goes some way towards explaining your highly informed and
clearly-reasoned posts which are one of the bulwarks of this ng. Your
knowledge again throws up fascinating highlights.
You describe the NCI as the nearest thing to the 'Commander-in-Chief'
I was wishing into being. Because:

>'It dispenses more money for cancer research than any other institution
> and therefore has a great role in determining what research is funded
> and what is not. There are also some private institutions including the

> American Cancer Society, the Lance Armstrong Foundation, and some
>others, that dispense funds for research and therefore determine what
> research should be done and by whom.'

You believe private companies spend relatively little, for the reasons
you set out. This is really interesting news to me.
You mention the mix of really learned scientists and medics deciding
the best avenues for research for NCI and other public funds. They:

>'read and discuss the latest research and form opinions about what
>is promising and what is not.'

Lots of snips then, you conclude your post:

>…on the whole, I'm not sure how to go about producing a better
process."

I agree it is very good. But Alan, equally it would appear the NCI is
the nearest we have to a headquarters from which expand the major
multilateral thrusts battling towards a Pca cure. So the NCI stands
out as a focal point for any possible solution to the question - if a
development in this direction was thought to be of value. Surely it
must be?

How about: A team incorporating top computer modellers and top
scientists and docs across the spectrum of research - as now sit on
the NCI boards - aimed at collating and integrating all research.
Wouldn't that logically round off the NCI's funding structure? And
maybe give it powerful impetus?

Obviously you don't speak for the NCI Alan. But I value your views.
Would you see no merit in at least developing the thought? Or a better
alternative?
----------------------------------------------------------------------
The work I do is all information dissemination rather than
scientific programming. I work on the system that prepares the
data that goes onto http://www.cancer.gov.

However, I've gotten interested in the science behind it all and
try to read books on biology and chemistry. I'm slowly becoming
more knowledgeable.

....

> You believe private companies spend relatively little, for the reasons
> you set out. This is really interesting news to me.

The drug companies spend much more on advertising, marketing, and
lobbying than they do on research. A good part of that money is
dedicated to convincing people, voters and government officials,
that they are spending more money on research than on
advertising.

Nowadays, the drug companies spend even less money on research
than they did, say, ten years ago. The new model of drug company
drug discovery is:

Get in bed with universities, medical schools, and biotech
startup companies.

Let those organizations fund their own research by getting
government research grants and some venture capital.

If, and only if, truly promising research comes out, wave big
bucks at the professors and buy out the biotechs to get the
marketing rights.

The idea is, don't ever spend money on basic research. Let the
government do that. Buy the fruits of the research when you
already know it's likely to pan out.

So the taxpayer funds the research. If it fails, the taxpayer is
out the money. If it succeeds, the drug company buys the rights,
the government gets nothing, and the taxpayer is not only out the
money but must also pay for the huge profits that the companies
make in order to get the drugs that their taxes paid to develop.

I won't say that the drug companies never invest money in
research. They do invest some. But the amounts have been
declining in the last decade.

Do I sound bitter about that?

In my view the drug companies, by sucking the money out of the
health system, are one of the major obstacles to progress.

There are others, of course, who disagree. And even I do believe
that the typical scientist and technician working at a drug
company is sincere in his or her attempt to advance science and
health. But the organization is, after all, not dedicated either
to science or health. It's dedicated to making profits for the
stockholders. The two interests do not coincide, and where they
conflict, there's no question about which interest wins.

How about: A team incorporating top computer modellers and top
> scientists and docs across the spectrum of research - as now sit on
> the NCI boards - aimed at collating and integrating all research.
> Wouldn't that logically round off the NCI's funding structure? And
> maybe give it powerful impetus?

In a way, NCI does attempt to do that.

They have a team of people who read every single article
published in the top 200 or so medical and cancer journals, in
every issue.

If someone reading an article thinks it may be significant, they
xerox it and send it out to one of the board members for his
review. He reads it and, if he (or she) thinks it's good he says
so and it will be sent out to two more board members for their
review. One of the people will volunteer or be appointed to make
a presentation to the board as a whole.

The board meets about 5 or 6 times per year, the people coming in
to Rockville, Maryland, or appearing by video conference. At the
meeting they thrash out all of the research that they think is
significant since their last meeting.

As a result of their discussions, they might do any of the
following:

Edit the state-of-the-art summary that NCI publishes for each
type of cancer, revising NCI's recommendations to cancer
practitioners. Over 500 such summaries are maintained on a
regular basis.

Add articles to the recommended bibliography that they urge
oncologists to read.

Make recommendations to NCI regarding the funding of types of
research - either to increase funding in a specific area, or
to reduce it. Reducing is just as important as increasing
because the research budgets are fixed every year and NCI can
only increase funding in one area by cutting it in another.

I don't know the exact numbers, but I'm pretty sure that upwards
of 100 people are involved in this process.

So there really is a lot of collation going on.
--------------------------------------------------------------------------------

Steve
All in all, I wonder how many people die waiting for so many results of
research and clinical testing; all so that a few don't die from the new
drug?
---------------------------------------------------------------------------------------------

There's a good article about this in the October, 2007 issue of
Scientific American.

The issue is more complex than it seems on the surface. However,
as you surmise, there certainly are people who lose their lives
who would have survived longer, or even been cured, if they had
access to investigational drugs for which no openings existed in
clinical trials.

On the other hand, we don't want desperate patients to be
victimized by unscrupulous quacks who steal their money and feed
them trash, and we don't want everyone opting out of clinical
trials because they can get the drug for sure and don't want to
try what could turn out to be a placebo - leaving the controlled
trials empty of patients.

And then there's the question of where they'd get the drugs.
Current laws actually allow investigational drugs to be given to
dying patients under certain circumstances and if the drug
company agrees to do it. But it often happens that the companies
won't do it. They make small batches by hand for use in the
trials. They haven't invested money in creating a serious
manufacturing process for the drug, and won't until they see it
pass trials and win FDA approval. If they ramp up
production to sell to everyone, they'll be out a lot of money if
the drug fails to win approval - and most drugs do fail. If they
charge the full cost of hand production (assuming it's expensive,
I don't think it always is) they'll only be able to sell to rich
patients and will be accused of gouging. So they regularly
refuse to sell such drugs to patients outside the trials.

I once thought this was a no-brainer. When someone is dying,
give him any drug he wants. I still think that _might_ be right,
but I'm no longer certain. I now think there still need to be
controls, but I'm not sure how far the slider on those controls
should be moved to one side or the other.

Alan

-----------------------------------------------------------------------

Unfortunately, I'm not any kind of authority. I'm afraid that
quoting me would be fruitless since no reputable reporter would
or should write a story, and no reputable member of parliament
would or should draft legislation, based on my inexpert opinion.
However I did derive my opinion from what I think is an
authoritative source.

Most of what I've said is my interpretation of what I read in a
book by Dr. [snipped]. Dr. [snipped] was editor of the New England
Journal of
Medicine, one of the most prestigious medical journals in the
world. She published her book in 2004.

As you would expect, her book is controversial. The drug
companies and their supporters regard it as anti-business
propaganda which, if its recommendations were implemented, would
harm drug development, harm patients, and slow progress in
medicine. Her supporters believe that her recommendations would
reduce the cost of drugs and could accelerate drug development.

----
It has gotten a
lot of reaction from the public, but I don't know how much effect
it's had on changing the way business is done. Certainly the
current American administration is hostile to its approach. The
next administration may be less so (or may not, the drug industry
spends more on lobbying than any other industry and actually has
more lobbyists in Washington than there are congressmen and
senators.)

Alan
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The above is just excerpts of longer posts.
I do not agree with some statements made in it, but gives a broadbrush
view of what's happening with pharmaceuticals.
(since somebody asked)
J