Seasteading & Clinical Trials?

[Dmitriy]

Malthouse,
Which greedy corporation are you referring to? The one that made the computer that you are typing on or the one that made it possible for you to fly anywhere around the world for a few hundred bucks?
Nobody is going to produce the cure for you just because you need it; they would need much more of an incentive than that.
Regulations might have come about with good intentions, but at this point in time what they do is prevent many good ideas to be realized and slow down progress.
Regulations are here because some government bureaucrats think that you’re stupid and can’t make your own decisions, and better off wasting your life just sitting in your wheelchair.

[malthouse]

Dimitriy,

We could play ping pong with this till the cow's come home but I feel we may bore everyone. I did not level any accusations at any corporation per se, I was just generalising about why we need a regulatory environment.

I get as pissed off with red tape as the next person but I feel confident BP may have treated the Gulf of Mexico with a tad more respect if they were as free wheeling as Union Carbide....

And Wise, If I were a billionair, I would be more then happy to finance your idea.

[malthouse]

Not! If they were NOT as free wheeling as Union Carbide....

[chris arnold]

Pelican and Paolo,

As I was leaving NYU in the mid-1990's, I gave some thought to creating a clinical trial network using ships. The ships would be equipped to do surgery and rehabilitaiton. They would stop at ports around the world and provide therapy and rehabilition, as well as followup examinations. The goal would not be to bypass regulatory agencies but rather to save money by not having to duplicate clinical trial facilities.

I don't know what percentage of the world's population can be reached by ship but it must be at least half or more of people with spinal cord injury in the world. I even thought of having trucks on the ship that would have built in operating rooms that can be driven inland. England, Italy, and most of Europe are readily accessible. Each ship would have a helicopter to take teams of doctors inland. The East and West Coast of the United States, coastal areas of China, India, Central and South America, Australia, Japan, Taiwan, and Middle East should be accessible.

Probably two ships would be sufficient. I went to the length of estimating the expenses of buying two old cruise ships and the cost of refitting and running them. It is cheaper than buying, building, and staffing a hospital. Just an idea.

Wise.

Very interesting. A good example of latersl thinking?

[paolocipolla]

Paolo,

The SCI Community is larger than the AIDS community was in the 1980's when they convinced the FDA to create a new category of drug approval called "compassionate use". By the way, that category is still in existence and can be used for treatments of spinal cord injury, as long as you can show that there is no other therapy that works. The AIDS community, to my knowledge, never advocated circumventing the FDA. They worked with the FDA, NIH, and industry.

Wise.

Wise,

referring to the document about the AIDS movment "Back to Basics"

http://www.fastercures.org/documents...asicsFinal.pdf

I would like to quote a few short parts:

1) page 3
"The successes of the HIV/AIDS advocacy movement were the result of a unique moment in time when the illness and death of thousands of people catalyzed action"
2) page 9
"Never before had this country seen thousands of sick people laying their bodies down on Wall Street, or chaining themselves to the fence of the FDA, or storming the NIH. ""You have to be able to inspire people at a level of civil disobbedience"" note Jim Curran, M.D., who was then the director of HIV/AIDS at the CDC."
3) page 10
"We were dying and we looked like we were dying - said Larry Kramer, the founder of ACT UP"
....
"Kramer said that - what makes activism work is anger and fear, and I do not think I could work without that - "

4) page 11
In summary-- the real transition of the movement occoured between 1988 and 1990 with two specific demostrations:
- October 1988 demonstartion at the FDA when more then 1000 activists partecipated
- May 1990 demonstration at the NIH "Storm the NIH"

So my point is that the AIDS movement had a power to negotiate with the NIH and FDA that the SCI community does not have.

I am quite sure the SCI community will never be able to organize demostration with an impact compareble to the ones done by the AIDS movement, otherwise we would have already done it.

In 7 years I have seen progress in SCI research, but it hasn't been fast enough to make me hope I can walk very soon, so I am ready to become radical in this fight for a cure, as being nice didn't work.

May I ask you a question?
Why Stem Cell Inc. went to Switzerland to do the clinical trial?

Paolo

[paolocipolla]

Pelican and Paolo,

As I was leaving NYU in the mid-1990's, I gave some thought to creating a clinical trial network using ships. The ships would be equipped to do surgery and rehabilitaiton. They would stop at ports around the world and provide therapy and rehabilition, as well as followup examinations. The goal would not be to bypass regulatory agencies but rather to save money by not having to duplicate clinical trial facilities.

I don't know what percentage of the world's population can be reached by ship but it must be at least half or more of people with spinal cord injury in the world. I even thought of having trucks on the ship that would have built in operating rooms that can be driven inland. England, Italy, and most of Europe are readily accessible. Each ship would have a helicopter to take teams of doctors inland. The East and West Coast of the United States, coastal areas of China, India, Central and South America, Australia, Japan, Taiwan, and Middle East should be accessible.

Probably two ships would be sufficient. I went to the length of estimating the expenses of buying two old cruise ships and the cost of refitting and running them. It is cheaper than buying, building, and staffing a hospital. Just an idea.

Wise.

Wise,

people with chronic SCI can easily travel. Don't foget that.

With a boat you will have to staff the boat, crew members plus medical stuff.

With a hospital you need just the medical stuff. You don't need to buy a building, you just rent what you need where is more convenient.

Stem Stell Institute in Panama seems a possible model to consider.
What is very important is to do things with scientific rigour and in a fully transparet way.

Paolo

P.S. here is a hospital ship example, but it is easier to move people with chronic SCI than a whole hospital and a rehab center IMO
http://www.naveospedale.it/chi-siamo/

[GRAMMY]

May I ask you a question?
Why Stem Cell Inc. went to Switzerland to do the clinical trial?
Paolo

Paolo, It's my understanding that Aileen Anderson and Brian Cummings worked for many many years in collaboration with this company StemCells Inc. Dr. Armin Curt (Switzerland) was named the (PI) Principal Investigator for this particular trial. The collaborations are quite extensive.
http://www.stemcellsinc.com/Science/...aborations.htm
I would imagine the Swiss Health Authority would be easier to work with than the FDA.

StemCells Inc. do currently have clinical trials in the USA for other indications.
http://www.stemcellsinc.com/Therapeu...cal-Trials.htm

[StemCells&AtomBombs]

Pelican and Paolo,

As I was leaving NYU in the mid-1990's, I gave some thought to creating a clinical trial network using ships. The ships would be equipped to do surgery and rehabilitaiton. They would stop at ports around the world and provide therapy and rehabilition, as well as followup examinations. The goal would not be to bypass regulatory agencies but rather to save money by not having to duplicate clinical trial facilities.

I don't know what percentage of the world's population can be reached by ship but it must be at least half or more of people with spinal cord injury in the world. I even thought of having trucks on the ship that would have built in operating rooms that can be driven inland. England, Italy, and most of Europe are readily accessible. Each ship would have a helicopter to take teams of doctors inland. The East and West Coast of the United States, coastal areas of China, India, Central and South America, Australia, Japan, Taiwan, and Middle East should be accessible.

Probably two ships would be sufficient. I went to the length of estimating the expenses of buying two old cruise ships and the cost of refitting and running them. It is cheaper than buying, building, and staffing a hospital. Just an idea.

Wise.

Did you ever figure out the costs? I know it was almost twenty years ago, but it would be an interesting figure to hear.

[StemCells&AtomBombs]

Paolo,

The SCI Community is larger than the AIDS community was in the 1980's when they convinced the FDA to create a new category of drug approval called "compassionate use". By the way, that category is still in existence and can be used for treatments of spinal cord injury, as long as you can show that there is no other therapy that works. The AIDS community, to my knowledge, never advocated circumventing the FDA. They worked with the FDA, NIH, and industry.

Wise.

I understand about 'compassionate use' but how could it be used in terms of spinal cord injury. With AIDS it was easy to prove (I think). "Let me use this new drug quickly, or I'll die." Would we fit the category if something really good came about? Would it work by speeding up all the clinical trial phases or would it eliminate clinical trial phases?
I ask because you probably already know the answer without having to search for the information.

In regards to the AIDS community vs the SCI community...
Well, I'm still thinking about this question.

[chris arnold]

I understand about 'compassionate use' but how could it be used in terms of spinal cord injury. With AIDS it was easy to prove (I think). "Let me use this new drug quickly, or I'll die." Would we fit the category if something really good came about? Would it work by speeding up all the clinical trial phases or would it eliminate clinical trial phases?
I ask because you probably already know the answer without having to search for the information.

In regards to the AIDS community vs the SCI community...
Well, I'm still thinking about this question.

As I said before, when the Grim Reaper is imminent, actions go into overdrive.

[paolocipolla]

Wise,

when you have time I would like to know if you think my arguments make sense or not.

Thank you.

Paolo