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    Seasteading & Clinical Trials?

    Could biotechs of the future look to offshore pre-clinical and clinical studies like this?

    Silicon Valley billionaire funding creation of artificial libertarian islands

    Pay Pal founder and early Facebook investor Peter Thiel has given $1.25 million to an initiative to create floating libertarian countries in international waters, according to a profile of the billionaire in Details magazine.
    Thiel has been a big backer of the Seasteading Institute, which seeks to build sovereign nations on oil rig-like platforms to occupy waters beyond the reach of law-of-the-sea treaties. The idea is for these countries to start from scratch--free from the laws, regulations, and moral codes of any existing place. Details says the experiment would be "a kind of floating petri dish for implementing policies that libertarians, stymied by indifference at the voting booths, have been unable to advance: no welfare, looser building codes, no minimum wage, and few restrictions on weapons."



    Read full article here...

    It might be impossibly radical but hey, worth a discussion on a Sunday afternoon

    #2
    WaterWorld for a Cure?

    (KLD)
    The SCI-Nurses are advanced practice nurses specializing in SCI/D care. They are available to answer questions, provide education, and make suggestions which you should always discuss with your physician/primary health care provider before implementing. Medical diagnosis is not provided, nor do the SCI-Nurses provide nursing or medical care through their responses on the CareCure forums.

    Comment


      #3
      Jach Welch, of General Electric fame, floated an idea somewhat like this back in the 90s. Although, his goal was to get around labor laws and unions and get the cheapest labor possible.

      The ocean is the next frontier and outer space is next in line after that.

      Comment


        #4
        Some people say the FDA is not a problem... well the history of the AIDS movements proves that the FDA was a problem for them and they forced the FDA to change.
        Unfortunatly the SCI community is way smaller than the AIDS community so I think it is unlikely we can workout things with the FDA as quicly as the AIDS mvement did, so I am 100% in favor of moving out of the FDA regulatory envronment.

        We have to do things according to scienze, that is what really matters, not regulations.

        Paolo
        In God we trust; all others bring data. - Edwards Deming

        Comment


          #5
          Even with the FDA's strict rules, many medications are recalled after they have been approved.

          Comment


            #6
            Here is a little idea for all to think about. There is a White house website for people to petition the government. https://wwws.whitehouse.gov/petition...popular/0/2/0/
            There is a doubt however, whether they listen to people. Anyway, we could create a petition that would allow for people with SCI, researchers, and doctors to bypass the FDA and proceed with “special cases” trials.
            Few things to consider:
            1. To get many people to support the petition, it should include as many debilitating incurable conditions and fatal illnesses as possible.
            2. There should be not conflict of interest: all of trials should be voluntary and paid by researcher, or third party donors, and not the patient.
            3. Only those patients are accepted who are willing to bear responsibility for all of the consequences. And they must prove that they or their sponsor can bear the financial burden if a trial goes wrong, so the government or taxpayers are not on the hook financially.

            If anyone is up to it, and want to write such a petition --you have my vote.

            Comment


              #7
              Originally posted by lepups3 View Post
              Even with the FDA's strict rules, many medications are recalled after they have been approved.
              The only way to eliminate risk is to stop developing new therapies.

              Please, if you have time, read the following link paying particular attention at how the AIDS movement changed the existing FDA rules.

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

              It may take a while to down load the PDF

              In case it does not work refer to this link.

              http://www.fastercures.org/index.cfm...alyzing_Change

              Paolo
              In God we trust; all others bring data. - Edwards Deming

              Comment


                #8
                Originally posted by paolocipolla View Post
                Some people say the FDA is not a problem... well the history of the AIDS movements proves that the FDA was a problem for them and they forced the FDA to change.
                Unfortunatly the SCI community is way smaller than the AIDS community so I think it is unlikely we can workout things with the FDA as quicly as the AIDS mvement did, so I am 100% in favor of moving out of the FDA regulatory envronment.

                We have to do things according to scienze, that is what really matters, not regulations.

                Paolo
                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.

                Comment


                  #9
                  Regulations came about not for fun. They came about because people and communities would get exploited or injured by greedy and selfish wealthy individuals and or corporations!! Stop talking about crap bullshit kooky ideas about oil platform type Islands and concentrate on real issues. IF, and I mean IF a super wealthy person wants to waste good money on a stupid idea like that, then that's a reflection on them, not the laws in any certain country they choose to winge about..

                  PS. If any of you think that this would be a good idea I challenge you to go and work out there and see how well you would be treated.

                  These ideas are only ever floated by super rich people who resent having to pay their fare share of tax!!

                  Comment


                    #10
                    Malthouse, who are you directing all of that to ?
                    www.adventuresofcolinandheather.blogspot.com !

                    Comment


                      #11
                      Billionairs Colin, Billionairs. If they could just support Wise and his research/clinical trials rather than floating hairbrained ideas about oilrig style tax havens we'd all be better off.

                      Comment


                        #12
                        Originally posted by malthouse View Post
                        Regulations came about not for fun. They came about because people and communities would get exploited or injured by greedy and selfish wealthy individuals and or corporations!! Stop talking about crap bullshit kooky ideas about oil platform type Islands and concentrate on real issues. IF, and I mean IF a super wealthy person wants to waste good money on a stupid idea like that, then that's a reflection on them, not the laws in any certain country they choose to winge about..

                        PS. If any of you think that this would be a good idea I challenge you to go and work out there and see how well you would be treated.

                        These ideas are only ever floated by super rich people who resent having to pay their fare share of tax!!
                        I think you are quite right about the kooky ideas. However, conventional is not always right, and Paolo's point about risk is totally valid; the question is how calculated that risk? Patients are not all fools, and have the right to make a choice.
                        2010 SCINet Clinical Trial Support Squad Member
                        Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature.

                        Comment


                          #13
                          Originally posted by malthouse View Post
                          Billionairs Colin, Billionairs. If they could just support Wise and his research/clinical trials rather than floating hairbrained ideas about oilrig style tax havens we'd all be better off.
                          I agree completely.
                          2010 SCINet Clinical Trial Support Squad Member
                          Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature.

                          Comment


                            #14
                            Originally posted by Fly_Pelican_Fly View Post
                            Could biotechs of the future look to offshore pre-clinical and clinical studies like this?



                            It might be impossibly radical but hey, worth a discussion on a Sunday afternoon
                            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.

                            Comment


                              #15
                              wow, very interesting posts.

                              Comment

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