FDA, medical seastead, Randy Hencken, intent, get approval, Kafka, comments, strategies, communication, buerocracy, visionary, frontier development, interference, progress speed up, project development strategy, oceanic freedom, mobilis in mobili, seasteads, ethics matters, not antiquated rulesets,
This thread contains comments and tougths about the process to get answers and clearance from FDA if a medical seastead could be performed…see the 5 thread posts from the seasteading.org blog below.
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they are a interference agency they will interfer.
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project setup strategies.
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only a “true believer” in the “value of the sistem” would even try to work within…
…if you come in with “something interruptive” never ask the “interrupted party” if they are OK with you interrupting…
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play it fast and mobile
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give them a reason to declare themselves “out of jurisdiction” they will take it gratefully. Instead of fighting the case to supreme court. - it is in their buerocratic nature.
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as a model what road “trying to get clarification” will take you down - and how you will “end dying before clarification comes” - read Kafka’s “The Castle”
Kafka-The Castle:
Project setup questions:
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If seasteading is about escape the soffocating grip of land based monopols (http://www.seasteading.org/2014/10/power-market-report-interviews-randolph-hencken/) - why would you try to get approval by a soffocating monopol organisation in first place?
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If using the mobilis in mobili (http://concretesubmarine.activeboard.com/t58935854/subdue-to-nobody/ ) card to break free from jurisdiction is the key value of seasteading why would you build the project “around and inside US jurisdiction” instead of breaking free of it.
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why would you give your fiercest interferer a year of headstart by informing him directly over your intentions and loose one of your strongest cards “the surprise factor” moving faster than they can.
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why would you allow them and even assist in deploying their strongest weapon (eternal delay of formal processes) against your project before even starting it, instead of putting their “fussy rulings and slow movements” against THEM - (try to catch me if you can - i am moving fast and worldwide - you can’t )
Since you did contact them - technically you are now in a “open permit process” and if you build a seastead now, a FDA lawyer will turn that against you for not waiting until the “due process is done”. If you had built without asking, you would have in favor that there is no law “against” building medical seasteads outside of US jurisdiction and obviously can’t be. What your intervention now allows them is to “put a passus on a existing law” saying something like “FDA competence expands to US citicens wherever in the world might be” - expanding their jurisdiction.
as you masterly describe in your blog - there is no incentive for an FDA burocrate to move things forward - this works both ways - there is also no incentive for them to get involved in a lawsuit on a fussy legal base to punish a venture that is “obviously out of their jurisdiction” … because it did not ask them for a permit. Even more so if this venture is stuffed with good lawyers and arguments to defend its point. - And has public support because it is doing ethical good medicine helping patients.
On the other hand in “asking for permit” you already recognized that you aknowledge them in actually “being a entity you should ask” - so you handed your strongest card over without a fight. That is a "business implementation strategy you might want to rethink…
On the other hand you learned a lot about your oponent and how he works, you now have a much better picture how to handle him, how to beat him, how to defend yourself in case action comes in…
- read more here:
http://concretesubmarine.activeboard.com/t56351996/business-and-third-party-interference-freedom/
http://concretesubmarine.activeboard.com/t58935854/subdue-to-nobody/
According to Paul Watzlawick (Austrian-American family therapist, psychologist, communications theorist, and philosopher. A theoretician in communication theory and radical constructivism…)
You can not “not communicate”.
If you do not communicate you communicate a lot - for example:
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your communication is so irrelvant that i do not find it worth an anwer.
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your question is so difficult that i HAVE no answer. (and as i have no answer and no legal base i will not present a fight if you do it)
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i have an answer but i will not communicate it, because you will not like what you hear…
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and especially in this case - if i say nothing you are blocked anyhow - your investors will go away frustrated - the project will be buried and i like that.
So i would rather try to find out what of the 4 reasons is the most likley for this non-comunication - plan my project according to the findings…and move it forward before the investors get bored and step out. Finally the interesting and investment worthy part of the project was “to break free” - so if you get it “entangled anyhow” the project is dead by nature of logics.
Project deveopment base questions:
Ask yourself the following questions:
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What is the probability that the FDA officials i was talking with (sleeping on their desks trying to avoid work not even capable to produce an answer ) will develop a "fierce military enforcement branch that comes after me when i operate patients in my seastead near Jamaica in territorial waters of Colombia? - boarding my platform, interrupting surgery in progress getting VERY bad press.
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What is the probability that Coast Guard / Navy will enforce something that is already declared out of jurisdiction by Customes and Border protection. Does FDA even have contacts or agreements with the Navy ?
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In the light of learning that FDA officials are “press sensitive” do i really believe that they want to produce pictures of a worldwide recognized indian surgeon arrested in a war operation to protect US special business interests…?
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What is the capacity to fund, persue, proyect out to sea, of FDA in general - do i not fear a sleepy paper mouse to act like a furious elephant here ?
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What are the legal and management resources i need to defend my case successfully - or put it on the long waiting list for supreme court - in case the mouse acts like an Elefant because special business interestes inflate their budget and capacity.
(If you put a med-stead on a ship the ship is structurally gone after 15 years of operation - so a shipstead has a service span that allows you to operate for 15 years at most - so if you have a pendent process on its way to supreme court - it does basicly not matter what the court rules in the end. You can make a lot of money in 15 years of operation.)
All this you need to collect data for, discuss it in your board, with your investors, and then get an ACTION plan.
on the topic oceanic med research platform i wrote:
… i am quite familiar with this topic from my years as product group manager in the pharmaceutical industry, in fact i was in a case where a non FDA approved experimental substance from the research pipeline was handed out to European top medics (university clinics) for special cancer treatment of terminal ill patients. We got a special permit to “circumvent the approval sistem” because all involved top experts considerd it “obsolete and non applieable for terminal illness” even then – that was back in 1994 in Vienna Austria… Interference freedom in pharma research and fast track for new treatments has just increased its urgency since then. A big problem is also this nasty habit of american patients to sue their doctors … for all kind of real or imagined failure… medic science is not always exact science where you can do double blind experiments on geneticly identcial patients to measure “successfull” or “correct” treatment. Even many established treatments are just a “educated guess” this opens the door for endless multi million law suits that are fought on base of “diverging expert opinions” in courts where the judge has no idea of the subject…so moving out of jurisdiction is definitly a way to fast track things in advanced treatments with a high uncertainty component. At the moment the sistem puts a “slow buerocratic apparatus” in charge of the decision what dose of uncertainty is the correct one. In a future this decision might rest in the patients hands supported by a “ethics commission” of medic experts. You might want to choose a different dose of treatment risk for “flu treatment of healthy babies” than for “last chance treatment of terminal ill cancer patients”. The current sistem is not flexible enough. A “blockchain voting sistem” might help to find “politicly correct” decisions without going over the sclerotic FDA approval sistem.
You probably need to fear patient law suits fought in US courts against you much more than FDA approval questions…
I think we can take for given that no US warship will “open fire” “arrest personal” or “tow to a police pier” or “interrupt by any means”- someting like this - no matter what happens on the legal and ruling front - just to avoid the “political fire” this unevitably would bring up. - This is a “project base condition” you can count on - the applyable ruleset does not matter. Doing something like that would just not “feel right” for 99,9% of the planetary population - and this is something that matters. Admirality law and war style blockades are authority processes that are trending to the trash basket of history for the reasons described here - http://concretesubmarine.activeboard.com/t58993851/humanity-growing-out-of-its-childhood-pants/ - these things are born in a different century made for a different society - things are changing… http://concretesubmarine.activeboard.com/t57838040/blockchain-technology/
Instead of adapting your project 100% to the ruleset of the century gone - you need to make sure that it has the “ethical approval” of “most of mankind” - this - and the protection of the sea - will be sufficient.
If you are a visionary and move a visionary project forward, you need to act, talk, defend yourself like a visionary, you need visionary investors to support your cause. Uncertainty is part of the deal. Asking FDA for a permit and clarification is acting like a bureaucrat…asking for “relevant legal frames” is acting like a bureaucrat…the eternal surreal pain of K in Kafkas novel comes from the fact that he is trying to break out of the sistem while stuck inside the sistem and acting inside the sistem.
So stop acting like K and start acting like a visionary or K’s “eternal pain” will all be yours… FDA is really good in BEING the Castle - as close as it gets in a real world application…
the antithesis to the castle is : http://concretesubmarine.activeboard.com/t58935854/subdue-to-nobody/
We really need to stop asking and investigating what FDA would say - because the core of IMPLEMENTING our FREEDOM is, that it does not MATTER what they say.
If you have Lawyer capacity in your project, focus those Lawyers to predict correctly what a legal attack on your project will contain in its core, and how you can defend your project. Instead of focus them on matters like “investigate what is the ruling of FDA”
Have in mind that defense is easy if you do something “etical appoved by mankind in general and by global press in special” on your seastead - if you are involved in “trafficking orgrans” from poor indians to rich americans on the transplant list - this “ethical approval of mankind” will not be on your side and ways to shut you down will be found by somebody under some ruling code.
As long as you do good ethical strong medicine nobody under no ruling code will be able to shut you down, defense will always be easy for your lawyers.
As american citicen you commit 3 felonies per day anyhow - no matter what you do - http://www.threefeloniesaday.com/Youtoo/tabid/86/Default.aspx
And somebody will come after your project to try to pray on it involving it in lawsuits anyhow - http://www.economist.com/news/leaders/21614138-companies-must-be-punished-when-they-do-wrong-legal-system-has-become-extortion
This is part of the game we need to escape from - this is what seasteading is about…
http://concretesubmarine.activeboard.com/t56351996/business-and-third-party-interference-freedom/