LDN Trials -Urgency- a Multiple approach

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LDN Trials -Urgency- a " Multiple " approach

I'd like to add my 2 cents to the discussion on whether or not we

should, as a group, be pushing for a trial.

I believe trials are essential because they effect public (and

Doctor) opinion. We are not going to change that, or human

conditioning (others must know better than we do thinking) any time

soon.

No need to rehash the reasons justifying a trial as Yash did that

nicely several posts back.

What I would like to add is also focusing on getting anyone and

everyone (including the " Societies " ) to lobby hard for changes

everywhere to the laws and rules governing the use of FDA approved

drugs for off label afflictions (I just don't believe MS is one

disease or even a disease as we typically know diseases to be).

If the goal is to see as many folks as possible hearing about and

having ready access to LDN, than lobbying for changing the way Off

Label use happens will not only free up LDN, but countless other

drugs. Most of the drugs seeing extensive off label use seem to be

like LDN in that they are older (beyond patent protections) and

relatively cheap (little incentive for Pharmas to Clinical Test).

Not to also rehash or bash big pharma, but their focus will always

be looking forward, not back, unless laws are changed. They want us

using the newest latest greatest because that is where they make

their money (patent protection and premium pricing).

Changing Off Label use laws can look several ways. First is to grant

new or extended patents for Drugs covering new uses. There are many

issues related to this making it tough, but not impossible. This

would provide incentives to Pharmas to do Clinical Trials on Drugs

out of patent protection for " other " uses. Unless I am misinformed I

don't think new or extended patents are possible in most places now.

Another, and perhaps easier option would be to see laws or rules

that specifically allow Off Label use, even if the user has to sign

a release of some sort to remove the Liability obstacles (fear of

being sued - Doctors, Pharmas and even Societies for " recommending "

an Off Label Drug). It seems many Neuros (Pharma fear or control

aside) are unwilling to prescribe Off Label Drugs for fear of being

sued. My first Neuro was " afraid " with respect to RXing LDN, and so

much as said so! Again this is a complicated issue and presented

here only as the base concept.

I am continuing to correspond with the MS Society (somewhat one way

at present) focusing on not only Trials, but lobbying for changes to

Off Label use rules and laws, not only for LDN but for all Off Label

use Drugs (by definition these drugs are already " approved " and for

something, as well as " safe " ). Perhaps the Societie's position on

not directly doing Clinical Trials is in a grey area mandate wise

(at least according to them), but lobbying certainly is not.

Sorry this was so Long!

Best Alan