Anon says:
Expanded Access for drug use QsAs 4-15-13MG.pdf
I am attaching the FDA guidelines for expanded access use of drugs and the process involved in qualifying for them and how it all works.
This is critical in understanding the role of the HLC and how they operate/purpose.
After reading this over, it is clear that the HLC are acting on behalf of sponsors - they are agents for pharma companies. And they target JW patients in this activity.
Most of the alternative procedures and drugs that the HLC negotiate for JW patients are accessed thru this expanded access program. This document explains what that is, and how it is beneficial, not just to the patient, but to the developer of the drug and to the FDA in evaluation of the safety and risk factors.
The line that connects the HLC to the profits and benefits of pharma companies and research projects is undeniable. The HLC are agents that work for these interests.
So...that type of relationship- between the HLC and the pharma/medical supply companies - would foster a different kind of pressure than just the one brought to bear on the JW patient. the pressure placed upon the doctors to act as sponsors for the use of alternative/expanded access drugs, would be intense.
It seems as the the pressure and influence that the HLC are exerting is two-fold. I have heard and read accounts of doctors where the negotiations with HLC are terribly uncomfortable
The HLc aren't pushing a religious doctrine - they are alternative drug pushers - they deal in blood products
...some thoughts about the role of the HLC as agents for pharma companies - agents who pressure the medical community to sponsor drugs...to fall under that category of use, a doctor must be named as a sponsor
If the HLC makes the claim that they are a 'benevolent' association of some kind, with the WT not getting any kickbacks, etc...blah blah blah...just acting in the patient's best interests, blah blah blah...then the focus of investigation has to change. The HLC has to be seen as acting in the interests of pharma and medical device companies, regardless of whether they get paid or not...the company they are dealing with to access these products are benefiting
Here is where the pressure could be put - on the tax returns of the pharma sponsors and medical device companies the HLC act on behalf of. They will be for-profit companies and would have to declare volunteer labor that would benefit them. The tax man should be looking at those "expanded access" drug companies and assessing all that free labor that the HLC is doing for them...