A patient’s life belongs to the patient, not to the government. The ultimate decision must be in the hands of the patient. It is terrible that the SCOTUS judges do not understand the basic concept of individual rights, and the right to one’s life.

As another blogger said, “Legalize Drug (medical drugs) now!”

Pharmalot notes that the Supreme Court has decided not to grant cert on the Abigail Alliance case, which had to do with terminally ill people’s right to access experimental drugs. Seems like a shame to me, because I think it…

http://www.fda.gov/cber/rules/expandind.htm

Funny how we haven’t (at least I haven’t) heard anything new since then, even though these proposed rules were issued more than a year ago.

Of course, considering Part 11 still remains unrevised (despite FDA saying it would be done in 2005), aspects of PDUFA III remain unfulfilled, et al, I guess it’s no surprise.

Seems the FDA would do well to read the Peanut Butter Manifesto:

http://online.wsj.com/public/article/SB116379821933826657-0mbjXoHnQwDMFH_PVeb_jqe3Chk_20061125.html

I travelled the USA a lot, talked to people, made friends.
The USA are a great country. Americans are nice and friendly people. It’s its ruling class that leaves much to be desired - and its obsession to rule the world.

I acknowledge this comment is way OT, and I’ll stop here.

Very kind regards,
phil

PS. phil is from Italy, another country with great people and a very bad ruling class. ;-)

There are regulatory provisions to allow drugs to be supplied to critically ill patients for which no alternative is available and the company is allowed to charge the patient on a cost-plus basis. ( A physician should apply for what’s known as a Treatment IND from the FDA)

Still, the manufacturing capabilities are extremely limited at this point.

John Dean apparently has written about this in his recent book “Conservatives Without Conscience.” I have not read his book but am familiar with some of the research on the subject, plus the book which originated the concept. With which I essentially agree.

I saw Dean on CSpan recently and everything he said ‘rang true’ hence my decision to bring this up. With morbid fascination, sadness and alarm I have watched this socio-cultural-political debacle forming for more than twenty years.

The Court decision is simply one more manifestation.

1) Who is responsible and what would happen if the patient died due to a drug reaction?
2) What happens to the results? In other words, does “curing” a patient in this highly uncontroled environment constitute proof that the drug works? Most likely the patient will die — giving the impression that the drug does not work. Is that somehow incorporated into future FDA filings as a “risk”?
3) What formulation would the drug be provided in? What dose should be used? Translation of animal results into human results is plauged with problems.
4) What should the pharma company charge? Given that the market is only a few patients, the “real” cost is likely to easily be in hundreds of thousands of dollars for a treatment. What if the patients can’t afford it?

Given all these questions (and more that I can’t think of at the moment), I seriously doubt that pharma companies would be even willing to sell experimental drugs to patients.