Our friends at the Abigial Alliance "lose" a round in court but sharpen the debate on access to medicines and exposes a glaring weakness in the FDA's -- and Richard Padzur -- argument about why it shoud keep denying dying patients the right to try experimental drugs....
Dying denied right to unapproved drugs
APPEALS COURT SAYS FAMILIES SHOULD ASK CONGRESS TO ACT
By David G. Savage
Los Angeles Times
WASHINGTON - People who are dying do not have the right to obtain unapproved drugs that are potentially life-saving, even if their doctors say the treatment offers their best hope for survival, a U.S. appeals court in Washington, D.C., ruled Tuesday.
In an 8-2 decision, the court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.
Note the term "wide use." I believe the Abigail Alliance and others can make the case that they are not asking for wide use but targeted, tailored and scientifically responsible use that is consistent with their constitutional rights under the Fifth Amendment. This notion that somehow such rights are trumped by Padzur's effort tot take a wrecking ball to accelerated approval is a joke. The FDA is inconsistent on who gets what and when with respect to access to medicines and I don't think the Supreme Court is going to let this "wide use" nonsense pass particularly since the Alliance is not asking for patients to determine when a product is safe but only to have the FDA create a regulatory pathway for allowing dying patients access.
And let's by clear who the real independent operators are: Padzur is one of those free lancers, along with Graham and the now departed David Ross who acted as a FDA of one under the protection of Waxman and Grassley.
http://www.mercurynews.com/healthandscience/ci_6570788?nclick_check=1
Dying denied right to unapproved drugs
APPEALS COURT SAYS FAMILIES SHOULD ASK CONGRESS TO ACT
By David G. Savage
Los Angeles Times
WASHINGTON - People who are dying do not have the right to obtain unapproved drugs that are potentially life-saving, even if their doctors say the treatment offers their best hope for survival, a U.S. appeals court in Washington, D.C., ruled Tuesday.
In an 8-2 decision, the court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.
Note the term "wide use." I believe the Abigail Alliance and others can make the case that they are not asking for wide use but targeted, tailored and scientifically responsible use that is consistent with their constitutional rights under the Fifth Amendment. This notion that somehow such rights are trumped by Padzur's effort tot take a wrecking ball to accelerated approval is a joke. The FDA is inconsistent on who gets what and when with respect to access to medicines and I don't think the Supreme Court is going to let this "wide use" nonsense pass particularly since the Alliance is not asking for patients to determine when a product is safe but only to have the FDA create a regulatory pathway for allowing dying patients access.
And let's by clear who the real independent operators are: Padzur is one of those free lancers, along with Graham and the now departed David Ross who acted as a FDA of one under the protection of Waxman and Grassley.
http://www.mercurynews.com/healthandscience/ci_6570788?nclick_check=1
