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FDA

This may have been posted but I continue to read about waiting for FDA approval, well maybe this case will finally tell them to get the "F" out of peoples lives who need and want new drugs!
"von Eschenbach" is the head of the FDA!!!!!!!

A recent ruling of the District of Columbia United States Court of Appeals weakened the Food and Drug Administration (FDA) drug-approval monopoly.

In the case of Abigail Alliance v. von Eschenbach, the court ruled "in some circumstances there is a constitutional right" to use drugs not approved in advance by the Food and Drug Administration (FDA), according to Robert F. Nagel writing in "The Weekly Standard."

If other levels and branches of the federal government maintain this ruling, it would put some additional meaning to Americans' unalienable right to life and liberty, as articulated in our Declaration of Independence.


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Avatar universal
Interesting.  I just saw a "Law and Order" series recently about a woman suing a drug company for taking her out of a clinical trial for a diabetes drug that was damaging, of all things, her liver.  She wanted back in.

I received the frustrating news Thursday that my local doc will be running a PROVE 3 trial right here in my own home town, but has already crossed off my name due to a history of retinal bleeding on Infergen.  I am hopping mad!  He knows the retinal issue occurred when I was on a high dose of Infergen for my size and had untreated blood pressure.  My blood pressure is now under control with medication.  You can find plenty of info on the web about 47% of patients developing retinopathy on IFN treatment, particularly if they're hypertensive, which I was.  Retinopathy resolves once treatment is completed, with no damage to eyes.  Now that we know this is a problem with me, I have offered to undergo as many retinal exams as the doctor or Vertex want, at my expense.  My local doc knows I wanted to forego Infergen and wait for VX-950, but he said I didn't have time to wait.  Well, nothing's changed.  I assume I still don't have time to wait, (Stage 3) but I am, and now the drug he knows I want is here and he won't give it to me because of a past event that has now been rectified; the high blood pressure.  I get so mad I could scream!

So my local doc is forcing me to commute two hours to a large city to get the very same treatment I could have right here in my home town, requiring that I spend money on travel, possibly hotels, etc., etc., and that's if the big-city doc even lets me into PROVE 3.  I hope he will.  It seems optimistic.  What doesn't seem fair is that I should be excluded from PROVE 3 where I have my husband and people to help me and be forced into this rush-hour, traffic-clogged city to get the same treatment.  It's a shame that we can't force our doctors into giving us treatment, or can we?  Sorry.  I'm just fuming!!!!!!!
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92903 tn?1309904711
Why 'dat? Otherwise you might not could hold yourself back?
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Avatar universal
Don't know if others had heard but in California, 72 million was designated to the advancement of stem cell research in our state last week.
Im not a big Arnie fan, but he sure did the right thing on this subject.
Keep hope alive everyone!
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86075 tn?1238115091
hey, that's great news huh? yeah, I wasn't a big Arnie fan either, just glad he's married to who he's married to...he he, ooops, wrong side of the forum!
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Avatar universal
AMEN TO THAT BROTHER.
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Avatar universal
UCLA law professor Eugene Volokh believes that access to medicines not yet approved by the FDA could be defended under a right to "medical self-defense."

Although Volokh describes the use of this right in several other scenarios, in this article we are only looking at it in the context of medicines not approved by the FDA for prescription or sale in the United States.

In an article forthcoming in the April 2007 Harvard Law Review, Volokh writes, "Lethal self-defense
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