birdwatcher - Это FDA

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August 10th, 2007

11:54 am

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Это FDA
On Tuesday, the U.S. Court of Appeals for the D.C. Circuit ruled 8-2 that terminally ill patients who have exhausted all available treatments have no constitutionally protected right to access experimental treatments not yet approved by the federal Food and Drug Administration. A panel of the D.C. Circuit previously had ruled 2–1 in favor of the terminally ill patients who brought the case, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach.

Из заявления в суд: "The challenged policy prohibits mentally competent patients with no other treatment options from purchasing investigational drugs -- medicines showing initial evidence of safety and efficacy in clinical trials, but not yet approved -- even though their physicians recommend these drugs as their best hope of surviving or of prolonging their lives."

The Abigail Alliance is named for Abigail Burroughs, who died of head and neck cancer in 2001 after failed attempts to access Erbitux (cetuximab) through the FDA’s existing channels. (In 2006, the FDA approved Erbitux for treatment of head and neck cancer.) The Abigail Alliance now represents similarly situated, terminally ill patients who only want one last shot at life. Eschenbach is commissioner of the FDA.

Current Mood: blah
Tags: fda

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Comments

From:	fentucci
Date:	August 10th, 2007 06:27 pm (UTC)

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обалдеть можно. не верится, что это америка.

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From:	birdwatcher
Date:	August 10th, 2007 06:29 pm (UTC)

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Однако за время пути
Собака могла подрасти.

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From:	glocka
Date:	August 11th, 2007 12:11 am (UTC)

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Шишек это не колышет, им местные лекарства до лампы:

"You wouldn’t believe how many FDA officials or relatives or acquaintances of FDA officials come to see me as patients in Hanover. You wouldn’t believe this, or directors of the AMA, or ACA, or the presidents of orthodox cancer institutes. That’s the fact."

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From:	birdwatcher
Date:	August 11th, 2007 12:37 am (UTC)

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смеяцца или плакадь...

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From:	averros
Date:	August 11th, 2007 03:50 am (UTC)

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Отстреливать.

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From:	ant_fugue
Date:	August 12th, 2007 02:04 am (UTC)

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Unsurprising.

When a person goes to see a doctor for any illness, it is important to remember that what if offered is FDA-approved treatment plan. For anything more complicated than a self-limiting minor illness, it is up to the patients (or their parents / relatives) to exhaust other options, especially if the treatment required is not urgent (i.e. a heart attack patient has few choices, but a cancer patient has tons of choices).

This is not to say that FDA-approved treatments are bad... it's not not a full scope of what is available.

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From:	ant_fugue
Date:	August 12th, 2007 02:07 am (UTC)

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This is a very contravesial issue.

On one hand, I mean, yea this is gross.

ON the other hand, these policies are the reason snake oil is not sold on the streets, which is something I also would not want to see.

I don't really have a solution that is universal... common sense would be nice, but who is to be the judge?

I just really feel for the families.

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