Tuesday, August 7, 2007

"No Drugs For You" per the FDA

An appeals court decision in DC has setup the potential for a very important Supreme Court hearing on the rights of the terminally ill. The court ruled 8-2 against the Abagail Alliance which supports the rights for dying patients to get access to experimental medications. The FDA is opposed to this measure. The finding by the judges stated that the constitution does not guarantee access to experimental drugs that have not been studied enough to be deemed safe and effective. (Read the court brief here.)

One of the cases cited in support of the decision was Washington v. Glucksberg, which is the Supreme Court Decision on the right to assisted suicide case from 1997, that challenged the Oregon law on PAS. The basic result from that decision was no federal/constitutional right exists but that this is a state matter. The Cruzan case is also referenced.

The FDA has a few programs that allow early access to medications before full clinical trials (Phase I, II, III) have been completed. These programs are not deemed to be adequate by the Abigail Alliance given the many hurdles and time needed to get these medications approved. The crux of the argument is that dying patients don't have time to go through a lengthy approval processes, and they are willing to take the risk for potential improvement, so what do they have to lose?

The FDA has argued the 'Pandora's Box phenomena.' Once more access to poorly tested drugs is achieved, proper clinical trials would not be done, and this would put more patients at risk and unsafe drugs would come to market. You have to feel a little sorry for the FDA. On one hand they are getting dunked on the issue of releasing medications to early to market before safety test are done or scrutinized appropriately and they are also getting shelled for not releasing medications fast enough. You can't please all of the people all of the time.

The footnotes are very interesting legal reading, such as how the argument may have different merit if you are arguing 'to save someone's life' or 'to have access to experimental drugs.' Some of the interesting quotes on drug regulation history:

Henry VI’s royal decree in 1447 that gave grocers the power to inspect “anis, wormseed, rhubarb, scammony, spikenard, senna and all sort of drugs belonging to medicine, so as not,
in the buying of these to be hurt in their bodily health.”

“[W]hen the Society of Apothecaries was chartered independently ([in] 1617), its master and wardens were empowered to inspect any pharmacy and to burn before the offender’s door all drugs and preparations they deemed corrupt or unwholesome.”

The judges make a clear point in changing the terms from 'access to life-saving drugs' to 'access to potentially life-saving drugs' which is key in a situation when trials have not concluded efficacy.

In these cases it is always interesting who files aimci curae on behalf of which party. ASCO and the National Organization for Rare Disorders sided with the FDA.

(via WSJ Health Blog)

And a couple of quick ones:

Sid Schwab at Surgeonsblog has three wonderfully written pieces 'On Death.' Take 15 minutes and read them at your leisure. Bring them to your team meeting and read them, discuss them, or just keep them to yourself.

Morphine gets some good press, and some bad press, and its own song. The lyrics to the song 'Lips Like Morphine' has the curious line that seems to contradict the treatment of dyspnea:

I want a girl with lips like morphine,
Blow a kiss that leaves me gasping.

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Another Pallimed Quiz:

Sorry I missed this very important anniversary, but can anyone tell me what is so important about July 22 in the history of US Hospice and Palliative Care? Shiny silver quarter to anyone who posts the answer in the comments. (PS that was a hint not a promise of a coin)

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