Without your Consent

[MiaCulpa]

Did you know that the FDA can give drug companies -- and your hospitals -- the right to participate in testing experimental drugs on you without your consent? It's being done today, and has been done with 15 other drugs! Pardon the blogwhore, but I think this is something everyone should be aware of:

http://miaculpa.blogspot.com/2007/05/when-no-consent-doesnt-mean-no.html

Included in the post is a list of hospitals in the nation that participate, there are 20 of them!

-Diane

[jojo54]

1. Typical of what this administration is allowing to happen in our great country.

"Several years ago a clinical trial of a blood substitute called PolyHeme finished with worrisome results. Ten of 81 patients who received the fake blood suffered a heart attack within seven days, and two of those died. None of the 71 patients in the trial who received real blood were found to have had a heart attack.

PolyHeme's maker, Northfield Laboratories Inc., quietly shut down the trial and didn't publicly disclose the results, which are described in internal documents viewed by The Wall Street Journal."

Thank goodness no hospital is doing this in my state.

Welcome to DU!

[MiaCulpa]

3. thanks for the welcome!

I stop in and read more often than I post, most everyone seems to 'know' each other well here.

[thecrow]

9. FDA approved this in *1996*, not recently

From the article: "In 1996, Polyheme was approved by the FDA for use without consent in trauma patients. The only means for patients usually rendered incapable of providing informed consent is the wearning of a medical bracelet requesting to opt out of the trial."

*******************************************************************

Not that I'm blaming Clinton; he may have opposed this.
It is "Typical of what this administration is allowing to happen in our great country" but it was started in 1996.

Fortunately my local hospital suspended this but my question is why did they ever start to do it? Are hospitals forced to participate in these programs?

And where do you get one of those "Please exclude me from any testing while I'm unconscious" bracelets?
I think I should start making them....

[mainegreen]

2. Well, it's a bit more than that:

You must be unable to consent yourself, authorized parties on your behalf must be unreachable in a timely manner, you are in a life threatening situation, and no other effective treatment is available.

law

They can't just up and test people willy-nilly because they feel like it.
At least that's what I read out of the law.

[MiaCulpa]

5. Re: it's a bit more than that

"no other effective treatment is available"

I've yet to hear of a hospital being completely without any type of blood, there are rare types, but nothing compatible?

[mainegreen]

6. If that is true

then they broke the law. I'm not saying hospitals don't break the law. I know they do. I'm just saying based on what I read out of that law that is not legal.
I fully expect these hospital(s) to be sued into smoldering little piles if this gets out.

[MiaCulpa]

7. I don't think they can be sued

That rule that gives the fda the authority to approve this makes it all 'okay' Given their track record, doesn't make me feel none too safe.

[mainegreen]

8. Sure they can be sued.

There is nothing in that law that immunizes hospitals from suit if they fail to follow the standards set forth in that law.
Will they be sued? Probably not. I'm sure the hospital's lawyers have figured out how much to 'settle' for to prevent that from ever happening. God forbid their insurance rates go up due to a malpractice suit!

[TechBear_Seattle]

4. I would think that was highly illegal

I've participated in a drug study, one of the HIV vaccine tests. Protocols mandated by federal law in the wake of the Tuskeegee scandal required full disclosure of all possible side-effects, no matter how unlikely, and frequent questions along the lines of "Do you really understand what you are getting in to and are you sure you will accept these risks?" Each time I went in for a shot of the vaccine (four in the base study, three more in a booster study) I had to sign a consent form.

It boggles the mind that the federal government would violate its own laws on human research and conduct studies on people unable to give informed consent. How in the bloody hell is this not criminal?