Posted on 06/08/2006 9:54:17 AM PDT by neverdem
ASSOCIATED PRESS
WASHINGTON -- In a public health emergency, suspected victims would no longer have to give permission before experimental tests could be run to determine why they're sick, under a federal rule published Wednesday. Privacy experts called the exception unnecessary, ripe for abuse and an override of state informed-consent laws.
Health care workers will be free to run experimental tests on blood and other samples taken from people who have fallen sick as a result of a bioterrorist attack, bird flu outbreak, detonation of a dirty bomb or any other life-threatening public health emergency, according to the rule issued by the Food and Drug Administration.
In all other cases, the use of an experimental test still requires the informed consent of a patient, as well as the review and approval of an outside panel.
"To be candid, I hope it is a hypothetical problem. I hope we spent a lot of time creating a rule we never have to invoke," said Dr. Steve Gutman, director of the FDA's in-vitro diagnostics office.
Determining what constitutes a life-threatening public health emergency would be left up to the laboratories doing the testing. That creates the potential for conflicts of interest and other abuses, critics said.
"I don't like a rule like this because its most likely use is likely to be a form of abuse. The emergency exception it creates will be stretched to encompass non-emergency situations," said Jim Harper, director of information policy studies at the Cato Institute.
The FDA said it published the rule to ensure the ability to identify quickly whatever chemical, biological, radiological or nuclear agent is involved in a terrorist attack or natural outbreak of disease. Doing so could save the lives of those being tested as well as of others exposed, the FDA said.
"Baloney," said Dr. Deborah Peel, chairwoman of the Patient Privacy Rights Foundation, a watchdog group. "This sounds like they're taking for themselves the right to test individuals every time they declare a public health emergency. There is no way getting consent would delay testing."
The FDA said that obtaining informed consent in those cases would be impracticable or unfeasible.
The rule lays out a scenario where a laboratory discovers what appears to be an unusual bug in a sample taken from a patient before a public health emergency was even suspected. With the apparent bug in the lab but the patient gone, going back for permission to use a confirmatory but experimental test - often the only type of test available - would introduce "unacceptable delays," the FDA said.
"They're basically overriding state informed-consent laws," said Sue Blevins, president of the Institute for Health Freedom. Blevins said her group advocates for informed consent but that in emergencies it could be sought after the fact.
"If they don't have the time to get it, at least inform them retroactively what's been done, so people can keep track of what information has been collected from them," Blevins said.
The rule took effect Wednesday but remains subject to public comment until Aug. 7. The FDA said it published the rule without first seeking comments because it would hinder the response to an outbreak of bird flu or other public health emergency.
"Nobody said two airplanes would fly into the World Trade Center, did they? We wouldn't have written the rule unless we thought it was a possibility," Gutman said.
The FDA said the lack of such an exemption impeded the public health response to the Severe Acute Respiratory Syndrome, or SARS, epidemic of 2003.
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On the Net:
Food and Drug Administration rule: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-8790.htm
For a diagnostic test, this guy sounds like he joined the looney left. I hope the rest of the Cato Institute keep their heads on tight.
"WASHINGTON -- In a public health emergency, suspected victims would no longer have to give permission before experimental tests could be run to determine why they're sick, under a federal rule published Wednesday. Privacy experts called the exception unnecessary, ripe for abuse and an override of state informed-consent laws. "
You can't find out what is wrong with me, but you better treat me.
Oh boy! And the screw turns!
What's the problem? Especially when you don't know - what you don't know - to make the diagnosis?
This smells like another tail wagging the dog = creating a crisis to remove a freedom, or sleight of hand to make a fool.
How does being glib help to make a diagnosis? What freedom is being lost?
"In a public health emergency, suspected victims would no longer have to give permission before experimental tests could be run to determine why they're sick, under a federal rule published Wednesday. Privacy experts called the exception unnecessary, ripe for abuse and an override of state informed-consent laws.
"Health care workers will be free to run experimental tests on blood and other samples taken from people who have fallen sick as a result of a bioterrorist attack, bird flu outbreak, detonation of a dirty bomb or any other life-threatening public health emergency, according to the rule issued by the Food and Drug Administration."
Glib? Never mind, neverdem. You're too young to understand.
I wish. I'm old enough to understand medicine. This isn't a treatment. How is this a threat to anyone? If someone is sick enough to provide a biological specimen, how would an experimental diagnostic test harm them? No physician would provide treatment based upon an experimental test. Results would have to be corroborated by a standardized test.
>No physician would provide treatment based upon an experimental test<
And no physician is into cloning human embryos either, or performing abotions, right?
I understood the article to mean that the patient had no right to refuse treatment, proven or experimental.
You didn't understand it. Read it again slowly. First, here's the definition of diagnosis:
diagnosis (di·ag·no·sis) (di”əg-no´sis) [dia- + Gr. gnôsis knowledge] 1. the determination of the nature of a case of disease. 2. the art of distinguishing one disease from another.
My problem is not with diagnosis. My problem is with all the caveats that turn up in each paragraph, which could add up to our bodies, if ill, could no longer under our own jurisdiction. I suppose I am saying this badly, but it has been a lonnnnnng day. God bless.
Ping
Not directly about the flu, but possibly related.
They are arrogating the "authority" to override the BoR! They can show up at your door, and compel you to "come along, now" for "testing."
And who gets to decide if such "testing" is "necessary"? The labs who benefit from administiring the tests!
I'd love to be an auto mechanic operating under those rules. I'd get to knock on doors, inform people that I was taking their car in for "diagnostics", and then after hauling it off, write my own ticket!
Then, there's the question of what's to be done based on the results of the "tests."
Fortunately, we know the answer to that question.
The only "help" that the government is on record as being prepared to deliver is quarantine, travel restrictions, and the like.
Keep in mind that similar testing is done on poultry. Entire flocks will be destroyed -- including ALL poultry owned by anyone within a six mile "ring of death" -- if they get a positive test for "avian flu."
The problem is that "avian flu" is extremely common, prevalent in wild birds and many poultry flocks. We're not talking about H5N1, though. We're talking about "avian flu", which has numerous harmless varieties. If they find antibodies for "avian flu", then they shift into "better safe than sorry" mode.
It's somewhat reminiscent of the comparison between Anthrax and "BT". What is "BT"? Its a common insecticide, in widespread use. It is also nearly identical to Anthrax. Basically, "BT" is "Anthrax for Bugs." It's the same disease, but a strain that is harmless to anything other than bugs.
Can you imagine the results of burning the fields of a farm -- and every farm in a six mile circle -- if they found BT present?
It's the same logic that's being used with bird flu, and now it looks like they're going to start using it on people too.
Well, if you've got a massive infrastructure, and you've spent billions of dollars building it out, and have massive numbers of employees on the payroll, then what harm can come from drumming up some work for them?
So what if thousands (or millions?) of people are swept up in "false-positive" results? Isn't it better to quarantine them, or relocate them to "facilities", than it would be to "risk" the possibility of one of them having real bird flu?
This is nothing new. The same brand of "logic" has been used for decades to advance the gun control agenda.
Isn't panic such a fantastic tool?
I think I need to go puke...
The mandatory testing and treatment is part of the old quarantine laws. That used to be common in the days where quarantines were used.
Not good, but not new.
I'm not too worried about this. Making a diagnosis could be critical in controlling a potential epidemic of whatever.
Since I'd like to know whether or not I have something, I don't feel like I'm surrendering anything worth protecting, especially when other peoples' lives are potentially at stake.
I read and re-read the article, trying to find the part where "rights" were going to be infringed by involuntary taking of samples or by failing to fully disclose the known intent to perform some test.
The permission has already been given for the blood to be removed for testing - either by informed consent from a competent person or under the "reasonable man" doctrine. I wouldn't think there would even be a ghost of a concern about tests on those samples.
There is potential for this to be rankly abused, and that is why it is cause for concern.
It cannot be assumed that any power usurped by the government will be always used to the benefit of the individual or of mankind. Instead those powers should be viewed through the aperture of "What would Hitler have used this for?" before consideration is given to ceeding them to government.
Good comment, Dog Gone.
In fact, the tests are "in vitro" and on "left over" samples.
For those truly concerned, the actual Federal Register notice and opportunity to comment are at
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-8790.htm
a.) Actually achieved the purpose for which it was intended?
b.) Didn't expand far beyond it's original mandate?
c.)Whose original stated cost wasn't wildly underestimated?
d.) Wasn't riddled with unintended consequences?
The Tobacco Epidemic? Come with us...
The Obesity Epidemic? Come with us.
The IED* epidemic? Come with us, unless of course you have an IED* episode right now, in which case we'll be back later...
The road to hell is paved with good intentions.
* IED - Intermittent Explosive Disorder (road rage)
I have seen this on other avian flu sites (I have collected quite a few of them, freepmail me if you want a list - maybe you check them already). It doesn't seem that great to me, but what do I know?
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