Informed Consent Waived in Public Crisis

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Informed Consent Waived in Public Crisis

 

By ANDREW BRIDGES, Associated Press Writer

 

Wednesday, June 7, 2006

 

 

Informed Consent Waived in Public Crisis

- By ANDREW BRIDGES, Associated Press Writer

Wednesday, June 7, 2006

 

(06-07) 17:11 PDT WASHINGTON, (AP) --

 

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.

 

___

 

On the Net:

 

Food and Drug Administration rule:

 

www.fda.gov/OHRMS/DOCKETS/98fr/E6-8790.htm

 

 

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