Where will it end???? Informed Consent Waived in Public Crisis

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June 7, 2006

Informed Consent Waived in Public Crisis

By THE ASSOCIATED PRESS

Filed at 9:24 p.m. ET

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.