Effect Measure

Experimental health tests in an emergency without informed consent

Posted by revere on October 31, 2007
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I am a strong supporter of privacy and civil liberties. But I confess I don’t get the opposition to this rule, just promulgated by FDA on an expedited basis, without going through public comment:

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. (AP via MSNBC)

Three privacy experts are quoted in vigorous opposition. At least two of the three take a consistent conservative libertarian position. The third seems to be fixated on medical privacy. I consider myself a socially left libertarian but I cannot understand the reasoning in opposition to this, which seems excessively doctrinaire, inflexible and relying on a slippery slope absolutism. It is true that there is absolute discretion on the part of the testing laboratories in deciding on what constitutes a life-threatening emergency, but it is harder to see the potential for abuse. If it is stretched to include non-emergency situations (e.g., to develop a commercial testing product) then the patient has a course of action under civil remedies. If they are never told their blood has been used for this purpose they have been unfairly exploited in some sense but not significantly harmed.

In a way the rule is probably not needed, as in a real emergency diagnostic testing will proceed without many of the niceties. Part of the problem here is that no one trusts this administration to tell the truth or to make judgments for anyone’s benefit but their own and their cronies. That’s a problem of their own making.

Having said that, this rule seems reasonable to me. If there’s something about it not visible on the surface I’d like to know. I’m educable.

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Comments

  1. #1 Marissa
    October 31, 2007

    You’re right Revere. If someone comes in the ER with an ILI-like or suspicious disease, or something that can’t be nailed down, they’re going to run exhaustive tests, send samples to the state and/or CDC, etc. This will happen no matter what rules are in place.

  2. #2 Caledonian
    October 31, 2007

    I’m not sure that it’s wise to make a rule permitting this, even if it’s understood that it will occur anyway. Keeping the medical establishment on the defensive will mean that they’ll have to use discretion in determining when to break the rules.

    People have a disturbing tendency to go as far past the formal rules as they think they can get away with – as with speed limits, the rational response is to craft the restrictions so that when they’re violated, people are still within safe and reasonable bounds.

    No engineer crafts a design whose stated breaking limits match the posted warnings – they have to be capable of handling more than that.

  3. #3 Phytosleuth
    October 31, 2007

    Why the hurry? (“expedited”) Why without public comment?
    Could this “rule” be used to force something on a citizen? Could it be stretched say…for vaccinations? Or to test vaccinations? This administration has not earned trust. Sneaky behavior by an administration that has tried to garner more and more control? What KIND of experimental tests are they suggesting? Gee. Do you think its for our benefit? Really?

  4. #4 revere
    October 31, 2007

    Phyto: My understanding is that this is only for unapproved tests on body fluids or tissues for diagnostic purposes so wouldn’t cover vaccinations. In an emergency many things will be done that aren’t approved. Like others, I worry about what the Bush nutcases will do or want to do, but there are some things that aren’t worth the effort to fight over, especially as there is more than a grain of reasonableness in this one (IMO).

  5. #5 daedalus2u
    October 31, 2007

    My guess it is being pushed through for DNA testing, and that “health emergency” will be defined very broadly, as in the obesity epidemic is a health emergency, an automobile accident is a health emergency. Anything that lets some favored contractor get access to large quantities of DNA for fishing expeditions. Maybe Halliburton. They have done such a bang-up job in Iraq, no doubt they could handle this too.

    The DNA information will go into some government data base and be cross correlated. Finding out who is related to who. Once you have the DNA of a few near relatives, any crime scene DNA (or other DNA) is trivial to identify. Maybe you could find something useful, such as illegitimate children of political opponents.

  6. #6 revere
    October 31, 2007

    daedulus: Well, if that’s the case I would certianly be concerned. If someone has better info, please send it on.

  7. #7 M. Randolph Kruger
    October 31, 2007

    Might be that you can never trust your government to do the right thing Revere. You post on this often and the above has always been abused. They tested on the blacks in Alabama, they tested on pregnant women, they blew up an atomic bomb and then had troops run in towards it to check the effects. This is the forerunner of human biometric tracking and tracing.

    Sen. Fred Thompson put a stop to it regarding informed consent because up until the 80′s it was legal for them to mass experiment and all they had to do is inform “local health officials.” There is a whole division now in every part of government that by law requires the informed consent. Its a Republican plan indeed, but it could or would be used by left or right wing more extreme wingnuts to promulgate human testing in the interest of the “public good” or any other life threatening public emergency. When does government have the right to invade your body? At what point would they come in and say okay, now you need this goddamn RFID microchip so we can track you day and night and know what you are doing. We are sure you have a problem…. we just arent sure what. Thats testing Revere. Long range and ultimate control. How about your DNA? Urps, thats an error that creates diabetes. Theres one for cancer. All they have to do is create a situation and then they are testing for what? Anything they damned well want to say and you have to….submit!

    Thats the opposition and for one someone isnt thinking this one thru beyond the first intention which might be good. Governments always take liberties and then use the courts to slow any damages or compensation claim. I dont give a shit about regulations, they try testing me or a family member or treat an illegal treatment they are going to need a whole new ER after I get thru with them. They’ll be rationing healthcare after I get done.