Seattle Trauma Center To Test Experimental Drug On Unconscious Patients Without Consent

By Darren Smith, Weekend Contributor

Harborview Medical Center LogoPatients with brain injury brought in to the emergency department of Harborview Medical Center could be subjected to enrollment in a drug trial experiment while they are unconscious and without their express consent.

The hospital, having the largest and most capable trauma center in Washington, frequently admits patents statewide for traumatic brain injury, often of the most serious circumstances. The hospital regularly participates in studies of medications like other hospitals but a new study to test a medication currently prescribed for other hemorrhage disorders in other parts of the body is undergoing human trials for brain injury. The study is bringing forth some opposing views within the realm of medical and legal ethics as to patient informed consent, medical research, harm reduction, and individual rights.

The Seattle Times reported that the hospital will be testing Tranexamic Acid, which according to the U.S. National Institutes of Health:

Tranexamic acid is useful in a wide range of haemorrhagic conditions. The drug reduces postoperative blood losses and transfusion requirements in a number of types of surgery, with potential cost and tolerability advantages over aprotinin, and appears to reduce rates of mortality and urgent surgery in patients with upper gastrointestinal haemorrhage. Tranexamic acid reduces menstrual blood loss and is a possible alternative to surgery in menorrhagia, and has been used successfully to control bleeding in pregnancy.

The trial at Harborview and nine other centers in the U.S. and Canada is the first to systematically test Tranexamic Acid given as early as possible to patients with significant traumatic brain injury (TBI) and will measure not only survival, but neurological outcomes at six months, according to Dr. Eileen Bulger, Harborview’s chief trauma doctor and that site’s principal investigator for the new study. Dr. Bulger states that there is no other method to treat some emergency conditions. The test is a hopeful drug candidate aimed at preventing a major cause of death and disability after a traumatic brain injury.

Because brain-injury patients are often unconscious, Dr. Bulger and other researchers believe it’s crucial to deliver the drug immediately to brain-trauma victims age 15 and older, unless a parent objects. The TBI patient will automatically be enrolled in the study by emergency personnel who will inject the Transexamic Acid or a standard saline solution.

Researchers are hopeful that Tranexamic Acid will prove to be of great aid in saving lives and lessening disability of TBI patients. TBI is the leading cause of death among trauma center patients and of those under forty years of age. According to the study proposal, more than 1.6 million people each year suffer brain injuries, with 52,000 deaths and 80,000 permanent severe neurological disabilities. Nevertheless no consent drug trials have presented in the past some patients with significant risks to their health or even deaths.

FDA LogoIn 2008 the Washington Post reported the U.S. Food and Drug Administration had approved for experimentation several artificial blood solutions to patients; many of which through no consent drug trial enrollments by reason of unconsciousness on arrival at a trauma center. Several of these artificial bloods were found to triple the occurrence of heart attacks and increase the likelihood of death by thirty percent. Like numerous other drugs tested, there is always a chance for failures, hence the need for trials before release into public formularies. Yet, some patients were injured under a no consent doctrine.

It seems however that bypassing informed consent is allowed under federal regulations if the research team provides information to the community about the study and the ability to “opt-out”.

Harborview stated it took steps toward community notification.

In the Seattle Times article Harborview reportedly plans to reach out to non-English-speaking communities and sports leagues, including the Cascade Bicycle Club, Dr. Bulger said, and use social media such as Twitter and Facebook and local media outlets.

They will also distribute study brochures at food banks, soup kitchens and homeless shelters. As they did last time, researchers also plan a random telephone survey to ask community residents for their opinions on the study. In all, the Harborview study site has budgeted $34,000 for community notification and consultation.

“We’re really trying to canvass the whole community widely,” said Dr. Bulger, who hopes to start the one-year study this fall or winter.

The hospital provided a phone number and e-mail address individuals may contact to pre-emptively opt-out of the program and it was even suggested that they can wear a bracelet indicating they wished to not be included in the Tranexamic Acid Study.

Traumatic Brain Injury CT ScanBut is such an effort moot or beneficial? Most of the citizenry of Washington State does not attend the groups or functions the Harborview outreach program seeks to contact. Washington has a population of nearly seven million and expecting that if half the population would not consent to such a procedure it is rather shortsighted to believe three and a half million citizens would choose to wear the bracelet, call a phone number, or send an e-mail to opt-out even if they heard about the procedure to begin with. Seattle is not the only community serviced by Harborview and many medevac flights depart from remote areas of Washington destined for Harborview.

The ethical controversy is not limited to community notification but also includes the ethics of no consent experiments as a whole.

George Annas, Chairman of the Department of Health Law, Bioethics & Human Rights at Boston University stated, “I think the whole concept of doing research on people without consent is bad. I want researchers to take informed consent as seriously as they take their study.”

One has to also ask at what point do we allow physicians and policy makers the right to decide patients do not have the ability to consent to treatments that are experimental in nature. Continuing to expand the no consent nature of experiments could prove to be detrimental if such experiments injure many patients and results in a public outcry that could lead to the stifling of experiments generally by law makers. It also could be argued using persons as test subjects is more convenient and expedient when the patient is unconscious and broad consent is then invoked to obtain a result. It is somewhat analogous to the Implied Consent for Blood Testing laws which, as a condition to receiving a driver license, the driver is deemed to have consented to a DUI blood draw if under suspicion of DUI and unconscious.

Another ethical debate can be if the use of Tranexamic Acid could help a patient with a TBI, is it ethical to instead administer a saline solution and possibly deny that person a better medical outcome solely for the purposes of generating statistics?

What is clear is that this issue represents a divide between individual rights and community health with regard to consent. But at what point can an individual have the expectation that if in their most vulnerable moment in life, the hospital will not use them for experimentation purposes?

By Darren Smith

Seattle Times
Washington Post
National Institutes of Health (Tranexamic Acid)
United States Census Bureau
RCW 46.20.308 (DUI Implied Consent)

The views expressed in this posting are the author’s alone and not those of the blog, the host, or other weekend bloggers. As an open forum, weekend bloggers post independently without pre-approval or review. Content and any displays or art are solely their decision and responsibility.

40 thoughts on “Seattle Trauma Center To Test Experimental Drug On Unconscious Patients Without Consent”

  1. This is an ethical minefield.

    However, who can sign up voluntarily for a drug used to treat traumatic brain injuries? By definition, it would be an emergency, and the patient would be either unconscious or incapacitated. Time is absolutely of the essence. And anyone with medical power of attorney would not have much time to research the pros and cons.

    The animal trials that would be required for this drug to make it to clinical trial stage must be horrific, although the drug would do a lot of good if it works.

  2. As a “legal fiction,” informed consent may exist, if only as a shared misunderstanding of human neurological function and form. As a neurological function, informed consent, as in the use of TXA in seriously to severely impact-brain-traumatized human persons is, to me, evidence that the adversarial legal system is foundationally insane.

    All of human life, as no less all of life, is an experiment in which we are all confined. A rather simple understanding of the ramifications of accurate understanding of quantum mechanical aspects of biology, in its present state of development, may decently inform anyone who can think accurately that it is physically and physiologically impossible to ever make the measurements necessary for informed consent about anything whatsoever.

    I have never been “MIrandized,” and I hope to never, never ever, be “Mirandized.” Why? Because I reject entrapment as being in any way of informed consent.

    Imagine that a police officer mistakes me for someone else who, in the ordinary sense, may have perpetrated a criminal act, an act which I did not perpetrate. Imagine that said police officer is absolutely certain that the perp (me) has been caught and that said police officer is absolutely mistaken in being absolutely certain.

    Imagine that said police officer has recited a standard form of the Miranda warning, and has ended the recitation with a form of, “Do you understand your rights as they have been read to you?”

    Imagine that I am actually truthful, and, in being actually truthful, say, in response to the final question of the recited Miranda warning which the police officer recited, “No.”

    Imagine that the police officer recites the Miranda warning again, and, again, I say to the police officer, “No.”

    At what stage in my endlessly saying, “No,” to the question, “Do you understand your rights as they have been read to you,” might said police officer decide that I am engaged in some form of unlawful obstruction?

    I do not, and can not, understand anything which I have not already done, for I understand that understanding is of the form of learning which happens through the doing of something.

    Imagine that said police officer arrests me and imagine that I am subsequently a defendant at trial. Imagine that I am called upon to testify in the witness box, and that I am asked, per Wisconsin statute, “In the testimony that you are about to give, do you swear to tell the truth, the whole truth, and nothing but the truth, so help you, God?” or am asked, “In the testimony that you are about to give, do you affirm that you will tell the truth, the whole truth, and nothing but the truth, under penalty of perjury?”

    Imagine that, to either the God version of an oath or the perjury version of an affirmation, I unrelentingly reply, “No.” What chance might I have for a “fair trial”?

    Much of my lifelong (more than 75 years) encounter with human society has “learned” me to recognize that human evolution has more to achieve before human society becomes safe for living humans.

    Perhaps, if human society becomes sufficiently safe for fictitious persons (corporations?), that will be as though a waypoint in the course of human social evolution which makes possible human society becoming safe for living humans?

    As I have a genetic condition now labeled, “attenuated familial adenomatous polyposis,” and my not committing suicide by medical care neglect requires that I sign informed consent agreements to which I do not consent, the entrapment of adversarial law continues to form, in my mind, a truly tragic atrocity.

    Such informed consent as I am capable of having denies to me the right to commit suicide by adversarial law enforcement procedures.

  3. ** on 1, July 12, 2014 at 7:54 am zarathustraSmiles

    This drug, should first be tested on ‘Tea Party’ Rethuglicans…… Just to make sure that it is safe….**

    ZS,

    Among other laws/Common Law you may wish to do a search of what the “Nuremberg Code” is & those already “Hung” after a Fair Trial for acting on your type believe.

    Why? Because the odds are increasing you might just get someone like me as your Judge, Prosecutor or on the Jury at your trial.

    You feel safe posting about violent assaults against humans on the Internet don’t you.

    Some of us feel these type issues are not the place for you type Commie/Nazi beliefs.

    But you just keep eating your GMO foods & taking their toxic vaccines.

  4. Caveat Emptor.

    How did this escape from Science and insinuate itself into Medicine if it is entirely or fractionally without efficacy? This protocol needs fast-track litigation if questions like this exist.

    We presume the doctors are the good guys and that drugs are tested appropriately. It seems self-evident that pharma, the hospital and the doctors would act to keep their malpractice premiums as low as possible. Likely the patient began taking risk when he got out of bed in the morning.

    In church, you put your faith in the hands of God.

    In life, you put your faith in the hands of doctors.

    C’est la vie!

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

    “First, do no harm?” What is that? What’s the inverse?

    Isn’t that intuitive to all but criminals?

  5. anon

    From the above Mayo Clinic link:

    “Cheap and battle-tested, TXA saves civilian lives”

    “Tranexamic acid (TXA) is an anti-fibrinolytic that blocks the action of plasminogen, an enzyme that dissolves blood clots. It has been used for decades to minimize blood loss in planned surgeries, control oral bleeding in people with hemophilia and treat heavy menstrual periods.

    In 2010, a British trial involving more than 20,000 people in 40 countries showed that TXA could also significantly reduce the risk of fatal bleeding events in trauma patients, potentially saving 128,000 lives each year.

    Donald Jenkins, M.D., medical director for the Level I Trauma Center at Saint Marys Hospital, one of Mayo Clinic’s hospitals in Rochester, Minn., says surgeons were skeptical at first.”
    ===========================
    It depends on the jurisdiction that the “Seattle Trauma Center” is under.

    One state does it one way, another state does it another way.

    Same with countries.

    Same with Paul’s Borg Babes.

    States license corporations, doctors, and hospitals.

  6. Annie

    I agree Raff, every attempt should be made to contact the family, but there are cases in which it can’t be done. I can’t see witholding life giving treatment just because there may be an issue with informed consent in being a part of the study, if the protocol is to use the experimental drug. I wouldn’t want mere saline if this Tranexamic Acid has much better outcomes. It’s not like they don’t have plenty of experience with it already. If I had a relative that had an injury and was treated only with saline, while this Tranexamic Acid was available, I would be highly upset, especially of my relative had a bad outcome. I understand that if the experimental drug causes more harm, then it would be upsetting too. A conundrum.
    ============================
    The ifs have it.

    The legal exposure for using an experimental drug without consent ought to be distasteful to a hospital.

    If it is not experimental that is one thing, if it is experimental then a hospital is not using proper risk management to use it without consent.

    It is like non-consensual sex.

    It isn’t like Paul letting down his shields for 7 of 9. 😉

  7. I agree Raff, every attempt should be made to contact the family, but there are cases in which it can’t be done. I can’t see witholding life giving treatment just because there may be an issue with informed consent in being a part of the study, if the protocol is to use the experimental drug. I wouldn’t want mere saline if this Tranexamic Acid has much better outcomes. It’s not like they don’t have plenty of experience with it already. If I had a relative that had an injury and was treated only with saline, while this Tranexamic Acid was available, I would be highly upset, especially of my relative had a bad outcome. I understand that if the experimental drug causes more harm, then it would be upsetting too. A conundrum.

  8. From the above Mayo Clinic link:

    “Cheap and battle-tested, TXA saves civilian lives”

    “Tranexamic acid (TXA) is an anti-fibrinolytic that blocks the action of plasminogen, an enzyme that dissolves blood clots. It has been used for decades to minimize blood loss in planned surgeries, control oral bleeding in people with hemophilia and treat heavy menstrual periods.

    In 2010, a British trial involving more than 20,000 people in 40 countries showed that TXA could also significantly reduce the risk of fatal bleeding events in trauma patients, potentially saving 128,000 lives each year.

    Donald Jenkins, M.D., medical director for the Level I Trauma Center at Saint Marys Hospital, one of Mayo Clinic’s hospitals in Rochester, Minn., says surgeons were skeptical at first.”

  9. i have a question here over 13 yrs ago my father was in the hospital and was to undergo quadruple by pass. Minutes before he was to go into surgery, he was asked if he would consent to being involved in a study that was investigating a new way of doing heart surgery. Instead of opening up the chest, they would go through the side of the torso through small holes. He consented In theory it was supposed to help in healing time and recovery, but in reality it just caused severe scarring which prevented my Dad from having further much needed heart surgery.

    My issue is it is supposed to be informed consent. Going into a a patients room minutes before life risking surgery was to be conducted is plain wrong. My Dad was told he case was so severe he had a 50/50 chance of surviving the surgery. A person’s mind is on his life, family, etc before surgery and it is not in the state to discern and make a sound choice for something like entering a clinical study. I thought it as extremely unfair and plain wrong what they did. Informed consent is being to of the possible benefits and hazards of a trial. It is also learning more about the trial and the drug or surgery that is going to be involved in the study. One needs more than 20 minutes before surgery to give a true informed consent.

  10. Annie,
    I understand that no one carries their Medical POA or Living Will with them, but experimental treatment should never be attempted without permission. I understand the urgency involved, but at the very least attempts should be made to contact next of kin who may have knowledge of the patients wishes. What if the experimental treatment actually harms the person?

  11. The stuff is safe. It is effective for other conditions. Above all do no harm. Yep, meets that criterion. It might be effective. Chemistry says it should be. Why not try it. Can’t hurt, might help.

  12. I don’t get the ethics of withholding a medication you believe works (in fact, you are trying to prove just that). Isn’t there a more humane approach?

  13. Again, what some folks might be missing is that an unconscious brain injured patient is in an emergent situation and no one ( family) is even notified yet. The decision must be made to use the experimental drug immediately. Who carries around their advanced directives or living will with them on a dail basis? I would want the drug used on myself if in an emergent situation and not withheld because of some issue of informed consent, but that’s just me. If one must wait for informed consent in an emergent situation, it could mean the difference in life or death.

  14. Jack

    Just to clear up some confusion:

    As I understand the current protocol, saline (hypertonic saline to be exact) is the standard treatment for TBI. As such, receiving the saline is not the same as; no treatment at all.

    ======================
    Good point.

  15. rafflaw

    The idea of forced testing is scary. I agree that a health care power of attorney or living will directive would be useful in this situation and other serious medical issues. Will the hospitals require a specific mention in the POA of wanting to opt out of any experimental testing?
    =============================
    One would think that as much specificity as possible would be a better way to go for all concerned.

    In a normal world, if they put a consent form on their website, prepared the way their lawyers want it, and we potential patients fill it out, printing a copy for ourselves, then there will be a record of communication and coherence.

    Plus, they will be protected from whatever lawsuits that could ensue from the way it is being done now, and plus the patients will also be happier about it having been done above board.

    Again, then those that have not consented and therefore are not treated with the experimental drug can become a “control group” for comparison purposes.

    Those consenting and being treated with the experimental drug can be compared with those not consenting and not being treated with it.

    If the consenting, treated group does better than the control group, then the drug would seem to be working as designed.

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