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. Doc: “As Annie stated,

    If you don’t want it, better have some legal docs, something specific like end of life, will request or a POA. Who wants a Robo Cop rebuild?”

    Why should the burden be on the patient? We’ve gotten along just fine with ‘informed consent’ and I for one don’t see any reason to change. George Annas had the right idea: ““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.” If you want to do such a study, fine, but do the study on people who have to option to ‘just say no”.to me seems to be ethically wrong.

  2. Military Use of Non-FDA-Approved Drugs in Combat

    What is the difference between “research” and “treatment”? Can informed consent be waived? If so, under what circumstances, and who has the authority to grant waivers?
    Consider well-known arguments for the conclusion that military organizations should not be entitled to use experimental drugs on troops without first obtaining the informed consent of those troops.

    I was in boot camp at Ft. Dix NJ. Winter. A swine flu outbreak killed 8 trainees. We marched to an area, lined up, and were shot in the arm with a gun. Yeah, I got sick.
    Lost weight, about 155 lbs to 100lbs. Started to recover in Ft. Gordon Ga. Still in training, ASA.

    I don’t take any flu shots today. But I could eat the spit of someone who is infected, and not get sick. What was in that Army multi shot?

  3. What are the side effects? Usually a drug commercial on tv has this whole slew of statements: dont take demerol if….

  4. 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.

    What I would be most interested in are the potential risks vs. benefits. For example; If tranexamic acid provides no known significant additional risks, but may not produce better expected outcomes, logic dictates that there would no good reason to deviate from currently established protocol. (If it ain’t broken, don’t fix it.)

    The purpose of this kind of testing is to see if tranexamic acid can provide better short-term and long-term outcomes. If it does not…no reason to change the protocol. However, if it does result in better long-term prognosis, it should be adopted.

    Maybe the best way to explain this would be to say that both saline and tranexamic acid are suitable treatments for TBI. In fact, tranexamic acid MIGHT be better, but not worse. The only way to know more about it is to do some testing.

  5. 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?

  6. Darren,

    COMMENT EATEN.

    I assume it will be retrieved as you always do, so I will not repeat it.

    My comment that was published above mentioned that consent is becoming a dinosaur in many venues.

    I offer this as one brazen example (Helpless Children Without Counsel).

    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.” – Darren

    If the hospital knew in advance that drugs were to be used in experiments, couldn’t it have made that public and asked the state to help, or allow citizens to place a consent form in their wallet, purse, or perhaps an online sign up page?

    Then any treatment of those who consented could be treated with the drug as needed.

    Then the results could be compared with those who did not or could not give consent for results.

    There would, then, be a control group to compare results with those who were treated with the drug and those who were not.

    If the drug proves valid and helpful, start spreading the news and more and more people will consent.

  7. Is this really news?
    Of course unconscious brain trauma patients are going to be treated without their express consent.
    And as to using new drugs for these injuries, on whom else would you use them?
    Seems like a bunch of unremarkable sequiturs.

  8. Betty,

    Not sure, but it’s use is part of NATO (US, UK, Australia) in a combat operation.

    FYI, Medical Journal of Australia has an in depth write up on TXA.

    As Annie stated,

    If you don’t want it, better have some legal docs, something specific like end of life, will request or a POA. Who wants a Robo Cop rebuild?

  9. They always give the okay to experiment on the helpless who cannot speak for themselves.
    Opt-out?! FU! Give me the incentive and option to opt-in with info placed onto drivers license.

  10. When someone is incapacitated they cannot give their consent.

    Perhaps a statement on a drivers license, like for organ doners, would be a way to provide consent.

    And/or their doctor could place a consent notice in their file.

  11. Did the patients in the Afghanistan trial give informed consent? Did they have the option?

  12. I’d want to make sure that as Randjet suggested, that there wouldn’t be those patients who would receive the saline without their permission instead of the drug. If this drug is being used as protocol for TBI treatment anyway, why not learn something? All sorts of decisions are made to save an unconscious patient’s life until a healthcare power of attorney/next of kin is contacted and involved in decision making. Some of those treatment decisions are a matter of life and death and must be made immediately. I am curious to know if it will be used on all TBI or on just some coming into the ER.

  13. While at first blush this study may seem appropriate under the extreme circumstances of the patients, it most assuredly is not. The fact that this drug is already in use in the UK with good results means that patients who are given saline solution will not be given any treatment at all and thus will most assuredly suffer injury. The statement is made in support of no consent that there are no treatments for “some emergency” conditions. Hospitals do take steps to stop bleeding when patients arrive with TBI with the no consent study it would appear that the patients on saline will receive no treatment. This is unacceptable.

    I hate to be cynical here but I am. Allowing no consent drug trials in this instance will began more erosion in the rights of patients in hospital settings. Patient care and safety is often sacrificed for money and convenience. In this case I fear the benefits of being a test facility including but not limited to the money involved may be the driving force here as it is in other drug trial scenarios.

  14. Doctors and Lawyers…..Before we dive into the legal consent part…TXA has a history….The UK has been using TXA since 2010!

    Military Application of Tranexamic Acid in Trauma Emergency Resuscitation (MATTERs) Study.

    OBJECTIVES:
    To characterize contemporary use of tranexamic acid (TXA) in combat injury and to assess the effect of its administration on total blood product use, thromboembolic complications, and mortality.

    DESIGN:
    Retrospective observational study comparing TXA administration with no TXA in patients receiving at least 1 unit of packed red blood cells. A subgroup of patients receiving massive transfusion
    (≥10 units of packed red blood cells) was also examined. Univariate and multivariate regression analyses were used to identify parameters associated with survival. Kaplan-Meier life tables were used to report survival.

    SETTING:
    A Role 3 Echelon surgical hospital in southern Afghanistan.

    PATIENTS:
    A total of 896 consecutive admissions with combat injury, of which 293 received TXA, were identified from prospectively collected UK and US trauma registries.

    MAIN OUTCOME MEASURES:
    Mortality at 24 hours, 48 hours, and 30 days as well as the influence of TXA administration on postoperative coagulopathy and the rate of thromboembolic complications.

    RESULTS:
    The TXA group had lower unadjusted mortality than the no-TXA group (17.4% vs 23.9%, respectively; P = .03) despite being more severely injured (mean [SD] Injury Severity Score,
    25.2 [16.6] vs 22.5 [18.5], respectively; P < .001). This benefit was greatest in the group of patients who received massive transfusion (14.4% vs 28.1%, respectively; P = .004), where
    TXA was also independently associated with survival (odds ratio = 7.228; 95% CI, 3.016-17.322) and less coagulopathy (P = .003).

    CONCLUSIONS:
    The use of TXA with blood component-based resuscitation following combat injury results in improved measures of coagulopathy and survival, a benefit that is most prominent in
    patients requiring massive transfusion. Treatment with TXA should be implemented into clinical practice as part of a resuscitation strategy following severe wartime injury and hemorrhage.

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

  16. My only objection would be to getting the saline solution instead of the experimental drug’s use. If I have a TBI, the chances of my surviving without death or impairment is rather slim. In other cases, I would object to doing this without consent, but this is rather extreme, and should be given some latitude.

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