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

By Darren Smith, Weekend Contributor

Patients 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.

In 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.

But 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)

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