The Washington PostDemocracy Dies in Darkness

A bioethicist warns that informed consent is endangered

A technician at Northfield Laboratories in Evanston, Ill., holds two bags filled with PolyHeme in 2004. The company’s clinical trial of the blood substitute drew criticism for operating under an exemption from informed-consent requirements. (AP Photo/M. Spencer Green)

Michael Hickson, a father of five living in Texas, was one of millions of Americans who contracted covid-19 in 2020. The 46-year-old African American, who had become a quadriplegic after having a heart attack while driving in 2017, died in June at St. David’s South Austin Medical Center, six days after the hospital ended treatment for him. Before his death, Michael’s wife, Melissa, met with his attending physician, who she says decided against the further treatment she had requested because he had no “quality” of life.

As Harriet A. Washington writes in her new book, “Carte Blanche: The Erosion of Medical Consent,” Hickson’s story speaks to some of the urgent legal and societal issues of medical ethics. Among these is the decision to withhold treatment, one of the key ways in which Washington sees the imperative of informed consent slipping away. As she writes, “Withholding care from those deemed to have a poor quality of life or those for whom treatment is assumed to be futile, the policies rob patients of their right to consent.” Such issues have become unavoidable during the coronavirus pandemic, but they play out against a background of related medical ethics questions that Washington ably considers.

Throughout “Carte Blanche,” which focuses primarily on experimental research, Washington explores issues such as whether patients in nursing homes are adequately informed of the risks, and how nonconsensual medical testing has long disproportionately targeted African Americans, soldiers and the incarcerated. Washington’s thesis is that medical consent is generally breaking down and that this crisis is exacerbated in the realm of experimental research by the fact that many Americans have only a vague understanding of consent, thinking it revolves primarily around signing a legal document to the affirmative. It is much more than that, she says. “Informed consent helps to enforce ethical principles of autonomy, beneficence and justice, and the signed form is only one piece of evidence buttressing a researcher’s claim that she has explained everything a subject reasonably needs to know in order to make the best decision about whether he wants to participate.”

Washington, the author of works such as “Medical Apartheid” (2006), which focused on the history of medical experimentation on Black Americans, draws on her earlier research, as well as media reports and historical cases both largely unknown and notorious. She discusses the Nuremberg Code, the set of ethical guidelines for human research produced in the aftermath of Nazi-era experimentation, and the Tuskegee study, which ran from 1932 to 1972 and withheld treatment for 600 Black men diagnosed with syphilis who thought they were receiving care. As Washington shows, it’s a history that exemplifies the many ways African Americans, Jews and other marginalized groups have been subjected to abusive research experiments — often without their knowledge or consent.

A medical ethicist who lectures in bioethics at Columbia University, Washington also shares more recent stories of individuals and their families who found themselves within the gradations of what it means to “consent” to medical treatment or an experimental study. She finds that some were unable to consent because of their conditions. She cites others, such as those in the military, who received experimental drugs after being coerced or threatened with reprisal if they did not consent. Some were simply deceived into consenting. A disproportionate number of people in these scenarios were African American.

Taken in isolation, each of these examples is deeply disturbing. In aggregate, they lay bare systemic failures that effectively rob vulnerable individuals of their agency and expose them to potential harm. That has, as Washington shows in the opening chapters of her book, become especially clear during the coronavirus pandemic. The quest to care for the surge of infected patients, especially in nursing homes but also in hospitals where resources have been stretched thin, has placed in stark relief related decisions surrounding informed consent and care.

Washington looks at the case of a Texas nursing home doctor who reportedly gave hydroxychloroquine to dozens of patients in April 2020, shortly after the U.S. Food and Drug Administration gave the anti-malarial drug an emergency-use authorization to treat covid-19, despite the paucity of supporting data. Some of those patients suffered from dementia, which made them unable to offer informed consent. Washington points out that the physician also did not elicit informed consent from some designated family members. Acknowledging the crisis clinicians faced in such environments, Washington writes, “The staggeringly high rates of coronavirus infection in nursing homes filled with susceptible elderly certainly constitutes an emergency, but it does not present an excuse for abandoning ethical behavior, especially when caring for the powerless who cannot effectively express their own opinions about their medical fate nor advocate for themselves.”

Washington also discusses examples of patients who were unknowingly pulled into medical trials while receiving treatment. In 2006, Martha Milete was shot in the chest by burglars in her Detroit home. Bleeding heavily, she was given an artificial blood cell substitute called PolyHeme, made by Northfield Laboratories, while en route to the hospital in an ambulance. Like more than 700 others around the country, she had been enrolled — unwittingly and without consent — in a Phase 3 clinical trial on PolyHeme use for victims of traumatic injury from 2003 to 2006. That study drew widespread criticism because it operated under decade-old regulations allowing clinical emergency research under an exception from informed-consent requirements.

At the hospital, Milete remembers people who were not part of her medical team repeatedly drawing her blood. Outraged when she learned they were researchers, she ordered them to stop. Washington asked her if anyone from the hospital or research team had told her she had been enrolled in the experiment. Milete replied: “No, my daughter told me. The medical staff never told me. . . . There was a coordinator who kept telling nurses to ‘take more blood, take more blood.’ She was in cahoots with the research people.”

PolyHeme, Washington says, “provided an example of how a study could be legal yet unethical.” As she points out, that research also had a troubling racial dimension, one that resonates throughout much of the book: Thirteen of the cities that ultimately completed the PolyHeme trial, or 65 percent, had Black populations considerably higher than the national African American representation of 13 percent, and some had disproportionately high Hispanic populations as well.

“Carte Blanche” is particularly bracing when it highlights such racial disparities, and even more so when weaving together decades-old stories with topical ones from today. The echoes of the past reinforce the grave need to stop what Washington views as the creeping erosion of consent. Laypeople, in particular, will find the book a tight and informative historical overview of the ways informed consent has been evaded, but they may also be heartened by the systemic reforms Washington says are needed to restore its central place in American medical research and care.

She advocates, for example, for resolving financial conflicts of interest within institutional review boards, which monitor biomedical research involving human subjects, and for the formal education of medical research subjects through coursework. Washington says eschewing “newspeak” is also vital, noting, “The honest sharing of information and debate concerning human medical experimentation that must inform any decision about consent is rendered impossible by the corruption of the language and semiotics adopted by researchers, their institutions, and by too many ethical experts.” In this regard, especially, her book is a welcome step in the right direction.

Carte Blanche

The Erosion
of Medical Consent

By Harriet A. Washington

Columbia Global Reports

184 pp. $15.99