Experimental Overreach

Why doctors and researchers must ask for consent

Army Spc. Angel Laureano holds a vial of the COVID-19 vaccine at Walter Reed National Military Medical Center (Department of Defense/Lisa Ferdinando)
Army Spc. Angel Laureano holds a vial of the COVID-19 vaccine at Walter Reed National Military Medical Center (Department of Defense/Lisa Ferdinando)

In her award-winning 2007 book, Medical Apartheid, and other highly regarded works, Harriet A. Washington highlights the ethical shortcomings of American policy on medicine and health—especially the many ways that medicine both enforces suffering on Black Americans and reinforces the concept of racial difference. Her new book, Carte Blanche: The Erosion of Medical Consent, takes on the question of ethics directly.

Philip Alcabes: More than 70 years have passed since the Nuremberg Code, almost 50 since the unmasking of the Tuskegee study. Isn’t informed consent a settled issue at this point? In Carte Blanche, you write about “exception from informed consent” (EFIC) studies. If informed consent is regarded as indispensable, what basis is there for any exception?

Harriet A. Washington: Most Americans, and a fair number of practicing physicians, think that informed consent is indeed an inalienable component of medical research, guaranteed to subjects in the United States. It certainly should be. U.S. doctors and lawyers confronted the Nazi architects of the Holocaust in the Nuremberg Doctors Trial of 1947. The trial took place under the auspices of the U.S. Army; the accused were German physicians who had medically abused and killed captive subjects who were never told what was to be done to them and of course never gave consent. The Americans devised the Nuremberg Code during the trial to ensure that murder and genocide thinly disguised as medical research would never happen again. The code’s first tenet reads, “The voluntary consent of the subject is absolutely essential.”

Despite the lip service paid to it, the Nuremberg Code was set aside almost immediately, in favor of the less restrictive guidance of the World Medical Association Code of Medical Ethics. The late physician and medical ethicist Jay Katz, of Yale University, mused that American scientists saw the Nuremberg Code as “a good guide for Nazi barbarians but unnecessary for more ethical U.S. researchers.” The centuries of abusive nonconsensual research, especially on African Americans, that had gone on before the Nazis thus continued after the code was devised.

As you say, the book has many examples of EFIC studies, such as soldiers forced into the risky testing of malaria medications and the U.S. Atomic Energy Commission injecting unsuspecting hospital patients with the fiendishly toxic and radioactive element plutonium. After the dramatic abuses of the Tuskegee syphilis study and deadly forcible prison research, laws guaranteed Americans informed consent, at least on paper. But researchers bypassed eliciting subjects’ consent by obtaining waivers of informed consent for studies on a case-by-case basis. Then a 1996 law was passed that provided a waiver for certain types of medical research said to carry only “minimal risk.” Such studies are exempted from consent requirements—so studies such as those where the potent drug ketamine is administered without subjects’ permission are allowed, despite the fact that subjects given ketamine often lose their ability to breathe and wake up in the hospital the next day on a ventilator.

In Carte Blanche, I go into some detail on studies that exploit another 1996 change in the Federal Code of Regulations: withholding informed consent from unconscious trauma victims. The researchers justify this on the premise that something must be done urgently to treat them. This is a less than compelling rationale because it conflates treatment, which has been proven effective and safe, with experimentation using unproven modalities that may be neither. Also, the subject is denied not just elaborate informed consent but also any form of consent, even being able simply to say “yes” or “no” to research.

This approach is an ethical error. If a person (or her legally appointed representative) cannot give consent, she should be treated with duly tested standard care as if there were no experiment to worry about.

PA: Reading Carte Blanche, I found myself surprised at how frequently military personnel are special subjects of EFIC research. Is what you call “investigational servitude” supposed to be part of national service?

HAW: Military urgency lowers resistance to nonconsensual studies. The rules allow our military to maintain its ability to protect American interests and fight our enemies, of course. On this basis, the military has the power to force soldiers to take FDA-approved medication to maintain their fitness for battle. But since the 1950s, the Department of Defense has also enjoyed immunity from prosecution for inducing medical and surgical injuries, even if those injuries were caused by medical negligence. This lack of accountability encouraged a cultural climate wherein soldiers were also forced into risky research such as testing radiation’s effects and testing malaria drugs.

The Department of Defense has also used its mammoth budget and its influence within the FDA to encourage and fund research studies with civilians for products that would benefit soldiers—like the artificial blood substitutes it hoped would prolong the lives of soldiers and pilots injured hours or days away from the nearest hospital. The military partnered with the companies that manufactured these products, participated in secret meetings with the FDA, and had military doctors help design the trials and then tout their virtues in medical journals and in The New York Times .

PA: Nowadays, many health professionals say that the Tuskegee study explains why Black Americans might mistrust the medical apparatus. Accordingly, they go to great lengths to reassure Black people that it’s now okay to come for diagnosis and treatment, okay to get the coronavirus vaccine, even okay to enroll in a research protocol. You don’t seem to agree fully.

HAW: History and objective research tell us something very different. The constant invocation of the U.S. Public Health Service’s study of syphilis at Tuskegee to explain African-American wariness of the healthcare system is worse than erroneous: it is intellectually lazy. Tuskegee is invoked because most people are unaware of the scores of abusive research studies over four centuries of U.S. history, as I documented in Medical Apartheid. These took place in every area of American medicine, from bloodily invasive antebellum human experimentation to racialized anatomical appropriation, to genetics, intelligence, surgery, and radiation studies, to infectious disease research, to research on children.

Instead of accurately citing four centuries of racialized medical abuse, commentators have made Tuskegee an overburdened icon, suggesting that Black Americans are overreacting to a single study rather than to consistent abuse in the U.S. healthcare system. In fact, Professor Thomas LaVeist published several papers documenting that this long history, not Tuskegee, lies at the heart of African-American medical distrust. In LaVeist’s work, Black subjects who had never heard of Tuskegee were more likely to distrust the medical-research system than those who knew about Tuskegee.

Questioning African-American behavior is a mistake. It’s a subtle form of blaming the victim. To know why Black Americans are largely disconnected from today’s healthcare system, you have to scrutinize the system itself. We know that Black Americans are less likely than whites to have a personal physician or health insurance. Rampant bias that separates Black patients from care has also been documented, including a 2016 University of Virginia study showing that half of medical students surveyed, and a good proportion of practicing physicians, believe that Blacks’ bodies are different from whites’ and that Black people feel less pain than whites. The fact that physicians are less likely to listen to and empathize with Black patients, are likely to dismiss Black patients in pain as drug-seeking and send them away untreated, and to subject them to a variety of implicit/explicit biases that result in substandard care suggests how the untrustworthiness of the American healthcare system is the villain, not the fear of Tuskegee.

The claim that African Americans would fail to engage in Covid-19 vaccine trials because of Tuskegee was, simply, a fiction. Ten percent of those enrolled in both the Moderna and Pfizer-BioNTech trials were Black, nearly mirroring the proportion in the population (about 12 percent): a very respectable showing.

PA: I used to teach a course on the policies related to organ transplantation. The students really liked the policy in Spain and some other European nations, wherein you are considered a potential organ donor unless you explicitly opt out. That way, kidneys and so forth are automatically available should someone die suddenly in a car crash. Are you with my students on this?

HAW: No, I’m afraid not. I see it as another aspect of medicine that catalyzes today’s assault on informed consent: so-called presumed consent. In some European countries, such as Spain and Greece, organ “donors” cannot withhold permission to retrieve their organs after death. One still needs to procure permission for drug testing and much research, but involuntary collection reigns for organ donation on this presumed-consent basis. If you are brain-dead or dead, your organs will be collected and distributed without your consent. Some European countries provide legal routes for opting out by you or your survivors if you express a refusal to donate, but others do not.

What those who urge the United States to adopt such schemes fail to appreciate is that they seldom travel well. Spain, for example, maintains ambulances whose role is not to speed to the ailing and save their lives, but solely to retrieve viable organs immediately from those declared dead at the scene. But when New York City attempted to pioneer a similar program around 2008—the “organ recovery ambulance” under the Rapid Organ Recovery service—widespread outrage ensued, and the program never got off the ground.

Presumed consent advocates point to the insufficiency of organs freed up by voluntary donation and insist that involuntary donation—presumed consent—will free up much-needed organs and save lives. I analyze this claim in Carte Blanche and find it wanting in a number of ways. One example: their arguments cling to the illogical nomenclature of “donors” and “donation”—veiling the fact that you aren’t a donor if you are not voluntarily giving something to someone. Advocates also insist that no major religions proscribe organ transplantation. They seemingly are comfortable violating proscriptions by “minor” or unrecognized religions—and overriding firmly held individual beliefs that may not rely upon the precepts of organized religion.

Moreover, presumed consent alone doesn’t drive the variation in organ donation rates. I explain the reasons in the book, but in general you can see how infrastructure, organizational schemes, wealth, investment in healthcare, availability of donors, and public attitudes all play potent roles. A 2009 report by the UK’s Technology Assessment Programme concludes that it “cannot be inferred … that the introduction of presumed consent legislation per se leads to an increase in donation rates.”

PA: Do people really need to give consent if the situation is dire—for instance if they are sick with Covid or if they are living in a place where disease is common and death comes early, as in many of the poorest parts of the world? Could physicians argue that they have an entitlement, even an obligation, to forgo consent and do what seems best?

HAW: Consent is a bit more nuanced in clinical medical care, where doctors can sometimes make a good case for treating a patient without eliciting formal consent. In general, informed consent is required for treatment and for dissemination of patient information, but in a situation where a patient faces illness or death, yet is unable to communicate his wishes, a doctor can justify dispensing with informed consent when it is reasonable to infer or assume that the patient would want to be treated. Here’s an example: it’s reasonable to assume that an injured man who walks into an emergency room but faints before he can ask for help has come there because he wishes to be treated. Likewise, a woman who collapses on the street would probably want a nearby physician to treat her. But we shouldn’t make the same assumption that the fainting woman would welcome the attentions of a bystander who sprinkles herbs or snake oil on her to see if that would help her recover. The latter is experimentation with an unapproved approach, not approved treatment, and we can’t logically assume that she would consent to that.

What about people who urgently need care, but only an experimental treatment is available? Many argue that unconscious people in dire straits can’t give informed consent. Something indeed must be done to treat the patients, but the answer is not to test an untried approach on their bodies without their permission.

Moreover, there’s no provision in the law or policy to ensure that a trauma victim is indeed unconscious and cannot give consent: this is simply assumed, without evidence. In Carte Blanche, I write of how unwitting research subject Martha Milete woke up in the ambulance to see attendants infusing her with the experimental blood substitute PolyHeme.

Nomenclature is also important: people in research studies are subjects, not patients. Unlike with the treatment of patients, who can expect that their health and wellness are the goals of medical attention, maximizing the health of any one research subject is not the goal of medical experimentation. Successful completion of the study is the goal and the experimental modality (which is not an approved “treatment”) is not tailored to the subjects’ health needs.

The only ethical course is to treat unconscious and/or injured patients with the approved standard of care, as in the fainting-woman example, but not to use experimental treatments without consent.

PA: What about those places where disease is common and death comes early, as in many of the poorest parts of the world? Could physicians there argue that they have an entitlement, even an obligation, to forgo consent and do what seems best?

HAW: Living in an area where colonial disruption and the resulting poverty and internecine warfare separate people from healthcare does not give Western doctors and research institutions ethical license to subject people to involuntary research. Doing so is unethical. It is not driven purely by concern for the residents’ health status.

In my research I’ve found that as much as 90 percent of medical research by Westerners is now conducted in African countries, Brazil, Thailand, or in other parts of the developing world. Why? Because high-quality research can be concluded much more quickly and cheaply there. The proffered rationale is that non-Westerners’ disease rates are higher and they will benefit disproportionately if the testing shows a drug being studied to be safe and effective.

But the testing may also reveal the drug to be ineffective, to evoke dangerous adverse effects, or even be fatal. That has happened, as I write about in the book. And even when a drug proves to be safe and effective, it is typically priced out of reach of the people on whom it was tested.

This means that the risks of the research are borne by people in the global South but any benefits accrue to people in the wealthy world. It belies claims of beneficence that are meant to validate the involuntary testing of drugs and biologicals abroad. This violates distributive justice.

Permission required for reprinting, reproducing, or other uses.

Philip Alcabes trained as an infectious-disease epidemiologist and has been writing about health and illness for the Scholar since 2004. He is a professor of public health at Hunter College of the City University of New York. He is the author of Dread: How Fear and Fantasy Have Fueled Epidemics from the Black Death to Avian Flu, a history of epidemics as social phenomena.


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