Carte Blanche: The Erosion of Medical Consent

Columbia Global Reports

by Harriet A. Washington

“Urgent, alarming, riveting, and essential.” —Ibram X. Kendi

Carte Blanche is the alarming tale of how the right of Americans to say “no” to risky medical research is being violated. Patients' right to give or withhold consent is supposed to be protected by law, but for decades medical research has been conducted on trauma victims—who are disproportionately people of color—without their consent or even their knowledge.

Harriet A. Washington, the author of Medical Apartheid , is again exposing a large-scale violation of patient, civil, and human rights. She reveals that the abuse first began in the In 1990, the Department of Defense forced an experimental anthrax vaccine on ground troops headed for the Persian Gulf. After a 1996 loophole to federal law permitted research to be conducted even on private citizens, particularly trauma patients, the military has pressed ahead to impose nonconsensual testing of the dangerous and sometimes lethal blood substitute PolyHeme among civilians, quietly using it on more than 20,000 non-consenting victims. Since then, more than a dozen studies have used the 1996 loophole to give risky and potentially deadly drugs to patients without their knowledge, especially people of color, many of whom were already justifiably distrustful of racial bias in medicine. Carte Blanche is an exposé of a U.S. medical-research system that has proven again and again that it cannot be trusted.

Genres: Medicine, Nonfiction, History, Science, Audiobook, Politics, Government

150 pages, Paperback

First published February 23, 2021

About the author

Harriet Washington is the author of Deadly Monopolies: The Shocking Corporate Takeover of Life Itself and of Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present, which won the 2007 National Book Critics’ Circle Award and was named one of the year’s Best Books by Publishers’ Weekly. She has won many other awards for her work on medicine and ethics and has been a Research Fellow in Ethics at Harvard Medical School, a fellow at the Harvard School of Public Health, a Knight Fellow at Stanford University, a senior research scholar at the National Center for Bioethics at Tuskegee University and a Visiting Scholar at the DePaul University College of Law.

Reviews

[Dan · Rating 3 out of 5]

Washington effectively illustrates how medical research routinely violates the principle of informed consent and how it is generally the most vulnerable groups to find themselves subject to being involuntarily experimented on, sometimes with grisly results. Washington illustrates how soldiers, people who live in underdeveloped countries, prisoners, and people who live in poor urban largely non-white neighborhoods are targets for research that one way or another skirts the requirements of consent. She makes brilliant points about how language has been weaponized to blur the understanding of what medics experimentation is and purposely conflate the concepts of experimentation with treatment. The purpose of treatment is the focus on healing an individual patient, the purpose of experimentation is to discover if a given treatment is safe, effective, and better than previous standard of care. Calling experimental subjects things like "patients" implies that what happens has the goal of healing the subject rather than finding out if something works. This short book is crammed with examples of not just studies that fail the standard of informed consent, but also feature other ethical lapses- financial conflicts of interest, failure to stop experiments promptly when treatments cause harm, and IRBs that are at best asleep at the switch but as often as not themselves have conflicts of interest.

Washington does prove her thesis, but the execution here feels a bit slap dash. First off, I think I take issue with the idea that she's describing an "erosion" of consent here. Given the history of medical experimentation it really feels like there was never a point when informed consent was universally practiced so much as that as this idea became more and more problematic a flimsy scaffolding of artiface was built to make experimentation without consent appear ethical with new concepts like "community consent" and "deferred consent" which are not really consent at all. Beyond a few typos, I also found at times there were moments that begged further illucidation that might have been cut out for the purpose of brevity but felt like they were purposefully vague or misleading. In the chapter on the anthrax vaccine, she used an excerpt from leaked government documents that the military contested were fake and touted that an independent analysis concluded that said documents "cannot be summarily dismissed as fraudulent" as apparent proof that they were genuine. In the chapter on PolyHeme, she describes a variety of morbid outcomes that a patient had after receiving the blood substitute PolyHeme, but it was not clear to me that these outcomes had nothing to do with the violent trauma that the patient initially suffered that put them in the position of needing blood in the first place. In the ketamine chapter, she describes ketamine as a "powerfully addictive street drug," which strikes me as a loaded and imprecise phrase, especially given that it isn't sourced or noted in any way. None of this fundamentally undermines any of her points Washington makes about consent in medical experimentation. Her conclusive chapter on reforming consent processes and experimentation structures is clear and brilliant and shows that she does not only have a good idea of the problems, but best ideas on how to act right now and solve them.

[Quanita · Rating 5 out of 5]

I was introduced to this author on the C-SPAN "In Depth" program. In this time it is hard to believe how people can be subjected to experimemtal medical procedures and drugs without their consent, but it is happening. This is a real eye opener.

[Erin · Rating 5 out of 5]

This is essential reading for anyone working, volunteering, or interested in healthcare. Social justice advocates, scientists, students of history, politicians, leaders of higher education and research institutions, human rights watchers and government critics will also make good use of the information and recommendations within. I’d consider it required undergrad reading.


Thanks to Common Ground Health, Rochester, NY, for the gift of this book.

[Kat · Rating 4 out of 5]

Erudite, persuasive, and authoritative, Dr. Washington educates us about the gradual erosion of the concept of informed consent in several spheres of modern life, including more recent examples such as triage and the rationing of resources during COVID-19. This is a very thought-provoking work, especially for anyone who has worked in research and consented subjects. It made me reexamine the nuanced and veiled nature of the language we use in research, and somewhat uncomfortably brought to fore the reality that I have likely encouraged therapeutic misconception when talking to my patients about clinical research. Is this avoidable or inevitable? Dr. Washington suggests that perhaps we should employ third-parties to secure consent from patients we want to enroll in studies, in order to minimize conflicts of interest. Fascinating field of study here. Highly recommended read for anyone even remotely adjacent to the research world.

[Rebecca · Rating 5 out of 5]

In this short book, Washington gives readers a timely and expansive look at how (and why) the medical research community has undermined public trust, particularly the trust of marginalized communities who are disproportionately subjected to this research. The final chapter lays out concrete solutions for addressing this issue by reforming the process for reviewing proposed experiments, and for preparing participants to give truly informed consent. Essential reading for researchers, healthcare workers, and anyone committed to social justice or their own rights.

[Christopher · Rating 4 out of 5]

Invaluable but quite repetitive, which shouldn't be the case for such a short book.

[Matt · Rating 2 out of 5]

First off, Washington retreads a lot of her same arguments from Medical Apartheid so if you’ve read that recently, this’ll be an even faster read.
I was disappointed by that, especially because she seems not to have added any new info and just repeats the same talking points. One of the things I left Medical Apartheid wondering was, “Is there any new Info in these cars she cites?”

Anyway, as much as I appreciate the work she has done and even agree with some of her points, at the end of the day, this book is a jumbled mess. The author compares studies from the early 1900’s to present day trials, without acknowledging the massive change of society or the institutions. She cherry picks facts and laments over and over how no one will call her back for an interview. The one person she does interview, the framing of it left a bad taste in my mouth as the way she writes it, you half expect it to end with her saying, “And then everyone clapped. Oh, and that person I corrected? Albert Einstein.”

Hatchi matchi. I work in research, I see and agree with a lot of the lapses she identifies, but it feels as if every medical person or institution in this book has 100% malicious motives, and every former research subject interviewed has been victimized and forever scarred, solely by the exploitation of these researchers.

I really hope I get to see the author speak someday, and I hope she sounds less sanctimonious then she reads. I dunno. There’s also the fact that she clearly has no
Medical training and only views these problems through the sterile lens of a bystander. Her ignorance of the day to day medical system hinders her making points about the changes that should take place because they come across as hyperbolic and conspiratorial.

I’m not saying she’s wrong. I’m just saying, she assumes a greater depth of knowledge about the realities of clinical research than her writing evidences.

[Lisa · Rating 5 out of 5]

Eye-Opening AF

From the author who brought us Medical Apartheid, we now have a second book that is just as alarming as the first, but maybe even worse considering we're all at risk—even today, in 2021.

Here's the deal: You could be used in medical research and you would never be the wiser.

But no, you say...They can't do anything without my consent, right?

Wrong. In 1996 there were addenda added to the Code of Federal Regulations that enabled researchers to bypass your consent. In other words, you can't just say no.

I'm glad author Harriet Washington is watching out for us. She may be the only one. And I'm not sure there's a way to protect yourself and your family from this—even if you ARE aware of the laws. The book is a quick read—only a little more than 150 pages. Highly recommend.

[Amanda · Rating 4 out of 5]

There is a fascinating selection of examples here that I hadn’t considered when starting. I thought government mandated vaccinations would be the main part of this, but was I thankfully wrong. Forced army vaccinations, racial sterilisations, blood transfusion experiments on civilians, drug experiments on civilians suffering mental health crises - all without proper medical consent.

- [ ] “President Bill Clinton signed Presidential Executive Order 13139 that allows the DOD to experiment on service personnel without their consent or knowledge, if deemed in the interest of national security.”
- [ ] “Since 1996, being forced to participate in medical research has been permitted under the Federal Code of Regulations statute CFR 21 50.23-4, provided certain conditions are met. One of those conditions is that the prospective subject must be a trauma victim.”

[Kathy · Rating 2 out of 5]

Quotable:

Informed consent is much more than a piece of paper. 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.

In December 2017, the science-challenged Trump administration banned seven terms from official use by Centers for Disease Control and Prevention officials: vulnerable, entitlement, diversity, transgender, fetus, evidence-based, and science-based.

[Javon Maye · Rating 5 out of 5]

"Carte Blanche" offers a poignant exploration of systemic racism from various perspectives, including those of poor whites, Blacks, the disabled, and military personnel. Harriet Washington's incisive analysis exposes how white privilege perpetuates inequality and injustice across society, shedding light on the shared struggles and intersectional dynamics that bind marginalized groups together. Her work underscores the urgent need for systemic reforms to ensure fairness and justice for all.

[April A · Rating 4 out of 5]

Important topic, mostly well-written, however it seems like Washington's medical knowledge limitations make her unaware of some things that actually are best practice (or known at the time) and what isn't eceptional or gotcha at some times. Takes away some of her authority on the topic, which is frustrating because she's so well written.

[Lisa · Rating 5 out of 5]

How much do any of us know about what we are consenting too? I feel a huge impetus to inprpve consenting in my research. It was there before - but O feel almost guilty going into a field with so much contreversy.

[Alex · Rating 5 out of 5]

Definitely a must read for anyone in the healthcare field but also easily readable by laypeople. The author does a great job of pretty seamlessly explaining medical jargon and the research studies she uses as examples. (also there's a glossory in the back)

[Turnlung · Rating 4 out of 5]

Short and important.

[Gaby García · Rating 5 out of 5]

Eye opening and soooo well-written. It was easily digestible, and some parts were hard to read through, but absolutely necessary for all to read.

[Janus Chow · Rating 3 out of 5]

It's an important (and worrisome) topic but it's so dry. Think CSPAN

[Rae]

Anthrax vaccine. Ketamine. Deception. Military. Maddening.

[Sharon Knightley · Rating 5 out of 5]

For such a slim book this is some heavy reading, especially when one of the examples given happened just down the road from where I live. Harriet Washington clearly and terrifyingly explains in detail the current medical experiments that have occurred (and continue to occur) to unsuspecting people.