When bioethicists want to justify their own existence, they routinely point to the infamous Tuskegee Syphilis Study. It’s a gripping story. Back in 1932, the U.S. Public Health Service started a study of 399 black men with latent syphilis, plus a control group of 201 black men without syphilis. Contrary to what I’ve sometimes heard, the researchers never injected anyone with syphilis. However, they grossly violated the principle of informed consent, with disastrous consequences:
As an incentive for participation in the study, the men were promised free medical care, but were deceived by the PHS, who never informed subjects of their diagnosis and disguised placebos, ineffective methods, and diagnostic procedures as treatment.
The men were initially told that the “study” was only going to last six months, but it was extended to 40 years. After funding for treatment was lost, the study was continued without informing the men that they would never be treated. None of the infected men were treated with penicillin despite the fact that by 1947, the antibiotic was widely available and had become the standard treatment for syphilis.
Why do bioethicists habitually invoke the Tuskegee experiment? To justify current Human Subjects Review. Which is bizarre, because Human Subjects Review applies to a vast range of obviously innocuous activities. Under current rules, you need approval from Human Subjects merely to conduct a survey – i.e., to talk to a bunch of people and record their answers.
The rationale, presumably, is: “You should only conduct research on human beings if they give you informed consent. And we shouldn’t let researchers decide for themselves if informed consent has been given. Only bioethicists (and their well-trained minions) can make that call.”
On reflection, this just pushes the issue back a step. Researchers aren’t allowed to decide if their human experiment requires informed consent. However, they are allowed to decide if what they’re doing counts as an experiment. No one submits a formal request to their Human Subjects Review Board before emailing other researchers questions about their work. No professor submits a formal request to their Human Subjects Review Board before polling his students. Why not? Because they don’t classify such activities as “experiments.” How is a formal survey any more “experimental” than emailing researchers or polling students? To quote The Prisoner, “Questions are a burden to others; answers, a prison for oneself.”
The safest answer for bioethicists, of course, is simply: “They should get our approval for those activities, too.” The more territory bioethicists claim for themselves, however, the more you have to wonder, “How good is bioethicists’ moral judgment in the first place?”
To answer this question, let me bring up a bioethical incident thousands of times deadlier than the Tuskegee experiment. You see, there was a deadly plague called COVID-19. Researchers quickly came up with promising vaccines. They could have tested the safety and efficacy of these vaccines in about one month using voluntary paid human experimentation. How?
Step 1: Vaccinate half the volunteers and give the other half a placebo.
Step 2: Wait a week, then inject all the volunteers with COVID-19. (Alternately, give half of each subgroup a placebo injection).
Step 3: Compare the COVID infection rates of the vaccinated and unvaccinated 2-4 weeks later.
In the real world, researchers only did Step 1, then waited about six months to compare naturally-occurring infection rates. During this period, ignorance of the various vaccines’ efficacy continued, almost no one received any COVID vaccine, and over a million people died. In the end, researchers discovered that the vaccines were highly effective, so this delay really did cause mass death.
How come no country on Earth tried voluntary paid human experimentation?* As far as I can tell, the most important factor was the formal and informal opposition of bioethicists. In particular, bioethicists converged on absurdly (or impossibly) high standards for “truly informed consent” to deliberate infection. Here’s a prime example:
An important principle in human challenge studies is that subjects must give their informed consent in order to take part. That means they should be provided with all the relevant information about the risk they are considering. But that is impossible for such a new disease.
Why can’t you bluntly tell would-be subjects, “This is a very new disease, so there could be all sorts of unforeseen complications. Do you still consent?” Because the real point of bioethics isn’t to ensure informed consent, but to veto informed consent to whatever gives bioethicists the willies.
I’m no paternalist, but I understand paternalism. Paternalists want to stop people from harming themselves. The goal of bioethicists, however, is far stranger. Bioethicists want to stop people from helping others! Even if experimental subjects heroically volunteer to be injected for no money at all, bioethicists stand on guard to overrule them.
I’ve said it before and I’ll say it again: Bioethics is to ethics as astrology is to astronomy. If bioethicists had previously prevented a hundred Tuskegees from happening, COVID would still have turned the existence of their entire profession into a net negative for humanity. Verily, we would be better off if their field had never existed.
If you find this hard to believe, remember: What the Tuskegee researchers did was already illegal in 1932. Instead of creating a pile of new rules enforced by a cult of sanctimonious busybodies, the obvious response was to apply the familiar laws of contract and fiduciary duty. These rules alone would have sent people like the Tuskegee researchers to jail where they belong. And they would have left forthright practitioners of voluntary paid human experimentation free to do their vital life-saving work.
In a just world, future generations would hear stories of the monstrous effort to impede COVID-19 vaccine research. Textbooks and documentaries would icily describe bioethicists’ lame rationalizations for allowing over a million people die. If the Tuskegee experiments laid the groundwork for modern Human Subjects Review, the COVID non-experiments would lay the groundwork for the abolition of these deadly shackles on medical progress.
Which is further proof, in case you needed any, that we don’t live in a just world.
* At least as I’m writing. Maybe this will have started by the time you read this.
READER COMMENTS
Eric B Rasmusen
Feb 16 2021 at 10:13am
One your best. (Your best?)
Someone should write a book about how when there’s a fiasco, the common response is to pass a law or implement a policy that wouldn’t have prevented it. Almost always, the fiasco wouldn’t have happened if people had followed existing rules or common sense, and the new policy is either orthogonal to the old policy or wouldn’t have been obeyed any more than the old one was. For example, after the fiasco of WW1, in the 1920’s there were lots of disarmament and World Peace treaties. Hitler and the Japanese militarists came along and either refused to sign, or violated them.
J Mann
Feb 16 2021 at 10:20am
You’ve probably read Scott Alexander’s essay, “My IRB Nightmare,” but if you haven’t, I recommend it strongly.
J Mann
Feb 16 2021 at 10:20am
Sorry, the link didn’t take:
https://slatestarcodex.com/2017/08/29/my-irb-nightmare/
MarkW
Feb 16 2021 at 1:17pm
I was just going to link that. Having helped someone work through the IRB process, I can attest that Alexander’s description was not at all exaggerated.
Henri Hein
Feb 16 2021 at 11:47pm
I hadn’t seen it. That was gold. Even for Scott Alexander. I was thinking exactly how it’s a great example of run-amok bureaucracy when he made his public-choice style argument about how all the procedural hurdles is to the benefit of big businesses.
Aladin
Feb 16 2021 at 11:35am
While I largely agree, as someone who has looked into clinical trial designs, there definitely is room for ethics in the trial you set up.
For example, almost no clinical trial is exactly 50 50 when the stakes are that high. Because its unethical and generates almost no statistical value. One can do 240 people get the vaccine and only 60 placebo and get a similar data set. We are of course expecting that everyone injected would get covid under a placebo right?
The only concerning part is having such a large control study when you know, per phase II, that the vaccine is safe. And you know the virus is highly contagious. There is no need for that.
My overall point is that while criticism of bioethicists is warrented, economists should design these studies in consultation with someone rather than simply state it and then say its obvious.
JFA
Feb 17 2021 at 5:36am
“For example, almost no clinical trial is exactly 50 50 when the stakes are that high. Because its unethical and generates almost no statistical value. One can do 240 people get the vaccine and only 60 placebo and get a similar data set. We are of course expecting that everyone injected would get covid under a placebo right?”
The Pfizer and Moderna vaccine phase 3 trials were both 1:1 randomization. The Moderna trial had about 15,000 people in each arm of the study, and the placebo arm had 185 symptomatic cases (11 in the vaccinated group). You need enough people who received the placebo to get Covid in order to measure the efficacy.
I shudder to think how long this would have taken if they had followed your guidelines of only 20% getting the placebo (which would be around 6000 participants in this case). 3 months longer? 4? Instead, 70 percent of the over 60s in Israel got the first dose by Jan 10, and most are now fully vaccinated. While the US role out has been much slower, a large portion of the oldest age groups getting their vaccine. About 44 percent of the over 70 population in Virginia have received their first dose.
I’m really glad your version of ethics was not in charge of designing the trial.
Noname
Feb 16 2021 at 3:20pm
Interesting article. I work in this field and you raise some good points, but miss out on important historical developments that aren’t Tuskegee. Never forget, bioethicists also like to invoke the Nazis.
I think that you’re missing an important aspect of the challenge trials.
The Nuremberg Code outlines another core set of principles that guide the Common Rule and Belmont Report. These were established by physicians and researchers (bioethicists weren’t a thing in 1947).
Quote: “No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.”
At the stage you’re talking about we had a priori reason to believe that ~1/100 people exposed would die or be severely injured. This is unlike other challenge trials for diseases with more established treatments (e.g., malaria). Protocol determined exposure to the disease makes the choice to expose the individual part of the experiment. Passive exposure of healthcare workers has a different ethical dimension following deontological principles (rather than pure consequentialism). As we’ve developed better treatments, it’s pretty clear we can now expose folk to covid without anticipating mortality a priori (i.e., we believe we know how to safely treat the disease). I believe that these are the conditions under which the ongoing challenge trials are being conducted.
One other note: possibility of unknown risks are communicated to research subjects all the time. It is what a phase one trial is, basically. The people saying that that precludes the possibility of informed consent are wrong.
One other note: you may be interested in the work conducting by NHS to randomize treatment of patients in the NHS system to evaluate treatment of COVID (https://www.recoverytrial.net/).
Phil H
Feb 16 2021 at 10:25pm
I’m not sure BC has identified the stumbling block correctly. The rule that stops doctors doing challenge trials is nothing to do with trial ethics. It’s simply the “first, do no harm” rule that pervades medicine. The keystone reference isn’t Tuskegee, it’s Mengele.
Furthermore, the complications of injecting a reasonable number of subjects with a disease that is known to be highly infectious are large. You’d have to keep them all locked up, essentially, to prevent infection spreading. But if you do that, then how well are you simulating real world efficacy for your vaccine?
The problem with economists telling doctors they’ve got it all wrong is that economists, by the definition of their profession, don’t know the details of what they’re talking about. It is *possible* that BC’s idea of challenge trials would work. But it seems much more likely to me that doctors know what they’re doing.
JFA
Feb 17 2021 at 6:53am
It’s not an ethical problem if the participants have to stay isolated somewhere, only a logistical one. At the beginning of the pandemic, it would have been very cheap to rent a hotel/motel since travel had tanked. Regarding simulating real world conditions: presumably exposing the participants directly to SARS-CoV-2 in the trial is an absolute worse case scenario of real world exposure, so in that sense a challenge trial gives more information much more quickly than a traditional trial about efficacy.
“But it seems much more likely to me that doctors know what they’re doing.” The discussion is over the input of bioethicists, not doctors. Doctors’ expertise, qua doctor, is relevant only insofar as it is needed to carry out the trial, not in whether or not to carry out the trial. From reading any academic output from ethicists in general and bioethicist in particular, there is not a whole lot of agreement on various issues.
We rely on expertise to make informed decisions, but it is unclear to me what expertise bioethicists have that nullifies the input of any ordinary person thinking about making weighty decisions. My sense is that the people lining up to volunteer for challenge trials are probably more informed and more aware of what is known and unknown about the risks of participation than most participants in a regular vaccine trial.
Phil H
Feb 17 2021 at 11:18pm
“The discussion is over the input of bioethicists, not doctors.”
These people you speak of do not exist. There is no group of “bioethicists” who are not also doctors/biomedical researchers. And the doctors who are also bioethicists certainly don’t wield a large amount of political power. This whole complaint is just a fantasy.
Yesterday, news of the first challenge trials in Britain came out. I don’t think it was Bryan Caplan’s doing. It’s just the medical profession working methodically through its procedures to the point where they can do a challenge trial in reasonable safety and confidence that they’ll get good data.
JFA
Feb 18 2021 at 7:22am
You are probably right that it is not a group of bioethicists solely (though they are on the various review boards at many places), but when people make these decisions, they are acting in that role (not the role of doctor or researcher). They are influenced by what is written in the area of bioethics. Regarding these decisions, there is no expertise these people have that is not subject to scrutiny from the average Joe.
KevinDC
Feb 18 2021 at 4:44pm
This is just false. Lots of bioethicists are not doctors or medical researchers – in fact, from what I can tell based on a brief survey of the field, people with a medical background seems to be a minority presence in bioethics. As Wikipedia notes:
Scanning through various journals related to bioethics, it looks as though the vast majority of work is produced by philosophy Ph.Ds, not by MDs. And many prominent handbooks on codes of medical ethics used by medical organizations and hospitals are written by moral philosophers with no actual medical experience or medical background.
Just to be clear, I’m not claiming that medical doctors or people with medical training are totally absent from the discussion about bioethics. But to declare that “There is no group of ‘bioethicists’ who are not also doctors/biomedical researchers” is very far from reality.
Henri Hein
Feb 16 2021 at 11:45pm
Steve Landsburg made a similar point last year.
Jason Sorens
Feb 17 2021 at 8:34am
Agree with the main point, but if you’re doing a survey that does not collect personally identifiable information, you can apply for an exemption from full IRB review to your designated IRB official, and in my experience that’s an easy and straightforward process. Just don’t want any potential survey researchers deterred by that prospect.
Comments are closed.