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5 Unethical Medical Experiments Brought Out of the Shadows of History

Prisoners and other vulnerable populations often bore the brunt of unethical medical experimentation.

By Allison Futterman
January 11, 2021 5:30 PM
Source: Discover Magazine

medical instruments on a table - shutterstock
Source: Discover Magazine
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(Credit: PanatFoto/Shutterstock)

Most people are aware of some of the heinous medical experiments of the past that violated human rights. Participation in these studies was either forced or coerced under false pretenses. Some of the most notorious examples include the experiments by the Nazis, the Tuskegee syphilis study, the Stanford Prison Experiment, and the CIA’s LSD studies.

But there are many other lesser-known experiments on vulnerable populations that have flown under the radar. Study subjects often didn’t — or couldn’t — give consent. Sometimes they were lured into participating with a promise of improved health or a small amount of compensation. Other times, details about the experiment were disclosed but the extent of risks involved weren’t.

This perhaps isn’t surprising, as doctors who conducted these experiments were representative of prevailing attitudes at the time of their work. But unfortunately, even after informed consent was introduced in the 1950s, disregard for the rights of certain populations continued. Some of these researchers’ work did result in scientific advances — but they came at the expense of harmful and painful procedures on unknowing subjects.

Here are five medical experiments of the past that you probably haven’t heard about. They illustrate just how far the ethical and legal guidepost, which emphasizes respect for human dignity above all else, has moved.

Learn more about Informed Consent

The Prison Doctor Who Did Testicular Transplants

From 1913 to 1951, eugenicist Leo Stanley was the chief surgeon at San Quentin State Prison, California’s oldest correctional institution. After performing vasectomies on prisoners, whom he recruited through promises of improved health and vigor, Stanley turned his attention to the emerging field of endocrinology, which involves the study of certain glands and the hormones they regulate. He believed the effects of aging and decreased hormones contributed to criminality, weak morality, and poor physical attributes. Transplanting the testicles of younger men into those who were older would restore masculinity, he thought.  

Stanley began by using the testicles of executed prisoners — but he ran into a supply shortage. He solved this by using the testicles of animals, including goats and deer. At first, he physically implanted the testicles directly into the inmates. But that had complications, so he switched to a new plan: He ground up the animal testicles into a paste, which he injected into prisoners’ abdomens. By the end of his time at San Quentin, Stanley did an estimated 10,000 testicular procedures.

The Oncologist Who Injected Cancer Cells Into Patients and Prisoners

During the 1950s and 1960s, Sloan-Kettering Institute oncologist Chester Southam conducted research to learn how people’s immune systems would react when exposed to cancer cells. In order to find out, he injected live HeLa cancer cells into patients, generally without their permission. When patient consent was given, details around the true nature of the experiment were often kept secret. Southam first experimented on terminally ill cancer patients, to whom he had easy access. The result of the injection was the growth of cancerous nodules, which led to metastasis in one person.

Next, Southam experimented on healthy subjects, which he felt would yield more accurate results. He recruited prisoners, and, perhaps not surprisingly, their healthier immune systems responded better than those of cancer patients. Eventually, Southam returned to infecting the sick and arranged to have patients at the Jewish Chronic Disease Hospital in Brooklyn, NY, injected with HeLa cells. But this time, there was resistance. Three doctors who were asked to participate in the experiment refused, resigned, and went public.

The scandalous newspaper headlines shocked the public, and legal proceedings were initiated against Southern. Some in the scientific and medical community condemned his experiments, while others supported him. Initially, Southam’s medical license was suspended for one year, but it was then reduced to a probation. His career continued to be illustrious, and he was subsequently elected president of the American Association for Cancer Research.

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The Aptly Named ‘Monster Study’

Pioneering speech pathologist Wendell Johnson suffered from severe stuttering that began early in his childhood. His own experience motivated his focus on finding the cause, and hopefully a cure, for stuttering. He theorized that stuttering in children could be impacted by external factors, such as negative reinforcement. In 1939, under Johnson’s supervision, graduate student Mary Tudor conducted a stuttering experiment, using 22 children at an Iowa orphanage. Half received positive reinforcement. But the other half were ridiculed and criticized for their speech, whether or not they actually stuttered. This resulted in a worsening of speech issues for the children who were given negative feedback.

The study was never published due to the multitude of ethical violations. According to The Washington Post, Tudor was remorseful about the damage caused by the experiment and returned to the orphanage to help the children with their speech. Despite his ethical mistakes, the Wendell Johnson Speech and Hearing Clinic at the University of Iowa bears Johnson’s name and is a nod to his contributions to the field.

The Dermatologist Who Used Prisoners As Guinea Pigs

One of the biggest breakthroughs in dermatology was the invention of Retin-A, a cream that can treat sun damage, wrinkles, and other skin conditions. Its success led to fortune and fame for co-inventor Albert Kligman, a dermatologist at the University of Pennsylvania. But Kligman is also known for his nefarious dermatology experiments on prisoners that began in 1951 and continued for around 20 years. He conducted his research on behalf of companies including DuPont and Johnson & Johnson.

Kligman’s work often left prisoners with pain and scars as he used them as study subjects in wound healing and exposed them to deodorants, foot powders, and more for chemical and cosmetic companies. Dow once enlisted Kligman to study the effects of dioxin, a chemical in Agent Orange, on 75 inmates at Pennsylvania’s Holmesburg Prison. The prisoners were paid a small amount for their participation but were not told about the potential side effects.about:blankabout:blank

In the University of Pennsylvania’s journal, Almanac, Kligman’s obituary focused on his medical advancements, awards, and philanthropy. There was no acknowledgement of his prison experiments. However, it did mention that as a “giant in the field,” he “also experienced his fair share of controversy.”

The Endocrinologist Who Irradiated Prisoners

When the Atomic Energy Commission wanted to know how radiation affected male reproductive function, they looked to endocrinologist Carl Heller. In a study involving Oregon State Penitentiary prisoners between 1963 and 1973, Heller designed a contraption that would radiate their testicles at varying amounts to see what effect it had, particularly on sperm production. The prisoners also were subjected to repeated biopsies and were required to undergo vasectomies once the experiments concluded.

Although study participants were paid, it raised ethical issues about the potential coercive nature of financial compensation to prison populations. The prisoners were informed about the risks of skin burns, but likely were not told about the possibility of significant pain, inflammation, and the small risk of testicular cancer.

Despite your doctors accolades what is their professional history? How do you feel about their history? Is there anything controversial in their history?

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‘Unchecked’ Experiments on People Raise Concern

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Source: The New York Times
By Sheryl Gay Stolberg
Featured Photo Source: Unsplash, Philipp Wuthrich

On the outskirts of the nation’s capital, tucked away on the sixth floor of a suburban office building, there is a little-known computer data base: a state-by-state accounting of the experiences of every cat, dog, hamster, guinea pig, chimpanzee, rabbit or farm animal used in a laboratory experiment.

Here in the Government’s Division of Animal Care, one can discover precisely how many guinea pigs were subjected to biomedical research in 1995 (333,379). Or how many chimpanzees felt pain during research but were comforted with medication (19,712). Civil servants have compiled such numbers for 31 years, ever since Congress passed the Animal Welfare Act.

But there are no comparable figures for people. ”We have better information about animal experiments than we do about human experiments,” said R. Alto Charo, of the President Clinton’s National Bioethics Advisory Commission.

More than two decades after the Federal Government issued regulations to protect human subjects of medical experiments, the research landscape has changed so much that many doctors and scientists are not necessarily covered by the rules. For example, an entire area of study, embryo research, has grown in the private sector over the last 20 years.

The regulations were the direct legacy of the notorious Tuskegee study, which was halted 25 years ago, amid revelations that the Government had withheld treatment for syphilis to black men in Tuskegee, Ala., without their consent.

The Federal regulations were aimed at establishing the twin pillars of ethical research for subjects of federally-financed studies: the assurance that patients would be warned of risks and that an independent panel would evaluate the experiment before it was conducted.

But as President Clinton prepares to issue a formal apology to the subjects of the Tuskegee study on Friday, there is mounting concern that the Government’s protections do not go far enough.

On Capitol Hill, Representative Christopher Shays, Republican of Connecticut, convened a hearing last week to determine the scope of lapses and violations of ethics in experiments. He was startled by the testimony, including accounts of ethics panels, institutional review boards, or I.R.B.’s, set up as profit-making ventures to evaluate proposed experiments for research groups that pay them.

”I found it amazing,” Mr. Shays said. ”I am struck by the fact that we have I.R.B.’s that can be created by anyone, that we don’t even know how many there are. I think the more we get into this the more we are going to realize how casual this process really is.”

Moreover, certain privately financed research is not bound by the rules. The loophole means some people — no one knows how many — are participating in studies that are wholly unregulated. When there are complaints, there is nothing the Government can do.

”There is unchecked human experimentation taking place,” said Dr. Gary B. Ellis, director of the Federal Office for Protection from Research Risks. How much is impossible to determine. But documents obtained from the research protection agency revealed several examples of possible lapses, though the names of those making the complaints were withheld.

In one instance, the parents of a 3-year-old boy with a rare genetic disease enrolled him in an experimental bone marrow transplant program in 1990, at a state university hospital. The parents said their son emerged from the treatment with profound brain damage, unable to walk, talk or feed himself. There was no way to know if the treatment caused the damage, but in a 1991 letter to the protection agency, his parents said that the consent form they had signed had not fully explained the risks of the procedure.

”Had we been informed of this risk we would not have consented to the transplant,” the couple wrote. ”We are now faced with the expense and challenge of caring for a brain-damaged child who will now live a much longer life span because they corrected his disease.”

In another case, an Oregon breast cancer patient complained that the hospital in which she had received chemotherapy had released information from her medical records to researchers without her consent.

In both cases the research was privately financed, so Dr. Ellis could not investigate. ”We have incident after incident where we get to the point where we determine that we don’t have the authority,” he said. ”It’s very frustrating.”

Senator John Glenn, Democrat of Ohio, has been seeking to close this gap. He introduced a bill, the Human Research Subject Protections Act of 1997, that would require informed consent and board review of all experiments, regardless of who paid for them. The bill also would create criminal penalties for violators — a provision that has drawn criticism from the Pharmaceutical Research and Manufacturers Association of America, which often finances private research.

”We believe in informed consent and our companies bend over backwards when we deal with patients,” said Mark Grayson, the group’s spokesman. But criminal penalties were unwarranted, he said.

Dr. William E. Gibbons, who directs research on genetic testing of embryos at the Jones Institute for Reproductive Medicine in Norfolk, Va., was also skeptical, saying his scientists already follow Federal guidelines.

”How bad a problem do we actually have?” Dr. Gibbons asked. Replied Senator Glenn: ”One violation is too much.”

Experts point out that the debate over ethics in human experiments is occurring at a time when medical research is safer than it has ever been. History is dotted with scientific horrors beyond the Tuskegee study, notably the gruesome Nazi experiments of World War II and human radiation experiments financed by the Government during the cold war.

These low points in the annals of medicine gave rise to the current system. The concept of informed consent, that patients must be told in advance about how the experiment might help or hurt them, is rooted in the Nuremberg Code by which the Nazi experiments were judged in postwar trials. But it was not until 1974, two years after the Tuskegee study was disclosed, that the Fedeal Government enacted a set of comprehensive rules designed to protect volunteers for research.

Informed consent was one cornerstone of the new rules. The creation of institutional review boards was the other. Today, these provisions are so universally accepted they are referred to as the Common Rule.

The Common Rule applies to three research categories: studies supported by 17 Federal agencies that adhere to it, including the Department of Defense; experiments to prove the efficacy of a new medicine or device and gain the Food and Drug Administration’s approval, and research paid for with private money but conducted by academic researchers whose employers have signed agreements with the Government. About 450 universities now require that their scientists to adhere to the Common Rule.

Although it has been updated six times in the past 23 years (there are now specific provisions for children, prisoners and pregnant women) many ethics experts say the nature of research has changed so dramatically since the Common Rule was drafted that a thorough re-examination is in order.

”The old model presumes that you would do research to find out some important new basic facts about health,” said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. ”Current research might be for a pharmaceutical company to put a new drug on the market to compete with the five ones that are already there for, say, insomnia or weight loss. The risks and benefits may be different.”

In addition, Dr. Caplan said, the boom in research paid for by private industry has created a new phenomenon: commercial review boards that have generated a wave of what Dr. Caplan called ”I.R.B. shopping” by researchers.

At last week’s Congressional hearing, Dr. Benmjamin Wilfond, a pediatrician who sits on the review board at the University of Arizona, recalled how one proposal was shopped around.

Not long ago, he said, his board rejected a plan by a university researcher to test a new anti-inflammatory treatment for childhood asthma. The experiment, which was to be paid for by the company seeking approval of the new drug, called for half of the children to receive the new treatment and the other half to receive a placebo. Some of the children given the placebo were to have discontinued their current therapy; the univeristy board thought that was unethical.

Later, Dr. Wilfond said, he learned that the same experiment was being conducted by a private doctor who had submitted the plan to an ethics panel in another state.

What, if anything, Congress can do about lapses is unclear; Government has traditionally been loath to interfere with the private practice of medicine, and no regulatory system is foolproof. ”The situation that we have created is generally effective,” Dr. Harold Varmus, director of the National Institutes of Health, told Representative Shays last week. ”But it’s not perfect.”

But Ms. Charo, of the bioethics commission, said she believed that expanding the Common Rule to cover all research would be a good first step. At least, she said, regulators might then be able to gather basic statistics for humans as they do for other species. After all, she added wryly: ”I’m an animal too.”A version of this article appears in print on May 14, 1997, Section A, Page 1 of the National edition with the headline: ‘Unchecked’ Experiments on People Raise Concern. 

Is medical treatment or care without ‘informed consent’ even when experimental ever ethical? What should the laws that govern informed consent look like? Why?

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The Largest Unethical Medical Experiment in Human History – Georgia Institute of Technology

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Source: Georgia Institute of Technology
This monograph describes the largest unethical medical experiment in human history: the implementation and operation of non-ionizing non-visible EMF radiation (hereafter called wireless radiation) infrastructure for communications, surveillance, weaponry, and other applications. It is unethical because it violates the key ethical medical experiment requirement for “informed consent” by the overwhelming majority of the participants. The monograph provides background on unethical medical research/experimentation, and frames the implementation of wireless radiation within that context. The monograph then identifies a wide spectrum of adverse effects of wireless radiation as reported in the premier biomedical literature for over seven decades. Even though many of these reported adverse effects are extremely severe, the true extent of their severity has been grossly underestimated. Most of the reported laboratory experiments that produced these effects are not reflective of the real-life environment in which wireless radiation operates. Many experiments do not include pulsing and modulation of the carrier signal, and most do not account for synergistic effects of other toxic stimuli acting in concert with the wireless radiation. These two additions greatly exacerbate the severity of the adverse effects from wireless radiation, and their neglect in current (and past) experimentation results in substantial under-estimation of the breadth and severity of adverse effects to be expected in a real-life situation. This lack of credible safety testing, combined with depriving the public of the opportunity to provide informed consent, contextualizes the wireless radiation infrastructure operation as an unethical medical experiment.

Indeed, at the hart of many unethical medical experiments is the lack of informed consent and the loss of consent. Would you recognize an unauthorized and unethical medical experiment if you saw one? What would it look like? How would one report it? In fact in the past some governments have been apart of unethical experiments. The most widely known of these in recent history were the experiments conducted by the Nazis.

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Ethical or exploitative—should prisoners participate in COVID-19 vaccine trials?

Source: Science Mag
Photos Source: Science Mag
By Eli Cahan Sep. 14, 2020 , 1:50 PM

Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

As 38 clinical trials seek tens of thousands of volunteers to receive doses of experimental vaccines, researchers are discussing how to find and recruit participants effectively and ethically. Some people who are especially vulnerable to COVID-19 have not been well represented in studies—or represented at all. Prisoners, for instance, have borne a heavy burden of COVID-19, with more than 125,000 U.S. prisoners infected, and more than 1000 dead. But prisoners have also been excluded from the trials out of concern that they might be coerced into participating or exploited if they do.

Now, some researchers argue that including prisoners in studies could offer outsize health benefits. Correctional facilities have experienced many COVID-19 outbreaks and are structurally unsuited to social distancing (among other precautions). And so, the researchers argue, like other people at high risk of catching the disease, prisoners should be allowed to participate in clinical trials. 

ScienceInsider spoke with George Annas, a lawyer and bioethicist at Boston University, whose research addresses ethics and human rights in clinical trials, and Lauren Brinkley-Rubinstein, a sociologist and epidemiologist at the University of North Carolina, Chapel Hill, who studies management of infectious disease and substance abuse in incarcerated people. Both have published about health and ethics in holding facilities during the pandemic: In July, Annas wrote in The New England Journal of Medicine about inhumane medical practices in immigrant detention centers and, and in August, Brinkley-Rubinstein and colleagues argued in JAMA that prisoners should be included in vaccine trials.

This interview has been edited for brevity and clarity.

Q: What clinical research has been done historically in correctional facilities? Has it been done well?

George Annas: The history is pretty dark. It’s a history of research done without consent, without oversight, and without consequences. It starts in some respects with the Nazis, since Holocaust research—or pretend research, really—was done in prisoners to get scientific information for the German state. Another famous experience was John Charles Cutler’s 1940s experiments in Guatemalan prisons. In those experiments, prisoners were deliberately infected with gonorrhea, syphilis, and chancroid.

Lauren Brinkley-Rubinstein: There are lots of instances of prisoners being intentionally infected with diseases in order to develop new drugs, including malaria and hepatitis C. Horrible things happened at San Quentin [State Prison], including giving prisoners experimental testicular transplants. I think dark is the right word.

Q: Is any COVID-19 vaccine research taking place in correctional facilities? Has anyone put forward serious proposals to do such research?

L.B.R.: There was some conversation at the federal level at the initiation of large vaccine trials to include people involved in some way with the criminal justice system. My colleagues and I had a couple of phone calls with people involved in running those trials to see if it was something they’d entertain. There was some openness to it. But ultimately, including incarcerated populations felt too cumbersome. Between the ethical risks and the operational obstacles to actually get the sites up and running, it would have required a lot of extra effort.

G.A.: Up until recently, there’s really been no excuse to do research in these settings. But it’s a strange and perhaps intriguing group to study, because they’re almost definitely going to be exposed to the virus. So, it could give you answers you may not get if you trial the general population—who may not ever be exposed. That’s why we’re looking again. I’m not a big fan of prison research, but I am a big fan of science, so I think we should look at all these things again.

L.B.R.: Still, I think part of this conversation should be focused on people on probation or parole—the high-risk population that is criminal justice involved, but not presently incarcerated.

G.A.: Yeah. I’d be much more amenable to efforts to bring people on probation or parole into trials. They would be unshackled, literally, from some of the risks of exploitation we think about for prisoners who receive perks for “good” behavior and punishment for “bad” behavior.

Q: Could this kind of research actually benefit incarcerated people if they participate?

L.B.R.: It definitely could, assuming the vaccine works. Incarcerated people do have different risks, in terms of the barriers they face to getting certain elements of routine health care along with their potential to be exploited. But they also potentially would gain more from vaccination, given these settings are extreme amplifiers of infection.

G.A.: But the risk if an experimental vaccine doesn’t work is that these individuals won’t only be disappointed, but they’ll feel they were lied to or exploited.

L.B.R.: Another big part about why understanding these contexts is important is that we do eventually want vaccines to be made available to these populations. But there are lots of implementation issues that are very particular to jails and prisons. How do we store the vaccines under potentially very specific conditions? How do we monitor patients for side effects after injections? How we manage any needed follow-up, like a booster shot? We need to get expertise to optimize these programs when vaccines are eventually deployed. I don’t think that alone is justification to do a trial, but it is such a big part of vaccines being effective once they are approved. It’s something we’ll have to figure out.

Q: Could there be broader public health advantages for doing COVID-19 vaccine research in correctional facilities? Would experimental use of vaccines in correctional facilities benefit staff, neighboring communities, and more distant ones?

L.B.R.: If the experimental vaccines work, then the public health benefit of focusing vaccine resources—even during trials—on correctional facilities cannot be overemphasized. We’ve already seen that jail churn plays a tremendous role in community transmission.

G.A.: To me, it’s a different experiment. You can’t use community results to justify research on individuals. The risk-benefit analysis needs to come out right for the individual before they can consent to being in the trial.

Q: If such research is undertaken, how will we know whether ethical safeguards did enough to protect participants’ rights?

George Annas (left) and Lauren Brinkley-Rubinstein (right) GEORGE ANNAS AND LAUREN BRINKLEY-RUBINSTEIN

G.A.: There probably is no replacement for asking the participants themselves. Did they feel exploited? Did they feel used? Did they feel fulfilled? Did they feel part of something bigger?

L.B.R.: This is really at the crux of the issue. We’d have to ask, but also to appoint oversight boards that have prisoner representation. And we’d have to adopt other safeguards to ensure we are doing things ethically.

Q: Would giving prisoners the option to participate in a vaccine trial set a precedent for future research? What about continuing to withhold access?

G.A.: I think the question of “if not now, when?” is a very good one. We have a worldwide pandemic with a giant prisoner population that’s very susceptible to the disease and is dying from it. If we’re not going to permit research in that circumstance, we’re never going to permit it.

L.B.R.: Also, if we can figure out how to do this right—given the stakes right now—that could give back some element of power or respect that is otherwise not present in these places.

G.A.: It’s a question of whether we treat prisoners as human beings with agency, who are allowed to participate in something for the public good.

L.B.R.: Our approach to experimentation in prisons has been very binary: a history of serious abuses of power when we have run trials, versus the decision to completely avoid including prisoners in trials. We have to ask ourselves whether there’s a middle path.

G.A.: And considering a middle path, but then deciding it’s too much work—that would be an extreme position, too.

Q: As the prospect of an approved vaccine nears, fierce debate surrounds who should receive it first. According to current Centers for Disease Control and Prevention guidance, prisoners are not considered separate from the general population, putting them last in line. In contrast, a draft proposal released this month by the National Academies of Sciences, Engineering, and Medicine said prisoners should get vaccinated after health care workers, but before the general population. Where do you think incarcerated people belong on the priority list?

L.B.R.: Based on the evidence have about outbreaks, incarcerated people should be at the top tier. There’s a clear connection between what happens in these institutions and what happens in the community. When we have infections that spread in jails or prisons like wildfire, and staff going in and out and in and out, we’re making COVID infection more likely everywhere. If the only thing you cared about was your own health, you would still make the decision to prioritize them.

G.A.: People at the highest risk should receive the treatment first. That includes prisoners. It’s that simple, really. 

doi:10.1126/science.abe7861

As we are in the midst of the only Pandemic in recent history desperately in search of a vaccine, one must question the ethics employed in medical trails and the medical industries murky and dark history with experimentation not to mention fraud and scams. Without a current doubt those who find an effective vaccine will reap financial benefit. Every country on the globe is interested. Are you willing to take a vaccine? A health professional once stated, there is no profit in health. The profit is in disease. As many are trying to decided who should have the vaccine first and reporting in those population most affected by the corona virus, one must ask if these populations should also bare the brunt of clinical trials as well. Are clinical trials on unknowing and those not asked ever ethical and permissible?

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