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Reckoning with Medicine’s Unseemly Past

(Victims of the Guatemala Syphilis Experiment. National Archives and Records Administration/Via

“How does such an advanced nation and forward-looking profession embrace ‘medicalized mass murder’ and a philosophy calling for the ‘annihilation of life unworthy of living’? How did those who pledged to follow ‘the Hippocratic tradition of healers,’ they ask, ‘become killers’?”

In November of 2023, The Lancet published a lengthy treatise illuminating “[the] distinctive and disturbing…role health professionals played in formulating, supporting, and implementing inhumane and often genocidal policies” during Adolf Hitler’s Third Reich. Recognizing that “health science curriculums…rarely cover” this tragic saga in world history, the esteemed medical journal argues the “medical crimes committed” by Nazi doctors are the “best-documented historical example of medical involvement in transgressions against vulnerable individuals and groups.” That ugly chapter, the authors of executive summary further state, is a much needed “roadmap for the integration” of the profession’s “shameful history” into current “health science curriculums worldwide.”  

Despite its belated propagation, The Lancet’s commission should be commended for addressing a much overlooked issue—research ethics—and publishing a well-documented, nearly 75-page chronicle of the embarrassing “historical evidence” exposing medical complicity in the Holocaust. This Commision believes that its document is invaluable for educating young doctors and what they call “teaching for tomorrow.” Centered on Nazi Germany’s moral collapse and the disturbing fact that “physicians joined the Nazi Party and its affiliated organizations in higher proportions than any other profession,” The Lancet’s commission hopes to show “that scientific logic alone cannot prevent ethical transgressions.” What is needed is an educational environment that requires “learning about and reflecting on this history” and its “importance for all the health sciences.”

The report not only examines the “disturbing fact” that “German physicians willingly joined the National Socialist German Workers Party” in shocking numbers but also “collaborated in the dismissal and persecution of their Jewish colleagues”; participated in the “forced sterilization” of hundreds of thousands of those deemed genetically inferior; subjected many thousands more to “forced medical research”; and, ultimately, played a significant role in killing “people on an industrial scale.” The evidence further discloses “few health professionals openly refused to collaborate in any of these activities…arguably the most extreme example of medical complicity in unethical transgressions.”   

Although it may come as a surprise to many readers to learn that so many physicians joined the Nazi Party,” The Lancet’s report paradoxically reveals that years earlier Germany was “the first country to introduce official regulations for experimental medical research in human beings” and “one of the first countries in the world to have mandatory courses in medical ethics.” What is to be made of this contradiction: How does such an advanced nation and forward-looking profession embrace “medicalized mass murder” and a philosophy calling for the “annihilation of life unworthy of living”? How did those who pledged to follow “the Hippocratic tradition of healers,” they ask, “become killers”? 

Some readers may be optimistic that the answers to those questions (and others) in The Lancet’s well-argued brief will encourage British medical leaders to take the profession’s sordid episodes seriously and incorporate them as a regular part of medical school training. However, this report is likely to receive the same unimpressive response as its American equivalent decades earlier. The Nuremberg Code—an American invention—is a remarkable document by any standard or measure. But, as bioethicist Jay Katz observed, it was “relegated to history almost as soon as it was born.” The American medical community’s underwhelming response to it—and the subsequent ethical violations and treatment of the vulnerable—should prove a discomforting dose of realism to those at The Lancet calling for greater “awareness of the substantial power of medical professionals in society and the inherent potential for abuse of this power.” 

The Imprisoned as Research Material 

If one had walked into the Philadelphia Prison System in the postwar era, he would have been confronted with a chilling collection of sights and sounds running the gamut from screams of desperation and cruel verbal assaults from grim-faced prisoners to the disturbing military-like discipline of scowling black Muslims marching in lock-step through the institutions like conquering armies. For the several thousand held captive in three steel and stone fortresses—two dating back to the Victorian Era—survival was a daily challenge. Some chose to offer themselves up as research material for the local scientific community—a decision almost all would come to regret.  

In addition to the bleak landscape, loss of freedom, and constant threat of violence that characterizes most state prisons and urban jails, there was something else, something more alarming and unexpected in the Philadelphia lock-ups: the shocking specter of hundreds of men strapped and wrapped in gauze pads and medical tape that made the inhabitants look like survivors of Antietam or Passchendaele. Whether passing through Holmesburg Prison’s formidable, dome-covered rotunda; the House of Corrections’ dark, miserable cell blocks; or the Detention Center’s relatively clean, but no less violent corridors, inmates covered in medical dressing littered the carceral gulag. 

But the wounds were not from crude, homemade shanks used in cell-block brawls or exercise yard gang wars. They were from the endless machinations of Ivy League doctors, recurring waves of medical researchers, and myriad corporate entities who flocked to the prisons situated along the Delaware River to perform clinical trials that could be done nowhere else—or at least not with the unfettered freedom that came with using the bumper crop of hoodlums, miscreants, and social flotsam and jetsam locked behind bars there.

Desperate for money—whether to purchase prison commissary items, acquire an attorney, or make bail—prisoners signed up as incarcerated guinea pigs for the princely sum of a dollar a day. When questioned about their decision to become part of the all too ubiquitous “patch tests,” many cockily replied with something to the effect of: “Ain’t no big deal, I’m just selling them doctors a piece of my skin.”

“It was an opportunity to get a couple dollars,” recalled Irvin Moore at an event last month at Princeton University. He was just a desperate teenager on a forbidding cellblock when confronted with the decision. “I didn’t understand what it was about, but they said they’d pay me seven bucks if I’d participate in the experiment.” Soon after the patches were applied, “they started to burn my back and legs,” said Moore. “They took the flesh right off of me.”  

The University of Pennsylvania and the United States Army brought trailers into Holmesburg Prison for secret chemical warfare studies in 1968.

Deceived about which drugs, concoctions, and procedures were being tested on them and convinced by medical professionals attired in white lab coats with M.D. and Ph.D. emblazoned on their lapels that the experiments were harmless, the trap was set. The confluence of ill-informed, poverty-stricken prisoners and a top university’s enterprising dermatology program that placed commerce on an equal footing with academic training, culminated in one of the nation’s more robust and disquieting for-profit law enforcement operations.

Add to that the hundreds of men who offered themselves up for daily blood draws to benefit blood bank operatives, and one can easily argue the backend of Philadelphia’s criminal justice system experienced a hostile take-over by the medical-industrial sector. The upshot of the municipal hijacking should have been clear to all: prisoners—most of them black and untried from the early 1960s on—now found themselves “sentenced to science” as well as the county prison system. 

In the Shadow of the Nuremberg Code

And all of it—from its inception in the early 1950s to its termination in the mid-1970s—in direct violation of the Nuremberg Code, the landmark medical ethics document American jurists crafted at the Nazi Doctors Trial at the conclusion of World War II. After sentencing Karl Brandt, Karl Gebhardt, Joachim Mrugowsky, and four other highly respected German physicians to death, and nine others to long prison terms for heinous high-altitude, freezing, typhus, mustard gas, and incendiary bomb experiments at extermination camps such as Auschwitz, Dachau, and Ravensbrück , the jurists brought forth a document consisting of ten principles designed to ensure such scientific travesties were never repeated. They hoped to construct some reasonable guardrails on human experimentation and guide the world’s medical community on the proper elements of ethical research.

The Code’s first principle alone should have precluded the use of the imprisoned as raw material for experimentation for it not only stressed the “voluntary consent” of the test subject as “absolutely essential,” but also emphasized “the person involved should… be able to have free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion.” Unfortunately, only those who spent time behind bars could truly appreciate the punishing, visceral grasp of imprisonment, and what the Nuremberg jurists were trying to accomplish.

Although a landmark event, the document had no impact on medical research in the United States. In fact, prison testing grew exponentially in the post-war years. Eventually over half of the American states would have prisons hosting investigatory medical initiatives running the gamut from testicular radiation studies in Oregon and Washington, flash burn studies in Virginia, sexually transmitted disease studies in Indiana and Texas, malaria and infectious hepatitis experiments in Illinois and Georgia, and live cancer cell injections in Ohio. 

What should have been banned according to any fair-minded reading of the Nuremberg Code, became a gold mine of opportunity for scientific investigators. By the early 1970s, according to Alan B. Lisook, former chief of clinical investigations for the Food and Drug Administration (FDA), most American prisons had an open-door policy regarding medical research. “Over 90% of all Phase I drug studies,” said Lisook, “were initially tested on prison inmates.”

Albert M. Kligman’s wide-ranging scientific explorations in Philadelphia’s penal system cornered the research market, enabling him to become a prolific author, campus celebrity, and one of the world’s most famous dermatologists. He also became a highly sought out Phase I investigator for Big Pharma. “Kligman may have done more testing than any other doctor in the country,” said Lisook. “If he wasn’t number one, he was up there,” he continued. With clients such as Dow Chemical, R.J. Reynolds, Johnson & Johnson, the United States Army, and a multitude of others, and testing everything from dioxin, herpes simplex, radioactive isotopes, and various chemical warfare agents on the “acres of skin” at his disposal, it was if he had been granted a dazzling celestial gift from the research gods. “Things were simpler then,” Kligman recounted years later of his free-wheeling abuse of imprisoned Philadelphians: “Informed consent was unheard of. No one asked me what I was doing. It was a wonderful time.”

How did things go so wrong in the nation’s third largest city (at the time), as well as so many other places across the country? And not just prisons, but as medical historian Ulf Schmidt argues, other institutions holding “the economically weak, underprivileged and relatively powerless sections of society.” Even those holding infants and children, such as Letchworth Village Colony for the Feebleminded in New York, the Ohio Soldiers and Sailors Orphans Home, and Sonoma State Hospital in California, became hotbeds of experimentation. Why were so few in the general public, and especially in the healthcare arena unmoved by the weak, the easily misled, and the darker-skinned among us being used as cannon-fodder for medical researchers?     

Scholars who have looked into the disappointing history of the Code’s rise and quick demise agree that disinterest—even outright opposition—was present from the very beginning. In fact, the historical record shows that the United States had something of a schizophrenic perspective on the issue of war crimes and unethical research. Why, for example, did the United States insist on the trial of the Nazi doctors but give a free pass to General Ishii Shiro, a ruthless Japanese microbiologist, whose infamous Unit 731 committed a lengthy list of hellish chemical and biological experiments that killed thousands in Manchuria prior to and during the war? Princeton University professor Gary Bass in his 2023 book Judgment at Tokyo argues that the “United States was secretly covering up what it knew about some of Japan’s most shocking atrocities.” He continues: “the U.S. government was eager to tap Ishii’s sinister knowledge,” and the “failure to prosecute the Japanese involved in biowarfare is one of the gravest stains on the Tokyo trial.” 

And we cannot lose sight that at the same time Nazi doctors at Nuremberg were being lectured on the proper way to conduct human research, physicians in the United States were exploiting hundreds of unschooled, syphilitic sharecroppers in Macon County, Alabama. They even went a step beyond, by exporting the experiment and giving syphilis and other sexually transmitted diseases to approximately 5,000 Guatemalan soldiers, prisoners, mental patients, and orphans. How, we are forced to ask ourselves, was all this horrid experimentation occurring in the nation that put the Nazi medical establishment on trial? The nation that executed the worst medical malefactors, and produced a set of principles to ensure such transgressions were never repeated?    

The Code, according to esteemed medical ethicist, Katz, was practically dead on arrival. It was viewed by a comfortable American medical establishment as “a good code for barbarians, but an unnecessary code for ordinary physician-scientists.” In other words, many bought into the reassuring notion that Nazi medicine (and the outlandish research it fostered) was so extraordinary, so fiendish that it would never again be replicated. Hence, a new code of ethics regarding medical research was unnecessary. The Nazi doctors, as medical historian David Rothman described the prevailing mindset, were viewed as a group apart: “nothing they did, and no code drawn up in response to them, was relevant to the United States.”

The Declaration of Helsinki

But the Nuremberg Code did exist and as weak as it was from an implementation standpoint, it set a restrictive standard that doctors, especially in the United States, found professionally stifling. Some of the Code’s “hard and fast” rules, opponents declared, constrained scientific investigation and would thwart progress. As medical historian Susan Lederer has written, members of the World Medical Association (WMA) found the Code something like a research straitjacket. For example, “the third rule in the Nuremberg Code [was] too restrictive as it provides that no human experimentation should be undertaken without prior experiment on animals.” Protections regarding the use of children and captives were equally problematic for a research community valuing speed, economy, and the absence of bureaucratic obstacles. 

Years of discussion and debate ensued. The 32 nations that made up the WMA had a difficult time arriving at a code of research ethics they could all agree on. The “long and winding road” of competing interests eventually culminated in a working set of principles at their 1964 meeting in Finland. The Declaration of Helsinki, as it would come to be known, became a milestone event, but not all were pleased. Critics took note of the “sturdy American stamp” on the final, water-downed product. The Lancet, for instance, “regretted” the “weakened” protections for test subjects the Nuremberg Code had championed 17-years earlier. As The Lancet’s report opines of the dubious effort to undermine the Code, “the American Medical Association and the pharmaceutical industry successfully argued to weaken the Nuremberg informed consent principle before inclusion in the Declaration of Helsinki.”

In coming years the Declaration of Helsinki would witness additional revisions, almost all of them designed to lessen the constraints imposed on them by the earlier Code. Currently celebrating its 60th anniversary, some disgruntled ethicists and medical practitioners remain firm in their belief that the Declaration of Helsinki could have been so much more.

The Gelsinger Case

By the late 1970s and the aftermath of the shocking Tuskegee Syphilis Study revelations, new governmental guidelines would be put in place to ensure vulnerable populations such as those warehoused in prisons, mental asylums, and orphanages would no longer be trafficked as unwitting test subjects. But ethical breaches—and the damage they inflict on research subjects—continued to occur. One of the more tragic was the much publicized case at the dawn of the 21st century concerning an Arizona teenager who came East to participate in a groundbreaking gene therapy experiment. The controversial case, as Robert Steinbrook would write in a Stanford University medical publication, “shook the confidence of the public and the federal government in the competence and ethics of clinical research and the institutions where they work and led to efforts to improve the protection of research participants.” 

Jesse Gelsinger was an outgoing 18-year-old high school student with an interest in wrestling and motorcycles, working part-time at a local Tucson supermarket. After some challenging years and uncomfortable restrictions, he had learned to live with his rare metabolic disorder: ornithine transcarbamylase deficiency (OTC). The disease prevents the body from breaking down ammonia, a metabolic waste product. The build-up of the product can cause death soon after birth, but Jesse had a comparatively mild case where a strict non-protein diet, daily medication, and constant monitoring of his health contributed to his leading a fairly normal life.  

(Jesse Gelsinger in June of 1999 in Philadelphia on the day he was interviewed about participating in the clinical trial. Photo by Mickie Gelsinger)

Cognizant of his own struggles and health limitations, and desiring to help newborns suffering from more deadly forms of OTC, Jesse volunteered for a University of Pennsylvania gene therapy experiment designed “to establish a safe dose of the vector—an adenovirus similar to the common cold virus” that would infect the patient’s liver cells and implant a new, healthy gene in the patient’s DNA passport. Jesse and the other seventeen test subjects would not benefit from their participation in the clinical trial, but Jesse was eager to contribute and be part of a cutting-edge scientific breakthrough. 

Eighteen hours after infusion Jesse developed cognitive problems and jaundice, symptoms not experienced by earlier test subjects who only displayed flu-like reactions. Soon after, he developed system inflammatory syndrome and a dangerous blood clotting disorder. Lung, liver, and kidney failure quickly followed. His entire system was shutting down. On September 17, 1999, just four days after the gene transfer, Jesse Gelsinger died

Jesse’s death shook the academic and medical research communities and received wide-spread media coverage. Governmental agencies and appointees were forced to respond. As Donna Shalala, Secretary of the United States Department of Health and Human Services under President Bill Clinton, put it, “the tragic death of Jesse Gelsinger focused national attention on the inadequacies in the current system of protection for human research subjects.” In January of 2000, the FDA suspended human research at the University of Pennsylvania’s Institute for Human Gene Therapy, and similar programs around the country were eventually shut down as well.

The many investigations that followed illuminated a number of unethical missteps that contributed to Jesse’s death. It was determined that the scientific version of “Russian roulette” contributing to a patient’s death might have been avoided if consent forms had been more accurate and if misrepresentations had not occurred. There was no mention, for example, of the deaths of rhesus monkeys in an earlier trial, nor the liver and toxicity damage suffered by earlier OTC trial subjects. There was also Jesse’s concerning pre-trial liver function tests, which should have excluded him as a test subject. And there was no detailed explanation of the financial windfall that James Wilson and the University of Pennsylvania would reap if their gene transfer project proved successful.

Since Jesse’s death quarter of a century ago, the field of gene therapy has recovered and scientific initiatives of all types including CRISPr, an advanced method of targeting and fixing damaged genes have emerged, garnering considerable institutional and financial support. Diseases such as Huntington’s, diabetes, cystic-fibrosis, hemophilia, multiple sclerosis, heart disease, and others still need to be conquered. But as observers succinctly argue about the nature of scientific research, after the normal laboratory and animal testing has been completed, “eventually you need humans” as test subjects.

That brings us back to the original dilemma. As Berkeley bioethics professor, Osagie Obasogie laments, “Contrary to hopes of human research reform spurred by Jesse Gelsinger’s death, oversight has flattened, profit motives have become more entrenched in medical research, and the pool of human subjects has come to focus on the vulnerable, both at home and abroad.” 

The Forever Orphan: Research Ethics

The Lancet’s commission recognizes, “Research in humans is inherently associated with potential conflicts between the production of new knowledge and the protection of potentially vulnerable subjects of research.” Doctors and experimenters working under the Nazi ethos “simply didn’t care about their victims’ humanity.” The same can be said of many of their American counterparts—and others around the world—who used the vulnerable as means to an end: for the advancement of knowledge and science. Too often members of the medical profession—even prominent members with celebrated reputations—traveled the dangerous road from “healing to harming.”

Distinguished post-Nuremberg Code researchers such as Chester Southam, Hilary Koprowski, James Ketchum, A. Bernard Ackerman, and Albert Kligman all took liberties with test subjects, placing them at risk. And all recalled no mention of the Code during their time in medical school. Research ethics in general was given short shrift. It is that sin of omission that The Lancet’s report hopes to rectify.

However, if The Lancet’s authors hope to build a “medical culture” based on “moral courage from individuals and professional groups” through ethics-centered instruction—or what they call “history-informed professional identity formation”—they will need to do more than issue a lengthy treatise on Nazi era crimes committed by physicians. In fact, one could argue that the well-intended report has already begun gathering dust on the shelves at medical school libraries. A report, no-matter how sobering and well-documented, cannot be expected to interrupt a long-standing culture based on self-interest and unrestrained human experimentation.  

Just as medical students need to learn anatomy, they must also learn medical history and that includes the egregious mistakes and dark chapters in the profession’s past. The attraction to Nazism, the lure of eugenics, and the ethical stains of Tuskegee, Holmesburg, Willowbrook, and the many others that blight the medical landscape should not be masked or avoided. Only then can physicians become the “change agents” and proper “stewards of professional ethics” that The Lancet desires. Knowing right from wrong, and valuing “truth-telling, whistleblowing, and ethical conduct” will require more than a well-crafted position paper.

Paul Gelsinger is a medical ethics advocate and the father of Jesse Gelsinger.

Allen M. Hornblum is a former criminal justice official and the author of several books on the use of vulnerable populations as test subjects, including Acres of Skin, Sentenced to Science, and Against Their Will (with Judith L. Newman and Gregory J. Dober). 

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