Martyrs to Science? When Research Participants Die

By Neuroskeptic | December 29, 2015 4:40 am

In a short piece for the American Medical Association Journal of Ethics, Susan E. Lederer discusses what happens when research participants die in the course of medical research.

doctormask

Lederer opens by noting that in the 1950s, little outrage greeted the reports of deaths among volunteers. For instance:

In March of 1952 James S. Leedom (known as “Stan”) was an 18-year-old freshman honors student at Seattle University, and one of 40 volunteers in a University of Washington study of the safety of blood storage. Leedom received a transfusion of blood that had been preserved for more than three weeks and had become inadvertently contaminated with bacteria. He died three days later. In the newspaper reports about Leedom’s death, two themes were repeated: the safety of the research and the absence of blame.

First, the investigators expressed their confidence in the research project. Although Robert Williams, chair of the department of medicine, and hematologist Clement Finch could not explain how the student had received contaminated blood, each informed reporters that they “would gladly participate in the same experiment tomorrow”. But the response of Leedom’s father was more surprising. When he was interviewed by reporters, Stanley Leedom explained that he held no one at fault in the research. “I don’t blame anyone for this” he said. “I just don’t want this tragedy to deter in any way from the blood donor program or these experiments”

Lederer points out that more recent participant fatalities have tended to draw much stronger reactions. Take, for instance, the 1999 death of Jesse Gelsinger:

In 1999 Jesse Gelsinger, an 18-year-old man with a rare metabolic disorder, died in a clinical trial of gene therapy at the University of Pennsylvania… Gelsinger’s death, the first recognized death from gene therapy trials, prompted suspension of similar trials, numerous public inquiries, and a lawsuit that resulted in fines for the University of Pennsylvania and the Children’s National Medical Center.

A watershed in attitudes towards research deaths came in 1966, Lederer says, with Henry K. Beecher’s paper “Ethics and Clinical Research“. Beecher criticized 22 experiments in which participants had been exposed to risk without informed consent.

Among the worst of these cases was a trial in which 157 patients suffering from typhoid fever were denied an effective antibiotic treatment, chloramphenicol. 23% of them died. In the participants who did get antibiotics, just 8% died. Beecher calculated that 23 people died as a direct result of the experiment.

Lederer notes that in an earlier draft of the paper, Beecher went even further, calling the victims “martyrs to science” – a phrase that had previously been applied to those scientists who had died in the course of their studies.

ResearchBlogging.orgLederer SE (2015). Dying for Science: Historical Perspectives on Research Participants’ Deaths. AMA Journal of Ethics, 17 (12), 1166-71 PMID: 26698591

CATEGORIZED UNDER: ethics, history, papers, select, Top Posts
ADVERTISEMENT
  • http://nonsignificance.blogspot.com non_sig

    So what is your opinion on the deaths and the (increased) reaction to them?
    (Sorry if I missed it.)

    Personally I think it depends on how predictable the death (or harm) was, whether or not all security measures that where reasonably possible were taken, on the goals of the study and how realistic they were, if the consent was truly informed and other things (that don’t come to my mind atm).

    I can’t judge on these studies but I think that accidents can always happen so no study (and in general no activity) can be completely without risk. Taking part in a study is most likely a greater risk than not taking part in one (apart from when no other treatment than that studied is available/helpful & maybe some other exceptions) but the participants should be honestly informed about risks associated with and potential benefits of the study so that they can weigh this themselves. But I think that potential benefits (for the individual, a group of people, e.g. patients or in case of basic research for gain of knowledge and thereby potential future people/patients/societies) are often exaggerated and that this doesn’t allow for informed consent anymore. The same if the risks are downplayed, of course.

    • http://blogs.discovermagazine.com/neuroskeptic/ Neuroskeptic

      “But I think that potential benefits (for the individual, a group of people, e.g. patients or in case of basic research for gain of knowledge and thereby potential future people/patients/societies) are often exaggerated and that this doesn’t allow for informed consent anymore”

      I agree. Although the benefits of any given study are ultimately unknowable because any study might, in theory, indirectly lead to great and unexpected benefits. Only in retrospect can we identify which studies were most important.

      But research volunteers should be informed of this uncertainty, and not led to believe that a certain basic research experiment will have some kind of direct benefit for our understanding of certain diseases etc.

    • Peter Aleff

      The alleged medical concern for the safety of research participants and for informed consent is a Potemkin facade with nothing behind it. This is best illustrated by the SUPPORT baby-asphyxiating experiment that was conducted from 2005 to 2009 in 23 U.S. hospitals on 1316 premature babies. These were assigned to either high oxygen breathing help or the knowingly fatal low-oxygen group. The researchers had estimated beforehand that 4 percent of the babies in that group would either die or suffer severe brain damage. Indeed, 23 “extra” babies died in that group, or 3.5 percent, whereas the brain damage has not yet been published. The probability of this correlation was computed as 96 percent.

      When I brought the pre-Nuremberg-Code “ethics” in that experiment to the attention of the “Office for Human Research Protection”, they took two years to find out that the “informed consent” forms had lied to the parents by omitting any mention of the well-known risks, but they did nothing about the deliberate killing of the 23 suffocated babies.

      Moreover, the Universities led by the Chair and the Vice Chair of the President’s Commission of the Study of Bioethical Issues had both participated in this deliberately murderous experiment which was published in the NEJM in May 2010. Yet a couple of years later, while the tallying of the brain damage was still going on, that same Commission falsely reassured the President and the American Public that such risks from medical research were now improbable because the rules about informed consent protected current research subjects. This was a blatant lie by that Commission, but they never got called on the carpet for it.

      Moreover, a U.S. District Judge in Alabama recently dismissed the malpractice suit against the trial leader in Birmingham, Alabama, by the parents of three babies harmed in that experiment. She accepted the defendant’s claim that all the damage was due only to prematurity, and that therefore even the lack of informed consent was irrelevant. However, the SUPPORT study had used the same protocol of withholding a known remedy from subjects kept in the dark about the risks that was used in the rightly infamous Tuskegee syphilis study, centered a mere two hour drive from Birmingham.

      President Clinton apologized publicly on behalf of the U.S. for that unethical Tuskegee study and established the Bioethics Center at the University of Tuskegee to assure the “never again” promise in his apology. That much touted Center got millions of dollars to do its job but the only accomplishment mentioned on its website is the creation of a small memorial garden with a plaque featuring that “never again” rhetoric. Yet, its faculty were notably absent from the 45 medical signatories of a protest paper against the absence of informed consent in the knowingly baby-killing SUPPORT experiment.

      For more info on this miscarriage of alleged medical ethics in the present-day U.S., and the documentation of the above assertions, see http://retinopathyofprematurity.org/62RelapseToPreNurembergCodeBioethics.htm and the other relevant pages on that site.

      The current claims of the medical research establishment about concern for human participants are simply a dishonest smokescreen to hide the conscious return to the Nazi-doctor practices prohibited by the Nuremberg Code and Helsinki Declarations of medical ethics as well as U.S. Federal Regulations.

  • http://www.mazepath.com/uncleal/qz4.htm Uncle Al

    We enjoy an abundance of capital crime-convicted criminals. I do not favor execution (IV administer 5 mg of etorphine). I favor medical disassembly. “martyrs to science” get 72 snickerdoodles in heaven. Let’s get these boys fed.

  • Pingback: Martyrs to Science? When Research Participants Die – Neuroskeptic | the neuron club()

  • Pingback: Sleep Deprivation Alters Brain Connectivity | Breaking World News()

  • Pingback: “Martyrs to Science? When Research Participants Die” - Mad In America()

NEW ON DISCOVER
OPEN
CITIZEN SCIENCE
ADVERTISEMENT

Neuroskeptic

No brain. No gain.

About Neuroskeptic

Neuroskeptic is a British neuroscientist who takes a skeptical look at his own field, and beyond. His blog offers a look at the latest developments in neuroscience, psychiatry and psychology through a critical lens.

ADVERTISEMENT

See More

@Neuro_Skeptic on Twitter

ADVERTISEMENT

Discover's Newsletter

Sign up to get the latest science news delivered weekly right to your inbox!

Collapse bottom bar
+