Ten Years Later: Jesse Gelsinger’s Death and Human Subjects Protection
Research

Osagie Obasogie

, 10/22/2009

Ten Years Later: Jesse Gelsinger’s Death and Human Subjects Protection

(Research) Permanent link

Last month marked the tenth anniversary of Jesse Gelsinger’s death. While perhaps not quite a household name, Gelsinger is vividly remembered among many medical researchers. His death during a gene therapy clinical trial in September 1999 rocked the field like nothing else since the Tuskegee experiments. But sadly, the questionable research practices that led to Gelsinger’s death have only become more troublesome in the past decade. Indeed, protections for clinical trial participants seem to be waning at the very moment they are needed most.

Gelsinger suffered from orinthine trascarbamlase deficiency (OTCD), a rare metabolic disorder that prevents the body from breaking down ammonia. Many children with OTCD die at a young age, but Gelsinger had a mild version and led a fairly normal life through medicine and a special diet. Since a single-gene defect is responsible for OTCD, researchers considered it a prime candidate for gene therapy, a still-experimental treatment that attempts to replace defective genes with normal ones.

Gene therapy was the embryonic stem cell research of the 1990s; its ability to cure was thought to be boundless and the hype was astronomical. Its promise was both therapeutic and financial: billions of dollars stood to be made from curing diseases as rare as OTCD and as common as cancer, leading several companies to invest millions in the technology.

Gelsinger enrolled in an OTCD clinical trial at the University of Pennsylvania as an altruistic measure. He knew he would not benefit from the study himself, but wanted to help those with more severe cases. The researchers sold the clinical trial to Gelsinger and his family as a relatively safe test of a new mechanism to deliver healthy OTC genes to patients’ livers.

However, shortly after the researchers injected Gelsinger with the replacement genes his ammonia levels skyrocketed. Within a few days, he suffered brain damage and organ failure, and was in a coma. His family then removed him from life support. He was 18 years old.

The Gelsinger family initially took Jesse’s death as an unfortunate and unforeseeable event; they held no grudge against the Penn researchers and continued to support their efforts. But a series of revelations in the following weeks quickly eroded this goodwill – and threw the gene therapy field into a whirlwind.

At the center of this turmoil was the information gap between researchers and patients that can quickly turn a volunteer into a victim. What constitutes informed consent? And what’s relevant to a patient’s decision to participate in a clinical trial? Penn’s clinical trial was seriously lacking in at least three respects.

First, although Gelsinger and his family were under the impression that the pre-clinical animal studies had affirmed the trial’s safety, two monkeys had actually died. This information appeared on the consent form submitted to the National Institutes of Health review board, but did not appear on the form signed by Jesse.

Moreover, the Penn researchers did not disclose to either the Gelsingers or federal regulators that human volunteers in the same study had suffered adverse reactions – side effects serious enough to have halted the trials had they been reported. Not reporting adverse events in gene therapy clinical trials is clearly wrong, but it seems to have been par for the course in the 1990s: evidence collected shortly after Gelsinger’s death showed that fewer than six percent of adverse events associated with gene therapy were properly reported at this time.

Lastly, the lead researcher in the Penn study – James Wilson – did not disclose to the Gelsingers that he was conducting the clinical trial with a private company in which he had a stake. Wilson had a direct financial interest – not merely an academic one – in the trial’s successful outcome. In fact, documents and press releases discovered by then-Washington Post reporters Deborah Nelson and Rick Weiss showed that Wilson’s company had attracted significant investments. If Wilson could devise a way to deliver good versions of the OTC gene to Gelsinger and others like him, his company could then patent the gene delivery system and use it to try to cure other, more common genetically linked disorders, such as cancer. Wilson stood to make millions.

Jesse Gelsinger’s death highlights the dire consequences that can result when patients’ vulnerabilities run up against researchers’ scholarly – and yes, financial – ambitions. Jesse may have thought twice about participating in the clinical trial had any one of these three issues been disclosed, let alone all of them.

These failures to disclose important information – along with other violations of clinical ethics and standard research protocols – led the Food and Drug Administration to sanction and repudiate the Penn researchers. And Gelsinger’s family sued Wilson and others at Penn involved in the study, leading to an out-of-court settlement. Many thought, including Jesse’s father, that the revelations, government sanctions, and civil lawsuit would lead to widespread reform.

This has not come to pass. Indeed, things have moved in quite the opposite direction. More than ever, clinical trials are the lifeblood of the pharmaceutical and biotech industries. Profitability depends upon developing new drugs, which in turn depends upon continued testing on human subjects. It has been reported that 80 percent of all drugs tested on humans never receive FDA approval, and companies can lose as much as $5 million each day that a new drug’s approval is held up. Demand for quick, easy, and plentiful access to human test subjects has become insatiable as companies seek to swiftly move drugs from bench to trench.

This situation has led to a number of emerging and proposed research practices involving human subjects that are troubling. Not unlike the Gelsinger trial, they leverage information asymmetries and participants’ vulnerabilities to secure access to broader (and cheaper) pools of subjects.

First, a disproportionate number of human subjects are impoverished or undocumented workers. The practice of paying participants – often hundreds to as much as a few thousand dollars – suggests that the health risks stemming from clinical trials are largely shouldered by people who are doing it for the money. Selling your body to medical researchers is a way to make ends meet for a growing number of people, particularly during a recession. There’s even a new term for it: guinea-pigging.

For some, guinea-pigging is a way to get needed cash. For others, it’s simply a way to get some type of minimal health care. This situation is becoming increasingly common as the clinical trial industry looks to the developing world for more subjects. A recent report in the New England Journal of Medicine said that for the 20 largest American drug companies, one-third of their phase 3 clinical trials are performed completely outside of the U.S and that over 50 percent of the sites are foreign, with the developing world becoming a key destination. While this might provide an economic boom and offer some level of medical attention to the world’s poor, it may also promote a dynamic where thin human subjects oversight can give license to questionable research practices.

For example, Pfizer recently settled a lawsuit that stemmed from a clinical trial of Trovan – an orally administered antibiotic used to treat meningitis – during an outbreak in Nigeria. Running a clinical trial in the midst of an epidemic when a known treatment already exists would be unthinkable in the United States. Such practices raise serious ethical and legal questions that undercut the human rights sensibility permeating all human subject protections.

Prisoners are also becoming persons of interest for those conducting clinical research. Dramatic abuses in the past led to protections that restrict their participation in clinical research, but now there is a growing call to give researchers greater access to prison populations. In 2006, the Institutes of Medicine recommended that the federal government change current restrictions on enrolling prisoners in behavioral and biomedical research. But is it appropriate to expect prisoners to be able to provide “informed consent” for possibly risky clinical trials when they do not have the autonomy to decide, for example, when to go to bed or when to eat? 

In the midst of these efforts to expand the subject pool at what may be the expense of research protections, gene therapy – and the exuberance originally behind it – is making a comeback. Gene therapy is once again being pushed to the forefront of research agendas; recent advances include research on immune deficiency diseases and rare forms of blindness. But none have been as tantalizing as research out of Oregon where scientists have been able to swap the genes between monkey eggs as proof-of-concept that defective genes in the mitochondria can be replaced by healthy genes before being fertilized.

While this form of gene therapy is different from the delivery mechanisms tested in the Gelsinger trial, similar dangers – both known and unknown – are involved. And these scientists are not bashful about their ambitions. Lead researcher Shoukrat Mitalipov has said this research “can rapidly be translated into clinical trials for humans, and approved therapies.”

In many ways, we seem to be coming full circle. 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 potential human subjects has come to focus on the vulnerable, both at home and abroad. And the confidence behind recent attempts at gene therapy often exceeds the evidence for its safety and efficacy in humans.

Jesse Gelsinger did not die in vain. He remains a powerful symbol of why researchers must do right by the very subjects they depend upon and, moreover, why greater federal oversight of human research subjects is needed. But the 10-year anniversary of Jesse’s death is a sober reminder that much work remains if we are to prevent similar tragedies in the future.

Osagie K. Obasogie is an associate professor of law at the University of California, Hastings College of the Law, a visiting scholar at the University of California, San Francisco, and a senior fellow at the Center for Genetics and Society.

 

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