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Jesse Gelsinger: Sacrificed To Greed?

Twenty hours after being injected with a modified adenovirus, the same one that causes the common cold, eighteen year-old Jesse Gelsinger developed jaundice, and sank into a coma. As his organs began to fail at an accelerating rate, he was placed on life support. Three days later, the vibrant young man was brain dead. As members of his family watched, he was removed from life support and died.

His death never should have occurred. That it did stands as silent testimony to the way the influence of money and lust for power has corrupted the conduct of medical research in America. It also is a warning of what the future may hold if this corruption is allowed to continue unabated.

He Just Wanted To Help

An altruistic young man, Jesse had agreed to participate in a gene experiment that promised to lead to a cure for a rare disorder he had called ornithine transcarbamylase deficiency, or (OTC). About one infant in 40, 000 is diagnosed with the genetic disorder, which prevents the liver from metabolizing ammonia. It is fatal for infants born with the most severe form of the condition.

Jesse knew that the clinical trial he was enrolled in would not cure him, but he was anxious to participate in the hope that it might help others. What he did not know was that finding a cure for OTC was merely an excuse to run experiments with other, far-reaching financial implications. It is not too much to say that Jesse was sacrificed on an altar of greed. It also illustrates the amorality that permeates many of our nation’s most respected academic institutions and the failure of either the government or the media to call them to task for that amorality -- even where it costs human lives.

The Race To Cash In

In September 1990, Dr. W. French Anderson injected white blood cells into a four year-old girl who suffered from a genetically based immune deficiency. The cells had been altered to contain the gene that she lacked. With this action, he created that decade’s Holy Grail of Medicine. The multi-billion dollar race to develop gene therapies for a wide range of disorders was on. Jim Wilson, a biologist at the University of Pennsylvania was determined to win that race.

Wilson founded Genovo Inc. in 1992, to develop new gene therapies. Within seven years the firm would have over $22 million in funding, roughly a quarter of which went to underwrite the Institute for Human Gene Therapy at the University of Pennsylvania. He would soon be recognized as a leader in genetic research. For Genovo, however, the question was where to concentrate its efforts.

Once a decision was made concerning the condition that would be targeted in their experiment, the next key decision was how to deliver the bio-engineered genes. Wilson and his collaborators thought the choice was obvious: the adenovirus, the same one that infects you when you get a cold.

The trouble was, in other gene experiments using the adenovirus as a carrier, subjects experienced serious side effects. Indeed, one experiment attempting to find a gene therapy for cystic fibrosis had to be cancelled when a patient’s lungs became inflamed.

By 1993, Genovo was conducting experiments on mice with OTC. Therapies that work in mice, however, do not always work in humans. To get some indication of how safe a therapy might be in human subjects it must first be tested on higher species, specifically primates. Here, the results were less encouraging.

Safety studies were conducted on baboons and rhesus monkeys. All four of the monkeys developed severe inflammation of the liver, and blood clotting disorders when treated with the first version of the virus.

Questions About Penn’s Animal OTC Studies

Even more shocking, an FDA investigation found that the animal studies, which served as a basis for the later human trials, were fraught with deficiencies and violations of the rules.

In a fifteen-page letter to the University, the FDA cited a broad range of specific examples including:

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  • Violations of the research protocol for the project explained away as “amendments” to the design that were not written until long after the actual experiments were completed.
  • Failure of researchers to properly dilute the viruses used in some of their animal studies.
  • Use of viruses that were more than two years old, and that had past their expiration dates.
  • Understating the degree of liver damage experienced by the experimental animals.
  • Inconsistencies in pathology reports. In one instance a report stated that a monkey had been euthanized, while another lab report said the animal had been “found dead.” Since the deaths of monkeys during these experiments had predicted the complications Jesse Gelsinger experienced, any information concerning their demise would be particularly important.

The NIH conducted tests of a strain of adenovirus closely related to the one Wilson’s group was using on macaque monkeys. All of the test animals fell seriously ill and while they recovered, one suffered permanent liver damage. In a German study using rabbits, the adenovirus caused symptoms identical to those that eventually killed Jesse.

It wasn’t just animal experiments with the adenovirus, which demonstrated deadly potential. An experiment at the University of California sponsored by the Schering-Plough Corporation, in which terminal cancer patients had their livers infused with an adenovirus ultimately was cancelled due to adverse effects.

Questions And Concessions

Because of reports about adverse events such as these, two reviewers on the Recombinant DNA Advisory Committee (RAC) who were overseeing the proposed experiment became concerned about the potential risks of Wilson’s study.

Indeed, they were so concerned due to the deaths of the animals in his earlier tests that they felt the therapy should not be tested on asymptomatic volunteers and recommended against the trial. Wilson, however was not about to give up. To mollify them, he made certain concessions to the reviewers.

Among them was the concern about how subjects were going to be recruited. Wilson agreed to recruit only through their physicians.

Despite this promise, in 1997, one of Wilson’s co-investigators, Mark Batshaw, wrote articles for the National Urea Cycle Disorders Foundation newsletter (the publication of the organization concerned with OTC) recruiting volunteers. The articles also appeared on the group’s website. One person who saw them was young Jesse Gelsinger’s pediatric geneticist.

It was Batshaw’s articles that led Jesse Gelsinger to the Genovo experiment.

Ignoring The Rules With Fatal Consequences

From the moment Jesse heard about the OTC study, he wanted to volunteer. But, before Jesse could be accepted, he had to be tested. The study’s rules required that test subjects had a blood-ammonia level below 75 micromoles per liter, and that they were otherwise in good health. Initial tests conducted in Philadelphia on his eighteenth birthday showed Jesse’s blood -ammonia level was 47, well within the study limits. Excited now, he flew home and waited for the call to come back and be infused with the adenovirus.

Jesse arrived at the University of Pennsylvania hospital on September 12, 1999, to begin the treatment. He was assured that other patients had received the same dose he was going to get with no serious complications. But, when Jesse’s blood was routinely tested prior to the infusion, his blood-ammonia level was 91, higher than the study rules permit.

The doctors overseeing the trial decided to ignore the rules and proceeded with the infusion. Initially, it appeared that the treatment was working. Jesse’s blood-ammonia level fell to 60. Jesse also felt nauseous and had a high fever, but the doctors were not concerned. Other patients taking the treatment had the same reaction.

Roughly twenty hours into the experiment, on the morning of September 14, it was apparent that something was seriously wrong. Jesse was showing signs of liver toxicity. His skin had the yellowish hue that indicated he had developed jaundice. Doctors ordered a blood test of Jesse’s bilirubin, a byproduct of the breakdown of red blood cells. The test confirmed their worst fears. Jesse’s bilirubin was four times normal. This meant that either Jesse’s liver was failing, or that his red blood cells were breaking down faster than his liver could metabolize them. The latter condition was the same type of clotting disorder that had killed the monkeys in the earlier experiments.

By the afternoon of the 14th, he had slipped into a coma. As the evening advanced, things got progressively worse. Although Jesse’s blood-ammonia level had initially dropped, it was spiking out of control now. By 11:30 it had reached 393 micromoles per liter (eleven times the normal level). His doctors decided to put him on a kidney dialysis machine. That helped some, but not enough, because now, other things were going wrong.

Jesse was put on a ventilator, and given a drug to relax his lungs. Even at 100 percent oxygen though, he wasn’t getting enough. A liver transplant was considered, but Jesse wasn’t a good candidate. Desperate to keep oxygen flowing to Jesse’s brain, the doctors decided to take a radical step: Extracorporeal membrane oxygenation or ECMO. This was a procedure where an external mechanical lung is used to remove carbon dioxide from the blood and add oxygen. It had only been used on about a thousand patients, and half had died.

By September 16th, Jesse was slipping into a cascading multiple organ failure. By Friday morning, Jesse was brain dead. His father called for a chaplain. After a brief service, Jesse’s life support was removed and he died.

Uninformed Consent

One of the most basic protections for participants in medical research trials is the notion of “informed consent.” Volunteers are supposed to be told about all the risks they face, even the relatively remote ones. Formal requirements for informed consent as well as for the voluntary participation to which they are essential date from the Nuremberg Trials that followed the horrific Nazi experiments of World War II.

Researchers at the University deliberately omitted key information from the consent form Jesse Gelsinger signed, not the least of which was any reference to the deaths of rhesus monkeys from the same condition that eventually cost his life. Can there be any doubt that the omission could only have been intended to lull prospective participants into a false sense of security?

A later investigation would reveal just how extensive the cover-up had been.

Shocking Revelations

Dr. Steven A. Masiello, Director of Compliance and Biologics for the Department of Health and Human Services addressed a scathing letter to Mark Batshaw on November 30, 2000, noting:

“ … Study documents show that you had a pivotal role in the conduct of the study. Although you were not responsible for all aspects of the study, you were in a position to influence how the study was conducted. The violations listed below do not reflect all of the deficiencies of the study, but identify those for which you bear some responsibility.”

What followed was a list of some twenty major violations of law and regulation in the gene therapy experiment that killed Jesse Gelsinger. Among the most serious of these were enrolling volunteers who should not have been accepted and failing to notify the Penn Institutional Review Board of serious adverse events that should have caused the study’s termination.

As it turns out, it was not just the Institutional Review Board or Jesse who were kept in the dark. On February 2, 2000, Delores Aderman, also a volunteer in the Penn OTC study reported that she too had experienced serious liver damage from the experiment, although unlike Jesse she recovered. At the time the adverse event occurred, however, researchers concealed it from her saying “everything went good.” She only realized what had happened after she read news reports about the experiments following Jesse’s death and was able to piece together the truth. She is outraged at the deception.

The Truth About Gene Therapy Experiments Comes Out

Before the death of Jesse Gelsinger it was widely accepted in the general public that gene therapy was safe, if as yet unproven. After all, nearly 4, 000 patients had participated in experiments involving genetic material, and Jesse apparently was the first individual to suffer from serious consequences. In the days and weeks following the tragedy at Penn, however, it became clear just how wrong that impression really was.

As a result of Jesse’s death, researchers affiliated with Harvard University revealed that three of the first seven participants in a gene therapy experiment they were conducting had died, and another had suffered serious adverse effects. The Boston hospital where the research was taking place had halted the research the previous summer, but despite the requirement that adverse events be reported “immediately” it was not until the events at Penn provoked a public furor that the ones in Boston were reported. But they were just the beginning.

Reports of adverse events, including deaths connected to gene therapy experiments poured in to federal regulators. By the end of January, 2000, the total number reported had risen to 691, of which 652 were not submitted until after the tragedy in Pennsylvania. This meant that less than 6 percent had been filed in a timely manner as required.

This was more than just a paperwork problem. And what of the victims?

Paul Gelsinger, Jesse’s father told a Senate Committee:

“… It looked safe. It was presented as being safe. Since it would benefit everybody, I encouraged my son to do this. … I was misled. That’s what hurt the most. This was not as it was presented.”

Perhaps the most disturbing aspect of the Gelsinger affair, is the fact that those most responsible for his death seem to have escaped any culpability.

Targeted Genetics Inc. announced on September 20, 2000, that it was acquiring Wilson’s company Genovo Inc. in a deal with an estimated value of $91 million. Crime may not pay, but breaking federal rules apparently does.

(For a more detailed review of the experiment that killed Jesse Gelsinger see Cancer Cover-Up published by Cassandra Books at

portrait-Kathleen-Deoul-150x150About Kathleen Deoul

Internationally acclaimed wellness advocate Kathleen B. Deoul founded Cassandra Books. In taking this step, Kathleen hopes to bring her message of health and hope to people all over the world. Full profile

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