July 31

TGN1412 Deadly Drug Trial Victims Told To Expect Early Death

The Sunday Times reports (below) that the victims of the deadly TGN 1412 experiment have been told that the toxic effect of a single dose of this monoclonal antibody face contracting cancer and other fatal diseases as a result.

The revelations about this experiment provide a jolting lesson in reality: they shed light on the secretive world of a largely unregulated human experimentation industry. Contrary to public perception, there is no reliable "human subject protection system." The current system of institutional review boards (research ethics committees) offers little protection for patients / subjects: its primary function is to protect the institution and its research staff from liability. IRBs routinely rubber stamp approval on experiments that play Russian roulette with human lives–not out of malice–but to speed up the drug development process for greater profitability and market expansion

An example of a dubious drug experiment was conducted at Yale University. The drug, olanzapine (Zyprexa), is an atypical antipsychotic whose label warnings–including a black box–warn about lethal drug effects, including diabetes. See: http://www.alexanderlaw.com/zyprexa/side-effects.html  Eli Lilly, the manufacturer, paid $700 million to settle a lawsuit involving 8,000 plaintiffs–some of who died as a result of the drug.

The full impact of adverse consequences from the exposure of the young adolescents in Yale’s experiment will likely not fully be known at the experiment’s conclusion.  Adverse drug effects don’t always present immediately upon ingestion–they often emerge much later.

The next time a doctor asks you to be a "participant" in a drug trial or "study," think twice, and become informed.
Ask the doctor what guarantees he / she is willing to sign his/her name to?
Ask what is actually known about the substance you are being asked to test?
Ask if and how much the doctor has to gain from the experiment?

Before signing ANY informed consent to research document get informed. A few suggested questions can be found at: https://ahrp.org/InformedConsent/InformedConsent.php

Commenting about the TGN 1412 catastrophic experiment, Dr Ezekiel Emanuel, Chief of Clinical Bioethics at the US National Institutes of Health (NIH) was quoted in the International Herald Tribune, (April)  stating:  "This is a terrible tragic event but so far I don’t see any clear ethical problems."

We applaud the Health Care Renewal blog to which a group of physicians post, for reminding readers that "Emanuel formerly expressed indignation when the NIH made conflict of interest rules more stringent, so that his secretary would no longer be allowed to keep stock holdings in health care companies worth more than US $15,000, as noted in this post."

Health Care Renewal: "Addressing threats to health care’s core values, especially those stemming from concentration and abuse of power."

Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org
The Sunday TimesJuly 30, 2006
Elephant Man drug victims told to expect early death
David Leppard

VICTIMS of the disastrous “Elephant Man” drugs trial have been told they face contracting cancer and other fatal diseases as a result of being poisoned in the bungled tests. One of the six victims was told last week he is already showing “definite early signs” of lymphatic cancer.
He and three others have also been warned that they are “highly likely” to develop incurable auto-immune diseases.

The men were paid £2,000 each to volunteer as human “guinea pigs” in the trial at Northwick Park hospital, northwest London, last March. They suffered heart, liver and kidney failure and were left seriously ill after being given TGN1412. The drug was made by TeGenero, a German firm.

The men had been told by doctors they would not suffer any life-threatening illnesses.

Nav Modi, 24, whose bloated face and swollen chest led to the nickname “Elephant Man”, said he did not know how long he would live.
“It’s a really bizarre feeling when you discover you might be dead in a couple of years or even in a couple of months,” he said. “I feel like I’ve given away my life for £2,000.”

Modi’s lawyer, Martyn Day, of Leigh Day solicitors, said the four victims he was representing were considering legal action against Parexel, the firm that ran the trial. He believes they are eligible for up to £5m in damages. The company denies responsibility for the outcome of the trial.

The Sunday Times has seen the medical assessment of four of the victims, completed last week by immunologist Professor Richard Powell.
According to Powell, one man, known simply as Patient A, “has definite early signs that a lymphoid malignancy is developing”.


Saturday, April 08, 2006
The TGN 1412 Trial "Raises a Number of Big Red Flags"

We previously posted about the disastrous trial, implemented by Parexel International , of a new monoclonal antibody designated TGN 1412, manufactured by TeGenero AG. All six healthy volunteers who got the antibody soon became critically ill (see our most recently here). The International Herald Tribune has done some investigative reporting on this trial.

First, the Tribune confirmed that TeGenero, the manufacturer of TGN 1412, was aware prior to the trial of the possibility that subjects might undergo "cytokine release syndrome" after taking the drug. This syndrome had apparently been observed in some animal testing, although the species of primates tested did not manifest the syndrome. TeGenero, however, felt that this reaction was "not expected," in the human trial.

The Tribune interviewed a survivor of the trial, who stated:

He believed "he was participating in a fairly standard trial of a painkiller like ibuprofen, for arthritis."
He said that "the novelty of TGN 1412 never came up in upbeat pre-trial briefing, adding: "I had no idea it altered the immune system.’"
"At Parexel’s orientation meeting there was little time to read the study’s 11-page consent form before signing, Rob O. said. Headaches and bruising were listed as potential side effects, as well as the possibility of a severe allergy. But that risk was downplayed."
Once the trial was underway, the investigators continued to dose subjects even after the first subjects had started to experience adverse effects. "About the time Rob. O’s infusion started, at 9:10 am, the first patient had actually passed out in the adjacent room…." charged one of the subjects’ attorneys.
Since the trial, "the companies [TeGenero and Parexel] have been unwilling to meet with the trial subjects or provide more data…."
The Tribune quoted Dr Michael Ehrenstein of University College London, who said that human research on TGN 1412 was "a high risk strategy." Michael Goodyear, described as an oncologist and medical ethicist at Dalhousie University, Halifax, Nova Scotia, Canada, said that the conduct of the trial "raises a number of big red flags."

Nonetheless, Dr Ezekiel Emanuel, Chief of Clinical Bioethics at the US National Institutes of Health (NIH) , said "This is a terrible tragic event but so far I don’t see any clear ethical problems." (Note that Emanuel formerly expressed indignation when the NIH made conflict of interest rules more stringent, so that his secretary would no longer be allowed to keep stock holdings in health care companies worth more than US $15,000, as noted in this post.)

In my humble opinion, this newspaper article raises further serious questions about whether research subjects were adequately informed about the nature of the trial and its possible risks, and why the investigators continued to administer the drug after the first subjects had begun to experience adverse effects.

Hopefully, further investigations will afford more transparency, and will lead to improved conduct of trials that put the interests of patients ahead of the imperative to "speed your product through clinical development." (The latter phrase is currently a promise made by Parexel on its web-site.)posted by Roy M. Poses MD at 11:56 AM

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