GM drug trial disaster / Eternal life battle / Echoes of Hwang (12/4/2006)


"I think it was misleading not to tell participants that that this drug was genetically engineered from hamster cells and that it was designed to alter their immune system."

All taken from BioEdge

Although British authorities say that a drug trial which made six healthy young men violently ill was conducted properly, critics have savaged their informed consent form. The drug, TGN1412, was a monoclonal antibody, a promising type of treatment which has seldom been approved for humans.

Bioethicists claim that the document did not sufficiently inform participants of possible dangers and did not depict the treatment as a novel drug that could harm the body's immune system. The 13-page form also appealed to the subjects' need for money and threatened to withhold their GBP2,000 payment if they withdrew early.

The drug company "failed to adequately disclose the degree of uncertainty around a first-in-man trial," said Michael Goodyear, a Canadian cancer physician and research ethicist. "The risks were well known. They're not disclosed in the consent form."

Goodyear and two other medical ethicists assessed the study's risk-disclosure form for Bloomberg News. Parexel, a US company which conducts clinical trials for pharmaceutical companies, has declined requests to release the document. TeGenero, the small German biotech which designed the drug, says it did not have a copy. The bioethicists had several gripes, according to Bloomberg:

*the financial penalties for not cooperating were daunting. "If you leave the study and exercise your right not to give a reason or are required to leave the study for non-compliance, no payment need be made to you," the document said. "That's very coercive language," says Greg Koski, 56, a physician and former head of the U.S. Office for Human Subject Protection.

*the volunteers were not told that 75% of them would receive the drug. US bioethicist Arthur Caplan says he considers it a major" ethical violation to withhold the actual chance of receiving the drug. "The subjects needs to be able to say these aren't odds I want," he told Bloomberg.

*the description of possible side effects was misleading. The consent form says that TGN1412 was designed to treat arthritis, other inflammatory illnesses and leukemia and that it had "no significant side effects" in animals. "I think it was misleading not to tell participants that that this drug was genetically engineered from hamster cells and that it was designed to alter their immune system," Goodyear commented. "Reasonable people would think twice before allowing an experimental drug to change their immune system."

*the form mentioned the possibility of a "cytokine burst" which it described as "a hives-like allergic reaction". In fact, this is what damaged the men's immune system. "Since monoclonal antibodies are known to cause Cytokine Release Syndrome, which can be fatal, and Parexel was even planning for this, the subjects should have been warned," Goodyear says. "They might have decided the risk wasn't worth GBP2,000." - Bloomberg, Apr 10


[image caption: "At 167, he will still be an ace. "] Immortality beckons, says Ronald Bailey, science editor of Reason, an influential American libertarian magazine, and the partisans of mortality are powerless to stop it. Writing in the London Times, he predicts a 20 to 40-year extension of the average life span by 2050. And by the end of the century he predicts five-generation picnics with great-great-great grandmas playing tennis at the age of 150. He looks forward to "human bodies and minds enhanced by advanced drugs and other biotherapies; the conquest of most infectious and degenerative diseases; and genetic science that allows parents to ensure that their children will have stronger immune systems, more athletic bodies and cleverer brains. Even the possibility of human immortality beckons."

But there is a hitch: malign forces from the Dark Side are working to scupper Bailey's dream. "An extraordinary coalition of left-wing and right-wing bio-conservatives is resisting the biotechnological progress that could make it a reality. Forget Osama bin Laden and the so-called clash of civilisations. The defining political conflict of the 21st century will literally be the battle over life and death," he writes.

What Bailey is referring to is scepticism on both right and left (if those tags are appropriate) not just about whether immortality is feasible, but even if it is desirable. Daniel Callahan, a leading US bioethicist, has declared, "there is no known social good coming from the conquest of death". And Dr Leon Kass, former head of the President's Council on Bioethics, says, "the finitude of human life is a blessing for every human individual, whether he knows it or not".

In Bailey's future, organs can be regenerated and "antisocial tendencies and crippling depression will all be managed by individual choice through biotech pharmaceuticals and even generic treatments". Fanciful as this vision may seem, it is being taken seriously and is even being described as a moral obligation in some circles. "The highest expression of human nature and dignity is to strive to overcome the limitations imposed on us by our genes, our evolution and our environment," writes Bailey. - London Times, Apr 8


The leading journal Nature is getting abundant experience in dealing with scientific fraud nowadays. Hard on the heels of an investigation into the cloning research of disgraced Korean stem cell scientist Hwang Woo-suk, Nature has discovered that several papers from a Japanese laboratory were probably faked.

The problem came to light last year when the RNA Society of Japan asked Tokyo University to investigate a dozen papers from a lab run by biochemist Kazumari Taira, following complaints from other researchers. Taira and his co-author Hiroaki Kawasaki were unable to supply some data -- because of bad record-keeping and computer failure, Taira said. And then it appears that Kawasaki faked the data which he did supply. This was detected because he allegedly used software which was not available in 2003 when the experiment was conducted.

Now the university has decided that there is a "high possibility" that a dozen papers on RNA technology from Taira's lab have been faked. According to a March 29 statement, the papers had "no reproducibility and no credibility". Taira has already asked that five of his papers be retracted, although Kawasaki has refused to do so. A university committee is to submit a report on the scandal this week. - Nature, Apr 6

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