GMWatch: Drug Trial Consent Form Flawed.

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GMW: GM DRUG TRIAL DISASTER/ETERNAL LIFE BATTLE/ECHOES OF HWANG"GM WATCH" <infoWed, 12 Apr 2006 09:38:21 +0100GM WATCH dailyhttp://www.gmwatch.org---*CONSENT FORM FOR DRUG TRIAL DISASTER FLAWED, SAY CRITICS*POLITICAL BATTLE LOOMING OVER ETERNAL LIFE*ECHOES OF HWANG IN POSSIBLE JAPANESE FRAUD"I think it was misleading not to tell participants that that this drugwas genetically engineeredfrom hamster cells and that it was designed to alter their immunesystem."---All taken from BioEdgehttp://www.australasianbioethics.org/Newsletters/199-2006-04-11.htmlCONSENT FORM FOR DRUG TRIAL DISASTER FLAWED, SAY CRITICSAlthough British authorities say that a drug trial which made sixhealthy young men violently ill was conducted properly, critics havesavagedtheir informed consent form. The drug, TGN1412, was a monoclonalantibody, a promising type of treatment which has seldom been approvedforhumans.Bioethicists claim that the document did not sufficiently informparticipants of possible dangers and did not depict the treatment as anoveldrug that could harm the body's immune system. The 13-page form alsoappealed to the subjects' need for money and threatened to withhold theirGBP2,000 payment if they withdrew early.The drug company "failed to adequately disclose the degree ofuncertainty around a first-in-man trial," said Michael Goodyear, aCanadiancancer

physician and research ethicist. "The risks were well known.They'renot disclosed in the consent form."Goodyear and two other medical ethicists assessed the study'srisk-disclosure form for Bloomberg News. Parexel, a US company whichconductsclinical trials for pharmaceutical companies, has declined requests torelease the document. TeGenero, the small German biotech which designedthe drug, says it did not have a copy. The bioethicists had severalgripes, according to Bloomberg:*the financial penalties for not cooperating were daunting. "If youleave the study and exercise your right not to give a reason or arerequired to leave the study for non-compliance, no payment need bemade toyou," the document said. "That's very coercive language," says GregKoski, 56, a physician and former head of the U.S. Office for HumanSubjectProtection.*the volunteers were not told that 75% of them would receive the

drug.US bioethicist Arthur Caplan says he considers it a major" ethicalviolation to withhold the actual chance of receiving the drug. "Thesubjects needs to be able to say these aren't odds I want," he toldBloomberg.*the description of possible side effects was misleading. The consentform says that TGN1412 was designed to treat arthritis, otherinflammatory illnesses and leukemia and that it had "no significantside effects"in animals. "I think it was misleading not to tell participants thatthat this drug was genetically engineered from hamster cells and that itwas designed to alter their immune system," Goodyear commented."Reasonable people would think twice before allowing an experimentaldrug tochange their immune system."*the form mentioned the possibility of a "cytokine burst" which itdescribed as "a hives-like allergic reaction". In fact, this is whatdamaged the men's immune system. "Since

monoclonal antibodies areknown tocause Cytokine Release Syndrome, which can be fatal, and Parexel was evenplanning for this, the subjects should have been warned," Goodyearsays. "They might have decided the risk wasn't worth GBP2,000." -Bloomberg, Apr 10POLITICAL BATTLE LOOMING OVER ETERNAL LIFE[image caption: "At 167, he will still be an ace. "] Immortalitybeckons, says Ronald Bailey, science editor of Reason, an influentialAmerican libertarian magazine, and the partisans of mortality arepowerless tostop it. Writing in the London Times, he predicts a 20 to 40-yearextension of the average life span by 2050. And by the end of thecentury hepredicts five-generation picnics with great-great-great grandmasplaying tennis at the age of 150. He looks forward to "human bodiesand mindsenhanced by advanced drugs and other biotherapies; the conquest of mostinfectious and degenerative diseases; and genetic

science that allowsparents to ensure that their children will have stronger immune systems,more athletic bodies and cleverer brains. Even the possibility of humanimmortality beckons."But there is a hitch: malign forces from the Dark Side are working toscupper Bailey's dream. "An extraordinary coalition of left-wing andright-wing bio-conservatives is resisting the biotechnological progressthat could make it a reality. Forget Osama bin Laden and the so-calledclash of civilisations. The defining political conflict of the 21stcentury will literally be the battle over life and death," he writes.What Bailey is referring to is scepticism on both right and left (ifthose tags are appropriate) not just about whether immortality isfeasible, but even if it is desirable. Daniel Callahan, a leading USbioethicist, has declared, "there is no known social good coming from theconquest of death". And Dr Leon Kass, former head of

the President'sCouncilon Bioethics, says, "the finitude of human life is a blessing for everyhuman individual, whether he knows it or not".In Bailey's future, organs can be regenerated and "antisocialtendencies and crippling depression will all be managed by individualchoicethrough biotech pharmaceuticals and even generic treatments". Fanciful asthis vision may seem, it is being taken seriously and is even beingdescribed as a moral obligation in some circles. "The highest expressionof human nature and dignity is to strive to overcome the limitationsimposed on us by our genes, our evolution and our environment," writesBailey. - London Times, Apr 8ECHOES OF HWANG IN POSSIBLE JAPANESE FRAUDThe leading journal Nature is getting abundant experience in dealingwith scientific fraud nowadays. Hard on the heels of an investigationinto the cloning research of disgraced Korean stem cell scientist

HwangWoo-suk, Nature has discovered that several papers from a Japaneselaboratory were probably faked.The problem came to light last year when the RNA Society of Japan askedTokyo University to investigate a dozen papers from a lab run bybiochemist Kazumari Taira, following complaints from otherresearchers. Tairaand his co-author Hiroaki Kawasaki were unable to supply some data --because of bad record-keeping and computer failure, Taira said. And thenit appears that Kawasaki faked the data which he did supply. This wasdetected because he allegedly used software which was not available in2003 when the experiment was conducted.Now the university has decided that there is a "high possibility" thata dozen papers on RNA technology from Taira's lab have been faked.According to a March 29 statement, the papers had "no reproducibility andno credibility". Taira has already asked that five of his papers

beretracted, although Kawasaki has refused to do so. A university committeeis to submit a report on the scandal this week. - Nature, Apr 6- "Our ideal is not the spirituality that withdraws from life but the conquest of life by the power of the spirit." - Aurobindo.

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