GM DRUG TRIAL DISASTER/ETERNAL LIFE BATTLE/ECHOES OF HWANG

[Guest guest]

GMW: GM DRUG TRIAL DISASTER/ETERNAL LIFE BATTLE/ECHOES OF HWANG

" GM WATCH " <info

Wed, 12 Apr 2006 09:38:21 +0100

 

 

 

 

GM WATCH daily

http://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 drug

was genetically engineered

from hamster cells and that it was designed to alter their immune

system. "

---

All taken from BioEdge

http://www.australasianbioethics.org/Newsletters/199-2006-04-11.html

 

CONSENT FORM FOR DRUG TRIAL DISASTER FLAWED, SAY CRITICS

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

 

POLITICAL BATTLE LOOMING OVER ETERNAL LIFE

[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

 

ECHOES OF HWANG IN POSSIBLE JAPANESE FRAUD

 

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

 

 

 

 

 

-