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Death in Gene Therapy Experiment Rocks Field - Human Genetic News

Thursday, August 30, 2007
Posted in Genetic Engineering Human Rights | Tagged Genetic Engineering, Human Rights

The recent death of a woman in a gene transfer study of arthritis has shaken the experimental field known as “gene therapy.” Neither the Food and Drug Administration nor the sponsoring company, Seattle-based Targeted Genetics Corporation, has yet confirmed that her death was caused by the experimental treatment. But the 36-year-old Illinois mother& rsquo;s symptoms began to develop just after she had received an injection of genes carried by engineered viruses.

The Center for Genetics and Society has called for greater transparency and accountability in two press statement (1,2) and in the Washington Post article that provided the most comprehensive news on the tragedy. Below is an op-ed by CGS’s Osagie Obasogie.

Gene Therapy Risky Business for Patients
Osagie K. Obasogie, Seattle Post-Intelligencer - August 16, 2007

Targeted Genetics Corp. is caught in the middle of a brewing storm: Jolee Mohr, a vibrant 36-year-old mother, recently died while participating in a gene therapy clinical trial for arthritis run by the Seattle-based biotech firm.

Since the ’80s, gene therapy — an experimental procedure that attempts to treat a disease by replacing damaged genes with new ones — has been widely touted as modern medicine’s next marvel. Sad to say, it has been implicated in an assortment of “serious adverse events” and deaths; no gene therapy treatment has ever been deemed saf e or effective enough to receive FDA approval.

Although the FDA has not confirmed Mohr’s cause of death, all available evidence points to the engineered virus given to her during the clinical trial. Until now, the most well known gene therapy death was Jesse Gelsinger’s, an 18-year-old with a rare metabolic disorder.

Gelsinger died when his immune system responded poorly to the treatment — symptoms similar to Mohr’s. Also like Mohr, Gelsinger died when the risky gene therapy procedure was used to treat a non-life-threatening condition that could have been managed with safer alternatives.

What’s going on here? Why is an unproven procedure linked to multiple deaths being tested on people with non-fatal illnesses?

Read more…

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And Behind This Door…
“Artificial life likely in 3 to 10 years,” is the title of a recent widely published Associated Press article, and the message of the scientists interviewed therein.

Foolproof DNA?
News this week that a World War II airman’s body was found in the Sierra Nevada Mountains raised several families’ hopes that their lost loved ones might have been recovered. Promisingly, DNA technologies might be of assistance. But what’s troubling is how some continue to oversell DNA forensics’ truth-telling abilities.

Health Care 2.0?
Both Google and Microsoft are planning to forays into health care information, according to a widely circulated article in the New York Times.

Is He for Real? Are You?
If I were paying this guy to think, I’d want a refund. Unless perhaps I was just doing it for the laughs.

Biotechnology Appeals t o Our Lizard Brains
Will technologies with enormous power to reshape both society and individuals be initially introduced for frivolous purposes? Will pet cloning and gene therapy for sexual confidence make human reproductive cloning and genetic modification technically feasible and more palatable?

Sicko Profits
While Moore pays close attention to the insurance industry’s shady practices, little consideration is given to the burgeoning field of biomedicine and how some of its key players are rewriting the rules in ways that might even make today’s insurance executives blush.

Don’t Bite the Hand that Feeds You
Given the magnitude of Keirstead’s promotional activities, his undisclosed personal financial interest, and his own statement of clinical trials “in about a year” back in 2002, his pronouncements on the timeline for embryonic stem cell trials should receive the same skepticism as those of Okarma.

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Home DNA Tests Create Medical, Ethical Quandaries
by Victoria Colliver, San Francisco Chronicle, August 21st, 2007
Recent growth in at-home genetic tests, such as those which indicate the sex of a future child, raises concerns.

Death Points to Risks in Research
by Rick Weiss, Washington Post, August 6th, 2007
Jolee Mohr died from massive bleeding and organ failure, leaving behind a 5-year-old daughter and a host of questions.

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New Mo. group targets stem-cell work
by David A. Lieb, Associated Press, August 22nd, 2007
Missouri’s battle over embryonic stem cell research intensified today as a new group proposed a ballot measure seeking to outlaw a particular research method that voters narrowly endorsed just last year.

Latest Genealogy To ols Create a Need to Know
by Ellen Rosen, New York Times, August 18th, 2007
Researching their roots has become a passion for many Americans. As web sites and genealogical societies proliferate and DNA testing becomes more widely available, the tools for tracing a family tree are becoming more accessible - and the hunt is often intriguing.

For the First Time, FDA Recommends Gene Testing
by David Brown, Washington Post, August 17th, 2007
Food and Drug Administration officials said yesterday they are bringing to doctors’ attention the potential usefulness of getting a patient’s genetic profile before prescribing warfarin, one of the most widely used — and most danger ous — drugs on the market.

Who’s the daddy? US sperm banks must be better regulated
by Alison Motluk, New Scientist, August 9th, 2007
Now a small, not-for-profit company is beginning to fill in these gaps. In doing so, it threatens to expose just how common errors in the American fertility industry might be, and how little oversight exists to stop these problems from happening or to deal with them if they do occur.

Within Discredited Stem Cell Research, a True Scientific First
by Nicholas Wade, New York Times, August 3rd, 2007
The world of stem cell research was set reeling two years ago when its most successful practitioner, the Korean scientist Hwang Woo Suk, was found to have fabricated much of his work. But according to a new post-mortem of his research, he did achieve a scientific first, though not the one he claimed.

Center for Genetics and Society, 436 14th Street, Suite 700, Oakland, California 94612