The Desert Sun from Palm Springs, California • Page 34

The Desert Sun D6 Thursday, December 9, 1999 Health COUNTER TOPS Kitchen Baths Bars cnnnce door pnomem? CALL Abracadabra GARAGE DOOR COMPANY Residential Commercial Radio Dispatched Crlw Expertly Trained Technicians Same Day Service. Bonded Insured Free Estimates FDA faults gene-therapy researchers in teen's death DuPont Certified Shop Residential Commercial Surfaces By AmenCbntd (760)773-1080 No Magic, No Truck 74804 Joni Drive 8 vst Gn ea Sex vj ce 564-5 322 Palm Desert VISA I Cont. Lie. 689373 I.ic.7u3u()u BiiirtmiiiiiiinrT it WW my- ByPaul Recer TMIi ASSOC.IATI!l I'UliSS BETHESDA, Md. An Arizona teenager who died in a gene therapy experiment should never have been part of the study and researchers who conducted it violated at least two rules of the testing, federal officials said Wednesday.

Food and Drug Administration officials said Jesse Gelsinger, 1 8, "did not meet the entry criterion" for participating in an experiment in which his liver was injected with a virus carrying a corrective gene. Researchers at the University of Pennsylvania, where the experiment was part of a series of gene therapy trials, denied the accusation and said they would defend their work at a hearing today at the National Institutes of Health. The allegations were announced Wednesday after a daylong hearing before an NIH advisory committee investigating the death and looking at safety issues in gene therapy experiments. The panel, called the Recombinant DNA Advisory Commits tee, or RAC, also is considering new guidelines to sharpen federal control and force public disclosure of problems in gene therapy experiments. The RAC's hearing, before a packed auditorium, is to resume to day and is expected to continue through Friday.

Gelsinger's death, the first directly blamed on a gene therapy experiment, prompted the review of the emerging medical treatment. The Tucspn teen-ager suffered from a genetic liver disorder and was enrolled in a University of Pennsylvania trial designed to correct his condition by inserting normal genes into his liver. Gelsinger died within days of the experiment. Kathryn Zoon, chief of the FDA's Center for Biologies Evaluation, said preliminary findings show Gelsinger had elevated ammonia in his blood, an indication of a distressed liver, when he received the gene injection. She also said the Pennsylvania researchers failed to notify the FDA of two other patients in the therapy experiments who suffered liver damage severe enough to halt the trial.

Zoon said the researchers also failed to mention on patient consent forms that a monkey died after receiving experimental gene therapy. Dr. James Wilson, head of the University of Pennsylvania team, said Gelsinger did meet the FDA requirements when he enrolled in the trial, but his ammonia levels were "slightly elevated" just prior to the injection. For All Your Holiday Entertaining, Featuring Handmade Hors d'oeuvres, Gourmet Foods and Our Famous Cheese. IOOKING COMPANY THK ASMICIATHO HUiSS Tastings Daily at our Famous Sample-Bar.

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1 1 to 4. 73540 EL PASEO PALM DESERT, CA 92260 (760) 568-1998 Teen victim: Jesse Gelsinger, 18, poses near a statue at the University of Pennsylvania. The death of Gelsinger was the first caused directly by experimental gene therapy. Stunted protein may be Alzheimer's key Researchers find due in abnormal protein's influence on enzyme GCDoo Ksamo rani) mj (sawn chshs I Bv Malcolm Rittkr THI-: ASSOClA Scientists have found another potential clue to understanding what goes wrong in the brain to cause Alzheimer's disease. The work, while preliminary, suggests a possible new approach to treatment.

Researchers focused on a crucial enzyme in brain cells and a protein that controls its activity. Their findings suggest that if brain cells produce an abnormal, stunted version of this protein, the enzyme can run amok, leading to death of brain cells. That could play a role in causing Alzheimer's. Scientists found the shortened pro- tein in the autopsied brains, of Alzheimer patients. In test-tube studies, jhc stunted version made die enzyme overactive, killing rat brain cells.

'lTie work could help explain why certain cells in Alzheimer brains typically contain abnormal protein tangles. These tangles, along with protein deposits called plaques, are hallmarks of the disease. Scientists are trying to figure out what roles the tangles and the plaques each play in causing Alzheimer's. RESEARCH TEAM: The new work is reported in today's issue of the journal Nature by a team including Li-Huei Tsai, an associate pathology professor at Harvard Medical School and a researcher at the Howard Hughes. Medical Institute.

She said scientists might be able to develop new treatments if they can figure out how to block production of the stunted protein or keep the enzyme under control. John Trojanowski, who studies Alzheimer's at the University of Pennsylvania, said the work suggests a new direction for research. The study describes a story with three main actors: the normal protein p35, the stunted version p25, and the enzyme Cdk5. 'The enzyme's job is to chemically modify certain other proteins to make them active or inactive. The enzyme itself is activated when the normal protein p35 binds to it.

That makes sure the enzyme is active only at the right times and in the right place. OVER-ACTIVATED: The study indicates that trouble begins when brain cells somehow trim p35 to produce p25. This version keeps the enzyme activated constantly and lets it go anywhere inthe cell. So the enzyme could start modifying proteins it should leave alone, while ignoring other proteins that it should act on. The result is chaos lethal to the cell.

For one thing, the enzyme abnormally modifies a protein called tau. That hinders tau in doing its normal job of stabilizing crucial supply lines called microtubules in the brain cells. In Alzheimer's, these microtubules are thought to collapse because they lose this stabilization, while strands of modified tau form the hallmark tangles. In test-tube experiments, the scientists found evidence of microtubule collapse in rat brain cells exposed to a p25-driven enzyme. LUNCH i Sundav Mexican Brunch ieuy one Scrap TOP PRICES PAID ir Plastic, Copper TrV Glass bottles, brass "KZ'tr Aluminum, Batteries Computer paper Palm Springs Recycling Center 280 Oasis Road, Palm Springs (760) 325-3377 36630 N.

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