Clinical Trial

A California biotechnology company said yesterday that it would buy privately held Biosyn Inc., of Huntingdon Valley, in a deal valued at $30 million to acquire a contraceptive gel intended to prevent the transmission of HIV. Biosyn was founded in 1989 by two University of Pennsylvania researchers to develop a vaginal lubricant that prevents pregnancy and many sexually transmitted diseases, including AIDS. Over the years, Biosyn secured $50 million in grants and $18 million in investment to get its lead product, a microbicide gel called Savvy, into late-stage clinical tests.

A doctor is thinking of trying a new drug on a 67-year-old patient because a study shows it works well in men only slightly younger. But the doctor doesn't know about a clinical trial that found serious side effects in older patients. Those results were never published. John Schneider, a doctor of internal medicine and a member of the American Medical Association's Council on Scientific Affairs, fears that that scenario happens all too often. Because drug companies often do not reveal the contents of studies that make their drugs look bad, he said, many doctors are frustrated because they sometimes prescribe medications without knowing all the information about them and possible side effects.

Colleen Jacoby last spoke to Traci Johnson on Friday, the night before Johnson is reported to have committed suicide. "On the phone, she was laughing, she was happy," Jacoby said of her call from Northeast Philadelphia to her best friend in Indianapolis. At 9 p.m. Saturday, a doctor at Indiana University Hospital pronounced Johnson dead, a suicide, according to an incident report from the Indianapolis Police Department. Johnson, 19, a 2002 graduate of Bensalem High School, had been found hanging by a scarf from a bathroom shower rod in the Lilly Laboratory for Clinical Research.

Wyeth has hired the consulting firm Accenture Ltd. to manage its pharmaceutical data operations for clinical trials, and, as a result, will cut 215 jobs. Last Friday, about 80 Wyeth employees were laid off, including 65 in Collegeville, Montgomery County, the company said. An additional 135 Wyeth employees, including 98 at offices in Collegeville, have been hired by Accenture, a management and technology consulting firm based in New York. Financial terms of the agreement were not disclosed.

Paul Gelsinger stood before an audience of thousands of doctors and clinicians who test experimental treatments on humans to make a heartwrenching plea: Don't let what happened to my son happen to others. Gelsinger's son, Jesse, 18, died in a gene-therapy experiment at the University of Pennsylvania in September 1999. Since then, revelations of accidents and abuses at other respected research institutions have made it clear Jesse's tragedy was not an isolated one. Step-by-step testing of new treatments on humans is essential to medical progress, and about 3 million Americans a year now sign up for 80,000 "clinical trials.

Sixty days after he received an artificial heart at Hahnemann University Hospital, James Quinn was doing well enough that the staff is planning his transfer to a private nursing facility nearby, the hospital announced yesterday. When Quinn was chosen to be part of a limited trial of the new, completely implantable device, doctors estimated that he had a 70 percent chance of dying of heart failure within a month. Designers of the clinical trial defined a successful outcome as 60 days of survival with improved quality of life, the hospital said.

When it comes to breast implants, nothing mimics the fleshy fullness of a real breast better than silicone gel. The problem - as everyone knew by the time silicone-filled implants were banned in 1992 - is that when the gel leaks out of its rubbery silicone pouch, the glop can get stuck in breast or other tissues, causing disfiguring swelling and lumps. That's why a Dallas-based plastic surgeon developed an implant filled with a thicker, stickier silicone gel that he says prevents leakage or migration of the substance.

Daniel Baum-Baicker is off at summer camp, along with his MTV cap, Flyers jersey, and photos of his cherished hamster, Vadslav, who stayed at home in upper Bucks County. Daniel also packed his medicine, including 42 white capsules sealed in thick silver packets. At 11, he is among an increasing number of children nationwide taking part in pharmaceutical clinical trials. Daniel, who was diagnosed in February with a gastrointestinal condition called Crohn's disease, initially balked at becoming a subject of drug tests under way at Children's Hospital of Philadelphia.

Five months after the death of a patient in a gene-therapy experiment at the University of Pennsylvania, the school has named the head of an independent review panel that will evaluate clinical trial programs. William H. Danforth, M.D., chancellor emeritus and vice chairman of the board of trustees at Washington University in St. Louis, will be chairman of the panel that will study the oversight and monitoring of clinical trials at Penn's Institute for Human Gene Therapy (IHGT)

For two days after he was born, Brandon Joseph Ross was constantly feeding at his mother's breasts. But try as he would, he couldn't make his lips form a seal around her nipples, and little of her protein-rich milk ever reached his belly. With his weight rapidly dropping, his parents were concerned. On the morning of May 14, Susan and David Ross decided to try a radical new way to feed their son - at least from an American perspective. Sitting in a chair next to her bed in the maternity ward at Pennsylvania Hospital, Susan Ross swaddled her new baby in a cotton cloth and gently lifted a small stainless-steel cup to his lips.