Md. failing to find women for breast cancer study National project will test drug

November 20, 1992|By Deidre Nerreau McCabe | Deidre Nerreau McCabe,Staff Writer

A highly publicized national breast cancer prevention study that began seven months ago is floundering in Maryland because participating hospitals so far have been unable to recruit 100 women.

The six hospitals -- Harbor Hospital Center, University of Maryland Medical Center, Johns Hopkins Hospital, Mercy Medical Center, Greater Baltimore Medical Center and Maryland General Hospital -- have been able to sign up just 17 women.

Harbor Hospital Center in Brooklyn has yet to find a single participant, baffling the doctor coordinating the five-year study there.

"We were worried about how we would accommodate all these new patients," said Dr. Russell R. DeLuca, an oncology specialist at Harbor. "I guess we thought there was so much concern about preventing breast cancer, there would be lots of interest in this study. That hasn't happened."

University of Maryland Medical Center received more than 300 calls from interested women after the study was announced April 29, but only a few of those who are eligible are participating.

Researchers hope the five-year, $60 million study of 16,000 women -- designed by the National Surgical Adjuvant Breast and Bowel Project -- will determine whether the prescription drug, tamoxifen, can prevent breast cancer in high-risk women. The drug, tamoxifen, is now used to treat women who already have breast cancer.

Although adverse publicity about risks associated with the study may have slowed recruitment from the start, many states have continued to enroll women at a faster pace than Maryland, organizers said.

Lori Psillidis, a spokeswoman for the project, said most "clinical centers," a cluster of cooperating hospitals, have enrolled 20 to 50 women.

Hospitals have until April 1994 to meet their quota.

The slow start for the study here is particularly puzzling, some doctors said, because Maryland ranks ninth in the nation for breast cancer deaths.

Dr. Gary I. Cohen, director of the cancer center at Greater Baltimore Medical Center, said Maryland is behind because it lacks a coordinated effort. "Outside the two university hospitals, there is no coordination with community hospitals or with private physicians. The University of Maryland and [Johns] Hopkins have not reached out to help other hospitals," he said.

To date, he said, GBMC has only three participants, despite aggressive attempts to identify women with high risk.

Dr. George Elias at the University of Maryland Medical Center -- ++ the statewide coordinator -- agreed that recruitment was going badly but disagreed about the lack of coordination.

Doctors and nurses on the project point to a number of factors working against them.

Dr. DeLuca said hospitals discovered after they agreed to participate that there was no money available to cover additional physicians' visits, mammograms and blood work. Because most insurance companies will not cover such charges, the added expense over a five-year period may have discouraged some women.

And then there were the reports of hidden side effects, which prompted a congressional hearing in October. Women's health advocates, including the National Women's Health Network, said that the study was too dangerous and that healthy women should not be given tamoxifen.

Many critics said participating hospitals were failing to warn participants about serious side effects, including the possible development of blood clots, liver tumors, uterine cancer and premature onset of menopause.

In addition, the length of the study may be a turnoff for some women, said Sally Brown, who is heading the effort for the University of Maryland Medical Center. Others decide against participation when they learn they may get a placebo rather than tamoxifen.

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