By Danielle Kost
Democrat and Chronicle

(Wednesday, January 30, 2002) -- Excellus Inc. wants the state to narrow a law that often requires insurance companies to cover experimental treatments.

Although area doctors in general agree with Excellus' thinking, they worry about taking any health care options away from someone with a life-threatening illness.

Excellus, the parent company of BlueCross Blue-Shield of the Rochester Area, believes that experimental treatments should be covered only if patients are enrolled in a randomized clinical trial. There would be few exceptions.

"The mere fact that the study is going on means that they don't know if it's more effective than treatments already out there," said Dr. Jonathan Kaplan, senior vice president and medical director for Excellus.

Excellus is now contacting legislators to raise awareness about the law.

"This is one of the difficulties of the intersection with the insurance system and people's need for medical care," said Sen. Richard Dollinger, D-Brighton. "These are tough questions."

Excellus officials say that their efforts are driven by a desire to ensure quality care, not by profit motives.

Yet the controversial call to alter the law stems from one of the largest and most publicized randomized clinical trials, which tested bone marrow transplants as a potential treatment for breast cancer.

Results were deemed promising in the early phases of the study.

As a result, 30,000 breast cancer patients underwent bone marrow transplants in the United States between 1990 and 2000. Only 1,000 were enrolled in randomized clinical trials for the procedure.

At the end of the clinical trial process, though, scientists said the bone marrow transplants were no more effective than standard treatments such as chemotherapy.

Kaplan contends that the health of Excellus members who received the treatment failed to improve and it cost the company millions.

Dr. Ira Shoulson, a University of Rochester professor of neurology, said that he supports Excellus' efforts to emphasize the importance of randomized clinical trials. But he said that the insurer's suggested change to the law raises other concerns such as the appearance of "coercion" of trial candidates.

Peter Robinson, chief operating officer of Strong Health, also praised Excellus' defense of clinical trials but said patients facing death might not have time to wait for a clinical trial.

Angela Pavone, 45, of Spencerport dramatically improved her breast cancer prognosis through an experimental treatment. The radiation treatment had been traditionally used for brain tumors.

Pavone received the treatment through a clinical trial, but it was not randomized. She chose this route because in randomized trials some patients receive placebos or traditional treatments.

"I didn't want to chance taking nothing," she said.

Kaplan said that he recognizes the potential for life-altering decisions.

" I think the main downside is that there is an element in choice in patient preference that patients will not have," he said.