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Cancer study
volunteers face insurance
‘gray zone’

By Helen Altonn
Star-Bulletin

The University of Hawaii's Cancer Research Center is administering about 150 studies for new cancer treatments and it has a shortage of patients, says Director Carl-Wilhelm Vogel.

Such human research studies may result in improved survival, disease remission or even a cure, but fewer than 3 percent of Hawaii's adult cancer patients participate, according to the center.

Even those receiving standard treatment in the control arm of a clinical trial do better than if they were to get the same treatment outside the trial, Vogel said.

"Everything is properly documented and followed up. Patients receive more attention. Things are done more efficiently."

The drawback, Vogel said, is financing a patient's participation in the study.

While a physician can offer patients a chance to be eligible for a clinical trial, there is no guarantee that their insurance plan will cover it, he said.

President Clinton last week directed Medicare to begin covering costs of routine patient care associated with clinical tests of new drugs and medical treatments.

Clinton said too few older Americans participate in such trials. "As America ages, we must provide all our seniors they must be provided with affordable, quality health care."

Vogel said the chances of cancer increase with age so it's even more important to have older people in clinical trials, but they're underrepresented.

He said every center director gets letters from cancer patients. "I just had one yesterday from Texas asking, 'Do you have a trial? My son has an unusual bone tumor.' People would like to participate, especially if no conventional therapy is available."

But patients want to know beforehand whether their insurance will cover the treatment, Vogel said.

The Hawaii Medical Service Association, Hawaii's largest health care insurer, has no clear policy, he said. "This is a gray zone."

'Investigational' therapy

Cliff Cisco, HMSA senior vice president, said that if a particular therapy in clinical trials is considered "investigational" by the Food and Drug Administration, it's not covered.

"It's not a blanket statement, but traditionally we went along with the FDA interpretation of 'investigational.' "

But Cisco said HMSA's policy regarding payments for clinical trials for cancer is under review. The association is working with specialists in cancer treatment in trying to revise its guidelines relating to developing drugs, he said.

There are many more clinical trials than there used to be, Cisco noted, pointing out that funding by the government and some of the agencies doing the testing has dried up. "The industry is looking for more funding and that has to come from health plans."

Dr. Jonathan Cho, Honolulu medical oncologist, said participation in clinical trials among children with cancer is about 60 percent nationally and 85 percent in Hawaii.

But adult patient participation in studies is low across the nation, primarily because of anticipated high costs of treatment, he said.

A new study has shown, however, that costs of clinical trials are no higher than costs of standard treatment.

The study was recently presented at the annual meeting of the American Society of Clinical Oncology in New Orleans. It was sponsored by the Association of American Cancer Institutes and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago.

The study evaluated medical charges for six months of care for 70 cancer patients at five cancer centers.

Thirty-five patients who received care in the second phase of clinical trials, testing the safety of a drug, were matched to 35 control patients receiving standard care.

The average charge for treatment for the six months was $57,542 for trial patients and $63,721 for control patients.

Expensive, time-consuming

Vogel cited problems getting physicians to participate in clinical trials, as well as patients.

"To put a patient on clinical trial requires much more time, paperwork and effort by the physician," he said.

Physicians involved with trials make less money because they can see fewer patients, he said. "So there is a question, can one compensate there?"

It's also difficult to get neighbor island patients in the trials because frequent visits and lab tests are required, Vogel said.

"We have some programs where they actually pay for patients to come here and participate in trials, but it's another barrier."

Vogel said he has plans to develop a comprehensive cancer center "which would make clinical trials much easier and accessible for patients in Hawaii." He is working with oncologists to develop a mutually acceptable program, he said.

Educational, cultural and other factors prevent people from taking advantage of clinical trials, Vogel added. "Some people don't want to be guinea pigs."

But from society's point of view, he said, "If you don't try something out, eventually there will be no progress. At some point you have to be first."