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INSIDER NEWS
Monday, February 13, 2006

By Janet Dunphy

A local hospital facility has found a new calling that helps pay the bills.

Bon Secours Maryview Behavioral Medicine Center is participating in clinical drug trials using psychiatric medications. About 67 patients have participated in the program since Maryview began the joint venture with the Centers for Behavioral Health in Rockville, Md., 10 months ago.

“It’s a good thing for hospitals to get involved with financially and they are generally held in higher esteem,” said Allan Erbe, director of behavioral medicine services. “We’re doing it for the image and to advocate for the underserved.”

Erbe said he could not disclose the financial arrangements as part of the contract. However, he said it does allow the behavioral center to provide care for two to three additional patients per day.

“It’s just another payment source for the hospital,” Erbe said.

Seven clinical trials focusing on schizophrenia and bipolar disease have been completed and an eighth is on the way. The participants are both adults and adolescents and tend to be chronically ill patients who are not making progress on their current medications, Erbe said.

The behavioral center is a 54-bed facility with four nursing units that provides both inpatient and outpatient treatment. CBH is a for-profit company.

The double-blind studies, some of which involve placebos, include existing drugs as well as medications that aren’t on the market yet. Efficacy and combination doses are also part of the trials. Metabolic effects are also tracked.

So far the doctors have found at least one patient who was previously misdiagnosed, being treated as a schizophrenic when he is bipolar. One medication from the trials is moving toward Food and Drug Administration approval.

The participants get a small stipend to compensate them for their time. For some it is the first time they have ever had a paying job, been able to interact better socially or go to school.

Before the clinical trials ever began, the protocols were examined by internal hospital committees and an institutional review board from Chesapeake Research Review Inc., which is based in Columbia, Md. A local human rights committee for mental health also reviewed the protocols as is required by state law. The latter group has to be made aware of the drug trials, but cannot stop them.

Maryview, which has a Catholic tradition, has a full-time vice president for mission who also reviewed the joint venture.

“You have to balance the money with the mission,” Erbe said.

The joint venture involves two contracts, one between CBH and Maryview and another between CBH and the private physician group that has privileges at the behavioral center, Churchland Psychiatric Associates. The physicians contract to be the investigators and also would not disclose their pay.

Additionally, Erbe said he hoped the opportunity to participate in drug trials would help with physician recruitment and retention. He said physicians are often frustrated because of patient loads and less one-on-one time with the patients.

Only a few patients are involved with the trials at one time, Erbe said. Plus, the physicians are able to track them on an outpatient basis after the trial is over, something that managed care often will not allow.

“Physicians have gotten away from that in their daily practice,” said Erbe, who has a background in psychiatrics, counseling and administration. “They are pushing paper.”

The hospital’s policy of uncompensated, or free, care also makes the trials attractive.

“It’s like being able to practice psychiatry the way I did 10 years ago,” said Dr. Kenneth Lovco, the medical director of Maryview’s behavioral medical services and managing partner of Churchland Psychiatric Associates. “It’s gratifying and I can follow them longer.”

The patients are being recruited from the private practice and word of mouth. Valerie Jones, a dual diagnosis case manager with the Norfolk Community Services Board, said she had one client who was involved in the trials.

“He had some hospitalization before and apparently there was some improvement,” said Jones, referring to his time spent in two Maryview trials. “It’s beneficial because it helps the field of mental health overall.”

Erbe agrees, but said the hospital didn’t take the decision to perform the clinical trials lightly.

“We all had misgivings. We didn’t want to exploit people,” he said. “We’re going to do what’s ethical for the patient.”

A number of safeguards are built in to protect the patient, Erbe said, including a legal document that includes HIPAA, or the Health Insurance Portability & Accountability Act, language that in part safeguards patient confidentiality. CBH has two employees onsite, the drug companies have monitors and all of the results are reported to the Food and Drug Administration, which can visit at any time.

For Lovco, the biggest qualm was what happens if the patient doesn’t respond to the medication or the placebo.

“We identify that quickly and stabilize them,” he said, adding that one-third make progress on the placebo.

Also, if a patient is removed from a trial, he is stabilized and not just dropped, said Lovco, who describes himself as a data collector.

In the case of an “open label,” Lovco and his associates would know what medication and dosage the patient is receiving. Still, double-blind studies aren’t revealed for 15 years.

Janet McNiff, a CBH employee, is the study coordinator with an office at the Behavioral Medicine Center. Besides ensuring that the trials follow protocol, she organizes patient visits and keeps Lovco and the staff informed. Every time a new study starts, McNiff attends investigator meetings to be trained so she can relay information to the physicians.

McNiff, a nurse, said she also provides information to outreach groups and organizations like the Norfolk CSB to take care of patients who have failed in the system.

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Bon Secours Hampton Roads Health System is a leading health care organization known for providing care for the whole person with grace and clinical distinction. Bon Secours brings together a network of hospitals, primary care practices, ambulatory care sites and continuing care facilities to provide quality health care services to the residents of Hampton Roads. Bon Secours, which employs more than 4,500, includes: Bon Secours DePaul Medical Center, Bon Secours Maryview Medical Center, Mary Immaculate Hospital, Bon Secours Health Center at Harbour View, Bon Secours Maryview Nursing Care Center and St. Francis Nursing Center.

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