Drug giant Schering-Plough Corp. has hired a Georgia physician network to collaborate on a disease-management program for hepatitis.
The program's goal of early detection and treatment of the disease is endorsed by public health professionals, who view hepatitis C as a growing threat. But the deal raises ethical questions about whether drug companies should fund disease-management programs, which could create demand for their products.
Schering-Plough recently gained FDA approval for an expensive breakthrough drug therapy used to treat chronic hepatitis C cases.
Under the agreement, Georgia Primary Care Network, a 450-physician independent practice association managed by PhyMatrix, will give patients questionnaires designed to detect those who are at risk for the hepatitis C virus.
The IPA will develop diagnosis and treatment protocols and enroll physicians and patients in the program, which will be managed by Medical Research International, a PhyMatrix division that specializes in outcomes research.
Integrated Therapeutics Group, a Schering-Plough subsidiary, will help develop treatment protocols and provide physician and patient education and compliance materials, according to PhyMatrix.
A price tag for the three-year contract was not disclosed.
As many as 400,000 patients could be screened, of which some 6,000 are expected to carry the virus, said Richard Pierzchajlo, M.D., chairman of the Atlanta-based IPA.
Those determined to be at high risk will be tested. People who test positive will be referred to specialists for treatment. Some 70% of hepatitis C carriers eventually develop liver disease, making them candidates for drug therapy.
PhyMatrix officials said they hope to create a model program for detecting hepatitis C, which infects an estimated 4 million Americans. The national Centers for Disease Control and Prevention in October recommended routine testing of those at risk for carrying the blood-borne virus, which has a death rate that could surpass that of AIDS.
"What we're doing is essentially following CDC recommendations," Pierzchajlo said. "All adults should be screened in this way."
But some healthcare professionals raised questions about the deal. James Learned, director of treatment, education and research at People with AIDS Health Group, a New York-based support group, called it "frightening."
"The standard of care will be whatever Schering-Plough wants it to be," Learned said. Drug companies "have a different agenda than physicians or people living with the disease."
T. Jake Liang, M.D., chief of liver diseases at the National Institutes of Health, said the development of disease-management protocols should be overseen by unbiased specialists.
"I'm sure this (program) is a marketing strategy to bring more patients into the arena where they can be treated. There's nothing wrong with that, but the issue is whether the patients are being treated or cajoled," he said.
Schering-Plough declined to comment. The company, headquartered in Madison, N.J., gained approval in June for its Rebetron Combination Therapy, which is considered the leading treatment for chronic hepatitis. The therapy costs $17,280 for a standard 48-week course of treatment.
Herbert Rakatansky, M.D., vice chairman of the American Medical Association's Council on Ethical and Judicial Affairs, said disclosure is key.
"The patients must be informed that they're being screened for hepatitis and that it's being paid for by the company that makes the leading product," he said.
John Niles, vice president of PhyMatrix's clinical studies division, said the Schering-Plough mark appears on the questionnaires, given to patients during office visits. It won't be ballyhooed as a Schering-Plough program, he said.
Rakatansky said the primary-care physicians should not accept more than fair-market value for their services. Accepting excessive compensation could amount to a payment for referrals, which is illegal, said the gastroenterologist, who is a professor of clinical medicine at Brown University in Providence, R.I.
PhyMatrix's medical research international division will be paid a project management fee, while individual physicians will be compensated according to the number of patients they screen and the length of time patients stay in the program, said Michael Heffernan, chief executive of PhyMatrix's Clinical Studies subsidiary.
Pierzchajlo said the IPA has not consulted with its contracted health plans, which ultimately must pay for testing and treatment, about the program. The IPA does not accept risk for specialty services and pharmacy costs.
Pierzchajlo called Rebetron an expensive therapy but said it could ultimately save money. "I think managed-care companies want to identify people with chronic illnesses and treat them early."
As of August, West Palm Beach, Fla.-based PhyMatrix managed about 12,000 physicians in at least 30 states. Earlier this year it shifted its focus to managing clinical research trials. It says it hopes to develop other disease-management programs with pharmaceutical companies.
