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Article on Godofsky’s Hep-C Clinic

Bradenton doctor chips away at Hepatitis C virus - Medical office runs 10 to 20 drug trials a year
By KATHLEEN MCLAUGHLIN
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BRADENTON - When Eliot Godofsky started treating viral hepatitis in 1996, about 10 percent to 15 percent of patients could be cured. After the introduction of some new drugs, that rate is up to 50 percent. Godofsky likes those numbers, but he knows they could be even better. "HIV is controllable. Hep-C is potentially curable."

That's why his Bradenton-based medical office - the nation's largest infectious disease practice specializing in viral hepatitis - runs 10 to 20 drug trials a year. Private practice physicians get involved in clinical research for many reasons: money, experience with cutting-edge treatment, access to drugs for patients.

Godofsky says his prime motivator is fundamental: "The benefit to me is to cure people who thought they were incurable."

The 46-year-old came to Bradenton to join Michael Bach, a pioneer in HIV/AIDS treatment who died of melanoma in 1998. Bach & Godofsky, M.D. PA, which now employs 6 other doctors, still staffs the HIV/AIDS clinic that Bach opened in Manatee County. But Godofsky has expanded the scope of the practice and become an expert on viral Hepatitis. Part of that includes doing early-stage drug trials, such as the one for Peregrine Pharmaceuticals that began Aug. 29.

He hopes to help find something that will work for the roughly 50% of people who don't respond to treatment, which involves a yearlong course with debilitating side effects.

The virus: The hepatitis C virus is more widespread than HIV, but it gets relatively little attention. About 4 million people in the United States are infected with hepatitis C, while about 1 million have HIV. No national fund like the one established by the Ryan White CARE Act for HIV pays for hepatitis drugs. Treatment, not including lab work, costs about $20,000 per year, Godofsky said.

There are a lot of drugs under research for hepatitis C, but there is not a high-profile, independent center testing them head-to-head, said Lisa Ball, executive director of the Hepatitis Resource Network, a doctors education group.

Sharing needles is the most common cause forof the illness, representing 60 percent of new infections. Although commonly associated with illegal drug use, hepatitis crops up unexpectedly in many middle-aged people because the disease can stay in the body for 10 to 20 years without causing anything more than flu-like symptoms, said Michelle May, the nurse practitioner who runs clinical trials for Godofsky.

Some patients trace their risk back to recreational cocaine use, in which they shared straws, May said. One woman's only identifiable risk factor was the fact that she was a seamstress. She might have pricked her finger on a needle used by someone else. A lot of people don't realize they can be cured. Some go through the treatment, only to find themselves among the "non-responders." "The worst part of my job is helping them through 12 months of therapy, then 6 months later having to call and say, 'Your virus is back,'" May said.

There are 12 to 15 companies trying to develop new drugs, and many of them contact Godofsky's office for trials.

Godofsky thought Peregrine's drug, Tarvacin, looked promising. The small California company realized the antibody treatment it was developing for cancer tumors might work against hepatitis and other viruses.

The Bradenton doctor agreed to the trial because the drug seems to have low toxicity, and it's a novel approach: Patients will get one intravenous injection of the antibody, which might block the virus from invading liver cells and remove the virus from the body.

Supporting treatment:
Godofsky was drawn to research as an intellectual pursuit, but he has become an expert on the ins and outs of using it to support the practice. He gave a presentation on it last year at the annual meeting of the Infectious Diseases Society of America. Listed among the reasons for doctors to get involved in trials was "cost-effective income production." The medical office gets "good" reimbursement for patient visits and lab reviews with limited billing and collections overhead. Doctors spend no time with managed care, Godofsky notes.

One of his tips on setting up a budget for a clinical trial was "do not be afraid to negotiate." "Physicians are not usually terrific businessmen," but can be, Godofsky says. Research is not a profit center, Godofsky acknowledges, but by using it he can support the staff required to care for the disease. Treating viral hepatitis requires a lot of patient monitoring and education. It can also be very complicated. About 10% of viral hepatitis sufferers also have HIV. Doctors know little about how the drugs used to treat the two viruses separately might interact. Making a living at that kind of medicine is difficult, said Ball, the executive director of the Puyallup, Wash.-based Hepatitis Resource Network. "There's no procedure, so it's not particularly well-reimbursed," she said. "But patients have lots of questions." Many doctors don't want to be involved.

Godofsky is on the board of directors of the organization, which was started in 1997 to raise awareness of Hepatitis C among physicians. Infectious disease doctors proved to be more interested in the disease than liver or intestinal doctors, Ball said. They are used to dealing with trying to get paid for the time they spend consulting, and many, like Godofsky, do it for the intellectual challenge. Bach is what brought Godofsky to Bradenton: "He had that zest or lust for research." After his partner died, Godofsky said, he worked 7 days a week, 20 hours each day for the subsequent year and a half. "I kept the research going. I kept the HIV care going. I gradually added more and more doctors."

Now the seven doctors, including Godofsky, cover the three hospitals in Manatee County and the Michael Bach Treatment Center. They also work with Infectious Disease Associates of Sarasota. Bach and Godofsky also runs a wound care center and a large outpatient IV clinic. The IV clinic, which is open every day, sees 80 to 100 people each day.

Godofsky estimates that he has a patient base of about 1,000 and that he accepts about 300 new patients a year.

Patients: May, the nurse practitioner who runs trials for Godofsky, does not have to recruit patients, even for early phase trials where the focus is on establishing safe doses, not treatment. "They clamor to do these phase-one trials," she said. "They want to make something good out of something bad."

Fort Lauderdale resident Philip Younger is the kind of patient who would benefit from a breakthrough drug. He's among the 50% who didn't respond to treatment, even after 3 courses. The 56-year-old was diagnosed with the disease in 2000 and soon started treatment: three shots a week of one drug, interferon, and 6 pills a day of another, Ribavirin.

Younger, hurt on his job moving furniture, took work as as telemarketer to accommodate the side effects: headaches, fever, muscle aches and loss of appetite. He went on three medications to counteract the insomnia and depression. During that time, Schering-Plough came out with an improved drug, and he tried that, too. Younger went through 15 months of treatment, but the virus came back six months after the treatment ended. Younger tried another company's drug. That didn't work, either. "It's a freaky virus," he said.

Younger, who now works for a patient advocacy group called Hep-C Alert, said the treatment at least bought time for his liver, which showed no cirrhosis in his latest biopsy. "I live right, eat right, hope for the best and counsel people on hepatitis," he said. Younger said that if he could take the time off work, he would join a trial now.

"I've always said I would shoot toothpaste if it would get rid of this virus," he said.

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