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When Michael O'Donnell, MD, University of Iowa urologist, first evaluated interferon-alpha and BCG as a combination
therapy for bladder cancer, he envisioned it to be the therapy of the future.
On the way to that future, O'Donnell put into practice his career philosophy—first, identify a clinical problem, then search for a possible solution in the laboratory,
test the possible solution in clinical trials, and finally introduce it into mainstream clinical practice.
Traditionally, BCG is the most effective superficial bladder cancer treatment. Unfortunately, when used alone it is only effective in 60 to 75 percent of patients, and long-term
remission (more than five years) is only achieved in half the patients. Interferon-alpha used alone is only effective in about 40 percent of patients, and while it is associated
with fewer side effects, it is expensive and cancer relapses are fairly common.
O'Donnell's research trial is believed to be the first to indicate that the combination therapy of interferon-alpha and BCG works for people with aggressive forms of bladder cancer
who previously failed treatment with BCG alone.
O'Donnell has been working on the combination therapy since 1994. He set up two clinical trials in Boston while at Beth Israel Deaconess Medical Center. He personally lobbied
Schering-Plough, one of the largest pharmaceutical companies in the world, to fund a phase II study. The study opened in May 1999 and by January 2001, more than 1,100 patients
were enrolled nationwide, both private and academic.
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Early clinical trial results show that 55 percent of patients, previously failing BCG, treated with this combined immunotherapy approach are disease-free more than 2.5 years
after treatment. The disease-free rate for repeat BCG treatment alone is less than 20 percent.
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