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Vol. 38, No. 18 |
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5-22-2006 Alumnus Ruffolo speaks at Patil lectureIf professor Popat Patil hadn't taken young pharmacy student Robert Ruffolo under his wing some 37 years ago, millions more people might have lost their lives to congestive heart failure. Studying under Patil for eight of his nine years as an Ohio State undergraduate and graduate student led Ruffolo, now president of research and development for Wyeth Pharmaceuticals, on the exciting - and often trying - path of drug discovery. Ruffolo was a key player in the discovery of carvedilol (brand name Coreg), a small white tablet that he says revolutionized the way congestive heart failure is treated. Ruffolo returned to campus May 11 to deliver the keynote talk during the inaugural College of Pharmacy Research Day and Popat N. Patil Symposium. The symposium celebrated Patil's 48 years of teaching, research and service to the college. The day also included a poster session, showcasing College of Pharmacy research from the undergraduate to the faculty level. Students and faculty, including Patil and his wife, filled a classroom in Parks Hall to listen as Ruffolo told tales of the time he spent in Patil's laboratory and of the Ohio State education that prepared him for a lifetime of drug discovery and development. "Congestive heart failure is a bad disease," said Ruffolo, before he launched into some scary statistics: Ruffolo was in graduate school when he became interested in studying heart disease. Back then, in the early 1970s, scientists were just beginning to understand how the sympathetic nervous system affected the heart. Several years after earning his Ph.D. from Ohio State, Ruffolo began working for SmithKline Beecham, where he helped discover and develop carvedilol, Ruffolo and his colleagues eventually found that the molecule stopped every last one of the steps of heart failure, offering unprecedented protection against heart failure. The problem was, this drug worked in part as a beta-blocker, and beta-blockers were contraindicated for treating CHF. "But we had data to show that this should be the drug of choice for heart failure," Ruffolo said. Still, the data did not please everyone. Some of his former colleagues vocalized their unease, calling Ruffolo an idiot and likening his studies to those carried out by Nazi scientists "One thing I learned in Parks Hall was to take criticism," Ruffolo said. But the FDA and internal review boards from various companies, universities and hospitals agreed that clinical trials should go forward. In the end, carvedilol worked. Phase 3 clinical trials, which included thousands of patients with CHF, showed that the drug reduced mortality rates by Carvedilol worked so well, in fact, that the study's data safety monitoring board shut the trial down. It was unethical to keep patients on the placebo, which in this study were the drugs thought to be the best standard of care for heart failure at the time. "I won't ever forget the day," Ruffolo said. "I was in London at the time, taking a nap, and my boss called. He told me that the data safety monitoring board had stopped the trial. I thought we had killed people and it was my fault. But they stopped the study because it was unethical to maintain the placebo arm. "I cried for hours, because it was almost 17 years of agony and fear and what other people had said, and I worried every minute of every day and every night that people might die on this drug," he continued. "But we ended up saving a lot of lives." Even after three decades of experience in the pharmaceutical industry, Ruffolo still credits the courses he took in Parks Hall as the most valuable parts of his training. Rarely does a day go by when he doesn't use something he learned while in school at Ohio State. "There wasn't a course I took that wasn't useful," Ruffolo said. "Most of the techniques and logic that I used in the discovery of carvedilol were the techniques and logic that I learned in this building."
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