Benedictine College Discovery Day Speaker Focuses on Ethics, Drugs, and the FDA

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Dr. David J. Graham, best known for his research leading to the removal of such drugs as Fen-Phen, Rezulin and Vioxx from the market, will be the keynote speaker for Benedictine College's signature Discovery Day event.

Benedictine College is known for its concentration on community and its focus on teaching ethics across all disciplines. On April 5, the college will feature a well-known public servant who has challenged the ethics of both government agencies and big business. Dr. David J. Graham, best known for his research leading to the removal of such drugs as Fen-Phen, Rezulin and Vioxx from the market, will be the keynote speaker for the school’s signature Discovery Day event. Student research presentations will take place throughout the day, with Graham’s keynote address set for 1:00 p.m. in the O’Malley-McAllister Auditorium on the college campus in Atchison, Kan.

Graham is currently the Associate Director for Science and Medicine within the U.S. Food and Drug Administration’s Office of Drug Safety. He has published numerous research papers and textbook chapters and is recognized nationally and internationally for his expertise in the field. Within FDA, he is the only medical officer ever to be promoted to the rank of master medical reviewer.

During his 20-year career in drug safety, Graham’s research has contributed to the withdrawal of ten marketed drugs. He also has shown that most FDA risk management programs have had little or no effect on improving the safety profile of problem drugs for which they were designed.

In August 2004, Graham completed a study of myocardial infarction risk with rofecoxib (Vioxx), showing that it substantially increased patient risk. He estimated that from 88,000 to 141,000 Americans had experienced myocardial infarction as a result of rofecoxib use, of which up to 61,000 were fatal, comparable to the number of US soldiers killed during the Vietnam War. Pfizer voluntarily removed Vioxx from the market in September 2004.

In November 2005, Graham testified before the Senate Finance Committee and described structural, cultural and scientific biases within the FDA that guarantee the approval and continued marketing of unsafe medicines. Since then, he has spent much of his personal time advocating for FDA drug safety reform and for free-speech rights for government scientists.

Graham is the recipient of the Shafeek Nader Trust’s Award for Civic Courage, the Association of Certified Fraud Examiners’ Cliff Robertson Sentinel Award, and the American Public Health Association’s Award for Excellence.

Benedictine College is a Catholic, Benedictine, liberal arts and residential college located on the bluffs above the Missouri River at Atchison, Kan. The mission of the college is the education of men and women in a community of faith and scholarship.

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Stephen Johnson