Please join us for Medicine Grand Rounds on Friday, April 18, 2014 for the presentation titled:

When Pharma and FDA Fail Us: What Happened to Vioxx™   and ASR XL™?

Two case studies of new drug and device products, regulation by the FDA, marketing, company behavior, and patient health

By

David W. Nierenberg, MD

Professor of Medicine and Pharmacology & Toxicology

Geisel School of Medicine at Dartmouth

Dartmouth-Hitchcock Medical Center

8:00 a.m. – 9:00 a.m.

Auditorium E, Rubin Building, Dartmouth-Hitchcock Medical Center

Co-sponsored by Clinical Pharmacology and the Department of Medicine

Geisel School of Medicine at Dartmouth

Objectives – Participants will be able to:

1. Describe the process by which the FDA approves new drugs
2. Describe the process by which the FDA approves new implantable medical devices
3. Compare the processes which the FDA uses to track performance of new drugs and new devices once they have been approved
4. Explain what “went wrong” with two best-selling medical products - Vioxx™  and  the  ASR XL™ hip replacement system

David W. Nierenberg, MD currently serves as Section Chief of Clinical Pharmacology and Toxicology at DHMC, director of the Year 2 SBM Program at Geisel School of Medicine at Dartmouth, and also Senior Advising Dean at Geisel School of Medicine at Dartmouth. He established the section of clinical pharmacology at DHMC with his arrival here in 1981, and has led that section for 33 years.  Since 1995 he has served as the Edward Tulloh Krumm Professor of Medicine and Pharmacology/Toxicology. 

Dr. Nierenberg received his MD degree from Harvard Medical School in 1976. He performed his internship and residency in internal medicine at the Beth Israel Hospital in Boston, and completed a two-year clinical/research fellowship in clinical pharmacology and toxicology at the University of California, San Francisco. In 1980-81 he was invited to the Stanford Medical Center to serve as chief medical resident. 

Since 1981, Dr. Nierenberg has developed different aspects of clinical pharmacology here at Geisel and DHMC—developing an active clinical consultation service, a clinical and translational research program now led by Dr. Lionel Lewis, and a rigorous Y4 course in clinical pharmacology required of all of our senior medical students.

Dr. Nierenberg has written more than 78 peer-reviewed scientific articles, and served as a senior editor on two editions of the major US textbook in clinical pharmacology. He has served as President of the American Society for Clinical Pharmacology and Therapeutics; served on the NBME to help write both Step 1 and Step 3 of their exam sequence; and has served on several national committees for the AAMC. In 2008, he was one of the recipients of the annual Glaser AOA/AAMC Distinguished Teacher Award, and has won numerous teaching awards at DMS as well.

David W. Nierenberg, MD has stated that he has no financial interests or arrangements in association with this presentation.

If you are unable to attend and would like to either view Grand Rounds live on your computer or if you would like to view it another time, please use this link.

http://med.dartmouth-hitchcock.org/education/dept_medicine_grand_rounds_live.html