ARLINGTON, Va.- Unexpected liver damage caused by a new treatment for diabetes, life-threatening side-effects from weight loss drugs, disfiguring skin problems seen with a recently approved AIDS treatment- what do these events have in common? In each case, the serious adverse effects of a newly approved treatment only came to light after the drugs entered the marketplace. And in each case, the current clinical trial and drug approval system was put under scrutiny.
Unexpected adverse reactions to recently approved prescription and over the counter drugs, along with dangerous interactions among otherwise safe drugs highlight some of the issues now facing the consortium of academic researchers, regulatory officials and pharmaceutical industry representatives who together make up the world of new drug development.
Members of the media will have an unprecedented opportunity to hear and interview leading authorities from all of these sectors as they gather to discuss these and other issues at the annual meeting of the American Academy of Pharmaceutical Physicians.
"While there may be increased pressures to get new drugs to patients faster, these must be balanced with the need to perform ethical and safe clinical studies. This year's AAPP conference brings together an excellent roster of true experts from all side of the drug development world for frank discussion of current and future issues in drug development, a crucial but often overlooked field of medicine, said David Shapiro, MD, Vice-President and Trustee, American Academy of Pharmaceutical Physicians.
Some of the leading issues that will be discussed include:
-
Pediatrics: In light of the new FDA requirements for pediatric studies, how can
the
safety and efficacy of drugs intended for pediatric patients be evaluated in
clinical trials without putting children at risk?
AIDS: Has pressure on the FDA to 'fast track' new AIDS treatments put patients at risks of adverse reactions?
Managed Care: Do managed care restrictions reduce patients access to new treatments?
Biotechnology: What are the opportunities and the challenges for the next millennium?
-
Regulatory:
Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA
Steven Aurecchia, MD, Division of Over the Counter Drug Products, FDA
Academia:
Raymond Woosley, MD, PhD, Chair, Department of Pharmacology, Georgetown
University.
David Shapiro, MD, Senior Advisor, Scripps Clinic, La Jolla, CA
Industry:
Philip J. de Vane, MD, Vice-President Clinical Affairs, Wyeth-Ayerst
Laboratories
B. Gil Price, MD, Director of Medical Affairs, Medimmune, Inc.
Zofia E. Dziewanowska, MD, PhD, Senior VP, Cypros Pharmaceuticals
Patient/Consumer:
Ms. Nancy Sander
Allergy and Asthma Network
"Drug development is an increasingly complex process. Patients, physicians and investors are all keen to see new medical advances become available more quickly. However, whenever safety problems arise with marketed drugs the development and approval process is publicly scrutinized. Physicians involved in pharmaceutical medicine have responsibilities to oversee the process ethically, whether they work in biopharmaceutical companies, regulatory agencies or as clinical investigators," said Dr. Shapiro.
The American Academy of Pharmaceutical Physicians is a non-profit association dedicated to enhancing the proficiency of pharmaceutical physicians, promoting the acquisition and dissemination of knowledge concerning the therapeutic action, investigation, and development of medicines and diagnostics, as well as protecting the welfare of patients and clinical study participants.