The Perfect Storm - Drug Safety And Avandia (Rosiglitazone) - Inside Endocrine Practice, Volume 13, Number 3

Main Category: Diabetes
Also Included In: Endocrinology
Article Date: 08 Jun 2007 - 1:00 PDT


Richard Hellman, MD, FACP, FACE, one of the nation's prominent experts on patient safety, is calling for a major change in the way drugs are reviewed after FDA approval. Dr. Hellman believes the recent firestorm surrounding rosiglitazone (Avandia) may prevent ongoing studies from accurately determining the safety of the drug in many patient populations.

Dr. Hellman's editorial, scheduled to be published in the May/June edition of the Endocrine Practice, entitled "The Perfect Storm - Drug Safety and rosiglitazone," has also been pre-published on the AACE website (www.aace.com.).

"This issue is so timely and important to the safety of our patients," said Lewis E. Braverman, MD, Editor-in-Chief of Endocrine Practice, the scientific journal of AACE, "that I thought it appropriate to obtain Dr. Hellman's insight into the public discourse on the rosiglitazone issue as soon as possible."

In the editorial, Dr. Hellman calls upon industry to increase its efforts to review drugs once they are approved by the FDA. In addition, Dr. Hellman asks the federal government and independent research facilities to increase efforts to test efficacy of treatments for a wide spectrum of patient populations.

Dr. Hellman points out that, while Avandia is at the center of the current controversy in drug safety, multiple conditions, including systemic shortcomings, tight budgets, and lack of coordination between the governmental (FDA) and private sector (institutions and industries), have collided to create what he terms as a "perfect storm" in drug safety. The story of the controversy surrounding Avandia highlights the difficulties due to the flaws in the current methods of ongoing monitoring of drug safety.

Dr. Hellman states that everyone is interested in drug safety until it comes time to pay the bill. He calls upon the government, pharmaceutical companies, and research institutions to take a proactive role in the continuing evaluation of drugs after they receive FDA approval. Dr. Hellman concludes that we all have a shared responsibility for formulating a new policy to protect the public safety and to prevent future "perfect storms."

Visit www.aace.com/pdfs/HellmanEditorial.pdf to read the editorial in its entirety.

About Richard Hellman, MD, FACP, FACE

Dr. Hellman is President of the American Association of Clinical Endocrinologists (AACE), sits on the AACE Board of Directors, and is a Fellow of the American College of Endocrinology (ACE). He is in private practice in North Kansas City, Missouri, and is a clinical professor of medicine at the University of Missouri/Kansas City School of Medicine (UMKC). He graduated from the Chicago Medical School and completed his post-graduate training at the University of Kansas Medical Center. Dr. Hellman is a member of Alpha Omega Alpha, the national medical honor society. He spent nine years as a full-time faculty member of the University of Missouri/Kansas City School of Medicine, where he held the position of Associate Professor of Medicine and Director of Endocrine Programs. Dr. Hellman is the Medical Director of the Heart of America Diabetes Research Foundation.

About Endocrine Practice

Endocrine Practice is the official scientific publication of the American College of Endocrinology (ACE) and the American Association of Clinical Endocrinologists (AACE). It publishes the latest information in the treatment of diabetes, thyroid disease, obesity, growth hormone deficiency, sexual dysfunction, and osteoporosis, among others. The journal contains original articles, case reports, review articles, AACE Medical Guidelines for Clinical Practice, commentaries, editorials, and visual images. The total circulation of Endocrine Practice exceeds 6,000. Of these readers, 94 percent are physicians who treat endocrine-related disorders. Readership includes 900 subscriptions in 84 countries, as well as many medical schools and research facilities.

About AACE

AACE is a national, professional medical organization with more than 6,000 members throughout the United States and 84 foreign countries. Founded in 1991, AACE is an association of clinical endocrinologists, physicians whose advanced, specialized training enables them to be experts in the care of endocrine disease, such as diabetes, thyroid disorders, growth hormone deficiency, osteoporosis, cholesterol disorders, hypertension, and obesity. For further information about AACE, visit http://www.aace.com.

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