Bernardo Fernandez, M.D.
Sarvam TerKonda, M.D.
Board Recognizes Residents
At the October 2015 meeting, the Board recognized two residents as part of the Resident Recognition Program: Jack D. Stringham, M.D.— University of Miami Bascom Palmer Eye Institute and William Taylor Palfrey, Jr., M.D.— University of Florida—Jacksonville. The Board recognized these residents because, among other things, they demonstrate extraordinary medical and social competence and skill expected of young medical professionals.
The Board also recognized Elissa R. Engel — medical student at University of Central Florida. Medical students are nominated by their Deans for professionalism, moral character, compassion and intellect essential to the future leaders of our medical profession and because peers and faculty already respect the medical student as an outstanding physician to be. Congratulations to the awards recipients!
Information on Stem-cell Clinics Offering Unapproved Therapies
Physicians and their patients should be aware of the risks involved in unapproved stem-cell therapies and regenerative medicine offered in clinics throughout Florida. Although certain stem-cell therapies offer hope and hold great potential in treating devastating conditions, the FDA has approved few treatments involving stem cells. The Florida Board of Medicine encourages physicians and their patients to educate themselves about the potential risks associated with therapies offered by stem-cell clinics. Physicians are also encouraged to consider the regulatory consequences when providing unapproved stem-cell therapies.
FDA approved therapies use hematopoietic stem cells to treat diseases of the blood and immune system. But the majority of therapies offered by stem-cell clinics use adipose-derived stem cells packaged as a product called stromal vascular fraction (SVF). Procedures using SVF have become increasingly popular because of the relative ease of acquiring the cells. Although the FDA has not determined that SVF is safe or effective in treating any disease, U.S. clinics sell SVF-based procedures to patients with myriad conditions from benign conditions such as hair loss to chronic and life-threatening diseases such as heart failure, muscular dystrophy, and Parkinson’s disease. These clinics neither claim their treatments are effective nor explicitly state that they’re unfounded. Their websites frame their work as experimental, although none of the clinics are conducting FDA-approved clinical trials, and emphasize the potential regenerative capabilities of stem cells. Their language is intentionally imprecise and exploits the vulnerability of patients with debilitating diseases¹.
Physicians providing or considering providing stem-cell therapies should have an IND (Investigational New Drug Application) or a Single Patient IND for Compassionate or Emergency Use. If you have a question about providing stem-cell therapies to your patients it is recommended that you look at applicable FDA guidance or contact the FDA. Links with information about FDA guidance and Compassionate Use INDs are provided below. Licensed Florida physicians providing unapproved stem-cell therapies could potentially face disciplinary action against their medical license. Physicians could face allegations of violating the Medical Practice Act for failing to meet the prevailing professional standard of care, or for performing any procedure or prescribing any therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed, and written consent. Physicians may also run afoul of federal law which may have adverse consequences on their medical licensure. For additional information about stem-cell therapies please visit:
FDA Physician Request for a Single Patient IND for Compassionate or Emergency Use: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm163982.htm
FDA Cellular & Gene Therapy Guidelines:
¹Weiner, Zivin. N Engl J Med 2015; 373:985-987.
Healthiest Weight Florida: A Life Course Approach
Healthiest Weight Florida is pleased to announce the availability of a free, 2-credit Continuing Medical Education (CME) course, Healthiest Weight: A Life Course Approach. This monograph was produced as a collaboration between the Florida Department of Health and the Florida Medical Association (FMA). It is available free of charge to all physicians licensed in Florida, whether they are FMA members or non-members. For information on accessing the course, click the link below: http://www.healthiestweightflorida.com/activities/life-course.html
Board Meeting Attendance for CME Credit
Florida Administrative Code Rule 64B8-13.005 allows physicians to attend a full day of disciplinary hearings to earn five (5) hours CME credit in risk management or ethics. The Board’s next meeting is scheduled for December 4, 2015 at the Hyatt Regency Jacksonville Riverfront, 222 East Coastline Drive, Jacksonville, Florida. The meeting begins at 8:00 am. Be sure to sign in with staff upon arrival to ensure proper credit.
Did you know . . . . The renewal window for physician’s whose licenses expire January 31, 2016. To renew, go to www.FLBoardofMedicine.gov. Once there, click on the Renew tab and follow the online instructions. Be sure to upload all of your CME to your account at www.ceatrenewal.com.
Florida Board of Medicine
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