A large number of cancer therapies are approved by the FDA without randomized clinical trials and only increase median survival by 2.4 months, according to a new review article published in the Journal of the American Medical Association (JAMA). This may come as a surprise and disappointment considering the urgent goals of cancer research to develop new drugs that improve survival and quality of life, and the large cost burden of these drugs despite limited efficacy. As the authors surmise: âMany of these drugs were approved to address an unmet medical need. We believe this need still exists.â
The review, which looked at data from 2000 to 2016 covering 92 new FDA-approved cancer therapies for 100 indications, found that 44 percent of the indications were approved by the FDA without supporting evidence from randomized clinical trials. This means that patients and healthcare providers lack critical data regarding the benefits and potential harms of these new cancer therapies as they become available. Quality of life data was not reviewed in this study, although a 2017 JAMA Oncology article reported that of new cancer drugs introduced from 2003-2013 only 42 percent led to an increase in quality of life, and 45 percent were also associated with âreduced patient safety.â
Although there is no panacea when it comes to cancer, functional medicine has a great deal to offer at a lower cost and lower risk. Here are some of the latest resources on this topic from Dr. Kara Fitzgerald:
Kara Fitzgerald, ND, received her doctor of naturopathic medicine degree from the National University of Natural Medicine in Portland, Oregon. She completed the first Counsel on Naturopathic Medicine-accredited post-doctorate position in nutritional biochemistry and laboratory science at Metametrix Clinical Laboratory under the direction of Richard Lord, PhD. Her residency was completed at Progressive Medical Center, a large, integrative medical practice in Atlanta, Georgia.
Dr. Fitzgerald is the lead author and editor of Case Studies in Integrative and Functional Medicine and is a contributing author to Laboratory Evaluations for Integrative and Functional Medicine and the Institute for Functional Medicine (IFM)âs Textbook for Functional Medicine. With the Helfgott Research Institute, Dr. Fitzgerald is actively engaged in clinical research on the DNA methylome using a diet and lifestyle intervention developed in her practice. The first publication from the study focuses on reversal of biological aging and was published 04-12-2021 in the journal Aging. She has published a consumer book titled Younger You as well as a companion cookbook, Better Broths and Healing Tonics and has an application-based Younger You Program, based on the study.
Dr. Fitzgerald is on the faculty at IFM, is an IFM Certified Practitioner and lectures globally on functional medicine. She runs a Functional Nutrition Residency program, and maintains a podcast series, New Frontiers in Functional Medicine and an active blog on her website, www.drkarafitzgerald.com. Her clinical practice is in Sandy Hook, Connecticut.
Additional publications
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