Nearly Half of New Cancer Therapies Approved by FDA Lack Randomized Clinical Trial Evidence & Only Prolong Life by Weeks

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: “Many of these drugs were approved to address an unmet medical need. We believe this need still exists.”

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 “reduced patient safety.”

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:

Stage IV Cancer: Dr. Patrick Hanaway’s Personal Experience with Functional & Integrative Modalities

A Journey Through Breast Cancer: A Clinician’s Personal Experience

Increased Coffee Intake Linked to Survival in Patients with Advanced or Metastatic Colorectal Cancer

New Data on the Effects of Ketogenic Diet in Breast Cancer

Author: Kara Fitzgerald, ND

https://www.drkarafitzgerald.com/

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)’s 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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Dr. Fitzgerald’s book is an extraordinary integration of a vast amount of diverse information that makes practical sense of the complex interplay between our genes, the folate/vitamin B12 cycle, homocysteine, and the clinical importance of methylation.

Jeffrey Bland, PHDPresident PLMI

I was thrilled to see the principles of a methylation food plan. This helped to confirm my teaching principles.

Kylene Bogden, MS, RDN, CSSD, LDNCleveland Clinic Center for Functional Medicine

The nutrition methylation webinar has fabulous information on methylation and specific nutrients that are required to support the process. I think I can speak for our team of dietitian nutritionists in saying that it is valuable to connect the science and biochemistry from Dr. Fitzgerald’s point of view with the nutrition and implementation from Romilly. They are a knowledgeable team! I love that this is a food-first approach with an emphasis on food and dietary intervention for sustainable long-term nutritional support. Food is not just medicine, it’s information for methylation and you can’t supplement your way out of a bad diet!

Brigid Titgemeier, MS, RDN, LDCleveland Clinic Center for Functional Medicine

I enjoyed the presentation and really appreciated the food first approach. There were many talking points to help solidify this concept with patients, particularly those that don’t “buy in” to the food first approach or simply want to take a supplement.

Lindsay Malone, MS, RD, CSO, LDCleveland Clinic Center for Functional Medicine

Dr. Kara Fitzgerald always produces clinically relevant and compelling cutting-edge content in her blogs, PodCasts and newsletters and I try to never miss one. Her dept of knowledge in the functional medicine paradigm and its relevance to modifying the course of the chronic disease epidemic is not only valuable, but inspiring. She is a respected colleague and I always appreciate the effort she puts into keeping up the important dialogue between integrative and functional medicine clinicians, as well as her clear desire to educate the health care consumer in the process. Dr. David M. Brady (University of Bridgeport, Designs for Health, Inc., Diagnostic Solutions Labs, LLC, and DrDavidBrady.com)

David BradyDoctor

I want to drop you a note to tell you how much I enjoy your newsletter-Your newsletter is no doubt the best newsletter I receive. It’s not too long, not too short, yet chock full of great info, and, most importantly for the reader, enjoyable to read because your playfulness comes through. All of this separates your newsletter from the pack. You are doing a superb job, and it’s a pleasure to read! Keep it up!

Robert Hedaya, MDClinical Professor of Psychiatry

I’ve had the opportunity to review Dr. Kara Fitzgerald’s blogs. She is a well-recognized leader of functional, integrative medicine. Her blogs effervesce with her enthusiasm for her subject matter and convey her genuine warmth and compassion for her patients. She writes in an engaging style while conveying significant and meaningful information about the varied topics she has covered. They are simply fun to read and easy to learn from her wealth of experience.

Shalesh Kaushal, MD PhD

Dr. Kara’s blogs are current, scientifically sound, and relevant to clinical care. Her case studies and reviews are focused on how to improve clinical thinking and outcomes using a systems biology and functional medicine approach. They are one of my favorite learning tools and I look forward to her insights and interviews monthly!

Sarah Lobisco, NDND, IFM-CP

Dr. Fitzgerald is what you get when you merge a brilliant clinical brain with a powerful loving heart. Her ability to incorporate seemingly disparate details into a mosaic of meaning that can improve patient care is extraordinary. The opportunity to learn from her should never be missed without great reason.

David H. Haase, MDIFM-CP, FABFM, DABIHM, CNS, BCN

Kara and I have co-authored case studies for peer-reviewed articles and textbooks over the years. I love reading her blog, while evidenced-based and geared towards the professional, the casual style makes for fun reading!

Dr. Mark Hyman, MD9 Time NY Times Best Selling Author

I thoroughly enjoy reading your blog and recommend it to the medical students. It is interesting, informative and up to date as well as an excellent supplement to their text.

Albert E. Dahlberg, MD, PhDProfessor, Brown University

Dr. Kara Fitzgerald’s writing style is clear, concise, well-translated from scientific gobbledygook to understandable every language. And most importantly, it’s accurate.

Dr. Tom O’BryanFounder: The Gluten Summit

Of the myriad blogs I receive in my inbox, Kara’s is one that I actually read! It’s funny, clinically relevant and smart.

Sara Szal, MDNYT Best Selling Author, Clinician

I am a regular reader of Dr Fitzgerald’s blog/newsletter. I read it because it is useful. Dr. Fitzgerald, stimulated by a recent article, looks into the bulk of the literature and synthesizes the relevant takeaways. Dr Fitzgerald is brilliant and always delivers clinical pearls.

Tom Sult, MDIFM Faculty, Author, Clinician

Wading through emails is not an ideal part of my day. For this reason, I’m very particular about who’s information I want coming into my inbox. When I see an email come in from Dr Fitzgerald, I stop what I am doing and I read it fully right then so I don’t miss it. Her content is always interesting, clinically relevant, cutting edge and many times entertaining as well. I only wish one thing: that she’d write more!

Ben Lynch, NDExpert on MTHFR & Epigenetics

Dr. Fitzgerald has her finger on what’s happening in holistic and integrative health and medicine. I love reading her blog! It’s always right on the mark!

Liz Lipski, PhD, CCN, CNS, CHNAuthor, Lecturer, Educator

I love reading Dr Fitzgerald newsletter! It is both funny and relevant and offers great info for my patients and colleagues.

Susan Blum, MD, MPHNYT Best Selling Author

Dr. Kara Fitzgerald is a clear, brilliant, and insightful clinician. She always seems to unwrap the story of the patient so well, then identifies the pertinent imbalances and together with the patient initiates the therapeutic plan with successful treatment. She is rare in the education and clinical circles. I always learn from her blogs, conversations, case studies, and lectures. She is an outstanding educator and functional medicine physician.

P. Michael Stone, M.D., M.SCertified Functional Medicine Clinician

I am so happy to have found Dr. Fitzgerald, Romilly and Rhonda who all care about my well being. My life has changed for the better and I will continue whatever staff recommends so I can enjoy my family and feel great.

Victoria O

I wanted to find the root cause for my health concerns, to treat the primary cause and not the symptoms. Dr. Fitzgerald’s approach is radically different. She is tuned in to me. She responds to me within 24 hours. The intimacy of working with Dr. K is different than the yearly physical.

John J

Nearly Half of New Cancer Therapies Approved by FDA Lack Randomized Clinical Trial Evidence & Only Prolong Life by Weeks

Author: Kara Fitzgerald, ND

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