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

cancer therapy

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

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