A new study investigating the long-term survival, financial, and quality of life benefits of a variety of cancer drugs has found that some cancer drugs retain their FDA approval, though research has shown they provide patients with no overall survival or quality of life benefits and can be quite expensive.
Presently, there is an absence of strong evidence supporting the financial, survival, and quality of life-related benefits of various cancer drugs approved by the US Food and Drug Administration (FDA). An article previously published in JAMA (Journal of the American Medical Association) demonstrated that 18 out of 36 cancer drugs approved by the FDA from 2008-2012 studied did not produce any overall survival benefits. In the absence of reliable evidence of long-term benefits to cancer patients, it is impossible for patients and health care providers to make informed treatment decisions. Researchers evaluated all FDA review results and peer-reviewed articles involving these 18 drugs to ascertain whether any quality of life or annual cost benefits have been gained. Researchers undertook an extensive literature search using the PubMed search engine for articles involving the clinical trials and the fda.gov website for cancer drug review summaries.
Overall, the search yielded 466 articles and 31 met the researchers’ inclusion criteria; FDA summaries were available for 15 out of the 18 drugs. For a cancer drug to be approved, postmarket studies on the drug must be conducted. However, the randomization of these studies can be compromised due to some controls (ie. those not receiving the drug in the clinical trial) receiving the treatment drug external to the study. This is an issue as the study’s design can no longer be considered truly random, and the results are no longer unbiased. An investigation of the cancer drug costs indicated that the annual cost estimates for the 18 drugs were between $20 237-169 836; 13 drugs had exorbitantly high annual cost estimates over $100 000. The researchers’ analysis of the cancer drugs indicated that despite postmarket studies failing to demonstrate significant quality of life and overall survival benefits in comparison to placebos, the majority of these drugs remain FDA-approved and stay on the market.
In summary, health care providers and patients need to ensure that they carefully and adequately assess the financial and long-term quality of life and overall survival benefits and risks of particular cancer drugs depending on the available clinical trial research and FDA drug reviews.
Written By: Melissa Booker