Men Should Be Part of Breast Cancer Clinical Trials, Says FDA

Medical Malpractice

The Food and Drug Administration has issued guidelines for the inclusion of men in clinical trials testing the efficacy of breast cancer drugs. This is a major step because, as men in West Virginia and across the U.S. should know, breast cancer does affect men. The percentage of breast cancer patients who are men is less than 1%, but the risk for it is still there.

Because men are so rarely affected by breast cancer, there is a lack of FDA-approved treatments for breast cancer that are specifically for men. Those treatments that are for men are based on data gathered from female breast cancer patients. Yet men’s bodies react to different drugs than women’s bodies do, so the need for more treatment options is a pressing one.

Besides recommending that men be a part of clinical trials, the FDA states that investigators should give a scientific rationale if they choose to exclude men. Where the clinical trial excludes men or limits their number, investigators should explore the potential for including men in the FDA-approved indication for the drug in question. This is in cases where the drug will have no perceived difference in efficacy between men and women. For more data supporting inclusion in the indication, investigators could hold, for example, single-cohort studies.

Breast cancer is among the most frequently misdiagnosed cancers. Diagnostic errors can lead to unnecessary treatments and preventable harm, so victims are entitled to compensation. To pursue a medical malpractice case, though, victims must prove the doctor failed to live up to an objective standard of care. That negligence must then be linked to the injuries. This is where a lawyer and his or her team of investigators, medical experts and other third parties may be of benefit. Victims may leave all negotiations to their lawyer.