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FDA pushes for inclusion of men in breast cancer clinical trials

Some men in Pennsylvania may not be aware that they run the risk for breast cancer. Less than 1% of breast cancer patients are men, which has led to only limited efforts to come up with breast cancer treatments that are specific to men. The Food and Drug Administration, in its effort to correct this oversight, has issued guidelines for the inclusion of men in future clinical trials of breast cancer drugs.

The FDA guidelines state that investigators must give a scientific rationale for why they want to exclude men from these trials. Where men are excluded or the number of enrolled men is limited, an effort should be made to include men in the FDA-approved indication for the drug, at least where there is no foreseen difference in the drug’s efficacy on men and women.

The FDA also encourages the gathering of additional data specifically for men through single-cohort studies. Since men’s bodies react differently to medications than women, the inclusion of men in these trials and studies is a major step.

For one thing, it can lead to more FDA-approved breast cancer treatments for men to choose from. It can also make breast cancer drugs available to men that were previously approved only for women.

Breast cancer being rare in men, it’s liable to be the subject of a misdiagnosis or a delayed diagnosis. Diagnostic errors are involved in a great many cases under medical malpractice law, and those who believe they were the victims of such an error may be able to pursue a case themselves. However, they may want a lawyer by their side. The lawyer might help them prove that the doctor was negligent and that this negligence led to their harm before he or she proceeds to negotiations.