FDA Finds Men Are Too Often Excluded From Breast Cancer Trials

Although roughly 23,800 adults are diagnosed with brain and spinal cord tumors each year, breast cancer retains its spot in the top five most common cancers in the U.S., with approximately 226,870 new cases predicted to occur in 2012. And while breast cancer is the most frequently diagnosed cancer among women and is known as the second most prevalent cause for cancer deaths in women, the U.S. Food and Drug Administration has made it clear that men are too often excluded from the conversation.

Although women have to had to fight for equality and inclusion in countless other areas, they do tend to dominate topics related to breast cancer. Certainly, it’s rarer to receive this diagnosis as a man, as men comprise less than 1% of all patients with breast cancer diagnoses. But when men are diagnosed with this disease, according to research, it tends to be deadlier for male patients. A recent analysis of 1.9 million patients published in the Journal of the American Medical Association revealed that, even when men are diagnosed with breast cancer at the same stage as women are, their survival rate is markedly lower than that of female patients. Researchers found that while women had a 91.7% three-year survival rate, men displayed only an 86.4% survival rate.

Tragically, that means that many male breast cancer patients could well pass away from their condition. And while 14% of life insurance policy benefits are ever disbursed, the higher mortality rate observed might make some men seriously consider investing in a policy to ensure their loved ones are provided for in the event of a fatal case.

That said, those fatal cases might decrease if men were included in breast cancer treatment clinical trials. While women can benefit from mammography screenings (which, when conducted every two years among older women, can reduce breast cancer deaths) and are typically included many clinical trials for new medications. Women were once excluded from these studies if they were within their childbearing years, but those restrictions have since been lifted. However, the FDA has found that men are usually excluded from new treatment trials, meaning that there’s very little data to show whether these treatments are safe or effective for male patients. There are even drugs that are available only to women, which limits treatment options for men with breast cancer.

As a result, the FDA is stressing that researchers include male patients in breast cancer treatment clinical trials. Even if there are very few male patients included due to lower diagnosis numbers, at least having some kind of male representation when testing new drugs will allow experts to make more informed decisions when it comes to treatment. Right now, there’s a lack of certainty about whether those approved treatments will work in men. And considering that men are often diagnosed in the later stages of the disease, the FDA is concerned that male patients could be missing out on potentially life-saving options. One study actually found that one in five men who should have received anti-estrogen therapy — and medical experts feel that older treatment methods are being prioritized over more effective ones among male breast cancer patients. And considering that another recent study revealed that mammography screening in men may actually be more effective than we realized, there’s even more reason to start including men in a conversation that truly does impact them.

Following the released guidance by the FDA for researchers, Forbes interviewed Rod Ritchie, a National Breast Cancer Coalition Project LEAD graduate and patient advocate, who explained: “Pink charities have ignored men for so long and researchers have likely not considered us statistically relevant. Men are currently treated using the results of research on women. Only with access to trials will we know if this is best for us. Once men realize that they’re welcome to participate and join a study, they will help all men become the beneficiaries of research results.”