FDA Calls For Men To Be Included In Breast Cancer Clinical Trials
Although breast cancer in men is not often publicized in the media, it is very important to know that men are at risk of the disease too. It is estimated that about 2,600 men will be diagnosed and 500 will die of breast cancer each year. However, because men contribute less than 1% of all cases, they are typically not included in clinical trials for treatment.
Since men have not historically been included in clinical trials, it is very possible they are not receiving optimal care. The drugs and treatment options they are prescribed have only been tested and approved for women.
The Food and Drug Administration (FDA) is calling for this to change. In their recent draft guidance, the FDA recommends the inclusion of men in breast cancer clinical trials to help improve the clinical management of the disease in male breast cancer. The FDA also states that if researchers propose to exclude male patients from a breast cancer trial, “scientific rationale should be included.” Furthermore, the FDA will not consider “low expected accrual rates of male patients with breast cancer” as sufficient rationale for excluding male patients moving forward.
The move seems to be working already… Following the FDA’s announcement, some breast cancer drug studies have extended eligible enrollment criteria to men.
Reports of Breast Implant-Related Illnesses Prompt FDA Review
New safety concerns over breast implants has prompted the FDA to hold a two-day meeting to hear from researchers, patients, plastic surgeons, and implant manufacturers. The hearing was scheduled for March 25th and 26th, 2019.
Concerns surfaced recently following the publication of the first study to review breast implant safety data following the FDA’s approval of silicone implants. The study, published in Annals of Surgery, is the largest ever study of silicone breast implants.
The researchers analyzed data on nearly 100,000 patients enrolled in the study between 2007 and 2010. More than 80,000 patients received silicone implants (Allergan or Mentor); the rest received saline implants. Seventy-two percent of the patients underwent primary breast augmentation, 15 percent had revision augmentation, 10 percent had primary breast reconstruction, and three percent had revision reconstruction procedures.
The authors found silicone implants are generally safe but are also associated with a slightly higher risk of a few rare diseases including Sjogren’s syndrome (8-fold increase), scleroderma (7-fold increase), rheumatoid arthritis (6-fold increase), stillbirth (4.5-fold increase), and melanoma (4-fold increase). One case of BI-ALCL (rare lymphoma associated with textured implants) was reported.
The findings have been disputed by many experts, including federal health regulators, who nevertheless scheduled the public meeting to consider implant safety.
“These findings aren’t meant to suggest implants caused these problems,” said Dr. Mark Clemens, an MD Anderson professor of plastic surgery, Breast Advocate App contributor, and the senior investigator of the study. “They’re associations, which underscore the need for more research in this area, but do provide key safety information for women and their providers to consider when thinking about cosmetic or reconstructive surgery with breast implants.”
Since the publication, the FDA has also issued a statement acknowledging that implantable devices, including breast implants, may make some people sick. “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices… [which can include] inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.”
Following the hearing and consideration of all the information presented, the FDA released this statement.
