Health Highlights: Oct. 22, 2018
Proposed Trump Administration Rules Threaten Transgender People's Civil Rights Immunotherapy-Chemo Combo Extends Lives of Women With Aggressive Breast Cancer Ready-to-Eat Salads Recalled Hackers Steal HealthCare.gov Data of 75,000 People
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Proposed Trump Administration Rules Threaten Transgender People's Civil Rights
A new legal definition of gender being considered by the Trump administration could remove civil rights protections for transgender people.
The focus is on the legal definition of sex under Title IX, the federal civil rights law that bans gender discrimination in education programs that receive government financial assistance, according to The New York Times.
A draft proposal from the Department of Health and Human Services would define sex as either male or female, unchangeable, and determined by the genitals a person is born with. Any dispute about a person's sex would have to be settled through genetic testing.
"The sex listed on a person's birth certificate, as originally issued, shall constitute definitive proof of a person's sex unless rebutted by reliable genetic evidence," according to the proposed HHS definition, The Times reported.
After more than a year of discussions, HHS is expected to formally present the new definition to the Justice Department before the end of the year, according to Trump administration officials.
If the Justice Department decides that the new definition is legal, it can be enforced across government agencies.
The new definition would halt federal recognition of about 1.4 million people who recognize themselves as a gender other than the one they were born into, The Times reported.
"This takes a position that what the medical community understands about their patients -- what people understand about themselves -- is irrelevant because the government disagrees," Catherine Lhamon, who led the Education Department's Office for Civil Rights in the Obama administration and helped write transgender guidance, told The Times.
This is the latest in a series of Trump administration attempts to reverse recognition and protections of transgender people. It has sought to prevent transgender people from serving in the military and has legally challenged transgender civil rights protections in the health care law.
"Transgender people are frightened," Sarah Warbelow, the legal director of the Human Rights Campaign, which promotes the rights of lesbian, gay, bisexual and transgender people, told The Times.
"At every step where the administration has had the choice, they've opted to turn their back on transgender people," Warbelow said.
Immunotherapy-Chemo Combo Extends Lives of Women With Aggressive Breast Cancer
Treatment with immunotherapy plus chemotherapy extended the lives of women with an aggressive form of breast cancer longer than chemotherapy alone, researchers report.
The findings could lead to the first U.S. Food and Drug Administration approval of an immunotherapy drug to treat breast cancer and may change the standard of care for women with advanced triple-negative breast cancer, according to The New York Times.
Triple-negative tumors occur in only about 15 percent of patients with invasive breast cancer in the United States (nearly 40,000 each year), but account for as many as 30 to 40 percent of breast cancer deaths.
The study included 902 patients treated at 246 medical centers in 41 countries. Half received chemotherapy alone (nab-paclitaxel/Abraxane), and half received chemotherapy plus Genentech's immunotherapy drug atezolizumab (Tecentriq), The Times reported.
Atezolizumab belongs to a class of drugs called checkpoint inhibitors, which help immune system T-cells recognize cancer and attack it.
Median survival was 17.6 months among those who received chemotherapy alone and 21.3 months among those who received the combination therapy. That difference was not statistically significant.
But among women with a marker called PD-L1 on their cancer cells, median survival was 15.5 months among those who received chemotherapy alone and 25 months in the combination group.
Those results have not been analyzed statistically, and the patients are still being followed, The Times reported.
The study was published Oct. 20 in the New England Journal of Medicine and was presented at the European Society for Medical Oncology annual meeting in Munich.
Genentech has submitted the data to the FDA to get approval of atezolizumab for treatment of triple-negative patients with the PD-L1 marker.
"This is truly a game changer," study author Dr. Sylvia Adams, from NYU Langone Health's Perlmutter Cancer Center, told The Times.
She noted that cancer patients with the PD-L1 marker tend to respond better to checkpoint inhibitors than those without it. The marker was present in 41 percent of patients in this study.
After initial treatment with chemotherapy and immunotherapy, some patients have been doing well for two or three years with immunotherapy alone, Adams told The Times.
She added that the "million-dollar question" is whether they can safely stop the immunotherapy if they have no sign of cancer. For now, they are continuing with immunotherapy.
While she has received no payments from drug companies, her medical center did receive funding from Genentech to pay for the research, Adams said.
The new study "is a big deal and has been the buzz of the breast cancer research world," Dr. Larry Norton, of Memorial Sloan Kettering Cancer Center in New York City, told The Times.
He was not involved in the study, but has done paid consulting work for the past two years for Genentech.
The study results are "very significant" and it seems that chemotherapy "takes away the invisibility cloak the cancer has managed to put on," Dr. Ingrid Mayer, a breast cancer specialist at Vanderbilt University, told The Times.
She was not part of the study, but has received consulting fees from seven drug companies, including Genentech.
The chemotherapy may help trigger the immune system, in part by killing cancer cells that then leak compounds that T-cells detect and begin to hunt, Mayer explained.
Ready-to-Eat Salads Recalled
Possible salmonella and listeria contamination has led to the recall of ready-to-eat salads sold at Whole Foods, Trader Joe's and other stores, the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) said.
A number of companies have announced recalls. GHSE, LLC recalled a salad product sold in retail locations in Florida, Georgia and South Carolina. Mary's Harvest Fresh Foods, Inc. recalled one salad and one wrap product sold at Trader Joe's and other stores in Washington, Oregon and Idaho.
GH Foods Ca. LLC recalled four salad products sold at stores in California, including Whole Foods. Prime Deli Corporation recalled two salad products sold at stores in Texas, CNN reported.
"The problem was discovered on Oct. 15, 2018, when GHSE, LLC received notification that the corn used in the production of their ready-to-eat salad product was being recalled by their corn supplier due to Listeria monocytogenes and salmonella concerns," according to the FSIS.
There have not been any confirmed cases of illnesses linked to the recalled products, according to the agency.
"FSIS is concerned that some product may be in consumers' refrigerators. Consumers who have purchased the products are urged not to consume them. These products should be thrown away or returned to the place of purchase," FSIS advised.
Hackers Steal HealthCare.gov Data of 75,000 People
The personal data of about 75,000 people has been stolen from HealthCare.gov-linked system by hackers, the U.S. Centers for Medicare and Medicaid Services said.
The hacked system was shut down and efforts are being made to restore it before Nov. 1, when sign-up begins for health care coverage under the Affordable Care Act, the Associated Press reported.
The hacked system is used by insurance agents and brokers to directly enroll customers. The HealthCare.gov website used by the general public was not affected, according to CMS.
The agency said that affected customers will be notified and offered credit protection, the AP reported.