Health Highlights: Oct. 23, 2017
Dozens of New Breast Cancer-Linked Gene Mutations Identified FDA Warns Maker of Faulty Blood Lead Tests New Shingles Vaccine Approved by FDA Judge Overturns $417 Million Award in Baby Powder/Ovarian Cancer Case Jambalaya Likely Cause of Salmonella Outbreak in Louisiana
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Dozens of New Breast Cancer-Linked Gene Mutations Identified
Researchers have discovered 72 previously unknown gene mutations linked with breast cancer.
The team of 550 researchers at 300 institutions worldwide identified 65 gene mutations that are common among women with breast cancer and seven associated with estrogen-receptor-negative breast cancer, which doesn't respond to hormonal therapies, such as the drug tamoxifen, CNN reported.
The findings, published Monday in the journals Nature and Nature Genetics, bring the total number of known gene mutations associated with breast cancer to nearly 180.
The researchers examined DNA in blood samples taken from nearly 300,000 women, about half of whom had breast cancer, CNN reported.
It's long been known that BRCA1 and BRCA2 gene mutations significantly increase breast cancer risk. Fifty-five to 65 percent of women with a BRCA1 mutation and about 45 percent of women with a BRCA2 mutation will develop breast cancer by age 70, according to the U.S. National Cancer Institute.
But BRCA1 and BRCA2 mutations are present in less than one percent of women and explain only a fraction of all inherited breast cancers, CNN reported.
That's why this international team wanted to look for other genetic mutations associated with breast cancer.
The newly discovered mutations only slightly -- between 5 to 10 percent -- increase a woman's risk of developing breast cancer, according to Jacques Simard, a study author and professor and researcher at Laval University, Quebec City, Canada.
However, there are so many of them that their "overall contribution is larger" than BRCA1 and BRCA2, noted research leader Doug Easton, a professor at the University of Cambridge in the U.K., CNN reported.
The combined effects of two or more of these smaller risk gene mutations may increase a woman's riks of breast cancer, he explained.
Women with a number of these newly-identified genetic mutations would likely benefit from earlier mammography screening, Peter Kraft, a study author and professor at Harvard T.H. Chan School of Public Health, told CNN.
FDA Warns Maker of Faulty Blood Lead Tests
A warning letter over its blood lead testing systems has been sent to Magellan Diagnostics Inc., the U.S. Food and Drug Administration said Monday.
The FDA cited several violations of federal law, including marketing significantly modified versions of two "blood lead testing systems without the agency's required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results."
Earlier this year, the FDA warned that Magellan's LeadCare test systems performed on blood drawn from the vein may provide falsely low results and launched an investigation, which included an inspection of the company's facility.
"The FDA has serious concerns about Magellan Diagnostics' actions after learning about inaccuracies in results using its blood lead testing devices -- tests that the American people depend on," Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health, said in an agency news release.
"The evidence uncovered during the inspection shows that the company put patients at risk after it recognized that its tests could provide inaccurate results and failed to take appropriate steps to report this issue and work through a strategy to effectively mitigate problems with the FDA," St. Pierre said.
Magellan "has until Nov. 10, 2017 to notify the FDA about specific steps the company has taken to address these violations and to prevent them from recurring. If the company fails to promptly correct these violations, the FDA may take additional action, such as seizure, injunction and civil money penalties," according to the news release.
New Shingles Vaccine Approved by FDA
A new, more effective shingles vaccine has been approved by the U.S. Food and Drug Administration.
The new vaccine from GlaxoSmithKline will be the second shingles vaccine available in the U.S. market. The other is from Merck and was introduced in 2006, the Associated Press reported.
Shingles is a painful condition caused by the chickenpox virus. Anyone who's had chickenpox carries the virus that causes shingles.
A study funded by Glaxo found that the company's Shingrix vaccine prevented shingles in about 90 percent of people. Merck's Zostavax vaccine is about 50 percent effective, the AP reported.
Shingrix will cost $280 for the required two shots. Zostavax costs $223. Most insurance plans cover the vaccination.
Both vaccines are for adults 50 and older, but the Centers for Disease Control and Prevention recommends vaccination for people 60 and older, partly because vaccination loses effectiveness over time, the AP reported.
Judge Overturns $417 Million Award in Baby Powder/Ovarian Cancer Case
A $417 million jury award two months ago to a women who claimed her ovarian cancer was caused by baby powder has been overturned by a judge.
The plaintiff was Eva Echeverria, who alleged that she developed ovarian cancer through her use of Johnson & Johnson talc-based baby powder for feminine hygiene, the Associated Press reported.
But on Friday, Los Angeles County Superior Court Judge Maren Nelson granted the company's request for a new trial. There were errors and jury misconduct in the previous trial, there wasn't convincing evidence that Johnson & Johnson acted with malice, and the award for damages was excessive, Nelson ruled.
Even though Eva Echeverria has died, the decision will be appealed, according to her attorney, Mark Robinson Jr.
"We will continue to fight on behalf of all women who have been impacted by this dangerous product," he said in a statement, the AP reported.
Johnson & Johnson has faced hundreds of similar lawsuits and jury awards have totaled hundreds of millions of dollars. In one of those cases, a Missouri appellate court last week threw out a $72 million award to the family of an Alabama woman who died. Citing a Supreme Court decision, the appeals court said the state wasn't the proper jurisdiction for such a case.
Jambalaya Likely Cause of Salmonella Outbreak in Louisiana
Jambalaya sold at a community fundraiser is the suspected cause of a salmonella outbreak in Louisiana that has sickened dozens of people and may have caused one death, officials say.
The jambalaya was sold at an event in Caldwell Parish in northern Louisiana on October 16, the Louisiana Department of Health said in a statement, CNN reported.
As of Oct. 19, there had been 49 confirmed cases of illness among people ages 15-70.
"Health officials believe that at least 300 people were served the suspect jambalaya and are anticipating there will be more reports of illness in the next several days," the health department said. "One death has occurred and an autopsy is occurring to determine if the death was caused by this illness or other causes."
The department said any food bought from the fundraiser, including side dishes that could have come into contact with the jambalaya, should be thrown away, CNN reported.