Health Highlights: Oct. 30, 2018
Texas Lesbian Couple Is First to Both Carry Same Baby Infection Control Team Sent to NJ Rehab Facility Where 9 Children Died Food Labels May be Required to List Sesame Allergen: FDA NIH Halts Stem Cell Trial for Heart Failure Due to Concerns About Fake Data
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Texas Lesbian Couple Is First to Both Carry Same Baby
Using a special type of in-vitro fertilization, two women in a same-sex couple became the first to both carry their baby.
"This represents the first time that two women have both physically carried their child together," fertility specialist Dr. Kathy Doody of The Center for Assisted Reproduction, who works with husband Dr. Kevin Doody, told CBS News.
Ashleigh and Bliss Coulter of North Texas had their son Stetson through what's called effortless IVF, using Bliss' eggs and a donor's sperm.
Instead of placing the sperm and eggs into incubators, they are put into a device called an INVOcell that's placed in the body for five days where the eggs are fertilized and early embryo development begins.
In this case, Bliss carried the INVOcell. The embryos were frozen and one was transferred to Ashleigh, who carried the baby to term, CBS News reported.
The couple refer to 5-month-old Stetson as their miracle baby. "The way that Mr. Stetson came into this world was pretty special," Ashleigh said.
"This is a revolutionary type of IVF," Kevin Doody told CBS News. "It's more accessible, it's more affordable and it's truly more natural."
This the first time the Doodys have had a same-sex couple go through Effortless IVF, but they've performed the process for around 200 heterosexual couples.
Effortless IVF typically costs about half as much as traditional IVF, according to the Doodys.
Infection Control Team Sent to NJ Rehab Facility Where 9 Children Died
Infection control experts are being sent to a New Jersey rehabilitation facility where an adenovirus outbreak has killed nine children, state health officials said Monday.
"A total of 25 pediatric cases have been associated with this outbreak," at the Wanaque Center for Nursing & Rehabilitation in Haskell. "A staff member at the facility -- who has since recovered -- also became ill as part of the outbreak," according to the state health department, NBC News reported.
Adenovirus typically causes cold-like symptoms, but can be fatal in weakened patients. The children at Wanaque have developmental disorders or immune deficiencies.
The infection control experts will also visit other facilities similar to the Wanaque Center, as well as a public hospital where a different type of infection occurred in four premature babies. One of the babies died, NBC News reported.
"The team will visit University Hospital, Wanaque Center for Nursing & Rehabilitation in Haskell, Voorhees Pediatric Facility in Voorhees, and Children's Specialized Hospital in Toms River and Mountainside," the health department said.
The team will reinforce basic infection control procedures, Dr. Shereef Elnahal, the state's health commissioner, told NBC News.
Food Labels May be Required to List Sesame Allergen: FDA
Sesame may become the latest food allergen that has to be listed on labels, the U.S. Food and Drug Administration says.
Currently, eight major food allergens must be declared on labels: eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans, CNN reported.
"Unfortunately, we're beginning to see evidence that sesame allergies may be a growing concern in the US," FDA Commissioner Dr. Scott Gottlieb said Monday. "A handful of studies, for example, suggest that the prevalence of sesame allergies in the U.S. is more than 0.1 percent, on par with allergies to soy and fish."
The undeclared presence of allergens is a public health issue and one of the main causes of food recalls, according to the FDA.
Research suggests that more than 300,000 Americans have sesame allergy, according to Lisa Gable, CEO of the nonprofit group Food Allergy Research and Education.
"The consensus of both doctors and advocacy groups that support people with food allergies is that sesame is growing into being a national problem and should absolutely be added as one of the allergens to be disclosed on labeling," she told CNN.
Allergic reactions to sesame vary from person to person and can range from mild to life-threatening, according to the group.
Currently, sesame "could be in an ingredient list under a word like tahini or even under a very generic term like 'natural flavor,' so the worry is that it could be something that even a very careful patient or family might not know is in the food," Dr. Robert Wood, president of the American Academy of Allergy, Asthma and Immunology, told CNN.
The FDA is seeking more information from allergy and food experts "so we can learn more about the prevalence and severity of sesame allergies in the U.S., as well as the prevalence of sesame-containing foods sold in this country. These include foods that, under current regulations, may not be required to disclose sesame as an ingredient."
"I think there's enough evidence to suggest that sesame allergy is as common as a lot of the other foods that are already included in the labeling law, if not more common," Dr. Scott Sicherer, director of the Jaffe Food Allergy Institute and professor of pediatrics at the Icahn School of Medicine at Mount Sinai, told CNN.
"Including it as part of our U.S. labeling laws makes perfect sense to me," he said.
NIH Halts Stem Cell Trial for Heart Failure Due to Concerns About Fake Data
A clinical trial assessing the use of stem cells to treat heart failure patients has been paused by the U.S. National Heart, Lung, and Blood Institute because it's based partly on what may be falsified or fabricated data from the laboratory of a Harvard Medical School-affiliated researcher.
The $63-million CONCERT-HF trial will remain on hold while its data and safety monitoring board conducts a review to ensure the trial meets the "the highest standards for participant safety and scientific integrity," the NHLBI said Monday.
The patients in the study are being notified and the follow-up protocol of the trial will be continued for all patients who have already been treated.
The trial was launched to investigate whether a certain type of cardiac stem cell, either alone or in combination with other stem cells from the bone marrow, is safe and benefits patients with chronic heart failure, who have few treatment options.
Heart failure patients have a low quality of life and about half die within five years of diagnosis, according to NHLBI.
The clinical trial is based on research from a number of laboratories, including that of Harvard-affiliated Brigham and Women's Hospital heart researcher Piero Anversa. But the university recently announced that a years-long investigation discovered "falsified and/or fabricated data" in 31 papers from Anversa's laboratory, the Washington Post reported.
Anversa worked at the hospital until 2015. Last year, the hospital reached a $10 million settlement with the Justice Department to settle allegations that fake data was used by Anversa's laboratory in grant applications for federal funding.
Before working at Brigham and Women's Hospital, Anversa worked at New York Medical College. The college released a statement saying it launched an investigation after "serious concerns" had been raised about a 17-year-old study, the Post reported.
Last week, the New England Journal of Medicine retracted one Anversa laboratory paper and flagged two others with an "expression of concern," and is waiting for more information on those two papers.
Before the NHLBI announcement, scientists had called for the study to be stopped.
"I think that the trial should be halted, and they should have an external review," Darryl Davis, a cardiologist at the University of Ottawa Heart Institute studying how to regenerate heart tissue, told the Post.
"The Anversa data comprised part of the rationale for that trial, and I think we have to understand better what these cells actually can do before we subject the patients to the risk of having an invasive procedure," Davis said.
Anversa's lawyer said his client stands by his studies' findings and that Anversa only learned from the Harvard probe that a longtime colleague who left his lab in 2013 had improperly altered images, the Post reported.
In many cases, those images can be replaced with correct images, and the results will still be valid, according to Anversa, his lawyer said.
"There is nothing wrong with c-kit positive cardiac stem cells, and the trial will answer the questions concerning their efficacy in patients," Anversa said in an email, the Post reported.