Health Highlights: Oct. 29, 2018
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
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.
Ninth Child Dies in Virus Outbreak at N.J. Facility
A ninth child has died in an adenovirus outbreak at a New Jersey rehabilitation center, state health officials said Sunday.
They said the unidentified child who died Saturday evening at the Wanaque Center for Nursing and Rehabilitation in Haskell was “medically fragile,” CBS News reported.
There have been 25 cases associated with the outbreak.
“This is a tragic situation, and our thoughts are with the families who are grieving right now,” Health Commissioner Dr. Shereef Elnahal said in a statement. “We are working every day to ensure all infection control protocols are continuously followed and closely monitoring the situation at the facility.”
Adenoviruses account for about 5 to 10 percent of fevers in young children, but most patients recover. However, the children at Wanaque appear to have been at increased risk for serious adenovirus infections due to their other health problems, CBS News reported.
Children at the center are severely disabled, according to the Bergen Record.
Wide Variation Seen in Pelvic Shapes: Study
There is significant racial variation in the structure of the human pelvis, according to a study that could change how babies are birthed.
Doctors’ understanding of the pelvis has long been based on anatomical studies of people of European descent, but researchers measured 348 skeletons from around the world and found a wide range of pelvic shapes, The New York Times reported.
That was “remarkable and unexpected,” according to the authors of the study published Oct. 29 in the journal Proceedings of the Royal Society B.
In general, people of sub-Saharan origin had the deepest pelvises back-to-front and Native Americans had the widest side-to-side. Europeans, North Africans and Asians were in the middle of the range, The Times reported.
Since pelvic shape can be quite different, it’s likely “that the birthing process is also highly variable,” Helen Kurki, an anthropology professor at the University of Victoria in Canada, told The Times.
She said this study contradicts the belief “that there is one ‘right’ way to birth a baby,” Kurki said, and indicates that might be better to take a a more individualized approach to childbirth.
Trump Announces Plan to Cut Drug Prices
Trying to cut high drug costs, the prices paid by Medicare for certain prescription drugs would be based on those in other advanced industrial nations, according to a proposal announced by the Trump administration.
“This is a revolutionary change,” President Donald Trump said in a speech on Thursday at the U.S. Department of Health and Human Services, The New York Times reported. “Nobody’s had the courage to do it, or they just didn’t want to do it.”
The move would cut costs for Medicare and save beneficiaries millions of dollars, according to the Times.
Under a demonstration project in half the country, Medicare would create and use and “international pricing index” to decide how much to pay for drugs covered by Part B of Medicare.
A recently-released government study said that Medicare paid 80 percent more than other advanced industrial countries for some of the most expensive prescription medicines, The Times reported.
The proposal was met with skepticism by Democrats.
“It’s hard to take the Trump administration and Republicans seriously about reducing health care costs for seniors two weeks before the election when they have repeatedly advocated for and implemented policies that strip away protections for people with pre-existing conditions and lead to increased health care costs for millions of Americans,” said Senator Chuck Schumer of New York, the Democratic leader, The Times reported.
A number of health care-related announcements have been made by the White House ahead of next month’s midterm elections. Health care has been a major focus of Democrats in their campaigns, including high drug prices and warnings that Republicans will remove protections for people with pre-existing medical conditions.