| Health & Wellbeing
September 15, 2018 - September 21, 2018
Mom’s use of opioids in pregnancy may stunt kids’ learning
Feb. 13, 2018 file photo, a week-old baby lies in a neonatal intensive
care unit bay at the Norton Children’s Hospital in Louisville, Ky. This
particular NICU is dedicated to newborns of opioid addicted mothers, who
are suffering with newborn abstinence syndrome. The area is kept dark
and quiet due to increased production of neurotransmitters in newborns
of addicted mothers, which can disrupt the nervous system and
overstimulate bodily functions. (AP Photo/Timothy D. Easley)
Chicago (AP) - Learning
disabilities and other special education needs are common in children
born with opioid-related symptoms from their mother’s drug use while
pregnant, according to the first big U.S. study to examine potential
long-term problems in these infants.
About 1 in 7 affected children
required special classroom services for problems including developmental
delays and speech or language difficulties, compared with about 1 in 10
children not exposed to opioids before birth, the study found.
The study highlights the
“absolutely critical” importance of early detection and intervention,
before these children reach school age, to give them a better chance of
academic success, said Dr. Nathalie Maitre, a developmental specialist
at Nationwide Children’s Hospital in Columbus, Ohio. “It really confirms
what those of us who do neurodevelopment follow-up of these children are
The study involved about 7,200
children aged 3 to 8 enrolled in Tennessee’s Medicaid program. Nearly
2,000 of them were born with what doctors call “neonatal abstinence
syndrome.” It’s a collection of symptoms caused by withdrawal from their
pregnant mother’s use of opioid drugs like prescription painkillers,
heroin or fentanyl. The drugs can pass through the placenta into the
developing nervous system.
Tremors, hard-to-soothe crying,
diarrhea and difficulty feeding and sleeping are among signs that
infants are going through withdrawal.
In Tennessee, hard hit by the
nation’s opioid epidemic, the rate of affected infants soared from less
than one per 1,000 hospital births in 1999 to 13 per 1,000 births in
Whether the study results would
apply elsewhere is uncertain but in Tennessee, most children born with
withdrawal symptoms are enrolled in that state’s Medicaid program. Also
in Tennessee, a syndrome diagnosis qualifies kids to receive early
Maitre, who wasn’t involved in the
study, said she suspects the research may underestimate the magnitude of
the problem, because it only captures kids who haven’t slipped through
The only previous comparable study
was in Australia, published last year, showing that affected children
had worse academic test scores in seventh grade than other kids.
The new study looked at how many
kids were referred for possible learning disabilities and received
school-based services for related difficulties. It did not examine
Results were released Thursday by
the journal Pediatrics.
The researchers said taking into
account other factors that could affect children’s development -
including birth weight and mothers’ education and tobacco use - didn’t
change the results.
Study co-author Dr. William
Schaffner of Vanderbilt University said it makes sense that opioid use
in pregnancy could affect children’s later development. Some studies
have found brain differences in affected children including in a region
involved in certain types of learning.
But Dr. Mary-Margaret Fill, the
lead author and a researcher with Tennessee’s health department, said
these children “are definitely not doomed. There are great programs and
services that exist to help these children and their families. We just
have to make sure they get plugged in.”
Weight-loss drug Belviq seems safe for heart, study finds
For the first time, a drug has been shown
to help people lose weight and keep it off for several years
without raising their risk for heart problems - a safety
milestone that may encourage wider use to help curb the obesity
The drug, Belviq, has been sold in the
United States since 2013 and is the first of several new
weight-loss medicines to succeed in a long-term heart safety
study now required by federal regulators to stay on the market.
“Patients and their doctors have been
nervous about using drugs to treat obesity and for good reason.
There’s a history of these drugs having serious complications,”
said study leader Dr. Erin Bohula of Brigham and Women’s
Hospital in Boston.
With this study, Belviq has been
convincingly shown safe for the heart, she said.
Although Belviq did not raise heart risks,
it didn’t lower them either, as many had hoped it would. The
weight loss it produced was fairly modest - after 40 months,
Belviq users had shed 9 pounds (4 kilograms), twice as much as
those on dummy pills.
It may be that weight loss alone is not
enough to lower heart risks, or that there needs to be more to
do that, some doctors said.
Results were discussed Sunday at a European
Society of Cardiology meeting in Munich and published by the
New England Journal of Medicine. Belviq’s maker, Eisai Inc.,
sponsored the study and many of the researchers consult or work
for the company.
Worldwide, 13 percent of adults are obese
and 39 percent are overweight, raising their risk for a host of
health problems. Diet and exercise are the first steps doctors
recommend, but medicines also can be considered for people with
dangerously high weight who cannot drop enough pounds by other
Several popular diet medicines were
previously withdrawn from sale after they were found to raise
the risk for heart valve damage, suicidal thoughts or other
problems, prompting the new requirement for heart safety
Belviq is an appetite suppressant that
works by stimulating brain chemicals to give a feeling of
fullness. It costs roughly $220 to $290 a month in the United
Researchers tested it in a study of 12,000
people who were either obese or overweight with heart disease
risk factors such as high blood pressure or cholesterol. They
were given Belviq or dummy pills to take twice a day and offered
lifestyle and diet advice.
At one year, 39 percent on Belviq and 17
percent on dummy pills had lost at least 5 percent of their
starting weight. Several previous studies also found the drug
effective for weight loss.
After about three years, 6 percent of each
group had suffered a heart-related problem or death.
Fewer people on Belviq developed diabetes -
8.5 percent versus 10.3 percent on dummy pills.
Serious side effects were similar, but more
on Belviq stopped taking their pills because of them - 7 percent
versus 4 percent. Common side effects included dizziness,
fatigue, headache and nausea.
Dangerously low blood sugar happened in 13
people on Belviq versus four in the other group; all but one
case involved people also taking diabetes medicines, which lower
Tests for heart valve damage were done on
3,270 participants but no big differences in rates were seen.
Suicidal thoughts or behavior were reported in 21 people on
Belviq versus 11 on dummy pills, but more on the drug had a
history of depression and the difference was so small it could
have been due to chance, Bohula said.
In a commentary, two of the journal’s
editors, Drs. Julie Inglefinger and Clifford Rosen, said there
might be alternatives to Belviq. Liraglutide, when used to treat
diabetes, also causes weight loss and lowers heart risks, though
it hasn’t been tested for cardiac safety at the dose used for
For now, Belviq “may be best used on a
cautious basis, according to the needs of individual patients,”
they write. (AP)
September 8, 2018 - September 14, 2018
Hopes rise again for a drug to slow Alzheimer's disease
Oct. 7, 2003 file photo shows a section of a human brain with
Alzheimer's disease on display at the Museum of Neuroanatomy at the
University at Buffalo, in Buffalo, N.Y. On Wednesday, July 25, 2018, two
drug makers said an experimental therapy slowed mental decline by 30
percent in patients who got the highest dose in a mid-stage study, and
it removed much of the sticky plaque gumming up their brains. The drug,
called BAN2401, is from Eisai and Biogen. (AP Photo/David Duprey)
Chicago (AP) -
Hopes are rising again for a drug to alter the course of Alzheimer's
disease after decades of failures. An experimental therapy slowed mental
decline by 30 percent in patients who got the highest dose in a
mid-stage study, and it removed much of the sticky plaque gumming up
their brains, the drug's makers said Wednesday.
The results have been
highly anticipated and have sent the stock of the two companies involved
soaring in recent weeks.
The drug from Eisai and
Biogen did not meet its main goal in a study of 856 participants, so
overall, it was considered a flop. But company officials said that 161
people who got the highest dose every two weeks for 18 months did
significantly better than 245 people who were given a dummy treatment.
There are lots of caveats
about the work, which was led by company scientists rather than academic
researchers and not reviewed by outside experts. The study also was too
small to be definitive and the results need to be confirmed with more
work, dementia experts said. But they welcomed any glimmer of success
after multiple failures.
optimistic," said Maria Carrillo, chief science officer of the
Alzheimer's Association, whose international conference in Chicago
featured the results.
"A 30 percent slowing of
decline is something I would want my family member to have," and the
drug's ability to clear the brain plaques "looks pretty amazing," she
About 50 million people
worldwide have dementia, and Alzheimer's is the most common type. There
is no cure - current medicines just ease symptoms. Some previous efforts
to develop a drug to slow the disease may have been tried too late,
after much damage had already occurred. The new drug aimed sooner, in
people with early Alzheimer's, and the drug works at an earlier step in
formation of the sticky brain plaques.
Study participants were
given one of five doses of BAN2401 or a dummy treatment via IV. After
one year, the companies said the drug didn't meet statistical goals. But
after 18 months, they saw a benefit in the highest dose group.
What makes it tricky,
though, is that they used a new way to measure mental decline, a scale
that combines parts of three other widely used tests. This is the first
study to use that measure, and it's unclear how much of a difference a
30 percent slowing of decline makes - whether it allows someone to
continue to bathe or feed himself, for instance.
"It's intriguing, but
these are designs we're not used to seeing," and it will require more
study for doctors to feel comfortable with this as a measure of success,
said one independent expert, Dr. Julie Schneider of Rush University
Medical Center in Chicago.
On one traditional
measure of thinking skills, those at the highest dose declined 47
percent less than people given a dummy treatment.
Brain scans added
evidence that the drug might be effective. All participants had signs of
the sticky plaques that are the hallmark of Alzheimer's at the start of
the study, but 81 percent of people on the highest dose saw all signs of
them disappear after 18 months, an Eisai official said.
Side effects leading to
discontinuation of treatment occurred in 19 percent of those on the high
dose and 6 percent of the dummy treatment group. Cases of brain
swelling, which have been seen in other treatments targeting the plaques
in the brain, occurred in two people in the placebo group and 16 of
those in the high dose group.
Other dementia experts
"That's a very hopeful
outcome. It means we may be on the right track," said another scientist
with no role in the work, Dr. Stephen Salloway, neurology chief at Brown
University in Providence, Rhode Island.
Dr. Reisa Sperling, a
neurologist at Harvard-affiliated Brigham and Women's Hospital in
Boston, said it's important to realize that this is not a cure, just
possibly a slowing of decline.
"We're not suddenly
returning people back to their pre-Alzheimer's baseline," she said.
Dr. Lynn Kramer, chief
medical officer of Eisai's neurology unit, said the companies would talk
with regulators about further studies.
Shares of Biogen, based
in Cambridge, Massachusetts, and Eisai, based in Tokyo, soared after
July 5 when they announced that the drug had slowed the progression of
early Alzheimer's disease for certain patients. Biogen's stock jumped
19.6 percent in one day, its biggest move in 14 years, and has continued
to rise. Eisai rocketed 40 percent in two days.
Biogen stock gyrated in
aftermarket trading after the study results were released. After
switching between gains and losses several times, it fell 6.5 percent.
September 1, 2018 - September 7, 2018
Birth control app highlights emerging health tech market
demonstrates using the Natural Cycles smartphone app in London, Friday, Aug.
17. The mobile fertility app has become the first ever digital contraceptive
device to win FDA (US Food and Drug Administration) marketing approval. (AP
London (AP) -
The condom, the pill and now, the smartphone?
Natural Cycles, a
mobile fertility app, this month became the first ever digital contraceptive
device to win FDA marketing approval. Women take their temperatures and
track their menstrual cycle on the app, which uses an algorithm to determine
when they’re fertile and should abstain from unprotected sex or use
protection. In effect, it’s a form of the rhythm or calendar method.
The Swedish startup
says it’s effective and lets women avoid side effects common with other
methods like birth control pills. But reports of unwanted pregnancies and
investigations by authorities in two countries in Europe, where it received
EU certification in 2017, have raised questions about marketing what is
essentially a health monitor as a contraceptive.
Natural Cycles boasts
more than 900,000 users, and such fast growth underscores risks for
regulators and concerns among health professionals as they grapple with the
rapidly emerging market for mobile and digital health applications.
“Apps are incredibly
popular and there’s nothing inherently wrong about using tech to support our
health,” said Bekki Burbidge, deputy chief executive of the Family Planning
Association, a British sexual health organization. “But they’re also an area
that is fairly unregulated and it can be hard to sort the good, evidence-
and research-based apps from the bad.”
The app is similar to
hundreds of other period trackers already available, most of which are aimed
at helping women conceive. But FDA approval means it can be marketed as a
mobile contraceptive, giving it an edge in the mobile medical apps market,
which is forecast to grow to $11.2 billion by 2025, up from at $1.4 billion
in 2016, according to BIS Research. The makers of Natural Cycles acknowledge
it’s not 100 percent effective and some women might still get pregnant even
if used perfectly.
The Food and Drug
Administration regulates apps and gadgets that collect or track medical
information as medical devices, though it doesn’t scrutinize many more that
merely perform simple tasks like tracking calories.
contraceptive apps needs to be extremely careful to ensure that women
understand exactly what they’re signing up for and the limitations, the
Faculty of Sexual and Reproductive Healthcare of the Royal College of
Obstetricians and Gynecologists said in a statement.
The FDA gave its
approval based on data from Natural Cycles involving 15,570 women who used
the app for an average of eight months. The FDA said that if the app is used
correctly all the time, 1.8 percent of women would get pregnant over one
year. The “typical use” failure rate, which factors in human error, was 6.5
The birth control
pill’s failure rate is 9 percent, while for condoms it’s 18 percent and 24
percent for fertility-awareness methods, but those figures are backed up by
much more long-term data.
The company’s founders,
Elina Berglund and Raoul Scherwitzl, are a married couple who are both
former physicists. Berglund was part of a team of scientists looking for the
Higgs boson particle at the European Organization for Nuclear Research, or
CERN, in Switzerland. They pivoted from science to startups when they wrote
the algorithm to help them have a baby and then developed an app to tap
The app is free to
download but the company charges $10 a month to use it. Its claims were
called into question in January, after Swedish regulators started
investigating reports that 37 women who used it became pregnant anyway.
The Swedish Medical
Product Agency said it’s looking into whether the number of unwanted
pregnancies falls within the app’s claimed effectiveness rate, and the
investigation is expected to wrap up in September.
Natural Cycles said
that as a condition of EU certification, it must continue monitoring user
data, which it says show that the typical-use effectiveness rate remains at
“We care deeply each
and every time one of our users becomes pregnant,” the company said in a
statement. “One of the ongoing challenges with all forms of contraception is
that there is always a statistical chance of unintended pregnancy, since no
method is 100 percent effective.”
FDA spokeswoman Deborah
Kotz said the agency was aware of the Swedish reports but felt they were
consistent with its knowledge of risks associated with the app.
“An increase in the
absolute numbers of unintended pregnancies is expected with a growing number
of users,” she said.
Standards Authority, meanwhile, says it’s looking into whether paid-for
Facebook posts that claim Natural Cycles is a “highly accurate contraceptive
app” and “clinically tested alternative to birth control methods” are
“We have launched a
formal investigation and will publish our findings in due course,” the
Burbidge said more
outside research into fertility apps is needed because “at the moment
there’s not enough independent evidence” on their reliability. She added
that women using such apps need to be motivated and aware of factors that
can make it less effective, such as travel, alcohol, stress or not getting
enough sleep, which can all affect temperature readings.
“There’s so much you
can do that makes it not perfect,” she said.