Pain-pill guidelines for children spark a
The Food and Drug Administrationâ€™s decision in August to
officially approve use for certain children as young as 11, meaning doctors
wouldnâ€™t have to prescribe it off label, has triggered fierce debate.
side are some elected officials and addiction specialists who say the move
could expand access to a drug at the center of an epidemic of painkiller and
heroin abuse in the U.S. that was responsible for 24,000 overdose deaths in
other are some physicians and families say the FDA move provides necessary
guidance to doctors treating children with serious conditions. Doctors have
had to rely on adult dosing information when prescribing the painkiller to
children off label.
is an extended-release version of oxycodone, an opioid painkiller. Because
of its formulation, it can smooth out peaks and valleys of pain. Patients 19
and younger represented about 1% of dispensed prescriptions for oxycodone in
2014, according to IMS Health Holdings Inc., a healthcare data company.
requesting that the maker of OxyContin, Purdue Pharma LP, perform studies of
the drugâ€™s effects on children, FDA officials determined it was safe for
youths 11 and older and established appropriate prescribing guidelines.
use of OxyContin in pediatric patients isnâ€™t the intent, FDA officials say.
The agency approved the drug only for treating those with severe, long-term
pain, such as cancer patients or those recovering from major spinal surgery,
who were already taking an opioid painkiller.
marijuana, psychotherapeutics - a category that includes painkillers - are
the most-abused group of drugs among children ages 12 to 17, according to
the Substance Abuse and Mental Health Services Administration. Nonmedical
use of OxyContin among 10th- and 12th-graders increased from 2002 to roughly
2009, but it has declined since then, according to the annual Monitoring the
Future survey, which tracks youth drug use.
elected officials in states grappling with rampant painkiller abuse are
Ludwinski, director of research programs at Solving Kidsâ€™ Cancer, a
research-advocacy group, said a child who starts taking OxyContin illicitly
presents a separate issueâ€”one she said she is familiar with, living in an
area of West Virginia devastated by painkiller abuse.
18, eight U.S. senators, including Joe Manchin (D-WV) and Kelly Ayotte
(R-NH), signed a letter to the FDA â€śto express our dismayâ€ť and to call for a
review of its decision.
Another group of lawmakers has requested a
Senate hearing to examine the FDAâ€™s decision. And Manchin is promoting a
bill that would require the agency to consult with an advisory committee
before approving any opioid painkillers and, if it rejects the panelâ€™s
advice, to explain before Congress why.
Visit the Wall Street Journal for the article.
Elephants' low cancer rates explained
have enhanced defenses against cancer that can prevent tumors forming, say
scientists. They were trying to explain why the animals have lower levels of
cancer than would be expected by their size.
at the University of Utah said "nature has already figured out how to
prevent cancer" and plan to devise new treatments. But experts said the
focus should be on the "ridiculous" and "absurd" things humans do to
a train of thought that says every cell can become cancerous so the more of
them you have, the more likely you are to get cancer. So if an elephant has
100 times as many cells as a person then the trunk-swinging mammals should
be 100 times more likely to have the disease.
the analysis, published in the Journal of the American Medical
Association, showed only 5% of elephants die from cancer compared to up
to 25% of people. The scientists turned to the elephant's DNA - the
blueprint of life - to find an explanation.
caused by mutations in a cell's DNA that produce faulty instructions leading
to rampant growth as the cell spirals out of control,
animals also have "smoke alarms" that detect the damage and either lead to
the cell being repaired or killed. One of these alarms is called TP53, and
while humans have one TP53 gene, elephants have 20. As a result, elephants
seem far more keen to kill off cells on the cusp of going rogue.
Schiffman, one of the researchers and a pediatric oncologist, said: "By all
logical reasoning, elephants should be developing a tremendous amount of
cancer, and in fact, should be extinct by now due to such a high risk for
Mel Greaves, from the Institute of Cancer Research in London, says we should
focus on why humans have such high levels of cancer.
the BBC News website: "In terms of adaptive mechanisms against cancer we
have the same as a chimp, but we get a lot more cancer than a chimp."
evolutionary sense "success" is judged by the number of descendants you have
rather than how long you live.
have the greatest reproductive success towards the end of their lives, while
humans can live for decades after the menopause.
It means there is little evolutionary pressure
in humans to develop ways of preventing cancer in old age.
Visit BBC for the report.
Ask a MacArthur genius: How are hospitals trashing the
every day that an environmental activist becomes a leading voice in
healthcare, but thatâ€™s what happened to Gary Cohen, a new MacArthur fellow.
By looking under the hood of hospitals, heâ€™s discovered a few nasty secrets
â€” and inspired big changes for a community of scientists and practitioners
whose healing practices were actually hurting the world around them.
hospitals to clean up their own house,â€ť said Cohen, whose
organization, Hospitals Without Harm, has managed to tackle issues as
diverse as the use of mercury in medicine and what hospital patients eat.
environmentalist, Cohenâ€™s ears perked up in the 1990s as he started to hear
about endocrine-disrupting chemicals like dioxins. These nasty compounds are
found in the environment, but they persist in the fatty tissues of humans
and animals, messing with hormones, compromising the immune system and even
causing cancer. When Cohen heard that hospitals were the largest source of
dioxin emissions in the United States, it stopped him in his tracks.
â€śHospitals were the poster child for this chemical,â€ť he recalled, noting
that they then had to treat people whose endocrine systems theyâ€™d destroyed.
â€śIt was insane! Hospitals were poisoning people in the service of healing
them.â€ť Cohen started digging, lifting the proverbial log that was the
healthcare system and finding a seething underbelly of bugs, dirt and
distasteful practices. Not only were hospitals spewing dangerous chemicals
into the environment, but they were also disposing of huge amounts of
mercury from thermometers â€” mercury that then made its way into the water
supply, fish and back into human bodies.
there were the incinerators. At the time, hospitals burned most of their
trash. Cohen remembers seeing plastic tubing, pizza boxes and even computers
thrown into on-site incinerators along with medical waste like
pharmaceutical products. But when he and his colleagues contacted hospitals
to find out who was in charge of regulating their stoves, they learned that
they were being advised by incinerator salespeople, not sustainability
sees the problem with healthcare as one of miscommunication. Hospital
administrators donâ€™t always realize that it can cost less to implement
sustainable practices, especially ones that allow them to flex their buying
power to further drive down cost. Professional training is a concern, too.
Thereâ€™s still work to be done - and lots of
it. Hospitals themselves admit that they are part of the problem: In 2012,
the Healthier Hospitals Initiative estimated that the average hospitals
generates 26 pounds of waste per staffed bed per day. (Thatâ€™s exponentially
higher than the average of 4.40 pounds of solid waste the Environmental
Protection Agency estimates is produced by individual Americans). And a 2014
Harris poll sponsored by Johnson & Johnson found that just 22 percent of
hospitals have a current purchasing policy that takes the environment into
Visit Washington Post for the story.
New website with information on the proper disposal of
NeedyMeds has released a redesigned,
updated and expanded
website containing the most comprehensive information on the proper way to
dispose of used needles, syringes and other sharps.
over a year compiling information on the regulations and disposal sites for
all 50 states," said Leah Zaroulis, the project lead person. "We list over
2,600 disposal sites for home-generated sharps through out the country."
disposal of used needles, syringes, and other sharps exposed to bodily
fluids is a growing issue. Improperly-disposed sharps exposes workers to a
variety of potentially serious diseases including HIV, hepatitis and other
blood borne pathogens.
no charge to use the website and all use is anonymous," said Zaroulis. "Our
goal is to make the site as easy as possible to use. There is no
registration or log in and we learn no identifiable information about those
who use the website. People can also call our toll-free helpline 9am-5pm
Eastern Time at 1-800-643-1643."
website, previously managed by the Coalition for Safe Community Needle
Disposal, was totally redesigned and all the information updated. The site
includes information on pharmaceutical company take-back programs, state
health and solid waste department contacts, and general information on the
proper handling and disposal of used needles and syringes.
Study analyzes use of 7 low-value services in Choosing
analysis of seven clinical services with minimal benefit to patients
identified as part of the Choosing Wisely campaign found significant
declines in two services: the use of imaging for headaches and cardiac
imaging in low risk patients, according to an article published online by
JAMA Internal Medicine.
the use of unnecessary medical procedures and treatments is important in
controlling health care expenditures. Choosing Wisely includes more than 70
lists of about 400 recommendations of frequently used medical practices or
procedures that are of minimal clinical benefit to patients.
Agiro, Ph.D., of HealthCore, Wilmington, DE, and coauthors examined the
frequency and trends of some of the earliest Choosing Wisely recommendations
from 2012 using medical and pharmacy claims from Anthem-affiliated Blue
Cross and Blue Shield healthcare plans for about 25 million members.
authors identified seven services: imaging tests for headache with
uncomplicated conditions; cardiac imaging for members without a history of
cardiac conditions; preoperative chest x-rays with unremarkable history and
physical examination results; low back pain imaging without red-flag
conditions; human papillomavirus (HPV) testing for women younger than 30;
antibiotics for acute sinusitis; and prescription nonsteroidal
anti-inflammatory drugs (NSAIDs) for members with select chronic conditions
(hypertension, heart failure or chronic kidney disease).
Use of imaging
for headache decreased from 14.9 percent to 13.4 percent
decreased from 10.8 percent to 9.7 percent
Use of NSAIDs increased
from 14.4 percent to 16.2 percent
HPV testing in younger
women increased from 4.8 percent to 6.0 percent
sinusitis remained stable decreasing only from 84.5 percent to 83.7 percent
Use of pre-operative
chest x-rays (ending utilization 91.5 percent) and imaging for low back pain
(53.7 percent utilization throughout the study) remained high with no
four of the seven had statistically significant changes, which is
unsurprising given the large sample size, the clinical significance is
uncertain, the authors note.
The authors acknowledge limitations because
the study was based on administrative claims data that do not adequately
capture the clinical circumstances that led to the service being ordered so
the recommendation may be appropriate for an individual patient. Visit
JAMA for the study.
Doctors 'failed to spot' Ebola nurse Pauline Cafferkey
had fallen ill again
family of nurse Pauline Cafferkey have claimed doctors "missed a big
opportunity" to spot she had fallen ill with Ebola again when she was told
she had a virus when she attended a clinic.
Cafferkey said it was "absolutely diabolical" the way her sister, who
originally contracted Ebola while volunteering in Sierra Leone last year,
had been treated.
Cafferkey, 39, was admitted to the Queen Elizabeth University Hospital in
Glasgow on Tuesday after feeling unwell. She has since been flown to the
Royal Free Hospital in London where she is being treated in an isolation
Cafferkey told the Sunday Mail that her sister had gone to a GP out-of-hours
clinic at the Victoria Hospital in Glasgow on Monday night but the doctor
who assessed her diagnosed a virus and sent her home.
know if the delays diagnosing Pauline have had an adverse effect on her
health, but we intend to find out. It has not been good enough.
Greater Glasgow and Clyde told the paper: "We can confirm that Pauline did
attend the New Victoria Hospital GP out-of-hours service on Monday.
management and the clinical decisions taken based on the symptoms she was
displaying at the time were entirely appropriate.
appropriate infection control procedures were carried out as part of this
episode of care."
Cafferkey, 39, from South Lanarkshire, was diagnosed with Ebola in December
after returning to Glasgow from Sierra Leone via London.
critically ill and spent almost a month in an isolation unit at the Royal
Free Hospital before being discharged in late January.
been shown to persist for weeks or even months in parts of the body and in
Visit the Telegraph for the story.
Pfizer is targeting a deadly bacterium that thrives in
can strike healthy, young people with no known risk factors, survive a
barrage of antibiotics, and sometimes be fatal. The bacterium, which often
resides on peopleâ€™s skin, is usually harmless. But some varieties can turn
deadly if they lead to an infection that invades the lungs or bloodstream.
antibiotic-resistant strain frequently found in hospitals is responsible for
about 75,000 serious infections and 10,000 deaths in the U.S. a year,
according to the Centers for Disease Control and Protection. Attempts to
create a vaccine have been disappointing. That hasnâ€™t stopped Pfizer from
pharmaceutical giant has spent more than 15 years working on a vaccine
against the bug and is in the midst of testing it on patients preparing to
undergo elective spinal surgery. A 2,600-person trial is expected to be
completed in 2017, and, depending on the results, the data could be
submitted to the U.S. Food and Drug Administration in support of Pfizerâ€™s
application for regulatory approval.
trial produces a viable drug, Divan predicts Pfizerâ€™s annual revenue from
the single-shot vaccine could reach as much as $5 billion. That would make
it one of the most lucrative vaccines of all time. It would also help Pfizer
replenish its pipeline following patent expirations for profitable
blockbusters such as cholesterol treatment Lipitor and arthritis drug
drugmakers have tried to bring a staph vaccine to market. Robert Daum,
director of the University of Chicagoâ€™s MRSA Research Center, says prior
experimental vaccines were able to ignite an immune response in trial
patients, but not in a way that protected them against infection.
Biopharmaceuticals, before its 2012 merger with Biota Pharmaceuticals,
failed to show that its staph aureus vaccine could prevent infection
in a late-stage, 3,600-person trial. Merck gave up on staph vaccine
development in 2011 after its trial of 8,031 patients showed that while
those who received the vaccine developed antibodies to ward off the
bacterium, they were also more likely to die if infected.
researchers are trying a multipronged approach. Two of the vaccineâ€™s
components go after a capsule that cloaks the bacterium and prevents the
immune system from recognizing it. Another deprives the organism of
manganese, which staph needs to stay alive and fight the bodyâ€™s immune
response. A fourth targets the mechanism staph uses to lodge itself in the
body and let the infection take hold. Pfizer, in an e-mailed statement,
described the results from a previous trial of the vaccine as â€śencouraging.â€ť
worried Pfizerâ€™s vaccine wonâ€™t protect against types of staph that are more
prevalent outside hospitals. â€śWhat Iâ€™m looking for is a more generalizable
vaccine that works against multiple staph syndromes and multiple strains.â€ť
The company says it sees the potential to expand the uses for its staph
vaccine. Says Pfizerâ€™s Anderson: â€śOne could envision there are many areas
and populations that could benefit from prevention of this disease.â€ť
bottom line: Pfizerâ€™s vaccine against staph aureus, now in trials,
could become a $5 billion-a-year blockbuster - if it works.
Visit Bloomberg for the story.
Study reveals why gowns and gloves can be so dangerous
for hospital workers
hospital ought to be the last place to get a life-threatening infection, but
it happens. A new study helps explain why.
Researchers asked real hospital workers to remove gowns and gloves smeared
with fake bacteria. When they did, the fake bacteria wound up on their skin
or clothes 46% of the time, according to their report published Monday in
JAMA Internal Medicine.
words, the odds that these healthcare professionals could take off their
protective coverings without contaminating themselves were only slightly
better than the flip of a coin.
hospital workers werenâ€™t staffing the gift shop or validating parking
tickets. Of 435 simulations performed in the study, 246 were done by nurses,
72 by doctors and 117 by folks like phlebotomists, physical
therapists, dietitians and radiology technicians.
researchers, led by Dr. Myreen Tomas of the Cleveland Veterans Affairs
Medical Center, recruited these volunteers from four hospitals in the
Cleveland area. The workers put on â€ścontact isolation gownsâ€ť and nitrile
gloves, then were given half a milliliter of a fluorescent lotion that
glowed under a black light - a stand-in for invisible pathogens. They were
asked to rub the lotion on their gloved hands for 15 seconds, then wipe
their hands over their gowns. After that, they got a clean pair of gloves.
volunteers were asked to remove their gowns and gloves the way they normally
would. When they were done, the researchers used the black light to see if
any lotion was left behind.
hospital workers got the lotion on their clothes and skin 38% of the time
when they took off their gowns and 53% of the time when they took off their
gloves. Overall, the average â€ścontaminationâ€ť rate was 46%.
of all four hospitals were about equally likely to contaminate themselves,
the researchers found. In addition, all of the different kinds of workers
were about equally likely to make a mistake in putting on or taking off
their personal protective equipment. The most common mistakes were failure
to pull gloves over the wrist, taking gowns off over the head (instead of
pulling them away from the body), putting on gloves before the gown and
touching the outside of a dirty glove when taking it off.
volunteers made a mistake, they wound up contaminated 70% of the time. But
even when they followed the procedures perfectly, they still contaminated
themselves 30% of the time.
hospital responded to these results by launching an effort to train
employees on how to don and doff gowns and gloves according to
the protocols recommended by the Centers for Disease Control and Prevention.
Workers watched a 10-minute video, then practiced their technique for 20
certainly helped. The training reduced the contamination rate from 60% all
the way down to 19%, according to the study. But it wasnâ€™t perfect.
contamination of skin and clothing was reduced by the intervention, it was
not reduced to zero,â€ť the study authors wrote.
results help explain why multidrug-resistant bacteria are such a stubborn
threat in hospitals. Other studies of real-world conditions have found that
between 2% and 5% of hospital workers caring for colonized patients wind up
with the pathogens on their hands after taking off their gloves. In one
study, 24% of those treating patients with Clostridium difficile got
spores on their hands.
the solution is to make sure healthcare workers get better training on how
to put on their gowns and gloves, and how to take them off, the study
authors wrote. But training can do only so much.
workers should disinfect their gowns and gloves before they take them off,
either with bleach or possibly ultraviolet C light.
Ultimately, the best solution may be to redesign personal protective
equipment so that itâ€™s easier to remove without contaminating oneself, the
study authors wrote.
wonâ€™t happen overnight, but some improvements might be easy to make. For
instance, hospitals could provide gowns in a variety of sizes instead of
relying on a one-size-fits-all approach. The researchers noted that in their
observations, workers who were either petite, tall or large had more trouble
removing their gowns safely. Visit
the Los Angeles Times for the article.