Report raises safety questions on popular blood thinner
scientific study suggests the makers of the blood thinner Pradaxa may have
held back information that may have prevented serious bleeding complications
among some of the million or so Americans using it. Meanwhile, the maker of
Pradaxa, German pharmaceutical giant Boehringer Ingelheim, vehemently denied
that it held back important safety data.
Ingelheim introduced Pradaxa in 2010 as a replacement for the older drug
Coumadin, which had been in use for decades. A major selling point was that
Pradaxa offered the benefits of stroke prevention without the hassle of
frequent blood monitoring needed with Coumadin.
As with any
blood thinner, the concern with Pradaxa was the increased risk of bleeding
in patients taking it. Major bleeding with Pradaxa at its currently
recommended dose occurs in 3.11 percent of patients taking it each year,
according to the major trial that led to FDA approval of the drug. The total
incidence of bleeding events with use of the drug, including minor and major
bleeding, is 16.42 percent per year.
Pradaxa suggests that it carries a lower risk of bleeding into the brain
than Coumadin does, along with a lower risk of life-threatening bleeds and
minor bleeding. A large Medicare study published in May confirmed prior
knowledge that Pradaxa carries a higher risk of major stomach and intestinal
at the University of Ottawaâ€™s Institute for Safe Medication Practices (ISMP)
wanted to find out whether monitoring the levels of Pradaxa in the blood of
patients using it would help doctors avoid bleeding complications. To do
this, they looked at Boehringer Ingelheimâ€™s own data exploring the impact of
blood level monitoring in conjunction with Pradaxa use.
researchers said the data show that up to 40 percent of all deaths and
serious bleeding events related to Pradaxa could have been avoided by simple
blood testing. Checking blood levels periodically, they said, might have
allowed doctors to lower the dose of Pradaxa or temporarily stop it in
patients with dangerously high levels. This in turn might have prevented
some bleeding complications. The paper was published in BMJ.
Additionally, the researchers say that Boehringer Ingelheim had this
information before Pradaxa was approved in 2010, but that they left it out
of the safety information presented to the FDA during the drugâ€™s approval
process. Specifically, they said they found internal reports showing that
the companyâ€™s scientists raised safety concerns about serious bleeding, but
that these concerns may have gone unheeded by their superiors
statement, Boehringer Ingelheim said that the simulations that served as the
basis for these concerns were preliminary and not reliable, and that it
would have been inappropriate to report the simulations. They said they did
provide the raw data to the FDA.
by ABC News, the FDA declined to comment on the BMJ report. It also did not
say how often pharmaceutical companies choose not to report the results of
simulations like these to regulators.
Boehringer Ingelheim reached a settlement worth $650 million with about
4,000 people related to alleged bleeding problems with Pradaxa. In a
statement released in connection with the settlement, Boehringer Ingelheimâ€™s
counsel said the company stands behind that drug and believes the claims
lacked merit, but decided to settle to avoid protracted litigation.
Visit ABC News for the story.
Fist bumping beats germ-spreading handshake, study
bumpingâ€ť transmits significantly fewer bacteria than either handshaking or
high-fiving, while still addressing the cultural expectation of hand-to-hand
contact between patients and clinicians, according to a study published in
the August issue of the American Journal of Infection Control, the
publication of the Association for Professionals in Infection Control and
study from the Institute of Biological, Environmental, and Rural Sciences at
Aberystwyth University in the United Kingdom, researchers performed trials
to determine if alternative greetings would transmit fewer germs than the
traditional handshake. In this experiment, a greeter immersed a
sterile-gloved hand into a container of germs. Once the glove was dry, the
greeter exchanged a handshake, fist bump, or high-five with a sterile-gloved
recipient. Exchanges randomly varied in duration and intensity of contact.
exchange, the receiving gloves were immersed in a solution to count the
number bacteria transferred during contact. Nearly twice as many bacteria
were transferred during a handshake compared to the high-five, and
significantly fewer bacteria were transferred during a fist bump than a
high-five. In all three forms of greeting, a longer duration of contact and
stronger grips were further associated with increased bacterial
expands on the recent call from the Journal of the American Medical
Association (JAMA) to ban handshakes from the hospital environment.
providersâ€™ hands can spread potentially harmful germs to patients, leading
to healthcare-associated infections (HAIs). HAIs are among the leading
causes of preventable harm and death in the United States. The U.S. Centers
for Disease Control and Prevention estimates that one in 25 hospitalized
patients develops an HAI and 75,000 patients with HAIs die during their
hospitalization each year.
Visit APIC for the study.
Glaxo files its entry in race for a malaria vaccine
experimental malaria vaccine GlaxoSmithKline filed with regulators Thursday
could help fight one of the world's biggest killersâ€”but rival company
Sanaria Inc. has a potentially more effective shot in the works. If Europe's
regulators give Glaxo's vaccineâ€”called RTS,Sâ€”the green light, it could be in
use as soon as 2015, paving the way for a mass vaccination program across
make RTS,S the world's first vaccine against malaria or any parasitic
disease. In clinical trials, RTS,S almost halved malaria cases in children
aged 5 months to 17 months, and by around a quarter in young babies. Malaria
kills an estimated 600,000 people a year, most of them African children.
Sutherland, head of the department of immunology and infection at the London
School of Hygiene and Tropical Medicine, said Glaxo's vaccine could make an
important public-health contribution.
is a major advance, it is far from a perfect solution. Its efficacy is lower
than had been hoped, and its protection appears to diminish over time. Data
released in October showed its effects after 18 months were less than had
previously been seen over a year.
malaria-vaccine candidates, including a program by Crucell NV, a division of
Johnson & Johnson, have been shelved in recent years. RTS,S, which has been
supported by the Path Malaria Vaccine Initiative and the Bill and Melinda
Gates Foundation, took 30 years to develop. Big drug companies have
typically shunned the field as too complex and unprofitable. Glaxo plans to
sell RTS,S at just 5% above cost.
there is another player in the race, Rockville, MD-based biotech company
Sanaria, founded by Stephen Hoffman, an infectious-disease expert, in his
kitchen. Dr. Hoffman worked on an early predecessor of RTS,S and has been
testing experimental malaria vaccines on himself since 1987.
vaccine, called PfSPZ, showed impressive results in an early-stage clinical
trial involving 57 people last year. PfSPZ demonstrated complete protection
against malaria in all six patients that received the highest dose.
now testing the vaccine in larger trials in Mali, Tanzania, Equatorial
Guinea, the U.S. and Germany. Dr. Hoffman said he hopes that if all goes
well, it could be filed with regulators in 2017.
RTS,S, which focuses on a single protein of the parasite, PfSPZ uses a
version of the whole parasite, made by hand-dissecting mosquitoes. That may
confer greater protection.
question the feasibility of PfSPZ's large-scale production and delivery in
Africa, since it must be stored in supercold liquid nitrogen. But Dr.
Hoffman is confident his team can scale up production if the vaccine is
approved, and cites several veterinary vaccines used in Africa that are
delivered in similar ways.
Visit the Wall Street Journal for the article.
Veterans deal expands medical care, includes $15 billion
and Senate negotiators reached an agreement that includes $15 billion to
help ease U.S. military veteransâ€™ long waits for care, according to a
summary congressional staffs are providing to veteransâ€™ groups.
expands the type of non-VA hospitals and clinics where veterans could
receive care, authorizes leases for 27 new VA facilities, and allows the
Department of Veterans Affairs secretary to fire senior executives and
create penalties for falsifying data.
agreement was reached almost two months after VA Secretary Eric Shinseki
resigned as an inspector general report showed widespread mismanagement,
such as keeping phony lists to hide the long waits veterans face for medical
appointments. At least 35 veterans died while awaiting care in Phoenix,
according to acting VA Secretary Sloan Gibson.
includes $10 billion in emergency funding to give veterans who canâ€™t get a
VA medical appointment the option to receive non-VA care, and $5 billion to
pay for hiring staff. It also gives the VA secretary complete authority to
immediately fire senior executives, while providing employees with
streamlined appeal rights.
and Senate passed differing proposals to provide more funding and streamline
waiting times, and a conference committee was appointed to come up with a
final plan. The measure passed by the House cost $44 billion, while the
Senate plan was $35 billion.
and Democrats involved in the negotiations had said they agreed on most
policy changes, though financing remained a sticking point late last week.
The VA has
a $160 billion budget and runs the nationâ€™s largest integrated healthcare
system. An internal audit in June showed that more than 120,000 veterans
hadnâ€™t received a medical appointment or were waiting more than 90 days for
care. That number was cut to about 42,400 by July 1, VA data show.
Visit Bloomberg for the story.
Total darkness at night is key to success of breast
light at night, which shuts off nighttime production of the hormone
melatonin, renders breast cancer completely resistant to tamoxifen, a widely
used breast cancer drug, says a new study by Tulane University School of
Medicine cancer researchers. The study, "Circadian and Melatonin Disruption
by Exposure to Light at Night Drives Intrinsic Resistance to Tamoxifen
Therapy in Breast Cancer," published in the journal Cancer Research,
is the first to show that melatonin is vital to the success of tamoxifen in
treating breast cancer.
investigators and co-leaders of Tulane's Circadian Cancer Biology Group,
Steven Hill and David Blask, along with team members Robert Dauchy and
Shulin Xiang, investigated the role of melatonin on the effectiveness of
tamoxifen in combating human breast cancer cells implanted in rats.
first phase of the study, we kept animals in a daily light/dark cycle of 12
hours of light followed by 12 hours of total darkness (melatonin is elevated
during the dark phase) for several weeks," says Hill. "In the second study,
we exposed them to the same daily light/dark cycle; however, during the 12
hour dark phase, animals were exposed to extremely dim light at night
(melatonin levels are suppressed), roughly equivalent to faint light coming
under a door."
by itself delayed the formation of tumors and significantly slowed their
growth but tamoxifen caused a dramatic regression of tumors in animals with
either high nighttime levels of melatonin during complete darkness or those
receiving melatonin supplementation during dim light at night exposure.
findings have potentially enormous implications for women being treated with
tamoxifen and also regularly exposed to light at night due to sleep
problems, working night shifts or exposed to light from computer and TV
melatonin levels at night put breast cancer cells to 'sleep' by turning off
key growth mechanisms. These cells are vulnerable to tamoxifen. But when the
lights are on and melatonin is suppressed, breast cancer cells 'wake up' and
ignore tamoxifen," Blask says.
could make light at night a new and serious risk factor for developing
resistance to tamoxifen and other anticancer drugs and make the use of
melatonin in combination with tamoxifen, administered at the optimal time of
day or night, standard treatment for breast cancer patients.
Visit Tulane for the study.
Agency for Toxic Substances and Disease Registry releases
first set of data from National ALS Registry
About 4 in
100,000 people live with Amyotrophic Lateral Sclerosis (ALS), also known as
Lou Gehrigâ€™s disease in the United States, according to the first data
summary released by the Agency for Toxic Substances and Disease Registry.
A report in
Morbidity and Mortality Weekly Report (MMWR) displays data from the National
ALS Registry. This is the only known data that identifies all ALS cases
among people living in the United States. Data in the Registry come from two
sources: national administrative databases and self-reports from people
living with ALS.
reportâ€™s findings cover the period from Oct. 19, 2010 through Dec. 31, 2011
and include: A total of 12,187 people were identified with ALS. (Based on
2011 Census data); Overall, ALS was more common among whites, males,
non-Hispanics, and persons aged 60â€“69 years; White men and women were twice
as likely to have ALS as black men and women (3.8 per 100,000 compared to
1.9 per 100,000); and Males had a higher rate of ALS than females (across
all racial groups).
There is no
cure for ALS. The disease causes the nerve cells throughout the body to stop
working, leading to paralysis and usually death within two to five years of
diagnosis. ALS is not tracked yearly by health officials in the same manner
as other diseases and conditions like heart disease and diabetes in the
United States with the exception of Massachusetts. Persons with ALS who
register via the National ALS Registry can complete brief surveys that may
lead to a better understanding of possible risk factors for the disease such
as genetics, environmental, and occupational exposures.
Visit CDC for more information.
Study links shift work to risk for Type 2 Diabetes
workers, especially men, may be at higher risk for type 2 diabetes compared
to people not on such schedules, a new study suggests. Also at special risk
are shift workers who don't work on a set schedule, with shifts moving
around at various times of the day.
findings are "not at all surprising," said one expert, Dr. Alan Manevitz, a
clinical psychiatrist at Lenox Hill Hospital in New York City. "Physicians
have long known that working shifts disrupts many key body chemicals,
creating a ripple effect that can lead to ailments such as gastrointestinal
disorders, cardiovascular disease and even cancer," he said. "Now type 2
diabetes can be added to this considerable list."
In the new
review, researchers analyzed data from 12 international studies involving
more than 226,500 people.
led by Zuxun Lu of Huazhong University of Science and Technology in Wuhan,
China, took several factors into account, such as workers' shift schedules,
their body mass index (BMI, a calculation of height and weight), family
history of diabetes and their level of physical activity.
the findings weren't able to show a direct cause-and-effect relationship,
the researchers found that any amount of shift work was linked to a 9
percent greater risk for developing diabetes. Gender also played a role --
for men engaged in shift work, the risk jumped to 37 percent.
the reason why men are at greater risk than women isn't clear, the
researchers believe that testosterone levels may play a role. Prior studies
have pointed to an association between low testosterone levels and insulin
resistance and diabetes, the researchers noted.
levels of this male hormone are regulated by the internal body clock, Lu's
shifts moved around through different periods of the day were especially
likely to develop type 2 diabetes than those who worked normal "office
hours." The study found rotating shift work to be linked to a 42 percent
greater risk for diabetes.
to Lu's team, erratic working schedules make it more difficult for the body
to establish a sleep-wake cycle, and poor sleep may worsen insulin
resistance, a precursor to diabetes.
studies have also linked shift work to weight gain and obesity, a big risk
factor for type 2 diabetes. And the researchers note that shift work can
also affect cholesterol levels and blood pressure.
expert said other factors may be at play as well.
hormone, known to elevate blood glucose when present in excess, peaks at 1
a.m.," noted Dr. Gerald Bernstein, director of the Diabetes Management
Program at Friedman Diabetes Institute at the Beth Israel Medical Center in
New York City. "Shift work also often makes it more difficult to schedule
regular meals and exercise." Still, Bernstein said that "even with a strong
risk for diabetes I would not discourage someone from taking a job that is
based on shifts." Instead, he said "it would be better to screen shift
workers regularly for pre-diabetes and intervene to slow the progression to
full-blown diabetes." (HealthDay)
Visit NIH for the study.
Palos Community Hospital improves operating room
efficiency with RTLS technology
Community Hospital, the major healthcare provider for Chicago's southwest
suburbs, is improving efficiency and patient care in its surgery department
with Advantages OR, a patient flow system powered by the Real-time Locating
System (RTLS) from Versus Technology, Inc.
suites are dynamic environments where numerous staff and patient
interactions must take place before, during and after surgery. If these
interactions don't happen in the correct order, or in a timely manner,
surgery schedules can be delayed, resulting in longer stays for patients and
inefficient use of expensive resources, such as surgeon and OR time.
Community Hospital is overcoming these inherent challenges by improving the
flow of patients through surgery using the Versus Advantages OR patient flow
system. The solution was added to their existing Versus RTLS in March of
patients and staff wear a Versus Clearview badge to identify their locations
using a highly reliable and accurate infrared (IR) and radio frequency (RFID)
platform. The location information, along with integrated data from Palos'
Meditech EMR, is relayed to Advantages. The technology gives Palos:
visibility of patient locations and status (waiting for anesthesia, in
staff know where to go next (patient ready for surgeon, room ready for
data collection for historical reporting to help with process improvement
Advantages Asset Management system tracks 1,400 IV pumps across 400,000
square feet. The solution helps reduce loss, tracks utilization, and helps
ensure each department is properly stocked with ready-to-use pumps.
automates Rauland-Borg's Responder 5 nurse call system. When a patient calls
the nurse for assistance, the Clearview badge identifies her presence in the
room, automatically canceling the call. This allows the nurse to immediately
focus on the patient instead of searching for the cancel button.
Visit Wall Street Journal for the article.