A promising treatment from Bristol-Myers Squibb may be fast-tracking toward another approved use after researchers stopped a study early because the drug did better than an older treatment in patients with an advanced form of lung cancer.
Shares of the New York drugmaker jumped Friday morning after it said Opdivo fared better than the chemotherapy drug docetaxel when tested in a late-stage study involving patients with an advanced form of non-squamous non-small cell lung cancer. The main goal of the study was measuring overall survival rates.
Late-stage research is generally the final phase of clinical testing for a drug before regulators decide whether to approve it.
Bristol-Myers
said an independent data monitoring committee made the decision to stop
the study early. It did not detail the results that prompted that
decision.
The
582 patients in the study had been previously treated and were
receiving intravenous injections of either Opdivo or docetaxel.
Opdivo
is part of a new class of immuno-oncology drugs that harness the immune
system to attack cancer cells. Last month, federal regulators approved
it for patients with the most common form of lung cancer, advanced
squamous non-small cell lung cancer.
In
December, the Food and Drug Administration also granted an accelerated
approval to Opdivo for melanoma, the deadliest form of skin cancer.....Source
Pam Mace was a healthy nurse who enjoyed golfing, skydiving, and
running twice a day, but when she developed stroke-like symptoms at only
37, she struggled to get medical answers for a year.
In July 2000, after experiencing excruciating headaches, numbness,
fainting spells and high blood pressure, Mace learned she had
dissections or tears in three arteries, as well as two aneurysms.
"It felt like someone was tightening my head with a screwdriver," said
Mace, now 50 and living in Michigan. "I was a nurse, and I knew
something was wrong. I thought I was going to die."
Mace finally got a diagnosis: fibromuscular dysplasia or FMD, a poorly
understood cardiovascular disorder that strikes women up to 10 times
more than men and can trigger life-threatening stroke and heart attacks.
Stress makes heart attack recovery tougher for women
As attention focuses on heart health during February, Mace, now executive director of the Fibromuscular Dysplasia Society of America, wants younger women to be aware of a serious, often hidden or misdiagnosed condition.
"Anytime a young woman has high blood pressure or a spontaneous
coronary artery dissection, doctors should think FMD," she said.
FMD is characterized by abnormal cell development in the artery wall, causing narrowing, aneurysms or tears. It differs from atherosclerosis, in which plaque causes the stenosis.
About 65 percent of the time, it affects the renal arteries, which
lead from the heart to the kidneys, causing uncontrolled hypertension.
But in Mace's case, the stenosis was in the carotid and vertebral
arteries.
Mace was diagnosed in 2001 at the Cleveland Clinic, but when she
looked for resources and support among the nation's major heart and
stroke organizations, none had even heard of FMD, she said.
For a year, doctors prescribed medications and dismissed her fears,
some even telling her she was depressed and to "get on with [her] life."
"To me, knowledge is power, but nobody cared to look for the cause," said Mace.
The disorder was first described in a European medical journal in
1938, and sporadic research was conducted in the United States in the
1950s and 1960s.
FMD is "more common than thought," said Dr. Heather Gornik, a Cleveland Clinic cardiologist and director of its FMD clinic.
"Until a decade ago, it was relegated to the realm of medical zebras,
or very rare diseases," said Gornik, who treats Mace. "Not many people
were writing about it. It was not taught well in medical school and
there was a huge problem with awareness and detection."
"Now, we are making great strides," she told NBC News.
There are no statistics on how many Americans have FMD, but as doctors learn more, diagnoses are increasing.
Women aged 30 to 50 are at greatest risk for FMD, but it can also
affect children and the elderly. Causes are still poorly understood, but
recent studies suggest hormonal influences and genetics.
In 2009, the FMD Society of America funded a registry based at the University of Michigan, which now tracks 1,200 patients at 14 medical centers, one of them the Cleveland Clinic.
Of those in the registry whose carotid arteries were affected, 40
percent went on to have a "major vascular event," such as a stroke, said
Gornik.
Because it is a variable disorder, some have no symptoms at all.
Studies of kidney transplants show that 4 to 6 percent of healthy donors
may have FMD on their CT scans, according to Gornik.
Courtesy of Pam Mace
Pam Mace is back to running after experiencing dissections or tears in her carotid and vertebral arteries because of FMD
Affected arteries are easy to recognize as they take on a "string of
beads" appearance. Symptoms of an affected carotid artery include a
pulsating noise or "bruit" that can be heard in the neck.
"A classic example is a woman in her 40s or 50s with migraines or a
whooshing noise in her ear that might be dismissed," said Gornik. "But
if you listen carefully to hear the bruit, doctors can make the
connection."
Treatment may include medications for blood pressure and clots, or vascular procedures such as angioplasty or surgery.
"FMD may not be curable," she said. "But it is not a death sentence."
Today, Mace has stents in her carotid arteries and is on medication to
prevent clots and stroke. She is as active as ever. She ran a 5K, and
went on a medical mission to Haiti.
Thanks to her efforts, the National Organization for Rare Disorders,
the National Stroke Association and the American Stroke Association,
which featured Mace on its 2007 cover, now recognize FMD as a cause of stroke.
"I am determined," said Mace, "that no one else goes through what I did."....Source
The study tells us that the "an apple a day keeps the doctor away"
aphorism was coined in 1913 but was based on the original form with a
different rhyme, some 149 years ago in Wales: "Eat an apple on going to
bed and you'll keep the doctor from earning his bread," went the proverb
in Pembrokeshire.
The University of Michigan School of Nursing researchers in Ann Arbor
believe giving such medical proverbs an empirical evaluation "may allow
us to profit from the wisdom of our predecessors."
For the study's measure of keeping the doctor away, Matthew Davis, PhD,
and co-authors evaluated an outcome of no more than one visit a year to
the doctor as a means of investigating the proverb's success in daily
apple eaters compared with non-apple eaters.
So did a daily apple succeed in keeping the doctor away? No, it did not.
There was no statistically meaningful difference in visits to the
doctor for daily apple eaters in the analysis. But the study did find
that an apple a day kept the pharmacist away.
'Avoiding the use of health care services'
When socio-demographic and health-related characteristics such as
education and smoking were taken into account, daily apple eating was
not associated with successfully keeping to a maximum of one
self-reported doctor visit a year.
Of the 8,399 participants who answered a questionnaire to recall their
dietary intakes, 9% (753) were apple eaters and the remainder, 7,646,
were non-apple eaters.
The apple eaters showed higher educational attainment, were more likely
to be from a racial or ethnic minority, and were less likely to smoke.
The data for the analysis came from the National Health and Nutrition
Examination Survey conducted during 2007-08 and 2009-10.
"While the direction of the associations we observed supports the
superiority of apple eaters over non-apple eaters at avoiding the use of
health care services, these differences largely lacked statistical
significance," say the authors after accounting for the differences in
apple-eaters that - beyond the effects of the apple-eating itself -
could have explained why they used health care services less.
An apple a day means one of at least 7 cm diameter
To analyze apple-eating against visits to the doctor, the researchers
compared daily apple eaters with non-apple eaters. An apple a day
counted if the participants answered that they had at least 149 g of raw
apple.
Eating less than this amount counted as no daily apple-eating, and apple
consumption based purely on juices or sauces was also excluded. The
study also looked for any response to increasing the amount of daily
apple-eating by comparing doctor visits from people who ate no apples
with those who ate one small apple, one medium apple or one large apple
daily.
The analysis shows no relationship between apple "dose" and the
likelihood of keeping the doctor away in terms of "avoiding health care
services." Except, found the authors, for avoidance of prescription
medications.
The study found that apple eaters were more likely to keep the doctor
away, but this was before adjusting for the socio-demographic and health
characteristics of the survey respondents - 39.0% of apple-eaters
avoided more than one yearly doctor visit, compared with 33.9% of
non-apple eaters.
The daily apple eaters were also more likely to successfully avoid
prescription medication use (47.7% versus 41.8%) - and this difference
survived statistical analysis.
The association between eating an apple a day and keeping the pharmacist
away, then, was a statistically significant finding, whereas keeping
the doctor away failed to hold true.
Nor did the proverb show any effect in an analysis of overnight hospital stays or mental health visits - there was no difference for apple eaters in the likelihood of keeping either of these two away.
The overall conclusion of this study was that only one finding supported
the long-standing wisdom. Apple eaters "were somewhat more likely to
avoid prescription medication use than non-apple eaters." Source
For many men, there are few aesthetic conditions more stressful than hair loss. But there may be hope–a new report shows that plucking hairs could actually help in the regeneration of new hair.
For someone facing significant hair loss, it’s hard to imagine
plucking out the last few hairs in a desperate gamble to generate hair
growth. But that’s what researchers at the University of California are
now suggesting. They recently found that plucking follicles can actually
stimulate the scalp, resulting in the growth of entirely new hairs. In
fact, researchers found that such a practice could lead to a significant
hair growth spurt.
Furthermore, researchers found that plucking hairs in one area of the
head could actually lead to hair growth in other parts of the scalp.
It’s worth noting that the research was carried out on mice. To date,
no humans have been used to test the findings. Still, Cheng-Meng
Chuong, a professor of pathology at the University of Southern
California, is hopeful the study will lead to promising new treatments
for hair loss.
“The work leads to potential new targets for treating alopecia, a
form of hair loss,” Chuong said. “It is a good example of how basic
research can lead to a work with potential translational value.”
The best part: plucking hairs is hardly expensive. If future research
supports the study’s findings, it could help men facing hair loss
regenerate growth without spending thousands of dollars on costly hair
loss products. Source
Avoiding foods that contain nickel significantly decreased body fat and
body-mass index in overweight women allergic to the metal, especially
those in early menopause, according to a pilot study in PLoS One.
The study found an unusually high prevalence of nickel allergy in women
and men who were overweight or obese compared with the general
population. Nickel, a trace element found in water, soil and food, is
the most common cause of metal allergies. Foods that contain high levels
of nickel include whole grains, legumes, cocoa and some vegetables, the
study said.
Researchers recruited 87 patients, mostly women, in their early 50s from
the allergy unit of the Italian Red Cross in Rome. Their average BMI
was 32, or obese.
Nickel allergies were diagnosed in 60% of the women and 13% of the men.
Nickel allergy affects approximately 13% of women and 2% of men in the
general population, researchers said.
The allergic subjects were prescribed a balanced, normal-calorie diet
that eliminated or restricted foods containing higher concentrations of
nickel. After six months, 56% of women following the diet had lost 5.1%
of their body fat, trimmed 4.6 inches from their waistlines and saw
their BMIs drop by 4.2 points. Men were excluded from the final analysis
because of their small numbers, researchers said. Source
