PSORIATIC ARTHRITIS NEWS AND VIEWS
VOLUME- 6 ISSUE- 15
December 30, 2006
PSORIATIC ARTHRITIS MEDICAL NEWS
CHRONIC FATIGUE SYNDROME CAMPAIGN LAUNCHED
U.S. health officials stress disease is real, though treatments remain
elusive
By Amanda Gardner - HealthDay Reporter
(HealthDay News) -- U.S. health officials recently launched a major campaign
to increase awareness of chronic fatigue syndrome, an illness that has
labored under an intense level of controversy.
"This disease has been shrouded in a lot of mystery. Sometimes people
question if it's real or not real," Dr. Julie Gerberding, director of the U.S.
Centers for Disease Control and Prevention, said at a news conference. "We hope
to help patients know they have an illness that requires medical attention and
help physicians be able to diagnose the illness, and be able to validate and
understand the incredible suffering that many people and their families
experience in this context."
The campaign will consist of public service announcements, brochures, and a
"tool kit" for health-care professionals and a photo exhibit called "The Faces
of Chronic Fatigue Syndrome," which will travel to cities across the country
throughout 2007.
"We hope this will be a turning point in the public's awareness of the
disease as well as in health-care professionals' ability to diagnose and treat
it," Kim McCleary, president and CEO of the CFIDS Association of America, said
at the news conference.
"This launch is so important to increasing understanding of this illness,"
added Dr. Nancy Klimas, of the University of Miami Miller School of Medicine.
"Historically, lack of credibility of this illness has been a major stumbling
block."
According to Dr. William Reeves, of the CDC's National Center for Infectious
Diseases, the level of impairment experienced by people with chronic fatigue
syndrome is comparable to that of multiple sclerosis, AIDS, end-stage renal
failure and chronic obstructive pulmonary disease.
One CFS patient, Adrianne Ryan, said that sometimes taking a walk or a
shower was too much, and resulted in her collapsing for weeks afterwards. Ryan
is
a former marathoner.
Doctors still don't know what causes CFS or how to treat it successfully,
but more than 4,000 studies over the past two decades show definite underlying
biological abnormalities, said Dr. Anthony Komaroff, of Harvard Medical
School.
"This is not an illness that people can imagine they have. It's not a
psychological illness," he said. "That debate, which has raged for 20 years,
should
now be over."
Among other things, Komaroff pointed out, the brain hormone systems of
people with CFS are different than those without the disease. Brain functioning
is
also impaired and cells' energy metabolism seems to be compromised.
Analyses of the activity levels of 20,000 genes in people with CFS have
found abnormalities in genes related to the part of brain activity mediating the
stress response, Reeves said.
Some 1 million Americans suffer from the disease. Women are affected at
about four times the rate as men and non-white women are affected more than
white
women. The disease can affect any age and demographic but is most likely to
strike when a person is 40 to 59 years of age.
According to a large study conducted in Wichita, Kans., only half of people
with CFS have consulted a physician and only 16 percent have been diagnosed
and treated, although studies have shown that those who get appropriate care
early in the illness have better long-term results. A quarter of people with
the disease were unemployed or receiving disability, with the average affected
family foregoing $20,000 annually in income. That amounts to $9.1 billion in
lost income and wages for the U.S. economy as a whole, the study found.
While there's reason to be happy with advances in the basic scientific
knowledge of the disease, Klimas said she was less happy with advances in care.
Over the past 20 years, she said, she has treated more than 2,000 people with
CFS who were "angry and defiant, frustrated, trying to convince physicians,
friends and families that this was a real illness."
"We need much more work to understand the biological underpinnings and
translate this into clinical practice," she said. "At the same time, there are
effective strategies we can use right now, treatments that do help and help
significantly."
Visit the U.S. Centers for Disease Control and Prevention (_www.cdc.gov_
(http://www.cdc.gov) ) for more on chronic fatigue syndrome.
SOURCES: Nov. 3, 2006, teleconference with Kim McCleary, president and CEO,
CFIDS Association of America, Charlotte. N.C.; Julie Gerberding, M.D.,
director, U.S. Centers of Disease Control and Prevention, Atlanta; William
Reeves,
M.D., National Center for Infectious Diseases, CDC, Atlanta; Anthony Komaroff,
M.D., Harvard Medical School, Boston; Nancy Klimas, M.D., University of
Miami, VA Medical Center; Adrianne Ryan, CFS patient Copyright Ā© 2006
ScoutNews,
LLC. All rights reserved.
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SCIENTISTS HOPE BODIES CAN FIGHT CANCER
Scientists are investigating new strategies to harness the human body's own
immune system to fight skin cancer.
LONDON (AP) -- In a departure from the standard chemotherapy treatments,
which flood patients with toxic chemicals to kill cancer cells, doctors are
trying to provoke the body's natural defenses to do the same thing. Two such
techniques to combat melanoma were reported in papers presented this week in
Prague at a European cancer research meeting.
The strategies are the first attempts to suppress the body's T-regulatory
cells, which normally keep the immune system in check. In cancer, oncologists
theorize that it may be helpful for the immune system to remain active, thereby
unleashing it on the cancer.
"This is a fundamentally different approach to treating cancer," said Dr.
Alexander Eggermont, professor of surgical oncology at the University of
Rotterdam, Netherlands, the conference's chairman. Eggermont was not connected
to
either of the skin cancer research papers.
While the research is still preliminary, the scientists' novel approach to
attacking cancer has already produced some promising results.
In a paper presented by Dr. Jason Chesney of the JG Brown Cancer Center in
Kentucky seven patients with advanced skin cancer were given a drug combination
of diphtheria toxin and interleukin 2, intended to knock out the body's
T-regulatory cells. In five of the seven patients, tumors shrank or remained
stable.
By wiping out the T-regulator cells, the drug prevented the immune system
from shutting down, thus priming the body to mount a continuous attack against
cancer, Chesney explained.
"This is a landmark study," said Dr. Anna Pavlick, director of the melanoma
program at New York University, who was not involved in the study. "What it
shows is that by suppressing T-regulatory cells, we can take the brakes off a
patient's immune system."
Though Pavlick says it's too early to change how patients are treated based
on Chesney's study alone, she believes the methodology merits further
research.
"It's like having permanent chemotherapy," said Chesney. "You're inducing
your own immune system to stick around and keep this cancer from growing."
Advanced melanoma is a devastating disease for which there is no effective
treatment. The average life expectancy is about nine months, and less than 20
percent of patients survive more than two years after diagnosis.
In another study presented Wednesday, Dr. Jeffrey Weber, a professor of
medicine at the University of Southern California in Los Angeles, described how
he and colleagues were able to block a protein on T-regulatory cells, thus
inhibiting them enough for the immune system to attack cancerous cells. Patients
were given shots of an antibody aimed at the T-regulatory cells. Out of 25
patients tested, 24 are alive after 17 months, and three are free of cancer.
If this strategy of manipulating the immune system proves successful, the
whole framework of cancer treatment might be changed. Until recently,
chemotherapy was thought to be the best way to eliminate tumors. Yet while
chemotherapy certainly reduces the size of tumors, it cannot prevent their
recurrence,
and is only a short-term solution.
"If we can change the rules of the game by keeping the immune system active,
we might be able to prevent tumor regrowth," said Eggermont.
Allowing the immune system to run wild does not come without risk; doctors
admit it could lead to autoimmune diseases including hepatitis, colitis or
dermatitis. Still, most say those conditions are manageable, and are outweighed
by the prospect of beating skin cancer.
Earlier this year, scientists at the U.S. National Cancer Institute used a
similar technique, turning regular red blood cells into cancer-killing agents.
That involved genetically engineering red blood cells in a laboratory and
artificially producing billions more of them before re-injecting them into
patients.
However, the strategies employed by Chesney and Weber are far more
straightforward, as they don't involve genetic manipulation in a laboratory.
Both Chesney and Weber say it will be years before their strategies are
sufficiently tested to know if they work on a wide scale. Nevertheless, if their
hypotheses prove correct, they could also be applied to other types of cancer
in which T-regulatory cells are known to play a role, such as breast, kidney,
or esophageal cancer.
"This is how successful therapies get started," said Dr. Rick Bucala, a
professor at Yale University's School of Medicine. While Bucala says that it
would be "highly significant" if the immune system could be effectively used
against cancer, he cautioned there was still too little data. "Nothing in
science
is meaningful until it's been replicated."
Copyright 2006 The Associated Press. All rights reserved.
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BACK SURGERY OFTEN NO BETTER THAN WAITING
Study: Patients improved after two years, even without operation
The Associated Press
CHICAGO - Two big government-funded studies on back surgery for painful
herniated disks show no clear-cut reason to choose an operation over other
treatment.
The pain and physical function of the patients, who were suffering from a
condition called sciatica, improved significantly after two years whether or not
they had surgery. However, neither strategy offered complete relief.
The results indicate patients should choose which treatment they get for the
ailment, the researchers said.
āIn back surgery for this particular condition, thereās actually a
choice,ā
said lead author Dr. James Weinstein of Dartmouth Medical School. āIf you
donā
t want the risk of surgery, you can do watchful waitingā and still get well.
The condition involves disk cartilage bulging between vertebrae in the lower
spine and pressing against a nerve. It can cause excruciating burning pain
called sciatica, radiating from the lower back into the legs; patients often
have difficulty walking.
About 250,000 Americans have disk surgery for sciatica each year, while
another quarter-million instead choose physical therapy, painkillers or rest
until they feel better. The surgery costs about $6,000, Weinstein said.
The findings, published in Wednesdayās Journal of the American Medical
Association, are the first from a big government-funded research project on
spine
surgery. Patients were treated at 13 spine centers in 11 states.
One study involved 472 patients aged 42 on average that were followed for
two years after being randomly assigned to surgery or noninvasive treatment,
which included education, physical therapy or painkillers. Surgery involved
removing part of the bulging disc in a standard operation often done on an
outpatient basis.
Patients in both groups had much-improved scores on measures of pain,
physical function and disability during periodic evaluations; differences
between
the groups werenāt statistically significant.
Ninety-five percent of surgery patients had no complications, but 4 percent
required a second surgery within a year.
In the other study, the researchers followed for two years 743 patients who
chose surgery or other treatment. It found a clearer advantage to surgery,
including quicker relief in the first months. After three months, 82 percent of
surgery patients reported major improvement, compared with 48 percent of
nonsurgery patients. Those differences shrank over two years, however, and the
researchers said the self-reported results should be interpreted cautiously.
In the randomized study, many patients didnāt stay in their assigned group:
Almost half those assigned to noninvasive treatment ultimately had surgery,
and more than one-third of those assigned to surgery ended up choosing less
invasive treatment instead.
That patient crossover makes drawing conclusions tricky and may account for
surgery showing no superiority over other treatments, Weinstein said.
No one in either study developed a rare but feared disabling condition
called cauda equina syndrome, which should ease the minds of patients and
surgeons, said Dr. Eugene Carragee of Stanford University Medical Center.
āSometimes people with mild sciatica have elected to go ahead with the
surgery in order to avoid a theoretical neurological catastrophe,ā but now
patients can avoid surgery with a realistic expectation that theyāll feel
better in
a year or two, said Carragee, who was not involved in the research.
The study shows how tough it is to find scientific evidence that back
surgery works better than other treatments.
For one thing, patients willing to be randomly assigned to surgery are
probably different than most patients; their pain could be less, for example,
making them more inclined to roll the dice and be assigned to treatment other
than surgery.
Another problem: Most surgery studies have no placebo group to rule out the
benefits that come with patientsā faith in surgery.
Using sham surgery as a placebo, in which patients have incisions but no
real treatment, raises ethical questions, but has been done in some research ā
and some patients say they feel better.
āItās critical that we evaluate the real role of surgery in peopleās
lives,ā
said Dr. David Flum of the University of Washington. āStudies like this
that donāt have a placebo arm make it very difficult to figure out how much of
the effect is the operation versus the patientsā and the surgeonsā hopes for
the operation.ā Ā© 2006 The Associated Press. All rights reserved.
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SIX TIPS TO PRO-ACTIVELY REDUCE SAD
The winter season can be a busy and joyful time of year. But for many,
changes in light and temperature combined with the stresses of holiday events
and
heightened expectations can increase anxiety and cause depression. Seasonal
Affective Disorder (SAD) is a mood disorder associated with depression
episodes and related to seasonal variations in light. Andrea Rogers, Supervisor
for
Intensive Outpatient Programs in the Department of Psychiatry at
Cedars-Sinai, offers warning signs and suggestions to combat seasonal affective
disorder
this Holiday season.
"As Seasons change, there is a shift in our "biological internal clocks" or
circadian rhythm due partly because of changes in sunlight patterns," says
Rogers, "These changes combined with the stresses of Holiday travel, sensitive
family dynamics and managing expectations can build a recipe for depression
during the winter months. Juggling these variables can be challenging and can
make it difficult to enjoy the joys of the season."
According to the National Mental Health Association, the most difficult
months for SAD sufferers are January and February, and younger persons and women
are at higher risk.
Melatonin, a sleep-related hormone secreted by the pineal gland in the
brain, is produced at increased levels in the dark. Melatonin also may cause
symptoms of depression. When daylight savings time ends, and it begins getting
dark earlier in the day, production of the hormone increases, which may cause
depressive episodes. These biological variables mixed with environmental
conditions such as cold weather, emotional reactions to holidays and anxiety can
create a recipe for depression that can cast a "blue" cloud over the holiday
season.
Phototherapy or bright light therapy has been shown to suppress the brain's
secretion of melatonin. The device most often used today is a bank of white
fluorescent lights on a metal reflector and shield with a plastic screen. For
mild symptoms, spending time outdoors during the day or arranging homes and
work places to receive more sunlight can be helpful.
Six tips to pro-actively reduce or eliminate environmental stressors and
symptoms of SAD:
Let go of the past! The holidays bring out the "traditionalist" in most
people, and many of us are caught up in trying to make the holidays just like
years past. The reality is, every year brings about new circumstances, surprises
and colorful characters who are bound to "rock the boat" during your
"perfect" holiday celebration. "Reduce your anxiety about holiday traditions by
acknowledging your opportunity to maximize your current circumstances to build
new traditions, build on old ones, and abandon unrealistic expectations." Says
Rogers
Pace yourself. Unlike any other time of year, the holiday season is a time
of celebrations, family gatherings, winter activities and entertaining
visitors. These variables added on to an already busy lifestyle can cause
unnecessary
anxiety and hopelessness when projects begin "falling through the cracks".
The key to managing additional responsibilities and social commitments during
this time is to pace yourself and organize your time. Make a list and
prioritize your most important activities. Accept help, and allow for quiet
time at
regular intervals.
Acknowledge your feelings. The holiday season does not automatically banish
reasons for feeling sad or lonely. If you have experienced the loss of a loved
one, are far from family and/or friends, or are generally affected by
changes in weather and light, it is OK to acknowledge that these feelings are
present - even if you choose not to express them.
Don't drink too much! Excessive drinking only perpetuates anxiety and
depression. If you are prone to depression around this time of year, keep your
alcohol intake to a minimum.
Create a support system. Spend time with people who are supportive and care
about you. If that isn't your family, then spend this time with friends. If
you are far from home or alone during special times, make a proactive effort to
build new friendships or contact someone you have lost touch with.
Seek treatment. Sometimes, SAD can get the best of us, even when
pro-actively reducing stressors. If you are experiencing symptoms of depression
during
the winter months that are uncommon for you any other time of year, contact a
mental health professional who can provide counseling and treatment to help
you "weather the storm."
This information has been provided with the kind permission of Cedars-Sinai
Medical Center, Los Angeles, California.
************************************************
BOOST YOUR SELF-ESTEEM AND YOUR HEALTH
A lack of confidence, a reluctance to trust your instincts, and treating
yourself badly could be signs that it's time to improve your self-image.
'Try a Little Tenderness'
How can you improve your self-esteem and develop a more realistic opinion of
yourself?
Each day, do one thing to take care of yourself
Replace a junk-food snack with a piece of fruit; take a 10-minute walk at
lunchtime; floss your teeth.
Talk to yourself as you would to a friend
Replace your usual self-criticism with words of encouragement. Instead of "I
never do anything right," try "I do many things well."
Start a brag file
Take credit for your accomplishments no matter how small.
Spend time with people who make you feel good
You donāt have to avoid constructive criticism from supportive friends, but
avoid people who only want to tear you down.
Take on a new challenge and reward yourself when you reach your goal
Start small, with easily reachable goals. Then work up to greater challenges.
Exercise regularly
Activity is good for physical and emotional health. Aim for 30 minutes of
moderate-intensity exercise five or more days a week.
If these self-help measures don't work, consider getting professional help
from a qualified therapist or counselor.
You won't find it down an aisle of the supermarket or in a bottle in your
medicine cabinet. Your doctor can't prescribe it and you canāt buy it for
your
birthday. But without it, you could be more susceptible to the common cold
and more vulnerable to depression, heart disease and drug and alcohol abuse.
It's self-esteem, a reflection of how much you value, appreciate and approve
of yourself. A healthy self-esteem means you like yourself, believe you
deserve love and happiness, and feel confident in what you can accomplish.
But if you're plagued by low-self esteem, chances are you have an inner
critic living rent-free in your head, one that whispers (or shouts), "I'll
always
be alone," "I'm stupid and boring," "I'm useless."
Regular verbal beatings such as these, along with a lack of confidence, a
reluctance to trust your instincts and opinions, and treating yourself badly
could be signs that it's time to improve your self-image. Think a little more
Donald Trump and a little less Woody Allen.
"What's (Self) Love Got To Do With It?"
Besides making you feel worthless and unlovable, low self-esteem is
hazardous to your health. The negative emotions or moods it triggers, such as
anxiety
and depression, can increase the risk for heart disease. How? They wear down
the emotion-sensitive immune system and are associated with increases in
inflammation, which has been linked to heart disease.
Low self-esteem can raise blood pressure and lead to unhealthy behaviors
such as smoking, excessive drinking and avoiding social contact.
Low self-esteem can sap your motivation to take care of yourself. If you
don't like yourself very much, blowing off steam with a six-pack after a bad day
looks a whole lot more appealing than jogging six miles. Studies have shown
that people with high self-esteem are more likely to exercise regularly.
"Don't Worryā¦Be Happy"
A healthy self-esteem is an important key to positive emotional states.
That's what experts call joy, contentment, feeling relaxed and gratitude. These
positive states help buffer you against stress and they contribute to
emotional and physical well-being.
Shakespeare was onto something when he wrote "Mirth and merrimentā¦bars a
thousand harms and lengthens life." Modern science is beginning to confirm the
Bard's wisdom. Here are some recent findings linking positive emotions to good
health:
Laughing and coping by using humor improved immune function and increased
the level of an immune system protein, the body's first line of defense against
colds.
Positive emotions reduced the readmission rate of people hospitalized with
heart disease.
Optimism (having a positive outlook and being able to bounce back from bad
events) cuts the risk for heart attacks by half and has been linked to better
recovery from heart bypass surgery.
Positive emotions help counteract the bodyās reaction to stress.
Positive emotions produce more flexible, creative and efficient thinking.
Positive emotions are associated with better sleep.
āTry a Little Tendernessā
***********************************************************
EXERCISE AND CALORIE CUTTING LOWER DIABETES RISK EQUALLY
By Neil Osterweil, MedPage Today Staff Writer
Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of
Pennsylvania School of Medicine.
Eat less? Exercise more? For diabetes prevention, it's a toss up.
Decreasing caloric intake and increasing activity are equally effective at
improving glucose tolerance and insulin sensitivity, reported researchers here.
"Both diet and exercise provide profound benefits to reduce the risk of
diabetes," said Edward Weiss, Ph.D., of Saint Louis University, and colleagues.
"Both those who restrict calories and those who exercise benefit from weight
loss."
"We thought exercise probably would produce greater benefits," Dr. Weiss
said. "But both of these are providing beneficial health improvements."
In a year-long study, Dr. Weiss and colleagues evaluated nonobese, healthy
adults in their 50s who were part of a longevity study. The participants were
at the high end of normal in terms of body mass index.
The investigators wanted to see whether energy expenditures achieved through
exercise could both produce weight loss and further improve glucose
tolerance and insulin action through mechanisms independent of weight loss.
They enrolled 46 sedentary men and women from the ages of 50 to 60 with BMIs
of 23.5-29.9 kg/m2. The participants were randomly assigned to either 12
months of exercise training or 12 months of calories restriction (18 in each
group).
The remaining 10 participants were assigned to a healthy lifestyle
intervention as controls. The intervention consisted of advice for a healthy
diet if
requested, plus free passes to an offsite yoga facility to use at their
option, although few took advantage of the classes or advice, the investigators
noted.
All participants underwent oral glucose tolerance tests at baseline and at
12 months to measure insulin sensitivity and areas under the curve for both
glucose and insulin. The investigators also measured the glucoregulatory factors
adiponectin and tumor necrosis factor α, and used dual-energy x-ray
absorptiometry to measure fat mass.
Members of the caloric restriction group met weekly with a dietitian who
helped them with individual meal plans, portion-size reduction, and substitution
of low-calorie density foods for high-calorie ones. The goal was a 16%
reduction in calorie intake for the first three months, and a 20% restriction
for
the remainder. The dieters were monitored with food diaries and with the
doubly labeled water test, a measure of metabolism.
The exercise group members met weekly with an exercise trainer and had open
access to a fitness center. They exercised for 60 to 90 minutes daily and
tracked their progress on a heart-rate monitor that also recorded calories
burned.
"As they got fit, the treadmill could be speeded up," Dr. Weiss said. "They
could exercise on a steeper grade and they could burn more calories. All of
them learned very quickly the most efficient way to burn more calories was
through cardio. If they pushed themselves, the numbers added up quickly."
The authors found that while the exercisers had more rapid results, there
were no significant differences in energy deficits between the exercise and diet
groups at one year, as shown by changes in body weight and fat mass.
In both the exercise and caloric restriction groups the insulin sensitivity
index increased and the glucose and insulin areas under the curve decreased
from baseline to the end of the study. There were no significant differences
between exercisers and dieters. Among controls, however, insulin sensitivity,
glucose, and insulin measured remained unchanged at one year.
In addition, there were "marginally significant" increases in adiponectin,
and decreases in the ratio of TNF-α to adiponectin among the exercisers and
calorie cutters, but not among controls.
The authors concluded that "weight loss induced by exercise training or
calorie restriction improves glucose tolerance and insulin action in non-obese,
healthy, middle-aged men and women. However, exercise-induced weight loss does
not appear to be greater than that induced by calorie restriction."
Dr. Weiss said that it's still not known whether the combination of exercise
and caloric restriction will be able to provide greater benefits that either
intervention alone. The research was funded by the National Institutes of
Health.
Primary source: American Journal of Clinical Nutrition
Weiss EP et al. "Improvements in glucose tolerance and insulin action
induced by increasing energy expenditure or decreasing energy intake: a
randomized
controlled trial." Am J Clin Nutr; 84: 1033 Ā© 2004-2006 MedPage Today, LLC.
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NEW CLUE TO RED WINEāS HEART PROTECTION
Grapes from southwest France contain higher levels of healthy ingredient
Reuters
NEW YORK - Scientists in the U.K. have identified āoligomeric procyanidinsā
as the likely ingredient in red wineās polyphenols that contributes to heart
health and longevity. And some red wines contain more procyanidins than
others.
In the journal Nature, Dr. Roger Corder, from Queen Maryās School of
Medicine and Dentistry in London, and his associates note that not everyone
agrees
that red wine actually possess heart-healthy properties, which they say may be
due to the complexity and variability in the constituents in different wines.
To look into this issue, the investigators cultured human blood vessel cells
and exposed them to 165 different wines to identify the polyphenols with
most potent effects on blood vessels.
They found that procyanidins suppress production of a protein called
endothelin-1 that constricts blood vessels. High-performance liquid
chromatography
identified oligomeric procyanidins as the specific phenolic constituent
responsible for this effect.
People living in Nuoro province, Sardinia, and southwest France have higher
than normal average longevity. And wines from those regions, Corder and
colleagues found, had a 2- to 4-fold higher inhibitory effect on endothelin-1
and
significantly higher oligomeric procyanidin levels than wines from Australia,
Europe, South America, the US, and Sardinia.
Corder and his associates maintain that traditional wine-making methods and
use of the flavonoid-rich grape Tannat commonly grown in southwest France
result in high levels of oligomeric procyanidins in the local wine.
The researchers are hopeful that further investigation of oligomeric
procyanidins-rich wines and foods will provide insight into how blood vessel
function might be optimally maintained. Copyright 2006 Reuters Limited. All
rights
reserved.
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FDA HALTS SALES OF SOME LEG CRAMP DRUGS
Unapproved quinine medicines pose serious risks, agency says
The Associated Press
WASHINGTON - Companies have 60 days to stop selling unapproved prescription
drugs made with quinine and dispensed by the millions each year.
The new Food and Drug Administration order, released Tuesday, applies to the
roughly eight companies that make and sell the drugs, most commonly
prescribed to treat leg cramps. It does not affect the single FDA-approved
quinine
drug sold to treat some types of malaria.
That FDA-approved medicine, heir to a traditional use of the drug that dates
to the 1800s, today accounts for just one-half of 1 percent of the estimated
4 million annual prescriptions written for quinine drugs. Doctors prescribe
the vast majority of the drugs for leg cramps, a use that the FDA warned
patients and doctors could pose serious safety risks.
Many unapproved quinine drugs donāt bear warnings of those risks, including
the toxic effects of even a slight overdose, agency officials said.
Since 1969, quinine drugs have been linked to 665 reports of serious adverse
events, including 93 deaths, according to the FDA.
Many of the unapproved drugs now sold entered the market before later
changes to federal law that now require medicines to be tested for safety and
effectiveness before gaining FDA approval. The FDA estimates that the several
hundred unapproved drugs on the market account for about 2 percent of
prescriptions written each year.
Messages left with Watson Pharmaceuticals Inc. of Corona, Calif. and Ivax
Corp. of Miami, now part of Israelās Teva Pharmaceutical Industries Ltd., were
not immediately returned.
The companies are among the eight that the FDA said have made or sold
unapproved quinine products. The agency added that some manufacturers already
have
stopped selling the drugs; it wasnāt immediately clear if the two companies
were among them.
Also Tuesday, the FDA said interstate shipments of unapproved quinine drugs
must cease within 180 days.
Ā© 2006 The Associated Press. All rights reserved. Ā© 2006 MSNBC.com
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HEARTBURN DRUGS LINKED TO HIP-FRACTURE RISK
Nexium, Prilosec may make it harder for body to absorb calcium, study says
The Associated Press
CHICAGO - Taking such popular heartburn drugs as Nexium, Prevacid or
Prilosec for a year or more can raise the risk of a broken hip markedly in
people
over 50, a large study in Britain found.
The study raises questions about the safety of some of the most widely used
and heavily promoted prescription drugs on the market, taken by millions of
people.
The researchers speculated that when the drugs reduce acid in the stomach,
they also make it more difficult for the body to absorb bone-building calcium.
That can lead to weaker bones and fractures.
Hip fractures in the elderly often lead to life-threatening complications.
As a result, doctors should make sure patients have good reason to stay on
heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the
University of Pennsylvania School of Medicine.
āThe general perception is they are relatively harmless,ā Yang said. āThey
often are used without a clear or justified indication for the treatment.ā
Some people find relief from heartburn with over-the-counter antacids such
as Tums, Rolaids and Maalox. For others, these medicines do not work well.
Moreover, heartburn can be more than a source of discomfort. People with chronic
heartburn can develop painful ulcers in the esophagus, and in rare cases,
some can end up with damage that can lead to esophageal cancer.
Dr. Sandra Dial of McGill University in Montreal, who was not involved in
the study but has done similar research, said patients should discuss the risks
and benefits with their doctors and taper off their use of these medicines if
they can.
Nexium, Prevacid and Prilosec are members of a class of drugs known as
proton pump inhibitors. The study found a similar but smaller risk of hip
fractures for another class of acid-fighting drugs called H2 blockers. Those
drugs
include Tagamet and Pepcid.
The study, published in Wednesdayās Journal of the American Medical
Association, looked at medical records of more than 145,000 patients in
England,
where a large electronic database of records is available for research. The
average age of the patients was 77.
The patients who used proton pump inhibitors for more than a year had a 44
percent higher risk of hip fracture than nonusers. The longer the patients took
the drugs, the higher their risk.
The biggest risk was seen in people who took high doses of the drugs for
more than a year. That group had a 2½ times greater risk of hip fractures than
nonusers.
Yang said that for every 1,262 elderly patients treated with the drugs for
more than a year, there would be one additional hip fracture a year
attributable to the drugs. For every 336 elderly patients treated for more than
a year
with high doses, there would be one extra hip fracture a year attributable to
the drugs.
Dr. Doug Levine of AstraZeneca PLC, which makes Nexium and Prilosec, said
the study does not prove that proton pump inhibitors cause hip fractures. It
merely suggests a potential association, he said, adding that doctors need to
monitor their patients for proper dosage and watch how long they take the
drugs.
Dr. Alan Buchman of Northwestern University, who was not involved in the
research, said the study should not change medical practice, since doctors
already should be monitoring the bone density of elderly people taking the drugs
and recommending calcium-rich diets to all patients.
āMost people are not taking enough calcium to start with,ā he said. He also
wondered if a similar result would have been found in a sunny climate,
because vitamin D from sunshine helps with calcium absorption.
Also, Buchman said it not known whether the acid-fighting drugs prevent
esophageal cancer. He said the risk of esophageal cancer has been exaggerated in
the marketing of these drugs.
āI think the risk has been overplayed and scared the community,ā Buchman
said.
Heartburn medicines are heavily advertised in āAsk your doctor about ...ā
commercials in this country, particularly during the evening news.
Nexium is the second-biggest-selling drug in the world, behind the
cholesterol medicine Lipitor, with global sales totaling $4.6 billion last year,
according to IMS Health, which tracks drug sales.
Yang and his co-authors disclosed in the paper that they have worked as
consultants and received speaking fees from companies making acid-fighting
drugs.
The study was funded by the National Institutes of Health and the American
Gastroenterological Association/GlaxoSmithKline Glaxo Institute for Digestive
Health.
Men in the study had a higher drug-associated risk of hip fracture than
women, possibly because women may be more aware of osteoporosis and may get more
calcium in their diets, Yang said. He plans more research on whether
calcium-rich diets or calcium supplements can prevent the problem.
Ā© 2006 The Associated Press. All rights reserved. Ā© 2007 MSNBC.com
*********************************************************
RESEARCHERS FORESEE IMAGES THAT PROVE PAIN
(The New York Times News Service)
Researchers foresee a day when people tortured by chronic, unexplained pain
will be able to prove that they really hurt -- evidence that could help
sufferers be taken more seriously and could even lead to better treatments.
Recent studies suggest that prolonged, ongoing pain leaves a signature in
the brain that can be detected using advanced imaging techniques.
In other work, researchers at Massachusetts General Hospital and elsewhere
have found that excruciating nerve damage can be detected in bits of skin the
size of a pinhead. And genetic tests may someday prove useful, researchers
believe: Certain genes appear to be linked to lower pain thresholds and a
tendency to develop chronic pain.
Most of the research remains years from helping patients, but as it comes to
fruition, "what it means is that no longer can they say, 'it's all in your
head,"' said Jim Broatch, who leads an advocacy group for people with a
specific chronic pain disorder.
Clinical proof of pain could make an enormous difference for patients -
emotionally, with unsympathetic relatives and colleagues, and legally, in
battles
with insurers and employers, researchers say.
And as science uncovers more of the objective signs of pain, that knowledge
may help with diagnoses, treatment, perhaps even the development of drugs,
they say.
Late last month, German researchers reported that they had turned up
microstructural changes in the brains of people who had suffered for years from
lower back pain.
The study of 40 patients, presented at the Radiological Society of North
America conference in Chicago, used a type of brain scanning called Diffusion
Tensor Imaging, which can detect long-term changes in the nerve pathways in the
brain.
The scan identified three areas involved in pain processing that showed
signs of heightened activity. It was as though pathways that had started as
single-lane roads had been expanded into four-lane superhighways, as more and
more
signals traveled along them, said researcher Juergen Lutz.
"With these objective and reproducible correlates in brain imaging, chronic
pain may no longer be a subjective experience," Lutz said in a press release.
Other work focuses on the theory that people who have chronic pain may have
something wrong with their pain-killing system.
Last month, University of Michigan researchers reported findings that
patients with fibromyalgia, a chronic pain disorder, have abnormally low levels
of
natural opiate-like painkillers in parts of their brains.
The study, presented at a rheumatology conference, "also just validates that
these people are in pain," said researcher Richard E. Harris.
"They're trying to turn on their analgesic system but it's not enough to
reduce the pain."
Brain imaging of pain is still too experimental for clinical use but that is
coming, Harris said. "I'd say it will probably be five or 10 years until we
can have a patient walk into a doctor's office and say, 'I have pain,' and the
doctor says, 'I want to refer you out to a specialist who does imaging to
verify that or find out where your pain is located,"' whether in the brain,
spinal cord, or elsewhere, he said.
Proving the presence of pain through genetic testing is probably even longer
away, Harris and others said. Several studies have established a link
between a gene known as "COMT" and pain disorders, including one that can affect
the jaw; a mutation in that same gene seems to predispose people to low
pain-killing opioid activity in the brain and low pain thresholds, published
research suggests.
Other work is much further along. At Mass. General, for example, Dr. Anne
Louise Oaklander is already measuring "the objective correlates of pain" by
counting the numbers of pain-sensing nerve endings in tiny skin samples from
patients with unexplained pain. Paradoxically, patients with previously
unexplained pain tend to have fewer such endings.
Such skin biopsies allow researchers to diagnose "small fiber neuropathies,"
the nerve damage that is sometimes a side effect of diabetes and other
diseases. The nerve endings are so tiny that they have been largely invisible,
Oaklander said, but skin biopsies are "opening a window into the pain system,
allowing us to see when it is damaged."
Oaklander's work recently helped a college athlete who suddenly began
experiencing an unbearable burning sensation in his palms and on the soles of
his
feet, according to a paper slated for publication in the February issue of the
journal Anesthesia & Analgesia.
Greg Palladino, a lacrosse goalie at Southern New Hampshire University, was
on a team trip to Bermuda last year when he began suffering a pain that only
submersion in ice would alleviate. It was as though broken glass were running
through his veins, he told his doctors.
He returned home and was treated repeatedly at area hospitals for weeks.
Despite extensive tests, the doctors were baffled, said Palladino's father,
Steven. Drug after drug failed to help, and he lost 55 pounds in a matter of
weeks.
When Oaklander was called in, she did a skin biopsy that showed conclusively
that Palladino's "erythromelalgia" -- his red, burning appendages - stemmed
from severe damage to small nerve fibers that apparently came on because of
an auto-immune reaction. For some reason, his body had started attacking its
own nerve cells.
The biopsy gave doctors the confidence to put Palladino on enormous doses of
steroids to stop the auto-immune attack, and he has almost completely
recovered, his father said.
Palladino was - in a way -- lucky that he had tissue damage that could be
detected; many patients, Oaklander said, have very real pain that is caused by
undetected problems in their nervous system, afflicting them with "an
invisible disability that leaves no traces."
"It's a wiring problem," she said. "It's like when your oil light on your
dashboard goes on, and you think, 'My car must be low on oil,' but you pull over
and check your oil and it's fine, and you realize it's an electrical
problem. These are people who have electrical problems in their pain system,
and
their neurons are firing as much as if they had a broken leg, only their leg is
fine."
For patients with chronic unexplained pain, the lack of physical proof of
their suffering compounds it, pushing some as far as suicide.
"You feel like you're malingering, you feel like you're crazy," said Mary
Beth Ludington, patient representative for Jim Broatch's group, the Reflex
Sympathetic Dystrophy Syndrome Association, which helps people with pain
disorder. "I used to feel like a wimp until I was diagnosed. Then it was,
'Hallelujah! I'm not crazy and I'm not a big wimp! There's a reason for this,
and a
name.' It really validates the suffering that a lot of people go through."
Copyright 2006 The New York Times News Service.
**************************************************
Editorās note: In 2007, I will be reducing the number of newsletters to once
a month. When news items are especially heavy I will, on occasion, publish
an additional newsletter as warranted. I have certainly enjoyed bringing you
ā
the newsā during 2006 and hope that it has been helpful to you.
Good Health to All,
Jack Nicholas
Newsletter Editor
_Cornishpro@..._ (mailto:Cornishpro@...)
Issue 2006- 15
12/30/06