PSORIATIC ARTHRITIS NEWSLETTER NO. 120

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PSORIATIC ARTHRITIS NEWS AND VIEWS

Volume 7 Issue 05 Publication No. 120

August 23, 2007

HIGH-NORMAL GLUCOSE BOOSTS HEART ATTACK FAILURE RISK

By Neil Osterweil, Senior Associate Editor, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of

Pennsylvania School of Medicine.

STOCKHOLM, -- Glucose levels at the top end of the normal range ratchet up

the congestive heart failure hazard for patients already at high risk,

revealed an analysis of two international studies.

Among more than 31,000 patients with one or more coronary, peripheral, or

cerebrovascular diseases, or diabetes with end-organ damage, fasting plasma

glucose levels at baseline independently predicted hospitalization for

congestive heart failure, found Claes Held, M.D., Ph.D., of the Karolinska

University

Hospital here, and colleagues.

Even a " high-normal " glucose level may not be so normal for the risk of

heart failure, they reported online in Circulation, Journal of the American

Heart

Association.

" You can look at blood glucose much like blood pressure or cholesterol, " Dr.

Held said. " Even if you have normal blood glucose, there is a gradual

increase in risk wherever you start on the scale. If the blood sugar is 'high

normal' there is a higher risk than those with 'low normal' fasting blood

glucose

levels. "

The authors found that after controlling for age and sex, each increase of 1

mmol/L (18 mg/dL) in fasting plasma glucose was associated with a

1.10-fold-increased risk of hospitalization for congestive heart failure (95%

confidence interval, 1.08 to 1.12; P<0.0001).

" This illustrates that blood glucose by itself is a continuous risk factor

for developing heart failure because all of these patients were free of heart

failure when they enrolled in the trials, " said Dr. Held.

The authors, including investigators from Sweden, Canada, England, Germany,

and Australia looked at the associations between fasting plasma glucose and

risk of hospitalization for congestive heart failure during follow-up in

patients who were enrolled in two clinical trials of the antihypertensive agent

telmisartan (Micardis).

The cohort included 25,620 patients enrolled in ONTARGET (Ongoing

Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial), and

5,926

enrolled in TRANSCEND (Telmisartan Randomized Assessment Study in ACE

Intolerant Subjects With Cardiovascular Disease).

The patients, all with one or more coronary, peripheral, or cerebrovascular

diseases, or diabetes with end-organ damage, had baseline fasting plasma

glucose levels measured.

The authors conducted interim analyses blinded for randomized treatment to

compare baseline glucose with the adjusted congestive heart failure event rate

at a mean follow-up of 886 days. They also created multivariable

regression models controlling for age, sex, smoking, previous myocardial

infarction,

diabetes status, hypertension, medications (aspirin, β-blockers, and

statins), creatinine and waist-to-hip ratio.

The mean age of the patients was 67, and 69% were men. Of the total 31,546

patients, 37% (11,708) had a diabetes diagnosis prior to enrollment, and 3.2%

(1,006) were newly diagnosed with diabetes at study entry.

During follow-up in the two trials, there were 2,882 primary events,

including 1,067 cardiovascular deaths, 926 MI, 823 strokes, and 668

hospitalizations

for congestive heart failure.

The association between glucose and congestive heart failure hospitalization

persisted when the investigators controlled for the additional factors of

smoking, previous myocardial infarction, hypertension, waist-to-hip ratio,

creatinine, diabetes, and use of aspirin, β-blockers, or statins (hazard

ratio,

1.05; 95% confidence interval, 1.02 to 1.08; P<0.001).

Higher glucose levels were also associated with increased risk for a

composite endpoint of congestive heart failure hospitalization and/or

cardiovascular

death. The hazard ratio for each increment of 1 mmol/L glucose was 1.09 (95%

CI, 1.07 to 1.10; P<0.001) in a model adjusted for age and gender.

Each 1 mmol/L rise increased the risk for the composite endpoint by 9% for

all patients, 3% for patients without diabetes, 5% for patients with diabetes.

" These findings for congestive heart failure are consistent with a previous

study that showed that an abnormal response of the two-hour glucose value on

the standard oral glucose tolerance test was an independent predictor of

congestive heart failure in a prospective population-based cohort of elderly

men, "

the authors wrote.

" Our data also are consistent with accumulating evidence showing that

elevated glucose is a progressive risk factor for cardiovascular disease

outcomes

even with levels below the threshold for a diagnosis of diabetes mellitus, and

that an elevated fasting plasma glucose is associated with higher mortality

in healthy subjects and in those with established congestive heart failure

without known diabetes mellitus. "

They acknowledged that the results of the analysis, which come from ongoing

randomized trials, could have been influenced by treatment assignment. They

also did not have access to information on blood pressure, glucose control,

time since diabetes diagnosis, or left ventricular function at baseline.

The ONTARGET/TRANSCEND trials are sponsored by Boehringer Ingelheim Pharma

GmbH. Dr Held was supported by grants from the Janne Elgqvist foundation, the

and Edith Fernstrom Foundation, and the Swedish Heart Lung Foundation.

Co-author Prof. Hertzel Gerstein has received a research grant for studies on

insulin to reduce cardiovascular events and is a consultant for

Sanofi-Aventis. He has received honoraria for speaking engagements for

Sanofi-Aventis. The

other authors reported no conflicts.

The information presented in this activity is that of the authors and does

not necessarily represent the views of the University of Pennsylvania School of

Medicine, MedPage Today, and the commercial supporter. Specific medicines

discussed in this activity may not yet be approved by the FDA for the use as

indicated by the writer or reviewer.

© 2004-2007 MedPage Today, LLC. All Rights Reserved.

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HOW TO PRAISE YOUR KIDS

By McCarthy, M.D. - Boston Children's Hospital

As parents, we're supposed to praise kids because it boosts their

self-esteem and helps them achieve, right? Maybe not. According to some recent

studies,

the answer depends on how you praise kids.

Praise " Smarts " or Effort?

Carol Dweck, PhD, a psychologist at Stanford University, studied praise and

its effect on children when she was at Columbia University in New York City.

She and her colleagues randomly divided 400 5th graders from New York City

public schools into two groups. The students were taken out of the classroom

individually and given a relatively easy series of puzzles to do. When they

were finished, one group of students was praised for intelligence and told,

" You

must be smart at this, " while the other group was praised for effort and

told, " You must have worked really hard. "

Then the students were given a test to take. They could choose one that was

either harder or easier than the first test. Researchers told the children

that if they chose the hard test, they'd learn a lot by doing it. Dweck found

that 90% of the children who were praised for their effort on the first test

chose the harder test while the majority of the children who were praised for

their intelligence on the first test chose the easier one.

Dweck took the study one step further and gave the students a very hard test

that they would surely fail. The children who were praised for their effort

on the first test kept trying to figure the test out. Many even enjoyed it.

Children who were praised for their intelligence, however, were upset by the

test's difficulty, as if failure would mean that they weren't smart after all.

The last part of the study was even more interesting. The children were

given another easy test, similar to the first one they took. The group of

children who had been praised for their effort on the first test raised their

scores

by about 30%. The group praised for their intelligence scored about 20%

lower — even though the test wasn't any harder.

What does this tell us? According to Dweck, children who are praised for

their intelligence don't want to look stupid. They worry that maybe they aren't

as intelligent as people tell them they are. So they lose their motivation to

try harder tasks and instead choose tasks they know they will succeed at, and

get very unnerved by failure.

Children who are praised for their effort, on the other hand, believe they

are capable of taking on new challenges, are more motivated, perform better and

are more likely to take failure in stride.

The Growth Mindset

Intelligence is something that can grow with effort — a concept Dweck calls

the " growth mindset. " To show how critical it is to focus on the effort a

child puts into a task, Dweck and her colleagues did another study with a group

of underachieving, middle school students in New York City. Half the students

took a class on study skills; the other half took the same class, but were

also taught that intelligence grows with effort. The students who learned the

growth mindset went on to do much better in school than those who didn't

learn it.

It's hard to stop telling our kids they are smart. There are times when a

child may need to hear it. But if all a child hears is that he is smart, it can

backfire. It's important that children know that effort counts and that

mistakes are part of learning — and not the end of the world.

Ways To Praise

Here are examples of how to praise a child's effort:

" You must have studied really hard to get this grade on your test. "

" I like your answer to this question—you can tell you really thought about

it. "

" You did such careful work on your math homework, no wonder you got so many

right! "

" I'm proud of how hard you worked on your project. "

" I know this homework is hard for you, but if you keep working hard like you

are, I know you can do it. "

Specific praise is better than general praise. It's natural to feel a bit

suspicious of general praise, such as " You're so smart, " " You're such a good

soccer player, " " What a nice person you are. " Studies have shown that children

are suspect of general praise as early as preschool. When the praise is more

specific, however, it's not only more believable but it can help guide

behavior:

" I love the colors you picked for your drawing. "

" I really liked how you shared your toys with your sister. "

" You are doing so well at sounding out words when you read. "

" I liked how you kicked the ball to your teammates, and listened to your

coach. "

" I'm proud of how hard you tried at your swim meet today. "

" You did such a great job memorizing your lines for the play. "

Many parents use general praise because they want their child to feel

special and loved. They worry that specific praise might leave a child feeling

that

their approval is somehow conditional. General praise, they think, feels

unconditional. But research on praise, including Dweck's, suggests that parents

may need to rethink this approach.

The Bottom Line

Praise is important, but there are other ways to make a child feel loved,

build a strong relationship and raise a child who is confident and motivated to

learn:

Put aside housework, turn off the TV, get off the phone or computer and read

a story, play a game, go for a walk, or otherwise spend time with your

child. It sends the powerful message that there's nothing more important than

being with them.

Give hugs, and say " I love you. "

Show up for your child's soccer games and concerts.

Hang your child's artwork on the refrigerator.

Do your best not to yell even when you've had an awful day.

Say, " I know you can do it! " when your child is feeling discouraged.

Back to top

McCarthy, M.D. is a senior medical editor for Harvard Health

Publications. She is an instructor in pediatrics at Harvard Medical School, an

attending physician at Children's Hospital of Boston, and co-director of the

pediatrics department at Martha Eliot Health Center, a neighborhood health

service

of Children's Hospital. The author of two books, Learning How the Heart Beats

(Viking, 1995), and Everyone's Children (Scribner, 1997), Dr. McCarthy was a

regular columnist for Sesame Street Parents Magazine from 1995 to 1998 and

currently is a contributing editor for Parenting Magazine.

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EMOTIONS MAY INFLUENCE ARTHRITIS PAIN

Study Shows Fear, Distress Can Affect Patients' Perception of Pain

By Salynn Boyles - WebMD Medical News - Reviewed By Louise Chang, MD

The fear and distress arthritis patients feel about their condition can make

a big difference in how they perceive the pain that comes with it, a novel

brain-imaging study shows.

The findings suggest that interventions designed to reduce pain-related fear

and anxiety, such as behavioral therapy, should play a bigger role in the

treatment of chronic arthritis pain, the study's researcher tells WebMD.

" Most arthritis patients don't have access to these types of therapies, or

if they do, they tend to get them after they have lived with pain for many

years, " says neuro-rheumatologist K.P. , MD. " We believe patients

would fare better if they were treated with these therapies much earlier. "

The Pain Systems

The study by and colleagues from the University of Manchester

Rheumatic Diseases Center is the first to directly examine how the brain

processes

arthritis pain using a specific type of brain imaging.

Two parallel areas within the brain have been identified as pain processing

centers -- the lateral system and the medial system.

While both systems share many of the same functions, earlier work by the

University of Manchester research team identified the medial system as being

more involved in the emotional aspects of pain, such as fear and stress.

The lateral system was found to be more involved in processing sensory

aspects of pain, such as pain location and duration.

Studies involving healthy volunteers subjected to controlled pain made it

clear that the way people think about their pain can change their perception of

it, says.

" That may sound obvious, but a lot of people with pain think they have no

control over what they are feeling, " he says. " The fact is that the brain rules

in terms of pain perception. "

In their latest study, the researchers attempted to determine if people with

chronic pain respond in a similar way.

Six women and six men with knee osteoarthritis (OA) were recruited for the

trial. Brain imaging was performed when the subjects were experiencing

arthritis pain, when they were pain-free, and when they were experiencing

controlled,

heat-related pain to the arthritic knee administered by the researchers.

For all 12 patients, both types of pain activated both pain systems. But

activity within the medial system was much greater when the patients were

experiencing arthritis pain.

The findings suggest that for these patients, arthritis pain was more

strongly associated with fear and distress than other types of pain. The study

appears in the April issue of the journal Arthritis and Rheumatism.

Treatment Implications

The fact that high concentrations of natural opiates are found in the medial

pain system has implication for researchers searching for new drugs to treat

arthritis and other chronic pain conditions, says.

" Drugs that enhance naturally occurring opiates may have fewer side effects

than synthetic opiates like morphine, " he tells WebMD.

Nondrug treatments designed to teach patients how to better perceive and

cope with their pain also target the medial system.

The brain-imaging research is not the first to find that positive thinking

can influence the perception of chronic pain.

In a 2005 study conducted at Wake Forest University, volunteers were

subjected to similar levels of experimental pain. But those trained to perceive

the

pain as minimal reported much lower pain levels than those trained to expect

severe pain.

More importantly, they also showed less pain-related activity on brain scans.

" Expectations of decreased pain powerfully reduced both the subjective

experience of pain and activation of pain-related brain regions, " Wake Forest

neuroscientist Coghill, PhD, says in a press release.

SOURCES: Kulkarni, B. Arthritis and Rheumatism, April 2007; vol 56: pp

1345-1354. K.P. , MD, FRCP, professor of neuro-rheumatology,

University of Manchester Rheumatic Diseases Center, Manchester, England.

Coghill, PhD, neuroscientist, Wake Forest University School of Medicine, Wake

Forest, N.C. © 2007 WebMD Inc.

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MEN’S SKIN MORE SUN-SENSITIVE

Sun Causes Faster-Growing, Worse Skin Cancer in Males, Mouse Study Shows

By J. DeNoon - WebMD Medical News - Reviewed By Louise Chang, MD

Skin cancer due to sun exposure appears faster -- and is more severe -- in

males than in females, mouse studies show.

It's well known that men are more likely to get skin cancer than women are.

Men get twice the overall number of skin cancers and three times more squamous

cell carcinomas than women do, notes Tatiana M. Oberyszyn, PhD, assistant

professor of pathology at Ohio State University in Columbus.

Why? Researchers usually say this is because men are more likely than women

to have outdoor jobs -- and that they are less likely to protect their skin

with sunscreen, shirts, and hats. Oberyszyn wondered whether this is true.

To test the theory, Oberyszyn's team exposed a breed of hairless mice to

ultraviolet rays from a sun lamp. The mice underwent eight- to 10-minute tanning

sessions three times a week for six months. That was enough to give both male

and female mice skin cancer.

" We found males got skin tumors earlier, got more of them, and more of the

tumors were severe, " Oberyszyn tells WebMD.

Men’s Skin More Sensitive?

What was going on? Tests of male and female mouse skin turned up a

surprising finding. The male skin cells carried fewer antioxidants than the

female

skin cells.

" Our skin is exposed to both physical and environmental stimuli all the

time, " Oberyszyn says. " Our immune system keeps us healthy. But the immune

system

can overreact sometimes. You get overproduction of reactive oxygen species

-- and antioxidants protect against this. "

The researchers are now looking at human skin to see if men really are like

mice.

" We think male skin is just more sensitive, " Oberyszyn says. " Perhaps men

need something that would provide with them more antioxidants -- maybe diet,

maybe a skin cream. In addition to sunscreen, maybe men need to pay more

attention to their skin than women do. It is not a cosmetic thing; it really is

a

health issue. "

nne Berwick, PhD, is the head of cancer epidemiology and prevention at

the University of New Mexico in Albuquerque. Berwick agrees with Oberyszyn

that there's a huge difference between men's skin and women's skin.

However, she notes that men really do get more exposure to cancer-promoting

ultraviolet light than women do.

" This current study is solid, good research, but it is not the whole story, "

Berwick says. " I would hate to see people taking more antioxidants or

putting it on their skin because of this. The differences between male and

female

skin are due to intrinsic biology and are not simply a matter of antioxidants

themselves. "

The Oberyszyn study appears in the April 1 issue of Cancer Research.

SOURCES: -Ahner, J.M. Cancer Research, April 1, 2007; vol 67,

manuscript received ahead of print. Tatiana M. Oberyszyn, PhD, assistant

professor of

pathology, Ohio State University, Columbus. nne Berwick, PhD, professor

of internal medicine; chief, division of epidemiology; head of cancer

epidemiology and prevention, University of New Mexico, Albuquerque. © 2007

WebMD

Inc. All rights reserved. © 2007 MedicineNet, Inc. All rights reserved.

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PROTEIN MAY BE KEY TO RHEUMATOID ARTHRITIS

By Janice Billingsley - HealthDay Reporter

In the quest for the causes of and potential treatments for rheumatoid

arthritis, Japanese researchers have identified a protein that could be a target

for future therapy.

Rheumatoid arthritis (RA) is a chronic and disabling autoimmune disease that

first attacks the fluid that surrounds the joints, causing it to thicken and

grow abnormally, damaging the joints and surrounding cartilage rather than

protecting them. More than 2 million Americans suffer from the illness,

according to the Arthritis Foundation.

By identifying a protein that appears to be one of the culprits in the

unhealthy buildup of this fluid, which is called synovial fluid, Dr. Yasushi

Miura

and her colleagues at Kobe University School of Medicine hope that a new,

targeted medication can be developed to treat the disease.

" The protein Decoy receptor 3 (DcR3) is one of the pathological factors of

RA and can be a new therapeutic target for treatment, " said Miura, an associate

professor in the division of orthopedic sciences at the medical school.

Her findings are in the April issue of Arthritis & Rheumatism, the journal

of the American College of Rheumatology.

DcR3 is a member of the large tumor necrosis factor receptor (TNFR) " super

family, " which has been identified in the last decade as important in the

regulation of cell growth and cell death, fundamental processes in biology, said

Dr. Hoffman, director of the division of rheumatology and immunology at

the University of Miami School of Medicine in Florida.

" We have known of the importance of cell growth and cell death in studying

cancer but more recently have found that it is also important in autoimmune

diseases like RA and lupus, " he said.

It was the similarity between the growth of malignant tumors and the

abnormal growth of synovial tissue, called hyperplasia, that sparked Miura's

research into DcR3 and rheumatoid arthritis. DcR3 is known to be produced in

tumor

cells, including lung and colon cancers.

What Miura and her colleagues found was that DcR3 works with another member

of the TNFR family to slow the normal cell death of synovial fluid cells,

resulting in the hyperplasia that causes some of the inflammation characteristic

of rheumatoid arthritis.

Hoffman said: " This is a novel application of the connection between this

specific member of the TNFR super family and RA, and studies like this are how

we advance science. But it is currently a giant leap to suggest that this

could be a therapy for RA. "

For their study, Miura and her colleagues isolated and cultured synovial

fluid from19 patients with rheumatoid arthritis, obtained during total knee

replacement surgery. For comparison, they also extracted synovial fluid in the

same manner from 14 patients with osteoarthritis.

The researchers then exposed the synovial fluid to another TNFR protein

called Fas, which induces cell death, called apoptosis. Finally, the fluid was

incubated with a pro-inflammatory member of the TNFR family, called TNFa. The

TNFR family includes proteins that both induce and retard cell death, Miura

explained.

While DcR3 was present in the same amounts in the fluids of both the

rheumatoid arthritis and osteoarthritis patients, when the TNFa was introduced,

DcR3

production increased in the fluid of the RA patients, slowing down the

Fas-induced cell death. The rate of cell death did not change in the fluid of

the

osteoarthritis patients, perhaps, Miura suggested, because the TNFa levels

were higher in the fluid of RA patients to begin with.

Miura said the results show that DcR3 acts in conjunction with TNFa to

suppress the cell death necessary to keep synovial fluid healthy, and research

aimed at reducing the amount of DcR3 in the synovial fluid in rheumatoid

arthritis patients could be productive.

Dr. Lindsey, head of rheumatology at the Ochsner Clinic Foundation

in Baton Rouge, La., said, " We are always looking for better and more specific

targets to control immune response, and this study is very intriguing. "

Lindsey said there are drugs available that inhibit those proteins that

suppress cell death, but because they are " global, " rather than targeted to

particular proteins, there are many side affects, including infection.

SOURCES: Yasushi Miura, M.D., Ph.D., Kobe University School of Medicine,

Kobe, Japan; Lindsey, M.D., head of rheumatology, Ochsner Clinic

Foundation, Baton Rouge, La.; Hoffman, M.D., professor of medicine,

microbiology and immunology, director of the division of rheumatology and

immunology,

University of Miami School of Medicine, Florida; April 2007, Arthritis

& Rheumatism Copyright © 2007 ScoutNews, LLC. All rights reserved.

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FDA WARNS CONSUMERS ABOUT COUNTERFEIT DRUGS FROM MULTIPLE INTERNET SELLERS

The Food and Drug Administration (FDA) is cautioning U.S. consumers about

dangers associated with buying prescription drugs over the Internet. This alert

is being issued based on information the agency received showing that 24

apparently related Web sites may be involved in the distribution of counterfeit

prescription drugs.

On three occasions during recent months, FDA received information that

counterfeit versions of Xenical 120 mg capsules, a drug manufactured by

Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two

different Web

sites. Xenical is an FDA-approved drug used to help obese individuals who

meet certain weight and height requirements lose weight and maintain weight

loss.

None of the capsules ordered off the Web sites contained orlistat, the

active ingredient in authentic Xenical. In fact, laboratory analysis conducted

by

Roche and submitted to the FDA confirmed that one capsule contained

sibutramine, which is the active ingredient in Meridia, an FDA-approved

prescription

drug manufactured by Abbott Laboratories.

While this product is also used to help people lose weight and maintain that

loss, it should not be used in certain patient populations and therefore is

not a substitute for other weight loss products. In addition the drug

interactions profile is different between Xenical and sibutramine, as is the

dosing

frequency; sibutramine is administered once daily while Xenical is dosed

three times a day.

Other samples of drug product obtained from two of the Internet orders were

composed of only talc and starch. According to Roche, these two samples

displayed a valid Roche lot number of B2306 and were labeled with an expiration

date of April 2007. The correct expiration date for this lot number is actually

March 2005. Pictures of the counterfeit Xenical capsules provided by Roche

can be viewed at _http://www.fda.gov/bbs/topics/news/photos/xenical.html_

(http://www.fda.gov/bbs/topics/news/photos/xenical.html) .

Roche identified the two Web sites involved in this incident as

brandpills.com and pillspharm.com. Further investigation by FDA disclosed that

these Web

sites are two of 24 Web sites that appear on the pharmacycall365.com home

page under the " Our Websites " heading. Four of these Web sites previously have

been identified by FDA's Office of Criminal Investigations as being associated

with the distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from outside of

the United States. Consumers should be wary, if there is no way to contact the

Web site pharmacy by phone, if prices are dramatically lower than the

competition, or if no prescription from your doctor is required. As a result,

FDA

strongly cautions consumers about purchasing drugs from any of these Web

sites which may be involved in the distribution of counterfeit drugs and

reiterates previous public warnings about buying prescription drugs online.

Consumers

are urged to review the FDA Web page at _www.fda.gov/buyonline/_

(http://www.fda.gov/buyonline/) for additional information prior to making

purchases of

prescription drugs over the Internet.

The 24 Web sites appear on pharmacycall365.com.

AllPills.net

Pharmacy-4U.net

DirectMedsMall.com

Brandpills.com

Emediline.com

RX-ed.com

RXePharm.com

Pharmacea.org

PillsPharm.com

MensHealthDrugs.net

BigXplus.net

MediClub.md

InterTab.de

Pillenpharm.com

Bigger-X.com

PillsLand.com

EZMEDZ.com

UnitedMedicals.com

Best-Medz.com

USAPillsrx.net

USAMedz.com

BluePills-Rx.com

Genericpharmacy.us

I-Kusuri.jp

U.S. Food and Drug Administration press release #P07-76, May 1, 2007 © 2007

MedicineNet, Inc. All rights reserved.

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WHAT ARE BIOLOGICS?

The Star Online

Most medicines are created by combining chemicals. In contrast, “biologic

drugs†are made from human or animal proteins. These medications, which are

made

from proteins, are specifically designed to help correct the body’s

processes that cause diseases like rheumatoid arthritis, ankylosing

spondylitis,

psoriatic arthritis and psoriasis.

Biologics are not “new†medications – they have been in used for more than

100 years. Vaccines and insulin are considered biologics because they are

derived from living sources. Only recently, however, have biologics that are

specifically targeted towards the mentioned diseases begun to emerge as

promising new treatment options.

Biologics are different from other medications for the mentioned diseases

because they are designed to block those diseases early in their development –

in the immune system.

Biologics are designed to treat the mentioned diseases by “going afterâ€

immune cells that went out of order in the body. Some biologics target a type of

immune cell called a T cell, while others target the chemical messengers

released by activated T cells (an example is a TNF-alpha, which is explained

later).

T cells are the so-called “generals†for the immune system because they

normally recognize bacteria and viruses and coordinate the immune response to

eliminate these foreign invaders.

In the diseases mentioned earlier, for unknown reasons, certain T cells are

mistakenly activated and may migrate to the knee joint in RA patients. Once

they are there, they begin to act as if they are fighting an infection or

healing a wound, which sets off a chain of events that lead to joint damage.

Certain biologics are then designed to prevent the activation and/or

migration of T cells.

Normally, TNF- alpha (tumor necrosis factor-alpha) also helps fight

infections, and it communicates messages between cells. In people with RA,

TNF-alpha

is produced in excess amount by activated T cells. The messages communicated

by TNF-alpha lead to joint pain and stiffness and other symptoms associated

with RA.

Several biologic medications have been developed to treat RA and other

disease, and they work by binding to TNF-alpha and preventing it from

communicating with cells. It has been found that these TNF-alpha blocking agents

are also

effective to different degrees in treating psoriatic arthritis and

psoriasis.

Biologic can be very effective at improving these diseases, but how well

they work will vary for each person. For some people, biologic treatments may

not work at all for their disease. For others, one biologic may not work but

another may be effective. This is because the various biologics work by

different mechanisms.

The side effects for biologic medications vary. Commons side effects for all

biologics include respiratory infections, flu-like symptoms and reactions at

the site of injections (such as swelling, itch or rash) These are generally

mild.

Anyone considering taking a biologic medication should talk to a doctor

about short and long term side effects and risks, and carefully weigh those

against the risk of all treatment options.

Certain factors may play a role in determining what is an appropriate

treatment for an individual.

In some cases, biologic medications may not be prescribed if a person’s

immune system is already significantly compromised – for example, if the

patient

is on another immunsuppresant. People with active infections may not be

eligible for some biologics.

If a major infection develops while taking a biologic, it is usually

recommended that the medication be temporarily stopped. In addition, screening

for

tuberculosis or other hidden infections may be required before treatment is

started with certain biologics.

Biologics are very complex medications to produce, and it can take decades

of research and development before a biologic is approved and ready for

patients to use. On top of that, it normally takes a several months to produce

a

single vial of biologics.

The key features of biologics are:

1. Taken by injections (either in a doctor’s office or at home, depending on

patient’s preference).

2. Treatment schedule and frequency varies

3. Will improve disease in most patients, but not all

4. Biologics have a different set of risks than other treatments

5. May be generally safer than other systemic medications during pregnancy

and conception

6. Short term side effects are generally minor, although an allergic-type

reaction to the injection can occur

7. Some biologics have long-term safety data, but for newer biologics the

long term safety is still being evaluated

8. It is expensive because of difficulty in R & D and manufacturing it. ©

1995-2005 Star Publications (Malaysia) Bhd

******************************************************

ENBREL, REMICADE, AND HUMIRA HAVE DRAMATICALLY TRANSFORMED THE DRUG MARKET

FOR THE TREATMENT OF PSORIATIC ARTHRITIS

However, Pipeline Includes Very Few Therapies for Patients Who Do Not

Respond to TNF-Alpha Inhibitors, According to a New Report from Decision

Resources

WALTHAM, Mass., PRNewswire/ -- Decision Resources, one of the world's

leading research and advisory firms for pharmaceutical and healthcare issues,

finds

that the recent emergence of three high-priced biologic agents - -

Amgen/Wyeth/Takeda's Enbrel, Centocor/Schering-Plough/Tanabe's Remicade, and

Abbott/Eisai's Humira -- has dramatically transformed the drug market for

treating

psoriatic arthritis.

The new Pharmacor report Psoriatic Arthritis finds that although no drugs

had been approved for treating the disease prior to 2002, the TNF-alpha

inhibitors Enbrel, Remicade, and Humira have emerged over the past five years as

highly effective treatments for psoriatic arthritis in the world's major

pharmaceutical markets (the United States, France, Germany, Italy, Spain, the

United

Kingdom, and Japan). The psoriatic arthritis market, which had previously

been served by inexpensive drugs that were used off-label, is now characterized

by a small but significant percentage of patients who are treated with

high-priced TNF-alpha inhibitors.

Despite the success of TNF-alpha inhibitors, the report finds that the

pipeline for psoriatic arthritis is notably weak and includes few therapies with

novel mechanisms of action. Additionally, only one of the novel agents in dev

elopment, Centocor/Medarex's dual interleukin inhibitor known as CNTO- 1275,

is expected to launch.

" Although TNF-alpha inhibitors have expanded treatment options, some

psoriatic arthritis patients do not respond to these agents, and few therapies

in

development are likely to satisfy this need, " said Joanna Kim, analyst at

Decision Resources. " By 2015, Centocor/Medarex's CNTO-1275 will be the only

therapy approved for psoriatic arthritis that has a mechanism of action not

based

on the inhibition of TNF-alpha. "

Copyright © 1996-2003 PR Newswire Association LLC. .

**************************************************

AGING AMERICANS CRANK UP NATION’S FINANCIAL BURDEN

By Judith Groch, Senior Writer, MedPage Today

SAN FRANCISCO, The aging population has escalated the national price tag for

arthritis and other rheumatic conditions by nearly 25% in seven years,

investigators here reported.

Citing a decline in hospital costs for the conditions from 1997 through

2003, and stable average costs for medical care, the aging population stood out

as the primary cause for the rise in national expenditures, the researchers

reported in the May issue of Arthritis and Rheumatism.

Those with arthritis and other rheumatic conditions increased to more than

46 million, some 21% of the population, and treatment costs hit $80.8 billion,

said Yelin, Ph.D., of the University of California San Francisco, and

colleagues at the CDC.

Arthritis patients included those with osteoarthritis or rheumatoid

arthritis, while other disorders included lupus, gout, and bursitis.

The data emerged from the Medical Expenditures Panel Study, a national

probability sample of households. The researchers tabulated medical care costs

for

adult respondents, stratified by arthritis status, and used regression

techniques to assess the medical care expenditures attributable to arthritis and

related rheumatic diseases, plus individual loss of income.

Among other findings:

Expenditures for arthritis medications almost doubled. This increase

resulted from jumps in both the mean number of prescriptions (from 18.7 to 25.2

per

person) and the mean cost of a prescription, which rose to $65 from $48.

Inpatient hospital costs to treat these conditions declined from $508 to

$352 per person.

As a result, the average total spent on medical care for these conditions

remained surprisingly stable: $1,762 in 1997 and $1,752 in 2003.

Nationwide in 2003, raw loss of earnings among employed patients with

arthritis or other rheumatic conditions totaled $108 billion, up from $99

billion

in 1997.

Of that amount, after controlling for demographics and comorbidity, $1,590

was attributable to arthritis and other rheumatic conditions (versus $1,946 in

1997), for a total of $47.0 billion (versus $43.3 billion in 1997).

The investigators said the number of persons with arthritis and other

rheumatic conditions is projected to increase steadily to nearly 67 million by

2030, so that the economic impact is likely to continue to grow.

Because the ability to prevent the onset of various types of arthritis is

limited, Dr. Yelin's team called for cost-effective efforts to decrease mean

medical expenditures and reduce unemployment. To accomplish this requires

greater use of underutilized interventions, such as self-management education

and

programs to increase physical activity, they concluded.

Primary source: Arthritis and Rheumatism - Yelin T al " Medical Care

Expenditures and Earnings Losses Among Persons With Arthritis and Other

Rheumatic

Conditions in 2003, and Comparisons With 1997 " Arthritis & Rheumatism 2007; 56:

1397-1407. © 2004-2007 MedPage Today, LLC. All Rights Reserved.

**************************************************

CALORIES, NOT CARBS, COUNT MOST FOR DIETERS

‘Glycemic load’ has no effect on average weight loss - Reuters

When it comes to losing weight, the number of calories you eat, rather than

the type of carbohydrates, may be what matters most, according to a new study.

The findings, published in the American Journal of Clinical Nutrition,

suggest that diets low in “glycemic load†are no better at taking the pounds

off

than more traditional — and more carbohydrate-friendly — approaches to

calorie-cutting.

The concept of glycemic load is based on the fact that different

carbohydrates have different effects on blood sugar. White bread and potatoes,

for

example, have a high glycemic index, which means they tend to cause a rapid

surge

in blood sugar. Other carbs, such as high-fiber cereals or beans, create a

more gradual change and are considered to have a low glycemic index.

The measurement of glycemic load takes things a step further by considering

not only an individual food’s glycemic index, but its total number of

carbohydrates. A sweet juicy piece of fruit might have a high glycemic index,

but is

low in calories and grams of carbohydrate. Therefore, it can fit into a diet

low in glycemic load.

However, the effort of figuring out what’s an allowable carb might not be

worth it, if the new study is any indication.

Principal investigator Dr. B. , of Tufts University, Boston,

and colleagues found that a reduced-calorie diet, whether glycemic load was high

or low, was effective in helping 34 overweight adults shed pounds over one

year.

Study participants who followed a low-glycemic-load diet ended up losing

roughly 8 percent of their initial weight, as did those who followed a

high-glycemic-load diet.

“The bottom line is that in this study we don’t see one single way to eat

that is better for weight loss on average,†told Reuters Health. Of

course, that doesn’t mean â€anything goes†as long as you’re cutting

calories.â€

A super-sized serving of French fries won’t do any dieter any good, she

noted.

Carefully controlled study

Both diets her team used in the study were carefully controlled. For the

first 6 months, participants were provided with all the food they needed, and

both diets were designed to cut their calories by 30 percent while providing

the recommended amount of fiber, limiting fat and encouraging healthy foods

like fruits and vegetables.

The comparable outcomes suggest that, among healthy diets, no single one

stands out as better, according to . So the focus should be on calories,

rather than specific foods to avoid or include.

“Focusing on calories is something we need more of, especially when portion

sizes are so absurd,†said, referring to the portions served at so

many U.S. restaurants.

This doesn’t mean, however, that there’s no place for diets that focus on

glycemic load, according to the researcher. Some studies, for example, have

found that low-glycemic index foods might help control blood sugar in people

with type 2 diabetes.

And in their own research, said she and her colleagues have found

that low-glycemic index diets do seem more effective for overweight people who

naturally secrete high levels of the hormone insulin, which regulates blood

sugar.

Copyright 2007 Reuters Limited. All rights reserved. © 2007 MSNBC.com

*************************************************

LOW FAT, VEGGIE-BASED DIET LOWERS CHOLESTEROL

By Amy Norton NEW YORK (Reuters Health)

Though low-fat diets have long been advocated for lowering high cholesterol

levels, a study published Monday points up the importance of replacing fatty

foods with nutritious fare -- not fat-free cookies and chips.

In a comparison of two low-fat diets -- one plant-based and one packed with

the convenience foods typical of the American diet -- researchers found that

the plant-based menu lead to greater reductions in study participants' LDL

cholesterol, the " bad " form of cholesterol linked to cardiovascular disease.

After four weeks, the 59 men and women who followed the vegetarian-style

diet saw their total cholesterol fall by an average of 18 points (that is,

milligrams per deciliter of blood) and their LDL drop by 14. That compared with

9

and 7 points, respectively, among 61 adults on the comparison diet.

According to the researchers, the findings underscore what experts now

generally believe about traditional dietary advice for cutting cholesterol: the

directive to go low-fat was overly simplistic.

It's thought that the advice led many people to opt for reduced-fat

processed foods, but not the fruits, vegetables and whole grains that can help

lower

cholesterol, according to lead study author Dr. D. Gardner of

Stanford University in California.

The simple avoid-fat message, he noted in an interview with Reuters Health,

has been changing in recent years to instead advise people on what foods to

favor -- including fruits, vegetables, beans, nuts and whole grains.

And these latest findings support that move, Gardner and his colleagues

report in the March 3rd issue of the ls of Internal Medicine.

Their study included 120 adults between the ages of 30 and 65 who had mildly

elevated LDL cholesterol. The two diets that participants were randomly

assigned to follow were both low in total fat -- 30 percent of daily calories --

and saturated fat, which was limited to 10 percent of calories. The diets were

also equal in their amounts of cholesterol, protein and carbohydrates.

Where they differed was in the food choices. One diet was made up of large

daily doses of whole grains like oats and brown rice, along with vegetables,

soy protein, fruit, beans and nuts. The saturated fat was provided by modest

amounts of butter, eggs and cheese.

The other diet, according to Gardner, was meant to emulate what the typical

American might eat when cutting fat: foods like skinless chicken, potatoes,

low-fat cheese and reduced-fat snack foods.

As mentioned, the vegetarian-style group showed total and LDL cholesterol

declines that were twice that of the other group after four weeks.

The benefits were not universal, as the researchers found great variation

from person to person in each group. Some people saw large declines in their

cholesterol levels, while a small number in each group showed increases.

Overall, however, the plant-based plan met with greater success.

The secret of the plant-based diet, Gardner said, does not come down to any

single food component. Instead, the benefit likely stems from the combination

of natural cholesterol-fighters found in such foods, including fiber and

so-called plant sterols -- cholesterol-lowering compounds that are now being

added to some margarines and juices expressly for that purpose.

But people need not go totally vegetarian to get a cholesterol benefit,

according to Gardner, who noted that simply avoiding meat does not make a diet

healthy. Instead, it's the inclusion of produce, beans, whole grains and nuts

that seems key.

" What we're talking about is moving toward a plant-based diet, " Gardner said.

The study serves up an " important reminder that diet, in addition to drugs,

can play a role in achieving cholesterol targets, " according to an editorial

published with the report

The findings should give an " injection of new enthusiasm " for using diet to

treat high cholesterol, write Dr. J.A. and colleagues at the

University of Toronto in Canada.

As far as the palatability of the diets used in the study, Gardner noted

that some people in the vegetarian group were initially skittish about such

" weird " items as soy burgers and vegetarian burritos -- but just as many people

in the conventional-diet group were at first " disappointed " with their

assignment.

In the end, he said, both groups gave generally high ratings to their diets.

SOURCE: ls of Internal Medicine , May 3, 2005.

Copyright © 2005 Reuters Limited. All rights reserved. © 1996-2005

MedicineNet, Inc. All rights reserved.

***************************************************

SATISFIED WITH YOUR MEDICAL? DON’T BE

Many people fear health care reform will make the situation even worse

COMMENTARY By Bazell, Chief science and health correspondent MSNBC.com

Do you think you are getting good medical care? Chances are, you do.

However, it may not be as good as you think.

In the debate over health care reform, certain ideas suddenly become quite

fashionable with pundits. A current notion is that most Americans are indeed

satisfied with their health care — or at least don’t want it to change

much.

The numbers support this notion. A poll conducted last October by the Kaiser

Family Foundation, ABC News and USA Today revealed that 89 percent of

Americans are personally satisfied with their health care.

Sure, everyone knows about the 45 million uninsured in the U.S., but three

times that many people do have health insurance.

Most people have heard the statistics that we pay ridiculously more for our

health than other industrialized countries (twice as much per person as

Germany, for example) and that our outcomes are far worse (the U.S. is 45th in

the

world in life expectancy, according to the Central Intelligence Agency's

World Factbook). We hear the numbers about the massive death rates from medical

errors in this country. And we all hate rising premiums and co-pays, and fear

losing our insurance.

Doing just fine, thank you

But when it comes to proposals to change the system, a “not in my backyardâ€

syndrome sets in. Most people believe things are personally " just fine,

thank you. " They fear systemic change might make the situation worse for them.

This head-in-the-sand denial is hindering meaningful reform of an ailing health

care system.

Even if people are satisfied with their own doctor and the care they

receive, there is plenty of evidence that health care in this country needs to

improve.

In medicine, unlike the automobile or appliance industries, a satisfied

customer is hardly the best indicator of a good product. That is certainly true

from the perspective of those who pay for the care, including taxpayers and

insurers. If someone complaining of mild chest pain arrives at the doctor and

gets a fancy $30,000 MRI that reveals no heart problems, he or she would likely

be thrilled. Never mind that a routine electrocardiogram — which costs a few

hundred dollars at most — and an antacid tablet might have accomplished the

same result.

It is not just a question of extra expense. Cancer patients who suffer the

horrible side effects of unneeded chemotherapy often believe their doctor saved

their life. How could they know the treatment was unnecessary?

You may come away from a doctor checkup feeling OK, but a survey by the RAND

Corporation, published in the New England Journal of Medicine in 2003,

revealed that almost half of Americans treated for common conditions were

receiving substandard care. The authors concluded their findings “pose serious

threats to the health of the American public.â€

Good medicine isn't easy

Developing good medicine isn't always easy.

A major fad of health care reform is called “Pay for Performance.†In

recent years several public and private groups, including the National Committee

for Quality Assurance, have been working to detail the basic standards of care

for hospitals, doctors and health insurance plans. The goal is to give

individuals and employers the tools to make wise decisions. The government

agency

that runs Medicare and Medicaid fully endorses the idea and has begun

providing financial incentives for hospitals that meet specific detailed goals.

Last

month the agency said it would pay doctors a 1.5 percent bonus for agreeing

to comply with the guidelines. Private insurers usually follow the agency’s

lead.

The guidelines are neither surprising, nor difficult. Offer influenza

vaccine and smoking-cessation advice. Get blood sugar, cholesterol and blood

pressure under control in diabetics. Take similar proven actions for other

conditions.

So far there's little evidence that “Pay for Performance†means better

care.

Just like the frequent examinations required by the No Child Left Behind law

can encourage teachers to “teach to the test†rather than educate the

students, “Pay for Performance†can yield unintended consequences. To get

the

extra pay, hospitals rush to comply with the guidelines. In an article last year

in the Journal of the American Medical Association (JAMA), Dr. Wachter

detailed how ridiculous it had become at his hospital, the University of

California, San Francisco Medical Center. Non-physician “case managers,†he

wrote, will question a doctor as to whether a patient with a severe infection or

a heart attack had smoking-cessation advice or a flu shot — even before they

get the treatment needed to save their lives.

A study last December in JAMA found no improvement in mortality at hospitals

that were best at meeting the guidelines.

The offer of a little extra cash for individual doctors to comply with the

guidelines is too new to see any results. It is likely that many doctors will

resent the extra paperwork and the intrusion on their prerogative to practice

medicine as they see fit.

Besides, why should doctors change if most Americans are still satisfied

with their care? Ultimately, the fear of losing insurance and the

ever-increasing premiums and co-pays will convince people we really aren’t

getting that

good of care and that we need change.

Unfortunately, we are not there yet.

*****************************************************

Good Health to All,

Jack

Newsletter Editor

Volume 7 - Issue No. 5

Publication No.120 - August 23, 2007

..

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