PSORIATIC ARTHRITIS MEDICAL NEWS

CAMPAIGN AIMS TO CHANGE DRUG LABELS
by Janelle Carter - The Associated Press WASHINGTON (AP) -

Boldly printed drug labels and a new education campaign is the cornerstone of
a plan by consumer advocates and the government to make over-the-counter
drugs more user-friendly.

The National Council on Patient Information and Education kicked off its new
``Be MedWise'' campaign Tuesday with help from the Food and Drug
Administration and other health organizations.

The campaign, which will include television and radio spots, coincides with
the government's changeover to new labels for these drugs.

Most over-the-counter drugs manufactured after May will carry the new
standardized ``Drug Facts'' label. The remainder of such drugs will comply by
2005. The FDA estimates that scores of medications are already carrying the
new label.

``The purpose was to create simplicity,'' said Dr. Linda Katz, deputy
director of FDA's division of Over-the-Counter Products. She added that the
new labels carry a larger print size to help consumers read the products. The
use of bullets, spacing between lines and clearly marked sections are other
changes aimed at improving readability.

``With this kind of labeling, one would hope consumers would be better
informed,'' Katz said.

Americans buy about five billion over-the-counter drugs each year to treat
routine health problems, the FDA estimates. The number has increased as more
and more drugs have made the switch from prescription to over-the-counter
status.

But according to government studies, many Americans - particularly senior
citizens - misuse over-the-counter drugs because the lettering is too small.
Consumers have also complained that words like ``indications,'' and
``precautions'' are too technical and confusing, the FDA said.

The lack of understanding is keeping consumers from using nonprescription
drugs correctly, officials said. A survey conducted by the National Council
on Patient Information and Education found that 69 percent of adults take
more than the recommended dose at a single time while 63 percent take the
next dose sooner than directed. About 44 percent of those surveyed took more
than the recommended number of doses in a day.

Currently, FDA requires over-the-counter drug labels to include all the
information consumers need for safe and effective use. Still, the information
often appears in different places on the label depending on the brand.

Under the new rule, the words ``Drug Facts'' appear in bold large print at
the top of the label. The following must appear in order, usually on a
package's outside container or wrapper:

The product's active ingredients, including the amount in each dosage unit;

The purpose of the medication;

The uses/indications for the drug;

Specific warnings, including when a product should not be used under any
circumstances and when it is appropriate to consult with a doctor or
pharmacist. The warnings section also describes side effects that could occur
and substances or activities to avoid;

Dosage instructions addressing when, how and how often to take medication;

The product's inactive ingredients, which is important information for those
with specific allergies.
Copyright 2002 The Associated Press.

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GENE THERAPY FOR RHEUMATOID ARTHRITIS PROMISING IN EARLY TRIALS
-Frankfurt, Germany (Reuters Health)

Preliminary research into a gene therapy treatment for rheumatoid arthritis
has yielded promising results, indicating that it might be possible to
develop anti-inflammatory injections that need to be given just once every
few months, German researchers report.

Dr. Axel Baltzer, of the University Hospital in Dusseldorf, told Reuters
Health that phase I clinical trials of the gene therapy confirmed that the
treatment has no serious side effects and that this method to treat joint
diseases is feasible.

"We can show that this is a method will enable us to give long-term treatment
of rheumatoid arthritis with just one injection," he said.

The developer of the treatment is Dr. C. H. Evans of Harvard Medical School
in Boston, Massachusetts. Dr. Evans and colleagues in the US conducted phase
I research on nine patients, while in German phase one research has thus far
been done on three patients by Dr. Baltzer and Dr. Peter Wehling, now
operating a biotech company in Dusseldorf.

Dr. Baltzer said research on the 12 patients, all with advanced rheumatoid
arthritis, followed the same basic procedure. Cells were drawn from an
arthritic joint, cultured, and transduced to produce the anti-inflammatory
protein interleukin-1 receptor antagonist.

After a few weeks of culturing, a solution of treated cells was injected into
two joints. In the placebo-controlled study, one additional joint was
injected with non-treated cells and one joint injected with a saline
solution.

In the US, patients participating in the study had already been slated for
joint replacements. The injections were given four weeks before replacement
surgery, and were producing the desired anti-inflammatory protein effectively
for at least 4 weeks, Dr. Baltzer said. In Germany, the injection was shown
to be effective for six weeks, until all transduced tissues were resected. In
both the US and Germany, the treatment resulted in some patients with pain
relief of a few months, he said.

Dr. Baltzer said the researchers will publish study results within the next
few months and hope to begin phase II studies this year.

"This could be the first step in finding a cure for rheumatoid arthritis," he
said. "But right now our goal is to find a way to help people suffering from
rheumatoid arthritis for an extended period of time with just one injection."

Copyright © 2001 Reuters Ltd. All rights reserved.

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HOW DO DRUGS GET TO MARKET? By Harold J. DeMonaco, M.S. Massachusetts
General Hospital

Ever wonder how a new prescription drug makes it to market? Well, the U.S.
Food and Drug Administration (FDA) have thought a lot about that and have a
well-orchestrated process for drug companies to follow.

Pharmaceutical companies develop new drugs in a very systematic way, at least
at the outset. Because we know a good deal about many diseases right down to
the molecular level, we can use computer modeling to design drugs to work in
very specific ways. So, if the drug company is interested in developing drugs
to treat heart disease (angina, for example), they can design drugs that
will, at least theoretically, act directly where they want them to.

For example, we know that people with angina have a problem with blood flow
to the heart muscle. This reduced blood flow is caused by cholesterol buildup
in and/or an abnormal, abrupt narrowing of the blood vessels that supply the
heart (called coronary artery vasospasm). We know that by blocking some
enzymes or enhancing the effects of others we can change the way blood
vessels work. Drug companies use this kind of information to design new
drugs.

Some new drugs aren't designed but are found in nature. For example, in 1958
the National Cancer Institute began a screening program of 35,000 plants,
looking for anticancer agents. In the bark of the Pacific yew tree
researchers found a substance that is now a drug called paclitaxel (also
known as Taxol), used in the treatment of breast, ovarian and lung cancer.

And just plain old luck sometimes leads to drug discoveries. The
anticonvulsant valproic acid (also known as Depakote and Depakene) was
discovered quite by accident - it was being used as a solvent for another
drug being tested.

Once a drug is identified and purified, it is tested in animals. These early
tests are used to see if the drug does what we think it should do and if it
is safe. Many people have questioned the need for this kind of testing, but
it is essential, at least at the moment, because as good as our understanding
of disease is, there are always surprises. Computer models aren't foolproof
and only testing in living systems (like animals or humans) can give
definitive answers. Testing new drugs for their ability to produce birth
defects is also done in these early animal studies.

If the drug seems to work and seems like it is safe in the animal tests, the
drug company applies to the FDA for approval for testing in humans. The
approval is called an Investigational New Drug Exemption and allows the drug
company to test the drug under a specified set of conditions. The testing is
done in very structured phases, each designed to answer different questions.

Phase 1 - These studies help define the dose of the new drug and its toxicity
(negative effects). Phase 1 studies test the drug for the first time in a
small group of volunteers to ensure safety of the drug.
Phase 2 - These studies further define the safety and evaluate the
effectiveness of the new drug in a larger group of patients with a particular
disease or disorder.
Phase 3 - These studies are carefully designed to show that the drug works as
intended, has a low incidence of toxicity and can be taken safely by
patients. The testing is done in a larger group of volunteers and compares
drug's effectiveness with that of other treatments being used.
Phase 4 - This phase of testing occurs after the drug already has been
approved for use and is being prescribed to the general population. These
studies continue to monitor the effects of the drug, along with any side
effects, that occur with long-term use.
If a new drug makes it through all of the required Phase 3 testing, drug
companies can apply to the FDA to obtain market approval. This process is
called a New Drug Application . The time period from discovery to the NDA can
be as short as three to five years or as long as decades, with recently
estimated drug company costs of up to $500 million. Only a small minority of
drugs actually make it to the NDA step. Most drugs tested fail to live up to
expectations somewhere in the process.

The FDA relies on volunteer medical specialists to review the NDAs in
addition to career scientists in the agency itself. The volunteers serve on
scientific advisory committees that make recommendations to the FDA on drug
approvals. The actual approval of the drug is made by a dedicated group of
scientists at the FDA.

It is important to remember that the testing of new drugs is done on no more
than a couple of thousand research subjects and under very controlled
settings. Only when used in large numbers of patients will the true value of
a new drug be realized. Regardless of how testing is done, the true risks and
benefits of a new drug can be seen only after months, if not years, of use.

Harold J. DeMonaco, M.S. is the director of Drug Therapy Management and the
chair of the Human Research Committee at the Massachusetts General Hospital.
He is author of over 20 publications in the pharmacy and medical literature
and routinely reviews manuscript submissions for eight medical journals.

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LYME DISEASE REPORTS HIT NEW HIGH .c The Associated Press - 2002

ATLANTA (AP) - Reported cases of Lyme disease, the tick-borne illness that
can cause fatigue, sore joints and heart damage, climbed to a record high in
2000, the government reported Thursday.

The Centers for Disease Control and Prevention said it recorded 17,730 cases,
up 8 percent from 1999. The disease was found in 44 states and the District
of Columbia, with six states Lyme-free.

Lyme cases nearly doubled in the 1990s, in part because more Americans built
homes in the woods, exposing themselves to ticks, according to the CDC.

The disease causes fatigue, fever and joint pain that can persist for weeks,
and some patients develop severe arthritis. Lyme disease also can badly
damage the heart and nervous system if it goes untreated by antibiotics.

Daily tick checks, vaccinations and insect repellent are recommended as
preventive measures.

In 2000, 95 percent of Lyme cases reported to CDC came from just 12 states,
almost all of them in the Northeast. Copyright 2002 The Associated Press

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BODY'S DEFENDER GOES ON THE ATTACK - By Mary Duenwald

The slightest provocation - a mosquito bite, a mild sunburn, a tiny splinter
- the body mounts a hair-trigger defense, sending cells and natural chemicals
to destroy dirt or germs and repair the damage. As a result, the site of
injury becomes red, swollen, warm and painful - inflamed.

Inflammation happens so frequently that people often do not even notice it.
And it occurs not only on the skin, but internally too, when viruses invade
the body or the stomach is irritated by spoiled food. It is the body's
fundamental way of protecting itself.

In the long run, however, inflammation can harm the very tissues it is meant
to heal. Its destructive side has long been evident in diseases like
rheumatoid arthritis, in which inflammation cripples the joints, and multiple
sclerosis, in which it destroys the insulation surrounding nerve fibers.

But now scientists are coming to realize that inflammation may underlie many
other common chronic diseases that come with aging, including
atherosclerosis, diabetes, Alzheimer's disease and osteoporosis. Inflammation
is also implicated in asthma, cirrhosis of the liver, some bowel disorders,
psoriasis, meningitis, cystic fibrosis and even cancer. "It's beginning to
look as if getting old and ultimately wearing down and dying are tied
inextricably with the defense mechanism that keeps you alive and in good
repair when you're younger," said Dr. Russell Tracy, a professor of pathology
and biochemistry at the University of Vermont.

The reason may reach far back into human history, to the hunter-gatherers who
lived in peril of infections and injuries. Natural selection would have
favored those with a vigorous inflammatory response and few would have lived
long enough to suffer the long-term consequences.

"It is possible that the adaptive pattern of an earlier time has resulted in
a maladaptive response in our modern environment," said Dr. Paul M. Ridker,
director of the Center for Cardiovascular Disease Prevention at Brigham and
Women's Hospital in Boston.

By studying inflammation, medical scientists hope ultimately to find new ways
of treating a variety of chronic illnesses. What goes on inside the arteries
has been a particular area of interest.

For most of the 20th century, doctors thought of blood vessels as a simple
network of pipes - a plumbing system that could become clogged by the
accumulation of cholesterol. "It was really a hydraulic, nonbiological view,"
said Dr. Peter Libby, chief of cardiovascular medicine at Brigham and Women's
Hospital.

According to this view, if cholesterol deposits grew too large, there would
not be enough room left for blood to flow, and the patient would begin to fee
l chest pains. If a coronary artery became entirely plugged, the person would
suffer a heart attack.

But severe blockages, it turns out, cause at most three out of 10 heart
attacks. The rest occur in people whose blood is flowing freely, through
arteries narrowed by less than half their capacity. These lesser blockages a
re usually found in people who die of heart attacks relatively young, in
their 40's or 50's. For these deaths, doctors needed a new explanation.

Inflammation had been a suspect as early as the mid-1800's, when Dr. Rudolph
Virchow, a German pathologist, suggested that injured and inflamed arteries
might cause heart attacks. The idea was revived, briefly, in the mid-20th
century, but was little noticed as doctors focused on low-fat diets and
cholesterol-reducing drugs. The cholesterol therapies were effective - but
still, half of all heart attacks and strokes were happening in people with
normal cholesterol levels.

By the 1980's, cardiologists were re-examining inflammation. For example, Dr.
Libby took cells from the arteries of rabbits and irritated them with a
bacterial toxin. Sure enough, the artery cells began releasing proteins
called cytokines, which promote inflammation.

Gradually, researchers put together a new narrative for heart attacks and
strokes: immune-system cells that cause inflammation burrow into the artery
wall and begin gobbling up droplets of fat. These fat- filled cells form a
plaque and inflammation thins its fibrous cap. Eventually, the cap ruptures,
and the plaque's contents spill into the bloodstream - along with
pro-inflammatory cytokines, which encourage clotting. Suddenly, the artery
fills with a cloud of rapidly coagulating blood cells. If the cloud is large
enough, it forms a clot that blocks the artery and causes a heart attack or
stroke.

"This is an idea that has emerged in a popular way in only the last few
years," Dr. Libby said. "The blood vessel is a living, breathing organ. And
the plaque is not just a graveyard for cholesterol debris; it's teeming with
cells."

A primary goal for heart attack prevention, Dr. Libby and others say, should
be to keep inflammation to a minimum.

Cardiologists have found a new way to assess a person's risk of
atherosclerosis: they measure a substance in the blood called C-reactive
protein, a marker of inflammatory activity. Two large studies - one in men
and one in women - have demonstrated that the higher a person's C-reactive
protein level, the greater the risk of a heart attack or stroke.

Doctors nationwide are adding the C.R.P. test to cholesterol screening to
assess people's risk of atherosclerosis. (President Bush had his C- reactive
protein level checked in August; it was low.)

"The things that lower C.R.P. levels include diet, exercise and smoking
cessation," Dr. Ridker said - strategies long known to cut heart attack risk.

Studies have shown that statin drugs, prescribed to lower cholesterol, can
also lower C.R.P. This research raises the tantalizing possibility that
statins may be used to prevent heart attacks even in people whose cholesterol
levels are normal. But Dr. Ridker cautioned that the evidence was still too
preliminary to warrant such use of statins.

He said he hoped soon to launch a nationwide study of statins in people with
low cholesterol but high C-reactive protein levels.

Inflammation may also be important in diabetes. Dr. Ridker and others have
found that elevated C.R.P. levels are associated with a higher- than-average
risk of developing Type 2 diabetes - the kind that occurs in adults.

In diabetes, excess body fat - a major risk factor for the disease - may be
part of the inflammatory picture. Fat cells produce cytokines, the proteins
that promote inflammation. Studies have shown that people who develop Type 2
diabetes have relatively high levels of these cytokines. Researchers think
the cytokines may interfere with the body's ability to use its own insulin,
thus bringing on diabetes.

In osteoporosis, the same cytokines seem to accelerate the rate at which bone
is broken down. The disease often arises in women after menopause, when
estrogen levels drop. Dr. Sundeep Khosla, an endocrinologist at the Mayo
Clinic in Rochester, Minn., said estrogen protected against bone loss by
decreasing the production of cytokines. When estrogen declines, cytokine
levels rise, and bone is lost.

In Alzheimer's disease, inflammation happens in and around the protein
deposits - known as amyloid plaques - that accumulate in the brain. For many
years, doctors thought that this inflammation was caused by the plaques. But
studies have shown that cytokines help create the plaques in the first place.

"Inflammation is directly damaging neurons," said Dr. Paul Aisen, a professor
of neurology at Georgetown University Medical Center.

Asthma, too, is an inflammatory disease. Doctors have known this for more
than a decade, and commonly prescribe anti-inflammatory steroids to help
prevent asthma attacks. Still, as is true for Alzheimer's disease,
osteoporosis and diabetes, the exact ways in which inflammation promotes
asthma have yet to be worked out.

Inflammation is even believed to be a player in cancer. Tumors spread by
commandeering the body's inflammatory mechanisms. Cancer cells dig into
neighboring tissue in essentially the same way that inflammatory cells invade
the lining of arteries, Dr. Libby said. Inflammation is also involved in
angiogenesis, the growth of small blood vessels that support tumors.

Researchers say it is important to find out what causes inflammation to begin
with. In asthma, it appears to be airborne allergens like dust mites and cat
dander. But in other diseases, the trigger is harder to discern.

In atherosclerosis, many scientists believe that oxidized fat droplets,
circulating in the bloodstream, irritate the artery wall. Some suspect
certain viruses or bacteria.

Many studies have suggested that some common viral and bacterial infections
increase the risk of heart disease. The suspect bugs include Herpes Simplex
1, a virus that causes cold sores; cytomegalovirus, which typically causes no
symptoms; the bacteria involved in gum disease; H. pylori, which causes
stomach ulcers; and Chlamydia pneumoniae, which causes bronchitis and
pneumonia. Chlamydia has been found in many arterial plaques.

Yet it is not clear that any of these infections directly irritate the artery
walls. Dr. Tracy and other experts speculate that infections may play only an
indirect role, by heightening the body's inflammatory response.

In the same way, Dr. Tracy said, smoking, obesity and arthritis can also
crank up inflammation. Obesity promotes inflammation because fat cells
produce cytokines. In a recent Italian study, a group of obese women were
able to significantly lower their cytokine levels by losing 10 percent of
their body fat.

The idea that bacteria are not directly involved in atherosclerosis may
explain why studies so far have failed to show that taking antibiotics can
reduce a person's risk of heart attacks. But some anti-inflammatory drugs do
seem to make a difference.

ACE inhibitors, drugs commonly used to treat high blood pressure, also appear
to reduce inflammation. The drugs help prevent heart attacks, strokes and the
complications of diabetes, possibly because they block the action of
angiotensin, a protein that not only constricts blood vessels but also seems
to promote inflammation.

Many other anti-inflammatory drugs exist. The most familiar is aspirin,
already taken daily by many people to help prevent second heart attacks. Dr.
Ridker's studies show that aspirin works best at preventing heart attacks in
people with high C- reactive protein levels.

Scientists are searching for new anti-inflammatory drugs, and also hope to
learn why some people seem more susceptible to inflammation than others.
Lifestyle almost certainly plays a role, but genes may, too.

"Inflammation in general may provide us with a whole series of new targets
for therapy that will treat and prevent diseases in ways we previously had
not thought of," Dr. Ridker said. "That makes medical research awfully
exciting right now.
Copyright 2002 The New York Times Company

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The following is our sixth in an ongoing series about less common forms of
arthritis.

POLYMYALGIA RHEUMATICA

The term polymyalgia comes from the Greek poly(many), myo (muscle) and
algia(pain). This condition causes pain in the muscles of the lower back,
thighs, hips, neck, shoulder and upper arms, as well as in other parts of the
body. The rare condition arises when the synovium (the membrane that
surrounds the joints, bursa and tendons near the shoulders and hips) becomes
inflamed. Typically, polymyalgia rheumatica affects people older than 50,
with more women affected than men. Left untreated, it can lead to stiffness
and significant disability. In some cases, though, symptoms do not advance
and may even dissipate in a few years. In a minority of cases, polymyalgia
rheumatica is associated with giant cell arteritis, a condition in which
blood vessels in the neck and head (and sometimes elsewhere) are inflamed.

Your doctor will diagnose this condition based on a physical examination
coupled with your description of your symptoms. With polymyalgia rheumatica,
the pain may come on suddenly either in the lower back, hips and thighs or
around the shoulder and neck areas and is typically worse in the morning.
Certain symptoms, such as headache, jaw pain with chewing or high fever may
suggest the presence of giant cell arteritis. The erythrocyte sedimentation
rate (ESR), a measure of body-wide inflammation, is commonly elevated in
polymyalgia rheumatica and may be helpful for diagnosis and to recheck during
treatment.

Most often, polymyalgia rheumatica will run its course within several years.
In the meantime, noninflammatory agents (frequently in the form of low-dose
prednisone) and physical therapy may be helpful in controlling the
discomfort. The treatment may change if signs of giant cell arteritis
develop. High-dose (rather than low-dose) corticosteroids are advised for
giant cell arteritis to prevent blindness or other complications.

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HEART MAY BE ABLE TO REPAIR ITSELF - (The Associated Press)

Challenging generations of medical lore, researchers have found striking new
evidence that the human heart can repair itself.

Doctors have long assumed that damage from a heart attack or other ailment is
irreversible and that the heart cannot regenerate tissue the way other organs
can. But that belief has been shaken by recent research.

A team of American and Italian researchers demonstrated last year that heart
muscle cells multiply after a heart attack. Now they have shown that in heart
transplant patients, primitive cells from the patient travel to the new heart
and grow new muscle and blood vessels.

The researchers studied men who received transplanted hearts from women, and
discovered male cells in the donated female hearts.

The discovery could help scientists eventually devise treatments to fix bad
hearts.

"There have been hints from animal studies that the cells could migrate
before, but this is the first demonstration in a human that it is actually
possible," said John Fakunding of the National Heart, Lung and Blood
Institute, which helped pay for the study in Thursday's New England Journal
of Medicine.

The researchers found that heart muscle and blood vessels grew rapidly in the
new hearts after transplant. They calculated that as much as one-fifth of the
donor heart had been rebuilt by the recipient's own cells.

"Clearly this shows that the heart has the ability to regenerate," said Dr.
Roberto Bolli of the University of Louisville, who wrote an accompanying
editorial. "It could be a milestone discovery if we learn how to exploit this
phenomenon for therapeutic purposes to regenerate heart muscle in patients
with heart failure."

The researchers looked for the male Y chromosome in eight female hearts that
were transplanted into men. After the heart recipients died, tissue samples
were taken from each donor heart and from remnants of the old heart not
removed during transplant surgery.

The researchers found evidence of the primitive cells with stem cell
characteristics in the remnants of the old hearts, as well as in the donor
hearts. The primitive cells from the recipient could also have come through
the patient's bloodstream.

"We have the first strong suggestions that the heart has primitive cells -
meaning cardiac stem cells - which could be used in the future to repair the
heart," said Dr. Piero Anversa, who led the researchers at New York Medical
College in Valhalla, N.Y., and the University of Udine and the University of
Parma in Italy.

Stem cells are master cells that transform themselves into certain types of
tissue, such as muscle, skin or bone. Doctors believe stem cells could one
day be used to replace or fix failing organs.

Anversa said he and his colleagues are working to identify whether a cardiac
stem cell exists and whether it can be manipulated to promote heart repair.
"This is the work that we will be doing for the next couple of years," he
said.

In the meantime, Anversa said his belief that the heart can repair itself is
slowly gaining acceptance. "I think it is going to be more and more difficult
to challenge us." he said. Copyright 2002 The Associated Press

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Here in the United States the January and February blahs are almost over -
THINK SPRING !!!!!!!!!

Good health to all.

Jack Nicholas - Editor
Cornishpro@aol.com
Issue 2002 - 02/18/02 - 4