PSORIATIC ARTHRITIS NEWSLETTER NO. 78

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PSORIATIC ARTHRITIS NEWS AND VIEWS

VOLUME- 4 ISSUE- 20

December 31, 2004

PSORIATIC ARTHRITIS MEDICAL NEWS

TWO NEW PSORIASIS TREATMENTS COMING SOON?

Two New Psoriasis Treatments May Be Ready for Human Testing

Dec. 16 (HealthDayNews) -- Two separate approaches to treating psoriasis, a

painful condition that attacks the skin, have shown promise in the lab and may

be ready to try on humans.

The first is an experimental drug called benzodiazepine-423 (Bz-423) that is

a chemical cousin of the anti-anxiety drugs Valium and Xanax, a new

University of Michigan study finds.

In human skin cultures designed to model psoriasis, the researchers found

that Bz-423 suppressed cell growth. Psoriasis is characterized by unchecked cell

growth.

" Currently, the best treatments for skin lesions associated with psoriasis

are topical steroids, but the problem with those drugs is that they're not

selective for the disease-causing cells. They affect normal cells as well, and

repeated use over time can lead to tissue destruction, " Glick, a professor

of biological chemistry, said in a prepared statement.

" What makes our compound particularly exciting is that it has the potential

to be applied topically, and it shows very good selectivity for models of the

disease-causing cells versus normal cells. So we believe the problems

associated with repeated topical steroid use could possibly be alleviated with

compounds like this, " Glick said.

He and his colleagues hope to begin human clinical trials with Bz-423 in the

near future.

Glick is a shareholder in GMP Immunotherapies Inc., which signed an

exclusive patent license and a sponsored research agreement with the University

of

Michigan to develop Bz-423 and other compounds.

The second study goes to the cause of psoriasis itself. A Dec. 12 news

release from The University of Texas M.D. Cancer Center in Houston says

scientists have identified a protein called STAT3 that initiates psoriasis when

the body's immune system is activated to fight off a wound, burn or some

other invasion.

The scientists actually developed a skin cream that cured the itching,

redness and scaling that psoriasis caused in the study mice. The ointment can

also

prevent recurrence, they said.

DiGiovanni, Ph.D., the study's lead investigator and director of M.D.

's Department of Carcinogenesis, said in the news release, " We may have

found an entirely new treatment option for psoriasis. " The study appears in

the January 2005 issue of the journal Nature Medicine.

Until now, the cause of psoriasis has remained a mystery. According to the

news release, patches of skin that become inflamed are most often the scalp,

elbows, knees, and lower back. Treatments have been most effective in slowing

down its progress, but nothing exists to cure psoriasis, DiGiovanni says.

" We may have found the link - the change in keratinocytes [skin cells that

make keratin, the substance that comprises hair, nails and skin] that

cooperates with the immune system cells necessary for development of human

psoriasis. "

Preidt - SOURCES: University of Michigan, news release, December

2004; news release, The University of Texas M.D. Cancer Center,

Houston,

Dec. 12, 2004 - Copyright © 2004 ScoutNews LLC.

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SHOVEL SNOW SAFELY

Experts list precautions you can take before you tackle this winter chore

Dec. 11 (HealthDayNews) -- Shoveling snow can be more than a chore; it can

be a health hazard if you don't take some basic precautions, warns the Canadian

Physiotherapy Association (CPA).

Back injuries, muscle strains, hypothermia and heart attack are among the

potential dangers. The CPA offers the following advice for safe shoveling:

Before you start shoveling, take time to warm up and stretch your muscles.

Warm, relaxed muscles are less likely to suffer strains than cold, tight

muscles.

Choose the right shovel. A shovel's handle length is right for you when you

can slightly bend your knees, bend forward 10 degrees or less, and hold the

shovel comfortably in your hands as you begin a shovel stroke. A plastic shovel

blade is lighter than a metal one, so it puts less strain on your back.

Ergonomic shovels with a bent shaft are better than straight shaft shovels.

When you hold the shovel, keep your hands at least 12 inches apart. This

increases your leverage and reduces the strain on your body.

When you lift snow, squat with your legs apart, bend your knees and keep

your back straight. Make sure to lift with your legs and don't bend at the

waist. Scoop up small amounts of snow and walk to where you want to dump it.

Spraying a lubricant or silicone on your shovel will help prevent snow from

clinging to it.

Step in the direction that you're throwing the snow. This will prevent

twisting in your low back.

If there's heavy snow, tackle it in two stages. First, skim off the top

layer and then remove the bottom layer. Don't overload your shovel. If you can't

say a long sentence in a single breath, you're working too hard. Take a break

or reduce the intensity of effort.

Take plenty of breaks while you shovel. Every so often, stand up straight

and walk around to extend the lower back. Place your hands on the back of your

hips and bend backwards slightly for several seconds.

Dress properly. Wear mitts, not gloves. Dress in layers. The inner layers of

clothing should be made of material that wicks perspiration away from your

body. Don't wear cotton. It traps moisture close to your body. Outer layers

should be windproof and water-resistant. Wear a scarf and hat to reduce heat

loss. Your footwear should have good treads that will prevent slips or falls.

If you have any health problems or are in poor shape, don't shovel. Before

winter, arrange for someone to clear the snow off your driveway and sidewalks.

Preidt - SOURCE: Canadian Physiotherapy Association, news release,

December 2004 Copyright © 2004 ScoutNews LLC.

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MORE EVIDENCE OF INFLAMMATION’S ROLE IN HEART DISEASE

Even infection can have inflammatory effect on blood vessels, research finds

By Ed Edelson - HealthDay Reporter

Dec. 15 - Two studies an ocean apart illustrate the growing importance of

inflammation as a contributor to heart attack, stroke and other cardiovascular

diseases.

In the United States, researchers at the Harvard School of Public Health

report that blood levels of C-reactive protein, a molecular marker of

inflammation, rank with cholesterol levels as indicators of future coronary

heart

disease.

And in England, researchers at the London School of Hygiene and Tropical

Medicine report that an ordinary infection -- such as the flu -- may raise the

risk of heart attack or stroke over the next few days because of an

inflammatory effect on blood vessels.

Both studies appear in the Dec. 16 issue of the New England Journal of

Medicine.

Inflammation is the process by which the body responds to injury or

infection. Laboratory evidence and results from clinical and population studies

suggest that inflammation is important in atherosclerosis, the process by which

fatty deposits build up in the lining of arteries, according to the American

Heart Association.

The British study was undertaken because inflammation is known to play a

long-term role in cardiovascular disease, said study author Liam Smeeth, a

senior lecturer in epidemiology.

The idea that an infection could have an immediate damaging effect on the

endothelium, the delicate lining of the blood vessels, came from laboratory work

done by Dr. Valliance of University College London, Smeeth said. So,

the British researchers looked at the record of infections reported by

nearly 40,000 people who had had a stroke or heart attack.

" The risk of both events were substantially higher after a diagnosis of

systemic respiratory tract infection and were highest in the first three days, "

the researchers reported. Urinary tract infections also raised the risk, but to

a lesser extent, the study found.

There was one bit of good news: Getting vaccinated against influenza,

tetanus or pneumonia did not increase the risk of a cardiovascular event, as the

researchers suspected might happen.

" Either it [vaccination] produces no inflammatory effect or it has an effect

only in a subgroup of people, " Smeeth said. " That is reassuring news. "

The Harvard report used data from two studies that have been following more

than 120,000 health professionals, male and female, for many years. They

underwent a large number of blood tests, including markers of inflammation, at

the start of the study. The researchers looked at those levels in the 239 women

and 265 men who had heart attacks or died of heart disease over the next six

to eight years.

A high level of C-reactive protein -- more than 3 milligrams per liter of

blood -- increased the risk of such an event by nearly 70 percent, compared to a

reading lower than 1 milligram per liter, after adjusting for the presence

of two other risk factors, diabetes and high blood pressure, the researchers

found.

Blood levels of cholesterol and other lipids were stronger predictors of

trouble, but " the level of C-reactive protein remained a significant contributor

to the prediction of coronary heart disease, " they reported.

Right now, measuring blood levels of C-reactive protein are " supplementary

to measuring traditional risk factors, " such as cholesterol, blood pressure and

obesity, said Dr. Nieca Goldberg, chief of women's cardiac care at Lenox

Hill Hospital in New York City, and a spokeswoman for the American Heart

Association.

" There are individuals in whom we would want to measure C-reactive protein,

such as those who have coronary disease but no other risk factors and those at

borderline or intermediate risk, " she said. " But we are not at the point

where we would use it as the sole determinant of risk. "

K. Pai, a research associate at the Harvard School of Public Health

and lead author of the journal report, said she agreed with that assessment.

" Using it [C-reactive protein levels] in conjunction with these other risk

factors probably would be best, " Pai said.

SOURCES: Liam Smeeth, PhD, senior lecturer, epidemiology, London School of

Hygiene and Tropical Medicine, England; Nieca Goldberg, M.D., chief, women's

cardiac care, Lenox Hill Hospital, New York City; K. Pai, Sc.D,

research associate, Harvard School of Public Health, Boston; Dec. 16, 2004, New

England Journal of Medicine Copyright © 2004 ScoutNews LLC.

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PSORIATIC ARTHRITIS DRUG HUMIRA SUBMITTED FOR U.S. AND EUROPEAN APPROVAL

News release dated December 17, 2004, and thanks to Szczygiel for

sending this in.

Abbott Laboratories today announced it has simultaneously submitted a

supplemental Biologics License Application (sBLA) with the U.S. Food and Drug

Administration (FDA) and a Marketing Authorization Application (MAA) to the

European Medicines Agency (EMEA) seeking approval to market HUMIRA®

(adalimumab)

for psoriatic arthritis, an autoimmune disorder that combines symptoms of

psoriasis, such as dry, scaly skin with arthritis symptoms, including joint

pain

and inflammation.

The filings are based on two placebo-controlled studies, including data from

the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), a Phase

III clinical trial showing patients on HUMIRA achieved significant improvement

in both arthritic and psoriatic signs and symptoms. Results from the ADEPT

trial were recently reported at the American College of Rheumatology congress

in San , Texas, in October.

" HUMIRA has been an effective treatment for people with rheumatoid arthritis

and our research shows great promise for treating psoriatic arthritis and

other inflammatory autoimmune conditions, " said Aruffo, Ph.D.,

president, Abbott Bioresearch Center and Immunoscience Development Center,

Abbott.

" This is encouraging news for the millions of people afflicted with such

diseases worldwide. Abbott will continue to research the potential of HUMIRA and

other compounds as part of our commitment to use scientific innovation to

address major unmet medical needs. "

HUMIRA is currently approved by the FDA and the EMEA for the treatment of

moderate to severe rheumatoid arthritis (RA) in adult patients when the response

to disease-modifying antirheumatic drugs (DMARDs), including methotrexate,

has been inadequate.

" This news is encouraging for psoriatic arthritis patients and for the

dermatologists and rheumatologists who have limited therapeutic options for

treating this difficult disease, " said Philip Mease, M.D., lead study

investigator,

Swedish Medical Center and University of Washington School of Medicine,

Seattle. " The HUMIRA data shows patients experienced significant relief from

joint symptoms along with marked improvement in skin symptoms. Among those with

significant psoriasis, about seven out of 10 patients achieved clear or almost

clear skin. "

About the ADEPT Trial

The placebo-controlled, double-blind study assessed the efficacy and

tolerability of HUMIRA in 313 adults with active psoriatic arthritis (defined as

three or more swollen joints and three or more tender joints) who had an

inadequate response to therapy with nonsteroidal anti-inflammatory drugs

(NSAIDs).

Patients received placebo or 40 mg of HUMIRA administered subcutaneously every

other week, the same dose as the RA indication.

The study found that patients' psoriatic arthritis skin symptoms showed a

significant response to HUMIRA. Of the 69 patients with greater than three

percent of body surface involvement who were treated with HUMIRA, 42 percent

achieved a PASI 90 response at 24 weeks, which reflects at least a 90 percent

improvement in psoriasis symptoms assessed by the Psoriasis Area and Severity

Index (PASI). Nearly one-third of patients achieved a PASI 90 by week 12, which

was maintained through the study.

Patients' arthritic symptoms exhibited a rapid response to HUMIRA, with

nearly 60 percent of patients achieving ACR20 at week 12, one of the study's

primary endpoints, and sustaining response through week 24. American College of

Rheumatology (ACR) scores measure the percentage of improvement in tender and

swollen joint count and other clinical measures. At the 24-week follow-up,

nearly one-fourth of these patients achieved ACR70, which means patients had a

70 percent improvement in arthritis signs and symptoms.

The rates of adverse events and serious adverse events in the study were

comparable between HUMIRA and placebo. Among patients taking HUMIRA, the most

common adverse events (those affecting at least five percent of patients) were

upper respiratory infection, nasopharyngitis, injection site reaction,

headache and hypertension. The safety profile of HUMIRA in the psoriatic

arthritis

population was similar to that observed with HUMIRA in the rheumatoid

arthritis population.

About Psoriatic Arthritis

Psoriatic arthritis is an autoimmune disorder that combines symptoms of

psoriasis, such as dry, scaly skin and patches of red, raised skin known as

plaques, with arthritis symptoms including joint pain and inflammation. Common

symptoms of psoriatic arthritis include varying degrees of psoriasis activity

along with stiffness, pain, swelling and tenderness of the joints, which can

lead to a reduced range of motion and potential severe joint destruction.

Left untreated, psoriatic arthritis can be a progressively disabling

disease. The arthritic manifestations often include debilitating disease of the

hands and feet, as seen in rheumatoid arthritis; as well as painful inflammation

of the tendon insertions, tendonitis and arthritis of the spine. Psoriatic

arthritis is most often found in patients who suffer from psoriasis, a chronic

skin disease that affects nearly three percent of the world's population. It

is estimated that up to 30 percent of people with psoriasis also develop

psoriatic arthritis.

Like rheumatoid arthritis, psoriatic arthritis is an autoimmune disorder in

which a human protein, tumor necrosis factor-alpha (TNF-á), has been suggested

to play a role in disease development. HUMIRA, which is a fully human

monoclonal antibody that resembles antibodies normally found in the body, works

by

specifically blocking TNF-á.

Important Safety Information

Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA.

Serious infections and sepsis, including fatalities, have been reported with

the use of TNF-blocking agents, including HUMIRA. Many of these infections

occurred in patients also taking other immunosuppressive agents that in

addition

to their underlying disease could predispose them to infections. The

combination of HUMIRA and anakinra is not recommended.

TNF-blocking agents, including HUMIRA, have been associated in rare cases

with demyelinating disease and severe allergic reactions. Infrequent reports of

serious blood disorders and rare reports of lymphoma have been reported with

TNF-blocking agents. Patients with rheumatoid arthritis, particularly those

with highly active disease are at a higher risk for the development of

lymphoma. The potential role of TNF-blocking therapy in the development of

malignancies is not known.

The most frequent adverse events seen in the placebo-controlled clinical

trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site

reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent

vs. 13

percent), injection site pain (12 percent vs. 12 percent), headache (12

percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11

percent

vs. 9 percent). Discontinuations due to adverse events were 7 percent for

HUMIRA and 4 percent for placebo. As with any treatment program, the benefits

and risks of HUMIRA should be carefully considered before initiating therapy.

About HUMIRA

HUMIRA is the only fully human monoclonal antibody approved by the FDA and

the EMEA for reducing the signs and symptoms, inhibiting the progression of

structural damage, and improving physical function in adults with moderately to

severely active rheumatoid arthritis (RA) who have had insufficient response

to one or more disease-modifying antirheumatic drugs (DMARDs). HUMIRA can be

used alone or in combination with methotrexate or other DMARDs. HUMIRA offers

convenient every-other-week dosing by subcutaneous injection (shot beneath

the skin) via a specially designed pre-filled syringe.

HUMIRA is the first fully human monoclonal antibody approved in Europe for

RA, and the first tumor necrosis factor-alpha (TNF-á) antagonist approved with

an indication for use with methotrexate or as monotherapy. To date, HUMIRA

has been approved in 54 countries and prescribed to more than 83,000 patients

suffering from rheumatoid arthritis worldwide.

Clinical trials are currently underway evaluating the potential of HUMIRA in

other autoimmune diseases, including juvenile rheumatoid arthritis (JRA),

psoriasis, Crohn's disease and ankylosing spondylitis.

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FDA URGES ALTERNATIVES TO CELEBREX

Pfizer finds increased heart risk with pain reliever

The Associated Press - Dec. 18, 2004

NEW YORK - The U.S. Food and Drug Administration is advising doctors to

consider alternatives to pain reliever Celebrex in the wake of a study that

showed it increased the risk of heart attack and strokes at high doses.

Pfizer Inc. said Friday it will leave Celebrex on the market, although the

same problems led Merck & Co. to withdraw its painkiller Vioxx from the market

in September.

“We’re leaving open all regulatory decisions as we move forward. But we do

not have a decision on the fate of the product,†Acting FDA Commissioner

Lester Crawford said Friday. “We do have great concern about this product

(Celebrex) and the class of products.â€

Crawford said doctors should think about other types of drugs to help

patients relieve pain. Doctors said they were already inundated with calls from

nervous patients and were pledging to curtail their use of the drug.

The disclosure sent Pfizer’s stock tumbling Friday amid fears it would

cripple sales of what had been the most-prescribed drug for treating arthritis.

Shares of Pfizer, the world’s largest pharmaceutical maker, plunged $3.23, to

close at $25.75 on the New York Stock Exchange. The decline wiped out almost

$25 billion of Pfizer’s market value.

Both Celebrex and Vioxx are a type of drug called cox-2 inhibitors. Vioxx

was pulled from the market in September because it doubled patients’ risk of

heart attack and stroke.

“I think the trial concludes the controversy about whether there is a class

effect of these drugs. Now there is clear evidence of it,†said Dr. Garret A.

FitzGerald, a cardiologist at the University of Pennsylvania. “You would need

to believe the earth is flat if you thought this was just a coincidence.â€

National Institutes of Health director Dr. Elias Zerhouni said that he

ordered a full review of the more than 40 agency-supported studies involving

cox-2

inhibitors.

Risk at high doses found

News of the increased heart risk for Celebrex patients came in one of two

long-term cancer prevention trials.

The National Cancer Institute, which was conducting the study for Pfizer,

said patients in the clinical trial taking 800 milligrams of Celebrex had a 3.4

times greater risk of cardiovascular events compared to a placebo. For

patients in the trial taking 400 milligrams of Celebrex the risk was 2.5 times

greater. The average duration of treatment in the trial was 33 months.

In the 2,000 patient study, 15 individuals taking 400 mgs, 20 patients

taking 800 mgs and 6 patients on placebo suffered either a cardiac-related

death,

heart attack or stroke.

The study was intended to show whether Celebrex could prevent precancerous

growths called polyps in patients that had already had at least one such

growth.

A separate cancer study done by Pfizer found no increased heart risk with

patients taking 400mg of Celebrex per day.

What next for Pfizer?

Pfizer chairman and chief executive Hank McKinnell, who takes Celebrex, told

CNN’s a Zahn that he plans to continue using the drug. Dr. ph

Feczko, president of worldwide development for Pfizer, said the results in the

trial finding increased risk of heart attacks were inconsistent with the other

cancer prevention trial and a “large body of data†that the company had

collected.

Feczko said that sales of Celebrex will continue because “it has not shown

in totality that it increases the risk of heart attacks.†He said Pfizer still

hadn’t seen the data from the NCI study so he couldn’t speculate on how the

two trials could have such different outcomes.

FitzGerald, who has been critical of cox-2 inhibitors, said he doesn’t

believe Pfizer should take Celebrex off market but must find the appropriate

patient population for the drug. -2s were developed to be gentler on the

stomach than older pain relievers called nonsteroidal anti-inflammatory drugs,

such

as naproxen, that are associated with gastrointestinal problems. But unlike

Vioxx, Celebrex was never statistically proven to decrease the risk of ulcers.

It also doesn’t reduce pain better than older drugs.

Those claims prompted U.S. Rep. Joe Barton, R-Texas, and U.S. Rep.

Dingell, D-Mich., to ask Pfizer on Friday for documents regarding Celebrex and

Bextra, the company’s other -2 inhibitor. They want to know what

information

Pfizer had about the NCI study when it made the safety statements. © 2004 The

Associated Press.

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ALEVE LATEST DRUG TO DRAW SCRUTINY

December 21, 2004 WASHINGTON (AP)

An Alzheimer's disease prevention trial was suspended after researchers said

there were more heart attacks and strokes among patients taking naproxen, an

over-the-counter pain reliever in use for 28 years and commonly known under

the brand name Aleve.

The study, involving some 2,500 patients, was to test whether naproxen or

Celebrex, both pain relievers, could reduce the risk of Alzheimer's disease

among healthy elderly patients who were at an increased risk of the disease.

Officials at the National Institutes of Health said the study was suspended

after three years when it was found that patients taking naproxen had a 50

percent greater incidence of cardiovascular events -- heart attack or stroke --

than patients taking placebo.

Another factor, officials said, was the announcement last week that

advertising for Celebrex was being halted after a study found that high doses of

the

drug were associated with an increase in heart attack risk. Preliminary data

from the Alzheimer's study, however, did not indicate an increased risk for

heart attack or stroke for Celebrex, officials said.

Lester Crawford, acting commissioner of the Food and Drug Administration,

acknowledged Tuesday that the conflicting studies are confusing and call for

continued evaluation. For now, he recommended following the dosage

recommendations for the drugs.

" Any drug taken long enough and at high enough dosage can cause some

difficulty, " Crawford said on NBC's " Today. "

" It would be premature to say what we we're going to do with either one of

these drugs, Celebrex or Aleve, " he said. " However, we will keep all regulator

options open and make some determinations as quickly as possible based on the

data. "

Celebrex, a prescription drug, and naproxen are both commonly used to treat

the joint pain of arthritis. Naproxen has been approved for sale, first as a

prescription and then as an over-the-counter drug, since 1976. Celebrex is in

the same class -- COX2 enzyme inhibitors -- as Vioxx, an arthritis drug

recently taken off the market by its manufacturer after it was linked to an

increase in heart attack and stroke.

Officials acknowledged that the implications for the continued use of

naproxen are not clear and will require further study.

Dr. Kweder of the FDA said the NIH study is the first to show that

naproxen might increase the risk of heart attack or stroke and that the findings

are " confusing. " No immediate action, however, is expected toward naproxen,

she said.

" We are not contemplating any specific regulatory action over the next few

days, " Kweder said. " We will be working with the NIH to try to understand the

data better and determine what will be appropriate from there. "

Patients who routinely take naproxen should follow the drug package

instructions carefully, Kweder said, including the directions to not take it for

more

than 10 days, and to consult a doctor if pain persists.

Efforts to obtain reaction Monday night produced no answers at phone numbers

for Bayer Healthcare, the maker of Aleve.

In the earlier studies of the COX2 drugs, an increase in cardiovascular

events was noted only after a long-term use of the medications.

The Alzheimer's disease study was being conducted by the National Institute

on Aging, an arm of the NIH. It called for 2,500 patients aged 70 or older and

who had a family history of Alzheimer's, to take either Celebrex, naproxen

or a placebo.

The group was divided and each division, or arm, was assigned to receive one

of the drugs or placebo. The drugs were blinded, which means the patients

did not know which medication they were taking, or if they were taking a

placebo.

The goal was to determine if the pain-relieving drugs lowered the risk of

developing Alzheimer's disease. The study started three years ago and was to

continue for a few more years. Officials said the patients in the study will be

monitored for developing Alzheimer's or cognitive decline, but will not be

given the test drugs.

Dr. Elias A. Zerhouni, the director of the National Institutes of Health,

said the study linking heart attack to Celebrex last week was a major factor in

deciding to suspend the Alzheimer's study.

He said there was a question whether patients in the study would continue to

take their medicine since they knew they might be taking Celebrex.

Suspending the study, Zerhouni said, " is the prudent thing to do. "

Breitner of the Veterans Affairs medical facility in Seattle and the

University of Washington, an investigator in the trial, said only preliminary

data is available. But he said it suggests that among the 2,500 patients in the

study, about 70 suffered stroke or heart attack. There were 23 deaths. There

were 50 percent more of the cardiovascular events among patients taking

naproxen than among those taking placebo, he said. Copyright 2004- The

Associated

Press.

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CONSUMERS FEELING PAIN FROM DRUG NEWS

December 22, 2004 - WASHINGTON (AP)

With Vioxx off the market and heart-risk questions being raised about

Celebrex and Aleve, what is someone who needs pain relief to do?

That's a question vexing many Americans, and the answers aren't immediately

clear.

These are drugs widely used for arthritis, a condition that can require

long-term treatment.

Yet Dr. Kweder of the Food and Drug Administration says patients who

routinely take naproxen, the generic name for Aleve, should follow the drug

package instructions carefully, including directions not to take it for more

than 10 days consecutively.

While the voluntary withdrawal of Vioxx on Sept. 30 led to questions about

two other drugs in its class, Celebrex and Bextra, the report that indicated

naproxen also might pose a heart risk was unexpected.

" Aleve sort of hit us by surprise, " said Dr. Bruno of the New York

University School of Medicine.

Naproxen, sold both over the counter as Aleve and in stronger prescription

versions, has been on the market for almost three decades. It is a different

class of drug than the other three in question.

It was under investigation by the National Institutes of Health for possible

benefits in Alzheimer's patients when researchers found a higher risk of

heart attack and stroke than in patients given placebos. The trial was halted,

NIH announced Monday.

Bayer HealthCare, which makes Aleve, said Tuesday it has not seen the

research data but plans to cooperate with federal authorities.

" In the meantime, we are in agreement with the FDA's recommendations that

Aleve can be used safely as directed for pain relief and that consumers should

not take the product for longer than 10 days unless directed to do so by a

physician, " the company said in a statement.

One thing most experts tend to agree on is a need for patients who take any

of the drugs in question to discuss the risks and benefits with their

physicians to decide what's best.

" I think it is premature to make any judgment, " about naproxen, said Dr.

H. Klippel, president of the Arthritis Foundation.

Celebrex and other drugs known as -2 inhibitors are important drugs being

used to treat an important problem, Klippel said. " This is an opportunity

for people taking -2 inhibitors to have a discussion with their doctor about

medications and other approaches to treat arthritis, " he said.

Bruno noted that the reported cardiovascular problems have occurred in

people who took the drugs over long periods of time. Both Aleve and the -2

drugs remain in the body for extended periods, remaining in contact with body

tissues a long time, which may bring part of the damaging effect, he added.

" I don't think for the average person, taking these drugs for a short period

of time, there's a reason to panic with any of these drugs, " said Bruno, who

also is the New York Yankees' internist.

" When you've got pain, the safest thing is to just take an over-the-counter

medicine, taking an over-the-counter dosage. That doesn't mean taking like

five times the recommended dose, " he said.

" And you take it for short periods of time, less than 10 days,

intermittently, and I find it very hard to believe that people would have bad

effects, "

Bruno said.

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

Hospital in Baton Rouge, La., stressed that the studies need to be put in

perspective.

All the problems occurred in long-term studies, and the medications have

proven safe in short-term trials of six weeks to six months, he said.

" My advice is patients who have serious heart disease should question their

doctor about whether they need to stay on these medicines indefinitely, " he

said. " For people who use these medicines intermittently now, or have little

risk of heart trouble, I don't think they need to be alarmed. " Dr. Mark

Fendrick, a University of Michigan physician who helped develop published

guidelines for patients and doctors on choosing alternative painkillers, urged

that

people taking either Celebrex or Bextra " immediately contact their doctors "

about whether to continue.

" Long-term use of any nonsteroidal anti-inflammatory medication can be

dangerous and requires supervision by a medical professional, " Fendrick said.

" Anyone taking over-the-counter NSAIDs for chronic pain or inflammation should

consult their doctor. People taking these drugs for occasional, intermittent

pain should be careful not to take more than the recommended dose. " Copyright

2004 The Associated Press.

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My wish for each and every one of us is a healthier New Year, with the hope

that our skin will be better, the joints won't be as swollen, the pain will

be less, and our bodies allow us a day or two of just being normal again.

Good Health to All and Happy New Year

Jack

Newsletter Editor

_Cornishpro@..._ (mailto:Cornishpro@...)

Issue 2004 12/31/04-20