FDA OK's Bristol Myers' arthritis drug

The Food and Drug Administration has approved Bristol-Myers Squibb's rheumatoid-arthritis drug Orencia.

Orencia works by slowing the progression of structural damage in patients with rheumatoid arthritis and improves physical function in RA patients who have had inadequate responses to other drugs, the company said.

"Bristol-Myers Squibb is committed to discovering and developing innovative medications that address areas of significant unmet need," said CEO Peter Dolan. "There is clearly a need for more therapies for rheumatoid arthritis, and Orencia has the potential to help many people with this serious disease. Orencia is our first internally-discovered biologic and it further diversifies our pharmaceutical portfolio."

Orencia is the first in a new class of agents for the treatment of RA that selectively modulates a co-stimulatory signal required for full T-cell activation, the company said, and is also the first RA therapy proven safe and effective for patients for whom tumor necrosis factor (TNF) antagonists don't work.

Australian man convicted for growing marijuana for elderly arthritis patients

Craine Lucas Wattam, 37, has been found guilty of growing marijuana at his residence in Darwin, though the Court found that the man was cultivating the medicinal plant at the request of elderly citizens living in Palmerston.

• A Darwin court has heard that a man who has pleaded guilty to growing marijuana intended to supply it to elderly people suffering arthritis.
• Craine Lucas Wattam, 37, pleaded guilty in the Northern Territory Supreme Court to unlawfully cultivating a commercial quantity of cannabis.
• Police discovered the 45 plants when they visited his Darwin River property on an unrelated matter in January this year.
• The court heard that Wattam had been approached to grow the plants by a group of elderly people in Palmerston who used the drug to relieve symptoms of arthritis.
• Their own backyard plants had been persistently raided by thieves.
• The court heard Wattam had simply scattered seeds in pots and did not intend to grow that number of plants.
• Nor did he intend on profiting from them.
• He has been sentenced to nine months' jail suspended immediately.

Light at the end of the tunnel for arthritis sufferers

There is at last a light at the end of the tunnel for Arthritis sufferers. The disease which can cause severe pain, leaves many incapacitated with a reduced quality of life. Osteoarthritis is a form of rheumatic disease, and it affects as many 2 million people in the UK alone. But now British scientists say they have made a significant step towards finding a new treatment for osteoarthritis, a disease that can leave people unable to walk. Apparently researchers at Bristol University have successfully grown new cartilage from a patient's own stem cells and are hopeful that the technique will allow them to eventually carry out transplants. But they do warn it could take over a decade to perfect the technique. The scientists grew a piece of cartilage using stem cells, which are self-renewing and have the ability to grow into blood, bones or organs. The cells were taken from the bone marrow of people undergoing hip replacement operations because of the disease. They were then placed in a solution to help them develop and then grown into a scaffold made up of polyglycolic acid, which is the same material used to make dissolvable, surgical stitches. Once the cartilage is transplanted, the scaffold should melt away. Because the patient's own cells are used to create the cartilage, the new technique is expected to surmount problems of transplant rejection, as well as avoiding the ethical concerns over using human embryos. Many experts are encouraged by the success but see it as a milestone rather than a breakthrough. Although there is no single cause of osteoarthritis, several factors increase the likelihood of getting it, including being over 40, female, overweight or having an existing injury to a joint. Osteoarthritis means that the smooth cartilage that takes the strain in a normal joint becomes rough, brittle and weak and in order to compensate, the bone beneath it thickens and spreads out, forming knobbly outgrowths. The membrane surrounding the joint also thickens and the fluid-filled space within it becomes smaller. As the disease progresses bits of cartilage may break away from the bone, causing the bone ends to rub together and the ligaments to become strained. This causes a great deal of pain and changes the shape of the joint. Osteoarthritis is most common in the hands, knees, hips and feet but some people also develop it in the back and neck.

Stem cells give new hope to arthritis sufferers

Scientists in England predict they will have a "cure" for osteoarthritis within the next decade, with the help of stem cell technology.

Researchers at the University of Bristol successfully grew new human cartilage from stem cells taken from the patient's own bone marrow -- a first.

The development paves the way for cartilage transplant operations for people who suffer from osteoarthritis, one of the most severe forms of arthritis, which can leave people unable to walk.

This technique is promising because it overcomes the problems of transplant rejection, since the patient's own stem cells are used to make the cartilage.

As well, the fact that it uses the patient's own stem cells, rather than human embryos, avoids ethical concerns.

In this experiment, scientists took the stem cells from the bone marrow of people undergoing hip replacement surgery, because of osteoarthritis.

The cells were placed in a special solution to help them grow, and in just over a month, experts ended up with a half-inch piece of cartilage.

Experts warn that the technique could take up to 10 years to perfect.

"I think we should be encouraged but not overly excited. At the moment this is a milestone but not really a breakthrough," professor George Nuki, from the British Society for Rheumatology, said, the BBC website reported.

Osteoarthritis is one of the most common forms of arthritis. It involves the breakdown of a joint's cartilage, which cushion the ends of bones, and allows for easy movement.

It commonly affects older people. Men are more likely to have osteoarthritis than women under the age of 55. Over the age of 55, it becomes more common in females, according to the U.S.-based Arthritis Foundation.

While a single cause of osteoarthritis isn't known, risk factors include age, weight and having a previous injury at a joint. Genetics can also play a part.

The disease typically affects major joints, such as the hips, knees and lower backs. It can also affect the neck, small finger joints, the base of the thumb and the big thumb.

Supplements help mend, not mask, pain

I'm 75 years old and play softball, volleyball and jog. I take glucosamine and chondroitin for my arthritis pain. Is this good?

R.G., Summerfield, Fla.



Yes. The human body produces glucosamine and chondroitin, which in turn produce the cushion between your joints. The more squishiness you have between your joints, the less pain you feel. So supplements (which are often derived from animals or shellfish) are not "painkillers," like prescription drugs, but actually help mend the underlying cause of pain.

Not all studies on glucosamine and chondroitin show positive results, but at least these dietary supplements don't cause fatalities. When top prescription pain relievers (like Vioxx or Bextra) are pulled from the market because of fatalities, and serious doubts shroud Celebrex and other nonsteroidal anti- inflammatory drugs, called NSAIDs (like naproxen and ibuprofen), clinicians become open-minded for the sake of their patients in pain. Almost 70 million people in the United States live with some form of arthritis, and the excruciating cost of that is more than $80 billion a year.

One study recently compared glucosamine to the painkiller acetaminophen, sold under brand names such as Tylenol and Excedrin.

For 24 weeks, 318 patients with knee osteoarthritis took either glucosamine (1,500 mg), acetaminophen (1,000 mg three times a day) or a placebo. People taking glucosamine reported the most benefit for their discomfort and immobility. And there is no risk to the liver with glucosamine, as there is with acetaminophen.

More recently, findings from a study by the Glucosamine/Chondroitin Arthritis Intervention Trial proved that the combination of glucosamine and chondroitin was effective in treating moderate to severe knee pain from osteoarthritis; and, the kicker is, these two naturally derived substances outshined our fabulous pharmaceutical, Celebrex, over the course of six months. There were 1,538 people in this notable study. It was funded not by a supplement manufacturer but, rather, the National Institutes of Health, in Bethesda, Md. A total of $14 million was spent on this project - the largest placebo-controlled, double-blind clinical trial ever conducted for glucosamine and chondroitin.

Go for reputable brand names or generic equivalents.

Freer joints will ease pain of arthritis

Q: I suffer from arthritic pain and stiffness in my knees and fingers and I would like some help with that. Also, I have recently been experiencing some gastric upset and would like your recommendations for that as well.

A: Try the remedy Knotgrass Complex at a dose of 20 drops, twice a day before meals in a little water to help with the knees and fingers. This has a cleansing effect on the joints and will help to reduce inflammation and pain. For the gastric problems, I would recommend Gastronol at a dose of 2 tablets, two to three times a day, 15 minutes before meals.

It would also benefit both problems if you reduce or avoid acid-forming foods in your diet, such as pork, tomatoes and citrus fruit

Selenium: Low selenium linked to osteoarthritis risk
People with low levels of selenium in their bodies face a higher risk of knee osteoarthritis, according to researchers from University of North Carolina at Chapel Hill Thurston Arthritis Center. The study compared x-ray evidence of knee osteoarthritis in 940 study participants with how much selenium was in their systems. Study participants who had less of the trace mineral than normal in their systems faced a higher risk of the osteoarthritis in one or both knees.

Future studies may focus on whether selenium supplements may help reduce the risk of osteoarthritis. Selenium can be toxic, so supplements are not being recommended. A healthy diet is recommended. According to the American College of Rheumatology, "food distribution patterns in the U.S. ensure most people get the low doses of selenium needed, particularly if they eat a variety of foods from several sources."

Health Watch: Juvenile Arthritis

When we think of arthritis, we tend to think of the elderly, not young children. However, thousands of youngsters live with juvenile rheumatoid arthritis everyday. Some get better over time, and others continue to have problems well into adulthood. Here is more about this condition, found in tonight's Health Watch Report.

You would not know it by looking at her, that 7-year-old Kaylee Adams suffers from juvenile rheumatoid arthritis.

"When she was about 20 months old she had fallen and sprained her finger. We thought it was just a sprain and nine months later we got a diagnosis," said Kaylees mom Kim Adams.

Juvenile rheumatoid arthritis affects about one in every thousand children. The good news is most of the cases are mild. According to Dr. Barry Myones, a pediatrician, it can affect one or more joints, as well as the eyes, and the pain is usually at its peak in the morning.

"They can't move if the weather changes, if the barometric pressure changes, or if it gets cold. Sometimes the stiffness can last all day long," said Myones.

Not only does the disease put a damper on certain activities for kids, but it can also affect them emotionally because they are not like all the other kids.

"Kids will become depressed, and that causes problems with their development and interaction with their peers, as well as interaction within the family, and there's a lot of family stress," said Myones.

A new generation of biological modifier medications that block specific immunological signals with regards to the disease have made living with juvenile rheumatoid arthritis much easier for patients.

Kaylee's daily dose of medication not only allows her to be active with her little sister, but it also puts her mother's mind at ease.

"My first thought after we got the diagnosis we went to a seminar and there were people my age in wheelchairs, and crippled, and we thought was going to be our future. But the medications nowadays are amazing," said Adams.

Between 80 to 90 percent of children will eventually grow out of their condition, however, the small percentage that do not, can sustain long-term problems, such as permanent cartilage damage or joint deformities.

If you would like more medical news, visit our health partners Web sites:

M.D. Anderson Cancer Center:http://www.mdanderson.org/

The Mayo Clinic: http://www.medicaledge.org

Baylor College of Medicine:http://public.bcm.tmc.edu/

Increased Risk of Rheumatoid Arthritis by eating Red Meat

red meat higher risk

A study conducted by British researchers found that high levels of red meat in a person’s diet may increase the risk of developing inflammatory arthritis.

A team of British researchers found that dietary habits were part of the cause of the onset of rheumatoid arthritis, along with genetics. Lifestyle choices can account for about 40% of the risk. Cigarette smoking has also been a contributor in developing rheumatoid arthritis. Nutritional factors are still not clear, but some studies have shown that eating fish is beneficial, drinking coffee is bad, and drinking in moderation for women is good.

The researchers found vitamin C from not eating fruit also increased the risk of inflammatory arthritis. This lack of vitamin C increase risk as much as 3 x’s. The study was first published in Arthritis & Rheumatism Journal, back in December 2004. The interesting finding was that the researchers also discovered that eating a high level of red meat also increased the risk for inflammatory arthritis.

The University of Manchester, with lead researchers, Alan Silman and Deborah Symmons, started with a combination of 25,000 men and women ages 45 through 75. Within this sample there were 88 patients that were newly diagnosed with inflammatory arthritis of more than 2 joints. Also there was approximately 40 percent that were considered by the American college of Rheumatology for rheumatoid arthritis baseline. Each participant took extreme care in keeping a 7 day food diary that included measuring food portions to report more accurately amount of food that was eaten, as well as what was eaten. They also answered whether or not they were smokers

The lack vitamin C intake was not as significant in this study, but what they found was the ones who ate the highest amount of red meat had a 2 x’s higher risk for developing rheumatoid arthritis. Those patients that consumed high levels of red meat with other meat products had the similar showings. The dietary fats did not seem to have an increase in risk.

Because there is a genetic factor to rheumatoid arthritis, it may not cause everyone the same risk for developing the inflammatory disease. “It may be that the high collagen content of meat leads to collagen sensitization and consequent production of anticollagen antibodies, most likely in a subgroup of susceptible individuals,” the authors for the studies say. “Meat consumption may be linked to either additives or even infectious agents, but, again, there is no evidence as to what might be important in relation to RA.”

“A high level of red meat consumption may represent a novel risk factor for inflammatory arthritis or may act as a marker for a group of persons with an increased risk from other lifestyle causes,” Dr. Pattison and colleagues report. “It is unclear whether the association is a causative on

Health officials won't revive arthritis drug

Bextra, an anti-inflammatory drug for arthritis sufferers, will not be allowed back on the Canadian market.Based on recommendations from an expert safety panel, Health Canada said yesterday the cardiovascular risks of the drug, including heart attack and stroke, outweighed its benefits. Officials said it also causes rare but severe and potentially fatal skin reactions more often than other drugs in its class."We concluded that there is insufficient evidence to establish the safety of the drug for its recommended use," said spokesperson Jirina Vlk.Bextra was withdrawn voluntarily from the market in April by drug giant Pfizer after severe skin reactions affected seven people in Canada.The drug falls into the same controversial class of drugs as Vioxx and Celebrex, known as cox-2 inhibitors. Vioxx, once the most popular painkiller in Canada, was pulled from the worldwide market in September 2004.New warnings of cardiovascular risks have subsequently been issued for Celebrex.In a written release, Pfizer Canada said "Bextra is an important treatment option ... (and) it should continue to be available for those patients who could benefit from it."A Health Canada expert safety panel issued a report last summer recommending Vioxx be allowed back on the market. However, panel members in an 8-5 vote said Bextra should not be. Bextra was approved for sale in December 2002 and 665,783 prescriptions were filled in Canada last year.

`Good science' to study pain pills and heart woes

Should the millions of North Americans who are at risk of heart problems take painkillers for arthritis?That's what a huge international study by The Cleveland Clinic hopes to find out. With an unusual mix of industry, academic researchers and government oversight, the study also aims to restore public confidence in the wake of the Vioxx debacle. "There's only one way — through good science," said Dr. Steven Nissen, the Cleveland cardiologist who will lead the study. "We know the burden is upon us to do this right." Drug safety and the credibility of research have been concerns in recent months since Vioxx and Bextra were pulled from the market because of evidence they can raise the risk of a heart attack or stroke. That left Pfizer Inc.'s Celebrex as the only available cox-2 inhibitor available. The drugs became blockbusters because they were gentler on the stomach than older pain relievers. Many people who switched to over-the-counter pain relievers called non-steroidal anti-inflammatory drugs, or NSAIDs, then had a new worry when the U.S. Food and Drug Administration ordered stronger warning labels earlier this year. The new study will test Celebrex and two types of NSAIDs — ibuprofen (sold as Motrin, Advil and other brands) and naproxen (Naprosyn, Aleve). About 20,000 people throughout the United States, Eastern Europe, Canada, Australia and South America will be randomly assigned to get one of the three — neither they nor their doctors will know which — and a drug to prevent stomach irritation so each pain reliever's true effectiveness can be assessed. Drugs and follow-up medical monitoring will be free. To be eligible, participants must have had a heart problem in the past, such as a heart attack, blocked arteries or chronic chest pain, or diabetes, stroke or clogged vessels in the neck or legs. "The idea here is if you know what happens in the highest-risk individuals, you will know how to use the drugs in people at lower risk," Nissen said. "We will have 10 times the statistical power of any trial ever done of these drugs." Pfizer will fund the study, expected to cost more than $100 million, but independent researchers will collect and control the results and have offered to make all of them public, not just bottom-line conclusions. No top researchers can have financial ties to any pain-drug manufacturers. "This is a very interesting model" for a public-private partnership to do medical research, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, which will appoint a representative to serve on the study's executive committee. "We believe this is an effective and appropriate way to conduct this study," said Pfizer spokeswoman Mariann Caprino. The study will be called PRECISION, for Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen. Results are expected in about four years. Dr. Alastair Wood, a Vanderbilt University physician who heads the FDA's non-prescription drug advisory panel, called the study "a good idea." "One of the underlying assumptions is that naproxen is safest," but that has not been rigourously tested, he said. Nissen also has served on FDA drug advisory panels and chaired one on the cox-2 drugs. He and another Cleveland Clinic cardiologist, Dr. Eric Topol, were among the first to publish warnings about Vioxx's safety.

'India Lacks Multidisciplinary Approach For Juvenile Rheumatoid Arthritis Patients’

It is said that 60 out of 1,00,000 children in the US and the UK are affected with juvenile rheumatoid arthritis. With as many as 12,000 children in Mumbai estimated with paediatric rheumatoid arthritis, the formation of Juvenile Arthritis Support group at Mumbai's Jaslok Hospital signifies an important milestone. And that is why Canada-based Dr Ross Petty, Head of the Division of Rheumatology in the Department of Pediatrics at BC's Children's Hospital and the University of British Columbia, was at Jaslok Hospital, invited by Dr Raju Khubchandani, a pediatrician with special interest in Paediatric Rheumatology. Dr Petty is credited with theestablishment of The Arthritis Society, the first comprehensive programme in paediatric rheumatology in Canada. He is the recipient of the Ross Award, a prestigious honour given by the Canadian Paediatric Society for contribution to the care of children and youth. Both the rheumatologists spoke to Rita Dutta about various aspects of the disease.

Dr Ross Petty	Dr Raju Khubchandani

Please brief me about the Juvenile Arthritis Support group started at Jaslok Hospital.

Dr Khubchandani: Jaslok hospital was the first to launch paediatric rheumatology services in the city of Mumbai, three years ago. Besides patient care, the department has done its bit in spreading awareness about children with joint diseases amongst patients, parents and physicians. In the last few years, we realised that joint/muscle and connective tissue diseases in children can devastate families and that such families are often in need of educational inputs, emotional support and empowerment to cope. So while 'juvenile arthritis' refers to a specific disease entity, the scope of JAS would be to provide such inputs to families and kids with joint, muscle and connective tissue diseases in general. It is important to note that JAS is not a facility, which provides financial aid or arranges subsidised care.

Which other Indian hospitals have such support groups for juvenile arthritis? Do most hospitals in the western countries have such support groups?

Dr Petty: This is the first one I know of. Many Western countries do have active support groups for various chronic illnesses. Arthritis support groups in the UK and Europe are very active and function independent of hospitals as voluntary organisations.

What are the most prevalent forms of juvenile arthritis? What is the incidence of its various forms?

Dr Petty: Many childhood illnesses, like systemic lupus erythematosus, dermatomyositis, leukemia, and infections, can cause symptoms of arthritis. It is important that these diseases be identified and appropriately treated. If there are 400 million children in India, it is likely that one-quarter of of million children have some kind of arthritis. This represents an enormous disease burden, well beyond the capacity of the current number of rheumatologists and paediatric rheumatologists to care for optimally. I understand from colleagues in India, that there is also a very severe shortage of physical therapists, occupational therapists and nurses, who are trained and experienced in helping in the care of children with arthritis.

Dr Khubchandani: There are no incidence or prevalence figures available for India. If one goes by the UK or North American data of a prevalence of 60 per 1,00,000 children and assumes a 20 million Mumbai population with about 40 per cent as children, an assumed number of 12,000 kids at any point in time in Mumbai would be suffering from juvenile rheumatoid arthritis. Add to this, other diseases like lupus and dermatomyositis Kawasaki disease and many more diseases with joint manifestations and we have a huge burden. One important point to be noted is that with the eradication of polio this group of disorders will emerge as the largest cause of physical handicap.

What are the various forms of juvenile rheumatoid arthritis? What are the symptoms of juvenile rheumatoid arthritis? Can a child affected with juvenile rheumatoid arthritis lead a normal life?

Dr Petty: In general, children with arthritis have pain and swelling in one or more joints. Young children sometimes do not complain of pain, but they may limp, be stiff in the morning, or alter their play patterns. Activities which were formerly easy for the child to perform, become difficult. The symptoms are often most severe in the morning ("morning stiffness"), and may improve with activity. In some children, many joints, including those of the hands, are affected. Such children have severe pain, stiffness and lose range of motion in the affected joints. Any joint, including those of the neck, spine and jaw may be affected.

Children with a particularly severe form of disease (systemic arthritis) have fever, rash, enlarged lymph nodes, spleen, liver, and anemia in addition to arthritis. With the passage of time, if the child is untreated, the joints become chronically swollen, lose range of motion, and eventually may be destroyed. Severity of disease, and its effects on the child depends on at least two factors. First, there are many types of juvenile arthritis, and some types (like polyarthritis: many affected joints, or systemic arthritis) are more severe than other types (like oligoarthritis: few affected joints). The second factor that determines the severity of the effects of the disease on the child is treatment. Children who are untreated, or who are treated late in the course of disease have the worst outcome than those who are treated early. In the hands of a physician, who is expert in the management of children with arthritis, even children with severe forms of the disease can have an excellent outcome.

How does one diagnose juvenile rheumatoid arthritis? Are all the diagnostic methods available in India?

Dr Petty: Juvenile arthritis and various other joint diseases involve clinical or bedside diagnosis. Investigations are often required to access activity, detect complications or monitor therapy. All such modalities should be available at any medium or large hospital in India.

What should be the first line of treatment for juvenile rheumatoid arthritis?

Dr Petty: As of now, there is no cure for childhood arthritis as administration of drugs does not cure the disease. However, medicines available today are very effective at controlling the disease and that may seem like the disease has gone away entirely. Initial treatment usually begins with one group of drugs, called non-steroidal anti-inflammatory drugs (NSAIDs) such as naproxen or ibuprofen.

If these drugs fail to completely control the disease, other medications are used. These depend on the type of disease, its severity, the patient's preferences, and other factors. They include cortisone-like drugs as a pill prednisolone) or injections into the affected joints (triamcinolone hexacetonide). Other important drugs used to control the disease include methotrexate, hydroxychloroquine, sulfasalazine and the new biologic agents such as etanercept and infliximab. With careful use of these drugs, the disease can be controlled in most children, although they usually require medications for many years.

What are the hindrances to the treatment?

Dr Petty: Geographic distance plays an important role, but the most important barrier to care is limited awareness on the part of parents and primary care physicians (general practitioners, paediatricians) about the signs of the disease. Too often, arthritis is thought not to occur in a child, or symptoms are ascribed to other causes (usually trauma). There is still a wide-spread belief that nothing can be done about arthritis. Nothing, could be farther from the truth. The advances made in understanding arthritis in the last decade have revolutionised the outcome for children with these diseases.

What are major breakthroughs in the treatment of juvenile rheumatoid arthritis in the recent past?

Dr Petty: The drug methotrexate, which is very cheap, represents one important breakthrough and recently the biological agents, which are yet very expensive the world over, have changed the complexion of the disease.

Are there enough experts in juvenile rheumatoid arthritis in India and worldwide?

Dr Petty: There is a world wide shortage of paediatric rheumatologists. It is estimated that there are about 700 qualified / trained specialists, of which about 500 would be in North America and Europe. Canada has the largest number when one uses the doctor to population ratio. I learnt from this trip that there are about half a dozen centres in India. The arthritis care model that we have in Canada is centered around the child and family, and includes the expertise of paediatric rheumatologists, physical and occupational therapists, nurses, social workers and nutritionists, all of whom make important contributions to the care of children with arthritis. That model has not yet been developed in India, although there is considerable interest in doing so.

Please tell me about the research chairs constituted on Dr Petty’s name back at Canada.

Dr Petty: With the possibility of finding a cure for arthritis, The Arthritis Society, BC and Yukon Division (TAS) has launched a USD 10.5 million campaign in June 2004 to fund two research chairs in arthritis research. The two research chairs, held at the University of British Columbia will focus on research into paediatric rheumatology, proteomics and genomics to understand the fundamental mechanisms of the disease.

Anti-arthritis drug stirs action

A CLASS action has been launched on behalf of hundreds of Australians who suffered heart attacks and strokes after taking the anti-arthritis drug Vioxx.

Lawyers Slater and Gordon yesterday filed a writ in the Supreme Court of Victoria seeking damages for at least 400 victims, including relatives of up to 50 people who died while using the drug.

They are seeking compensation against US drug manufacturer Merck & Co Inc and its Australian subsidiary Merck Sharp & Dohme Australia, who assembled, marketed and distributed the tablets.

The class action comes after Vioxx was withdrawn from sale under a global recall on September 30, last year.

About 250,000 Australians used the drug before it was recalled.

Slater and Gordon lawyer Richard Meeran said the law suit was a “compelling legal case” because the product was defective, a fact he said the companies were aware of almost from the outset of its distribution to the public.

Ottawa bans arthritis drug

The federal government has banned a popular arthritis drug because it may cause a heart attack or stroke.

Sales of Bextra have been suspended since last April when the federal government approached its maker, Pfizer Inc., after concerns were raised in the United States and Europe about its possible side effects.

The drug, which racked up global sales of $1.3 billion in 2004, has now been banned permanently.

"The decision to stop the sale of Bextra is based on information submitted by the manufacturer, Pfizer Canada Inc.," Ottawa said in an announcement late Friday afternoon. "Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use."

A Pfizer spokesman was unavailable for comment.

• FROM DEC. 9, 2004: Heart warnings added for painkiller Bextra

Health Canada started a review of Bextra and related drugs following Merck & Co. Inc.'s withdrawal of a similar drug, Vioxx, in September 2004. Bextra was suspended in April across Canada, the United States and Europe after regulators voiced concerns over cardiovascular risks.

Vioxx remains suspended, but the federal government said in July that it would be allowed back on the market if requested.

Group sues drugs maker

A GRANDFATHER who says his life was blighted by an anti-arthritis drug yesterday became the face of a class action against a pharmaceutical giant.

Graeme Peterson, 55, says he was healthy but that after taking Vioxx he devloped heart problems.

Mr Peterson suffered his first heart attack in December 2003 after taking Vioxx for almost four years to treat arthritis in his hips and neck.

"I took it for an arthritic condition," he said.

"I would have lived with that arthritic condition given the choice. I wasn't given the choice."

Law firm Slater and Gordon yesterday launched a Supreme Court class action against American maker Merck & Co and its Australian subsidiary Merck Sharpe & Dohme (Australia) Pty Ltd.

The firm represents more than 400 people who took Vioxx and suffered heart attacks and strokes but it is believed 250,000 Australians used the drug.

It was withdrawn from sale last year because of safety fears.

The writ alleges Merck failed to warn doctors, pharmacists and the public that an ingredient of Vioxx significantly increased the risk of arterial thrombosis and cardiovascular conditions.

Mr Peterson, of Mornington, said his heart condition meant he was much less active.

The grandfather of seven was global safety manager for BHP but now works only part-time.

Slater and Gordon special counsel Richard Meeran said Merck had not warned doctors and the public about possible cardiovascular risks associated with Vioxx.

Some Suffering Severe Pain Find Comfort In Dietary Supplements

BOSTON -- For the 21 million Americans who suffer from arthritis, safe and effective pain relief is hard to find.NewsCenter 5's Heather Unruh reported Wednesday that when a major study by the National Institutes of Health found the dietary supplements Glucosamine and Chondroitin eased the pain for people with moderate to severe osteoarthritis, it should have been cause for celebration. Instead, it has sparked debate.In Europe they have been sold as drugs for decades, but in the United States Glucosamine and Chondroitin are dietary supplements and are not regulated by the government. Still, the combination is widely promoted in the United States as pain relief for osteoarthritis of the knee."It's one of the top selling supplements, certainly because it's effective," Johnson Drug's Stephen Bernardi said.But, no scientific evidence existed to back up claims of its effectiveness -- until the NIH Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) study. Researchers followed more than 1,500 people with knee osteoarthritis over six months.They found that for the entire group, a combination of Glucosamine and Chondroitin had no more effect on pain than a placebo.But, when researchers narrowed the findings to the participants with moderate to severe pain, the results were much different. Seventy-nine percent of participants who took the supplements reported pain relief compared to 69 percent who took Celebrex and 54 percent who took a placebo."Unlike pain relievers, which just cover up the symptoms, taking Glucosamine and Chondroitin actually improves the health of the joints," said Dr. Jason Theodosakis, author of "The Arthritis Cure."But many doctors say the narrowed findings don't tell the whole story."The results just really weren't that impressive -- not impressive enough for me to suggest another pill to a patient who probably, given the population that has arthritis, is already on a lot of pills," Brigham and Women's Hospital Dr. Elinor Mody said.Years of running left Dr. Ronda Rockett with knee arthritis at a young age. Six months ago her doctor recommended she give up jogging, strengthen her muscles and take Glucosamine and Chondroitin."I definitely think this medication has helped me but the reality is, I've also had to do those other things in order to help my symptoms. So, I think it's a combination of the different therapeutic interventions," Rockett said.

Major Painkiller Trial to Start

The Cleveland Clinic will direct a large-scale clinical trial to determine the cardiovascular safety of three painkillers commonly used by arthritis sufferers.

The trial will focus on three drugs -- ibuprofen (Advil/Motrin), naproxen (Naprosyn or Alleve) and celecoxib (Celebrex) -- all of which belong to the class of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). Celebrex is a cox-2 inhibitor, a member of a newer class of NSAIDs that avoided the gastrointestinal problems of the older drugs. Two other cox-2 painkillers, Vioxx and Bextra, have been pulled off the market because of documented heart risks.

The Cleveland Clinic trial, which will enroll 20,000 at-risk heart patients, is an attempt to figure out whether the NSAIDS that remain on store shelves pose any cardiovascular risks.

"We've desperately needed this. The entire public confidence in terms of what is safe for pain has been eroded," said lead investigator Dr. Steven Nissen, who is the director of the clinic's Cardiovascular Coordinating Center.

"This is the trial that we've all been waiting for," added Dr. Mark Fendrick, an internal medicine professor at the University of Michigan. "It examines commonly used pain relievers at dosages frequently used in primary care, in patients at risk for cardiovascular events."

But the trial is also being funded by Pfizer Inc., which makes Celebrex, and experts worry that the integrity of the results could be called into question.

"I think the National Institutes of Health should take responsibility for conducting this type of clinical trial, where controversy and potential harm to the population are at stake," said Adil Shamoo, a professor of bioethics at the University of Maryland and co-founder of CIRCARE, a nonprofit dedicated to the protection of people used in research and medical treatment.

There is also the fact that the Cleveland Clinic itself was the subject of a lengthy expose published Monday by the Wall Street Journal. The article highlighted extensive ties between the institution and AtriCure, a company that makes equipment used in surgeries performed at the clinic.

According to the Journal article, a venture-capital partnership that the Cleveland Clinic helped found and invested in owns about 4.1 percent of AtriCure's stock. Patients were not told of these ties.

"In light of the problems they just had, I'm surprised they're doing this," Shamoo said. "What I would like to see are conflict-of-interest statements and complete financial disclosures for all involved, and the patients should be told that. This will affect what they're doing and the integrity of the research."

Nissen, who is also the president-elect of the American College of Cardiology, noted that special measures have been taken to guard the integrity of the trial's findings.

Pfizer will basically stay out of the trial, which has been dubbed the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen) trial, he stressed.

"We've done some very unusual things," Nissen added. "The executive committee to run the trial does not have a Pfizer person on it. It's all academic. I have asked the academic participants to all agree that they will accept no honoraria, speaking fees, etc. from any manufacturers of drugs in this class."

In addition, Nissen intends to place the trial's database into the public domain by giving it to the National Heart, Lung, and Blood Institute.

"We're going to make this trial so transparent that everybody will believe it," he said. "We're committed to doing this in a way that, for patients and physicians, answers the questions using the best scientific methods and integrity."

Nissen, along with Dr. Eric Topol (also of the Cleveland Clinic), was one of the first to reveal the potential risks associated with Vioxx. Since then, several studies have pointed out similar risks, and Vioxx manufacturer Merck & Co. is now immersed in litigation over whether the drug caused heart deaths.

The Vioxx saga took a new twist last week, when the editors of the prestigious New England Journal of Medicine published a rare "Statement of Concern." It charged that the authors of a major study called VIGOR, published in the journal in 2000 and subsequently used as a strong argument for the drug's safety, withheld information on three heart attacks and other cardiovascular events among participants taking Vioxx. Executives of Merck were among that study's authors.

The unusual accusation was released last Thursday afternoon, as jurors in Houston began deliberations in the first federal trial against Merck. On Monday, a mistrial was declared after the jury declared it could not reach a unanimous verdict.

Topol, who testified against Merck during the latest Vioxx trial, is not on the executive committee of the Cleveland Clinic study that is about to get underway. However, he is advising Nissen. "We didn't want to have more than one individual from any single center," Nissen said. "He has been very generous with advising us. I will keep him engaged."

The trial participants are expected to be enrolled over 18 months and will be followed for an average of two years. In addition, the researchers will be collecting information on pain relief and on gastrointestinal bleeding.

The study will end when 700 of the participants have died or suffered a heart attack or stroke, according to a New York Times report. That's a number consistent with what would be expected in such a group even without use of painkillers, the newspaper said.

apanese study confirms impact of seasonal change on rheumatoid arthritis

Dr. Noriko Iikuni, of the Institute of Rheumatology, Tokyo Women's Medical University, issued a statement summarizing the findings of new research, saying that climate and weather do indeed affect the condition of rheumatoid arthritis.

• Many rheumatoid arthritis (RA) patients believe changes in the seasons trigger fluctuations in their symptoms, and now a study out of Japan appears to support that view.
• Specifically, the study found that the pain of RA rises as seasonal temperatures fall.
• "Physicians can easily dismiss seasonal changes as having an impact on patients with rheumatoid arthritis yet, in reality, the differences in weather and climate are having an impact," researcher Dr. Noriko Iikuni, of the Institute of Rheumatology, Tokyo Women's Medical University, said in a prepared statement.
• Her team reviewed data collected from more than 1,800 RA patients between October 2001 and April 2004.
• The volunteers averaged nearly 58 years in age and had suffered from RA for an average of over 10 years.
• The study looked at the patients' disease activity, score, tender joint count, swollen joint count, health assessment questions, pain scale, laboratory test results that indicated amount of pain and inflammation, and response to treatment.
• Both subjective and objective results indicated that the RA patients experienced a significant decrease in RA activity from spring to fall, and an equally marked increase from fall to spring.
• "For the majority of rheumatoid arthritis sufferers, the period between fall to spring will give rise to more problems whereas symptoms will ease between the spring and fall.
• Awareness of this very real influence on these patients should play a role in more effective treatment management," Iikuni said.
• The findings were to be presented Monday at the annual scientific meeting of the American College of Rheumatology, in San Diego.

Orange juice could protect you against arthritis

Dr. Alan J. Silman, from The University of Manchester in the UK, has led a study of 25,000 subjects, and the findings suggest that arthritis may be defended against considerably by daily consumption of orange juice, which contains carotenoids that Silman and colleagues have found helpful in preventing arthritis.

• The researchers' findings appear in the American Journal of Clinical Nutrition.
• Eighty-eight subjects developed arthritis during follow-up and they were matched to 176 healthy comparison subjects.
• Average daily intakes of the carotenoids beta-cryptoxanthin and zeaxanthin were 40 and 20 percent lower, respectively, for arthritis patients compared with healthy subjects.
• By contrast, consumption of two other well-known carotenoids, lutein and lycopene, did not seem to protect against arthritis.
• Further analysis showed that subjects with the highest beta-cryptoxanthin and zeaxanthin intake were about half as likely to develop inflammatory polyarthritis than those with the lowest intake.
• "These data add to a growing body of evidence that some dietary antioxidants, such as the carotenoids beta-cryptoxanthin and zeaxanthin as well as vitamin C, may be protective against the development of" arthritis, the authors conclude.

Arthritis Therapy May Help Ease Some MS Symptoms
by John C. Martin	Article Date: 12-12-05

A natural product that some medical experts claim may be able to ease some symptoms of arthritis^1,2 might do the same for some people with multiple sclerosis (MS). That's the conclusion of a new study using animals to test the product's effectiveness.³

Does it Work in People?
A group of neurologists at Thomas Jefferson University and the Jefferson Hospital for Neuroscience in Philadelphia used a group of mice to test the product's efficacy against a disease similar to MS. Doses of the product, known as glucosamine, dramatically postponed the symptoms of the disease, experimental autoimmune encephalomyelitis (EAE), and improved the animals' ability to move and walk.

The important question that still remains is whether these benefits can be replicated in people. "It would be fantastic if glucosamine works in humans because we have a product that has a long track record for safety, and most importantly, can be given orally," said Abdolmohamad Rostami, MD, PhD, professor and chairman of Neurology at Thomas Jefferson University and one of the study's chief researchers.

Most current therapies for MS are given by injection.

Easing Symptoms in Diseased Mice
Glucosamine is a natural substance in the body that is believed to increase levels of substances that experts believe are deficient in the origins of osteoarthritis. It also is believed to repair destructive enzymes that play a role in the disease.⁴ In MS, it's believed glucosamine fends off destructive immune system cells.

In this animal trial, Rostami, Guang-Xian Zhang, MD, PhD, an assistant professor of Neurology, and others gave some mice doses of glucosamine, while other rodents did not receive the product. In the intervention group, mice received glucosamine either orally, intravenously, or intraperitoneally, in which the product is infused in the animals' abdominal region. They also tested the effect of the product in a group of animals before symptoms appeared and in a second group in which symptoms had already begun to appear.

In each case in which glucosamine was used, the onset or progression of symptoms was significantly delayed, the study team wrote. That is, the mice that received the product took longer to become ill, and when they did become ill, the disease was much less severe, the study found. Glucosamine was as effective when given early in the disease or after the mice became ill.

Blocking Immune Cells
It's believed glucosamine works by suppressing the ill-effects of the immune system. MS (and EAE) is believed to be an autoimmune disease. For an unknown reason, the body's immune system begins to attack normal body tissue. Specifically, a fatty substance that insulates nerve fibers in the central nervous system is damaged, as are the nerve fibers themselves in some cases. When this occurs, communication between the nerve fibers is disrupted, causing the neurological impairment that is seen in the disease.⁵

In this case, glucosamine affects the production of specific immune system cells known as T cells. There are two types of T cells: TH1 promotes inflammation as part of the immune response and TH2 cells suppress it. "We've shown that glucosamine modulates the immune response by producing more TH2 responses, suppressing brain inflammation," explained Rostami, who is also head of the Neuroimmunology Laboratory in the department of Neurology at Thomas Jefferson University. "At the same time, it suppresses TH1 response."

When the rodents' spinal cords were examined for this research, the study team found less inflammation and myelin damage in those given glucosamine.

Combination Therapy Possible?
"As a therapy, it might be used in combination with other proven treatments, such as beta-interferon and Copaxone," Rostami explained. He and his colleagues are currently studying the feasibility of such a therapy combination in the same group of mice to search for any possible adverse effects. They're also trying to determine if glucosamine can hinder the relapses that occur in the relapsing/remitting form of EAE, similar to what occurs in MS.

"As glucosamine is able to effectively suppress acute EAE, has low or absent toxicity, and has been safely used in humans orally, our study suggests a potential use for this drug alone or in combination with other disease-modifying immunotherapies to enhance their efficacy and reduce their doses in MS and possibly other autoimmune disorders," the researchers wrote.

Conflicting Information
In clinical trials involving people with osteoarthritis, glucosamine hasn't always shown that its effective at reducing symptoms. In one study last year,⁶ more than 200 patients with symptoms of osteoarthritis of the knee were enrolled to test the product's safety and efficacy. The patients were assigned at random to receive either doses of glucosamine or a placebo, an intervention that has no therapeutic effectiveness, as a comparison.

The researchers tested the effectiveness of the product for its ability to reduce pain and ease stiffness. However, they wrote, "There was no difference between treatment and control groups [the group taking a placebo] in terms of change in pain score, stiffness, physical function … and analgesic use."

Acupuncture could prove effective in reducing arthritis pain

Dr. Brian Berman, from the University of Maryland School of Medicine in Baltimore, led a trial study that observed the effects of acupuncture on arthritis victims, and the results were that pain was reduced 40 percent.

• They were randomly assigned to one of three treatments - genuine acupuncture, "sham" acupuncture, or a self-help course that teaches patients to manage their own condition.
• Throughout the 26 week trial, participants continued to receive their normal standard medical care, including anti-inflammatory drugs and pain relievers.
• By the eighth week, genuine acupuncture patients showed a significant increase in function compared with both the sham treatment and self-help groups.
• Overall, pain was reduced by about 40% and function improved by almost 40% in the volunteers receiving acupuncture.
• The trial, led by Dr Brian Berman, from the University of Maryland School of Medicine in Baltimore, was funded by the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Arthritis and Muscoloskeletal and Skin Diseases (NIAMS).
• NCCAM director Dr Stephen Straus said: "For the first time, a clinical trial with sufficient rigor, size, and duration has shown that acupuncture reduces the pain and functional impairment of osteoarthritis of the knee.
• NCCAM has been building a portfolio of basic and clinical research that is now revealing the power and promise of applying stringent research methods to ancient practices like acupuncture."
• Dr Berman said: "This trial, which builds upon our previous NCCAM-funded research, establishes that acupuncture is an effective complement to conventional arthritis treatment and can be successfully employed as part of a multidisciplinary approach to treating the symptoms of osteoarthritis."
• Sham acupuncture, which has been employed in a number of other trials, has been criticised for not providing a fool-proof control condition.
• It is claimed that even if needles are not placed in the correct treatment points they might trigger a response in the patient.
• Because of the difficulty of faking needle insertion, designing acupuncture trials is notoriously difficult.
• In the United States, about five million people a year receive acupuncture treatment.

Nine-Year-Old With Arthritis Inspires On The Ice

Darcy Pohland

It's a disease often associated with the elderly. But 1,100 Minnesota children age 16 and younger have rheumatoid arthritis, the most serious kind.

"Sometimes I'm sad because I can't do everything that everyone else is doing," said Allie Ray, a nine-year-old fighting the disease.

But Allie isn't letting arthritis keep her on the bench. Instead, she's inspiring others through sports.

"I have good days and I have bad days," Allie said.

For a child who suffers from arthritis, putting on snow pants and boots without stiffness or pain can be a huge accomplishment.

"It's usually in my knees or ankles, fingers or wrists," she said.

Allie was just six when she was diagnosed with arthritis. Her mother noticed a swollen ring finger.

"We were dumbfounded," said Allie's mother, Leslie Ray.

"I thought only old people got arthritis," Allie said.

Despite her limitations, Allie perseveres physically. She dances, figure skates, plays soccer and loves hockey.

"It's quite unusual for children to be that active with arthritis," Leslie said.

Allie helps manage her pain and stiffness with medications and common sense.

"When I hurt out there I go in right away," Allie said of her time on the ice.

But, that's not always easy.

"I feel sad that I have to sit out," she said.

Even so, Allie wants to inspire other children now and in the future. She is a junior ambassador for the Arthritis Foundation and helps other kids cope with the disease.

"I want to be a pediatric rheumatologist," she said. "That's the kind of doctor that helps kids with arthritis."

Edinburgh Researchers bring hope to arthritis sufferers

THOUSANDS of arthritis sufferers could benefit from a new pill being developed by scientists at Edinburgh's Western General Hospital.

The researchers are aiming to produce a mass-market tablet which would provide rheumatoid arthritis sufferers with a more powerful treatment than is currently widely available.

The most effective treatment available for patients at the moment is known as anti-TNF therapy. However, the treatment is so expensive only 750 patients in Scotland receive it, and patients have to undergo the discomfort of a series of injections.

The Western General scientists believe they can develop a tablet which would replace the existing anti-TNF therapy.

Dr Rob van't Hof and his team at the hospital's rheumatic diseases unit have been awarded £100,000 to develop the treatment over the next three years.

The grant has come from the Arthritis Research Campaign (ARC) which was responsible for pioneering anti-TNF drugs.

The drugs work by blocking the action of TNF (tumour necrosis factor), a molecule responsible for increasing levels of inflammation in rheumatoid arthritis sufferers.

Dr van't Hof said his laboratory had spent the last two years attempting to find a way the medication could be developed as a tablet - something which would save patients repeated trips to hospital for injections.

"We think we have now hit on the first generation of drugs that could be really useful," said the senior scientist.

"We are getting to the stage we could give it as a tablet and that would be extremely useful and a cheaper alternative to current therapy."

The medical scientists are now stepping up their laboratory tests but hope to begin clinical trials in patients within three years. If successful, the new medication could become widely available within the next decade.

"Rheumatoid arthritis is a pretty widespread disease and if we are successful, this would be of benefit to hundreds of thousands of people," said Dr van't Hof.

"You could never claim to have found a cure for rheumatoid arthritis because it is something which would return as soon as you stopped taking the treatment.

"But what we are hoping for is to control the disease and make people have a decent life, a good quality of life, without the pain and without the crippling side effects."

Rheumatoid arthritis is a disease in which the lining of the joints become swollen, causing damage to the bone in the joint.

Almost 400,000 people in the UK have the disease and there are more than 6000 sufferers in the Lothians, 175 of which receive anti-TNF treatment. About three times as many women as men are affected.

People with the degenerative disease often begin to complain of stiffness between the ages of 40 and 50. In severe cases, it can impede walking to the extent that victims need to use a wheelchair.

The Arthritis Research Campaign raises funds to promote medical research into the cause, treatment and cure of arthritic conditions and currently funds £3 million of research in Edinburgh.

A spokeswoman said: "Dr van't Hof's research, while in its early stages, has great potential and could lead to more people with rheumatoid arthritis being able to get on to therapies that may transform their lives.

"At the moment the high cost of anti-TNF drugs means that not all patients who need them get them and producing a cheaper alternative could make a real difference to a very large number of people."

Professor of rheumatology at the Western General Hospital, Stuart Ralston, said if Dr van't Hof's work was successful it would be welcomed.

He said: "Anti-TNF therapy is a very effective treatment, probably the most effective, but the production costs are high. Obviously in the NHS this is an issue so we have to limit its use to the most severe patients. We think this is a fantastic project and certainly worth pursuing."

Wonder drug 'gave me my life back'

FORMER factory worker Isabella Inglis was wheelchair-bound and in excruciating pain because of arthritis until doctors gave her what she believes is a wonder drug.

Miraculously, after spending nine months in hospital, unable to move without help, she can now walk again and has an active social life.

The grandmother said thanks to weekly injections with anti-TNF drug therapy, she can now walk again and enjoy an active social life.

She said: "I have got my life back. It's amazing. I am still sore but I can walk and I can go out and do so much more than I have been able to do in the past. It's brilliant."

Mrs Inglis, 68, of Bo'ness, was finally able to leave hospital five years ago after doctors at the Western General Hospital decided she would benefit from the treatment.

The first signs of rheumatoid arthritis set in when she was only 28 and from there her condition degenerated rapidly. Since then, she has endured an ankle and two knee replacements.

Recalling life before the treatment, she said: "I just couldn't move and I was so sore I had to get lifted in and out of bed, showered, washed and dressed.

"I couldn't do anything for myself. I was so sore that anytime anyone touched me I would cry - it was excruciating.

"I am still sore but now I can put up with it and I can take painkillers. I can go to the bingo and I no longer have to rely so much on my husband. I am so lucky because I had a good doctor and I have got my life back."

The role of Type II Collagen in rheumatoid arthritis

Rheumatoid arthritis ( RA ) is an autoimmune disease characterized by chronic inflammation of the joints, which gradually erodes the cartilage and bone.
The agents of destruction include inflammatory cells, cytokines, and protein-degrading enzymes known as matrix metalloproteinases ( MMPs ).
The vicious cycle begins when inflammatory cells infiltrate the tissue lining the joints and consume excess oxygen.
In addition to unleashing MMPs, the oxidative stress provokes non-enzymatic glycation – a chemical binding of sugar molecules and proteins. Telltale signs of glycation have been found in blood, urine, and synovial fluid of rheumatoid arthritis patients.

The primary protein in cartilage, Type II Collagen ( CII ) is crucial to joint health and function. Yet, the involvement of CII in the process of joint inflammation has proven difficult to substantiate. To gain a clearer understanding of CII's role in the pathogenesis of rheumatoid arthritis, researchers at Queen Mary, University of London and others studied its behavior within an inflamed joint, when modified by oxidants linked to inflammation or by ribose, a five-carbon sugar common to all living cells.

For their investigation, the researchers collected blood serum samples from 31 rheumatoid arthritis patients. Between the ages of 65 to 93 years, the patients had disease in varying stages and were receiving different treatments.
For control purposes, serum samples were also collected from 41 patients with other inflammatory joint diseases, including osteoarthritis and lupus, as well as back pain, osteoporosis, and gout. Both rheumatoid arthritis and non-RA samples were analyzed for their ability to bind to pure and natural CII, obtained from bovine cartilage, and to CII that had been chemically modified.
The modified CII included three oxidants present in the rheumatic joint – hydroxyl radical, hypochlorous acid, and peroxynitrite – and ribose.
The results were evaluated by a state-of-the-art 3-D fluorescent profile, followed by enzyme-linked immunosorbant assay ( ELISA ) and Western blotting.

Of the 31 rheumatoid arthritis serum samples analyzed, only 3 showed antibody binding to natural CII – affirming this protein as an innocent bystander in autoimmunity and its inflammatory toll on the joints.
However, the percentage of samples that exhibited antibody binding increased 4-fold when tested with modified CII.
In fact, 45 percent of all rheumatoid arthritis samples were assessed with moderate to strong antibody binding reactions. CII treated with hypochlorous acid was the most reactive, followed by CII treated with peroxynitrite, glycation, and hydroxyl radical, respectively. In contrast, only 1 non- rheumatoid arthritis sample showed strong antibody binding to modified CII.

" The present findings support the possibility that chemical modification of self antigens, in rheumatoid arthritis in particular and in inflammation in general, is the cause of formation of neoepitopes," reflects the study's leading author, Ahuva Nissim. " We propose that the oxidative modification of CII creates a CII autoantigen." This hypothesis has important implications for the further study and enhanced understanding of the pathology of rheumatoid arthritis.

November 2000 NEJM article about VIGOR trial left out heart attack data.

Merck Concealed

NEJM (The New England Journal of Medicine) has dropped a bombshell in an editorial, Expression of Concern, written by Jeffrey M. Drazen, M.D. (the journal's editor-in-chief), George D. Curfman, M.D. (executive editor), and Stephen Morrissey, Ph.D. It is alleged in the editorial that Merck & Co., the maker of Vioxx, withheld data and information that would affect conclusions drawn in the manuscript about the VIGOR (Vioxx Gastrointestinal Outcomes Research) study which appeared in the New England Journal of Medicine on November 23, 2000.

The VIGOR study compared gastrointestinal events in rheumatoid arthritis patients who were randomly assigned Vioxx or naproxen. Cardiovascular events were also monitored during the study. Three myocardial infarctions (heart attacks) which occurred in the Vioxx group were not included in data submitted for the NEJM article.

NEJM Editors Didn't Think Information Was Intentionally Concealed

NEJM editors learned about the myocardial infarctions in 2001 from updated information made public by the U.S. Food and Drug Administration (FDA). NEJM editors believed the information about myocardial infarctions which occurred in the Vioxx group during the VIGOR trial was learned too late to be included in the November 23, 2000 article published in NEJM.

However, a memorandum dated July 5, 2000 which surfaced following subpoena during the ongoing Vioxx litigation has revealed new information. At least two authors of the November 23, 2000 article knew about the myocardial infarctions before the manuscript was submitted to NEJM and 4 1/2 months before publication of the article.

The Discrepancy Which Revealed The Omission

Merck had submitted the manuscript for the November 23, 2000 article about the VIGOR trial on paper and also on a computer diskette. Editing of the manuscript was based solely on the print version. NEJM did not review the computer diskette until October 5, 2004, just days after Merck pulled Vioxx from the market. The review of the computer diskette revealed that information about the three myocardial infarctions was not included in the print manuscript.

Drazen, Curfman, and Morrissey claim in their editorial that by concealing the information about the myocardial infarctions, conclusions were drawn in the published article which were inaccurate.

Back In Merck's Court

Authors of the VIGOR article have reportedly been asked to submit a correction to NEJM. A response to the allegations is expected from Merck. Meanwhile, Merck continues to battle in court over its liability in more than 7,000 lawsuits. The legal liability which some analysts estimate to be about $50 billion caused Merck to announce the termination of 7,000 jobs and closing of eight research and production facilities just last week.

Instructor uses tai chi to help others get relief from pain, relax

By Alexia Campbell

Since the moment Adele Gold saw a man practicing tai chi on the Inca Trail in Peru, she knew she had to try it. Fifteen years later, she is still learning,— and teaching it.

The circular, synchronized movements Gold shows her class not only improve the flow of chi energy, they also relieve arthritis pain. Twice a week, she teaches more than a dozen students at the Arthritis Foundation in West Palm Beach how to use motions from the 600-year-old Chinese practice to target discomfort in their joints.

"I've seen improvements in people as far as pain and even flexibility," she said. "It also takes some of the stress away from everyday life."

The controlled movements have relieved some of the arthritis soreness Gold suffered from for years. Now she says she has more strength in her legs and motion in her neck and back. Gold teaches the low-impact sun style, which avoids deep knee bending.

The ancient exercise does more than soothe physical pain.

"It's very meditative," she said. "You're thinking of nothing but what you are doing."

The concentration on breathing and fluid gestures is one of the reason's tai chi is referred to as "meditation in motion." Gold leads her students through such sequences as the "brush knee" and the "wave hands like clouds," which require complete focus and attention. Although tai chi has martial arts roots, its movements resemble a slow, graceful dance.

Gold studied the art form for several years in Stuart before receiving her teaching certificate through the Arthritis Foundation. After giving classes at a health club and at a retirement home in Palm Beach County, Gold now prefers teaching through the Arthritis Foundation, where she says students are more dedicated and likely to return.

Before her first encounter with tai chi, Gold decided to follow in her brother's footsteps and study medicine. She graduated from the University of Kentucky with a degree in medical technology.

After her first visit to West Palm Beach soon after, she decided she could not leave the area.

"I came for a vacation and stayed for 55 years," she said.

Gold worked at Good Samaritan Hospital in the medical lab.

She eventually met and married Martin Gold, a schoolteacher and coach. One of the many activities she enjoyed with him was tennis.

Now a widow, Gold plays tennis twice a week and maintains her active lifestyle.

If a few days pass without exercising, Gold says she begins to feel stiffness and aching. Yoga is another outlet for her which she says improves her balance.

"Any exercise is good, just moving makes you feel better, go and walk around the block at least," she said.

Marijuana intended for elderly arthritis sufferers, court told

A Darwin court has heard that a man who has pleaded guilty to growing marijuana intended to supply it to elderly people suffering arthritis.

Craine Lucas Wattam, 37, pleaded guilty in the Northern Territory Supreme Court to unlawfully cultivating a commercial quantity of cannabis.

Police discovered the 45 plants when they visited his Darwin River property on an unrelated matter in January this year.

The court heard that Wattam had been approached to grow the plants by a group of elderly people in Palmerston who used the drug to relieve symptoms of arthritis.

Their own backyard plants had been persistently raided by thieves.

The court heard Wattam had simply scattered seeds in pots and did not intend to grow that number of plants. Nor did he intend on profiting from them.

He has been sentenced to nine months' jail suspended immediately.

Gold injections treat lion's arthritis

ROME -- Veterinarians at Rome's zoo treated an elderly lion for arthritis by inserting some 50 gold pellets into the animal's muscles, officials said Wednesday.

The Asian lion, named Bellamy, had difficulty walking until the procedure two weeks ago in which 24-karat gold pellets were inserted into his spinal muscles near the joints, said the zoo's chief veterinarian, Klaus Gunther Friedrich.

He said the gold helps to relieve muscle contraction around painful areas. The technique has been used before on dogs, cats and a tiger, but Friedrich said Bellamy was believed to be the first lion to undergo the treatment.

Friedrich said he did not believe the small amount of gold used was worth much.

"The lion is getting old. If we hadn't intervened, the situation would have got worse," crippling the lion's mobility, Friedrich said.

Bellamy is nearly 13 years old, Rome's Bioparco zoo said. Life expectancy in the wild is around 16 years, but it can be longer for lions in captivity.

After the 3 1/2-hour operation, Bellamy appeared a little weak and shaky but was able to walk. Small dots along his back indicate where the injections were made.

"I think he lost his pain now. Obviously, I can't ask him but I can observe him and it looks like the pain is absolutely reduced. It's a great result," Friedrich said.

Toenails point to arthritis risk

Low selenium level in nails is associated with osteoarthritis of the knees

Low levels of the mineral selenium in toenails have been linked with an increased risk for having worn out knee joints.

The finding suggests selenium supplements may someday have a role in treating or preventing osteoarthritis, the wear-and-tear form of arthritis, says Dr. Joanne Jordan, an associate professor of medicine and orthopedics at the University of North Carolina in Chapel Hill.

"These data are preliminary but they certainly clear the way for future studies to confirm these results and to examine whether selenium supplements, taken in the right quantities, can reduce the development and progression of osteoarthritis."

She says toenails, which grow slowly, provide a better estimate of selenium in the body over a longer period of time than blood testing.

Jordan and her colleagues analysed toenails for selenium in 940 people whose average age was 60 years.

"The lower the selenium level was, the more severe the osteoarthritis. Looked at another way, for every 0.1 part per million increase in the toenail selenium level, the odds of having knee osteoarthritis went down by about 15 per cent."

People with the most selenium in their toenails were 40 per cent less likely to have knee osteoarthritis than those with the lowest levels.

Jordan says this is the first study of its kind to show this, so more studies will be needed to verify the findings.

dnaJP1 appears effective for rheumatoid arthritis

Researchers at the University of California, San Diego ( UCSD ) School of Medicine have announced successful completion of Phase II clinical trials of a novel drug for the treatment of rheumatoid arthritis ( RA ).

The new drug, dnaJP1, is a peptide derived from a naturally occurring protein, dnaJ, which generates inflammation in rheumatoid arthritis patients, whose inflammatory-control mechanisms are impaired. The impairment causes the body’s T cells – which trigger inflammation to kill and clear foreign pathogens in the body – to attack the body’s own tissues.

“ In essence, we re-educated the immune system T cells to be tolerant of the dnaJP1 amino acid sequence, which would usually contribute to inflammation in rheumatoid arthritis patients,” Salvatore Albani, director of the Translational Research Unit of the Clinical Investigation Institute ( CII ) at the UCSD School of Medicine, said.

DnaJP1 works by resetting the ability of the patient’s immune system to tolerate dnaJ, thus transforming a potentially damaging trigger into a tool for controlling the disease.
Oral ingestion of dnaJP1 is key, because the mucosal immune system found in the gut has the ability to “teach” the body to view a protein as one that isn’t dangerous or foreign. Much as food is ingested into the body and not rejected, the body tolerates dnaJP1.

Current medications for treating rheumatoid arthritis range from anti-inflammatory drugs, such as Aspirin, to corticosteroids and medicines that alleviate symptoms by suppressing or killing the body’s immune response, basically crippling the body’s ability to defend itself against other infectious diseases or cancer.

“ Such drugs are costly, have potentially dangerous side effects and are inconvenient to administer,” Albani said. “Our drug leaves the patient’s natural immune responses intact. This differs profoundly from what is currently available to patients.”

DnaJP1 was found effective in a double-blind, placebo-controlled trial sponsored by the National Institutes of Health, which took place between 2000 and 2005 and involved 160 patients enrolled in centers nationwide including UCSD, Stanford University, Johns Hopkins University, the Mayo Clinic, and Virginia Mason Medical Center in Seattle.

Patients received 25mg of dnaJP1 daily by mouth for six months, and the treatment was found to be safe and well-tolerated. When compared with a placebo, patients in the treatment group experienced lessening of symptoms such as swollen joints, tenderness, pain and decreased mobility.

Improvement was particularly significant at the follow up visits, indicating a lasting effect of the drug. Efficacy was quantified in data generated from physicians, patients and laboratories, measuring improvement according to standards set by the American College of Rheumatology ( ACR ) from the beginning to later points in the trial.

ACR 20 response was in the 50-55% range; ACR 50 in the 30-40% range; and ACR 70 in the 15-20% range of patients completing the trial.

Rheumatoid arthritis, or inflammation of the joints, is a chronic, painful disease affecting one percent of the U.S. population, or more than 2 million people. It occurs three times more often in women than men, targeting people of every age. The condition simultaneously strikes joints on both sides of the body, such as the hands or feet or knees but can also affect the skin, eyes, lungs, heart, blood, nerves or kidneys. It is an incurable disease, with most therapies focusing on symptom relief.

“ Although the current available drugs pose risks to patients, the first two trials of dnaJP1 have not raised any significant safety concerns and offer an improved treatment option for patients with rheumatoid arthritis,” said Albani.

Arthritis sufferers misusing painkillers�

ISLAMABAD: Thousands of patients with severe arthritis are adding over-the-counter medication to prescribe drugs because GPs are limiting their doses amid safety fears.

The effectiveness of conventional painkillers is being hamstrung by concerns about their side effects, such as bleeding and other severe intestinal problems which can be fatal, according to researchers including Martin Green, chief executive of the charity Counsel and Care for the Elderly.

They report that GPs are not always prescribing to appropriate levels, meaning the drugs are not controlling pain as they should, and that doctors seem reluctant to use a new generation of drugs which have fewer side effects. Patients, therefore, are often turning to other pain-relieving drugs and creams instead.

Work by Mr Green and Brian Crichton, a GP and GP trainer in the West Midlands, suggests that a quarter of patients take over-the-counter medications as well as their prescriptions, and a quarter of doctors order low doses for drugs they prescribe, hoping they can control pain without side effects.

The pair report the findings from an electronic poll of 2,000 doctors and questionnaires returned by more than 3,100 patients with osteoarthritis in the journal Current Medical Research and Opinions. The research was funded by the drug company Merck Sharpe and Dohme.

It is thought that 2,000 people a year might die from complications linked to conventional treatments, still small compared with the millions suffering from osteoarthritis - many of whom are not on prescription drugs at all.

The research suggests patients are four times more likely to be dissatisfied with the poor pain relief caused by the drugs than by side effects such as stomach upsets.

The government's national institute for clinical excellence, which monitors the cost-effectiveness of treatments, last year endorsed the new generation of drugs only in those patients who might be at high risk of developing stomach side effects.

These included people over 65, those with gastrointestinal problems, and those already taking other medicines that could cause ulcers. The drugs themselves cost more money, but their supporters argue they more than make up for that by preventing return visits to GPs, hospital treatment and the need for other drugs to counter side effects.

Dr Crichton said: "If you are on a prescription painkiller and it is not working for you don't add another painkiller you have bought yourself. Always ask the advice of your doctor or local pharmacist."

Long protest brings arthritis relief

A self-employed gardener from Lyttelton is celebrating after taking on the Government and winning.

Devoted dad Richard Crowe spent months protesting after discovering a subsidised drug – TNF alpha inhibitor drug adalimumab (Humira) – which helped his young daughter cope with debilitating rheumatoid arthritis, was not available to other sufferers in New Zealand.

"I was pretty angry about it," Crowe said.

"It seemed as if people (who) were too ill to stand up for themselves weren't getting a good deal."

Crowe had seen his 13-year-old daughter, Rebecca, respond to the drug – described as a miracle cure – by resuming active life and going to school full-time, having had to rely on a wheelchair beforehand.

The drug, which costs up to $30,000 a year, is subsidised by government drug-buying agency Pharmac for sufferers who begin using it as children, but not for those diagnosed as adults – despite being just as effective for older patients.

Crowe, who is the spokesman for Arthritis Action, came into contact with up to 300 sufferers who were prevented from receiving the drug except by paying for it privately, including young people unable to have children or continue university studies because of their illness.

Crowe spent 20 hours a week for six months on the campaign, and took the fight to the Human Rights Commission on the grounds of age discrimination.

The hard work paid off in May, when the commission accepted Pharmac's policy was discriminatory.

On Monday, the agency announced that from January 1 it was releasing funding so the drug could be subsidised for anyone with severe rheumatoid arthritis.

Crowe said members of his group were "over the moon" on hearing of the decision.

"For some of these people it's as dramatic as getting up from their wheelchairs and walking. Certainly, for my daughter, she couldn't even sit up. Now she's going to school full-time."

Pharmac said the investment was worth $35 million over the next five years, with up to 1000 people expected to be prescribed the drug by the end of that period.