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A beer, a denim jacket and a Man U strip… my memory box for Dad

November 30, 2006

When a loved one is facing a terminal illness, it deeply affects the whole family, right down to the youngest, as the McCluskey family from Comber discovered. In order to cope, even the strongest of families need support. Ann McCluskey tells Jane Bell how Northern Ireland Hospice Care helped her family through, and far beyond, her husband Jim’s death from lung cancer and why they want to give something back to the charity during its Christmas appeal
30 November 2006

When the end was inevitable, Jim McCluskey knew that he wanted to die in his own bed at home, with his family around him. Ann, his wife of 34 years, and their seven children were able to see it through, with the help and support of Northern Ireland Hospice Care.

“The support the Hospice gave us helped us give Jim what he wanted and that, in turn, gave me comfort,” Ann says.

Jim, a former youth football coach, died in March last year at the age of 56, just six months after being diagnosed with lung cancer.

“He was one of those people who hated going to the doctor and anything to do with hospitals,” says Ann. “He had to be coaxed every time.”

By the time it could be put off no longer, the outlook was very poor. From his diagnosis in September 2005, he wasn’t expected to make it to Christmas. As he faced his last months, for Jim there was no question: home was where he wanted to be, with his family.

“I sat with him all day, every day,” says Ann, “and his sister, Lottie, sat with him at night, so I was able to rest and carry on the next day.”

Early death

While her husband’s early death, before they could even begin to enjoy a well-earned retirement together, hurts deeply, it soothes Ann that they were able to nurse him at home.

“We’d been together since I was 17 and he was 21,” she says simply. “I miss him every day, but it does helps that we were all there for him right to the last and that he got his wish to be at home to the end.”

The McCluskeys are a big family - the eldest son, also named Jim, turns 35 at Christmas, quickly followed by brother Darwin (34) and sisters Annette (32) and Fiona (31) and, after a gap, Jonty (now 20) and 18-year-old Marty. The youngest sibling, Aaron, is just nine, little older than some of Ann’s seven grandchildren. And, as a family, it was instinctive to pull together.

Even so, extra support was welcome in their hour of need. “Jim was mobile until after Christmas. He was still at home, but had to go back into hospital briefly for tests and treatment,” Ann explains.

Given the advanced stage of his aggressive cancer, he decided not to go down the route of radiotherapy and chemotherapy, but to spend the time remaining to him at home.

The family was put in touch with Hospice nurse specialist Sue Foster, who became a regular visitor. “As well as nursing care and sorting out medication, Sue was very supportive. Whatever we wanted to do, she would help,” says Ann.

“She listened to Jim’s fears and he was able to talk to her. There may have been things Jim didn’t want to burden us with. And whatever helped him, helped us.”

Minimise stress

After one necessary hospital stay, for an operation, medics feared he wouldn’t make it.

When he did rally and was able to be moved, the family took him home right away. Ann praises the hospital staff’s care and understanding - even bending the rules to allow Jim to be admitted on the day of his operation, rather than the customary night before, to minimise his stress.

“When it came down to it, he didn’t want to die in hospital. He wanted to die in his own home, with all of us close at hand,” Ann says. For the last five weeks when he was bedridden at home, Sue came out and helped us through.

“For the last two days he was on oxygen and they had to increase his medication for pain relief. But, with Hospice help, it was still possible to care for him here. He got the death he wanted - and that gave me ease.”

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Careful path

It was a trial for everyone in the family but, at the time, it was impossible to tell how the loss of his father was affecting young Aaron, who was just seven. Ann had trod a careful path between preparing the child in advance and protecting him.

She recalls: “I tried to break it to him gently, telling him during the illness that his daddy was sick and there are some sicknesses you just can’t cure.”

Breaking the news of Jim’s death, she took the child aside and tried to explain to him in simple visual terms, using a cast-off dressing gown, her belief that while the body is left behind, the soul goes on. With the rest of the family, Aaron had viewed the body and attended the funeral.

He appeared to be coping well but months later it seemed to really hit him. “After Christmas he was really angry all the time,” explains Ann. “Everything seemed to annoy him. It only seemed to be hitting him then.”

Again, when they needed help, the Hospice team stepped in. Lorraine Graham, social worker at Northern Ireland Hospice Care, offered one-to-one counselling which, Ann says, made all the difference.

The conversations which drew Aaron out were more like gentle, exploratory ‘games’ that allowed him to express what was really going on.

It emerged, for instance, that other children had been teasing him about not having a dad. And it came out in conversation that the child had been fretting about a time, when his father was bedridden, he had come bursting noisily into the room, tripped and had been told “Be careful, your daddy’s sleeping, he’s sick”.

“Nobody else even remembered it,” says Ann. “The Hospice team are wonder workers. And their support doesn’t end with the death. The counselling really helped Aaron. He calmed right down again.”

Memory box

He and his mum have since attended a bereavement weekend organised by Northern Ireland Hospice Care and plan to go away on the next weekend, to be held at Corrymeela.

“It was good to meet other parents in the same position, to be able to talk and express your concerns,” she adds. “And it helped Aaron to meet other children his age who had lost a parent.”

Ann helped her youngest boy put together a memory box containing special things like the now outgrown denim jacket and Manchester United strip Jim gave his son.

“He even insisted on putting a can of beer in there ‘for Daddy’,” she smiles.

Everyone in the family has their own way of remembering. When younger daughter Fiona married in August, an extra ‘button hole’ bloom was ordered for her late father.

Her mother-in-law, Geraldine, also died of lung cancer just a month after the ceremony.

As the second Christmas since Jim’s death approaches, the family will be taking an active part in the Northern Ireland Hospice Care Christmas Lights appeal, which culminates in the Ceremony of Lights on December 19.

The McCluskeys will be there and hope that many others will show their support, too.

Anyone wishing to sponsor a light can make a donation to Northern Ireland Hospice Care, Head Office, 18 O’Neill Road, Newtownabbey

Posted by toshko under Pain Relief News | Comments (0)

FDA - MedWatch - Dolophine (Methadone Hydrochloride) - Reports of Death, Narcotic Overdose, and Serious Cardiac Arrhythmias

November 28, 2006

ROCKVILLE, Md., Nov. 27, 2006-FDA notified healthcare professionals of reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone’s cardiac toxicities (QT prolongation and Torsades de Pointes).

The reports underscore the importance of knowing methadone’s toxicities and unique pharmacologic properties, including dosing and monitoring recommendations.

FDA Public Health Advisory
Methadone Use for Pain Control May Result in Death and
Life-Threatening Changes in Breathing and Heart Beat

FDA has received reports of death and life-threatening side effects in patients taking methadone. These deaths and life-threatening side effects have occurred in patients newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers. Methadone can cause slow or shallow breathing and dangerous changes in heart beat that may not be felt by the patient.

Prescribing methadone is complex. Methadone should only be prescribed for patients with moderate to severe pain when their pain is not improved with other non-narcotic pain relievers. Pain relief from a dose of methadone lasts about 4 to 8 hours. However methadone stays in the body much longer—from 8 to 59 hours after it is taken. As a result, patients may feel the need for more pain relief before methadone is gone from the body. Methadone may build up in the body to a toxic level if it is taken too often, if the amount taken is too high, or if it is taken with certain other medicines or supplements.

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To prevent serious complications from methadone, health care professionals who prescribe methadone should read and carefully follow the methadone (Dolophine) prescribing information PDF document

FDA is issuing this public health advisory to alert patients and their caregivers and health care professionals to the following important safety information:

* Patients should take methadone exactly as prescribed. Taking more methadone than prescribed can cause breathing to slow or stop and can cause death. A patient who does not experience good pain relief with the prescribed dose of methadone, should talk to his or her doctor.

* Patients taking methadone should not start or stop taking other medicines or dietary supplements without talking to their health care provider. Taking other medicines or dietary supplements may cause less pain relief. They may also cause a toxic buildup of methadone in the body leading to dangerous changes in breathing or heart beat that may cause death.

* Health care professionals and patients should be aware of the signs of methadone overdose. Signs of methadone overdose include trouble breathing or shallow breathing; extreme tiredness or sleepiness; blurred vision; inability to think, talk or walk normally; and feeling faint, dizzy or confused. If these signs occur, patients should get medical attention right away.

FDA recently approved new prescribing information for methadone products approved for pain control. The information in the new prescribing information is based on a review of the scientific literature completed by FDA. A Medication Guide for patients is planned.

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CACI: Torture in Iraq, Intimidation at Home

November 22, 2006

Dogged by serious allegations of human rights abuses in Iraq, a leading profiteer from the Iraq war engages in intimidation campaigns against journalists in America who seek to expose its practices.

Consider the unique problems faced by the corporate suits at CACI International, a defense contractor whose services have included “coercive” interrogations of prisoners in Iraq - interrogations most people simply call “torture.”

Think about the image problems a major multinational corporation faces after becoming inextricably linked with the abuses at Abu Ghraib, a firm whose employees have contributed to the iconic images of the occupation of Iraq - the symbols of American cruelty and immorality in an illegal war. What can a company like that possibly do to protect its brand name after contributing to the greatest national disgrace since the My Lai massacre?

CACI’s strategy has been two-fold: its flacks have distorted well-documented facts in the public record beyond recognition, and its senior management has lawyered up, suing or threatening to sue just about every journalist, muckraker and government watchdog who’s dared to shine a light on the firm’s unique role as a torture profiteer.

Lately, the company’s sights have been set squarely on Robert Greenwald, director of Iraq for Sale: The War Profiteers, in which CACI plays a starring role. Greenwald has been in a back-and-forth with CACI’s CEO, Jack London, and its lead attorney, William Koegel, during “months of calls, emails and letters” in what Greenwald calls a campaign to “intimidate, threaten and suppress” the story presented in the film.

“The threatening letters started early, trying to get us to back off,” Greenwald told me. “We refused, and went back at them with a very strong letter saying, ‘no, you’re war profiteers and we won’t be silenced.’ Like any bully, they backed down when confronted. No lawsuit was filed- they’re a paper tiger.”

The story they don’t want told is of a federal contractor that, according to the Washington Post, gets 92 percent of its revenues in the “defense” sector. The Washington Business Journal reported that CACI’s defense contracts almost doubled in the year after the occupation of Iraq began, and profits shot up 52 percent.

Yet CACI insists it isn’t a war profiteer (a subjective term anyway), but was just answering an urgent call in Iraq. In a letter to Greenwald, Koegel wrote: “the army needed … civilian contractors to work as interrogators” because the military didn’t have the personnel, and CACI responded to the “urgent war-time circumstances” and “has no apologies.”

But while the firm had experience in electronic surveillance and other intelligence functions, it, too, didn’t have the interrogators. Barry Lando reported finding an ad on CACI’s website for interrogators to send to Iraq, and noted that “experience in conducting tactical and strategic interrogations” was desired, but not necessary. According to a report by the Army inspector general, 11 of the 31 CACI interrogators in Iraq had no training in what most experts agree is one of the most sensitive areas of intelligence gathering. The 205th Military Intelligence Brigade, which was in charge of interrogations at Abu Ghraib when the abuses took place, didn’t have a single trained interrogator.

“It’s insanity,” former CIA agent Robert Baer told The Guardian. “These are rank amateurs, and there is no legally binding law on these guys as far as I could tell. Why did they let them in the prison?”

That’s one of many questions the company doesn’t care to have asked. It’s common for corporations to be fiercely protective of their brand’s image, often obsessively so. That’s true of multinationals selling soda pop or accounting services or military intelligence. But a company on a federal contract that rents out interrogators who become involved in a torture scandal that ends up splashed across the cover of Time Magazine - that’s the kind of thing that can be a real problem for the PR flacks back at corporate headquarters.

Colonel William Darley with the Military Review wrote of Abu Ghraib’s impact:

We have never recovered from the Abu Ghraib thing. And it’s likely all the time we’re in Iraq, we never will. It will take a decade and beyond. I mean, those pictures, a hundred years from now, when the history of the Middle East is written, those things will be part and parcel of whatever textbook that Iraqis and Syrians and others are writing about the West. Those pictures. It’s part of the permanent record. It’s like that guy in Vietnam that got his head shot. It’s just a permanent part of the history. That will never go away.

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But CACI’s tried hard to make it go away. The company sued Air America Radio host Randi Rhodes for $11 million for defamation, including $10 million in punitive damages. The supposed defamation? Rhodes read a portion of an interview with Janice Karpinski, the former Brigadier General who commanded the MPs at Abu Ghraib. The suit was dismissed with a summary judgment in April.

After the Institute for Policy Studies named CACI and CEO London in its annual “Executive Excess” report on CEO pay, they received “a blistering seven-page letter” from London himself, demanding that CACI be removed from the report. Later, Sarah Anderson, one of the study’s co-authors said she got “a rather ominous email just saying that they were monitoring everything I wrote about them.”

Then a blogger at Blogcritics got the “CACI treatment” for reporting on the Air America suit, as did the online media watchdog Newsbusters. When David Rubenstein, a columnist for the alternative paper Pulse of the Twin Cities, wrote an article about former Minnesota Congresman Vin Weber that mentioned CACI, it triggered, as Rubenstein would later recall, “a bombastic two-page single-spaced letter” from London with a “wholesale attack on my credibility.” Runbenstein wrote of London’s letter:

He doctors a quote from a newspaper interview. He quotes selectively from a Senate hearing. He constructs logical absurdities and lays them out as if they were pronouncements from an oracle. Apparently he thinks because he is the CEO of a $1.6-plus billion company that is willing to throw its weight around, he can say whatever he wants. It’s a calculated strategy to shut down critics.

According to the New Standard, CACI has even characterized suits brought against it by human rights lawyers as slander. In a press release responding to a case brought by the Center For Constitutional rights on behalf of prisoners abused at Abu Ghraib, CACI’s attorneys said the firm “rejects and denies the allegations of the suit as being a malicious recitation of false statements and intentional distortions” and called the allegations of abuse “ill-informed” and “slanderous.”

After the article ran, The New Standard got a threatening letter (PDF) that quickly made its way around the internet.

CACI’s problem is, ultimately, with reality. The firm claims that it was vindicated by the military’s investigations into Abu Ghraib, including in a Washington Post editorial by Koegel in which he wrote that “no CACI employee has been charged with any misconduct in connection with interrogation work.” It’s technically true in that no CACI employee has faced formal charges - it’s unclear what jurisdiction civilian contractors in Iraq fall under, if they fall under any - but the Taguba Report (PDF) said that CACI’s Steven Stephanowicz had encouraged MPs under his command to terrorize inmates, and “clearly knew his instructions equated to physical abuse.”

The irony is that by trying to spin Abu Ghraib and bully the media into ignoring the story, CACI has violated the fundamental rules of corporate crisis management. PR consultants who specialize in the field talk about the “Tylenol model” - named for the pain-relief medication that faced a crisis in the 1980s after some of its bottles were found to contain cyanide. According to the experts, companies facing a crisis must “demonstrate concern, care and empathy” for the victims of its actions and should always “treat the media as a distribution channel, not as enemies.” Rule number one is: “take responsibility.”

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New Safety Data Presented on Osteoarthritis Pain Medication Lumiracoxib

November 21, 2006

Lumiracoxib reduced risk of upper gastrointestinal ulcer complications in both younger and older patients compared to traditional NSAIDs, according to latest findings1

New sub-analysis showed NSAID treatment for 4 weeks significantly increased blood pressure compared to lumiracoxib2

WASHINGTON, DC — November 20, 2006 — Novartis announced that lumiracoxib, an investigational oral selective COX-2 inhibitor non-steroidal anti-inflammatory drug (NSAID), reduced the incidence of ulcer complications in both younger (aged 50-65) (0.16 vs. 0.60%, P =.0006) and older (aged 65 and older) (0.55 vs. 1.34%, P =.0004) patients.1 Another subanalysis showed that NSAID treatment for four weeks significantly increased blood pressure compared to lumiracoxib.2 These new post-hoc subanalyses from the largest, published, one-year gastrointestinal outcomes study of osteoarthritis (OA) patients to date, Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), are being presented at the 70th annual meeting of the American College of Rheumatology (ACR).

“Many patients are at significant risk of ulcer complications if they take non-selective non-steroidal anti-inflammatory drugs (NSAIDs). The TARGET study showed a 79% reduction in patients on lumiracoxib compared to naproxen and ibuprofen.” said lead investigator Professor Chris Hawkey, University Hospital, Nottingham, United Kingdom. “Lumiracoxib has been extensively studied, and if approved in the United States, its GI-safety profile could provide a much needed option for appropriate patients.”

OA is the most common form of arthritis, affecting 21 million Americans, and is a leading cause of chronic pain and disability.3

Significance of GI Safety Profile
GI safety concerns for patients using NSAIDs are much more serious than an upset stomach or heartburn.4 Up to 16,500 people in the United States are estimated to die each year as a result of severe bleeding ulcers in the stomach and intestine, which usually occur without warning.5

A sub-analysis of the TARGET study examined rates of GI ulcer complications in patients between the ages of 50 and 65 and those aged 65 years and older, treated with lumiracoxib or traditional NSAIDs.1

“People tend to experience more and more osteoarthritis pain as they get older. However, their risk for GI complications from pain medications also increases, making it very challenging to treat this population,” said Professor Hawkey. “The results of the study demonstrate a clear GI benefit in patients over 65 who were treated with lumiracoxib.”

Study patients were treated for one year with lumiracoxib 400 mg once daily (4 times the dose currently studied for OA), or the generally accepted therapeutic doses of naproxen 500 mg twice daily or ibuprofen 800 mg three times daily. Randomization was stratified by age and low-dose aspirin (ASA) use. Significant reductions were not seen in patients who were also taking low-dose aspirin (100 mg or less per day) for cardioprotection.1

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Blood Pressure Data
A second sub-analysis of TARGET compared the short-term effect of lumiracoxib to that of traditional NSAIDs on blood pressure. Compared to lumiracoxib, the NSAIDs naproxen and ibuprofen significantly increased systolic (0.4 vs. 2.3 mmHg, P <.0001) and diastolic (-0.1 vs. 0.7 mmHg, P <.0001) blood pressure after four weeks, based on the mean change from baseline. These findings are consistent with the previously reported blood pressure changes after 52-weeks of treatment in the TARGET study.2

About TARGET
The TARGET study, the largest published one-year safety outcomes study in osteoarthritis patients to date (n=18,325), has demonstrated that lumiracoxib significantly reduced the incidence of serious upper GI complications by 79% compared with the NSAIDs ibuprofen and naproxen in patients not taking aspirin.6 In a separate post-hoc sub-analysis, lumiracoxib reduced the risk of ulcer complications within the first month of use.7 Furthermore, compared to NSAIDs, lumiracoxib demonstrated a comparable cardiovascular safety profile,8 and a significantly smaller effect on blood pressure.9

In TARGET serious adverse events were reported in 6% of patients receiving lumiracoxib, the same rate seen in patients receiving non-selective NSAIDs (naproxen or ibuprofen). Adverse events requiring study discontinuation occurred in 16% of lumiracoxib patients and 18% of NSAID patients. The most frequently occurring gastrointestinal events were dyspepsia (25% of lumiracoxib patients compared with 26% of NSAID patients) and upper abdominal pain (10% vs. 13%). All other GI events occurred in less than 10% of patients in both groups.10 In a specific analysis of cardiovascular outcomes in TARGET incidence of events — defined as a primary endpoint of nonfatal and silent myocardial infarction, stroke, or cardiovascular death — was low and comparable in both groups. At one year, lumiracoxib had 59 events (0.65%) and the non-steroidal anti-inflammatory drugs had 50 events (0.55%) with a 95% confidence interval, P =.5074.9

Lumiracoxib was recently approved for use in the EU to treat OA and in Canada to treat OA of the knee. Other previously published studies have shown that lumiracoxib offered pain relief similar to the osteoarthritis medication celecoxib.11,12,13,14

Health authorities including the U.S. Food and Drug Administration (FDA) have concluded that the benefit/risk profile of selective COX-2 inhibitors remains positive when used in their target patient populations. Health authorities have determined that NSAIDs should be used at the lowest possible dose for the shortest possible duration.

About Lumiracoxib
Lumiracoxib is a selective COX-2 inhibitor that is being studied for the treatment of osteoarthritis and acute pain. Lumiracoxib has the largest body of evidence supporting the launch of any NSAID, with over 34,000 patients in a completed clinical trial database. This includes the TARGET trial, involving 850 study centers in 30 countries, which established the GI and cardiovascular safety profile of lumiracoxib.

Recent events have demonstrated that selective COX-2 inhibitors and traditional NSAIDs have both risks and benefits, and physicians need to evaluate a patient’s health history before prescribing these medications.

Lumiracoxib, under the trade name Prexige®, is already approved in more than 50 countries and is available in 15. It is expected to become available in European countries during 2007 and 2008. Novartis plans to resubmit lumiracoxib for US approval in 2007.

Posted by toshko under Pain Relief News | Comments (0)

Drug Provides Pain Relief for Fibromyalgia

November 20, 2006

(Ivanhoe Newswire) — A drug used to treat nerve pain or seizures may also be beneficial for patients with fibromyalgia, according to new research.

Fibromyalgia affects between 2 percent and 5 percent of the U.S. population — most commonly women. It’s often misunderstood, but symptoms include widespread chronic muscle pain and tenderness, fatigue, sleep disturbances and memory problems. There is no FDA-approved treatment for fibromyalgia to date.

Investigators from the University of Kentucky in Lexington conducted a study to measure the effectiveness of the drug, pregabalin (Lyrica). The study included 1,051 participants with fibromyalgia. The patients were given one of three doses of the drug for six weeks. At the beginning of the trial, the average pain score of the participants was 78 on a 100-point scale.

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Study authors found more than 60 percent of the participants reported a more than 50-percent reduction in pain. Researchers enrolled more than 500 of these patients into a second 26-week study, which was designed to determine how long the medication would relieve pain. Half received pregabalin, and the other half received a sham medication.

Study authors conclude pregabalin has a significant benefit for longer-term pain relief in patients with fibromyalgia. Researchers report the participants who did not take the medication noticed their pain had worsened by day seven compared to day 34 for those on the medication. By the end of the second study, researchers found 60 percent of the patients on placebo had their pain return compared to only 32 percent of those on pregabalin.

SOURCE: American College of Rheumatology Annual Scientific Meeting, Washington D.C., November 8-15, 2006

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Roy pIrRUNg column: When it comes to pain relief, think long-term

November 20, 2006

Have you been bombarded by an excess amount of TV commercials promoting pain relief?

Do you know what a non-steroidal anti-inflammatory drug (NSAID) is? And if you do, did you know they cause 107,000 hospitalizations and 16,500 deaths each year?

So, what is a person to do to reduce pain, and also reduce the risk for developing arthritis?

These questions need answers, so the next time you have knee pain or other joint pain, you know what to reach for.

To start with, the risk of developing arthritis can be reduced dramatically by losing weight.

At least five studies have shown that the nutrients glucosamine and chondroitin can improve the long-term effects of patients prone to arthritis.

Other studies have shown MSM (methylsulfonylmethane) to also have a significant impact.

And lastly, omega-3s, an essential fatty acid found in coldwater fish, such as salmon and tuna, as well as flax seed and its oil, offer anti-inflammatory properties.

Made from the shells of shellfish and refined corn, glucosamine stimulates cartilage and aids in synthesizing glucosaminoglycans and proteoglycans—both chemicals that assist in the repair and rebuilding of worn-out joints.

These compounds also allow cartilage to flex and absorb physical shock, while at the same time suppressing destructive chondrocytes, known to break down cartilage.

Clinical studies over a 20-year period have proven glucosamine provides many benefits.

It has been shown to slow the progression of osteoarthritis, ease osteoarthritis and joint pain, rejuvenate synovial fluid, promote healthy and flexible joints, help the body heal itself, lubricate joints and bathe the joints continually in a healthy protective fluid that builds glucosaminoglycans and proteoglycans.

Chondroitin has been studied extensively and proven to be an anti-inflammatory, more effective than NSAIDs, protecting cartilage from degenerating prematurely. It also works well with glucosamine by stimulating cartilage production.

In numerous clinical studies, which were critically analyzed, an average improvement in pain and function of 78 percent and 44 percent, for glucosamine and chondroitin, respectively, was shown.

MSM, a natural sulfur compound, is found in all living things. It actually is the third-most prominent compound in your body, behind water and sodium.

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This essential dietary sulfur is unlike those classified as bad sulfur — sulfa, sulfate, sulfite, and sulfide.

The sulfur in MSM is classified as sulfonyl and is as safe as Vitamin C, and just as important to the health of your body.

This element is needed by your body to make cell walls permeable, allowing water and toxins to flush out properly.

Working with Vitamin C, it builds healthy new cells, stimulates the growth of healthy new skin, hair and nails, while providing a flexible bond between cells.

Lastly, it has been shown to improve health problems such as arthritis and promote circulation.

Omega-3s’ anti-inflammatory properties make it a sure bet to improve health and reduce the risk of inflammatory diseases and its associated pain.

Glucosamine, chondroitin and MSM can be found in supplement form in most health food stores and may need to be taken over a period of several weeks before your body will notice its effects.

Eating more cold-water fish and using bread products containing ground flax or adding a flax supplement, such as Natural Ovens’ Flax Complete, will also produce the desired effect.

Another side effect of NSAIDs, one often overlooked in people’s desire for a quick fix, is cartilage loss.

That said, start thinking long-term when it comes to pain relief. Reach for some of the natural products available to improve joint health and eliminate one of the causes of future problems for the quick fix today.

Roy Pirrung is a World and American Ultramarathon champion, American record-holder and a member of the USA Track and Field Masters Hall of Fame.

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Oxymorphone Long-Term Trial Data Presented at the American Academy Of Physical Medicine And Rehabilitation Meeting

November 14, 2006

Long-Term Open-Label Data Presented for Patients with Chronic, Moderate to Severe Low Back Pain and Chronic Moderate to Severe Osteoarthritis Pain

HONOLULU, HAWAII — November 13, 2006 — Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., presented data from several clinical trials of Opana® ER (oxymorphone HCl) extended-release tablets CII. Results from these open-label studies were presented last week at the 67th Annual Assembly of the American Academy of Physical Medicine and Rehabilitation (AAPM&R).

Opana® ER was approved in June 2006 by the U.S. Food and Drug Administration (FDA) for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

Two of the studies presented at the meeting were open-label, one-year extensions of placebo-controlled, blinded studies in patients with moderate-to-severe chronic low back pain and osteoarthritis pain. Study results demonstrated that Opana® ER provided durable, effective pain relief in those patients who completed the full one year study period.

“Pain can be a chronic condition, and long-term trials involving pain treatments are extremely important,” said David A.H. Lee, MD, PhD, Chief Scientific Officer of Endo Pharmaceuticals. “These trial results demonstrate that, in these patients with chronic pain resulting from lower back conditions or osteoarthritis, Opana® ER provided safe, durable pain relief.”

Additionally, data from a third open-label study showed that long-term treatment with Opana® ER in opioid-naïve patients with moderate-to-severe chronic pain who completed the trial resulted in significant improvements in all pain quality of life measures, which were maintained throughout the course of the study period.

Dr. Lee continued, “Pain can often interfere with normal everyday activities and as a result can have a dramatic impact on patients’ quality of life. This trial indicates that Opana® ER minimized this disruption due to pain in these patients’ daily lives.”

Long-Term Effectiveness, Dosing and Tolerability of Opana® ER in Patients with Chronic Lower Back Pain
This open-label extension study evaluated the effectiveness, dosing and tolerability of Opana® ER in 93 patients who had completed a previous short-term, randomized, double-blind, placebo-controlled trial of Opana ER for moderate-to-severe chronic lower back pain. Patients were given Opana® ER twice a day for one year with the dose adjusted as needed and were allowed Opana® (immediate-release oxymorphone) as rescue medication for breakthrough pain as needed.

Opana® ER provided durable effective pain relief throughout the one-year trial
90.2% of patients rated their pain medication as good, very good, or excellent at final visit
Pain was measured by the Brief Pain Inventory (BPI) 0-10 point scale (higher scores indicate worst pain). Throughout the one-year study, the average pain scores ranged from 4.4-4.9 and at final visit, it was 4.6 (±2.1).

Mean daily doses of Opana® ER and Opana® increased from 93.7 mg to 135.2 mg and from 13.9 mg to 21.3 mg respectively over the one year period.

Commonly reported adverse events (<10%) included influenza, back pain, headache, upper respiratory tract infection, insomnia and urinary tract infection.

Long-Term Safety and Effectiveness of Opana® ER in Patients with Chronic Osteoarthritis Pain
This open-label extension study evaluated the safety, effectiveness and dosing of Opana® ER in 61 patients who had completed a previous randomized, placebo-controlled trial of Opana® ER for moderate to severe chronic pain associated with osteoarthritis of the knee or hip. Patients taking active drug in the previous trial were given Opana® ER twice a day at their prior dose for one year, whereas patients previously receiving placebo were given Opana® ER 20 mg twice a day for one year.

Opana® ER provided consistent and effective pain relief throughout the one-year trial
At each study visit 85% or more of patients rated their pain medication as “excellent,” “very good,” or “good”.

Pain was measured by Pain Recall Scores (Visual Analog Scale [VAS]). Recall scores for least, worst, and average pain decreased over the first six weeks and stabilized thereafter.

There was only a modest increase in the mean daily dose over the one-year period; week 1 (49.3 mg) to week 10 (55.2 mg) and week 52 (62.0 mg).

Most discontinuations were due to nonserious adverse events, which were more commonly reported in previously opioid-naïve patients.

The most commonly reported adverse events (>10%) included constipation, nausea, somnolence, diarrhea, headache and arthralgia.

Effective Dose Titration and Long-Term Treatment with Opana® ER Improves Quality of Life in Opioid-Naïve Patients with Chronic Moderate-to-Severe Pain
This open-label study evaluated Opana® ER on pain reduction and improvements in quality of life in 60 patients during long-term treatment for moderate to severe chronic pain. In this study, 126 opioid-naïve adults with moderate or severe chronic pain who responded poorly to nonopioid analgesics were gradually titrated to a stable dose of Opana® ER for three of five consecutive days. Stabilized patients continued Opana® ER treatment for up to five additional months. Sixty patients completed the follow-up period. Immediate-release Opana® was available as a rescue medication for breakthrough pain. Patients rated the impact of pain on their daily activities with a variety of quality of life measures using a 0-10 scale (0 represented no interference, 10 represented complete interference).

Opana® ER provided significant improvements in all patient-reported pain quality of life measures (including activity, work, enjoyment of life, walking, sleep, mood, and relationships)
Treatment with Opana® ER improved pain quality of life measures by 60%–70% and effects were maintained throughout the trial (P < .001 for all measures at all months).

The mean daily dose remained stable (range: 27.8–30.8 mg) with 68.1% of patients using immediate-release Opana® as a rescue medication for breakthrough pain at some point during the course of the maintenance period. Mean daily dose of rescue medication ranged from 1.3-1.5 tablets per day.

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Most common adverse events were constipation, nausea, and nasopharyngitis.

Important Safety Information
Opana® ER and Opana® are opioid agonists and Schedule II controlled substances with an abuse liability similar to morphine. Opana® ER and Opana® can be abused in a manner similar to other opioid agonists, legal or illicit.

WARNING:
Opana® ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Opana® ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Opana® ER is NOT intended for use as a prn analgesic.

Opana® ER Tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.

Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

Opana® ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery), or if pain is mild or not expected to persist for an extended period of time.

Opana® ER and Opana® are contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of Opana® ER and Opana®; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated.

Respiratory depression is the chief hazard of Opana® ER and Opana®, particularly in elderly or debilitated patients.

The most common adverse drug reactions (≥10%) in all clinical trials for Opana« ER were nausea, constipation, dizziness (excluding vertigo), vomiting, pruritus, somnolence, headache, increased sweating, and sedation. The most common adverse drug reactions (≥10%) reported in all clinical trials for Opana« were nausea and pyrexia.

About Pain
Pain of all types is under-treated in our society; however, experts concur optimal management of chronic pain requires around-the-clock coverage with an analgesic agent. More than 50 million Americans suffer from chronic pain and 25 million suffer from acute pain. Pain costs the United States more than $100 billion annually. Additionally, pain contributes to more than 50 million lost workdays each year.

About Opana ER and Opana® Tablets
Opana® ER and Opana® tablets were formulated using oxymorphone hydrochloride, a semisynthetic, pure mu-opioid agonist that had been available previously only as an injectable formulation. Both products have been proven to achieve effective relief in multiple moderate-to-severe pain models, in opioid-naïve and opioid-experienced patients. Both Opana® ER and Opana® are available by prescription only.

Opana® ER’s clinical profile has demonstrated that it can be dosed consistently on a twice-daily basis and is well-tolerated when titrated effectively. Opana® ER has also shown maintenance of effective pain control at a stable dose over the three-month period of the pivotal clinical trials, which the company believes highlights the durability of its analgesic effect. Opana® ER utilizes a patented delivery system that was specifically developed to provide continuous delivery of medication over a 12-hour period, helping patients maintain a steady level of pain relief. Experts agree that patients suffering from moderate-to-severe chronic pain which is present much or all of the day need around-the-clock coverage with an analgesic agent to sustain pain relief.

Opana® ER has been studied in a wide range of chronic pain conditions, including low back pain, osteoarthritis pain, and cancer pain. Endo developed Opana® ER using Penwest Pharmaceuticals’ proprietary time-release technology, TIMERx®-N.

Immediate release Opana® is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate. Opana® has been studied in multiple post-operative pain models, including orthopedic and abdominal procedures. Immediate-release Opana® is a proprietary product developed by Endo.

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Arthritis :: Botox can treat Knee Pain

November 1, 2006

Mayo Clinic seeks adults who are age 40 or older and have knee pain that has not responded to medicines, exercise or physical therapy for a research study.

The purpose of this research study is to find out what effects (good and bad) the botulinum toxin (Botox) has on patients with knee arthritis.

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Eligible participants will have been diagnosed with knee arthritis that can be confirmed by x-ray.

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