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Posted by john on July 6th, 2007 — in Celebrex Top News
06-July-2007: Hedex Extra was meant to be the drug that pushed the envelope for millions of low-income Kenyan blue-collar workers shopping for a pain reliever.
It was heavily marketed as one of the country’s most potent painkillers, but now global pharmaceutical giant GlaxoSmithKline (GSK) is having a headache over the recall of this product.
Yesterday, it emerged that GSK is investigating a possible factory slip up that resulted in an error in its formulation—under the watch of the industry regulator, Kenya’s Pharmacy and Poisons Board.
But GSK said in a faxed statement that the product had been incorrectly stored in excessive temperatures above 30 degrees, causing the breakdown of the ingredient aspirin to form crystals of salicylic acid.
“Ingesting a dose of Hedex Extra damaged through incorrect storage may cause irritation to the mouth, throat and stomach.”
Hedex Extra was also meant to turbo-charge the growth of GlaxoSmithKline’s block-buster painkiller, Hedex, which was facing intense competition in the low end of the market, a category that was increasingly coming under competition from lower price name brand drugs, a host of generics and even fakes.
Just like GSK’s other pain relief brand, Panadol and Panadol Extra that targets more affluent consumers, Hedex Extra was launched as a product extension to Hedex, a companion and fighter brand against the likes of Beta Healthcare’s Mara Moja and Action in a bid to carve a bigger share of Kenya’s Sh2 billion analgesic drug market.
However, by the time Hedex Extra was brought to the market in January 2006, insiders knew that there were problems with the product’s formulation and there had been consumer complaints over the side effects of the drug.
It had been specially formulated for the Kenyan market with an extra pain relief strength than is usually marketed in Europe and other African markets.
Yesterday, it emerged in media reports that GSK had recalled Hedex Extra from the market. Business Daily’s interviews with retailers and pharmacists reveal that GSK started withdrawing the drug from the market in March and as late as last month.
Kenya’s Poisons and Pharmacy Board, which regulates the manufacture and marketing of drugs, confirmed that GSK started recalling the product in March. Until yesterday, GSK had not issued a public announcement over the product recall as industry standards requires in global medical marketing.
“In March, it was brought to our attention that there was a problem with Hedex Extra,” said Dr Wilfred Ochieng, Head of the Inspectorate division at the Pharmacy and Poisons Board, the governing body of the pharmaceutical industry.
However, on Thursday, GSK said the drug had been recalled because of Acetyl Salicylic Acid was breaking down too fast releasing a by-product in unusually high concentrations than was medically allowed. This was making consumers who take it to experience severe irritation in the mouth and throats and even causing stomach upsets. This was after the company says that it received complaints from Mombasa.
A super strong pain killer, it contained a heady mix of paracetamol, aspirin and caffeine and was marketed as providing extra fast relief for not just head aches, but also migraines, back aches and tooth aches.
“The issue is currently being investigated by its manufacturers. Just four batches had a problem. We decided in liaison with GSK that it would be best to withdraw the product pending investigations,” said Dr Ochieng, “The recall of the product does not mean Hedex Extra is bad for consumers, it just means there is a slight defect, which can be resolved in time.”
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A possible problem in its formulation could be to blame for the drug manufacturers latest headache with the product.
Dr Ochieng said factors leading up to the recall could be rooted in factory issues, confirming it was a stability issue, a phenomenon that makes Asprin start degenerating turning a normally harmless drug into a toxic one.
The Kenyan version of the drug — it is sold in varying strengths in different countries around the world — was specially formulated for the local market.
Industry players say it contained the largest admissible amounts of its various components allowed under the law.
“I believe it should have been offered in a single dose rather than in the usual double pack. It was really powerful,” said a pharmacist, who declined to be named.
The Kenyan version of Hedex Extra was the result of several years of research for the multi-national drug company. It was however more powerful than a similar product sold in other markets.
The drug was slated to be a front-runner for the British pharmaceutical firm in the highly competitive analgesics market, where generics are taking a bite out of GSK’s profits from its flagship Panadol.
The struggle to gain a share in Kenya’s Sh2 billion over-the-counter painkillers market has occupied both international and local manufacturers, who are competing against counterfeits and a growing generic presence.
In a country where 60 per cent of the population self-medicates, Hedex Extra was positioned to take on Mara Moja — produced by locally based competitor Beta Heathcare — and the growing generic segment on its strong formulation claim.
Kenya’s over the counter (OTC) market has attracted several major international pharmaceutical firms such as: GSK, AstraZeneca Group Plc, Novartis Consumer Health SA, Pfizer Consumer Healthcare Inc, Aventis SA, and Sanofi Winthrop Industries. There are also a number of local manufacturers such as Beta Healthcare and Dawa Pharmaceuticals.
Within the pain relief category, local firms now control over 80 per cent of sales. Companies like GSK manage to maintain their share through a mix of higher pricing models, guarantees on quality and aggressive marketing.
Hedex Extra rode the back of a localized marketing campaign Boda Boda (bicycle taxi) challenge after sponsorship of its successful soccer fiesta, Hedex Cup was cancelled.
GSK is the oldest company in OTC health care in Kenya, with annual sales said to total over US$400 million per year, according to research firm, Euromonitor. The company is aggressively fighting off the rising generic wave with market share figures reportedly falling from 52 per cent in 2005.
Last year, the British pharmaceutical firm staved off a potential recall of its famed Panadol brand, which was under scrutiny in other countries after one batch was withdrawn from the market.
The Pharmacy and Poisons Board have withdrawn two other products from the market in the last two years.
One, nimesulide, was a key component of children’s cold and flu medications and was withdrawn following an international ban of the product. The other was an infection depressant.
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Posted by john on July 2nd, 2007 — in Celebrex Top News
The venom of the predatory marine snail Conus Magus is one of the most potent painkillers on the planet. It has a greater potency than morphine, but works in an entirely different way.
The snail’s venom – which it uses to stun and paralyse its prey – targets proteins in cell membranes whose job it is to allow calcium ions to pass in and out.
These so-called “calcium channels” are thought to play an important role in stimulating the nerves that deliver pain signals, as well as in other processes such muscle contraction, heart pace-making and hormone release. The venom targets a particular subgroup known as N-type calcium channels , which play a role in some kinds of pain.
Now, the pharmaceutical company Astrazeneca says it has developed a number of synthetic agents that also act on N-type calcium channels to reduce pain. The company believes they could be used to tackle persistent acute pain where other painkillers have not worked, or cannot be used, in people with cancer or other very severe diseases.
Read the full snail-venom pain relief patent application.
Inhibiting HIV
The human immunodeficiency virus (HIV) has the fiendish ability to rapidly replicate, mutate, and acquire resistance to drugs.
The virus does this by converting viral RNA into viral DNA, then inserting the viral DNA into the genome of a host cell. The RNA to DNA conversion is mediated by HIV enzymes called reverse transcriptase and protease.
Current drug cocktails for HIV treatment inhibit the action of these enzymes, thereby slowing down replication of the virus. However, the rapid emergence of drug resistance limits the ability of these drugs to safely and effectively treat AIDS.
This is why the American pharmaceutical company Pfizer, in New York, US, is looking to inhibit the action of a third enzyme called integrase, which is heavily involved in the process of inserting the viral DNA into the host’s genome.
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Pfizer says it has identified a number of potent and selective HIV-integrase inhibitors which could do the trick. The company suggests that the new compounds, or their salts, inhibit integrase when administered to an infected cell in the correct amount, and can be taken orally as pills or liquids.
Of course, the patent makes no claims about the efficacy of the treatment, but the approach certainly looks interesting.
Read the full inhibiting HIV patent application.
Mimicking pot
Tetrahydrocannabinol, the active ingredient in marijuana, has attracted a lot of attention from drugs companies, and not just because of its psychoactive effects at staff parties.
The compound has a number of potential therapeutic benefits, such as being an appetite stimulator for people with AIDS or cancer patients undergoing chemotherapy.
But fabricating the compound isn’t easy. Tetrahydrocannabinol is destroyed by heat and light, and is easily oxidised in air.
For these reasons, the various ways of making it are either unfeasibly long, or result in a disappointingly low yield. Which is why the Johnson Matthey company (JM) in London, UK, is excited about its latest breakthrough in which it reacts together a diester and olivetol to synthesize tetrahydrocannabinol.
JM says the yield can reach 75%, and the process can easily be scaled up to industrial levels.
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Posted by john on June 30th, 2007 — in Celebrex Top News
Unreasonable failure to treat pain is poor medicine, unethical and also an “abrogation of a fundamental right”, according to Dr Frank Brennan of Sydney’s Calvary Hospital in Kogarah.
Writing in Anesthesia & Analgesia, the official publication of the International Anesthesia Research Society, Dr Brennan says inadequate pain treatment is an entrenched problem around the world and is related to cultural, societal, religious, and political factors - including the acceptance of torture.
Poorly controlled pain has many and potentially serious adverse effects, both physical and psychological, as well as “massive social and economic costs to society,” Dr Brennan and co-authors write.
In a special article in the July issue, Dr Brennan and his colleagues summarise the medical, legal, and ethical arguments for transforming access to pain management into a global human right, according to a statement posted on Newswise.
They say that a growing international consensus urges change in several areas toward the goal of recognising effective treatment for pain as a fundamental human right.
The authors write, “Medicine is at an inflection point, at which a coherent international consensus is emerging: the unreasonable failure to treat pain is poor medicine, unethical practice, and is an abrogation of a fundamental right.”
Cancer pain is a special concern, with up to 70 per cent of cancer patients experiencing severe pain caused by their disease or its treatment.
The authors outline the “complex and overlapping” reasons for delay in recognising the ethical and legal importance of pain management, according to Newswise.
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Although pain relief is clearly a core value of medical ethics, the legal foundation for a right to pain management is less clear.
Frustrated with the slow pace of change, many pain medicine professionals are promoting legislative solutions, the authors say. Some governments, notably including Australia and the state of California, have passed statutes explicitly defining the right to adequate pain management, protecting medical practitioners who treat pain in terminally ill patients, or introducing requirements for pain management and education.
Dr Brennan and his colleagues call on the United Nations to consider declaring an International Year of Pain Management, Newswise reports.
They also call on the World Health Organisation and other international bodies to create a single organisation unifying all aspects of obligation on national governments in the area of pain control.
“Much work and continuing vigilance will be required to make the transition from asserting that pain management is a fundamental human right, to a future in which appropriate pain management is a global reality,” the authors conclude.
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Posted by john on June 25th, 2007 — in Celebrex Top News
Acupuncture is becoming more and more popular today as a viable way to treat chronic disease and pain. It’s an ancient method to treat the ill, created thousands of years ago by the Chinese.
Ning Qian, a graduate of the Nanjing Traditional Medical University in China, practiced in China for 16 years before moving to the United States in 1994. She is approved by the Texas State Board of Medical Examiners (Texas State Board of Medical Examiners Acupuncture Permit No. AC00091).
“The World Health Organization recognizes 47 different kinds of diseases that can be treated with acupuncture, including migraine and tension headaches, neurological ailments, muscle spasms, fibromyalgia, paralysis, asthma, sexual dysfunction, diarrhea, hypertension, menstrual cramps, and infertility,” says Ning.
Ning also treats stress, depression, arthritis, sciatica, back/neck pain, frozen shoulder, carpal tunnel syndrome, allergies, tennis elbow, and other various sports-related injuries.
“In China, acupuncture is used on more than 200 conditions,” she adds.
China Acupuncture Clinic
* » 2315 50th St., Suite C & D
* » (806) 796-2969
* » Open 8:30 a.m. - 5:30 p.m., Monday-Friday; 8:30 a.m. - 12:30 p.m., Saturday
Discover nature relief from aches and pains through acupuncture. The clinic uses sterile disposable needles. Ning Qian is approved by the Texas State Board of Medical Examiners, permit No. AC00091. Ning also uses Chinese herbal remedies to help further enhance the treatments.
Ning states that the body contains 360 major acupoints, or areas where the needles are placed, which run along 14 main channels. When the needle is placed into the acupoint, she says, it allows blood and energy to flow into the area more readily. Unlike traditional Chinese acupuncture, slight voltage is applied to the needle to make it pulsate, which increases the treatment’s effectiveness, she explains. This has replaced hand-turning the needles during treatment. Generally, there is minimal sensation. The sensation varies according to the body’s constitution and the nature of the ailment or pain.
However, needles are not placed in one specific area where there is pain, Ning says. For example, if a client has pain in his or her right shoulder, it’s not unusual to place needles into the calf on the right leg, since the main channels continue down that area of the body.
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The majority of Ning’s clients come in for treatment of pain. Many seek a remedy for their sinus conditions brought on by the area’s cotton crop. Others try acupuncture to quit smoking, lose weight or fight headaches.
“A lot of people are seeking a natural treatment in order to reduce the number of medications they take,” she says.
Acupuncture helps people gain better health by balancing the body’s energy. Research shows that many health problems are treatable with acupuncture, achieving successful results without drugs, but Ning stresses that it’s important that acupuncture be performed by an educated, trained practitioner.
In compliance with federal health standards, China Acupuncture Clinic uses only surgical-grade steel, single-use, sterile, disposal needles during each treatment session.
In combination with acupuncture treatments, Ning also recommends Chinese herbs to help enhance the results of the treatments. These natural, ancient remedies are used to combat common problems from PMS, allergies, and fatigue to eczema, cold and flu symptoms, and sciatica. Herbal remedies are available at China Acupuncture Clinic; ask Ning which will work best for you.
Call China Acupuncture Clinic today at (806) 796-2969 to schedule your appointment or come by and discover the different types of herbal remedies available.
Ning Qian’s office is located at 2315 50th St., Suite C & D, across from Highland Community Hospital. Hours are Monday through Friday 8:30 a.m. to 5:30 p.m. and Saturday 8:30 a.m. to 12:30 p.m. The clinic accepts worker’s compensation cases.
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Posted by john on June 23rd, 2007 — in Celebrex Top News
Stowe, VT (PRWEB) June 23, 2007 — To ease the pain drivers are feeling at the pump, one of Vermont’s most historic inns is offering relief to its guests in the form of a special room package that includes a $50 gas card for a free ride home.
Booking summer travel now guarantees some of the best deals especially since AAA is warning that gas prices may hit a new record by the end of May. Guests at the Green Mountain Inn can take advantage of the Free Ride Home Package deal from March through September. Fortunately for Vermont vacationers the state is home to some of the least expensive gas prices in the country, according to GasBuddy.com. Several stations in Vermont report gas prices well below the national average of $3.04.
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Green Mountain Inn guests don’t need to fill their tanks to enjoy outstanding outdoor activities including: hiking, biking, canoing, kayaking, swimming, fishing, golf, and more. “The unique aspect about the Green Mountain Inn is that we are centrally located in Stowe village, so it’s very convenient for our guests to be able to walk to shops or hiking trails right from our front door,” said Patti Clark, Innkeeper at The Green Mountain Inn. Plus the Inn offers two acclaimed restaurants onsite, the Whip Bar & Grill and the Main Street Dinning Room. And access to a free Stowe shuttle is available across the street from the Inn.
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Posted by john on June 17th, 2007 — in Celebrex Top News
TORONTO, June 15 /CNW/ - Topical pain relief containing methyl salicylate is commonly used by millions of Canadians to ease pain, improve lifestyle and enhance athletic performance. It is a safe and popular alternative to ingested pain medicines that are directly associated with serious and deadly side effects.
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As with any substance methyl salicylate can be toxic at high concentrations. Water itself is toxic, at easily reached levels, and has been associated with deaths in public water-drinking contests. Used as directed by the manufacturer topical pain relief containing methyl salicylate is safe and effective. MEDISTIK(TM), produced in Canada by Natureteq Inc.(TM), is the gold standard in topical analgesics. MEDISTIK(TM) is a unique, highly effective pain reliever and anti-inflammatory used by high-performance competitive athletes and rehabilitation specialists. It contains Methyl Salicylate, Menthol and Eucalyptus Oil and is free of banned substances defined by the Canadian Centre for Ethics in Sports and the World Anti-Doping Association.
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Posted by john on June 13th, 2007 — in Celebrex Top News
PAINKILLER company, CeNeS has published more good news about its lead product M6G, which is completing late-stage clinical trials after years of development.
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M6G is set to rival morphine, which has long-held the lead in pain relief.
The drug has fewer side-effects, and latest results show patients need significantly less sedation after an operation, making it ideal for day-surgery.
Morphine tends to cause nausea in women, who are more prone than men to suffer in this way, but M6G cuts this right back.
Neil Clark, ceo, said: “It’s estimated that at least 277 million units of injectable analgesics were used to treat pain in the US last year.
“The US post-operative pain market is worth $1.7 billion, and we’re confident that M6G will establish a strong position globally.
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Posted by john on June 10th, 2007 — in Celebrex Top News
DOW JONES NEWSWIRES
Merck & Co. (MRK) said a Phase II trial of its MK-0974 product significantly improved migraine pain relief two hours after dosing compared with placebo, and the relief was sustained throughout 24 hours.
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The Whitehouse Station, N.J., pharmaceutical company said MK-0974, an investigational oral calcitonin gene-related peptide receptor agonist, is now in Phase III clinical development to treat acute migraines in adults.
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Posted by john on June 5th, 2007 — in Celebrex Top News
People with chronic heart disease may soon be able to throw out their pain pills.
Doctors at the Victor Chang Institute have shown that occasional hormone injections can be far more effective.
Patients with heart disease have damaged blood vessels causing chest pain or angina.
In a trial treatment, researchers at the Victor Chang Institute gave 20 patients injections of a drug used for bone marrow transplants.
They found the hormone switched on stem cells in the heart, forming new blood vessels and alleviating pain.
“What we have seen with the majority of patients is that their angina hasn’t disappeared completely but it has largely abated,” Dr Peter McDonald, from St Vincents Hospital, said.
“This is a matter of giving patients a course of injections for five days in a row, once every three months potentially,” Prof Bob Graham, from the Victor Chang Institute, said.
Yvonne Moore, 75, had two heart bypasses and was told by her doctors there was nothing more they could do.
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She says the new treatment has changed her life.
“It’s been such a success,” she said.
“It’s given me my life back.
“I can do anything the sky is the limit now.”
After the success of the first trial, doctors will now recruit 40 patients with chronic heart disease.
Halfof the participants will get injections of the hormone, the rest will get a placebo.
The technique could reduce the need for heart transplants.
“This will at least if not eradicate the need for a heart transplant, prolong the time before they would need a heart transplant,” Professor Graham said.
It is hoped the treatment will be offered more widely within three years.
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Posted by john on June 2nd, 2007 — in Celebrex Top News
Cortisone, Novocain used to counter foot injury; guard says playing in past 2 wins worth discomfort
By Brian Windhorst and George M. Thomas
Beacon Journal sportswriters
AUBURN HILLS, MICH. - All you need to do is look at any visible area of Larry Hughes’ skin to know his feelings about needles.
He’s the proud owner of dozens of tattoos and adds to the collection every year. So having to face a sharp edge doesn’t shake him, which is a good thing these days.
In an effort to offset the hot and throbbing pain from the torn plantar fascia in his left foot, the Cavaliers’ Hughes has decided to take pain-relieving injections. Before Game 4 on Tuesday and Game 5 of the Eastern Conference finals on Thursday, Hughes took a dose of cortisone and Novocain, he said.
“It’s not a heavy dose of the cortisone, it’s more of a medicine to give me some comfort,'’ Hughes said. “It doesn’t really work; I just figured it was best that I’d at least try it. It helps with the pounding I take.'’
Hughes has played through pain in the past, playing nearly two months with a fractured finger last season before having surgery. When he was with the Washington Wizards, he played a half with a broken wrist. This season, he came back early from a painful high ankle sprain.
After his essential, gutsy performance Thursday, Hughes said he had little idea he had logged more than 29 minutes, but he said it felt like it.
Was the cost too high? A limping Hughes had to be helped from the court by assistant trainer Ken Snead.
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“It was definitely worth it, the last two games,'’ Hughes said as he peeled off a sock and began to soak the injured foot in ice water. “We knew what we needed to do as far as a team, and I wanted to be a part of it, so it was definitely worth it.'’
Despite the pain, Hughes said he will try to play Saturday in Game 6 in Cleveland.
Silencing a big critic
TNT analyst Charles Barkley heaped criticism on LeBron James after Game 1 of the Pistons series because James dished off the ball to Donyell Marshall for a 3-point attempt at the end of the game. Barkley left the air Thursday calling James’ 48-point performance one of the best in playoff history.
James dominated late in the fourth quarter and answered his critics with two relentless drives to the hoop, each topped off with a ferocious dunk to push the Cavaliers into overtime. The only blemish on a memorable period: two missed free throws.
James only accentuated that dominance in the second overtime, and he eventually hit the winning shot on a driving layup.
“The simple fact I was able to will my team to victory is definitely pleasing to me,'’ he said in postgame interviews. “This is definitely a big win, one of the biggest wins in Cavaliers franchise history, for me and my teammates.
“But we have a goal; we can’t dwell on this tonight when we have another game on Saturday. We have got to do our best to try to win that ballgame and get where we wanted to be all year.'’
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