A meta-analysis of the efficacy of fibromyalgia treatment

Based on this meta-analysis and despite the

heterogeneity of specialised care studies and of the other

limitations described in this article, treating fibromyalgia in

specialised care offers no clear advantages.
<http://www.springerlink.com/index/3426720G5X241795.pdf>

CYMBALTA: Lilly earnings soar and beat analyst forecasts

World News | January 28, 2011 Kevin Grogan

Eli Lilly has posted a strong set of figures for the fourth quarter, with the antidepressant/fibromyalgia blockbuster Cymbalta and the lung cancer drug Alimta once again driving sales.

Net income reached $1.17 billion, up 28% and ahead of analyst forecasts, while sales reached $6.19 billion, a rise of 2%. Lilly noted that revenues were reduced by $70 million due to the impact of US health care reform.The most striking performances came from Cymbalta (duloxetine), up 19% to $984.6 million and the lung cancer drug Alimta (pemetrexed) which increased 9% to $569.0 million. Lilly’s best-selling drug continues to be the antipsychotic Zyprexa (olanzapine), which had turnover of $1.34 billion, a dip of 2% but up 4% to $669.3 million in the USA, a rise driven by higher prices.John Lechleiter, Lilly's chief executive, said the results "capped a year of solid financial performance in which we achieved volume-driven revenue growth along with good expense control". He added that "we remain committed to our strategy of accelerating the flow of potential new medicines through our pipeline and are prepared to meet the challenges of patent expirations for several of our products".


For 2011, earnings per share are forecast to reach $3.92-$4.07, including the impact of US healthcare reform of $400-$500 million for the year.
http://www.pharmatimes.com/Article/11-01-28/Lilly_earnings_soar_and_beat_analyst_forecasts.aspx

Prescription Drug List Available to Help Fibromyalgia Patients

Fibromyalgia Prescriptions Drug List Includes Cymbalta, Lyrica and Savella

Common events that can cause Fibromyalgia to worsen include: weather extremes (either too cold or too humid), physical activity extremes (too much or too little), stress, and poor sleep.  It is rare for fibromyalgia patients to experience a restful night’s sleep; they usually have trouble falling asleep or, once asleep, there will be frequent awakenings.  Poor sleep patterns lead to increased pain and increased pain results in poor sleep patterns, creating a self-destructing loop.  It follows then that it is not uncommon for fibromyalgia patients to suffer from major depression, which may result in the inability to focus (known as “fibro fog”), feelings of hopelessness, and not wanting to participate in favorite activities.

Manging Fibromyalgia

Aside from the administering of a prescription drug list medicine, there are techniques used to manage fibromyalgia, however, such as exercising at least three times a week, which has been shown to decrease pain and improve one’s general health (but it should not be overdone as that can increase pain). Monitoring dietary intake has also been known ease the condition, as certain foods seem to aggravate it (aspartame, MSG, caffeine and tomatoes for instance). Other techniques include managing stress situations, which decreases fibromyalgia symptoms and finally, acupuncture, which can help relieve pain in some patients.  Trying the recommended strategies in combination with a medicines prescription from the Fibromyalgia prescription drug list can substantially improve the patient’s symptoms and quality of life.

http://www.prescriptiondrugs.com/trackback/12956

I Don't Like to Exercise

Ellen Greenlaw: Reviewed by Louise Chang, MD

Fibromyalgia specialists often recommend exercise as a way to help improve fibromyalgia symptoms. But what happens if you don’t like to exercise? Or when exercise only seems to bring on more pain and no relief from fibromyalgia symptoms? This is the case for one member of WebMD’s fibromyalgia community. She says that she feels really sore after movement and just wants to sleep. “Everything I read says I MUST exercise, and I just do not feel like it. So, any ideas?”
One man laments that he can’t exercise the way he used to. But he says that mild stretching is helpful. He tells her to stretch “just to the point where you start to feel the pull, then hold it there and release.” And if she feels sore after stretching, he suggests a taking a hot bath to help relieve the pain. His routine is to soak in a hot tub for 30 to 60 minutes right before bed. “Most of the time by the next morning, I’m nearly human again,” he says.
Another fibromyalgia community member also finds hot water helpful to ease aches and pains. “I actually found that a hot shower in the morning before I go for my walk with my dog helps loosen me up a bit,” she says. She stretches in the shower and uses the hottest water she can stand. Then she takes another short shower when she returns from the walk and takes short walks every two to three hours throughout the day. “It helps to keep me loose to help get through the day. But take it one day at a time…do what you can and be happy with what you can accomplish,” she says.
Another woman reports that swimming has helped ease her fibromyalgia pain . “I started floating around in the pool for a few days, and then doing half laps,” she says.  Once she was swimming laps regularly, she also started doing easy exercises at home. “I started with the easiest one I could find. Then after a week or so I add another very easy exercise to my program,” she says. “There are days that I feel I only can do one exercise, and that is okay -- at least I’m moving.” Getting exercise really does make her feel better, she adds.
Another  fibromyalgia community member tried using a Wii Fit interactive video game. Although some of the balance exercises were too difficult, she found one she could do. It involved just sitting on the board and being still. “I’ve found it’s a great way to be aware of my muscles and it’s an easy way to start out,” she says. She also tried the yoga deep breathing and very mild stretching with the Wii and found them helpful. “I’m still dealing with the frustration of what I used to be able to do vs. now, but I suppose I will come to terms with it in time,” she says.
One other community member suggests isometrics or tai chi. “Slow, tight movements contract the muscles and help strengthen them,” she says.
http://www.webmd.com/fibromyalgia/features/i-dont-like-exercise

Depomed: extended release gabapentin

Jan.20, 2011: Tro Kalayjian
Tuesday, Depomed (DEPO) announced that Abbott (ABT) is disputing elements of their contract regarding DM-1796, an investigational extended-release gabapentin formulation. According to the conference call and press release, CEO Carl Pelzel is "perplexed" by Abbott's last minute maneuvers and expressed haste in beginning the mediation process and, if needed, binding arbitration.
Issues with the contract
The issues are relatively unknown. Depomed received a letter from Abbott stating that Abbott believes they are no longer required to market DM-1796. The implied message from the press release and the conference call was that Abbott may not be content with the contract for DM-1796 or that it may be out of their therapeutic focus. Abbott inherited the agreement for DM-1796 from its recent acquisition of Solvay Pharmacueticals. During the conference call, Mr. Pelzel noted that Abbott has North American rights for DM-1796 only for pain states, including: post herpetic neuralgia (PDUFA date 1/30/11), diabetic peripheral neuropathy (Phase 2 completed) and fibromyalgia. It was also noted in the call, that Abbott does not own the rest-of-world rights or the rights for non-pain indications, like: restless leg syndrome, chronic migraines, epilepsy, or hot flashes (currently enrolling in a Phase 3 trial).
The story gets more complicated
Furthermore, Depomed simultaneously announced that DM-1796 has been given provisional orphan drug status by the FDA, and with it, 7 years of market exclusivity. Even with Orphan Drug Status for DM-1796, why does Abbott view DM-1796 as a poor fit? Do they feel short-handed? The answer may involve the topic of off-label use.
Anticonvulsants, and especially gabapentin, are typically used “off-label”, which means not for an FDA approved indication. Many of the estimates that various analysts have used to quantify a market potential for DM-1796 have included generic gabapentin and Lyrica sales & scripts. But, other estimates have demonstrated that only 20% of those sales are for FDA approved indications. That means that the majority of sales for this class of drug comes from off-label use.
Abbott may have banked on the fact that some physicians would naturally migrate from the use of Lyrica and generic gabapentin to DM-1796, owing to its convenient dosing and its tame side effects profile. Under the current agreement, Depomed could hypothetically partner its gabapentin formulation with another pharmaceutical company for another indication, and the results would be that both Abbott and the hypothetical partner would be fighting for the same off-label scripts. Even Serada, Depomed's investigational drug for the treatment of hot flashes, could potentially be used off-label as a competitor to DM-1796. This may not be competition that Abbott is willing to compete against. Furthermore, due to widespread abuses, off-label sales are now more tightly regulated, making those lofty sales projections for DM-1796 somewhat less attainable.
Depomed has an excellent litigation track record
Even if Abbott inherited a crappy contract, that doesn’t mean they can snub it and move on. Depomed has an incredible litigation track record, dealing with patent and contract issues of this kind. All of Depomed’s legal history has ended in its own favor, bringing in cash settlements from; Bristol Myers Squibb (BMY), Biovail (BVF), Esprit (now (AGN)), King (KG), and Teva (TEVA). In August, Depomed was one of the few pharmaceutical companies that evaded a gabapentin manufacturing lawsuit with Pfizer (PFE).
During Tuesday’s conference call, Depomed’s CEO implied that the costs to Abbott to exit the deal could be more than $100 million, not including the roughly $50 million dollar milestones due on NDA approval. Furthemore, Mr. Pelzel reassured investors that DM-1796 launch date would not be delayed, if approved.
Trade name leaked by FDA
In a previous article, I purported that the tradename for DM-1796 could have been GRALISE. It has come to my attention that the actual name could be GAPREZA.

Forest Laboratories; Savella

Savella, which is approved for the management of fibromyalgia, posted sales of $24.6 million, up significantly from the year-earlier sales of $15.4 million. Sales are being driven by the company's promotional efforts.
Savella was launched in late April 2009. We believe the product may have multi-hundred million dollar potential. In early October 2010, Savella was moved into tier II unrestricted coverage on several managed care organizations. Improved formulary access should help boost sales. Forest Labs entered into a collaboration and distribution agreement with Janssen to commercialize Bystolic and Savella in Canada.
http://www.prnewswire.com/news-releases/zacks-analyst-blog-highlights-comerica-incorporated-sterling-bancshares-citigroup-forest-laboratories-and-ironwood-pharmaceuticals-114201369.html

FDA to Limit Acetaminophen in Pain-Killers

Written by Daniel Sayani

18 January 2011

The U.S. Food and Drug Administration announced yesterday that it will limit the active pain-reducing ingredient in the pain medications Percocet and Vicodin. FDA officials indicated that they would order drug manufacturers to reduce the amount of acetaminophen to 325 milligrams per tablet or dosage unit in pain medications such as Percocet or Tylox, which are a combination of acetaminophen and the opiate-derived oxycodone, and Vicodin or Lortab, a combination of acetaminophen and hydrocodone. The announcement comes as the latest attack waged on chronic pain sufferers by the FDA, Drug Enforcement Agency (DEA), and other regulatory agencies which are attempting to take an even greater role in controlling which medications, procedures, and medical services are available to patients. Within a three-year period, the FDA plans to completely phase out what it deems “high-dose” prescription medications containing acetaminophen. Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER), asserted: FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. Overdose[s] from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death. The FDA claims that these latest efforts are necessary in order to “protect” the public against the possible side effects of these medications, such as liver damage. However, a side effect as dramatic as liver damage typically occurs only after prolonged use of acetaminophen-containing products (including over-the-counter Tylenol), especially when combined with alcohol, or when multiple acetaminophen-containing products are taken at the same time. Research also suggests that many reported cases of acetaminophen overdose-related liver damage may not be the result of accidental overdoses, but instead, suicide attempts. In a study that included all patients admitted to an inner city hospital over a 39-month period for acetaminophen overdoses, the number of suicide attempts exceeded the accidental cases by nearly three-fold. The research (Acetaminophen Toxicity in an Urban County Hospital), published in the New England Journal of Medicine (Volume 337: 1112-1118), by Dr. Frank V. Schiedt, also found that the suicidal patients ingested almost twice as much acetaminophen as those in the accidental-overdose group, and that those who accidentally overdosed on acetaminophen showed greater levels of liver necrosis (i.e., sustained liver failure), possibly due to concomitant alcohol abuse. Research (and common sense) also indicates that severe liver injury generally results only when individuals misuse acetaminophen-containing prescriptions or over-the-counter drugs. Such misuse often entails either their taking more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, taking more than one acetaminophen-containing product at the same time, or drinking alcohol while taking the drug. The FDA requirements, which seek to include mandatory labeling on prescriptions alerting patients to the possible risk of liver damage, do not consider these broader circumstances. The federal government is once again unnecessarily intruding upon the sanctity of the patient-doctor relationship — contrary to the fundamental Lockean notion that the individual is the effective owner of his body, and has the right to determine what he will do with it (while acknowledging that God, as Creator, is ultimately in control of the body — and prohibits individuals from doing anything contrary to self-preservation, according  to John Locke’s Second Treatise on Government). Even more ominous was the FDA’s recommendation in July of 2009 that these prescription medications be phased out completely. An FDA panel voted 20-17 last summer to eliminate Percocet, Vicodin, and Lortab, claiming that “their role in deadly overdoses” was sufficient grounds for declaring a ban on them. In response to the earlier proposed ban, the New York Times reported that Johnson & Johnson released a statement saying it “strongly disagrees” with the proposed restrictions on acetaminophen, adding that such limits would be likely to “lead to more serious adverse events as consumers shift to other over-the-counter products” such as Advil and aspirin. Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee had ignored studies showing that doses sold by her members — two pills of 500 milligrams, up to four times a day — were safe. “I think this is a very effective dose and one needed for individuals who experience chronic pain,” she added. Many doctors also believe that efforts at limiting acetaminophen dosages or banning medications such as Vicodin and Percocet are irresponsible and ill-informed. According to Dr. Sean Mackey, Chief of Pain Management at Stanford University Medical Center, these FDA restrictions will only place more burdens on health care providers and patients. He notes, “More people will be suffering from pain" ... and "more people will be seeing their doctors more frequently and running up health care costs." Dr. Gil Fanciullo, a pain management specialist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and member of the American Pain Society, notes, “If these drugs were not available to our patients, there would be a stampede toward the doctor to try to figure out an alternative treatment for them because they're such widely used drugs.” The results would be either under-treatment of pain, or putting patients on even stronger narcotics. Better labeling of medicines that have acetaminophen is the answer, rather than making them less available, he affirms. While medicine is waging the war against pain, the FDA is waging war against pain sufferers. The FDA’s latest effort to limit the legally-permissible amount of acetaminophen in pain medications, like its earlier effort to ban these truly life-preserving medications for pain sufferers, represents a years-long assault on chronic pain sufferers, carried out in the interests of “fighting the drug war” and “protecting the public.”      According to Dr. Ronald T. Libby, Professor of Political Science at the University of North Florida, in his book, The Criminalization of Medicine: America’s War on Doctors, the federal government, through its excessive regulations and restrictions, has made the work of physicians in the field of pain management incredibly difficult. Libby says that the DEA, emboldened by the FDA’s punitive policies, has been instrumental in making many physicians shy away from prescribing opioids such as Vicodin and Percocet, “causing millions of Americans to suffer from chronic pain even as therapies were available to treat it.” Indeed, many health care professionals and epidemiologists believe that chronic pain is the number one public health crisis faced by the United States, exacerbated by the fact that chronic pain often goes untreated because of government regulations. Libby explains, The DEA's painkiller campaign has cast a chill over the doctor-patient candor necessary for successful treatment. It has resulted in the pursuit and prosecution of well-meaning doctors. It has also scared many doctors out of pain management altogether, and likely persuaded others not to enter it, thus worsening the already widespread problem of underrated untreated chronic pain. Such regulations serve to curtail efforts toward raising consciousness on chronic pain as an epidemiological concern which demands a concerted, sympathetic response on behalf of health care providers. According to Dr. Peter Croft’s book Chronic Pain Epidemiology: From Aetiology to Public Health, “little attention has been paid to chronic pain as a public health problem or to the potential for its prevention, even though it can be studied and assessed using concepts and ideas from classical epidemiology,” although chronic pain poses a long-term demographic, economic, and occupational strain on society as a whole. The FDA’s proposals to limit accessibility to pain medication are fundamentally flawed, according to Karen Lee Richards, co-founder of the National Fibromyalgia Association, an organization devoted to representing the interests of the more than estimated five million Americans who suffer with the disease (according to 2005 Centers for Disease Control and Prevention statistics). Richards says that FDA regulations on pain medication aimed at reducing the number of acetaminophen overdoes are ineffective: Personally, I'm not convinced banning these drugs will make a significant difference in the number of acetaminophen overdoses. On the other hand, as long as both components of the medications are still available and the only difference is taking two tablets instead of one, it might help make patients more aware of what they're actually taking so they don't unintentionally get an overdose of acetaminophen. Bureaucracy is no substitute for personal responsibility. According to FDA Acetaminophen Policy Panel member Dr. Jan Engle, head of the Department of Pharmacy Practice at the University of Illinois-Chicago, “If you keep track of what you’re taking, none of this is an issue for you.” Consumer education, rather than nanny-like scolding, is the proper approach to mitigating acetaminophen-related complications. While the new FDA restrictions fall short of the earlier recommended ban on medications such as Percocet and Vicodin, as of January 14, 2014, prescription pills may contain no more than 325 milligrams of acetaminophen. However, over-the-counter acetaminophen is not facing the same restrictions currently, as the FDA has stated that it has no intention of imposing such restrictions on over-the-counter drugs because of the more lengthy and complicated requirements for doing so. So in three years, over-the-counter acetaminophen will actually be stronger than the acetaminophen prescribed by doctors — which is illogical, considering the FDA’s long-term goals of reducing the medicine's toxicity. According to Sidney Wolfe, director of health research at the Washington-based consumer group Public Interest, “It is inexcusably poor judgment on the part of the FDA to have failed to take action concerning this major source of acetaminophen consumption and, consequently, acetaminophen toxicity.” By imposing such restrictions on prescriptions, doctors and pharmacists will likely face reduced reimbursements and will see lower overall revenues, while patients may actually be at greater risk, as they will be taking higher dosages of acetaminophen without medical supervision. The FDA has merely fired the next shot in a government-initiated battle that seems interminable for those who live with the horror of chronic, debilitating pain.

http://www.thenewamerican.com/index.php/usnews/health-care/5943-fda-to-limit-acetaminophen-in-pain-killers

Fibromyalgia & Obesity: Cause, Effect or Vicious Cycle?

Tuesday January 11, 2011

Yet another study has pointed a finger at something pretty obvious -- a lot of us with fibromyalgia are obese. Researchers say the obese participants had more pain, worse sleep, less sleep and poorer flexibility.
It's not surprising that, as a group, we're overweight: most of us are far less active that we used to be; some of us take medications that cause weight gain; a lot of doctors and researchers believe we have some sort of metabolic problem; we're prone to sleep disorders, and a sleep-deprived body won't lose weight. So yes, we get fat.
Researchers in the study didn't look at whether obesity was a cause or effect -- likely because we have prior research indicating that obesity is a risk factor for fibromyalgia and vice versa. Instead, they were trying to gauge the effect.
It makes sense that excess weight makes symptoms worse: it puts more strain on our bodies; it's harder to get comfortable to sleep; obesity can lead to sleep apnea, which can seriously disrupt your sleep; both fibromyalgia and obesity make exercise more difficult, which leads to less strength and flexibility.
Of course, it can also go the opposite way. A lot of us develop fibromyalgia secondary to other health problems, especially chronic pain, thyroid problems, and blood-sugar issues -- all of which can cause weight gain. And let's face it, obesity is an epidemic all it's own.
So regardless of why we're overweight, this study shows that it makes fibromyalgia symptoms worse. That's bad. So what can we do about it?
The researchers concluded that weight management may need to be incorporated into treatment regimens. The really great doctors out there are probably already working on that, by encouraging a healthy diet and appropriate levels of activity.
However, I have to shudder when thinking about the other doctors and what they'll be saying. It was already common enough for them to say, "You've got fibromyalgia because you're fat. Lose weight and you'll feel better." What they fail to do is address the reasons we're overweight and recognize that it's not easy. Healthy people struggle with weight loss. We struggle more.
That said, I am working hard at losing weight to improve my health and my appearance. I'm trying not to be de-railed by the fact that it's really, really hard -- I have to limit my activity or I'll put myself into a flare, it's often difficult to shop for and cook healthy meals, and I can tell you it takes a heck of a lot more work to lose a pound than it used to.
I think what we need to take away from this research is that it doesn't really matter whether we're fat because we're sick or we're sick because we're fat -- the extra pounds makes us worse and also put us at risk for other health problems. We should do what we can to improve our health overall, but we have to remember that it's likely to be a long, tough road.
Meanwhile, we need to ignore the doctors and other people who want to make our illness our fault because of our weight.
Have you been able to improve your symptoms through weight loss? What helped you lose weight? Have you lost weight, only to have your symptoms stay the same or get worse? Share your weight loss stories by leaving a comment below!

Dr. Ranchhodbhai Chaudhary, MD - Internal Medicine Physician

January 12, 2011

Q: What is the treatment for Fibromyalgia?

A: The goal of treatment for fibromyalgia is a multimodal approach to reduce fatigue and to allow appropriate sleep and activity routine. It includes both pharmacologic and non-pharmacologic treatments that are individualized for patients. Non-pharmacologic treatments are exercise, cognitive behavioral therapy, and psychotherapy. Educating patients that fibromyalgia is not a life-threatening disorder, not associated with deformity or with increased mortality or early death is critical to optimal management and improves the outcome. Light aerobic exercise appropriately titrated to an individual’s aerobic threshold, is as effective as any medication. Patients should stay away from narcotics to prevent further fatigue.

Duloxetine in the treatment of chronic pain due to fibromyalgia

Alan Wright, Kyle E Luedtke, Chad VanDenBergCenter for Clinical Research, Mercer University, Atlanta, Georgia, USA

Abstract: Duloxetine is a serotonin-norepinephrine reuptake inhibitor approved by the US Food and Drug Administration for the treatment of fibromyalgia and painful diabetic neuropathy at doses of 60 mg daily. Duloxetine has been shown to significantly improve the symptoms of chronic pain associated with these disorders, as measured by the Fibromyalgia Impact Questionnaire, Brief Pain Inventory scores, the Clinical Global Impressions Scale, and other various outcome measures in several placebo-controlled, randomized, double-blind, multicenter studies. Symptom improvement generally began within the first few weeks, and continued for the duration of the study. In addition, the efficacy of duloxetine was found to be due to direct effects on pain symptoms rather than secondary to improvements in depression or anxiety. Adverse events including nausea, constipation, dry mouth, and insomnia, were mild and transient and occurred at relatively low rates. In conclusion, duloxetine, a selective inhibitor for the serotonin and norepinephrine transporters, is efficacious in the treatment of chronic pain associated with fibromyalgia or diabetic neuropathy, and has a predictable tolerability profile, with adverse events generally being mild to moderate.

http://www.dovepress.com/duloxetine-in-the-treatment-of-chronic-pain-due-to-fibromyalgia-and-di-peer-reviewed-article-JPR

Resource Utilization and Costs in Employees with Fibromyalgia Treated with Pregabalin or Duloxetine

James Harnett PharmD, MS et al.^1,*, Article first published online: 28 DEC 2010

 

Objective:  To evaluate changes in health-care resource use and costs after initiating pregabalin or duloxetine in employees with fibromyalgia (FM).

Methods:  Employees (18 to 64 years old) with at least one claim for an FM-attributable medication within 60 days following an FM diagnosis were identified using the Thomson Reuters MarketScan^® Commercial Database (2006 to 2008). Patients newly initiated on pregabalin were propensity score matched to patients newly initiated on duloxetine. These treatment cohorts were evaluated for changes between the 6-month pre- and post-initiation periods in health-care utilization including prescriptions, imputed medically related work loss and expenditures. Pre- to post-initiation changes were compared between pregabalin and duloxetine using a difference-in-difference approach based on univariate statistics and multivariable models.

Results:  A total of 731 employees with FM initiated on pregabalin (89.9% female, mean age 47.1 ± 9.7 years) were matched with 731 employees initiated on duloxetine (89.5% female, mean age 47.1 ± 9.8 years); other demographic and clinical characteristics were also comparable between cohorts. The adjusted marginal effects were not statistically significant for pre- to post-changes in opioid utilization (P = 0.856), number of FM-attributable (P = 0.151) or FM-related medications (P = 0.462), and all-cause (P = 0.323) or FM-attributable (P = 0.991) expenditures. Pregabalin was associated with a significantly lower probability of any medically related work loss of 3.2 percentage points (P = 0.030) compared with duloxetine, but changes in indirect costs were not significantly different (P = 0.600).

Conclusions:  The changes in health resource utilization and costs after initiation of pregabalin were not significantly different than the changes observed after initiation of duloxetine. These results not only demonstrate an overall similarity of resource utilization, but also suggest cost neutrality between pregabalin and duloxetine.
http://onlinelibrary.wiley.com/doi/10.1111/j.1533-2500.2010.00440.x/abstract;jsessionid=2FCD70E38647EE879D5768EF62FB56AC.d01t02

Propoxyphene (Darvon) Withdrawn From US Market

Allison Gandey: 11/19/2010

November 19, 2010 — The US Food and Drug Administration (FDA) has asked that propoxyphene, sold under the brand names Darvon and Darvocet by Xanodyne Pharmaceuticals, be removed from the US market. The decision will also affect generic manufacturers and the makers of propoxyphene-containing products.
New clinical data showing that the drug puts patients at risk for potentially serious or even fatal heart rhythm abnormalities has prompted regulators to act. An estimated 10 million patients have used these products.
At a press conference today, John Jenkins, MD, director of the Office of New Drugs, said the new numbers tipped the risk–benefit ratio against the drug.

The withdrawal will include brand name, generic, and all propoxyphene-containing products.

"For the first time, we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart," said Gerald Dal Pan, MD, director of the Office of Surveillance and Epidemiology.
The FDA is advising healthcare professionals stop prescribing propoxyphene. Patients who are currently taking the drug should not abruptly halt their medication but should contact their physician as soon as possible to discuss switching to another pain-management therapy.
"Long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative," Dr. Dal Pan added. "Once patients stop taking propoxyphene, the risk will go away."
Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received 2 requests to remove propoxyphene from the market.
In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.
Withdrawal Already Underway in Europe
A phased withdrawal of propoxyphene is already underway in Europe. The European Medicines Agency made that decision in June 2009. The FDA had considered a withdrawal last year but decided instead to allow continued marketing with a new boxed warning alerting patients and healthcare professionals of the risk for fatal overdose. The agency also required Xanodyne to conduct a new safety study assessing questions about the effects of propoxyphene on the heart.
The results of this study, combined with new epidemiologic data and medical examiner reports, prompted this latest regulatory action.
Should the FDA have acted sooner? Dr. Dal Pan told Medscape Medical News that regulators did not feel there was sufficient evidence before now. "The new information on the effects of the electrical activity on the heart was the final piece to the puzzle," he said.
"These new heart data significantly alter propoxyphene's risk–benefit profile," Dr. Jenkins added. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."
http://www.medscape.com/viewarticle/732887?src=top10

Duloxetine use

Objective:  The study aims to examine predictors associated with duloxetine adherence and its association with healthcare costs among fibromyalgia patients.

Methods:  Administrative claims from both commercially and Medicare supplemental-insured fibromyalgia patents aged 18+ who initiated duloxetine in 2006 were analyzed. Initiation was defined as a 90-day clean period without duloxetine. The dispense date of the first duloxetine prescription was denoted as the index date. Two cohorts were constructed based on duloxetine adherence over the 12-month postindex period (high adherence as medication possession ratio ≥ 0.8). Predictors of high adherence were examined via logistic regression. Generalized linear regressions were performed to estimate the association between duloxetine adherence and healthcare costs.

Results:  A total of 4,869 commercially and 566 Medicare supplemental-insured fibromyalgia patients were identified. Two-thirds of patients had low adherence. Higher duloxetine average daily dose (ADD) was associated with increased adherence (reference group = 30 mg; Commercial: Odds ratio [OR] = 3.03, 2.40, and 3.73 for 31 to 59 mg, 60 mg, and > 60 mg, respectively, all P < 0.05; Medicare supplemental: OR = 3.11, 2.33, and 4.76 for 31 to 59 mg, 60 mg, and >60 mg, respectively, all P < 0.05). Commercially insured patients with high adherence had significantly lower total healthcare costs than low-adherence patients (−$1,164, P < 0.05), primarily because of lower inpatient (−$2,222, P < 0.05) and outpatient (−$1,075, P < 0.05) costs. Medicare supplemental-insured patients with high adherence had similar overall and inpatient costs, but significantly lower outpatient costs (−$2,025, P < 0.05).

Conclusion:  Fibromyalgia patients with higher duloxetine ADD were more likely to adhere to the therapy. High duloxetine adherence was associated with lower (Commercial) or similar (Medicare supplemental) healthcare costs.
http://onlinelibrary.wiley.com/doi/10.1111/j.1533-2500.2010.00431.x/abstract;jsessionid=42859CD7803D77B64B24969880E2F0E4.d02t01

Cardiovascular safety of non-steroidal anti-inflammatory drugs

British Medical Journal  2011; 342:c7086 (Published 11 January 2011)

Implications and conclusions

The observation that cardiovascular risk is not clearly associated with specificity of cyclo-oxygenase-2 inhibitors implies that no prediction of cardiovascular risk can be made based on such specificity. Therefore the use of other non-steroidal anti-inflammatory drugs not covered by our analysis should be reconsidered, as well as the over the counter availability of non-steroidal anti-inflammatory drugs such as diclofenac or ibuprofen. In general, naproxen seems to be the safest analgesic for patients with osteoarthritis in cardiovascular terms but this advantage has to be weighed against gastrointestinal toxicity and the need for concomitant prescription of a proton pump inhibitor in many patients. In the light of the results of one study,28 celecoxib 400 mg prescribed once daily may be considered as an alternative option. Other alternatives include paracetamol and opioids. Compared with placebo, however, paracetamol results in only a small reduction in pain and may be associated with clinically relevant hepatotoxicity, even in dosages recommended for musculoskeletal pain.42 43 The analgesic effect of opioids is somewhat more pronounced but outweighed by large increases in the risk of adverse events.44 In conclusion, the options for the treatment of chronic musculoskeletal pain are limited and patients and clinicians need to be aware that cardiovascular risk needs to be taken into account when prescribing.

http://www.bmj.com/content/342/bmj.c7086.full?sid=c139b292-30b1-4c80-825c-f4c9874ad5b1

High doses of common painkillers increase stroke risk, warn researchers

British Medical Journal study links ibuprofen to highest risk of stroke over long term

The Guardian,  12 January 2011

Experts looked at 30 clinical trials to examine the effects of painkillers on health. Photograph: Nitschkefoto / Alamy/Alamy

Commonly used painkillers increase the risk of heart attacks and strokes when taken at high doses or over the long term, according to research.

Experts analysed more than 30 clinical trials on more than 116,000 patients to examine the effects of painkillers on people's health.

The fears relate to non-steroidal anti-inflammatory drugs as well as newer anti-inflammatory drugs known as Cox-2 inhibitors.

Doctors regularly prescribe such drugs to treat painful conditions, including osteoarthritis.

They are given at much higher doses than those found in over-the-counter remedies, which are used for occasional headaches, aches and pains.

The study, in the British Medical Journal, found that compared with a dummy drug lumiracoxib increased the risk of heart attacks, while ibuprofen was linked to the highest risk of stroke (more than treble the risk).

Diclofenac almost tripled the risk, while etoricoxib and diclofenac were associated with around a fourfold increased risk of suffering death from cardiovascular causes.

The authors, from the University of Bern in Switzerland, said: "Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms."

In an accompanying editorial, Prof Wayne Ray, from the department of preventive medicine in Nashville, said: "Naproxen seemed least harmful.

"Cardiovascular risk needs to be taken into account when prescribing any non-steroidal anti-inflammatory drug."

Overall, the number of heart attacks and strokes reported was low compared to the number of patients.

In 29 of the trials, there were a total of 554 heart attacks and in 26 trials there were 377 strokes. In 28 trials there were 676 deaths.

http://www.guardian.co.uk/science/2011/jan/12/high-doses-painkillers-stroke-risk

Fibromyalgia treatment articles: reference

A survey of treatment articles
http://media.surveysavvy.com/studies/L2172/search2/search?q=%2BFibromyalgia+Pain+Treatment&FORM=RCRE1

Treating Fibromyalgia in Teens and Children

A team of specialists works together to treat fibromyalgia in children and teens. This team can include a:

• Pediatric rheumatologist (a doctor who specializes in treating children with arthritis and other rheumatologic diseases)
• Psychologist
• Physical therapist

Though there currently is no cure for fibromyalgia in children (or adults), several good treatments are available to help manage its symptoms, including:
Coping strategies.One of the most effective ways to treat fibromyalgia in teens and children is by using coping strategies to manage the pain. A technique called cognitive behavioral therapy helps children with fibromyalgia learn what triggers their pain and how to deal with it. It's very helpful for improving kids' ability to function, and relieving their depression. Other behavior-based approaches to treating fibromyalgia include muscle relaxation and stress-relieving techniques (such as deep breathing or meditation).
Medication. Medications may be used to treat adults with fibromyalgia. Rheumatologists may try some of these same medicines in children. However, the safety and effectiveness of fibromyalgia drugs isn't as well studied in children as in adults.
Exercise. Exercise is an important part of fibromyalgia treatment. Children with fibromyalgia who stay active tend to have less intense pain and less depression. A physical therapist can show kids the best exercises for fibromyalgia and can teach them how to ease into an exercise program gradually so they don't get injured.
Physical therapy. Physical therapy and massage can ease some of the muscle soreness that children with fibromyalgia experience.
For teens and children who are struggling with fibromyalgia, these treatments can bring help and hope. Getting enough rest and exercise and relieving stress can help control fibromyalgia so that kids with the condition can stay symptom-free over the long term.
http://www.webmd.com/fibromyalgia/guide/fibromyalgia-in-children-and-teens?page=2

Fibromyalgia Home Remedies

 Experiencing muscular pain all over your body? When you are signaled with myriad of signs and symptoms of fibromyalgia, you should not leave yourself unprotected, especially if you are ready and capable to follow a daily exercise regimen that will target those problematic body locations.

Fibromyalgia is a condition affecting mostly women (usually in the age group of 35 to 60) compared with men, in which intense pain is experienced emanating from the muscles, joints, tendons and ligaments which is also accompanied by tiredness and lethargy. It can hinder productivity and get in the way of safe and cool life. What actually could be the right treatment of cure for this fibromyalgia? Of course, keeping in view the emergence of everyday new side effects, home remedies are the ultimate complete cure for this physical pain. The natural remedies can further be segregated into two segments – Regular Exercise and Home Remedies.  

Regular Exercise for Fibromyalgia Fibromyalgia patients generally take therapeutic exercise sessions in healthcare institutions, where they can be overviewed by trained medical staff. People grappling with fibromyalgia can also take this exercise regimen in the comforts of their own homes, or enroll in an aerobic or gym class wherein they can receive the guidance of a personal trainer.

• Studies and case studies have also shown that people having fibromyalgia can simmer down their pain and keep a check of their health & wellness by complying with a regular exercise program. Exercise for fibromyalgia can include running a treadmill, riding a bicycle, aquatic exercises, or even strength building, (generally under the supervision of a trainer) and of course yoga also. 
• Yoga is known to soothe the mind and soul while strengthening and balancing a person. In a way, yoga enables a person displaying the signs & symptoms of fibromyalgia keep a track of his/her health, more so as the condition generated some sort of hindrance in the way the body is able to process pain. Persons suffering with the arthritis-related disorder experience decreased blood pressure to a few areas of the brain which generally helps in letting the body handle pain.
• Opting for a natural treatment like exercise in lieu of medication to soothe the pain, inflammation, and in most of instances, depression accompanying fibromyalgia can be fruitful. People's bodies, usually, react in several ways. A right exercise for fibromyalgia for one person may not be at all suitable for another.
• One exercise which has been considered as evergreen and effective even for the old people is water aerobics. It develops stamina while offering comfort and relief to the symptoms and effects of fibromyalgia. Water aerobics also generates motivational strength for patients who join a group class/activity.
• Although there are myriad of medication available for fibromyalgia, the best medication for fibromyalgia is still believed to be the natural home remedy. In the long run, natural pain relief is better as it is easier to administer. Natural treatment is also considered to be better as there are generally no noticeable side effects witnessed.

Whatever form of exercise the person suffering with fibromyalgia undergoes, it's imperative to keep in mind that the results may not come quickly. The positive effects may take more time compared with medicines and drugs.  

Fibromyalgia Home Remedies 

• To several person's surprise, a lot of the components that can be facilitated to deal with this kind of pain are mostly found at home - in our daily diet. 
• Honey and lemon have many powerful healing substances, and in addition to being used for cooking, they can also be used to treat fibromyalgia pain. A few teaspoons of lemon and honey blend with a glass of warm water and if taken twice a day, work wonders. Not only does it help treating the fibromyalgia, it also has other healing agents for the body. If small quantity of turmeric is also incorporated, it becomes a very strong cocktail. Turmeric is a very strong antiseptic with healing properties. The only drawback is the pungent taste of turmeric. 
• Don’t use white flour, white sugar and salt. If you can cut down your sugar intake, it would not only alleviate your fibromyalgia pain, but would also heal your body in general. For those who have a sweet tooth, start using brown or raw cane sugar. White flour is not advisable for you to consume. You must totally rely on whole grain flour. And also keep the silent killer salt at bay as much as possible.
• Scrubbing warm vinegar on your aching muscles and joints is yet another very effective home treatment. Vinegar and its components have been used for years to cure chronic joint and muscular pain. This product could not catch much eye balls as people just don't believe that such a simple substance can have medicinal properties.
• The most prominent hidden factor behind all this is the faith in what you are doing. Don't just administer vinegar on your joints and aches just because you got information through some article and you are simply trying it out to ward off the pain. Believe in what you are doing and its results. When you consume something or apply an ointment or take a drug that is meant for relieving you from pain, alert your subconscious mind that what you are applying or doing will ultimately cure your trouble.

The best way to take natural remedies into your stride is to take one small step at a time, or in different stages, and then to retain and sustain the physical activity.

http://www.altiusdirectory.com/Lifestyle/fibromyalgia-home-remedies.html

Jazz Feels No Pain Following FDA Rejection of JZP-6

Following the overwhelming negative FDA panel vote against Jazz Pharmaceuticals’ (JAZZ) fibromyalgia treatment JZP-6, the agency’s complete response letter did not come as a surprise. What may surprise is that Jazz shares have recovered nearly all their value since the advisory committee vote two months ago.
Even as the FDA document asked for additional clinical work to clarify the safety of taking JZP-6, along with risk mitigation questions, Jazz shares were up 8% last week to $10.95 by close on Wednesday. This surprising behavior - just two months after shares fell more than one-fifth to $7.96 on the day following the adcom vote - likely reflects the fact that investors were holding out little real hope of the drug reaching the market, even before the advisory committee review. Investors appear to have moved on; it would not be surprising if the company now does the same by drawing a line under this project.
New trials needed
The complete response letter delivered Monday to the California company specified additional trials to test the safety of JZP-6 when taken with other medications, chairman and chief executive Bruce Cozadd said in an investor conference call.
This issue was raised at a joint meeting of the FDA’s Arthritis and Drug Safety and Risk Management Advisory Committees back in August. JZP-6, generically known as sodium oxybate and with a planned trade name of Rekinla, is a lower-formulation of Jazz's narcolepsy therapy Xyrem (Jazz hears adcom sing from different song sheet, August 23, 2010). Experts said the difference in the brand names held the potential to cause medication errors by prescribers who did not know they were the same molecule.
In addition, there were questions surrounding the safety of the middle-of-the-night dosage, which could be left unprotected by adult bedsides and consumed by children, experts claimed at the adcom meeting. The FDA also requested a clarification on selection of an appropriate patient population.
Jazz had submitted additional data and revisions to its planned risk evaluation and management strategy (REMS) to the FDA following the adcom meeting, Mr Cozadd said. The complete response letter said the FDA did not factor this new information in its regulatory response, so there is the possibility that the company has already taken steps to address regulators’ concerns.

Setback
Even though investors appear to have taken this decision in their stride, this news represents a big miss for the company. With analysts from Jefferies forecasting sales of $216.4m in 2015 before the adcom vote, the product would have represented Jazz’s biggest growth driver.
Capstone Investment remained much more skeptical, penciling in $41.4m in sales in 2012, the year Jefferies was forecasting $112.4m.
Jefferies remained bullish following the adcom vote, trimming forecasts to $154.6m in 2015, but still estimating a launch in 2011. With the call for new trials and the real chance of the company abandoning this project, these forecasts are likely to move to zero.

Missing their water
Investors appeared to be completely ignoring the optimism of analysts. With the net present value of Xyrem representing 96% of the company’s market capitalization of $425m, it could be concluded that the stock market was not assigning any value to JZP-6, even before the adcom vote. The fall in August could be put down to a typical instant reaction to a negative event.
The company faces difficult choices if it wants to fund further trials. The company had $9.6m cash on June 30 and $32.7m debt, and only raised money from shareholders in the first half of the year, to help refinance this debt.
Paying for another round of expensive trials will be a hard call; investors may prefer Jazz to start playing another tune.
http://seekingalpha.com/article/230432-jazz-feels-no-pain-following-fda-rejection

Savella: Forest Laboratories Inc.

Forest Laboratories Inc. (NYSE: FRX) is scheduled to release fiscal third-quarter earnings before the opening bell on Tuesday, January 18, 2011. Analysts, on average, expect the company to report earnings of 99 cents per share on revenue of $1.10 billion. In the year-ago period, the company reported earnings of 97 cents per share on revenue of $1.06 billion.

Forest Laboratories, Inc. develops, manufactures, and sells branded and generic forms of ethical drug products. The Company’s United States products are marketed directly, or detailed, to physicians by its salesforces. Its principal products include Lexapro to treat depression; Namenda to treat Alzheimer's disease; Bystolic, beta-blocker to treat hypertension; and Savella for the treatment of fibromyalgia.

Forest Laboratories is trying hard to come up with new drugs that can help replace lost revenue when its antidepressant drug Lexapro goes off patent in March 2012.  The drug generated $2.3 billion in revenue last year. Similarly, the company's Alzheimer's drug Namenda faces patent expiration in April 2015. According to IMS Health, Namenda had U.S. sales of $1.2 billion for the twelve months ended March 31, 2010.

Late in October, the company said that U.S. Food and Drug Administration approved Teflaro for the treatment of community-acquired bacterial pneumonia. Forest expects Teflaro to be available to wholesalers by January 2011. Early in November, Forest Laboratories and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) reported positive top-line results from a late-stage clinical trial assessing the efficacy and safety of investigational drug linaclotide in patients with irritable bowel syndrome with constipation. The companies expect to submit an NDA with the FDA for both the IBS-C and CC indications in the third quarter of calendar year 2011Last month, Forest Laboratories Ireland Limited, a wholly owned subsidiary of Forest Laboratories, Inc. and Gruenenthal entered into a license agreement for the co-development and commercialization of a novel oral small molecule analgesic, GRT 6005, and its follow-on compound GRT 6006. Both compounds were discovered and developed by Gruenenthal and represent novel first in class molecules with unique pharmacological and pharmacokinetic profiles that may enhance their effect in certain pain conditions. Early in January, Forest Laboratories and Almirall S.A. said that their lung disease drug aclidinium met its primary endpoints in a late stage clinical trial. Regulatory submissions in Europe and the US for aclidinium bromide monotherapy are both planned for mid 2011. Forest Laboratories has licensed US rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world. The companies are jointly involved in the development of the compound.

Among other developments, Forest Laboratories entered into a definitive collaboration and distribution agreement for Bystolic and Savella in Canada with Janssen Pharmaceutica NV and Janssen pharmaceutical respectively, on behalf of Janssen Inc., which will market the products in Canada.

http://www.themarketfinancial.com/forest-laboratories-inc-nyse-frx-q3-earnings-preview/121277

FDA Approves Antidepressant Cymbalta for Back Pain

 Kia Bryan :  January 5, 2011

 

Lower back pain can strongly impair your everyday life—from having trouble lifting your groceries to impeding your workout regime. It seems relief might come from an unlikely source: the antidepressant duloxetine (commonly known as Cymbalta).  Based on the success of duloxetine in pain-related research, the Food and Drug Administration (FDA) recently approved duloxetine for the treatment of chronic back pain. According to the FDA’s press release, “Since its initial approval, about 30 million patients in the United States have used Cymbalta. It was approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008.”

A new study conducted by Lilly Research Laboratories (the makers of Cymbalta) found that participants who took it had a significant reduction in lower back pain. Almost half of patients had a 50 percent reduction of lower back pain, plus a significantly improved quality of life compared to participants that took a placebo.

The random, double-blind study was conducted in multiple test sites around the world including the U.S. The subjects had experienced moderate lower back pain consistently for six months before the study but some were later disqualified if they were diagnosed with depression, taking potentially interfering medications, or had previously undergone back surgery.
The participants were randomly put in two groups for the duration of the 12-week study: 198 participants received a 60 mg dose of duloxetine daily, while 203 participants received a placebo. The participants also completed surveys that evaluated lower back pain severity, overall body functioning, mood, activity level and medication tolerability.

Participants who took duloxetine experienced a consistent reduction of lower back pain throughout the 12 weeks. They also reported a significant improvement in mood, body functioning and activity level compared to participants who took placebos. However, a significantly larger portion of participants in the duloxetine treatment group discontinued the medication because of adverse side effects: nausea and dry mouth were the most reported, although neither was severe. Results from a related study showed that duloxetine reduced the severity of depression and physical pain symptoms that often coincide with depression.

Of course, this method of treatment may not work for everyone. If you are experiencing physical pain, talk to a doctor or counselor about other types of medication and alternative treatments.
http://fyiliving.com/depression/fda-approves-antidepressant-cymbalta-for-back-pain-treatment/#ixzz1AYIhXdc4

OXYTOCIN MAY OFFER BENEFITS IN TREATMENT OF CHRONIC PAIN

 Dr. James Howenstine, MD. :  January 5, 2011  :  NewsWithViews.com

The hormone oxytocin is used to induce labor in pregnant women. Large amounts of oxycytoxin are released during childbirth and the uterus is stimulated to contract. There is now research evidence that this hormone has a valuable role to play in healing fibromylgia, PTSD (Post Traumatic Stress Disorder), and sexual dysfunction in females (delayed or inability to experience orgasms).

Dr. Jorge Flechas has done considerable research with Oxytocin. Twenty years ago he became aware that there were at least 20,000,000 patients with fibromyalgia who had no effective therapy.

Dr. Flechas learned that patients with fibromyalgia had only about one third the levels of DHEA that was present in normal persons. Nearly every patient he encountered advised him that that stress greatly intensified the symptoms. Patients with fibromyalgia who were free of symptoms often developed a severe recurrence of their symptoms when they found themselves in a new stressful situation. One patient was quite well on therapy until she learned that her son had died. Within 24 hours she had reappearance of a full flare-up of her illness. These patients also are aware that having an orgasm brought about a dramatic decrease in their symptoms for up to 4 hours.

Dr. Guy Abraham, former head of infertility at UCLA Medical School, advised Dr. Flechas that orgasm is followed by marked elevation of oxytocin levels. Oxytocin produces the feeling of warmth all over, cuddling and relaxation. Oxytocin appears to counteract the effects of stress. Lack of oxytocin is not rare in the general population.

Most women find the pain in childbirth so unpleasant that during delivery they decide to never have another child. Dr. Flechas reports that Oxytocin seems to have the fascinating ability to cause the brain to be unable to recall the severe pain that occurs with childbirth. This certainly plays a role in why most women proceed to have more than one child.

Some patients seem to use sexual activity as a method to decrease stressful situations. Oxytocin appears to be an effective anti-stress hormone. There is also substantial literature supporting the concept that it is effective in pain control.

Soldiers returning from the Vietnam War with Post Traumatic Stress Disorder were found by Dr. Flechas to have an insufficiency of oxytocin. These patients were successfully treated with oxytocin.

In 1992 Dr. Flechas took care of a woman who been involved in a terrible airplane crash. This crash triggered a relapse of her fibromyalgia which often follows physical injury particularly neck trauma. She had continuous pain in a breast that had been injured in the accident. This was associated with generalized pain compatible with fibromyalgia. She related that in all 5 of her pregnancies physicians were forced to use oxytocin. This had encouraged her to be suspicious she could be lacking oxytocin. She was given intravenous oxytocin and proceeded to leave Dr. Flechas’s office in one hour pain free. She also noted that her energy levels which had always been subnormal and had never permitted her to undertake a physical activity lasting more than 20 minutes. She went shopping with her husband for 4 hours and proceeded to have sexual relations with her husband which resulted in the best orgasm she could recall for 5 years. She advised Dr. Flechas that she was awakened from sleep at 3 AM with reappearance of all her fibromyalgia pain. Her pain relief from oxytocin therapy had lasted 18 hours.

Dr. Flechas decided to do a test study to see if she could detect whether she was getting oxytocin or not. Identical intravenous fluid bags were prepared. One contained oxytocin and the other did not. Within 5 minutes of being given a bag which contained no oxytocin she told Dr Flechas she was not receiving oxytocin. She knew this because the preceding day when given oxytocin within 5 minutes of starting the oxytocin infusion she developed a heat sensation involving ears, hands and feet. This sensation was absent. Oxytocin controls the capillary circulation in the arms and legs. Cold hands and feet without an adequate explanation are indications oxytocin deficiency is probably present.

Dr. Flechas is convinced that the primary factor governing the presence or absence of adequate oxytocin is the patient’s exposure to stress. When a woman who is breast feeding becomes very stressed it is common for breast milk to dry up resulting from decreased oxytocin production caused by stress.

Dr. Frank Shellenberger has noted that menopause appears to be a factor pushing women into fibromyalgia. Correcting deficient estrogen levels causes fibromyalgia symptoms to improve.

Patients with oxytocin insufficiency often have experienced emotional or physical trauma immediately before symptoms began. Physical findings seen in these patients include cold hands and feet and a blanched white pasty appearance in the skin of the face and ears. These patients with oxytocin lack often give a history of lack of orgasms (anorgasmia). They tend to dislike being held and cuddled. They often appear agitated and full of anxiety. Another common symptom they have is loss of memory for social events.

Because there is no readily available blood test to establish oxytocin deficiency a trial of oxytocin therapy is warranted. An intramuscular injection of 1 cc. (20 units of oxytocin) combined with ½ cc. of lidocaine to alleviate pain can be used. Warming up of the hands, ears, and feet within 5 to 10 minutes is a good sign that oxytocin deficiency is probably present. This should be associated with increased libido, improved energy and decreased pain within one or two hours.

In order to avoid daily injections the Belmar Pharmacy (800-525-9473) has formulated oxcytocin embedded in a wax matrix. This permits oxcytocin to get absorbed into lymphatic channels which permits oxcytocin to escape destruction by the liver. Blood levels have been proven to rise within an hour. This formulation requires a prescription from a physician.

Post Traumatic Stress Disorder, Anxiety States, and other diseases may respond to oxcytocin. Research has discovered that oxcytocin is not solely created in the pituitary gland but can be made in ovaries, testicles, adrenal glands, pancreas, heart, gastrointestinal tract, thymus, pineal gland and retina. This raises the possibility that other sites may be experiencing symptoms relating to oxcytocin lack that are yet to be identified.

Oxytocin levels rise in relaxed patients and fall in stressed patients. Administration of any hormone to a patient may not result in a beneficial effect if the patient has become resistant to the effect of the hormone being given. When this occurs it raises suspicion that either estradiol or DHEA is lacking. Correction of a deficiency of either estradiol or DHEA restores responsiveness to oxytocin.

There is sufficient evidence that oxcytocin can be valuable to patients with fibromyalgia to warrant a trial of oxcytocin in these patients. The wax formulation from Belmar Pharmacy may prove more practical than injections.

Malignancies create major stress in nearly every patient. A common problem in patients with malignancies is pain management. Pain may appear at sites where malignant cells are located due to tumor cells releasing lactic acid which is painful. Additionally tumor masses can press on nerves generating painful stimuli. A safe therapy like oxcytocin would become very valuable in caring for cancer patients if it could be shown to be effective in alleviating pain caused by malignancies. This is of major importance because the narcotics and synthetic pain drugs stimulate the growth of cancer cells [1] which obviously impairs the ability of patients to recover.

Footnotes:

1, Singleton, P.A., Moss, J., Effect of preoperative opiods on cancer recurrence: a hypothesis Int Immunopharmacol. 2010 Sept. 1149-52
2, Campos, G et al 2010 Elsevier B.V. Department of Pharmacology University of Bologna, Italy

© 2011 Dr. James Howenstine - All Rights Reserved

http://www.newswithviews.com/Howenstine/james186.htm

Study suggests placebos may have place in treatment

Jan. 3, 2011 :   Marie McCullough :  Inquirer Staff Writer

Will a placebo work only if the patient believes it's real? Does a placebo have to be innocuous, like a sugar pill? Do placebos have a place not just in research but in modern medical treatment? For some answers, we turn to a provocative new study by Harvard researchers, and to psychologist James D. Herbert, director of Drexel University's anxiety treatment and research program.
The Harvard study, published last month in PLOS One, a journal of the Public Library of Science, found that 37 patients with irritable bowel syndrome who were given pills described as "placebo pills, like sugar pills" reported more symptom relief than 43 patients who simply met with doctors.
The results defy the conventional wisdom that harnessing the "placebo effect" for treatment requires the doctor to do something unethical: Deceive the patient.
"Placebo research has really been stuck because of ethical concerns," Herbert said.
The ethics and effects of placebos are complex. For example, study after study has shown that placebos work almost as well as anti-
depressants known as SSRIs.
And Herbert suspects the fakes would be every bit as effective if pharmaceutical companies used "active" placebos - pills with the same side effects as SSRIs, including nausea and low libido.
In the 1960s, when active placebos were permitted in studies, they lifted mood just as well as most older antidepressants. But today, a placebo that makes patients "feel crappy" is considered unethical, Herbert said.
As for the Harvard study, that placebo was not truly inactive, as patients were told "placebo pills . . . have been shown in clinical studies to produce significant improve-
ment in IBS symptoms through mind-body self-healing. . . ."
"I doubt that if they said, 'Here's a sugar pill, just take it,' that you'd see the same results," Herbert said. "Placebo effect is all about expectations."
That's why he believes prescribing placebos would be appropriate for certain patients with conditions shown to benefit from psychological as well as medical therapy - illnesses such as depression and fibromyalgia. Cancer would be a different story.
"You have to be careful not to overgeneralize," he said.
http://www.philly.com/inquirer/health_science/weekly/20110103_Study_suggests_placebos_may_have_place_in_treatment.html#ixzz1AYH6qgQt

Adeona Pharmaceuticals; Effirma; Flupirtine

Adeona Pharmaceuticals, Inc. operates as a pharmaceutical company that develops medicines for central nervous systems and autoimmune diseases. It primarily focuses to in-license clinical-stage drug candidates that have already demonstrated a certain level of clinical efficacy and develop them further to either commercialization or development collaboration. The company is developing various clinical-stage drug candidates that include Effirma, a centrally-acting investigational oral drug for the treatment of fibromyalgia syndrome.  Adeona Pharmaceuticals, Inc. has a partnership with Meda AB, to develop flupirtine for the treatment of fibromyalgia syndrome. The company was founded in 2001 and is headquartered in Ann Arbor, Michigan.
http://www.tradingmarkets.com/news/press-release/aen_aen_chgs_shz_stvi_tlr_vvtv_vvtvu_buyins-net-market-maker-surveillance-report-stvi-tlr-shz-chgs-vvtv-aen-winning-stocks-with--1391868.html

Central Neuropathic Pain

Central Neuropathic Pain: Cymbalta--- Another Failed Trial

December 29, 2010

Summary

Treatment of neuropathic pain remains an enigmatic dilemma for most physicians.  Presently there are no drugs FDA approved for central neuropathic pain.  The use of drugs utilized for diabetic peripheral neuropathy and fibromyalgia, most notably Cymbalta (Eli Lilly), Lyrica (Pfizer) and Savella (Forest), as well as generics such as  gabapentin, tricyclic antidepressants and older anticonvulsants remain the mainstay of therapy.

Analysis

Central neuropathic pain remains relatively treatment resistant, with most patients not achieving more than 30% pain relief.  Many patients with traumatic spinal cord injury with severe neuropathic pain choose no pain medication, given the minimal effect and high side effects of conventional (non-intrathecal) medications.  This double blind placebo controlled trial of Cymbalta (duloxetine, Eli Lilly) in patients with central neuropathic pain secondary to spinal cord injury or stroke, while showing a trend favoring Cymbalta, failed to show a statistically significant result for the primary endpoint.
The absence of a statistically significant endpoint means no clinically meaningful result, and no new label.
Nuedexta, Avanir's combination of ultra-low dose (10mg) quinidine with 20 mg of dextromethorphan showed a robust and rapid response in multiple sclerosis patient's with central neuropathic pain.  Although recently approved for PBA (Pseudobulbar affect), the effect seen in central neuropathic pain in MS patients was dramatic, and in additive to that achieved by concomitant use of narcotic or non-narcotic analgesics.  Avanir has released similar exemplary data for patients suffering diabetic peripheral neuropathy.
Central neuropathic pain remains an open field.  There are presently no drugs FDA approved for central neuropathic pain in the US, and only one (Lyrica) outside the US. With the upcoming launch of Nuedexta for PBA, and the positive data seen previously in double blind placebo controlled trials in MS pain, one can only hope that Avanir will follow Eli Lilly and soon fund trials in central neuropathic pain.  A successful trial of Nuedexta in central neuropathic pain could be expected to add markedly to Avanir's valuation.
http://www.glgroup.com/News/Central-Neuropathic-Pain--Cymbalta----Another-Failed-Trial-52020.html

Mindfulness therapy no help in fibromyalgia trial

By Amy Norton : Dec 28, 2010

NEW YORK (Reuters Health) - A program aimed at easing stress with meditation and yoga may not be much help for people with the chronic-pain condition fibromyalgia, a recent study suggests.The study, published in the journal Pain, looked at the effects of so-called mindfulness-based stress reduction -- a technique developed by researchers at the University of Massachusetts in 1979 that combines mindfulness meditation and gentle yoga postures.
The technique is now available throughout the world -- in the form of an eight-week program of classes -- to help people manage general stress or health problems, including chronic pain.
For the new study, researchers led by Dr. Stefan Schmidt, of the University Medical Center in Freiburg, Germany, tested the program's effects among 177 women with fibromyalgia.
They found that women assigned to the mindfulness program showed no greater gains in health-related quality of life than those assigned to a waiting list for treatment.
That meant no significant improvements in either physical symptoms or emotional well-being.
"I'm surprised it didn't work better than it did," Dr. Alex Zautra, a professor in psychology at Arizona State University in Tempe, told Reuters Health. Zautra, who was not involved in the study, said he would have expected better results since people with fibromyalgia would seem to be good candidates for the mind-body therapy.
Fibromyalgia is a syndrome marked by widespread pain -- including discomfort at specific "tender points" in the body -- along with symptoms like fatigue, irritable bowel and sleep problems. It is estimated to affect up to 5 million U.S. adults, most commonly middle-aged women.
The precise cause of fibromyalgia is unknown. There are no physical markers, like inflammation or tissue damage in the painful areas -- but some researchers believe the disorder involves problems in how the brain processes pain signals.
Standard treatments include painkillers, antidepressants, cognitive-behavioral therapy and exercise therapy. However, many people with fibromyalgia find that their symptoms persist despite treatment.
One reason, some researchers suspect, may be because standard treatments do not specifically address the role psychological stress and emotions can play in triggering pain.
Studies have found that people with fibromyalgia have higher-than-average rates of stressful life events, like childhood abuse and marital problems. There's also evidence suggesting they are less aware of their own emotions and have more difficulty holding on to positive feelings compared to people without fibromyalgia.
The idea behind mindfulness practices, Zautra said, is that people become more aware of how they are feeling, emotionally and physically, from moment to moment. Then they can start to see how their emotions affect their perceptions of their physical symptoms.
But maybe the problem, Zautra said, is that "awareness by itself is not enough for patients with fibromyalgia."
That is, people with the disorder may need extra help in learning how to manage the emotions that come up when they meditate or practice mindfulness-based yoga.

http://www.reuters.com/article/idUSTRE6BR3MN20101228