Battered woman imagery in pfizer’s new fibromyalgia ad
Pfizer has recently upped the stakes in its campaign to depict fibromyalgia as a “real” medical condition. In an non-branded “disease awareness” TV ad that I saw last night, this point was hammered home by images of a woman showing black and blue bruises over her body. She says something like “Maybe if people saw me this way, they will believe that fibromyalgia is a real medical condition.” What I saw were disturbing images reminiscent of battered woman syndrome. The whole thing smacked of desperation on Pfizer’s part to sell more drugs and represents DTC advertising sinking to a new low in exploiting women’s fears! I was not able to capture an image of the woman from my TV, so I am using the image above left that I found at the Medical Advocates/Battered Women web site. It accurately conveys the message that Pfizer put on the screen. (If you can get an actual screen shot of the ad, please send it to me at johnmack@virsci.com). The ad urges viewers to visit the FibroCenter Web site where they can find information about a treatment option; ie, Lyrica, Pfizer’s drug approved for the treatment of fibromyalgia. Perhaps Pfizer is getting desperate to sell more Lyrica in the face of criticisms that fibromyalgia is not a real medical condition. The cartoon on the right from the Dry Bones Blog is a case in point. Adverse Event Reporting Be Damned! Tell Us Your Story! Meanwhile, if you visit the FibroCenter Web site you may be surprised to find that Pfizer is soliciting stories from patients (note: the same form can be accessed from the Lyrica.com site): “Are you living with fibromyalgia? Would you be willing to share your story with others, so that they may learn from your experience? If so, please answer a few short questions to get started …” (see here). There are several multiple choice questions, but what shocks me is the box for an open-ended response with the instruction: “Please use this space to share your story about living with fibromyalgia. Please limit your story to 3000 characters or less. (Approximately 500 words.)” WOW! What an opportunity to collect ADVERSE EVENTS, which Pfizer must then submit to the FDA. I always thought — and pharma people have always said — that one of the reasons the industry is shunning Web 2.0 social network sites is the possibility that they would then have to report a slew of adverse events to the FDA. And who wants that? But here is Pfizer doing just that! If nothing else, this can be used as a case study to counteract the main argument pharma has used against social media engagement. Pfizer also collects personal information that will uniquely identify people who “tell their stories”: “In case it is selected for publishing on the site, we will need to collect your name, city, state, phone number, as well as your e-mail address so that we may notify you. By submitting your information, you agree that it will be governed by the Consent and Release statement below.” The consent form also admits that Pfizer is collecting personal medical information: “I grant my consent to use my name, biographical data and relevant medical history by Pfizer Inc in any Permitted Use identified below.” Pfizer, of course, hopes to collect contact information about patients so they can send them information about LYRICA (it says it will do that in the consent form). But it may be collecting more than it bargained for. For example, Pfizer may collect stories such as the following, which I found in one of the first comments to the Dry Bones blog post I cited above: “Having put up with Fibro since I was 25 (18 years ago)- I can tell you it exists. I loved the toon! I won’t be taking Lyrica though, I keep it under control through weight control, light exercise and relying on G-d, “for man shall not live by bread alone, but by every word that proceeds from His mouth.”OK, “G_d” may not be Lyrica’s #1 competitor, but life style changes may be. However, you won’t find THAT option in the main menu at the FibroCenter Web site — “A Community of Education, Support and Understanding for People With Fibromyalgia.” You’ll have to dig deeper. (Source: Pharma Marketing Blog)
Fibromyalgia has highly negative impact on lives of muslim bedouin women
Though research frequently focuses on patient populations in urban areas of developed countries, fibromyalgia “has been described and studied in various sociocultural settings in both developed and developing countries.” In their study published in Seminars in Arthritis and Rheumatism [2007 Oct 29] researchers at Ben Gurion University of the Negev (Beer Sheva, Israel) aimed to assess the clinical manifestations of fibromyalgia and describe its effect on quality of life in the “unique setting of Muslim Bedouin women in the southern Israel Negev desert area.”They evaluated 102 Bedouin women were recruited from a primary health care clinic in the Negev, all of whom fulfilled the American College of Rheumatology (ACR) criteria for fibromyalgia diagnosis. Tender points were assessed using manual dolorimetry (an instrument used to measure pain tolerance) and pain level, anxiety, depression, and quality of life were also assessed using various questionnaires.The study population was characterized by a low educational level, a high rate of consanguinity, a high number of children per mother, and a high rate of polygamy. There was a high frequency of classic [fibromyalgia] symptoms such as pain and fatigue, as well as anxiety and depression. The overall impact of [fibromyalgia] on quality of life was exceedingly high (8.9 on a scale of 0 to 10).The researchers concluded that fibromyalgia is relatively common among Muslim Bedouin women and has a “very significant impact on their quality of life as well as on their dependents.” They suggest that physicians who provide primary care to this population must be attentive to the manifestation and impact of fibromyalgia and its related disorders. (Source: The Fibromyalgia Research Blog)
Effects of yoga and tui na on fibromyalgia
A study conducted by the Pulmonary Division at University of São Paulo (Brazil) intended to verify whether techniques of yoga with and without the addition of traditional Chinese medicine modality Tui Na would “improve pain and the negative impact of fibromyalgia on patients’ daily life.” The results are published in the Journal of Alternative and Complementary Medicine [2007 Dec; 13(10):1107-14].Forty women with fibromyalgia were randomly assigned to two groups. One group participated in Relaxing Yoga (RY) and the other received Relaxing Yoga plus Touch (RYT), for “eight weekly sessions of stretching, breathing, and relaxing yogic techniques.” RYT patients also received manipulative techniques of Tui Na, an ancient hands-on Chinese technique that uses acupressure to bring the body into balance.The outcome of the study was measured using the Fibromyalgia Impact Questionnaire (FIQ), pain threshold at the 18 FMS tender points, and a verbal assessment of pain. The visual analog scale (VAS) for pain was assessed before and after each session and on the follow-up.Seventeen (17) RYT and 16 RY patients completed the study. Both RY and RYT groups showed improvement in the FIQ and VAS scores, which decreased on all sessions. The RYT group showed lower VAS and verbal scores for pain on the eighth session, but this difference was not maintained on the follow-up. Conversely, RY VAS and verbal scores were significantly lower just on the follow-up.The results of this study show that yoga techniques are “valid therapeutic methods” for fibromyalgia. The addition of a touch-based modality further improved the outcome of treatments. However, over a longer period of time patients who received only Relaxing Yoga (without Tui Na) reported less pain, which suggests that “a passive therapy may possibly decrease control over fibromyalgia symptoms.” (Source: The Fibromyalgia Research Blog)
Immunological changes in fibromyalgia & other chronic pain conditions?
The newest issue of the medical journal Neuroimmunomodulation [2008 Feb 1;14(5):272-280] includes the results of a study conducted by Department of Anesthesiology of Ludwig Maximilians University, Munich, Germany. The study address immunological changes in chronic pain patients, specifically complex regional pain syndrome (CRPS) and fibromyalgia (FMS), both of which the researchers describe as “chronic pain syndromes occurring in highly stressed individuals.”Despite the known connection between the nervous system and immune cells, information on distribution of lymphocyte subsets under stress and pain conditions is limited. Lymphocytes are white blood cells that play a critical role in the body’s defenses. They include T cells, B cells, and natural killer cells. They also modulate the activities of other cells.The researchers performed a comparative study of 15 patients with CRPS, 22 patients with FMS and 37 age- and sex-matched healthy controls. Their aim was to investigate the influence of pain and stress on lymphocyte number, subpopulations and the Th1/Th2 cytokine ratio in T lymphocytes.Lymphocyte numbers did not differ between the groups studied. However, when the subtypes of lymphocytes were studied using quantitative analyses, it became evident that there was “a significant reduction of cytotoxic CD8+ lymphocytes in both CRPS… and [fibromyalgia]… patients as compared with healthy controls. Additionally, CRPS patients were characterized by a lower percentage of IL-2-producing T cell subpopulations reflecting a diminished Th1 response in contrast to no changes in the Th2 cytokine profile.”The article concludes that future studies are necessary in order to answer “whether such immunological changes play a pathogenetic role in CRPS and [FMS] or merely reflect the consequences of a pain-induced neurohumoral stress response, and whether they contribute to immunosuppression in stressed chronic pain patients.” (Source: The Fibromyalgia Research Blog)
Fda approves cymbalta for fibromyalgia
The FDA approved duloxetine (Cymbalta) as a medication for fibromyalgia earlier this week. Cymbalta is a serotonin-norepinphrine reuptake inhibitor. It is also used for anxiety, major depression and peripheral diabetic neuropathy. It has been shown to be effective for some fibromyalgia patients. Cymbalta, made by Lilly, is the second drug to ever be approved for fibromyalgia. Last year Lyrica (pregabalin), an anti-convulsant, became the first fibromyalgia drug approved by the FDA.The added indication [for fibromyalgia] was approval on the basis of data from two three-month clinical trials of 874 fibromyalgia patients. In both studies, compared with placebo, duloxetine was associated with more than a 30% reduction in pain as measured by the Brief Pain Inventory (BPI) 24-hour average pain scale.Moreover, patients randomized to duloxetine reported significant pain relief during the first week of treatment.In both studies the majority of duloxetine patients — 65% in one study and 66% in the other — said they felt better since beginning treatment with 60 mg of duloxetine daily, as measured by a self-assessment (Patient Global Impression of Improvement).Cymbalta’s side effects include nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation. Twenty percent of duloxetine patients discontinued the study drug because of side effects. (Source: The Fibromyalgia Research Blog)
Gender differences in chronic pain and depression rates
In October’s Psychosomatics (2007 Oct;48(5):394-399), Canadian researchers present results of an epidemiological study of “gender differences in the prevalence of depression in four chronic pain conditions and pain severity indices in a national database.”In 131,535 adults, the prevalence of depression in women (9.1%) was almost twice that of men (5%). One-third (32.8%) had a chronic pain condition (fibromyalgia, arthritis/rheumatism, back problems, and migraine headaches). The prevalence of depression in individuals with chronic pain conditions was 11.3%, versus 5.3% in those without. Women reported higher rates of chronic pain conditions and depression and higher pain severity than men…. Depression and chronic pain conditions represent significant sources of disability, especially for women. (Source: The Fibromyalgia Research Blog)
Cost-effectiveness of spa treatment for fibromyalgia
In an article subtitled “General Health Improvement Is Not For Free” (Rheumatology [Oxford], July 17, 2007) rheumatology researchers in the Netherlands examine the cost-effectiveness of a course of spa treatment for fibromyalgia patients compared with usual care only. They studied 134 patients, who were randomly assigned to a 2 1/2 week spa treatment course in Tunisia or to a regular course of care only. Effectiveness was measured via multiple scales, and costs were reported from societal perspective.The data from 128 of the patients was analyzed, and the information indicated that general health improvement was experienced by the spa treatment group up to 6 months after the treatment. After one year, there were no significant differences between the two groups. The mean incremental cost of spa treatment was 1211 Euros per patient, which was made of up of the cost of thalassotherapy, airfare and lodging, or “or euro885 per patient based on a more realistic cost estimate.Researchers concluded that “[t]he temporary improvement in quality of life due to an adjuvant treatment course of spa therapy for patients with [fibromyalgia] is associated with limited… costs per patient.” (Source: The Fibromyalgia Research Blog)
Relief From Fibromyalgia
Aching bones, stiff shoulders, fatigue and difficulty sleeping may all be indications of fibromyalgia. There is no known cure, so it is important to find as much relief from fibromyalgia as possible. Many sufferers have found relief from fibromyalgia by making changes to their lifestyle. Simple ch
Breaking news! first fibromyalgia drug wins fda approval
June 21, 2007, will is a major landmark in the history of fibromyalgia treatment. Yesterday Pfizer, Inc. won federal approval for Lyrica as the first treatment for fibromyalgia. This means that Lyrica will be the first drug that can be marketed specifically as a treatment for fibromyalgia patients, unlike the many drugs that have been prescribed for fibroomyalgia patients for “off-label” uses. This also will have implications for the insurance industry and the potential for policies to cover this medication for insured patients.Lyrica is an anti-convulsant that was previously approved by the FDA for the treatment of seizures, post-herpetic pain and diabetic neuropathy.According to CBS, the “FDA warned that common side effects of the drug included mild-to-moderate dizziness and sleepiness. Also, the agency said that Lyrica reduces pain and improves daily functions for some patients with fibromyalgia, but that not everyone derived benefit from the drug in studies.”In the wake of this groundbreaking news, the FDA has published a page on their site about the debilitating affects of fibromyalgia and ways for patients to cope with it, including information about the new “fibromyalgia medication.” You can see this page at: http://www.fda.gov/consumer/updates/fibromyalgia062107.html (Source: The Fibromyalgia Research Blog)
