The number of spinal cord injuries among senior citizens (age 70 and above) has increased five times in the past 30 years, as compared with younger spinal cord injury patients, researchers at Thomas Jefferson University Hospital and Jefferson's Regional Spinal Cord Injury Center of the Delaware Valley recently reported.
As the population within the United States ages, it is estimated that 20 percent of its population will be older than age 65 by the year 2040, and will likely impact spine surgeons and spinal cord rehabilitation centers as these patients become a larger proportion of the spinal cord injury (SCI) population. The findings were just presented by Jefferson neurological surgeons at a meeting in Phoenix, Ariz. of the Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons.
"Spinal cord injuries in older patients are becoming more prevalent," said James Harrop, M.D, Assistant Professor of Neurological and Orthopedic Surgery, Jefferson Medical College of Thomas Jefferson University, one of the study's primary investigators. "The mortality of these patients is much greater than younger patients and should be factored in when considering aggressive interventions and counseling families regarding prognosis." However, they also found that these patients have had an increase in survival over this period.
Admissions by geriatric SCI patients have increased five-fold and the percentage of geriatric patients within the SCI population has increased from 4.2 percent to 15.4 percent since 1980. In comparison to younger patients, geriatric patients are less likely to have severe neurological deficits but have higher rates of mortality. Researchers reviewed a database of 3,481 consecutive acute penetrating and blunt spinal cord and spine-injured patients treated at Jefferson Regional Spinal Cord Injury Center over a 28-year period (1978-2006).
Overall annual admissions for SCI at Jefferson's Spinal Cord Injury Center have increased 60 percent since the early 1980's, but geriatric SCI admissions have increased more than 580 percent during that same time period, the researchers found.
"This increase is likely a result of an aging population and propensity for these patients to have SCI with minor trauma," Dr. Harrop noted. "Falls continue to be the predominant mechanism for geriatric spinal cord injuries with 74 percent of geriatric injuries resulting from a fall in this series."
Geriatric patients also appear prone to traumatic spinal cord injuries due to:
(1) changes in bone quality with aging
(2) increasing prevalence of cervical spinal stenosis with older age
(3) an increased rate of motor vehicle accidents per mile driven
It is also believed that these older patients have an increased risk of mortality due to their concurrent medical illnesses, as well as their limited ability to overcome traumatic injuries, they said.
Mortality, both during hospitalization and the first year after injury, was much higher in the geriatric population-- approximately eight times higher, the study showed.
Mortality during hospitalization was 3.2 percent for adult patients less than age 70 and 27.7 percent for geriatric patients. Mortality one year after getting out of the hospital was 5.4 percent for the adult patients and 44.4 percent for the geriatric patients. In both cases of mortality (hospital and one-year), high-quadriplegic injuries were found to have the highest mortality and paraplegic injuries had the lowest mortality.
Contact: Jeff Baxt
Thomas Jefferson University
воскресенье, 23 октября 2011 г.
четверг, 20 октября 2011 г.
Patients Transitioned From Fosamax(R) To Denosumab Achieved Greater Gains In Bone Mineral Density Vs Those Continuing On Alendronate
Amgen (NASDAQ:AMGN) announced full data
results from a non-pivotal Phase 3 head-to-head, double-blind trial comparing bone
mineral density (BMD) gains in postmenopausal women with low bone mass who
transitioned from weekly oral alendronate (Fosamax®) to denosumab versus those who
continued alendronate therapy. In addition, patient preference data from another nonpivotal
head-to-head trial comparing denosumab to weekly oral alendronate were
announced today at the 2008 American Society of Bone and Mineral Research
(ASBMR) Annual Meeting in Montreal.
"Data from these trials highlight the potential for a new treatment option for the millions
of postmenopausal women worldwide with osteoporosis," said Roger M. Perlmutter,
M.D., Ph.D., executive vice president of Research and Development at Amgen. "In the
bisphosphonate transition study, it is particularly exciting to see significant bone density
gains in patients on denosumab who previously were treated with alendronate, as this
type of result has not been reported in any previous study transitioning patients from
one bisphosphonate to another. We believe these data coupled with data from a
separate Phase 3 head-to-head trial that reported patient preference for twice-yearly
subcutaneous injections versus a weekly oral therapy suggest denosumab offers the
promise to be a welcome new option for patients."
Effect of Denosumab versus Alendronate on Bone Mineral Density (BMD) and
Bone Turnover Markers (BTM) and Safety in Women Previously Treated with
Alendronate (Abstract # 646)
Data presented from the bisphosphonate transition study, also known as the STAND
(Study of Transitioning from AleNdronate to Denosumab) trial, demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater
increases in BMD versus those achieved with alendronate at all sites measured. For the
primary endpoint, denosumab resulted in significant increases in BMD at the total hip
compared with alendronate (1.9 percent vs. 1.05 percent, p
Preference and Satisfaction with a 6-monthly Subcutaneous Injection Versus a
Weekly Tablet for Treatment of Low Bone Mass (Abstract # 434)
As part of the DECIDE (Determining Efficacy: Comparison of Initiating Denosumab vs.
AlEndronate) trial, patients were given a questionnaire after 12 months of treatment to
gauge preference on mode of administration as well as satisfaction with frequency of
dosing of twice-yearly subcutaneous injections versus weekly oral tablet. More than
three-quarters of patients in both study arms preferred subcutaneous injection over oral
pills (77 percent vs. 23 percent, p
results from a non-pivotal Phase 3 head-to-head, double-blind trial comparing bone
mineral density (BMD) gains in postmenopausal women with low bone mass who
transitioned from weekly oral alendronate (Fosamax®) to denosumab versus those who
continued alendronate therapy. In addition, patient preference data from another nonpivotal
head-to-head trial comparing denosumab to weekly oral alendronate were
announced today at the 2008 American Society of Bone and Mineral Research
(ASBMR) Annual Meeting in Montreal.
"Data from these trials highlight the potential for a new treatment option for the millions
of postmenopausal women worldwide with osteoporosis," said Roger M. Perlmutter,
M.D., Ph.D., executive vice president of Research and Development at Amgen. "In the
bisphosphonate transition study, it is particularly exciting to see significant bone density
gains in patients on denosumab who previously were treated with alendronate, as this
type of result has not been reported in any previous study transitioning patients from
one bisphosphonate to another. We believe these data coupled with data from a
separate Phase 3 head-to-head trial that reported patient preference for twice-yearly
subcutaneous injections versus a weekly oral therapy suggest denosumab offers the
promise to be a welcome new option for patients."
Effect of Denosumab versus Alendronate on Bone Mineral Density (BMD) and
Bone Turnover Markers (BTM) and Safety in Women Previously Treated with
Alendronate (Abstract # 646)
Data presented from the bisphosphonate transition study, also known as the STAND
(Study of Transitioning from AleNdronate to Denosumab) trial, demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater
increases in BMD versus those achieved with alendronate at all sites measured. For the
primary endpoint, denosumab resulted in significant increases in BMD at the total hip
compared with alendronate (1.9 percent vs. 1.05 percent, p
Preference and Satisfaction with a 6-monthly Subcutaneous Injection Versus a
Weekly Tablet for Treatment of Low Bone Mass (Abstract # 434)
As part of the DECIDE (Determining Efficacy: Comparison of Initiating Denosumab vs.
AlEndronate) trial, patients were given a questionnaire after 12 months of treatment to
gauge preference on mode of administration as well as satisfaction with frequency of
dosing of twice-yearly subcutaneous injections versus weekly oral tablet. More than
three-quarters of patients in both study arms preferred subcutaneous injection over oral
pills (77 percent vs. 23 percent, p
понедельник, 17 октября 2011 г.
New Hip And Groin Disorders Guidelines From ACOEM Available
The American College of Occupational and Environmental Medicine (ACOEM) today published new medical treatment guidelines for providing care to workers with injuries and disorders of the hip and groin. The new guidelines, which represent the latest chapter in ACOEM's comprehensive publication Occupational Medicine Practice Guidelines, are available on line now via ACOEM's APG-I web application; a print version will be available in the fall of 2010, when the Third Edition hard-copy of Occupational Medicine Practice Guidelines is published.
More than 200 recommendations are featured in the new set of guidelines, focusing on diagnostic and other testing and treatments for hip and groin disorders. Conditions covered include acute, subacute, and chronic hip pain; hip osteoarthrosis; gluteus medius tendinosis and tears; trochanteric bursitis and greater trochanteric pain syndrome; femoroacetabular impingement, "hip impingement" and labral tears; osteonecrosis; hamstring and hip flexor strains; groin strains and adductor-related groin pain; lower abdominal strains; meralgia paresthetica; epididymo-orchitis; and hip fractures.
The new guidelines were developed by a multi-disciplinary panel that included specialists in occupational medicine, orthopedic surgery, and physical therapy. The guidelines follow ACOEM's enhanced methodology, highlighted by original systematic research and evidence-weighted recommendations.
"These new guidelines provide the most up-to-date, evidence-based approaches to care for occupational injuries available today, and will serve as a great help to occupational medicine community and all musculoskeletal injury providers," said Kurt Hegmann, MD, MPH, FACOEM, Editor in Chief of the Practice Guidelines.
An extensive volume of literature was used to develop the evidence-based recommendations in the new chapter. More than 1,500 references are featured, including 625 high- and moderate-quality randomized controlled trials or crossover trials.
Other highlights of the new chapter include:
- Discussion on the prevention of venous thromboembolic disease.
- Recommendations on hip arthroplasty and surgical recommendations for hip fracture.
- Recommendations for pre and post-operative rehabilitation, including hip arthroplasty and hip fractures.
- An appendix which covers anesthetic issues for hip surgery patients.
- An overview of each treatment option, indicating the existence or lack of evidence, and whether the option is costly, invasive, and has high/low risks or side effects.
- Algorithms for the different hip and groin disorders which offer quick and accurate guidance for cases with different progressions, circumstances, or outcomes.
ACOEM has announced that updates to ankle/foot, neck, knee and shoulder guidelines will follow electronic publication of the hip and groin chapter and will part of the Third Edition release later this year.
First published in 1997, Occupational Medicine Practice Guidelines has become the leading source in the United States for evidence-based guidelines used by occupational physicians and other health care professionals. ACOEM's guidelines are also used extensively by insurers, employers, attorneys, and other individuals and organizations involved in health and safety in the workplace.
To order an electronic version of the new chapter, or for more information about Occupational Medicine Practice Guidelines, visit acoem.
Source
American College of Occupational and Environmental Medicine
More than 200 recommendations are featured in the new set of guidelines, focusing on diagnostic and other testing and treatments for hip and groin disorders. Conditions covered include acute, subacute, and chronic hip pain; hip osteoarthrosis; gluteus medius tendinosis and tears; trochanteric bursitis and greater trochanteric pain syndrome; femoroacetabular impingement, "hip impingement" and labral tears; osteonecrosis; hamstring and hip flexor strains; groin strains and adductor-related groin pain; lower abdominal strains; meralgia paresthetica; epididymo-orchitis; and hip fractures.
The new guidelines were developed by a multi-disciplinary panel that included specialists in occupational medicine, orthopedic surgery, and physical therapy. The guidelines follow ACOEM's enhanced methodology, highlighted by original systematic research and evidence-weighted recommendations.
"These new guidelines provide the most up-to-date, evidence-based approaches to care for occupational injuries available today, and will serve as a great help to occupational medicine community and all musculoskeletal injury providers," said Kurt Hegmann, MD, MPH, FACOEM, Editor in Chief of the Practice Guidelines.
An extensive volume of literature was used to develop the evidence-based recommendations in the new chapter. More than 1,500 references are featured, including 625 high- and moderate-quality randomized controlled trials or crossover trials.
Other highlights of the new chapter include:
- Discussion on the prevention of venous thromboembolic disease.
- Recommendations on hip arthroplasty and surgical recommendations for hip fracture.
- Recommendations for pre and post-operative rehabilitation, including hip arthroplasty and hip fractures.
- An appendix which covers anesthetic issues for hip surgery patients.
- An overview of each treatment option, indicating the existence or lack of evidence, and whether the option is costly, invasive, and has high/low risks or side effects.
- Algorithms for the different hip and groin disorders which offer quick and accurate guidance for cases with different progressions, circumstances, or outcomes.
ACOEM has announced that updates to ankle/foot, neck, knee and shoulder guidelines will follow electronic publication of the hip and groin chapter and will part of the Third Edition release later this year.
First published in 1997, Occupational Medicine Practice Guidelines has become the leading source in the United States for evidence-based guidelines used by occupational physicians and other health care professionals. ACOEM's guidelines are also used extensively by insurers, employers, attorneys, and other individuals and organizations involved in health and safety in the workplace.
To order an electronic version of the new chapter, or for more information about Occupational Medicine Practice Guidelines, visit acoem.
Source
American College of Occupational and Environmental Medicine
пятница, 14 октября 2011 г.
A Novel In Vivo Method For Quantifying The Interfacial Biochemical Bond Strength Of Bone Implants
Since the breakthrough introduction of osseointegrated implants in the 1980s, great efforts have been made towards surface innovation of clinical implants.
So far, in vivo methods to determine biochemical bonds of the implants are as of yet essentially unexplored and remain challenging. In fact, it is extremely hard to exclusively measure interfacial biochemical bond in vivo.
To the best of our knowledge, the present study may be the first report of an in vivo method to identify an interfacial biochemical bond and quantify its bonding strength, which provide the key of knowledge for the better understanding on biochemical bonding in implant integration.
Proceedings of the Royal Society B: Biological Sciences
Proceedings B is the Royal Society's flagship biological research journal, dedicated to the rapid publication and broad dissemination of high-quality research papers, reviews and comment and reply papers. The scope of the journal is diverse and is especially strong in organismal biology.
rspb.royalsocietypublishing
So far, in vivo methods to determine biochemical bonds of the implants are as of yet essentially unexplored and remain challenging. In fact, it is extremely hard to exclusively measure interfacial biochemical bond in vivo.
To the best of our knowledge, the present study may be the first report of an in vivo method to identify an interfacial biochemical bond and quantify its bonding strength, which provide the key of knowledge for the better understanding on biochemical bonding in implant integration.
Proceedings of the Royal Society B: Biological Sciences
Proceedings B is the Royal Society's flagship biological research journal, dedicated to the rapid publication and broad dissemination of high-quality research papers, reviews and comment and reply papers. The scope of the journal is diverse and is especially strong in organismal biology.
rspb.royalsocietypublishing
вторник, 11 октября 2011 г.
Race For New Hips, Patient Treatment Preferences Play An Important Role In Racial Disparities
Study highlights impact of patient preferences on race disparity in surgeons' recommendations for joint replacement.
A recent study by researchers at the VA Center for Health Equity Research and Promotion in Pittsburgh, Pennsylvania, suggests that patient treatment preferences play an important role in racial disparities in total joint replacement utilization observed in the US. Different attitudes toward total joint replacement procedures held by African American and white patients explained racial disparities in whether orthopedic surgeons recommended the procedure to patients. These findings by Dr. Leslie Hausmann, from the VA, and her colleagues, are published online in the Journal of General Internal Medicine, published by Springer.
Osteoarthritis of the knee or hip is a leading cause of disability in the US. Total joint replacement is the most effective surgical option available to treat moderate to severe cases. Numerous studies have shown racial disparities in the utilization of the procedure. In particular, African-American patients are significantly less likely than white patients to undergo total joint replacement.
To explore potential reasons for this racial disparity, Dr. Hausmann and her team examined whether orthopaedic surgeons were less likely to recommend total joint replacement to African-American patients compared to white patients, and whether African-American patients were less likely to undergo the procedure within six months of study enrollment.
The researchers recruited patients from orthopedic surgery clinics in two large, tertiary care Veterans Affairs* hospitals in Pittsburgh and Cleveland. In total, 120 African-American and 337 white patients seeking treatment for knee or hip osteoarthritis were enrolled. Before their appointment with a surgeon, patients completed a survey asking them about their preferences for total joint replacement as a treatment option and their expectations regarding knee/hip pain management. The actual appointment was audio-taped and the patients were surveyed again after the visit to assess their impression of the exchange. The researchers also examined patients' medical records after the visit and again after six months.
They found that African-American patients were less likely to receive a recommendation for total joint replacement than white patients of similar age and disease severity. This racial difference disappeared when the researchers took patients' willingness to undergo the procedure into consideration, suggesting that race differences in total joint replacement recommendations were largely driven by patient treatment preferences. That is, African Americans showed a lower preference for the procedure than whites, and patients who had a lower preference for the procedure were less likely to receive a recommendation for it. Furthermore, patients who received a recommendation for joint replacement were much more likely to have undergone the procedure within six months compared to those who did not receive a recommendation for joint replacement. Of those patients who received a recommendation for joint replacement, 22% of African Americans had undergone the procedure within six months compared to 45% of whites.
The authors conclude: "These findings underscore the unique importance of patient preference in shaping decision-making about total joint replacement. Given the consistent race differences found in patient preferences for the procedure, coupled with the strong impact of patient preferences on its recommendation in the orthopedic setting, reducing disparities may require efforts to understand patient treatment preferences."
Source: Springer Science+Business Media
A recent study by researchers at the VA Center for Health Equity Research and Promotion in Pittsburgh, Pennsylvania, suggests that patient treatment preferences play an important role in racial disparities in total joint replacement utilization observed in the US. Different attitudes toward total joint replacement procedures held by African American and white patients explained racial disparities in whether orthopedic surgeons recommended the procedure to patients. These findings by Dr. Leslie Hausmann, from the VA, and her colleagues, are published online in the Journal of General Internal Medicine, published by Springer.
Osteoarthritis of the knee or hip is a leading cause of disability in the US. Total joint replacement is the most effective surgical option available to treat moderate to severe cases. Numerous studies have shown racial disparities in the utilization of the procedure. In particular, African-American patients are significantly less likely than white patients to undergo total joint replacement.
To explore potential reasons for this racial disparity, Dr. Hausmann and her team examined whether orthopaedic surgeons were less likely to recommend total joint replacement to African-American patients compared to white patients, and whether African-American patients were less likely to undergo the procedure within six months of study enrollment.
The researchers recruited patients from orthopedic surgery clinics in two large, tertiary care Veterans Affairs* hospitals in Pittsburgh and Cleveland. In total, 120 African-American and 337 white patients seeking treatment for knee or hip osteoarthritis were enrolled. Before their appointment with a surgeon, patients completed a survey asking them about their preferences for total joint replacement as a treatment option and their expectations regarding knee/hip pain management. The actual appointment was audio-taped and the patients were surveyed again after the visit to assess their impression of the exchange. The researchers also examined patients' medical records after the visit and again after six months.
They found that African-American patients were less likely to receive a recommendation for total joint replacement than white patients of similar age and disease severity. This racial difference disappeared when the researchers took patients' willingness to undergo the procedure into consideration, suggesting that race differences in total joint replacement recommendations were largely driven by patient treatment preferences. That is, African Americans showed a lower preference for the procedure than whites, and patients who had a lower preference for the procedure were less likely to receive a recommendation for it. Furthermore, patients who received a recommendation for joint replacement were much more likely to have undergone the procedure within six months compared to those who did not receive a recommendation for joint replacement. Of those patients who received a recommendation for joint replacement, 22% of African Americans had undergone the procedure within six months compared to 45% of whites.
The authors conclude: "These findings underscore the unique importance of patient preference in shaping decision-making about total joint replacement. Given the consistent race differences found in patient preferences for the procedure, coupled with the strong impact of patient preferences on its recommendation in the orthopedic setting, reducing disparities may require efforts to understand patient treatment preferences."
Source: Springer Science+Business Media
суббота, 8 октября 2011 г.
New Journal To Be Launched By SAGE: Geriatric Orthopaedic Surgery & Rehabilitation
Geriatric Orthopaedic Surgery & Rehabilitation is a new bimonthly journal being launched in September 2010 by SAGE, the world's leading independent academic and professional publisher.
Geriatric Orthopaedic Surgery & Rehabilitation will address a broad range of musculoskeletal disorders in the aging patient through peer-reviewed research reports and reviews, technical perspectives, case studies, and other evidence-based articles.
"The fastest growing portion of our population is the segment over 65 years old. Most older individuals will experience an orthopaedic problem as they age," said Stephen Kates, MD, the journal's founding Editor. Geriatric Orthopaedic Surgery & Rehabilitation will fill an important void in the medical literature and serve as home to scientific articles concerning older orthopaedic patients."
Contributors and readers will include orthopaedic surgeons, geriatricians, physiatrists, anesthesiologists, and other physicians specializing in care of the older adult.
"The projected incidence of musculoskeletal problems among the aging Baby Boomer population is staggering," said Ron Epstein, SAGE Director of STM Journals. "We anticipate that Geriatric Orthopaedic Surgery & Rehabilitation will prove a critical resource for the physicians and other health care providers who work with older patients with bone fractures, joint replacement, and related problems. Dr. Kates is one of the foremost clinicians and teachers in this field, and we are excited to work with him as the journal's Editor."
Geriatric Orthopaedic Surgery & Rehabilitation will be published bimonthly beginning in September 2010.
Source:
Jim Gilden
SAGE Publications
Geriatric Orthopaedic Surgery & Rehabilitation will address a broad range of musculoskeletal disorders in the aging patient through peer-reviewed research reports and reviews, technical perspectives, case studies, and other evidence-based articles.
"The fastest growing portion of our population is the segment over 65 years old. Most older individuals will experience an orthopaedic problem as they age," said Stephen Kates, MD, the journal's founding Editor. Geriatric Orthopaedic Surgery & Rehabilitation will fill an important void in the medical literature and serve as home to scientific articles concerning older orthopaedic patients."
Contributors and readers will include orthopaedic surgeons, geriatricians, physiatrists, anesthesiologists, and other physicians specializing in care of the older adult.
"The projected incidence of musculoskeletal problems among the aging Baby Boomer population is staggering," said Ron Epstein, SAGE Director of STM Journals. "We anticipate that Geriatric Orthopaedic Surgery & Rehabilitation will prove a critical resource for the physicians and other health care providers who work with older patients with bone fractures, joint replacement, and related problems. Dr. Kates is one of the foremost clinicians and teachers in this field, and we are excited to work with him as the journal's Editor."
Geriatric Orthopaedic Surgery & Rehabilitation will be published bimonthly beginning in September 2010.
Source:
Jim Gilden
SAGE Publications
среда, 5 октября 2011 г.
Court Of Appeal To Re-Evaluate NICE Osteoporosis Decision, UK
Servier Laboratories Limited has been granted permission by the Court of Appeal to challenge a High Court decision made at a Judicial Review in February this year, in which Servier was previously successful in its claim that the National Institute for Health and Clinical Excellence (NICE) had unlawfully failed to provide the economic model underlying its Guidance for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. 1,2
The Court of Appeal will hear Servier's appeal against February's ruling on one legal point - misinterpretation of Servier's clinical data on the reduction of risk of hip fracture by its osteoporosis treatment, Protelos® (strontium ranelate).
Michael Sumpter, CEO of Servier Laboratories Ltd, commented; "We are delighted with today's decision granting Servier the right to appeal on the basis of the irrational consideration by NICE of data submitted by Servier during the appraisal process."
NICE refused to accept a post hoc analysis of a randomised controlled trial titled "The TReatment Of Peripheral OSteoporosis" ("TROPOS"), which was specifically requested by European Medicines Agency's (the "EMEA") scientific committee and clearly showed the efficacy of Protelos in teducing the risk of hip fracture. It was accepted as the basis for granting a licence for reduction of risk of hip fracture in post menopausal osteoporotic women by the European Commission on the recommendation of the EMEA.
Servier challenged NICE at Judicial Review because it believes the osteoporosis guidance unfairly and unnecessarily restricts access to Protelos for many patients who could benefit from it. Servier remains satisfied with the ruling by Mr Justice Holman on 19 February 2009 that NICE acted with procedural unfairness and, therefore, unlawfully by not releasing the economic model on which it based its decisions in the osteoporosis guidance. As a result of the February ruling, NICE has shared a copy of the economic model with the stakeholders who submitted evidence for the current NICE guidance. In addition, the current guidance is now being re-evaluated.
Professor Tim Spector, Consultant Rheumatologist at St Thomas' Hospital said; "Many of my patients are unable to tolerate the treatment recommended by NICE under the current guidance, but I have to wait for their disease to deteriorate before I can give them an alternative treatment. This leaves them unprotected from the risk of fracture for many years. While the previous court ruling means that the original NICE guidance is already under review, today's decision means there is a greater chance of the appropriate data being considered. This will hopefully result in new guidance that is simpler and more flexible, giving clinicians a real choice in prescribing for women with osteoporosis, who all have individual needs."
Osteoporosis is a severe disease that affects one in two women over the age of 50 and one in five men. Up to 20% of women who suffer a hip fracture die within the first year of a fracture.3 Half of those suffering an osteoporotic hip fracture can no longer live independently as a result of the injury. Following a hip fracture, 64% need a walking aid and half can no longer move about outside on their own.4
The appeal will be heard by the Court of Appeal in due course. The date will be confirmed by the Court.
About the Judicial Review
-- In January 2009, Servier challenged NICE on three grounds:
1. Lack of transparency around the economic model used to evaluate cost effectiveness
2. Misinterpretation of Servier's clinical data around hip fracture data
3. Unlawful discrimination on the basis of disability
-- On 19 February 2009, the High Court found in Servier's favour on ground one: Lack of transparency around the economic model used. The Judge ruled that the procedure by which the NICE guidance on treatments for primary and secondary prevention of osteoporosis was produced (Final Appraisal Determination dated 30 June 2008) was unlawful and the guidance must therefore be re-evaluated. The Judge ruled that the current guidance will not be quashed pending re-evaluation.
-- In light of February's decision NICE has been ordered to grant access to the economic model to stakeholders who will be given the opportunity to comment on the assumptions NICE made when developing the guidance. NICE will then be required under their legal duty of transparency to re-evaluate the guidance in light of the comments it receives.
-- The High Court did not find in Servier's favour on grounds two and three.
About the NICE guidance
-- The Final Appraisal Determinations (FADs) on the treatment of osteoporosis were published on 26 June 2007. An appeal hearing involving the National Osteoporosis Society, the Alliance for Better Bone Health and Servier Laboratories took place in October 2007. A decision upholding the appeal was published in December 2007 and the revised FADs were published by NICE in July 2008. Servier's second appeal took place in September 2008. Subsequently, technology appraisal guidance for both the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women was published in October 2008. The Judicial Review took place 20-22 January 2009. The decision by Mr Justice Holman was announced on 19 February 2009.
About Servier Laboratories Limited
-- Servier Laboratories Limited is the UK subsidiary of The Servier Research Group, a research-based pharmaceutical company specialising in innovative pharmaceuticals. Servier UK offers a range of products in a number of medical areas: cardiovascular disease, especially hypertension and cardiac disease, diabetes, osteoporosis and diseases of the central nervous system. Servier develops truly innovative drugs and invests in therapeutic areas where there is an unmet patient need.
About osteoporosis
-- The World Health Organisation defines osteoporosis as a progressive skeletal disease characterised by low bone mass and micro-architectural deterioration of bone tissue with a consequential increase in bone fragility and susceptibility to fracture. There is increased risk of fracture particularly of spine, hip, pelvis and forearm. It is predominantly a disease of post-menopausal women and risk of fracture increases with age. Fractures caused by osteoporosis affect one in two women and one in five men over the age of 50.
About Protelos
-- Protelos is a true innovation which was developed to improve quality of life for osteoporosis patients.5,6,7 Protelos is unlike other treatments and works by building bone to promote bone strength and reducing hip and spinal fractures.8,9,10 Unlike more traditional osteoporosis treatments the most common side effects of Protelos are mild and transient.11
References
1. Case number CO/2469/2008 between The Queen on the application of Servier Laboratories Ltd and the National Institute for Health and Clinical Excellence
2. National Institute for Health and Clinical Excellence (NICE). 'Alendronate, etidronate, risedronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women' and 'Alendronate, etidronate, risedronate, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women'. Available from https://nice.uk (last accessed February 09)
3. Cooper C, et al. Am J Epidemiol 1993;137:1001-1005
4. Osnes EK, Lofthus CM, Meyer HE, et al. Osteoporos Int 2004;15:567 - 574
5. Jiang Y, Zhao JJ, Genant HK. Osteoporos Int 2006;17(suppl2):late breaking news
6. Arlot ME, et al. J Bone Miner Res 2008;23(2):215-222
7. Ammann P, et al. J Bone Miner Res 2004;19(12):2012-2020
8. Protelos SPC
9. Meunier PJ, et al. N Engl J Med 2004;350:459-468
10. Reginster JY, et al. Arthritis Rheum 2008;58(6):687-1695
11. Reginster JY, et al. J Clin Endocrinol Metab 2005;90(5):2816-2822
Source
Servier
The Court of Appeal will hear Servier's appeal against February's ruling on one legal point - misinterpretation of Servier's clinical data on the reduction of risk of hip fracture by its osteoporosis treatment, Protelos® (strontium ranelate).
Michael Sumpter, CEO of Servier Laboratories Ltd, commented; "We are delighted with today's decision granting Servier the right to appeal on the basis of the irrational consideration by NICE of data submitted by Servier during the appraisal process."
NICE refused to accept a post hoc analysis of a randomised controlled trial titled "The TReatment Of Peripheral OSteoporosis" ("TROPOS"), which was specifically requested by European Medicines Agency's (the "EMEA") scientific committee and clearly showed the efficacy of Protelos in teducing the risk of hip fracture. It was accepted as the basis for granting a licence for reduction of risk of hip fracture in post menopausal osteoporotic women by the European Commission on the recommendation of the EMEA.
Servier challenged NICE at Judicial Review because it believes the osteoporosis guidance unfairly and unnecessarily restricts access to Protelos for many patients who could benefit from it. Servier remains satisfied with the ruling by Mr Justice Holman on 19 February 2009 that NICE acted with procedural unfairness and, therefore, unlawfully by not releasing the economic model on which it based its decisions in the osteoporosis guidance. As a result of the February ruling, NICE has shared a copy of the economic model with the stakeholders who submitted evidence for the current NICE guidance. In addition, the current guidance is now being re-evaluated.
Professor Tim Spector, Consultant Rheumatologist at St Thomas' Hospital said; "Many of my patients are unable to tolerate the treatment recommended by NICE under the current guidance, but I have to wait for their disease to deteriorate before I can give them an alternative treatment. This leaves them unprotected from the risk of fracture for many years. While the previous court ruling means that the original NICE guidance is already under review, today's decision means there is a greater chance of the appropriate data being considered. This will hopefully result in new guidance that is simpler and more flexible, giving clinicians a real choice in prescribing for women with osteoporosis, who all have individual needs."
Osteoporosis is a severe disease that affects one in two women over the age of 50 and one in five men. Up to 20% of women who suffer a hip fracture die within the first year of a fracture.3 Half of those suffering an osteoporotic hip fracture can no longer live independently as a result of the injury. Following a hip fracture, 64% need a walking aid and half can no longer move about outside on their own.4
The appeal will be heard by the Court of Appeal in due course. The date will be confirmed by the Court.
About the Judicial Review
-- In January 2009, Servier challenged NICE on three grounds:
1. Lack of transparency around the economic model used to evaluate cost effectiveness
2. Misinterpretation of Servier's clinical data around hip fracture data
3. Unlawful discrimination on the basis of disability
-- On 19 February 2009, the High Court found in Servier's favour on ground one: Lack of transparency around the economic model used. The Judge ruled that the procedure by which the NICE guidance on treatments for primary and secondary prevention of osteoporosis was produced (Final Appraisal Determination dated 30 June 2008) was unlawful and the guidance must therefore be re-evaluated. The Judge ruled that the current guidance will not be quashed pending re-evaluation.
-- In light of February's decision NICE has been ordered to grant access to the economic model to stakeholders who will be given the opportunity to comment on the assumptions NICE made when developing the guidance. NICE will then be required under their legal duty of transparency to re-evaluate the guidance in light of the comments it receives.
-- The High Court did not find in Servier's favour on grounds two and three.
About the NICE guidance
-- The Final Appraisal Determinations (FADs) on the treatment of osteoporosis were published on 26 June 2007. An appeal hearing involving the National Osteoporosis Society, the Alliance for Better Bone Health and Servier Laboratories took place in October 2007. A decision upholding the appeal was published in December 2007 and the revised FADs were published by NICE in July 2008. Servier's second appeal took place in September 2008. Subsequently, technology appraisal guidance for both the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women was published in October 2008. The Judicial Review took place 20-22 January 2009. The decision by Mr Justice Holman was announced on 19 February 2009.
About Servier Laboratories Limited
-- Servier Laboratories Limited is the UK subsidiary of The Servier Research Group, a research-based pharmaceutical company specialising in innovative pharmaceuticals. Servier UK offers a range of products in a number of medical areas: cardiovascular disease, especially hypertension and cardiac disease, diabetes, osteoporosis and diseases of the central nervous system. Servier develops truly innovative drugs and invests in therapeutic areas where there is an unmet patient need.
About osteoporosis
-- The World Health Organisation defines osteoporosis as a progressive skeletal disease characterised by low bone mass and micro-architectural deterioration of bone tissue with a consequential increase in bone fragility and susceptibility to fracture. There is increased risk of fracture particularly of spine, hip, pelvis and forearm. It is predominantly a disease of post-menopausal women and risk of fracture increases with age. Fractures caused by osteoporosis affect one in two women and one in five men over the age of 50.
About Protelos
-- Protelos is a true innovation which was developed to improve quality of life for osteoporosis patients.5,6,7 Protelos is unlike other treatments and works by building bone to promote bone strength and reducing hip and spinal fractures.8,9,10 Unlike more traditional osteoporosis treatments the most common side effects of Protelos are mild and transient.11
References
1. Case number CO/2469/2008 between The Queen on the application of Servier Laboratories Ltd and the National Institute for Health and Clinical Excellence
2. National Institute for Health and Clinical Excellence (NICE). 'Alendronate, etidronate, risedronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women' and 'Alendronate, etidronate, risedronate, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women'. Available from https://nice.uk (last accessed February 09)
3. Cooper C, et al. Am J Epidemiol 1993;137:1001-1005
4. Osnes EK, Lofthus CM, Meyer HE, et al. Osteoporos Int 2004;15:567 - 574
5. Jiang Y, Zhao JJ, Genant HK. Osteoporos Int 2006;17(suppl2):late breaking news
6. Arlot ME, et al. J Bone Miner Res 2008;23(2):215-222
7. Ammann P, et al. J Bone Miner Res 2004;19(12):2012-2020
8. Protelos SPC
9. Meunier PJ, et al. N Engl J Med 2004;350:459-468
10. Reginster JY, et al. Arthritis Rheum 2008;58(6):687-1695
11. Reginster JY, et al. J Clin Endocrinol Metab 2005;90(5):2816-2822
Source
Servier
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