Haemophiliac Died With But Not From Variant CJD
The UK’s Health Protection Agency said earlier today, 17 February, that a post mortem on a patient with haemophilia had found evidence in his
spleen of abnormal prion protein that causes variant CJD (vCJD) but it did not kill him: he died with rather than from the disease which is commonly
called mad cow disease.
The post-mortem is part of an ongoing study by the UK Haemophilia Centre Doctors Organisation and the National CJD Surveillance Unit that started
in 2001.
The patient was a man in his seventies and had died of a condition unrelated to vCJD. He had not shown any symptoms of vCJD before he died, and
had shown no other neurological problems either. The first sign of vCJD was from the post mortem.
The HPA, who are working with the UK Haemophilia Centre Doctors Organisation, said this will not change the way that haemophilia patients are
cared for or treated, and are doing all they can to inform patients with bleeding disorders about this situation and that further investigations
are also taking place.
Haemophilia patients already know from their doctors about the possibility that they may have been exposed to vCJD through use of clotting factors
derived from plasma of infected donors.
All patients treated with plasma sourced and pooled in the UK between 1980 and 2001 were told in 2004 that they were classed as at risk of
vCJD for public health reasons: in other words there was a risk they were infected and their blood could pass this onto others. At that time the risk
was a theoretically calculated one, quite small, but not real until this latest finding.
The chances of a person infected with the vCJD abnormal prion protein developing symptoms of the disease are unknown, and probably depend on
how susceptible they are; it may be the case that some infected people never develop symptoms.
The HPA said the latest finding does not change the public health vCJD “at risk” status of patients with bleeding disorders, even though this is the first
time that abnormal vCJD prion protein has been found in a haemophilia patient, or anyone treated with plasma products. The risk status does not
change because measures have already been in place for some years that are based on a theoretical risk which has now become real but not changed
in size.
As professor Mike Catchpole, Director of the Health Protection Agency’s Centre for Infections, explained:
“This new finding may indicate that what was until now a theoretical risk may be an actual risk to certain individuals who have received blood plasma
products, although the risk could still be quite low.”
“We recognise that this finding will be of concern for persons with haemophilia who will be awaiting the completion of the ongoing investigations and
their interpretation,” he added.
The HPA said the main priority now was to make sure patients were informed about this finding and can talk to a doctor at their haemophilia centre
as soon as possible.
“This finding does not change our understanding of the risk from vCJD for other people in any specific way. But it does reinforce the importance of
the precautionary measures that have been taken over the years,” said Catchpole.
“UK plasma has not been used for the manufacture of clotting factors since 1999 and synthetic clotting factors are provided for all patients for whom
they are suitable,” he said.
The authorities don’t know how the patient got vCJD; there are more investigations to do yet.
What they do know is that he was treated with several batches of clotting factors derived from UK donors before 1999, when the vCJD blood safety
measures were brought in. This included one batch of Factor VIII (the blood clotting factor that is faulty in people with haemophilia) made using
plasma from a donor that developed symptoms of vCJD six months after donating blood in 1996.
Click here for more information about vCJD (from the
HPA).
Sources: HPA news release.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Society Launches Pharmacy Practice Framework
The first ever Pharmacy Practice Framework Pharmacy Practice: Medicines focussed and
Patient centred has been published by the Royal Pharmaceutical Society outlining the many
roles and functions which pharmacists are responsible and accountable for in their daily
professional lives.
The Framework defines the core common roles expected of a newly qualified pharmacist and
demonstrates their unique contribution to health and health care delivery. It is a guidance
document as it describes the activities that pharmacists should be capable of in their early
career.
Many healthcare professions in most employment sectors across Great Britain and
internationally have adopted similar frameworks which are used by both professional
leadership and regulatory bodies.
The focus on clinical practice and safe medicine usage covers the range of pharmacy sectors,
although the Society acknowledges that areas such as academia, industry and veterinary
pharmacy will require more focussed development outside of this general framework to better
reflect the balance of practice in these areas.
Crucially, the Society intends for the framework to inform the public, other health care
professionals and service users, on the expectations of pharmacists and their practice, and
how they contribute to the delivery of safe, effective and high quality personal care of patients
and the public.
The roles described within the framework together seek to meet the objective of patient safety,
quality of care and collaborative practice and include the:
-management of risks in the in the delivery of professional services and patient care;
-requirement to seek continuous improvement; and
-requirement to formulate treatment or care options with the input from other members
of the healthcare team as appropriate.
Steve Churton, the Society’s President, says; “This excellent new resource sets out what a
pharmacist should be capable of in the early days and months of their professional career.
“It is hugely important, especially in this time of momentous change for pharmacy that the
starting point for a pharmacist’s life in practice is clearly defined, and the Practice Framework
does just this.”
Development of the Framework has aligned with the current pharmacy undergraduate
curriculum as well as the debates about the future curriculum, the Society’s Code of Ethics and
the various national strategies for developing pharmacy services.
The Pharmacy Practice Framework is published as a 50-page booklet and is available to
download from the Society’s website at http://www.rpsgb.org/pdfs/practiceframework.pdf.
Royal Pharmaceutical Society of Great Britain
IPI Expands Consortium Of Leading Children’s Hospitals With Addition Of Two Nationally Recognized Pediatric Institutions
The Institute for Pediatric Innovation (IPI), Inc., a nonprofit focused on transforming unmet needs for pediatric care into product opportunities for industry, today announced the expansion of its Consortium of Pediatric Hospitals — a group of highly regarded children’s hospitals that collaborates with the Institute in its mission.
The Children’s Hospital, Denver (Aurora, CO), and Children’s Hospital of Wisconsin (Milwaukee), recently became members of the Consortium, joining three founding Consortium members: University Hospitals Rainbow Babies and Children’s Hospital (Cleveland, OH), Lucile Packard Children’s Hospital at Stanford (Palo Alto, CA), and Children’s Mercy Hospitals and Clinics (Kansas City, MO). All five hospitals are widely regarded as innovators in the field of pediatric care.
IPI seeks to transform pediatric healthcare from a neglected orphaned market to a magnet for industry and investor interest. IPI’s Consortium of Pediatric Hospitals is helping to identify the medical products that are most needed to improve the care of children. Clinicians from the Consortium hospitals help to identify issues, set priorities, and specify and test products.
“Since the formation of our Consortium in 2007, we’ve made significant strides in defining urgent needs for drugs and devices for clinical care of children, and initiating development of these products,” said Donald Lombardi, CEO of IPI. “We are pleased to expand the Consortium with these prestigious pediatric hospitals, which provide invaluable data about the real-world medical needs of children and contribute to our enormous base of resources for pediatric innovation.”
“We are always evaluating new methods and partnerships to advance the frontiers of pediatric care,” said Dr. Jim Shmerling, D.H.A., President and CEO, The Children’s Hospital, Denver. “We believe that our work with IPI will play a significant role in our efforts to deliver the highest quality, most advanced care for children.”
“We know that children are not just little adults — and that their medical treatment is unique,” said Cinthia Christensen, RN, JD, Executive Vice President, Children’s Hospital of Wisconsin. “The IPI consortium brings together top experts in pediatrics to facilitate advances in care that will benefit all children.”
About the Institute for Pediatric Innovation (IPI)
The Institute for Pediatric Innovation is a nonprofit organization formed to improve pediatric care by stimulating development of medical devices and drugs designed specifically for care of babies and children. Working with a Consortium of Pediatric Hospitals, IPI strives to identify the most needed products. IPI organizes public, private, nonprofit and for-profit collaborations in product innovation and licenses the resulting products to companies for commercial development. IPI is led by an experienced team of experts in licensing technology in pediatric medical care, commercializing medical technology, and marketing medical devices and pharmaceutical products. To date, IPI has received support from its consortium members along with the Ewing Marion Kauffman Foundation, Children’s Medical Ventures, Inc., AGA Medical and Oxford Bioscience Partners.
Institute for Pediatric Innovation
ThermaFreeze Successfully Completes FDA Compliance Testing With Intertek For Consumer Use Of ThermaFreeze(R) Ice Pads
Red Bank, NJ-based ThermaFreeze Products Corporation (PINKSHEETS: TFZP) today announced the completion of FDA compliance testing on its ThermaFreeze® ice pads used to keep foods and beverages cool in variety of consumer applications. “Now that we have successfully completed our FDA compliance testing at Intertek for direct food contact, toxicity and child safety, we are now ready to begin retail distribution throughout the United States with our distribution partners,” stated James Bolton, COO of ThermaFreeze Products Corporation.
Intertek offers solutions to help companies develop and execute product testing plans to determine a product’s compliance status with regards to material/chemical make-up under FDA guidelines; to determine which elements need to be replaced or redesigned; and to determine how new compliant materials and components will perform in the field: providing not only environmental compliance but also product reliability.
About Intertek
Intertek is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers’ products and processes, supporting their success in the global marketplace.
About ThermaFreeze
ThermaFreeze™ Products Corporation (http://www.thermafreeze.com) manufactures and markets a patented, innovative refrigerant product designed for use in the commercial shipment of perishables, and for use as a consumer compress and chiller product. ThermaFreeze™ refrigerant is flat, lightweight and flexible, even when frozen.
Legal Notice Regarding Forward-Looking Statements
No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Additional disclosure information can be found on the ThermaFreeze website at http://www.thermafreeze.com.
ThermaFreeze
vCJD Abnormal Prion Protein Found In A Patient With Haemophilia At Post Mortem
Evidence of infection with the agent (abnormal prion protein) that causes variant Creutzfeldt-Jakob Disease (vCJD) has been found at post mortem in the spleen of a person with haemophilia.
The patient, who was over 70 years old, died of a condition unrelated to vCJD and had shown no symptoms of vCJD or any other neurological condition prior to his death. The vCJD abnormal prion protein was only identified during post mortem research tests.
The Health Protection Agency is working with the UK Haemophilia Centre Doctors Organisation to ensure all patients with bleeding disorders are made aware of this preliminary information which is being further investigated. This new finding will not change the way patients with haemophilia are cared for or treated.
A final view as to how vCJD abnormal prion protein was transmitted to this haemophilia patient has yet to be reached because investigations are continuing to determine the most likely route of transmission. It is known that the patient had been treated with several batches of UK sourced clotting factors before 1999, which is when measures to improve the safety of blood in relation to vCJD were introduced. The patient’s treatment had included one batch of Factor VIII that was manufactured using plasma from a donor who went on to develop symptoms of vCJD six months after donating the plasma in 1996.
This is the first time that vCJD abnormal prion protein has been found in a patient with haemophilia, or any patient treated with plasma products. This new finding, however, does not change the public health vCJD ‘at risk’ status of patients with bleeding disorders.
Haemophilia patients have previously been informed by their doctors of their possible increased risk of exposure to vCJD via clotting factors. In 2004 all patients with bleeding disorders who had been treated with UK-sourced pooled plasma products between 1980 and 2001 were told that, owing to potential vCJD infectivity from these products they were to be classified as at-risk of vCJD for public health purposes.
Professor Mike Catchpole, Director of the Health Protection Agency’s Centre for Infections, said:
“This new finding may indicate that what was until now a theoretical risk may be an actual risk to certain individuals who have received blood plasma products, although the risk could still be quite low. We recognise that this finding will be of concern for persons with haemophilia who will be awaiting the completion of the ongoing investigations and their interpretation.
The priority is to ensure that patients are informed of this development and have access to the latest information and specialist advice from their own haemophilia centre doctor as soon as possible.
“This finding does not change our understanding of the risk from vCJD for other people in any specific way. But it does reinforce the importance of the precautionary measures that have been taken over the years.
“Since the risk of vCJD transmission through blood was first considered, a number of precautionary measures have been introduced to minimise the risk from the UK blood supply. UK plasma has not been used for the manufacture of clotting factors since 1999 and synthetic clotting factors are provided for all patients for whom they are suitable.”
Notes
1) The post-mortem tests were carried out as part of a research study jointly coordinated by the UK Haemophilia Centre Doctors Organisation and the National CJD Surveillance Unit. The study was commissioned in 2001 and is ongoing.
2) The likelihood of a person who is infected with the vCJD abnormal prion protein going on to develop symptoms of the disease is uncertain and may depend on individual susceptibility. It is possible that infected individuals may never develop symptoms.
3) Haemophilia is a genetic blood condition in which an essential clotting factor is either partly or completely missing. This causes a person with haemophilia to bleed for longer than normal. Treatment for haemophilia is usually by replacing the missing clotting factor (factor VIII) through regular injections which helps the blood to clot and minimises the likelihood of long term joint damage.
4) In 2004 all patients with bleeding disorders who had been treated with UK-sourced pooled plasma products (e.g. clotting factors for individuals with haemophilia) between 1980 and 2001 were told that, owing to potential vCJD infectivity from these products, they would be classified as at-risk of vCJD for public health purposes.
The start date of 1980 is thought to be the earliest date the agent (abnormal prion protein), that causes BSE in cattle and vCJD in humans, could have entered the food chain. The end date of 2001 is the last possible expiry date of any product manufactured by UK fractionators that had been sourced from UK donors up until 1998.
5) The government introduced a number of measures from 1997 onwards to safeguard blood and plasma supplies.
– Since 1997 all cases of vCJD that are reported to the National CJD Surveillance Unit and diagnosed as having ‘probable’ vCJD, result in a search of the UK Blood Services blood donor records. If the patient has donated blood, any unused parts of that blood are immediately removed from stock. The fate of all used components of blood from the donor is traced, and surviving recipients informed of their risk.
– In July 1998, the Department of Health announced that plasma for the manufacture of blood products, such as clotting factors, would be obtained from non-UK sources.
– Since October 1999, white blood cells (which may carry the greatest risk of transmitting vCJD) have been removed from all blood used for transfusion.
– In August 2002 the Department of Health announced that fresh frozen plasma for treating babies and young children born after 1 January 1996 would be obtained from the USA, extended to all children under 16 years of age (Summer 2005).
– In December 2002, the Department of Health completed its purchase of the largest remaining independent US plasma collector, Life Resources Incorporated. This secures long-term supplies of non-UK blood plasma for the benefit of NHS patients.
– Since April 2004, blood donations have not been accepted from people who have themselves received a blood transfusion in the UK since 1980. This has been extended to include apheresis donors and donors who are unsure if they had previously had a blood transfusion (August 2004).
– Since late 2005, blood donations have not been accepted from donors whose blood was transfused to patients who later developed vCJD.
– The UK Blood Services continue to promote the appropriate use of blood and tissues and alternatives throughout the NHS.
6) Specialist advice and care concerning vCJD is available from:
The National CJD Surveillance Unit, based at the Western General Hospital Edinburgh: http://www.cjd.ed.ac.uk. The NHS National Prion Clinic, based at The Hospital for Neurology and Neurosurgery, Queen Square, London http://www.nationalprionclinic.org/
7) For further information about vCJD go to:
http://www.hpa.org.uk/cjd
http://www.hpa.org.uk/vcjdplasmaproducts
http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/CJD/fs/en
http://www.blood.co.uk/
http://www.cjd.ed.ac.uk
http://www.nationalprionclinic.org/
Health Protection Agency
Personal Private Medical Insurance Launched By NPA Insurance
NPA Insurance is launching Private Medical Insurance designed for pharmacists and their families. The NPA’s medical insurance offers comprehensive benefits such as out-patient, inpatient and day-treatment. Complementary therapies and medicines are also included as standard along with helpful advice lines and a claims service with experienced and friendly staff.
Key benefits
– A comprehensive product covering complementary medicines and therapies – these could include physiotherapy, chiropractic, osteopathy, acupuncture or homeopathy
– No excess
– Easy arrangement of treatment over the phone
– Optional cover for long term health conditions such as heart and cancer treatment
– Easy transfer from existing private health insurer
– A range of helpful advice lines and a 24 hour counselling service.
A bespoke group health scheme can be arranged for larger groups.
Paul Coleman, NPA Insurance Director, explains some of the particular advantages of taking out medical insurance from NPA Insurance: “Our research showed that many NPA members already have some form of health insurance but that there is a need for a more comprehensive offering. We believe our policy will fulfil this need.
“We have made transferring from an existing provider easier and we offer the same rates to customers switching from their existing health provider as we offer to first time customers. Making a claim is even easier. In most circumstances, our customers will simply need to call the Claims Helpline and treatment will be arranged and approved over the telephone – no forms will have to be completed. This makes things so much simpler, and is likely to be especially helpful at a time when you could be under particular stress.”
Notes
Core Benefits – Cover Available
Out-patient
Specialist consultation fees – Core benefit
Diagnostic tests – Core benefit
Physiotherapy, chiropractic, osteopathy, acupuncture or homeopathy – Core benefit
Heart treatment – Core benefit
Cancer treatment – core benefit
In-patient and day-treatment
Diagnostic tests – Core benefit
Surgeons’ and Anaesthetists’ fees – Core benefit
Hospital charges – Core benefit
Physiotherapy – Core benefit
NHS cash benefit – Core benefit
Parent accommodation – Core benefit
Heart treatment – Additional benefit
Cancer treatment – Additional benefit
Our dedicated UK based call centre will be happy to supply more detailed information and can give an immediate quotation over the phone. Please call 0800 496 0426 between 08.30 a.m. – 5.30 p.m. Monday – Friday.
Further information can also be obtained from http://www.npainsurance.co.uk.
NPA Insurance
Priligy™ (Dapoxetine) Receives First Regulatory Approvals For The Treatment Of Premature Ejaculation (PE) In Finland And Sweden
Janssen-Cilag EMEA, a division of Janssen Pharmaceutica N. V., announced that Priligy™(dapoxetine) has received marketing authorisation in Finland and Sweden for the on-demand treatment of premature ejaculation (PE) in men 18 – 64 years of age. These approvals follow the positive outcome of a decentralised marketing authorisation procedure in seven European Union countries: Sweden, Austria, Finland, Germany, Spain, Italy and Portugal. The procedure was finalised in December 2008, and Finland and Sweden are the first countries worldwide to grant marketing authorisation for this compound. National approvals and licenses in the other five European countries are expected to follow. Dapoxetine is not approved for marketing in the United States.
Dapoxetine is a drug specifically developed for the on-demand treatment of PE and is the first oral medication (tablet) to be approved for this condition. Dapoxetine has been extensively evaluated in five randomised, placebo-controlled Phase III clinical trials involving more than 6,000 men with PE and their partners. This is the largest and most comprehensive clinical trial programme to date for a drug therapy to treat PE. Dapoxetine is a unique, short-acting, selective serotonin reuptake inhibitor (SSRI) designed to be taken only when needed, that is 1-3 hours before sexual intercourse is anticipated, rather than every day.
Dapoxetine will be marketed by Janssen-Cilag, marking another significant advance in the company’s commitment to developing innovative, high quality treatments for unmet medical needs.
Premature Ejaculation
PE is a distressing sexual dysfunction that can be present from the first sexual encounter or can develop later in life. Depending on the methodology and criteria used to evaluate the prevalence of PE in studies, the reported proportion of men affected with this condition at some point in their lives has ranged from 4-30%. Experts in PE from the International Society of Sexual Medicine (ISSM) define the condition as consisting of three major components: a short time to ejaculation (prior to or within about one minute), lack of ejaculatory control and negative personal impact or distress related to ejaculation. Unlike erectile dysfunction (ED), which tends to affect older men, PE has similar prevalence across all age groups. In fact, more men are believed to experience PE than ED.
A combination of physiological and psychological factors are believed to influence the mechanism of ejaculation. Men with PE appear to go through the same process of ejaculation as other men, but it happens more quickly and with a reduced feeling of control. Research suggests serotonin plays a central role in the timing of ejaculation.
About dapoxetine
ALZA Corporation, a Janssen-Cilag affiliate, licensed dapoxetine from PPD-GenuPro in 2001 with exclusive worldwide rights to develop and commercialise the compound for urogenital therapies, including premature ejaculation.
The clinical trial programme for the use of dapoxetine in premature ejaculation was conducted by Johnson & Johnson Pharmaceutical Research and Development. The product will be marketed by Janssen-Cilag in most countries where regulatory approval has been granted.
Product Availability
After approval in a specific country, Priligy (dapoxetine) will only be available by prescription from a healthcare professional.
The product is expected to be made available for purchase in licensed pharmacies in the countries where approved around April 2009, after all local regulatory requirements related to packaging and pricing are finalised. Janssen-Cilag will provide official confirmation of the exact date of product availability in each individual country. Applications for marketing authorisation in other countries are under review.
Unapproved imitations (counterfeit) of dapoxetine have been sold. Government officials from around the world have warned of the potential risks associated with counterfeit drugs, including the risk of death. As for any prescription medication, patients should buy Priligy (dapoxetine) only from a pharmacy that is officially licensed by government authorities. Patients should be especially cautious of internet pharmacies, as many of these are unlicensed.
About Janssen-Cilag
The Janssen-Cilag companies are part of the Johnson & Johnson family of companies. They have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at http://www.janssen-cilag.com.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
J&JPRD is part of the Johnson & Johnson family of companies. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Janssen-Cilag’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.comor on request from Johnson & Johnson. Janssen-Cilag does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
Johnson & Johnson
St. Jude Medical Welcomes Introduction Of Legislation To Help People Suffering From Pain
St. Jude Medical, Inc. (NYSE:STJ) welcomes the introduction of the National Pain Care Policy Act of 2009, H.R. 756. Intended to raise awareness about the growing issue of pain, this legislation is focused on improving access to patient care in the United States.
Led by U.S. House of Representatives members Lois Capps (D-CA) and Mike Rogers (R-MI), this legislation would help to improve outreach, provider education and training, research and awareness of acute and chronic pain. It would specifically address the complex problem of pain by:
– Creating an Institute of Medicine Conference on Pain Care
– Forming a Pain Consortium at the National Institutes of Health
– Providing pain care education and training for health care professionals
– Initiating a comprehensive public education and awareness campaign
“We are proud to support this important legislation,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “St. Jude Medical is dedicated to supporting programs and policies that raise awareness of the growing problem of chronic pain and improve access to care from highly skilled pain management specialists.”
Pain is a significant public health problem in the United States. The National Center for Health Statistics estimates that 76.2 million Americans have suffered from pain that lasts longer than 24 hours. The annual cost of chronic pain in the United States, including healthcare expenses, lost income, and lost productivity, is estimated to be $100 billion.
H.R. 756 is a reintroduction of H.R. 2994, which passed the House of Representatives in 2008. The Senate was unable to act upon the bill due to the short amount of time left in the session, requiring this resubmission. Supporters of the National Pain Care Act of 2009 hope that it will clear both the House and Senate during the 111th Congressional session and be signed into law.
For more information on the National Pain Care Policy Act or to support this legislation, visit the American Pain Foundation (APF) at http://www.painfoundation.org. St. Jude Medical supports educational outreach efforts through such organizations as the APF, National Pain Foundation (http://www.nationalpainfoundation.org), American Society of Interventional Pain Physicians (http://www.asipp.org), the Neuromodulation Therapy Access Coalition (http://www.neuromodulationaccess.org), and others.
St. Jude Medical is a market leader that develops, manufactures and markets implantable neuromodulation products with the goal of improving the quality of life for millions of people who suffer from disabling chronic pain and nervous system disorders. More than 45,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems. Patients can obtain more information about neurostimulation pain therapies at http://www.PowerOverYourPain.com.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 14,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit http://www.sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
St. Jude Medical
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Public Cancer Center Becomes First In South-East Asia To Introduce RapidArc Radiotherapy Treatments From Varian Medical Systems
Doctors in Hong Kong have carried out the first treatments in south-east Asia using a new, faster form of radiotherapy that extends more advanced care to more patients. A 74-year- old patient with localized prostate cancer became the region’s first patient to receive treatment using RapidArc radiotherapy technology from Varian Medical Systems .
Clinicians at the Pamela Youde Nethersole Eastern Hospital (PYNEH) in Hong Kong said they were delighted with the first treatment, which took just two to three minutes to deliver, much faster than conventional IMRT (intensity modulated radiotherapy) treatments. “IMRT treatments are time-consuming because tumors are targeted by a complex sequence of fixed radiation beams from multiple angles but the RapidArc treatment is dramatically faster,” said Dr. T.K.Yau, consultant radiation oncologist.
“With this new technology, cancer patients in Hong Kong can receive a faster, more comfortable and more precise radiotherapy treatment,” he added. “The RapidArc treatment can produce comparable or even better dose conformity compared with IMRT treatments but with shorter treatment times. It means that more of our patients can be treated with advanced IMRT-quality treatments.”
Dr. Yau said the hospital now plans to expand the range of RapidArc treatments to include other pelvic tumors and head & neck cancers. PYNEH is one of six public cancer centers in Hong Kong.
RapidArc, which delivers a precise and efficient treatment in a single or multiple arcs of the treatment machine around the patient, was introduced early last year by Varian, the world leader in radiation therapy equipment and software. Since its launch, more than 70 hospitals worldwide have commenced clinical treatments and PYNEH is the first in the South-East Asia region, just as it was the first to introduce image-guided radiotherapy (IGRT) to Hong Kong in 2006.
Doctors at PYNEH treat patients using three Varian linear accelerators including a Clinac® 23Ex accelerator equipped with RapidArc radiotherapy technology, as acquired in 2008 thanks to a private donation. Dr. Yau says his department plans to equip a second accelerator with RapidArc in the coming months.
About Varian Medical Systems
Varian Medical Systems, Inc., of Palo Alto, California, is the world’s leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes and digital detectors for X-ray imaging in medical, scientific, and industrial applications and also supplies X-ray imaging products for cargo screening and industrial inspection. Varian Medical Systems employs approximately 5,100 people who are located at manufacturing sites in North America and Europe and in its 60 sales and support offices around the world.
Varian Medical Systems
Pharmaceutical Package – An Opportunity To Demonstrate Commitment To The Safety Of Europe’s Citizens
EFPIA, the voice of the pharmaceutical industry in Europe, today urged the European Parliament to make the Commission’s proposals for safe, innovative and accessible medicines for European citizens a priority. Enterprise Commissioner Günter Verheugen will meet today with the Parliament’s Health Committee to make their initial exchanges on the recently launched European Commission’s Pharmaceutical Package.
Ahead of this exchange of views, Brian Ager, EFPIA’s Director General, called upon the Parliament and Member States to act decisively and to make the issue of patient safety a priority; “It is the responsibility of EU decision-makers to ensure safety for its citizens; this exchange of views provide the platform for the European Parliament to demonstrate their commitment to this duty of care.”
The hearing, which will mark the beginning of the Parliament’s review of the Commission proposals, is expected to be one of the few remaining occasions for discussion before the election of a new Parliament. Mr. Ager added; “This is a pivotal meeting; we have already experienced delays in getting these measures out, this is the opportunity to re-energize the process and give it the momentum it deserves”.
The Commission’s proposals, welcomed by EFPIA for their Commission’s recognition of the importance of the pharmaceutical sector to Europe, were announced in December 2008. The package of measures includes three separate legislative proposals; on modernizing pharmacovigilance to improve the safety of medicines; on improving patient safety by reducing the infiltration of counterfeit medicines into the supply chain; and on improving patient access to high-quality health and medicines information.
The proposals have to be discussed by both the European Parliament and the Council of Ministers as part of the codecision procedure before the proposal can be translated into law.
About EFPIA
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 32 national associations and 43 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,200 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
The pharmaceutical industry accounts for no less than 19,3% of global business R&D expenditure. It is the sector with the highest ratio of R&D investment to net sales (15,9%). However, between 1990 and 2007, R&D investment in United States grew 5.2 times whilst in Europe it only grew 3.3 times, and there is rapid growth in the research environment in emerging economies such as China and India.
Today around 645,000 people work in this sector and it is estimated that three to four times more employment is generated indirectly both upstream and downstream. A significant proportion of people employed are highly skilled and 107,000 work in research and development. The European research-based pharmaceutical industry generates a substantial trade surplus, which was estimated at about €49,000 million for 2007. It has contributed significantly to reducing the European Union’s trade deficit in high-tech products – today almost a quarter of the EU’s high-tech exports are pharmaceutical products.
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