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News in brief, April 18, 2007

The latest news in brief

Company news

Resolute makes US debut
European healthcare consultancy Resolute Communications is opening a New York City office this month, marking its first presence in the US. Laurie Hurley, who most recently served as senior vice- president and partner in Fleishman-HillardísNew York healthcare practice, will lead the North American business. Hurley has worked at Burson-Marsteller and Edelman, as well as on the client side, managing corporate, internal and product communications at the biotech firm Gilead Sciences. Resolute, which is headquartered in London, was founded about five years ago and now has 50 employees. The firm was started by joint CEOs, Paul Blackburn, formerly Fleishman-Hillardís UK managing director, and Anna Korving, formerly director of Ketchumís UK healthcare practice. It counts Johnson & Johnson, Abbott, Pfizer and Shire among its clients.

Quintiles opens first India lab
UK-based contract research organisation (CRO), Quintiles, has opened its first central laboratory in India. The Mumbai-based lab has begun proficiency testing for certification by the College of American Pathologists (CAP), and will augment the core clinical research and electrocardiogram (ECG) businesses Quintiles already has in the same location. The new lab will be one of only a few global central laboratories operating in India and Quintiles says it will use this competitive advantage to persuade more of its clients to conduct trials in the region. Quintiles has drug discovery partnerships with around 35 companies, mainly in the US.

Ranbaxy joins Jupiter Bioscience for marketing
According to local media reports, Indian pharmaceutical company, Ranbaxy says it is to enter a 10-year co-marketing agreement with India-based Jupiter Bioscience to enter the USD 6bn global peptide pharmaceutical market. Jupiter will give licence to Ranbaxy for five generic peptide drugs in anti-cancer, anti-diuretic, osteoporosis and growth hormones segments, for around USD 3bn. Ranbaxy is to chose 3.2m equity share warrants of Jupiter Bioscience on preferential basis. According to terms, both companies will share the profits. Jupiter will retain marketing rights to drugs independently or with other partners for different markets. The peptide market is worth approximately USD 6-7bn, represents a significant opportunity for generic players, according to analysts.

Renovis and Pfizer extend research collaboration
Renovis has announced an agreement with Pfizer to extend the term of the companies' worldwide collaboration to research, develop and commercialise small molecules that target the vanilloid receptor, VR1. The agreement extension will offer Renovis additional research funding through 30 June 2008 and reflects Pfizer and Renovisí strategy to advance multiple, small molecule VR1 antagonists toward clinical development. The VR1 receptor is a member of a related group of ion channel proteins known as the transient receptor potential (TRP) family that mediate and influence cell signalling. Inhibitors of VR1 are predicted to be useful in the treatment of pain, urinary incontinence and other diseases and disorders. Under the terms of the extension, Pfizer will continue to fund all aspects of the collaboration including the research and preclinical development efforts at Renovis through June 30, 2008. Other terms of the collaboration and licensing agreements between Pfizer and Renovis have not been changed.

Fortis Healthcare to tap capital market with IPO
India-headquartered Fortis Healthcare is to undergo an initial public offering (IPO) to fund its expansion plans. The company has decided to issue 45,996,439 shares at INR 10 each at a price band between INR 92 and INR 110 a share. The issue opens for subscription from 16 to 20 April 2007. The net issue will constitute 20.19 per cent of the post issue paid up equity share capital of the company. The shares of the company will list on BSE and NSE. JM Morgan Stanley, Citigroup Global Markets and Kotak Mahindra Capital are the lead managers of the issue. Intime Spectrum Registry has been appointed as the registrar of the issue. Fortis also announced it was looking at southern cities, such as Chennai, to set up hospitals and added it should have a presence there in six monthsí time. The company has 11 hospitals, out of which seven are in the national capital region. According to executives, there may not be much of a difference in the operational costs of hospitals in Delhi, Mumbai and in southern metropolitan areas, but the lower land cost and also the salary levels in the south would give higher profitability. Ranbaxy Holding owns the name Fortis and the logo and Fortis Healthcare pays a licence fee to Ranbaxy Holding for the right to use the word 'Fortis' and the logo.

Genaera cuts jobs to focus on obesity pipeline
US biopharmaceutical company, Genaera, has revealed that its board of directors has approved management's plan to focus corporate resources on the development of trodusquemine (MSI-1436) ñ a centrally-acting appetite-suppressant for the treatment of obesity. The trodusquemine programme, along with Genaera's partnership with MedImmune on the development of anti-interleukin-9 (IL9) antibody for the treatment of asthma, will form the cornerstone of Genaera's research activities in the short-term. As a result, Genaera says it will have to reduce its workforce by approximately 30 per cent over the next three months and pursue the divestiture of certain non-core assets. MSI-1436 has shown the ability to reverse co-morbidities associated with obesity, such as abnormal glucose metabolism and cholesterol elevation. Genaera says it will begin a phase I clinical study in Q2 2007. The anti-IL9 antibody is in phase II for the treatment of asthma and has been implicated in the pathogenesis of asthma and other respiratory diseases. Preclinical data suggest that IL9 neutralising monoclonal antibodies may help reduce airway hyper-reactivity, mucous production and inflammation. Genaera could receive up to USD 54m in future milestone payments and is entitled to royalties on sales of commercial products resulting from the collaboration with MedImmune. The company estimates that it will incur restructuring charges of approximately USD 500,000 in Q2 and Q3 2007 associated with the job cuts.

Coley licenses VaxImmune to Merckís vaccine programmes
Coley Pharmaceutical Group has revealed that it has licensed its VaxImmune vaccine adjuvant to Merck & Co for the incorporation into the latter firmís vaccine programme, which is developing treatments for certain infectious diseases and Alzheimer's disease. Merck has agreed to pay Coley an upfront license fee of USD 4.0m. Coley will receive milestone payments of up to USD 33m, as well as royalties from the sale of any products commercialised during the span of the agreement. Merck will have a worldwide, non-exclusive license to VaxImmune for use in its vaccines programme. VaxImmune is a proprietary Toll-like receptor 9 (TLR9) agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with preventative or therapeutic vaccines. VaxImmune has been evaluated in approximately 35 clinical trials of vaccines in development for various cancer indications, infectious diseases and bio-warfare defence.

Regulatory news

Gilead opens new Irish plant to host expansion plans
US biopharma company, Gilead Sciences, is to invest in a new EUR 60m plant in Ireland to expand manufacturing capacity and achieve growth targets. The west-Dublin based facility will conduct activities carried by the firm's other Dublin site, which has reached maximum capacity and cannot meet the revised manufacturing targets. Gilead says that a planning application for the 8.1 hectare site, which will contain 18,580 square meter of buildings will be submitted by the end of April 2007. The company added that construction should complete by the end of 2008, with operations to begin in Q1 2009. The new plant will act as a ìfill and finish facilityî, as well as other logistical and warehousing support structures, and will also accommodate future expansion plans for a new tabletting facility. Gilead uses its Irish facilities for the manufacture, packaging and distribution of the company's products and the supply of anti-HIV medications to developing countries.

GSK wins FDA approval for Altabax
UK pharmaceutical firm, GlaxoSmithKline (GSK), has received FDA approval for its antibacterial, Altabax (retapamulin ointment), for the topical treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes strains, which are the two most common types of bacteria in impetigo. Altabax is first in a new class of prescription topical antibacterials to be approved by the FDA in nearly two decades. The ointment is indicated for use twice daily for a five-day period in patients nine months of age and older. Other prescription topical antibacterials are used as much as three times daily for up to 12 days. The FDA reviewed phase III data examining the safety and efficacy of Altabax twice daily for five days versus placebo ointment in the treatment of impetigo, as well as additional safety data from other clinical studies. The findings showed that after five days of treatment, the rates of clinical success, defined as response of impetigo at end of therapy wherein no further antibacterial treatment was needed, were greater in the Altabax group (85.6 per cent) than in the placebo group (52.1 per cent). Microbiological success rates were also greater in the Altabax group (91.2 per cent) than in the placebo group (50.9 per cent). Altabax was generally well tolerated throughout the study.

PDUFA controversy builds in US
The Prescription Drug User Fee Act (PDUFA) continues to court controversy in the US. The law has been questioned over whether it protects US consumers from potentially harmful drugs. The act was passed by Congress in 1992 to establish user fees paid by drug companies to the FDA to review and vote on new drug applications (NDAs). User fees are expected to reach USD 438m in 2008, as well as accounting for more than 42 per cent of all the money the FDA receives for regulating drugs. Opinions about PDUFA, which has to be renewed every five years and is set to expire on 30 September 2007, range from those who think the user fees reduces the FDAís independence from drug companies to those who believe the funds are essential for continued financing of the FDAís activities. Others say that more of these funds should be spent on drug safety than is currently planned by the FDA.

Abbott wins FDA approval of coated Niaspan tablet
The FDA has approved Abbott's new coated Niaspan (niacin extended-release tablets). Niaspan is the leading medication for boosting HDL cholesterol and studies have shown that for every one per cent increase in HDL cholesterol is associated with a two per cent decrease in heart disease risk. Niaspan is the only FDA-approved, once-daily extended-release prescription niacin formulation for the treatment of lipid disorders with an ability to significantly raise HDL cholesterol. Collective results from three major clinical studies show an average 22 per cent increase of HDL for patients receiving 2,000 mg of Niaspan at night. Niacin is also indicated for the secondary prevention of heart attacks, and in combination with a bile acid binding resin, niacin is indicated to promote regression of coronary atherosclerosis in patients with history of coronary artery disease.

NICE removes ban on brain cancer drugs
The UKís National Institute for Health and Clinical Excellence (NICE) has removed a ban on two drugs which may help patients with brain cancer. Schering-Ploughís Temodal (temozolomide) and MGI Pharmaís Gliadel (polifeprosan 20 with carmustine implant) may now be obtained through the National Health Service. The 2005 ban was based on cost-effectiveness, which had caused anger because Temodal was invented by British scientists funded by Cancer Research UK. Gliadel is a wafer that, when placed at the excision site of a brain tumour, clears remaining cancer cells and keeps the tumour from recurring. Both drugs have been available in the US and Canada. The U-turn comes on the back of Eisaiís winning a judicial review over NICEís rejection of its Alzheimerís disease (AD) drug, Aricept (donepezil). Eisai has denied that its withdrawal of a supplemental EU application to the European Medicines Agency (EMEA) for Aricept was in any way connected to NICEís ruling to limit the use of AChE inhibitors in AD. The EMEA asked Eisai to provide more data to demonstrate if the drug led to improvements in every day activities in patients with severe AD. NICE has already accepted that the treatment improves cognition.

Biotechnology news

M&A activity augments US biotechnology revenues
Total revenue from global biotech companies reached the USD 70bn mark in 2006 and the sector is being bolstered by increasing numbers of M&A deals, according to an Ernst & Young report. The average takeover premium paid in transactions worth more than USD 500m was 60 per cent in 2006, which is more than twice the average M&A premium paid between 2003 and 2005. US public biotechnology company revenues totalled USD 55.8bn (GBP 28.1bn) in 2006, or 76 per cent of the USD 73.4bn global total. R&D spending in the US was USD 23bn, or more than 82 per cent of the USD 28bn spent by publicly held biotech companies globally. The common strategy for large pharmaceutical firms is to acquire biotechs to help boost flagging in-house drug pipelines. The report adds that biotech firms often have the most promising technological knowledge for developing new medicines, which has driven a new interest in early-stage platforms and technologies rather than just late-stage products. Increased M&A activity has also augmented the value of the International Biotechnology Trust (IBT), which is managed by UK-based investment company, IBT. A company spokesperson confirmed that M&A was still the preferred exit route for quoted and unquoted sectors, both of which have benefited the trust. Due to increased M&A activity, the trust has seen net assets rise by GBP 6.2m as a result. The share price rose 19.8 per cent over the past six months and the NASDAQ Biotech Index rose by 1.2 per cent.

Medical education news

HES increases range of Clinical Experience Programmes
Healthcare Education Services (HES) has increased its range of Clinical Experience Programmes. In 2007, the range has been extended to include osteoporosis, rheumatoid arthritis and osteoarthritis and Parkinsonís disease, in addition to its existing Oncology, Cardiology and Diabetes programmes. The programmes provide an opportunity to learn theory and witness it in practise during visits to relevant hospital departments and laboratories. Delegates can observe and discuss the impact of disease with individuals experiencing the illness, as well as members of the multi-disciplinary team caring for them. HESí programmes are designed to be interactive with open forum sessions and opportunities for question and discussion with experts in the field. The programmes are appropriate for personnel with a medical or non-medical background.

Journal of Craniofacial Surgery launches CME programme
US publication, the Journal of Craniofacial Surgery (JCS), has initiated a new series of continuing medical education (CME) articles for practicing craniofacial and paediatric plastic surgeons. The first CME-accredited activity in the new series appears in the March 2007 issue of JCS. The first CME offering features an update on speech evaluation in velopharyngeal dysfunction (VPD), authored by Bonnie E Smith, Professor and Director of Speech Pathology at University of Illinois Medical Center at Chicago, and David P Kuehn, Professor of Speech and Hearing Sciences at University of Illinois. Smith and Kuehn share their experience and expertise in speech evaluation of children and adults with VPD: a common cause of speech problems, most commonly related to inadequate repair of cleft palate. The authors emphasise the role of careful, structured evaluation to identify the subtle speech abnormalities associated with VPD a key consideration in choosing the most appropriate management approach. The JCS CME programme is accredited by Lippincott CME Institute, a subsidiary company of Wolters Kluwer Health. The former is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide CME for physicians.

FDA provides new webpage for medical devices
The FDA has published a new web page to inform the public about the status of post-approval patient studies for certain recently approved medical devices. Modern devices provide significant health benefits, but the full magnitude of some potential risks does not always emerge during the mandatory clinical trials required for approval. The FDA sometimes orders post-approval studies to address remaining issues, such as the product's performance once it becomes more widely available or is used over a longer period of time. Companies must in general submit interim post-approval study status reports every six months for the first two years of the study and annually thereafter until the final report has been submitted. The new web page includes information on all post-approval device studies ordered by FDA since 1 January 2005. Each listing includes the company's name, the product's name, the approval number and date and describes the study and whether it is meeting its reporting deadlines. No information on clinical data is available because the studies may be ongoing and include personal and confidential information. There are currently more than 40 listings on the webpage. The Institute of Medicine called for public reporting of post-market studies in a 2005 study on paediatric devices. That same year, FDA initiated an internal review of its ability to monitor post-approval studies. As a result, the agency shifted responsibility for tracking these studies from its pre-market staff to its post-market staff and set up a new electronic system for them to do so. The new web page is available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm

LegalView.com launches FDA drug database
The FDA has approved LegalView.comís drugs database, which lists relevant information on over 3,800 drugs and medications. The database was designed as a free resource for consumers concerned about drug side effects, interactions and dosage information. The FDA drug database is a part of LegalView's other drug-related resources, including practice areas on unsafe drugs, recall information for medications, such as Zelnorm (tegaserod), Procrit (epoetin alfa) and Permax (pergolide), and informative articles and blogs on medical devices like the Composix hernia mesh patch and Guidant defibrillators. Listing dosage, generic, manufacturer and form information, as well as approval date and current FDA status, LegalView's FDA drug database can be viewed by clicking on the following link: http://fda-drugs.legalview.com/

People news

SHIL loses CEO and gains chairman
CEO of Scottish Health Innovations (SHIL), Cameron Macdonald, has left to become managing director of Controlled Therapeutics Scotland (CTS), an East Kilbride drugs delivery firm specialising in women's health. SHIL has appointed Peter Shakeshaft as its chairman to replace Barry Sealey, a colleague at Edinburgh-based informal investment syndicate, Archangel. Macdonald has headed up SHIL, into which the Scottish Executive, Scottish Enterprise, Highlands and Islands Enterprise, and Department of Trade and Industry have invested millions of pounds. The investment was made to aid SHIL to become a technology transfer and commercialisation hub and release potential spin off technologies from the NHS. SHIL has already invested in Touch EMAS (now Touch Bionics) a company spun out from Lothian Primary Care Trust to create the world's first fully modular prosthetic arm. Another SHIL-led enterprise is that with Australian medical device maker, Compumedics, which has developed an ultrasound treatment for stroke patients. In his new role, Macdonald will alternate between Scotland and CTS's Philadelphia-based subsidiary firm Cytokine PharmaSciences, where he will be a vice-president.

Ipsen appoints new vice-president
France headquartered pharmaceutical company, Ipsen, has appointed Sean McKercher to the new position of vice-president of commercial development in North America. The new position was created due to Ipsenís increasing commercial activities and partnerships in the region. McKercher will report to Christophe Jean, Ipsenís executive vice-president and COO, and will be based in the companyís Boston office. McKercher will be responsible for overseeing the management of the companyís various US drug partnerships and participate in the development of its North American business strategy and implementation. McKercher has 25 years of experience in the pharmaceutical industry, most recently with Abbott, where he was business unit manager of specialty pharmaceuticals for Abbott Canada, commercial director for the Pacific/Asia/Africa regions, general manager for South Africa and Region Africa prior to his most recent roles in Abbottís US pharmaceutical division. While in the US, he was general manager of the Strategic Alliance Franchise, Abbottís USD 2bn promotion agreement with Boehringer-Ingelheim and most recently general manager of marketing and sales operations where he led a team of 200 people in providing support to all of Abbottís US pharmaceutical activities.

Vasogen institutes changes to senior management to cut costs
US-headquartered biotechnology company, Vasogen, has revealed senior management changes initiated to improve organisational efficiencies and help deliver additional cost reductions. Effective immediately, COO Christopher Waddick will also assume the title of CFO, replacing Paul Van Damme, who has left the company. Waddick has been with Vasogen for the past 10 years and previously served as Vasogen's CFO from 1997 to 2005 prior to the appointment of COO in 2005. Also, vice-president of scientific affairs and a member of Vasogenís board, Eldon R Smith, will assume all responsibilities of the position of CMO and head of cardiovascular development previously held by Dr Jay Kleiman, who has elected to retire. Dr Smith has been with Vasogen since 1996 and has been responsible for the company's cardiovascular programmes. The company's lead product is its Celacade technology, which triggers an immune response to the physiological process which regulates inflammation, and is in late-stage development for the treatment of chronic heart failure. Vasogen is also developing VP025, an early-stage new drug candidate for the treatment of certain neurodegenerative diseases.

Financial news

Genentech reports successful Q1 FY07
Genentech has posted a 68 per cent jump in Q1 FY07 profits, with results boosted by the company's ophthalmic treatment, Lucentis (ranibizumab injection), and robust sales of cancer drug, Avastin (bevacizumab). Lucentis sales were expected to taper off in 2007 as patients transitioned to lower dosage treatments. The company reported a rise in net income to USD 706m, or USD 0.66 per share from USD 421m, or USD 0.39 a share, for the same period a year earlier. Excluding items, Genentech earned USD 792m, or USD 0.74 a share, from USD 491m, or USD 0.46 a share, a year earlier. Genentech is majority owned by Swiss drug company, Roche, and reported a 43 per cent rise in total operating revenue in Q1 FY07 to USD 2.8bn from USD 2.0bn a year ago. Product sales increased to USD 2.3bn from USD 1.6bn a year earlier. Analysts has expected earnings of USD 0.67 a share and revenue of USD 2.7bn. Product sales in the US increased to USD 2bn from USD 1.6bn a year ago. Lucentis, which has been approved for wet age-related macular degeneration, achieved sales of USD 211m. The companyís core drugs also experienced a sales boost, as Avastin increased 34 per cent to USD 533m. The drug was recently approved to treat lung cancer as well as colorectal cancer. Rituxan (rituximab), a non-Hodgkin's lymphoma treatment, posted a 12 per cent sales rise to rest at USD 535m, while sales of breast-cancer treatment Herceptin (trastuzumab) rose seven per cent. Herceptin drug received expanded approval in November 2006 to include treatment for women who have just had breast surgery to treat their cancer.

Eli Lilly releases positive Q1 FY07 results
Eli Lilly have posted strong financial results for Q1 FY07, raising its FY07 sales and adjusted earnings per share guidance as a result. Sales increased 14 per cent to rest at USD 4.2bn. Sales for Alimta (pemetrexed), Byetta (exenatide), Cialis (tadalafil), Cymbalta/ Yentreve (duloxetine ), Forteo (teriparatide), Strattera (atomoxetine), Symbyax (olanzapine/ fluoxetine) and Xigris (drotrecogin alfa) grew 57 per cent collectively to reach USD 1.3bn, accounting for 30 per cent of total sales, compared with 22 per cent of total sales in Q1 FY06. However, reported net income and EPS in the same time period were USD 508.7m and USD 0.47, respectively, compared with Q1 FY06 net income of USD 834.8m and EPS of USD 0.77. The fall was attributed to in-process R&D charges associated with the acquisition of ICOS and OSI in-licensing agreement and restructuring charges associated with manufacturing decisions. Excluding these charges, adjusted net income and earnings per share both grew nine per cent, to USD 913.3m and USD 0.84, respectively. Lilly says it should earn between USD 2.63 and USD 2.73 per share or USD 3.30 to USD 3.40 per share, excluding items in FY07. The prediction exceeds prior predictions of USD 3.25 to USD 3.35 pr share and surrounds Wall Street's current view of USD 3.33. Lillyís raised R&D spend reflects the trouble the company is having with its pipeline. The FDA has rejected the company's appeal of an approvable letter for diabetic retinopathy product, Arxxant (ruboxistaurin). Lilly still has an approval pending from the European Medicines Agency for the drug.

Nestle to acquire Novartisí infant nutrition arm for USD 5.5bn
Nestle, the world's largest food and drink company, has revealed it will buy Gerber Products from Swiss pharmaceutical company, Novartis, for USD 5.5bn, giving it the largest share of the global baby food market. The acquisition further develops Nestle's recent expansion into health and nutrition, following its purchases of the US weight loss firm, Jenny Craig, and Novartis Medical Nutrition. Gerber leads the US baby-food market, with a 79 per cent share, according to Morgan Stanley. Adding Gerber will help the company's nutrition business generate annual sales of close to USD 8.2bn. Nestle said it expects Gerber to generate sales of around USD 2bn inn FY07. Nestle shares fell 0.7 per cent to CHF 406.10 in Zurich, while Novartis shares were up at CHF 67.40. Novartis, has divested several non-core businesses recently, selling its medical-nutrition division to Nestle for USD 2.5bn in December 2006. Novartis now focuses on prescription medicines, vaccines and selling low-cost generic drugs and OTC medicines. Analysts said although the price appeared high at first sight, it was in line with similar deals. The acquisition should complete in H2 2007, subject to approval by regulatory authorities, according to a Nestle spokesperson.

HIV drugs to exceed USD 10bn by 2015
The launch of new drugs and an increase in the number of people diagnosed with HIV is set to make anti-retroviral medicine a USD 10.6bn market by 2015, according to a Datamonitor report. The HIV/AIDS market is set to undergo significant changes over the next 10 years as new, novel pathway drugs are launched. Abbott has received widespread criticism regarding drug pricing in developing countries, such as India and Thailand, where it is currently in legal and governmental talks. Abbott has agreed to cut the price of Kaletra by over 50 per cent in such countries, but has refused to sell a new and improved version of the drug in countries where international patent laws are ignored. New HIV drugs on the market include Pfizer's maraviroc, a CCR5 inhibitor, and Merck & Coís raltegravir, an integrase inhibitor, which should launch in 2007 and 2008, respectively. Novel HIV treatments offer a lifeline to treatment-experienced patients who longer respond to existing drugs. Critics say that tighter patent rules in developing countries could damage the generics drugs industry, leaving millions of people without access to cheap medicines. Pharmaceutical companies state that patent protection is essential to reward innovation leading to new drugs. An article in New Scientist said that pharmaceutical companies were not as innovative as they seemed: real innovation, as measured by the number of applications for "innovative products" to the FDA, has been dropping off over the past ten years, even though companies have increased R&D spending by 50 per cent.

R&D news

Drugs for Parkinson's disease may ease stroke-related disability
Researchers at the Washington University School of Medicine in St Louis have shown that stroke damage in a brain region known as the putamen is strongly linked to motor neglect, a condition that makes patients slow to move toward the left side. Similarly, Parkinson's disease (PD) patients are also slow to initiate responses involving movement. Scientists attribute this deficit in PD to loss of neurons that use the neurotransmitter dopamine to regulate activity in the putamen. Lead author, Professor Ayelet Sapir, a postdoctoral researcher in neurology at Washington University, confirmed that the data indicated patients with damage to the putamen might respond differently to dopamine treatment than patients who have neglect from stroke damage to other parts of brain. Sapir and other researchers want to link damage in a given right brain region to a particular set of symptoms. Many problems after a right-brain stroke fall under the broad heading of neglect: the inability to detect a stimulus or do something about it. Neglect is highly disabling as it interferes with a number of basic activities such as dressing, self-care and driving. Of 29 patients tested, six were able to respond promptly to left-side stimuli, suggesting they had motor neglect. When Sapir compared high-resolution magnetic resonance imaging brain scans from the two groups, she found a consistent pattern: all patients identified as having motor neglect had damage to the putamen, while those who still responded slowly to left-side stimuli did not. Sapir hopes to eventually develop a battery of tests to allow clinicians to dissociate the different kinds of neglect and develop new treatments.

Home HIV test in development
US-based diagnostic products, immunoassays and diagnostic tests manufacturer, OraSure Technologies, is to file its OraQuick OTC HIV home test kit with the FDA. OraSure added that it will partner with professional health services group, Constella, to provide vital counselling and referrals to consumers of the test. HIV testing currently requires the direct involvement of medical professionals and/or counsellors based at a doctor's office, clinic or hospital. Home-collection kits, such as Home Access HIV-1 Test System, exist already, but samples must be sent to a home access laboratory for testing, with the results provided in three to seven days over the telephone. OraSure has been conducting clinical studies and developing new packaging and labelling, as it prepares to submit an application to the FDA for approval of the OTC test kit. Orasure say that a critical component of the ongoing development of the test is the incorporation of a consumer counselling system. OraSure signed an agreement with Constella in early April 2007 to develop the counselling aspect. Constella has operated the US Centers for Disease Control (CDC) nationwide HIV/AIDS clearing house and call centre and will develop a counselling system compliant with both FDA and international regulatory and quality standards. The system will offer phone and website access 24 hours a day, seven days a week to assist consumers who use the assay and, when necessary, provide medical referrals. OraSure has completed laboratory studies as preliminary steps toward FDA approval of the test. Clinical trials will continue throughout 2007 and 2008, after which the company plans to submit an application for FDA approval.

Risk of infection from defibrillators
Patients with implanted defibrillators are more likely to suffer infections than those with pacemakers, a study has shown. The US study of 1,087 patients with implanted cardiac devices showed the rate of pocket infection without blood stream infections (BSI) was higher among patients with implantable cardioverter-defibrillators (ICDs) than those with permanent pacemakers. Researchers studied the medical records of the patients and ascertained whether blood stream infection had occurred, then looked to see if cardiac devices had become infected. Thirty-six per cent of patients with defibrillators and blood stream infections had device infection. In comparison, three per cent of patients with permanent pacemakers and blood stream infections had device infection.

NHS news

UK doctors suffer from poor morale
According to a UK-based study conducted by Hospital Doctor magazine, over 50 per cent of doctors suffer from "poor" or "terrible" morale at work, with over two-thirds unwilling to recommend a career in medicine. Many doctors blame the UK government targets and reforms for the lack of morale. Only two per cent of doctors described their level of morale at work as "excellent", with 54 per cent describing working life as "poor" or "terrible". Asked how NHS reforms had affected morale, 47 per cent said they were unhappy with the reconfiguration of hospital services, which will see more care moved into the community. Sixty-three per cent added that changing workloads had damaged morale and nearly 50 per cent said morale among junior doctors at their NHS trust was "terrible" since the introduction of changes to specialist training.

BUPA to sell off hospitals
Private health insurer BUPA is planning to sell off its 26 hospitals, according to a Nursing Times (NT) report. The company confirmed to NT that it was considering the move, which would potentially affect the 2,000 nurses who work in the hospitals collectively. It is believed that BUPA wants to focus its attention on the ever-growing care home sector instead. A company spokesperson said: "We are undertaking a review to establish whether, given the significant changes in the UK healthcare economy and in particular the increasing role the private sector is playing in that market, there may be benefits for the customers and other stakeholders of BUPA Hospitals and the BUPA Group in a sale of BUPA Hospitals. BUPA is in preliminary discussions with potential purchasers of BUPA Hospitals.

Health news

Severely obese fastest growing overweight group in US
People who are 45 kilos or more overweight are the fastest-growing group of overweight people in the US. The researchers, whose report will be published later this year in the journal Public Health, found that the proportion of Americans with a BMI of 30 or more increased 24 per cent between 2000 and 2005. They also found the proportion of the severely obese was 50 per cent higher in 2005 than it had been in 2000. The researchers found that based on self-reported height and weight, which tends to underestimate the weight part, three per cent of Americans are already severely obese (body mass index of 40 or higher). The proportion of people with a BMI of 40 or more increased by 50 per cent and the proportion of Americans with a BMI of 50 or more increased by 75 per cent. The number of bariatric procedures, which include stomach stapling and stomach bypass surgery, rose to around 200,000 in 2006 from 13,000 in 1998. More than 30 per cent of Americans are overweight, with a BMI between 25 and 29, and another 30 per cent on top of that are obese, defined as having a BMI of 30 or above.

18th April 2007

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