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Antisoma Starts Phase II Trial Of AS1402 In Breast Cancer

2008-09-30T10:00:00.000-07:00

Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) announced that it has started a phase II trial evaluating the addition of AS1402 to the endocrine (hormonal) therapy letrozole in post-menopausal women receiving first-line treatment for advanced breast cancer.

Approximately 110 patients will be randomly assigned to receive either letrozole plus AS1402 or standard treatment with letrozole alone. The safety of the AS1402-letrozole combination will be evaluated and its efficacy compared with that of letrozole alone. Measures of efficacy will include response rates, time to tumour progression, progression-free survival and clinical benefit rate. Final results are expected in 2010.

The phase II trial builds on a phase I study in patients with heavily pre-treated breast cancer, which showed that AS1402 monotherapy was well-tolerated and was associated with prolonged stable disease in a number of patients.

AS1402 targets a cancer-associated form of the cell-surface protein MUC1. This form is found in approximately 90% of breast cancers and in a wide range of other tumours. Tissue culture studies have shown that AS1402 binds to MUC1 on cancer cells and leads to their destruction by antibody-dependent cellular cytotoxicity (ADCC), a process involving recruitment of the immune system. Recent studies have shown that MUC1 up-regulates the oestrogen signalling pathway targeted by endocrine therapies. This provides a particular rationale for combining AS1402 with letrozole in Antisoma's phase II trial.

Hospitals in the US, Russia, Ukraine, Poland and France are taking part in the phase II study. The trial's Principal Investigator, Professor Nuhad Ibrahim, of the MD Anderson Cancer Center, University of Texas, said: "There is a clear rationale for testing AS1402 in this group of breast cancer patients, and we are pleased to be participating in this well-designed study."

Antisoma's Chief Operating Officer, Dr Ursula Ney, added: "Worldwide, over 90,000 women each year receive endocrine treatment for advanced breast cancer, so many patients could benefit from any add-on therapy that improved outcomes in this setting. Our phase II study rigorously tests the value of adding AS1402 to endocrine treatment and, if positive, will provide a firm basis for progress to a pivotal phase III trial in breast cancer."

Background on the AS1402 phase II trial

Additional details of the phase II trial of AS1402 will be available shortly at http://www.clinicaltrials.gov. In this study, the anti-MUC1 antibody AS1402 is being tested in combination with a widely used endocrine (hormonal) therapy, letrozole, which belongs to the class of aromatase inhibitors. This is the first study to evaluate AS1402 as part of a combination regimen, phase I trials having tested AS1402 as a single agent. It is believed to be the first trial to combine a MUC1-targeting antibody with endocrine treatment for cancer. Endpoints in the phase II trial include response rates, time to tumour progression, progression-free survival and clinical benefit rate (sum of patients showing a response or disease stabilisation by 'RECIST' (Response Evaluation Criteria In Solid Tumours)).

Background on AS1402

AS1402 (huHMFG1, previously known also as R1550 and Therex) is a humanised antibody against a form of MUC1 found on the surface of various cancers. The drug has successfully completed phase I studies in breast cancer. It was licensed by Antisoma from the Imperial Cancer Research Technologies, the technology transfer arm of the Imperial Cancer Research Fund (now Cancer Research UK).

AS1402 is a humanised antibody that attacks cancer cells by recruiting the patient's immune system, particularly natural killer cells. This is the process of antibody-dependent cellular cytotoxicity (ADCC), which has been demonstrated during experiments in vitro with the AS1402 antibody. A growing body of evidence links the MUC1 protein targeted by AS1402 with cancer progression and metastasis. In particular, MUC1 has been implicated in changes in intracellular signalling and altered interactions with extracellular matrix components such as ICAM-1. These findings reinforce the relevance of MUC1 as a target for anti-cancer treatments and open up the possibility that, in addition to mediating ADCC, naked anti-MUC1 antibodies such as AS1402 may exert effects on cancer cells by altering the interactions of MUC1 with other proteins.

Background on Antisoma

Antisoma is a London Stock Exchange-listed biopharmaceutical company that develops novel products for the treatment of cancer. The Company has operations in the UK and the US. Please visit http://www.antisoma.com for further information about Antisoma.

Antisoma Plc

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It's Your Doctor Calling: Fibromyalgia Sufferers Sought For Motivational Study

2008-09-30T07:00:00.001-07:00

Researchers at the Indiana University School of Medicine seek 200 people with fibromyalgia to determine if motivational reminder telephone calls can prompt patients to exercise more regularly.

Fibromyalgia is a disease that causes pain in joints and muscles in about 5 percent of the population. Although not life-threatening, fibromyalgia can have a debilitating effect on a person's quality of life by causing body aches, headaches, stiffness and disrupted sleep. One of the common prescriptions for the disease is exercise.

Eligible participants include fibromyalgia patients between the ages of 18 and 65 years who have been diagnosed by a rheumatologist and who have no medical conditions that restricts participation in moderate physical activity.

The ongoing study will evaluate how effectiveness of exercise-based motivational interviewing.

Individuals interested in the study can go to http://www.fibrofit.netto pre-qualify, or call Janna Hilligoss at 317-274-1755 for more information .

http://www.fibrofit.net

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Supplements No Better Than Placebo In Slowing Cartilage Loss In Knees Of Osteoarthritis Patients

2008-09-30T07:00:00.000-07:00

In a two-year multicenter study led by University of Utah doctors, the dietary supplements glucosamine and chondroitin sulfate performed no better than placebo in slowing the rate of cartilage loss in the knees of osteoarthritis patients.

This was an ancillary study concurrently conducted on a subset of the patients who were enrolled in the prospective, randomized GAIT (Glucosamine/chondroitin Arthritis Intervention Trial). The primary objective of this ancillary study was to investigate whether these dietary supplements could diminish the structural damage of osteoarthritis. The results, published in the October issue of Arthritis & Rheumatism, show none of the agents had a clinically significant effect on slowing the rate of joint space width loss - the distance between the ends of joint bones as shown by X-ray.

However, in line with other recent studies, the researchers observed that all the study's participants had a slower rate of joint space width loss than expected, making it more difficult to detect the effects of the dietary supplements and other agents used in the study.

Rheumatologist Allen D. Sawitzke, M.D., associate professor of internal medicine at the University of Utah School of Medicine, was lead investigator. "At two years, no treatment achieved what was predefined to be a clinically important reduction in joint space width loss," Sawitzke said. "While we found a trend toward improvement among those with moderate osteoarthritis of the knee in those taking glucosamine, we were not able to draw any definitive conclusions."

More than 21 million Americans have osteoarthritis, with many taking glucosamine and chondroitin sulfate, separately or in combination, to relieve pain. The original GAIT, led by University of Utah rheumatologist Daniel O. Clegg, M.D., professor of internal medicine, was a multicenter, randomized, national clinical trial that studied whether these dietary supplements provided significant pain relief to people with osteoarthritis in the knees. GAIT found that the supplements produced no more pain relief than placebo (New England Journal of Medicine, February 2006), although a subset of the original GAIT participants with moderate to severe osteoarthritis knee pain appeared to receive significant pain relief when they took a combination of glucosamine and chondroitin sulfate.

In this ancillary study, GAIT patients were offered the opportunity to continue their original study treatment for an additional 18 months, for a total of two years. Participants remained on their originally assigned GAIT treatment: 500 mg of glucosamine three times a day; or 400 mg of chondroitin sulfate three times a day; or a combination of the two supplements; or 200 mg of celecoxib daily; or a placebo.

X-rays were obtained at study entry and again at one and two years. Joint space width was measured on 581 knees from 357 patients. None of the trial groups showed significant improvement. The group taking glucosamine had the least change in joint space width, followed by the groups taking chondroitin sulfate, celecoxib, placebo and the combination of both dietary supplements.

The total joint space width loss over two years for each group was:
0.013mm (glucosamine)

0.107mm (chondroitin sulfate)

0.111mm (celecoxib)

0.166mm (placebo)

0.194mm (glucosamine and chondroitin sulfate)

The interpretation of the results was problematic because the placebo group's joint space width loss was much less at two years than the 0.4mm the researchers' expected. Based on other large studies published in scientific journals, the researchers hypothesized that a loss of 0.2mm or less at two years would mean a slowed rate of cartilage loss. However, because the reduction in rate of joint space loss for all the groups was under the 0.2mm threshold, the researchers concluded none of the agents significantly slowed the loss of joint space width.

Josephine P. Briggs, M.D., director of the National Center for Complementary and Alternative Medicine, one of the study's funders, said although no definitive conclusions can be drawn about the two dietary supplements yet, "the results of the study provide important insights for future research."

Clegg said the trial shed light on osteoarthritis progression, techniques that can more reliably measure joint space width loss, possible effects of glucosamine and chondroitin sulfate, and on identifying patients who may respond best as further studies are pursued.

The other centers in the study were: The Arthritis Research and Clinical Centers, Wichita, Kan.; University of Arizona, Tucson; Case Western Reserve University, Cleveland; Cedars-Sinai Medical Center; Los Angeles; Indiana University, Indianapolis; University of California, Los Angeles; University of California, San Francisco; University of Pittsburgh.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases also funded the study. Both it and the National Center for Complementary and Alternative Medicine are part of the National Institutes of Health.

Source: Phil Sahm

University of Utah Health Sciences

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Retrospective Analysis Of Phase 3 Data Suggest Wyeth's Investigational Compound Bazedoxifene

2008-09-30T06:00:00.000-07:00

A retrospective analysis of Phase 3 two-year data presented at the annual meeting of the North American Menopause Society (NAMS) suggest that postmenopausal women treated with bazedoxifene/conjugated estrogens (BZA/CE) may experience incidence of breast tenderness and abnormal mammograms no greater than those treated with placebo. BZA/CE is an investigational compound being studied by Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), for the treatment of moderate-to-severe menopausal vasomotor symptoms such as hot flashes and night sweats, and for the prevention of postmenopausal osteoporosis. Wyeth describes this compound as a tissue selective estrogen complex (TSEC).

In a retrospective analysis of data from another phase 3 study, treatment with Wyeth's investigational compound bazedoxifene (BZA) alone did not appear to increase mammographic breast density in postmenopausal women with osteoporosis compared to raloxifene (the active comparator) or placebo over two years. BZA is an investigational selective estrogen receptor modulator (SERM) under development for the treatment and prevention of postmenopausal osteoporosis.

Data Highlights

NAMS Poster Titled: Breast Effects of Bazedoxifene/Conjugated Estrogens in a Randomized, Controlled Trial of Postmenopausal Women

In the phase 3 study involving 3,397 postmenopausal women, primarily designed to evaluate the effects of BZA/CE on the endometrium and bone mineral density, mammograms were taken at baseline, and again at years one and two as part of the safety evaluation. Breast tenderness was reported in daily diaries. A retrospective analysis suggested no significant differences in the incidence of breast tenderness or abnormal mammograms between the BZA/CE groups at any of the doses studied and placebo or raloxifene.

In this study, the incidence of treatment-emergent adverse events, serious adverse events, and withdrawals due to adverse events were similar among the active treatment groups and placebo.

NAMS Poster Titled: Effects of Bazedoxifene on Mammographic Breast Density in Postmenopausal Women with Osteoporosis

A retrospective study examined mammograms in a subset representing 726 postmenopausal women from a primary phase 3 fracture reduction study of BZA, raloxifene, and placebo. The objective was to evaluate the quantitative changes in mammographic breast density after 24 months of treatment. This study indicated treatment with BZA over 24 months did not affect mammographic breast density in postmenopausal women with osteoporosis. Changes in breast density with BZA were similar to those with raloxifene and placebo.

Also presented at the NAMS meeting were data on the effects of BZA/CE on sleep and overall menopausal symptoms.

About TSEC

Wyeth describes the pairing of a selective estrogen receptor modulator (SERM) and one or more estrogens as a TSEC. The TSEC concept is based on the blended tissue-selective activity of the components, which is hypothesized to yield different clinical results than those provided by either the SERM or estrogen(s) alone.

About Menopause

According to the U.S. Census Bureau, in 2006, there were approximately 20 million women of menopausal age (45-54 years) in the United States. As many as 50 percent to 90 percent of women going through menopause experience vasomotor symptoms, such as hot flashes, which can greatly impact a woman's life. Furthermore, between 10 percent and 40 percent of postmenopausal women experience symptoms of vulvar and vaginal atrophy, which typically do not subside without treatment.

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. For additional information about the company, please visit http://www.wyeth.com.

The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, clinical trial data are subject to differing interpretations, and the views of regulatory agencies, medical and scientific experts and others may differ from ours. In addition, there can be no assurance that bazedoxifene/conjugated estrogens or bazedoxifene will ever receive regulatory approval or be successfully developed and commercialized. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward-looking statements include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Zypadhera(TM) Receives Positive Opinion From The European Committee For Medicinal Products For Human Use (CHMP) For Treatment Of Schizophrenia

2008-09-30T05:00:00.010-07:00

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Zypadhera (olanzapine powder and solvent for prolonged release suspension for injection, also known as olanzapine long-acting injection) for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral olanzapine, Eli Lilly and Company (LLY) announced.

The opinion issued by the CHMP will need to be ratified by the European Commission before the new indication is considered approved. The Commission usually makes a decision within two to three months of a CHMP recommendation.

Olanzapine long-acting injection is an investigational formulation that combines olanzapine, an atypical antipsychotic, with pamoic acid resulting in a salt that sustains the delivery of olanzapine for a period of up to four weeks. Long-acting injectables have been associated with improved treatment for patients who struggle with adherence to oral medications.(i)

"Because of the chronic and severe nature of schizophrenia, persistent challenges with adherence and the limited number of depot formulations available, we believe that olanzapine long-acting injection has the potential to become a valuable treatment option for patients," said David McDonnell, M.D., clinical research physician at Lilly.

The CHMP opinion was based on a comprehensive data package comprising eight studies, involving 2,054 patients, including a double-blind, placebo- controlled, fixed-dose study (HGJZ)(ii); a double-blind, oral olanzapine- controlled, fixed-dose study (HGKA)(iii); and six open-label studies(iv). In these trials, olanzapine long-acting injection (LAI) was found to be similar to olanzapine oral in terms of rate of symptom exacerbation and showed a similar safety profile as the oral formulation with the exception of injection-related events, including olanzapine LAI Post-Injection Syndrome. (v) Additionally, the trials showed that olanzapine long-acting injection (LAI) separated from placebo as measured by total PANSS score reduction over 8 weeks of treatment, and a drug effect that was observed as early as one week from the first injection.(vi); olanzapine long-acting injection was studied as a once every-four week and a once every-two week injection, without the need for oral antipsychotic supplementation.

As of August 31, 2008, across all clinical trials, olanzapine LAI Post- Injection Syndrome events, including a range of symptoms of sedation (from mild in severity to unconsciousness) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment), have been seen in 0.07 percent of injections and 1.4 percent of patients, all of whom have recovered fully. (vii)

As part of the marketing authorization, Lilly has proposed a comprehensive risk minimization plan for identifying and managing olanzapine LAI Post- Injection Syndrome. The plan includes a requirement for a post-injection observation period described in the product labeling, and an extensive healthcare provider training and educational program.

Earlier this month, Zypadhera was approved for use in New Zealand. Independent regulatory reviews of olanzapine LAI applications for schizophrenia are ongoing in the United States, Canada, Australia and other countries.

About Long-acting Injectable Antipsychotic Medications

The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines state that poor or partial treatment compliance is a major problem in the long-term treatment of schizophrenia. Depot formulations should be considered as a treatment option when a patient expresses a preference for such treatment due to convenience or if it is determined that a depot formulation is necessary to help with compliance.(viii)

Long-acting antipsychotic formulations have been associated with improved treatment adherence and reduced treatment failures.(ix) By administering long- acting medications, healthcare professionals know when patients have received their medication and can immediately detect non-adherence when a patient fails to return for a scheduled injection.* Different from both oral and injected short-acting formulations, long-acting formulations of antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time.(xi)

About Schizophrenia

Schizophrenia is a severe and debilitating illness with such symptoms as delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices or visions), disorganized speech and severe disorganized or catatonic behavior. These signs and symptoms are associated with marked social or occupational dysfunction. Features of schizophrenia consist of characteristic signs and symptoms that have been present for a significant portion of time during a one-month period, with some signs of the disorder persisting for at least six months.(xii) In addition to these symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population.

About Olanzapine

Since olanzapine was introduced in 1996, it has been prescribed to more than 26 million people worldwide. Olanzapine is not recommended for use in patients under 18 years of age.

In Europe, olanzapine is indicated for schizophrenia and in clinical trials, it has shown to be effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. It also is indicated for the treatment of moderate to severe manic episodes and, in those patients whose manic episode has responded to olanzapine treatment, it is indicated for the prevention of recurrence in patients with bipolar disorder.

SAFETY INFORMATION

Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases. In some cases, a prior increase in body weight has been reported, which may be a predisposing factor. Appropriate clinical monitoring is advisable, particularly in diabetic patients and in patients with risk factors for diabetes mellitus for which regular glucose control is recommended.

Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials. Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline. Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.

The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time. In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.

As with all antipsychotic medications, a rare and potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) has been reported rarely with olanzapine. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.

Also, as with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD increases as the duration of treatment. If signs and symptoms of TD are observed a dose reduction or discontinuation should be considered and it should be noted that the symptoms can temporally deteriorate or even rise after discontinuation.

Other potentially serious adverse events include low blood pressure, seizures, elevated prolactin levels, elevated liver enzymes, thromobembolism, neutopenia, sweating, insomnia, tremor, anxiety, nausea, or vomiting.

Olanzapine should not be used in patients who have a hypersensitivity to the drug nor those with narrow angle glaucoma. It should not be used to treat dementia-related psychosis and/or behavioural disturbances because of an observed increase in death and cerebrovascular accident. It should also not be used in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease.

The most frequently (seen in >/= 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels, glucosuria, increased appetite, dizziness, akathisia, parkinsonism, dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases, rash, asthenia, fatigue and oedema.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.co.uk

P-LLY

This press release contains forward-looking statements about the safety and efficacy of olanzapine long acting injection (LAI) and reflects Lilly's current beliefs. However, as with any investigational pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, regulatory milestones and commercialization. There is no guarantee that olanzapine LAI will be approved for the treatment of schizophrenia or that if approved, it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

References

i. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics prescribed more often and what can be done about it? Advances in Psychiatric Treatment (2005) 11: 203-211.

ii. Lauriello J., Lambert T., Andersen S., Lin D., Taylor C.C., McDonnell D. Olanzapine Long-Acting Injection: An 8-Week Double-Blind, Randomized, Placebo-Controlled Study in Acutely-Ill Patients with Schizophrenia. Journal of Clinical Psychiatry. May 2008.

iii. Detke H., McDonnell D., Kane J., Naber D., Sethuraman G., Lin D. Olanzapine Long-Acting Injection for the Maintenance Treatment of

Schizophrenia: A 24-Week, Randomized, Double-Blind Trial. Data presented at Schizophrenia International Research Society Meeting. June 21-25, 2008.

iv. McDonnell D., Andersen S., Detke H., Watson S. 160-week interim results from an open-label extension trial of olanzapine long-acting injection. Data presented at Schizophrenia International Research Society Meeting. June 21-25, 2008.

v. Detke H., McDonnell D., Kane J., Naber D., Sethuraman G., Lin D. Olanzapine Long-Acting Injection for the Maintenance Treatment of Schizophrenia: A 24-Week, Randomized, Double-Blind Trial. Data presented at Schizophrenia International Research Society Meeting. June 21-25, 2008.

vi. Lauriello J., Lambert T., Andersen S., Lin D., Taylor C.C., McDonnell D. Olanzapine Long-Acting Injection: An 8-Week Double-Blind, Randomized, Placebo-Controlled Study in Acutely-Ill Patients with Schizophrenia. Journal of Clinical Psychiatry. May 2008.

vii. McDonnell D., Sorsaburu S., Brunner E., Detke H., Andersen S., Bergstrom R., Mitchell M., Ogle K., Watson S., Corya S. Post-Injection Delirium/Sedation Syndrome Observed with Olanzapine Long-Acting Injection. Data Presented at European College of Neuropsychopharmacolgy Meeting. August 30-September 3, 2008.

viii. Falkai P., Wobrock T., Lieberman J., Glenthoj B.,Gattaz W.F., Moller H.J & WFSBP Task Force On Treatment Guidelines For Schizophrenia. The World Journal of Biological Psychiatry, 2006; 7(1): 5/40

ix. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics prescribed more often and what can be done about it? Advances in Psychiatric Treatment (2005) 11: 203-211.

x. Kane J.M et al. Guidelines for depot antipsychotic treatment in schizophrenia. European Neuropsychopharmacology, Volume 8, Number 1, 1 February 1998, pp. 55-66(12). p. 58.

xi. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics prescribed more often and what can be done about it? Advances in Psychiatric Treatment (2005) 11: 203-211.

xii. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, fourth edition, 2000, pp. 298.

Eli Lilly and Company
http://www.lilly.com

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VEGF Trap-Eye: New Data Confirm Successes In The Treatment Of Age Related Macular Degeneration

2008-09-30T05:00:00.009-07:00

VEGF Trap-Eye can achieve durable improvements in visual acuity and in biologic measurement parameters in the formation of new blood vessels in the treatment of age-related macular degeneration (AMG). This was shown in the final evaluation of a Phase 2 study presented at the annual meeting of the Retina Society in Scottsdale, Arizona. These parameters include retinal thickness and active choroidal neovascularization lesion size (the damaged part of the retina). Bayer HealthCare and Regeneron Pharmaceuticals, Inc (Nasdaq:REGN) are developing VEGF Trap-Eye together. The treatment successes continued for up to a year.

The study showed that VEGF Trap-Eye was also associated with a reduction in the size of the choroidal neovascular membrane (CNV), the active lesion that is the underlying cause of vision loss in patients with wet AMD. Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p

"Progression of the active CNV lesion and resulting vision impairment are an inevitable consequence of untreated wet AMD. The reduction in total active CNV lesion size achieved with VEGF Trap-Eye treatment in this Phase 2 clinical study could potentially translate into clinically meaningful outcomes in the larger, controlled Phase 3 studies that are underway," stated Jason Slakter, M.D., head of the independent reading center for the study and a Clinical Professor of Ophthalmology, New York University School of Medicine, New York.

In this double-masked Phase 2 trial, participants were initially treated with either monthly or quarterly fixed dosing for 12 weeks and then continued to receive treatment for another 40 weeks on a PRN (as needed) dosing schedule. Patients receiving fixed monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks (i.e. 4 fixed doses) followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p

Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 mg for 12 weeks followed by PRN dosing also achieved mean decreases in retinal thickness versus baseline of 143 microns (p

While PRN dosing following a fixed quarterly dosing regimen (with dosing at baseline and week 12) also yielded improvements in visual acuity and retinal thickness versus baseline at week 52, the results generally were not as robust as those obtained with initial monthly treatment.

"Anti-VEGF therapy has dramatically changed the treatment paradigm for wet AMD, and improvement in visual acuity is now feasible in most patients. The biggest challenge we have is that with our current drugs, the majority of patients need frequent injections into their eye to maintain their visual acuity gains," stated David M. Brown, M.D., a study investigator and a retinal specialist at The Methodist Hospital in Houston."These study results reinforce our interest in further exploring whether continued administration of VEGF Trap-Eye on an as-needed basis after an initial period of fixed dosing can maintain a durability of effect over time in controlled Phase 3 clinical studies."

VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. There was one reported case of eye inflammation (culture-negative endophthalmitis/uveitis) in the study eye, which was deemed not to be drug-related. The most common adverse events were those typically associated with intravitreal injections.

About the Phase 3 Program in Wet AMD

Regeneron and Bayer HealthCare initiated a Phase 3 global development program for VEGF Trap-Eye in wet AMD in August 2007. In two Phase 3 trials, VIEW 1 and VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet age related macular degeneration), the companies are evaluating VEGF Trap-Eye dosed 0.5 mg every 4 weeks, 2 mg every 4 weeks, or 2 mg every 8 weeks (following three monthly doses) in direct comparison with ranibizumab (Lucentis®, a registered trademark of Genentech, Inc.) administered 0.5 mg every four weeks according to its U.S. label during the first year of the studies. PRN dosing will be evaluated during the second year of each study. The VIEW 1 study (http://www.regeneron.com/vegftrap_eye.html) is currently enrolling patients in the United States and Canada and the VIEW 2 study (http://www.view2study.com) is currently enrolling patients in Europe, Asia Pacific, Japan and Latin America. The companies are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, diabetic eye diseases, and other eye diseases and disorders. Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

About VEGF Trap-Eye

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye, which lead to the development of wet AMD. The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related placental growth factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. Blockade of VEGF, which can prevent abnormal blood vessel formation and vascular leak, has proven beneficial in the treatment of wet AMD.

About Wet AMD

Age-related Macular Degeneration (AMD) is a leading cause of acquired blindness. Macular degeneration is diagnosed as either dry (nonexudative) or wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating blind spots in central vision, and it can account for blindness in wet AMD patients. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.

Forward looking statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

View drug information on Lucentis.

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Monthly Replacement Contact Lens Wearers Report A Decrease In Wearing Comfort Over The Course Of A Month, Research Shows

2008-09-30T05:00:00.008-07:00

Monthly replacement contact lens wearers notice a decline in lens performance in weeks three and four of wear, a survey reveals. Findings from the research among monthly lens wearers in France, in which 20 different brands of lenses were represented, show a decrease in wearing comfort over the course of a month, with no significant differences between wearers of hydrogel and silicone hydrogel monthly replacement lenses.

About seven in ten monthly silicone hydrogel (71 percent) and hydrogel (68 percent) wearers reported a decrease in wearing comfort as the month progressed. Asked which week of the month, in general, they start to notice that their lenses become more uncomfortable, 95 percent said they become aware of discomfort in weeks three and four. Monthly silicone hydrogel wearers who experienced discomfort tended to notice it earlier in the lens cycle than hydrogel wearers.

"Discomfort and, in particular, dryness-related discomfort is a prime reason that many contact lens wearers either reduce or discontinue wearing their contacts," says Sheila Hickson-Curran, Director, Medical Affairs, VISTAKON®, Division of Johnson & Johnson Vision Care, Inc. "This study suggests that contact lens wearers should talk to their eye care professional if they are noticing a decline in lens performance over time."

Discomfort and other eye related problems could also occur for lens wearers who exceed the recommended wear and replacement schedule of a lens, according to Dr. Hickson-Curran.

Even though doctors and manufacturers provide instructions about caring for and wearing contact lenses, less than half of wearers (46 percent) always replace their contact lenses in accordance with their doctor's recommended schedule, with younger wearers less likely to be compliant according to Americans' Attitudes & Perceptions About Vision Care, a 2006 survey of 3,700 Americans conducted by Harris Interactive® on behalf of The Vision Care Institute™, LLC, a Johnson & Johnson Company.

"It is quite simple," Hickson-Curran notes. "If you wear a daily disposable contact lens, put in a fresh new lens every day; a bi-weekly, once every two weeks, and a monthly, once a month. By not following instructions on proper wear and care, contact lens wearers are more likely to experience discomfort and may put themselves at greater risk for infection or other serious complications."

To help contact lens wearers be compliant, VISTAKON® offers a complimentary online reminder service called ACUMINDER™. Available at http://www.acuminder.com, visitors can elect to receive an automatic reminder about changing or ordering new contact lenses via e-mail, cell phone text message, and/or a computer desktop prompt. A newly launched application for Facebook users (http://www.acuminder.com/facebook) expands its functionality into a multipurpose lifestyle tool that can also send out reminders for just about anything, such as taking daily medications, doctors' visits, work deadlines, important social events and more.

ACUMINDER™ users self report that they are becoming more compliant thanks to the reminder service, which is open to all contact lens wearers. In its first year, more than 11,000 contact lens wearers signed up for ACUMINDER™. In a January 2008 survey, bi-weekly contact lens wearers reported a marked improvement in their contact lens behavior -- the average number of days between lens changes decreased from 19 days to a near-perfect compliance of 15 days.

About the Research

An independent market research company conducted an online survey among consumers in France during October and November 2007. Johnson & Johnson Vision Care, Inc., sponsored the survey although subjects were unaware of the sponsor's identity. The sample was randomly selected from a consumer database of contact lens wearers designed to be representative of all existing brands in the French market. In total, 20 different brands of lenses were represented. The monthly replacement lens SUREVUE® Brand Contact lenses (not available in the United States) was the only Johnson & Johnson Vision Care product represented, since the company's ACUVUE® Brand Contact lenses are recommended for daily, weekly, or bi-weekly replacement.

Data was analyzed for a total of 434 existing contact lens wearers who completed the survey. Of these, 271 were wearing monthly replacement hydrogel lenses and 163 wore monthly silicone hydrogel lenses. All wearers were aged from 18-40 years and were frequent contact lens users, wearing their lenses at least three days a week and either all day long or during the day. Lens wearing history (i.e., number of years' wear) and care regime were not investigated in this survey.

ACUVUE® Brand Contact Lenses are available by prescription only for vision correction. An eye care professional will determine whether contact lenses are right for you. Although rare, serious eye problems can develop while wearing contact lenses. To help avoid these problems, follow the wear and replacement schedule and the lens care instructions provided by your eye doctor. Do not wear contact lenses if you have an eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. If one of these conditions occurs, contact your eye doctor immediately.

ACUVUE® , SUREVUE® ,ACUMINDER™, and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.

Johnson and Johnson
http://www.jnj.com

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EVAR Offers Better Results Than Open Repair In High Risk Patients

2008-09-30T05:00:00.007-07:00

Endovascular aneurysm repair (EVAR) yields better results than open surgical repair (OSR) in high risk patients with similar costs, according to a one-year trial study which appears in the October issue of the Journal of Vascular Surgery, published by the Society for Vascular Surgery.

Data was collected from 342 patients who had an abdominal aortic aneurysm (AAA) of more than 5.5 centimeters and required elective AAA repair at London Health Sciences Center (LHSC), London, Ontario, Canada, where EVAR has been used since 1997. Of the 192 patients at a high risk of postoperative complications, 140 received EVAR and 52 had OSR.

In this one-year non-randomized prospective study, demographic, medical, health care resource utilization, cost and quality of life data were collected to determine incremental costs and effects associated with each of these procedures. Sensitivity analyses were conducted to extrapolate the one-year mortality results to a five-year time horizon under various assumptions regarding convergence of mortality rates and re-intervention rates (for EVAR patients only).

"Even with similar baseline characteristics, postoperative complications occurred more frequently in OSR patients at a high-risk of surgical complications," said Dr. Guy De Rose, MD, medical director of surgical care at LHSC and an associate professor of surgery from the division of vascular surgery at the University of Western Ontario in London, Ontario, Canada. "The 30-day mortality rates were 0.7 percent for EVAR and 9.6 percent for OSR and significantly fewer EVAR patients had postoperative complications such as pulmonary edema, pneumonia or sepsis. In addition, the EVAR patients spent less time in the hospital and were less likely to be admitted to the ICU."

Dr. De Rose noted that, despite the cost of the endograft (approximately $10,000), the total average initial costs of hospitalization for high risk EVAR and OSR patients were similar ($28,139 vs. $31,181 respectively). He added that total one-year medical and indirect costs also were similar at $34,146 vs. $34,170 respectively. At one-year, all cause mortality was statistically lower in EVAR patients (7.1% vs. 17.3%). Five-year extrapolations indicated that EVAR may be cost-effective compared to OSR in high-risk patients over the long-term.

"Our study found that EVAR was a cost-effective strategy compared to OSR in high risk patients and had lower postoperative complications and lower mortality rates," said Dr. De Rose. He added that the quality of life experienced by the participating patients was similar between the two groups during the year following surgery.

"We are continuing to collect data on these patients and the longer-term results will provide more information regarding the cost-effectiveness of EVAR compared to OSR in high risk patients," explained Dr. De Rose.

The LHSC collaborated with the Programs for Assessment of Technology in Health (PATH) Research Institute, St Joseph's Healthcare Hamilton/McMaster University in Hamilton, Ontario, Canada on the current study. This study was conducted at the request of the Ontario Ministry of Health and Long-Term Care to provide evidence to the Ontario Health Technology Advisory Committee to support policy recommendations regarding the use of EVAR in Ontario.

About Journal of Vascular Surgery

Journal of Vascular Surgery provides vascular, cardiothoracic and general surgeons with the most recent information in vascular surgery. Original, peer-reviewed articles cover clinical and experimental studies, noninvasive diagnostic techniques, processes and vascular substitutes, microvascular surgical techniques, angiography and endovascular management. Special issues publish papers presented at the annual meeting of the Journal's sponsoring society, the Society for Vascular Surgery. Visit the Journal web site at http://www.jvascsurg.org.

About the Society for Vascular Surgery

The Society for Vascular Surgery (SVS) is a not-for-profit society that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. SVS is the national advocate for 2,600 vascular surgeons dedicated to the prevention and cure of vascular disease. Visit the web site at http://www.VascularWeb.org.

Society for Vascular Surgery

633 N St. Clair, 24th Fl.

Chicago, IL 60611

United States
http://www.vascularweb.org

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Baxter's Antimicrobial IV Technology Now Shown To Kill Six Common Pathogens, Including MRSA And VRE

2008-09-30T05:00:00.006-07:00

Baxter Healthcare
Corporation announced that it received 510(k) clearance for expanded
labeling for the first antimicrobial needleless intravenous (IV) connector,
V-Link Luer-activated device (LAD) with VitalShield protective coating.
With a new federal policy restricting reimbursement for
healthcare-associated infections (HAIs) taking effect on October 1,
healthcare professionals are seeking effective techniques and technologies
to reduce the risk of contamination from a broad array of pathogens
(infection-causing agents) within their hospitals.

Launched earlier this year, V-Link with VitalShield has now been shown
to kill at least 99.99 percent of six common pathogens known to cause
catheter-related bloodstream infections. The U.S. Food and Drug
Administration (FDA) cleared expanded labeling for V-Link with VitalShield
based on V-Link's ability to combat three additional pathogens:
vancomycin-resistant Enterococcus faecalis (VRE), Escherichia coli (E.
coli) and Staphylococcus epidermidis (coagulase negative). These three
pathogens improve upon the previously cleared labeling, which included
methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa
and Enterobacter cloacae.

Testing has demonstrated V-Link with VitalShield is effective against
this broad spectrum of microorganisms and retains antimicrobial efficacy
for up to a 96-hour period. In vitro testing for V-Link with VitalShield
was conducted using six strains of six common pathogens known to cause
bloodstream infections. V-Link with VitalShield is already available in the
United States, Canada, Puerto Rico, Australia and New Zealand, and Baxter
plans to launch the product in Europe later this year.

V-Link with VitalShield's expanded indications for use include VRE, a
multi-drug resistant organism, which over the past 20 years has been
increasingly reported as a source of healthcare-associated infections.(1,2)
Pathogens such as VRE and MRSA can contaminate medical devices used to
deliver IV fluids and medication to patients. The V-Link device is uniquely
coated on both inner and outer surfaces with a proprietary silver-based
antimicrobial technology, VitalShield, which helps to prevent contamination
and growth of these pathogens within the device.

"The revised labeling and expanded indications for use further validate
the broad spectrum antimicrobial coverage and effectiveness of V-Link with
VitalShield in lowering the risk of pathogen contamination," said Francois
Lebel, MD, vice president of Clinical and Medical Affairs for Baxter's
Medication Delivery business. "This additional microbial coverage and
long-lasting effect give healthcare professionals added confidence that
they are taking extra precaution to address patient safety."

"Bacteria can contaminate needleless IV connectors, particularly if
healthcare workers do not adhere to proper infection prevention measures.
In my practice, we have begun to evaluate this device and hope to see if
its use leads to lower bloodstream infection rates," said James Steinberg,
MD, associate professor of medicine in the Division of Infectious Diseases
at Emory University School of Medicine.

Starting this October, the Centers for Medicare and Medicaid Services
(CMS) will no longer reimburse U.S. hospitals for costs required to treat
healthcare-associated infections, including catheter-related bloodstream
infections. As the new CMS policy takes effect, healthcare facilities will
look to adopt infection control strategies to improve patient care and
avoid financial penalties.

V-Link with VitalShield Data Results to be Shared at ICAAC/IDSA

Baxter announced today that study results for V-Link with VitalShield
will be presented on October 27 during the first-ever joint meeting of the
American Society for Microbiology and the Infectious Diseases Society of
America (48th Annual ICAAC/IDSA 46th Annual Meeting) in Washington, DC. The
study reviews the effectiveness of V-Link with VitalShield in an in vivo
model of MRSA-generated catheter-related bloodstream infection and will be
presented by Mark Rupp, MD, medical director and professor of infectious
disease at the University of Nebraska Medical Center.

"Catheter-related bloodstream infections are clinically significant
infections with broad implications for both patients and our healthcare
system," said Dr. Rupp. "The data I am presenting at the ICAAC/IDSA meeting
indicate that this silver-coated catheter connector valve may provide a
protective effect against MRSA."

About V-Link Luer-activated device with VitalShield protective coating

Many hospitalized patients need a steady supply of medications or
fluids delivered into their bloodstream. Typically, an IV catheter is
placed in a patient's vein to allow direct access to the bloodstream. In
the process of injecting medications or fluids into a sterile line, surface
or other environmental contaminants may be introduced.

V-Link with VitalShield, a needleless IV connector used with the
catheter or IV tubing, helps to prevent contamination and growth of
specific pathogens within the device at the point of entry to the patient's
bloodstream. Reduction in colonization or microbial growth on the device
has not yet been studied to substantiate a reduction in bloodstream
infections. Silver is a well-known antimicrobial agent, and the V-Link
device is coated on both inner and outer surfaces with a specially designed
formulation, VitalShield, which has been shown to be effective against a
broad spectrum of microorganisms. The silver antimicrobial agent helps
prevent the contamination and growth of these pathogens within the V-Link
device. The antimicrobial agent is not intended to be used as a treatment
for existing infections.

V-Link with VitalShield is the first introduction of Baxter's newly
developed Vital Infusion Systems product line -- an integrated portfolio of
products developed to promote safety and reliability, and decrease risks
associated with IV therapy.

About Healthcare Associated Bloodstream Infections

Researchers have estimated that more than 400,000 vascular
catheter-related bloodstream infections occur each year in the United
States alone.(3) The Centers for Disease Control and Prevention (CDC)
reported in 2007 that MRSA infections cause an estimated 18,650 deaths per
year in the U.S., which are more per year than is caused in the U.S. by
HIV/AIDS.(4,5) In 2004, VRE caused approximately one out of every three
infections in hospital intensive-care units, according to the CDC.(6) There
are several types of healthcare-associated infections -- of these,
bloodstream infections are the most costly and life-threatening, resulting
in an average increase in mortality rate of 18 percent when compared to
patients without a bloodstream infection.(7,8,9) According to U.S.
estimates, healthcare-associated bloodstream infections cost an average of
$34,000 in increased direct hospital costs and can increase patient
length-of-stays by 23 days.(10,11)

Many hospitals and other healthcare facilities have developed extensive
control programs to prevent the occurrence of infections. Even when
clinicians in hospitals do their best to practice good hygiene techniques,
the risk of potential device contamination by pathogens may still persist.

About Baxter

Baxter Healthcare Corporation is the principal U.S. operating
subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International
Inc. develops, manufactures and markets products that save and sustain the
lives of people with hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma, and other chronic and acute medical
conditions. As a global, diversified healthcare company, Baxter applies a
unique combination of expertise in medical devices, pharmaceuticals and
biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the
potential of V-Link with VitalShield to impact catheter-related infections
and Baxter's intention to launch V-Link with VitalShield in Europe later
this year. These statements are based on assumptions about many important
factors, including the following, which could cause actual results to
differ materially from those in the forward-looking statements: the effect
of V-Link with VitalShield on catheter-related infections; our ability to
make V-Link with VitalShield and other new products, including those
associated with the Vital Infusion Systems product line, available for sale
in accordance with our plans; customer and market acceptance of V-Link with
VitalShield, products associated with the Vital Infusion Systems product
line and other new products; clinician practices and procedures; future
actions by the FDA and other regulatory bodies and government authorities
with respect to the company's infusion pumps and other products; and other
risks identified in Baxter International Inc.'s most recent filing on Form
10-Q and other SEC filings, all of which are available on the company's
website. The company does not undertake to update its forward-looking
statements.

References

1. Broadhead J, Parra D, Skelton P. Emerging Multiresistant Organisms
in the ICU: Epidemiology, Risk Factors, Surveillance, and Prevention. Crit
Care Nurse Q 2001; 24(2): 20-29.

2. Lee P, Ferguson D, Laffan J. Vancomycin-Resistant Enterococcus Avium
Infections. Infectious Diseases in Clinical Practice, 2004; 12(4): 239-244.

3. Raad I. Intravascular-Catheter-Related Infections. Lancet, 1998;
351: 893-98

4. Klevens, et al. Invasive Methicillin-Resistant Staphylococcus aureus
Infections in the United States. JAMA, 2007; 298(15): 1763-1771.

5. Centers for Disease Control and Prevention. HIV/AIDS Surveillance
Report: Cases of HIV Infection and AIDS in the United States and Dependent
Areas. 2005: 16-17.

6. National Institute of Allergy and Infectious Diseases. Antimicrobial
(Drug) Resistance -- Vancomycin-Resistant Enterococci (VRE) Overview.
Retrieved June 10, 2008.

7. Stone W, Braccia D, Larson E. Systematic Review of Economic Analyses
of Health care-associated Infections. Am J Infect Control, 2005; 33:
501-509.

8. Infection Control in the Intensive Care Unit -- Second Edition.
Springer Milan; 2005.

9. Berenholtz S, et al. Eliminating Catheter-related Bloodstream
Infections in the Intensive Care Unit. Crit Care Med, 2004; 32(10):
2014-2020.

10. DiGiovine B, et al. The Attributable Mortality and Costs of Primary
Nosocomial Bloodstream Infections in the Intensive Care Unit. Am J Respir
Crit Care Med, 1999; 160: 976-981.

11. Pennsylvania Health Care Cost Containment Council.
Hospital-acquired Infections in Pennsylvania. November 2006.

Baxter Healthcare Corporation
http://www.baxter.com

Other news:

Cepheid Receives FDA Clearance For First Rapid On Demand Molecular Diagnostic Test For MRSA And S. Aureus

2008-09-30T05:00:00.005-07:00

Cepheid (Nasdaq:
CPHD) announced it has received clearance from the U.S. Food & Drug
Administration (FDA) to market its Xpert(TM) MRSA/SA Skin and Soft Tissue
Infection (SSTI) test, which runs on the GeneXpert(R) System, for the rapid
detection of Methicillin-resistant Staphylococcus aureus (MRSA) and
Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and
soft tissue infections.

In less than one hour, Cepheid's Xpert MRSA/SA SSTI test processes
specimens from suspected skin and soft tissue infection swabs to determine
if a patient is infected with MRSA or SA, giving physicians and surgeons a
powerful new tool to aid in selecting the most effective antibiotic therapy
to improve patient management.

"The ability to detect MRSA or SA in less than one hour, versus two to
three days with current culture methods, will enable clinicians to make
real- time decisions as to the best course of treatment or management. The
ability to accurately identify MRSA and SA on a more timely basis is
important in managing both hospital-acquired and community-acquired
infections. According to data from the Centers for Disease Control (CDC),
there are approximately 12 million patient visits in the U.S. each year for
skin infections," said John Bishop, Cepheid's Chief Executive Officer. "We
are very pleased to announce the first molecular SSTI diagnostic test for
MRSA and SA, building on our established position as the leader in the HAI
(Healthcare Acquired Infections) testing market. With our expanding test
menu, we expect Cepheid's GeneXpert System to continue to be the molecular
platform of choice for the management of HAIs."

MRSA is a bacterium that has become resistant to multiple antibiotics
including penicillin and cephalosporins. Current culture-based lab testing
methods require 48-72 hours to determine if a skin or soft tissue infection
is caused by MRSA or SA. As a result, physicians and surgeons often
prescribe broad-spectrum antimicrobial therapies while awaiting culture
results.

"Millions of patients visit emergency departments and urgent care
clinics each year for treatment of 'staph' infections in skin and
underlying tissue, many caused by MRSA. Because culture-based antibiotic
test results are not available to physicians for several days, physicians
have been forced to make decisions about wound drainage and antibiotic
therapy without having the benefit of supportive laboratory data," said Dr.
Donna Wolk, Division Chief of Clinical Microbiology, College of Medicine;
and Research Associate, BIO5 Institute at The University of Arizona. "Our
clinical trial data show that this new laboratory test makes it possible to
accurately detect a staph infection before a patient is released, and it
provides information to support treatment choices. In addition, the
GeneXpert System supports informed antibiotic choices whereby prescribing
antibiotics of last resort can be reserved for those patients truly
infected with MRSA, therefore, reducing the chances of microbes further
developing antibiotic resistance."

Community Acquired Infections in the ER & Healthcare Acquired Surgical
Site Infections

MRSA and SA infections are national medical concerns that place
millions of lives at risk and add millions of dollars to healthcare costs
each year - both in outpatient, or community-acquired infections, and
in-patient, or surgical site infections acquired within the healthcare
environment.

The Centers for Disease Control recently reported that an estimated 12
million people in the United States seek outpatient medical attention each
year for skin and soft tissue infections, of which MRSA plays a major role.
Significant incremental healthcare costs associated with these infections
are a result of additional follow-up visits, changes in antimicrobial
therapy, and transmission of infections to family members and the
community.

The Institute of Healthcare Improvement reports that about 800,000
surgeries are complicated by infections annually. Cost to the health care
system to treat these infections is estimated at $9.5 billion, largely due
to extended hospital stays following surgery. According to a study
published in Clinical Infectious Diseases, increased length of stay is 18
days following a MRSA infection and 9 days for a SA infection.

Xpert MRSA/SA SSTI delivers actionable test results to assist
physicians and surgeons in selecting accurate treatment plans for improved
patient outcomes, better antimicrobial stewardship, and a reduction in both
community- acquired and healthcare-acquired infections.

About the GeneXpert(R) System Molecular Diagnostic Platform

The GeneXpert(R) System is a closed, self-contained, fully-integrated
and automated platform that represents a paradigm shift in the automation
of molecular analysis, producing accurate results in a timely manner with
minimal risk of contamination. The GeneXpert System is the only system to
combine on- board sample preparation with real-time PCR (polymerase chain
reaction) amplification and detection functions for fully integrated and
automated nucleic acid analysis. The system is designed to purify,
concentrate, detect and identify targeted nucleic acid sequences thereby
delivering answers directly from unprocessed samples. Modular in design,
the GeneXpert System has a variety of configurations to meet the broad
range of testing demands of any clinical environment.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand
molecular diagnostics company that develops, manufactures, and markets
fully- integrated systems for genetic analysis in the clinical, industrial
and biothreat markets. The company's systems enable rapid, sophisticated
genetic testing for organisms and genetic-based diseases by automating
otherwise complex manual laboratory procedures. The company's easy-to-use
systems integrate a number of complicated and time-intensive steps,
including sample preparation, DNA amplification and detection, which enable
the analysis of complex biological samples in its proprietary test
cartridges. Through its strong molecular biology capabilities, the company
is focusing on those applications where rapid molecular testing is
particularly important, such as identifying infectious disease and cancer
in the clinical market; food, agricultural, and environmental testing in
the industrial market; and identifying bio-terrorism agents in the
biothreat market. See http://www.cepheid.com for more information.

This press release contains forward-looking statements that are not
purely historical regarding Cepheid's or its management's intentions,
beliefs, expectations and strategies for the future, including those
relating to product performance and future market opportunities and market
size. Because such statements deal with future events, they are subject to
various risks and uncertainties, and actual results could differ materially
from the company's current expectations. Factors that could cause actual
results to differ materially include risks and uncertainties such as those
relating to: unforeseen manufacturing problems; regulatory developments and
practices regarding testing levels; customer and market acceptance of the
product; the failure of products to perform as expected, whether due to
manufacturing errors, defects or otherwise; the impact of competitive
products and pricing; potentially lengthy sales cycles in some markets;
reimbursement rates for the products; and underlying market conditions
worldwide. Readers should also refer to the section entitled "Risk Factors"
in Cepheid's Annual Report on Form 10-K for 2007 and in its most recent
quarterly report on Form 10-Q, each filed with the Securities and Exchange
Commission.

All forward-looking statements and reasons why results might differ
included in this release are made as of the date of this press release,
based on information currently available to Cepheid, and Cepheid assumes no
obligation to update any such forward-looking statement or reasons why
results might differ.

Cepheid
http://www.cepheid.com

Other news:

ThromboGenics Announces Promising Results Of MITI IV Phase II Trial In The Treatment Of Acute Stroke With Microplasmin

2008-09-30T05:00:00.004-07:00

ThromboGenics NV (Euronext Brussels: THR), a biotechnology company
focused on novel therapies for eye disease, vascular disease and cancer,
announces positive results from its MITI IV Phase II trial to evaluate the
safety and preliminary efficacy of microplasmin when administered
intravenously to acute stroke patients. The trial showed that microplasmin
was generally well tolerated and also provided some interesting preliminary
efficacy data. The overall results of the study were presented by Dr.
Vincent Thijs on September 27 at a Late-Breaking Clinical Trial session at
the World Stroke Congress.

The MITI IV (Microplasmin In Treatment of Ischemic stroke -
IntraVenous) trial was a Phase II, multicentre, randomized, double-blinded,
placebo-controlled, ascending-dose clinical trial evaluating the safety and
preliminary efficacy of the intravenous administration of microplasmin in
40 patients, 4 to 12 hours after onset of acute ischemic stroke. The trial
investigated three dose regimens of microplasmin (2, 3, and 4 mg/kg total
dose) compared to placebo. Clinical outcomes were assessed at seven days
and 30 days post-treatment, and at each of these visits neurological
assessments were performed.

The study found that microplasmin was generally well tolerated with no
evidence of increased bleeding risk; there were no systemic bleeding events
reported and there was no evidence of increased rate of bleeding in
general, in those patients that had been treated with microplasmin compared
to those treated with placebo.

In addition, the study provided some interesting preliminary efficacy
results. Approximately 25% of patients treated with microplasmin had
reperfusion (restoration of blood flow) within eight hours of being
treated, this compares with 10% of placebo-treated patients. Moreover, of
the patients who had more severe vascular blockages, 33% of patients
treated with microplasmin achieved reperfusion compared with 14% of
placebo-treated patients. Due to the small number of patients in this
study, neither of these end points were statistically significant. However,
the study also showed that microplasmin-treated patients had a
statistically significant improvement in the level of damage to the blood
brain barrier compared to placebo-treated patients, measured using the
marker of matrix metalloproteinase (MMP). MMP activation plays a crucial
role in the pathogenesis of brain edema and hemorrhagic transformation
after ischemic stroke.

Professor Vincent Thijs, Lead Principal Investigator of the trial,
commenting on the results said, "I am delighted that we were able to
present these interesting results at the World Stroke Congress. The results
show that microplasmin is safe and generally well tolerated with no
evidence of increased bleeding risk. Moreover, the results also support
previous preclinical studies that have shown that microplasmin is able to
lyse clots and may also have certain vascular protective properties."

Dr. Patrik De Haes, CEO of ThromboGenics, commenting on today's
announcement said: "I am very pleased that we have been able to
successfully conclude this study of microplasmin in patients with stroke.
The results that have been reported show that the product is well tolerated
and could potentially be of benefit in this indication of high medical
need. However, as we have stated previously, our current view is that it
only makes sense for ThromboGenics to move forward with the development of
microplasmin for vascular indications in cooperation with a partner, given
the costs and risks involved. We believe that by focusing on the
development of microplasmin for eye disease, where we have already
generated encouraging clinical data, and carefully utilizing our resources
on the other opportunities in our pipeline, we will continue to generate a
high return for ThromboGenics' shareholders."

About ThromboGenics

ThromboGenics is a biotechnology company focused on the discovery and
development of biopharmaceuticals for the treatment of eye disease,
vascular disease and cancer. The Company has several programs in Phase II
clinical development including microplasmin, which is being evaluated as a
treatment for vitreoretinal disorders and as a thrombolytic agent for
vascular occlusive diseases. ThromboGenics is also developing novel
antibody therapeutics in collaboration with BioInvent International; these
include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403
for cancer.

ThromboGenics has built strong links with the University of Leuven and
the Flanders Institute for Biotechnology (VIB) and has exclusive rights to
certain therapeutics developed at these institutions. ThromboGenics is
headquartered in Leuven, Belgium and has subsidiaries in Dublin, Ireland
and New York, U.S. The Company is listed on Eurolist by Euronext Brussels
under the symbol THR. More information is available at
http://www.thrombogenics.com.

Important information about forward-looking statements

Certain statements in this press release may be considered
"forward-looking". Such forward-looking statements are based on current
expectations, and, accordingly, entail and are influenced by various risks
and uncertainties. The Company therefore cannot provide any assurance that
such forward-looking statements will materialize and does not assume an
obligation to update or revise any forward-looking statement, whether as a
result of new information, future events or any other reason. Additional
information concerning risks and uncertainties affecting the business and
other factors that could cause actual results to differ materially from any
forward-looking statement is contained in the Company's Annual Report.

ThromboGenics NV
http://www.thrombogenics.com

Other news:

Watson Announces Positive Data For RAPAFLO(TM)(silodosin), Its Investigational Product For BPH, At Regional AUA Conferences

2008-09-30T05:00:00.003-07:00

Watson
Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical
company, announced that investigators presented efficacy and safety
data on silodosin, its investigational treatment for benign prostatic
hyperplasia (BPH, or prostate enlargement), at two regional meetings of the
American Urological Association (AUA). The trade name for silodosin will be
RAPAFLO(TM).

These abstracts included results of Phase 3 studies, which showed that
treatment with RAPAFLO for up to one year effectively reduces the symptoms
of BPH and is well tolerated without causing any significant changes in
blood pressure or adverse cardiac effects. Cardiac safety data further
demonstrated that RAPAFLO, used alone or in combination with medications
for erectile dysfunction (ED), showed only minimal effects on blood
pressure or heart rate.

"We are excited by these clinical data as they further support the
strong and sustained efficacy, as well as the safety and tolerability of
RAPAFLO that have been demonstrated in other trials," said Edward Heimers,
Jr., Executive Vice President and President of Watson's Brand Division. "As
a highly selective alpha-1A blocker, we believe that RAPAFLO will address
an important medical need in urology. Earlier this year, the New Drug
Application for RAPAFLO was filed, and we look forward to working with the
U.S., Food and Drug Administration to make this treatment option available
to patients."

Data at the New England Regional AUA

At this year's New England Regional meeting of the AUA, investigators
presented two abstracts on the efficacy and safety of RAPAFLO.

The first abstract was a pooled analysis of two Phase 3 double-blind,
placebo-controlled trials involving 923 generally healthy men ages 50 or
older, with signs and symptoms of BPH, including a peak urine flow rate
(Qmax) between 4 and 15 mL/sec (mean of 8.7 to 8.9) and International
Prostate Symptom Score (IPSS) > or = 13 (mean of 21.3). Patients were
randomized to either 8 mg RAPAFLO once daily (n=466) or placebo (n=457) for
12 weeks.

After 12 weeks of treatment, RAPAFLO significantly improved urinary
symptoms, including IPSS (the primary endpoint), compared to placebo (mean
reduction of -6.4 vs. -3.5, respectively; p

Over the course of 12 weeks, treatment was well tolerated and the
effect on blood pressure was similar between the RAPAFLO and placebo
groups. Incidences of treatment-related dizziness and headache were low.
Adverse events were minimal and were generally mild and related to
retrograde ejaculation (reduced semen). There were no treatment-related
cardiac events or hypertension.

The second abstract included data from a 9-month, open-label extension
trial involving patients who had successfully completed the two previous
12-week, Phase 3 trials. A total of 661 patients were enrolled to receive
RAPAFLO 8 mg once daily for an additional 40 weeks; 435 (65.8%) completed
the extension study. A safety evaluation was based on adverse events, vital
signs and clinical laboratory tests, electrocardiography (ECG), and
physical examinations. An efficacy endpoint was change in IPSS at 40 weeks.

All 661 patients were included in the safety evaluation. Over the
course of one-year of treatment, RAPAFLO was shown to be safe and well
tolerated. Sixty-five percent (65.2%) of all patients reported at least one
adverse event; less than one third of these (28.4%) were drug related.
There were no serious drug-related adverse events. RAPAFLO was not
associated with any clinically meaningful changes in blood pressure,
clinical laboratory parameters, ECG results, or physical examination
findings. Retrograde ejaculation (reduced semen) was the most common
adverse event, though it rarely leads to drug discontinuation.

In the evaluable population of 429 (64.9%) patients, the IPSS decreased
by a mean of 3.1 points between weeks 0 and 40. Although the change was
larger (mean .4.4 points) in patients previously given placebo, the total
score also decreased (mean .1.6 points) in patients previously treated with
RAPAFLO. Treatment with RAPAFLO for up to one year also reduced IPSS
irritative subscore (-1.7 points in patients previously on placebo and -0.6
in patients continuing RAPAFLO) and obstructive subscore (-2.7 in patients
previously on placebo and -1.0 in patients continuing RAPAFLO).

Data at the Mid Atlantic Regional AUA

A placebo-controlled, open-label, crossover trial, presented at the Mid
Atlantic Regional meeting, evaluated the concomitant use of RAPAFLO with
the maximum doses of sildenafil or tadalafil, two agents commonly used to
treat ED.

In the study, 22 healthy men (ages 45 to 78 years) received 8 mg
RAPAFLO once daily for 21 days. On days 7, 14, and 21, subjects randomly
received a single dose of 100 mg sildenafil, 20 mg tadalafil, or placebo.
Resting (baseline) and standing orthostatic measurements were performed 0h
(predose) to 12h after single-dose treatment. A positive orthostatic test
was defined as a decrease in systolic (or diastolic) blood pressure by >30
(or >20) mm Hg, increased heart rate (>20 bpm), or orthostatic symptoms on
change of position, such as dizziness.

Overall, concomitant use of RAPAFLO and maximum doses of sildenafil or
tadalafil in healthy men caused no symptomatic changes in blood pressure,
heart rate, or orthostatic symptoms. The cumulative number of positive
orthostatic tests was similar for all treatments -- in 16 subjects or
= 65 years (sildenafil, 6; tadalafil, 8; placebo 5).

"These data provide important new evidence about this potential
treatment option for BPH. Considering that many men with BPH also have
other co-morbid conditions, including erectile dysfunction, heart failure,
hypertension and coronary artery disease, it's important to find
complementary treatments that can be used with other medications without
deleterious cardiovascular interactions, including the prolongation of the
QTc interval and do not complicate patient care," said Norman Lepor, M.D.,
a cardiologist and associate clinical professor of medicine, University of
California, Los Angeles (UCLA) and attending cardiologist at the Heart
Institute at Cedars-Sinai Medical Center.

About RAPAFLO(TM) (silodosin)

RAPAFLO is a highly selective alpha-1 adrenergic receptor antagonist
under development in the US for the treatment of the signs and symptoms of
benign prostatic hyperplasia (BPH). RAPAFLO binds with high affinity to the
alpha (1A) receptors in the prostate causing the smooth muscles in these
tissues to relax, resulting in an improvement in urine flow and a reduction
in BPH symptoms. The binding affinity for the alpha (1B) receptors that
cause smooth muscle relaxation and blood pressure effects in the
cardiovascular system is significantly lower, thereby maximizing target
organ activity for treating BPH while minimizing the potential for blood
pressure effects. RAPAFLO was originally developed by Kissei Pharmaceutical
Co., Ltd. in Japan and licensed to Watson for the US, Canada and Mexico
markets.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading
specialty pharmaceutical company that develops, manufactures, markets,
sells and distributes brand and generic pharmaceutical products. Watson
pursues a growth strategy combining internal product development, strategic
alliances and collaborations and synergistic acquisitions of products and
businesses.

The mission of Watson Urology is to offer products and services that
improve the quality of patients' lives, and satisfy the needs of physicians
who specialize in the diagnosis, management, and treatment of urological
disorders. By advancing education and support for urological diseases, we
are creating the differences that make life more livable.

In the U.S., the Watson portfolio includes: Oxytrol(R); TRELSTAR(R) LA;
TRELSTAR(R) Depot; Androderm(R); ProQuin(R) XR, under a co-promotion
agreement with Depomed, Inc.; and AndroGel(R), under a co-promotion
agreement with Solvay Pharmaceuticals, Inc. The Watson portfolio also
includes a number of products under development including: silodosin, a
product under development for the treatment of benign prostatic
hyperplasia; a six-month formulation of TRELSTAR(R) (triptorelin pamoate
for injectable suspension), under development for the treatment of advanced
prostate cancer; and OTG, under development for overactive bladder.

For press releases and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.

Forward Looking Statement

Any statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements that
reflect Watson's current perspective of existing trends and information as
of the date of this release. Except as expressly required by law, Watson
disclaims any intent or obligation to update these forward-looking
statements. Actual results may differ materially from Watson's current
expectations depending upon a number of factors affecting Watson's
business. These factors include, among others, the difficulty of predicting
the timing or outcome of product development efforts and FDA or other
regulatory agency approvals or actions, if any; whether the results of
clinical trials for silodosin and other information will be sufficient to
support approval by FDA or other regulatory authorities; the impact of
competitive products and pricing; market acceptance of and continued demand
for Watson's products, including silodosin; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in Watson's
periodic public filings with the Securities and Exchange Commission,
including but not limited to Watson's Annual Report on Form 10-K for the
year ended December 31, 2007.

Watson Pharmaceuticals, Inc.
http://www.watsonpharm.com

View drug information on Androderm; AndroGel testosterone gel; Oxytrol.

Other news:

NeoVista Unveils 18 Month Data On Novel Wet AMD Therapy At Retina Society Meeting

2008-09-30T05:00:00.002-07:00

NeoVista, Inc. made public
yesterday 18-month data from the company's Phase II feasibility study
examining its novel epiretinal brachytherapy for treatment of the wet form
of age-related macular degeneration (AMD) at the 41st Scientific Meeting of
the Retina Society. The long-term data from the study, which was initiated
to test the safety and efficacy of their therapy when used in conjunction
with Avastin(R) (bevacizumab), showed a marked advancement in mean visual
acuity results at month 18, while only a limited number of patients
required additional injections of Avastin.

"We're very delighted with the latest data from our Phase II study, as
not only did the visual acuity improve in our patients over the long-term,
but very few patients received additional injections as well," said John N.
Hendrick, President and CEO of NeoVista. "The ultimate pledge of this
therapy continues to be demonstrated as the long-term data hold promise in
minimizing the treatment burden both for patients and physicians, not to
mention the overall financial burden for the healthcare system."

NeoVista's revolutionary therapy applies a targeted dose of beta
radiation to the leaking blood vessels that affect central vision;
concomitantly, two injections of an antivascular endothelial growth factor
(anti-VEGF) agent are delivered to maximize the acute therapeutic response.
Preliminary data show that NeoVista's targeted radiation therapy can be
safe for both the patient and the physician, and may be able to restore the
patient's vision. The current standard of care for wet AMD requires
persistent injections of anti-VEGF drugs for an indefinite period.

The ongoing multicenter feasibility study enrolled 34 trial
participants (with a mean age of 72 years) from June 2006 to April 2007 at
two centers in Brazil and one in Mexico. These patients, with predominantly
classic, minimally classic, or occult (with no classic) choroidal
neovascularization (CNV), received a single 24 Gy treatment of NeoVista's
epiretinal brachytherapy in combination with two intravitreal injections of
Avastin, one dose prior to or at the time of radiation delivery and another
one month later, depending on which arm of the trial the patient was
enrolled in. Additional therapy was delivered based upon the investigator's
evaluation of disease activity.

Analysis of 18-month follow-up on the first 25 trial participants to
reach that milestone shows a mean improvement in visual acuity of 10.7
letters using the Early Treatment Diabetic Retinopathy Study (ETDRS) test;
96 percent of patients lost 15 letters or fewer, 76 percent gained some
letters, 44 percent gained 15 or more letters, and 8 percent gained 30 or
more letters. Of particular interest, 68 percent of the patients in the
study did not require additional injections of Avastin throughout the
18-month period and the average number of additional injections within this
subset was only 2.4 injections by month 18.

Most of the limited number of adverse events were related to the
vitrectomy procedure (retinal tear, retinal detachment, subretinal
hemorrhage, and vitreous hemorrhage), rather than the epiretinal
brachytherapy. To date, no instances of radiation toxicity have been
reported by the Doheny reading center.

The data were presented at the Retina Society Meeting by Nelson R.
Sabates, MD, Professor and Chairman, Department of Ophthalmology,
University of Missouri-Kansas City (UMKC) School of Medicine and the lead
investigator in NeoVista's ongoing Phase III study, CABERNET (CNV Secondary
to AMD Treated with BEta RadiatioN Epiretinal Therapy).

"The data released demonstrate that NeoVista's concomitant approach has
the potential to offer patients a less frequent treatment option that is
just as effective, if not more effective, than the current standard of
care," said Dr. Sabates. "It's highly encouraging to continually see
patient outcomes improving as the study progresses."

In contrast to other forms of radiation therapy for wet AMD, NeoVista's
approach delivers the peak dose of energy directly to the lesion without
damaging the normal retinal vasculature. Utilizing strontium 90, the
focused energy is delivered to a target area up to 3 mm in depth and up to
5.4 mm in diameter. Importantly for patients, the systemic exposure to
radiation is minimal, as the effective dose to the entire body from
NeoVista's epiretinal device is less than that from a typical chest x-ray.

With the continued promise of these Phase II trial results, NeoVista
continues to enroll patients in the company's pivotal trial, CABERNET.
CABERNET is a multicenter, randomized, controlled study that will enroll
450 subjects at 45 sites worldwide, evaluating the safety and efficacy of
NeoVista's epiretinal brachytherapy delivered concomitantly with the
FDA-approved anti-VEGF therapy Lucentis(R) (ranibizumab) versus Lucentis
alone.

"The Royal National Institute of Blind People (RNIB) welcomes the
results of the Phase II study for NeoVista's therapy, which may increase
the treatment options for people with wet AMD," said Barbara McLaughlan,
RNIB Campaigns Manager for Eye Health and Social Care. "It is our hope that
these results are confirmed in the Phase III trial that is now being
conducted as wet AMD is the leading cause of sight loss in the UK and
patients need a variety of choices of proven treatments to be available in
the National Health Service so they can choose the therapy that's best for
them."

About NeoVista, Inc.

NeoVista, Inc. is a privately held development-stage medical device
company based in Fremont, California. NeoVista's epiretinal beta radiation
therapy is currently being studied in a definitive Phase III clinical study
to support eventual filing for regulatory approval to market the product in
the United States. For more information about the company, the clinical
trial or this novel wet AMD therapy, please visit the company's Web site at
http://www.neovistainc.com.

NeoVista, Inc
http://www.neovistainc.com

View drug information on Avastin; Lucentis.

Other news:

Synvista Therapeutics Receives Approval To Begin Phase 2 Trial Of Topical SYI-2074 In Psoriasis

2008-09-30T05:00:00.001-07:00

Synvista
Therapeutics, Inc. (Amex: SYI) announces that it has received approval from
the Israeli Ministry of Health to begin a Phase 2 trial of a topical
formulation of SYI-2074 in mild-to-moderate plaque psoriasis. The trial is
expected to begin enrollment in the fourth quarter of 2008 at three sites
in Israel, and is designed to enroll a total of 30 patients in a
randomized, placebo-controlled study. Top-line results are expected in the
first quarter of 2009.

Previously, it has been reported that SYI-2074 blocks TNF-alpha
activated expression of cell adhesion molecules, I-CAM and V-CAM, which may
be essential for cellular migration. The TNF-alpha signaling pathway is an
established target for drug development in psoriasis and other autoimmune
diseases. As a topical, SYI-2074 is not expected to have the side effects
associated with systemic treatment using anti-TNF agents.

Noah Berkowitz, M.D., President and Chief Executive Officer of Synvista
said, "There have been successfully developed drugs that also interfere
with TNF-alpha signaling, but these similar drugs are given as injections
and are indicated for more severe forms of psoriasis. We believe that a
topical drug will provide patients with an important alternative in the
treatment of this disease."

About Psoriasis

According to the National Institutes of Health as many as 7.5 million
Americans have psoriasis, a non-contagious, lifelong skin disease. The most
common form, plaque psoriasis, appears as raised, red patches or lesions
covered with a silvery white buildup of dead skin cells, called scale.
Psoriasis varies from person to person, both in severity and how it
responds to treatment. Psoriasis is now recognized to be a disease that can
be modified by drugs that inhibit TNF-alpha signaling. Current treatment
for severe psoriasis includes biologic drugs that are costly, potentially
toxic, and require intravenous administration. In addition, steroids often
work for patients with mild-to-moderate psoriasis, yet they carry side
effects and are generally not recommended for long-term use.

About Synvista Therapeutics

Synvista Therapeutics is a biopharmaceutical company developing
diagnostics and drugs to diagnose, treat and prevent cardiovascular disease
in people with diabetes. The Company has developed a clinical diagnostic
test for Hp2-2 Diabetes. The genetic or protein form of this test can be
used to identify diabetic patients at high risk for cardiovascular
complications. These patients may benefit from a particular formulation of
vitamin E. The Company is also developing a kit to measure CML
(carboxy-methyllysine), another potential cardiovascular risk marker.

Synvista Therapeutics is developing oral antioxidant drugs to treat the
HDL dysfunction seen in Hp2-2 Diabetes, a disease affecting almost 7
million patients in the United States. The Company is also developing
alagebrium, a proposed breaker of advanced glycation endproducts (AGEs) for
the treatment of systolic and diastolic heart failure. Diastolic heart
failure represents a rapidly growing market of unmet medical need,
particularly common among diabetic patients. Alagebrium has demonstrated
relevant clinical activity in two Phase 2 clinical trials in heart failure,
as well as in animal models of heart failure and nephropathy, among others.
Alagebrium has been tested in approximately 1,000 patients in multiple
Phase 1 and Phase 2 clinical trials, allowing Synvista Therapeutics to
assemble a sizeable human safety database.

For more information, please visit the Company's Web site at
http://www.synvista.com.

Any statements contained in this press release that relate to future
plans, events or performance are forward-looking statements that involve
risks and uncertainties including, but not limited to, the risks associated
with the events described in this press release, future clinical
development of Synvista Therapeutics' diagnostic tests and product
candidates, and other risks identified in Synvista Therapeutics' filings
with the Securities and Exchange Commission. Further information on risks
faced by Synvista are detailed under the caption "Risk Factors" in Synvista
Therapeutics' Annual Report on Form 10-K for the year ended December 31,
2007. These filings are available on a website maintained by the Securities
and Exchange Commission at http://www.sec.gov. The information contained in
this press release is accurate as of the date indicated. Actual results,
events or performance may differ materially. Synvista Therapeutics
undertakes no obligation to publicly release the result of any revision to
these forward- looking statements that may be made to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.

Synvista Therapeutics, Inc.
http://www.synvista.com

Other news:

Potentia Pharmaceuticals Announces Positive Safety Data And Study Expansion In Phase I Trial For Lead Drug Candidate POT-4

2008-09-30T05:00:00.000-07:00

Potentia Pharmaceuticals, a
privately held biotechnology company developing medicines for the treatment
of age-related macular degeneration (AMD) announced that the
Company's leading drug candidate, POT-4, has shown early positive safety
results in its Phase I study. POT-4 is a complement inhibitor, which shuts
down the complement activation cascade that could otherwise lead to local
inflammation, tissue damage and upregulation of angiogenic factors such as
vascular endothelial growth factor (VEGF). Based on this mechanism of
action, POT-4 holds the potential to be effective against both dry and wet
AMD.

"POT-4 has generated encouraging safety and tolerability data in this
Phase I study and holds significant promise as a novel agent for treating
AMD; a debilitating condition for which there is no cure," said Cedric
Francois, President and CEO of Potentia. "As a result of the favorable
early data, it was decided to expand the trial to permit further dose
escalation, with the goal of prolonging the pharmacological benefit from
POT-4. Potentia looks forward to the presentation of the Phase I data at a
future medical conference and, with additional information gained from the
extension of the study, to the initiation of Phase II trials in the
future."

About AMD

AMD is the leading cause of blindness in the elderly of the western
world and affects more than 10 million patients in the United States alone.
The current standard of care for AMD relies primarily on angiogenesis
inhibitors, an approach geared towards the approximately 10-15% of AMD
patients with complications resulting from ocular angiogenesis (growth of
new blood vessels and bleeding in the back of the eye). No drug currently
on the market has been approved for the treatment of the remaining
patients, who suffer from the so-called "dry" form of the disease.

About the Complement System and POT 4

Complement activation is an inflammatory process involving dozens of
plasma proteins, ultimately leading to cell membrane disruption through the
membrane attack complex (MAC). Activation of the complement system is an
important part of the body's defensive immune response against pathogens
such as bacteria and viruses. In spite of its defensive function,
inappropriate or excessive complement activation can have destructive
consequences if left unchecked. Over the past three years, multiple
scientific publications have strongly linked variants of genes encoding
components of the complement system with a predisposition toward AMD.

POT-4 binds tightly to complement component C3, preventing its
participation in the complement activation cascade. As C3 is the central
component of all major complement activation pathways, its inhibition
effectively shuts down downstream complement activation that could
otherwise lead to local inflammation, tissue damage and upregulation of
angiogenic factors such as vascular endothelial growth factors (VEGF).

About Potentia

Potentia Pharmaceuticals, Inc. is an early stage biotechnology company
focused on developing novel therapeutics and drug delivery technologies to
address chronic inflammatory diseases, with an initial emphasis on diseases
of the eye such as age-related macular degeneration.

Potentia Pharmaceuticals, Inc.
http://www.potentiapharma.com

Other news:

VEGF Trap-Eye Final Phase 2 Results In Age-related Macular Degeneration Presented At 2008 Retina Society Meeting

2008-09-29T14:00:00.000-07:00

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare AG announced that VEGF Trap-Eye achieved durable improvements in visual acuity and in biologic measures of neovascular disease, including retinal thickness and active choroidal neovascularization lesion size, for up to one year in a Phase 2 study in the neovascular form of Age-related Macular Degeneration (wet AMD). The results were reported today in two oral presentations at the 2008 annual meeting of the Retina Society in Scottsdale, Arizona. Slides, including data reported at the presentations, are available on the Regeneron website (http://www.regeneron.com on the Presentations Page, under the Investor Relations section).

In this double-masked Phase 2 trial, patients were initially treated with either fixed monthly or quarterly dosing for 12 weeks and then continued to receive treatment for another 40 weeks on a PRN (as needed) dosing schedule. Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p

Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 mg for 12 weeks followed by PRN dosing also achieved mean decreases in retinal thickness versus baseline of 143 microns (p

While PRN dosing following a fixed quarterly dosing regimen (with dosing at baseline and week 12) also yielded improvements in visual acuity and retinal thickness versus baseline at week 52, the results generally were not as robust as those obtained with initial fixed monthly dosing.

"Anti-VEGF therapy has dramatically changed the treatment paradigm for wet AMD, and improvement in visual acuity is now feasible in most patients. The biggest challenge we have is that with our current drugs, the majority of patients need frequent injections into their eye to maintain their visual acuity gains," stated David M. Brown, M.D., a study investigator and a retinal specialist at The Methodist Hospital in Houston. "These study results reinforce our interest in further exploring whether continued administration of VEGF Trap-Eye on an as-needed basis after an initial period of fixed dosing can maintain a durability of effect over time in controlled Phase 3 clinical studies."

In this Phase 2 study VEGF Trap-Eye was also associated with a reduction in the size of the total active choroidal neovascular membrane (CNV), the active lesion that is the underlying cause of vision loss in patients with wet AMD. Patients initially receiving either a 2.0 mg or 0.5 mg monthly fixed dose of VEGF Trap-Eye for 12 weeks followed by PRN dosing experienced statistically significant 3.41 mm2 and 1.42 mm2 reductions in mean CNV size at 48 weeks (the final one-year analysis from the independent reading center) versus baseline, respectively. Patients in the 2.0 mg monthly cohort also achieved a statistically significant 1.75 mm2 reduction in total lesion size. A reduction in total lesion size was not seen in the cohort initially dosed with 0.5 mg monthly.

"Progression of the active CNV lesion and resulting vision impairment are inevitable consequences of untreated wet AMD. The reduction in total active CNV lesion size achieved with VEGF Trap-Eye treatment in this Phase 2 clinical study could potentially translate into clinically meaningful outcomes in the larger, controlled Phase 3 studies that are underway," stated Jason Slakter, M.D., head of the independent reading center for the study and a Clinical Professor of Ophthalmology, New York University School of Medicine, New York.

VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. There was one reported case of culture-negative endophthalmitis/uveitis in the study eye, which was deemed not to be drug-related. The most common adverse events were those typically associated with intravitreal injections.

"These study results confirm the rationale for our Phase 3 clinical program for VEGF Trap-Eye in wet AMD," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "These trials are designed to optimize improvement in visual acuity with fixed-dosing regimens of either every 4 weeks or every 8 weeks for one year and then study how these vision improvements can be maintained with as-needed dosing in the second year."

About the Phase 2 Study in Wet AMD

In the double-masked, prospective, randomized, multi-center Phase 2 trial, 157 patients were randomized to five dose groups and treated with VEGF Trap-Eye in one eye. Two groups initially received monthly doses of 0.5 or 2.0 milligrams (mg) of VEGF Trap-Eye (at weeks 0, 4, 8, and 12) and three groups received quarterly doses of 0.5, 2.0, or 4.0 mg of VEGF Trap-Eye (at baseline and week 12). Following the initial 12-week fixed-dosing phase of the trial, patients continued to receive therapy at the same dose on a PRN dosing schedule based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria. Patients were monitored for safety, retinal thickness, and visual acuity. The primary endpoint results from the fixed dosing period were presented at the 2007 Retina Society conference in September 2007. Week 32 results were presented at the 2008 Association for Research in Vision and Ophthalmology annual meeting in April 2008.

About the Phase 3 Program in Wet AMD

Regeneron and Bayer HealthCare initiated a Phase 3 global development program for VEGF Trap-Eye in wet AMD in August 2007. In two Phase 3 trials, the companies are evaluating VEGF Trap-Eye dosed 0.5 mg every 4 weeks, 2 mg every 4 weeks, or 2 mg every 8 weeks (following three monthly doses) in direct comparison with ranibizumab (Lucentis®, a registered trademark of Genentech, Inc.) administered 0.5 mg every 4 weeks according to its U.S. label during the first year of the studies. PRN dosing will be evaluated during the second year of each study. The VIEW1 study is currently enrolling patients in the United States and Canada and the VIEW2 study is currently enrolling patients in Europe, Asia Pacific, Japan, and Latin America. The companies are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, diabetic eye diseases, and other eye diseases and disorders. Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

About VEGF Trap-Eye

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye, which lead to the development of wet AMD. The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. Blockade of VEGF, which can prevent abnormal blood vessel formation and vascular leak, has proven beneficial in the treatment of wet AMD.

About Wet AMD

Age-related Macular Degeneration (AMD) is a leading cause of acquired blindness. Macular degeneration is diagnosed as either dry (nonexudative) or wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating blind spots in central vision, and it can account for blindness in wet AMD patients. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.

About Regeneron Pharmaceuticals, Inc.

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron's web site at http://www.regeneron.com.

Forward Looking Statement

This news release discusses historical information and includes forward-looking statements about Regeneron and its products, development programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of Regeneron's drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize its product and drug candidates, competing drugs that are superior to Regeneron's product and drug candidates, uncertainty of market acceptance of Regeneron's product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including Regeneron's agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2007 and Form 10-Q for the quarter ended June 30, 2008. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.

Regeneron Pharmaceuticals, Inc.

View drug information on Lucentis.

Other news:

Is It Ethical To Include Pregnant Women In Research?

2008-09-29T05:00:00.001-07:00

Why aren't pregnant women included in most clinical trials?

That's the question posed by leading bioethicists at Duke University Medical Center, Johns Hopkins and Georgetown Universities, who say it's time to confront the challenges that have led to the exclusion of pregnant women from important research that could positively impact maternal and fetal health.

"Only in the last two decades did people recognize that women were being excluded not just from the risks, but from the benefits of research -- primarily because of their potential to become pregnant or because of concerns that female physiology - such as menstrual cycles - might complicate study results," says Anne Drapkin Lyerly, MD, an obstetrician/gynecologist and medical ethicist at Duke.

She is the lead author of a paper appearing online and then in print in the November 2008 edition of the International Journal of Feminist Approaches to Bioethics detailing the justifications for responsibly including pregnant women in research. "While we've made significant progress in correcting the gender imbalance, we have a long way to go in protecting the health and safety of pregnant women and the fetuses they carry."

The Institute of Medicine has recommended that pregnant women be "presumed eligible" for participation in research since 1994. However, the authors say the "delicate condition" continues to be grounds for near-automatic exclusion from research, despite the need for more effective treatment for women during pregnancy

More than four million women give birth in the U.S. each year, and many face medical conditions during their pregnancies that require clinical treatment. In fact, Lyerly says chronic diseases occurring during pregnancy are common: chronic hypertension and diabetes complicate nearly four percent of pregnancies each year; and an estimated 500,000 pregnant women experience psychiatric illness, cancers, autoimmune diseases and other conditions that require treatment. But in the absence of research on how medications work in pregnant women, doctors are often left guessing about how to safely and effectively treat patients through pregnancy.

"Our best predictions when it comes to dosing medications can be disastrously wrong," says Lyerly. "This conservative stance doesn't help anybody. Without adequate research on how drugs are metabolized during pregnancy, how they are absorbed, distributed in and excreted by the body, whether they cross the placenta or affect the fetus, we have little to no evidence on how to optimize the health of pregnant women or the fetuses they carry."

Lyerly and her colleagues at Johns Hopkins University's Berman Institute of Bioethics and Georgetown University clearly recognize the many challenges that need to be addressed in order to safely include pregnant women in clinical research. In fact, they are convening a meeting with officials from the FDA, NIH and leading experts in obstetrics, gynecology and maternal/fetal medicine next year to address these issues and come up with practical, public policy and moral solutions.

"It's not simply a matter of including pregnant women in studies," Lyerly explains. "We need to address what we need to do to ensure maternal and fetal safety, which diseases we should study first, and what we should do when pharmaceutical companies or institutions say no."

Lyerly's co-authors on this paper are Margaret Little, a senior research fellow at Georgetown University's Kennedy Institute of Ethics, and Ruth Faden, executive director of the Johns Hopkins Berman Institute of Bioethics.

Source: Debbe Geiger

Duke University Medical Center

Other news:

Promising New TB Drug Receives Phase 2 SBIR

2008-09-29T05:00:00.000-07:00

Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat infectious diseases of epidemic potential, has announced that it received a $2.3 million, three-year Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) for the development of SQ641, a promising new tuberculosis (TB) drug with potential to provide early and prolonged bacterial clearance during the intensive phase of TB treatment.

The Phase 2 SBIR grant will fund the conduct of several IND-related critical path studies, including delivery optimization in vivo.

Dr. Carol Nacy, CEO of Sequella said, "The NIH is a model example of how strong public/private partnerships help advance new infectious disease therapies into the drug pipeline and we thank them for this grant support. SQ641 is a potentially powerful antitubercular compound with a unique target of action. The SBIR grant award is scientific validation of our research and development efforts to identify important new drugs for diseases of concern to the global health community."

Results of the completed Phase 1 SBIR grant demonstrated that SQ641 has superior in vitro activity against Mycobacterium tuberculosis compared to all other TB drugs. It has a unique mechanism of action and a unique target, the translocase 1 (TL-1) enzyme, which is not the target of any existing antitubercular. In addition, SQ641 possesses exceptional activity against all members of the Mycobacteria family of bacteria, including M. tuberculosis, M. avium complex, and other pathogenic nontubercular Mycobacteria.

About SQ641

SQ641 is the lead drug candidate from a 7000-compound library of semi-synthetic TL-1 inhibitors developed as potential treatments for TB or bacterial pneumonia (Streptococcus pneumoniae). The compound inhibits TL-1, an enzyme required for cell wall synthesis in all bacteria, including Mycobacteria. Sequella licensed the compound library from Daiichi-Sankyo (November 2004). Daiichi-Sankyo identified the compound class and performed extensive research and preliminary preclinical development on several drug leads. Sequella has exclusive rights to the series of TL-1 inhibitors for the treatment of TB and all other indications for nearly every worldwide market.

About Sequella

Sequella is a clinical stage biopharmaceutical company focused on commercializing improved treatments for infectious diseases of epidemic potential. The company leverages its global influence, R&D platforms and infectious disease expertise to proactively address emerging health threats. Through focused execution, clear commercialization pathways, and strategic partnerships, Sequella intends to commercialize a broad product portfolio designed to treat global health threats with significant market opportunity.

About the NIH and NIAID

The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/. National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research - at NIH, throughout the United States, and worldwide - to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.

Forward-Looking Statement

This press release contains forward-looking statements that are subject to risks and uncertainties, and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Sequella disclaims any intent or obligation to update forward-looking statements, except as required by law. Additionally, the project described above is supported by Award Number RA44A1066442 from the National Institute of Allergy and Infectious Diseases. The content of this release does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.

Source: Alicia Moran

Sequella

Other news:

Bioheart Reports Promising Results From Preclinical Study Of Adipose Derived Acute Cell Therapy

2008-09-27T05:00:00.001-07:00

A preclinical study involving
the injection of adipose-derived stem cells (ADSCs) into the myocardium
(heart muscle tissue) of infarcted rats, was recently completed at the
Jordan University of Science and Technology in Irbid, Jordan by medical and
veterinary doctors from that institution and the University of Jordan in
Amman, Jordan.

The study, led by Mahmoud Abu-Abeeleh, MD, Assistant Professor of
Cardiac Surgery, University of Jordan School of Medicine, Amman-Jordan,
showed evidence of regeneration of cardiomyocytes (heart cells) subsequent
to injection of ADSCs following heart attack, or acute myocardial
infarction (AMI). The study consisted of 99 nude rats* randomized into one
of six treatment arms (including a control group receiving
injection-vehicle containing cell media only). ADSCs for the treatment
groups were obtained from humans using the TGI 100 Cell Isolation System
for collection of endothelial progenitor cells (bone-marrow derived cells)
and stem cells from adipose (fat) tissue. Bioheart has secured an
exclusive, worldwide license to, upon commercial approval, sell or lease
the more advanced TGI 1200 System, manufactured by Tissue Genesis, Inc. for
the treatment of AMI.

Upon histological analysis, the control group animals showed a tendency
toward granular tissue formation (scar formation), active phagocytosis
(removal of pathogens or dead cells), variable angiogenesis (new blood
vessel formation) when evaluated at 10 days, early fibrosis (fibrous
connective tissue formation) when evaluated at 30 days and, in some cases,
established fibrosis when evaluated at 60 days. The treatment arms,
however, showed a tendency toward cardiomyocyte regeneration, prominent
angiogenesis (growth of new blood vessels) when evaluated at 10 days, and
reduction in the infarction size when evaluated at 60 days. In some of the
treated animals, minimal scarring area was observed when compared to the
control group, with as much as a 90 percent reduction in myocardial scar
size versus the average scar size of the control group.

Nude rats lack an immune system, which allows for the use of human
cells in preclinical studies.

These results are indicative of cardiomyocyte regeneration and suggest
that the injection of ADSCs after AMI may have the potential to help the
infarcted heart return to normal function.

"The study data suggest that injection of adipose-derived stem cells
decreased the amount of damage from myocardial infarction by assisting in
the formation of functional myocardial cells," said Dr. Abu-Abeeleh. "This
is a significant and encouraging finding, which adds to the growing body of
investigational evidence of using adipose-derived stem cells in the
treatment of heart attacks and warrants further study of Bioheart's Acute
Cell Therapy."

Fat tissue is an abundant and readily available source of endothelial
progenitor and adult stem cells and is easily extractable from a patient
using mildly invasive techniques.

The advanced TGI 1200 System is a compact, fully automated cell
isolation system for the rapid processing of patient-derived fat tissue to
separate, isolate and produce large yields of endothelial progenitor cells
and stem cells. Tissue Genesis, Inc., is currently seeking certification to
apply the CE Mark for commercial sale and distribution of the TGI 1200 as a
tissue processing system within the European Union. The study, sponsored by
Bioheart, Inc., was organized by the Philadelphia BioMed Product
Development Centre, an indirect wholly owned subsidiary affiliated with a
member of Bioheart's Board of Directors. Study objectives included
assessment of the distribution and phenotype of the transplanted ADSCs and
complete macroscopic exam and histopathology of selected tissues in a total
of six differentiated study groups of approximately 15 subjects each.

A proposed pathway for seeking regulatory approval of Bioheart Acute
Cell Therapy using the TGI 1200 System has been developed and additional
preclinical studies involving pigs, testing for the safety and efficacy of
the therapy, commenced in the first quarter of 2007 at Indiana University.

"We are very proud of our pre-clinical work with adipose-derived stem
cells," said Howard J. Leonhardt, Bioheart CEO and Chief Technology
Officer. "We hope that this and other pre-clinical studies will allow us to
obtain IND approval for the start of a human clinical trial involving these
cells for use in patients soon after they have a heart attack."

"The results of these Bioheart preclinical studies affirm our belief
that the adipose-derived cells isolated from adipose tissue by the TGI
System have the potential to assist in the treatment of a variety of
medical conditions, including heart attacks," said Anton C. Krucky,
President and CEO, Tissue Genesis, Inc. "We are excited to be associated
with the foundational work of Bioheart in this area of potential heart
treatment."

ABOUT ACUTE MYOCARDIAL INFARCTION

Acute myocardial infarction (heart attack), results from the sudden
deprivation of circulating blood to the myocardium (heart). This results
from the clogging of an artery, potentially due to a build-up of
cholesterol in the inner wall of blood vessels that distribute blood to the
heart muscle, or thrombosis (clot). This can lead to a part of the heart
muscle becoming permanently damaged, resulting in some death of myocardial
tissue (necrosis). Each year, more than one million people in the United
States suffer a heart attack.

ABOUT BIOHEART, INC.

Bioheart, Inc. (Nasdaq: BHRT) is committed to delivering intelligent
devices and biologics that help monitor, diagnose and treat heart failure
and cardiovascular diseases. Its goals are to improve a patient's quality
of life and reduce health care costs and hospitalizations. Specific to
biotechnology, Bioheart is focused on the discovery, development and,
subject to regulatory approval, commercialization of autologous cell
therapies for the treatment of chronic and acute heart damage. Its lead
product candidate, MyoCell(R), is an innovative clinical muscle-derived
stem cell therapy designed to populate regions of scar tissue within a
patient's heart with new living cells for the purpose of improving cardiac
function in chronic heart failure patients. The Company's pipeline includes
multiple product candidates for the treatment of heart damage, including
Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem
cell treatment for acute heart damage, and MyoCell(R) SDF-1, a therapy
utilizing autologous cells that are genetically modified to express
additional potentially therapeutic growth proteins. For more information on
Bioheart, visit http://www.bioheartinc.com.

ABOUT TISSUE GENESIS, INC.

Tissue Genesis, Inc. (http://www.tissuegenesis.com) is a leader in adipose
(fat) derived regenerative medicine solutions to address a wide range of
therapeutic needs including vascular, cardiovascular, and other
regenerative medical applications. The company expects its technology,
expertise and products to isolate autologous adipose-derived regenerative
cells at the point of care for immediate patient needs. Through its
business partners, such as Bioheart, the company is extending the
development and application of its technology and platform products to
reach worldwide markets in the potential wide use of cell therapy.

Forward Looking Statements:

Except for historical matters contained herein, statements made in this
press release are forward-looking and are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Without
limiting the generality of the foregoing, words such as "may", "will",
"to", "plan", "expect", "believe", "anticipate", "intend", "could",
"would", "estimate", or "continue" or the negative other variations thereof
or comparable terminology are intended to identify forward-looking
statements.

Investors and others are cautioned that a variety of factors, including
certain risks, may affect our business and cause actual results to differ
materially from those set forth in the forward-looking statements. These
risk factors include, without limitation, (i) our ability to secure
additional financing; (ii) the timely success and completion of our
clinical trials; (iii) the occurrence of any unacceptable side effects
during or after preclinical and clinical testing of our product candidates;
(iv) regulatory approval of our product candidates;(v) our dependence on
the success of our lead product candidate; (vi) our inability to predict
the extent of our future losses or if or when we will become profitable;
(vii) our ability to protect our intellectual property rights; (viii) our
inability to predict the extent of our future losses or if or when we will
become profitable; and (viii) intense competition. The company is also
subject to the risks and uncertainties described in its filings with the
Securities and Exchange Commission, including the section titled "Risk
Factors" in its Annual Report on Form 10-K for the year ended December 31,
2007, as amended by Amendment No. 1 on Form 10-K/A and its quarterly report
on Form 10-Q for the quarters ended March 31, 2008 and June 30, 2008.

Bioheart, Inc.
http://www.bioheartinc.com

Other news:

Established Safety Profile Of Spiriva Confirmed By 30 Rigorously Controlled Clinical Trials And The Landmark Trial UPLIFT

2008-09-27T05:00:00.000-07:00

Boehringer
Ingelheim and Pfizer Inc have released a new analysis of 30 rigorously
controlled clinical trials, including UPLIFT, confirming the long term
safety profile of Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation
powder). The new and expanded safety data contradicts the conclusions about
tiotropium in an article by Singh et al. published in the September 24th
issue of the Journal of the American Medical Association.(1) Both companies
considered it important to release these data to ensure doctors have the
most comprehensive, up-to-date safety information on tiotropium in order to
make the best treatment decisions for their patients.

Because COPD (Chronic Obstructive Pulmonary Disease) patients have in
general a higher cardiovascular risk than the average population(2),
cardiovascular safety in a COPD medication is of critical importance.
Therefore Boehringer Ingelheim has put special emphasis on the broad
investigation of Spiriva including its cardiovascular safety.

The latest analysis of 30 placebo-controlled double-blind, randomized
trials with data from 19,545 COPD patients (tiotropium 10,846, placebo
8,699) conducted by Boehringer Ingelheim demonstrated that there is no
increased risk of death (all-cause) or death due to cardiovascular events
in patients treated with Spiriva, specifically:

-- No increased risk of total (all-cause) mortality (relative risk ratio
for all cause mortality= 0.88, 95% CI=0.77, 0.999)

-- No increased risk of mortality due to cardiac (relative risk ratio for
mortality due to cardiac events= 0.77, CI = 0.55, 1.03) and vascular
events (relative risk ratio for mortality due to vascular events= 0.44,
95% CI = 0.19, 1.02).

-- No increased risk in stroke (relative risk ratio for stroke = 1.03, 95%
CI = 0.79, 1.35), and

-- No increased risk for myocardial infarction (relative risk ratio for
myocardial infarction 0.78, 95% CI = 0.59, 1.02) associated with
tiotropium.(3)

The UPLIFT results demonstrate that there is no increased risk of total
mortality or cardiovascular mortality in COPD patients treated with
Spiriva.

"We strongly disagree with the conclusion reached by Singh et al. We
have disclosed to regulatory authorities worldwide this important
information, which is part of a very robust analysis of all our
double-blind, placebo-controlled, parallel group trials with a duration of
at least 4 weeks. Our analysis, which includes data from the four-year
UPLIFT trial, supports the safety profile of Spiriva," commented Dr Andreas
Barner, Vice Chairman of the Board of Managing Directors at Boehringer
Ingelheim, responsible for Research, Development and Medicine. "Patients
and physicians can be confident that Spiriva is a safe and effective
medication. In clinical trials and since its introduction, we have
collected extensive safety data adding up to an exposure of more than 10
million patient years."

Peer-reviewed meta-analyses of aggregate published data like Singh et
al have their appropriate place in scientific research. However, these
analyses have well-recognized limitations, such as combining study
summaries rather than analyzing individual patient data, or not correcting
for patients who dropped out of trials early.

Most of the evidence in the analysis by Dr. Singh and colleagues is
contributed by a single study, the Lung Health Study, involving a different
anticholinergic medication, ipratropium. In this study, most of the
cardiovascular deaths occurred among patients who were not using their
medication. Other limitations include the inability to adjust for treatment
duration and accounting for patients who discontinue the trial early,
apparent double-counting of trials and combining placebo and active
comparator drugs in the control group.

The integrated safety data presented today includes data from the
UPLIFT trial, a study that includes mortality as a pre-specified endpoint.
UPLIFT (Understanding Potential Long-term Impacts on Function with
Tiotropium), one of the largest COPD trials ever undertaken, involved 5,993
COPD patients from 37 countries around the globe over a four-year treatment
period. Patient safety during the trial was closely followed by an
independent Data Safety Monitoring Board.

The complete results of the UPLIFT trial will be presented on October
5th during the European Respiratory Society 2008 Annual Congress in Berlin.

About Spiriva(R) HandiHaler(R)

Spiriva HandiHaler is a once-daily inhaled maintenance prescription
treatment for breathing problems (airway narrowing) associated with chronic
obstructive pulmonary disease (COPD). COPD includes both chronic bronchitis
and emphysema.

Spiriva does not replace fast-acting inhalers for sudden symptoms.

Do not swallow the Spiriva capsule. Only use the HandiHaler device to
take the Spiriva capsule. Do not use the HandiHaler to take any other
medications.

Do not get Spiriva powder in your eyes.

The most common side effect with Spiriva is dry mouth. Others include
constipation and problems passing urine. For a complete list of reported
side effects, ask your doctor or pharmacist.

Tell your doctor about your medicines, including eye drops, and
illnesses like glaucoma and urinary or prostate problems. These may worsen
with Spiriva.

If you have vision changes, eye pain, your breathing suddenly worsens,
you get hives, or your throat or tongue swells, stop taking Spiriva and
contact your doctor.

Do not use Spiriva if you are allergic to atropine, ipratropium,
tiotropium bromide, or lactose. A lactose allergy is not the same as
lactose intolerance.

Read the step-by-step Patient's Instructions for Use for Spiriva before
you take your medicine.

For full prescribing information, please visit http://www.spiriva.com.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is
the largest U.S. subsidiary of Boehringer Ingelheim Corporation
(Ridgefield, CT) and a member of the Boehringer Ingelheim group of
companies.

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 135 affiliates in 47 countries and approximately 39,800
employees. Since it was founded in 1885, the family-owned company has been
committed to researching, developing, manufacturing and marketing novel
products of high therapeutic value for human and veterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of US $15.0 billion
(10.9 billion euro) while spending approximately one-fifth of net sales in
its largest business segment, Prescription Medicines, on research and
development.

For more information, please visit http://us.boehringer-ingelheim.com.

Pfizer Inc: Working together for a healthier world(TM)

Founded in 1849, Pfizer is the world's largest research-based
pharmaceutical company taking new approaches to better health. We discover,
develop, manufacture and deliver quality, safe and effective prescription
medicines to treat and help prevent disease for both people and animals. We
also partner with healthcare providers, governments and local communities
around the world to expand access to our medicines and to provide better
quality health care and health system support. At Pfizer, more than 80,000
colleagues in more than 90 countries work every day to help people stay
happier and healthier longer and to reduce the human and economic burden of
disease worldwide.

References

(1) Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of
major adverse cardiovascular events in patients with chronic obstructive
pulmonary disease. A systematic review and meta-analysis. JAMA.
2008;300:1439-1450. de Luise C, Lanes SF, Jacobsen J, Pedersen L, Sorensen HT.
Cardiovascular and respiratory hospitalizations and mortality among users
of tiotropium in Denmark. European J Epidemiol 2007;22:267-272.

(2) Huiart L, Ernst P, Suissa S. Cardiovascular morbidity and mortality
in COPD. Chest.2005;128:2640-2646.

(3) Boehringer Ingelheim, Data on file.

Boehringer Ingelheim
http://us.boehringer-ingelheim.com

View drug information on Spiriva HandiHaler.

Other news:

More people cleared to give blood

2008-09-26T10:04:00.000-07:00

Some people with diabetes and high blood pressure are to be allowed to donate blood for the first time.

A committee of experts has ruled it is safe for these groups to give blood, even if they are taking medication to control their condition.

However, donors must have no complications or underlying medical conditions - and people taking insulin for diabetes remain barred.

There were concerns that donating blood might compromise diabetes medication.

And doctors were concerned that people on medication to lower their blood pressure might be at an increased risk of fainting when giving blood.

However, the UK Blood Services Standing Advisory Committee on Care and Selection of Donors decided that neither concern was backed by hard evidence.

In the UK almost one in 20 people has diabetes, and increasing numbers are being diagnosed with the type 2 form of the condition, which mainly affects adults.

However, the majority manage their condition by taking tablets and most are fit and healthy.

High blood pressure, or hypertension, also affects around one in 20 people in the UK, but the cnodition is being treated at a much earlier stage than previously, and with an increasingly wide range of drugs.

However, to ensure that it is safe to give blood donors have to fill in a health check questionnaire and talk to a trained member of staff before pressing ahead.

Many affected

Dr Lorna Williamson, medical director of NHS Blood and Transplant, said: "Type 2 diabetes and high blood pressure are diagnosed in increasing numbers of people.

"Many were regular blood donors who were saddened when they had to stop donating.

"Guidelines are in place to ensure safety of both donors and patients.

"The committee regularly reviews new evidence and that has shown that it is safe for them to donate so this restriction has been lifted."

Libby Dowling, of the charity Diabetes UK, said: "We welcome these new guidelines and are pleased that some people with diabetes are now eligible to donate blood if they wish to.

"There are 2.3 million people with diabetes in the UK and these new regulations mean that a significant proportion of people with the condition can now help save lives by donating blood."

On average the blood services across the UK need 8,200 donations each day to keep up stocks.

Blood cannot be keep for more than a relatively short period of time, and so the blood services have sufficient stocks to meet demand for just 9-10 days.

[Via BBC News | Health | UK Edition]

Other news:

From BBC Health

2008-09-26T10:02:00.000-07:00

BBC - Health - Mens health - Testicular cancer

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Testicular cancer

Dr Rob Hicks

Testicular cancer affects a man's testes. If it's detected early enough, it's almost always curable.

In this article

Causes
Examine them

Prevention
Symptoms

Diagnosis and treatment

The testes are a man's sperm production factories. On average, about 300 million sperm are produced by the testes every day. They also produce the male sex hormone testosterone that's responsible for a man's physical characteristics.

Testicular cancer is the most common cancer affecting young men between the ages of 19 and 44. If it's detected early enough it's almost always curable - with the majority of men who have treatment making a full recovery. So why are men still dying from it every year?Causes

It's not known why testicular cancer occurs or why one man is more likely to get it than another. It may be hereditary. If you have a close male relative with testicular cancer then you could be ten times more likely to develop it.

Men who had an undescended or partly descended testicle are five times more likely to develop testicular cancer.
Examine them

After a warm bath or shower look out for:

Testicle swelling
A pea-sized hard lump on the testicle
A dull ache
A sharp pain felt around the testicle or in the scrotum

If something doesn't feel right get it checked out - don't ignore it.Prevention

Some research suggests regular exercise may prevent testicular cancer from developing. If a boy with an undescended testicle has it corrected before the age of ten then his risk drops back down to the average risk a man has of developing testicular cancer, which is about one in 450.

But until more is understood about why testicular cancer develops the emphasis is on being more aware and examining your testicles regularly. Then if cancer does develop it can be detected and treated early on.

Ideally, examine your testicles every month. Get used to what your testicles feel like normally. If you're not sure what they're supposed to feel like then ask your doctor to show you.

Self-examination is best done after a bath or shower when the scrotum is relaxed. It's no good examining them when you have an erection because the scrotal sac is too tight, preventing you from feeling the testes properly.

Holding your scrotum in the palms of the hands, use your fingers and thumbs to examine the shape, size, consistency and smoothness of the testes. It's not unusual for one testicle to be larger than the other or for one to hang lower than the other.

Don't die of embarrassment

The reasons men give for not examining their testicles include embarrassment, fear of finding something wrong and uncertainty about how to examine themselves or what to look for.

Others remember sporting days, when any testicular contact was associated with excruciating pain and wrongly believe that self-examination will be painful.

Some men leave it to their partners to take responsibility. Often it's a woman who discovers the problem and encourages her partner to see the GP.

If something doesn't feel right then get it checked out by your doctor, don't ignore it.Symptoms

A painless lump or swelling in either testicle
Enlargement of the testicle
A feeling of heaviness in the scrotum
A dull ache in the scrotum or the groin
Pain or discomfort in the testicle or scrotum
A sudden collection of fluid in the scrotum

If you notice any of these, or if you're worried and just want some reassurance that everything is all right, then ask your GP to check you. Don't ignore any changes or worries.
Diagnosis and treatment

To diagnose testicular cancer your GP will examine your testicles and feel for any lumps or swellings. Your GP may need to refer you to the hospital for treatment and will arrange for an ultrasound scan that will show any changes in the structure of the testicles.

If you're referred to a specialist, they may arrange for you to have an orchidectomy (removal of the testicle). The testicle is then sent to the laboratory for tissue testing. If the tumour is low grade, a 'watchful waiting' policy may be adopted. If the tumour is more advanced, then chemotherapy, or occasionally radiotherapy, may be used.

A prosthetic testicle replaces the one removed to ensure the scrotum appears normal. Having a testicle removed shouldn't affect a man's sex life or his chances of becoming a father.

This article was last medically reviewed by Dr Rob Hicks in November 2006.
First published in April 2001.

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NHS care map

2008-09-26T09:31:00.000-07:00

BBC NEWS | Have Your Say | Have Your Say map: Emergency care
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Have Your Say map: Emergency care

Serious concerns have been raised about the state of emergency care in England by an NHS watchdog.

In a review of services, including A&E, out-of-hours GPs, NHS Direct, walk-in and ambulances care the Healthcare Commission found 40% of areas were not good enough.

What are emergency care services like in your area? Have changes to services such as out-of-hours assistance left you confused?

You can see the responses so far on the map - click the "Add your comment" button below to add your own.

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The map is part of a trial to find new ways of showing comments sent in by our readers.

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[Via BBC News | Health | UK Edition]

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Fast movers

2008-09-26T08:48:00.000-07:00

A health watchdog has raised serious concerns about the state of emergency care in England.

But there is much variation and services in the North-East have been singled out by the Healthcare Commission for consistently high quality of care.

A pilot scheme to better direct ambulance services to those who really need them has substantially contributed to these glowing reports.

Operators at the ambulance control centre use specialist computer systems called Pathway to determine who needs an ambulance and who could be treated nearer to home, for example in a walk-in centre.

Paul Benstead, aged 39, has worked as a paramedic since 1992 and is currently a one-man rapid response unit with a high speed car, based in South Shields.

The control centre place him and his colleagues at "hot spots" around the North-East so they can quickly get to the scene of a traffic accident or heart attack.

"It's like they've got a crystal ball sometimes - we're never more than a couple of minutes away," he says.

Because the control centre can direct the non-life-threatening cases to other parts of the health service, the ambulances are free to attend the emergencies they are designed for.

"If you think back to the 1980s you would have fleets of ambulances outside casualty because they didn't have enough beds - you could be waiting 20 minutes to half an hour before you could even deliver your patient."

He added he had heard of other ambulance trusts which were really struggling to meet response times simply because the system was "clogged up".

"If the NHS is to have a viable future, things like this are essential - we can't be stuck in the old days of working."

Increasing demand

Calls to the ambulance service in the North East have doubled in recent years and are set to increase further.

Those managing the service say they had two choices - either provide more ambulances or use existing services more efficiently.

Paul Liversidge, director of ambulance operations said only 65% of people calling 999 are now transported by ambulance to hospital.

The others are dealt with by walk-in centres, GPs, mental health teams, or even home visits from nurses.

"We can identify the life-threatening calls immediately and then as the questions progress we can determine whether there's an alternative."

Detailed analysis of the Pathway pilot will be done before it is rolled out to any other services.

"There will be an evaluation process to make sure that clinically there's no weaknesses.

"We can look at particular questions, change the wording if necessary.

"We're not sending ambulances in 35% of cases and that's of benefit to the ambulances and the whole healthcare community as well as the patients."

Members of the public were initially reticent about the scheme because the culture had always been to bring everyone who called 999 into hospital.

But staff report once people get used to the system they are often happy they do not have to go to casualty.

"The walk-in centres have been a big hit," adds Paul, one paramedic who is "100%" behind the new system.

"They're oversubscribed so they actually need more of them."

[Via BBC News | Health | UK Edition]

Other news:

Scots drinkers down more spirits

2008-09-26T07:55:00.000-07:00

People in Scotland drank almost two litres more pure alcohol last year than those living in other parts of Britain, according to new research.

The figures from Scottish Health Action on Alcohol Problems (Shaap) were based on alcohol sales data.

They showed an average Scot over the age of 16 consumed 11.8 litres compared to 9.9 litres in England and Wales.

The higher level north of the border was due to the fact that Scots drinkers consumed more spirits.

In total, almost eight million more litres of pure alcohol were consumed in Scotland in 2007.

Shaap, an independent medical advocacy group, said basing the research on sales figures gave a more accurate picture than other surveys because people often under-report how much they drink.

For most types of drinks, the amounts purchased were similar across Britain.

However, there was a notable difference in the level of spirits bought in Scotland - an average figure of 3.5 litres per person, compared to 1.8 litres in England and Wales.

Spirits made up around 29% of all alcohol sold in Scotland last year, but constituted less than a fifth of alcohol bought in England and Wales.

Shaap said the survey helped explain why the number of deaths linked to alcohol was higher in Scotland.

Scottish Government proposals to tackle Scotland's "booze culture" are currently being debated at Holyrood.

They include raising the off-licence alcohol purchase age from 18 to 21, a minimum pricing structure for alcohol and a crackdown on drinks promotions.

Urgent action

Dr Bruce Ritson, chairman of Shaap, said the figures underlined the need for urgent action and declared the organisation's support for Scottish ministers' plans.

He said: "What these figures reinforce is the need to act now to reduce overall alcohol consumption in Scotland.

"The most effective and efficient means of reducing the demand for alcohol are to regulate price and availability."

He added: "Over the past few decades we have seen a progressive liberalisation of the alcohol market in the UK, with the result that alcohol is now available in more places, for longer periods, and at more affordable prices.

"Unfortunately, in that time we have also seen a rise in consumption and an escalation of alcohol-related damage."

[Via BBC News | Health | UK Edition]

Other news:

SA joy at demise of 'Dr Beetroot'

2008-09-26T07:26:00.000-07:00

South African Aids campaigners have serenaded the new health minister and rejoiced at the departure of her controversial predecessor.

A group of activists sang outside the Cape Town flat of Barbara Hogan and drank champagne.

They have long called for the dismissal of Manto Tshabalala-Msimang, known as "Dr Beetroot" for her advocacy of healthy eating rather than drugs.

Some 5.5 million South Africans are HIV-positive.

This is more than in any other country in the world.

'Ecstatic'

The government of former President Thabo Mbeki has long been criticised for not doing enough to distribute the anti-retroviral drugs that scientists say are the most effective way of combating Aids.

Dr Tshabalala-Msimang said the drugs were too expensive for South Africa and warned of possible harmful side-effects.

Barbara Hogan spent eight years in prison for fighting apartheid

Instead, she urged people with HIV to eat lots of garlic and beetroot.

South Africa's leading Aids lobby group, the Treatment Action Campaign (TAC), said Ms Hogan had been one of the few MPs to speak out on HIV/Aids during Mr Mbeki's time in office.

"She has a reputation for being hard-working, competent and principled," a TAC statement said.

"We believe that the period of politically supported AIDS denialism has ended," it said.

Ms Hogan spent eight years in prison in the 1980s for campaigning against the white minority apartheid government.

She has been an MP for the ruling African National Congress since apartheid was ended in 1994.

Aids Law Project attorney Fatima Hassan said the group was "ecstatic about the appointment of Barbara Hogan," the Sowetan newspaper reports.

"Manto Tshabala-Msimang should have been replaced a long time ago," she said.

The Cape Times newspaper reported that Ms Hogan came onto her balcony and told the serenading activists she was "deeply touched".

Mr Mbeki resigned on Thursday, to be replaced by Kgalema Motlanthe, who carried out a cabinet reshuffle.

Dr Tshabalala-Msimang was moved to become a minister in the president's office.

[Via BBC News | Health | UK Edition]

Other news:

'North-South' gap in mothers' age

2008-09-26T07:15:00.000-07:00

Women in southern England are likely to wait longer than those in the north to have children, statistics show.

The birth figures, covering England and Wales, revealed that childbearing in many parts of the south peaked when women were aged 30 to 34.

In contrast, women in northern regions and Wales were more likely to give birth between the ages of 25 and 29.

A population scientist said that differing career choices could be partly responsible.

The birth rate in England and Wales has actually been rising slowly since 2001, following a sharp decline in the 1990s, according to the Office for National Statistics.

It collected data for 2006 on the age of mothers and analysed these according to local authority area to build up a more detailed regional picture.

Births peaked among women aged 30 to 34 in 45% of these authorities, and these were predominantly, although not exclusively, in southern England.

On a national level, the figures provide further evidence that more women are delaying having children.

In 1986, childbirth peaked between 25 and 29 in nearly all local authorities, while in 2004, the early 30s was the time of peak childbearing across England and Wales as a whole.

Some local authorities have had consistently low or high birthrates over the past 20 years.

Newham in London, and Blackburn with Darwen in Lancashire have always been in the top ten, while Durham and Cambridge tended to prop up the table.

Career choice

Professor Paul Boyle, a population scientist from the University of Liverpool, said the reasons for the differences were not entirely clear.

He said: "We know that this delay can be strongly related to women trying to extend their careers, and it is possible that this is more likely in the south of England.

"But this may only partly contribute to this - the research into this kind of geographical variation has not been done."

He warned that while both groups of women were likely to have the intention to have the same number of children, those who chose to delay motherhood until their 30s might be unable, for biological reasons, to achieve this.

[Via BBC News | Health | UK Edition]

Other news:

Ending in tears

2008-09-26T07:03:00.000-07:00

"I just landed badly and broke my leg. It's broken in two places below the knee."

Safety advice varies between different manufacturers. That is why Dr Newton feels a few simple rules would avoid serious injury.

He feels you should always fit a safety net, making sure it is securely fastened and only allow one child at a time.

He also says anyone below five years of age should not be allowed to use a recreational trampoline.

He found 76% of the total patient group was accounted for either by children under the age of five, children who had fallen off an unfenced trampoline or children who had injured themeselves whilst bouncing on a trampoline at the same time as another child.

Dr Newton said: "The greatest risk seems to occur when two children of very different ages are on a trampoline.

"If you have one large child and one small child the risk of injury is significantly increased.

"That is because the force of the bounce the large child generates is going to have a very unpredictable effect on the smaller child and lead to them being thrown in such a way that they are likely to sustain injury."

Of course jumping up and down is very good excercise - so its all a question of minimising risks to gain the greatest benefit.

At least I now have some pretty horrific pictures of broken bones with which to scare the kids.

[Via BBC News | Health | UK Edition]

Other news:

China stops tainted sweet sales

2008-09-26T03:02:00.000-07:00

A Chinese sweet maker has stopped domestic sales of one of its best-known brands after it was found to contain the industrial chemical melamine.

The company, Guanshengyuan, has already halted exports of the popular White Rabbit candy, made from milk.

It is the latest development in the food safety scandal involving milk contaminated with melamine.

A growing number of countries have already banned or restricted imports of Chinese products containing milk.

At least 13,000 children in China are still in hospital as a result of drinking contaminated powder milk. Four babies have died and some 53,000 made ill.

'Tragedy'

Guanshengyuan is a subsidiary of Bright Foods - one of the dairies at the centre of the contaminated milk scandal.

Its announcement that it was halting all sales of White Rabbit candy follows the decision to recall exports to more than 50 countries, after some of its sweets tested positive for melamine in Singapore earlier this week.

Ge Junjie, a vice-president of Bright Foods, said the firm had taken the decision to halt sales, even though the results of tests were not yet known.

"It's a tragedy for the Chinese food industry and a big lesson for us as it ruined the time-honoured brand," he was quoted by the Shanghai Daily as saying.

Both Canadian and British regulators have already asked shops to withdraw White Rabbit sweets, while the Philippines has ordered all Chinese-made dairy products to be pulled from shelves.

Meanwhile, a Europe wide ban on all children's food containing any traces of milk imported from China came into force on Friday morning. Other Chinese food is being tested.

Officials in Brussels are emphasising that as far as they know there has been no contamination of food originating from China, the BBC's Europe correspondent Chris Mason says.

Peak reached?

The scandal came to light earlier this month when baby milk powder from the Sanlu Group was found to contain the industrial chemical melamine.

Since then, at least 22 other companies have been implicated - and milk products made by the Yili, Mengniu and Bright Foods groups have been recalled both at home and abroad.

On Friday, the World Health Organisation's China representative said the scandal may have peaked, but warned there could be more deaths.

"We might be starting to see the end of it, even if I don't think we are yet at that level, because there is now vigorous testing, not only in China, but in other countries," said Hans Troedsson.

Melamine is used in making plastics and is high in nitrogen, which makes products appear to have a higher protein content.

Health experts say that ingesting small amounts does no harm but sustained use can cause kidney stones and renal failure, especially among the young.

[Via BBC News | Health | UK Edition]

Other news:

Malaria battle given $3bn boost

2008-09-25T23:30:00.000-07:00

World leaders and philanthropistshave pledged nearly $3bn (£1.6bn) to fight malaria at a summit in New York.

The meeting, at the UN, is looking at ways of meeting the Millennium Development Goals - targets on reducing global poverty by the year 2015.

Donors hope the money will be enough to eradicate malaria by that time.

The money includes $1.1bn (£598m) from the World Bank and $1.6bn (£870m) from the Global Fund to Fight Aids, Tuberculosis and Malaria.

The British government and private organisations such as the Bill and Melinda Gates Foundation have promised the rest.

Malaria still kills more than a million people each year, according to the World Health Organization.

The funding, will be used to support rapid implementation of the first ever Global Malaria Action Plan (Gmap).

Long-term effort

World Bank President Robert Zoellick said in a statement that the extra money would help "sharply reduce the numbers of malaria-related deaths and illness" in the next three years.

According to Gmap's projections, more than 4.2 million lives can be saved between 2008 and 2015, if its plan is put into action, and the foundation can be laid for a longer-term effort to eradicate the disease.

The BBC's Heather Alexander says leaders are focusing on eradicating malaria to counter criticisms that the millennium targets will not be met.

British Prime Minister Gordon Brown joined the presidents of Rwanda and Tanzania as well as the UN Secretary General Ban Ki-moon to reassure the world that their goal is achievable.

Alongside the offers of money came reassurance from African leaders that efforts are working.

President Paul Kagame, of Rwanda, said malaria deaths have fallen by more than 60% in his country.

The Bill and Melinda Gates Foundation is to provide $168.7m (£91m) to fund a Malaria Vaccine Initiative for research on a new generation of anti-malaria vaccines.

Microsoft founder Mr Gates said: "We need innovation, new drugs, and the most dramatic thing we need is vaccine.

"If we build on this momentum, we can save million of lives and chart a long-term course for eradication of this disease."

Britain's Department for International Development pledged £40m ($73.5m) to support the Affordable Medicines Facility for Malaria.

It also pledged to increase its malaria research funding to at least £5m ($9.1m) a year by 2010 and supply 20 million of the 125 million bed nets still needed in affected areas.

[Via BBC News | Health | UK Edition]

Other news:

Auction bidding 'driven by fear'

2008-09-25T22:27:00.000-07:00

Worries about losing out at auctions may drive participants to pay over the odds, a brain imaging study shows.

Websites such as eBay have fuelled the sale of goods through auctions, with some people becoming hooked.

Brain scans of people taking part in an auction showed those "overbidding" had a greater response to losing than to winning, the Science journal reported.

The US researchers said the findings went against the theory that paying too much is driven by the "joy of winning".

In the first part of the research, 17 participants took part in either an auction game with a partner or a lottery game.

Both involved winning money but in the auction game, the idea was to outbid your partner, whereas in the lottery game winning was simply down to chance.

A type of scan called functional magnetic resonance imaging (fMRI) showed that in the auction game there was an exaggerated response to loss in the striatum - part of the brain associated with reward - but hardly any response to winning.

The greater the tendency to overbid, the stronger the response to loss suggesting that the prospect of losing the competition caused participants to bid too high, the researchers said.

Testing loss

In a separate study, the team from New York University provided three groups of participants with an auction game but with different circumstances.

One group was asked just to make bids, one was told if they won the auction they would get a $15 bonus and the other was given a bonus up-front but told they would lose the $15 if they failed to win the auction.

Although the outcomes were the same for all winners - an extra $15 - those in the "loss" group consistently bid higher than the others.

Study leader Professor Liz Phelps said: "We thought we would see an exaggerated response when people won but we found the opposite.

"In the study they didn't know which person they were bidding against so this was more like an eBay auction.

"The effects may be even more exaggerated in a sit-down auction," she said.

Professor Nigel Nicholson, an expert in organisational behaviour at London Business School, said the results made a lot of sense as "loss aversion" is known to be a strong driver of human behaviour.

"People hate to lose much more than they like to win."

He added that these types of imaging studies were helping to boost understanding of decision-making, for example in the stock market.

[Via BBC News | Health | UK Edition]

Other news:

Region determines cancer risk gap

2008-09-25T22:08:00.000-07:00

The difference between the cancer risk of the poorest and the most wealthy varies between English regions, researchers have discovered.

Experts looked at 300,000 cases of common cancers between 1998 and 2003.

They biggest variation was in male lung cancers, where there was a much smaller gap between rich and poor in the east of England than in the north east.

Experts said the paper, published in the journal BMC Cancer, would help cancer prevention work.

The study was carried out by a team from the North West Cancer Intelligence Service and the UK Association of Cancer Registry.

They took information from all eight English cancer registries on breast, lung, cervical and skin cancers.

The team also looked at the age people were when diagnosed with the cancers.

They said it was known that socio-economic status could affect cancer risk.

Lung cancer is usually caused by smoking, which is more prevalent among poorer groups, so it is expected that rates of the disease will be higher there.

The biggest difference was in male lung cancers in the north east - rising from 48 men per 100,000 among the wealthiest to 130 per 100,000 among the poorest.

But the gap was much smaller in the east of England, where 41 men per 100,000 of the most affluent were diagnosed with lung cancer compared with 85 per 100,000 of the most deprived.

'Focus'

The incidence of cervical cancer is much lower, but differences were still seen.

Among the poorest women in the north west, 16 per 100,000 were diagnosed with the disease compared with seven per 100,000 of the wealthiest.

But in London, 10 per 100,000 of the most deprived were diagnosed compared with six per 100,000 of the most affluent women.

There was less variation in breast and skin cancer rates between the richest and poorest, although they were slightly more common among the more affluent.

Lorraine Shack of the North West Cancer Intelligence Service, who led the study, said it showed that measures to help people protect their health and prevent them developing cancer needed to be targeted at specific groups.

"There has been a lot of success with such programmes in the most affluent communities, so we need to aim for the same success in the poorest communities."

Catherine Thomson, Cancer Research UKs head of statistical information, who worked on the study, added: "It's important that we understand how the level of wealth affects the chances of a person getting different types of cancer.

"This knowledge should help ensure that money spent on screening programmes and on cancer prevention is focused on those groups where the need is greatest."

Dr Lesley Walker, director of cancer information, said: "It is important that everyone adopts a healthier lifestyle which includes giving up smoking, adopting a better diet, drinking alcohol in moderation and avoiding excessive exposure to UV radiation to lower their risk of developing the disease."

[Via BBC News | Health | UK Edition]

Other news:

Police against ecstasy downgrade

2008-09-25T21:42:00.000-07:00

Senior police officers have written to a government advisory panel urging it to leave ecstasy as a Class A drug, the BBC has learned.

The Advisory Council on the Misuse of Drugs is meeting to discuss whether the drug should be downgraded to Class B.

Incoming head Prof David Nutt has said ecstasy is less harmful than cocaine or heroin and should be reclassified.

The government went against a recommendation in May when it moved cannabis from Class C to B.

The meeting over ecstasy could set the government on another collision course with the Advisory Council, should it recommend reclassification.

The panel will review the latest evidence before making its decision.

As part of the discussions, panel members will consider the submission from the Association of Chief Police Officers, stating that transferring ecstasy to class B would send out an "unfortunate message".

'Relative damage'

An estimated 250,000 people in England and Wales take ecstasy every month.

Professor Colin Blakemore, from Oxford University and the UK Drug Policy Commission, said all drugs were dangerous but that the issue was one of "relative harm".

"The problem, one of the problems, is the assumption that if the advisory council recommends that ecstasy should be downgraded they're in a sense encouraging people to use it - that's not the case at all.

"They are simply making a statement about the relative damage associated with ecstasy compared with crack cocaine and heroin, where it is at the moment."

The Transform Drug Policy Foundation, a charity that says prohibition is the major cause of drug-related problems, said this latest review would only result in "little more than posturing on all sides".

A spokesman said: "Given that the government overruled the council on cannabis reclassification, the entire exercise is doomed before it had begun."

'No safe dose'

As a Class A drug, the penalties for possession and supply are the most severe.

Possession carries a maximum sentence of up to seven years in prison, an unlimited fine or both.

Dealers face a maximum jail term of life imprisonment, an unlimited fine or both.

Possession of Class B drugs carries a maximum prison sentence of five years, while dealing can attract a term of up to 14 years.

The Home Office has said ecstasy should stay in class A because there is no such thing as a "safe dose".

In May, Home Secretary Jacqui Smith announced plans to reclassify Cannabis as a Class B drug.

This was despite the council stating it should remain as Class C.

[Via BBC News | Health | UK Edition]

Other news:

Concerns over emergency NHS care

2008-09-25T21:14:00.000-07:00

Serious concerns have been raised about the state of England's emergency care services by an NHS watchdog.

The Healthcare Commission found 40% of areas were not good enough after looking at A&E, out-of-hours GP, NHS Direct, walk-in and ambulance care.

The report said changes to services had left patients facing delays and confused about where to go for help.

Critics said the report raised fears over the reform of the NHS, but the government said care would improve.

In recent years, ministers have been overseeing a radical reshaping of emergency care.

Hospitals have been encouraged to become centres of excellence by concentrating on the most specialist aspects of care.

Meanwhile, other providers, including walk-in centres and out-of-hours GP services, are expected to work in partnership to deal with the less serious cases.

The Healthcare Commission said this required good management and communication between different parts of the NHS.

But the report found this was lacking with just a third of the 152 primary care trusts, which are responsible for coordinating local services, having active networks in place.

And individually, each part of the urgent and emergency care service had its own problems.

Less than a half of GP services had arrangements in place to divert callers to the out-of-hours provider - most GPs gave up responsibility for night and weekend care as part of a new contract four years ago.

Out-of-hours providers were also struggling, with a third failing to respond to calls quickly enough.

And ambulances were finding it dfficult to get back on the road quickly enough after taking patients to A&E.

Guidelines say this should be done within 15 minutes of arriving at hospital but in some areas this happened in only 10% of cases.

'Cornerstone'

The problems mean that in many areas too many patients are turning up at A&E instead of using other services, with over half of the visits to some units deemed unnecessary.

The watchdog gave its backing to piloting one number for emergency and urgent care calls so that patients could be signposted to the correct service. The 999 number, however, would still be available for life-threatening situations.

Jim Wardrope, president of the College of Emergency Medicine, questioned what he called the "headlong" rush to introduce all the different services.

"Patients seem to understand the function of the A&E service and their GP service.

"They are less clear about the plethora of other urgent services that have been developed."

And shadow health minister Mike Penning said the reforms were failing, adding: "Patient outcomes are being neglected."

But Professor Sir George Alberti, the government's emergency care tsar, claimed most of the care offered was of a "high standard".

He added: "We are not complacent and we recognise the importance of encouraging continuous improvement in local services to ensure the delivery of timely, high quality care to patients."

Overall, the Healthcare Commission judged 33% of PCT areas as best performing, 27% better performing, 22% fair performing and 18% least well performing.

Fair and least well performing mean the trust areas were not hitting targets or standards where ones were in place.

[Via BBC News | Health | UK Edition]

Other news:

Fish oil brain study 'laughable'

2008-09-25T10:23:00.000-07:00

A study in which fish oil was given to pupils in County Durham has been dismissed as "laughably incompetent".

Durham County Council said children who took the Omega-3 supplements during the school year performed better in exams.

It claimed out of 3,000 students who took part, almost a third showed significant improvements in GCSEs.

Dr Ben Goldacre said it was bad science because there was no separate study of pupils not taking fish oil. The council admits the trial was not definitive.

Dr Goldacre, an award-winning medical writer, said: "I think it is a laughably incompetent analysis of a laughably incompetent piece of research.

"In my view it is unethical to perform incompetent research on children in this way."

However Dr Goldacre added that just because the study was poorly conducted, that did not mean there was no benefit to taking fish oil supplements.

"I do think it's possible that fish oils might be helpful to improve school performance in children."

Dave Ford, from the council's children and young people's services department, carried out the initiative with the help of an educational psychologist.

They matched students who showed improved results to those, of similar abilities and backgrounds, who did not take the tablets.

However, the council explained that there was no controlled study of those children who were not given supplements as part of the study, which took place in the school year ending in summer 2007.

Mr Ford said: "This study has produced some interesting and possibly exciting issues that could be the basis for future scientific trials.

"There seem to be some very clear indications that pupils taking the supplement do significantly better."

Mr Ford added that the council made no claim the results of its GCSE study could be attributed to Omega-3 supplements alone.

[Via BBC News | Health | UK Edition]

Other news:

EU limits imported Chinese food

2008-09-25T09:36:00.000-07:00

The European Commission is imposing a ban on EU imports of Chinese baby food that contains any traces of milk, while other Chinese food will undergo tests.

The measures come amid a health scare over milk powder contaminated in China with the industrial chemical melamine. It has caused several deaths there.

The commission says all imported products from China containing more than 15% milk powder will be tested.

Random testing will be done on all such products already on sale in the EU.

The EU does not import milk or other dairy produce from China, but processed foods such as biscuits and chocolates might have traces of milk powder, commission health spokeswoman Nina Papadoulaki told the BBC News website.

[Via BBC News | Health | UK Edition]

Other news:

Sarahs unite for health campaign

2008-09-25T08:57:00.000-07:00

Gordon Brown's wife Sarah has met US vice-presidential hopeful Sarah Palin at a dinner to promote better support for childbirth in developing countries.

The two, who met in New York, have turned in political show-stopping performances in recent days.

Mrs Brown was hailed by British papers for her surprise decision to take to the Labour conference stage this week.

And Mrs Palin was widely lauded in the US media for her speech earlier this month to the Republican convention.

Those present at the women's dinner urged UN Secretary General Ban Ki-Moon and global leaders to renew their commitments to deliver the Millennium Development Goal of reducing maternal mortality by 75% by 2015.

Motherless millions

The UN estimates that in 2005, a woman died every minute of complications related to pregnancy and childbirth - more than 500,000 women a year.

Almost all of these women, 99 per cent, live and die in developing countries, the UN says.

Sarah Brown, Queen Rania of Jordan and Rupert Murdoch's wife Wendi.

In sub-saharan Africa, a woman's risk of dying from treatable or preventable complications during pregnancy is one in 22, compared with one in 7,300 in developed regions.

Every year, more than one million children are left motherless and children who have lost their mothers are up to 10 times more likely to die prematurely than those who have not.

Sarah Brown co-hosted the dinner for influential women less than 48-hours after taking to the stage in Manchester to defend her husband's record as Prime Minister at the Labour Party conference.

Those present at the dinner included many first ladies, model Elle Macpherson, Duchess of York Sarah Ferguson, Jordan's Queen Rania, former Irish President Mary Robinson and media mogul's Rupert Murdoch's wife, Wendi Murdoch.

[Via BBC News | Health | UK Edition]

Other news:

Pharmacy advice 'frequently poor'

2008-09-25T08:07:00.000-07:00

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Pharmacy advice 'frequently poor'

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Shoppers react to their exeprience with pharmacy staff

Staff at pharmacies are frequently giving inappropriate and occasionally dangerous advice to patients, a survey has suggested.

Staff at Which? magazine visited 101 pharmacies in the UK, and claimed they received "unsatisfactory" advice on a third of occasions.

In some instances, powerful migraine drugs were sold without any supervision by the pharmacist.

One pharmacy body said its own "mystery shoppers" had seen improvements.

The government and pharmacy organisations are keen for some medicines previously available only with a GP prescription to be dispensed "over-the-counter".

However, this often relies on pharmacy teams asking the right questions before selling the medicine, and the Which? survey suggests this is not always happening.

They found that independent pharmacies were most likely to give the wrong advice, or not carry out the right checks.

The Which? staff confronted the pharmacies with one of three scenarios - a request to buy "Imigran Recovery", a migraine medication; a patient complaining of two weeks' of diarrhoea after returning from abroad, and a request for the "morning-after pill" designed to test whether a customer's privacy could be respected.

Imigran Recovery should only be dispensed following a series of questions set by the Medicines and Healthcare Products Regulatory Agency, but Which? ranked 13 out of 35 visits as "unsatisfactory".

In 40% of the 13, the pharmacy assistant did not even alert the pharmacist before handing over the drug.

The patient with travellers' diarrhoea should have been asked about symptoms and advised to see a GP if they had not already done so, in case the diarrhoea was due to a serious infection.

However, 14 out of 32 visits were "unsatisfactory", with one assistant suggesting the symptoms were caused by irritable bowel syndrome instead.

Indiscreet questions

The request for emergency contraception was dealt with poorly in seven out of 34 visits - in two pharmacies, the woman was questioned about her sex life within earshot of other customers.

Neil Fowler, the editor of Which?, said: "People are increasingly turning to pharmacies for the sort of advice they might have gone to their GP for in the past - but we're concerned that in some cases they're getting advice which is unsuitable and potentially unsafe."

The National Pharmacy Association, which represents community pharmacies, said that while the survey was reassuring about the skills of pharmacists themselves, it showed there was "room for further improvement" in other pharmacy staff.

A spokesman said: "In this study the expertise of the pharmacist is shining through. Work needs to be done to increase the support given to the whole of the pharmacy team."

She said the association had been "encouraged" by the results of its own "mystery shopping" exercise.

The Royal Pharmaceutical Society agreed that there were issues that needed to be addressed, but said that the survey covered fewer than 1% of all pharmacies in the UK.

A Department of Health spokesman said its research had shown the public was satisfied with pharmacy services.

But he said that April's pharmacy White Paper set out plans for measures to deal with "unwarranted variations" in standards and quality of service delivery.

"We are currently consulting on proposals to enable primary care trusts to take effective action where contractors are not achieving acceptable performance standards."

Have you received incorrect medical advice from a pharmacist? Are you a pharmacist? What challenges do you face when trying to give a customer medical advice? Send us your comments using the form below:

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[Via BBC News | Health | UK Edition]

Other news:

School's jab ban 'not justified'

2008-09-25T04:55:00.000-07:00

A Roman Catholic school's decision to prevent girls receiving the cervical cancer vaccine on its premises was "disappointing", a health boss said.

Governors at St Monica's High School in Prestwich, Greater Manchester, said they had concerns about the possible side effects of the injections.

The head teacher of the school said he could not comment on the decision.

Dr Peter Elton, the borough's director of public health, said the governors' concerns were "not justified".

The vaccine gives immunity to key strains of the sexually-transmitted Human Papilloma Virus (HPV), responsible for 70% of cervical cancers. Experts believe it could save hundreds of lives in the UK each year.

It is given in a course of three injections over six months and is being offered to all year-eight girls.

Dr Elton said schools were the best places to immunise children because when parents have to make special arrangements uptake was often lower.

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Experts believe vaccinating against HPV could save hundreds of lives

"It is very important that we have the maximum number of children vaccinated against HPV, that all girls get vaccinated," he said.

"The way we can get the most done is by having them at school, so we are naturally disappointed when we can't go into a school to vaccinate girls.

"They [the governors] recognise it as a very effective vaccine but they have these other concerns and we think they are not justified."

Governors at St Monica's - which has 1,200 pupils - have sent a letter to parents outlining concerns about possible side effects.

It states: "We do not believe that school is the right place for the three injections to be administered.

"Therefore, governors have taken the decision not to allow the school premises to be used for this programme."

Although some religious groups are opposed to the vaccine because of fears it may encourage promiscuity, the governors make no moral objection to the programme.

In its advice on the HPV vaccine, the Department of Health said it had undergone rigorous safety testing as part of the licensing process.

[Via BBC News | Health | UK Edition]

Other news:

Fish 'reduces early eczema risk'

2008-09-24T23:28:00.000-07:00

Adding fish to a child's diet before the age of nine months could lessen the chances of developing eczema.

The rate of the painful skin condition has risen in Western countries in recent years, and scientists believe diet may be partly to blame.

Swedish scientists tracked the health of children in 5,000 families, and said that early introduction of fish cut the risk by a quarter.

The research was published in Archives of Disease in Childhood.

The children were all part of an ongoing health study looking at almost 17,000 infants born in 2003 in western Sweden.

Some of the families involved agreed to fill in questionnaires about diet and home environment when the child was six months and 12 months old.

Any evidence of eczema was also recorded, and the results analysed. At six months old, 13% of the families said their child had already developed eczema, and this rose to 20% by their first birthday.

Genes appeared have the most powerful effect - children with a sibling or mother with eczema were almost twice as likely to be affected by 12 months.

Breast feeding, the age at which dairy products were introduced, and the presence of a furry pet in the home had no detectable influence on eczema.

However, the introduction of fish before nine months cut the risk by 25%.

Omega-3 link

The researchers wrote: "The fact that fish is rich in omega-3 fatty acids could partly explain the effects found in this cohort."

However, they said they found no measureable difference between children who ate white fish, and those who ate other types of fish richer in omega-3, making it hard to say for certain.

Dr George Du Toit, a paediatric allergy specialist, said that fish had been linked to allergic reactions and eczema.

He said: "The connection between diet and eczema is complex.

"Eczema, particularly severe eczema, is commonly associated with the presence of food allergy.

"Parents of young children with eczema may therefore wish to consult with their doctor prior to the introduction of foods that commonly cause allergy, such as cows milk, peanut and even fish."

A spokesman for the National Eczema Society welcomed the study, agreeing that the genetic component of the condition was likely to be the most significant, and urging parents to avoiding harsh soaps and detergents on the skin from a young age in families predisposed to the condition.

[Via BBC News | Health | UK Edition]

Other news:

What to Do When You're Out of Sick Days

2008-09-09T10:36:00.000-07:00

You wake up for work, only to realize that the stuffy nose and sore throat you had last night have gotten worse. Or alternatively, you wake up feeling fine, but your child comes in to tell you that they aren't feeling well.

The act covers people who work for the government, educators and people in companies with more than 50 employees. Enacted in 1993, it allows an employee to take up to 12 weeks off during a 12-month period to care for themselves or an ill child if they are taking care of them. However, that time off is unpaid.

"There is job protection that's afforded to the employee," said Ken Cope, an absence management practice leader at Hewitt LCG, a disability and absence management firm.

In the last 24 months, Cope noted, some states have enacted legislation to help employees when they need to miss work for illness or other personal reasons, which can include domestic violence or taking care of an injured family member who served in the military. The act recently expanded to include that situation.

"A lot of legislation is taking place at the state level to address this same issue," he said.

Cope notes that employees who are out for a certain period (typically more than seven days) can start using short-term disability leave, but that would not apply for an absence of a few days.

But while needing to take a day off may not cost you your job, doctors are quick to emphasize that prevention is the most important step, and those can be taken now.

[Via ABC News: Health]

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Ginny Hanrahan To Be First Chief Executive Officer At Health And Social Care Professionals Council, Ireland

2008-05-12T13:51:00.015-07:00

Minister for Health Children, Ms. Mary Harney the annunciation The healthiness and Social worry Professionals' the appointment Virginia (Ginny) first Chief Executive Officer.

Doctors Without Borders relief plane gets permission to land in Yangon

2008-05-12T13:51:00.013-07:00

As earliest Doctors Without Borders/MÃ©decins Sans FrontiÃ¨res(MSF) naturalness plane receives permission to land in Yangon tomorrow, Saturday, the international nil mortal organization has formerly emergency MSF scales up, null a need for fresh technical experts and further supplies in the coming days.

Ginny Hanrahan To Be First Chief Executive Officer At Health And Social Care Professionals Council, Ireland

2008-05-12T13:51:00.011-07:00

The Minister haleness Children, Ms. Mary Harney announcement by The Health and gregarious Care Professionals' Council of the designation Virginia nil as first Chief Executive

Doctors Without Borders relief plane gets permission to land in Yangon

2008-05-12T13:51:00.009-07:00

the prime Doctors Borders/MÃ©decins nil relief plane receives consent to estate in Yangon Saturday, the international medical humane confederation has already its emergency program. null scales up, there is a need for more and further supplies in the coming days.

Cancer Research UK Honours Business

2008-05-12T13:51:00.007-07:00

Cancer Research UK nil week celebrated its inaugural Business Supporters' Awards, posh observance of the contribution made by business aid the kindheartedness beat cancer.

Depressed Teenagers Making Themselves Worse With Marijuana Says US Government Report

2008-05-12T13:51:00.005-07:00

null fresh White House clap says that multitudinous American teenagers who null depressed and use to alleviate situation are more likely make it worse prostrate chance developing more serious intellectual health such as schizophrenia, anxiety, and even suicide.

McCain's View Of Judicial Philosophy Is More Than 'Campaign Plank,' Opinion Piece Says

2008-05-12T13:51:00.003-07:00

Republican null aspirant Sen. vocalization on Tuesday, during he outlined null philosophy "pledged to nominate qualified judges volition leave legislating to the people," is not a "campaign plank" only "one of our core ideas," Tony Perkins, president of the Family inquest null writes in a USA Today conviction

Issue Module Presents Background On Health Care In 2008 Election

2008-05-12T13:51:00.001-07:00

Issue Health Care a 2008 Election Issue, Kaiser Family The emerge module information on health worry in null 2008 election, including civil null about health care candidates' reform proposals.

University Of Alabama Receives $3M NIH Grant To Study Health Issues That Affect Rural, Elderly Blacks

2008-05-12T13:50:00.001-07:00

University of Alabama-Birmingham received a $3 million, NIH grant money three pilot projects devote on nil health disparities among rural, elderly blacks, Birmingham advice reports.

New Genetic Models Could Be Key To Understanding Underlying Mechanisms Of Cardiac Arrhythmias, Sudden Cardiac Death

2008-05-11T12:12:00.001-07:00

new peruse by researchers at Rhode Island Hospital provides much-needed insight into the molecular nil cause arrythmia, null irregular heartbeat, and it precipitate cardiac one of the nation's leading

News From The Journal Of Clinical Investigation

2008-05-11T11:17:00.001-07:00

How slow-paced growth a fetus can cause diabetes as an growth retardation which results in baby a low preponderance nil has been to the development type 2 diabetes in has been suggested is because the articulation of central genes is altered during development and this disease arrearage later in

Swimmer Needs 20 Stitches After Pelican Crashed Into Her

2008-05-11T11:16:00.001-07:00

Debbie Shoemaker, 50, swimming off the null coast in prize Island near Petersburg, nil pelican was evidently diving for bow crashed into her nil mistake and tore a gash into Shoemaker's cheek with long beak. bird did not come through collision. Shoemaker, from Toledo, Ohio, USA, was immediately hospital where she needed 20 nil

Imagining Study Finds Equity And Efficiency Are Encoded Differently In The Brain

2008-05-11T10:21:00.001-07:00

Which is more food a few hungry people or null sundry food go waste so that everyone nil a share? A study this dashing Science finds that most people elect the that the brain responds in unique null and inequity.

Virus Hijacks Cell Division Machinery

2008-05-11T09:03:00.001-07:00

nil are masters of null duping their cells helping them grow and A different con null institute that mortal can impersonator a common regulatory protein hijack normal cell growth machinery, disrupting a cell's primary anti-cancer mechanism.

Sexual Health Screening Without Mention Of Sex

2008-05-11T08:06:00.001-07:00

Young women would accept age-based for the sexually transmitted nil but would dearth trial exist to everyone, rather than people 'singled out' null to sexual history.In the published mod BioMed Central exposed access journal contagious the Australian interviewed did not like discussing sex with their GPs.

New Technique Measures Ultrashort Laser Pulses At Focus

2008-05-11T07:08:00.001-07:00

Lasers that emit pulses of light are used numerous null microscopy, orb nil spectroscopy controlling chemical reactions. But the quality of the nil limited distortions caused by lenses and other optical components that are role null the experimental instrumentation.

Study Shows Racial Discrimination Has Different Mental Health Effects On Asians

2008-05-11T06:10:00.001-07:00

The first national con of Asians subsistence in the United shows that for some individuals, strong to ethnicity can sentry negative null racism. For strong ties to ethnicity can indeed make null jar of discrimination worse.

Scientists Demonstrate Method For Integrating Nanowire Devices Directly Onto Silicon

2008-05-11T05:14:00.001-07:00

Applied scientists at University in collaboration with researchers null German universities of Gottingen, and Bremen, have developed a novel technique fabricating nanowire electronic that may unique epoch be suitable for high-volume nil student Mariano Zimmler Federico Capasso, Robert L.