Sunday, September 30, 2012

One in 10 Employees in Europe Have Missed Work Due to Depression - More Than 21,000 Working Days Lost, According to New Survey

One in 10 Employees in Europe Have Missed Work Due to Depression - More Than 21,000 Working Days Lost, According to New Survey

Depression causes an average of 36 lost working days per episode

Managers report need for better legislation, including training and counselling to tackle the problem

BRUSSELS, October 1st /PRNewswire/ — One in 10 working people surveyed in Europe have taken time off work because of depression, with an average of 36 days lost per episode of depression, according to a new survey from the European Depression Association. This equates to more than 21,000 days of lost working time in this group of people. However despite the size of the problem, nearly one in three managers reported they had no formal support or resources to deal with employees who have depression, and 43% called for better policies and legislation to protect employees.

Commenting on the results, MEP Stephen Hughes said, “Depression in the workplace is an employment and societal challenge that is causing serious damage and which requires attention and action from the European Union. The inclusion of depression in the workplace in the new European Commission Strategy for Health and Safety at Work, backed up in the coming two years with legislative action, would represent excellent progress towards protecting Europe’s workers more effectively and ultimately contributing to economic and social prosperity.”

Depression is the predominant mental health challenge among working-age people and more than 30 million European citizens will suffer from depression at some point in their life.1 The IDEA survey (Impact of Depression in the Workplace in Europe Audit) polled more than 7,000 people in Europe and found that 20% of respondents had received a diagnosis of depression at some point. The highest rate was in GB (26%) and the lowest in Italy (12%). Among workers experiencing depression, those in Germany (61%), Denmark (60%), and GB (58%) were most likely to take time off work, while those in Turkey were the least likely to take time off (25%).

The costs of depression were estimated at €92 billion in 2010 in the EU, with lost productivity due to absenteeism (taking time off work) and presenteeism (being present at work while ill) representing over 50% of all costs related to depression.1 In the IDEA survey the average number of days taken off work during the last episode of depression was 36 days, with Germany and GB having the highest (41 days) and Italy (23 days) having the lowest.

Despite the high rates of absenteeism due to depression, one in four of those experiencing depression stated they did not tell their employer about their problem. Of these, one in three said they felt it would put their job at risk in the current economic climate.

The cognitive symptoms of depression (concentration difficulties, indecisiveness, and/or forgetfulness) cause significant impairment in work function and productivity,2 and are present 94% of the time in an episode of depression.3 However, the survey shows that awareness of these symptoms is poor: when asked to identify signs of depression only 33% said forgetfulness, 44% indecisiveness and 57% trouble concentrating. In contrast 88% identified low mood or sadness as a sign of depression.

Among the managers surveyed, approximately one in three reported there was no formal support in place to help them deal with depression in employees. The lack of support was highest in Germany (44%) and lowest in Turkey (10%). Managers in GB (55%) were most likely to have support from their HR department, while managers in Turkey were most likely to receive support from a medical professional (79%).

When asked what is needed to support employees with depression in the workplace, managers most often cited more counselling services and better government legislation and policies. In Turkey managers were most likely to call for better legislation (55%) and training for all employees (63%). Managers in GB and Turkey wanted better counselling services (56% and 53%), while German managers prioritised line manager training (53%).

Dr Vincenzo Costigliola, President of the European Depression Association said “The results of the IDEA survey show that much needs to be done in raising awareness and supporting employees and employers in recognising and managing depression in the workplace. We ask policymakers to consider the impact of depression on the workforce and charge them with addressing depression and workers and workplace safety.”

Full results of the IDEA survey will be published in 2013.

Contact: Colette Green, OgilvyHealthPR, Email: colette.green@ogilvy.com, Tel: +44(0)207-108-6028.


Notes for Editors

The European Depression Association (EDA)

EDA is an alliance of organisations, patients, researchers and healthcare professionals from 17 countries across Europe. Each year on October 1, EDA organises European Depression Day to raise awareness of depression across Europe. The theme of this year’s campaign is ‘Depression and the Workplace’. On October 1, a group of policy experts and stakeholders will meet in Brussels to continue discussions on how best to address the burden and impact of depression in the workplace in Europe. This meeting follows the Expert Roundtable on Depression in the Workplace held on 5 June 2012 by MEP Stephen Hughes. The overall aim of the meeting is to secure binding EU legislation on depression in the workplace.

The EDA is sponsored by the European Medical Association, International Scientific Association, Centro Lombardo Recuperi Industriali, L.A. Nuova Stampa and H. Lundbeck A/S.

About the IDEA (Impact of Depression in the Workplace in Europe Audit) Survey

The research was conducted using Ipsos MORI’s online panel, between 30 August and 19 September 2012. Questions were asked online of 7,065 adults aged 16-64 who are workers and managers, or have worked and managed within the last 12 months, across Europe. Results are weighted to ensure the sample was representative of this profile. Full data tables are available upon request. The survey was supported by an educational grant from H. Lundbeck A/S.


References

  1. Olesen J, Gustavsson A, Svensson M, et al. The economic cost of brain disorders in Europe. Eur J Neurol 2012; 19:155-162
  2. Greer TL, Kurian BT, Trivedi MH. Defining and measuring functional recovery from depression. CNS Drugs. 2010;24(4):267-284
  3. Conradi HJ, Ormel J, de Jonge P. Presence of individual (residual) symptoms during depressive episodes and periods of remission: a 3-year prospective study. Psychol Med. 2011; 41:1165-1174

Source: www.prnewswire.com

Today’s Headlines – Sept. 28, 2012

Today’s Headlines – Sept. 28, 2012

Today’s early morning highlights from the major news organizations, including reports about political and policy-oriented health care developments.

The Washington Post: Medicare Working To Boost Obama In Swing States, Poll Finds
Voters in three critical swing states broadly oppose the far-reaching changes to Medicare -associated with the Republican presidential ticket and, by big margins, prefer President Obama to handle the issue, according to new state polls by The Washington Post and the Kaiser Family Foundation. For seniors in Florida, Ohio and Virginia, Medicare rivals the economy as a top voting issue (Aizenman, Cohen and Craighill, 9/27).

The Associated Press/Washington Post: Looking Past Entitlements, Senior Voters Ask How They Will Fare In An Obama Or Romney Economy
Get in line, Medicare and Social Security. Seniors, like just about everyone else, have money on their minds. Who wins the trust of seniors … will be a deciding factor in the presidential election. That should be good news for Mitt Romney, because those 65 and older have backed the Republican candidate in both of the last two presidential elections. But President Barack Obama has been pounding Romney and his running mate, Rep. Paul Ryan, on their plan for Medicare. Those attacks are starting to bear fruit for Obama, who is gaining ground among seniors in two key battlegrounds: Florida and Ohio. Still, Romney has the edge nationally among seniors — in no small part thanks to seniors’ concerns about Obama’s handling of the economy (9/27).

For more headlines …

The New York Times: Obama Fills In Blanks Of Romney’s Plans, And GOP Sees Falsehoods
The Obama campaign has run advertisements charging that Mitt Romney’s Medicare plan “could raise seniors’ costs up to $6,400 a year” and that his tax proposal “would give millionaires another tax break and raises taxes on middle-class families by up to $2,000 a year” (Cooper, 9/27).

Politico: What Obama Isn’t Saying About Medicare
As Woodward explains in “The Price of Politics,” Obama was willing to make significant changes to the cherished federal health care plan for seniors last year as part of a grand bargain with congressional Republicans. And 2011 was hardly the first time Obama considered confronting the costly and popular program; it’s also highly likely it won’t be the last if he’s reelected (Martin, 9/27).

Los Angeles Times: Obama And Romney Campaigns Take Battle To Virginia
Both candidates are heavily targeting women in Virginia, particularly in the northern suburbs of Washington, where Romney campaigned Thursday. Democrats are accusing Republicans of waging a “war on women” by targeting reproductive rights. They point to a measure that failed in the Virginia Legislature this year that would have required trans-vaginal ultrasounds before a woman could have an abortion. … Outside groups are also weighing in, airing ads that feature Romney’s vow this year to eliminate funding for Planned Parenthood. A GOP group is running an ad featuring a young woman jogging with her daughter in a stroller, while the narrator describes herself as a former Obama voter whose husband was laid off twice (Mehta, Reston and Memoli, 9/27).

Los Angeles Times: Paul Ryan Does Not Need To Be Unmuzzled, Paul Ryan Says
Instead, the Wisconsin congressman pointed out that he has concentrated his efforts on interviews with regional reporters, which often go unreported by national news outlets but are designed to target voters in specific markets. … But Ryan has not avoided places where he is likely to encounter hostile crowds. Last week, he gave a speech to the national AARP convention in New Orleans, where he was booed for advocating the repeal of the president’s healthcare law and the restructuring of Medicare for future retirees (Abcarian, 9/27).

The Associated Press/Washington Post: Presidential Coattails A Potential Factor In Some Tight Races For Control Of Senate
They will help shape a number of key Senate and House races. The prospect of presidential coattails — or the opposite, a drag — is factoring into the way races down the ballot are being run, especially in close contests. … The impact and potential of coattails is less clear in the House. …  Romney’s struggle to overcome his remarks at a meeting with donors offered an early demonstration of how the top of the ticket can quickly shake other races. His comment … that 47 percent of Americans think they are “victims” entitled to government help and that he doesn’t worry about “those people,” sent Republican Senate candidates scrambling. … There are, after all, a lot of Republicans in that 47 percent — seniors, for example, who depend on government programs like Medicare and Social Security after paying into them for decades (9/27).

The Washington Post: Kaine Ad Hits Allen On Medicare, Social Security
Timothy M. Kaine upped the ante Thursday in the battle over seniors in Virginia, launching a new ad hitting George Allen for his record on Social Security and Medicare (Pershing, 9/27).

The Associated Press/Washington Post: National Issues Make Nevada Senate Race A Nail-Biter Over Ethics, Medicare
Rep. Shelley Berkley ended her speech at a recent gathering of union members and retirees here by bringing up a potentially risky subject — her husband, Dr. Larry Lehrner. Lehrner was supposed to be an albatross in the seven-term congresswoman’s attempt to replace Republican Dean Heller in the U.S. Senate, because his involvement in a kidney transplant program that Berkley pushed to save sparked a House Ethics Committee investigation of the congresswoman. But Berkley focused instead on health care, luck and love (9/27).

The Wall Street Journal: Some Firms’ Workers Will Choose From Array Of Benefits
Is health insurance just the beginning? A handful of employers may go even farther than Sears Holdings Corp. and Darden Restaurants Inc., which plan to give workers a set sum of money next year to use in choosing among health plans (Mathews, 9/27).

The Associated Press/Washington Post: Public Citizen Advocacy Group Tracks Rise In Pharmaceutical Settlements With State Governments
Federal and state prosecutors have collected more than $30 billion from drug companies for alleged fraud and illegal marketing over the last 20 years, according to a new report by consumer advocacy group Public Citizen (9/27).

Los Angeles Times: Free Healthcare Clinic At LA Sports Arena Draws 4,800
Many of the 4,800 people seeking care at the annual massive free clinic this weekend will become eligible for health insurance in 2014 when the national law takes effect. Organizers said raising awareness about the healthcare changes is crucial (Gorman, 9/27).

The Associated Press/Washington Post: Md. Health Reform Panel Approves State Health Plan As Benchmark In Health Care Reform
A Maryland panel working on implementing federal health care reform voted Thursday to use the state employee health plan as a benchmark for other plans that will be available to small businesses and individuals for two years, starting in 2014 (9/27).

The Associated Press/Washington Post: Liberal Oklahoma Pastors Protest Hobby Lobby Suit Challenging Coverage Of Morning-After Pill
Christian activists attempted Thursday to deliver a petition to Hobby Lobby criticizing its challenge to a portion of the new federal health care law, but guards at the company’s headquarters turned them away. … Schmitz said more than 80,000 people had signed copies of a petition circulated nationwide by Faithful America, an online Christian group, and UltraViolet, which promotes women’s rights. Schmitz said he intends to mail the petition to the company. Lawyers representing Hobby Lobby this month sued the federal government claiming it should not be forced to provide workers with health insurance that covers the morning-after and week-after pills (9/27).


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Internationale Studie unterstreicht Notwendigkeit der Unterstützung von Psoriasispatienten, die unter Isolation, Stigmatisation und Angstgefühlen leiden

Internationale Studie unterstreicht Notwendigkeit der Unterstützung von Psoriasispatienten, die unter Isolation, Stigmatisation und Angstgefühlen leiden

KOPENHAGEN, Dänemark, September 30, 2012 /PRNewswire/ --

  • LEO Pharma hat die erste wirklich umfassende internationale Studie mit qualitativen und quantitativen Daten zur Erforschung des Einflusses von Psoriasis durchgeführt.
  • Das Ergebnis: Das Leben der Patienten ist geprägt von Gefühlen der Einschränkung, Isolation, Stigmatisation und Angst; diese Gefühle sind wichtiger als der diagnostizierte Schweregrad der Symptome.

Die Daten der Untersuchung mit dem Titel "Belastung durch Psoriasis" wurden an diesem Wochenende auf dem 21. EADV-Kongress in Prag, Tschechische Republik, präsentiert. Die Ergebnisse der Untersuchung, die eine quantitative Online-Befragung von 3 822 Psoriasispatienten umfasste, zeigten, dass bei 73 % der befragten Patienten die Krankheit einen mäßigen bis hohen Einfluss auf ihr Leben hat.[1]

Die Multimedia-Pressemitteilung finden Sie unter:

http://multivu.prnewswire.com/mnr/prne/leo-pharma/56611 

Personen mit Psoriasis leiden unter Effloreszenzen, die zu dicken, roten, schuppigen Hautschäden überall am Körper führen können.[2] Die Haut ist häufig entzündet und juckt[2],[3]; die aktuelle Studie betont jedoch, dass die psychologischen Auswirkungen der Psoriasis das Leben der Patienten noch stärker beeinträchtigen.[1]

Zu den in der Untersuchung analysierten Faktoren gehören der Einfluss der Belastung durch die Symptome, die Beziehung zum betreuenden Arzt, patientenspezifische Faktoren sowie der psychologische Einfluss der Psoriasis, d. h. inwieweit die Krankheit diktiert, wie die Patienten ihr Leben führen.[1] Die Faktoren mit dem stärksten Einfluss bezogen sich auf tägliche Aktivitäten, Stigmatisation, Isolation und Angstgefühle. Die diagnostizierte Ausprägung der Symptome war jedoch kein signifikanter Faktor.[1]

Dr. Anthony Bewley, Whipps Cross University Hospital und Barts and the London NHS Trust, Großbritannien, sagte zu dieser Untersuchung: "Die tatsächliche oder vermeintliche Reaktion anderer kann das Leben der Patienten zu einem echten Kampf machen. Wir müssen unsere Patienten aktiv über diese Probleme befragen und die Behandlung entsprechend ändern. Wir planen weitere Analysen dieser umfassenden Datensammlung, denn wir glauben, die Ergebnisse werden zu einer individuellen Anpassung der Therapie beitragen".

"Die physikalischen, psychologischen und sozialen Auswirkungen von Psoriasis können das Leben der Patienten nachhaltig beeinflussen", sagte Gitte P. Aabo, Präsidentin und CEO von LEO Pharma. "Damit wir Psoriasispatienten die besten Chancen zur Verbesserung ihrer Lebensqualität geben können, müssen wir die Probleme angehen, die die einzelnen Patienten haben. Durch die Untersuchung ‚ Belastung durch Psoriasis' lernen Ärzte, Krankenschwestern und Pfleger mehr über den Einfluss der Psoriasis auf das Leben der Patienten und können so zur Entwicklung von Möglichkeiten zur Behandlung dieser Krankheit beitragen."

Quellen

1.    Bewley A, Ersser S, Hansen M, Pevac C. Psychosocial and symptomatic burden of psoriasis for patients in Europe, the USA and Canada. (Psychologische und symptomatische Belastung durch Psoriasis für Patienten in Europa, den USA und Kanada) Zusammenfassung präsentiert auf dem EADV-Kongress in Prag, 27.-30. September 2012 (ID-Nr. PRA12-0920).

2.    Basavaraj KH, Navya MA, Rashmi R. Stress and quality of life in psoriasis: an update (Stress und Lebensqualität bei Psoriasis: Aktualisierung). Int J Dermatol 2011;50:783-92.

3.    A.D.A.M. Medical Encyclopedia. Psoriasis. (abgerufen im Mai 2012 unter http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001470/.)


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Saturday, September 29, 2012

Lilly Releases Phase II Results for Monoclonal Antibody Ramucirumab in Lung Cancer

Lilly Releases Phase II Results for Monoclonal Antibody Ramucirumab in Lung Cancer

INDIANAPOLIS, Sept. 29, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new data from two Phase II ramucirumab (IMC-1121B) trials in patients with non-small cell lung cancer (NSCLC). Results were presented today during the Lung Cancer – Metastatic Poster Session at the ESMO 2012 Congress (European Society for Medical Oncology), 1:00 p.m.2:00 p.m. CET, in Vienna, Austria.

Interim data for a study in chemotherapy-naive patients with advanced NSCLC treated with ramucirumab in combination with first-line ALIMTA® (pemetrexed for injection)/platinum-based chemotherapy (Abstract #1245) and final data for a study in patients treated with ramucirumab in combination with paclitaxel/carboplatinum chemotherapy (Abstract#1287) were presented. The pre-specified interim analysis of progression-free survival (PFS) (Abstract #1245) and final six-month PFS rate (Abstract #1287) support continued development of ramucirumab in lung cancer.

"We are encouraged by these results from two Phase II trials indicating ramucirumab may be beneficial to patients with non-small cell lung cancer," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "These findings support our ongoing evaluation of ramucirumab for lung cancer patients and will need to be confirmed in larger pivotal studies."

Abstract # 1245
A randomized open-label Phase II study of 140 chemotherapy-naive patients investigated ramucirumab in combination with first-line chemotherapy in advanced nonsquamous NSCLC. Patients were randomized based on histology (nonsquamous [Arms A versus B]; squamous [Arms C versus D]). Enrollment of patients with squamous histology [Arms C versus D] is ongoing. Therapy in Arm A included Lilly's ALIMTA (500 mg/m2) plus carboplatin (AUC=6) or cisplatin (75 mg/m2) once every three weeks, while therapy in Arm B included ramucirumab (10 mg/kg), ALIMTA (500 mg/m2) plus carboplatin (AUC=6) or cisplatin (75 mg/m2) once every three weeks.

The primary endpoint for the interim analysis was PFS. Other interim endpoints included change in tumor size, disease control rate (DCR), and safety. Interim median PFS, based on a pre-specified analysis, was 4.3 months for Arm A, the control arm, and 6.3 months for Arm B, the experimental arm (hazard ratio, 0.48; 90% CI: 0.31-0.74). DCR was 72 percent for Arm A and 87 percent for Arm B.  

The most frequently observed (>10%) grade three or higher adverse events (AEs) on Arm B were thrombocytopenia (Arm B, 22% vs Arm A, 19%), neutropenia (18% vs 17%), fatigue (12% vs 17%), anemia (10% vs 16%), hypertension (10% vs 1%) and nausea (10% vs 7%).

Based on these interim analyses of PFS and acceptable tolerability and safety, investigators concluded that ramucirumab supports further study as a potential treatment with first-line platinum-based chemotherapy in nonsquamous NSCLC. 

Abstract # 1287
An additional Phase II open-label study investigated ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with advanced NSCLC. Patients with squamous histology and treated brain metastases were allowed. Forty patients received treatment, receiving ramucirumab (10 mg/kg), paclitaxel (200mg/m2) and carboplatin (AUC=6) on day one of a three-week cycle for up to six cycles, followed by maintenance ramucirumab.

The primary endpoint was PFS at six months. Secondary/exploratory endpoints were safety, overall response rate, overall survival rate at one year, pharmacokinetic and pharmacodynamic (PK/PD) profiles and immunogenicity. The overall DCR (CR+PR+SD) reached 90 percent and PFS at six months was 59.0 percent (95% CI = 41.3%-72.9%). Median PFS was 7.85 months.

The most frequently observed (>5%) grade three or higher ramucirumab related AEs were neutropenia (13%), thrombocytopenia (10%), fatigue (8%) and febrile neutropenia (8%).

Investigators concluded that ramucirumab in combination with paclitaxel and carboplatin shows potential efficacy based on the overall DCR (CR+PR+SD) of 90 percent and PFS rate at 6 months of 59.0 percent, and is well tolerated by patients with NSCLC in this Phase II study.

"Ramucirumab is one of the key molecules in Lilly's pipeline and represents one of the largest clinical programs currently underway at Lilly, with six Phase III trials ongoing around the globe including one in lung cancer," said Lilly's Gaynor. "With the breadth of ramucirumab trials we have underway, we have a tremendous opportunity to potentially affect how cancer patients across multiple tumors are being treated."

Notes to Editor

About Ramucirumab
Ramucirumab is a fully human IgG1 monoclonal antibody receptor antagonist designed to bind the extracellular domain of vascular endothelial growth factor (VEGF) receptor-2, thereby blocking the interaction of VEGF ligands (VEGF-A, VEGF-C, and VEGF-D) and inhibiting receptor activation. VEGF receptor 2 is considered a primary mediator of angiogenesis. When activated by VEGF ligands, VEGF receptor 2 promotes endothelial cell proliferation and survival, migration, and vascular permeability.

Ramucirumab, which Lilly gained through its 2008 acquisition of ImClone Systems, is being investigated in clinical trials as monotherapy and in combination with other anticancer therapies.

for the treatment of breast cancer, gastric cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, bladder cancer, urethra cancer, ureter cancer, renal pelvis carcinoma, prostate cancer, ovarian cancer and glioblastoma multiforme. It is in late-stage clinical evaluation for the treatment of breast, colorectal, gastric, hepatocellular and lung cancer.

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer has long been the most common cancer in the world, representing nearly 13 percent of all new cancers and causing nearly 1.4 million deaths annually.[1] About 85 – 90 percent of all lung cancers are NSCLC.[2]  The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.

NSCLC comprises a group of histologies or tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses,[3] as well as histologies classified as 'other.'

For more information on NSCLC, please visit www.lillyoncologynewsroom.com.

About Lilly Oncology
For more than four decades, Lilly Oncology, a division of Eli Lilly and Company, has been dedicated to delivering innovative solutions that improve the care of people living with cancer.  Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of 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.

P-LLY

ATONC00091     29 September 2012

Important Safety Information for ALIMTA® (pemetrexed for injection)

What is the most important information that I should know about ALIMTA?
ALIMTA can suppress bone marrow function, which may cause low blood cell counts.

ALIMTA may not be appropriate for some patients.

If you are allergic to ALIMTA, tell your doctor because you should not receive it.

If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.

Your doctor will prescribe a medicine called a "corticosteroid" to take for 3 days during each treatment with ALIMTA. Corticosteroids lower your chances for getting skin reactions with ALIMTA.

It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.

  • You must take folic acid every day for at least 5 days out of the 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are getting treatment with ALIMTA, and for 21 days after your last treatment.
  • Your doctor will give you vitamin B12 injections while you are getting treatment with ALIMTA. You will get your first vitamin B12 injection during the week before your first dose of ALIMTA, and then about every 9 weeks during treatment.

You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.

What should I tell my doctor before receiving ALIMTA?
If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.

Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other medicines may affect each other, causing serious side effects. Especially, tell your doctor if you are taking medicines called "nonsteroidal anti-inflammatory drugs" (NSAIDs) for pain or swelling.

What are the possible side effects of ALIMTA?
Most patients taking ALIMTA will have side effects. Sometimes it is not always possible to tell whether ALIMTA, another medicine, or the cancer itself is causing these side effects.

Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death.

The most common side effects of ALIMTA when given alone or in combination with cisplatin are:

  • Stomach upset, including nausea, vomiting, diarrhea, or constipation. You can obtain medicines to help control some of these symptoms. Call your doctor if you get any of these symptoms.
  • Low blood cell counts:
    • Low red blood cells. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath.
    • Low white blood cells. Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4°F) or other signs of infection, call your doctor right away.
    • Low platelets. Low platelets give you a greater chance for bleeding. Your doctor will do blood tests to check your blood counts before and during treatment with ALIMTA.
  • Tiredness. You may feel tired or weak for a few days after your ALIMTA treatments. If you have severe weakness or tiredness, call your doctor.
  • Mouth, throat, lip, or food pipe sores (stomatitis, pharyngitis, esophagitis). You may get redness or sores in your mouth, throat, or on your lips, or you may feel pain or difficulty when drinking or swallowing food. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor if you get any of these symptoms.
  • Loss of appetite. You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you.
  • Rash. You may get a rash or itching during treatment. These reactions usually appear between treatments with ALIMTA and usually go away before the next treatment. Skin reactions or rashes that include blistering or peeling may be severe and could lead to death. Call your doctor if you have any of these symptoms.

Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn't go away.

These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist.

How is ALIMTA given?
ALIMTA is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).

For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information accompanying this booklet, visit www.ALIMTA.com, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

This press release contains forward-looking statements about the potential of ramucirumab as a treatment of various cancers and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product 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.

[1] World Health Organization International Agency for Research in Cancer, GLOBOCAN 2008, Section of Cancer Information, http://globocan.iarc.fr/factsheets/cancers/lung.asp, (Accessed June 20, 2012).

[2] American Cancer Society, "What Is Non-Small Cell Lung Cancer?," December 16, 2010, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (October 20, 2011).

[3] American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 20, 2009, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (October 20, 2011)..

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American Academy of Pediatrics Redefines Levels of Intensive Care for Newborns

American Academy of Pediatrics Redefines Levels of Intensive Care for Newborns

Children's Omaha is the only Level IV NICU serving multi-state region

OMAHA, Neb., Sept. 29, 2012 /PRNewswire-USNewswire/ -- New standards published by the American Academy of Pediatrics (AAP) establish Children's Hospital & Medical Center in Omaha, Neb., as the only Level IV Regional Newborn Intensive Care Unit serving Nebraska, western Iowa and South Dakota.  Level IV is the highest level of care as defined by the AAP.

Children's meets a number of strict criteria including:

  • Experience in the care of the most complex and critically ill newborns.
  • The availability of subspecialists on-site and available 24/7 including heart surgeons, pediatric surgical subspecialists and pediatric anesthesiologists.
  • The experience and expertise to provide surgical repair of complex congenital conditions including serious heart defects.
  • The ability to transport critically ill newborns by ground, helicopter and fixed wing aircraft.
  • And, the ability to facilitate and provide outreach education.

The new standards were published in the September 2012 edition of the medical journal, Pediatrics

"The AAP has taken a significant step in redefining these classifications of care.  It's important to understand all newborn intensive care units aren't alike.  As the only Level IV NICU in the state, Children's Hospital & Medical Center is uniquely qualified to care for the sickest babies," said Lynne Willett, M.D., Clinical Service Chief of Neonatology at Children's.  "Neonatologists, nurses, pediatric surgeons and specialists, and a skilled critical care transport team – we are all here and working together to give these newborns the most comprehensive care available."

Since 2004, Children's had been recognized as a Level IIIC unit, the highest level as noted by past AAP standards.  Based on capabilities and provider types, the new classifications define units as:  Level I, well newborn nursery; Level II, special care nursery; Level III, Newborn Intensive Care Unit; or Level IV, Regional Newborn Intensive Care Unit.

"Children's is widely recognized as a regional resource providing advanced diagnostics and treatments.  Patients come to our unit from other NICUs, hospitals, and health systems across the state and beyond," said Dr. Willett.

Children's Hospital & Medical Center (www.ChildrensOmaha.org) is recognized as a 2012-13 Best Children's Hospital by U.S. News & World Report in cardiology and heart surgery, and cancer.  Located in Omaha, it is the only full-service, pediatric health care center in Nebraska providing pediatric specialty services across a five-state region and beyond. 

SOURCE Children’s Hospital & Medical Center

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RELATED LINKS
http://www.ChildrensOmaha.org


Source: www.prnewswire.com

Chiropractic Care Enhances Children's Overall Health

Chiropractic Care Enhances Children's Overall Health

BLOOMINGTON, Minn., Sept. 29, 2012 /PRNewswire-USNewswire/ -- Irritation to a young person's nervous system can begin in utero. The baby's position during delivery (natural or cesarean) can create stress on their nervous system. Even a "normal, healthy" birth can induce 40-50 pounds of pressure on a newborn's neck and spine.

Dr. Carrie Getzmier, chair of the Minnesota Chiropractic Association Communications Committee says "gentle chiropractic care not only removes this nerve interference, but also stimulates the immune system, enhancing the child's overall health."

Ear infections, colic, sleep disturbances, tilted head position, difficulty breast-feeding, reflux and constipation or diarrhea are all symptoms parents should watch for, explained Dr. Getzmier.

Bumps and falls can also create joint dysfunction and nerve irritation to a young person during the developmental years. These may present as:

  • Headaches
  • Growing pains 
  • Osgood-Schlatter's (Jumper's knee)
  • Difficulty sleeping
  • Bed-wetting
  • Difficulty concentrating or staying focused
  • Stomach aches, heartburn, or indigestion
  • Sports injuries
  • Skin Disorders
  • Asthma
  • Allergies

A variety of care approaches should be considered to enhance your child's health and well-being. Dr. Getzmier adds that "parents should also consider wellness evaluations that look at nutrition and exercise as fun ways to be healthy and have energy."

A great website for parents to reference regarding conditions and research is www.icpa4kids.com. To locate a doctor of chiropractic near you, go to the Minnesota Chiropractic Association at www.mnchiro.com.

About the Minnesota Chiropractic Association
Created in 1927, the Minnesota Chiropractic Association is the only professional organization in Minnesota that solely represents the chiropractic professional on a multi-level and integrated service basis.  

RESEARCH

Study shows Chiropractic Extremely Safe for Children

A study published in the December 2009 issue of the scientific periodical, the Journal of Clinical Chiropractic Pediatrics shows that chiropractic care is extremely safe for children. In research for this report, the study author undertook a review of all previously published reports of "adverse events" for chiropractic care delivered to children.

In this study the author, a chiropractor from the Anglo European College of Chiropractic, and lead tutor for Advanced Practice for Chiropractic Pediatrics, Joyce Miller, B.Sc., D.C., D.A.B.C.O., set out to review and examine the chiropractic safety record for care of children in comparison to the safety record of medications given to children. She noted that the safety issue of medications given to children is an increasing concern.

In her published study, Dr. Miller reported that according to the United Kingdom's, National Patient Safety Agency, in 2006 out of a total of 33,446 reports of medical pediatric care, 19% experienced a medication problem, 14% had a procedural safety breech, 9% showed errors in documentation, and an additional 7% had errors in medical clinical assessment.

The reported results of the authors research showed that there were six separate published reports that addressed safety of what was called "Manual Therapy" for children delivered by either chiropractors or medical practitioners. The author specifically looked at the care rendered by chiropractors for the purpose of this study.

The results showed that over a 59 year time frame, a systematic review of the literature only uncovered 8 incidences of hurt or harm to children due to chiropractic adjustments.  With an estimated 30 million pediatric adjustment visits to chiropractors made each year, the risk factor is calculated to be extremely low.

In her conclusion, Dr. Miller wrote, "Based on the published literature, it appears that manipulation, when given by a skilled chiropractor with years of training carried out with low forces recommended for pediatric care, has few side effects in the healthy infant and child and their recorded incidence is exceedingly low.

Reference: http://www.nowyouknow.com/

Additional research and information can be located at www.icpa4kids.org.

Contact: Debra Hurston
952-882-9411

SOURCE Minnesota Chiropractic Association

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http://www.mnchiro.com


Source: www.prnewswire.com

Friday, September 28, 2012

Boston Scientific Receives FDA Approval of First-in-Class S-ICD® System for Patients at Risk of Sudden Cardiac Arrest

Boston Scientific Receives FDA Approval of First-in-Class S-ICD® System for Patients at Risk of Sudden Cardiac Arrest

NATICK, Mass., Sept. 28, 2012 /PRNewswire/ -- The U.S. Food and Drug Administration has granted Boston Scientific Corporation (NYSE: BSX) regulatory approval for its S-ICD® System, the world's first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA).  The S-ICD System sits entirely just below the skin without the need for thin, insulated wires -- known as electrodes or 'leads' -- to be placed into the heart.  This leaves the heart and blood vessels untouched, offering patients an alternative to transvenous implantable cardioverter defibrillators (ICDs), which require leads to be placed in the heart itself.

"The S-ICD System establishes the first new category of cardiac rhythm management devices since the introduction of cardiac resynchronization therapy," said Raul Weiss, M.D., Associate Professor-Clinical, Cardiovascular Medicine at The Ohio State University.  "Doctors now have a breakthrough treatment option that provides protection from sudden cardiac arrest without touching the heart."

Approval of the S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients at risk of SCA.  The S-ICD System met the primary endpoints of the study, and results were presented earlier this year at the Heart Rhythm Society 33rd Annual Scientific Sessions.  The study results support that the S-ICD System is an important new treatment option for a wide range of primary and secondary prevention patients.

"With the addition of the S-ICD System, we believe Boston Scientific has a compelling and highly differentiated portfolio that will help fuel our growth strategy," said Hank Kucheman, chief executive officer, Boston Scientific.  "We are the only company to offer an FDA-approved subcutaneous implantable defibrillator and expect this to be the case for several years.  The S-ICD System, coupled with our numerous recent regulatory approvals and our other innovative products, such as the WATCHMAN® Left Atrial Appendage Closure Device and Alair® Bronchial Thermoplasty System for the treatment of severe asthma, demonstrates our continued commitment to developing and bringing to market innovative products for physicians and their patients."

Sudden cardiac arrest is an abrupt loss of heart function.  Most episodes are caused by the rapid and/or chaotic activity of the heart known as ventricular tachycardia or ventricular fibrillation.  Recent estimates show that approximately 850,000 people in the United States are at risk of SCA and indicated for an ICD device, but remain unprotected.

"Each year, thousands of patients indicated for an ICD are not referred to a specialist and remain untreated," said William T. Abraham, MD, FACC, Director, Division of Cardiovascular Medicine at The Ohio State University Heart Center.  "The S-ICD System is an important new treatment option that has the potential to improve patient acceptance of ICD therapy."

The S-ICD System is designed to provide the same protection from sudden cardiac arrest as transvenous ICDs.  The system has two main components: (1) the pulse generator, which powers the system, monitors heart activity, and delivers a shock if needed, and (2) the electrode, which enables the device to sense the cardiac rhythm and deliver shocks when necessary.  Both components are implanted just under the skin—the generator at the side of the chest, and the electrode beside the breastbone.  Unlike transvenous ICDs, the heart and blood vessels remain untouched.  Implantation with the S-ICD System is straightforward using anatomical landmarks, without the need for fluoroscopy (an x-ray procedure that makes it possible to see internal organs in motion).  Fluoroscopy is required for implanting the leads attached to transvenous ICD systems.

Boston Scientific expects to begin a phased launch of the S-ICD System that will expand over time as medical professionals are trained on the safe and effective use of the system.  The company acquired the S-ICD System earlier this year when it completed the acquisition of Cameron Health, Inc.  The S-ICD System received CE Mark in 2009 and is commercially available in many countries in Europe as well as in New Zealand.  To date, more than 1,400 devices have been implanted in patients around the world. To download a high-resolution image of the S-ICD System go to: http://bostonscientific.mediaroom.com/home.

The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

The WATCHMAN device is an investigational device in the United States.  It is limited by applicable law to investigational use and not available for sale. 

About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties.  For more information, please visit:  www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our business plans and growth strategy, markets for our products, regulatory approvals, the importance of the S-ICD System, our technology, clinical trials, product launches, product performance and competitive offerings.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement, legal and regulatory conditions; clinical trials and outcomes; new product introductions; product performance; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  Such factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.

SOURCE Boston Scientific Corporation

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http://www.bostonscientific.com


Source: www.prnewswire.com

Ansell mène à bien son projet d'acquisition de Comasec SAS

Ansell mène à bien son projet d'acquisition de Comasec SAS

MELBOURNE, Australie, September 28, 2012 /PRNewswire/ --

Ansell Limited (ASX : ANN), un leader mondial en matière de solutions de protection, a annoncé aujourd'hui avoir mené à bien son projet d'acquisition de Comasec SAS, la transaction ayant été validée par accord réglementaire. L'opération se chiffre à 101,5 millions d'euros.

Ansell va désormais entamer le processus d'intégration des deux sociétés, grâce auquel les clients d'Ansell et de Comasec auront accès à un portefeuille plus diversifié de produits et à une offre élargie de produits et de solutions. Dans le cadre du programme d'intégration, Ansell travaillera activement à rassembler le meilleur des deux entreprises au profit de leur clientèle commune.

Magnus Nicolin, PDG d'Ansell, explique : « L'ensemble du processus d'intégration se fera de manière graduelle, en prenant le temps d'apprendre à mieux connaître les activités de Comasec. Nous allons cependant accorder une priorité immédiate à la mise au point de produits et solutions novateurs combinant l'expertise des deux sociétés et améliorer les solutions proposées à nos clients. D'autres annonces seront faites ultérieurement ; entre-temps, les deux sociétés fonctionneront comme elles en ont l'habitude. »

Ansell a annoncé son intention d'acquérir Comasec le 7 août 2012. Comasec est un acteur majeur sur le marché des gants de protection régi par la réglementation européenne sur les Équipements de Protection Individuelle (EPI). Présente en Amérique du Nord, la société est spécialisée dans la fabrication des gants de protection chimique, mécanique et thermique, des gants destinés à la manipulation des aliments, des gants de protection contre les coupures et des boîtes à gants. Ses marques principales sont Comasec, Marigold et Marigold Industrial.

L'acquisition permettra de renforcer la position d'Ansell sur le marché en rapide expansion, mais fragmenté, des gants de protection à usage industriel. Elle améliorera aussi de manière significative la présence d'Ansell sur un certain nombre de marchés verticaux importants, notamment dans les secteurs de la mécanique, de la chimie, de l'alimentaire et des services.

Pour plus d'informations, veuillez contacter :

À propos d'Ansell

Ansell est un leader mondial dans le domaine de la protection de la santé et de la sécurité en proposant des solutions de haute qualité pour l'amélioration du bien-être. Implanté en Amérique du Nord, en Amérique du Sud, dans la zone EMEA et en Asie, Ansell emploie plus de 10 000 personnes à travers le monde et occupe les premières places dans le monde sur les marchés des gants industriels et médicaux ainsi que dans le domaine de l'hygiène sexuelle et du bien-être.

Les activités d'Ansell couvrent quatre secteurs : Medical Solutions (Solutions pour les professionnels de santé), Industrial Solutions (Solutions pour l'industrie), Specialty Markets (Marchés de spécialités) et Sexual Wellness (Hygiène sexuelle et bien-être).

Pour de plus amples informations sur Ansell et ses produits, visitez le site http://www.ansell.eu.

SOURCE Ansell Healthcare

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Source: www.prnewswire.com

Ocean Thin Films Releases Ultraviolet Multispectral Imaging Camera–SpectroCam-UV

Ocean Thin Films Releases Ultraviolet Multispectral Imaging Camera–SpectroCam-UV

MUMBAI, September 28, 2012 /PRNewswire/ --

SpectroCam Provides Sensitive Detection From UV Across to Near-IR

An ultraviolet (UV) multispectral imaging (MSI) system is now available from Ocean Thin Films. The SpectroCam™-UV multispectral imaging camera provides sensitive detection from UV across the visible spectrum and into the near-IR. The SpectroCam-UV is a powerful tool for high level research.

Photo: http://halmapr.com/OTF/SpectrocamUV.jpg

SpectroCam (www.spectrocam.com) is the world's first fully configurable, video-speed MSI camera. With eight interchangeable, customer defined filters, users can test many filter options, in combination with the powerful image processing software, to greatly reduce development times and speed products to market.SpectroCam makes multispectral imaging accessible to everybody from university researchers to high volume OEM equipment makers.

To accommodate an even wider scope of applications, the new SpectroCam-UV's sensor range has been extended into the UV and can be paired with filters available throughout the UVA, UVB and UVC wavelengths. In addition to the camera, Ocean Thin Films offers turnkey UV imaging packages that include UV-compatible optics and light sources.

With a full range of standard filter wavelengths, and the ability to create custom optical filters to meet application needs, Ocean Thin Films provides the right instrument to support a wide array of applications. The SpectroCam family of cameras offers the most flexible and powerful imaging tools for biomedical, forensic, agricultural, industrial and surveillance applications.

The SpectroCam platform is easily integrated into a variety of OEM systems and can be modified to meet specific mechanical and environmental needs.

About Ocean Thin Films:

Ocean Thin Films designs and produces precision optical coatings, components and assemblies that enable a wide variety of products and specialty applicationsl.Leveraging comprehensive know-how in thin film coating development, the company provides expert design assistance for collaborative custom-engineered solutions, from rapid prototyping through high-volume contract manufacturing.You can view Ocean Thin Films' press release archive at: http://halmapr.com/news/thinfilms/. Ocean Thin Films is a subsidiary of Halma p.l.c.

Website: www.oceanthinfilms.com

About Halma:

Halma p.l.c. is an international market leader in safety, health and sensor technology. A public company listed on the London Stock Exchange, it has 3,600 employees in 36 subsidiaries worldwide. Halma's subsidiaries make products that protect lives and improve the quality of life for people through innovation in market leading products which make its customers safer, more competitive and more profitable. These subsidiaries are assisting India's economy in areas such as manufacturing, energy, water and waste treatment, the environment, construction, transport and health. For further news about Halma in India and to subscribe to the Halma India RSS News Feed please visit our news blog.

Website: www.halma.com

Company contact for Ocean Thin Films:

Bhushan Dhakras, bhushan.dhakras@oceanthinfilms.com, 91-22-67080400, 91-99300 21866, Fax: 91 22 67080405

Primary Media Contact: Mr Kuniyur J. Srinivasan, Srini@halma.com, 91-22-6708 0400

Secondary Media Contact: Damian Corbet, damian.corbet@halma.com, 44-1494-789152

SOURCE Ocean Thin Films

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Source: www.prnewswire.com

Medicaid Helps D.C. Clinic Care For Ex-Prisoners

Medicaid Helps D.C. Clinic Care For Ex-Prisoners

Dr. Ilse Levin specializes in internal medicine, but you could say she really focuses on incarceration medicine. Levin works at a community health center in southeast Washington, D.C., that pays a lot of attention to treating a population that is often left out of health care: newly released prisoners.

"I have patients who've been locked up for 40 years," Levin says. "They have no idea how to get refills, how to go to a pharmacy. Often, they don’t know how to take their own medications, especially things like insulin."

When prisoners get out, they often don't have a job and, therefore, don’t have health insurance. That could be changing soon, though.

The eligibility requirements for Medicaid are expanding in 2014 as a part of the health overhaul law. Right now, Medicaid in most states is mainly targeted toward children, families and the disabled. After the Medicaid expansion goes into effect, even single, adults who don’t have children will be eligible.

Some states and the District have gotten a head start and rolled out the Medicaid expansion early. That means Levin can get reimbursed for the care she provides to patients like Keith Snowden, a D.C. resident who got out of prison last year.

Snowden had been dealing with out-of-control hypertension for years, even before he went to prison in 2009 for selling stolen cars and counterfeit IDs. At his first post-prison visit to Levin’s clinic, his blood pressure was off the charts ‑ 227 over 153.

"The hospital was right next door. They wouldn't let me walk next door," Snowden recalls. "I had to have the ambulance come pick me up. It was that bad."

Snowden says he had been taking blood pressure medication for years to no effect. Levin conducted a barrage of tests and eventually discovered the culprit: a tumor weighing on his adrenal gland. Snowden had it surgically removed recently; now his blood pressure is back on the charts.

"It took the free doctor for me to go and figure out my problem," Snowden says. "I really owe my life to her for being so diligent and trying to figure this out."

Calling Levin a "free doctor" isn’t entirely accurate. Her clinic is a federally qualified community health center run by the charitable non-profit Unity Health Care. Doctors and other caregivers there treat patients regardless of their ability to pay, but the kind of life-saving care Levin provided to Snowden costs money.

Levin says it’s much easier to provide appropriate care now that D.C. has moved forward with the health law’s Medicaid expansion, allowing her patients to get health insurance.

"Now, everyone gets Medicaid," she says. "And suddenly I can get them their medications, I can get them to see a specialist, I can get the studies done. And it is amazing. It's completely changed my practice."

Not everyone getting out of prison will be eligible for Medicaid, however. The governors of at least half a dozen states say they wont participate in the Medicaid expansion because it's too expensive.


Source: feeds.kaiserhealthnews.org

Thursday, September 27, 2012

OncoGenex Announces Initiation Of A Phase 3 Trial For Custirsen In Advanced Non-Small Cell Lung Cancer

OncoGenex Announces Initiation Of A Phase 3 Trial For Custirsen In Advanced Non-Small Cell Lung Cancer

BOTHELL, Wash. and VANCOUVER, British Columbia, Sept. 27, 2012 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today the initiation of ENSPIRIT, a Phase 3 trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have progressed after initial chemotherapy treatment has failed. The trial will investigate if combining custirsen with docetaxel, a standard second-line NSCLC chemotherapy, has the potential to improve survival outcomes compared to docetaxel alone in these patients.  Two formal interim analyses are planned for stopping the trial early based on inadequate evidence of clinical benefit or futility. No interim analyses for claiming efficacy are planned.

"Despite breakthroughs in molecular targeting for advanced NSCLC, most patients require chemotherapy and unfortunately, often progress to require second-line treatment," said Cindy Jacobs, Ph.D, MD, Chief Medical Officer and Executive Vice President of OncoGenex Pharmaceuticals. "Given custirsen's enhancement of taxanes pre-clinically as well as with a wide range of anti-cancer agents, even in chemo-resistant models, we are eager to learn if custirsen can improve docetaxel outcomes in patients with progressive NSCLC."

Custirsen is unique in that it augments anti-cancer treatments by blocking the production of clusterin, a protein linked to faster rates of cancer progression and shorter survival duration.  A single-arm trial in first-line NSCLC evaluating custirsen in combination with a gemcitabine/platinum-based chemotherapy regimen demonstrated a median overall survival of 14.1 months, decreased serum clusterin levels in 95% of patients evaluated, and an acceptable safety profile. In this trial, lower serum clusterin levels correlated to longer survival outcomes.

"The custirsen development program now has three Phase 3 studies enrolling patients to evaluate the potential benefit of combining custirsen with chemotherapy regimens," said Scott Cormack, CEO and President of OncoGenex Pharmaceuticals. "We are pleased that Teva has initiated this Phase 3 study of custirsen in advanced NSCLC, a difficult disease to treat and where effective and tolerable treatment options are desperately needed."

Custirsen received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treatment of patients with castrate-resistant prostate cancer (CRPC) receiving first-line docetaxel chemotherapy. The Phase 3 SYNERGY study, evaluating a survival benefit in the first-line CRPC setting, continues to accrue patients and is expected to complete enrollment later this year. Additionally, OncoGenex recently announced initiation of patient enrollment in AFFINITY, a second Phase 3 study in patients with CRPC, evaluating a survival benefit in combination with second-line chemotherapy, Jevtana® (cabazitaxel).

For more information on the ENSPIRIT trial, please visit http://clinicaltrials.gov/ct2/show/NCT01630733.

ABOUT ENSPIRIT

ENSPIRIT is an international, randomized, open-label study that will enroll approximately 1,100 patients with advanced or metastatic NSCLC who have been previously treated with a first-line platinum-based chemotherapy and have documented disease progression. Patients will be randomized to receive custirsen plus docetaxel or docetaxel alone. The primary objective of the study will be overall survival with additional secondary and exploratory analyses of other efficacy outcomes and biomarker relationships. Two formal interim analyses are planned for stopping the trial early based on inadequate evidence of clinical benefit or futility. No interim analyses for claiming efficacy are planned.

ABOUT CUSTIRSEN

Custirsen is the only compound currently in development designed to inhibit the production of clusterin, a protein commonly over-produced in cancer cells, and one cause of treatment resistance. As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to 294 patients with various types of cancer. Some of the patients experienced a variety of adverse events, the majority of which were associated with other treatments in the protocol and the disease. The majority of adverse events were mild and the most common adverse events associated with custirsen consisted of flu-like symptoms. The most common serious adverse events (SAE) associated with custirsen were febrile neutropenia, fever, pleural effusion, and dyspnea. Each SAE event was observed in approximately 2%-4% of patients.

ABOUT ONCOGENEX

OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical Industries Ltd. (NYSE:  TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. OGX-427 is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com.

ONCOGENEX' FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning our anticipated product development activities, such as expected clinical trial initiation and completion and statements regarding the potential benefits and potential development of our product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that final trial results will not demonstrate the same or any potential benefit as observed in preliminary trial results, the risk that subsequent studies may not confirm earlier trial results, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product, the risk that our cash resources are insufficient to fund our planned activities for the time period expected and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

JEVTANA® is a registered trademark of sanofi-aventis.

SOURCE OncoGenex Pharmaceuticals, Inc.

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http://www.oncogenex.com


Source: www.prnewswire.com

The VWR Foundation Contributes Over $200,000 in 2012 to Support Research, Science Education, Health and Well-Being Initiatives

The VWR Foundation Contributes Over $200,000 in 2012 to Support Research, Science Education, Health and Well-Being Initiatives

RADNOR, Pa., Sept. 27, 2012 /PRNewswire/ -- VWR International, LLC, announced today that its corporate foundation, the VWR Foundation, granted over $200,000 to date in 2012, supporting organizations and initiatives committed to scientific research and education, as well as health and well-being. This year the VWR Foundation supports a diverse group of organizations dedicated to bringing advancements, training, and knowledge to their communities and beyond.

(Logo: http://photos.prnewswire.com/prnh/20120927/NY82365LOGO )

"Every year, the VWR Foundation strives to better its support of the science community and to date, we have already doubled the dollars we gave in 2011," stated Jim Bramwell, President of the VWR Foundation. "We also continue to look for organizations that embody our mission as we feel it is our responsibility to give back to the communities where we live and work on a daily basis."

Upholding the Foundation's commitment to science education, the Foundation has awarded funds to numerous organizations with a focus in science education, including Junior Achievement of Delaware Inc., an organization that inspires and prepares young people to succeed locally and in the global economy through work readiness, entrepreneurship, and financial literacy.  

Also receiving a grant is the Moorseville, Indiana-based JRSI Foundation Inc, a foundation dedicated to advancing hip and knee replacement procedures for patients suffering from debilitating arthritis and associated disorders. The grant will fund JRSI's student internship program in the investigation of clinical biomechanics and orthopedic surgery for the improvement in long-term treatment of arthritis-associated disorders.

Maintaining true to its mission of supporting health and well-being initiatives, the VWR Foundation granted funds to the Professionals Analyzing Pap Smears Inc. of Redlands, CA, an organization devoted to establishing self-sustaining Cervical and Breast Cancer Screening Clinics in developing countries and underserved areas. Their clinics make these services accessible and affordable to all women regardless of social or economic status.

Other organizations receiving grants from the VWR Foundation in 2012 include Cristo Rey Philadelphia High School, Academy of Natural Sciences and Scripps Research Institute. If you know an organization that may be aligned with the VWR Foundation mission, please have them visit our website at www.VWRfoundation.org.

About VWR Foundation

The VWR Charitable Foundation was established in January 2009 by a group of VWR International, LLC associates with its missions focused on research, science education, health and well-being.  In July 2009, the VWR Foundation distributed its first grant.  More information about the VWR Foundation, including a grant application can be found at www.VWRfoundation.org.

SOURCE VWR Foundation

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http://www.vwrfoundation.org


Source: www.prnewswire.com

Wednesday, September 26, 2012

Beverly Hills Plastic Surgeon Payam Jarrah-Nejad Reiterates Humanitarian Convictions

Beverly Hills Plastic Surgeon Payam Jarrah-Nejad Reiterates Humanitarian Convictions

LOS ANGELES, Sept. 26, 2012 /PRNewswire/ -- Dr. Payam Jarrah-Nejad's commitment to the Hippocratic Oath was never in question. Beverly Hills plastic surgery is a growing field, but despite their high profile, surgeons like Jarrah-Nejad - aka "Dr. J," as he's affectionately known to his patients - aren't often reputed for their acts of loving kindness as much as they are for breast augmentation in Beverly Hills. For Dr. J, however, there is nothing more precious than his opportunities to touch the lives of those less fortunate. The developing world is overrun with conditions we in the United States would normally see treated easily. "Some of these are simple hand surgeries and burn treatments that we in the States take for granted."

Dr. J's humanitarian principles inform his approach to plastic surgery here in Beverly Hills as well. Patients describe him as "very attentive, and generous with his time." One patient remarked that it was comforting to know Dr. J routinely handles cases involving children, and other emergency reconstructive procedures, "because it just seems like it takes compassion and emotional strength to handle those cases," she said.

Dr. J recently returned from a trip to Peru with a renewed conviction about giving back. The small city of Ayacucho in The Southern Andes is far from the luxury of Rodeo Dr., and not located anywhere near Peru's primary tourists attractions. What attracted Dr. J, however, was the city's need for an experienced surgeon who could offer life changing surgery to some of its people. This summer, Ayacucho was the scene of a number of Dr. J's hand surgeries, facial reconstructions, cleft lip repairs, cleft palate repairs, rhinoplasty operations, and surgeries to reduce burn scars.

Now that Dr. J has returned to his busy Los Angeles routine, he wishes to express his heartfelt gratitude to those in the United States who helped him find Ayacucho, and those in Peru who accommodated him. He hopes that his colleagues will answer the humanitarian call. "I hope every surgeon in Beverly Hills finds an Ayacucho of their own," he says. When asked if volunteer work is a bother, he shakes his head. "The world is full of so much suffering, and plastic surgery is a career that gives you so much opportunity to alleviate part of it. How could anyone feel burdened by it?"

About Dr. Payam Jarrah-Nejad:

Dr. J is among the leading Beverly Hills facial and body plastic surgeons, along with performing reconstructive surgery, he's known for the rapid recoveries of his breast augmentation patients. To learn about how quick breast augmentation recovery can be, and find out more about his signature operations visit www.drjplasticsurgery.com.

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SOURCE Dr. Payam Jarrah-Nejad

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Skin Whitening Processes: Things You Need to Know

It is important for people thinking of going into skin whitening, to be fully informed about its rules before actually embarking on the process. However, there is nothing wrong if you whiten your skin today.This article gives a comprehensive analysis of all you need to know concerning skin whitening. You will be happy if you stick to the rules; the rules are accurate and had been used by many people over the years. Good luck in your ultimate search for a lighter, more beautiful and attractive skin. Get the rest of the article

Erectile Doctor Attends World Meeting on Sexual Medicine

Erectile Doctor Attends World Meeting on Sexual Medicine

SADDLE BROOK, N.J., Sept. 26, 2012 /PRNewswire/ -- Erectile Doctor, a website that provides men with privacy and discretion when seeking erectile dysfunction treatment, attended the SMSNA and ISSM 2012 World Meeting on Sexual Medicine in Chicago, IL, on Aug. 26-30 with XION Medical, a men's health company with products based on scientific literature. Attendees included scientists, urologists and a plethora of mental and physical health care professionals specialized in sexual health. The Sexual Medicine Society of North America (SMSNA) and the International Society for Sexual Medicine (ISSM) promote the best research methods, practices and ethics in the field of sexual function. Erectile Doctor attended the function to remain up-to-date on the most recent advances in sexual health, while raising awareness of its plan to offer men an alternative way to seek treatment for erectile dysfunction.

Erectile Doctor partnered with XION Medical because both companies devote themselves to sexual health. XION Medical aids in the identification and management of sexual dysfunction for people nationwide. They joined specialists from all over the world for the 18th Scientific Meeting of the SMSNA and the 15th World Meeting of the ISSM. The event provided the most cutting-edge research advances related to treating ED.

Dr. Muhammad Mirza, founder and creator, explains:

"Erectile Doctor is a revolutionary concept that helps both patients and doctors identify each other in a discreet manner. This allows patients to seek advice, diagnosis and treatment from health care professionals without jeopardizing their health using unsafe medications purchased over the internet."

Erectile Doctor is the first website of its kind to address and attend to one of the most under-diagnosed conditions: erectile dysfunction. This online portal provides men suffering from ED with the ability to receive treatment in a discreet manor from specialized doctors across the United States. Erectile Doctor is also a platform for physicians to become part of the first online directory devoted to treating ED while expanding their patient base.

Millions of men suffer from Erectile Dysfunction, yet are reluctant to seek help due to the taboo associated with the inability to perform sexually. Erectile Doctor eradicates the embarrassment of the disorder and provides men with a safe place to seek treatment.

To learn more or to register, visit www.ErectileDoctor.com.

SOURCE Erectile Doctor

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http://www.erectiledoctor.com


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Resverlogix termina el reclutamiento en el ensayo ASSURE

Resverlogix termina el reclutamiento en el ensayo ASSURE

CALGARY, Alberta, September 26, 2012 /PRNewswire/ --

Los datos de IVUS evaluarán la regresión de la placa en pacientes con enfermedad arterial coronaria

Símbolo TSX: RVX

Resverlogix Corp. (TSX: RVX) ha anunciado hoy la finalización del reclutamiento en ASSURE, un ensayo clínico en fase 2b destinado a los pacientes con enfermedades cardiovasculares de alto riesgo. ASSURE evaluará la capacidad de RVX-208, el inhibidor de la proteína BET de Resverlogix, para experimentar un retroceso de la enfermedad ateroesclerótica frente al placebo usando la tecnología intravascular de ultrasonidos (IVUS) en pacientes con enfermedad arterial coronaria (CAD).

"Terminar el reclutamiento del ensayo clínico ASSURE supone otro logro destacado para Resverlogix, a la vez que seguimos trabajando para demostrar la eficacia de RVX-208 en la regresión de la plaga ateroesclerótica", declaró Donald McCaffrey, director general y consejero delegado de Resverlogix. "RVX-208 estimula la producción de ApoA-I, aumentando las partículas funcionales HDL necesarias para el transporte inverso del colesterol. Esperamos anunciar los datos de primera línea de ASSURE en el primer semestre de 2013".

ASSURE es un ensayo clínico controlado por placebo de grupo paralelo, aleatorio, doble ciego, multicentro y de 26 semanas liderado por la Cleveland Clinic. El principal objetivo del ensayo será la evaluación de la reducción del volumen del ateroma desde la línea base hasta las semana 26 según se ha evaluado por medio de IVUS. Los objetivos secundarios de ASSURE serán la evaluación de la seguridad y tolerabilidad de RVX-208 y los efectos de RVX-208 en HDL y parámetros de lípidos no HDL. Usando los datos de IVUS también evaluaremos los cambios en la estabilidad de la placa, un factor importante que afecta al riesgo del infarto de miocardio.

Acerca de RVX-208

RVX-208 es una molécula pequeña única en su especie que inhibe los bromodominios BET. Está actualmente en ensayo clínico para el tratamiento de la ateroesclerosis. RVX-208 funciona eliminando la placa ateroesclerótica por medio del transporte de colesterol inverso (RCT), el proceso natural por el que la placa ateroesclerótica se transporta fuera de las arterias y se elimina del cuerpo por el hígado. RVX-208 aumenta la producción de ApoA-I, el principal bloque de construcción de partículas de lipoproteína de alta densidad funcional (HDL) y del tipo necesario para RCT. Como son de nueva producción, estas partículas funcionales HDL son planas y vacías, y pueden eliminar la placa de forma eficaz y estabilizar o invertir la enfermedad ateroesclerótica. RVX-208 está actualmente evaluándose en estudios de fase 2b por su capacidad de invertir y/o estabilizar la enfermedad de aterosclerosis. El fármaco candidato cuenta también con el potencial para tratar otras indicaciones, incluyendo las enfermedades neurodegenerativas.

Acerca de Resverlogix

Resverlogix Corp. (TSX: RVX) es una compañía cardiovascular en fase clínica con una tecnología de plataforma epigenética que modula la producción de proteína. Resverlogix está desarrollando RVX-208, una molécula pequeña de primera clase para el tratamiento de la ateroesclerosis. RVX-208 es el primer inhibidor de bromodominio BET en ensayos clínicos. Los nuevos compuestos que surgen de la plataforma de descubrimiento de fármaco epigenético de Resverlogix funcionan por medio de la inhibición de los bromodominios BET, y cuentan con el potencial para impactar en múltiples enfermedades, incluyendo el cáncer, enfermedad autoinmune y neurodegenerativa. Las acciones ordinarias de Resverlogix Corp. cotizan en la Bolsa de Valores de Toronto (TSX: RVX). Si desea más información visite la página web http://www.resverlogix.com.

Este comunicado contiene declaraciones de futuro que se refieren a las definidas en la legislación de valores de Canadá que no se basan en hechos históricos, incluyendo sin limitación las declaraciones que contienen palabras como "cree", "anticipa", "planea", "pretende", "podrá", "deberá", "espera", "continúa", "estima", "prevé" y otras expresiones similares. En concreto, este comunicado incluye las declaraciones de futuro relacionadas con investigación y desarrollo y el papel potencial de RVX-208 en el tratamiento de la ateroesclerosis. Nuestros resultados reales, eventos o desarrollos podrían ser materialmente diferentes de los expresados o implicados en estas declaraciones de futuro. No podemos asegurar que ninguno de los eventos o expectativas se produzcan o consigan. Por su naturaleza, las declaraciones de futuro están sujetas a numerosos riesgos e incertidumbres, incluyendo pero no limitándose, los factores de riesgo asociados con el Formulario de Información Anual de la compañía y con la MD&A más reciente, que se han incorporado aquí por referencia y con otros factores de riesgo adicionales comentados en otros documentos registrados de vez en cuando con las autoridades de valores, que están disponible por medio de SEDAR en la página web  http://www.sedar.com. Estas declaraciones de futuro contenidas en este comunicado están expresamente cualificadas por estas declaraciones de futuro hasta la fecha mencionada. La compañía no tiene ninguna intención, ni obligación o responsabilidad, excepto las obligadas por ley, de actualizar o revisar las declaraciones de futuro, ya sea como resultado de nueva información, eventos futuros u otros.

Si desea más información contacte:

Contactos de la compañía:            
Donald J. McCaffrey
Director general y consejero delegado
Resverlogix Corp.    
Teléfono: +1-403-254-9252
E-mail: don@resverlogix.com

Inversores institucionales de Estados Unidos:              
Susan Noonan
Socia administrativa        
S.A. Noonan Communications, LLC
Teléfono: +1-212-966-3650    
E-mail: susan@sanoonan.com

Sarah Zapotichny
Directora de relaciones con los inversores
Resverlogix Corp.
Teléfono: +1-403-254-9252
E-mail: sarah@resverlogix.com

Medios:
Matt Middleman, M.D.
Russo Partners, LLC
Teléfono: +1-212-845-4272
E-mail: matt.middleman@russopartnersllc.com

SOURCE Resverlogix Corp.

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