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Thursday, May 19, 2011

Jury orders Allergan to pay $212 mln in Botox case

LOS ANGELES | Fri Apr 29, 2011 5:33pm EDT

LOS ANGELES (Reuters) - A Virginia U.S. District Court jury has ordered Allergan Inc to pay $212 million to a man who claimed that injections of wrinkle-smoothing Botox left him with brain damage.

The jurors awarded 67-year-old Douglas Ray Jr $12 million in compensatory damages and $200 million in punitive damages, the company said on Thursday.

Ray said he was injured after getting Botox injections to relieve a hand tremor and writer's cramp, according to a report in the Richmond Times-Dispatch.

Allergan said in a statement that there was no evidence that the company failed to provide adequate information about the potential risks of the drug. It also said there was no proof that Botox caused his symptoms.

The company said it is evaluating the basis for an appeal, noting that Virginia state law caps punitive damages at $350,000.

Allergan agreed last year to plead guilty and pay $600 million to resolve a federal probe involving marketing Botox for unapproved non-cosmetic uses.

The Justice Department accused the company of paying kickbacks to doctors to prescribe Botox for unapproved uses -- such as treating headaches, pain and juvenile cerebral palsy -- and teaching doctors how to bill for such "off-label" uses.


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Thursday, May 5, 2011

Seasonal Influenza Vaccine and Risk of 2009 H1N1 Influenza

Background
Over the past week, there have been several media reports describing unpublished findings from seasonal influenza vaccine studies conducted in Canada. The findings from these studies suggest that getting the 2008-09 seasonal influenza vaccine (given last influenza season) increases a person’s risk of getting 2009 H1N1 influenza.  In the studies done in Canada, the increase in risk among vaccinated persons is approximately double the risk for unvaccinated persons. These studies could not determine which seasonal influenza vaccine had been given. This research has not been published in the medical literature or presented at a public scientific meeting. The results of these studies have been presented by Canadian investigators to CDC scientists, but there has not yet been an opportunity to review the studies in detail.

CDC Response
Preliminary results of studies conducted in the United States using methods similar to the Canadian studies suggest that receiving a seasonal influenza vaccine does not increase the risk of becoming ill with 2009 H1N1 influenza.  In addition, no other country has reported this finding. Only one study has been published on this issue, which reported data collected in Australia. The Australian study did not find any association between receipt of seasonal influenza vaccine and risk of getting 2009 H1N1 influenza. Australian researchers recently published these findings: Kelly H, Grant K. Interim analysis of pandemic influenza (H1N1) 2009 in Australia: surveillance trends, age of infection and effectiveness of seasonal vaccination. Eurosurveillance Volume 14, Issue 31, 06 August 2009. (http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19288). In addition, seasonal influenza vaccination leading to increased susceptibility to other influenza viruses has never been reported before.

CDC is working with scientists in Canada, the World Health Organization (WHO) and other countries to further investigate the findings from Canada and other countries. Studies in the United States also are continuing. Thus far, why findings from studies in Canada have been different from results of studies conducted in other countries is unknown.The influenza virus strains used to make the Canadian seasonal influenza vaccine were the same as used in the United States and many other countries. However, some seasonal influenza vaccines used in Canada are not available in the United States and vice versa. The Canadian studies reportedly cannot determine which vaccines study participants received.

CDC continues to recommend seasonal influenza vaccination for the 2009-10 influenza season. Currently the vast majority of influenza being reported to CDC is 2009 influenza A (H1N1). However, influenza is very unpredictable and seasonal influenza viruses might circulate at any point in the season. CDC does not recommend halting or deferring seasonal influenza immunization efforts.

The recommendations for who should get seasonal influenza vaccine have not changed. CDC recommends seasonal influenza vaccination for anyone who wants to reduce their chances of getting seasonal flu. Yearly vaccination is particularly important for certain groups of people, including those who are at high risk of having serious seasonal influenza -related complications or people who live with or care for those at high risk for serious seasonal influenza -related complications, including:

Children aged 6 months up to their 19th birthday Pregnant women People 50 years of age and older People of any age with certain chronic medical conditions People who live in nursing homes and other long-term care facilities People who live with or care for those at high risk for complications from flu, including: Health care workers Household contacts of persons at high risk for complications from the flu Household contacts and out of home caregivers of children less than 6 months of age (these children are too young to be vaccinated)

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES


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U.S. Preparedness to Respond to Avian Influenza A (H5N1) Strengthened by CDC/CSTE Partnership

For Immediate Release: May 15, 2007
Contact: Division of Media Relations
404-639-3286


Atlanta –A three-day training course which provides a standardized curriculum to state and local public-health responders about how to identify and control human infections and illness associated with avian influenza A (H5N1) is being released on-line today. The course, entitled "CDC/CSTE Rapid Response Training: The Role of Public Health in a Multi-Agency Response to Avian Influenza in the United States" is the result of a partnership between the Centers for Disease Control and Prevention (CDC) and the Council of State and Territorial Epidemiologists (CSTE). The course is available at http://www.cste.org/influenza/avian.asp.

"We are pleased to release a new avian influenza training program that our state and local public-health partners can use to train rapid response teams," says Joshua Mott, an epidemiologist in CDC’s Influenza Division who led the training development project. The training focuses on human health issues during an avian influenza investigation. Through lectures, reference materials and case studies, the course provides mechanisms to facilitate discussion and planning among people who may be called on to respond to avian influenza A (H5N1) in the United States.

To date, no H5N1 cases in birds or humans have been found in the United States or any other country in the Western Hemisphere. However, in parts of Asia, Africa and Europe, the H5N1 virus has caused widespread infections and deaths in poultry and 291 human illnesses, resulting in 172 deaths. Public-health officials around the world consider H5N1 to be the greatest current pandemic influenza threat.

Background: The CDC and CSTE worked with educators at the North Carolina Center for Public Health Preparedness to develop the curriculum for on-line release. The on-line version was modified from regional "train the trainer" courses that were conducted in early 2007 in Washington D.C.; Denver, CO; and Atlanta, GA. These regional courses included 295 participants and facilitators and represented local and state health agencies, federal agencies, including CDC and United States Department of Agriculture, and representatives from the wildlife protection and agricultural sectors, public-health laboratories, public-health veterinarians, nursing and industry. Training was provided to representatives of all 50 states; several large U.S. cities including Washington, D.C., Seattle, WA, Chicago, IL, Houston, TX and New York City, NY; and Puerto Rico, American Samoa and the Virgin Islands. A key component of the training was coordination between veterinary and human public-health agencies at the federal, state and local level.

"The unique aspect of the training is that it brings together human and animal health professionals, who would work together as part of a multidisciplinary response to an avian influenza threat," says Mott. "Importantly, this training program also teaches public-health response skills that are applicable to other emerging diseases."

CDC provided $2 million in funding to CSTE to support development of the materials, to support the in-person trainings, to adapt the materials for on-line access, and to assist states in replicating the response training in their states using this curriculum.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES


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Weekly Update on 2009 H1N1 Flu

CDC will host a press conference to update on 2009 H1N1 Flu.

Thomas R. Frieden, M.D., M.P.H., Director, Centers for Disease Control and Prevention

Thursday September 3, 2009 at 12 p.m. ET

Centers for Disease Control and Prevention
1600 Clifton Road NE
Atlanta, GA 30329
Tom Harkin Global Communications Center (Building 19), Press Room
For directions to CDC, please visit http://www.cdc.gov/about/resources/visitGuide.htm#direction.

Parking is available in the Building 19 parking deck located on CDC Parkway. Media should arrive at the CDC by 11:30 a.m. Media must present photo ID for access. Media who cannot attend in person can listen and ask questions by toll-free conference line. The briefing will begin promptly; media should dial in a few minutes before the start of the conference.


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Waterborne Diseases Could Cost over $500 Million Annually in U.S.

Hospitalizations for three common waterborne diseases cost the health care system as much as $539 million annually, according to research presented today at the International Conference on Emerging Infectious Diseases.

"These cost data highlight that water-related diseases pose not only a physical burden to the thousands of people sickened by them each year, but also a substantial burden in health care costs, including direct government payments through Medicare and Medicaid," says Michael Beach of the Centers for Disease Control and Prevention, an author of the study.

Currently, there are no well-documented data on the total health care costs associated with all waterborne diseases. However, using data from a large insurance claims database between 2004 and 2007, Beach and his colleagues estimated the hospitalization cost of three common waterborne diseases in the United States: Legionnaires' disease, cryptosporidiosis and giardiasis. For each case of disease, they calculated the cost paid by the insurer, the out-of-pocket cost to the patient, and the total amount paid.

Total estimated costs for hospitalization for the three diseases was $154-539 million, including $44-147 million in direct government payments for Medicare and Medicaid. Estimated annual costs for the individual diseases were: giardiasis, $16-63 million; cryptosporidiosis, $37-145 million; and Legionnaires' disease, $101-321 million.

Inpatient hospitalization costs per case averaged more than $34,000 for Legionnaires' disease, approximately $9,000 for giardiasis and more than $21,000 for cryptosporidiosis.

"When people think about these diseases, they usually think of a simple case of diarrhea, which is a nuisance but quickly goes away. However, these infections can cause severe illness that often result in hospital stays of more than a week, which can quickly drive up health care costs," Beach says.

Other symptoms can include rashes, eye and ear infections and respiratory or neurological symptoms and can even be fatal.

Modest investments in preventing these diseases could lead to reduced disease and significant healthcare cost savings, Beach says. Some examples of possible, low-cost interventions include public education campaigns, appropriate maintenance of building water systems, and regular inspection of pools and other recreational water facilities.

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The International Conference on Emerging Infectious Diseases is organized by the CDC, the American Society for Microbiology, the Council of State and Territorial Epidemiologists, the Association of Public Health Laboratories and the World Health Organization. More information on the meeting can be found online at www.iceid.org.


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Weekly CDC 2009 H1N1 Flu Update

CDC will host a press conference to provide an update on 2009 H1N1 flu and vaccine distribution.

Dr. Thomas R. Frieden, M.D., M.P.H., Director, Centers for Disease Control and Prevention

Friday October 30, 2009 at 1:30 p.m.

Centers for Disease Control and Prevention
1600 Clifton Road NE
Atlanta, GA 30329
Tom Harkin Global Communications Center (Building 19), Press Room

For directions to CDC, please visit http://www.cdc.gov/about/resources/visitGuide.htm#direction.

Parking is available in the Building 19 parking deck located on CDC Parkway. Media should arrive at the CDC no later than 1:00 p.m. Media must present photo ID for access.

Media who cannot attend in person can listen and ask questions by toll-free conference line. Please dial in a few minutes before the start of the conference.

This press briefing will be broadcast live at http://www.flu.gov/live.  We strongly encourage non-media to use this option for viewing.

*Please dial in 10 to 15 minutes before the start of the press conference. 
Media: 888-795-0855
Listen Only: 800-369-1890
INTERNATIONAL: 1-312-470-7280
PASSCODE: CDC Media

Important Instructions: If you would like to ask a question during the call, press *1 on your touchtone phone. Press *2 to withdraw your question. You may queue up at any time. You will hear a tone to indicate your question is pending.

BROADCAST ACCESS:
Call Crawford Communications Bookings at 1-800-243-1995 to make arrangements for broadcast feed.

TRANSCRIPT:
A transcript of this media availability will be available following the briefing at the CDC web site at http://www.cdc.gov/media.


View the original article here

Weekly CDC 2009 H1N1 Flu Update

CDC will host a press conference to provide an update on 2009 H1N1 flu and vaccine distribution.

Dr. Thomas R. Frieden, M.D., M.P.H., Director, Centers for Disease Control and Prevention

Friday October 30, 2009 at 1:30 p.m.

Centers for Disease Control and Prevention
1600 Clifton Road NE
Atlanta, GA 30329
Tom Harkin Global Communications Center (Building 19), Press Room

For directions to CDC, please visit http://www.cdc.gov/about/resources/visitGuide.htm#direction.

Parking is available in the Building 19 parking deck located on CDC Parkway. Media should arrive at the CDC no later than 1:00 p.m. Media must present photo ID for access.

Media who cannot attend in person can listen and ask questions by toll-free conference line. Please dial in a few minutes before the start of the conference.

This press briefing will be broadcast live at http://www.flu.gov/live.  We strongly encourage non-media to use this option for viewing.

*Please dial in 10 to 15 minutes before the start of the press conference. 
Media: 888-795-0855
Listen Only: 800-369-1890
INTERNATIONAL: 1-312-470-7280
PASSCODE: CDC Media

Important Instructions: If you would like to ask a question during the call, press *1 on your touchtone phone. Press *2 to withdraw your question. You may queue up at any time. You will hear a tone to indicate your question is pending.

BROADCAST ACCESS:
Call Crawford Communications Bookings at 1-800-243-1995 to make arrangements for broadcast feed.

TRANSCRIPT:
A transcript of this media availability will be available following the briefing at the CDC web site at http://www.cdc.gov/media.


View the original article here