Drugmaker preps market for diet pill
Tue, 22 May 2007 18:01:38 GMTBy CANDICE CHOI, AP Business Writer
NEW YORK - You won't lose weight in your sleep or shed pounds while eating anything you want — that's the sobering message from the maker of a weight loss pill poised to hit shelves next month.
GlaxoSmithKline on Tuesday opened an educational exhibit in New York City to prepare the country for alli, the first over-the-counter diet pill approved by the http://www.fda.gov
U.N. seeks bird flu vaccine for poor
Tue, 22 May 2007 18:14:20 GMTGENEVA - The U.N. health agency on Tuesday reached a preliminary agreement that seeks to ensure all countries share their H5N1 virus samples with the World Health Organization and that poor countries get a portion of future pandemic flu vaccines.
The draft resolution, which is expected to be formally adopted by the World Health Assembly on Wednesday, says that the agency will work out rules to guarantee "timely sharing of viruses" between affected countries and WHO, and ensure "fair and equitable distribution of pandemic influenza vaccines at affordable prices in the event of a pandemic."
The text, the result of strenuous negotiations between WHO member states, is written in very general terms without defining what a fair distribution of vaccines or timely sample sharing actually means. It also does not specify the details surrounding the formation of a pandemic flu vaccine stockpile, or how the stockpile would be distributed.
The discussion on virus sample sharing was among the predominant subjects at WHO's annual meeting against the backdrop of an ongoing battle with Indonesia over H5N1 virus samples.
Several experimental pre-pandemic vaccines based on H5N1 exist, but as the virus continues to mutate, scientists need to match the latest circulating strains to that in the vaccine, to ensure that the vaccines would work.
Indonesia has not shared any bird flu samples since last December, arguing that the pharmaceutical companies that could develop vaccines would make them too expensive for its population.
Though Indonesia's health minister last week announced that the country had shared three viruses with a WHO-accredited laboratory in Japan, it is uncertain whether further viruses will be shared.
China has also been reluctant to share samples. No H5N1 viruses have been received from China for nearly a year — during which time Beijing has reported several human bird flu cases. China is preparing five virus samples to share with WHO, but it is unknown when they will actually be sent, according to WHO.
WHO Director-General Dr. Margaret Chan last week harshly criticized countries that do not share their H5N1 virus samples, accusing them of crippling the world in the fight against a possible flu pandemic.
An Indonesian-led draft proposal by developing countries had asked WHO to give H5N1 virus samples to vaccine manufactures only with the consent of the donor country.
But the resolution passed by Committee A today said that "in times of public health emergencies of international concern," manufacturers should be given "full access" to viruses from WHO. Although the text falls short of defining what constitutes a public health emergency, WHO officials said it would apply in the case of a flu pandemic.
Keeping the resolution rather vague, much work remains to be done by a WHO working group that is supposed to formulate the terms and conditions for virus and vaccine sharing.
Diabetes pill tied to heart risks
Tue, 22 May 2007 03:04:59 GMTBy MARILYNN MARCHIONE, AP Medical Writer
A widely used diabetes pill raises the risk of heart attacks and possibly death, according to a scientific analysis that reveals what some experts are calling another http://www.nejm.org
GlaxoSmithKline: http://www.gsk.com
Glaxo clinical trial registry: http://ctr.gsk.co.uk
Food and Drug Administration: http:http://www.fda.gov
Avandia's label: http://www.diabetes.org
and http://diabetes.niddk.nih.gov/
N.J. lawmakers push proposals on autism
Tue, 22 May 2007 03:05:46 GMTBy TOM HESTER Jr., Associated Press Writer
TRENTON, N.J. - Amid concern about New Jersey having America's highest autism rate, state senators on Monday pushed toward law proposals to promote research into autism and provide lifetime care for those with the disorder.
The largest U.S. study of childhood autism found earlier this year that about 1 in 152 have the disorder, with the highest rate — 1 in 94 children — found in New Jersey.
Madeleine Goldfarb, a Livingston mother of a 13-year-old autistic son, said a crisis looms as children with autism approach adulthood without specialized services and with aging parents. A recent study found less than 13 percent of people with autism in New Jersey attend day programs and 89 percent live at home.
"We are woefully, woefully unprepared," Goldfarb said, lobbying senators to support creating a task force on adult autism.
Autism is a complex disorder usually not diagnosed in children until after age 3. It's characterized by a range of behaviors, including difficulty in expressing needs and an inability to socialize. Its cause is unknown.
The bills would establish a statewide autism registry, restructure a state research and treatment council, train teachers in autism awareness, instruct physicians in early detection, create the task force on adult autism and provide more money for research and treatment.
The proposals, pushed by Assembly Speaker Joseph Roberts Jr., D-Camden, were approved in March by the Assembly. The approval by the Senate health committee on Monday means they can now be considered by the full Senate.
"With our increased understanding of the spectrum of autism disorders comes the increased responsibility of providing a support system for families and individuals living with autism in the Garden State," said bill sponsor Sen. Loretta Weinberg, D-Bergen.
She said the task force on adult autism will focus on job training and placement, housing and long-term care.
"While New Jersey has done a lot to help children with autism, many times the support dries up when those children transition into adulthood," Weinberg said. "In some of the most severe cases of autism, individuals need structured support for their entire lives."
Obesity makes asthma worse study
Tue, 22 May 2007 19:21:01 GMTBy Megan Rauscher
NEW YORK - Obese adults with asthma are more likely than their leaner counterparts to have severe, persistent disease, according to a new large study.
In a telephone interview with Reuters Health, Dr. Brian Taylor of Emory Crawford Long Hospital, Atlanta, said: &;A lot of studies have clearly demonstrated that obesity is associated with asthma and we think actually that not only does obesity likely lead to asthma, but it may also lead to a more severe .&;
&;Our study does not prove that,&; he emphasized, &;but ... our findings stayed consistent.&;
Taylor's team classified 3,059 adults with asthma as normal weight, overweight, or obese, based on their body mass index. He reported the findings at the American Thoracic Society's conference in San Francisco
Obese patients, compared with normal-weight adults, were 47 percent less likely to have their asthma in remission and were 52 percent more likely to have severe persistent asthma, Taylor said.
They were also 66 percent more likely to report continuous symptoms, and 36 percent more apt to miss more than 2 days of work per year due to asthma.
Although the reason why obesity increases asthma severity is not entirely clear, evidence suggests that the hormone leptin, which is produced by fat cells and plays a role in weight regulation and asthma-related airway inflammation, may be involved.
Taylor and his associates are now involved in research looking at whether obese patients who undergo weight-loss surgery experience a lessening of their asthma compared with obese patients who do not have the surgery.
Inhaled steroids may not control kids39 asthma
Tue, 22 May 2007 16:27:47 GMTBy Megan Rauscher
NEW YORK - Daily inhaled steroid therapy is recommended to keep mild-to-moderate asthma from flaring up, but it seems there are children whose condition remains poorly controlled even though they consistently use inhaled steroids.
&;We are speculating that it is possible that there are kids who don't respond appropriately to steroid therapy and may in fact have genetic differences that lead to such steroid non-responsiveness,&; Dr. Gregory Sawicki from Children's Hospital Boston noted in a telephone interview with Reuters Health.
Sawicki reported findings from his group's study on Tuesday at the annual meeting of the American Thoracic Society in San Francisco.
Among 914 children with mild-to-moderate asthma, 425 were prescribed inhaled steroid therapy and 46 percent of them reported consistent inhaler use in the first year. Among children not prescribed inhaled steroid therapy, most reported well-controlled asthma.
After accounting for asthma severity and such, &;patients reporting consistent inhaled corticosteroid use over a 1-year period had higher odds of reporting poor asthma control compared to patients reporting no inhaled corticosteroid use,&; according to Sawicki.
&;Although adherence to medication was not assessed and may explain these findings, it is possible that some children have genetic differences that lead to a differential response to inhaled steroid therapy and such differences warrant further study,&; he told Reuters Health.
In this analysis, all commercially available inhaled corticosteroids were considered together; the researchers did not analyze whether any particular steroid was better than another.
Elan Wyeth plan advanced trials of drug
Mon, 21 May 2007 20:57:45 GMTBy SHAWN POGATCHNIK, Associated Press Writer
DUBLIN, Ireland - Ireland's Elan Corp. PLC and Wyeth of the United States said Monday they are planning advanced trials of a drug to combat Alzheimer's, the incurable brain disease that afflicts more than 20 million people worldwide.
The pharmaceutical companies are seeking regulatory approval to begin advanced "phase 3" trials of bapineuzumab, which they hope will eventually be used to stop the memory loss and dementia symptomatic of Alzheimer's.
Both companies said they plan to begin advanced studies in the second half of 2007 — several months ahead of their previous target — but do not expect to announce results from their current mid-stage, "phase 2" trials until 2008.
"It is important to remember that http://www.elan.com
http://www.wyeth.com
