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Archive for November, 2007

Cancer patient wins asbestos payout days before death

Wednesday, November 28th, 2007

A cancer sufferer won his High Court battle for compensation over asbestos exposure just days before he died.

George Alexander, lost his battle against the asbestos-related mesothelioma on Sunday (Nov 25).

The 71-year-old claimed his illness was caused by deadly fibres he inhaled while working as an electrical fitter in the Seventies and Eighties.

Last Thursday (Nov 22) he learned the council he used to work for had settled his High Court claim out of court in a deal worth £88,000.

By that point he had moved from his home in Langdale Road, Hove, to Martlets Hospice in Wayfield Avenue.

He spent the last days of his life at the specialist centre.

His solicitor, Helen England, said news of his victory boosted him as the end came.

She said: “He was really, really pleased.

“Hopefully it was a relief before he passed away.”

Mr Alexander claimed the mesothelioma he developed later in life cut his life expectancy by 12 years.

He claimed damages from the London Borough of Hammersmith and Fulham, who he worked for between 1973 and 1981.

A writ issued by Mr Alexander through solicitors Simpson Millar said he worked in a municipal laundry and swimming pool, maintaining boilers and pipework.

Mr Alexander said the pipes were lagged with old, crumbling asbestos, which fell on to the floor where he worked and walked.

The writ claimed he once disturbed asbestos lagging as part of work replacing an old boiler door. In 1978, he worked near contractors as they replaced asbestos.

Mesothelioma kills nearly 2,000 people in the UK every year.

The deadly disease can be caused by inhaling just one fibre of asbestos, which was commonly used for insulation and fireproofing in many buildings.

Miss England said: “Mr Alexander was one of thousands throughout the country who was suffering from the terminal disease of mesothelioma from being negligently exposed to asbestos by their employers.

“It is really important that Mr Alexander and those like him get the compensation they so rightly deserve to assist them during the time they have left and for the loved ones they leave behind.”

Exposure to asbestos is often indicated by pleural plaques - scars on the lining of the lungs. Though they are not cancerous, people with plaques live with the knowledge they have been exposed and could develop mesothelioma in future.

Last month the Law Lords ruled people suffering from pleural plaques had no right to compensation.

Emma Costin, a partner at Simpson Millar, represented Eastbourne claimant Hugh Speirs, 62, of Sovereign Harbour North, who described life with pleural plaques as “like living with a time bomb” .

She said: “The decision is devastating news to many thousands of innocent victims of asbestos and their families.

“A diagnosis of pleural plaques condemns a person to a lifetime of never knowing when a more serious condition is going to be diagnosed.

“This impacts on their loved ones as much as it does them.”

FDA advisers back stronger flu drug warnings

Wednesday, November 28th, 2007

U.S health advisers recommended on Tuesday stronger warnings on the labels of flu drugs made by Roche Holding AG and GlaxoSmithKline Plc, amid reports of abnormal and, in the case of the Roche drug, sometimes fatal psychiatric behavior.

The U.S. Food and Drug Administration advisory panel reviewed the small but rising number of cases, mostly in Japan, of patients taking Roche’s Tamiflu and Glaxo’s Relenza who have experienced hallucinations and delirium.

In the case of Tamiflu, some cases of erratic behavior, including jumping from buildings, resulted in deaths.

Although no direct link with the antiviral drugs has been established, the advisory panel recommended adding the new case reports to the drugs’ labels. The FDA typically takes the advice of its advisory panels.

The meeting was the third public review of flu drug safety, originally prompted by reports two years ago of a dozen deaths, including suicide, of children in Japan who took Tamiflu.

“The public expects to be made aware. I never hear on the public side, that they are getting too much information,” said Dr. Michael Fant, a pediatric expert at the medical school at the University of Texas, and panel member.

“If we’re still wrestling with it, to me even though we don’t have anything definitive, that in and of itself warrants conveying those concerns to the public.”

In March, Japan warned against prescribing Tamiflu to those aged 10 to 19 after reports of mostly young people showing signs of strange and erratic behavior after taking the drug.

FDA staffers have recommended a stronger label warning for Tamiflu to note patient deaths. For Relenza, addition of a warning about hallucinations and delirium is recommended.

Several panel members said that noting the fatalities in patients taking Tamiflu was appropriate in a new label, although a formal vote on that issue was not taken. The panel voted to generally note the newly reported cases of neuropsychiatric behavior seen with Relenza.

LINK UNCLEAR

Many of the experts said it should be noted that some unusual behavior was observed in flu patients who did not take the drugs, suggesting a possible link to the disease itself.

FDA staffers described reports of about 700 cases of psychiatric adverse events for both drugs, and 25 cases of pediatric deaths in patients taking Tamiflu, reported to the agency through May 2007. No fatalities were reported for Relenza.

Three of the deaths occurred in the United States, and causes included complications of flu.

Glaxo and Roche officials said they opposed label changes and cited data showing no causal link between the drugs and adverse events. It is “very difficult to differentiate drug from disease,” Dr. Jonathan Solsky of Roche told the panel.

About 48 million people worldwide have taken Tamiflu since it was approved in 1999, according to Roche. Relenza has been used by about 4 million people since its launch in 1999.

The flu virus is a major cause of death and illness in the United States. Complications from the illness kill about 36,000 Americans a year, a government expert told the panel. Children and the elderly are especially at risk.

One panel member said the benefits of Tamiflu are slim compared with the risks, however rare and uncertain.

“When we give Tamiflu to children who have influenza, we shorten (the duration of flu) by one day, a day and a half,” said Dr. Keith Kocis, a pediatric care doctor at the North Carolina Women’s Hospital, and an advisory panel member. “To me (the benefit is) relatively minor.”

Dr. David Kimberlin of the University of Alabama in Birmingham was in the minority when he warned against scaring the public, given the uncertainty about cause and effect.

“People are going to hear death” and assume causality, he said. “I think it’s allowing an overstatement.”

Roche accepts FDA’s Tamiflu proposal

Wednesday, November 28th, 2007

Swiss drugmaker Roche Holding AG has accepted a recommendation by a U.S. Food and Drug Administration panel to put a stronger warning label on its flu treatment Tamiflu, a spokeswoman said Wednesday.

But Martina Rupp said all patients with full-blown flu should be warned that the illness itself posed a risk of psychiatric problems, not just for those taking the Roche product. She stressed there was no causal relationship between Tamiflu and reported cases of delirium and hallucinations.

“It’s important really that the label reflects that influenza itself can trigger such events,” she said.

The FDA panel recommended Tuesday that Roche change the warning label for Tamiflu, which has been used by 48 million patients since its launch in 1999.

The drug’s label already mentions reports of delirium and self-injury, primarily among children in Japan, but some of the FDA’s experts suggested the language should mention that several patients have died as a result of these abnormal behaviors.

Nearly 600 cases of psychiatric problems have been reported in Tamiflu patients, with 75 percent of them coming from Japan. Five children there have died after “falling from windows or balconies or running into traffic,” according to the FDA.

Roche presented its own analysis of more than 150,000 patients to the FDA showing no connection between Tamiflu and increased risk of psychiatric problems.

“Over the last year we’ve been looking at a variety of data and undertaken additional studies that so far have shown no causality between Tamiflu and these events,” Roche product director David Reddy said in an interview Tuesday. “In fact, the data increasingly points to the role of influenza in these events.”

Rupp said influenza causes fevers that reach 104 Fahrenheit or higher, and people “need to know that this is associated with delirium and hallucination.”

Tamiflu sales totaled $1.1 billion in the first half of 2007. Sales have benefited in recent years from governments stockpiling the drug in case the bird flu virus that has ravaged poultry stocks in Asia mutates into a form that can be easily transmitted among humans, sparking a flu pandemic.

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