It seems that although she had been diagnosed and treated for MS, an autopsy revealed that Ms Smith never had MS, thereby making her enrollment in the trial problematic at best News Inferno reported.
The allegations in the lawsuit complaint contain a number of interesting facts. In February 2000, Anita Smith was diagnosed with MS and her neurologist began treating her with Avonex, another MS drug manufactured by Biogen.
In April 2002, she was enrolled in a clinical trial and began receiving Tysabri in addition to Avonex. During her treatment with Trysabri, she received thirty IV infusions beginning on April 12, 2002 and ending in January 2005.
Tysabri received fast-track FDA approval in November 2004, the same month that Ms Smith began to suffer severe neurological problems.
She was hospitalized on February 12, 2005, when diagnosed with PML, and died on February 24, 2005. Sales of Tysabri were suspended on February 28, 2005.
An autopsy confirmed that Anita Smith died of PML.
Based on animal and other studies, some of the scientists who developed Tysabri concluded as far back as 1992, that it was far too dangerous for use in humans. Dr Lawrence Steinman, a professor of neurology at Stanford University who participated in an animal study that led to the development of Tysabri, told the New York Times on March 1, 2005, that the FDA should not have approved the drug based on one year's data.
He said the risk of serious infections like PML was "unfortunately logical" given that Tysabri works by interfering with the immune system.
"I'm shocked that it happened so soon," he told he Times, "but I knew it was going to happen sooner or later."
Critic say the Anita Smith case highlights the problems with the way MS drugs are being tested.
"In recent years," the February 18, 2006 LA Times said, "drug companies have been trying out medicines on people with mild symptoms or none at all at the time of treatment, several experts say, including some who, like Smith, might not have the disease."
Ms Smith was diagnosed with MS after a bout of weakness in her right leg, followed by blurred vision. "Although the symptoms disappeared," the LA Times said, "she started taking injections of Avonex."
In fact, most of the 1,171 patients in Ms Smith's trial suffered no disabilities, according to FDA documents reviewed by the Times.
These trials broadened the market for MS drugs but, critics say, put patients who don't need powerful new medicines at risk.
Dr Steinman and another Stanford neurologist, Dr Annette Langer-Gould, have urged the FDA to tighten criteria for selecting patients for MS drug trials.
Dr Langer-Gould explained how Biogen lead the push toward earlier treatment of MS with a study on Avonex 6 years ago in patients who did not meet the clinical definition of MS in effect at the time.
The allegations in the lawsuit complaint contain a number of interesting facts. In February 2000, Anita Smith was diagnosed with MS and her neurologist began treating her with Avonex, another MS drug manufactured by Biogen.
In April 2002, she was enrolled in a clinical trial and began receiving Tysabri in addition to Avonex. During her treatment with Trysabri, she received thirty IV infusions beginning on April 12, 2002 and ending in January 2005.
Tysabri received fast-track FDA approval in November 2004, the same month that Ms Smith began to suffer severe neurological problems.
An autopsy confirmed that Anita Smith died of PML.
Based on animal and other studies, some of the scientists who developed Tysabri concluded as far back as 1992, that it was far too dangerous for use in humans. Dr Lawrence Steinman, a professor of neurology at Stanford University who participated in an animal study that led to the development of Tysabri, told the New York Times on March 1, 2005, that the FDA should not have approved the drug based on one year's data.
He said the risk of serious infections like PML was "unfortunately logical" given that Tysabri works by interfering with the immune system.
"I'm shocked that it happened so soon," he told he Times, "but I knew it was going to happen sooner or later."
Critic say the Anita Smith case highlights the problems with the way MS drugs are being tested.
"In recent years," the February 18, 2006 LA Times said, "drug companies have been trying out medicines on people with mild symptoms or none at all at the time of treatment, several experts say, including some who, like Smith, might not have the disease."
Ms Smith was diagnosed with MS after a bout of weakness in her right leg, followed by blurred vision. "Although the symptoms disappeared," the LA Times said, "she started taking injections of Avonex."
In fact, most of the 1,171 patients in Ms Smith's trial suffered no disabilities, according to FDA documents reviewed by the Times.
These trials broadened the market for MS drugs but, critics say, put patients who don't need powerful new medicines at risk.
Dr Steinman and another Stanford neurologist, Dr Annette Langer-Gould, have urged the FDA to tighten criteria for selecting patients for MS drug trials.
Dr Langer-Gould explained how Biogen lead the push toward earlier treatment of MS with a study on Avonex 6 years ago in patients who did not meet the clinical definition of MS in effect at the time.
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