Doctor’s Skeptical About Drug Restoring Speech In Alzheimer’s Patients
Posted on: Monday, 21 July 2008, 15:30 CDT
Doctors say a small study treating Alzheimer’s patients with a popular rheumatoid arthritis drug has shown promising results, but some worry that these early finding could raise premature hopes in patients and their families.
The study involved 12 patients who had greatly improved language recall shortly after treatment with Enbrel, or etanercept, an anti-inflammatory drug co-marketed by Amgen and Wyeth.
Dr. Edward Tobinick, director of the Institute for Neurological Research, a private medical group inc., in Los Angeles, who led the study, said patients showed verbal effects within a few minutes of the first dose.
Tobinick, who invented and holds several patents on a special method of injecting the drug into the neck, said he charges anywhere between $10,000 and $40,000 per patient for the treatments.
The Alzheimer's Association released a statement in January expressing concern after Tobinick's report on a single patient and the release of a striking video drew widespread attention.
"People with Alzheimer's and their families may place undue value on this new finding based on the dramatic language used in its description and the apparent immediate effect," the group said.
The group expressed concern to see work in other laboratories by scientists without financial interest in the product.
Dr. Sam Gandy, chairman of the Alzheimer's Association's medical and science council, said the latest study, done at Tobinick's clinic, was “not a proper trial".
The drug may work in the brain by blocking an excess of tumor necrosis factor-alpha or TNF-alpha, which may affect communication in the brain, according to Tobinick.
Language difficulties such as finding words were looked at in 12 patients with mild-to-severe Alzheimer's disease who were administered etanercept weekly for six months.
"There was a significant improvement in the majority of the verbal measures that were studied. The remainder showed a tendency toward improvement, which was not significant," Tobinick said.
“The study provides evidence that excess TNF, in the Alzheimer brain, may offer a new way to address this language dysfunction.”
Tobinick acknowledged the study is limited because people knew they were getting the drug. Alzheimer's patients in such open-label studies often show improvement.
Dr. Scott Turner, incoming director of the Memory Disorders Program at Georgetown University Medical Center in Washington, said placebo effect is an enormous problem in open-label studies.
“The true test must come from a more scientifically rigorous double-blind, placebo-controlled, randomized clinical trial,” Turner said. In such studies, patients receive either a dummy treatment or an active agent, and neither the doctor nor the patient knows which.
Also expressing concern about the research was Amgen, who claim there has been insufficient evidence so far.
The company released a statement on its website: “This off-label, unapproved treatment, administered by Dr. Edward Tobinick, is not supported nor endorsed by Amgen.”
Dr. Tobinick’s study was reported on Sunday in the journal BioMed Central.
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Source: redOrbit Staff & Wire Reports
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