Drug restores speech in Alzheimer's; experts worry
Some doctors are worried that early finding of a small study, which was conducted on Alzheimer’s patients, in which they were given a popular rheumatoid arthritis drug and showed dramatic improvements, will raise premature hopes among the patients and their family.
The study involved 12 patients who were treated with anti-inflammatory drug Enbrelor etanercept, co-marketed by Amgen and Wyeth, and shortly after showed improved language-recall.
The findings were published in the journal BioMed Central BMC Neurology on Sunday.
Dr. Edward Tobinick, director of Institute for Neurological Research, a private medical group inc., in Los Angeles, who led the study, said that they often see verbal effects within a few minutes of the first dose.
Tobinick, who invented and holds several patents on a special method of injecting drug into the neck charges anywhere between $10,000 and $40,000 per patient for the treatments.
The attention of Alzheimer’s Association was drawn by Tobinick’s report on a single patient and a release of a striking video in January, and thus the association released a statement expressing its concern.
According to the group, “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 also added they want to see work in other laboratories by scientists without financial interest in the product.
According to Dr. Sam Gandy, chairman of the Alzheimer's Association's medical and science council, “study done at Tobinick’s clinic does not offer that independent confirmation. It’s still not a proper trail.”
On the other hand, Tobinick feels that the drug may work in the brain by blocking an excess of tumor necrosis factor-alpha or TNF-alpha. Both of these may affect communication in the brain.
For six months, 12 patients with mild-to-severe Alzheimer’s disease were administered by looking at language difficulties, such as finding words.
Tobinick reported, “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.” The only limitation of the study was that Alzheimer’s patients often show improvement in open-label studies, and thus patients could have shown improvement because they knew that they were getting drugs.
Amgen in the month of April had said o its Web site, that this off-label, unapproved treatment, administered by Dr. Edward Tobinick, is not supported nor endorsed by Amgen. Thus the company too had expressed its concern regarding the study led by Tobinick for there was not much evidence regarding the study being successful.