Enbrel: A new voice for Alzheimer's?
Can a drug used to relieve symptoms associated with rheumatoid arthritis improve speech in Alzheimer’s patients? Yes, maybe………..
Etanercept (trade name Enbrel) is an RA anti-inflammatory drug from Wyeth and Amgen.
Enter Dr. Edward Tobinick, director of the Institute of Neurological Research, a private Los Angeles based medical group. Dr. Tobinick is a physician and inventor of a specialized method of injecting drugs into a patient’s neck. Ouch.
What Dr. Tobinick did in his frankly unscientific and limited study was inject Enbrel weekly for six months into twelve patients diagnosed with mild to severe Alzheimer’s.
He claims that these patients showed greatly improved language recall shortly after receiving the Enbrel, noting that …”We often see verbal effects within a few minutes of the first dose.”
Many patients and families may regard this as a reason for hope as memory and language cognition are major manifestations of Alzheimer’s. Unfortunately, there are several who caution against seeking out these Enbrel treatments.
This was not a scientifically rigorous double-blind, placebo controlled and randomized clinical trial.
1) This was an “open-label” study. In other words, the patients participating in the study knew what drug they were being given. The “placebo effect” is strong and undoubtedly could have influenced these patients. Bottom line: Patients tend to feel better because they know they are taking a drug and not a placebo, sugar pill or “dummy treatment” containing no medication.
2) This was not a double blind study. In other words, in a scientifically conducted clinical trial, neither physician nor patient knows who is being given the active agent Enbrel. Dr. Tobinick and his patients knew they were being receiving injections of Enbrel.
Another consideration here is cost. Dr. Tobinick charges between $10,000 and $40,000 for these treatments. Yikes and ouch again.
But the results are not all fanciful hopes. Through his research, Tobinick believes he has learned the reason why Enbrel may prove effective in Alzheimer’s: It works by blocking an excess of “tumor necrosis factor-alpha” (TNF-alpha), which may affect communication in the brain.
In laymen’s terms, necrosis is the death of a cell, with all its coordinated activities going haywire, eventually shutting its functions down resulting in cell death.
Tumor necrosis factor promotes an inflammatory response, which in turn causes many clinical problems associated with autoimmune disorders such as Crohn's disease, psoriasis, asthma and rheumatoid arthritis.
Tobinick believes that TNF–alpha may also impact regions in the brain associated with speech, and that a drug used to fight an autoimmune disease could help Alzheimer’s patients regain some speech function.
On learning the results of Dr. Tobinick’s study, the Alzheimer’s Association spoke out, cautioning hopeful patients and families to not place “undue value on this finding based on the dramatic language used in its description and the apparent immediate effect”. The Association also notes that “We need to see work……by scientists without financial interest…”.
Dr. Tobinick does concede that his study was limited. Clearly, more research needs to be done and we hope Tobinick, Amgen and Wyeth will continue exploring Enbrel’s potential and the role of TNF-alpha.
(Be sure to watch the accompanying video showing one woman’s rather striking response in a related study.)
Etanercept (trade name Enbrel) is an RA anti-inflammatory drug from Wyeth and Amgen.
Enter Dr. Edward Tobinick, director of the Institute of Neurological Research, a private Los Angeles based medical group. Dr. Tobinick is a physician and inventor of a specialized method of injecting drugs into a patient’s neck. Ouch.
What Dr. Tobinick did in his frankly unscientific and limited study was inject Enbrel weekly for six months into twelve patients diagnosed with mild to severe Alzheimer’s.
He claims that these patients showed greatly improved language recall shortly after receiving the Enbrel, noting that …”We often see verbal effects within a few minutes of the first dose.”
Many patients and families may regard this as a reason for hope as memory and language cognition are major manifestations of Alzheimer’s. Unfortunately, there are several who caution against seeking out these Enbrel treatments.
This was not a scientifically rigorous double-blind, placebo controlled and randomized clinical trial.
1) This was an “open-label” study. In other words, the patients participating in the study knew what drug they were being given. The “placebo effect” is strong and undoubtedly could have influenced these patients. Bottom line: Patients tend to feel better because they know they are taking a drug and not a placebo, sugar pill or “dummy treatment” containing no medication.
2) This was not a double blind study. In other words, in a scientifically conducted clinical trial, neither physician nor patient knows who is being given the active agent Enbrel. Dr. Tobinick and his patients knew they were being receiving injections of Enbrel.
Another consideration here is cost. Dr. Tobinick charges between $10,000 and $40,000 for these treatments. Yikes and ouch again.
But the results are not all fanciful hopes. Through his research, Tobinick believes he has learned the reason why Enbrel may prove effective in Alzheimer’s: It works by blocking an excess of “tumor necrosis factor-alpha” (TNF-alpha), which may affect communication in the brain.
In laymen’s terms, necrosis is the death of a cell, with all its coordinated activities going haywire, eventually shutting its functions down resulting in cell death.
Tumor necrosis factor promotes an inflammatory response, which in turn causes many clinical problems associated with autoimmune disorders such as Crohn's disease, psoriasis, asthma and rheumatoid arthritis.
Tobinick believes that TNF–alpha may also impact regions in the brain associated with speech, and that a drug used to fight an autoimmune disease could help Alzheimer’s patients regain some speech function.
On learning the results of Dr. Tobinick’s study, the Alzheimer’s Association spoke out, cautioning hopeful patients and families to not place “undue value on this finding based on the dramatic language used in its description and the apparent immediate effect”. The Association also notes that “We need to see work……by scientists without financial interest…”.
Dr. Tobinick does concede that his study was limited. Clearly, more research needs to be done and we hope Tobinick, Amgen and Wyeth will continue exploring Enbrel’s potential and the role of TNF-alpha.
(Be sure to watch the accompanying video showing one woman’s rather striking response in a related study.)
Tags: alzheimer's, arthritis, enbrel, etanercept, factor-alpha, necrosis, rheumatoid, tnf, tumor
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Permalink Reply by Stephanie Cooper on -
Wendy, thanks for sharing this with us. Definitely seems like a step in the right direction but more research needs to be done on this new drug. Hopefully a scientific study will have similar results and this drug really will improve speech in patients.
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Permalink Reply by Wendy Gammon, M.A., M.Ed. on -
Hi Stephanie!
I know this study was received less than enthusiastically by the scientific community---and with good reason. However, what positive pearl I took away from this was not necessarily Dr. Tobinick's rather shaky research methods, but the discussion of the potential role of TNF-alpha, and how it may impact speech in Alzheimer's.
One of the real challenges in AD is----still--- the difficulty pinpointing exact cause and brain geography associated with the disease. Even after all the ongoing research, we still continue to seek more exacting data. This could be another path open to exploration.
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