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Caution Urged on Alzheimer’s Drug Speculation
By
Michael A. Piekarz
Staff Writer
The
reported use of an arthritis medication, Enbrel (etanercept), as
a possible miracle cure for Alzheimer’s disease is creating
concerns among Alzheimer’s organizations and manufacturers
of the drug who worry that Alzheimer’s patients and their families
may develop false hopes based on limited or potentially-flawed studies.
In early 2008, Dr. Edward Tobinick and Dr. Hyman Gross released data reporting
that the rheumatology and psoriasis medication Enbrel reversed the early symptoms
of Alzheimer’s disease in one patient in a matter of minutes. The information
was reported in the Journal of Neuroinflammation.
The report featured the case of an 81-year-old Alzheimer’s patient who
had Enbrel injected into his spine. According to the report’s authors,
the patient was “noticeably calmer, less frustrated and more attentive” within
10 minutes of receiving the injection.
The results of a second study were reported this month in the journal BioMed
Central BMC Neurology. This study involved another dozen patients treated by
Dr. Tobinick. The patients reportedly showed improvement in symptoms including
improved memory and increased mental focus.
“We often see verbal effects within a few minutes of the first dose,” said
Dr. Tobinick.
In addition to being Director of the Institute for Neurological Research, a private
medical group in Los Angeles, Dr. Tobinick invented and holds several patents
on a specific method of injecting Enbrel into the neck. He reportedly charges
anywhere from $10,000 to $40,000 per patient for the treatments.
FDA-approved uses for Enbrel do not require injections into the spine. And Enbrel
has not been approved for the treatment of Alzheimer’s disease. The use
of the drug by Dr. Tobinick is “off label” – a term that refers
to the use of an approved drug to treat a condition not approved by the FDA.
A statement was issued by the Alzheimer’s Association recently regarding
the use of Enbrel to treat the disease. The statement expressed concern that
false hopes would be created in Alzheimer’s patients and their families
as a result of the published reports.
Much of the criticism leveled in the Association’s statement was directed
at potential bias and a lack of additional information supporting Dr. Tobinick’s
findings.
“This newly-published study is a small one. In addition, one of the lead
investigators has stock in the company that produces the drug and has a number
of patent positions in the area,” read the Association’s statement. “All
of this strengthens the need for independent confirmation to establish this finding.”
“Before this drug can become an accepted therapy for Alzheimer’s
disease, it would need to go through the FDA approval process, including randomized,
blinded clinical trials,” the statement continued. “We need to see
clinical studies in large, diverse populations. We need to see work in other
laboratories by scientists without financial interest in the product.”
The Alzheimer’s Association statement also expressed concern about an increase
in off-label use of Enbrel. The statement also questioned the reported method
of delivering the drug – injections by needle into the back of the neck
followed by a brief period with the head lowered and feet elevated – as
making Enbrel “very unlikely to succeed in a chronic condition such as
Alzheimer’s.”
The Alzheimer’s Association statement urged additional tests under more
rigorous conditions than those used by Dr. Tobinick.
Amgen, which manufactures the drug in conjunction with another company, Wyeth,
also issued a statement urging caution when considering the use of Enbrel as
an Alzheimer’s treatment.
“We have carefully examined these reports and believe that there is insufficient
and unsubstantiated scientific data to support the use of Enbrel as a means of
treating Alzheimer’s disease,” Amgen stated.
Much like the statement issued by the Alzheimer’s Association, Amgen’s
statement was critical of the technique used by Dr. Tobinick to administer Enbrel
as well as the validity of his testing methods.
Amgen also questioned the rapid results reported as “implausible when considering
the time required for resolution of an active inflammatory response and the potential
impact that this could have on cognition.”
According to Amgen, “Dr. Tobinick’s case studies have not been presented
at an appropriate medical or scientific meeting, nor have they been published
in a rigorous peer-reviewed medical journal. Anecdotes are not sufficient scientific
evidence to support treatment of Alzheimer’s disease with Enbrel.”
The Amgen statement disavowed support or endorsement of Dr. Tobinick’s
treatment.
This page and its contents ©2008
Metropolitan News Company, Inc.
