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Dramatic New Drug Therapy Using Enbrel - Too Good to be True?

Life Extension Magazine (Published by Life Extension Foundation -  which appears to be a magazine focusing on life style health and nutrition similar to Prevention Magazine) for August 2008, has a dramatic lead story by William Faloon. “Novel Drug Therapy Immediately Reverses Alzheimer’s Cognitive Deficits.” The drug featured is Enbrel (etanercept) a drug approved by the FDA in 1998 for the treatment of Rheumatoid Arthritis. The basic theory is that Enbrel blocks an inflammatory chemical that causes damage to the brain. The Enbrel is injected into the back of the neck followed by a brief period of the head lowered in a manner that will allow it to flow to the brain. (interspinous injections) This procedure is done once a week. A study was done with 15 Alzheimer’s patients having mild to severe stages of Alzheimer’s. . The article describes the results as: “Patients who received this drug into their brains experienced remarkable cognitive improvements within minutes that were sustained for up to three years.” It sounds too good to be true.....


Some Red Flags as I see them: 

1.  Side effects noted at the end of the article –“When administered systemically, it increases the potential risks for infection, low blood counts, lymphoma, demyelinating nerve disease, eye inflammation, congestive heart failure and death.”


2.  Also noted: “The long term side effects are not known when Enbrel is administered primarily to the brain as is being done in this....treatment.”


3.  Through an internet search, I found a very troubling item under the date of June 17, 2008. The item is in regard to the FDA, Enbrel and children. “The agency wants to beef up labeling for Enbrel to include a warning that, when used in children, the drug carries the risk of death. Enbrel is up for pediatric approval for use in psoriasis—currently it’s only approved for psoriasis use in adults—and in preparation for the advisory committee discussion tomorrow, FDA staffers combed the adverse events database. They found some serious problems in kids using Enbrel, such as malignancies, infections, and neurological problems, many of them life-threatening—and some deadly. Given the fact that the number of children on Enbrel is fairly small, these serious adverse events are a red flag, FDA said. The agency is recommending that the label be changed, regardless of whether the drug gets the additional psoriasis nod.”  Might not similar problems be found in the use with elderly dementia patients?


Note: When one considers all three of the above cautionary notes, the use of Enbrel reminds one of what it must be like to be tip toeing through a dangerous minefield.


4.  No approved clinical study has been done. Life Extension Foundation is seeking approval for an expanded study involving early stage Alzheimer’s participants. “Due to potential side effects of Enbrel, there are bureaucratic hurdles we have to comply with before initiating this formal study. Once we have institutional approval, Life Extension will initiate the study...We hope to keep the delay in launching this study to a minimum, but many of the regulatory aspects are out of our control.”


5.  A review of the Alzheimer’s Association web site reveals several cautions about the use of Enbrel. They provide the following points for consideration in their news item of 7/21/2008:


     a. “This was not a registered, controlled clinical trial. Clinicians should not take this report as grounds for off-label use of Enbrel for Alzheimer’s.”


     b. “The nature of the drug delivery technique used in this an unusual route for administering a drug intended for action on the brain.....makes Enbrel injection in this manner very unlikely to succeed in a chronic condition such as Alzheimer’s..”


     c. “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.”


     d. “This possible treatment strategy is very preliminary. 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. All of this strengthens the need for independent confirmation to establish this finding.


Too Good to be True? -  Time and much work is still be needed in order to answer this question!


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