Speaking of ethics, from the Bureau of Irresponsible Press Releases comes this headline:
Reversal Of Alzheimer's Symptoms Within Minutes In Human StudyHave any of the credulous commentators raving about this finding actually read the journal article in question? It's Open Access, so it's freely available to all when you click on a link in the Science Daily piece. Even a cursory perusal will indicate that the manuscript could not have been reviewed by anyone who follows the scientific method.
ScienceDaily (Jan. 9, 2008) — An extraordinary new scientific study, which for the first time documents marked improvement in Alzheimer’s disease within minutes of administration of a therapeutic molecule, has just been published in the Journal of Neuroinflammation.
... The study focuses on one of these cytokines, tumor necrosis factor-alpha (TNF), a critical component of the brain’s immune system. Normally, TNF finely regulates the transmission of neural impulses in the brain. The authors hypothesized that elevated levels of TNF in Alzheimer’s disease interfere with this regulation. To reduce elevated TNF, the authors gave patients an injection of an anti-TNF therapeutic called etanercept [aka Enbrel, used to treat rheumatoid arthritis]. ...Although suppressing inflammation with an anti-TNF agent may indeed be a promising treatment (e.g., Ryu & McLarnon, 2007), I think one must test its efficacy against a placebo. And what mechanism of action would mediate cognitive improvement within minutes, in a disease with complex pathology that takes years and years to develop?
The new study documents a dramatic and unprecedented therapeutic effect in an Alzheimer’s patient: improvement within minutes following delivery of perispinal etanercept, which is etanercept given by injection in the spine. Etanercept (trade name Enbrel) binds and inactivates excess TNF. Etanercept is FDA approved to treat a number of immune-mediated disorders and is used off label in the study.
The actual article (Tobinick & Gross, 2008) reads like physician's notes, not a research study or clinical trial. Here's the extent of their "immediate effect" (with absolutely no placebo condition, of course):
Ten minutes after dosing the patient was reexamined. He was noticeably calmer, less frustrated, and more attentive. He was able to correctly identify the state as California, and he identified the year as 2006. His responses to questioning seemed less effortful and more rapid, with less latency. He left for author HG's office for further testing.See also Etanercept Improves Alzheimer's Disease In Minutes for a critical discussion of this single-case study -- including the lack of a formal research protocol, the lack of any patient selection criteria (the gentleman in question may not be a typical dementia patient), the fact that the authors patented an off-label treatment [how can they do that? was it for the perispinal route of adminstration?], and links to a video interview with family members, for starters.
Ryu JK, McLarnon JG. (2007). Thalidomide inhibition of perturbed vasculature and glial-derived tumor necrosis factor-alpha in an animal model of inflamed Alzheimer's disease brain. Neurobiol Dis. Sep 15; [Epub ahead of print].
Tobinick EL, Gross H. (2008). Rapid cognitive improvement in Alzheimer's disease following perispinal etanercept administration. J Neuroinflammation Jan 9;5(1):2 [Epub ahead of print].
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