Etanercept Research Continues to Spawn Hope, Criticism

Drs. Edward Tobinick and Hyman Gross have published another study indicating the benefits of perispinal etanercept treatment for Alzheimer's disease. You can read their study here, because they like to publish their research in open access journals so people like you and me can learn about what they're doing.

As I've described in previous blogs, the treatment reduces the amount of TNF (tumor necrosis factor-alpha) in the brain; an excess of TNF has been associated with Alzheimer's disease.

The study describes how the treatment (over six months) improved language ability in a sample of 12 individuals at various stages of Alzheimer's. The researchers note that the study has some limitations. The sample is small, and it was an open label study, meaning that participants and family members knew that the treatment was being administered. No placebo was used. Still, the results clearly indicate that this method of treatment warrants further study (as an added bonus, the researchers made available a video of a caregiver who talks about the improvement in his father after just one treatment).

The study elicited criticism from two major entities. The Alzheimer's Association released a statement citing concerns that the study will engender false hopes among families dealing with the disease and that the study was not a randomized, double-blind clinical trial registered with the National Institutes of Health and the FDA.

Amgen, one of the co-marketers of Enbrel -- the brand name for etanercept -- also released a statement, saying that it did not endorse or support the experiment (Enbrel is currently FDA-approved for rheumatoid arthritis and some other conditions, but not for Alzheimer's disease).

I agree that more rigorous clinical trials should be conducted to determine the safety and efficacy of etanercept treatment for Alzheimer's. I understand the need to be cautiously optimistic. But here's my thing: Why are these smaller, less rigorous studies being dismissed, instead of being recognized for their potential? Most theories are studied at a smaller level in order to build justification for more wide-reaching investigations. Dr. Tobinick is open to coordinating larger clinical trials -- for instance, he recently spoke with the UK's Alzheimer's Society and Southampton University about doing just that.

He communicated with those organizations because large-scale clinical trials require cooperation among multiple entities. Ironically, the two major organizations that have criticized Dr. Tobinick's research have the power and means to help him accomplish what they are imploring him to do.

Drs. Tobinick and Gross are not the only scientists who think that TNF plays a role in Alzheimer's. At least 10 presentations at the 2008 International Conference on Alzheimer's Disease -- organized by the Alzheimer's Association and starting this weekend -- will focus on TNF and its role in the disease. Although I can't be there, you can bet that I'll be taking a virtual seat in the press room.

Illustration © Alzheimer's Disease Education & Referral Center