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07 November, 2011
Etanercept and Dementia Alzheimer’s Australia Position Statement
Two segments of Channel 9’s 60 Minutes over the past three weeks depicted perispinal etanercept as a breakthrough medical treatment for Alzheimer’s disease and other forms of dementia. The cases presented in the program suggest people have experienced remarkable improvements in memory and functioning after treatment.
Dementia is caused by diseases that damage and destroy the brain (Alzheimer’s disease is the most common of these), and a diagnosis of dementia can have a profound impact on patients and their families. Dementia is a terminal condition for which there is currently no cure.
As Australia’s peak body providing support and advocacy for the 267,000 people living with dementia, we understand very well the challenges that are faced on a daily basis by people with dementia and their carers. We understand too that those affected will always search for hope, wherever it may be.
The purpose of this statement is to present the facts that were not covered by 60 Minutes, and to offer an explanation to people whose hopes might have been unjustly raised.
The first point that needs to be made is that etanercept (perispinal refers to the method of administration) is not a proven treatment for dementia as it may seem to be based on the program.
Etanercept was developed in the 1990s as an advanced medication for inflammatory autoimmune diseases (some types of arthritis, and certain skin conditions like psoriasis). As part of its development, the drug underwent numerous clinical research trials involving thousands of patients to show first that it was safe, and second that it was an effective treatment for the intended conditions.
The outcome of these studies was that etanercept was shown to be beneficial for these specific conditions. However, the research also showed that there are a range of very serious possible side effects, including severe allergic reactions, reduction in immune function, infection, internal bleeding, seizures, and cardiac or respiratory problems. Because of these side effects the drug is only available in Australia to people with these specific conditions, and only when prescribed and monitored by a specialist immunologist or rheumatologist.
The large clinical research trials to test etanercept as a treatment for dementia are yet to be done. The method of administration for arthritis and psoriasis is different to the perispinal method shown in the program for Alzheimer’s disease. And while there is some research and a plausible theory about how the drug might work to counter the symptoms of dementia, it is just one of dozens of other drugs that are being studied in Australia and abroad.
The key issue is that etanercept has not been subject to a randomised controlled trial (RCT) as a treatment for dementia. Successful RCTs must be completed for any new drug before it can be approved for sale. Regulatory authorities worldwide require at least two RCTs before they will license a drug treatment; a safeguard that protects the public by ensuring that the new drugs are safe and effective, and also protects against unwarranted claims.
With further research, it is possible that etanercept will form a part of the range of safe, effective, tried and tested treatments for dementia. However, until the RCTs have actually been done, there is simply no way to know for sure.
There is nothing to prevent people making a choice to make a big financial commitment on a trip to America and to sign up for the perispinal etanercept treatment. It must be understood, however, that the treatment may or may not help. The case studies on the program may well be the best success stories rather than those for whom the treatment failed, and there could also be potentially serious risks involved.
Untested treatments may do more harm than good. The best course of action for anyone worried about a loved one or concerned about their memory is to seek medical advice from their GP or medical specialist.
Glenn ReesCEO, Alzheimer’s Australia
Scientia Professor Henry Brodaty Director, Dementia Collaborative Research Centre – Assessment and Better Care University of NSW