An Alzheimer's reality check
Staff Writer Tim Mullaney
Alzheimer's researchers — or the public relations machines trumpeting their work — should chill out. Frequent breathless reports about major breakthroughs are giving false hope to anyone who believes the hype about an imminent cure.
This was the message delivered in a recent column by McKnight's Editorial Director John O'Connor (note: he used more eloquent language than “chill out”).
I'm on board. I see so much of this type of Alzheimer's news that it's hard to get excited when yet another AD press release comes in. So it was with a reluctant click of the mouse that I opened an Alzheimer's-related report from the New York Academy of Sciences last week.
I'm glad that I did. The report is certainly not sowing false hope: It is a detailed reality check about the difficulties of bringing an effective Alzheimer's drug to market. It serves to put some of the more optimistic recent pronouncements in perspective.
Research group RTI prepared the report after gathering information from pharmaceutical executives and experts in Alzheimer's research. The Executive Summary immediately caught my attention with this fact: 22 prospective drugs recently have failed in the final phase of clinical trials, according to research published this year. Memantine was the last to win approval. That was in 2003.
Researchers have made progress in the last decade, of course. Some of the most breathless press releases have been about scientists' increasing understanding of the disease, rather than about drugs moving through the development pipeline. The expanding Alzheimer's knowledge base opens doors to potential treatments, as researchers are quick to note when heralding their findings. But the RTI report throws some cold water on these hopes as well, by laying out all the barriers to the development of Alzheimer's therapeutics.
These barriers include challenges associated with clinical trials, which are harder to execute for Alzheimer's than for other diseases, according to the report. Just getting people enrolled in a Phase III clinical trial for Alzheimer's typically takes two years. Other challenges include the lack of biomarkers that reliably mark the disease's progress and could be used to gauge treatment effects.
There are numerous other barriers, and the upshot is that the total cost of bringing an effective Alzheimer's drug to market is nearly $6 billion. That's three times the industry average.
I realize it might seem odd that I'm excited about an Alzheimer's report that is breaking bad news rather than good news. But it isn't all doom and gloom. The researchers identified a number of potential steps to change the status quo. If these reforms take place, an Alzheimer's drug could be brought to market for about $2 billion, according to RTI estimates.
Of course, some of these reforms have been floated before, to no avail. And some are so boilerplate as to sound practically meaningless (promoting public-private partnerships, anyone?). But it seems to me that at least some of these changes will have to be made if the next 10 years are to be more fruitful than the last 10, in terms of drug development.
I was particularly interested in some of the ideas for improving clinical trials, such as creating a global registry of potential participants. This is also an area of research that long-term care providers might increasingly contribute to, considering how many of the possible participants reside in nursing facilities. One idea is to create an integrated network of Alzheimer's disease centers, which would provide care to patients, conduct “natural history studies” and “provide well-characterized participants for clinical trials.”
The report was prepared for the “Alzheimer's Disease Summit: Path to 2024” event that took place last week in New York City. Some of the principles of the report were distilled in the “Summit Declaration of Alzheimer's Treatment and Prevention.” This declaration was signed by a number of prominent figures in long-term care, and the summit organizers are calling for other stakeholders to add their names. Click here to find out how.
It's perhaps too easy to be cynical about Alzheimer's research, thanks to how the results often are presented. In addition to creating false hope, the hype around promising findings also threatens to make people complacent, thinking that the Alzheimer's research machine is well-oiled and firing on all cylinders. This new report does a service by pointing out the huge challenges that remain. Signing your name to the declaration might be a merely symbolic gesture, but hopefully the report will remind everyone that Alzheimer's research still needs — and merits — our attention and activism.
Tim Mullaney is Staff Writer at McKnight's. Follow him @TimMullaneyLTC.