As you my recall, either from your own font of knowledge, or from our post on the 11th (with the rather uninspiring but fairly informative title “World Alzheimer’s Month (September 2013) and Day (September 21),” in spite of the staggering numbers of people who are impacted by Alzheimer’s disease (AD), national research money has lagged significantly behind other illnesses.
We noted that, in 2011, the National Institutes of Health (NIH) spent over $6 billion on cancer research–and less than $480 million on Alzheimer’s research. That same year the NIH spent $3 billion on AIDS research.
But what should I awake to this morning (this is the 19th–by the time I manage to get this post out this may all be old news–but I still hold by the concept of better late than never when it comes to world health), but news from MedPage Today’s “Morning Break” that the NIH said it was granting $45 million (which doesn’t catch it up to cancer or AIDS, I admit, but isn’t a bad start, either) to support clinical trials of new AD drugs, with the majority of the funding ($33 million) headed toward a prevention study that’s on, ironically, those without any signs of dementia at all.
Why in the world, you may be thinking, would the government be putting precious millions of dollars it doesn’t have towards studying people who are perfectly fine?
This, I grant you, is an excellent question.
But it is just the latest in a number of signs indicating a shift in the focus of Alzheimer’s research. Good money after bad has gone into research trials on treatments of people who already have AD.
Sadly, as anyone with a family member with the illness knows, the medications we have today only go so far (and that ‘so far’ is, in actuality, not far enough to get you around the block) in actually treating the symptoms of AD. It seems the government is finally getting around to acknowledging this fact.
Up to now the FDA has approved several drugs to treat AD, the most well-known of which are Aricept (donepezil) and Namenda (memantine).
But according to a 2010 study done by the Agency for Healthcare Research and Quality, the drugs both failed to delay the onset of AD and failed to either improve or even maintain mental function in early stages of the disease. This wasn’t news in 2010 either. Back in 2008 the American Academy of Family Physicians found the drugs’ performance underwhelming, writing of the two treatments, “the clinical relevance of these effects is unclear.”
The data continues to come in. A 2011 study gives its secrets away in its title, “Lack of evidence for the efficacy of memantine in mild Alzheimer disease,” where the researchers conclude, somewhat pessimistically I might add, both that a number (ok, they claim most) of the studies of the drug are flawed and then, to add insult to injury, neither of two, better, placebo-controlled trials on subjects with moderate AD found significant improvements on several crucial scales.
And as if that wasn’t bad enough, AD drugs ‘in the pipeline,’ so to speak, seem as if they’re doomed as a class. Between 1988 and 2011, 101 treatments failed somewhere in the testing phases, leaving only 3 medicines to make it to market, for a ratio of 34:1. PharmaTimes reports that of those 101 flunky meds, 83 have been permanently discontinued–officially–while the others are reported “suspended.” However, there has been no work done on these in the past two years. Safe to assume they’re goners, as well.
In short, the drugs we already have are serious under-performers, and the medications supposedly on their way to improve the situation. . well, they’ll never make it here.
You can see why the government has turned to prevention.
And the NIH has made this grant happen against all odds. The Obama administration had promised $100 million in funding for AD in 2013–but when all budgets got slashed, that promise went the way of so many governmental promises before.
But Dr. Francis Collins, director of NIH, was determined to see some cold hard cash put into AD research. As quoted in the Times, he took a little here and a little there, helping himself to bits of the budgets of 27 different NIH agencies until he had scraped together $40 million. The additional $5 million was given by the National Institute on Aging, part of the NIH.
Dr. Collins said, “The worst thing we could do would be to just hunker down and hold off tackling very important problems. . .Obviously, this is high-risk research, but goodness, the stakes are so high that we felt we had to go forward even in the face of the most difficult budget environment that anyone can remember in the N.I.H.”
So let’s get back to the healthy people. This is the largest dementia grant yet to be used to test a drug on people with no signs of a problem–650 of them, no less. Ranging from 65-70 years of age, the subjects have no symptoms of the disease, but there’s a catch. Not just any healthy–(I’m stuck here for an adjective. Do we say ‘older’? ‘Middle-aged?’ I don’t want to offend; perhaps an adjective is overrated here)–subject can be experimented on.
These subjects must have two copies of the [get ready–here’s your fancy science term for the weekend, one that it’ll pay to know as time goes on:] Apolipoprotein E4 (ApoE4) gene, a gene known to greatly increase the chances of one’s contracting Alzheimer’s. [More science to put in your pipe and smoke: More than half of people with two APOE4 genes will go on to develop AD, versus one-fourth with one gene, and 10% of people who are lack the gene completely.]
So that’s the plan.
Well, if you’re wondering if I forgot to save, or if WordPress acted up and cut out a piece of the post, neither is true. The plan is. . .that they haven’t fully developed the plan. I didn’t include the drug to be tested –because the researchers haven’t yet chosen the drug to be tested.
Any minute now.
But they’ve got some other key pieces nailed down. True, the drug us up in the air, but they do know they want to start in 2015, and they know this particular project will cost over $100 million, and they know they’ll get a big fat lot of it from the pharmaceutical industry (plus, of course, some from the grant).
So you can clearly see things are falling into place.
And taking a look at what can be done to prevent the illness from starting, surely seems to have more than a leg-up on trying to treat an illness already raging.
At least according to Dr. Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s center.
“[This] doesn’t mean we abandon people who need treatment,” the doctor said. “But from a public health perspective, if you want to prevent millions of people from getting the disease, this is the way we have to go.”