If it were any other disease, outraged patients and their families would be writing their legislators and demonstrating in front of drug makers’ headquarters. But Alzheimer’s is no ordinary disease, so the latest revelation that very few experimental drugs are being tested to see whether they might help people with moderate, let alone severe, dementia passed this week without so much as an indignant press release from advocacy groups or other Alzheimer’s organizations.
Patients with dementia “cannot advocate for themselves,” said Dr. Sam Gandy, a neurologist and Alzheimer’s researcher at the Icahn School of Medicine at Mount Sinai. “Caregivers are too exhausted to be advocates. This shifts the advocacy burden to either young people, who still think of themselves as invincible, or midlife people, whose lives are already overstuffed with children and aging parents, many of whom are in no hurry to add advocacy roles.”
The reason more and more clinical trials want nothing to do with patients who have moderate, let alone severe, Alzheimer’s, is simple: It’s too hard to make any difference in these advanced cases. The last Alzheimer’s drug was approved in 2003, and a litany of failures over the last decade has both cast doubt on the prevailing hypothesis of the disease (that you can slow or even reverse it by preventing the buildup of amyloid plaques and removing existing plaques) and persuaded many researchers — and drug companies — that the only way forward is prevention or, possibly, slowing the disease in the mildest, just-diagnosed cases.
Thanks for the reply, but I’m still doubtful. By the time you learn the drug works and you receive regulatory approval to launch, the patent term will have expired.
Can someone more knowledgable please explain the financial incentives for looking at early-onset AD in younger people? Suppose you start giving a drug to a group of people in their mid-50s with some markers of AD but who are asymptomatic people. Even if left untreated the cognitive decline would not start for years. So clinical trials demonstrating that the drug is effective would need to be extraordinarily long, and, even if successful, by the time went on the market there’d be very little if any patent term left. How is this supposed to work?
There 70million people with Alzheimer’s disease now worldwide and 200 million people at risk for AD worldwide. To do a AD Prevention study you need 60,000 to 100,000 people, half taking placebo and half taking the active drugs. If it works you have a market of 200-million people to sell to. So if it works you will still make out big!!!
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