In an effort to ease drug development for Alzheimer’s disease, the Food and Drug Administration is endorsing a new approach that would rely on biomarkers to approve medicines before patients show any signs of the illness, instead of demonstrating a drug alleviates symptoms.
To entice researchers, the agency would accelerate approval of a drug for people who do not show indications they have the disease if the treatment has an effect on a biomarker, according to a draft guidance released on Thursday. The agency did not specify any biomarkers, but presumably, this could include beta amyloid or tau, which are proteins believed responsible for triggering the disease.
Once a drug becomes available, a drug maker would then have to conduct additional studies to confirm its treatment offers a benefit, notably a change in cognition. This would also amount to a significant policy revision, because the FDA previously looked for treatments that could provide changes in function, as well as cognition.
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Our work at Theraphi in Vancouver using Biophysics Tools for Dementia Prevention; a combination of PEMF, transcranial devices and atmospheric cold plasma is producing remarkable rejuvenation in mood, motivation, motor skills and mental acuity in two clinical trials with 79 individuals aged 68-91. Canada can’t afford the catastrophic cost of Dementia Care and we’re not the least bit squeamish about which faculty the cure comes from. Our government is treating this with the urgency of a Manhattan Project.
Had these new guidelines been in existence for a few years we may well have have at least three drugs on the market to treat Alzheimer’s disease. The companies that market them could have made billions! Semagacestat, bapineuzumab, and dimebon moved a number of biomarkers but in later, properly done clinical trials simply did not work (Zuckerman et al BMJ 2015). Companies too are notorious for not completing the followup studies needed to show effectiveness post-approval and our increasingly worthless FDA, more and more lax on insisting they complete them, leaving worthless and dangerous drugs on the market.
I’ll put on my HealthNewReview hat here and note that the two sources quoted are entangled heavily with pharma–all the Alzheimer’s Advocacy groups take millions from them and Dr Lopez, and most academic Alzheimer’s researchers are consultants and/or have their research funded by pharma, so it’s not surprising they like to see this go ahead. Let’s declare these COIs please Ed.
Hi Susan,
Thanks for the note. And I’m aware of the point you raised, which I will be pursuing as a follow up this week (believe it or not, I’ve already started work on this).
And I’ve updated the post to reflect the financial ties, which I agree should have been noted initially.
Regards
ed
Wow! What a bad idea! Correlation between amyloid-beta accumulation and symptomatic evidence of dementia is poor. Rapid approval would open the door to sucking a lot of money out of insurance companies for ineffective drugs. Symptomatic markers (as measured by cognitive testing, like the MMSE) should be the only standard for approval. AD is such a common disease that we need to think carefully before opening the floodgates for pharmaceutical abuse of insurance companies.