Criticism of the Bredesen Protocol

Of the top ten causes of death globally, dementia is the only disease with no effective, sustainable treatment. Indeed, standard of care pharmaceutical approaches have simply not worked in over 400 clinical trials, at a cost of over 40 billion dollars. When it comes to therapeutics, mainstream medicine has nothing to offer and does not appear to be making progress.

In the meantime, our laboratory research has suggested a fundamentally different view of Alzheimer’s disease, as a network insufficiency — a coordinated set of molecules governing neuroplasticity by supply and demand: too little supply and/or too much demand, and you end up creating a framework for developing the pathophysiology that leads to Alzheimer’s. This realization suggested a novel way to treat it, with a comprehensive, personalized protocol, and we reported the first successes in 2014, followed by 100 case studies, and the first clinical trial success this month, with a larger, randomized controlled trial set to start in a few months.

While we welcome constructive cooperation with other health professionals — who claim to desire best patient outcomes — some destructive criticisms have persisted, despite the fact that the critics have nothing effective to offer their own patients. Below, please see my responses to the critics:

1 ) “Poor science” We’ve been criticized for conducting “poor science:” some of my colleagues believe that each of the individual strategies in the protocol should have been validated by its own clinical trial before putting them together as a protocol. This misses the entire point of our research and treatment — Alzheimer’s is a complex illness with multiple pathways involved, so treating any single one of them has little effect (like taking a car that is low on gas, oil, and brake fluid, and needs new tires and alignment, then just filling it with gas). Furthermore, the hundreds of previous trials testing one strategy at a time have never achieved a significant positive cognitive impact. Because Alzheimer’s is a network insufficiency, the entire network must be moved toward improved neuroplasticity. Yes, we KNOW that trialing one monotherapeutic at a time is commonly accepted practice, and considered “more scientific,” but it ignores the disease mechanisms, sacrificing better outcomes to make it more simplistic, thus easier to analyze because of having fewer variables. This may make sense for a grant application, but it is literally dooming the patients to poorer outcomes. We thus believe that Alzheimer’s is a multifactorial disease that must be treated by identifying and addressing the actual causes of the cognitive decline, rather than treating blindly with an ineffective drug — that’s not poor science, it’s good medicine.

2) “Wrong journals” After publishing well over 200 peer-reviewed journal articles in the mainstream press throughout my 30 years leading a laboratory, we began translating what we had learned into clinical practice. Because I was suggesting a novel hypothesis and treatment plan, it was challenging initially to get some of the more mainstream medical journals to publish our work (unlike Silicon Valley, medicine has a history of being very slow to accept change, even when it has nothing to offer a disease like Alzheimer’s). With the ongoing failure of the amyloid hypothesis, these mainstream journals are now beginning to look for novel, more effective ways of treating this disease, hence our recent clinical trial publication in the Journal of Alzheimer’s Disease.  

3) “Too soon” Some of my colleagues think that it’s “too soon” to offer the protocol. They suggest that it should be peer-reviewed in randomized, double-blind, placebo-controlled trials before it is offered to the general public. However, there is a time-honored tradition in medicine called compassionate care: when dealing with a fatal illness, it is common practice to offer promising experimental treatments while concurrently working to build scientific evidence. That is exactly what my team has done. We started in the laboratory, moved to clinical practice with a few case studies (Reversal of Cognitive Decline: a Novel Therapeutic Program), then additional case studies (Reversal of Cognitive Decline: 100 patients), then a proof-of-concept clinical trial (Precision Medicine Approach to Alzheimer’s Disease: Successful Pilot Project), and now a larger randomized clinical trial in progress. If we had waited, thousands of people who have used our protocol and seen improvement or stabilization would have died needlessly — is that really what the critics would have preferred?

4) “Standard of care not offered” Some have questioned why we don’t first offer “standard of care” to the patients. Of course this is always available, but most know it does not work, so most decline it. Mainstream medicine has no effective, sustainable treatment for those with cognitive decline. Often cholinesterase inhibitors like Aricept are prescribed, and may indeed improve symptoms for a short period, before ultimately leading to more severe decline than if they had never been prescribed. Many patients report being told “Good luck with that” or “Go home and wait for it” as the standard of care they were offered. Those who are “lucky” enough to be treated at top-notch memory care centers will typically be given a spinal tap, then followed as they decline, or offered the opportunity to participate in a clinical trial, none of which has been successful to date.     

5) “Too expensive” Let’s be clear, Alzheimer’s is a progressive, fatal disease, and dying of Alzheimer’s is much more expensive than treating it with our protocol. The costs of assisted living and ultimately nursing care (which are typically borne by patients’ families) are astronomically greater, and the outcome is never a positive one. Also, keep in mind that mainstream medicine still has nothing to offer, as evidenced by the FDA’s recent approval of Aduhelm, which was initially offered at over $50,000 annually (without factoring in the cost of ongoing physician visits, monthly infusions, regular MRI’s which would have added significantly to that cost) despite the fact that it had potentially severe, even fatal, side effects in over 40% of patients, without showing any benefit to cognition. It’s interesting to compare the treatment that cancer patients regularly receive to the treatment that Alzheimer’s patients receive. For cancer patients, health insurance typically covers not only all physician and hospital visits, but also aggressive, ultra-precision medicine approaches. In contrast, for Alzheimer’s patients, health insurance will only cover futile physician visits without covering the actual cost of palliative care as the disease progresses. We believe that Alzheimer’s patients deserve the same fighting chance for survival and the level of care that cancer patients receive, and we shall continue to push for Medicare and health insurance coverage for the protocol as the standard of care. 

6) “Conflicts of interest” While publishing several of my papers, I was enlisted as a consultant by two different companies — Apollo Health and Life Seasons — and this was appropriately disclosed in our clinical trial publication. We took care to separate the clinical trial, which was funded by a non-profit, from any interaction with those two corporations, and therefore none of the products or services offered by these two businesses was ever used for the patients described in the trial, and the companies were not involved in the planning or execution of the trial. In contrast, pharmaceutical companies routinely pay physicians, as well as the Alzheimer’s Association, in a clear conflict, as the paid physicians and Alzheimer’s Association then speak in favor of the ineffective drugs.

7) “The End of Alzheimer’s” I’ve received a lot of criticism for the title of my first book. I get it; many people think that it’s an overstatement of what is currently possible. The original title that I proposed was Wit’s End, but the publisher pointed out (correctly) that my suggested title did not clearly indicate the subject of the book. The publisher then decided on the title that was ultimately used, and although I disagreed with the publisher’s title, I felt it was more important to share our good results, and potentially help people in need, than it was to cancel the book’s publication over the title disagreement.         

Our goal is to reduce the global burden of dementia through widespread collaboration to enhance the overall treatment for patients. We welcome all practitioners to become leaders in this field and join our team. See Practitioner Training to learn more.