Smiling From Era to Era

By Dale Bredesen, M.D., Chief Science Officer for Apollo Health

There has been a lot in the recent news about potential fraud in Alzheimer’s research and Alzheimer’s drug development. Dr. Rammohan Rao, my long-time colleague, addresses this issue nicely in his newsletter piece this month, and I’ve had numerous podcast discussions about this topic recently, as well. Were the research results photoshopped? Was the drug development based on non-existent data? If so, should the researchers be forced to return the grant funding? Should the drug company be forced to return the investment? 

Didn’t we just leave this party? For the past year, we’ve been hearing about aducanumab, a drug approved by the FDA over the objections of its own advisory panel, indeed approved without evidence of efficacy in patients with Alzheimer’s disease. 

Again and again, and now once again, we see researchers and developers trying to fit a square peg into a round hole: trying to find a single species of amyloid that is “the cause” of Alzheimer’s disease; trying to find a single drug that will cure Alzheimer’s in every person (as if we are all identical); and then trying to convince a government administration that failure in data and trials should not prevent success at the cash register. When the most basic assumptions about a disease are incorrect, we will see repeated failure, fraud, and coercion in repeated attempts to squeeze the square peg of simplemindedness into the round hole of Alzheimer’s disease.  

The problem is far greater than any of the reports of potential fraud have claimed: we are witnessing the end of an entire era of medicine, and the birth of a new era. The Pharmaceutical Era is ending, and the Precision Era is dawning. The Pharmaceutical Era seeks to identify and treat a simple, critical target for each disease, and this has worked splendidly for infectious diseases such as pneumococcal pneumonia and tuberculosis. However, the major causes of mortality are now complex chronic illnesses such as neurodegenerative diseases, cancer, vascular disease, and diabetes, and these are not as amenable to the pharmaceutical approach as are infectious diseases. Thus neurodegenerative diseases have been, arguably, the greatest area of therapeutic failure in medicine.  

The Precision Era seeks to identify and target the many contributors to disease in humans, as individual, complex organisms. Alzheimer’s in different individuals has different genetics, different epigenetics, different biochemistry, different subtypes, and different responses to treatment. As our recent clinical trial showed, outcomes are much better when these many variables are taken into account. 

The Precision Era should prove to be a very exciting one: with a more sophisticated approach to human pathophysiology, more extensive data sets, the ability to “see” diseases coming years ahead of symptoms, and the ability to prevent and reverse most complex chronic illnesses, we should see improvements across the board in healthspan and lifespan, including a dramatic reduction in dementia. This era should continue to see evolution toward better and better outcomes. And when you are on the right track, and results are predictable and positive, there is no incentive to fudge the data.