Videos of mental and physical lapses and falls and episodes of disorientation by leaders of the Senate and by the President are concerning, but not in and of themselves diagnostic. But it is clear that with the current state of medical care, whatever is involved in their mental and physical decline is not immediately treatable.
There is a growing hope that someday soon cognitive decline will be treatable, and even reversible, if not for these leaders then for the next generation
Great advances have been made in understanding neurodegenerative diseases, with Alzheimer’s perhaps getting the most attention. But For years most treatments for these conditions were geared toward enhancing cognition without addressing underlying cellular changes in the brain.
All this has changed with the new anti-Alzheimer drugs that treat the disease by clearing protein plaques in the brain, seeming to usher in a new era. But is this the holy grail we have been waiting for?
In July we learned that a Biogen drug called Leqembi is now fully FDA approved. Then, within a few days Eli Lilly unveiled data about their drug donanemab, showing that it may be even more effective than Biogen’s. The battle for the minds and pockets of patients and insurers leads to huge profits.
But do these drugs cure Alzheimer’s, or any other forms of dementia? No. They are monoclonal antibodies that clean away the signature plaque proteins that characterize the disease after it develops. But these plaques do not happen on their own, and the drugs do not address the cause. Even though they slow the progress of the disease, the disease still wins. Hopeful patients who hear the news about these drugs will soon find their hope diminished.
But there is real hope to be found in the growing understanding of why the plaques and other symptoms develop, and in addressing the cause. A Harvard research team has shown that age, injuries and environmental can undermine the way DNA works. In a recent study they found that certain molecules can bring DNA back to an effective state and may lead to a future treatment of Alzheimer’s and other forms of dementia, and perhaps even aging itself. This clinical research is still in the early stages.
Another promising and growing area of study for Alzheimer’s and other brain diseases is neuroinflammation. Inflammation can be an adaptive process that allows cells to recover from injury. But when it is unabated and chronic in the central nervous system, it is linked to the onset of neurodegenerative diseases. So, what if we can interrupt or terminate it?
Various drugs with anti-inflammatory effects have been studied as possible Alzheimer’s treatments. In some cases we’ve seen encouraging reversal of cognitive decline, most notably with Pfizer’s Enbrel, although studies were eventually stopped when it was determined that the drug does not readily penetrate the blood-brain barrier {{Tumor necrosis factor α Inhibition for Alzheimer’s Disease - PMC (nih.gov)}}. Of drugs currently in active clinical studies, the candidate that has made it to Phase 3 is NE3017. {{NM101 Phase III study of NE3107 in Alzheimer's disease: rationale, design and therapeutic modulation of neuroinflammation and insulin resistance - PubMed (nih.gov)}} If successful outcomes persist as in earlier phases, this treatment could challenge Biogen and Lilly. But the cost of bringing it to market will be high.
For our political leaders, the finances of drug development present a dilemma. In the tax code there are research and development benefits that help already profitable companies but do little for smaller companies that don’t yet have a drug in the market. The small companies often become acquisition targets for larger companies that can get tax credits. That works well for society when it brings new drugs to the market. But some critics worry that acquisition credits allow large companies to protect their current product line-up by killing potential competition.
Still, there is one incentive that supersedes big dog eating little dog. In fact, companies benefit most when they can bring new drugs to market as the patents on older products end. But that distinction is oriented toward profits rather than patients. The whole system is dependent on political oversight that should support medical innovation. Luckily, with our current roster of aging politicians, they have a strong incentive to keep the system working in that direction.
Ken Blaker is a Los Angeles based healthcare and technology consultant focused on medical devices and FDA compliance.
