Longevity-Promoting Organization Calls for Accelerating FDA Approval of Longevity Medicines

Highlights:

• The current economic turmoil in the U.S. may be exacerbated by the rising aging population if something is not done soon.
• Public perception must align with current advances in aging science which points to targeting multiple chronic diseases with a single drug.
• A4LI proposes the FDA aligns its definitions of chronic disease and aging with the latest scientific progress, allowing for accelerated approval for longevity medicines.

As of May 16, 2023, the U.S. economy is in turmoil as the executive and legislative branches argue over where to spend American tax dollars. Raise the debt ceiling or cut government spending? Because Social Security (SS) and Medicare make up over 30% of the U.S. government’s spending budget, this could mean catastrophe for the health and well-being of many Americans, especially senior citizens (65 years and older), 25% of whom rely on SS for 90% of their family income. 

Unless some serious changes are made, the long-term survival of many individuals may be in danger. The percentage of senior citizens in the U.S. has reached record-breaking levels and is rapidly increasing. In just over a decade, senior citizens will outnumber the nation’s children. At this rate, the government will need to spend more on SS and Medicare to support the financial stability and health of an aging America. A bad situation for a faltering economy. 

Former CEO of the University of Maryland Medical Center, Stephen C. Schmpff, M.D., argues that the U.S. has a “sick care” system, not a health care system. We wait until our people are sick before providing medical treatment. In lieu of preventing sickness and disease, this paradigm places tremendous unnecessary costs on the economy. 

“Our current paradigm of chronic medical care is unsustainable, as it focuses on mitigating the progression of individual chronic diseases after they have arisen, with far less effort devoted to effectively curing or preventing these illnesses. This approach has led to escalating healthcare costs, impaired quality of life for patients, and increased use of healthcare resources.” – A4LI

To address the threat of an economic downfall stimulated by an aging America, The Alliance for Longevity Initiatives (A4LI) has made its mission to create “social and political action around the issues of combating age-related chronic conditions and increasing our number of healthy, disease-free years.” A summary of their viewpoint and plan is outlined here. 

The Way We Currently Look at Aging is Fundamentally Wrong

Chronological age is the primary risk factor for the top eight causes of non-accidental death in the United States:

• Heart disease 
• Cancers 
• COVID-19
• Stroke
• Respiratory illnesses
• Alzheimer’s
• Diabetes
• Kidney disorders

These and other chronic age-related conditions place enormous costs on patients and their families who as a nation spend an estimated $3.7 trillion per year on medical care and treatment. This is not to mention the billions of dollars the U.S. government spends on Medicare and SS for the millions of Americans who can’t afford healthcare or are unable to work due to chronic disease. If such chronic age-related diseases could be prevented, most medical expenses would be unnecessary. Furthermore, government spending could be reallocated to other sectors, such as scientific research and education that further promote disease prevention. 

“Although taxpayer-supported scientists and the pharmaceutical industry spend billions of dollars each year researching and developing therapies for individual age-related diseases, aging itself has long been considered inevitable and unalterable. This assumption is reflected in our national funding priorities, with less than 1% of the NIH budget devoted to studying the fundamental biological processes associated with aging.” – A4LI

A key problem with the public’s perception of aging is perhaps the idea that it’s unstoppable. An indomitable force to be reckoned with. A consequence of life. However, within the last few decades, our knowledge of aging has rapidly evolved. Now, it seems possible to slow the human aging process. Importantly, it appears that many chronic diseases occur due to the same underlying biological processes. 

The latest studies have revealed that small-molecule drugs targeting these age-associated biological processes (e.g. rapamycin) can slow aging and extend the lifespan of animals ranging from flies to mice. These same compounds, and other compounds (e.g. NAD+ boosters and senolytics) can also delay age-related diseases. This is not to say that there is much more work to be done. Human studies are lacking, and this is the gap A4L1 hopes to help fill. 

“It is essential that federal regulatory policy support a shift in the biotech and pharmaceutical industry towards developing medicines that address the root cause of chronic disease — the biological process of aging itself.” – A4LI

A Proposed Solution

Many biotechnology companies have already begun research on drugs that target the root cause of aging and chronic disease, so-called longevity medicines. 

“The intent of these medicines is not to extend lifespan per se but to modulate the biological processes underpinning healthy longevity, extending the years of healthy lifespan (healthspan) while shortening years of sickness.” – A4LI

Longevity medicines can potentially reduce mortality and healthcare costs for a rising aging population, which can boost economic growth. 

“Increasing healthy life will enable individuals to remain vibrant contributing members of society for a much longer period. Healthy people are not only more independent and happier, but they are more likely to participate in the labor force and more productive when they do, with each one-year increase in working lifespan predicted to drive a 1% increase in GDP (corresponding to $260 billion per year in the US).” – A4LI

However, we still have the problem of a sick care system. Drugs are currently approved on the basis of the drug targeting individual diseases in people who are already sick. Therefore, considering the high costs of clinical trials and long-winded approval processes for each indication, companies are not financially incentivized to pursue drugs that target multiple diseases. For these reasons, the FDA approval process does not accommodate longevity medicines. 

The purpose of A4LI’s Advanced Approval Pathway for Longevity Medicines is not only to promote the FDA’s recognition of longevity medicines — requiring a change in how they define aging and chronic disease — but also to uphold policies and incentives to accelerate the approval of longevity medicines.

“By incentivizing the development of drugs that can treat or even entirely prevent multiple chronic diseases simultaneously, we can create a more sustainable and effective healthcare system that significantly improves the quality of life for Americans.” – A4LI

For this to occur, an online petition is available for anyone to sign: Petition to Establish the Advanced Approval Pathway for Longevity Medicines.