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March 2, 2015

Why an Anti-Aging Drug Can Never Legally Exist

Can an Anti-Aging Drug Exist”

I found Does a Real Anti-Aging Pill Already Exist published recently in BloombergBusiness an interesting article because it touches upon a few key issues related to the aging process and the anti-aging movement. I will use the BloombergBusiness article as a means to discuss some of these issues and to hopefully clear up some confusion regarding aging.

anti-aging drug
Artwork courtesy of Pixabay

Drugs are for Diseases: Is Aging a Disease?

First, by law there can never be an anti-aging drug in the United States – at least at this point (2023). Why is that you might think. Well, for something to be called a drug in the United States it has to be something used to treat a disease. Health and Human Services does not recognize aging as a disease.

Now having said that, the FDA has approved some studies that are assessing the repurposing of drugs to slow or reverse the aging process. These include studies on rapamycin and metformin.

The United States Federal Government has determined that aging is not a disease. Secondly, a drug is something that requires a prescription from a physician to treat a disease or symptoms of a disease recognized by the Secretary of Health and Human Services (the government). If there is no disease there can be no legal drug to treat it. And, since aging is not a recognized disease in this country there cannot legally be drug to combat it. Drugs are for diseases.

Thus, one cannot prescribe growth hormone or any other drug specifically for anti-aging purposes, but such drugs can be prescribed to treat any condition recognized as a disease by the government. Thus, drugs that have anti-aging properties can be used to treat symptoms of aging such as those related to hormone deficiencies and other diseases such as depression, declining libido, decreased bone density, fatigue, muscle loss, hot flashes, mood swings, and so on.

Essentially, anti-aging “drugs” cannot be used to treat aging, but can and are legally used to treat the symptoms of hormone deficiencies and other diseases that contribute to aging. So it comes to down to legal definition.

So does an anti-aging drug already pill exist as the BloombergBusiness article suggests?  Yes, several exist in fact. You just cannot legally call them anti-aging pills. One way to get around this dilemma is to market and sell a product as a nutritional supplement. But, to do this a manufacturer cannot make any health claims regarding its supplement.

Being able to call something a drug is more desirable, though, as it gives the product legitimacy since it must be prescribed by a physician. Plus manufacturers can typically charge more for drugs than supplements.

In the end, that’s the main difference between a drug and a nutritional supplement. One is used to treat a disease recognized by the government after showing that it is effective in treating that disease (though the threshold for showing drug effectiveness is quite low). The other may well have beneficial effects in treating a disease but can make no claims as to such. One requires a prescription, the other does not.

TA-65 is the classic example of a product that was developed and tested as a drug but is being marketed as a nutritional supplement since it is an anti-aging product. It was developed by Geron and has been licensed to TA Sciences to be marketed as a anti-aging supplement to get around this aging is not a disease obstacle, though Geron maintains the rights to develop and use it as a drug to treat diabetes, cancer, and other diseases for which it might be beneficial. Reseveratrol is another supplement used for anti-aging purposes, while being tested as a drug to treat specific medical conditions.

To pursue something as a drug or as a nutritional supplement many times is determined by the profits that can be generated. Sometimes it’s more profitable for manufacturers to label something as a supplement and reach a greater market than pursue it as a drug for a limited and targeted market. Like many things it comes down to money. Many pharmaceutical companies also own nutritional supplement companies to fully capitalize on all markets.

Natural Aging versus Accelerated Aging?

On the surface concluding that aging is a natural process and not a disease seems reasonable. But, is it? Is aging entirely a natural process? Science, observation, and even biblical references indicate that the natural life-span is 120 to 125 years. Clearly, few of us live to this age, therefore most of us succumb to accelerated aging and die prematurely – before the time we are given or programmed to have.

It can be reasonably argued that accelerated aging is a disease and worthy of treatment. Diabetes is considered a disease and diabetes is the classic example or model of accelerated aging. In fact, all chronic diseases lead to accelerated aging. And, we treat those diseases and their symptoms, so why not openly treat the ultimate expression or symptom of those diseases – accelerated aging?

Anti-Aging, Life Extension, or Delaying Death?

In reality, anti-aging  and life extension efforts are really efforts not to extend the life span as much as they are efforts to thwart accelerated aging and premature death. In other words, anti-aging medicine isn’t trying to stretch your life from age 75 to 125. It’s really trying to lessen the time you take off the 125 years of living you’ve been programmed to enjoy. It’s a more appropriate way to look at its goal from this perspective.

Think of it like this. When you are born you are programmed to live or have been dealt  a 125 years of life (assuming you do not have an inherited disease that shorten life span). Every time you engage in an unhealthy habit or get a disease, and the longer you leave that disease unattended whether it be high blood pressure, stress, diabetes, obesity, heart disease, and so on, you are taking time off your 125 year clock.

Anti-aging, life extension, and age management all mean more or less the same. They are helping you tick time off your clock as slowly as possible – not adding time to the clock.

Thus, healthy aging is dying at the slowest rate possible.

Now, regenerative medicine is something else. Regenerative medicine is about repairing damaged tissue to new again thus extending life span beyond 125 years a possibility, at least in theory. We will discuss that topic further in an upcoming article.

Updated 4/24/2023


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Dr. Joe Jacko

Dr. Joe is board certified in internal medicine and sports medicine with additional training in hormone replacement therapy and regenerative medicine. He has trained or practiced at leading institutions including the Hughston Clinic, Cooper Clinic, Steadman-Hawkins Clinic of the Carolinas, and Cenegenics. He currently practices in Columbus, Ohio at Grandview Primary Care. Read more about Dr. Joe Jacko

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