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Credit: Joe Condor
Hype or help? Just months from market, Protandim has been heavily marketed and covered by the media, but human trials of its purported antiaging abilities are only just beginning
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Clarification: Moniker Mix-up
(December 7, 2004) After this article was published, Betterhumans was notified of an important clarification regarding the Protandim product that Lifeline Nutraceuticals aims to release in February 2005: It is not the peptide known as CMX-1152.
The article states: "Protandim was developed by Maynard, Massachusetts-based biotechnology company CereMedix, from which Lifeline has a license for the product. CereMedix discovered a group of peptides derived from proteins in the body that activate genes for natural antioxidant defenses." This statement appears because Lifeline's initial Protandim product candidate was CMX-1152. The Protandim product slated for market in 2005, however, is not CMX-1152. To support and complement CMX-1152, Lifeline developed a cofactor formulation called Protandim CF that it says is "a proprietary, patent-pending blend of botanicals, amino acids and various vitamins and minerals." In April 2004, Lifeline changed its focus to bring Protandim CF to market. "Due to contractual and developmental issues/delays/changes with CereMedix, Lifeline has redirected its efforts to concentrate initially on the Protandim CF product," the company stated. A few months later, in October 2004, the company announced that it would now refer to Protandim CF simply as Protandim, the same name previously used for its CMX-1152 product candidate. "Protandim CF has demonstrated remarkable results in pre-clinical studies as the better choice for an initial standalone nutraceutical product. As such, Lifeline has dropped the 'CF' from the name in order to underscore Protandim's uniqueness and efficacy," the company stated. The name change caused some confusion in this article. For example, the Denver Post ("once-a-day pill they say could extend life spans to 120 years or more") and 9News ("promises to not only make you live longer, but make you feel younger") quotes were for CMX-1152, not the compound now known as Protandim. Lifeline says that the Protandim slated for market in February 2005 "has been demonstrated to decrease oxidation by as much as 60% in humans in just the first 30 days of intake" and that this amount "is expected to increase even further after prolonged supplementation." It also says that while its research has not yet been completed, it has to date shown "shown consistent and beneficial results." We regret any confusion caused by the failure to properly distinguish between CMX-1152 and the Protandim product scheduled for release in February 2005.
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Last year, the
Denver Post described it as a "once-a-day pill they say could extend life spans to 120 years or more." As recently as February of this year, the Denver, Colorado-based NBC affiliate 9News stated that it "promises to not only make you live longer, but make you feel younger."
The pill in question, Protandim, purportedly causes the body to produce more of its own powerful antioxidants to fight the damaging effects of free radicals. While many people ingest antioxidants such as vitamin C in food and supplements, these must pass through digestive and other barriers, while Protandim is said to spur an increase in the body's internal defenses.
And you'll soon have a chance to buy it. The Denver, Colorado-based company behind Protandim, Lifeline Nutraceuticals, says that the pill will be released in February 2005. Armed with preclinical results from animals, and with a human trial underway, company president Bill Driscoll calls Protandim "the first true antiaging pill that the market has very eagerly been waiting for," one that is "measurably better than any combinations of currently available antioxidant supplements."
But on the eve of Protandim's launch, it's still not entirely certain what consumers should expect. Lifeline is unclear about Protandim's benefits, and recent research questions the effect it might have in humans. With so many supposed antiaging products on the market already, jaded consumers can be forgiven for skepticism. Protandim may overcome these challenges but for now its future's uncertain.
Longer life—or not
The main issues around Protandim, as it's readied for market, revolve around what exactly it's supposed to do, how exactly it works and whether its actions achieve the desired goals.
It's not easy to answer the first question. From the media coverage Lifeline endorses on its own Website, it's clear that over the past few years, the company's position on Protandim's benefits has fluctuated.
With the product just months from market, this inconsistency continues. The company's Website clearly states: "Lifeline's goal is to not only extend life expectancy, but to increase 'healthy life expectancy.'" Yet this isn't the position of Lifeline's director of science, Joe McCord of Denver's Webb-Waring Institute for Cancer, Aging and Antioxidant Research. When asked, McCord stated, "We are not conducting studies to extend the lifespan of mice, or of humans." Furthermore, he says, "Protandim is not a cosmetic product, nor is it designed to be an antiaging drug. It is designed to reduce oxidative stress due to elevated production of reactive oxygen species associated with various kinds of stress and with age-related diseases."
What does this mean? It means that, according to McCord, Protandim isn't expected to increase human lifespan nor reverse visible signs of aging. So why take it?
Protandim's supposed payoff is an increase in "healthy life expectancy," which Lifeline defines as "a term used to describe general improvement in health, increased energy, reduction of incidence and severity of age-related diseases typically experienced in the last ten years of life, and general improvement in the quality of life in these latter years."
So, while we won't become immortal supermodels taking Protandim, it might reduce or eliminate risks associated with some age-related illnesses. But does research support even these more modest benefits?
From semantics to science
What sets Lifeline apart from other supplement companies claiming the next big thing in antiaging? The science behind Protandim is part of the difference, says Lifeline.
To understand why Protandim might extend healthy life expectancy, you need to understand the free radical theory of aging. According to this theory, aging is at least partly a result of the damage caused by free radicals—harmful substances produced by metabolic activity in our bodies. "In essence, these are fragments of molecules that are inherently unstable and reactive. They are usually minor byproducts of incomplete combustion, not unlike the tailpipe emissions of a worn-out automobile," says McCord.
Protandim was developed by Maynard, Massachusetts-based biotechnology company CereMedix, from which Lifeline has a license for the product. CereMedix discovered a group of peptides derived from proteins in the body that activate genes for natural antioxidant defenses. Specifically, Protandim upregulates the production of three antioxidants: Superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GPX). These provide a ready defense against the damage caused by free radicals.
There is much evidence that free radicals contribute to disease and aging, and that antioxidants can help stem some of the damage. SOD—codiscovered by McCord in 1969—is sometimes stated to be the most significant antioxidant enzyme in the body. In a press release, Lifeline calls SOD the body's primary antioxidant and points out that studies have linked it to aging in 14 different species, including humans. Species with the most SOD have been found to live the longest, and Lifeline says that studies have found that the longer life comes in the form of extended youthfulness.
Are antioxidants enough?
But despite such findings, we don't have a complete picture yet of how free radicals and antioxidants affect aging.
A recent critic of the free radical theory of aging is Tony Segal, director of University College London's Centre for Molecular Medicine. In a study published this February, Segal and colleagues found reason to question the basis for antioxidant supplementation. The researchers found that certain immune system cells kill microbes using enzymes rather than free radicals, which contradicted the theory that free radicals were the killers, and hence were toxic enough to damage cells. "Our work shows that the basic theory underlying the toxicity of oxygen radicals is flawed," Segal said of the study. "Many patients might be using expensive antioxidant drugs based upon completely invalid theories as to their therapeutic potential. All the theories relating to their causation of disease by antioxidants must, at the very least, be evaluated."
Another study by Joel Parker of the University of Lausanne in Switzerland and colleagues, published this March, also found reason to question the antioxidant-longevity link—and more specifically, to question the link between SOD and longevity. Examining the production of a form of SOD in ants, the researchers found that the ants' production of free radicals was more important than their production of antioxidants in determining their longevity.
While it's doubtful that such findings are enough to undo the entire free radical theory of aging, they remind us at the very least that there are still unknown aspects to it. So while Protandim may very well increase the body's production of powerful antioxidants, this in itself is no guarantee that it will extend healthy life expectancy.
There are also competing theories of aging that look beyond the damaging effects of free radicals and oxidative stress. One such school of thought is the evolutionary theory of aging, which states that aging is caused by both an organism's genetics and its environment.
The idea driving the evolutionary theory is that organisms living in protected environments age more slowly than those in hazardous environments. The environmental factors help determine lifespan by regulating how genetics retard or hasten the aging process. In a 2002 publication, evolutionary theorist Thomas B.L. Kirkwood says, "If 90% of wild mice are dead by the age of 10 months, any investment in programming survival much beyond this point can benefit at most 10% of the population. This immediately suggests that there will be little evolutionary advantage in programming long-term survival capacity into a mouse." So, rather than proposing that there are genes whose primary function is to control aging, evolutionary theorists say that genes affect aging by determining how cellular resources are used.
If the evolutionary theory of aging is valid, then how much of the aging process is determined genetically, rather than by the damage of oxidative stress? Although it may not be a clear-cut matter of genetics versus oxidative stress, we can at least formulate a preliminary estimate. According to Kirkwood's publication, twin studies show that genetics determine a quarter to one-third of the lifespan puzzle.
Still, this only complicates rather than refutes the free radical theory. As Aubrey de Gray of the University of Cambridge's Department of Genetics in the UK says, "It's not possible to partition things into free radical damage versus other things, because everything affects everything else: our genetics determines the rate of free radical production, free radical scavenging, repair of free radical damage..."
Work in progress
What are consumers to make of all this when it comes to a buying decision?
With antiaging research still in its early stages, it's too early to tell for sure whether Protandim will offer tangible benefits.
To date, Lifeline has released statements indicating that its preclinical trials are completed and the first phase of human trials has begun. The preclinical study involved a 23-day experiment on mice. The results showed a reduction of lipid peroxidation by 60% to 75% in both plasma and liver, as well as a decrease of more than 90% percent in brain tissue. Lipid peroxidation refers to the oxidation of lipids, a process that can destroy cell membranes. The human trials will involve a 120-day study on volunteers over 18 years old.
So while Protandim has shown promise, and Lifeline appears genuinely committed to marketing a scientifically reputable product, there are still many questions. Is antioxidant upregulation in mammals enough to increase "healthy life expectancy?" Only long-term clinical trials can detail the good (and possibly bad) of Protandim's method of action. And then there's another nagging question: If Protandim works, will it work for everybody? Says Parker, "Evolutionary theory predicts that it is very unlikely to have one magic bullet that would work for everyone."
Patrick Bailey holds a master's degree in philosophy from the University of South Florida. He specializes in the philosophy of mind, neuroscience and theory of knowledge, and is a technical writer for the IT industry.
