Patient Zero and the institutional struggle for a disease-free future

 

Who decides who lives and who dies?

A philosophical quandary posed to most hollywood antagonists and a solitary rumination explored by those struggling with their spirituality, often in the face of recent loss. A question that, in America, actually has quite a simple and mundane answer:

The Food and Drug Administration, commonly referred to as the FDA.

In 2015, Seattle-based company BioViva approached the FDA with a gene-therapy that could potentially save up to 100,000 lives a day. But astronomical costs for governmental approval and semantics regarding the definition of “disease” stopped the public from seeing if this new treatment could save the lives of their loved ones.

If it seems to you that such hurdles should be leapt over at any cost necessary when considering the potential for so many lives saved, then you’re not alone. BioViva’s CEO, Elizabeth Parrish, agrees. Which is why she circumnavigated the FDA’s legality by flying to Colombia where she injected herself with BioViva’s untested gene-therapy, thus allowing her to make the claim that she is patient zero: the first human to successfully undergo cellular regeneration to fight back against the detriments of aging.

I interviewed Elizabeth recently to learn a little more about her gene-therapy and to figure out what had motivated her to defy the FDA by injecting herself with unapproved medicine:

I work with the best in the field, she told me. I understood the therapies and the risks, and we believed that this test would make the biggest impact at the global scale. Remember, the greatest risk factor of death is aging.

It seems an obvious statement: you get old and you die. But her gene-therapy doesn’t claim to do anything so miraculous as to make you immortal, so I asked her to further explain how her company goes about treating aging and why the FDA has blockaded her progress:

There are no incentives for researchers to research and cure aging…[because] our government and regulators do not consider aging a disease,… but cellular degeneration is directly associated with every symptom or aging disease on the planet including Alzheimer’s disease, heart disease, Parkinson’s disease, kidney failure, dementia, stroke and cancer. So, if you can make old cells act young, which is just an engineering problem, you can mitigate these diseases.

And apparently that engineering problem has a lot to do with a region of our cells called telomeres. These are compound structures of DNA that cap the ends of our chromosomes to protect them from the wear and tear of existence. But every time a cell divides these telomeres shorten, eventually getting too short to protect the cell, which then allows the effects of cellular aging to worsen and increases the likelihood that malfunctions (such as cancer or Alzheimers) will occur.

It seems a clear and concise argument: if you treat the telomeres with gene-therapy to prevent their breakdown, then you prevent a plethora of devastating diseases and the suffering that comes with them. But as many who study technology have long expected, regulations have stagnated as technology exponentially leaps into the sci-fi future. And our governments simply don’t know how to keep up:

Until recently there was nothing as powerful as gene therapy, gene editing and advanced cell therapies. The regulatory bodies have an outdated and overly-cautious system that blocks advancement rather than creating new avenues for companies and patients.

We need to stop being risk averse to new treatments and find out what happens in the human body. Everything else is just speculation.

She goes on to explain the core motivation for her fight :

Regulators are here to protect people from being taken advantage of, whilst we are here to give you an option should you wish to educate yourself and decide to take control of your medical and lifestyle choices.

She then informs me that both her and I will be dead some day, and that it was this very realization that crystallized her purpose:

This is the defining moment, when you realize you have lived a self serving life and are ready to give back to create change. [It’s then that] myths about how one should act or what one should do with their life fall away.

It’s this response that draws into the focus the essence of our concern: is death a personal issue, or should it be relegated to (and guided by the mythos of) human institutions like the government and the church?

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Denied by the Definition of Death

From its inception, America has been a country founded on Christian beliefs: of the 55 founding fathers, 49 were Protestant and 2 were Roman Catholic. And it wasn’t just the leaders who set the tone for religion in the US; the settlers who composed America’s early population were mostly puritans who migrated for the very purpose of creating a Protestant mecca: a new society free of the tainted beliefs that were dominating in England at the time. So strong was this desire to ensure Protestant rule that they became the very thing they fled from: expelling or threatening capital punishment to any who opposed their religious beliefs.

This resulted in a country where a lack of belief in Jesus Christ threatens anyone’s ability to rise in social status. To be godless (or to even choose the wrong god) is to be be a social pariah in the public eye (just look at our treatment of Muslims). And thus any person running for a government position must appease the beliefs of the 70.6% of Americans who identify as Christian—each of whom hold a vote come election time.

Thus, America’s definition of death became the Christian definition: a place of eternal bliss that we instinctively yearn for because it comforts us to know that there is some end to this difficult struggle that is reality.

Thus, when BioViva approached the FDA with their anti-aging therapy, a medicine that fends off death, they were told that their goals were invalid; they were told that it was natural for 100,000 people to die a day—because when the FDA drafted its definition of what a disease was, it was arguably using Christianity’s definition of death as a guide.

And so it would seem that our policy-makers have acquiesced to this spiritual stance as well, either because they don’t want to upset the status-quo, thus getting a black-mark on their record as unethical scientists, or because they themselves personally believe that death is a natural harbinger of solace.

But no matter the intent, this religious ideology has no place in a governmental entity dedicated to science. When exploring potential solutions, there should be no impetus that can usurp the scientific method; if we discover that our understanding of death is outdated—that science now in-fact has the ability to manipulate genes in a way that will allow us to save millions—then we must be willing to redefine death to represent the truth shown by our experiments and the resulting data; ie: that death is not only something we may be able to slow, but something we may even be able to stop altogether. Regardless of religion, shouldn’t any science be taken seriously if it shows valid evidence to heal? Shouldn’t the masses of the world be the ones allowed to decide if death is natural or not? To deny either is to prove the governmental agency that dictates our medical institutions and the health of its citizens harbors bias and is willing to deny humanistic progress when it doesn’t match their religious ideology—a blatant betrayal against the separation of church and state, as well as the personal freedom of choice offered to American citizens.

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Suffering Is A Great Source of Profit

Unfortunately, this religious bottleneck upon the scientific choices of personal health isn’t the only reason BioViva was denied. If anything it was merely the facade that hides the true culprit, a systematic issue that has long been corrupting our government:

Greed

America has the most expensive healthcare system in the world, and this is not by accident. Our country is driven by capitalistic forces, hence we have for-profit prisons, for-profit education, and yes, for-profit healthcare. And the companies that lead these industries spend a great deal of time and money decade after decade exerting influence on our governmental agencies and their policies via interests groups. The playing field tilts bit by bit, and eventually you end up with a government that allows a bag of saltwater (a saline IV) that cost 1$ to produce to be charged to hospital patients for upwards of 700$.(1)

With such blatant corruption allowed, it’s hard not to wonder if this influence has penetrated the FDA as well; and unfortunately, there’s some evidence to suggest it has. For starters, it takes an average of 2.6 billion dollars to get a drug approved by the FDA. Yes, you read that correctly: 2.6 billion dollars.(2)

So even if the FDA did declare death and aging a disease, basic math of economics tells us that it doesn’t expect many new-comers like BioViva to partake in the arena of medicine.

Out of America’s 6 million+ companies, only 223 companies can even claim a revenue of at least 2 billion. This means that if you start a company in hopes of creating life-saving medicine like BioViva has done, then you’ll have approximately a .00004% of being able to come within half a billion USD of approval. I don’t know of a single business person or gambler who would take those odds, because they are so negligible as to be virtually impossible.

While drug approval is obviously a difficult, dangerous, and expensive process, it’s hard to believe that Big Pharm’s interests groups haven’t held some sway to keep this blatant monopoly in-tact.

It’s even harder to believe when we have evidence that shows that the FDA has allowed conflict-of-interest-appointments in the past, allowing their board members to set policies for companies they stand to make a profit from. For instance, prior to running the FDA’s dietary supplement division from 2011-2014, Daniel Fabricant had been a senior executive with National Products Association, who were actively spending millions of dollars lobbying to block legislation that would put stricter laws on the 33-billion-dollars-a-year dietary supplement industry. And after his 3 years working for the government, Fabricant returned to NPA as their chief executive. His replacement as head of the FDA’s supplement division? Not surprisingly, another member of the NPA.

The executive director of the Center for Science in the Public Interest, Michael F. Jacobson, said of Fabricant’s involvement: “To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,”

And that’s where the mythos of money comes into play: if all of our policy makers largely go to the same universities, communicate within the same networks, jump between the same businesses and agencies, and are socially mingling amongst only their fellow politicians and business-people, then it is no surprise these people all have similar agendas. They have the same vested interests and are working towards the same ends, whether they’re doing it conspiratorially or not. Thus nepotism and cronyism run rampant, and the culture of our leaders becomes homogenized, radicalized.

Thus nepotism and cronyism run rampant, and the culture of our leaders becomes homogenized, radicalized.

(Again, I want to emphasize that I’m not saying the entire FDA is corrupt and maliciously wreaking havoc—though I do think that, like in any organization, there are likely a non-negligible amount of people who are actively extorting our livelihoods for the benefit of their greed; what I am trying to say is that many people in these governmental circles are working to ensure the financial security of themselves and their friends—just like we all do; except when they do it, we the people suffer for it and die from a lack of good medicine that fails to reach us at affordable prices.)

How can we accept that the very support system we fund with our taxes requires a financial offering that—similar to the supplement division and NPA—ensures only shared interests can afford to enter the realm of entities dedicated to healing our masses? By allowing such a system to continue, breakthrough science coming from lowly practitioners with good intentions are blockaded while cut-throat masters of business looking to pad their bottom-line (potentially with low quality chemicals and practices) get their medicine waved through, directly to our shelves and into our bodies. Shouldn’t we instead have a system with a higher level of integrity, where anyone who says I can heal 100,000 people a day is taken seriously and immediately supported by our government, regardless of religious definitions and potential for profiteering?

Regardless of FDA involvement, it’s obvious that the big pharmaceutical companies prefer this system: where the masses stay sick longer, continually filling their outrageously expensive prescriptions for a steady supply of approved drugs—which may or may not work—in the hopes that even a hint of their suffering may finally cease.

And so it’s for good reason they keep the barriers high; the pharmaceutical industry isn’t blind to the disruptive impact of technology and the startup-DIY culture. They’ve seen what has happened to the publishing and recording industries because of ebooks and iTunes and piracy. They’ve seen their peer’s sway on the world undermined by the garage tinkerers and programmers who created the powerhouse corporations like Google, Apple, Facebook, and Twitter, and they don’t want the same thing to happen to them.

Now naturally there are some good reasons the FDA has such a rigorous and expensive process. Would we really want just anyone to be allowed to make medicine for the masses without immense scrutiny? Of course not. But limiting drug distribution to a game of ‘who has the most money’ won’t encourage the development of beneficial medicine. If such impossible expectations had been in place 100 years ago, we may have never seen the arrival of Penicillin, which studies say have saved an estimated 200 million lives since Fleming’s discovered it in 1928. One must wonder how many more lives could be saved if we could end these aging-related diseases that BioViva and others are working to tackle?

The bottom line is that we need to change our healthcare system to one that allows for competition and innovation. In this age of DIYers and at-home BioHackers—with a generation empowered by online video tutorials, meetups, and forums—the average person has never been in a better position to spearhead a solution to any one of humanity’s greatest problems. But our governmental agencies and puritan beliefs simply haven’t kept up with the times, and because of this our progress is bottlenecked. Add in greed perpetuated by interests groups and nepotism, and we find a system that allows millions to suffer and die unnecessarily, with a disproportionate amount of those people being poor or colored.

Why we must fight for a new system.

It’s important to note that when we talk about these anti-aging therapies, or as they’re more scientifically called regenerative medicines, we’re not talking about immortality. Is that a possible result? Yes, potentially in the future, but what we’re really focused on here is healthy lifespans. It’s about ensuring that your body at 60 isn’t more susceptible to disease and suffering than your body was at 30. It’s about restrengthening muscle mass and ensuring we don’t throw a wrench in the spokes of healthy functioning and invite the chaos of cancer, Alzheimers and other diseases. We’re talking about simply ensuring we suffer less on our way to the grave.

We’re talking about simply ensuring we suffer less on our way to the grave.

This is a fight to no longer live in fear, to no longer let the looming specter of death drive us into neuroses and numbing; it’s about ensuring that every child born may experience the fullness of life as they see fit without the chaotic conditions of the universe delivering them a disability or illness that will strip from them their love for reality; a love that would strip from humanity itself, from each one of us, the gift of this person’s passions.

By redefining death, we can redefine what it means to be alive. And that’s what we must do as a people: change the definitions and remove from ourselves the fears of an afterlife that tells us we’re not allowed to play god; because that’s the only thing that will let our alzheimers-afflicted loved ones remember us; the only thing that will keep us from having to tell a child they’ll never again get to hear the loving words of their mother, or dance with her at the wedding—because mom has cancer, and instead of giving her gene-therapy we blasted her full of radiation and—not surprisingly—there were some complications…

If only we had the courage to stand up to interest groups and corporate greed, to the red-tape and regulations and the religious devotees who think their opinions should control our lives, then maybe—maybe—we’d see even more lives saved than the 9 million saved each year by penicillin. Maybe when our species has moved beyond paralyzing doctrine as a response to existential crises, we’ll move on to more important things, like healing our planet, redistributing wealth, and cultivating community, compassion, connection, and creativity.

It’s easy to say don’t play god when we have nothing to lose, but will we say the same when it’s our loved one’s life at risk? Just like we’ve done with surgery, antibiotics, and all the forms of modern medicine we commonly use everyday regardless of our faith, it is our duty to ensure that our society says “Yes, please do play god,” because one day when age creeps like mold over our spirits, we’ll wish we’d had the medicine to let us stay here a bit longer.

To see more about BioViva and their current efforts, visit their website here: http://bioviva-science.com/.

(1)http://www.fool.com/investing/general/2016/04/30/the-cost-of-developing-an-fda-approved-drug-is-tru.aspx

https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-developmentThe largest barrier to conducting clinical research—and the one into which most other barriers feed—is the high cost. Studies estimate that it now costs somewhere between $161 million and $2 billion to bring a new drug to market (DiMasi, Hansen, & Grabowski, 2003; Adams & Brantner, 2006; Morgan, Grootendorst, Lexchin, Cunningham, & Greyson, 2011) Inflation not considered in estimate. 

(2)http://www.nytimes.com/2013/08/27/health/exploring-salines-secret-costs.html

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Born and raised in Cincinnati, OH, Steven Parton moved to Portland, OR after getting a degree in Computer Science. As well as programming software, apps, and websites, he is an avid writer of novels and short stories, which can be found through Curious Apes Publishing. Like most Portlanders, he also rides a bike and loves IPAs.

Novels: Hello, World
Short Stories: GOLEM , Fire And Oil , BioSphere of Self.

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