The FDA is holding America back as we enter the transhumanist age.
Scientists increasingly agree that we're fast approaching a moment in medicine—probably within 30 years—where we won't just be significantly lengthening human lifespans, but probably conquering death too.
If this is the case, then the 150,000 people+ who die every day on Earth is doubly tragic. We may soon look back and mourn these hundreds of millions—our parents, friends, and loved ones—who just missed the time in history of achieving indefinite lifespans instead of ending up in a grave.
What this all means is science is nearing the final leg of the greatest race it's ever been in. Medicine's main goal will no longer be to just improve health, but to attempt to guarantee survival for every person that exists on the planet. Unfortunately, one significant challenge to medicine succeeding in this noble life extension aim comes from the most ironic and unlikely of places: the Food and Drug Administration (FDA).
On average, a new drug takes at least 10 years from creation to arrival in your cabinet in America. Additionally, Matthew Herper at Forbes reports that about $5 billion is spent on average in developing a new drug. New medical devices—especially life saving ones—take upwards of seven years to hit the market. For patients, some who are dying to get the drugs and devices, this may as well be an eternity. Nearly all of this has to do with the FDA and the bureaucratic labyrinth that exists to make sure medicine is safe in America.
Now don't get me wrong, I also want safe medicine. And for the most part, the FDA does that. But sometimes there are more important things than safe medicine, especially if you're suffering from a debilitating and terminal disease. For example, many people believe access to medicine before they die is more important than whether that medicine is safe or not. And with such a long, laborious, and costly medical approval process in the US, many inventors and companies that would like to create new medicine don't do it because of the prohibitive procedure of bearing a product from conception to sale.
Medicine's main goal will no longer be to just improve health, but to attempt to guarantee survival for every person that exists on the planet
It's no wonder start-up companies are opening shop in Europe and China, where clinical trials costs less and regulations in some cases are more lax. The obvious question is: How long can this continue before another nation becomes the pharmaceutical and medical device global powerhouse?
Imagine if you're a company, and you have a new heart disease drug that you want to create. You'd have to have cash on hand for a decade (or know you could get it) before you might—if the FDA approved you through its multiple stages—to make single sale on a drug. Now imagine you do the same process in Eastern Europe or Asia, and you only need half the cash on hand. You'd have a far better chance at actually bringing a life saving drug to market and making sure you company can survive until it does so.
There are a lot of reasons for the FDA's notorious regulatory hurdles. Rather than blame them specifically, though, it's easier to blame the true culprits—the vampires of capitalism: lawyers. They have made it so that a few deaths from a new drug (even one that helps tens of thousands of people live far better and longer) are enough to make it so that drug makers won't develop or carry the drug. Class action lawsuits are a reputation killer and simply too much a financial burden.
Tort reform, which I strongly support as a US presidential candidate, would have a major impact on the medical development field. But more importantly, we must bear in mind the concept of life hours—the concept that human beings have a certain amount of healthy, productive hours of life in them, and those hours should be protected at all cost. If a drug has made it so that a large section of people benefit and live longer, more productively because of it, then it's okay that a few don't and possibly even die. We must remember the greater good for society and ourselves, and measure life by life hours, and not our feelings.
I understand this type of thinking is not politically correct, but being politically correct is what healthy people have the luxury of doing. Those dying—those having their cells eaten by cancer, or their minds ravished by Alzheimer's, or the blood flow in their arteries stopped by blockage—tend to be more interested in what makes them healthy and what is functional for American medicine.
What's functional, given the amount of red tape the FDA and the legal system has cast all over American medical development in America is one of two choices.
We could attempt a total reboot of the FDA. Fire everyone and rehire those who are worthy. Ditch the old rules. Limit attorneys having anything to do with policy creation. Set new mandates that insist upon preserving people's life hours, not the bandage pharmaceutical culture America has as its main source of medicine. Also, make this new entity not just an institution that monitors and approves new drugs, but have it be an entity that facilitates America to systematically cure every disease on planet Earth—something that is possible to achieve in the next 50 years if enough resources are put into it. And lastly—the final nail in the coffin—change the FDA name to something new. Something bolder.
I support these actions against the FDA in theory. But I know it's not realistic. One doesn't just change such an embedded government institution without massive controversy, Congressional will, and Presidential support. So the other alternative makes more sense: Leave the FDA alone, but create a totally new institution—sanctioned by the government—whose mission is to encourage and green-light the speedy development of experimental drugs and medical devices for the public. Make it law that this new institution's drug and medical device trial period could not be more than a third of the FDA's average. The government sanction for such a new institution would give the needed authority for US citizens to trust (to some extent) the treatments they receive, while always understanding that such medicine was experimental.
The new drug and medical device field could then be split between traditional FDA approved medicine, and medicine that was more experimental and less proven—but cutting edge and, most importantly, available. Companies developing medical products would have the choice of which approval they sought. But both would be available to consumers with prescriptions.
Such a system would stop our innovators and scientists from going overseas, and keep jobs in America. It would also keep America in the running to remain the world leader in medicine as we enter the transhumanist age. Most importantly, it would keep America in the race to save lives without jeopardizing its regard for the public's safety. It transfers the responsibility to consumers, which any government should always strive to do. If consumers didn't want experimental or fast tracked medicines, they simply could go for FDA approved products only.
The reality is that every year millions of super sick and terminally ill people would likely be willing to try experimental drugs and medical devices rather than suffer or die. America should lead the way to help these people by creating a bold new institution that fast tracks these possible remedies and cures. It's the humane thing to do.
Zoltan Istvan is a futurist, author of The Transhumanist Wager, and the presidential candidate for the Transhumanist Party. He writes an occasional column for Motherboard in which he ruminates on the future beyond natural human ability.