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May 23, 2019 by Dr. Kyle Varner in Policy
If you ask for Special K on the street, you’ll likely be pointed in the direction of a shady alleyway instead of a supermarket.
That’s because “Special K” is slang for ketamine, a popular recreational drug.
But ketamine isn’t just a street drug, it’s actually on the World Health Organization’s Model List of Essential Medicines.
In fact, physicians have used ketamine since the 1970s. It’s a quick-acting anesthetic, it reduces pain and now we even know it can treat some cases of severe depression.
But scientists have known about the medicinal properties of ketamine for years, so why is this suddenly newsworthy?
The FDA is notorious for slowing down the introduction of new drugs, but they’ve finally got their act together this time and approved a nasal spray.
But here’s the kicker –it’s not actually ketamine. It’s esketamine.
So what’s the difference? Honestly, not much at all…
You can think of esketamine as left handed ketamine. Ketamine contains molecules in two different mirror image formations. Esketamine contains only the left handed molecules. This is called an enantiopure drug, and there is nearly no clinical difference.
But when it comes to the pharmaceutical industry, the difference is huge.
If we’ve known about ketamine for decades, why don’t we just use it for the conditions we know it can help?
Some scientists have argued that esketamine is much better at treating depression than regular ketamine. They said it was stronger, that patients recover from side effects quicker, and that they find it more pleasurable.
Yet others say the opposite. In short, the jury’s still out on that one.
But there’s a very big difference when it comes to profitability.
You see, ketamine is an older drug. The patent life has expired on it so it became eligible to be made into a more affordable generic drug. By contrast, esketamine is very much patented, so that means companies can profit from it –big time.
But the pursuit of money isn’t the only factor here. The FDA, despite the fact they finally approved it, have their own hoops you need to jump through as per usual.
Because ketamine is ‘dangerous and abusable,’ hence why it’s a popular street drug, the FDA is going to create roadblocks to make it more challenging to bring this drug to market.
Trying to get ketamine approved for psychiatric treatment rather than as an anesthetic is a very different beast legally speaking.
It will hundreds of millions of dollars to get through all of the clinical trials and regulations the FDA demands. After all, they’re forever paranoid about a new thalidomide scandal.
As usual, the combination of FDA regulations and corporate greed means this ‘new’ treatment does not come cheap.
The recommended treatment plan is to use the nasal spray twice a week for a month. This comes to an estimated total of $4,720 to $6,785.
That’s insane! Compounding pharmacies are making ketamine nasal spray for $60 per month!
But it doesn’t stop there.
The safety regulations don’t just increase the cost of making this drug, they also influence who gets it and when.
It all comes down to the Risk Evaluation and Mitigation Strategy (REMS). This is an FDA drug safety program to ensure drugs don’t cause more harm than help.
Sounds good in theory, but in practice, it just slows down the development of good drugs, and makes it more difficult for patients to access. Pharmaceutical companies also use this as a way to keep prices higher longer by locking generic manufacturers out of the market with dubious patent claims surrounding the REMS strategy.
This means we can’t use a tried and tested drug we know works, we have to reinvent it, go through a ton of legal oversight, and then companies can slap a big price tag on it.
Thanks, Big Pharma!
It’s great news that we’ve started to treat mental health as seriously as physical health. It’s a tricky business, and innovation is welcome in an area where a lot of treatments simply don’t work.
But let’s not kid ourselves here. The system does not make it easy for us. All of the legal obstacles create a big opportunity for companies to profit from old cures.
Worse, it means that billions of dollars that could go to researching new cures, instead get funneled into a process designed to get regulatory approval for copycats of old drugs. It turns research scientists into bureaucratic paper pushers.
That leaves us all worse off and it’s frankly disgusting.
This information is intended to help readers be more informed about their health options when speaking with a professional, but it should not be used alone to diagnose, treat, prevent or cure any disease or condition. Be sure to speak to a qualified doctor before taking any action to make sure that your choices reflect your actual health situation.