The ketamine trick: how to charge $ 885 for an antidepressant that costs 10 at any pharmacy

On March 5, the US FDA approved the use of esketamine for treatment-resistant depression. In other words, he approved a nasal spray antidepressant that many media outlets covered in terms of "revolutionary breakthrough." However, as soon as we analyze the case it becomes much more interesting.

The story of ketamine-based treatments for depression is the story of why the pharmaceutical industry needs serious reform that breaks with the perverse incentives of current intellectual property.

What is Ketamine?

Ketamine is a dissociative anesthetic widely used for the past 40 years in medicine and veterinary medicine. In 1962, Calvin L Stevens first synthesized ketamine while searching for a safe sedative for veterinary use. Human experiments began in 1964, demonstrating that it was the most usable and least toxic anesthetic on the market. Starting in 1970, with the approval of the FDA, the drug began to be used massively in the Vietnam War.

Around the same time, someone must have realized that, at subanesthetic doses, ketamine was capable of producing a huge number of effects ranging from mild perceptual distortions to very, very intense hallucinations. Although its non-medical use began then on the west coast of the United States, it was not until the late 1990s that dance culture became brutally popular as a drug. In 1999, the US put her on the list of controlled substances.

We come to the 2000s with a commonly used anesthetic heavily controlled for use as a recreational drug. It was just in that decade when studies began to appear that ketamine could be a good treatment for depression. In 2017, a systematic review went so far as to say that it could be "the most important advance in the treatment of depression in more than 50 years".

If we are rigorous, it doesn't take much to become the "biggest breakthrough" in a world like antidepressants where the placebo effect is huge, but it does point to something crucial: the evidence linking ketamine and depression was something worth studying. detail. Something that for 20 years was not done.

Why?

It is easier to understand than it sounds. Although questioned, the popularity of ketamine among treatment-resistant depression patients reached such a point that, in many countries, clinics began to make ketamine blood infusions to treat these problems even though they officially performed those infusions for other therapeutic purposes. Why did the health authorities not recognize this use if we all know that it is a real use?

Because no one had tried to have that use recognized. In principle, the drug authorities do not carry out the necessary studies to authorize drugs. Pharmacists collect the necessary data and request authorization from governments. What happens with ketamine is that it is an old acquaintance: it cannot be patented.

And, in these cases, it is commercially unfeasible to carry out the necessary studies to approve a new use of a drug. No company is willing to dedicate tens of years, hundreds of people and millions of dollars to obtain an approval that cannot be profitable. For years, ketamine waited for its patron: some public institution or a philanthropist who decided to take it out of limbo. But, perhaps because it is a narcotic, it never came. So the industry decided to use the "back door".

The Ketamine Trick

To be fair, it is not the "ketamine trick". It is a common practice in the world. What pharmaceutical companies usually do is look for a similar chemical compound, but with some small change (usually trivial) so that it can be patented. That's what Janssen did, and that's why what the FDA has approved is called esketamine.

With this trick, you can charge between 590 and 885 dollars per dose of something that today costs about ten dollars

An essentially identical compound, but "property" of the pharmaceutical. Something that will allow them to charge between 590 and 885 dollars per dose when the normal ketamine would cost about 10.

On the other hand, the approval of the use has not been without controversy. As most experts suggest, the approval procedure has been a little less demanding than usual. It is reasonable to think that this is for the simple reason that the evidence that ketamine has antidepressant effects equivalent to that of current products is overwhelming today. In fact, the report on esketamine itself makes this clear: that it is just as bad and good as the rest of antifepressants. The only thing missing was for someone to put the money on the table.

The antidepressant "revolution"

With approval, the FDA solves a problem: that of clinics that use ketamine in an unregulated way. However, it adds new ones: the treatment format. It is a nasal spray that must be applied twice a week for a month while taking another oral antidepressant. These applications, in addition, will have to be carried out in the hospital or clinic where patients must wait two hours under observation.

As I explained before, most of these clinics made ketamine blood infusions, that is, they applied the drug intravenously. Janssen proposed nasal spray with the idea of ​​lightening a cumbersome procedure that also requires a lot of human personnel. However, the FDA is not trusting and does not want to turn esketamine into a kind of covert legalization of the recreational drug.

The result is an expensive drug, with a less studied route of administration, a rather bureaucratic application procedure and with many doubts about its effectiveness. All to be able to use a treatment that is already used in thousands of clinics around the world. Sometimes the pharmaceutical industry is complete nonsense.

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