Why Won't the UK Legalise Ketamine As an Anti-Depressant?
People have been taking the dissociative anaesthetic as a mental health medication for years – but there are specific roadblocks holding it back.
"It saved my life," says Tiffany Snow. "I would recommend it to anyone who has treatment-resistant depression or who is suicidal." She's talking about ketamine, a drug obviously best-known for the hallucinogenic and dissociative effects of its K-holes – but one that's been creeping into mental health treatment. "I started suffering depression around age 14 and started ketamine treatment after my mum saw a TV show about it and recommended it to me," says 43-year-old Snow, a natural therapy practitioner from Arizona. "After my first infusion the depression was gone, although only for 24 hours."
In 2014, the UK government reclassified ketamine from a class C to a class B drug, in the face of mounting evidence that the drug can cause irreversible health damage, especially to the bladder, liver and cognitive functions. But ket, approved in the UK as an anaesthetic and for pain relief, has also been explored by the medical community as a radical new way to treat severe, refractory depression. "The evidence all points in one direction," says the Royal Pharmaceutical Society's spokesperson on mental health, David Taylor. "People who have depression seem to have their condition substantially improved within an hour or two within receiving intravenous ketamine, and there are no other drugs that are comparable in having that effect."
In 2014, spurred on by research taking place in the US (where ketamine is now used to treat depression) NHS consultant psychiatrist Rupert McShane headed up the first UK study on the drug as a treatment for depression with researchers at Oxford Health NHS Foundation Trust and the University of Oxford. But two years on, ketamine still hasn't been approved as an antidepressant in the UK, and an NHS webpage on the drug reads that it is "highly unlikely that ketamine will ever be prescribed in the same way as antidepressants". What's going on?
Taylor says the main reason ketamine hasn't been approved to treat depression is because it's a "very long process"; you've got to convince regulatory authorities that it's safe and fit for purpose. While George Freeman, UK life sciences minister, told a London conference in late April that "we can't continue as we have in the past" with how we approve new medication, at present the UK is one of the countries with the slowest uptake of new drugs in western Europe.
"There are some safety concerns over ketamine," says McShane, reflecting back on his study, "but I think the drug is safe, provided it's used in a medical context. There's no doubt there's something about ketamine – and presumably similar compounds – that could really be useful."
The three-week study gave people with refractory depression 40-minute intravenous ketamine infusions – where the drug is administered directly into the vein through a tube – twice a week. He treated 28 patients and none suffered memory or bladder problems as a result of the infusions, with some experiencing "highly beneficial responses". Some were sick and had anxiety. Suicidal tendencies among patients dissipated overall, and 20 percent of his patients thought it would be worthwhile to have more, intermittent ketamine treatments.
"The results of the study were the sort of thing that makes it all worthwhile – it reminded me a bit of the film Awakenings, which showed the discovery of the compound L-DOPA as a treatment for the 'sleepy sickness'. We had one patient who was very sick, had ketamine and got sufficiently well that they were able to write a really complicated, competitive grant application. They then won that grant."
Although McShane admits that ketamine doesn't work for everyone, he's adamant about developing the drug for use in the UK. Kevin Nicolson, CEO of Ketamine Wellness Centres in Phoenix, Arizona, agrees. Like McShane, he also compares ketamine depression treatment to an "awakening", and he has successfully medicated over 500 people in the past five years. Patients go to his centre as much as three times a week, or for less regular "maintenance sessions".
"I've been lucky enough to be bedside during more than 1,500 infusions," says Nicolson. "Some of our patients suffered for years with ineffective medicine, or medicine where the side effects were too devastating. I've seen people really get their lives back.
"These are patients who have been struggling in this fog of depression, this heaviness, this greyness for years, and sometimes they walk out of the first treatment – although it's usually the second where they really start to believe it – truly understanding what it feels like to not have that burden on them. It's unshackling. They start to have hope."
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On the practical side, Nicolson says at the centre they give all of their ketamine infusions intravenously, but that there's a debate raging in the US over the best way for ketamine to be medically administered. Psychiatrists who aren't trained in IV infusion therapy often give the drug as an intramuscular injection or snorted in powder form, but Nicolson believes the intravenous method would better help to prevent misuse if it was legalised in the UK.
"In the ideal situation there would be the availability of treatment centres," he says, "so that patients could get the appropriate dose at the appropriate time, reducing any kind of real kind of public concern in regards to abuse and overuse. Of course, ketamine can be found on the street, but comparatively the doses we use are dramatically low."
McShane and Taylor both believe that the difficulties with administering ketamine will play a part in its approval. While Nicolson doesn't seem too enthusiastic about the whole snorting thing, it seems likely that it is in this form that it will first reach UK shores. This involves a web of generic versions, because ketamine is long out of patent.
"There is one way round this," Taylor says, "through patenting the form. Johnson & Johnson has made a ketamine nasal spray. The patent is attached to it, and can't be easily copied." The spray uses an isomer of ketamine, also known as a "mirror image" drug, called esketamine, and is currently being fast-tracked by US regulators the Food and Drug Administration. You could see it available as soon as 2019.
"Given the evidence that I've seen you would think with the backing of Johnson & Johnson it would be approved in the UK, just as it's being fast-tracked in America," adds Taylor. "But with a drug like ketamine you just never know."
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