|Should regulators just chill out about the cannabis-based drug for multiple sclerosis made by GW Pharmaceuticals?|
The company has faced so many difficulties from watchdogs it might be enough to drive Geoffrey Guy, GW's executive chairman, to the weed he grows in huge quantities.
Guy prefers to unwind by boating in his native Dorset and does not even drink alcohol or coffee, let alone smoke dope, which he says he has never tried.
He admits running GW - the first company to attempt the complicated process of making a medicine using the entire cannabis plant - has been gruelling.
GW's main product, Sativex, is potentially a revolutionary medicine for people with MS. The under-the-tongue spray, made from cannabis grown in GW's top-secret greenhouses in the south of England, uses the plant's relaxing qualities to alleviate involuntary muscle spasms of MS patients, while not creating any of the hallucinogenic qualities of smoking a joint.
Yet, having been formed eight years ago, GW has disappointed investors by seemingly being on the brink of launching Sativex on the market, only to be thwarted by adverse regulatory rulings and disappointing results from some of its medical studies. The frustrations have led to accusations that Guy has over-promised and under-delivered.
Guy, a co-founder of GW and the G in its name, is normally relentlessly upbeat about the medical potential of cannabis.
But he concedes that the process of developing Sativex in a way that satisfies regulators has been tough: "It has been very, very difficult. I do suffer under the frustrations and some slightly unkind things have been said about us. On the other hand, spending a day with a patient restores it all, when you get a patient who says 'thank you Geoffrey for giving me my life back'."
The Barts-trained doctor points out that many of GW's hiccups with regulators were because he speeded things along. In the mid 1990s, MS patients desperate for something to alleviate their condition were using cannabis, only to find themselves charged with possession of an illegal drug. The courts tended to let them off or hand out suspended sentences, but the Home Office recognised the situation was unsatisfactory and encouraged a plan put forward by Guy to look at turning cannabis into a regulated medicine.
"When I started this programme I did it under a social, legal, medical imperative to work as quickly as possible. The transcripts of a House of Lords select committee in 2001 show it was lambasting the Department of Health for being so slow. The Department of Health was saying in late 2002 Sativex would be approved in 2004."
GW first submitted its dossier to regulators in the UK in 2003 as a treatment for both spasticity and neuropathic pain, which affects peoples nerves. To the company's dismay, it was rejected, on the grounds that separate trials should be conducted for each problem even though most MS patients suffer from both.
Two subsequent trials followed in spasticity, the latest of which was published in March. The study showed good results but just fell short of the efficacy standard demanded by regulators.
Guy admits they did not get the "slam dunk" but he insists the trials taken together show Sativex works, and he is confident that some regulators, perhaps on the Continent, will see it that way.
At the same time, GW has been doing trials of Sativex for neuropathic pain - a massive market - and is also conducting trials for cancer pain in the US.
Mindful of previous promises that have not come off, Guy is cautious about which indication it will focus on first. "I'm not saying it is going to be X or Y on a certain date. We've been caught out very badly on that before," he says.
The 51-year-old nearly died from pneumonia a few years ago and has been diagnosed with diabetes. He admits he is "exhausted", but adds "that is like saying to a marathon runner don't get tired at the end of the marathon".
He says "our European programme has been spreading, we have more positive results across the board and we have got into the US. And since the beginning of the year patients in the UK can get Sativex under prescription from their doctor."
Guy has made a lot of money in the drugs industry, though his 20pc stake in GW has almost halved in value since 2004 to about £18m.
His successes include developing narcotic analgesics and the first skin patch for hormone replacement therapy.
Guy found himself having a conversation on this subject with Margaret Thatcher, who complained about the old style hormone replacement treatment, delivered through jelly bags attached to the skin.
"I was on the British mission in Kiev in the late 1980s, on a stand about drug delivery.
"Margaret Thatcher - who is a chemist - was talking about HRT and said they are awfully crispy and fall off."
Much of Guy's work on HRT was done at Ethical, another drugs company he set up in 1985. He left it after the company "ran straight into the front of the biotech downturn" in 1996 and failed to list in London.
"I felt really, really bad about it at the time. Later it wasn't so bad when you considered that nobody else got away." The decision to leave, he says, was because "I always said if I find a time when I don't believe I can add anything the next day it is time to move on. So that is what I did."
After Ethical, Guy decided to pursue a hunch he had that cannabis might be the missing link in the naturally produced pain killers that include morphine and capsicum, from peppers.
To the doubters Guy can fairly claim he has made progress.
Sativex sales have started in Canada and there has been a small-scale distribution in Spain and the UK under a compassionate use scheme. GW has licensing partnerships with much larger drugs companies, such as Germany's Bayer and Almirall of Spain, which will net it £70m if it meets certain hurdles.
In the key American market the go-head by the Food and Drug Administration to carry out a late-stage trial on cancer pain is also a considerable opportunity.
Guy points out that due to the nature of his raw ingredients, GW's progress has been in the spotlight.
"It is like a cook being asked to choose a new recipe and being told people are going to sit in the kitchen all day and watch them make it. Every single thing, warts and all has been looked at. Most pharmaceuticals companies do not have to do that," he says.