GW Pharm responds to CC

Pioneering British physician Dr. Geoffrey GuyPioneering British physician Dr. Geoffrey GuyGW is a pioneering British company founded by physician, scientist and pharmaceutical product developer Dr. Geoffrey Guy in 1997. GW works to organically grow marijuana, extract the plant’s active ingredients and use those extracts to produce prescription medicines.
Dr. Guy granted his first-ever major interview for a marijuana magazine to Cannabis Culture three years ago (CC#26, UK doc grows pharmaceutical pot), and has continued to give our readers exclusive insight into GW’s efforts.

Before Guy founded GW, he specialized in phytochemistry, a science that studies the useful chemical properties of plants.

Guy got interested in marijuana’s phytochemical potential after reading a med-pot book by American medical marijuana advocate and registered nurse Mary Lynn Mathre.

“It seemed to me that here was a very useful plant, with a long history of medical applications, and there were patients and patient groups who swore to its effectiveness and safety,” Guy explains. “The legal and social situation surrounding the plant had obscured its potential medical uses, and I became intrigued by it.”

The doctor started discussing medical cannabis research with the British government; in 1998 the government granted GW Pharmaceuticals unprecedented licenses to cultivate, possess and supply cannabis as part of professional medical research.

Guy then entered into exclusive worldwide contract with Hortapharm, a Dutch company that had for ten years been permitted by the Netherlands’ government to develop specialized breeds of marijuana.

Hortapharm’s principal researchers are famous marijuana experts who refuse to allow the media to reveal their identities. Guy says the Dutch company’s stabilized, unique varieties of cannabis utilized in GW’s breeding, cultivation and selection program, have produced cannabis plants that contain high ratios of a specific cannabinoid, such as THC, CBD, or CBC.

Each cannabinoid possesses specific medical properties. GW is testing individual cannabinoids and combinations of cannabinoids on patients with a wide variety of medical problems.

The extracts have proven extraordinarily safe and effective in relieving complex and persistent medical conditions such as neuropathic pain and muscle spasms, Guy says.

And if groundbreaking clinical studies already conducted are supported by further studies now underway, Guy predicts GW could receive official approval for plant-based cannabis medicines in less than two years.

Such approval would result in GW prescription cannabis medicines becoming licensed across the European Union and the Commonwealth, Guy says, with Canada and Australia likely to join Europe in giving doctors the go-ahead to prescribe GW’s cannabis products.

“If we are successful, it means that a whole range of new medicines come on the market,” Guy says. “We have found that along with their amazing effectiveness in treating conditions that cannot be treated by currently available medicines, cannabis medicines are far safer than the ones they would replace.”

`We grow varieties ... that were designed specifically for us.``We grow varieties … that were designed specifically for us.`Marijuana monopolist?

Issue 41 of Cannabis Culture contained an article about GW Pharmaceuticals and medical cannabis, authored by writer, activist and Canadian Supreme Court petitioner David Malmo-Levine (CC#41, Will pot be patented?).

At first glance, it seems there would be little reason for marijuana proponents to do anything other than praise GW’s efforts.

After all, Dr. Guy almost single-handedly convinced the British government to let him grow tens of thousands of marijuana plants in secret glasshouses in Southern England, to let him test marijuana extracts on patients, and to legitimize the claims of med-pot advocates who for years have insisted that marijuana is good medicine despite a chorus of doubters who used previous “scientific” research to back up criticisms of med-pot.

“Before we started this research, there was only anecdotal evidence that this plant had medicinal properties, but the medical establishment had not taken such claims seriously for many years because plant medicines in general were considered too hard to properly produce, test, and administer,” Guy says. “Our research has proven that this plant is very useful.”

Malmo-Levine’s article raised issues that Cannabis Culture put to Dr. Guy three years ago during our initial interview with him. These issues involve politics, law, societal perceptions, corporate ethics, and ideology. British med-pot activist Free Rob Cannabis was one of the main critics of Guy’s approach; Cannabis Culture asked Guy about Cannabis’s claim that GW’s government cannabis license in lieu of general legalization amounted to an unfair monopoly that prevented patients from growing their own medicine.

Malmo-Levine accuses GW of seeking to create a medical cannabis monopoly by patenting plants, extraction techniques, medicines, and extract inhalers; GW benefits from marijuana prohibition because it gets to race ahead with research on its own while individuals are prevented from growing marijuana and experimenting with it themselves.

The critique places GW on par with Monsanto, which has long been criticized for its efforts to patent food crops and to resort to heavy-handed police state tactics to enforce those patents.

Malmo-Levine notes GW’s plans to build a cannabinoid “delivery device” that would include remote monitoring features and other safeguards designed to prevent people from using too much extract or from diverting extract to unauthorized users. He says the “inhaler” and its monitoring features would be costly and intrusive. He even says Guy is wrong to claim that smoking plant material is bad for the lungs, and he worries that GW might sue home growers for violating GW’s marijuana plant patents.

Guy is used to criticism from all sides of the cannabis debate, and he reacted with calm logic and sincerity when I questioned him about Malmo-Levine’s concerns.

“The first thing to recognize is that we are not ‘Big Pharma,'” Guy said. “Four years ago I had four staff members and since then we’ve spent $40 million dollars investing in clinical studies that have shown people what cannabis medicine can offer. That investment carried a lot of risk with it- maybe as much risk as operating a clandestine grow room. The activists who say GW wants a monopoly are often participating in another monopoly- the black market production and sales of marijuana- and that market is making huge profit producing cannabis that varies widely in quality, cleanliness, and medical efficacy.”

Guy says he has “no beef with people who grow, smoke, or provide their own cannabis,” but he says that unregulated cannabis markets don’t meet the needs of medical cannabis users.

“The unregulated marketplace produces expensive cannabis geared toward the recreational user,” he says. “This cannabis is high in THC, but often lacks cannabinoids that benefit specific medical conditions. Much of it is grown in conditions that do not assure quality control. Our cannabis is grown organically with no chemicals, no artificial fertilizers, no radon, as cleanly as possible, with zero contamination by molds and fungi. We grow varieties that contain unique cannabinoid profiles from plants that were designed specifically for us. We extract those cannabinoids and test them rigorously to see how they work to decrease specific medical conditions. Frankly, if people care about medical users, I don’t see how they can criticize a program that produces clean, safe medicines for people who need cannabis.”

USA versus the world

Although the British government’s handling of recreational marijuana use and cultivation is fraught with the same kinds of hypocrisy and inconsistencies that beset US law, Guy’s medical marijuana research has been facilitated by the British government, which has assured the doctor that successful completion of pharmaceutical testing programs will result in official approval of GW’s cannabis medicines.

“We expect to see licensing of our medicines within the next two years,” Guy says. “Europe and the Commonwealth have enthusiastically stated that they would welcome our products if they meet British standards. Health Canada is prepared to accept a dossier applying for approval. One European country’s health minister said that the day we receive approval in the UK, they want our products available in their country. The US stands alone, among Western nations, in resisting cannabis medicines.”

According to Guy, the US med-pot debate is tainted by its drug war, and by bureaucratic systems and regulations that work against rational scientific and humanitarian concerns.

“The US says it wants data generated in the US, so we will have to duplicate our testing there if they will allow it,” explains Guy, who has conferenced with high-ranking officials of US drug control and pharmaceutical regulatory agencies. “Their requirements are onerous and costly, but if our medicines are approved and being used across Europe, it is going to be hard for the US to dismiss the process. They’d have to criticize UK doctors and institutions whose reputations are beyond question. They’d have to ignore the clear scientific evidence from a variety of clinical trials. They’d have to ignore the fact that our cannabis medicines are providing relief to patients that no other medicines can provide.”

Growing medicine in clean and organic environment.Growing medicine in clean and organic environment.Spray me!

Guy asserts that “people who grow their own marijuana have nothing to worry about from GW Pharmaceuticals.”

“The pharmaceutical industry is a business, and everybody seeks to patent their processes, materials and products,” he says. “We’ve spent a lot of our own money and investors’ money developing these products, and we would not have done this if there was no chance to make profits. Nobody in the industry was seriously looking into cannabis research when we first started. We’ve spent five years doing research, and Hortapharm was doing work for ten years before that. If we had not done the work, there would have been little advance in cannabis research. Now that we have done the work, some other companies want to copy that, and we have to protect ourselves. We deserve to make a fair return on our investment, and that’s why we pursued patents for our plants, extracts, processes, and delivery devices.”

Would GW take legal action against a pot grower whose marijuana plants resembled GW’s patented plants?

“Of course not,” Guy said. “But if somebody breaks into our glasshouses or laboratories and steals some of our plants or products, we would take action against them. We’re not the police. We aren’t worried about people growing plants at home. We’re not patenting all known strains of cannabis. Frankly, a lot of these peoples’ fears borders on paranoia. If people get into trouble for growing cannabis, it won’t be because of my company, it will be because of the laws.”

GW is not the police, but Malmo-Levine and other critics lambasted GW for its plans to design cannabinoid delivery devices that could be remote-monitored by doctors, pharmacists and law-enforcement officials.

Guy says GW is still working on the best ways to administer cannabis extracts.

“Most patients want to take their medicine, get relief, and go on with their day,” Guy says. “They aren’t looking to get high. In some of our testing, patients did experience a high at first, until they learned to titrate their doses. Doctors and patients are working together to determine the proper doses and cannabinoid ratios. Presently, we’re focusing on a mucosal spray that will be sprayed in the mouth, because cannabinoids are absorbed well through red, shiny tissue. It can be the whole mouth; it doesn’t just have to be under the tongue.”

Safety issues, social concerns and government regulations stipulate that medicines be safely deliverable in controlled doses, and that patients not be allowed to easily share medicines with others. Guy says that even if “little Johnny got a hold of a bottle of our extracts and sprayed the whole thing in his mouth, he might get sick or really high, but he is not going to die. Cannabis is one of the safest medicines known to humanity. It is unlikely to cause death, even in extreme overdose.”

The medical effectiveness and safety of cannabis continues to inspire Dr. Guy, even as he works through the costly research protocols while facing criticism from cannabis advocates like Malmo-Levine as well as from cannabis opponents.

“I’m very glad I became interested in this plant,” he explains. “Our medicines are going to help millions of people in ways that are unique and safer than medicines they compete with. We can help patients who have experienced no relief from conventional medicines and who would otherwise have no access to cannabis. Patients want to be able to go to their doctors and then to their pharmacists and get a medicine that works well so that they can make the most of their lives. We emphatically say cannabis is a good medicine, and it’s time to stop all this silly debate about it.”Growing medicine in clean and organic environment.