My blog is dedicated to the exploration of industrial hemp in America including the rich history of all forms of cannabis, the evolving law and politics of hemp and marijuana, the many products made from cannabis and the capacity, real or imagined, of hemp to re-industrialize rural America and revitalize the American family farm.
Chuck Schumer Urges FDA To Quickly Issue CBD Rules
Senate Minority Leader Chuck Schumer (D-NY) says he wants the Food and Drug Administration (FDA) to expediently issue guidance so that hemp-derived CBD can be lawfully marketed.
In a press call on Wednesday, the senator said that the lack of regulatory clarity is inhibiting the growth of a burgeoning market, noting that while hemp and its derivatives were federally legalized through the 2018 Farm Bill, FDA has yet to release rules allowing CBD products to be sold. Most hemp farmers in upstate New York are producing cannabidiol, he said.
He referenced a letter that he and several other senators sent to FDA Acting Commissioner Ned Sharpless earlier this month, which asked the official to provide “an outline of your agency’s current plans for a specific regulatory framework related to CBD along with a timeline for when comprehensive enforcement policies for CBD products will be finalized and implemented” within 90 days.
“CBD is brimming with potential to be a billion dollar industry across New York State, bringing along countless jobs and truly meaningful economic development with it,” Schumer said in a press release. “But before that can happen, farmers, growers, producers, consumers and vendors need to know exactly what the rules of the road are and right now they’ve got no idea.”
“That’s why I’m calling on the FDA to do its job in a timely manner and issue guidance related to CBD classification, labeling, quality, marketing, and sales. And once the feds spell out these ABC’s of CBD, the industry will seed and grow from one corner of the state to the other, many jobs will be created in the industrial hemp space, and farmers will be able to safely cash in on this cash crop.”
Schumer said that FDA rules for cannabidiol are necessary not only to unleash the full potential of the hemp industry but also to ensure that CBD products are subject to rigorous quality control standards to protect consumers.
FDA, in turn, has said that it recognizes that Congress intended for hemp legalization to include the lawful marketing of CBD products but stressed that there are regulatory challenges that it’s working to address. Because the compound exists as an FDA-approved drug in the form of the prescription medication Epidiolex and hasn’t been introduced into the food supply before, the agency is exploring alternative regulatory pathways.
Schumer is far from alone in his interest in speeding up the rulemaking process. Senate Majority Leader Mitch McConnell (R-KY), who spearheaded the hemp legalization provision of the agriculture legislation, also contacted FDA and asked that the agency release enforcement discretion guidelines so that CBD businesses can proceed with some level of assurance that they won’t be penalized.
FDA said it is only targeting companies that make claims about the therapeutic benefits of CBD that it considers especially inappropriate. On Tuesday, FDA and the Federal Trade Commission sent a warning letter to a CBD business that they said met that standard.
Medical science pioneer Manuel Guzman on prospects for an approved cannabis anticancer drug
Cancer doesn’t play favorites. It doesn’t care what color you are, if you’re young or old, or whether you live in a penthouse apartment or a shanty town. When the diagnosis comes, as it will for half of us in our lifetime, we pin our hopes on accessing the best treatment to maximise our chance of survival.
Almost exactly a year ago, 30-year-old George Gannon found himself facing a bleak future. Doctors had discovered more than 12 tumors in his brain. The melanoma he’d had removed three years previously had metastasized.
The aggressive nature of George’sBRAFpositive melanoma meant that even with standard treatments of radiotherapy, immunotherapy, and chemotherapy, his tumors had increased in size. With a prognosis of six months and no options left on the table,cannabisseemed to be the only hope.
But living in theUKmeant that anything other than thehemp-basedCBDoils was illegal. So he turned to the black market.
George began taking his cannabis oil just before Christmas last year. By his nextMRIscan in March, his tumors had stopped growing. For the next few months he resumed low doses of chemo, never once stopping his cannabinoid therapy.
The next scan in August, was a surprise to both George and his oncologist:the main mass on his left ventricle had disappeared and the other remaining lesions had decreased in size.
The oncologist – who had repeatedly told George to stop taking cannabis oil – said it was the best day of his professional career. But he wouldn’t acknowledge that cannabis may have played a part in the cancer’s reversal.
The oncologist’s reaction typified the skepticism of health professionals with respect to cannabis and cancer. Without solid evidence from clinical trials, most doctors dismiss the idea that cannabis could have antitumoral effects in patients. Which begs the question – How far away are we from getting the solid clinical evidence necessary to convince the medical profession that cannabis is a serious anticancer treatment?
WHY SO FEW CLINICAL TRIALS?
The only way for a drug to make it into the oncologists’ anticancer arsenal is for it to successfully pass through three phases of randomized double-blind placebo clinical trials testing safety, dosing, and efficacy.
Thirteen years have passed since the first small pilot study was conducted by Professor Manuel Guzman and his group at the Complutense University in Madrid.
They tested the safety and antitumoral action ofTHCon a small group of patients with recurrentglioblastoma, an aggressive form of brain cancer – and the results were encouraging.
ProjectCBDspoke to Guzman to find why, more than a decade later, progress has been so slow. One answer lies in the nature of cancer itself.
“Cancer is a very complex disease,” says Guzman. “There are at least 150 different types of cancer from a histological point of view and there are hundreds if not thousands from a molecular or genetic profile standpoint. So when we speak about cannabis or any treatment for cancer,first you should define what type of cancer we are dealing with because it’s really unlikely that a unique substance or a mixture of related substances, as is the case in cannabis, will be effective in all types of cancer.”
To this date, all cannabis-based clinical trials have focused on patients with glioblastoma.GWPharmaceuticals followed up Guzman’s pilot study with a yet unpublished phase I/IItrial using Sativex, a 1:1THC:CBDsublingual tincture, alongside temozolomide, the standard chemotherapy treatment for glioblastoma.
According to a 2017GWPharma press release,administering a combination of Sativex and temozolomide increased one year survival rate by 30% and increased the median survival to 550 days from 369 days with temozolomide alone.
“[TheGWstudy] is the first and so far the only trial that has been conducted on cannabinoids and cancer that is more robust, that it is controlled by placebo, and is randomized,” says Guzman. “It’s also a double-blind trial in which neither the patient nor the doctor knows whether the patient is taking Sativex or the placebo.
“That trial was also promising. It has enhanced our optimism that maybe cannabinoid drugs can have an anti-tumour effect, at least in glioblastoma and at least in the relapsing phase. But we have very little clinical information only for one specific type of cancer. I hope that other cancers will be treated with cannabinoids in the frame of a controlled clinical trial. But to date we have nothing.”
Two further phaseIIglioblastoma clinical studies are also about to commence. This time, Guzman’s group will be assessing whether a 1:1THC:CBDratio combined with conventional cancer treatment is effective as a first line treatment rather than a relapsing state.
And an Australian study (5) investigating tolerability of different cannabinoid combinations alongside chemo, radiotherapy or immunotherapy is also currently recruiting.
SLOW PROGRESS - PHARMA’S ROLE
As exciting as these initial clinical findings might seem, progress is still painfully slow considering how long scientists like Guzman have been researching the antitumoral potential the cannabis plant holds. It seems like the odds are stacked against a cannabis-based anticancer drug ever making it to market.
Guzman: “Doing clinical research with cannabinoids is very complicated becauseTHC, which to me is the main active ingredient in cannabis, is controlled by the United Nations and is a schedule 1 drug. So, it is subjected to very strong restrictions in the production, manufacturing and exporting, etc. That means many clinicians and investors get frightened. They don’t want to get into so much bureaucracy and they prefer to go for substances that are not classified as schedule 1. In general, my experience is thatthe bar that is set for cannabinoid clinical trials is higher than for other substances.”
Dr. Guzman suggests the notable absence of pharmaceutical companies in cannabis-based drug development may also be holding up progress.
“Clinical trials are very much controlled by Big Pharma companies who have the financial means and resources. Philosophically speaking, I’m against the protection of the drug, but on the other hand, the pharma companies are not going to make any movement in any field unless they have the possibility to protect, to patent their products or the indications of their products. So that makes cannabis research more complicated because cannabinoids are natural products and can be extracted from the plant by anyone.”
One way to navigate the intellectual property quagmire is to concentrate on rare conditions with an ‘orphan’ status.Developing a drug fororphan diseasescan be an easier route to gainingFDAmarketing approval and enjoys various incentives such as tax breaks. Orphan status also allows for usually unpatentable substances such as isolated cannabinoids to be awarded exclusivity – and is likely the reason why the likes ofGWPharmaceuticals are concentrating on rare cancers like glioblastoma.
Another avenue is to patent specific cannabinoid combinations and ratios.This is another speciality ofGWPharma.
Guzman: “Basically the whole cannabis field is mined withGWpatents. So, whenever a new company starts to get interested in the field and they make a first overview of how the patent situation is, many times they leave because they realize that everything is basically controlled byGWPharma. They have been very intelligent in that respect and they are basically the owners of all the intellectual property rights, all active rights and future rights in this field. So that also scares companies.”
‘COMMON SENSE’ APPROACH FOR CANCER PATIENTS TAKING CANNABIS
Strategic decisions made in drug company boardrooms stalling the development of cannabinoid-based anticancer drugs means patients like George Gannon have little alternative but to figure out how to source their own cannabis oil, with all the difficulties that entails. Given the life-or-death stakes involved, Guzman does not begrudge someone’s decision to use cannabis oil for cancer. But he feels that a patient’s decision should be guided by common sense.
“First try toget a standardized preparation,’ Guzman says. “One has to know at least how muchTHCandCBDis present in the preparation, not ‘I’m just taking cannabis.’ There are a million types of cannabis. So try to get to know how muchTHC,CBDand other well-known active ingredients are present.
“And if you are using cannabis oil as a treatment, know at least that the oil has been produced withgood agricultural practicesand isnot contaminatedby different types of toxic substances: organic solvent residues, pesticides, heavy metals, mould etc.”
“I would include a regime of administrationstarting from very little, increasing over 3 or 4 weeks, until one gets a standard dose that is well tolerated and at least overtly efficient. Second, I would combineTHCandCBD, starting with moreCBDand then includingTHCto get it to a final balanced preparation. I can’t say exactly what is a balanced. Usually you can go for a ratio of say 1:5 ratio ofTHC:CBD.
“Third, as cannabinoids accumulate in the body because they are very lipophilic, in theory, receptors can desensitize and lose response. So, I’m in favor of including some‘wash out’ periodsfrom time to time when at leastTHCis taken out. I would say for instance 3 weeks of cannabis plus 4 or 5 days of wash-out, so there is time forCB1[cannabinoid] receptors to get re-sensitized.”
PATIENTS MUST SHARE RESPONSIBILITY FOR NORMALIZING CANNABIS
Many patients feel uncomfortable when faced with the question of whether or not to tell their oncologist about taking cannabis during cancer treatment. For Guzman, informing the medical team in charge of care is not only a matter of safety, but a major way of increasing awareness about cannabis within the medical profession itself.
“I think patients are very important, he says. “They are key players in this effort, and they have to push for cannabis to get into mainstream medicine. And one of the ways is simply by normalizing its use by patients. And yes, it’s likely that in some instances the physician is going to react negatively. But we have to try.
“Before I retire,” Guzman continues, “I’d like to know that using cannabis as a cancer treatment has been successful. But at the moment we don’t know. There are somepreclinical signals, and also some very tiny clinical signals supporting that there may be an anticancer effect of cannabinoids.
“We have to improve that. And the evidence must come from different sites. Not only controlled clinical studies, but also observational studies, case studies that are reported by doctors about individual patients, and also the active role that I believe patients must play.They have to push. They have to speak about it.We are many different actors, and altogether we have to work hand in hand, otherwise it’s going to be almost impossible.”
Mary Biles is a journalist, blogger and educator with a background in holistic health. Based between theUKand Spain, she is committed to accurately reporting advances in medical cannabis research.
Sales disappoint, stocks tumble and startups scramble for financing
An employee at a Canopy Growth facility in Ontario, Canada.PHOTO:CHRIS ROUSSAKIS/BLOOMBERG NEWS
The party is over for cannabis companies.
Share prices of marijuana producers tumbled last week, some by nearly 40%, after a string of disappointing quarterly reports and mounting skepticism about the industry’s rosy growth forecasts.
Among the news this week: Two U.S. companies scrapped a merger initially valued at nearly $700 million. One Canadian producer said its prospects had become so uncertain that it was pulling its forecast for next year. Another warned it needed to find new sources of funding.
“The capital markets have dried up,” said Brian Athaide, chief executive ofGreen Organic Dutchman HoldingsLtd., a marijuana grower. The Toronto-area company said Thursday that construction financing for two cultivation and processing facilities, one slated for more than 1.3 million square feet, was being delayed.
Meanwhile, the stock ofHexoCorp., a producer in a joint venture withMolson Coors BrewingCo., fell 38% last week. On Thursday, the Quebec company withdrew its revenue outlook of 400 million Canadian dollars (about US$300 million) for fiscal 2020, ending July 31, and said it expects fiscal 2019 revenue of between C$46.5 million to C$48.5 million.
Hexo Chief Executive Sébastien St-Louis cited lower sales and pot prices for the outlook, and said the company was making significant changes to its sales and operations strategy. The news came a week after Hexo’s finance chief had resigned. The stock closed Friday at C$3.35.
The darkening industry outlook derailed at least one large merger. Los Angeles-basedMedMen EnterprisesInc.said Wednesday that it was scrapping its proposed all-stock takeover of Chicago-based PharmaCann LLC. Both companies operate dispensaries in several U.S. states.
xSep 3, 2019x-30.1%
MedMen cited the difficult market conditions as one reason for walking away, noting that the Horizons Marijuana Life Sciences Index, which tracks cannabis stocks, has almost halved this year.
“The underperformance has made it increasingly more critical to allocate capital efficiently given the current industry headwinds,” MedMen said in a news release. A MedMen spokesman declined to comment.PharmaCann didn’t respond to a request for comment.
In the U.S., the use, sale or possession of marijuana is illegal under federal law, but a number ofstates have legalized cannabis.
Canada’s cannabis sector isdominated by five companieswhose total market value has plunged from about $40 billion in September 2018 to roughly $17 billion as of Friday.
The largest company isCanopy GrowthCorp., whose stock has declined more than 30% this year despite the backing of Corona brewer Constellation Brands Inc., which controls 38% of the company’s stock.
Constellation, which made a $4 billion investment in Canopy in August last year,wrote down the value of the investmentby $1.3 billion when it reported earnings earlier this month. On Thursday, Constellation’s finance chief was appointed Canopy’s board chairman.
Investors have grown pessimistic about the industry’s near-term outlook. Some companies are producing significantly more cannabis than they are able to sell in a Canadian retail market that is hampered by the government’sslow pace of licensing stores.
“People are less than pleased with the results out of Canada recently,” said Glenn Mattson, an analyst at Ladenburg Thalmann. “They are unhappy with the lack of retail infrastructure, and the ability to build up that infrastructure.”
