Interviews

Health Canada Interview

This article has been re-posted from the May – June 2005 Cannabis Health Journal.

The following interview was conducted by Cannabis Health with Dr. Richard Viau, Acting Director General of Health Canada’s Drug Strategy and Controlled Substances Programme.

In preparation for the interview, we polled various members of the global cannabis community for their questions. This community is highly educated and is made up of many organizations (governmental and N.G.O). It also includes consumers from every walk of life and culture; ethical/compassionate growers and providers, professionals, and scientists alike. The information currently available to this community is equally diverse as it comes from many sources and takes in all aspects of cannabis production – strain selection, growing methods, environmental conditions, curing and storage processes, secondary processing, product testing, delivery methods and more. Research analysis, comparison studies, and opinions circulate at the accelerated speed of today’s communications media. As the number of cannabis users has risen steadily, so has the demand for accurate information. The cannabis community openly shares information and techniques. A lack of disclosure from any producer, even though this is largely an unregulated industry, results in avoidance of the product. The overwhelming response to our poll indicated that concerns about access, production, and safety standards are at the top of everyone’s list.

Access

As many as one million patients in Canada use marijuana to manage conditions such as nausea, seizures and chronic pain. Statistics from Health Canada’s Office of Medical Cannabis show that as of March 4, 2005, only 813 patients were authorized to possess marijuana for medical purposes, and of those, only 150 were actually accessing Health Canada’s dried marijuana. We are informed by the cannabis community that the reasons for the low level of participation are many and varied:

    • Mistrust of HC/PPS product safety
    • Perceived inferior quality and potency of HC/PPS product
    • Lack of support from Canadian (and other) Medical Associations and most physicians due to a lack of clinical trial data and peer reviewed medical research relating to smoked herbal cannabis.
    • It takes significant time and effort for physicians and patients to fill out and submit MMAR application paperwork – especially as compared to the traditional prescription/pharmacy drug distribution model.
    • The legitimate concerns many applicants/patients feel about submit- ting personal information to the government – and police – regarding medical marijuana use.
    • The fact that HC is only making one strain of cannabis available to patients.

C a n n a b i s Health: Do you have information pertaining to the number of applicants under the MMAR as compared to the number of approved participants? How many applicants have been turned down?

Richard Viau: Since the MMAR regulations came into effect in July 2001, no completed applications for authorization to possess have been refused. Zero.

CH: What about the ones that are incomplete? Those who can’t get a doctor to sign, for example.

RV: Let me explain a little bit about how the process works. The process is pretty clear and transparent. The regulations themselves are quite clear. The regulations outline what is needed to be approved, and if the requirements are met, then the license will be issued. No problem. If the requirements aren’t met, there are no exceptions possible. Typically when people have applied and haven’t received, it’s because their application wasn’t complete. There are myriad pieces of information that people have failed to provide. In those instances the Office of Cannabis Medical Access will work with the applicant; call them on the phone, send a letter or email explaining very clearly what pieces of information are missing and what is needed to complete the application. In some instances they have actually phoned the physician because the applicant wasn’t able to clearly explain to the physician what the physician needed to do in order to fill out the application form. We provide all of the support we possibly can to the applicants. The intent is, in fact, to make the process as easy as possible and as simple as possible, but like any other regulatory process there are some requirements that are set out.

CH: How will the next amendments to the MMAR streamline the process and the paperwork for obtaining an authorization to possess?

RV: We have been cognizant of the feedback and advice from applicants and from our Stakeholders Advisory Committee. The proposed amendments will streamline the regulatory process, thereby streamlining the application process for an authorization to possess marijuana for medical purposes. The categories of symptoms under which a person may apply will be reduced from three to two. The current Categories 1 and 2 are merged into one category (Category 1). The need for a specialist to sign the medical declaration for this category will be eliminated. The old Category 3 will become Category 2. While applicants under this category will still need to be assessed by a specialist, the treating (family) physician can sign the medical declaration.

CH: What about the liability issue that the doctors raise?

RV: A revised Medical Declaration for the physician has been developed and it will only include those elements essential to confirm that the applicant suffers from a serious medical condition and that conventional treatments are inappropriate or ineffective.

CH: So they won’t actually be prescribing it, just providing a verification of illness.

RV: Correct.

CH: Can you address the concerns many applicants/patients feel about submitting personal information to the police regarding medical marijuana use.

RV: One of the proposed amendments is to provide exclusive authority for Health Canada to communicate limited information concerning the authorization process and licenses or licensees to police. That really is for the protection of the applicants. The police get complaints; somebody’s going by, sees a marijuana plant in the window and calls the police. The police don’t want to go barging in, knocking down doors and putting people at risk when there’s no need to, so they would much rather know. At no time will there ever be any medical information provided to the police. Strictly information…the name, how much you’re entitled to have in your possession is essential. That’s simply to make sure no undue legal action is taken.

CH: What recourse does a licensed medical user have if they feel they are being unduly harassed by police? Can they call Health Canada for help?

RV: The police do not work for Health Canada. Every police agency has a recourse mechanism, an ombudsman or some sort of investigative branch that looks into complaints of harassment or use of undue physical intervention and that sort of thing, and that is who these people should complain to. There will be a follow-up investigation and if the complaint is founded then action will be taken. Health Canada really has no role to play in that.

CH: When can we expect to see these amendments come into effect?

RV: I would think sometime later this spring. I can’t give you an exact date because that’s something that we don’t control. The current set of amendments was published in Part 1 of the Canada Gazette in October 2004. After Part 1 of the Canada Gazette, all of the inputs are analyzed, and comments responded to. If there’s need to make changes to the proposed amendments, those are made, and then the draft regulations go before Cabinet for final approval. We don’t control the agenda at that point. We do not control the timing of when the regulations will go before Cabinet for final approval.

CH: Could patients fill out the current forms and send them in so that they can be reviewed as soon as the new process is in place?

RV: Once the amendments have been published in Part 2 of the Canada Gazette the new procedures will take effect and applicants will be able to use the new forms and processes. Until that happens they still have to use the old process.

CH: Will you be collecting data from the patients or compiling any usage stats?

RV: That’s kind of speculative. When the amendments take effect we may find that everybody is happier than happy. If that’s the case, there will be no statistics to gather, so I’d rather not speculate as to what’s going to happen after the new amendments take effect. Let’s just let them take effect and then we’ll see what happens afterward.

CH: But you will be open to feedback from consumers?

RV: We always have been from the very beginning and will continue to be. People can contact us by email, regular mail, fax or a toll free phone number, all of which are available on our website.

CH: The latest amendments to the MMAR suggest that personal production and designated grower production licenses are going to be phased out, leaving HC the only legal source of cannabis. A lot of people are concerned about that; they want to grow for themselves.

RV: The designated grower and the ability to grow for yourself, still an option. The option hasn’t been removed. Indeed, if there is a move to change that, there will be ample consultation, ample discussion and ample opportunity for anyone and everyone affected to provide feedback. Everything will be considered and once everyone has had a chance to have input, then a final decision will be made.

QUALITY

CH: The first marijuana distributed by HC/PPS for patient consumption was blended with leaf and stem and had low levels of THC. Grinding cannabis is known to increase oxidation and deterioration of THC. Although the THC level is only one part of the effectiveness of the overall product, it is tied to consumption levels. The stronger it is , the less is needed, thereby reducing the risk incurred by smoking. In addition, the analgesic and anti-spasmodic effect appears to be more significant in cannabis with higher levels of THC. Have your requirements and standards for the product changed since that time?

RV: Let’s look at consistency. The grinding is to try and get more consistency because every plant is a little bit different from every other plant and it depends if you just take the primary bud or the secondary buds. It also depends on the maturity level and the time you harvest. There are a lot of factors that affect your THC level. We have been doing a lot of work to optimize all of those conditions so we can reduce those inconsistencies. One of the things that we do is the grinding so that, in fact, from batch to batch, even within a batch, when you take a sample it will be consistent. That is the reason behind that.

CH: I understand you are now taking a lot of the stems and sticks out so that the product is almost pure bud, is that correct?

RV: I will say that it is pure bud. To the extent that you can take all of the sticks and stems out, we do. Let’s talk a little bit about what quality means. Quality is not just THC levels. Quality is all about having a very clearly defined process, so that you know what all of the qualities of the product are and so that you have consistency in your product on an ongoing basis. One of the qualities that you want to know is the THC content. The THC content of the product that we are currently distributing is between 11% and 14% and indeed, one of the recipients of our product has commented to us that they were very, very pleased with it, because unlike the prod- uct they were getting from the black market, our product was consistent from batch to batch and it made it very easy for them to self-medicate. We find that sort of comment very helpful because it gives us an indication that we are on the right track.

CH: The THC level patients seem to be looking for is between 14 and 18%.

RV: I’ll tell you a couple of things about that because I know quite a lot about THC levels in marijuana. There are a lot of misconceptions out there about how much THC there is in marijuana. We’ve analyzed about 16,000 black market samples of marijuana so I think we have quite a lot of information about what black market marijuana is. The average THC content is 9.6% in the last two years and in previous years it was lower than that. There is only about 7% of marijuana seized by police that has THC that is over 14%. There’s also an interesting experiment that was done in Holland, where scientists went into the cafes. Users couldn’t differentiate between 14% and 18% THC content.

CH: So this has more to do with the cannabinoid profile, right?

RV: No, there’s another piece to it too. If someone from the black market claims their marijuana has X percent THC, how do they know that?

CH: There is no way right now, because there’s no testing available.

RV: That’s right. So how do they know that they’ve got 14 – 18%? They also don’t know what the cannabinoid profile is. The only way you can know is by testing and in fact, when you go out and test, you sometimes find that this product and that product, that are said to be different, have exactly the same profile. It’s perception.

CH: Is it possible for a licensee to submit a sample of their own marijuana for testing?

RV: The short answer is no. If they wanted it to be tested, they would have to go to a private testing laboratory and if a private testing laboratory wanted to get into testing marijuana for consumer use they would have to apply for a license to do that.

CH: So there’s no place right now patients can get their supply tested?

RV: No private testing laboratory has ever applied for licensing other than the two that do testing for Prairie Plant Systems. No other labs that we’re aware of have ever applied for a license to test marijuana for consumer use.

CH: Does HC plan to provide more than one strain for patient use or for research?

RV: For sure, the possibility of growing other strains has been considered, but right now, we haven’t made any decision. Right now, we’re working at making sure that we know anything and everything we need to know with the one strain. Get all the answers. Obviously once you have all the answers, it’s much easier should you decide to expand to other strains. Trying to do the experiments on three, four, five strains just expands your risk that many times. You want to work it out with one and then you move on.

CH: What strain is HC providing currently?

RV: What we are growing is Cannabis sativa L, subspecies indica, cultivar indica. That’s based on “The Key to Subspecies for Marijuana” published by E. Small and A. Cronquist in 1976. The reason I say this is that there is another set of nomenclatures for cannabis that other people use. E. Small is a research scientist at Agriculture Canada and he developed this nomenclature in the mid 70s and that is the one we are using.

CH: Many medical users maintain that different strains are effective in managing different symptoms and conditions. They are particular about how much sativa and how much indica they want in their mix because each one seems to have its own characteristics.

RV: As you know marijuana is not an approved drug anywhere in the world and indeed, there really is a lack of sound research to demonstrate the safety and efficacy of marijuana. Health Canada and the Canadian Institutes of Health Research (CIHR) are working as partners to facilitate a five year research plan called the Medical Marijuana Research Programme. One of the questions that researchers want to look at is whether or not, in fact, different cannabinoid profiles do or do not have any impact in treating different types of conditions. Right now there exists no scientific evidence in support of that thesis.

I go back to what I said earlier. Patients don’t know what they’re dealing with so how can you conclude that this profile or that profile helps you when you don’t know what the profile is? You can’t make that conclusion and that’s the problem with research that’s based on anecdotal information. There are information gaps and leaps of logic that are not supported by fact. When you do a controlled experiment, you may find that the leap of logic is supported or you may find that it’s not.

SAFETY

CH: Test results on an early batch of HC/PPS product, obtained through the Access to Information Act, showed unacceptable levels of heavy metals, bacteria, moulds, aflatoxins and mycotoxins. How do you respond to the concerns expressed by the Cannabis Community about the safety of HC/PPS product?

RV: Let’s talk about those test results. Those data refer to product that was grown while we were still in the development stage. It was never distributed to anyone – not researchers, not therapeutic users. On the question of heavy metals, we test every batch and I do recall being contacted by the individual who had requested the information. I’m a chemist, I have a PhD in chemistry and I explained to that person that the results he had in his possession were inconsistent with the results we had. They were out by orders of magnitude.

CH: Could it be because the product was old?

RV: No, it’s not a question of how old the product is. I believe there was an error in the analysis. I asked for information on which test lab had done it. Was it a reputable, accredited test lab? This information was not provided, making it very difficult to assess the credibility of the results.

CH: What can you tell us about the use of herbicides and pesticides on PPS product?

RV: If you want organic, I can tell you, we’re as organic as you’re going to get. We don’t use any herbicides, pesticides, nothing like that, absolutely prohibited. We use natural ways of dealing with grubs.

CH: So you use nematodes?

RV: Yes. I don’t want to get into revealing our trade secrets. (laughing).

CH: Of particular concern to the AIDS Foundation are bacteria and aflatoxins – opportunistic fungi which can infect via the respiratory tract. Can people with compromised immune systems rest assured that PPS product will be safe for them?

RV: Obviously, that is a concern. Indeed, how do you get aflatoxins? You don’t get aflatoxins unless you have mould. So how do you ensure that you don’t get mould? You ensure you don’t get mould by proper drying of your product. We dry the product at 25 degrees Centigrade, which is at the high end of the range of normal room temperature, and we get the moisture below 15%. Then we freeze and irradiate to ensure there are no viable mould spores on the product. We also test the product before it goes out for any presence of mould. Now I’ll come back to what I said earlier. When you’re buying from the black market or a designated grower, or when you’re growing for yourself, how do you know that there is no mould? Do you test? No, so you don’t know. The stuff you get from PPS, you know. There is NO mould.

CH: There’s controversy surrounding irradiation.

RV: We don’t think there’s any controversy. We think it’s the way to go.

CH: Could you explain to me the reasoning behind choosing the gamma irradiation as opposed to sterilization by heat?

RV: Something that you really need to know is that there are no health implications or impacts with the dose of gamma radiation that we use to irradiate the product. We use the lowest dose possible, and gamma irradiation is a process that has been used for a long time on a variety of food products including herbs and spices so this is nothing new. I think there is real misapprehension about the heat process. Heat sterilization involves putting the product in an autoclave and heating it to above 120 degrees Centigrade. If you did that to marijuana, I guarantee you would find very little THC left and you in fact would denature the protein of the plant, so there is no way we would ever consider using that as a method of sterilization.

CH: Are the terpinoids and CBD’s affected by the gamma irradiation?

RV: At the level which we irradiate it doesn’t affect them at all. We measure everything, the whole profile, before and after irradiation, and there is no significant difference that we can measure in any of these levels.

CH: Can you claim safety for material that is to be smoked or inhaled by extrapolation from standards for oral consumption?

RV: There are only two common smokable products: tobacco and marijuana. The fact of the matter is that marijuana is not an approved drug and there really is a lack of scientific data on the efficacy of marijuana as a drug. Indeed, one of the areas researchers have said they want to look at is administration. Is smoking, in fact, the best form of administration? We do know that there is a company from England that has applied to have a product that is derived from marijuana as a sublingual spray. Currently there are two products on the market in pill form that are ingested orally. So there’s still a lot of research that needs to be done on the question of safety and efficacy. We are currently engaged in a research project called the Mainstream Smoke Study, which uses smoke machines to capture the smoke and analyze all the constituents in it. I would expect sometime in this calendar year or early in the next that there should be some results coming out from that study.

CH: Some patients are looking now at vaporization as a harm reduction measure. Will you be looking at vaporization as well?

RV: Right now, we’re going to finish the smoking study and we’ll decide where we go after that.

CH: Health Canada’s OCMA Information webpage states that PPS conducts laboratory testing and quality control of its marijuana throughout the product’s life cycle; records of tests and their results are obtained and assessed against specifications to ensure compliance, and the product is not released for sale or supply prior to approval by the quality control department. Is the testing process also applied to packaged product and to product that has been in storage for varying lengths of time?

RV: For sure testing is a huge part of what we do. Basically, we test product after it’s harvested, we test product after it’s pack- aged and ready to go out the door to therapeutic users or to researchers. We test it before and after irradiation. Lots of testing, lots of testing. And we don’t only test for THC; we test for a variety of other things.

CH: You’re testing for cannabinoid profile, contaminants, biological problems, etc., correct?

RV: You’ve got it.

CH: Is HC willing to provide consumers with the data obtained in the ongoing testing process?

RV: We are in the process now of translating all of our test results for every batch we’ve sent out, and they will be posted on our website within a couple of weeks I would hope.

CH: Many medicinal users, because of their health condition, are in the lowest of income brackets. Given that HC can never hope to recoup the cost of the MMAR program, why is the price of your product so high? Why would a patient choose to buy at HC’s current price of $150 per 30 gm, when a product they believe to be superior is available on the black and grey markets for a comparable or better price?

RV: I want to be very clear that the program that we have is a compassionate program. We are supplying a legal source of marijuana and this eliminates legal and safety risks associated with the black market purchase or production of marijuana. So they’re getting all of this testing, this really controlled process. We’re moving to the process that you would use for the production of a biological drug. If you’ve ever seen the lengths to which drug companies go, that’s where we’re going. So, yes, there are some costs. I think that for a product with a quality and consistency that can’t be matched and for which they have no legal or safety concerns, the price is extremely reasonable. When you compare our price with the price of black market, based on information that we’ve had from police across the country, our price is two to three times lower than what people buy on the black market.

CH: Two to three times? No, the police typically inflate the value of seized drugs. Most of our patients are buying from ethical Mom and Pops at about $100 per ounce (30 grams).

RV: Let me be very clear… “ethical Mom and Pops”, what they’re doing is illegal. It’s black market. Unless they’re licensed, they’re illegal. If the police find these operations and raid them, these people will be charged with cultivation.

And so we come full circle. Until we can overcome the access hurdles, this is the dilemma faced by the medical users – those at the greatest risk due to their compromised health. The vast majority of medical users don’t have a supportive physician and must either find an ethical “ma & pa” grower, purchase from a compassion club if available, buy from the black market or grow it themselves. Those are the choices. Each one represents a risk, especially if the quality of the product is in question.

For additional information about legal access in Canada: http://www.hc-sc.gc.ca/hecs-sesc/ocma/
 

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