Monthly Archives: October 2016

Mission of the FDA and Cannabis

FDAIs the FDA meeting it’s stated mission?  When it comes to Cannabis, and other medications, it would seem not.

The stated mission of the FDA is:

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.

FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

Protecting the Public Health by assuring the safety, efficacy of drugs and devices.

When it comes to Cannabis they are not assuring that what is being sold is safe.  It’s been found that the cannabis sold in CO, WA and OR have had issues with mold, heavy metals, and non-organic grown cannabis making it’s way to the market.  If the FDA was doing it’s job it would be demanding the DEA re-schedule cannabis so that they can control production.

fda-otcAdvancing the public health

Again when it comes to Cannabis they are not advancing public health.  In fact they are actually hindering the public health by not allowing it to be monitored or even determining what needs to be monitored.

Speed Innovations that make medications more effective, safer, and more affordable.

Again they are failing.  It’s been well documented that in states where Cannabis medications are allowed the use of other medications have been reduced.  In most instances these medications are not as effective, not as safe or as affordable than Cannabis.  The research that has already been done, showing safety, shows that a variety of products are not being sped to market.

fda-safeHelping the Public get Information they need

They seem ready to promote new drugs made from chemical processes but when it comes to herbal items like Cannabis they fail.  Instead all you really hear from the FDA is when there is a problem with an approved medication.  Even “safe” over the counter medications the FDA is failing to protect the public.

It’s time for the FDA to turn itself around and become the organization it was meant to be.

The first step is to put then FDA in charge of the Controlled Substance Schedules.  Why the DOJ is in charge of what substances are on the various schedules simply doesn’t make sense from any aspect.  Having the DOJ enforce the substance laws makes sense, but why are they the ones to schedule a substance, is it logical?  Wouldn’t it make greater sense for a properly run FDA to be in charge of scheduling substances?  They are supposed to have all the information or are able to research and determine the information for substances that might be used as either a medication or as a food.  Doesn’t that make the FDA the logical people to determine if a substance can be sold and distributed?

The second step would be for the FDA to then approve Cannabis to be sold in the United States under the CSA.  Under the CSA there already is in place a registration process for manufacturers of substances including Cannabis.  It’s how so many pharmaceutical companies, the Mississippi Farm, the University of MN do research.  There is nothing in the CSA that says substances on Schedule I can’t be manufactured, distributed, it simply says there needs to be controled so that it doesn’t end up in the illicit market.  By licensing those, in states that allow it, to register and document what they produced and where it went would allow for recalls and other things that would benefit the consumer.

Let’s face it with 60-65% of the United States saying that we should legalize cannabis it’s time to change the system.  The FDA could make public sales controlled and the products safer for consumers which is what their mission is.

 

Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

marijuana-001In an article in Front. Pharmacol., 14 September 2016 Ethan Budd Russo the Medical Director of PHYTECS wrote extensively about the “Controversies” and in this article we will summarize some of the most important parts.

Among his many outstanding accomplishments we copy from his BIO

Ethan Russo, MD, is a board-certified neurologist, psychopharmacology researcher, and Medical Director of PHYTECS, a biotechnology company researching and developing innovative approaches targeting the human endocannabinoid system (“ECS”). The PHYTECS team pioneered scientific understanding of how the ECS regulates physiological functions including immunity, pain, inflammation, mood, emotion, learning, memory, metabolism, appetite, weight, sleep, embryo development, neuroprotection and stress responses.

Previously, from 2003-2014, he served as Senior Medical Advisor, study physician and medical monitor to GW Pharmaceuticalslogo for several Phase II and Phase III clinical trials of Sativex® for alleviation of cancer pain unresponsive to optimized opioid treatment, a Phase II study of Sativex to treat spasticity in cerebral palsy in children, various Phase I studies of Sativex drug abuse liability, and its effects on QTc interval and administration to patients with hepatic impairment, and Phase II studies of Epidiolex® for intractable epilepsy in children.

He graduated from the University of Pennsylvania (Psychology) and the University of Massachusetts Medical School, before residencies in Pediatrics in Phoenix, Arizona and in Child and Adult Neurology at the University of Washington in Seattle. He was a clinical neurologist in Missoula, Montana for 20 years in a practice with a strong chronic pain component. In 1995, he pursued a 3-month sabbatical doing ethnobotanical research with the Machiguenga people in Parque Nacional del Manu, Peru. He joined GW as a full-time consultant in 2003.

He has held faculty appointments in Pharmaceutical Sciences at the University of Montana, in Medicine at the University of Washington, and as visiting professor in the Chinese Academy of Sciences and Harvard Medical School.

It can be pretty much said that his creds are above reproach and he isn’t an anti Cannabis researcher, but he isn’t a pro smoking Cannabis supporter either.

In his 20 page report which you can get here he touches on just about everything. He also hold no punches as in his opening comments he states

Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents.

He does however make a mistake in his statement below.  There is no need for Cannabis to go through any approval process.

s there a pathway that will lead to the return of cannabis to mainstream medicine? The answer is clear, inasmuch as it has already commenced. It follows the same time-honored process that any pharmaceutical must attain to receive regulatory approval: proof of biochemical uniformity and stability along with safety and efficacy as proven by randomized clinical trials (RCT).

Unless sales occur in which case only testing for other issues should be addressed.  Cannabis has already proven itself to be safe, even varieties that produce large amounts of THC and other Cannabinoids. If it wasn’t safe you would see people dying in the streets from overdoses.  They do not even really show up in the Emergency Room, except for paranoia attacks and that has more to do with being worried about being arrested.

While he makes great comments about what would need to happen for Prescription type Cannabis they simply aren’t necessary given the safety of the product.  One thing he does address, not nearly enough emphasis is:

The biochemical variability of one chemovar to another is a primary challenge, while unregulated material may harbor pesticide residues, molds, bacteria, or heavy metals that endanger public health.

There does seem to be some sort of problem with people feeling good.  Not just releiveing a symptom but actually feeling better.  Which frankly seems at odds with all the other medications they shove down people to make them feel better.

In reality, patients are not seeking altered states from their medicine, but rather relief of pain or other complaints. Other cannabis-based medicines that follow will necessarily be required to meet similar benchmarks.

The problem with the current state run systems are a very real and possible source of a problem.

The singular controversy in this category is quality control. Short of a biochemical analysis by a certified laboratory employing verified phytocannabinoids standards, the cannabis consumer can have no real idea of the composition or consistency of the product that they purchase.

Labs that are doing testing may not be competent to test properly

The problem is compounded by the facts that technically almost all laboratories pursuing phytocannabinoid analyses in the USA are doing so illegally, most without benefit of a Schedule I license from the Drug Enforcement Administration (DEA). Additionally, many phytocannabinoid standards available commercially are reportedly suspect. There is additional difficulty in attempting to analyze cannabis confections, as the assays require ascertainment of cannabinoid content from a complex food matrix

He makes perfect sense when he states further in his paper

The author believes that full cannabinoid and terpenoid profiles are necessary for proper decisions by consumers in both the medical and markets

Can Cannabis as a plant be a medicine the Doctor seems to think so.  As he notes other plants have FDA approval and Cannabis has approval in other countries.  Adding:

Botanical medicines can even meet rigorous requirement of the American FDA as has already occurred for one topical agent (Veregen®, an extract of green tea, Camellia sinensis), and one single component botanical isolate taken internally, Fulyzaq® (crofelemer, from Croton lechleri). These approvals were achieved by following a blueprint that was updated in August 2015

FDAHere is a link to the FDA guidelines he speaks about – FDA

While he makes additional good points he misses that for over 10,000 years Cannabis has been used safely so passing any of these tests should be a simple matter.

If components of an extract are not already “Generally Recognized As Safe” (GRAS), clinical trials, safety-extension studies and rigorous quality control requirements all must be met. A botanical agent administered by a non-oral route, such as inhalation, requires additional pharmacology and toxicology documentation before initiation of RCTs.

What about kids?  Won’t they want to smoke Cannabis if they see others? NO according to the Doctors report.

The press frequently criticizes medicinal cannabis on the basis that acquiescence to its availability promotes usage by youth. To the contrary, analyses such as that undertaken by the US Government Accounting Office (GAO) reveal no increase in associated drug crimes or youth usage rates after passage of state laws allowing medicinal cannabis

He Concludes his paper

Conclusions

As the legal tide is turning on cannabis as a forbidden drug, experiments are ongoing in the various states (and other countries) as called for in Justice Brandeis’ “laboratories of democracy.” Daunting problems remain for those attempting to seek regulatory approval for smoked or vaporized cannabis as a prescription product, whereas nabiximols, a standardized oromucosal spray has achieved such approval in 27 nations based on its ability to demonstrate biochemical consistency, and safety and efficacy in randomized controlled trials. Pure CBD (Epidiolex) also appears headed for regulatory approval.

In contrast, the recreational market is facing numerous challenges in quality control, and addressing myriad safety concerns associated with newer, more potent preparations and novel delivery techniques. Science may provide suitable data for addressing these issues if commensurate research funding is forthcoming to meet the urgent need.

you can read the entire article here –

Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

Ethan B. Russo

 

Inch By Inch

01To quote the DEA “Inch By Inch” is how the DEA see’s the progression of Cannabis legalization.

With each state that puts forth legislation the DEA appears to create reports such as the one they released to us about Maryland and Virginia and it’s legalization movements.

First they see a state legalize for medical purposes, then they see recreational use legalized.  One by one, “Inch by Inch” the DEA see’s Cannabis being legalized across the nation.

In a couple of these documents we have recovered from the DEA under FOIA the mantra seems to be the same in the “Outlook”

wss_skunk_cured_bud“the changes in marijuana legislation in Maryland and Virginia since July 2014, the medical marijuana program in Maryland is most likely to impact the illicit marijuana trafficking situation. Despite regulations that are being implemented, marijuana availability will increase and potentially could be diverted into illicit markets.”

“In addition patients from out-of-state might register and take marijuana to other states to sell.  The legalization of recreational marijuana in Washington DC is also likely to affect the situation along it’s Maryland and Virginia borders.”

You can view the rest of the document here dea-was-dir-050-15

 

The State of The States, Cannabis

wss_skunk_cured_budEvery year the president, governors, city leaders give a state of the state address so we thought why not make a state of the states for Cannabis.  We’ve been able to kinda find all the laws as they are now, subject to change in Nov, so people can see the number of states that have legalized cannabis for one use or another.

It’s actually a pretty impressive list, a few years ago this list would have been much shorter

Alaska Stat. §§ 17.37.010 et seq. (medical), §§ 17.38.010 et seq. (recreational);
Arizona Rev. Stat. §§ 36-2801 et seq. (medical);
California Health & Safety Code §§ 11362.5 et seq. (medical);
Colorado Rev. Stat. §§ 12-43.3-101 et seq. (medical), §§ 12-43.4-101 et seq. (recreational);
Connecticut Gen. Stat. §§ 21a-408 et seq. (medical);
Delaware Code Ann. tit. 16, §§ 4901A et seq. (medical);
D.C. Code §§ 7.1671.01 et seq.(medical);
Hawaii Rev. Stat. §§ 329-121 et seq. (medical);
Ill. Comp. Stat. Ann. 130/1 et seq.(medical);
Maine Rev. Stat. tit. 22, §§ 2421 et seq. (medical);
Maryland Code Ann. Health-Gen §§ 13-3301 et seq. (medical);
Massachusetts Ann. Laws ch. 94C, §§ Appx. 1 et seq. (medical);
Michigan Comp. Laws Serv. §§ 333.26421 et seq. (medical);
Minnesota Stat. Ann. §§ 152.27 et seq. (medical);
Nevada Rev. Stat. §§ 453A.___ [2015 ch. 401, § 29] et seq. (medical);
New Hampshire Rev. Stat. Ann. §§ 126-X:2 et seq. (medical);
New Jersey Stat. Ann. §§ 24:6I-1 et seq. (medical);
New Mexico Stat. Ann. §§ 26-2B-1 et seq. (medical);
New York CLS Pub. Health Law §§ 1004.1 et seq. (medical);
Oregon Rev. Stat. §§ 475.300 et seq. (medical), Or. Rev. Stat. §§ ___.___ [2015 c.1, § 3] et seq. (recreational);
Rhode Island Gen. Laws §§ 21-28.6-1 et seq. (medical);
Vermont Stat. Ann. tit. 18 §§ 4472 et seq. (medical);
Washington. Rev. Code §§ 69.51A et seq. (medical), Rev. Code §§ 69.50.360, 69.50.363, 69.50.66, 69.50.401 (recreational).