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Leafly Exclusive: GW Pharma Is Moving CBD Bills on the Down Low

February 17, 2017
In news that could have profound implications for the legality and availability of cannabidiol (CBD) products, Leafly News has learned that the British pharmaceutical company GW Pharma and its American subsidiary Greenwich BioSciences are quietly moving proprietary CBD bills through at least two U.S. state legislatures, and could have plans for similar bills in other states.

The proposed measures would effectively give GW/Greenwich a temporary monopoly on legal CBD products in South Dakota and Nebraska.

The proposed measures, both taken from the same template, would effectively give GW/Greenwich a temporary monopoly on legal CBD products in South Dakota and Nebraska.

The pharmaceutical company’s lobbyists are moving in anticipation of the FDA’s expected approval of Epidiolex, a CBD-based drug that’s currently in Phase III clinical trials. Epidiolex has been developed by GW/Greenwich for the treatment of several rare childhood-onset epilepsy disorders. The company has been developing the drug for years, and FDA approval could come as early as this summer.

In a possibly related development, Greenwich BioSciences has recently retained the services of registered political lobbyists in at least nine state capitals. It’s unclear why the company chose South Dakota and Nebraska as pilot sites for these bills. Neither state allows any kind of medical cannabis, but both operate in fairly obscure regions where legislative bills typically don’t attract a lot of attention.

The move has alarmed some patient advocates in South Dakota and Nebraska, who have been fighting for years to pass medical cannabis laws. They fear that GW’s move could preempt their own efforts, undercut support for full medical legalization, and limit patient options to the GW/Greenwich patented product.

“SB 95 will block all current and readily-available CBD options for South Dakota’s children,” Melissa Mentele told Leafly. Mentele is the chairperson of New Approach South Dakota, the state’s main cannabis reform group. “It will make Epidiolex the only option. As we know, one medicine does not work for all patients. We can’t take away options for these catastrophically ill children and their families.”

'They want to be the only option. What happens when the only option doesn't work?'
Melissa Mentele, New Approach South Dakota

“The ‘FDA approved’ language is being pushed heavily by GW and Greenwich BioSciences for a reason,” Mentele added. “They want to be the only option in South Dakota. What happens when the only option doesn’t work?”

Leafly has reached out to Greenwich BioSciences for comment. The company has yet to respond

The South Dakota bill, SB 95, had its first committee hearing earlier this week. The bill exempts cannabidiol from the definition of marijuana and moves CBD from a state-designated Schedule I drug to a Schedule IV substance. The piece of the bill that’s critical to GW/Greenwich: These moves affect only cannabidiol products that have received federal FDA approval. Epidiolex is currently the only widely known CBD product nearing full FDA approval.

If the bill passes, GW Pharma and Greenwich Biosciences will effectively own a legal monopoly on CBD products in South Dakota and Nebraska—at least until another CBD-based product achieves FDA approval.

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A national lobbyist hiring spree  

GW Pharma and Greenwich BioSciences have never been active in American politics on the state level, in part because they really didn’t have a product to sell. With Epidiolex approaching market readiness, however, the companies have acquired political muscle all over the country. And they’re not exactly advertising it.

No mention of the South Dakota or Nebraska bills—or any bills potentially in the works in other states—can be found anywhere on the company’s websites.

At the same time, Greenwich BioSciences has recently retained the services of registered political lobbyists in a number of different states.

  • In South Dakota, the company is repped by Dennis Duncan, a Sioux Falls lawyer who’s known around Pierre as a longtime lobbyist. In Madison, Wisconsin state legislators are considering two separate cannabidiol legalization bills. Neither of those bills currently mention Epidiolex or FDA approval, but Greenwich BioSciences recently hired the local lobbying shop Martin Schreiber & Associates to look after its interests in the state capital.
  • In Nebraska, Greenwich BioSciences has retained the Lincoln lobbying shop Mueller Robak.
  • In Florida, the company has retained Douglas Russell, a former top official at the state’s heath care agency, to look after its interests in Tallahassee.
  • In Minnesota, no CBD bill has been introduced in the state legislature, but Greenwich BioSciences recently retained the St. Paul lobbyist Randy Morris as the company’s registered agent.
  • In Washington state, last month Greenwich BioSciences began paying political lobbyist Stephen J. Buckner $3,500 per month to look after its affairs. There is, as of yet, no CBD bill in Olympia.
  • In Idaho and Arizona, the company has retained the services of California-based lobbyist Kurt Stembridge. Stembridge may also be representing the company in Sacramento.

In South Dakota, lobbyist Dennis Duncan testified before a state senate committee earlier this week in favor of SB 95. He called attention to the bill’s pre-emptive requirement: “Before this drug can be rescheduled, it can be done only after FDA approval,” he said. “So it can’t be prescribed or dispensed prior to FDA approval.”

South Dakota Sen. Blake Curd, the state senate majority leader, sponsored the current bill. He gave a stirring endorsement of the safety of cannabidiol to his colleagues. “The one distinct difference with CBD oil is that it has no known lethal dose, no known toxic effect, and no known euphoria,” he said.

“You are more likely to drown in a vat of CBD oil than you are from taking it in any form,” Sen. Curd said.

Medical marijuana advocates introduced an MMJ bill last year, but Curd amended it to allow only possession and use of CBD for patients with severe seizure conditions. The bill ultimately failed.

 

Votes swing once GW backs it

Until now, the GW/Greenwich political move has flown mostly under the radar. Yesterday Cory Allen Heidelberger, a South Dakota political watchdog who puts out the Dakota Free Press, published the first skeptical take on SB 95. Heidelberger noted that South Dakota Attorney General Marty Jackley, one of the most powerful figures in state politics, “sat quietly behind the lobbyists for Greenwich BioSciences.” Jackley opposed last year’s bill on CBD, but has written in support of GW Pharma-developed products. Many of last year’s cannabidiol legalization opponents in South Dakota have similarly faded away in the face of this year’s GW/Greenwich bill.

Most national cannabis groups and patient advocates are unaware of company’s political move on cannabidiol. NORML has been tracking the South Dakota bill on its Action Alert List, but most groups haven’t given the CBD bills high priority.*

Mentele, chairperson of New Approach South Dakota, found out about them just a few days ago.

In Nebraska, only local patient advocates were available to testify against the bill, introduced there as LB 167. Jane Stanley, a patient with interstitial cystitis, told a legislative committee that CBD was the only medicine that helps her. But legalizing only in GW/Greenwich’s FDA-approved form would not allow her to benefit from the full healing benefits of cannabis.

“When you start isolating the cannabinoids from cannabis, it’s like taking out the codeine from hydrocodone and expecting it to do the same thing,” Stanley said.

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Dexter Schrodt also testified against the Nebraska bill. He’s head of the local chapter of Students for Sensible Drug Policy (SSDP). Edward Williams, leader of Nebraska Veterans for Medical Marijuana, also spoke in opposition.

Speaking in favor of the bill in Lincoln were Michelle Welborn, founder of the national Intractable Childhood Epilepsy Alliance; and Kim Robak, co-founder of the Lincoln lobby shop Mueller Robak.

The testimony of Welborn and Robak was curious, though. Welborn is a national patient advocate; she’s also the founder of Bravo Pharmaceuticals, a biotech startup that seeks to license products for rare diseases, including intractable childhood epilepsy.

On the agenda for the Jan. 25 Nebraska state senate committee meeting, which considered the Greenwich BioSciences-focused CBD bill, Kim Robak was listed as a representative of the Nebraska Medical Association. That is true—her lobbying shop is their registered agent. But Robak’s firm is also a registered and paid lobbyist for Greenwich BioSciences.

Leafly will continue to follow developments surrounding these and other CBD-related bills. For more information on cannabis-related legislation currently in play in statehouses around the country, see our updated bill tracking page.

* Update 2/22/2017: In its original form, this article failed to note NORML’s updates on South Dakota’s SB 95. Leafly regrets the error. Check out NORML’s Action Center for more info on other bills in play this year.

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Bruce Barcott

Leafly Senior Editor Bruce Barcott oversees news, investigations, and feature projects. He is a Guggenheim Fellow and author of Weed the People: The Future of Legal Marijuana in America.

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  • CBD HEMPINDICA
  • Open Minds

    It was only a matter of time before Big Pharma tried to muscle out the little guys….

    • James Peters

      They aren’t a major pharma compnay. ”Revenue for the twelve months ended 30 September 2016 of £10.3 million ($13.3 million) compared to £28.5 million for the twelve months ended 30 September 2015.” http://ir.gwpharm.com/releasedetail.cfm?ReleaseID=1002545 Pfizer on the other hand had revenues of almost $49 billion in 2015

      • Open Minds

        All Big Pharma companies started out as small companies. The fact that they are lobbying to pass laws that grant them a monopoly is typical of Big Pharma’s rapacious ways…

        • James Peters

          Governments create monopoly’s. We need them out of the way and get most of the chemicals in the plant removed from the Schedule I substances list. This should allow more competition which is a good thing. At the state and federal level then cannabis should be legalized for personal recreational use. As for medical use then the approval process should be no different from that used for any other potential medication.

          • ceebee

            I totally agree with James Peter.

            SOOOOOOO let us look at the “mechanism of action”: in the eco-political level: the Kefauver Harris Amendment requiring clinical trials in the US cost a company anywhere between $30-40 million USD. So, under these LEGAL requirements, does it not 1) explain the behavior 2) point to the Root Cause.

            I get it, this is underhanded manipulation by GW is appalling and unforgivable… however, who is really speaking out about the Root Cause of the horrors patients bodies scarified to “clinical trails” randomized arms? A patient is required to sign their right to sue for injuries away in clinical trials, however, when a patient has found something that works and is not Standard of Care or a clinical trial, they cannot do the same (or no doctor will tread in such territory for fear of the State Medical Peer Review Board condemnation and losing one’s medical license).

            To summon up $30-40 million USD, one must have a business plan and an ROI to recover the costs and pay the shareholders to presented the money to do the trial in the 1st place. GW is just following the logical conclusion that the System provides for them. Can you blame them? Or otherwise they would not be there (given the current legal system).

            Cannabis is no different once is gets classified as a pharmaceutical (as CBD was just recently in the UK).

            Besides the undercutting pharma control by legalized cannabis for personal recreational use (thought we know better for our own medical use), anybody targeting the Root Cause?

      • Geoff Jacobs

        BULLSHITE!!

        • James Peters

          So you think with revenues of £10.3 million this somehow makes them a major pharma company?

      • Stephen Patterson

        GW Pharma holds more patents on cannabis than all other pharma companies put together, even in processes that have been common knowledge for ever. Financially speaking you are right but, when it comes to cannabis, they are the largest company in the world. If you don’t believe me check the U.S. patent office.

  • Geoff Jacobs

    OK, here’s where I’m confused… GW Pharmaceutical is the same company that manufactures “Sativex”, the synthetic form of THC which is prescribed to cancer patients by doctors to fight anxiety, appetite loss and the nauseating effects of chemotherapy; the very same chemotherapy that they prescribe for patients, knowing that it will ultimately NEVER kill the cancer and cure the patient yet they get filthy rich from it??
    Also, in Georgia, the Governor Nathan Deal and Senator Rene Unterman were found to have taken campaign funds from GW Pharma in exchange for KILLING ANY LEGISLATION RELATED TO MEDICAL MARIJUANA???
    Surprisingly enough, the MORON Governor proceeded to pass a law, legalizing medical marijuana for the sake of “the children”, but, the imbecile didn’t make a provision for the patients to actually obtain the cannabis, and, you practically have to have one foot in the grave?!
    I don’t understand why GW is becoming involved with this other medicine, Epidiolex, unless they are attempting to become the monopoly??

    • James Peters

      Sativex (standardised whole plant oral mucosal spray) is approved for MS spasticity only. GW Pharma produce a number of standardized plant extract preparations, including one which is high in THC, and one, which is high in CBD. Sativex contains equal proportions of these, and, hence, almost equal amounts of THC and CBD. THC and CBD represent approximately 70% of the product, with 5% of other cannabinoids, the remainder being terpenoids, flavonoids, sterols, alkanes, and other chemicals found in the plants they use.

      Any treatment related side-effects from chemo are better dealt with using more effective drugs and cannabinoid based ones tend to only be used where other approaches fail http://www.jnccn.org/content/10/4/487.long http://www.cochrane.org/CD009464/GYNAECA_cannabis-based-medicine-nausea-and-vomiting-people-treated-chemotherapy-cancer Chemo does work otherwise it wouldn’t be used. How well depends on a number of factors such as type and stage of the patients cancer.

      As for Epidiolex (a proprietary oral solution of pure plant-derived CBD) then GW have proven this works in patients with Dravet and Lennox-Gastaut syndrome http://ir.gwpharm.com/releasedetail.cfm?ReleaseID=1002552 They are now waiting for FDA approval and hope this will be placed into Schedule 4.

      I view ”medical marijuana” as a backdoor way to get it legalized. Personally I’d rather advocates of legalization drop the charade, argue for legalization, and stop with the medical nonsense.

      • SteveSarich

        You really shouldn’t have taken on the hemp industry. You don’t have enough state lobbyists to fight all of the producers and processors of industrial hemp. And we’re already legal. And the CBD we produce is a tiny fraction of what your products will cost consumers. You can’t always get what you want… at least when you want to buy yourself a monopoly on cannabinoids. We WILL stop you!

  • lovingc

    GW needs to go back to Britain and leave the US out of this nonsense. I want my CBD to come from a plant that grows.

    • James Peters

      Straight from their site: ”Epidiolex is GW’s lead cannabinoid product candidate and is a proprietary oral solution of pure plant-derived cannabidiol, or CBD. GW’s Epidiolex development is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS).” https://www.gwpharm.com/epilepsy-patients-caregivers/patients

      • lovingc

        And?

        • James Peters

          You said: ”I want my CBD to come from a plant that grows.” Well their drugs are derived from plants. So I can’t see the problem?

          • SteveSarich

            Yours come from a Schedule 1 plant….our comes from a legal, non-psychoactive, and NON-scheduled plants. You have no product even approved yet. You can by CBD from hemp on Walmart and have it shipped anywhere in the US….overnight…for $27. So you give us a good laugh when, and if, your Epocalypse product is ever released….and let us know what you’re selling YOUR product for. We never get enough good belly-laughs down on the farm.

    • SteveSarich

      What GW Pharmaceuticals’ problem is, is that they are extracting their CBD from Marijuana, and then it’s fractionated to remove all THC. Now their product is going to end up as a scheduled drug….cause it’s derived from marijuana not hemp. The hemp people should have a field day. The Federal courts have already ruled that the DEA has not power over hemp, or ANY of its components….INCLUDING the naturally occurring trace amounts of THC. So GW should have just purchased the CBD from the hemp industry instead of trying to harm the hemp industry….because we fight back!

  • Jimmy Harris

    Will never buy any Big Pharma products. http://deltacbd.com is a small company where i have been getting my CBD products for over a year. I will continue to use this company regardless of what any Big Pharma company does. Power to the People!!

  • James Radina

    http://www.BioCBDplus.com has been shipping Hemp Derived Whole Plant, Water Soluble CBD products for 2+ years, with over 40 pages of testimonials. I sure hope that the people that really benefit from Whole Plant CBD are not taken from what they rely on for so many different reasons… with the number one thing, is getting off Pharma Drugs, so why would they want to get back on one?

  • UDEM

    Well, I guess I should have read the whole article, but I didn’t. I stop at the point where the writer said…GW would have a Monopoly! NOT! MJNA has leased the CBD patient from the US Government and have secured a “court” okay to distribute products in each of the 50 states, including…Mexico, Brazil, Puerto Rico, and soon Japan. Maybe the writer need to go back to the drawing board the knowledge that someone else has the patient…NOT GW!

  • SteveSarich

    In Kentucky they’re trying the same thing and the lobbyist there is long time politician, turned lobbyist, Bob Baddage….. CoSponsor is the name of his lobbying organization…I hope to kill that language….that has nothing to do with hemp.

    They are pushing another on in West Virginia, and I’ll know who the lobbyist is on that one tomorrow and I’m going to write a striker for that
    bill.

    The reason the pharma lobbyist in Washington has little to do is because Joy Beckerman seems to be do their actually lobbying here and she’s managed to stop Washington Hemp growers from growing or producing CBD. Joy works for the Hemp Industries Association. She has stated (yesteday) that she will attempt to kill my bill that will remove hemp from the State CSA! Why would a hemp industry representative try to kill the best hemp bill in the country? It’s already passed the State House….unanimously….and moves to the Senate this Thursday.

    Steve Sarich
    Washington State Hemp Commission
    HempCommission@gmail.com

  • There was an amendment that was put forward on a bill last week in Washington State I am helping out on, House Bill 1060. It’s a bill to allow sick kids to use medical cannabis in schools. This amendment would have made it so only FDA approved products would be allowed. The amendment was defeated and the bill was passed by the House of Representatives.

    The failed amendment was put forward by Rep. Brad Klippert…
    http://lawfilesext.leg.wa.gov/biennium/2017-18/Pdf/Amendments/House/1060-S%20AMH%20KLIP%20BLAC%20046.pdf

  • Rothers Langley

    The need for a good affordable priced product: the coo-op farmer’s choice of words would/could be non associated a penned solution) someplace

  • As is often the case with Mr. Sarich, his comments below regarding the Hemp Industries Association, WA HB 2064, and me are deliberately false and defamatory, and swiftly refuted by the public Legislative Record. I voted and testified on behalf of HB 2064 to remove industrial hemp from the Washington State Uniform Controlled Substances Act, as reflected on video and here at the bottom of Page 3: http://lawfilesext.leg.wa.gov/biennium/2017-18/Pdf/Bill%20Reports/House/2064%20HBR%20COG%2017.pdf.

    It should also be noted that there is no such thing as the Washington State Hemp Commission ~ please be aware of fraudulent entities and con artists masquerading as experts or authorities.

    Finally, the Hemp Industries Association, as is its historical practice, filed suit against the DEA in the 9th Circuit Court of Appeals on 1/13/17, the day the DEA’s Final Rule on Marijuana Extract went into effect because the legislative intent of Section 7606 of the Agricultural Act of 2014 was to allow for hemp botanical extracts and the DEA is abusing its authority in its interpretation of that federal law. We are awaiting that Ruling as of today (1/4/18).

    Joy Beckerman
    Principal, Hemp Ace International
    Vice President, Hemp Industries Association
    National Board of Directors, NORML
    http://www.HempAce.com