Israel Getting Syqed

Israel Getting Syqed

Several new developments come to light in this story from the Times of Israel, notably the entrance onto the Cannabis stage of a major cigarette maker.  The byline says Shoshanna Solomon but the piece reads like a press release from Teva. Not until the literal bottom line do we get the figurative bottom line: Philip Morris is a key backer of the Syqe inhaler.  O’Shaughnessy’s would have put that in the lede. I guess we just did. —FG

Israel’s Teva Pharmaceutical Industries Ltd. and Tel Aviv-based Syqe Medical said they signed a distribution and cooperation agreement to market medical cannabis in an inhaler.

Under the agreement, Teva will be the exclusive marketer and distributor in Israel of an inhaler developed by Syqe Medical for the delivery of medical cannabis. The accord marks the first time that a major global pharma company has agreed to market a medical cannabis product, according to Syqe.

 The Syqe inhaler has been used for more than a year at Haifa’s Rambam Hospital with the approval of the Health Ministry. This makes it the first hospital in the world to prescribe cannabis as a standard medical treatment.

As part of the agreement with Teva Israel, the Syqe inhaler is expected to receive Health Ministry approval for home use by next year.

Israel’s reputation as a high-tech hub and a lax regulatory environment has allowed the startup nation to become a leader in cannabis technology, with dozens of local firms focusing on the medical field.The international medical cannabis market is forecast to be worth approximately $20 billion within a decade. About 1% of the global population are potential medical cannabis users at some point during their lifetime.

As Huff wrote in “How to Lie With Statistics,” there’s nothing like a specific number —1% in this instance— to imply that real data supports an assertion that the author may have pulled out of his or her tuchus.  It doesn’t take data, only simple logic, to recognize that 100% of the global population are potential cannabis users at some point during their lifetime.

“Teva Israel is entering the field of medical cannabis out of a deep commitment to patients coping with pain, which is one of the company’s core therapeutic areas,” said Teva Israel CEO Avinoam Sapir, who also serves as Teva’s director for Africa and the Middle East, and as director of Innovation in Emerging Markets. “State-of-the-art technology and groundbreaking medical devices — such as those developed by Syqe Medical, and which generate tremendous therapeutic value for patients and medical staff alike — integrate perfectly into the strategy of Teva Israel.”

The accord aligns with Teva Israel’s strategy of investing in, or partnering with, local startups and groundbreaking Israeli initiatives to enable it access to innovative technologies and advanced medical devices, he said.

Precision doses

Syqe Medical, a developer of technologies for the pharmaceutical delivery of raw plants by inhalation, says it has developed the world’s first inhaler that enables the precise delivery of botanicals at the level of safety and precision of conventional drugs.

Medical cannabis is the first plant to be used in the inhaler. The company has completed clinical trials, which demonstrated the inhaler’s precision and compliance with pharmaceutical standards for the delivery of inhaled cannabis. Syqe Medical’s technology only modifies the physical structure of the plant, preserving all its characteristics and enabling safe, precise and measurable delivery by inhalation, Teva and Syqe said in a joint statement.

Until now, the quantities of active ingredients inhaled from cannabis have generally been unknown. In the absence of precise dosing, cannabis could not be prescribed as a standard medical treatment, causing difficulties for patients and the physicians who treat them.

“Precise dosing” and  monomolecular medicine go together like a horse and carriage.

The inhaler will allow medical professionals to prescribe an optimal dose of cannabis, alleviating the patient’s symptoms while minimizing the psychoactive effects. Another advantage of the inhaler is that it is a convenient  forpatients who are reluctant to smoke cannabis.

Syqe Medical chairman Dr. Eytan Hyam, former director-general of the Health Ministry, said the deal with Teva represents an “unprecedented development” for patients who need medical cannabis.

“Thanks to the Syqe inhaler, we are effectively moving from cannabis use to cannabis treatment. For doctors, the inhaler solves the problem of prescribing plants for smoking, and offers a solution for patients in that, for the first time, they will be able to receive a precise dose of medical cannabis,” he said

According to data provided by the companies, for 2016 there are about 26,000 patients licensed to use medical cannabis in Israel, some 90 percent of whom smoke it. The number of licenses is expected to double by 2018.

“The extent of medical cannabis use for the treatment of pain and other symptoms has increased significantly in recent years,” Prof. Elon Eisenberg, director of the Pain Research Department at Rambam Medical Center, said. “The main problem facing doctors and researchers is the inability to estimate the amount of cannabis that is administered via smoking or vaporization. The ability to do so forms the basis for administering proper treatment and conducting significant scientific research. The development of this inhaler fulfills our greatest hopes, to be able to administer accurate and reliable doses of cannabis. It constitutes a breakthrough in cannabis treatment and the medical use of cannabis in Israel and around the world.”

According to the terms of the strategic cooperation with Teva, Syqe Medical will be responsible for manufacturing the inhaler and disposable cartridges. They will be marketed and distributed by Teva Israel to relevant parties, including doctors, nurses, hospitals, pain clinics, oncology clinics and pharmacies. The Syqe inhaler is intended for patients suffering a variety of illnesses, based on indications approved by the Health Ministry.

Teva Israel and Syqe Medical are also setting up a support and training system for patients and medical professionals, consisting of a team of nurses to be established especially for this purpose.

To date Syqe has raised $33 million, including $20 million from Philip Morris International, according to data provided by the company.

While We’re in the Hood…

Sent by Zach Klein on the interplay of “medical use” and “legalization” in Israel —a blog post by Alan Flashman, MD:

Many cannabis activists in Israel saw the development of Medical Cannabis as a first step to legalization. With regards to the public mind, they were probably right. The public tends to give credence to medical usage and over the past few years has become used to the idea that while people use cannabis as a medication, it seems not to do any harm. This has contributed to the weakening of the popular demonization of cannabis created by the now largely discredited “War on Drugs.”

But “The times they be a’ changin’.” With the recent announcement by Israeli multinational pharmaceutical firm Teva of its entrance into the huge cannabis market, it looks like it may be time to take step up from changing the public mind (done that) to taking on the political morass called the State of Israel. What I am proposing is that strategists for legalization will find themselves out-maneuvered by the Master himself, with Medical Cannabis being manipulated by the State to prevent legalization.

Let me first introduce the reader to IMCA, The Israeli Medical Cannabis Authority. This Unit runs under the Ministry of Health. It was started and originally run something like a one-man-show by a psychiatrist. More recently there is a Medical Director who is a family doctor on the edge of retirement and a CEO who formally calls himself by the title “Magister” (that means he has a master’s degree and needs for you to know it). IMCA makes a great deal of noise, especially abroad, where the two directors seem to travel a lot to tell the rest of the world how to run a medical cannabis unit. Meanwhile back at home, these two operatives are subject to an unending stream of complaints by their “patients.”

Let me explain how this ingenious system works; it will not be hard to understand the complaints.A patient needs to be referred to IMCA by a specialist. There are practically no specialists in the HMOs who will do this, so the patient is forced to apply privately and pay the rather hefty specialist fee. Sometimes an HMO with provide some return, only if the specialist is on the HMO’s list of non-HMO Specialists. [Another Israeli invention with allusions to the Godfather, but we will leave it to another Blog.] The specialist goes on line and tries to figure his way through an online application with so many bugs and inappropriate menus that I know of many specialists who will not go near it. And that is the new improved version.

Some have called me and I spend hours guiding them when to choose the wrong menu item and then cross it out by hand. The specialist has absolutely no discretion, his application has to conform to “guidelines” created by IMCA with help of top-secret specialists. These guidelines require the patient to have already failed on at least several conventional medications, and they must provide proof that they have purchased and paid for these medications, with a form that almost no family gatekeeper in Israel has ever heard of. Here are, for example, the guidelines for Post Traumatic Stress Disorder, the only approved psychiatric “indication” – this means if you don’t have PTSD, a psychiatrist cannot refer you, even if you are self-treating and know that cannabis is helpful and does no harm:

  •         You have to suffer from PTSD for 3 years
  •         You have to have 30% disability
  •         You have to have tried [and paid for] two medications
  •         You have to have tried two psychotherapies
  •         You cannot have suffered psychosis or have any first degree relatives with psychosis

At the First Israeli International Conference on Medical Cannabis a few months back I pointed out the glaring deficiencies of these “guidelines,” but common sense should suffice here. Just one example, a single young man from abroad volunteered in the IDF during the last war (“Hard Edge”). He was traumatized and requested referral. He had experience with cannabis and knew it would do no harm. Despite my attempts and appeals, we could not overcome the fact that he was not sick long enough, not disabled enough (yet) and not yet failed in four treatments.

Let’s say we have gotten through the form and the guidelines. Next step, print the form. No kidding. Print the online form. Sign it, and have the patient sign it. Now fax it. No kidding, fax it. To a fax-to-mail number. [Recently an email address was added as an “improvement” –in 2016!] Now the patient (or the doctor if the patient cannot bear this) is required to call a phone to ask a clerk at IMCA if by any chance the said fax (which is now in the IMCA computer twice, once on line and once as fax to mail or mail) has been received. No kidding. And the answer tends to be “Call back in a week” or “We have no record” or Don’t call) even though it is in the computer. I hope the reader may be starting to suspect that such obvious mismanagement, which would get at least one director fired pronto in any business committed to its proclaimed goal, may not be entirely innocent. Too often the State of Israel hides its covert agendas behind “bureaucratic incompetence” that makes folks laugh, shrug shoulders, and most importantly accept the unacceptable. I myself am only now recovering from such an enervating reaction; this blog is part of my recovery.

Speaking of the unacceptable, I will complete my description, continuing with elements that I have personally witnessed. None of this is fantasy. After calling and re-faxing any number of times  – my personal record is 4 refaxing but clients have had more – IMCA confirms receipt of  the fax. In a few weeks, up to six, the client and the doctor receive a letter saying that the application was rejected.

This letter, like all communications from IMCA that have clinical urgency, are printed and sent snail mail. I kid you not. They have the emails of all parties in at least 3 places in their computer, but snail mail it is. Then the doctor downloads an “Appeal” form, prints it, writes it in longhand (no joke — there no digital appeals) and — you guessed it — faxes the appeal and then seeks confirmation as above until finally the appeal is considered. The appeals used to be reasonably prompt, so the directors “fixed” that and proclaimed that the “panel” (sorry, no information, top secret) is too I don’t know what to convene more often than once a quarter. Quarter? A hint at what the covert considerations could be. Who on earth convenes review panels for desperately ill and disabled people quarterly? Then by snail mail the doctor and patient receive notice of the rejection of the appeal. Rejection? With reasons like the panel does not accept the diagnosis (even though no one competent to overrule the expert who made the request sits on the “appeal panel”), or that the case does not fit the (absurd) strictures of the indication (patient not sick enough etc., did not buy enough medications, etc.)

About half-to two thirds of requests in my experience finally get approved. The license it printed and mailed to — you guessed wrong! — the cannabis grower. And you thought once there is a license, rational treatment begins! How naïve — just like I was a year ago. The grower tells the patient (not the doctor) that his license has arrived. The patient discusses with the grower what brand of cannabis to dispense — the doctor is completely excluded from this conversation with the justification that learning a few dozen names of plants is too much for someone whose only credential is medical school, residency and specialty boards. The growers’ representatives have usually finished high school and have lots of experience with  the plant itself.

A client is started on 20 grams a month, a very small amount enough for maybe ten percent of patients. The doctor has no say regarding the dose, even if the patient knows from experience that 20 grams will last no more than a week or two. A request to increase the dose (another fax and series of calls) is not considered for months, can be allowed only 10 grams at a shot and can never exceed 60 grams a month, even though at least 10 to 20% of patients need more, sometimes substantially more. So if you need 60 grams and get your application in the express lane, start to  finish will take most of a year. Slow lane, two years.

Many well-meaning activists have been fretting and fuming over this circus-like performance for several years. I believe it is time to recognize that the circus has been performing its task brilliantly. And just what might that function be? The current function of IMCA has been to prevent legalization. We activists have been outsmarted by the Master(s). Our energies have been diverted to a useless campaign, and while we thought every “success” in our struggles for rational and responsible medical cannabis would bring legalization closer, this is NOW no longer true.

Allow me to propose how the end result will demonstrate that the government has been using IMCA all along to prevent legalization:

  • Medical cannabis has changed the public mind about cannabis. So far so good.
  • This will allow the public to accept TEVA and Big-Pharma marketing “medications” made from cannabis. Not so good.
  • Big Pharma will be able to operate at their will, changing whatever they want in the plant.
  • The IMCA “circus” has proven that the Health Ministry can act at will regarding cannabis, and the interests of the patients are secondary to other (soon to be discovered as economic) interests.
  • IMCA will now phase out full-plant license in favor of (totally unproven) pharmaceutical derivatives.
  • IMCA  “trained” [indoctrinated] approved physicians (who are required to comply with all the absurd restrictions IMCA now imposes) will start giving licenses, replacing “untrained” experts who have not sworn fealty to IMCA rules.
  • Under the guise of “training,” the likes of which is unknown in any other realm of medicine, IMCA retains absolute control over medical cannabis.
  • The “government” will declare (former Health Minister Yael German made such an absurd declaration about 3 years ago) that anyone needing medical cannabis now has complete access. What this really means is that the only patients recognized by the IMCA rules can be considered to legitimately require medical cannabis. The implication is that anyone else is a drug addict or dealer.
  • The government will then bury legalization, thus making cannabis both a medical agent (but only in its Big Pharma packaging) and a dangerous drug in its natural form.

Impossible? How can the same substance be both medical and dangerous? Let me give you an example from another natural substance regulated in Israel in a uniquely absurd manner, putting economics before citizen welfare.

St. John’s Wort (hypericum perforata) has been recognized world-wide as an effective treatment for anxiety and depression for close to two decades. Google it in the USA – or anywhere on the planet except perhaps Ireland- and you will see that it is over the counter for self-medication, the dosage based on experience, the side effect profile exceptionally innocent. You can order dozens of preparations, including drops suitable for children. This is true for citizens of practically the entire world.

But not for citizens of Israel. Israel’s chief Pharmacist in in charge of food additives removed SJW from the OTC market in 2000, based on a bogus concern about SJW altering liver metabolism of other medications, a concern which the FDA itself shrugged off. People except Israelis seem able to figure this out themselves. For seven years , during the entire second Intifada when perhaps Israel’s entire population could have used it, SJW was unavailable in Israel, Trust me, I had to order it with a special form from a specialist in naturopathy who ordered from Germany and sold it at more than 5 times the price online.

Then, in 2007, the Pharmacist in charge of prescription drugs allowed one drug company, Rafa, to import one form of SJW, a drug called Remotiv, from the Swiss firm Zeller. It is available only with a physician’s prescription. After a year or two this agent was put in the “basket” of subsidized drugs, and now with the subsidy it cost only twice what it should. But it turns out that Remotiv may be only partially effective compared to the dozens of parallel agents, and our Health Ministry limits the maximal dose at a low level and restricts it to children over 11 years of age — all with no evidential basis. Rafa learned from the naturopath that I was somewhat unusual in my use of SJW and they asked me to come to the televised launching for Remotiv. I had what now seems a prophetic reply — “My launching would kill it.” I was thinking of the unfriendly response of my esteemed colleagues here. Little did I know nine years ago that the point of the particular importation was indeed to kill it.

As a result of such shenanigans,SJW is grossly underused in Israel and does not impact of the enormous market of antidepressants.

Get it? This is the fate awaiting “medical cannabis” — government control, over medicalization. If you keep an innocent herb like St. John’s Wort out of the hands of the public, Cannabis is an obvious candidate for exclusive medicalization for economic purposes.

So this blog is an urgent appeal to activists for cannabis legalization in Israel. Stop wasting time bellyaching about IMCA. We have been coopted. Drop everything else and begin immediately a smart internet campaign to convince politicians that opposition to legalization will be punished politically. I suspect you have no more than 3 to 6 months. Once cannabis is medicalized in the Israeli way, legalization will be a dead issue.

I hope I am wrong.  alan-flashman-medium-1But I’m not.


About The Author

Fred Gardner

managing editor, O'Shaughnessy's.