Posts Tagged ‘AGL’

Connecticut Recruiting Medical Marijuana Doctors

July 11th, 2015

State trying to recruit more medical marijuana doctors

By Ken Dixon
Connecticut Post
June 21, 2015 | PDF

With only a small fraction of the state’s doctors participating in Connecticut’s medical marijuana program, the agency that’s running it has begun a public-service blitz.

medical marijuana strains at Advanced Grow Labs in West Haven, Conn.

Photo: Brian A. Pounds / Hearst Connecticut Media Head production manager Dain Colandro takes cutting of new medical marijuana strains at Advanced Grow Labs in West Haven, Conn. on Wednesday, June 10, 2015.

The goal is to break through the stigma and lack of information that seems to be holding doctors back from registering, which they need to do to be able to prescribe the drug.

The state is reaching out to the 7,000 doctors in the Connecticut State Medical Society, with radio and print ads highlighting the medical benefits of marijuana, and showing that edibles and oils are steadily taking the place of smoking the plant’s flowers.

With only 222 doctors participating, the program is still double the size it was last October, when the first of the state’s six dispensaries began to supply marijuana from the four producers. It’s a sign of steady progress, said Department of Consumer Protection Commissioner Jonathan Harris.

“It will be interesting to see what our outreach efforts to the physicians are,” Harris said. “It’s a private sector model and it should be driven by the businesses, patients and doctors on the ground. It’s a unique position as a regulator to clear up the misinformation, tear down some of the barriers and give people some comfort that they’re not going to get into any kind of trouble if they participate.”

The radio spots are appearing on Hartford-area public radio.

Harris has been making speaking appearances throughout the state to get the word out on the 2012 law. “We want to make people better-informed when and how to participate.”

Fear of prosecution

Ken Ferrucci, senior vice president of policy and governmental affairs for the Connecticut State Medical Society, admits the organization has been cautious and didn’t have an official reaction to the outreach by the Department of Consumer Protection.

“We’ve been consistent in our position,” he said. “We did not support the bill originally and once it passed and became statute, we wanted to make certain physicians were free to participate without prosecution. The longer the program is in existence, the more willing physicians will participate, providing there is no legal action or enforcement. We have been supportive of education opportunities when we have been asked to provide medical information. We have circulated and do not try to prevent anyone from being educated on whether or not want to certify patients for the program.”

Medical marijuana is still illegal under federal law, but the U.S. Justice Department has said it will not prosecute those who are complying with the laws in their state.

Harris said the longer the federal government leaves the medical-marijuana program alone, the more patients and doctors will feel comfortable enough to join. In the 2012 legislation, when the Connecticut General Assembly agreed to change marijuana’s status from a dangerous Schedule I drug, with no medical benefits, to Schedule II, it challenged federal policy.

Expanding access

The agency plans for as many as three more dispensaries, particularly in lower Fairfield County and New Haven County, where half the state’s medical cannabis patients live. There are no dispensaries in New Haven County and the only one in Fairfield County is in Bethel, an hour-long drive from Greenwich.

A regional organization of pro-marijuana physicians called Canna Care Docs has opened an office in Hartford, with plans, according to its website, to open clinics Fairfield County and between New Haven and New London along Interstate 95.

“Depending on what the feds ultimately do, then you’ll have the lid totally take off,” Harris said, who’s optimistic about further growth. “It’s a medical model and we’re hearing more on the ground on the innovations in dose-able forms.”

David Lipton, the founder and CEO of Advanced Grow Labs in West Haven, is surprised that oils and edibles seem to be taking over the market, but he can understand why pharmacists in the dispensaries find it easier to suggest dosage amounts.

“You know that if you eat a cookie with 20 milligrams of THC, it’s easier and more exact to medicate yourself rather than buying a flower with 25 percent THC and smoking it,” Lipton said, noting a change in the kinds of products the dispensaries are asking for. “I believe that as more and more doctors are made aware that when they’re recommending this their patients getting something formulated, they’ll feel assured they’re getting the right amount of medicine.”

Products from Advanced Grow Labs and the other three growers have a variety of forms and potencies, including various balances in the psychoactive ingredient THC and other compounds called CBDs, which have been found to lessen the effect of seizures, among other benefits.

Angela D’Amico, co-founder of D&B Wellness, the Bethel dispensary, said she expected oils and edibles to come to the forefront, after 10 years of contact and experience with medical cannabis dispensaries and patients in California.

“Since we’ve gotten in the concentrated cannabis oil, with one-to-one ratios between THC and CBD, the oils have come to the top of our largest use,” D’Amico said. “People are getting away from smoking loose flowers. They’re using oils for e-cigarettes and concentrated cannabis oil delivered in syringes sublingually.”

There are 11 ailments for which patients may be certified for use of medical cannabis and six more have been authorized for inclusion and are currently being reviewed for submission to the legislative Regulation Review Committee.

Smoke and oil

Brian Tomasulo, 34, of Newtown, said that when his personal physician certified him last year, the only product available at the D&B Wellness Center was traditional marijuana flowers for smoking.

“Basically, as they brought out more products, the pharmacist suggested more direction,” he said.

Diagnosed two years ago with testicular cancer that spread to his lymphatic system and lungs, after six months of chemotherapy and remission the cancer spread to his brain, causing seizures. He’s back works part-time as a personal trainer.

Now, he mostly uses oils that he puts under his tongue, sublingually, for headaches, although he occasionally smokes cannabis for faster relief from pain including joint soreness. He uses strains of oil that have higher CBD levels in the morning and a higher THC percentage at night.

“My brain had been so inflamed, I had a hard time speaking,” Tomasulo said. “I’m more clear-headed now.”

 

The Brookings Institute – 420 Series of Articles – A Visit to Advanced Grow Labs

April 25th, 2015

| SERIES: 4/20 series

420 Series - Medical Marijuana in CTDuring my recent trip to study Connecticut’s medical marijuana system, I wanted to see its regulatory apparatus in action. I had studied Connecticut’s medical marijuana policies from afar, and wanted to get a better handle on how regulations impact the day-to-day operation of the system. I’m not a medical marijuana patient nor am I a Connecticut resident.  So, I could not experience the regulations from the consumer perspective, and opted instead to see marijuana regulations from the perspective of a marijuana producer.

Advanced Grow Labs dispensary

Photo credit: John Hudak

I visited one such producer, Advanced Grow Labs (AGL) in West Haven, CT. Ironically located up the street from the city’s police department, AGL is quite unassuming, but the impact of state marijuana regulations were readily apparent. In fact, the regulations were obvious prior to my visit. Because I am not an employee of AGL, the company needed prior approval from the Department of Consumer Protection (DCP) in order for me to visit.

The company’s sign is small—the state regulates the size of the sign for dispensaries and the production facility sign fits those parameters. Security—a topic the state prefers the details of which not be discussed in detail—was substantial including security staff, buzz and keycard systems, and blanket video surveillance—all to keep safe a type of facility and product which raises fears of external and internal theft.

Once inside—save a dull scent of cultivating marijuana—the company looked like any other business: a conference room, offices for senior staff, cubicles for junior staff. While largely unremarkable, that is a story rarely told about the cannabis enterprises—just how normal they look and function. With the exception of the facility holding substantial amounts of a product that is illegal under the Controlled Substances Act, it looks like any other business.

I first met with David Lipton, managing partner of AGL. He’s a businessman as mainstream as the look of his office space. He’s not a lifelong marijuana advocate. He was not drawn to the business by some ideological force. He saw a business opportunity and pursued it.

One of the few individuals in the state of Connecticut who is legally allowed to grow marijuana, his original success comes from owning outpatient surgical facilities—some of which offer abortion services. Lipton is certainly no stranger to regulation or controversial public policy.

From the start, I was curious to hear an owner’s perspective of running a business in one of the most tightly regulated product markets in the United States. To my surprise, Lipton was bullish about the system. He freely admitted that it took time, expertise and patience to get acquainted with all the rules and regulations that would govern his new enterprise, but noted “it’s a great program and a great model.” He went on to add that he “believe(s) in a highly regulated environment” for the medical marijuana market and that everyone participating “needs to have their A-game.”

Business owners often lament the burden—and added costs—that government regulation puts upon their enterprises, and Lipton was not shy to admit regulation slowed processes and added costs. However, he echoed an appreciation that the rules sought to advance legitimate goals. Those goals include limiting diversion and underage consumption, increasing product quality and safety, and protecting patients.

The conversation covered substantial ground around the topic of the interaction of regulation and business—normally a dry topic but one central to an enterprise’s success or failure. Two topics struck me with particular interest.

Escrow Requirements

Lipton discussed the startup costs for a grow facility. Under state laws and regulations, a company must deposit $2 million dollars in an escrow account in order to qualify for consideration as an operation. An enterprise must pay steep application and licensure fees. They include a non-refundable $25,000 application fee, and if approved, an additional $75,000 fee. Lipton described the escrow account and other provisions as a “safeguard,” but also noted it creates barriers for “mom and pop businesses” to enter the market.

In reality, those barriers to entry are profound, limiting the market to well-financed operations. Lipton went on to note those costs were incurred entirely separately from a business’ standard startup costs—construction, personnel, supplies, utilities, etc. It makes opening a marijuana enterprise in Connecticut a cost-intensive effort, requiring substantial capital and typically relying on teams of investors to buy in (unless they have “M.D.” after their name, as physicians are barred from having financial interest in a marijuana enterprise).

It should be noted, for anyone reading this post, if you’ve organized a few million dollars and are ready to put skin in the medical marijuana game in Connecticut, think again. The state has set caps on the number of growers and dispensaries in the state, and those current caps have been met and are holding firm. Thus, a small community of businesses—four grow operations and six dispensaries—serve a relatively small consumer market—3,635 registered patients.

Pre-clearance regulatory compliance

In order for AGL—or any marijuana producer in Connecticut—to bring new or original products to market (make them available to dispensaries), they endure a rigorous, costly, and time-consuming pre-clearance process. Lipton explained this process with regard to new strains of flower, extracts/oils, edibles or any other new product they produce. Before it can be sold, a certified, external testing company must visit the producer, take random samples of the product and subsequently test it for chemical composition and concentration (THC and CBD levels) and for pollutants, toxins, or other contaminants. Once that testing takes place and if the product meets the necessary standards, the lab issues a certificate of analysis. The company then transmits that certificate of analysis, a proposed label, a description of the product, photographs of the product and its packaging, and other necessary administrative materials to the Department of Consumer Protection (DCP). DCP can deny, approve, or require changes. The latter often leading to a back and forth process between the state and the firm. Final approval is required prior to transfer to a marijuana dispensary for sale.

The process provides the state, the producer, and the consumer relevant information about the product and assists in dosing. However, such a process draws into stark contrast competing pressures in the regulatory system around medical marijuana.

There are clear benefits to such a rigorous process in terms of product quality, product safety, consumer knowledge, and labeling accuracy. The pre-clearance for products helps prevent errors, rather than relying on a regulatory system that simply responds to errors.

Yet, there are costs to this type of system. Lipton explained that there are financial costs for lab testing and personnel time devoted to such compliance efforts, and such costs are naturally passed along to the consumer at the point of sale. In addition, fixed costs for such regulatory pre-clearance can encourage production of larger batches of product, rather than small-batch production. Small-batch production has increasing appeal in an industry working to distinguish products in a competitive marketplace. Finally, because only new products are subject to this process (the production of existing, tested, and approved products do not), such pre-clearance can stifle entrepreneurial innovation by incentivizing firms to rely on pre-approved products in lieu of new development. Regardless, the state and marijuana enterprises weigh such costs and benefits each day, as Connecticut medical marijuana market gets off the ground.

The discussion of regulatory compliance was an interesting one, but my experience with regulations did not end there. Soon, my tour of the grow facility began. Before it did, however, a costume change was required. Like on any research endeavor, I arrived at the facility in business apparel, but wearing those clothes on the tour violated state regulations. Soon I was in pocket-less hospital scrubs, rubber shoes, and a hairnet. The lack of pockets prevents diversion; the rubber shoes avoid slippage; the hairnet was required because I would enter the commercial kitchen in which edibles were produced (more on Connecticut’s edibles will come in a post tomorrow).

Video cameras littered the facility to ensure that every cubic inch of space was captured on film. Every room in which marijuana product was kept had a clearly marked sign and required an employee to use a keycard to access. As a visitor, I could not be left alone in the space.

As I was introduced to AGL’s staffers—many of who were young and seemingly eager employees (a team Lipton praised even behind closed doors)—those who handled product wore gloves. If they shook my hand, the gloves were replaced, as many of the spaces were as sterile and maintained as clinical settings. Entering a grow room, an employee who was tending the plants explained in detail the state ban on pesticides and other chemicals in grow rooms.

As the tour proceeded, it seemed every aspect of the business was regulated—some major and some minor. I asked frequently about different aspects of business practice, and almost every time the justification or explanation for that practice was compliance. Having read the authorizing legislation and subsequent DCP regulations, I knew that Connecticut’s medical marijuana regulatory apparatus was substantial, but it is not until you experience it in person that you understand its breadth.

That is not to critique this system. Many of the problems other states have experienced in areas like product quality, diversion, potency, dosing, and edibles have not yet cropped up in Connecticut. While the system is quite young, one would expect front-end problems to be more likely than problems arising in a mature system. Much of that may be due to the regulatory decisions—however pervasive—that the DCP has made. In fact, the very pervasive nature of the regulatory system may be its strength.

For perspective, I asked Lipton if he traveled to other states to see what their practices were like and if much could be learned—particularly for someone who asserted having no prior knowledge on marijuana cultivation. He said that he traveled and observed what he called “western models” and that he knew his business had to be dramatically different because such practices “wouldn’t pass muster in Connecticut under (its) regulations.”

From the outside looking in, it takes quite a bit to pass muster in Connecticut, but four marijuana producers and six dispensaries do so on a daily basis. I would argue it is an open, long-term question whether the Connecticut system can displace the illegal market and drive patients to use legal means to access marijuana. However, in the mean time, Connecticut’s marijuana producers operate under an immensely structured set of rules and regulations, and they’re still able to do what’s fundamentally necessary for an indoor marijuana grow operation: keep the lights on.

Medical Marijuana: More Patients, More Products, Low Profile

May 2nd, 2014

By Kenneth R. Gosselin
Hartford Courant
April 19, 2015 | electronic

Susan Gilchrist once took nine different medications to ease the chronic pain and fatigue of her multiple sclerosis.

Gilchrist, 32, is now off all those drugs, finding more relief, she says, than she has in more than a decade, now that she uses just one alternative drug: medical marijuana.

“I disassembled my shower chair, my cane is in the garage and my walker is in the basement storage,” Gilchrist said. “I can wake up and get out of bed. I don’t have to lay there for any amount of time for pills to kick in.”

Halfway through its first year, the state’s medical marijuana program has about 3,600 registered Connecticut residents, more than doubling from last fall — but still far below 20,000, by one manufacturer’s estimate, who could be served by existing medical marijuana manufacturers and dispensaries.

Manufacturers are shipping a growing number of products to dispensaries. The list started with what could be smoked but has expanded into oils for vaporizers, tinctures, strips that dissolve under the tongue and “edibles” such as cookies and cupcakes.

 Medical marijuana has been legal in Connecticut for six months. Courant photographer Mark Mirko got a behind-the-scenes look at where the marijuana is grown and produced, as well as how one patient uses the drug.

Medical marijuana has been legal in Connecticut for six months. Courant photographer Mark Mirko got a behind-the-scenes look at where the marijuana is grown and produced, as well as how one patient uses the drug. (Mark Mirko)

The state may add more conditions that can be treated by medical marijuana, and it already has eased its restrictions on raw buds. Buds up to the size of a dime can now be sold, a change in the initial requirement that they be ground up to ensure consistency.

The program still remains relatively low-profile, however. Doctors generally remain hesitant to recommend treatment to patients without more research.

In Tolland, Gilchrist — the mother of two teenagers — never thought she would become an advocate for medical marijuana. She didn’t smoke for fun, not liking the feeling. For months, Gilchrist resisted the urging of her husband, Colin, that she try medical marijuana.

“I gave in and finally tried it, and I found that I can relieve 90 percent of my symptoms with just marijuana,” Gilchrist said. “I started slow and increased every day. After a couple of months, I felt less high and just well.”

Gilchrist hasn’t spoken publicly until now about her use of medical marijuana. Gilchrist said she is well aware of criticism that patients taking medical marijuana are using their illness just to get high. Even within a Facebook community of MS sufferers with 18,000 members nationwide, Gilchrist said, there is a sharp divide on its use.

The National Multiple Sclerosis Society says it supports MS sufferers working with doctors to potentially use medical marijuana, where legal. Some MS patients have reported relief from their symptoms and research suggests that marijuana has the potential to manage the symptoms of MS, the society says.

“Additional research is needed and should be initiated to better determine the possible role [marijuana] could have in treating MS symptoms and helping people with MS to live their best lives,” according to a policy position statement provided by the society.

The society also is supporting clinical trials of different forms of marijuana products to test success in treating chronic muscle stiffness.

Gilchrist said she knows medical marijuana isn’t a cure. But the pain and muscle stiffness that had confined her to bed for days — sometimes months at a time — is receding into memory.

“This program has changed my life,” Gilchrist said. “The more people that know, I feel like we can change things, and that is my hope.”

Feeling better has encouraged Gilchrist to take better care of herself. She quit cigarettes and now has a healthier diet. She no longer struggles with prescription drug side effects that were sometimes worse than the ailments they treated. She said that often she could not take care of her home, her family or even walk the dog.

Gilchrist has been unable to work for eight years, but she is now considering going back to school to pursue a career in massage therapy.

“She’s a mom again,” Colin Gilchrist said. “She’s a wife again. She’s not just a patient.”

Inside The Grow Rooms

Sixty miles to the south of Gilchrist’s home, in West Haven, Advanced Grow Labs LLC, one of the state’s four medical marijuana manufacturers, is now shipping orders twice a week.

During a recent tour of the operation, managing partner David Lipton stressed that production meets the standards of a traditional pharmaceutical company within a complex framework of state regulation.

“Even though it is starting out as a plant, the end product is pharmaceutical,” Lipton said. “It’s tested, there are certification and analysis reports.”

The growing rooms — each focusing on a different stage of the plant’s life — hum with the sound of dozens of fans. Keeping air circulating guards against outbreaks of molds and other diseases that could wipe out a crop.

Lights in one room mimic the late summer sun and force plants to produce buds. Utilities in each of the four growing rooms alone cost $5,000 a month to operate — an example, Lipton said, of what makes medical marijuana manufacturing so expensive.

Advanced Grow Labs could produce 250 pounds of marijuana buds a month, Lipton estimates. But consumer demand in Connecticut is not even close to making those levels necessary.

Lipton walked alongside benches where dozens of marijuana plants are maturing in pots, a process that takes about 4 months. Lipton says you can tell when buds are ready to be harvested because hair-like “trichomes” on the bud containing the plant’s active ingredients — THC being the most well known — will begin to turn an amber color.

He stops at one plant. “Smell this,” he said. “It’s a very earthy plant. We sell a lot of this. It’s called ‘Tangerine.’ It has a smell that’s lemony.”

Lipton pulled a loupe out of his pocket and looked through it, peering at the plant’s trichomes.

“Ah,” he said, “this one is getting ambery.”

Oils, Drops, Edibles

Advanced Grow Labs is aggressively pursuing the development of different products, well beyond what is smoked.

“We’re now making a honey,” Lipton said. “You take a teaspoon of honey and add it to your tea and you have your medicine. And we’re doing a hazelnut chocolate spread. Some people don’t want to smoke. These are other options.”

In South Windsor, Prime Wellness of Connecticut — one of the state’s six dispensaries — opened last fall with product offerings that barely filled a page. Today, there are five pages with not only what is smoked but oils, waxes, drops and edibles.

Consumer traffic at the dispensary got a lift after the state allowed dime-sized buds to be sold in Connecticut, said Brett Sicklick, the dispensary’s director of operations.

The products offered are wide-ranging, Sicklick said, some with little to no psychoactive effects, the “high” typically associated with marijuana use.

Prime Wellness now has 450 registered patients, more than double the 200 or so when the dispensary opened last fall. The dispensary’s goal for the first year is 800 patients, he said.

“The reality is, I don’t believe anyone in this program is meeting their necessary number to break even on a monthly basis, suppliers and dispensaries,” Sicklick said. “We all knew it wasn’t going to get into the black quickly, so we planned accordingly.”

Sicklick added: “There’s definitely still a ways to go, but we are getting new patients registered every week.”

Prices Drop Slightly

A nagging worry from the outset was the price of medical marijuana compared with the cost of buying it on the street.

The tightly regulated industry, including sophisticated security and testing, pushes up costs for both manufacturers and dispensaries.

The state’s goal was to provide better, consistent quality products in a competitive environment that would eventually drive down prices.

The website priceofweed.com, which compiles user-reported entries anonymously for marijuana purchased on the street, gives an average current range of $266 to $334 an ounce in Connecticut, depending on quality. Based on 28 grams in an ounce, that would be roughly $9.50 to $12 a gram.

Sicklick said some medical marijuana prices are starting to move lower. For instance, one, 3.5-gram dried bud product initially sold for $64, or about $18 a gram. The price is now $50, or about $14 a gram. The earlier price included sales tax, but the most recent doesn’t — sales tax was eliminated on medical marijuana, Sicklick said, as of April 1.

Susan Gilchrist, the medical marijuana user in Tolland, said she is paying between $14 and $20 a gram for her medical marijuana.

Gilchrist said estimates that she is paying double at her dispensary compared to what is paid on the street. But it is worth it to her because the quality is consistent. Trouble is, insurance doesn’t cover her roughly $400-a-month costs for medical marijuana.

“I could get any other medicine covered, but not this one,” Gilchrist said. “So it’s hard to budget. Prices are coming down. But it is going to be slow.”

200 Doctors Sign On

When the state legislature legalized medical marijuana in 2012, it ended a wide-ranging sale ban in Connecticut that dated back more than 80 years.

Culturally, there is still resistance to medical marijuana, and some towns — the latest being Harwinton — continue to oppose medical marijuana outlets within their borders.

Jonathan Harris, commissioner of the state Department of Consumer Protection, said his agency is working to ease any stigma attached to medical marijuana and to convey that it is legal in Connecticut. The department also is emphasizing that the industry is heavily regulated, just like any other pharmaceutical drug.

“We’re not Colorado. We’re not some of the western states,” Harris said. “This is not about recreational use, but medicine giving people relief.”

Harris said his department also is out talking to physicians and in the next two months will launch public service announcements online targeted at doctors.

Initially, 11 medical conditions qualifying for medical marijuana were approved: glaucoma, post-traumatic stress disorder, cancer, HIV or AIDS, Parkinson’s disease, multiple sclerosis, damage to the nervous tissue in the spinal cord or intractable spasticity, epilepsy, cachexia, wasting syndrome and Crohn’s disease.

More may be added, including sickle cell disease, severe psoriasis and psoriatic arthritis and recurring back pain after surgery. Also, lawmakers may pass legislation to permit medical marijuana to be used by patients under the age of 18.

Doctors, who must register with the state to certify that patients qualify for medical marijuana, generally remain reticent. Only a sliver of Connecticut doctors — about 200 of the 10,000 practicing in the state — have registered.

The overriding concern, one doctors’ group says, is the lack of research.

“There isn’t any scientific basis that medical marijuana has the identified benefit for treatment of those conditions, or that it is more effective than what is now being prescribed,” said Matthew Katz, chief executive of the Connecticut State Medical Society, which has 6,000 members.

The legislature is considering funding studies. Dispensaries are collecting data to determine what works best for which conditions.

And even though medical marijuana has made a tremendous difference in her life, Gilchrist still worries about public perceptions.

Gilchrist doesn’t use her medical marijuana if her children’s friends are coming over, and she stores it in a combination safe in her bedroom.

“People are still on the fence about it,” she said. “Some people are still very much against it. It’s hard having kids. You don’t know what the other parents are going to think.”