A group of local doctors plans to open a medical marijuana testing facility in Columbia to ensure product quality as the state prepares to launch its burgeoning therapeutic cannabis industry.
Testing is required by state law for cannabis growers, which presented an opportunity for the group of four doctors, led by Dr. Andrew Rosenstein, chief of the division of gastroenterology at University of Maryland St. Joseph Medical Center.
Rosenstein said the doctors were worried about potential threats to some of their sickest patients from contaminants in cannabis that could complicate conditions rather than alleviate pain and other symptoms.
"Some of our cancer patients told us they were using marijuana, and one of my colleagues came to me and said they are legalizing cannabis in the state of Maryland for medical purposes and is there some role for us to play," he said. "If patients are going to be using it, then people like us need to make sure it's safe, pharmaceutical-grade product."
Maryland still is working out the details of what contaminants labs will need to test for, but the regulations will include heavy metals, pesticides and microbes such as E. coli that could harm users. The labs also will test for potency.
The testing regulations could stave off concerns in other states about testing inaccuracies. Health department officials in Washington state said they recently tightened rules, citing a need to "better protect qualifying patients by regulating medical marijuana products."
But other states have grappled with how to set standards for a drug that is still illegal at the federal level and not approved by the U.S. Food and Drug Administration. Many labs have sought to develop their own standards, including Steep Hill Labs Inc., the lab company with which Rosenstein's group of doctors is affiliated.
Based in Berkeley, Calif., Steep Hill has company-owned or affiliated labs in five other states where medical marijuana is legal, and plans to open more. Rosenstein said his group chose to work with this firm largely because of its push for uniform testing.
"With cannabis becoming accepted as medicine and therapy in cancer treatment, epilepsy and for other known medical conditions in over 30 states, bringing the highest medical standards to all aspects of the industry is critical," Jmîchae¿e Keller, Steep Hill's president and CEO, said in a statement.
Keller said Rosenstein's team "will benefit immediately from our extensive knowledge of the cannabis plant and our proprietary testing technology and, as we work together, we will all benefit from the Steep Hill Maryland team's extensive medical knowledge."
Rosenstein said none of the doctors plans on directing patients to use marijuana, but the group — two gastroenterologists and two pathologists — felt they had substantial experience in testing and compliance and that with some business direction they could create a successful cannabis lab. Steep Hill Maryland plans to invest between $600,000 and $1 million for equipment and property.
Others applauded the efforts to rein in business-friendly testing across the country, including Roy Upton, executive director of the American Herbal Pharmacopoeia, which has written what he called the most widely adopted testing standards.
Upton said all states permitting medical marijuana likely will adopt the same testing program eventually, or will develop testing methods that produce such similar outcomes that patients will be able to uniformly rely on products.
"For now, you can still shop results," Upton said. "You don't like the numbers from one lab, go to another. Until there is regulatory will and action taken against companies who aren't following some of the good lab practices or are falsifying findings, it'll still be the Wild West."
Maryland's decision to limit the number of growers will help state regulators keep a handle on quality, Upton said.
Del. Dan K. Morhaim, a physician who championed the legalization of medical marijuana in the General Assembly, said the state had the benefit of learning from other states and has written a number of safety measures into the law. Cannabis plants will be tracked with technology and there will be a robust list of contaminants to screen for. He also expects a push for uniformity in testing.
Researchers also will examine how beneficial medical marijuana is and for whom, which also may affect regulations.
"We thought about all of this from the get-go," Morhaim said. "But we will never be done tweaking the program because there is new science coming along all the time."
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Christopher Garrett, a spokesman for the Maryland Medical Cannabis Commission said it's now considering potential testing labs such as Steep Hill. They won't need licenses like growers and sellers but will need to register. The labs will need to be certified by an independent accreditation group to show they abide by accepted principles for safety and quality, much as how hospitals are certified, he said.
No firms have registered yet, Garrett said. Rosenstein said his group is completing the form and undergoing the accreditation process now.
Rosenstein said all of the partners have known each other for years and include another gastroenterologist from his practice, Dr. Amin Khan, as well as two pathologists, Dr. Charles J. Sailey and Dr. Adnan Khan. The Khans are brothers. Marc Rosenstein, who is Andrew Rosenstein's brother, and another business executive, Phillip Stripling, will help run the business.
They expect to be able to begin testing in about six months, which likely will beat the state's timetable for choosing licenses to grow or sell cannabis. Products are not expected to be available to patients until some time in 2017.
The state commission is reviewing 1,081 applications submitted for licenses related to medical marijuana in Maryland, including 146 for grower licenses, 124 for processor licenses and 811 for dispensary licenses. Only 15 processor and 15 grower licenses are expected to be issued.
Labs such as the local Steep Hill facility will compete for the growers' business.