THE WONDER DRUG

[Chip (OP)]

THE WONDER DRUG

Inside the medical marijuana industry's wild new frontier.

IN THE EARLY hours of a sparkling June morning, I walked into Cook Children’s Medical Center in Fort Worth, Texas, a nationally ranked network of clinics catering to all manner of childhood illnesses. The doors had just opened, and the first patients were trickling in alongside me.

I had come to meet Dr. Angel Hernandez, the director of the hospital’s pediatric epilepsy program. A trail of wall- mounted signs led me to the pediatric neurology ward, a bright and airy space with flat-screen TVs running cartoons nonstop. Decorative kites were strung up in the corridors, and rainbow curtains lined the windows.

Some of the kids in the waiting area that morning were alert and awake, others groggy. Some were strapped into special strollers designed for children with mobility problems, and some had shaven heads and healing scars. Hernandez came out to greet me, and I was surprised he recognized me after what felt like a very long time. He had diagnosed me with epilepsy in 2004 and treated me for several years.

For most people with epilepsy, diagnosis sets off a gauntlet of trial-and-error attempts to find the right medication. The process is tortuous, with seizures alternately dying down and flaring up while side effects— fatigue, nausea, liver damage, and more—develop without warning. This is partly due to the fact that “epilepsy” is actually a broad category that includes a number of distinct seizure disorders.

About 30 medications approved by the U.S. Food and Drug Administration are currently used to treat these conditions, and when a person first begins having seizures, there is often much tinkering with combinations and dosages. I spent years battling side effects like vomiting, dizziness, drowsiness, and severe headaches, which were alleviated only by yet another prescription medication. Parents who endure enough sleepless nights caring for a sick child can become desperate for a cure.

In the past few years, just such a cure has seemingly presented itself. Amid the less common remedies that can be found on the internet—special diets, meditation, biofeedback, surgical implants—a new product has recently gained prominence: CBD oil (sometimes known simply as “hemp oil”), so named for its chief chemical compound, cannabidiol, which occurs naturally in cannabis plants. In online forums and news articles, CBD has been hailed as a new frontier in epilepsy treatment, with parents testifying that it managed to stop their children’s seizures when nothing else could.

Over the past two years, 17 states have passed laws legalizing CBD so that patients can obtain the drug without fear of prosecution from local authorities. For intractable childhood epilepsies—the sorts of seizure disorders that for centuries have ruined lives and shattered families, the ones even specialists like Hernandez dread—CBD could be a miracle cure.

In his office, however, Hernandez was wary of the CBD boom. He advises well-meaning parents to think twice about voyaging into the world of over-the-counter hemp oil treatments, even if their circumstances are dire. “It’s a huge gimmick that a lot of companies are using,” Hernandez said. “You don’t know what you’re getting. ... There’s a major quality problem.”

Indeed, hemp oil products have grown out of a market largely devoid of regulations or safety protocols. The state of the CBD industry harks back to the age of elixirs and potions hawked from covered wagons to the awed denizens of pioneer towns. There are no industrywide standards in place to ensure that CBD oils are consistently formulated batch-to-batch.

There is no regulatory body screening products for pesticides, heavy metals, solvent residues, and other dangerous contaminants. The laboratories that companies contract to test their CBD products are themselves neither standardized nor consistently regulated. No medical research exists to recommend how much CBD a patient should take, nor is there detailed, reliable documentation of how CBD interacts with most epilepsy medications.

Taking CBD oil is like drinking milk and calling it calcium, Hernandez said: There’s some in there, but at very low concentrations dispersed among a host of other ingredients. And what those other ingredients are is anyone’s guess. “The thing to know is that CBD hasn’t gone through the safety controls, the efficacy controls that we usually use, the clinical trials,” Hernandez said. “The jury is still out regarding how safe this drug is.”

In the absence of regulation and research, the CBD industry trafficks in hard-sell marketing and a gray haze of half-truths, all the while profiting off the hopes of the desperate.

HEMP OIL HAS never been as popular as other marijuana products. With little to no THC, CBD-rich strains of cannabis don’t deliver the pleasant buzz recreational users seek out in marijuana. In the 1970s, however, scientists found that cannabidiol was effective in reducing seizures. The brain’s endocannabinoid system contains receptors that respond to CBD, producing anticonvulsant effects. Being plant-derived and native to the brain’s own chemistry, CBD is therefore one of the most natural options for seizure treatment available today. Still, not many people took interest in CBD until 2013, when a CNN documentary special, Weed, hosted by the network’s chief medical correspondent, Dr. Sanjay Gupta, highlighted CBD’s effectiveness in combating seizures. Since then, demand for hemp oil products has exploded.

CBD’s potential usefulness in treating certain conditions is yet another argument in favor of legalizing the entire cannabis plant. Removing cannabis from the federal list of Schedule I narcotics that are illegal under the Controlled Substances Act would allow scientists to research its full medical potential and pharmaceutical companies in the United States to develop marijuana-based drugs and submit them for FDA approval. Government-regulated labs could test products like CBD oil to ensure safety and quality. Doctors could prescribe marijuana- based medicines with full knowledge of potential side effects and drug interactions, and without fear of losing their medical licenses or being thrown in jail.

Support for legalization has steadily grown over the last several years. Today, medical marijuana is legal in 23 states and the District of Columbia. And even federal officials have begun to soften their stances. Last fall, outgoing Attorney General Eric Holder signaled his support for removing marijuana from the list of Schedule I narcotics. “I think it’s certainly a question we need to ask ourselves, whether or not marijuana is as serious of a drug as heroin,” Holder said.

This summer, Chuck Rosenberg, the acting administrator of the U.S. Drug Enforcement Administration, acknowledged that marijuana is not as dangerous as other Schedule I drugs and announced his agents would not be prioritizing marijuana enforcement. Still, as long as marijuana remains illegal under federal law, the haphazard system in which it is studied, produced, and distributed will remain, and Americans will not be able to take full advantage of its medicinal properties.


As the product is refined, wax is separated from key compounds, and the hemp oil settles at the bottom of a beaker.

Today, dozens of companies produce CBD in an array of forms. CBD can be inhaled through vape pens, applied in topical salves, ingested in edibles, or swallowed in oil-based tinctures. Oil has become the dominant CBD delivery method for kids with epilepsy, since it is easy to administer and ingest, and there is no shortage of it available for sale online. There are dozens of companies boasting names like Healthy Hemp Oil, Dose of Nature, and Natural Organic Solutions, each of them selling CBD products at prices ranging from trivial to dizzyingly steep. You don’t have to look hard to find them. If you have a PayPal account and $100 to spare, you could have a vial of hemp oil delivered to your doorstep.

One of the biggest players in this new industry is Medical Marijuana, Inc., a company formed in 2009 that operates out of Poway, California, just north of San Diego. It has played a leading role in the so-called Green Rush, as businesses have moved quickly to capitalize on the gradual legalization of marijuana for medical and recreational purposes by states across the country. The company’s spokesman, Andrew Hard, boasted that Medical Marijuana, Inc., “created the CBD industry and was first to market with CBD products.” Through its various subsidiaries, Medical Marijuana, Inc. sells some of the most recognizable products on the cannabis market— everything from Cibaderm CBD-infused shampoo to CanChew chewing gum. In 2014, the company generated $14.5 million in revenue.

Among the company’s many offerings is Real Scientific Hemp Oil, which it sells through its subsidiary HempMedsPx, also based in Poway. On its web site, HempMedsPx describes how its hemp “is grown in northern European microclimates, without the use of any pesticides, herbicides or chemical fertilizers.” The company promises that it “continuously scrutinizes and improves the processes to meet all regulations and exceeds quality standards.”


WHEN BRANDON KRENZLER’S daughter Mykayla was diagnosed with a form of childhood leukemia in 2012 at the age of seven, he began researching medical marijuana products that might ease her symptoms and blogging about the results. The next year, he received some samples of Real Scientific Hemp Oil, which he administered to Mykayla. But the oil made her sick.

Concerned about Mykayla’s stomach cramps, Krenzler, who lives in Portland, Oregon, sent a sample of the oil off to Going Green Labs in Albany, Oregon. Like most labs catering to the cannabis industry, Going Green mainly performs THC potency tests. According to Krenzler, when the lab tested his sample, it found that the Real Scientific Hemp Oil contained much more THC than HempMedsPx had claimed—3.8 percent, instead of roughly 1 percent. Krenzler said he was “disturbed” by the finding, and also by the implications it had for other parents of sick children. Medical marijuana is legal in Oregon, but Krenzler noted that in other states that have not legalized pot, anyone purchasing a product with more than a trace amount of THC could find themselves in legal jeopardy. “I feel that HempMeds had misrepresented their product,” Krenzler said.

Elias Anderson, one of the owners of Going Green, said representatives from HempMedsPx approached him after Krenzler published the lab’s findings on his blog. “They were like, ‘What are we gonna do about it?’” Anderson recalled, “And I was like, ‘Nothing. We have standards, and I stand behind my test results.’” Still, the company’s representatives were insistent and advised Anderson to have Kenzler take down the lab’s findings.

In an email to the New Republic, Hard, the Medical Marijuana, Inc. spokesman, contended that the sample of hemp oil that Going Green Labs tested had been “tampered with” by a competitor after Krenzler obtained it. “HempMedsPX, if anything, told the lab they cannot publish results from products [for which] they had no chain of custody tracked,” Hard said, “and if they did—that could prove to be very bad for the lab.” He also characterized Krenzler and Anderson as “haters” of Medical Marijuana, Inc., and suggested that much of the criticism of the company and its products comes from commercial competitors.

Yet when one looks at the industry more broadly, there is cause for concern. In February, as part of an investigation into the marketing claims of six hemp oil companies, the FDA analyzed 18 CBD products. What it found was disturbing: Many of these supposed CBD products were entirely lacking in CBD. Of the products tested, six contained no cannabinoids whatsoever. Another 11 contained less than 1 percent CBD. The product that tested highest in CBD, at 2.6 percent, was a capsule for dogs. In states that have legalized CBD, regulations can require CBD products to contain at least 5 percent CBD, more often 10 or 15 percent.

Low concentrations of CBD aren’t the only concern, either. Cannabis plants are hardy and tough, and their thick stalks possess a special property: bioremediation. When grown in contaminated soil, hemp plants absorb heavy metals and other chemical waste, effectively cleansing the terrain. While all plants absorb some chemicals from the soil, the structure, size, and genetic makeup of hemp make it especially adept at this task.

Cannabis is so effective that crops of industrial hemp were planted in the aftermath of the 1986 Chernobyl disaster to help purify heavily irradiated soil. When hemp stalks are used for fiber, paper, and other nonconsumptive industrial purposes, the contaminants absorbed into the plants pose no threat to humans.

A lab technician evaporates traces of food-grade solvents from the concentrated hemp oil.
Ingesting industrial hemp is another story. A 2001 study conducted in a British hemp processing plant found that residual industrial hemp dust contained microorganisms and other contaminants with the “potential to cause a range of ill health problems” if inhaled.

There are ways to strain dangerous contaminants out of raw hemp paste. And most companies stand behind their quality and safety procedures. “We continuously test all our products ... to ensure our consumers get the levels of natural constituents they expect from the quality hemp stalk oil they purchase,” HempMedsPx states on its web site. “Additionally, all our products are tested for safety, to ensure there are no solvents, heavy metals, or other potentially harmful materials in our oil. Because we take these steps, we are always confident in our products, and you can be too.”

Stuart Titus, Medical Marijuana, Inc.’s CEO, argues that hemp plants have a natural ability to rid themselves of contaminants. “The natural capabilities of the plant break down some of these long, large-chain molecules to their base components and, over time, just render them much less toxic,” he told me.

Dr. Ethan Russo, medical director at Phytecs, a biotechnology company spearheading research into plant- based medicines and the endocannabinoid system, took issue with Titus’s claim, however. “Bioaccumulators can recruit heavy metals from the soil,” Russo said, “but breaking them down would be alchemy.” Government regulation of the pharmaceutical industry is designed to protect consumers from unfounded scientific claims.

In the end, companies like HempMedsPx are asking consumers simply to trust them. CBD oils are never subjected to systematic testing by any U.S. regulatory body. The FDA regulates all pharmaceutical labs in the country. But cannabis labs like the ones that HempMedsPx and others use are not, because cannabis is not federally recognized as a legal drug.

All of this makes CBD remarkably difficult for even the most dedicated health care providers to manage safely. Dr. Kelly Knupp, an associate professor of pediatrics and neurology at the University of Colorado, and the director of the Dravet Syndrome program at Children’s Hospital Colorado, said families of epileptic children have tried to bring CBD oils to the hospital for testing. “They’re just concerned that they don’t know exactly who’s growing [the hemp],” Knupp said. “They know it’s not being regulated.” But because CBD is a Schedule I controlled substance, high-tech, regulated laboratories, like those at the University of Colorado, can’t accept, store, or test CBD oils, lest they risk prosecution. “There is no such lab that can take that product,” Knupp said, which leaves any testing up to the unregulated testing centers that cater to the cannabis industry.


DESPITE THE FACT that marijuana remains illegal at the federal level, companies like HempMedsPx claim their CBD products are legal in all 50 states. According to a legal opinion written by Medical Marijuana, Inc.’s attorney and submitted to the New Republic, “HempMedsPx’s CBD hemp oil, containing naturally occurring CBD and miniscule amount of THC, is exempted from the definition of marijuana, is not a controlled substance, complies with the Controlled Substances Act, and is legal on the federal level.” The opinion is based in large part on a 2004 court ruling which allowed the importation of hemp food products derived from the mature stalks of cannabis plants.

Yet the DEA has stated unequivocally that it considers CBD to be illegal under the Controlled Substances Act. “CBD derived from the cannabis plant is controlled under Schedule I of the CSA because it is a naturally occurring constituent of marijuana,” Joseph Rannazzisi, the deputy assistant administrator of the DEA, told a congressional panel in June.

“While there is ongoing research into a potential medical use of CBD, at this time, CBD has no currently accepted medical use in the USA.” Moreover, DEA spokesman Eduardo Chavez told the New Republic that Medical Marijuana, Inc.’s in-house opinion with regards to CBD has no merit. “The bottom line,” Chavez said, “is the oil is part of the marijuana plant, and the marijuana plant is currently a Schedule I controlled substance under federal law.”

read the whole article at http://www.newrepublic.com/article/122918/wonder-drug