Written by Cameron Scott
Medical marijuana is more
readily available thanks to a spate of new state laws. But there’s
nothing medical about the path most patients take to get it.
The popular explanation for medical
marijuana dispensaries that have popped up in states from Washington to
New York is that marijuana is a wonder drug — treating not just nausea and lack of appetite, but also pain, anxiety, epileptic seizures, and the symptoms of multiple sclerosis and schizophrenia.
The federal government refuses to allow people to use it, proponents say.
The story, however, isn’t quite so simple.
Few
doubt that the plant has at least a handful of valid medical uses. But
research into those uses isn’t yet up to scientific snuff. Many U.S.
studies are based on observations of patients who use marijuana on their
own, meaning the dose and balance of active ingredients often aren’t
standardized.
If the claims
for marijuana are true, then by rights it should be made available for
medical use. But there isn’t a single FDA-approved drug in use that is
as loosely regulated or as poorly understood as the buds, brownies, and
candies for sale at those dispensaries. Legal and logistical barriers to
clinical research on marijuana are among the biggest reasons why.
It
wasn’t until the mid-1990s that researchers explained how marijuana’s
best known ingredient, THC, works.
There are at least 79 other
potentially active chemicals in marijuana, many with no research on
their effects.
To better understand marijuana’s medical uses,
research would have to look a lot more like the drug development
research pharmaceutical companies do for their drug candidates.
“If
it turns out that a certain strain is really, really valuable, we’ll
understand that better if it’s done through standard medical process
rather than just being done where people can come in [to a dispensary]
and pick one,” Pacula said.
Few academics and no
American pharmaceutical companies are investigating cannabis-based drugs
the same way they once did synthetic opioids.
Why
hasn’t interest in medical marijuana led to controlled dosages, written
prescriptions, and insurance coverage? After all, aspirin is made from a
compound found in willow tree bark, but people don’t buy willow bark
and consume it in the way they see fit to treat headaches and fever.
The Research Gauntlet
Rick Doblin’s answer to the question of marijuana medicalization is long — more than two decades long, actually.
Doblin, who holds a Ph.D. in public policy from Harvard’s Kennedy School of Government, founded and directs the Multidisciplinary Association of Psychedelic Studies
(MAPS). MAPS is a California-based nonprofit whose mission is to
develop low-cost prescription medications from psychedelic drugs,
including marijuana.
Since 1992, MAPS has been trying
to obtain marijuana to use in medical research. MAPS first tried to get a
government license to grow its own marijuana to explore whether
vaporizers were a safer drug delivery system than marijuana cigarettes.
Marijuana
is the only Schedule I drug that the Drug Enforcement Agency (DEA)
doesn’t permit to be commercially produced for research.
MAPS sued the
DEA with a University of Massachusetts, Amherst, professor who sought a
license to become a second approved marijuana grower. In 2008, a judge
sided with MAPS, recommending that the DEA issue a license. It never
did.
The agency says that international treaties bind the government to using only a single source of marijuana.
That left MAPS just one option: to buy marijuana from the National Institute on Drug Abuse
(NIDA).
The University of Mississippi manages an acre-and-a-half plot
under its exclusive contract with NIDA to supply marijuana for
research.
In
2010, MAPS proposed a study on using marijuana to treat post-traumatic
stress disorder in veterans with NIDA marijuana. The proposal got the
green light from the DEA and the FDA. But it was rejected by another
federal agency, the U.S. Public Health Service.
The
Public Health Service review was set up to help NIDA evaluate medical
research proposals as it broadened its focus after the Institute of
Medicine argued in 1999 that cannabis deserved more study. Research on
other, arguably harder drugs, does not require the Public Health Service
review, which critics say only adds to the challenges of getting
medical marijuana research approved.
MAPS
made some tweaks to its study design and got the OK from the Public
Health Service. Just last month, the group secured its first marijuana
to use in research. A study testing the drug’s effects on 56 veterans
with post-traumatic stress disorder is gearing up to launch.
“It’s taken us 23 years,” Doblin said wearily.
MAPS
has reason to be frustrated with the single-source system, and some
academic researchers share Doblin’s complaints. Much of the most
promising recent research on medical marijuana focuses on cannabidiol,
or CBD, a non-psychoactive ingredient.
The British drug company GW Pharmaceuticals began testing a mixed CBD/THC product
in 1998. But NIDA only began measuring and controlling the
concentration of CBD in its supply earlier this year. Researchers
interested in the possible uses of any of the other 70-plus ingredients
in marijuana have nowhere to turn.
After its phase 2 study is complete, MAPS will
have to look for another legal source of cannabis. NIDA doesn’t supply
the drug for commercial purposes, and MAPS wants to get FDA approved to
sell cannabis as a prescription medication. For any drug to get FDA
approval, the product tested in the phase 3 trial must be exactly what
will be brought to market. Government pot won’t do.
The
number of bureaucratic hurdles has led some groups to allege the
federal government purposely blocks research into medical uses of
marijuana, a charge government agencies have denied. Earlier this month, the government said it would more than double its planned 2015 production of marijuana for medical research.
Federal
agencies may be turning away from the “reefer madness” biases of their
past, but now the floodgates are open and a patchwork of state programs
that supply marijuana directly to patients has stepped in to fill the
void.
State Legalization Is No Cure-All
The rise of more liberal marijuana laws — 20 states
have passed them since 2010 — is a victory for marijuana advocates and
anti-drug war reformers. But it’s not clear that the gray market for
marijuana these laws create is the best option for researchers and
patients whose interest in the drug is strictly medical.
Sure,
more patients can get marijuana. But they turn to it based on anecdote
rather than research, according to John Hudak, a governance expert at
the Brookings Institution. And their use of marijuana forces them
outside of the medical system.
Brian Keller, a
52-year-old former optician in Scottsdale, Arizona, suffers from
osteoarthritis, rheumatoid arthritis, and psoriatic arthritis. Chronic
pain forced him into medical retirement. Keller told Healthline that his
pursuit of medical marijuana began with a trip to a strip of seedy
doctor’s offices of the kind advertised in many alternative weeklies.
A 2013 survey
of Colorado physicians found that most felt they should have more
training and education before recommending marijuana to patients. Their
concerns have pushed medical marijuana to the fringes of the medical
establishment.
Smoking marijuana “makes me feel better
because I like to be on the computer, I like to be able to focus, and
you can’t do that when you’re stoned,” Keller said.
Keller’s
doctors have supported his choice — particularly because the
alternative is opioid painkillers, which are more addictive than
marijuana and just as mind-altering. But they didn’t suggest marijuana.
Nor did they ask about Keller’s use of it on the standard medical
paperwork he filled out.
It was dispensary staff — who aren’t required
to have any special training — who guided Keller through early
trial-and-error efforts to find a strain that relieved his pain without
getting him too stoned or keeping him up at night. As he found the right
type and strength of marijuana, he found himself unpleasantly drugged
once or twice. (He joked an indica strain has earned the nickname “in da
couch.”)
Colorado has reported an uptick in young
people showing up in hospital emergency rooms after using marijuana
since the state made recreational use of marijuana legal in 2010.
Mold
on the buds is a risk for people with compromised immune systems, Pacula
noted. But even with the loose system of oversight that has formed
around medical marijuana, the drug has caused few bad medical outcomes.
Though
it is easy for Keller to get marijuana, it’s not cheap. He pays about
$400 a month out of pocket. Keller would ideally like to be allowed to
grow the plant himself, he said. He’d rather go through standard medical
and insurance channels.
Keller isn’t alone. The
American Academy of Pediatrics and the Epilepsy Foundation say they
support the development of cannabis-based drugs under the FDA process.
Last
year, The New York Times reported that one family’s public success
using a high-CBD strain of marijuana oil to bring their young daughter’s
seizures under control was driving a migration of families with
children with severe seizure disorders to Colorado.
Drs. Orrin Devinsky
and Daniel Friedman of New York University’s Comprehensive Epilepsy
Center responded with an op-ed in the same paper urging caution.
“The
truth is we lack evidence not only for the efficacy of marijuana, but
also for its safety,” especially in children, the doctors wrote. “It is
troubling that while few barriers exist for parents to give their
children marijuana in Colorado, there are significant federal roadblocks
preventing doctors from studying it in a rigorous scientific manner.”
Patients have the most to gain from access,
which comes with more information about marijuana’s medicinal properties
— and its potential side effects.
“I think there’s
tremendous value in the clinical trial process,” said Kenneth Kaitin,
Ph.D., director of the Center for Drug Development at Tufts University.
“You’d understand the clinical pharmacology of the drug, a lot about the
correct mode of administration, and more about effects and side
effects. That all comes about with rigorous clinical trials, and in many
respects if you’re a patient I think you’re better served by having
something that’s gone through that process.”
Experiences
like Keller’s demonstrate that marijuana can have concrete medical
benefits for some patients, and they shouldn’t be kept in the dark about
what they’re putting into their bodies.
“There are
some states that are trying very hard to regulate the production and
quality of the product, but there’s certainly a huge gap in terms of
what states are doing versus what the FDA does in pharmaceuticals,” said
Hudak, of the Brookings Institution. “I think there is a lot of space
to improve the quality of testing, titrating and dosing when it comes to
medical cannabis.”
A Scheduling Conflict
The
biggest roadblock to higher quality research is the drug’s labeling as a
Schedule I controlled substance. That listing means the federal
government considers marijuana to have a high risk of abuse and no
legitimate medical use. Congress or the FDA could demote marijuana to a
less stringent schedule. Opioid painkillers such as OxyContin are Schedule II drugs, for example.
The AAP, the Epilepsy Foundation, and the American Medical Association (AMA) have all called on the federal government to move marijuana to a lesser schedule.
“Pharmaceutical
companies’ ability to conduct research on marijuana is oftentimes
stymied by federal scheduling. That creates a burden that just adds to
their costs. Even if they started to do research that could be used to
create cannabis-based medicines, the Schedule I status makes it
extraordinarily difficult for them to bring those drugs to market,”
Hudak said.
Researchers
don’t just have to jump through hoops to get marijuana. They have to
demonstrate to the DEA that they can account for every ounce of it once
they’ve gotten it.
Devinsky and Friedman said in their op-ed that they
were keeping their high-CBD strain — which doesn’t make users high — “in
a 1,200-pound safe in a locked room, in a building with an alarm
system.”
Federal
laws have created roadblocks imposing enough that even with global
interest in the medical uses of marijuana, foreign drug companies like
GW Pharmaceuticals and a handful of Israeli companies have the field
more or less to themselves. Even GW, with the support of the British
government has “struggled to get through clinical trials” in the United
States, Pacula said.
MAPS’s
move to pursue drug development through a benefits corporation nestled
within a non-profit makes clear that few expect cannabis drugs to
deliver lavish financial returns. Bringing a new drug to market costs
$2.5 billion, according to Tufts research. A drug based on marijuana
could shortcut part of the process, and chip away at the price, because
some of the work has already been done.
Whatever the cost, drug companies would look to
recoup their investment by guarding against competition with patents.
Marijuana, a plant with a 2,000-year history, isn’t a great fit for the
patent system.
“You can’t take a plant and patent it,”
said Kaitin. “You’d have to have some sort of a process for isolating
the active compound. But once you get away from product patents, the
patent strength starts to diminish. Patents are progressively less and
less of a protection because it’s a lot easier to reproduce a compound
using a slightly different process.”
In
the mid-1980s, with the AIDS crisis raging, AbbVie Pharmaceuticals,
then called Abbott Laboratories, won a patent and FDA approval for a
synthetic version of THC. The drug, taken in capsule form to treat
nausea and weight loss, never took off. Many patients reportedly prefer
smoking.
Pharmaceutical companies may also bring some of their own biases to the table.
“These
pharmaceutical companies answer to boards of directors, and often times
there are corporate interests that are still leery and skeptical of
cannabis,” Hudak said.
Even as the social stigma erodes, the pharmaceutical industry won’t necessarily see its incentives increase.
“If
more and more states allow legalized marijuana in the states and you
can buy it legally, what happens to your market?” Kaitin said.
State-by-state
laws aren’t ideal from any perspective. Patient advocates claim that
access to a drug shouldn’t be determined by ZIP code.
“You
have not just different rules at the state and federal level, but you
have different rules from state to state. That’s not really an effective
system of governance,” he said. “It creates a pretty messy system of
federalism that … isn’t ideal and at the end of the day may not be
sustainable.”
The Calm After the Storm?
Things can’t remain in the state of chaotic exuberance we’re seeing now. But it would be hard to unring the bell now that people in states like Arizona and Colorado expect to be able to buy marijuana at their local dispensary.A few things could happen to bring medical knowledge about cannabis and patient access to the drug into better sync, even if efforts at federal rescheduling continue to fail in Congress.
As more
evidence comes through suggesting marijuana can help patients, pressure
could build on federal agencies to facilitate more research. The AMA has
asked the government to do just that, and to guarantee that NIDA will supply “cannabis of various and consistent strengths.”
If researchers found that a delivery system
other than smoking — a patch or spray, for example — or an unknown
compound or process delivered better results or fewer unwanted side
effects, we could start to see cannabis-based medicines appear within
the medical system.
“What
would be required now would be some smart academic clinicians who
develop a new understanding or a better idea of how to use it that would
suggest that, if I really want a medical product that’s been tested, I
should get that. I think that would change the environment,” Kaitin
said.
Short of that, states could require that
marijuana be identified by strength and strain, a direction some are
already headed as regulations shift.
Many
of these steps could be taken independent of the policy conversation
about whether people should be able to use marijuana recreationally.
“When we decided to legalize alcohol after Prohibition, we still wanted to know what amount of ethanol was in it,” Pacula said.
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