DEA/FDA issues

This is article in its entirety including recent edits. It was originally published in
Washington Post April 29, 2016 with some updates I’ve added in 2023 
Bertha Madras is a professor of psychobiology at McLean Hospital and Harvard Medical
School, with a research focus on how drugs affect the brain. She is former deputy director for
demand reduction in the White House Office of National Drug Control Policy.
Marijuana currently resides in Schedule I of the Controlled Substances Act. To be listed in
this most restrictive category, the drug or substance must have a high potential for abuse,
has no currently accepted medical use in treatment in the United States and there is a lack
of accepted safety for use of the drug or other substance under medical supervision.
Petitions to de-list marijuana or move it out of Schedule I into II-V medical categories have
been festering for years. These proceedings can be initiated by the Drug Enforcement
Administration (DEA), the Department of Health and Human Services (HHS), Congress, or
by any interested party, including a drug manufacturer, a medical society or association, a
pharmacy association, a public interest group concerned with drug abuse, a state or local
government agency, an individual citizen
Data from 2015 indicate that approximately 30 percent of current cannabis users harbor a
use disorder — more Americans are dependent on cannabis than on any other illicit drug.
Yet marijuana advocates have relentlessly pressured the federal government to shift
marijuana from Schedule I — the most restrictive category of drug — to another schedule
or to de-schedule it completely. Among the stated rationales? “States have already
approved medical marijuana”; “rescheduling will open the floodgates for research”; and
“many people claim that marijuana alone alleviates their symptoms.”
Yet unlike drugs approved by the Food and Drug Administration, “dispensary marijuana”
has no quality control, no standardized composition or dosage for specific medical
conditions. It has no prescribing information on use (package inserts), no warning
labels and is not supported by high-quality studies of effectiveness, long-term safety or a
cost-benefit analysis. While the FDA is not averse to approving cannabinoids as medicines
and has approved several cannabinoid medications, albeit at much lower doses than
dispensary marijuana, the decision to keep marijuana in Schedule I was reaffirmed in
a 2015 federal court ruling. That ruling was correct.
To reside in Schedules II-V and be approved for diagnosing, mitigating, treating or curing a
specific medical condition, a substance or botanical must proceed through a rigorous FDA
scientific process proving safety and efficacy for a fixed range of doses, as well as fulfilling
CSA criteria. No form of “dispensary marijuana” with a wide range of THC levels and
delivery methods — butane hash oil, shatter, smokables, vaping products, edibles, liquids
— has gone through this rigorous process for a single medical condition (let alone 20 or 40
medical symptoms or diseases). Bud-tenders in “medical” dispensaries recommend various
strains, concentrates, edibles, etc, without scientific data to support these choices. In many
dispensaries, bud-tenders recommend marijuana for pregnant women, despite consistent
warnings of adverse effects on developing fetus.  Until 2015, the majority of clinical trials
reportedly used 3-10% THC marijuana; there is little evidence of improved efficacy for high

(20-90%) THC doses currently sold in legal markets and robust evidence that potent forms
of marijuana increase the risks for  a range of  adverse consequences.
To be approved by the FDA and categorized Schedule II-V (medicine) in the CSA, many
criteria that need to be fulfilled. Among these are the following:

  1. The drug’s chemistry must be known and reproducible. Evidence of a
    standardized product, containing a consistently ultra-high purity product that
    is pyrogen-, herbicide-, pesticide-, fungicide-free, a fixed dose, evidence-based dose
    range for safety/efficacy window, and known shelf life are required by the FDA. The
    chemistry of “dispensary marijuana” is not standardized. Smoked, vaporized or
    ingested marijuana may deliver inconsistent or unknown amounts of active
    chemicals. Levels of the main psychoactive constituent, THC, can vary from >1
    to 90 percent. Cannabidiol (known as CBD) produces effects opposite to THC, yet
    THC-to-CBD ratios are unregulated.
  2. There must be adequate safety studies. “Dispensary marijuana” cannot be
    studied or used safely under medical supervision if the substance is not
    standardized. And while clinical research on long-term side effects for use in chronic
    medical conditions has not been reported, drawing from recreational users we
    know that marijuana impairs or degrades brain function, as intoxicating levels
    interfere with learning, memory, cognition and driving. Long-term use is associated
    with risks for addiction to marijuana and other drugs, loss of motivation, reduced IQ
    and memory impairment, psychosis, anxiety, excessive vomiting, and reduced
    lifespan. Without a standardized product and long-term studies, the efficacy and
    safety of indefinite use of marijuana for chronic medical conditions remains
    unknown.
  3. There must be adequate and well-controlled studies proving efficacy. Twelve
    meta-analyses of clinical trials scrutinizing smoked marijuana and
    cannabinoids conclude that there is no or insufficient evidence or poor quality for
    the use of smoked marijuana for specific medical conditions. With various strains of
    raw marijuana or edibles, or high potency products for vaping, there are no high-
    quality, unbiased, blinded, randomized, placebo-controlled that weigh safety and
    efficacy over periods likely to be used for chronic medical conditions or
    comparisons with non-psychoactive medications. 
  4. The drug must be accepted by well-qualified experts. Medical associations
    generally call for more cannabinoid research but do not endorse smoked marijuana
    as a medicine. The American Medical Association: “Cannabis is a dangerous drug
    and as such is a public health concern”; the American Academy of Child and
    Adolescent Psychiatry: “Medicalization” of smoked marijuana has distorted the
    perception of the known risks and purposed benefits of this drug;” the American
    Psychiatric Association: “No current scientific evidence that marijuana is in any way
    beneficial for treatment of any psychiatric disorder … the approval process should
    go through the FDA.”
  5. Scientific evidence must be widely available. The evidence for approval of marijuana to treat medical conditions by state ballot and legislative initiatives did not incorporate rigorous, objective clinical trials published in reputable scientific journals nor was any rigorous scientific evidence made widely available for public scrutiny.

Marijuana fails to meet these five criteria (and others) for accepted medical use in the
United States and should continue to reside in Schedule I.
Is Schedule I drug a roadblock to marijuana research? Not really. When cannabidiol was a
Schedule I drug, quality clinical trials for treatment-resistant forms of seizure disorders
demonstrated safety-efficacy and the FDA approved a carefully formulated cannabidiol for
medical use. As a result, it was rescheduled. The major roadblock to five clinical trials using
smoked marijuana proposed by the California Center for Medicinal Cannabis Research was
not the Schedule I label, but the scarcity of patients willing to enroll in the trials. The
process for marijuana research could be streamlined by Drug Enforcement Administration
oversight and expansion of marijuana production, and a special sub-category of Schedule I
could further reduce paperwork. But moving marijuana to Schedule II “to promote
research” is unethical, as marijuana would then be designated a safe and effective medicine
in the absence of high-quality evidence.
Should we dismiss heartfelt appeals from people suffering various diseases, self-reports of
safety and effectiveness for a myriad of symptoms, and considering that many chronic,
debilitating ailments are inadequately managed? Human stories should not be ignored, and
rigorous, creative solutions can be formulated in response, including the use of FDA-
approved pure cannabinoids at dose ranges deemed relatively safe. However, the
“marijuana mess” and its “new realities” were created not by the federal government or by
medical community advocacy but by political activists using strategies to legalize medical
marijuana by circumventing the FDA, the only and highly effective federal agency that
safeguards our nation’s medicines. If the more than $100 million spent on ballot and
legislative initiatives had been used instead for quality clinical trials, our nation would
know much more about the therapeutic potential of various forms of marijuana.  Instead,
“dispensary marijuana” is evolving into a human experiment without informed consent.
We schedule and restrict psychoactive drugs because they can negatively affect the human
brain and behavior. For the vulnerable, the risks of using marijuana products daily and for
years is deeply concerning. Of brain diseases, substance use disorders are among the most
lamentable forms of human anguish. They are also among the most preventable.

Bertha K Madras, PhD
Professor of Psychobiology
Department of Psychiatry
Harvard Medical School

McLean Hospital
Mailman Research Center Room 315
115 Mill Street
Belmont MA 02478

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