“NOW MORE THAN EVER” 1

The ORG Responds to the DFAA on the FDA
By Mary Jane Borden
“NOW MORE THAN EVER”
8
Cheryl Shuman’s
successful tour
of Ohio to
promote the Ohio
Cannabis Rights
Amendment,
sponsored by the
Ohio Rights Group (ORG), concluded
in Cleveland a week ago with a
segment by Lee Jordan on the city’s
News Channel 5. Success becomes
self-evident when the opposition
appears, often in the form of the
Drug Free Action Alliance (DFAA),
which is headquartered on Huntley
Road in Columbus. The segment,
entitled “Northeast Ohio family seeks
medical cannabis in Colorado to find
effective treatment for seizures” and
aired on October, 25, 2013, included
several quotes from DFAA Executive
Director Margie Seidel to rebut
the use of cannabis for treating the
devastating seizures experienced by
Jordan Lykes who suffers from Dravet
Syndrome, a rare form of epilepsy.
In the first quote, Ms. Seidel states
that, “Medicine goes through a very
rigid process of study and research
through the FDA, a revered system
throughout the world.” Really?
Many of these FDA approved drugs
have proven to be harmful or even
deadly. For example, in 2009, drug
induced deaths, principally from
otherwise legal opiates, exceeded
deaths from motor vehicle accidents
for the first time since such tracking
began. There were 1,373 such deaths
in Ohio in 2009. Further, the FDA’s
own Adverse Event Reporting System
for prescription drugs reveals an
epidemic of serious patient outcomes,
reporting over 500,000 deaths and 3
million “serious outcomes,” with such
outcomes up by 90 percent in just
the last five years. By “serious,” the
FDA means that one or more of the
following were documented: “death,
hospitalization, life-threatening,
disability, congenital anomaly and/
or other serious outcome.” Over 200
medicines contain the FDA’s strongest
“black box” warning, and a record
number of drugs have been recalled
from the market.
To add insult to injury, the “very
rigid process of study and research”
conducted through this “revered
system,” is exorbitantly expensive. In
its 2012 exposé on drug development,
Forbes Magazine estimated the cost of
bringing one pharmaceutical drug to
market at an average of $4-11 billion,
over a time frame of about 12 years.
According to Forbes, fewer than 1
in 10 medicines that begin testing
in human clinical trials succeed in
becoming marketable medicines. The
magazine concluded, “The high cost
of developing drugs shouldn’t be a
badge of honor for drug firms; there’s
no reason it has to be this expensive
… Just because something was
expensive doesn’t make it good.”
Despite this deadly and expensive
system, Ms. Seidel goes on to
insist the “DFAA’s position is that
medical marijuana should meet the
same standards as other medicines
rather than being pushed as a voter
initiative.”
She emphasized that, “I’ve
never voted on an antibiotic, or an
antihistamine, nor am I qualified to
do that. I want to know what research
says so (when it’s taken) it’s the
same dose every time. You know
the side effects, how it reacts with
other medicines, foods. You want the
fidelity of it safe and accurate, not just
today but in the long term,”
But how can knowledge about
potential drugs or an understanding
their “fidelity” be achieved when
the approval of new drugs is on
the decline? Is it possible that the
pharmaceutical industry’s profitability
has been pinched by safety, accuracy
and cost concerns? For these reasons,
has it purposefully put the brakes
on drug development over the last
decade?
In 2010, the FDA reported that 21
new molecular entities (NMEs) had
received approval, which was slightly
lower than the ten-year average of
23. The agency principally blamed
this decline on a significant drop in
the number of applications filed by
the industry. In 1996, there were 45
applications for FDA drug approval.
The 21 in 2010 represented the lowest
number in 15 years.
However, Ms. Seidel may be right
about cannabis. Few of the studies
presently underway will meet that
clinical trial threshold for FDA
approval. Of the 85 clinical trials
for “cannab” listed at ClinicalTrials.
gov, only 35 are actively recruiting,
only four are in Phase 3 (fairly close
to market) and only two concern the
alleviation of suffering (ALS and
multiple sclerosis). The other two
focus on cannabis dependence.
This dearth of clinical trials does
not result from a lack of trying.
The FDA will approve cannabis
studies, but research continues to be
hampered by the plant’s presence
in the most restrictive Schedule I
of the Controlled Substances Act.
These restrictions make cannabis
the only substance to require study
approval from four governmental
agencies: not just the FDA, but also
the DEA (researcher must hold a DEA
license), the National Institute on
Drug Abuse (as a source of supply)
and the Department of Health and
Human Services (which can reject
an application even though the study
design has been approved by the
FDA). Such has been the case with a
trial proposed by the Multidisciplinary
Association of Psychedelic Research
(MAPS) to evaluate the use of
marijuana in the treatment of PTSD.
This clinical study has been delayed
for years.
As Channel 5 reported, the famed
Dr. Sanjay Gupta recently changed
his position on the use of cannabis
in medicine after he personally
observed the plant’s positive effects
on Dravet Syndrome seizure victims
like 4 year-old Charlotte Figi or 18
year-old Jordan Lyles. As he noted,
“Those studies [for which Ms.
Seidel advocates] are hard to do and
that is part of the problem.” Noting
that cannabis is one of the safest
medicines ever used over the course
of human history, never having been
associated with one overdose death,
Dr. Gupta acknowledged, “You start
to realize this is a medication, one
that can work when other drugs don’t
work. And it can be a lot safer for
children who have this intractable
epilepsy.”
Which brings us back to the Ohio
Cannabis Rights Amendment.
The “revered system” of drug
development in the United States
touted by Ms. Seidel has turned
deadly, costly and time consuming.
Perhaps the pharmaceutical industry
is realizing this as reflected through
its growing aversion to FDA approval.
“Safe and accurate” research into the
medicinal qualities of cannabis has
been thrown out the window by an
institutional bias against conducting
studies, despite the plant’s long
standing, extraordinary safety profile.
Within this tangled web, what is the
quickest and least expensive way by
which cannabis-based medicines can
be made available to patients such
as Charlotte, Jordan and millions of
others? The answer? A constitutional
amendment – voter initiative – for
it will cost as little as $5 million
(compared to $12 billion) and take
only one year (compared to 12 years).
With all of these factors combined,
which is the best course? Which
medication would you prefer? Which
would you give your child?
Update. Cheryl Shuman has given
1,000 percent to the Ohio Rights
Group’s campaign to pass the Ohio
Cannabis Rights Amendment, and
for that we are so very grateful. We
were very distressed to learn that
Cheryl collapsed while at the Drug
Policy Alliance Conference in Denver
and remains in the hospital as of this
writing. We view Cheryl as one of our
own. A sister and friend to our cause.
We love and support her in every
way. Our hearts and souls go out to
Cheryl and her family at this time of
need. May the love we and the world
have for you, Cheryl, restore you to
complete health. We want to again
welcome you home.