The courtroom drama is over. The political wrangling is in
temporary respite. And, the possibility of MAPS-sponsored FDA approved
clinical trials with marijuana is now hinging on a recommendation
to DEA Administrator Karen Tandy from DEA
Administrative Law Judge Mary Ellen Bittner, expected by summer
or fall of 2006.
Following two rounds of hearings and an aborted hearing in
January, lawyers for the DEA and lawyers from the ACLU and the
two Washington, DC, law firms working largely pro bono for
Prof. Lyle Craker, Ph.D., are now preparing final legal briefings.
The legal briefings, due April 27, will build legal arguments based
on the evidence presented in court during oral arguments, but
cannot introduce new evidence.
If Judge Bittner recommends that the
DEA issue a Schedule I manufacturing
license to Prof. Craker, it will be just that-a
recommendation. The DEA could still
reject the Judge’s ruling, leaving us with
the unenviable option of suing the DEA in
the Washington, DC, Circuit Court of
Appeals on the grounds that their rationale
for rejecting a favorable recommendation
was flawed, a process that could delay
the case for several more years. Therefore,
if Judge Bittner makes a favorable recommendation,
we will need to place political
pressure on the DEA to follow it, even
though we already have letters to the DEA
urging it to issue the license from 38
members of the House of Representatives
(36 Democrats and 2 Republicans), both
US Senators from Massachusetts (Kennedy
and Kerry), Republican strategist Grover
Norquist, and organizations such as the
California Medical Association, the
Lymphoma Foundation of America, the
United Methodist Church (UMC), and
several state nurses’ associations.
The Background
Although Federal law requires adequate competition in the production of Schedule I drugs [21 U.S.C. § 823(a)(1); 21 C.F.R. § 1301.33(b)], at present, the federal government’s National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana, but no other
Schedule I drug, that can be legally used in federally-approved research. This monopoly has been used to obstruct privately-funded research aimed at developing marijuana into an FDA-approved prescription medicine. For example, NIDA has refused to supply marijuana to two FDA-approved protocols sponsored by MAPS, preventing these studies from taking place. In addition, for the last two and a half years, NIDA has refused to sell 10 grams of marijuana to a MAPS sponsored laboratory study evaluating the effectiveness of a marijuana vaporizer, a non-smoking drug delivery device that eliminates the products of combustion that patients would inhale after burning marijuana. As NIDA well knows, sponsors will not invest millions of dollars into research studies until there is reliable access to a supply of high quality research material that can be used
both in research and–if the research should prove successful–as an FDA-approved prescription
medicine.
In June 2001, with support
from MAPS, Prof. Craker, Director
of the Medicinal Plant Program at
the UMass-Amherst Department
of Plant, Soil and Insect Sciences,
applied to the DEA for a license to
manufacture marijuana exclusively
for use in federally-approved
research. Prof. Craker’s facility
would have been funded by a grant
from MAPS. Yet the DEA has
refused to issue a Schedule I
manufacturing license to Prof.
Craker for over four and a half
years. DEA licensing is the final
regulatory hurdle in MAPS’ quest
to create a privately-funded
federally-approved medical marijuana
production facility, which
would pave the way for a serious
drug development effort aimed at
developing marijuana into an FDAapproved
prescription medicine.
One of the DEA’s key legal
arguments is that Prof. Craker’s
facility is not “in the public interest”.
During the first weeklong trial
that took place in August 2005, Prof. Craker’s lawyers
established through the testimony of long-time California
State Senator John Vasconcellos and former ONDCP
senior policy analyst Barbara Roberts that there is an
unmet demand for research that investigates the safety
and efficacy of marijuana’s potential therapeutic uses (see
Allen Hopper’s update in the Fall 2005 Bulletin at http://
www.maps.org/news-letters/v15n3-html/dea.html).
During the second weeklong proceeding in December
2005, DEA lawyers called their witnesses to the stand.
Amazingly, their testimony seemed to support MAPS’ case
more than their own.
The December DEA Hearing
The DEA first called on Prof. Mahmoud El Sohly,
Ph.D., NIDA’s marijuana grower at the University of
Mississippi. During cross examination, Prof. El Sohly was
asked to explain his personal commercial interests in
marijuana-based products. This includes both his THC
suppository and his new DEA license permitting him to
grow marijuana to extract THC for sale to the pharmaceutical
company, Mallinckrodt, to manufacture generic
Marinol. We established that Prof. El Sohly would have a
major conflict of interest if he were the sole supplier of
marijuana to MAPS for prescription use, since marijuana
would compete with products in which he has a personal
financial interest.
Prof. El Sohly also claimed that
he could provide marijuana of any
potency and cannabinoid (CBD)
content. When he later referred to
a document that contained information
on the marijuana in NIDA’s
inventory, Prof. Craker’s lawyers
asked to see it, and it was introduced
into evidence. As it turned
out, there was nothing in the
inventory that matched the THC
and CBD content that the Dutch
government is offering for sale for
medical use. When pressed about
the poor quality of his marijuana,
Prof. El Sohly made a mistake that
undermined the DEA’s case by
defensively questioning the
accuracy of a photo published in an
article by Ethan Russo, M.D.,
depicting seeds and stems from
marijuana Prof. El Sohly produced
for NIDA. Prof. El Sohly even
stated that the photo couldn’t have
been from NIDA’s cigarettes, but
could have been from the raw
material, prior to the removal of
seeds and stems. He then said that
the seeds looked larger than they
should have compared to the size of
the stems, and came close to claiming the photo was
fraudulently doctored.
After Prof. El Sohly ’s testimony, we contacted Al
Byrne, who was present when Russo’s photograph was
taken, to ask if he would testify to the unaltered nature of
the photo. Byrne agreed to submit a signed affidavit,
which we introduced into evidence on Friday, the last
scheduled hearing. The affidavit was submitted to DEA
lawyer Brian Bayly and Judge Bittner. The Judge then
asked Bayly whether he had any objections to introducing
the affidavit as rebuttal evidence.
This was one of the most telling moments in the
entire hearing-the classic pregnant pause. Bayly was silent
and stared at the letter for an extended period of time.Nobody in the courtroom said a word for more than a
minute. It was clear that Bayly was struggling to figure out
how to object to this affidavit. He remained still for so
long that Judge Bittner was compelled to speak again,
asking him once more if he had any objections. Bayly
shook off his paralysis and pored over the letter, paragraph
for paragraph, line for line, trying to exclude any
background information that wasn’t directly about the
photograph itself. MAPS’ attorney, Julie Carpenter,
skillfully argued that the background information was
helpful to provide context. The Judge then ruled to admit
the letter in its entirety. We now had Prof. El Sohly on
record claiming that NIDA marijuana
can’t possibly be as bad as it
really is, and we had photos and
witnesses to prove that it is indeed
that bad.
Then, in what seemed like an
attempt to intimidate Byrne into
withdrawing his affidavit, Mr.
Bayly said that he wanted to crossexamine
him under oath. All of the
other testimony had been completed
at that point, but the Judge
scheduled another hearing for
January 17 just to place Byrne
under oath on the witness stand.
What the DEA didn’t realize at that
time was that Byrne was eager to
have his day in court to tell the
Judge about the low quality of
NIDA’s marijuana. Predictably, a
few weeks later, after it became
clear that Byrne would not withdraw
his affidavit, the DEA cancelled
Byrne’s cross-examination.
Prof. El Sohly also claimed that
if NIDA-produced marijuana is
approved by the FDA as a prescription
medicine, researchers would
have no trouble switching to
another marijuana product with
similar THC levels. This erroneous claim later hurt the
DEA’s case once it was contradicted by the DEA’s other
witnesses.
During the third day, the DEA called on Steve Gust,
Assistant Director of NIDA, and our lawyers obtained
several very important admissions from him under oath.
First, he said that after the FDA has approved a protocol,
the PHS/NIDA review takes an additional three to six
months. This point strengthened our case that the NIDA
monopoly is obstructing the development of marijuana
into a prescription medicine, since time delays in pharmaceutical
drug development are expensive and substantially
impede the process. In contrast, the FDA has just 30 days
to respond to protocol submissions.
Then, Gust said that there is no formal appeal process,
but that if an appeal is made, it could take another three to
six months. He couldn’t explain why the PHS/NIDA
review of Chemic’s vaporizer protocol and request for 10
grams took more than two years. Furthermore, he admitted
that, unlike normal peer-review processes, the PHS/NIDA peer review process is composed entirely of government
employees, with no outside experts. These sorts of
delays, on top of the arbitrary nature of the review
process, are more than enough to persuade potential
funders of marijuana research that it isn’t worth investing
millions of dollars in a serious drug development effort.
Gust said that the purpose of
NIDA’s review is to ensure that the
protocols are scientifically meritorious,
and that the FDA merely
reviews them for safety. Unfortunately
for him, the official Health
and Human Services (HHS)
statement of policy about the
provision of marijuana to privately
funded studies says that the FDA
reviews Phase I studies primarily
for safety, but reviews Phase II and
Phase III protocols for scientific
merit. We directed Steve Gust to
that portion of the guidelines and
forced him to reluctantly admit
that the FDA doesn’t just review
for safety but also for scientific
merit. This clearly demonstrated
that the NIDA review is duplicative
and unnecessary.
During the forth and final day,
the first DEA witness was Eric
Voth, M.D., a prominent and longtime
prohibitionist. Even though
he was supposed to talk specifically
about the risks of diversion, he
couldn’t help but talk about the
risks of marijuana smoke compared
to tobacco smoke. This gave us an
opportunity to submit Dr. Donald Tashkin’s new study
showing no link between marijuana and lung cancer, in
which he found that marijuana actually has a slight
protective effect. We asked Voth about the comparison he
made between marijuana and tobacco smoke, and he
discussed Tashkin’s results in a rather accurate manner,
stating on the record that there is no scientific evidence
linking marijuana to lung cancer. He also explained that
cannabinoids have anti-tumor properties while nicotine
does not.
Voth then made claims about the dangers of highpotency
marijuana and stated that there is no evidence
that people self-titrate high-potency marijuana in a way
that enables them to inhale less smoke. He made several
other inaccurate claims about the addictive nature of
marijuana and its link with mental illness. This enabled us
to request that a chapter from Lester Grinspoon’s Marijuana:The Forbidden Medicine, “Measuring the Risks,” be entered
into evidence as a rebuttal. Even though Judge Bittner had
previously upheld a DEA request to block the text since the
risks and benefits of marijuana weren’t at issue in this case,
in this instance she agreed to our request. Thus,
Grinspoon’s chapter was officially entered as evidence,
contradicting Voth’s testimony in numerous ways.
The primary thrust of Voth’s testimony was that
marijuana has so many ingredients that it can’t possibly be
made into a medicine. He said that it
is difficult to standardize marijuana
because various strains have significantly
different chemical compositions,
implying that blocking us from
doing marijuana research doesn’t
matter since there is no way that the
FDA would accept the marijuana
plant as a prescription medicine.
This argument was more persuasive
until about 10 years ago, when the
FDA developed guidelines for
investigation of botanical medicines.
This argument also fundamentally
contradicted Prof. El Sohly ’s testimony-
that research could be conducted
with a strain of marijuana
provided by NIDA and then the
sponsor of research could easily
obtain FDA permission to market a
different strain-since NIDA can’t
legally provide marijuana for
prescription use.
Later in the day, over strenuous
DEA objections, we entered into
evidence FDA statements saying that
the FDA welcomes research protocols
evaluating whether the marijuana
plant deserves to be available
as a legal prescription drug. Once
again, the FDA’s willingness to place science over politics
was a major assistance to our efforts.
The DEA’s final witness was David E. Auslander,
M.D., an expert in pharmaceutical drug development. His
entire testimony substantially helped our case by reinforcing
Dr. Voth’s view that it is extremely difficult to standardize
a plant because different strains have significantly
different chemical “fingerprints”.
Most importantly, at the end of Auslander’s testimony,
we asked him if the FDA would be concerned about
the variation in chemical “fingerprints” of different
marijuana strains. He said yes, definitely. We then asked
him if it would be problematic for a pharmaceutical
company if it did research with one strain of a plant, got
FDA approval to market it, but then tried to market a
different strain with a different fingerprint. He said this
would matter quite a bit to the FDA and could require
replication of some clinical studies, which are very
expensive. This was the exact opposite of Prof. El Sohly ’s
testimony, in which he said we could conduct research
with NIDA marijuana and then just switch to another
plant. Prof. El Sohly was not presented to the Court as an
expert in pharmaceutical drug development, so
Auslander’s testimony therefore had more authority on
these points.
Auslander supported one of our key arguments, that
conducting research with NIDA
marijuana from Prof. El Sohly isn’t
reasonable since NIDA’s mission
doesn’t permit it to provide
marijuana for prescription sales,
just research. Therefore, if we use
NIDA marijuana in research and
the FDA approves prescription use,
we would have to apply to NIDA
to obtain the same strain from
Prof. El Sohly again. But, as we
established earlier, Prof. El Sohly
has fundamental conflicts of
interest, since he has other
marijuana-based products that
would compete, plus he could
charge anything he wanted
because there would be no competition.
The only other option
would be to apply for FDA approval
to market a different strain
from a new manufacturer, which
would present additional difficulties
because of the differing
chemical fingerprints of marijuana
strains. In any case, there is
currently no alternative supplier
with a DEA license, and starting a
new facility could take a year or
more, a costly delay if millions of
dollars had already been invested in research. In response
to our final questions, Auslander helpfully testified that
pharmaceutical companies must be assured of a reliable and
consistent supply of any drug that could be used in research
and made available for prescription sales.
While we can’t predict how Judge Bittner will
interpret the evidence presented over the two weeklong
trial proceedings, we are satisfied that our key arguments
were presented thoroughly and accurately in this landmark
struggle for scientific freedom•
To read transcripts of the court proceedings, media coverage,
or background information on the case, see MAPS’ DEA
lawsuit page on the internet at:
http://www.maps.org/mmj/DEAlawsuit.html |