- June 5, 2009: Craker’s lawyers filed potential witness and document lists regarding our pending Motion to Reconsider
- May 18, 2009: DEA filed an Interim Order requesting that Craker submit list of potential witness by June 5, 2009
- May 11, 2009: Craker’s Lawyers file update in First Circuit, U.S. Court of Appeals
- May 1, 2009: Final Order goes into effect, but DEA review of Motions to Reconsider still Pending
- April 29, 2009: Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden
- April 15, 2009: Congressmen John Olver and Sam Farr send letter requesting that Ogden intervene on behalf of Prof. Craker
- April 13, 2009: DEA lawyers file their final document post motions
- March 25, 2009: DEA Lawyers Extend to April 13 their reply to Prof. Craker's Supplemental Motion to Reconsider
- March 11, 2009: Lawyers for Prof. Craker Submit Supplemental Motion to Reconsider to the DEA
- March 9, 2009: LA Times Editorial Supports Craker, Says DEA Needs Enlightenment
- February 10, 2009: Request to DEA to Vacate Final Order of January 14, 2009
- February 9, 2009: DEA Extends Deadline to March 11 for Response to Final Order Rejecting Craker Marijuana License
- February 6, 2009: ASA gets 16 Members of the United States Congress to Sign a Letter to the Attorney General
- January 30, 2009: A Motion of Reconsideration was Filed in Response to the DEA’s Final Ruling
- January 18, 2009: ACLU Collection of Legal Submissions
- January 14, 2009: DEA refuses to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research
- October 10, 2007: Massachusetts Senators Kerry and Kennedy Commit to Send New Letter to DEA in Support of Prof. Craker
- September 18, 2007: Forty-Five U.S. Representatives Send Letter to DEA in Support of
Medical Marijuana Research
- July 12, 2007: ONDCP and DEA Officials Grilled on MAPS/Craker Case at Congressional Hearing on "DEA's Regulation of Medicine"
- May 12, 2007: Organizations Writing to DEA Supporting Prof. Craker
- May 4, 2007: Final Legal Brief filed in the Craker vs. DEA case
- April 15, 2007. The Sacramento Bee published an excellent op-ed about MAPS DEA Lawsuit
- March 26, 2007 DEA Attorney Submits "Exceptions" to ALJ Opinion
- February 22, 2007: DEA Lawyers to File Objections March 26
- February 21, 2007: Media Coverage of Judge's Decision in Favor of Prof. Craker
- February 13, 2007: MAPS Press Release Following Favorable Recommendation from Judge Bittner
- May 8, 2006: MAPS and DEA file final briefs for DEA Lawsuit
- April 28, 2006: Letter from Members of Congress to FDA
- April 22 - May 25, 2006: The FDA's statement on the medicinal marijuana generates op-ed criticisms
- April 21, 2006: FDA statement on medical marijuana, New York Times reports on responses to statement
- April 6, 2006. The Drugs and the Law Committee of the Association of the Bar of the City of New York sends a tremendous letter to DEA Administrator Karen Tandy.
- March 22, 2006 Report by Rick Doblin, Ph.D., MAPS
- January 6, 2006: DEA Hearing Report, by Rick
Doblin, Ph.D., MAPS
- December 20, 2005: DEA Hearing Report, by
- Sign-on Letter with list of signatories
- December 12, 2005: The Washington Post publishes
an article about the DEA Lawsuit.
- November 22, 2005: Grover Norquist letter to DEA
- Case For A Sign-On Letter to DEA Administrator
Karen Tandy supporting Proposed UMASS Amherst Marijuana Production
- Background on the University of Massachusetts Amherst
Marijuana Production Facility Project
- Statement Of Frederic M. Scherer, professor emeritus
at the John F. Kennedy School of Government, Harvard University.
- August 27, 2005: New York Times Op-Ed, "Marijuana
Pipe Dreams," by John Tierney.
- MAPS/Craker/DEA hearing transcripts
On June 5, Craker’s lawyers filed an impressive list of potential witnesses and documents regarding our pending Motion to Reconsider. DEA has until July 1 to decide whether or not to grant our Motion.
On May 18, DEA filed an Interim Order requesting that Craker submit by June 5, 2009, potential witness and document lists regarding our pending Motion to Reconsider. DEA also extended the effective date of its final ruling to July 1, 2009, leaving it three weeks to consider whether or not to grant our Motion to Reconsider.
On May 11, 2009, Prof. Craker’s lawyers filed an update in the First Circuit Court of Appeals. We have asked for a delay in consideration of our case until after we learn how DEA responds to our pending Motion, which they may accept or reject. On February 13, 2009, in a prescient defensive maneuver, Prof. Cracker’s attorneys filed a “placeholder” notice of appeal in the U.S. Court of Appeals for the First Circuit in Boston, preserving Prof. Craker’s right to appeal just in case DEA eventually denies the Motion to Reconsider; such a denial would effectively end the administrative proceedings and retroactively “finalize” the already-published final order denying his application. On March 12, the Court granted Prof. Craker’s attorneys’ request that the appeal be docketed but no further action be taken until such time as DEA rules on the Motion to Reconsider. The Court also ordered Prof. Craker’s attorneys to file an update every 60 days about the status of the case, with May 11 being the due date for the first update. If DEA denies the Motion to Reconsider, the appeal process is already started and a briefing schedule will be set. If DEA grants in part or in whole the Motion to Reconsider, the attorneys will focus on presenting new information to DEA and can further postpone (or completely eliminate the need for) the appeal.
May 1, 2009, was the effective date of DEA's final ruling rejecting Prof. Craker's license. However, we have still heard nothing from DEA in response to Prof. Craker’s Motion to Reconsider. Based on conversations between Allen Hopper, Prof. Craker’s ACLU attorney, and Teresa Wallbaum, Acting Deputy Chief for Policy and Appeals, US Department of Justice, Criminal Division, Narcotic and Dangerous Drug Section, and also additional conversations between Senator Durbin's staff and DEA officials, we have learned that DEA review of the Motion to Reconsider is still pending and that DEA intends to issue a written order adjudicating the Motion. We also learned that it is not rare for Motions to Reconsider, like the one filed here, to be resolved even after so-called “final orders” have become “effective.” In other words, there is still some possibility that DEA may grant in part or in whole the still-pending Motion to Reconsider, which could significantly change the “final” order.
On April 29, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEA's final decision regarding Prof. Craker's application for a license to grow marijuana for research. This follows a similar letter sent on April 15 by Congressmen John Olver and Sam Farr requesting that Ogden intervene on behalf of Prof. Craker.
On April 15 Congressmen John Olver and Sam Farr sent a letter to DEA requesting that Ogden intervene on behalf of Prof. Craker by asking the DEA to cease going forward on its May 1 deadline.
DEA lawyers file their final document seeking to counter arguments made by Prof. Craker's lawyers requesting a hearing to rebut new evidence and false claims made in DEA Acting Administrator Leonhart's January 14, 2009, Final Order. DEA's Final Order rejected DEA Administrative Law Judge Bittner's February 12, 2007, recommendation that it would be in the public interest for DEA to issue Prof. Craker, UMass Amherst, a license for a medical marijuana production facility. DEA's Final Order goes into effect May 1, unless a hearing or opportunity for written testimony is granted.
On March 25, DEA lawyers filed a motion extending to April 13 the deadline for DEA's reply to our Supplemental Motion to Reconsider, with the final order now going into effect April 24, unless our Motion to Reconsider is granted. We now have several more weeks to lobby the Obama Administration to accept ALJ Bittner's recommendation that it would be in the public interest for DEA to issue a license to Prof. Craker.
On March 11, 2009, lawyers for Prof. Craker submitted a powerful Supplemental Motion To Reconsider and Exhibits to DEA Deputy Administrator Michelle Leonhart, adding to a Motion to Reconsider filed January 30. These motions request a hearing to present opposing arguments to new evidence that DEA cited in its January 14, 2009, Final Order rejecting DEA Administrative Law Judge Bittner’s February 12, 2007 recommendation that Prof. Craker receive a license to grow marijuana for federally-licensed research. Prof. Craker’s facility would be sponsored by MAPS. Unless DEA grants the motion to reconsider, the final order becomes effective April 1, 2009.
The Los Angeles Times editorialized in favor of DEA licensing of Prof. Craker's medical marijuana production facility, citing as support President Obama's March 9, 2009 statement about scientific integrity. The LA Times editorial said, "DEA is one of the many federal agencies ready for enlightenment."
Attorney Julie Carpenter, Jenner & Block, wrote a letter to DEA on February 10, 2009, requesting that DEA vacate the final order published in the Federal Register on January 14, 2009. Unless the order is vacated, we'll go ahead this Friday and file an appeal with the DC Circuit Federal Court of Appeals
DEA Deputy Administrator Michelle Leonhart, in response to a compelling Motion to Reconsider filed by Prof. Craker’s lawyers and to a letter to new AG Eric Holder from 16 Congressional Representatives, agreed in a February 9, 2009, Order in Response to Respondent’s Request to extend to March 11, 2009, the deadline for a response to DEA’s January 14, 2009 Final Order. In that Final Order, DEA rejected ALJ Bittner’s February 12, 2007 recommendation that it would be in the public interest for DEA to license Prof. Craker to grow marijuana for federally-licensed research. Prof. Craker’s facility would be sponsored by MAPS.
Sixteen members of the United States Congress sent a letter to new Attorney General Eric Holder urging him to have DEA “amend or withdrawal the Final Order in this matter to permit President Obama’s new Deputy Attorney General and DEA appointees to review Prof. Craker’s merits, once they are in office.” This letter was orchestrated by our sister organization Americans for Safe Access (ASA), who also distributed a press release. The 16 signatories are Representatives John Olver, Maurice Hinchey, Ron Paul, Tammy Baldwin, Raul Grijalva, Sam Farr, Robert Wexler, Ed Pastor, Neil Abercrombie, Gary Ackerman, Lynn Woolsey, William Delahunt, Barney Frank, Zoe Lofgren, Michael Capuano, and Dennis Kucinich.
Lawyers for MAPS and Professor Lyle Craker filed a motion of reconsideration in response to theDrug Enforcement Administration’s (DEA) final ruling. MAPS and Professor Craker rebutted DEA’s final order with the support of theAmerican Civil Liberties Union (ACLU)on grounds that new evidence was introduced in the final ruling that was not included during testimony in the case.
ACLU has created a webpage with a comprehensive set of the legal documents in the Craker case and other commentary.
The Bush administration struck a parting shot to legitimate science on
January 14th, as the Drug Enforcement Administration (DEA) published in the Federal Register a final ruling refusing to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research. DEA's final ruling rejected the nearly 2-year-old recommendation of DEA Administrative Law Judge Mary Ellen Bittner. The prior recommendation on February 12, 2007, stated that it would be in the public interest to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for legitimate scientific research. The DEA’s contradictory ruling continues its policy since 1970 of forcing the controversy over the medical use of marijuana to be resolved through political struggles rather than scientific research. NIDA's monopoly fundamentally obstructs MAPS’ research aimed at developing smoked or vaporized marijuana into a prescription medicine.
Senior US Senators Edward Kennedy and John Kerry have agreed to send a new letter to DEA Administrator Karen Tandy urging her agency to accept the recommendation of DEA Administrative Law Judge Mary Ellen Bittner to grant a Schedule I license to University of Massachusetts professor Lyle Craker, PhD, for his proposed MAPS-sponsored medical marijuana production facility. An independent supply of research-grade medical marijuana is the key prerequisite for MAPS' plan to conduct the clinical trials necessary to develop marijuana into a legal US FDA-approved prescription medicine. In 2004, before our successful lawsuit against DEA, the duo of Massachusetts Senators sent a similar letter to DEA urging the agency to license Prof. Craker. In the coming months, MAPS and our allies will be targeting several key Senators to add their names to Kerry and Kennedy's letter, building on the momentum of last month's letter from 45 US Representatives to DEA in support of Prof. Craker's proposed facility.
The DEA has no deadline to decide whether to accept or reject Judge Bittner's non-binding ruling. As a result, we expect that DEA will continue to use its best weapon against medical marijuana research -- inaction.
On September 19, a letter signed by 45 members of the U.S. House of
Representatives will be delivered to U.S. Drug Enforcement
Administration (DEA) Administrator Karen Tandy urging her agency to
license UMass-Amherst professor Lyle Craker to establish the nation's
first privately funded research-grade marijuana production facility.
This letter demonstrates to DEA that there is a growing political will
to end the federal government's monopoly on the supply of marijuana
that can be used in FDA-approved research.
The bipartisan letter (pdf), co-sponsored by Reps. John Olver
(D-MA) and Dana Rohrabacher (R-CA), urges DEA to follow Administrative
Law Judge Mary Ellen Bittner's February, 2007 ruling in favor of Prof.
Craker. The law judge's ruling is non-binding and DEA has no deadline
to decide whether to accept or reject it.
Craker's applications for regulatory approval, legal efforts, and
proposed facility are sponsored by MAPS, which plans to design, fund,
and obtain government approval for the clinical trials necessary to
determine whether marijuana meets FDA requirements for medical safety
On July 12, in the new Congress's first oversight hearing on the federal government's role regarding medical marijuana, Reps. Bobby Scott (D-VA) and Jerrold Nadler (D-NY) grilled officials from ONDCP and DEA on their role in obstructing Prof. Lyle Craker's MAPS-sponsored medical marijuana production facility. Rep. Nadler asked a series of pointed questions about NIDA's unique monopoly on the supply of marijuana for FDA trials, Judge Bittner's recent ruling in favor of MAPS and Prof Craker, and the DEA's timeline for issuing a decision on whether to accept or reject Judge Bittner's "Recommended Ruling."
First, Nadler asked Rannazzisi why marijuana is the only Schedule One drug for which the federal government has a monopoly on supply. Rannazzisi cited international treaty obligations, a line of reasoning already disproved in court. Then, Nadler asked if the DEA would make a decision on Judge Bittner's ruling in favor of Prof. Craker by the end of Bush's term. When Rannazzisi couldn't answer, Nadler asked how long the DEA normally takes to process a recommendation from an administrative law judge. Rannazzisi said it varies from case to case, but Nadler wasn't satisfied, and continued the line of questioning by asking whether it takes closer to one year, two years, or five years. Rannazzisi asked to answer in writing following the hearing. Nadler insisted that he wanted a commitment that the decision would be made on Prof. Craker's application before the end of Bush's term in January, 2009.
To read the written transcript of this oversight hearing in HTML click here (html), or to read as a PDF click here (pdf).
DEA and NIDA's obstruction of medical marijuana research is becoming increasingly difficult for those agencies to hide from politicians -- and from the public, as evidenced by the increased media scrutiny of DEA's obstruction of MAPS and Prof. Craker:
"Scientists Stir the Pot for Right to Grow Marijuana"
The Economist editorial in support of Prof. Craker:
"Joint Action: A Victory for American cannabis researchers"
Los Angeles Times editorial in support of Prof. Craker:
"Not Enough Marijuana"
Associated Press (As published in the Boston Globe)
"UMass professor seeks to grow medical marijuana"
Washington Post (Also appeared in the San Francisco Chronicle)
"Researchers Press DEA to Let Them Grow Marijuana"
New York Times (online edition)
"Marijuana Researchers Make Progress in the Lab, but not in Washington"
Honolulu Star Bulletin
"Editorial: Medical Marijuana Research Should Not Be Hampered"
| Prof. Craker, assisted by a great legal team led by Julie Carpenter, Jenner & Block, Allen Hopper, ACLU, and Emanuel Jacobowitz, Steptoe & Johnson, and including Christina Alvarez, ACLU and Lauren Payne, MAPS, filed the final legal brief today in the Craker v. DEA case. This brief is a strong response to the DEA's "exceptions" to ALJ Bittner's recommendation that it would be in the public interest for DEA to register Prof. Craker as a bulk manufacturer of marijuana, to produce marijuana sponsored by MAPS.
|The Sacramento Bee published an excellent op-ed by
Claire Cooper entitled, "Rejected in Court, Medical Pot Advocates Turn
to DEA." The op-ed is an excellent summary of the legal and political
issues regarding our DEA lawsuit. It's a new world now that DEA
Administrative Law Judge Bittner has recommended that it would be in the
public interest for DEA to issue Prof. Craker a license for a
MAPS-sponsored medical marijuana production facility.
| DEA Attorney Charles Trant submitted DEA's "exception" to the February 12, 2007 opinion of ALJ Bittner. Trant objected to ALJ Bittner's recommendation that it would be in the public interest for DEA to give Prof. Lyle Craker a license for a MAPS-sponsored medical marijuana production facility. Lacking much in the way of a good argument, Trant spent lots of time talking about international treaty obligations, and criticizing MAPS President Rick Doblin, at one point comparing him to Pablo Escobar.
A detailed rebuttal is being prepared by Prof. Craker's legal team, to be submitted to the ALJ's office by May 4, 2007. A few weeks or so after that, ALJ Bittner will forward her recommendation, along with the dueling legal documents, to DEA for a formal ruling. A coalition of medical marijuana and drug policy reform groups will try to generate pressure on DEA from Congress, seeking Representatives and Senators willing to sign a letter to DEA Administrator Tandy, urging her to accept ALJ Bittner's recommendation. Unfortunately, DEA has no time limit for when it must issue its final ruling.
| The DEA's lawyers have requested an extra 20 days to file their objections to the Judge's decision. In doing so, they also granted MAPS' lawyers an additional 20 days. This means that the earliest the DEA will begin to process the Judge's recommendation will be in mid-May. At that point, the DEA Deputy Administrator has an unlimited amount of time to decided whether to accept or reject the Judge's non-binding recommendation to grant Prof. Craker a Schedule I license for his MAPS-sponsored marijuana production facility. We expect the decision could come from the DEA anywhere between 3-15 months from May.
Since the Judge¹s decision is non-binding, MAPS must coordinate another Congressional lobbying campaign after the DEA¹s lawyers file their objections on March 26. Our aim will be to generate sufficient pressure on the DEA to accept the Judge¹s recommendation by granting Prof. Craker a Schedule I license, thus breaking NIDA's marijuana research monopoly and finally paving the way for putting marijuana through FDA clinical trials.
| The top media outlets across the country are taking notice of MAPS' historic
legal triumph over the DEA. MAPS produced this podcast to
spread news of the case, its implications, and MAPS' plans to pressure DEA
to follow the Judge's recommendation.
Truth and Medical
Judge: Let prof grow medicinal
San Francisco Chronicle:
Judge sides with botanist on
McClatchey News' newswire article, which was carried in The Miami
Herald, San Jose Mercury-News, Seattle Post-Intelligencer and
Judge rules government supply
of marijuana is inadequate
St. Petersburg Times:
DEA stymies science
Northeast Mississippi Daily Journal:
Ole Miss may get competition
in growing marijuana
Reefer Madness: Judge Supports
Bid to Grow Research Pot
Contact Jag Davies, MAPS Director of Communications
(831) 336-4325 or firstname.lastname@example.org
For Immediate Release
February 13, 2007
DEA Judge Recommends End to Government Obstruction of Medical Marijuana
Historic Step Toward Nation's First Privately-Funded Marijuana Production
Washington, D.C. - University of Massachusetts-Amherst Professor Lyle
Craker, MAPS, the ACLU, and a broad array of medical and public policy
groups nationwide enthusiastically supported today's official recommendation
by Drug Enforcement Administration (DEA) Administrative Law Judge Mary Ellen
Bittner that Prof. Craker be permitted to grow research-grade marijuana for
use in privately-funded government-approved studies that aim to develop the
marijuana plant into a legal, prescription medicine. Judge Bittner ruled
that it is in the public interest to end the federal government's monopoly,
which it has maintained for over six decades, on the supply of marijuana
that can be used in FDA-approved research.
"This ruling is a victory for science, medicine and the public good," said
Prof. Craker. "I hope the DEA abides by the decision and grants me the
opportunity to do my job unimpeded by drug war politics."
Opinion and Recommended Ruling by Judge Bittner, who is appointed by the
U.S. Department of Justice, marks a unique window of opportunity in the six
year struggle by MAPS and Prof. Craker to gain a Schedule I DEA license to
grow research-grade marijuana for use by scientists in MAPS-funded, DEA- and
"For decades, politicians have said that marijuana has no proven medical
value while scientists have been denied the ability to prove otherwise,"
said Rick Doblin, Ph.D., president and founder of MAPS.
The court¹s ruling is only a recommendation to DEA Deputy Administrator
Michele Leonhart, however, not a binding ruling; thus, the DEA retains final
decision-making authority. In response, scientists, researchers, doctors and
medical marijuana patients nationwide are joining MAPS and the ACLU by
encouraging the DEA to comply with the court¹s finding and to halt federal
obstruction of medical marijuana research.
Prior to this recent ruling, organizations that had already written to DEA
in favor of Prof. Craker's application included the Multiple Sclerosis
Foundation, the Lymphoma Foundation of America, the National Association for
Public Health Policy, the United Methodist Church, Americans for Tax Reform,
the American Medical Students Association, several state nurses'
associations, the Massachusetts Dept. of Public Health, Massachusetts
Senators Kerry and Kennedy, 38 members of the US House of Representatives,
and the California and Texas State Medical Associations, the two largest US
state medical associations.
If the DEA grants Prof. Craker a Schedule I license, his proposed
research-grade medical marijuana production facility will be funded by MAPS,
a non-profit research organization that plans to design, fund, and obtain
government approval for the clinical trials necessary to bring marijuana to
market as a fully legal, prescription medication. MAPS has had two
FDA-approved marijuana studies blocked by NIDA, and would require a
reliable, high-quality supply of research material to justify the time and
expense to sponsor FDA-approved clinical research evaluating the risks and
benefits of marijuana as a potential FDA-approved medicine.
The ACLU and the Washington D.C. law firm Jenner & Block, LLP are co-counsel
for the case and are assisted by Steptoe & Johnson, LLP.
|Today, a final brief (PDF) was submitted to DEA Administrative Law Judge (ALJ) Mary Ellen Bittner by lawyers for Prof. Lyle Craker (lead lawyer Julie Carpenter, Jenner & Block, assisted by Allen Hopper, ACLU and Emanuel Jacobowitz, Steptoe & Johnson). Prof. Craker's lawsuit against DEA is for refusing to permit him to establish a MAPS-sponsored medical marijuana growing facility at the University of Massachusetts-Amherst. DEA also filed its final brief today (PDF). We anticipate that DEA ALJ Judge Bittner will issue her recommendation to DEA Administrator Karen Tandy within the next two to four months.
If ALJ Bittner issues an unfavorable recommendation, DEA wins and there will probably be no privately-funded medical marijuana research effort ever started until a more reasonable President is in office. If ALJ Bittner does issue a favorable recommendation, we will need to organize a major coordinated campaign to obtain letters of support from members of Congress, especially Republicans, urging DEA Administrator Karen Tandy to accept the favorable recommendation. Tandy will probably take several months to study the recommendation before issuing her final ruling. During that time is our period of maximum opportunity. In these turbulent times, it does seem within our reach for us to mobilize sufficient pressure on DEA to force the acceptance of a favorable recommendation. If ALJ Bittner does issue a favorable recommendation and Tandy rejects it, we can still sue DEA in the DC Circuit Court of Appeals, but that will take more time and money and will continue DEA's strategy of delay. Still, if DEA rejects a favorable recommendation, we should be able to inflict a significant blow to whatever remains of the credibility of DEA and ONDCP by showing the hypocritical nature of blocking research while supposedly objecting to medical marijuana on the basis of there not being enough research to prove that it should become an FDA-approved prescription medicine. DEA rejection of a favorable recommendation will also strengthen the case for state-level reforms.
|On April 28, 2006, a letter to FDA was sent by 24 Members of Congress asking for the scientific basis of the recent statement by FDA on the medicinal potential of marijuana.
The FDA's statement on the medicinal potential of marijuana, issued April 20, 2006, generated a number of editorial criticisms:
April 22, 2006: The New York Times
April 23, 2006: The Chicago Tribune
April 26, 2006: The San Diego Union-Tribune
April 27, 2006: The Economist
May 17, 2006: Medscape General Medicine
May 19, 2006: In These Times
May 25, 2006: Cancer Monthly
|The FDA issued a statement indicating that marijuana had no currently accepted medical uses. Stories in the New York Times, the Washington Post and the Associated Press reported on this statement and responses to it within and outside the medical community. Prof. Lyle Craker is quoted discussing his lawsuit against the DEA for refusing to issue him a license for a marijuana production facility. NIDA's marijuana was criticized for poor quality, but not for the more comprehensive lack of an "adequate and uninterrupted" supply that is the basis of Prof. Craker's lawsuit. FDA's statement wasn't that marijuana had no medical uses. Rather, what the statement actually means is that due to a lack of research data from large Phase III studies, which won't take place until NIDA's marijuana monopoly is broken, FDA will consider marijuana to have no currently accepted medical uses. This statment points yet again to the need for large-scale, privately-funded Phase III studies with smoked and vaporized marijuana, which DEA is blocking by refusing to issue Prof. Craker his license.
|The Drugs and the Law Committee of the Association of the Bar of the City of New York has sent a tremendous letter to DEA Administrator Karen Tandy urging her to issue a license to Prof. Lyle Craker for a MAPS-sponsored marijuana production facility. The letter, signed by Chair John H. Doyle III, Esquire, cites specific testimony from the hearings to support a series of legal arguments that make a compelling case for DEA's legal obligation to issue the license.
Lawyers from both sides of the case have agreed to extend the deadline to April 27 for the submission of final legal briefs in Prof. Lyle Craker's MAPS-supported lawsuit against the DEA for obstructing a MAPS-sponsored medical marijuana production facility. Prof. Craker's facility is a prerequisite to beginning MAPS-sponsored clinical trials into the risks and benefits of marijuana as a potential FDA-approved prescription medicine.
DEA Administrative Law Judge Mary Ellen Bittner is expected to make a decision three to six months after the briefs have been submitted. If Judge Bittner issues an unfavorable recommendation, obtaining a license for Prof. Craker's facility would require an Act of Congress or much more political pressure on DEA than we have brought to bear to date. If Judge Bittner issues a favorable recommendation, DEA Administrator Karen Tandy would probably take several months to prepare her ruling. During this time, MAPS would help initiate a major collaborative campaign to obtain letters of support for Prof. Craker's license from many members of Congress, focusing primarily on Republicans, using the letter of support we have already obtained from Republican strategist Grover Norquist.
On March 2, MAPS learned that it was awarded a grant of $35,500 from the Marijuana Policy Project (MPP) to cover legal expenses for the DEA lawsuit.
|Our lawyers learned that DEA has decided not to
hold the final hearing that had been scheduled for January 17, solely
in order to cross-examine under oath our rebuttal witness, Al Byrne.
Perhaps DEA lawyers read my commentary posted on the MAPS website
on December 20, 2005, in which I suggested that it would be wise for
them not to call Al as a witness since he would have persuasively
testified to the low quality of NIDA marijuana and to the veracity
of the picture of the seeds and stems in three NIDA marijuana cigarettes
that Prof. ElSohly had foolishly challenged as being somehow not accurate.
Probably, DEA lawyers were just trying to intimidate Al into withdrawing
his affidavit in order to avoid having to testify under oath inside
DEA headquarters. When that failed, they decided to cancel the hearings
regardless of my suggestions, which they haven't taken in other instances
anyway. In any case, there will now be no more courtroom drama, only
dueling legal briefs. At this point, I guess that the final briefs
will be due in several months and that DEA Administrative Law Judge
Mary Ellen Bittner will issue her recommendation to DEA Administrator
Karen Tandy in late Spring or early Summer 2006.
|I'm back home after a week in DC for the DEA hearings.
Our lawyers and I are convinced that the DEA witnesses ended up helping
our case substantially more than the DEA's case. The hearings are
now almost all over except for one additional witness who is scheduled
to testify on January 17. The story of this final witness will help
explain the DEA's self-destructing case (though whether the DEA Administrative
Law Judge Mary Ellen Bittner will recommend that Prof. Craker receive
his license is too difficult to predict).
The DEA called Mahmoud ElSohly, NIDA's grower at UMiss, as a witness
on both Monday and Tuesday. He claimed that he could provide marijuana
of any potency and CBD content and thus no alternative source of
supply was needed. At one point, he was looking at a document that
contained information on the marijuana in NIDA's inventory. We managed
to ask to see it and then get it introduced into evidence. There
is nothing in the inventory with a CBD content more than about half
of what the Dutch government is offering, and only small amounts
of high-THC content marijuana, which have even lower amounts of
CBD. There is nothing comparable to a strain offered by the Dutch
government, containing 18% THC and 0.8% CBD.
ElSohly consistently defended the quality of NIDA's marijuana.
He was quite sensitive about the quality of his product and explained
proudly about the new equipment that can take the seeds and the
stems out of NIDA's marijuana cigarettes. One of his mistakes was
to get defensive about the picture of the seeds and stems from 3
of NIDA's cigarettes that was published in Dr. Ethan Russo's article
about the study of the Compassionate Use patients. He got so defensive
that he ended up stating that the picture couldn't have been from
NIDA's cigarettes but could have been from the raw material, prior
to the seeds and stems being taken out. He even said that the seeds
looked larger than they should have compared to the size of the
stems and came as close as you could to claiming the photo was fraudulently
doctored without actually saying the word fraud.
After ElSohly's testimony, I contacted Al Byrne, who was in the
room when the picture was taken, and ask Al if he would testify.
After ACLU lawyer Allen Hopper had a conversation with Al's lawyer,
Al agreed to submit a signed affidavit that we tried to introduce
into evidence on Friday. The affidavit was submitted to DEA lawyer
Brian Bayly and the Judge. The Judge then asked Mr. Bayly whether
he had any objections to introducing the affidavit as rebuttal evidence.
At this point, one of the most telling moments in the entire hearing
took place, the classic pregnant pause. Mr. 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, a long, slow period
of time. We could tell that Mr. Bayly was struggling to figure out
how to object to this affidavit, and was perhaps also cursing ElSohly
for making such foolish and unnecessary statements. He remained
still for so long that Judge Bittner felt it necessary to speak
again, asking him once more if he had any objections. He then shook
off his paralysis and went over the letter paragraph for paragraph,
line for line, trying to exclude whatever background information
that wasn't directly about the photograph itself. Our attorney,
Julie Carpenter, did a great job of arguing that the background
information was helpful to provide context. The Judge then ruled
to admit the letter in its entirety! We now have ElSohly claiming
that NIDA marijuana can't possibly be as bad as it really is, and
we have photos and witnesses to prove that it is indeed that bad.
Then, in what seems like an example of pulling an even greater
defeat out of the jaws of a significant defeat, Mr. Bayly said that
he wanted to cross-examine Al Byrne! All the other testimony is
over, but the Judge was compelled to schedule another hearing date
on January 17 just to bring in Al to be placed under oath on the
witness stand. Al is eager to have his day in court in order to
be able to tell the Judge all he knows about the low quality of
NIDA's pot. What I think Bayly was hoping is that Al wouldn't want
to be called to testify, and we'd withdraw the affidavit. Once Bayly
learns that Al can't be intimidated into withdrawing his testimony,
we suspect that Bayly will decide to cancel his testimony.
ElSohly also was forced to explain his personal commercial interests
in marijuana-based products, such as his THC suppository and his
new DEA license permitting him to grow marijuana to extract THC
for sale to the pharmaceutical company, Mallincrodt, to manufacture
generic Marinol, which is now off-patent. We established that ElSohly
has a major conflict of interest if he were to be the sole supplier
of marijuana to MAPS for prescription use, if such use were permitted
ElSohly also claimed that if marijuana were to be approved by FDA
using marijuana provided by NIDA, that we would have no trouble
just switching to another product with similar THC levels. Testimony
on Friday by DEA's expert on pharmaceutical drug development blew
this apart, as I'll explain below.
In the DEA hearing on Wednesday, we got several very important
admissions out of Steve Gust, Assistant Director of NIDA. First
off, he said that the PHS/NIDA review of protocols, after FDA review,
takes between 3-6 months. This is incredibly damning since time
delays in pharmaceutical drug development are very expensive and
substantially impede the process. Alternatively, FDA has just 30
days to respond to protocol submissions. Then Steve Gust said that
there is no formal appeal process but that if an appeal is made,
it might take another 3-6 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. He also
claimed that there were FDA staff on the Chemic review committee
but couldn't name anyone from FDA and had to back off that claim.
He then said there is no clear way to obtain a list of the reviewers.
These sorts of delays, on top of the arbitrary nature of the review
process, are more than enough to persuade any funders of marijuana
research that it isn't worth investing millions of dollars in a
serious drug development effort. The problems with the NIDA review
process provide a strong argument for the research-restricting nature
of NIDA's monopoly on the supply of marijuana legal for FDA-approved
Steve Gust said that the purpose of NIDA's review was to make sure
that the protocols were scientifically meritorious, and that FDA
just reviewed for safety. Unfortunately for him, the official HHS
statement of policy about the provision of marijuana to privately-funded
studies says in no uncertain terms that 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 got him to admit, reluctantly, that FDA doesn't
just review for safety but also for scientific merit. He wouldn't
say it but this makes the NIDA review clearly duplicative and unnecessary.
We also got Gust to acknowledge that the priorities of the HHS
guidelines for providing marijuana to researchers are clearly skewed
away from research aimed at developing marijuana into a medicine
in its plant form, with the guidelines even using the word "must"
be aimed at developing marijuana extracts. He tried to dodge saying
that it wouldn't make any difference to NIDA if protocols were aimed
at developing the marijuana plant itself into a prescription medicine,
but he couldn't explain away the clear language of the guidelines.
Also on Wednesday, we were able to enter into the official exhibits
the updated Congressional sign-on letter to DEA urging approval
of Prof. Craker's license, which 38 Reps. have now signed. In order
to try to minimize and discredit it, DEA attorney Brian Bayly remarked
first off that if we got another several hundred or so, the hearings
wouldn't be necessary. Then he said that all the signatories were
probably Democrats, as if their support didn't indicate a significant
public interest in ending NIDA's monopoly on supply but were only
indicative of partisan sniping. We replied that we had two Republicans
and also a letter of support from Grover Norquist.
Thursday, the DEA had no witnesses and there were no hearings
Friday, the first DEA witness was Dr. Eric Voth, prominent and
long-time prohibitionist. Even though he was supposed to talk about
the risks of diversion, and not directly about the risks and/or
benefits of marijuana, he couldn't help but talk about the risks
of marijuana and compared marijuana smoke to tobacco smoke. That
gave us an opportunity to get something into evidence that we'd
been looking to do ever since my testimony in August, when I'd failed
to find a way to mention Dr. Donald Tashkin's new study showing
that marijuana wasn't linked to lung cancer, and actually had a
slight protective effect. We asked Dr.Voth about the comparison
he made between marijuana and tobacco smoke and he discussed Tashkin's
results in a rather accurate manner, getting on the record that
there is no scientific evidence linking marijuana to lung cancer!
We also got him to admit that the cannabinoids have anti-tumor properties
while nicotine does not.
Voth then made claims about the dangers of high-potency marijuana
and stated that there was no evidence that people self-titrated
high-potency marijuana in a way that enabled them to inhale less
smoke. He made other claims about the addictive nature of marijuana,
the link to mental illness, etc. This enabled us to ask that a chapter
from Lester Grinspoon's Marijuana-The Forbidden Medicine, "Measuring
the Risks," be entered into evidence as rebuttal, even though
the DEA had previously requested, and the Judge had agreed, to block
us from entering Lester's book since the risks and benefits of marijuana
wasn't at issue in this case. The Judge now agreed to let us provide
this information as rebuttal evidence, and Lester's excellent chapter
is now officially in evidence in this case, contradicting Voth's
testimony in numerous ways.
Voth's main point was that marijuana has so many ingredients that
it can't possibly be made into a medicine. He testified that it
was extremely difficult to standardize marijuana since different
plant strains could be so different from each other, 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 is the sort of argument that was more persuasive
up until about 10 years ago, before the FDA developed guidelines
for the investigation of botanical medicines.
Later in the day, over strenuous DEA objections, we were able to
enter into evidence FDA statements saying that FDA welcomes research
protocols aimed at evaluating whether the marijuana plant is safe
and efficacious and deserved to be available as a legal prescription
drug. Once again, FDA's willingness to place science over politics
was of major assistance to our efforts.
DEA's final witness, Dr. Auslander, was an expert in pharmaceutical
drug development. His entire testimony ended up substantially helping
our case. He started by reinforcing the view expressed by Dr.Voth
that it was extremely difficult to standardize a plant and that
different strains might look similar but had significantly different
"fingerprints" of the chemical composition. He admitted
that cloned plants had identical genetic fingerprints. Most importantly,
at the end of his testimony, we asked him if the difference in fingerprints
of different strains was something that FDA would be concerned about.
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 FDA and could require replication of some
clinical studies which are very expensive. What he didn't realize
was that this is the exact opposite of what ElSohly testified to,
saying we could conduct research with NIDA marijuana and then just
switch to another plant strain if we didn't want to get marijuana
for prescription use from him, of the same strain he grew for NIDA.
ElSohly was not presented to the Court as an expert in pharmaceutical
drug development, but Dr. Auslander was. His testimony therefore
is more important on these points. Dr. Auslander thus supported
one of our main points, that conducting research with NIDA marijuana
from ElSohly isn't reasonable since NIDA's mission doesn't include
providing marijuana for prescription sales, just research. Therefore,
if we use NIDA marijuana in research and prescription use is approved,
we either have to obtain the same strain from ElSohly, who has major
conflicts of interest since he has other products for which smoked
or vaporized marijuana would compete plus since he would lack competition
could charge anything he wanted, or we could try to obtain FDA approval
to market a different strain from a new manufacturer. However, switching
to a new manufacturer would present new difficulties due to the
different fingerprints of the different strains, even if we matched
THC levels (though in our opinion we should also have to match CBD
levels since this is a pharmacologically active cannabinoid). In
any case, there is no alternative supplier with a DEA license and
starting a new facility would take a substantial amount of time,
easily a year or more, with these time lags being very costly after
investing millions in research. In response to our final questions,
Dr. Auslander testified very helpfully that pharmaceutical companies
would want to be assured of a reliable and consistent supply of
a drug that could be used in research and also be available for
prescription sales. This is what we have been saying all along and
is something that isn't guaranteed as long as NIDA retains its monopoly.
We ended the week thankful for DEA's witnesses, eagerly looking
forward to the final testimony on January 17, though we would not
be surprised if DEA decides to cancel the cross-examination of Al
for a copy of the final letter sent December 6, 2005, PDF Format
DEA Administrator Karen P. Tandy
Drug Enforcement Administration
2401 Jefferson Davis Highway
Alexandria, VA 22301
Dear Administrator Tandy,
We are writing to express our strong support for the application
from Professor Craker, of the University of Massachusetts-Amherst,
for licensing as a bulk manufacturer of marijuana for distribution
exclusively to federally-approved researchers. We believe the DEA
licensing of Prof. Craker's privately-funded facility would be in
the public interest.
At present, the National Institute on Drug Abuse (NIDA) has an
unjustifiable monopoly on the production of marijuana for legitimate
medical and research purposes in the United States, grown under
contract to NIDA at the University of Mississippi. Federal law clearly
requires adequate competition in the manufacture of Schedule I and
II substances. (See 21 U.S.C. § 823(a)(1); see also 21 C.F.R.
§ 1301.33(b).) The licensing of Prof. Craker's facility would
provide privately-funded sponsors of FDA-approved research the necessary
opportunity to conduct studies with a strain of marijuana of their
own choosing, with immediate access to the strain for all FDA-approved
studies and for possible prescription use. None of this is the case
under NIDA's monopoly. Until an alternative source of supply is
available, important privately-funded research into the therapeutic
effects of marijuana for patients undergoing chemotherapy or suffering
from AIDS, glaucoma, multiple sclerosis, or other diseases will
not be initiated.
The University of Massachusetts-Amherst is one of the nation's
distinguished research universities, and it is highly qualified
to manufacture marijuana for legitimate medical and research purposes
with effective controls against diversion. NIDA's monopoly makes
very little sense given that the DEA has licensed privately-funded
manufacturers of virtually all other Schedule I drugs, including
LSD, MDMA (Ecstasy), and psilocybin.
As one of your predecessors, DEA Administrator Robert Bonner, stated,
"Those who insist that marijuana has medical uses would serve
society better by promoting or sponsoring more legitimate scientific
research, rather than throwing their time, money and rhetoric into
lobbying public relations campaigns and perennial litigation."
We urge you to grant Prof. Craker's application for registration
as a bulk manufacturer so that such legitimate and privately-funded
scientific research can be conducted.
Marijuana Monopoly Challenged
Craker from the University of Massachusetts at Amherst would like
to grow marijuana for pharmaceutical research. He is challenging
the government's control of the substance. (By Bob Stern -- (Springfield,
Researchers Want to Grow More Plants and Find More Medicinal Uses
By Marc Kaufman
Washington Post Staff Writer
Monday, December 12, 2005; A02
For decades, the federal government has been the nation's only
legal producer of marijuana for medical research. Working with growers
at the University of Mississippi, the National Institute on Drug
Abuse has controlled both the quality and distribution of the drug
for the past 36 years.
But for the first time the government's monopoly on research marijuana
is under serious legal challenge. The effort is being spearheaded
by a group that wants to produce medicines from currently illegal
psychedelic drugs and by a professor at the University of Massachusetts
who has agreed to grow marijuana for the group if the government
In a hearing due to start today before an administrative law judge
at the Drug Enforcement Administration, professor Lyle Craker and
his supporters will argue for a DEA license to grow the research
drugs. It is the climax of a decades-long effort to expand research
into marijuana and controlled drugs and of Craker's almost five-year
effort to become a competing marijuana grower.
"Our work is focused on finding medicinal uses of plants, and marijuana
is one with clear potential," said Craker, director of the medicinal
plant program of the university's Department of Plant, Soil and
Insect Sciences in Amherst, Mass., and editor of the Journal of
Herbs, Spices and Medicinal Plants. "There's only one government-approved
source of marijuana for scientific research in this country, and
that just isn't adequate."
The DEA, which has to license anyone who wants to grow marijuana,
The agency, as well as the National Institute on Drug Abuse, which
formally runs the marijuana research program, argues that it is
not in the public interest to have more than one source of marijuana,
in part because it could lead to greater illicit use. What's more,
they said in legal briefs, the Mississippi program supplies all
the marijuana that researchers need. Agency officials declined to
In his suit against the DEA for a license to grow marijuana, Craker
has backing from 38 members of Congress, the two senators from Massachusetts,
numerous medical societies and even Grover Norquist, the president
of the conservative Americans for Tax Reform.
The effort has been organized by Richard Doblin, president of the
Multidisciplinary Association for Psychedelic Studies (MAPS) and
a longtime advocate of medical research into controlled drugs. It
was Doblin who recruited Craker after the association concluded
it would never get a dependable supply of government marijuana.
"Dr. Craker has no goal here except to advance scientific research
into marijuana, and our goals are the same," said Doblin, whose
group is also sponsoring research into other controlled drugs, including
MDMA (better known as "ecstasy") and the psychedelic mushroom psilocybin.
"By controlling who can research marijuana and how they can do
it, the DEA has greatly limited promising research that could lead
to [government] approved medications," Doblin said.
The problems, he said, are not limited to winning approval to buy
the Mississippi marijuana. Doblin and other researchers contend
that the government marijuana is low in quality and potency and
could never be a stable source of basic ingredients if the Food
and Drug Administration ever did approve a marijuana-based medication.
Marijuana, or cannabis, is now listed as a Schedule I drug -- with
no medicinal use -- under the Controlled Substances Act. Its use
was initially restricted in 1937 and eliminated from medicinal practice
in 1942. On its Web site, the DEA lists marijuana as the most frequently
abused illicit drug in America.
Since the 1970s, however, researchers have found potential uses
for marijuana, or its active ingredient THC, in relieving nausea
and vomiting associated with chemotherapy and to help with appetite
loss in AIDS patients. A synthetic form of marijuana's active ingredient
has been made into a prescription drug, Marinol.
Doblin said there are potentially many other medicinal uses of
marijuana, including the treatment of multiple sclerosis and AIDS-related
neuropathy. He also said researchers believe that if they can perfect
a method of "vaporizing" marijuana -- allowing it to be inhaled
rather than smoked -- it would be easier to administer as medicine.
But because of fears of illicit use, he said, the agency has essentially
blocked the research. "I believe the DEA policy is one of delay,
and they've succeeded in essentially blocking marijuana development
for 30 years," Doblin said.
In its filings with Administrative Law Judge Mary Ellen Bittner,
the DEA disputes the charge that it is standing in the way of marijuana
It says that medical marijuana research is underway in California
using its Mississippi supply, and that the drugmaker Mallinckrodt
Inc. has a contract with the Mississippi supplier to produce extracts
of cannabis for its drug development program. In addition, DEA lawyer
Brian Bayly told the law judge in August, when the first five days
of testimony were heard, that the quality and potency of the government's
marijuana was acceptable to the researchers his agency surveyed.
The hearing is expected to continue through the week, with a decision
several months later. If Craker and his team prevail, however, the
DEA is not obliged to give him a license or change its policies.
And as a result, Craker and his team plan to continue lining up
political support, such as the Nov. 22 letter sent by Norquist to
"The use of controlled substances for legitimate research purposes
is well-established, and has yielded a number of miracle medicines
widely available to patients and doctors," Norquist wrote. "This
case should be no different. It's in the public interest to end
the government monopoly on marijuana legal for research."
Version | MS WORD Version
November 22, 2005
DEA Administrator Karen P. Tandy
Drug Enforcement Administration
2401 Jefferson Davis Highway
Alexandria, VA 22301
Dear Administrator Tandy:
I am writing today to urge the DEA to license a privately-funded
medical marijuana production facility, thus ending the government
monopoly on the supply of marijuana legal for FDA and DEA-approved
research. This would allow more controlled medical research using
cannabis plants. When in a controlled laboratory facility,
any agricultural product should be fair game for research and experimentation.
Over four years ago, Prof. Lyle Craker, University of Massachusetts-Amherst,
sought permission from DEA to grow cannabis for privately-funded
medicinal research. As a controlled substance, the DEA has discretion
to grant permission to grow the cannabis plant. The licensing of
this facility would provide privately-funded sponsors of FDA-approved
research the necessary opportunity to conduct studies with a strain
of cannabis of their own choosing, with immediate access to that
strain for all FDA-approved studies and for possible prescription
Scientific research on agricultural products should
not be influenced by politics. If the test subject
in question were dandelions, there would be no controversy here.
The fact that some choose to abuse the cannabis plant illegally
is immaterial. The use of controlled substances for legitimate research
purposes is well-established, and has yielded a number of miracle
medicines widely available to patients and doctors. This case should
be no different. It’s in the public interest to end the government
monopoly on marijuana legal for research.
President, Americans for Tax Reform
CASE FOR A SIGN-ON LETTER
TO DEA ADMINISTRATOR KAREN TANDY SUPPORTING PROPOSED UMASS-AMHERST
MARIJUANA PRODUCTION FACILITY
GENERAL POLICY ISSUE: Should the controversy
over the medical use of marijuana be resolved through FDA-approved
scientific research or through legal and political struggles? Should
the federal government facilitate or obstruct scientific research?
SPECIFIC POLICY ISSUE: Is it in the public interest
for DEA to license Prof. Lyle Craker, Director, Medicinal Plant
Program, Dept. of Plant, Soil and Insect Sciences, University of
Massachusetts Amherst, to establish a privately-funded facility
to produce marijuana exclusively for federally-approved and privately-funded
research, or should the federal government, through the National
Institute on Drug Abuse (NIDA), retain its unique monopoly on the
supply of marijuana that can legally be used in research?
CONTEXT: On June 6, 2005, the US Supreme Court
ruled, in Gonzales v. Raich, that the federal government can arrest
patients who use marijuana with their doctor’s recommendation
even if it is legal under state law. On June 29, 2005, the US House
of Representatives defeated the Hinchey Amendment, 161-264, which
would have prohibited the use of federal funds for the prosecution
of medical marijuana users in states that have passed laws allowing
medical marijuana programs.
Currently, the only process that could result in marijuana becoming
legal as a medicine under federal law is for privately-funded sponsors
to conduct scientific research with the aim of obtaining FDA approval
for its use as a prescription medicine. Unfortunately, NIDA’s
monopoly on the supply of legal marijuana is a fundamental obstruction
to privately-funded research, none of which is currently taking
place despite strong interest. The DEA wants to have it both ways,
denying that marijuana is a medicine because the FDA has not approved
it while simultaneously blocking research by refusing to allow the
University of Massachusetts Amherst to manufacture marijuana for
NIDA’s monopoly is against the public interest and may be
contrary to federal law, which clearly requires adequate competition
in the manufacture of Schedule I and II substances for research
purposes. [See 21 U.S.C. § 823(a)(1); see also 21 C.F.R. §
1301.33(b).] Researchers have unobstructed access to other Schedule
I and II drugs and marijuana should be no exception. Professor Craker
is suing the DEA in a DEA Administrative Law Judge hearing, but
the DEA can approve the project at any time.
MONOPOLY PROBLEMS: NIDA’s monopoly results
in arbitrary and lengthy delays or refusals in providing research
material. Chemic Labs, a DEA-licensed analytical lab, was made to
wait over two years for a reply to its request to purchase 10 grams
for research into vaporizers, a non-smoking delivery system which
the Institute of Medicine report recommended be developed. On July
27, 2005, NIDA refused to sell Chemic Labs the 10 grams, preventing
the study from taking place. NIDA has also refused to provide marijuana
to two FDA-approved protocols (Dr. Abrams, UC San Francisco, marijuana
for AIDS wasting syndrome-IND #43-542; Dr. Russo, U. Montana, marijuana
for migraines –IND #58,177). NIDA’s monopoly prevents
sponsors from conducting research with the strain of marijuana they
believe has the most potential. Furthermore, NIDA can legally provide
marijuana for research but is not authorized to provide it for prescription
use, should FDA approve such use. As a result, the strain of marijuana
NIDA provides for research might not even be available for prescription
use, an unacceptable uncertainty to sponsors.
RECOMMENDATION: The FDA cannot consider approving
marijuana for medical use until the federal government’s unique
monopoly on the production of marijuana for medical research is
broken. Members of Congress should sign onto a letter to DEA Administrator
Karen Tandy urging the DEA to approve Professor Craker’s application
in order to facilitate medical marijuana research.
|The University of Massachusetts-Amherst
(Dr.Lyle Craker, Director, Medicinal Plant Program, UMass Amherst
Department of Plant and Soil Sciences) in association with Multidisciplinary
Association for Psychedelic Studies (MAPS) is in the midst of the
process of seeking DEA permission to establish a medical marijuana
production facility to grow high-potency marijuana for FDA-approved
At present, the National Institute on Drug Abuse (NIDA) has a monopoly
on the supply of marijuana that can be used in research, seriously
hindering medical marijuana research. NIDA provides inferior, low-potency
marijuana to researchers whose protocols it approves and denies
marijuana even to FDA-approved protocols it doesn't approve, preventing
those studies from taking place.
No privately-funded sponsor (such as MAPS or alternatively a for-profit
pharmaceutical company) will invest significant sums in a realistic
drug development research program aimed at obtaining FDA-approval
for the prescription use of marijuana without first obtaining its
own independent source of supply of a drug whose quality, price
and availability it determines. There have been no US-based privately-funded
marijuana production facilities since 1942, when marijuana was removed
from the US Pharmacopoeia and its medical use was prohibited.
Dr. Lyle Craker originally submitted the application for a license
to DEA in June 2001. In December 2001, DEA claimed it was lost.
Subsequently a photocopy was resubmitted but UMASS/MAPS were told
in February 2002 that the photocopied application was invalid since
it didn't have an original signature. In July 2002, the original
application was returned, unprocessed, with a DEA date stamp showing
it had been received in June 2001. Dr. Craker resubmitted the original
application to DEA on August 20, 2002, which DEA finally acknowledged
UMASS/MAPS worked with the Marijuana Policy Project on a Congressional
sign-on letter to the DEA expressing support for the UMass Amherst
license. The letter was submitted to DEA Administrator Asa Hutchinson
on June 6, 2002 (attached).
DEA Administrator Asa Hutchinson responded in a letter to Rep.
Barney Frank on July 1, 2002 (attached). DEA questioned whether
this new facility would be in the public interest, since NIDA currently
grows marijuana for research. In response, MAPS drafted a document
explaining why it would be in the public interest for DEA to grant
a license for the UMass Amherst facility, and submitted the document
to DEA, the Office of National Drug Control Policy (ONDCP) and NIDA.
The DEA has also indicated that granting such a license might conflict
with US international treaty obligations, specifically the Single
Convention on Narcotic Drugs. In response, UMASS/MAPS worked with
Graham Boyd of the ACLU Drug Policy Litigation Project and Peter
Barton Hutt and Alexei Silverman, of the DC law firm Covington &
Burling, on the development of a legal document detailing why US
international treaty obligations do not prevent the licensing of
the UMass Amherst facility.
On July 24, 2003, DEA finally filed a notice in the Federal Register
about Prof. Craker's application, with a public comment period ending
on September 23, 2003. On October 23, 2003, Senators Kennedy and
Kerry wrote a letter to the Administrator of the DEA expressing
their strong support for DEA licensing of the facility. UMASS/MAPS
expected DEA’s approval or rejection of Dr. Craker's application
sometime before the end of 2003 but that did not occur as DEA delayed
any decision as long as possible.
On July 21, 2004, MAPS, Prof. Craker and Valerie Corral filed lawsuits
against DEA and also against HHS/NIH/NIDA for obstructing medical
marijuana research. On July 29, 2004, MAPS filed a motion to consolidate
the lawsuit against the DEA and the lawsuit against HHS, NIH and
NIDA. Shortly thereafter, on November 22, 2004, the Court required
DEA to respond by December 22, 2004 to the portion of the lawsuit
against DEA about the UMass Amherst marijuana production facility.
On December 3, 2004, MAPS mailed petitions for reconsideration
to the DC Circuit Court of Appeals, asking again for the Court to
pressure HHS and DEA for not responding in 17 ½ months to
their applications to purchase 10 grams and import 10 grams, respectively,
in both cases for marijuana vaporizer research.
On December 10, 2004, DEA finally rejected the application from
Dr. Lyle Craker, UMass Amherst, seeking a license to establish a
MAPS-sponsored facility to produce marijuana for federally-approved
research, 3 and 1/2 years after the application was initially filed.
On February 28, 2005, DEA filed its pre-hearing statement in the
DEA Administrative Law Judge (ALJ) hearing. In DEA's initial "Order
to Show Cause" explaining its rationale for rejecting Prof.
Craker's application, DEA claimed that it would be against the public
interest for it to approve the license, and that, in any case, US
international treaty obligations prevented DEA from issuing the
On April 22, 2005, UMass (Prof. Lyle Craker) filed his pre-hearing
statement to the DEA Administrative Law Judge for the hearing with
assistance from lead lawyer Julie Carpenter of Jenner & Block,
Allen Hopper of the ACLU Drug Law Reform Project, and Emanuel Jacobowitz,
Steptoe & Johnson, all working on a pro-bono basis.
On August 15, 2005, Chemic Laboratories received an official letter
indicating that NIDA refused to sell it10 grams of marijuana for
MAPS-sponsored research into the use of marijuana vaporizers. Chemic
Labs had applied to purchase the 10 grams more than two years before.
The initial round of hearings took place August 22-26, 2005, with
an additional week December 12-16, 2005, for DEA to present its
During the August hearings, DEA seemingly abandoned the claim that
US international treaty obligations prevent it from licensing Prof.
Craker’s facility, with a DEA official testifying on the stand
that there is nothing in DEA law or policy that prevents it from
licensing individual researchers from growing different strains
of marijuana. The central issue remaining is whether it is in the
public interest for DEA to license the UMass Amherst facility or
whether NIDA should retain its monopoly on supply, a monopoly that
clearly obstructs research.
Statement Of Frederic M. Scherer
in re Professor Lyle Craker
Drug Enforcement Administration Docket No. 05-16
September 15, 2005
1. I have been asked by representatives of Professor Craker to
submit this analysis in connection with the Docket 05-16 proceedings
before the Drug Enforcement Administration (DEA). I do so pro bono
publico. I am professor emeritus at the John F. Kennedy School of
Government, Harvard University, and visiting professor at Haverford
College, teaching a course on the economics of industry. Copies
of my short-form biography and a list of my testimony in judicial
and regulatory proceedings are attached as Appendices A and B.
2. The issue, as I understand it, is fourfold. First, DEA has the
legal authority to designate production sources for the lawful production
of such controlled substances as marijuana and is mandated under
by 21 U.S.C. 823(a)(1) to "limit the importation and bulk manufacture
of such controlled substances to a number of establishments which
can produce an adequate and uninterrupted supply of these substances
under adequately competitive conditions for legitimate medical,
scientific, research, and industrial purposes." Second, I understand
that DEA has licensed a single source, Professor El Sohly at the
University of Mississippi, to produce marijuana under contract to
the National Institute on Drug Abuse (NIDA), the output of which
is allocated by NIDA. Third, DEA has recently licensed Professor
El Sohly to grow marijuana for lawful commercial purposes under
contract to private industry. Fourth, I understand that Dr. Craker
is seeking authorization to establish an alternative competitive
source at the University of Massachusetts, whose output is to be
used solely for lawful experimental purposes. That application has
been denied, but is under review by the DEA in this proceeding.
3. I have been asked to address the testimony on August 25, 2005,
of Mr. Matt Strait of DEA. Mr. Strait testified in effect that a
problem of deficient competition does not exist because the DEA-licensed
University of Mississippi source "provides marijuana to researchers
at a not for profit basis.... I just don't necessarily see the argument
for competition." In other words, because supplies are provided
at cost, there is no lack of competition, since, according to Mr.
Strait, the words used in the Code of Federal Regulations "all
seem to be geared around the economics."
4. My interpretation of this rather imprecise testimony is that,
since the University of Mississippi source prices its supplies of
marijuana at cost rather than above cost, there is no monopoly problem;
the requisites of competition are satisfied.
5. My understanding is that, in addition to providing only marijuana
of relatively low potency, NIDA has in the past denied applications
for marijuana supplies to be used solely for legitimate research.
For those applications, the supply is constrained to zero. When
there is a market demand for a commodity and there is no supply,
any reputable economist would agree that the true price is the so-called
shadow price, also called the implicit price, that is, the price
consistent with finite demand but zero supply. Under the circumstances
here, the shadow price is infinity for certain demand functions,
i.e., those derived from Cobb-Douglas utility functions (Paul Douglas
was a U.S. senator in the 1950s), or in other special cases, the
price just above the price at which the demander's demand is choked
off to a quantity of zero. In either case, such a shadow price is
higher, usually much higher, than the price at which a monopoly
would maximize its profits. And the monopoly price is higher than
a competitive price. Thus, when a monopoly supplier denies supplies
to legitimate demanders, there is a very significant impairment
of competition -- more significant than if the supplier merely levied
a monopoly price.
6. Scholars of all ideological shades who accept the basic premises
favoring a market economy agree that refusal to supply by an entity
with monopoly power is at least as undesirable as supplying at a
monopoly price. As Friedrich A. Hayek observed in his book, The
Road to Serfdom (1976 University of Chicago revised edition, p.
Our freedom of choice in a competitive society rests on the fact
that, if one person refuses to satisfy our wishes, we can turn to
another. But if we face a monopolist we are at his mercy. And an
authority directing the whole economic system would be the most
powerful monopolist conceivable. While we need probably not be afraid
that such an authority would exploit this power in the manner in
which a private monopolist would do so, while its purpose would
presumably not be the extortion of maximum financial gain, it would
have complete power to decide what we are to be given and on what
terms... The power conferred by the control of production and prices
is almost unlimited.
Professor Hayek's book is considered the bedrock of contemporary
conservative economics. And I hardly need to say that Hayek abhorred
the kind of power he was describing. On the more liberal side (by
a modern, not 19th Century, definition of the term), consider the
1959 treatise by Carl Kaysen and Donald F. Turner, Antitrust Policy:
An Economic and Legal Analysis, p. 14:
The demand for limiting business power springs more often from
those who feel themselves at a disadvantage in interbusiness transactions
than it does from households ... Competition in this context is
desirable because it substitutes an impersonal market control for
the personal control of powerful business executives, or for the
personal control of government bureaucrats. The impersonality of
market regulation makes it fair in the eyes of those subject to
it; the sense of fairness is greater when the same restriction on
conduct is imposed by the market than when it is viewed as the result
of a personal decision by a powerful individual.
Shortly after publishing the book, Kaysen became an economic adviser
to President Kennedy; Turner was Assistant Attorney General for
Antitrust during the Johnson Administration.
7. In declaring under 21 U.S.C. 823(a) that controlled substances
should be supplied under "adequate competitive conditions"
for lawful purposes, the U.S. Congress was following a four-century
legal tradition. The seminal case is Darcy v. Allein, 1603, which
is reprinted in my compendium, Monopoly and Competition Policy,
vol. I, pp. 6-11. It condemned as contrary to the common law a grant
by Queen Elizabeth I of a monopoly over the supply of playing cards
in England. That and other High Court decisions led the Parliament
in 1623 to pass the Statute of Monopolies, which singled out patents
and copyrights as the sole allowable monopoly grants government
could make under English law. That policy was implicitly endorsed
by the U.S. Founding Fathers when they authorized Congress in Article
I, Section 8, of the Constitution to grant for limited times the
exclusive right to authors and inventors in their writings and discoveries,
but articulated expressly no other situations in which the government
was to confer exclusive rights.
8. It is my understanding that no exclusive patent rights limit
the supply of marijuana to lawful scientific users. Even for the
principal type of monopoly grant sanctioned in the U.S. Constitution,
Congress declared an explicit exemption in the Hatch-Waxman Drug
Price Competition and Patent Term Restoration Act of 1984 (Public
Law 98-417). The so-called Bolar amendment exempts would-be generic
suppliers of a drug from the exclusive rights of drug product patent
holders for the purpose of carrying out clinical trials in advance
of patent expiration so that their generic products can be ready
for marketing at the time valid patents expire.
9. A considerable part of my professional career has been devoted
to studying the relationships between market structure and technological
progress. One of my most important findings has been that innovation,
quality, and diversity of product characteristics satisfying consumers'
demands are more likely to be achieved when there are multiple producers
than when there is only one, i.e., a monopoly. For a summary, see
F. M. Scherer and David Ross, Industrial Market Structure and Economic
Performance (3rd edition: 1990), pp. 600-607 and 639-660.
10. To conclude, I believe Mr. Strait is quite wrong in testifying
that there is no impairment of competition when legitimate supplies
of marijuana are sold at cost to authorized customers. Competitive
problems emerge when costs are higher than those of alternative
sources, or when supplies are denied -- i.e., the quantity supplied
is zero -- to other would-be buyers who meet the scientific and/or
medical criteria of the Food and Drug Administration (FDA) or, in
the case of laboratory research, have the necessary DEA licenses.
Denial of a license to the University of Massachusetts to produce
marijuana for lawful scientific and medical purposes is contrary
to both the spirit of 21 U.S.C. 823(a)(1) and to sound public policy.
11. I swear that the statements in para. 1-10 above are true to
the best of my knowledge.
Frederic M. Scherer
| Marijuana Pipe Dreams
August 27, 2005
New York times
When the Supreme Court ruled in June that states could not legalize
marijuana for medical uses, Justice Stephen Breyer voted with the
majority. But during oral arguments, he suggested an alternative
way for patients to get it: let the federal Food and Drug Administration
decide if marijuana should be a prescription drug.
"Medicine by regulation is better than medicine by referendum,"
he said. In theory, that sounds reasonable. But what if the officials
doing the regulation are afflicted with a bad case of Reefer Madness?
If you doubt this possibility, you should have been at a hearing
that began this week at the Drug Enforcement Administration's headquarters.
Lyle Craker, a professor of plant and soil sciences at the University
of Massachusetts, asked an administrative judge to overrule the
agency so he could grow marijuana for F.D.A.-approved research projects
by other scientists.
Dr. Craker is a well-regarded agronomist who's being supported
by the American Civil Liberties Union and both of his senators,
Edward Kennedy and John Kerry. But for four years he's been stymied
by the D.E.A., which first stalled and then finally denied his request
for a permit.
There are precedents for his re quest, because researchers already
get supplies of other drugs - like heroin, LSD and Ecstasy - from
independent laboratories licensed to make them. But researchers
who want marijuana have only one legal source: a crop grown in Mississippi
and dispensed by the National Institute on Drug Abuse.
Scientists say they need an alternative partly because the government's
marijuana is of such poor quality - too many seeds and stems - and
partly because the federal officials are so loath to give it out
for research into its medical benefits.
Discovering benefits, after all, would undermine the great anti-marijuana
campaign that has taken hold in Washington. Marijuana is deemed
to be such a powerful "gateway" to other drugs that it's become
the top priority in the federal drug war, much to the puzzlement
of many scientists, not to mention the police officers who see a
lot of worse drugs on the streets.
People with glaucoma and AIDS have sworn by the efficacy of marijuana,
and there have been studies by state health departments showing
that smoking marijuana is especially good at controlling nausea.
Scientists would like to test these effects, but they can't do good
studies until they get good marijuana.
Critics of medical marijuana say that it's unnecessary because
patients can obtain the benefits of its active ingredient, THC,
through a drug that's already available, Marinol. But many patients
say it doesn't work as well. They point to the case of the writer
Peter McWilliams, who said smoking marijuana was the only way to
control the nausea brought on by the mix of drugs he took for AIDS
He was forced to switch to Marinol after a D.E.A. investigation
led to his conviction for violating federal laws against marijuana.
In 2000, several weeks before he was to be sentenced, he was found
dead in his bathroom. He had choked on his own vomit.
Phillip Alden, a writer living in Redwood City, Calif., told me
that marijuana was a godsend for him in dealing with the effects
of AIDS. He said it eased excruciating pains in his fingertips,
controlled nausea and enabled him to avoid the wasting syndrome
that afflicts AIDS patients who are unable to eat enough food.
But Mr. Alden said only some kinds of marijuana worked - not the
weak variety provided by the federal government, which he smoked
during a research study.
"It was awful stuff," he said. "They started out with a very low-grade
plant, rolled it up with stems and seeds, and then freeze-dried
it so that they probably ruined any of the THC crystals. All it
did was give me headaches and bronchitis. The bronchitis got so
bad I had to drop out of the study."
Mr. Alden was scheduled to testify at this week's hearing, but
he told me he had to withdraw because the D.E.A. refused to give
him legal immunity if he admitted using marijuana not from the government.
It's a shame the judge will be making a decision without hearing
him, but I can understand Mr. Alden's hesitancy.
D.E.A. officials have already shown they're quite capable of persecuting
someone who uses marijuana to deal with AIDS, and they may well
be even more eager to go after someone who encourages research into
their least favorite drug. When it comes to marijuana research,
the federal policy is "Just Say Know-Nothing."
- Transcript of
court hearing, Monday, December 12, 2005
Witness is Prof. Mahmoud ElSohly, NIDA's marijuana grower.
- Transcript of
court hearing, Tuesday, December 13, 2005
Witness is Prof. Mahmoud ElSohly, NIDA's marijuana grower.
- Transcript of
court hearing, Wednesday, December 14, 2005
Witness is Steve Gust, Assistant to the Director of NIDA
- (Hearing was not held on Thursday, December 15, 2005)
- Transcript of
court hearing, Friday, December 16, 2005
Witnesses are Dr. Eric Voth and Dr. Auslander.
- Transcript of
court hearing, Monday, August 22, 2005
Craker opening statement by Julie Carpenter, Witnesses are Lyle
E. Craker and Irwin G. Martin
- Transcript of
court hearing, Tuesday, August 23, 2005
Witnesses are Lyle E. Craker, Barbara Roberts, John Vasconcellos,
- Transcript of
court hearing, Wednesday, August 24, 2005
Witness is Rick Doblin
- Transcript of
court hearing, Thursday, August 25, 2005
DEA opening statement by Brian Bayly, Witness is Matthew Strait
- Transcript of
court hearing, Friday, August 26, 2005
Witness is Matthew Strait