1. June 5, 2009: Craker’s lawyers filed potential witness and document lists regarding our pending Motion to Reconsider
2. May 18, 2009: DEA filed an Interim Order requesting that Craker submit list of potential witness by June 5, 2009
3. May 11, 2009: Craker’s Lawyers file update in First Circuit, U.S. Court of Appeals
4. May 1, 2009: Final Order goes into effect, but DEA review of Motions to Reconsider still Pending
5. April 29, 2009: Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden
6. April 15, 2009: Congressmen John Olver and Sam Farr send letter requesting that Ogden intervene on behalf of Prof. Craker
7. April 13, 2009: DEA lawyers file their final document post motions
8. March 25, 2009: DEA Lawyers Extend to April 13 their reply to Prof. Craker's Supplemental Motion to Reconsider
9. March 11, 2009: Lawyers for Prof. Craker Submit Supplemental Motion to Reconsider to the DEA
10. March 9, 2009: LA Times Editorial Supports Craker, Says DEA Needs Enlightenment
11. February 10, 2009: Request to DEA to Vacate Final Order of January 14, 2009
12. February 9, 2009: DEA Extends Deadline to March 11 for Response to Final Order Rejecting Craker Marijuana License
13. February 6, 2009: ASA gets 16 Members of the United States Congress to Sign a Letter to the Attorney General
14. January 30, 2009: A Motion of Reconsideration was Filed in Response to the DEA’s Final Ruling
15. January 18, 2009: ACLU Collection of Legal Submissions
16. January 14, 2009: DEA refuses to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research
17. October 10, 2007: Massachusetts Senators Kerry and Kennedy Commit to Send New Letter to DEA in Support of Prof. Craker
18. September 18, 2007: Forty-Five U.S. Representatives Send Letter to DEA in Support of Medical Marijuana Research
19. July 12, 2007: ONDCP and DEA Officials Grilled on MAPS/Craker Case at Congressional Hearing on "DEA's Regulation of Medicine"
20. May 12, 2007: Organizations Writing to DEA Supporting Prof. Craker
21. May 4, 2007: Final Legal Brief filed in the Craker vs. DEA case
22. April 15, 2007. The Sacramento Bee published an excellent op-ed about MAPS DEA Lawsuit
23. March 26, 2007 DEA Attorney Submits "Exceptions" to ALJ Opinion
24. February 22, 2007: DEA Lawyers to File Objections March 26
25. February 21, 2007: Media Coverage of Judge's Decision in Favor of Prof. Craker
26. February 13, 2007: MAPS Press Release Following Favorable Recommendation from Judge Bittner
27. May 8, 2006: MAPS and DEA file final briefs for DEA Lawsuit
28. April 28, 2006: Letter from Members of Congress to FDA
29. April 22 - May 25, 2006: The FDA's statement on the medicinal marijuana generates op-ed criticisms
30. April 21, 2006: FDA statement on medical marijuana, New York Times reports on responses to statement
31. 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.
32. March 22, 2006 Report by Rick Doblin, Ph.D., MAPS
33. January 6, 2006: DEA Hearing Report, by Rick Doblin, Ph.D., MAPS
34. December 20, 2005: DEA Hearing Report, by Rick Doblin
35. Sign-on Letter with list of signatories
36. December 12, 2005: The Washington Post publishes an article about the DEA Lawsuit.
37. November 22, 2005: Grover Norquist letter to DEA
38. Case For A Sign-On Letter to DEA Administrator Karen Tandy supporting Proposed UMASS Amherst Marijuana Production Facility
39. Background on the University of Massachusetts Amherst Marijuana Production Facility Project
40. Statement Of Frederic M. Scherer, professor emeritus at the John F. Kennedy School of Government, Harvard University.
41. August 27, 2005:  New York Times Op-Ed, "Marijuana Pipe Dreams," by John Tierney.
42. 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 and efficacy.

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:

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"

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.

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.

Chicago Tribune
Truth and Medical Marijuana

Boston Globe:
Judge: Let prof grow medicinal marijuana

San Francisco Chronicle:
Judge sides with botanist on pot supply

McClatchey News' newswire article, which was carried in The Miami Herald, San Jose Mercury-News, Seattle Post-Intelligencer and others:
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

Austin Chronicle
Reefer Madness: Judge Supports Bid to Grow Research Pot

Contact Jag Davies, MAPS Director of Communications
(831) 336-4325 or jag@maps.org

For Immediate Release
February 13, 2007

DEA Judge Recommends End to Government Obstruction of Medical Marijuana Research
Historic Step Toward Nation's First Privately-Funded Marijuana Production Facility

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."

The 87-page 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 FDA-approved studies.

"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.

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.

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

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.

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 by FDA.

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 research.

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 Byrne.

Click for a copy of the final letter sent December 6, 2005, PDF Format

DEA Administrator Karen P. Tandy
Drug Enforcement Administration
Mailstop: AXS
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.

Respectfully,

Lyle 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, Mass.) Republican)

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 lets him.

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, disagrees.

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 comment further.

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 research.

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 DEA.

"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."

PDF Version | MS WORD Version

November 22, 2005
DEA Administrator Karen P. Tandy
Drug Enforcement Administration
Mailstop: AXS
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 use.

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.

Sincerely,

Grover Norquist
President, Americans for Tax Reform
www.atr.org

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 medical research.

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.

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 receiving.

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 license.

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 witnesses

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. 93):

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

John Tierney
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 and cancer.

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, Dale Gieringer
  
• 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