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."); document.writeln("
On June 5, Crakers Lawyers Filed Witness and Document Lists, DEA has until July 1 to respond.
"); document.writeln("On June 5, Crakers lawyers filed potential witness and document lists regarding our pending Motion to Reconsider. On May 18, DEA filed an Interim Order requesting that Craker submit witness and document lists by June 5, 2009. 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, we asked the First Circuit, US Court of Appeals (where in a defensive maneuver we have filed a new lawsuit against DEA) to delay consideration of our case until after we learn how DEA responds to our pending Motion.
"); document.writeln("On April 29, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEAs final decision regarding Prof. Crakers 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 by asking the DEA to cease going forward on its May 1 deadline.
"); document.writeln("On April 13, the DEA filed its final response to Crakers March 11 Supplemental Motion To Reconsider and Exhibits submitted 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 Bittners February 12, 2007 recommendation that Prof. Craker receive a license to grow marijuana for federally-licensed research. Prof. Crakers facility would be built at the University of Massachusetts Amherst and would be sponsored by MAPS.
From April 19 to April 22, 2009, MAPS President Rick Doblin went to Israel to work with Ministry of Health-approved medical marijuana producer Yohai Golan and Golans investors. Ricks efforts in Israel involved consulting with the Ministry of Health about the possibility of allowing production facilities to sell marijuana to Ministry of Health-approved patients in order to create a sustainable system. Currently, the Israeli government has only given Golan, and several other producers, permission to give away the medicine they grow, but not to sell it. Rick is hopeful that the Ministry of Health will eventually permit sales of marijuana, but he recognizes that the wheels of bureaucracy turn slowly.
"); document.writeln(""); document.writeln("On Tuesday, May 12, 2009, Mike Corral--an experienced medical marijuana grower from the Wo/mens Alliance for Medical Marijuana--arrived in Israel to consult with three different growing facilities on techniques to maximize yield while reducing costs. An anonymous donor funds Mikes work in Israel through MAPS.
On January 14, 2009, DEA issued a 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 built at the University of Massachusetts Amherst and would be sponsored by MAPS. Ending the federal monopoly on the supply of marijuana for research would be the beginning of a serious drug development effort aimed at transforming marijuana into an FDA-approved prescription medicine.
"); document.writeln(""); document.writeln("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. Crakers Motion to Reconsider. Based on conversations between Allen Hopper, Prof. Crakers 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. As the saying goes, Its good to be the King, since you can ignore your own deadlines.
"); document.writeln("On May 11, 2009, Prof. Crakers 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. Crakers attorneys filed a placeholder notice of appeal in the U.S. Court of Appeals for the First Circuit in Boston, preserving Prof. Crakers 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. Crakers 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. Crakers 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. We are hoping that new leadership at DEA appointed by President Obama will thoroughly review the administrative proceedings, perhaps allow the submission of additional information, and eventually grant Prof. Crakers application for a license to grow medical marijuana for FDA-approved research.
"); document.writeln("On April 29, 2009, 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 by asking DEA to cease going forward on its May 1 deadline. Since there has still been no final negative action by DEA, it appears these letters may have had an impact.
"); document.writeln("Now were back in waiting mode, with no deadline for DEA to file its decision regarding our Motion to Reconsider. Delay has always been DEAs preferred strategy. Until there is new leadership at DEA appointed by President Obama, delay is now our preferred strategy as well.
May 1 Comes & Goes Without DEA Action - Craker's Marijuana Production Application in Limbo.
"); document.writeln("The effective date of DEA's final ruling rejecting Prof. Craker's license was supposed to be May 1. However, we have heard nothing so far directly from DEA regarding a response to our pending Motion to Reconsider. Based on conversations between our attorneys and the Department of Justice, and Senator Durbin's staff and DEA, we have learned that DEA review of our Motion to Reconsider is still pending, and that it is not rare for such matters to take place after final orders have become effective. As a result on May 11, 2009, we asked the First Circuit, US Court of Appeals (where in a defensive maneuver we have filed a new lawsuit against DEA) to delay consideration of our case until after we learn how DEA responds to our pending Motion.
"); document.writeln("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 by asking the DEA to cease going forward on its May 1 deadline.
"); document.writeln("On April 13, the DEA filed its final response to Craker's attorney's March 11 Supplemental Motion To Reconsider and Exhibits submitted 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 built at the University of Massachusetts Amherst and would be sponsored by MAPS. We will inform our supporters as soon as we hear anything from DEA.
On Friday, March 6, MAPS brought Val Corral and Mimi Peleg of Wo/Mens Alliance for Medical Marijuana (WAMM) to Israel to work with Yohai Golan at his medical marijuana production facility. Joined by Rick Doblin, they had very productive meetings with the team that is producing marijuana for Israeli Ministry of Health-approved patients. Lester Grinspoon, MD, Donald Abrams, MD, and Rick Doblin agreed to be on the board of advisors for the production facility. The team is still negotiating with the Ministry of Health to obtain permission to sell their product to their patients; currently they are only legally allowed to supply the medicine free of charge. MAPS has arranged with the support of an anonymous donor for Mike Corral, a greenthumb gardener from WAMM, to go to Israel soon to further consult with the production facility in order to help maximize their yield.
"); document.writeln(""); document.writeln("Rick, Val, and Mimi were able to tour the facility, which includes a multi-acre greenhouse that is gradually filling up with medical marijuana plants in various stages of growth. Rick says, It is a tremendously exciting situation and we are looking forward to continuing to be involved in the project.
"); document.writeln(""); document.writeln("Furthermore, the Ministry of Health is granting licenses for people who have PTSD to use medical marijuana. Rick had a conversation with one of the doctors who prescribes marijuana to patients with PTSD. It is possible that we will become involved in a marijuana/PTSD study in Israel, which will complement and clarify our other MDMA/PTSD Studies.
On January 30, 2009, lawyers for Professor Lyle Craker filed a motion of reconsideration in response to the Drug Enforcement Administration’s (DEA) final ruling, which was the Bush Administration's parting blow to medical marijuana research. Professor Craker rebutted DEA’s final order with the support of MAPS and the American Civil Liberties Union (ACLU) on grounds that new evidence was introduced in the final ruling that was not included during testimony in the case.
"); document.writeln(""); document.writeln("On February 6, 2009, 16 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.
"); document.writeln(""); document.writeln("The motion of reconsideration and Congressional letter are responses to the Bush Administration’s last-minute obstruction of legitimate science on January 14th, when DEA filed in the Federal Register its 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. Her February 12, 2007, recommendation 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.
"); document.writeln(""); document.writeln("MAPS is hopeful that the Obama Administration will honor its commitment to science over ideology. The Obama administration should support MAPS’ efforts to sponsor research aimed at gathering evidence about marijuana to present to FDA, and should stop DEA’s and NIDA’s obstruction of our attempts to transform marijuana into an FDA-approved prescription medicine.
"); document.writeln(""); document.writeln("There are several media articles about DEA’s ruling on the MAPS in the media page.
On January 23, 2009, Gregory Goldstein, Health and Human Services (HHS) Senior Public Health Advisor, Office of the Assistant Secretary of Health, sent a letter to Chemic Laboratories. The letter requires Chemic to do a validation study showing that Chemic could reliably measure various cannabinoids. HHS is suddenly requiring this validation study before it will even review Chemic's November 6, 2008 reply to the June 18, 2008 Public Health Service’s (PHS) and National Institute on Drug Abuse’s (NIDA) critique of Chemic's January 16, 2008 protocol. In this way, HHS/NIDA avoided responding to the substance of Chemic Labs’ reply by insisting on a preliminary validation study. This latest message is part of a five and half year tactic of blocking MAPS-sponsored vaporizer research, since a validation study had not been mentioned before in the previous communications and critiques.
"); document.writeln(""); document.writeln("In the January 23, 2009 message, HHS provided a list of questions for Chemic Labs to use as guidance for the validation study, but in their own words the questions are “not inclusive of all aspects of method validation.” Therefore, we could spend $50,000 or more on this validation study and HHS could claim that we did not meet all of the requirements and could request additional expensive validation data, all before reviewing the vaporizer protocol itself, which would only cost an estimated $25,000.
"); document.writeln(""); document.writeln("What makes this especially frustrating is that a validation study isn't truly necessary for the sort of academic study we're seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as an FDA-approved medical device, which MAPS isn’t seeking to do. We're exploring collaborating with Dutch scientists from the University of Leiden, who are already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less than half the cost of the validation study.
"); document.writeln(""); document.writeln("We are wary of conducting a validation study, or even a cross-validation study, without HHS/NIDA having reviewed and approved the vaporizer protocol itself. We’ll get back to HHS after we determine if we can make a case for a cross-validation study, then we’ll ask for the vaporizer protocol itself to be reviewed and approved first before we spend money on any sort of a validation study.