Another last minute Bush Administration and DEA’s Obstruction of Scientific Freedom

[MagickMuffin]

February 6, 2009. Congress and Professor Craker Respond to Bush Administration and DEA’s Obstruction of Scientific Freedom:

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.

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.

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.

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.

There are several media articles about DEA’s ruling on the MAPS in the media page.

Health and Human Services and National Institute on Drug Abuse Place Another Hurdle in Front of Marijuana Vaporizer Research:

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.

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.

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.

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.

January 30, 2009. On January 30, 2009, lawyers for Professor Lyle Craker filed a motion of reconsideration in response to the DEAs final ruling, which was the Bush Adminstration's final blow to medical marijuana research.

January 26, 2009. Mimi Peleg Provides Guidance to Medical Marijuana Facility in Israel:

On Monday, January 26, MAPS funded Mimi Peleg of Wo/Mens Alliance for Medical Marijuana (WAMM) in Santa Cruz, CA, to travel to Victoria, British Columbia, Canada to meet with Philippe Lucas, founder of the Vancouver Island Compassion Society (VICS). Mimi and Philippe are advising a MAPS-supported medical marijuana production facility in Israel, licensed by the Israeli Ministry of Health. MAPS donated $15,000 as a matching grant to Yohai Golan’s medical marijuana production facility that is giving marijuana away for free to Ministry of Health-approved patients under the Israeli Health Minister’s guidelines. MAPS is also sponsoring Mimi Peleg and WAMM’s founder and president Val Corral to visit Israel next month for in-person consultation. An anonymous donor is covering expenses and Val and Mimi’s trip to Israel.

January 23, 2009. Gregory Goldstein, HHS Senior Public Health Advisor, Office of the Assistant Secretary of Health, sent a letter to Chemic on January 23, 2009, saying that HHS would require a validation study showing that Chemic could reliably measure various cannabinoids before it would even review Chemic's November 6, 2008 reply to the June 18, 2008 PHS/NIDA critique of Chemic's January 16, 2008 protocol.

However, there is no guarantee that PHS/NIDA would approve the protocol after funds for the validation study had been spent. Furthermore, a validation study could cost $40,000 and isn't really necessary for the sort of academic study we're seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as a medical device, a task best left to the manufacturer of that vaporizer. We're exploring a collaboration with Dutch scientists 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 then half the cost of the validation study.

Chemic initially submitted a protocol in June, 2003, seeking to purchase 10 grams from NIDA. That protocol was rejected on July 27, 2005, more than two years later. Chemic's reply to that rejection was submitted on September 9, 2005, and was ignored by NIDA for over two years and four months, prompting us to submit a new protocol on January 16, 2008, to see if it might somehow catalyze a review process.

Progress is slow in Chemic's efforts to purchase 10 grams of marijuana from the government's monopoly provider, NIDA. It's encouraging that the first hint in over 5 1/2 years that NIDA might actually sell Chemic 10 grams for its research took place on January 23, 2009, three days after Obama became President.

January 14, 2009. The Bush administration struck a parting shot to legitimate science on January 14th, as the Drug Enforcement Administration (DEA) refused 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 DEAs 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.

January 9, 2009. Medical Marijuana Donation Leveraged in Israel

For the last several years, MAPS has provided financial support for the development of the compassionate use of marijuana in Israel, in conjunction with a program of medical access developed by the Israeli Ministry of Health. The Ministry reviews applications from physicians on behalf of their patients and has licensed four different medical marijuana production facilities. These facilities have permits from the Israeli Ministry of Health to provide marijuana for free to Ministry-approved patients. Since the production facilities can only give marijuana away, they rely on donations to cover costs. An excellent article on the Israeli medical marijuana program was published recently in an Israeli newspaper, and has been translated by Dana Peleg, MA.

In November, MAPS offered $15,000 as a matching grant to Yohai Golan, who has one of the Ministry production licenses. In December, Yohai managed to obtain $15,000 as his match from Israeli donors and MAPS sent him our $15,000, provided by an anonymous donor. Over the last several weeks, Yohai has concluded negotiations with Israeli investors (not donors) who are providing sufficient funding (roughly $200,000 per year) to cover the provision of enough marijuana for 500 patients for the next two years. These investors are gambling that they can make money providing marijuana extracts to the pharmaceutical industry, since they can grow marijuana for this purpose as well as for free distribution to patients. In addition, they expect they will eventually be given permission to sell marijuana to patients, though how much research will have to be conducted first remains to be determined.

As a side project to the production facility, Yohai’s team will be producing organic cannabis oil tinctures that can be used as a substitute for smoking for patients who prefer not to – or cannot – inhale smoke or vapors from a vaporizer. The tinctures will use donated fair-trade organic olive oil produced by Palestinians in the West Bank and Israelis in Israel.

Yohai Golan has estimated that the value of the marijuana that they will give away is roughly $6 million per year, based on prices for legal Dutch medical marijuana and prices for medical marijuana in the US.

MAPS colleagues Val Corral and Mimi Peleg from the Wo/Mens Alliance for Medical Marijuana (WAMM) will travel to Israel, probably in February, to help Yohai create a functional administrative system to distribute the medicine that will be harvested at the end of March. MAPS will pay for their travel through funds that have been donated and restricted to this project. Prior to going to Israel, Mimi Peleg will travel to Victoria, Canada, to meet with Philippe Lucas, founder of the Vancouver Island Compassion Society (VICS), to learn about his approach to distribution and research. Previously MAPS has sponsored Philippe to consult with another medical marijuana production facility in Israel.

Yohai expressed his gratitude to MAPS President Rick Doblin PhD, “I would like to thank Rick for his constant support and late night chats helping me keep focused and looking ahead. Without his guidance and constant advice, I would not have come this far in Israel and would have given up.”

MAPS is extremely gratified that our original funding of a mere $15,000 was the catalyst for this significantly larger investment!

Bush Administration Last Minute Blow to Scientific Freedom

Only 10 days before the Bush Administration leaves office, the DEA has issued a final ruling denying a license to Prof. Lyle Craker, UMass Amherst, to grow marijuana for MAPS-sponsored medical research. The DEA is responding to a February 12, 2007 recommendation by DEA Administrative Law Judge Mary Ellen Bittner who found after extensive legal hearings that it would be in the public interest for DEA to issue Prof. Craker a license. The DEA is determined to protect the federal monopoly on the supply of marijuana that is legal for research that is held by the National Institute on Drug Abuse (NIDA). NIDA uses its monopoly to fundamentally obstruct research aimed at developing marijuana into an FDA-approved prescription medicine. For example, Chemic Labs has been seeking without success for over 5 1/2 years to purchase 10 grams of marijuana from NIDA for MAPS and CaNORML-sponsored research into the effectiveness of the Volcano vaporizer as a non-smoking drug delivery device.

We have yet to see the DEA brief, which we have been told is 180 pages. We'll be formulating a new strategy as quickly as we can to deal with this last minute blow to scientific freedom from the Bush Administration.

December 1, 2008. Israel Medical Marijuana Production Facility Receives $15,000 in Matching Funds: MAPS sent $15,000 to an Israeli medical marijuana production facility directed by Yohai Golan, who produces medical marijuana with a license from the Israeli Ministry of Health. This was a matching grant, which required Yohai to first raise $15,000, which he was able to do. The production facility has legal permission to grow and distribute marijuana to Ministry of Health-approved patients. However, the facility must give away the medicine for free and cannot sell it until marijuana has been approved as a prescription medicine by the Ministry of Health -which will require substantial clinical research. In the long run, this policy requiring the free distribution of medicine is an unsustainable model because the facility can only operate on donations while the patient base is steadily increasing. Meanwhile, some useful data is being gathered from the patients provided medicine by the facility and more doctors and patients are becoming comfortable with medical marijuana use.

November 6, 2008. Chemic Labs submitted a response to a June 16, 2008, critique of our vaporizer protocol (PDF) by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). We submitted the protocol to NIDA/PHS on January 16, 2008, along with three letters of support from peer reviewers.

We have now been trying without success for more than five years to purchase 10 grams of marijuana from NIDA for the expansion of our vaporizer research.

The questions about our protocol raised by NIDA/PHS were unusually exhaustive, sometimes questioning design elements that had been added in response to suggestions from prior reviewers, and seemed to have been intentionally designed to delay our ability to move forward with this study--which they were successful in doing. The NIDA/PHS critique discouraged and demoralized Chemic Labs, who in turn were slow to respond to NIDA.

Now that our response has been submitted, we are hopeful that NIDA will grant us permission to purchase government-grown marijuana for use in our vaporizer protocol. Unfortunately, we may need to wait another 6 months or so for NIDA/PHS to reply to our response to their critiques. There is no regulatory time limit governing the NIDA/PHS response. Weve already been waiting about three years for a NIDA/PHS response to our reply to their previous critique of an earlier protocol, which is why we went ahead and submitted our new protocol on January 16, 2008.

Slate Magazine contributor Amanda Schaffer wrote an excellent article on the promise of, and obstacles to, medical marijuana research. The article discusses a variety of successful research applications of marijuana and marijuana derivatives.

October 15, 2008. Were requesting that MAPS supporters actively help us recruit subjects for Dr. Abrams National Institute on Drug Abuse-funded study of vaporized marijuana in patients who are already using opioid medications for pain. This is one of only two medical marijuana studies in patients currently taking place in the US. Dr. Abrams investigation was scheduled to conclude in Fall 2008, but the study completion date has been extended to January 9th, 2009, in order to provide more time to recruit subjects. The study (PDF) was designed for 24 subjects, 16 of which have completed the study and an additional 8 more are needed. MAPS is supporting this study by paying for travel and lodging for participants who live outside of the San Francisco Bay area, with funding donated to MAPS by California medical marijuana dispensaries Capital Wellness Collective, Harborside Health Center, and Green Door, as well as from Oaksterdam University.

It is urgent that the study, finds the remaining subjects. Preliminary results are positive and the study will be more persuasive if the initially intended number of 24 subjects is actually enrolled. Supporters can help us by downloading flyers (PDF) and posting them at facilities such as medical marijuana dispensaries, and pain management centers. We would also appreciate it if people would post the text found in this link on appropriate web pages, blogs, and online forums. Subjects cannot have used marijuana within the previous 30 days, so pain patients on opiates from states without medical marijuana laws may be especially interested in volunteering for the study. If you would like more information about how you can help us recruit patients for this study, please contact: [e-mail]

October 10, 2008. David Bronner, of Bronner’s Magic Soaps, has agreed to donate $5500 to support research on patients who receive medical marijuana from an Israeli production facility under the direction of Tsachi Cohen. David had previously donated about $50,000 to Tsachi’s facility. These new funds are a grant to Dr. Ephraim Lansky for a study of the demographics, the amounts of marijuana used, and the effects of the marijuana on patients who have been receiving marijuana from the facility over the last several years

David has also donated $15,000 as a matching grant to a second Israeli medical marijuana production facility, led by Yohai Golan. Current Israeli medical marijuana regulations require that marijuana providers not charge for medicine. Providers must give the medicine away for free to Ministry of Health-approved patients, which is why the project needs subsidies. Yohai has raised $25,000 in matching funds from Israelis in response to David’s $15,000 matching grant, so we are now seeking an additional $10,000 to match the additional Israeli matching funds. If any MAPS supporters are able to or know someone who would be interested in helping match the other $10,000, please contact us.

David has also donated $5000 to Philippe Lucas of Vancouver Island Compassion Society (VICS) for research with patients who have been provided marijuana from VICS over the last several years. David had previously donated $8000 to this project. The goal of this research is to see if we can match demographics of patients with particular strains of marijuana, in order to see if particular strains are best for particular illnesses and medical needs.

More : http://www.maps.org/mmj/



Once again Blinded by Science.