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Emails May Reveal Obama’s Motive in Medical Marijuana Crackdown

Posted by  at 6:07 PM on June 8, 2012

Latest Emails Show the Extent Of Obama’s Ties To The Pharmaceutical Industry

obama marijuana

On the campaign trail Barack ‘Blaze a Blunt’ Obama promised not to sell out to special interests, but to stand up for change. Yet when big pharma came knocking at his door with a pile of money, he quickly changed his tune. The latest batch of emails released by House Republicans prove Obama will give in to any industry, so long as it serves his personal political purpose regardless of promises made to the contrary.

Back in 2009, drug industry lobbyists sought to stop Obama from supporting a bill aimed at lowering medicine prices by allowing the reimportation of certain pharmaceuticals. The obvious lever: support for his plan to overhaul healthcare. On June 3, 2009, a lobbyist sent an email to the presidents chief healthcare advisor, Nancy-Ann DeParle. Her response was that the administration had “made a decision, based on how constructive you guys have been, to oppose importation on the bill.”

During his campaign, Obama attacked the pharmaceutical industry, but as we all now know, when the chips are down, Obama folds like a wallet. The emails also detail Obama’s deep reliance on big pharma to finance the adevertising campaign in support of his healthcare overhaul. With Obama on the end of big pharma’s leash, no wonder he continues to crackdown on medical marijuana.

Basically, the prescription drug industry gave Obama 80 billion dollars in support of his healthcare plan in exchange for favorable treatment on other issues. From the beginning Obama promised to open up the decision making process to public view, but when the big drug boys came calling, all bets were off, and Obama starting making back-room deals.  I wonder how many back-room deals he’s made with respect to cannabis?

As an example of Obama’s two-faced dealings consider this email sent by  a union boss after meeting with Jim Messina, Obama’s then Deputy Chief of Staff for Operations, to discuss financing the healthcare overhaul advertising campaign, “They plan to hit up the ‘bad guys’ for most of the $, they want us to just put in enough to be able to put our names in it — he is thinking @100K.”

Ultimately, the deals were made, and Obama gave up his principles for dough. Bryant Hall, then senior vice president of the pharmaceutical group, said it best, “We got a good deal.”

Democrats have rushed to the President’s defense claiming it’s just business as usual. Hold on just a minute. I seem to remember something about change. Beyond his general statements, Obama specifically attacked big pharma on the campaign trail stating:

The pharmaceutical industry wrote into the prescription drug plan that Medicare could not negotiate with drug companies. And you know what? The chairman of the committee who pushed the law through went to work for the pharmaceutical industry making $2 million a year. That’s an example of the same old game playing in Washington. You know, I don’t want to learn how to play the game better. I want to put an end to the game playing.

Yeah right bud. We now know that was just the sort of double talk we’ve come to expect from Obama. I hope when his head stops spinning it’s still facing forward, or ‘Million Dollar Mitt’ might beat him in November. Obama had better snap out of it before it’s too late. I really don’t want see how bad things can become in this country under another dunderheaded Republican–do you?

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PUFMM | Patience United For Medicinal Marihuana

#OpCannabis #Cannabis #420 #OpCannabis420 #NoMoreProhibition

Medical marijuana monopoly

Currently, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of research-grade marijuana, but no other Schedule I drug, that can be used in FDA-approved research. NIDA uses its monopoly power to obstruct research that conflicts with its vested interests. MAPS had two of its FDA-approved medical marijuana protocols rejected by NIDA, preventing the studies from taking place. MAPS has also been trying without success for almost four years to purchase 10 grams of marijuana from NIDA for research into the constituents of the vapor from marijuana vaporizers, a non-smoking drug delivery method that has already been used in one FDA-approved human study.

NIDA has a government granted monopoly on the production of medical marijuana for research purposes. In the past, the institute has refused to supply marijuana to researchers who had obtained all other necessary federal permits. Medical marijuana researchers and activists claim that NIDA, which is not supposed to be a regulatory organization, does not have the authority to effectively regulate who does and doesn’t get to do research with medical marijuana. Jag Davies of the Multidisciplinary Association for Psychedelic Studies (MAPS) writes in MAPS Bulletin:[27]

NIDA administers a contract with the University of Mississippi to grow the nation’s only legal cannabis crop for medical and research purposes,[28] including the Compassionate Investigational New Drug program. A Fast Company magazine article pointed out, “Based on the photographic evidence, NIDA’s concoction of seeds, stems, and leaves more closely resembles dried cat brier than cannabis”.[29] An article in Mother Jones magazine describes their crop as “brown, stems-and-seeds-laden, low-potency pot—what’s known on the streets as “schwag””aka “Bobby Brown”[30] United States federal law currently registers cannabis as a Schedule I drug. Medical marijuana researchers typically prefer to use high-potency marijuana, but NIDA’s National Advisory Council on Drug Abuse has been reluctant to provide cannabis with high THC levels, citing safety concerns:[28]

Most clinical studies have been conducted using cannabis cigarettes with a potency of 2-4% THC. However, it is anticipated that there will be requests for cannabis cigarettes with a higher potency or with other mixes of cannabinoids. For example, NIDA has received a request for cigarettes with an 8% potency. The subcommittee notes that very little is known about the clinical pharmacology of this higher potency. Thus, while NIDA research has provided a large body of literature related to the clinical pharmacology of cannabis, research is still needed to establish the safety of new dosage forms and new formulations.

Speaking before the National Advisory Council on Drug Abuse, Rob Kampia of the Marijuana Policy Project criticized NIDA for refusing to provide researcher Donald Abrams with marijuana for his studies, stating that “after nine months of delay, Dr. Leshner rejected Dr. Abrams’ request for marijuana, on what we believe are political grounds that the FDA-approved protocol is inadequate.”[31]

In May 2006, the Boston Globe reported that:[32]

Then again, it’s not in NIDA’s job description-or even, perhaps, in NIDA’s interests-to grow a world-class marijuana crop. The institute’s director, Nora Volkow, has stressed that it’s “not NIDA’s mission to study the medicinal use of marijuana or to advocate for the establishment of facilities to support this research.” Since NIDA’s stated mission “is to lead the Nation in bringing the power of science to bear on drug abuse and addiction,” federally supported marijuana research will logically tilt toward the potential harms, not benefits, of cannabis.

Ricaurte’s monkeys

For more details on this topic, see Retracted article on neurotoxicity of ecstasy.

NIDA has drawn criticism for continuing to provide funding to George Ricaurte, who in 2002 conducted a study that was widely touted as proving that MDMA causeddopaminergic neurotoxicity in monkeys.[33] His paper “Severe Dopaminergic Neurotoxicity in Primates After a Common Recreational Dose Regimen of MDMA (‘Ecstasy’)” inScience[34] was later retracted after it became clear that the monkeys had in fact been injected not with MDMA, but with extremely high doses of methamphetamine.[35] A FOIArequest was subsequently filed by MAPS to find out more about the research and NIDA’s involvement in it.[36][37]

Alan Leshner, publisher of Science and former director of the National Institute on Drug Abuse (NIDA), has come under fire for endorsing the botched study at its time of publication… Leshner did help NIDA bring home the bacon: NIDA’s budget for Ecstasy research has more than quadrupled over the past five years, from $3.4 million to $15.8 million; the agency funds 85 percent of the world’s drug-abuse research. In 2001, Leshner testified before a Senate subcommittee on “Ecstasy Abuse and Control”; critics say Leshner manipulated brain scans from a 2000 study by Dr. Linda Chang showing no difference between Ecstasy users and control subjects. But NIDA insists it’s independent from political pressures. “We don’t set policy; we don’t create laws,” says Beverly Jackson, the agency’s spokesperson.

Effectiveness of anti-marijuana ad campaigns

In February 2005, Westat, a research company hired by NIDA and funded by The White House Office of National Drug Control Policy, reported on its five-year study of the government ad campaigns aimed at dissuading teens from using marijuana, campaigns that cost more than $1 billion between 1998 and 2004. The study found that the ads did not work: “greater exposure to the campaign was associated with weaker anti-drug norms and increases in the perceptions that others use marijuana.” NIDA leaders and the White House drug office did not release the Westat report for a year and a half. NIDA dated Westat’s report as “delivered” in June 2006. In fact, it was delivered in February 2005, according to the Government Accountability Office, the federal watchdog agency charged with reviewing the study.

D. E. A. | Vaporizer Research as of 2012, TODAY..

 

MAPS, in conjunction with the California branch of the National Organization to Reform Marijuana Laws, worked between 1993 and 2009 to sponsor research into the effects of vaporizers and water-pipes in filtering the fumes of inhaled marijuana. Our goal was to determine if water-pipes or vaporizers could reduce the health risks of smoking marijuana.

From 1993 to 2002, we sponsored research at DEA-licensed laboratories testing the content of combusted and vaporized marijuana for cannabinoid particulate and carbon monoxide levels.

Between June 2003 and August 2009, MAPS attempted to purchase marijuana from the National Institute on Drug Abuse for more research with vaporized marijuana. Due to excessive delays and frustration, in August 2009, the laboratory we were working with on the project withdrew its efforts.

MAPS is no longer working on specific vaporizer research, although our protocol for our marijuana/PTSD research requires some subjects to use a vaporizer and others to smoke marijuana.

 

Timeline of MAPS Blocked Vaporizer Research

February 6, 2009
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 Services (PHS) and National Institute on Drug Abuses (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 isnt 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. Well get back to HHS after we determine if we can make a case for a cross-validation study, then well ask for the vaporizer protocol itself to be reviewed and approved first before we spend money on any sort of a validation study.

 

 

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January 5, 2009
Dutch and US Marijuana Vaporizer Researchers Collaborate 

MAPS President Rick Doblin and Dutch PhD student Justin Fischedick of Leiden University, met with Joseph St. Laurent and Scott Goodrich at Chemic Labs, outside of Boston LINK to CHEMIC.  Justin and his associates have been conducting marijuana vaporizer research at Leiden University using the Volcano vaporizer. They have decided to share data and procedures with Joseph St. Laurent and Scott Goodrich, who have been trying without success for over 5 1/2 years to purchase 10 grams of marijuana from NIDA for MAPS and CaNORML-sponsored vaporizer research.

Justin and his associates have been looking mostly at what is in the marijuana vapors, such as cannabinoids and terpinoids. In order to determine whether vaporization is an effective harm reduction device, the Chemic researchers intend to mostly investigate what isn’t likely to be in the marijuana vapors, but is in marijuana that is burned. This research will focus on various tars and products of combustion such as carbon monoxide.

Chemic is waiting on reviewers from NIDA and the Public Health Service to review their latest reply to questions about their proposed protocol, submitted on November 6, 2008. Once permission is eventually obtained for their research, they will check with Justin to see what his team has learned and then move forward.

 

 

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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.

 

 

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June 18, 2008
NIDA Delays Vaporizer Research, Averts MAPS Lawsuit:

On June 18th, after a five month review process, the National Institute of Drug Abuse-Public Health Service (NIDA-PHS) finally responded to our revised vaporizer research protocol, submitted for review January 16, 2008. The submission included three supportive letters from peer-reviewers, confirming the scientific merit of the study and urging NIDA-PHS to approve it. By responding, NIDA/PHS avoided MAPS filing another lawsuit for unreasonable delay, which wed intended to file in the middle of August.

MAPS has still been waiting two years and nine months for NIDA/PHS to respond to our September 2005 reply (PDF) to their rejection of our previous vaporizer protocol (PDF), which we initially submitted in June 2003, after which it took them more than two years to evaluate! We submitted the revised protocol in January 2008 to see if that might motivate NIDA to respond, which it has.

According to Rick, The review is filled with issues designed to delay and exhaust us, that have little importance to the safety or relevance of the intended research, but I don’t think it will deter us for too long. We’ll respond thoroughly and quickly before the end of July, and then wait yet again for a reply. Now that NIDA/PHS are familiar with the issues and have articulated their concerns, their response to our comments should be faster. We’re already making progress in that the strategy of delay has been overcome and a review was issued.

If this situation werent so genuinely tragic for all the sick people who might benefit from this research, then it would simply appear ridiculous. All MAPS is requesting to do is purchase ten grams of marijuana—something virtually any high school student in the US could obtain—so that we can move forward with a study of a non-smoking delivery system for marijuana that might benefit people suffering from a wide range of debilitating, difficult-to-treat illnesses.

The FDA has thirty days to review complicated human protocols. With NIDA/PHSs dysfunctional review process, they have provided us with powerful evidence for why we need to break the NIDA monopoly on the supply of marijuana that can be used in research, said Doblin.

MAPS has been waiting since February 12, 2007 for the DEA to issue a final ruling in response to DEA Administrative Law Judge Bittners recommendation (PDF) that the NIDA monopoly on the production of marijuana legal for research be ended, and that Professor Lyle Craker be issued a DEA license for a MAPS-sponsored medical marijuana production facility.

 

 

 

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June 29, 2007
  Nature Medicine “Scientists Stir the Pot for Right to Grow Marijuana” by Arran Frood.
Nature published an excellent article (“Scientists stir the pot for right to grow marijuana”) about MAPS’ campaign to break the federal government’s illegal monopoly on the supply of research-grade marijuana for use in privately funded clinical studies that would determine whether marijuana meets the FDA’s standards for safety and efficacy.

 

 

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May 16, 2007
Two new studies, one from University of California-San Francisco, and the other from SUNY-Albany, provide strong evidence that vaporization has promising potential as a method of medical marijuana delivery. The first study, published online by the journal Clinical Pharmacology and Therapeutics, was conducted at UCSF by a team led by Donald Abrams, MD, and compared a commercially available vaporizer to smoking in 18 volunteers. The researchers found that, “vaporization of marijuana does not result in exposure to combustion gases, and therefore is expected to be much safer than smoking marijuana cigarettes.” Dr. Abrams was able to obtain permission from FDA to conduct his study based in part on data on the composition of the ingredients in marijuana vapor gathered in research sponsored by MAPS and CaNORML. That line of MAPS-sponsored research is currently blocked since NIDA has refused to sell marijuana for additional studies. Click here to read Dr. Abrams’ full report.

The second study, conducted by Mitch Earleywine, PhD, at SUNY-Albany, and published in Harm Reduction Journal, was based on an extensive survey of over 7,000 marijuana users. After adjusting for variables such as age and cigarette use, Earleywine found that vaporizer users were 60 percent less likely than smokers to report respiratory symptoms such as cough, chest tightness or phlegm, and that the effect of vaporizer use was more pronounced the larger the amount of marijuana used. Click here to read Dr. Earleywine’s full report.

MAPS hopes to eventually put vaporized marijuana through FDA clinical trials, but has been stalled since June 2003 because of NIDA’s monopoly on the supply of research-grade marijuana. Research into alternative delivery methods such as vaporization was one of the primary recommendations of the Institute of Medicine’s landmark 1999 report on medical marijuana.

Marijuana vaporization is an effective delivery method because it has the rapid action and easy dose adjustment of inhalation, but without the respiratory hazards associated with smoking. Unlike smoking, a vaporizer does not burn the plant material, but heats it just to the point at which THC and cannabinoids vaporize into steam.

 

 

 

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May 15, 2007
  The Walrus “Peaking on the Prairies” by Jake MacDonald.
The Walrus published a fascinating article entitled”Peaking on the Prairies” that describes Dr. Humphrey Osmond’s extensive psychedelic therapy research program in the 1950’s.

 

 

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March 17, 2007
On February 16, MAPS President Rick Doblin met with Joe St. Laurent and Scott Goodrich, the founders of Chemic Labs, the analytical laboratory that has conducted prior MAPS/CaNORML-funded vaporizer research. They discussed the development of a new vaporizer research protocol to submit to NIDA for review, once again seeking to purchase 10 grams from NIDA and seeking DEA permission to import 10 grams of high THC/high CBD marijuana from the Netherlands, with a cannabinoid content that NIDA doesn’t have available. The design work and the study itself, should we eventually obtain approval from NIDA, will be co-funded by MAPS and CaNORML, as have all ourprevious vaporizer research projects.

This new protocol seeks to analyze the constituents of the vapor produced in the Volcano vaporizer, from samples of NIDA marijuana that contain THC and samples of imported marijuana that contain both THC and CBD. During the meeting at Chemic, we reviewed in detail the critiques of the original vaporizer research protocol that the PHS/NIDA reviewers offered back in August 2005. We will make a few changes in the protocol so that this will be a new submission and we will respond in detail to each critique. The proposed methodology will call for testing at various temperatures, and will measure for carbon monoxide levels, cannabinoids and certain particulates.

PHS/NIDA’s handling of the original version of this protocol was another classic case of the dysfunctional nature of NIDA’s monopoly on research-grade marijuana. After waiting for more than two years for PHS/NIDA to review the protocol, during which time we unsuccessfully sued NIDA for unreasonable delay in the DC Circuit Court of Appeals, the critique that was finally issued contained several important misunderstandings and seemed to come from people who had barely even read the protocol. Chemic filed a response to the critiques in September 2005, which PHS/NIDA has totally ignored for more than 17 months. There seems to be no appeal process at all in the PHS/NIDA review of medical marijuana research proposals and there are certainly no deadlines that compel PHS/NIDA to respond within any reasonable period of time. This is in contrast to FDA, which must reply to protocol submissions within 30 days and has a clearly defined and prompt appeal process.

The new vaporizer protocol will be submitted to NIDA in April. Then, we anticipate a long wait. NIDA has successfully ignored Chemic’s response to its critiques but it will be more difficult for NIDA to ignore a new protocol submission.

 

 

 

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October 19, 2005
  Mother Jones Magazine “Respectable Reefer” by Gary Greenberg.
October 19, 2005. Mother Jones Magazine publishes, “Respectable Reefer,” an excellent article about medical marijuana by Gary Greenberg that discusses GW Pharmaceuticals, MAPS and drug war politics.

 

 

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August 18, 2005
  New England Journal of Medicine “Medical Marijuana and the Supreme Court” by Susan Oakie.
The Perspective Section of the New England Journal of Medicine published an article, “Medical Marijuana and the Supreme Court,” by Susan Oakie, MD, a contributing editor of the Journal. Click here for full text version.

 

 

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June 20, 2005
   “PDF Article” by .
A new political advertisement about medical marijuana, mentioning federal obstruction of research and providing a link to the MAPS website for more information, appeared in the National Review, the New Republic, the American ProspectThe NationReason Magazine, and The Progressive. The ad was placed by Common Sense for Drug Policy. 

 

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November 29, 2004
  Slate “Dude, Where’s My Integrity? Medical marijuana tests the Supreme Court’s true love of federalism” by .
Slate has recently published an extensive commentary on how the Supreme Court is and will approach Ashcroft v. Raich. MAPS had filed an amicus curiae concerning the obstruction of efforts to conduct FDA-approved medical marijuana research.

 

 

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November 22, 2004
  Scientific American “Current Restrictions on Marijuana Research are Absurd” by The Editors.
The popular science magazine Scientific American published an editorial in support of making it easier to perform medical marijuana research in the US, describing current restrictions on medical marijuana research as “absurd.”

 

 

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November 22, 2004
The Court required DEA to respond by December 22, 2004 to the portion of our lawsuit against DEA about the UMass Amherst marijuana production facility.  This is a positive development in that DEA can no longer just delay and not have to explain why.

 

 

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July 22, 2004
   “Newspapers around the country have carried an AP wire story on MAPS’ lawsuits” by .
Newspapers around the country have carried an AP wire story on MAPS’ lawsuits against DEA/HHS/NIH/NIDA for obstructing medical marijuana research. An original article from the Springfield Republican (in MA) is representative of the favorable treatment our suit has obtained in the media.

 

 

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April 1, 2004
Congressman Mark Souder, Chairman of the U.S. House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources, held a hearing about “Marijuana and Medicine: The Need for a Science-Based Approach.” MPP Executive Director Rob Kampia testified (video and transcript) and answered questions (video andtranscript). During his comments, he discussed the importance of MAPS’ vaporizer research efforts as well as the UMass Amherst project. 

March 19, 2004. Dr. Donald Abrams receives word that his FDA-approved Phase I vaporizer study is now ready to enroll subjects. He will be comparing cannabinoid and carbon monoxide levels and subjective effects in subjects who at different times inhale either marijuana smoke from a burning cigarette or marijuana vapors from the Volcano vaporizer. Being able to use a vaporizer in FDA-approved clinical trials is one of MAPS’ two prerequisites to justifying the expense of a $5 million effort to develop marijuana into an FDA-approved prescription medicine, the other prerequisite being an independent source of supply of marijuana for research other than using material from the National Institute on Drug Abuse (NIDA).

March 17, 2004. In an effort to find out what is going on with the Health and Human Services (HHS) review of the scientific merit of the vaporizer protocol, an exchange of email took place today between Willem Scholten, Head of the Dutch Office of Medicinal Cannabis and Rear Admiral, Assistant Surgeon General and Deputy Assistant Secretary for Health (Operations) Arthur J. Lawrence. Willem Scholten inquired about the status of the review.

Dr. Lawrence replied that the responsibility for the review was being shifted from his office and at the moment he didn’t know exactly to where or what was going on. He was, however, sure that, ” this protocol will, as all proposed protocols for this sort of research are, be given fullest consideration and deliberation in the scientific review.”

Somewhat dissatisfied with the review seemingly being on the slow track to nowhere, MAPS President Rick Doblin replied to Dr. Lawrence. He requested whatever help Dr. Lawrence could offer in expediting the review, noting that the protocol was first submitted for review on June 24, 2003 and that all we were asking for was to purchase 10 grams of NIDA marijuana and import 10 grams from the Dutch. He concluded by stating, “The vaporizer research project is part of MAPS’ efforts to work through the rigorous FDA drug review process to conduct exactly the sort of studies that DEA, ONDCP, NIDA, IOM, all claim to want to see conducted. Given the difficulties in purchasing a tiny amount of marijuana for this simple vaporizer research protocol, it should not be surprising why so many States have gone ahead and legalized the medical use of marijuana in one form or another without waiting for the FDA to approve its medical use on the basis of double-blind, randomized, placebo-controlled research.”

Also, Dr. Scholten informed MAPS that some vaporizer research with the same Volcano device was being conducted in the Netherlands. We’ve sent a message to the researcher and look forward to collaborating and sharing information.

January 29, 2004. The scientific review of the vaporizer protocol being conduced by the federal Dept. of Health and Human Services is now being supervised by Assistant Surgeon General Arthur J. Lawrence Ph.D. Mr. Joel Egertson, senior drug policy advisor to the Secretary of HHS, has retired and the responsibility for the review has been reassigned. A revised and updated package of information has been submitted today by Chemic Labs to Assistant Surgeon General Lawrence. If HHS determines that the vaporizer protocol is scientifically meritorious, NIDA will agree to sell us 10 grams of marijuana and DEA will be required to address our request to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis. The protocol is a rigorous investigation and, if reviewed in an unbiased manner, will be determined to be scientifically meritorious. MAPS initially requested permission in June 2003 to purchase marijuana from NIDA and import marijuana from the Dutch. This delay is clear evidence why NIDA’s monopoly on supply of research marijuana serves more to obstruct than to facilitate marijuana research.

December 16, 2003. MAPS received a grant of $13,000 for further vaporizer research from the Marijuana Policy Project. The grant includes $5,000 for the writing of a scientific paper about the results of the research for submission to a journal indexed in Medline. Also included is $8,000 for a study of the cannabinoid content of each of the 1st, 2nd, and 3rd balloons created by the Volcano vaporizer from the same sample of marijuana. We want to see if we can eliminate the use of the 3rd balloon in clinical research if only minimal amounts of cannabinoids are released the third time the same sample is heated and vaporized. This study can be conducted only after we have been able to obtain approval from HHS to purchase 10 grams of marijuana from NIDA, a time-consuming hurdle that wouldn’t be necessary if MAPS had its own independent source of supply of marijuana that could be used in federally-approved research (as we have with MDMA and psilocybin, for example).

December 4, 2003. The manufacturers of the Volcano vaporizer that MAPS and CaNORML are using in our vaporizer research, STORZ & BICKEL GMBH & CO. KG, announce that they have received the Dr. Rudolf Eberle Prize, the prize for innovation of the State of Baden-Wurttemberg. This prize has been awarded on an annual basis since 1985 to small and medium-sized industrial and craft firms who have successfully implemented outstanding technical innovations. The prize committee uses the criteria of technical progress, special entrepreneurial achievement and the economic success of the innovation to make its decision.

November 14, 2003. Vaporizer protocol likely to start early in 2004. According to Dr. Donald Abrams, “As far as I know we are awaiting our award from CMCR. All approvals are granted and we plan to commence the vaporizer protocol in January 2004.”

October 10, 2003. The analytical lab conducting the vaporizer research has received replies from NIDA and the DEA regarding its requests to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis and to purchase 10 grams from the National Institute on Drug Abuse (see entry below for June 24, 2003). The reply from NIDA came from Joel Egertson, Senior Drug Policy Advisor to the Secretary of Health and Human Services (HHS). Mr. Egertson wrote, “It has been determined that there is insufficient information in the application to judge the merits of the proposal. ” Mr. Egerston had been submitted the protocol for which the 10 grams was requested but asked for additional information that has already been generated from previous research protocols and has already been submitted to the FDA. This additional information will be submitted to Mr. Egerston very soon for HHS review.

The reply from DEA indicated that it would not proceed with the import permit until the scientific merits of the protocol had been accepted by HHS.

While a decision on these requests has been delayed, we believe we can adequately address all the issues raised by HHS and DEA. Yet again, this prolonged process to purchase tiny quantities of marijuana for important privately-funded research demonstrates the need for MAPS to sponsor a privately-funded facility to produce marijuana for federally-approved research, as we are attempted to do in partnership with Prof. Craker at UMass Amherst.

June 24, 2003. Grant for Vaporizer Study with Humans Approved Contingent upon Regulatory Approval.California’s Center for Medicinal Cannabis Research (CMCR) preliminarily approved Dr. Donald Abrams’ Phase I vaporizer research protocol and grant application, amounting to slightly more than $137,000, contingent upon the protocol obtaining all the necessary regulatory approvals. The study will compare subjective effects, cannabinoid blood levels and carbon monoxide levels in exhaled breath in subjects on six different days, three days smoking 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC, and three days vaporizing 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC.

The protocol now goes to FDA for its review, finally. The big question is whether the FDA will want more data than MAPS and California NORML have already gathered on the Volcano (www.vapormed.de) or will accept the data we have already submitted, which is more than FDA has about what is in marijuana smoke post-combustion. We should hear from FDA within 4-6 weeks or so.

Also reviewing the protocol will be NIDA (since NIDA pot is being requested), DEA (supposedly to see what it can do to prevent the diversion of research supplies), and the Research Advisory Panel of California (which reviews all Schedule I research in California). The key review will be by FDA, since it will decide whether or not MAPS and California NORML need to raise more funds for additional vaporizer research.

June 24, 2003. Maps Working to Import Dutch Cannabis for Research. MAPS has completed negotiations with the head of the Dutch Office of Medicinal Cannabis for the importation of ten grams of high THC, high CBD marijuana for use in the next phase of the vaporizer research project. Chemic Laboratories, where the project will be conducted, has submitted an application to the DEA for an import license. This request to the DEA is, to our knowledge, the first attempt to import the marijuana plant from the Netherlands, through the newly established Office of Medicinal Cannabis. Chemic Laboratories has also submitted a request to NIDA for ten grams of its best quality product for the vaporizer project.


  • “Study Shows Vaporizer Can Drastically Reduce Toxins in Marijuana Smoke”
    California NORML/ MAPS Press Release — May 2, 2003 
  • “Vaporizer Research: An Update”   (PDF Format)  
    Dale Gieringer, Ph.D. (canorml@igc.apc.org)
    MAPS Bulletin, Spring 2003; Volume XIII, Number 1


    April 15, 2003. Vaporizer Study Report. The Vaporizer report is now available. The findings show substantial reduction (about 99%) in certain toxins in the vapor as compared to marijuana smoke, and substantial amounts of cannabinoids produced by the vaporizer. The results could hardly have been better. This report has been submitted to FDA as part of Dr. Donald Abrams’ IND application to study subjective effects and cannabinoid blood levels in subjects who both smoke marijuana and then at a later time inhale marijuana vapors. We should hear from FDA in early May about what additional information, if any, it needs to have before deciding if the vaporizer can be used in a clinical trial.January 21, 2003. MAPS and CANorml sign a contract for a $25,000 protocol study to evaluate the contents of the vapor stream from the Volcano Vaporizer (http://www.vapormed.de). The purpose of the study is stated in the contract as follows: This protocol is intended to provide guidance on the completion of an extraction evaluation of emissions produced when marijuana is vaporized using the Volcano; to provide evidence of product efficiency to MAPS, which would subsequently design and seek agency (FDA) approval for the protocol development and initiation of a Phase I clinical investigation comparing cannabinoid blood levels in subjects smoking (i.e. pyrolysis) marijuana versus marijuana vaporized with the Volcano, and to meet the requirements of cGMP: 21 CFR Part 160.

    We expect the study to be completed by the end of March 2003.

     

     

     

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Water-pipe and Vaporizer Articles from MAPS Bulletin 1994-2004

Best Marijuana Argument Ever: Given By Superior Court Judge James P. Gray

Retired Superior Court Judge James P. Gray testifies in favor of a marijuana legalization bill in the California Assembly on October 28, 2009. Judge Gray is a member of Law Enforcement Against Prohibition, which any citizen can join for free at http://www.CopsSayLegalizeDrugs.com.

 

Proof Weed Cures Cancer!

Proof Weed Cures Cancer! (1 of 3)

Proof Weed Cures Cancer! (2 of 3)

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Proof Weed Cures Cancer! (3 of 3)

Must-Watch: Marijuana Legalization Hearing in Washington State

 Marijuana activists, politicians, and former and current law enforcement officials spoke to the Washington State legislature in support (and against) of Rep. Mary Lou Dickerson’s House Bill 1550, which would legalize cannabis and make it available for retail purchase in State-run liquor stores.

Part 1

 Part 2

 Part 3

 Part 4

Long term use of Medical Cannabis by Federal Legal Patients

U.S.government-grown medical marijuana is sent to several patients remaining on the Investigational New Drugs program. In 2002, Elvy Musikka, George McMahon and Irvin Rosenfeld spoke to the Cannabis Therapeutics Conference in Portland, Oregon about their health and experience of 20 years using Medical Cannabis. Hosted by Mary Lynn Mathre, Patients Out of Time.
Long term use of Medical Cannabis by Federal Legal Patients, Part 1 (Complete)

http://video.google.com/googleplayer.swf?docid=-1666087285986005807&hl=en&fs=true

At 2002 Cannabis Therapeutics Conference, Ethan Russo,MD presents results of comprehensive physical examinations of three patients recieving U.S. Government-grown medical marijuana over a 20 year period. The three patients are Elvy Musikka, George McMahon and Irvin Rosenfeld. Hosted by Patients Out of Time.
Long term use of Medical Cannabis by Federal Legal Patients, Part 2 (Complete)

http://video.google.com/googleplayer.swf?docid=-9112662989507508748&hl=en&fs=true

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