Archive for the ‘ Scientific Method ’ Category

Howard Simon: A.C.L.U. Exec. Dir. of Florida okays Medical Marijuana movement!

By Armani.
“By Howard Simon on June 12, 2013
Last week the American Civil Liberties Union issued a report (” The War on Marijuana in Black and White: Billions of Dollars Wasted on Racially Biased Arrests ” http://www.aclu.org/marijuana) confirming what everyone suspected: marijuana possession arrests are wasteful, destructive and marred by racial bias. The report, the first ever examining state and county marijuana arrest rates nationally by race, documents that while there were pronounced racial disparities in marijuana arrests 10 years ago – the problem has become significantly worse.”
 
Furthermore:
 
“Howard Simon has been a state affiliate Executive Director of the American Civil Liberties Union (ACLU) for almost four decades.  He is the ACLU’s most senior Affiliate Director.  Howard has served as Executive Director of the ACLU of Florida since October 1997, and prior to his appointment as Florida ACLU Director he served as Executive Director of ACLU’s Michigan affiliate for 23 years. Howard was raised in New York, and graduated from the City College of New York. He received a Ph.D.”
 
 
 
 
A.C.L.U. of Florida Executive Director

Always plan 6-7 steps ahead.

Plan 6-7 moves ahead always

( Courtesy, Howard Simon / June 7, 2013 )Howard Simon has been a state affiliate Executive Director of the American Civil Liberties Union (ACLU) for almost four decades. He is the ACLU’s most senior Affiliate Director. Howard has served as Executive Director of the ACLU of Florida since October 1997, and prior to his appointment as Florida ACLU Director he served as Executive Director of ACLU’s Michigan affiliate for 23 years. Howard was raised in New York, and graduated from the City College of New York. He received a Ph.D. degree from the University of Minnesota in legal and political philosophy and social ethics. Prior to his work with the ACLU, he taught philosophy at the University of Minnesota and was a faculty member in the Department of Philosophy and Religion at DePauw University in Indiana.

As Executive Director of the Florida affiliate of the American Civil Liberties Union, Howard has overall responsibility for ACLU’s legal, public education, legislative lobbying, and membership and fund-raising programs. Howard has been a frequent guest editorial writer in many Florida newspapers, and regularly appears in the media challenging politicians and government policies that assault constitutional freedoms. The ACLU of Florida has approximately 15,000 members, a staff of 30 and maintains staffed offices in Jacksonville, Pensacola, and Tampa in addition to its headquarters in Miami. The ACLU has been extensively involved in addressing the need for electoral reforms in Florida. Following the voting problems that occurred in the 2006 Congressional District 13 Election in Sarasota, the ACLU played a key role in securing the end of the use of paperless electronic voting systems in Florida, leading to the 2008 election in which every county used the same voting technology (the optical scan voting system) for the first time. The organization has also led efforts to end Florida’s Civil War constitutional provision requiring a lifetime voting ban of former felons.

The ACLU of Florida is in the forefront of efforts to resist many of the anti-civil liberties initiatives originating from the Legislature and the Scott Administration. The ACLU filed numerous cases challenging efforts to make it more difficult to register new voters, reduce the number of early voting days, specifically banning voting on the Sunday prior to the Tuesday November Election, and more difficult to have your voted counted by requiring more people to vote by provisional, rather than regular ballot. The ACLU has challenged the Governor’s Executive Order mandating drug/urine screen tests for state employees in the absence of suspicion of illicit drugs. Another ACLU lawsuit resulted in a federal order blocking the law requiring all applicants for Temporary Assistance for Needy families (TANF) to submit to a suspicionless drug/urine test.

Monsanto… Documented & Exposed.

 

Monsanto

 

Monsanto stock price 2000–2010.

Monsanto Company (NYSEMON) is a publicly traded Americanmultinational agricultural biotechnology corporation headquartered in Creve Coeur, Missouri. It is a leading producer of genetically engineered (GE) seed and of the herbicideglyphosate, which it markets under the Roundup brand. Founded in 1901 by John Francis Queeny, by the 1940’s it was a major producer of plastics, including polystyrene and synthetic fibers. Notable achievements by Monsanto and its scientists as a chemical company included breakthrough research on catalytic asymmetric hydrogenation and being the first company to mass-produce light emitting diodes (LEDs). The company also formerly manufactured controversial products such as the insecticide DDTPCBsAgent Orange, andrecombinant bovine somatotropin. Monsanto was among the first to genetically modify a plant cell, along with three academic teams, which was announced in 1983, and was among the first to conduct field trials of genetically modified crops, which it did in 1987. It remained one of the top 10 U.S. chemical companies until it divested most of its chemical businesses between 1997 and 2002, through a process of mergers and spin-offs that focused the company on biotechnology.

Monsanto was a pioneer in applying the biotechnology industry business model, developed byGenentech and other biotech drug companies in the late 1970s in California, to agriculture. In this business model, companies invest heavily in research and develop and recoup the expenses through the use and enforcement of biological patents. Monsanto’s application of this model to agriculture, along with a growing movement to create a global, uniform system of plant breeders’ rights in the 1980s, came into direct conflict with customary practices of farmers to save, reuse, share and develop plant varieties. Its seed patenting model has also been criticized as biopiracy and a threat tobiodiversity. Monsanto’s role in these changes in agriculture (which include its litigation and its seed commercialization practices), its current and former agbiotech products, its lobbying of government agencies, and its history as a chemical company, have made Monsanto controversial.

History

Monsanto was founded in St. Louis, Missouri, in 1901, by John Francis Queeny, a 30‑year veteran of the pharmaceutical industry. He funded the start-up with his own money and capital from a soft drink distributor and gave the company his wife’s maiden name. His father-in-law was Emmanuel Mendes de Monsanto, a wealthy financier of a sugar company active in Vieques, Puerto Rico, and based in St. Thomas in the Danish West Indies. The company’s first product was the artificial sweetener saccharin, which was sold to the Coca-Cola Company.  They got Francisco Vicente Aguilera murdered.

Then in 1919 Monsanto expanded to Europe by entering a partnership with Graesser’s Chemical Works at Cefn Mawr near Ruabon, Wales to produce vanillinaspirin and its raw ingredient salicylic acid, and later rubber processing chemicals. This site was later sold and closed in 2010. In the 1920s Monsanto expanded into basic industrial chemicals like sulfuric acid and PCBs, and Queeny’s son Edgar Monsanto Queeny took over the company in 1928.

In 1946 it developed “All” laundry detergent and began to market it; they sold the product line to Lever Brothers in 1957. Also in the 1940s, Monsanto operated the Dayton Project, and later Mound Laboratories in Miamisburg, Ohio, for the Manhattan Project, the development of the first nuclear weapons and, after 1947, the Atomic Energy Commission. In 1947 one of its factories was destroyed in the Texas City Disaster. Monsanto acquired American Viscose from England’s Courtauld family in 1949. In 1954 Monsanto partnered with German chemical giant Bayer to form Mobay and market polyurethanes in the United States. Continue reading

Toxicological Adverse Effects

Common Terminology Criteria for Adverse Events (CTCAE) and more

ctep.cancer.gov/reporting/ctc.html

Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC).

  • A key element of the reorientation of toxicity testing is the way in which adverse effects are understood, the topic of this post. Currently, the adverse effects “credible publications” are manipulated by the gov .. why?!??   Answer: corruption/profit.  This should cease and desist, humans should not be hurt & abused for profits in a republic where democracy thrives and justice prevails.

What is Toxicology?

www.toxicologysource.com/whatistoxicology.html

Toxicology is the study of the adverse effects of chemicals on living systems, whether they be human, animal, plant or microbe.

PUFMM | People United For Medicinal Marijuana

The government sayes its a schedule I , that is to say it has no medical use . But the synthetic form of THC, the main chemical ingredient in the cannabis plant is curently classified as schedule III, a prescribed pill trademarked as marinol.

Medical Marijuana has now been decriminalized in 16 U.S. states & in Cannada.

The American Medical Association & American College of Physicians have both called on the federal government to review cannabis as a schdule I substance.

The National Cancer Institute, a part of the National Institute of health, added cannabis to its website last year as a Complementary Alternative Medicine (CAM), & recoginzed that,”Cannabis has been used for medicinal purposes for thousands of years prior to its current status as an illegal substance.” It also has a 80% approval rating among Americans according to several polls.

EDUCATION IS TRUTH,. GET EDUCATED ,. GET IT DECRIMINALIZED,!!!!

Our #PUFMM Links

ENJOY!

 

 

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.

     

     

     

    View As Single Entry >


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

Proof Weed Cures Cancer!

Proof Weed Cures Cancer! (1 of 3)

Proof Weed Cures Cancer! (2 of 3)

]

Proof Weed Cures Cancer! (3 of 3)

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

Cancer cure with Dr. Burzynski using Cannabis Therapy!

The 2012 Republican Candidates on Marijuana | Marihuana | Cannabis | Hemp

As we approach the middle of January, Election 2012 is in full swing. Fresh off of the Iowa Caucuses, the six remaining Republican candidates move on to New Hampshire for their January 10th primary. As a non-profit organization, we are not permitted to endorse candidates for public office, but we hope this guide helps inform you of the marijuana policy positions of the various candidates.

(Note: I am not endorsing any of the candidates listed below and this is intended only as an educational overview of the candidates positions on marijuana policy.)

Republican Presidential Candidates 2012

Mitt Romney

Governor of Massachusetts (2003-2007)

Public Statements:

“People talk about medicinal marijuana, and, you know, you hear that story: People who are sick need medicinal marijuana. But marijuana is the entry drug for people trying to get kids hooked on drugs. I don’t want medicinal marijuana. There are synthetic forms of marijuana that are available for people who need it for prescription. Don’t open the doorway to medicinal marijuana.” 

(“Ask Mitt Anything” Event in Bedford, NH 2007 – source)

“We’ve got to not only continue our war on drugs from a police standpoint but also to market again to our young people about the perils of drugs.”

(New Hampshire Voter Event, August 17, 2011 – source)

“I believe marijuana should be illegal in this country. It is the pathway to drug usage by our society, which has made great scourges; it is one of the great causes of crime in our cities. I believe if we are at a state were, of course we are very concerned about people who are suffering in pain, and there are various means of providing pain management. And those who have had loved ones that have gone through an end of life with cancer know nature of real pain. I watched my wife’s mom and dad going through cancer treatments suffering a great deal of pain, but they didn’t have marijuana, and they didn’t need marijuana. Because there were other sources of pain management that worked as effectively.”

(Oct. 4 2007 at St. Anselm’s College, Manchester, NH – source)

“But having legalized [medical] marijuana is, in my view, an effort by a very committed few to try to get marijuana out in the public and ultimately legalize marijuana. They have a long way to go. We need less drugs in this society, not more drugs. I would oppose the legalization of marijuana in the country or legalization of marijuana for medicinal purposes because pain management is available from other sources.”

(Oct. 4 2007 at St. Anselm’s College, Manchester, NH – source)

Prior Activity: None

Ron Paul

House of Representatives for Texas’ 22nd (1976-1977, 1979-1985, 1997-Present)

Public Statements:

“This war on drugs has been a detriment to personal liberty and it’s been a real abuse of liberty, Our prisons are full with people who have used drugs who should be treated as patients — and they’re non-violent. Someday we’re gonna awake and find out that the prohibition we are following right now with drugs is no more successful, maybe a lot less successful, than the prohibition of alcohol was in the ’20s.”

(Comments Post-Iowa Caucus, 01/04/12 – source)

“Well, removing [marijuana] from the jurisdiction of the federal government and allowing the states to regulate it, like they would alcohol. And this seems to be strange for a lot of people, but I’m only going back to 1937 when that’s the way it was handled. The states always did this, and I’m motivated strongly also because the states legalize it for the use of medicinal purposes and it is helpful to people who have cancer or are getting chemotherapy. So this is not a huge radical idea, it’s something that was legal for a long, long time. And the war against marijuana causes so much hardship and accomplishes nothing. So I would say that marijuana, as far as causing highway problems, is miniscule compared to alcohol, and yet we knew prohibition of alcohol was very bad. So this is just getting back to a sensible position on how we handle difficult problems. And, for me, it should be the states.”

(Kudlow Report, June 23, 2011 – source)

“The role of the federal government is to protect our liberties. That means they should protect our religious liberties to do what we want; our intellectual liberty, but it also should protect our right to do to our body what we want, you know, what we take into our bodies.”

(Jay Leno Show, Dec. 2011 – source)

Prior Activity:

Co-sponsored HR 2306: Ending Federal Marijuana Prohibition Act of 2011

Sponsored HR 1831: Industrial Hemp Farming Act of 2011

Rick Santorum

House of Representatives for Pennsylvania’s 18th District (1991-1995)

US Senator from Pennsylvania (1995-2007)

Public Statements:

“There is a difference between legitimate issues of character — someone’s behavior — and the issue of whether someone who has done something wrong in their life, now because of those mistakes, can’t talk about what is the right thing to do. Politicians who have stumbled personally, are capable of making values-based arguments. I don’t think that’s hypocritical. That’s a dangerous line that many folks tend to cross over — that because you made a mistake, you can’t talk about this or that issue. We all make mistakes.

For example, I smoked pot when I was in college. Does that mean that I can’t talk about drug use? Does that mean that I can’t talk about how that’s a bad thing? Of course not. You learn from those experiences.

Even during that time, I knew that what I was doing was wrong. But just because I failed, that does not mean that I shouldn’t be able to talk about it. That’s a different issue. It’s not hypocrisy, as long as you don’t say, ‘I thought it was right, and now think it was wrong.’ If you knew what was going on, and most people do, you have moments of weakness. It happens to all of us. But that should not deter people from talking about what they believe is right.”

(National Review, March 2011 – source)

“Well, yeah, I admitted you know, back when I was running for the Senate, that when I was in college that I smoked pot and that was something that I did when I was in college. It was something that I’m not proud of, but I did. And said it was something that I wish I hadn’t done. But I did and I admitted it. I would encourage people not to do so. It was not all it’s made up to be.”
(Piers Morgan Tonight, August 31st, 2011 – source)

“I would think that [legalizing marijuana] would be an activity that is not consistent with American values.”
(Ames Straw Poll, September 2011 – source)

“I am adamantly opposed to the legalization of marijuana and other illegal narcotics I believe that this would lead to increased drug usage, especially among young people. While it is true that many Americans blatantly defy federal laws against the trafficking, sale, and use of illegal drugs, I believe a greater number of people are deterred from illegal drug use by the threat of arrest and prosecution.”

(1998 Constituent Letter Supplied to NORML – source)

“I believe that the drugs which are currently illegal should remain illegal. I am committed to maintaining the federal government’s role in the “war on drugs”, which is fought on many fronts by federal agents, local law enforcement, substance abuse counselors, teachers, parents, and concerned citizens.”

(1998 Constituent Letter Supplied to NORML – source)

Prior Activity:

Voted ‘Yes’ on HR 3540 in 1996 to add an additional $53 million (raising the total to $213 million) to international narcotics control funding, and pay for it by taking $25 million from international operations funding and $28 million from development assistance.

Newt Gingrich

House of Representatives for Georgia’s 5th District (1979-1999)

House Minority Whip (1989-1995)

Speaker of the House (1995-1999)

Public Statements:

“I think Jefferson or George Washington would have rather strongly discouraged you from growing marijuana and their techniques with dealing with it would have been rather more violent than our current government.”

(New Hampshire Voter Event, January 2012 – source)

“I would continue current federal policy, largely because of the confusing signal that steps towards legalization sends to harder drugs…I think the California experience is that medical marijuana becomes a joke. It becomes marijuana for any use. You find local doctors who will prescribe it for anybody that walks in.”

(Yahoo! News Interview, November 28th, 2011 – source)

“I don’t have a comprehensive view. My general belief is that we ought to be much more aggressive about drug policy. And that we should recognize that the Mexican cartels are funded by Americans. In my mind it means having steeper economic penalties and it means having a willingness to do more drug testing.”

(Yahoo! News Interview, November 28th, 2011 – source)

“I think that we need to consider taking more explicit steps to make it expensive to be a drug user. It could be through testing before you get any kind of federal aid. Unemployment compensation, food stamps, you name it.

It has always struck me that if you’re serious about trying to stop drug use, then you need to find a way to have a fairly easy approach to it and you need to find a way to be pretty aggressive about insisting–I don’t think actually locking up users is a very good thing. I think finding ways to sanction them and to give them medical help and to get them to detox is a more logical long-term policy.”

(Yahoo! News Interview, November 28th, 2011 – source)

Prior Activity:
Introduced and Sponsored the Drug Importer Death Penalty Act of 1996

Rick Perry

House of Representatives from Texas’ 64th District (1985-1991)

Lt. Governor of Texas (1999-2001)

Governor of Texas (2000-Present)

Public Statements:

“Crucial to understanding federalism in modern-day America is the concept of mobility, or “the ability to vote with your feet.” If you don’t support the death penalty and citizens packing a pistol, don’t come to Texas. If you don’t like medicinal marijuana and gay marriage, don’t move to California….”
(“Fed Up! Our Fight to Save America From Washington” by Rick Perry)

“When the federal government oversteps its authority, states should tell Washington they will not be complicit in enforcing laws with which they do not agree. Again, the best example is an issue I don’t even agree with—the partial legalization of marijuana. Californians clearly want some level of legalized marijuana, be it for medicinal use or otherwise. The federal government is telling them they cannot. But states are not bound to enforce federal law, and the federal government cannot commandeer state resources and require them to enforce it.”
(“Fed Up! Our Fight to Save America From Washington” by Rick Perry)

“[If] you want to go somewhere where you can smoke medicinal weed, then you ought to be able to do that.”

(Daily Show Interview, November 2010 – source)

“We can win the war on drugs but we have to fight it first. I know, I have to deal with this.”

(Republican Jewish Coalition 2012 Presidential Candidates Forum – source)

“The Governor does not support legalizing any drug. The Governor supports federal drug laws where appropriate. And while the Governor is personally opposed to legalizing the use of medical marijuana, if states want to allow doctor prescribed medical marijuana, it seems to him that under the 10th amendment, they have the right to do so.”

(Perry Spokesman Mike Miner to the Washington Post – source)

Prior Activity: None

Jon Huntsman

Governor of Utah (2005-2009)

US Ambassador to China (2009-2011)

Public Statements:

“Question: would you prosecute growers and sellers of marijuana in states where it has been made legal?

Jon Huntsman: I would let states decide that.”

(Townhall in Exeter, NH, June 2011 – source)

“I never saw him inhale.”

(Huntsman’s Childhood Friend in Politico – source)

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