Production, Analysis, & Distribution of Cannabis & Marijuana Cigarettes!

Solicitation Number: N01DA-10-7773
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute on Drug Abuse

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N01DA-10-7773 Notice Type:
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Added: Aug 05, 2009 9:03 am


The National Institute on Drug Abuse is soliciting proposals from qualified organizations having the capability to (1) grow, harvest, analyze, store and distribute GMP grade cannabis (marijuana) on large and small scales; (2) extract cannabis to obtain purified phytocannabinoids including delta-9-tetrahydrocannabinol (delta-9-THC), analyze, and store; (3) prepare marijuana cigarettes and related products; and (4) distribute marijuana, marijuana cigarettes and cannabinoids, and other related products for research and other Government programs upon NIDA authorization. Offeror must possess suitable and secure DEA approved outdoor and indoor growing facilities, research laboratory with appropriate analytical instruments, and experienced personnel to conduct the project tasks. Appropriate DEA approved secure facility for manufacturing of marijuana cigarettes, and their storage, and DEA Schedule I registration for marijuana and THC are essential. NIDA anticipates a 1-year with four 1 year options cost reimbursement type contract will be awarded. Additional quantity options for manufacturing cigarettes may also be required. In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations. The pertinent FDA's guidelines/guidance shall be followed. RFP No. N01DA-10-7773 will be available electronically on or about August 25, 2009. You can access the RFP through the FedBizOpps http://fbo.gov or through the NIDA website at the following address: http://www.nida.nih.gov/RFP/RFPList.html. The electronic RFP contains all information needed to submit a proposal. No printed version of the solicitation document or source list is available. NIDA will consider proposals submitted by any responsible offeror. Proposals will be due on or about October 9, 2009. This advertisement does not commit the Government to award a contract. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

U.S. Government Stopped Research After Finding That Marijuana Slowed Cancer Growth

Posted in Chronicle Blog by Scott Morgan on Mon, 06/16/2008 - 10:15pm

NORML's Paul Armentano has a disturbing account of the history of government research regarding the benefits of THC as a potential cancer treatment:


Not familiar with this scientific research? Your government is.

In fact, the first experiment documenting pot's potent anti-cancer effects
took place in 1974 at the Medical College of Virginia at the behest federal
bureaucrats. The results of that study, reported in an Aug. 18, 1974,
Washington Post newspaper feature, were that marijuana's primary
psychoactive component, THC, "slowed the growth of lung cancers, breast
cancers and a virus-induced leukemia in laboratory mice, and prolonged their
lives by as much as 36 percent."

Despite these favorable preliminary findings (eventually published the
following year in the Journal of the National Cancer Institute), U.S.
government officials refused to authorize any follow-up research until
conducting a similar - though secret - clinical trial in the mid-1990s. That
study, conducted by the U.S. National Toxicology Program to the tune of $2
million, concluded that mice and rats administered high doses of THC over
long periods had greater protection against malignant tumors than untreated
controls.

However, rather than publicize their findings, government researchers
shelved the results, which only became public after a draft copy of its
findings were leaked to the medical journal AIDS Treatment News, which in
turn forwarded the story to the national media. [timesheraldonline.com]

They haven't studied the issue since. And because the U.S. government holds a monopoly on "legal" marijuana that could be used for research purposes, they've been able to prevent independent researchers from further investigating marijuana's promising anti-cancer properties. Armentano notes that research overseas continues to produce very encouraging results.

Unfortunately, our government's blockade against marijuana/cancer research is so mindless and vindictive that it's almost impossible to convince anyone that they do things like this. It's a terrible and frequent conundrum for reformers that if we accurately describe the behavior of our opposition, we end up sounding crazy.

The Facts On Medical Marijuana!

Medical Marijuana

1. Since 1996, thirteen states have legalized medical marijuana use: AK, CA, CO, HI, ME, MI, MT, NV, NM, OR, RI, VT, and WA. Eight of the thirteen did so through the initiative process. Hawaii's law was enacted by the legislature and signed by the governor in 2000, Vermont's was enacted by the legislature and passed into law without the governor's signature in May 2004, Rhode Island's was passed into law over the governor's veto in January 2006, and New Mexico's legislation was signed into law by Governor Bill Richardson on April 2, 2007.

Source: National Organization for the Reform of Marijuana Laws (NORML), from the web at http://www.norml.org/index.cfm?Group_ID=3391, last accessed Sept. 19, 2008.

2. The Institute of Medicine's 1999 report on medical marijuana stated, "The accumulated data indicate a potential therapeutic value for cannabinoid drugs, particularly for symptoms such as pain relief, control of nausea and vomiting, and appetite stimulation."

Source: Janet E. Joy, Stanley J. Watson, Jr., and John A Benson, Jr., "Marijuana and Medicine: Assessing the Science Base," Division of Neuroscience and Behavioral Research, Institute of Medicine (Washington, DC: National Academy Press, 1999).

3. The Institute of Medicine's 1999 report on medical marijuana examined the question whether the medical use of marijuana would lead to an increase of marijuana use in the general population and concluded that, "At this point there are no convincing data to support this concern. The existing data are consistent with the idea that this would not be a problem if the medical use of marijuana were as closely regulated as other medications with abuse potential." The report also noted that, "this question is beyond the issues normally considered for medical uses of drugs, and should not be a factor in evaluating the therapeutic potential of marijuana or cannabinoids."

Source: Janet E. Joy, Stanley J. Watson, Jr., and John A Benson, Jr., "Marijuana and Medicine: Assessing the Science Base," Division of Neuroscience and Behavioral Research, Institute of Medicine (Washington, DC: National Academy Press, 1999).

3. In the Institute of Medicine's report on medical marijuana, the researchers examined the physiological risks of using marijuana and cautioned, "Marijuana is not a completely benign substance. It is a powerful drug with a variety of effects. However, except for the harms associated with smoking, the adverse effects of marijuana use are within the range of effects tolerated for other medications."

Source: Janet E. Joy, Stanley J. Watson, Jr., and John A Benson, Jr., "Marijuana and Medicine: Assessing the Science Base," Division of Neuroscience and Behavioral Research, Institute of Medicine (Washington, DC: National Academy Press, 1999).

4. The Institute of Medicine's 1999 report on medical marijuana examined the question of whether marijuana could diminish patients' immune system - an important question when considering marijuana use by AIDS and cancer patients. The report concluded that, "the short-term immunosuppressive effects are not well established but, if they exist, are not likely great enough to preclude a legitimate medical use."

Source: Janet E. Joy, Stanley J. Watson, Jr., and John A Benson, Jr., "Marijuana and Medicine: Assessing the Science Base," Division of Neuroscience and Behavioral Research, Institute of Medicine (Washington, DC: National Academy Press, 1999).

5. "Conclusions: Smoked and oral cannabinoids did not seem to be unsafe in people with HIV infection with respect to HIV RNA levels, CD4+ and CD8+ cell counts, or protease inhibitor levels over a 21-day treatment."

Source: Abrams, Donald I., MD, et al., "Short-Term Effects of Cannabinoids in Patients with HIV-1 Infection - A Randomized, Placebo-Controlled Clinical Trial," Annals of Internal Medicine, Aug. 19, 2003, Vol. 139, No. 4 (American College of Physicians), p. 258.

6. "This study provides evidence that short-term use of cannabinoids, either oral or smoked, does not substantially elevate viral load in individuals with HIV infection who are receiving stable antiretroviral regimens containing nelfinavir or indinavir. Upper confidence bounds for all estimated effects of cannabinoids on HIV RNA level from all analyses were no greater than an increase of 0.23 log10 copies/mL compared with placebo. Because this study was randomized and analyses were controlled for all known potential confounders, it is very unlikely that chance imbalance on any known or unknown covariate masked a harmful effect of cannabinoids. Study participants in all groups may have been expected to benefit from the equivalent of directly observed antiretroviral therapy, as well as decreased stress and, for some, improved nutrition over the 25-day inpatient stay."

Source: Abrams, Donald I., MD, et al., "Short-Term Effects of Cannabinoids in Patients with HIV-1 Infection - A Randomized, Placebo-Controlled Clinical Trial," Annals of Internal Medicine, Aug. 19, 2003, Vol. 139, No. 4 (American College of Physicians), p. 264.

7. In spite of the established medical value of marijuana, doctors are presently permitted to prescribe cocaine and morphine - but not marijuana.

Source: The Controlled Substances Act of 1970, 21 U.S.C. §§ 801 et seq.

8. "Nevertheless, when considering all 15 studies (i.e., those that met both strict and more relaxed criteria) we only noted that regular cannabis users performed worse on memory tests, but that the magnitude of the effect was very small. The small magnitude of effect sizes from observations of chronic users of cannabis suggests that cannabis compounds, if found to have therapeutic value, should have a good margin of safety from a neurocognitive standpoint under the more limited conditions of exposure that would likely obtain in a medical setting."

Source: Grant, Igor, et al., "Non-Acute (Residual) Neurocognitive Effects Of Cannabis Use: A Meta-Analytic Study," Journal of the International Neuropsychological Society (Cambridge University Press: July 2003), 9, pp. 687-8.

9. The DEA's Administrative Law Judge, Francis Young concluded: "In strict medical terms marijuana is far safer than many foods we commonly consume. For example, eating 10 raw potatoes can result in a toxic response. By comparison, it is physically impossible to eat enough marijuana to induce death. Marijuana in its natural form is one of the safest therapeutically active substances known to man. By any measure of rational analysis marijuana can be safely used within the supervised routine of medical care.:

Source: US Department of Justice, Drug Enforcement Agency, "In the Matter of Marijuana Rescheduling Petition," [Docket #86-22], (September 6, 1988), p. 57.

10. Organizations that have endorsed medical access to marijuana include: the Institute of Medicine, the American Academy of Family Physicians; American Bar Association; American Nurses Association; American Public Health Association; American Society of Addiction Medicine; AIDS Action Council; British Medical Association; California Academy of Family Physicians; California Legislative Council for Older Americans; California Medical Association; California Nurses Association; California Pharmacists Association; California Society of Addiction Medicine; California-Pacific Annual Conference of the United Methodist Church; Colorado Nurses Association; Consumer Reports Magazine; Kaiser Permanente; Lymphoma Foundation of America; Multiple Sclerosis California Action Network; National Association of Attorneys General; National Association of People with AIDS; National Nurses Society on Addictions; New Mexico Nurses Association; New York State Nurses Association; New England Journal of Medicine; and Virginia Nurses Association.

11. A few of the editorial boards that have endorsed medical access to marijuana include: Boston Globe; Chicago Tribune; Miami Herald; New York Times; Orange County Register; and USA Today.

12. Many organizations have favorable positions (e.g., unimpeded research) on medical marijuana. These groups include: The Institute of Medicine, The American Cancer Society; American Medical Association; American Nurses Association; Australian Commonwealth Department of Human Services and Health; California Medical Association; Federation of American Scientists; Florida Medical Association; and the National Academy of Sciences.

13. The Controlled Substances Act of 1970 established five categories, or "schedules," into which all illicit and prescription drugs were placed. Marijuana was placed in Schedule I, which defines the substance as having a high potential for abuse, no currently accepted medical use in the United States, and a lack of accepted safety for use under medical supervision. To contrast, over 90 published reports and studies have shown marijuana has medical efficacy.

Source: The Controlled Substances Act of 1970, 21 U.S.C. §§ 801 et seq.; Common Sense for Drug Policy, Compendium of Reports, Research and Articles Demonstrating the Effectiveness of Medical Marijuana, Vol. I & Vol. II (Falls Church, VA: Common Sense for Drug Policy, March 1997).

14. The U.S. Penal Code states that any person can be imprisoned for up to one year for possession of one marijuana cigarette and imprisoned for up to five years for growing a single marijuana plant.

Source: The Controlled Substances Act of 1970, 21 U.S.C. §§ 801 et seq.

15. On September 6, 1988, the Drug Enforcement Administration's Chief Administrative Law Judge, Francis L. Young, ruled: "Marijuana, in its natural form, is one of the safest therapeutically active substances known....[T]he provisions of the [Controlled Substances&#093 Act permit and require the transfer of marijuana from Schedule I to Schedule II. It would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of this substance."

Source: US Department of Justice, Drug Enforcement Agency, "In the Matter of Marijuana Rescheduling Petition," [Docket #86-22] (September 6, 1988), p. 57.

16. Between 1978 and 1997, 35 states and the District of Columbia passed legislation recognizing marijuana's medicinal value. States include: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IA, LA, MA, ME, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, RI, SC, TN, TX, VT, VA, WA, WV, and WI.

17. "In 2003, the Opium Act was amended to legalise the medical use of cannabis. Since September 2003, prescribed medical cannabis is available at pharmacies for patients with indicated disorders."

Source: Trimbos Institute, "Report to the EMCDDA by the Reitox National Focal Point, The Netherlands Drug Situation 2003" (Lisboa, Portugal: European Monitoring Centre for Drugs and Drug Addiction, Dec. 2003), p. 1.