MARIJUANA BLOGS & RESEARCH: facts on medical marijuana

SOURCE: Cannabis Science, Inc. / marketwire.com

Jul 27, 2009 13:23 ETCannabis Science to Apply to the FDA to Utilize Their Fast Track Procedures to Help Speed the Approval of Its Cannabinoid Medicines in Treatment of H1N1 Swine Flu as AP Report Predicts Swine Flu Could Hit up to 40 Percent in the USA
SAN FRANCISCO, CA--(Marketwire - July 27, 2009) - Cannabis Science, Inc. (OTCBB: CBIS), an emerging pharmaceutical cannabis company, is pleased to report that it is moving as fast as possible to assist in the fight against the threat of a deadly influenza pandemic. In conjunction with its recent re-organization, the Company has begun discussions with the FDA as its program moves forward to provide FDA approved solutions for several critical illnesses.

H1N1 Swine Flu:

According to the CDC (http://www.cdc.gov/flu/avian/) the Avian flu (H5N1) has a 63% mortality rate. Unfortunately, the Swine flu, while causing death at a much lower rate than the Avian flu, appears to also result in death via a similar mechanism. The common cause of death with these strains is organ failure, especially as seen in the lungs with the development of Adult Respiratory Distress Syndrome (ARDS). ARDS is caused by an excess immune-generated inflammatory response that leads to apoptosis (cell death) and subsequently to organ failure. The Company's approach will mimic how the human body uses endocannabinoids (cannabinoids that occur naturally in the body) to regulate immune activity and cell survival, by regulating inflammatory biochemistry. Excessive inflammatory responses are associated with numerous disease states including autoimmune diseases, neurological imbalances, and cardiovascular disease. Phytocannabinoids provide a natural means to supplement illness-specific endocannabinoid deficiencies.

Cannabis Science H1N1 Swine Flu Formulation:

We now know that the endocannabinoid system plays a critical role in maintaining human health. The human body produces Endocannabinoids on demand when they are needed. They help restore homeostasis (biochemical balance). The Cannabis plant produces Phytocannabinoids. When the human body has endocannabinoid deficiencies, it cannot effectively restore the healthy biochemical state needed to counter a particular illness. Phytocannabinoids from the Cannabis plant can replace the deficient endocannabinoid activity in the human body to restore a health-promoting level of cannabinoid activity. Cannabis Science will test its cannabis extract lozenge with FDA guidance and oversight to determine if it will reduce ARDS-associated deaths from both the Avian and Swine influenza infections.

Dr. Robert Melamede, Ph.D., Cannabis Science, Inc., President and CEO, believes there is enormous potential value for cannabinoids to naturally reduce excessive inflammatory immune responses, and the Cannabis Science lozenge formulation could reduce the mortality rate and allow infected individuals to develop a strong natural immunity upon recovery. Dr. Melamede is the former Chairman (ret) of the Biology Department at the University of Colorado (Colorado Springs.)

Dr. Melamede added, "Again, we recommend, based on sound scientific principles, that medical marijuana users should switch to edibles if they come down with an influenza infection. We believe that the irritation associated with the pulmonary route, when a person has an influenza infection, may lead to unnecessary deaths. In contrast, oral administration may prevent many deaths. We hope that due to the magnitude of this pandemic threat, that the FDA will fast track our proposal."

FDA's three rapid special drug release programs:

Fast Track, Accelerated Approval and Priority Review are approaches that are intended to make therapeutically important drugs available at an earlier time. They do not compromise the standards for the safety and effectiveness of the drugs that become available through this process. These revitalized FDA drug review approaches have yielded tangible results in bringing safe and effective drugs to patients with serious diseases more quickly. For example, since 1996, 68 drugs for cancer therapies have received priority review and approval. The FDA reviewed Gleevec, a treatment for chronic myeloid leukemia, in four months. Shortened review times have also brought promising treatments to patients with HIV/AIDS more quickly. Kaletra for the treatment of HIV/AIDS was reviewed and approved in 3.5 months. Pegasys, a combination product for the treatment of Hepatitis C, was approved for marketing in 4 months.

Fast Track, Accelerated Approval, and Priority Review have evolved over time. The FDA has been vigilant in assuring that reducing the time necessary for drug development has not compromised the safety and effectiveness of drugs for patients with serious diseases. The median time required to review a priority review drug was reduced from 13.9 months to 6.7 months.

About Cannabis Science, Inc.

Cannabis Science, Inc. is at the forefront of medical marijuana research and development. The Company works with world authorities on phytocannabinoid science targeting critical illnesses, and adheres to scientific methodologies to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products. In sum, we are dedicated to the creation of cannabis-based medicines, both with and without psychoactive properties, to treat disease and the symptoms of disease, as well as for general health maintenance.

This Press Release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. A statement containing works such as "anticipate," "seek," intend," "believe," "plan," "estimate," "expect," "project," "plan," or similar phrases may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the events or results anticipated by these forward-looking statements may not occur. Factors that could cause or contribute to such differences include the future U.S. and global economies, the impact of competition, and the Company's reliance on existing regulations regarding the use and development of cannabis-based drugs. Cannabis Science, Inc. does not undertake any duty nor does it intend to update the results of these forward-looking statements.

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."

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."

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."

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."

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.