Tag Archives: Clinical trial

AMA journal article suggests mandating participation in experimental vaccine trials ‘for the greater good’

Friday, January 20, 2012 by: Ethan A. Huff, staff writer

(NaturalNews) Some of the most deranged and sociopathic individuals on the planet hold respected positions of authority in medicine and at institutions of higher learning, and a recent journal article in the American Medical Association (AMA)’s Journal of Ethics serves as a reminder of this disturbing reality. In the article, two doctors from Oxford University in the UK advocate forcibly injecting individuals with experimental vaccines “for the greater good of society.”

PrisonPlanet.com reports that Oxford’s Susanne Sheehy, BM BCh, MRCP, DTM&H, and Joel Meyer, BM BCh, MRCP, together authored the paper, entitledShould Participation in Vaccine Clinical Trials be Mandated?. In it, the duo recommends “[c]ompulsory involvement in vaccine studies” in response to a general lack of willing volunteers, many of whom are not exactly comfortable sacrificing their bodies and their health to have a toxic brew of untested chemicals injected into them.

The totalitarian viewpoint of Sheehy and Meyer, both of whom are members of the UK’s Royal College of Physicians, is nothing short of frightening. That any human being is capable of convincing himself that forcibly injecting another human being with chemicals, live viral components, and other toxins is a good idea, is a shocking anomaly in and of itself. But this scenario becomes especially disturbing when those in positions of power adopt this psychopathic viewpoint.

Clearly stated in their paper, Sheehy and Meyer believe mandatory participation in vaccine trials is no different than requiring individuals to serve on jury duty, for instance, or to serve in the military. They also believe that forcing people to take experimental vaccines, even when such vaccines come with obvious “inherent risks,” is an individual’s required duty to give back to society.

Perhaps the most disturbing element of the paper, though, is its suggestion that “increas[ing] the severity” of diseases will help to facilitate “compulsory recruitment” into experimental vaccine trials. Deliberately creating more deadly strains of disease in order to scare people into vaccine programs, in other words, is apparently considered to be a valid approach by Sheehy and Meyer, whose passionate worship of vaccines have led them to such a preposterous notion.

A little bit of history on vaccine trials — it was revealed back in 2008 that at least 14 Argentinian children died as part of an experimental vaccine trial conducted by British pharmaceutical giant GlaxoSmithKline (http://www.buenosairesherald.com/article/88922/gsk-lab-fined-$1m-over-tests-that-killed-14–babies). Also in 2008, 21 homeless individuals in Poland died during an avian flu vaccine experiment (http://www.naturalnews.com/023665_vaccine_flu_homeless.html).

Sources for this article include:

http://www.prisonplanet.com/ama-journal-make-participation-in-vaccine-trials-mandatory.html

http://virtualmentor.ama-assn.org/2012/01/pfor1-1201.html

Source:

http://www.naturalnews.com/034706_vaccine_trials_mandatory_gunpoint_medicine.html#ixzz1klinLobF

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Medical research proven to be mostly flawed

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Source::http://www.naturalnews.com/031121_medical_research_fraud.html#ixzz1D4pdk4NB

Thursday, January 27, 2011 by: Alexander Frantzis, citizen journalist

(NaturalNews) Internationally recognized as the foremost expert in assessing the credibility of medical research, Dr. John Ioannidis made a most disturbing discovery. Up to 90 percent of published medical information directly relied on by doctors to determine treatment is misleading, exaggerated, or quite often flat out wrong. Even more unsettling, the medical community agrees with his assessment.

Starting his medical career at the beginning of the evidence based medicine movement, Ioannidis gravitated away from undertaking new research towards assessing the validity of previous research. Systemic inaccuracy emerged consistently at every level, and began to paint the picture that most studies were biased. Uniquely positioned as an expert statistician, Ioannidis carefully assembled a team, which spent a decade exploring the problem before publishing a landmark paper. It concluded:

With natural levels of researcher bias, generally imperfect research techniques, and a common tendency to focus on novel rather than plausible theories, wrong findings will be the norm. At the same time the scientific journals are strongly biased towards publishing the most novel claims and lack effective safeguards for filtering out inaccurate studies.

The paper showed both theoretically and empirically that 80 percent of non-randomized studies (the most common type), 25 percent of the “gold-standard” randomized trials, and nearly 10 percent of the “platinum-standard” large randomized trials were incorrectly executed.

To highlight the inability to weed out bad research, they focused on the 49 most highly regarded and cited research papers published in the past 13 years. Of those, 41% had later been disproved when tested, while 24% hadn’t even been retested. Upon further examination, 3 of these studies, which were later firmly disproved, they found scientists were more likely to cite the original inaccurate study, in one case for at least 12 years after it was discredited.

Economics appears to be an underlying cause of the research inaccuracies. A successful scientific career depends upon your research being funded and published. This intellectual conflict of interest motivates scientists to pursue and produce results that will be funded. Scientific journals are naturally biased towards publishing new, exciting research; they rely upon a vetted peer review process that is frequently commandeered by scientists in pursuit of career advancement. Worst of all are drug studies, funded by pharmaceutical companies and commonly corrupted by a much stronger financial conflict of interest.

It thus should come as no surprise that many medications originally shown to be both safe and effective in numerous large randomized control trials were later found to be dangerous. Vioxx, Zelnorm, and Baycol all were taken off the market for safety concerns, while the anti-depressants Prozac, Zoloft, and Paxil are now known to be no more effective than placebos.

Science, by definition, relies upon continual retesting of previous results by other scientists to protect against erroneous conclusions. Yet, this does not occur. In Ioannidis’ own words, the“odds that anything useful will survive from any of these studies are poor.”

Sources:
http://www.theatlantic.com/magazine…

http://www.plosmedicine.org/article…


Recent Research on Medical Marijuana

Emerging Clinical Applications For Cannabis & Cannabinoids
A Review of the Recent Scientific Literature, 2000 — 2011

 

Despite the ongoing political debate regarding the legality of medicinal marijuana, clinical investigations of the therapeutic use of cannabinoids are now more prevalent than at any time in history.

For example, in February 2010 investigators at the University of California Center for Medicinal Cannabis Research publicly announced thefindings of a series of randomized, placebo-controlled clinical trials on the medical utility of inhaled cannabis. The studies, which utilized the so-called ‘gold standard’ FDA clinical trail design, concluded that marijuana ought to be a “first line treatment” for patients with neuropathy and other serious illnesses.

Among the studies conducted by the Center, four assessed smoked marijuana’s ability to alleviate neuropathic pain, a notoriously difficult to treat type of nerve-pain associated with cancer, diabetes, HIV/AIDS, spinal cord injury, and many other debilitating conditions. Each of the trials found that cannabis consistently reduced patients’ pain levels to a degree that was as good or better than currently available medications.

Another study conducted by the Center’s investigators assessed the use of marijuana as a treatment for patients suffering frommultiple sclerosis. That study determined that “smoked cannabis was superior to placebo in reducing spasticity and pain in patients with MS, and provided some benefit beyond currently prescribed treatments.”

Around the globe similarly controlled trials are also taking place. A 2010 review by researchers in Germany reports that since 2005 there have been 37 controlled studies assessing the safety and efficacy of marijuana and its naturally occurring compounds, involved a total of 2,563 subjects. By contrast, most FDA-approved drugs go through far fewer trials involving far fewer subjects.

While much of the renewed interest in cannabinoid therapeutics is a result of the discovery of the endocannabinoid regulatory system (which we describe in detail later in this booklet), some of this increased attention is also due to the growing body of testimonials from medicinal cannabis patients and their physicians. Nevertheless, despite this influx of anecdotal reports, much of the modern investigation of medicinal cannabis remains limited to preclinical (animal) studies of individual cannabinoids (e.g. THC or cannabidiol) and/or synthetic cannabinoid agonists (e.g., dronabinol or WIN 55,212-2) rather than clinical trial investigations involving whole plant material. Predictably, because of the US government’s strong public policy stance against any use of cannabis, the bulk of this modern cannabinoid research is taking place outside the United States.

As clinical research into the therapeutic value of cannabinoids has proliferated – there are now an estimated 20,000 published papers in the scientific literature analyzing marijuana and its constituents — so too has investigators’ understanding of cannabis’ remarkable capability to combat disease. Whereas researchers in the 1970s, 80s, and 90s primarily assessed cannabis’ ability to temporarily alleviate various disease symptoms — such as the nausea associated with cancer chemotherapy — scientists today are exploring the potential role of cannabinoids tomodify disease.

Of particular interest, scientists are investigating cannabinoids’ capacity to moderate autoimmune disorders such as multiple sclerosis,rheumatoid arthritis, and inflammatory bowel disease, as well as their role in the treatment of neurological disorders such as Alzheimer’s disease and amyotrophic lateral sclerosis (a.k.a. Lou Gehrig’s disease.) In fact, in 2009 the American Medical Association (AMA) resolved for the first time in the organization’s history “that marijuana’s status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical research and development of cannabinoid-based medicines.”

Investigators are also studying the anti-cancer activities of cannabis, as a growing body of preclinical and clinical data concludes that cannabinoids can reduce the spread of specific cancer cells via apoptosis (programmed cell death) and by the inhibition of angiogenesis (the formation of new blood vessels). Arguably, these latter trends represent far broader and more significant applications for cannabinoid therapeutics than researchers could have imagined some thirty or even twenty years ago.

THE SAFETY PROFILE OF MEDICAL CANNABIS

Cannabinoids have a remarkable safety record, particularly when compared to other therapeutically active substances. Most significantly, the consumption of marijuana – regardless of quantity or potency — cannot induce a fatal overdose. According to a 1995 review prepared for the World Health Organization, “There are no recorded cases of overdose fatalities attributed to cannabis, and the estimated lethal dose for humans extrapolated from animal studies is so high that it cannot be achieved by … users.”

In 2008, investigators at McGill University Health Centre and McGill University in Montreal and the University of British Columbia in Vancouverreviewed 23 clinical investigations of medicinal cannabinoid drugs (typically oral THC or liquid cannabis extracts) and eight observational studies conducted between 1966 and 2007. Investigators “did not find a higher incidence rate of serious adverse events associated with medical cannabinoid use” compared to non-using controls over these four decades.

That said, cannabis should not necessarily be viewed as a ‘harmless’ substance. Its active constituents may produce a variety of physiological and euphoric effects. As a result, there may be some populations that are susceptible to increased risks from the use of cannabis, such asadolescentspregnant or nursing mothers, and patients who have a family history of mental illness. Patients with Hepatitis C, decreased lung function (such as chronic obstructive pulmonary disease), or who have a history of heart disease or stroke may also be at a greater risk of experiencing adverse side effects from marijuana. As with any medication, patients should consult thoroughly with their physician before deciding whether the medicinal use of cannabis is safe and appropriate.

HOW TO USE THIS REPORT

As states continue to approve legislation enabling the physician-supervised use of medicinal marijuana, more patients with varying disease types are exploring the use of therapeutic cannabis. Many of these patients and their physicians are now discussing this issue for the first time, and are seeking guidance on whether the therapeutic use of cannabis may or may not be advisable. This report seeks to provide this guidance by summarizing the most recently published scientific research (2000-2010) on the therapeutic use of cannabis and cannabinoids for 19 clinical indications:

Alzheimer’s disease
Amyotrophic lateral sclerosis
Chronic Pain
Diabetes mellitus
Dystonia
Fibromyalgia
Gastrointestinal disorders
Gliomas
Hepatitis C
Human Immunodeficiency Virus
Hypertension
Incontinence
Methicillin-resistant Staphyloccus aureus (MRSA)
Multiple sclerosis
Osteoporosis
Pruritus
Rheumatoid arthritis
Sleep apnea
Tourette’s syndrome

In some of these cases, modern science is now affirming longtime anecdotal reports of medicinal cannabis users (e.g., the use of cannabis to alleviate GI disorders). In other cases, this research is highlighting entirely new potential clinical utilities for cannabinoids (e.g., the use of cannabinoids to modify the progression of diabetes.)

The conditions profiled in this report were chosen because patients frequently inquire about the therapeutic use of cannabis to treat these disorders. In addition, many of the indications included in this report may be moderated by cannabis therapy. In several cases, preclinical data and clinical data indicate that cannabinoids may halt the progression of these diseases in a more efficacious manner than available pharmaceuticals.

For patients and their physicians, let this report serve as a primer for those who are considering using or recommending medicinal cannabis. For others, let this report serve as an introduction to the broad range of emerging clinical applications for cannabis and its various compounds.

Paul Armentano
Deputy Director
NORML | NORML Foundation
Washington, DC
January 7, 2011

* The author would like to acknowledge Drs. Dale Gieringer, Dustin Sulak, Gregory Carter, Steven Karch, and Mitch Earleywine, as well as Bernard Ellis, MPH, former NORML interns John Lucy, Christopher Rasmussen, and Rita Bowles, for providing research assistance for this report. The NORML Foundation would also like to acknowledge Dale Gieringer, Paul Kuhn, and Richard Wolfe for their financial contributions toward the publication of this report.

** Important and timely publications such as this are only made possible when concerned citizens become involved with NORML. For more information on joining NORML or making a donation, please visit: http://www.norml.org/join. Tax-deductible donations in support of NORML’s public education campaigns should be made payable to the NORML Foundation.


‘Gold Standard’ Studies Show That Inhaled Marijuana Is Medically Safe And Effective

State-Funded Clinical Trials Show Cannabis Eases Neuropathic Pain And Spasticity, Landmark Report Says

February 18, 2010 – Sacramento, CA, USA

Sacramento, CA: The results of a series of randomized, placebo-controlled clinical trials assessing the efficacy of inhaled marijuana consistently show that cannabis holds therapeutic value comparable to conventional medications, according to the findings of a 24-page report issued Wednesday to the California state legislature by the California Center for Medicinal Cannabis Research (CMCR).

Four of the five placebo-controlled trials demonstrated that marijuana significantly alleviated neuropathy, a difficult to treat type of pain resulting from nerve damage.

“There is good evidence now that cannabinoids (the active compounds in the marijuana plant) may be either an adjunct or a first-line treatment for … neuropathy,” said Dr. Igor Grant, Director of the CMCR, at a news conference at the state Capitol. He added that the efficacy of smoked marijuana was “very consistent,” and that its pain-relieving effects were “comparable to the better existing treatments” presently available by prescription.

A fifth study showed that smoked cannabis reduced the spasticity associated with multiple sclerosis. A separate study conducted by the CMCR established that the vaporization of cannabis – a process that heats the substance to a temperature where active cannabinoid vapors form, but below the point of combustion – is a “safe and effective” delivery mode for patients who desire the rapid onset of action associated with inhalation while avoiding the respiratory risks of smoking.

Two additional clinical trials remain ongoing.

The CMCR program was founded in 2000 following an $8.7 million appropriation from the California state legislature. The studies are some of the first placebo-controlled clinical trials to assess the safety and efficacy of inhaled cannabis as a medicine to take place in over two decades.

Placebo-controlled clinical crossover trials are considered to be the ‘gold standard’ method for assessing the efficacy of drugs under the US FDA-approval process.

“These scientists created an unparalleled program of systematic research, focused on science-based answers rather than political or social beliefs,” said former California Senator John Vasconcellos, who sponsored the legislation in 1999 to launch the CMCR. Vasconcellos called the studies’ design “state of art,” and suggested that the CMCR’s findings “ought to settle the issue” of whether or not medical marijuana is a safe and effective medical treatment for patients.

“This (report) confirms all of the anecdotal evidence – how lives have been saved and pain has been eased,” said California Democrat Sen. Mark Leno at the press conference. “Now we have the science to prove it.”

Full text of the CMCR’s report to the California legislature is available at online at: http://www.cmcr.ucsd.edu/CMCR_REPORT_FEB17.pdf.

For more information, please contact Paul Armentano, NORML Deputy Director, at: paul@norml.org, or Dale Gieringer, California NORML Coordinator, at:http://www.canorml.org or (415) 563-5858.

updated: Feb 18, 2010



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