Comparison of Cannabis with Other Standards Worldwide To Be Appr

2009.05.05

The standards applied worldwide are, for good reason, very high when it comes to the approval of new substances designed for medical use. These norms are largely based on quality, safety and effectiveness.

Quality

Requirements: development of constant forms of dosification covering the latest known compound. Clinical trials cannot be carried out without a constant form of dosification. All active ingredients must be identified, and their chemical properties must be known. The active ingredients must be tested for purity. There are maximum permitted levels with respect to impurities such as pesticides, bacteria and fungi, fertilizers and their products of decomposition. These tests must be recognized, and it must be possible to replicate them in any laboratory.

Cannabis contains over 400 chemical substances, in quantities that vary with the type of plant and method of cultivation. Many of these 400 substances are still unidentified. The concentrations of THC and other cannabinoids can also vary. For these reasons, it has to date not been possible to standardize the active ingredients. Cannabis is often contaminated with microbes, fungi, fertilizers and pesticides.

All scientific articles on cannabis or THC criticize the fact that testing is carried out on substances of varying composition. Some studies have been carried out with cannabis, others with synthetic THC such as Marinol or Nabilone, with cannabinol or with intramuscular injections of levonantradol.

Safety

The health consequences of smoking cannabis are serious, as is the danger of developing mental problems and addiction.

Physical health: The main risk is of damage to the lungs, as hundreds of carcinogenic substances are inhaled. This results in an increased risk of cancer of the respiratory organs and chronic lung damage.

Cannabis in the form of synthetic THC also has undesired effects on the brain. This has resulted in such conditions as attention deficit and loss of memory and perception, with a negative effect on movement coordination. These side-effects also exert a harmful influence on driver behavior and safety in the workplace. The long half-life period supposes heightened risk for persons who work, for example, with industrial or construction machinery, or in chemical plants or power stations.

Further consequences of cannabis consumption include harm to the hormone and immune systems.

Mental health: The smoking of cannabis can lead to general feeling of anxiety, loss of motivation, panic attacks, and ideas of persecution, psychotic symptoms and the onset of schizophrenia. Cannabis use can lead both to the onset of schizophrenia in persons so predisposed, or to a worsening of the symptoms in persons already suffering from this condition.

Dependency: Withdrawal symptoms can include restlessness, excitability, irritability, insomnia, nausea and muscular cramps.

Pregnancy/parenthood: The children of mothers who smoke cannabis during pregnancy suffer from stunted growth and have learning difficulties and behavioral problems, along with a ten-fold increased risk of contracting leukemia. This is in addition to the problems that arise if parents are unable, as a result of their drug consumption, to act as effective guardians and educators.

Effectiveness

The effectiveness of a substance is investigated accordingly in various clinical-test phases. These clinical tests are a vital prerequisite if a substance is to be approved for medicinal use.

Clinical test phase I involves trials of the substance on healthy test subjects in order to study bodily absorption rates, bioavailability, half-life period and the speed at which the substance is eliminated from the body.

Clinical test phase II is used to investigate the effect on patients with different symptoms and medical conditions in order to determine the most effective dose.

In phase III, large groups of subjects are tested in order to reveal any statistically relevant factors. Control groups, which are given only a placebo or generic standard medicine, are also included in the testing process. The study must be randomized and double-blind.

If all studies are successful, i.e. if the substance’s therapeutic properties are proven and there are no major problems with toxicity or serious undesired side-effects, the active ingredient is then recognized as a medicine and approved as such by the corresponding health authorities.

Cannabis has not undergone these clinical-test phases, and has not been recognized as a medicine by any public health authority. Therefore, its use is not harmless, it is possibly of no benefit and it can be a health risk.