Tuesday, November 09, 2010

American Government recruiting children to take drugs that are not to be taken by children

I reported this clinical trial here "Eli-Lilly studies SSRIs Cymbalta and Prozac in children 7-17 years old". This clinical trial started in 2009 and will end in 2011.

About ClinicalTrials.gov

ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

ClinicalTrials.gov currently contains 98,303 trials sponsored by the National Institutes of Health, other federal agencies, and private industry. Studies listed in the database are conducted in all 50 States and in174 countries ClinicalTrials.gov receives over 50 million page views per month 65,000 visitors daily.

The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with the Food and Drug Administration (FDA), as a result of the FDA Modernization Act, which was passed into law in November 1997. See the FDA document - Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions(March 2002).

You can read more about Clinicaltrial.org here.
This clinical trial started in 2009 and will end in 2011. I don't understand why do they need 3 years to test a drug that has already been tested. It would be time for the phase IV of clinical trials:

Phase IV

Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involvecerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Source: Wikipedia.
They don't care about the fourth phase of clinical trials and even consider what patients say as "anecdotal evidence". Drugs are supposed to be on the market even if they are killing people. The sole purpose of selling medicines is making money for those powerful few who profit.
Exposing children to these drugs is criminal.

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