
Recently I came across an article in The Scientist on the Clinical trials of drugs in the US by the Pharma Corporations.

Drugs ,it is reported that , are not tested on children and are marketed.
The FDA is of the opinion that Clinical Trials of Drugs conducted on Children give off reliable results,especially the contra-indications.
I am reproducing a real instance quoted in The Scientist.
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But the story of Paxil also illustrates the power of somewhat obscure laws that have saved children’s lives by changing the way drugmakers test their products.
Paxil—which increases extracellular levels of the neurotransmitter serotonin by inhibiting its reuptake into presynaptic cells—was approved by the US Food and Drug Administration in 1992, and by 2000 it was making the drug company GlaxoSmithKline (GSK) $2 billion per year. But around this time, problems with Paxil began to surface. Adult and adolescent patients were anecdotally reporting side effects, including sexual dysfunction, weight gain, high blood pressure, and increased suicidality—an uptick in thoughts of suicide or self-inflicted injury in some severely depressed patients. These reports of increased suicidality particularly worried pediatricians.
In 1999 the FDA sent GSK a letter requesting that the company conduct clinical trials of Paxil in children and adolescents. To sweeten the deal, the FDA offered GSK a 6-month marketing exclusivity extension for Paxil in return. This extension, which in effect would buy GSK 6 extra months of patent protection by delaying marketing of generic versions, was an incentive written into the FDA Modernization Act (FDAMA) of 1997.
GSK eventually agreed to conduct the requested studies and submitted the results to the FDA sometime in early 2002, after FDAMA had expired and been replaced by the Best Pharmaceuticals for Children Act (BPCA) of 2002. Though GSK’s own reports on preliminary studies of Paxil in adolescents indicated that it was safe and more effective than a placebo—a heavily disputed interpretation contained in the article reporting the results of the now infamous study 3291—the FDA’s analyses of Paxil studies found that suicidal thoughts, suicide attempts, and episodes of self-harm were almost twice as high in young patients with major depressive disorder taking the drug than among those taking a placebo. To boot, the agency found that the drug was no more effective than placebo in treating major depression in children and adolescents”
The point to be noted is that the Company doctored the report.
Imagine a Corporation earning Billions of Dollars, despite getting a undeserved
6 months of patent protection, the company thought it fit to doctor the
report,with scant report for Human Life.
The Companies dodge testing on Children because of Legal implications and high cost of testing on children.
Another point I note is that is testing drugs on Children Safe for them?
I also read an interesting comment on Patents.
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Featured Comment
Legislators should remember who pays their salaries and to whom they are responsible. If taxpayers fund any part of a research activity then (a) no patents or copyrights should issue as a result, and (b) all results and unprocessed data should be available freely, similarly funded by the taxpayers. If the researchers and their sponsoring organizations don’t like the bargain, they should seek funding from non-public sources.
tddial, Elsevier Abandons Anti-Open Access Bill“
VERY THOUGHTFUL AND VALID.
http://the-scientist.com/2012/03/01/are-the-kids-alright/#fn-21915-1
Related articles
- Warnings For Paxil Users (nicolehobbs.wordpress.com)
- Judge Rules Glaxo can Sell Generic Paxil: AttorneyOne.com Warns the Threat of Severe Birth Defects from Paxil Remains (prweb.com)




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