Purdue Pharma LP, the pharmaceutical company responsible for developing the highly addictive painkiller drug OxyContin (oxycodone), is so desperate to retain exclusivity on the soon-to-expire patent rights for its drug that it has decided to conduct clinical trials with OxyContin on young children. According to the Wall Street Journal (WSJ), more than 150 children between the ages of six and 16 will participate in the multi-site trial, which will be used solely to extend OxyContins exclusive patent by a mere six months. To say that testing of oxycodone on children can be risky is an understatement.
Set to expire in April 2013, the patent rights for OxyContin have been a financial goldmine for Purdue, as the drug just last year generated more than $2.8 billion in sales. And with numerous other drug companies chomping at the bit to begin manufacturing their own generic versions of OxyContin, which would obviously be sold for far less than the original formula, Purdue is feverishly trying to protect its cash cow by whatever means necessary.
In this case, that means taking advantage of the U.S. Food and Drug Administration (FDA)s pediatric testing incentive for drugs, which offers six-month patent extensions to drug companies who conduct clinical trial on children after those drugs have been approved. The FDA, in other words, is actually encouraging drug companies to test oftentimes dangerous and highly addictive drugs on children by dangling a patent extension carrot in front of their noses.
Why does the FDA do this? According to the agency, testing drugs on children helps to bridge the pediatric knowledge gap of how drugs that are approved for adults perform in children. Since doctors often prescribe drugs off label to children, the FDA considers aftermarket testing on children to be beneficial for society (http://www.fda.gov).
FDA patent extensions benefit drug companies, not society
In reality, however, the FDAs six-month patent extension incentive benefits only drug companies rather than society at large. OxyContin, after all, is not even approved for use in children, and Purdue admittedly has no intention of trying to gain FDA approval for the drugs use in children. The only reason Purdue is conducting the trial is to gain the extension, which will generate for the company far more in profits than the cost of conducting the trial and filing the FDA paperwork.
Meanwhile, the test children, which will literally be used as human guinea pigs, will be exposed to a drug that has been shown to be more addictive than hard street drugs like cocaine and heroin. Individuals that take OxyContin for prolonged periods of time, especially children, are also highly susceptible to extreme withdrawal symptoms when they stop taking the drug.
Prescription opioid painkillers like OxyContin are also extremely deadly, outstripping the number of deaths caused by cocaine and heroine combined by nearly 300 percent (http://www.naturalnews.com/024765_drug_drugs_DEA.html). According to the U.S. Centers for Disease Control and Prevention (CDC), as many as 40 Americans die every single day, which translates into about 15,000 per year, as a result of overdosing on prescription painkillers like OxyContin (http://abcnews.go.com).
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