Purdue Pharma LP conducting trial of OxyContin on children!

Big pharma corporation is seeking to create new generation of drug addicts.

STAMFORD, Connecticut (PNN) - July 5, 2012 - OxyContin manufacturer Purdue Pharma LP is currently undergoing a pediatric trial of the powerful painkiller to find out the effects of the drug on children, with the hopes of receiving an extension on the company's patent from the Fascist Police States of Amerika Food and Drug Administration (FDA).

The study takes a look at the safety of OxyContin tablets and how the drug is absorbed, broken down, and eliminated compared to adults. The company is also looking at if the drug relieves pain in children as well as it does in adults. News of the trial has prompted criticism of the motives behind testing the painkiller in children.

The study, which has been ongoing since November 2010, specifically looks at children between the ages of six to 16 with "moderate to severe pain" who are being treated with around the clock opioid medications. This includes children who suffered from cancer, sickle-cell anemia, post-operative pain or injuries such as severe burns causing this degree of pain.

One hundred fifty four patients have been enrolled at more than 80 different locations, with more subjects currently being recruited. Patients will receive at least a 20-mg daily dose of oxycodone for at least two weeks. The study will conclude in August 2013.

If the Purdue's study is completed within the FDA requirements, the pharmaceutical company will be given a six-month extension on their exclusive drug patent due to an incentive from the FDA and Congress. The FDA currently has a written request for pediatric studies for oxycodone. The extension is granted to companies that complete a study in response to a written request, and if the study is determined by the FDA to meet all the items asked for in the request.

Just today, the FDA issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone in order to protect the public from unsafe, ineffective and poor quality medications.

Allowing Purdue to keep its exclusive patent on OxyContin, which had more than $2.8 billion in sales in 2011, according to the Wall Street Journal, would be incredibly beneficial to the company. The 2013 patent on OxyContin will expire before the study is completed, but they have other patents on newer formulations of the drug that extend to 2025. The six-month extension would be added to the patents that expire in 2025.

James Heins, senior director of public affairs for Purdue, said that Oxycontin was not approved for use in children, and Purdue does not advocate the use of the drug for minors. Purdue is not seeking FDA approval for OxyContin for pediatric patients, but hopes the study will provide more information about the effects of the drug on children.

But, some doctors are concerned about the effect the study could have on minors. Dr. Andrew Kolodny, president of the Physicians for Responsible Opioid Prescribing and a practicing psychiatrist in New York, said he's concerned that children could become exposed to a lifetime of addiction.

"There's good medical evidence that suggests a brain that's not fully mature is at greater risk at developing the disease of addiction," said Dr. Kolodny, who also serves as head of psychiatry at Maimonides Medical Center in New York.

Kolodny is also concerned that many in the medical community trust drug makers, who might not be forthcoming with the effects of their drugs. Purdue admitted in 2007 that it misled doctors and the public about the additive effects of OxyContin.