OxyContin clinical trials conducted on kids

Pharmaceutical company testing highly addictive painkiller on children as young as six

In attempts to extend the patent on the highly addictive painkilling drug OxyContin, drug manufacturer Purdue Pharma is now conducting clinical trials across the nation testing the drug’s effects on children.

The Food and Drug Administration (FDA) says they will be restraining companies that market versions of the painkiller Oxycodone that have not undergone a federal review.

Many view this move by the agency as a step forward where drugs such as Oxycodone (OxyContin) and other opioid painkillers are increasingly being abused.

Meanwhile, Purdue Pharma has dozens of paid clinical trial sites across the country to document the effects of OxyContin when it is administered to children. These trials are already being conducting with the company hoping to enroll around 154 children, age range six to sixteen and would receive the dosing for a period of four weeks. Upon trial completion the results will be sent to the FDA.

Purdue insists their action is to help physicians who currently prescribed the drug off-label to children in which is a common practice in pediatric medicine when it comes to the treatment of conditions in children with moderate to severe pain.

These clinical trials being conducted on children comes from the FDA in which the agency had issued a written request for pediatric studies under Section 505A of the Federal Food, Drug and Cosmetic Act. The written request holds a listing of 350 drugs which does include Oxycodone.

Jim Heins, senior director for public affairs at Purdue Pharma had related to The Daily the company has no plans to seek permission to market OxyContin to pediatricians. They are doing it to see the effects of the drug in children who may need it for severe pain . Hines stated "These children have diseases such as cancer or sickle-cell anemia, post-operative pain, injuries such as severe burns causing this degree of pain", noted by Top News.

However, there are three physicians that are working on the trial with Purdue Pharma say that it appears the company is doing the research in order to get a six month extension on their patent.

Dr. Elliot J. Krane, MD, director of pain management service at Lucile Packard Children’s Hospital at Stanford University, California, stated to The Daily, “They are doing (the pediatric trial) for patent exclusivity, there’s no doubt about it in my mind — not out of largesse,” “That’s important for their bottom line.”

Negativity of this trial is coming physicians that are airing concern over children being allowed to take OxyContin and the fact abuse rates could climb even higher.

Physicians do have sound reasoning for concern. Just last year University of Michigan, Ann Arbor, researchers revealed one in five teens that receive prescription painkillers and other controlled substances are overdosing.

Do you believe painkillers such as OxyContin should be tested on children? Should these strong narcotics be prescribed to children and under what medical conditions should they be prescribed.

Do you believe these strong painkilling drugs prescribed to children will dramatically increase the rates of drug abuse, addiction and deaths?