Leonard Campanello, Co-Founder
John Rosenthal, Co-founder & Chairman
One Bridge St., Suite #300
Newton, MA 02458
For Immediate Release
Tuesday, Aug. 18, 2015
Media Contact: John Guilfoil
P.A.A.R.I. Calls on FDA to Issue Stricter Guidelines after Announcing it would Allow Oxycontin Prescriptions for Children As Young As 11-Years-Old
GLOUCESTER — Recognizing that there are terrible, life-threatening diseases that require advanced pain medicine and management, and the proven and devastating addictive effects of Oxycontin, the Police Assisted Addiction and Recovery Initiative (P.A.A.R.I.) today called on the U.S. Food and Drug Administration to offer lengthy and specific guidelines in the wake of its ruling allowing prescriptions of Oxycontin for children ages 11-16.
The status quo of warning labels on pill bottles and polite guidelines for doctors is what made Oxycontin and oxycodone products one of the leading contributors to the nation’s current opioid and heroin addiction epidemic.
In a letter to FDA Director Dr. Karen Mudthun, the P.A.A.R.I. Board of Directors states:
“Oxycontin and other oxycodone products are the cause of the nation’s current opioid epidemic. Eighty percent of new heroin addicts started by using prescription pain medications for medical or recreational purposes. Purdue Pharma and other manufacturers are responsible for much of the current crisis because they marketed the drugs for inappropriate uses and profited when millions of pills were ordered and sold to people who should not have gotten them. Therefore, any additional approval for expanded use of Oxycontin, especially for children, must be monitored by the FDA, State monitoring programs and by the medical profession, and pharmacies to make sure this very powerful and addictive medicine is used only for the very small number of tragic medical conditions for which it may provide relief. Strongly worded labels are not enough to stop unscrupulous drug dealers. … The nation is facing an epidemic of opioid addiction, and we call upon you to do more than simply give advice to the doctors, pharmacies, and pharmaceutical companies that created this problem.”
The request comes in light of unquestionable past abuses, including over-marketing and over-prescribing of Oxycontin to adults, which have contributed to a nationwide opioid addiction epidemic.
“Every prescription drug is a tool in a doctor’s medical bag, and it must be used properly. Having seen the devastating and addictive effects on Oxycontin for decades, the FDA’s approval of Oxycontin for children would be irresponsible at best and negligent at worst if the government fails to issue a mandate, severely restricting Oxycontin to only the cases in which its advanced effects are urgently needed, and the benefits outweigh the potential risks,” said John Rosenthal, the co-founder and chairman of P.A.A.R.I. “The overzealous use of this drug has already proven catastrophic in the past, and it is part of our mission as an organization to ensure that these grievous mistakes are not repeated with those most vulnerable, our children.”
On Aug. 14, the FDA approved the painkiller Oxycontin — an extended-release version of the opioid medicine, oxycodone — for pediatric patients 11-16 years old “to to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.”
In an article justifying the ruling, the FDA states “Thankfully, not many children experience the types of cancer pain, extensive trauma or surgeries that require long-term pain management.”
P.A.A.R.I. requests that the FDA go further than a blog post on their website.
“The government should mandate and codify restrictions on the use of this drug in children, rather than what it appears to be doing, which is giving doctors an excuse to prescribe a potentially dangerous narcotic under the banner of ‘pain management,'” Rosenthal said. “We’ve walked down this road already. We have already seen the effects of a veritable free-for-all of aggressive pharmaceutical company marketing and doctors over-prescription of Oxycontin and other opioids.”
In 2007 Purdue Pharmaceuticals, maker of Oxycontin, paid $600 Million after the company and executives pleaded guilty to criminal charges for misleading regulators, doctors and patients about the risk of addiction and potential for abuse of Oxycontin
The Police Assisted Addiction and Recovery Initiative (P.A.A.R.I.) was started to support local police departments as they work with opioid addicts. Rather than arrest our way out of the problem of drug addiction, P.A.A.R.I. committed police departments:
- Encourage opioid drug users to seek recovery
- Help distribute life saving opioid blocking drugs to prevent and treat overdoses
- Connect addicts with treatment programs and facilities
- Provide resources to other police departments and communities that want to do more to fight the opioid addiction epidemic
P.A.A.R.I. was created by Gloucester Police Chief Leonard Campanello and John Rosenthal to bridge the gap between the police department and opioid addicts seeking recovery.