By Michael C. Barnes
Let's hope the recent death of TV star Cory Monteith, which was linked to a toxic combination of heroin and alcohol, will spur the public - and our lawmakers - to renew our commitment to preventing and treating drug abuse.
The most pressing challenge is curtailing the unlawful availability and abuse of opioids, which include drugs like heroin. According to a new survey from Harris Interactive, opioid abuse touches nearly half of America's population.
In recent years, the increased availability of pain medications like hydrocodone and oxycodone has made prescription opioid abuse more prevalent. Today, nearly two million Americans either abuse or are dependent on prescription opioids. More troubling still, since 1999, accidental overdoses have increased fourfold.
Government officials now have the opportunity to approve an innovative new tool to help reduce this scourge.
In October 2009, the National Institutes of Health awarded $7.6 million to a small firm developing an implant to treat opioid addiction. Once inserted under a patient's skin, the implant provides constant delivery of the addiction-treatment medication buprenorphine over several months. By making daily doses unnecessary, this technology effectively eliminates the chance for patients to divert or abuse the medication.
A clinical trial revealed that the implant alleviated cravings and withdrawal symptoms while helping patients continue their treatment longer. The implant, which was shown to reduce the use of illicit opioids among patients, was deemed safe and effective by the American Society of Addiction Medicine and the Food and Drug Administration (FDA) Psychopharmacology Drugs Advisory Committee.
Unfortunately, in May, the FDA refused to approve the implant, requesting more clinical data. The main complaint was that the implant didn't promote prolonged abstinence among opioid addicts. The decision disregards medical literature, clinical practice, and science.
The implant conformed to FDA guidelines for abuse-deterrent treatments. It was proven to be both safe and effective, and it was created with funding from the NIH. It was even granted priority review by the FDA in the hopes of getting it to patients quickly.
No other government body considers abstinence a determining factor when assessing addiction treatments - and for good reason. By focusing on abstinence, regulators run the risk of overlooking other important goals, such as reducing the risk of death from overdose and blocking withdrawal symptoms.
This buprenorphine implant is one of the most promising new means of helping people succeed in treatment and regain their health and productivity. Regulators need to reverse their decision and get people the tools they need to recover from drug addiction.