Over the past few years the attention ascribed to drug abuse has risen considerably. For instance, on February 11, 2008, the New York Times ran a full page ad sponsored by THEANTIDRUG.COM. Contained within the advertisement, or infommercial, was the following, “In fact, drug treatment admissions for prescription painkillers increased more than 300 percent from 1995 to 2005” with the data attributed to SAMSHA. And another quote from the ad stated, “In fact, 70 percent of persons age 12 and older who abuse prescription painkillers say they get them from a relative or friend”; a statistic garnered from a SAMSHA survey. Furthermore, the advertisement was endorsed by no less than eleven professional groups including pharmacists, physicians, nurses and dentists. The ad also lists five ways parents can protect their children from a drug abuse behavior—ways equivalent to parents telling their kids:  “look both ways before crossing the street”. So, we have parents, eleven professional organizations, and SAMSHA (sounds impressive) yet we have a drug abuse problem. How come?

There are other interested parties who may also wish to contribute to this amicus briefing. In a February 10, 2009 FDA presentation, the “Risk Management of Controlled Substances” was delineated as a shared responsibility between five Federal Agencies. These five agencies are: FDA, DEA, NIDA, SAMSHA and CDC. It is an interesting exercise to review the responsibilities of each of these agencies. Besides assuring that human drugs are safe and effective, the FDA is also responsible for “taking appropriate action on the marketing of regulated products in a timely manner”. The DEA is responsible for preventing abuse and diversion of controlled substances without interfering with legitimate access to pain relief medications. Strategic support and research “across a broad range of disciplines” to improve prevention, treatment and policy in regard to drug abuse and addiction is provided through NIDA. The CDC is assigned responsibility of assuring protection from infectious occupational, environmental and terrorist threats. Lastly, SAMSHA—worth quoting from the FDA’s presentation—“is responsible for providing national leadership in the development of policies, programs and services to prevent the onset of illegal drug use, to bring effective alcohol and drug treatment to every community, to regulate the use of medications in the treatment of opioid dependence, and to analyze and disseminate national data such as the annual National Survey on Drug Use and Health and the Drug Abuse Warning Network.

Clearly, the Nation has committed enormous resources to combat drug abuse while part of our culture accepts recreational drug use.  Professional societies recognize well the detrimental effects to individuals and society of drug abuse. Civic organizations too have raised awareness to the problems of drug abuse and have offered alternatives to, or counseling for drug abuse. Still drug abuse prevails and is as pervasive as ever throughout society. It would appear we have created a perpetual motion machine and perhaps indirectly, promote drug abuse. Dr. Frankenstein would be proud! As a Nation have we created a living, breathing organism feeding on a human behavioral trait for which there is no solution? Have we brought the drug culture out of the background, out of the shadows, and into the full bright light of day, and legitimized it? Indeed, have we created a behemoth industry around drug abuse?

Can we take a stand for the advancement of mankind and its indomitable spirit? Pisgah Labs has taken a stand. We see daily the destructive consequences of drug abuse; it destroys lives; people suffer and the Nation’s well-being is in jeopardy. Pisgah Labs. Pisgah has discovered a platform technology which imparts anti-abuse features to commonly abused prescription drugs. The science they employ also contributes to the forensic science base needed by enforcement authorities. Indeed, Pisgah’s technology offers a whole new toolbox to the FDA, DEA, CDC, NIDA and SAMSHA. To the FDA, Pisgah’s product development pipeline offers opioid drug products with known safety and efficacy track-records; there are no surprises except to those intent on abusing the drugs. Surprise, you’re not getting high! To the DEA, a track and trace capability is added to their efforts to prevent diversion. NIDA’s strategic objectives are fulfilled through Pisgah’s broad-based technology applicable to a host of products and providing for measurable objectives to be met. SAMSHA accounting and reporting processes should see significant changes in the statistical assessment of nationwide drug abuse, and due to the decreased ability to abuse the various opioid drugs, the CDC should observe a decrease in infectious disease transmittal due to illicit drug use. The Department of Homeland Security can probably get in on this action too as domestic and international terrorism efforts supported by the illicit drug trade are diminished. The upside for the Department of Labor’s statistics should demonstrate employment and productivity boosts because of decreased drug use. You be the judge, but as a friend of the court we proclaim it’s no contest: Pisgah’s technology will provide an important economic up-side to the Nation’s economy while solving one of society’s greatest ills.