Breakthrough Therapy May Create New Legal Problems

Breakthrough Therapy May Create New Legal Problems

We are now entering the slippery slope where medical marijuana patients will have to register with a drug database. As Ketamine has historically been known as a party drug, those using it for depression treatment might find themselves suddenly caught up in the aggressive drugged driving enforcement because they merely have it in their systems, and may soon have to register in a database as well.

Onetime Party Drug Hailed As Miracle For Treating Severe Depression

This was a headline in the Washington Post February 1, 2016 and the story is found here.

Ever heard the phrase, for every action there is an equal reaction? That is the case here with this treatment. Here is why. Ketamine is an analog drug, or derivative drug of PCP. Ketamine was discovered in 1962. It is on the World Health Organization's List of Essential Medicines, of the most important medications needed in a basic health system. It is available as a generic medication. The wholesale cost is between 0.08 and 0.32 USD per dose. Ketamine is also used as a drug of abuse. As described in the article:

"Ketamine, popularly known as the psychedelic club drug Special K, has been around since the early 1960s. It is a staple anesthetic in emergency rooms, regularly used for children when they come in with broken bones and dislocated shoulders. It’s an important tool in burn centers and veterinary medicine, as well as a notorious date-rape drug, known for its power to quickly numb and render someone immobile."

Although useful, it is associated with Phencyclidine (PCP), due to Ketamine being an analog. PCP, also known as angel dust and Sernyl among others, is a dissociative drug (as is Ketamine). PCP was brought to market in the 1950s as an anesthetic pharmaceutical drug but was taken off the market in 1965 due to the high prevalence of dissociative hallucinogenic side effects. Likewise, ketamine was discovered by Parke-Davis researchers as a better-tolerated derivative for use as an anesthetic pharmaceutical drug. Since this time a number of synthetic derivatives of PCP have been sold as dissociative drugs for recreational and non-medical use.

In the word of medicine a drug is, "a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being." In the world of law enforcement training and enforcement a drug is defined as "any substance that, when taken into the human body, can impair the ability of the person to operate a vehicle safely." Law enforcement has created 7 Drug Categories in their training on Drugged Driving enforcement. PCP and Ketamine are Dissociative Anesthetics. These are further described as  drugs that inhibit pain by cutting off or dissociating the brain's perception of the pain. More specifically from the training materials regarding Dissociative Analgesics some of the bullet information is:

  • A distinct category all by themselves.
  • Symptoms may be confused with individuals under the influence of hallucinogens, stimulants and depressants.
  • PCP was originally manufactured as an intravenous anesthetic and was very effective anesthetic, it was discontinued for humans in 1967 because of very undesirable side effects.
  • Ketamine (Ketalar) is an analog.
  • Still used in animal surgery.
  • They cut off the brain’s perception of the rest of the body’s senses.
  • This sense is so strong that many users feel their head is actually separated from their body.
  • User have an increased pain threshold.  The user is impervious to the same pain sensations that would typically render a person incapacitated.
  • PCP and K create Resting Nystagmus and is likely Probable Cause to arrest for suspicion of DUID

In the not so recent past, the National Highway Traffic Safety Association has "determined" that drugged driving is more prevalent and more of a problem then alcohol based driving and have set out to create awareness, urge states to create laws, and enforce the already archaic laws on "drugged driving."

In a recent March 31, 2011 study, Drugged Driving Research: A White Paper-Prepared for the National Institute on Drug Abuse, Prepared by Robert L. DuPont, M.D., President, On behalf of the Institute for Behavior and Health, Inc. Drugged Driving Committee it was written that:

Drugged driving is a significant public health and public safety problem in the United States and abroad, as documented through a growing body of research. Among the research conducted in the US is the 2009 finding that 33% of fatally injured drivers with known drug test results were positive for drugs other than alcohol. Among randomly stopped weekend nighttime drivers who provided oral fluid and/or blood specimens in 2007, 16.3% were positive for drugs. While these and other emerging data demonstrate the drugged driving problem, the US has lagged behind other nations in both drugged driving research and enforcement. The White House Office of National Drug Control Policy’s (ONDCP) 2010 National Drug Control Strategy established as a priority reducing drugged driving in the United States. To achieve the Strategy's goal of reducing drugged driving by 10% by 2015, the National Institute on Drug Abuse (NIDA) enlisted the Institute for Behavior and Health, Inc. (IBH) to review the current state of knowledge about drugged driving and to develop a comprehensive research plan for future research that would hold the promise of making a significant impact by 2015. IBH convened an expert committee to develop this report. Committee members included top leaders across a broad spectrum of related disciplines including research, public policy, enforcement and law.

The following eight-point research agenda summarizes the Committee’s recommendations.

  1. Evaluate Impaired Driving Laws. Research on the impact of drugged driving laws, particularly zero tolerance (ZT) per se laws and alternative impaired driving laws, in the US and in other nations is needed to identify the most effective ways to reduce drugged driving. These research studies should identify the laws’ impacts on the prevalence of drugs in drivers on the road and in drug-related crashes.
  2. Evaluate and Improve Drugged Driving Data Collection. While existing data collection systems have shown recent improvements in collecting drugged driving data, there are new research opportunities that can significantly improve the data they provide. Specific recommendations include
    1. Fatality Analysis Reporting System (FARS): Conducting an initial study of the testing procedures in FARS states with good medical examiner systems could help determine which states can be used for estimating the current drugged driving level in the US to develop a national tracking system
    2. National Roadside Survey (NRS): Decreasing the length of time between administrations of the NRS would provide information on drugged driving trends. Oversampling the NRS in high-performing FARS states would permit the study of the relationship of enforcement, deterrence and interdiction and prevalence of drug use in the driving public. Creating a new research data collection system to gather drug data on drivers admitted to trauma centers could be a part of a trial monitoring system with FARS and NRS, capable of providing data to detect emerging problems and to track progress on the ONDCP goal of reducing the incidence of drugged driving. This document does not reflect Federal policy or the views of NIDA. 5
    3. Drug Evaluation and Classification (DEC) Program: Improving and expanding the DEC Program’s Drug Recognition Expert (DRE) data collection system to include the details of the DRE evaluations would improve the enforcement effectiveness of the program. Conducting a study of DRE programs would identify best practices.
    4. National Survey on Drug Use and Health (NSDUH) and Monitoring the Future (MTF): Integrating drugged and drunk driving as a focus of study for the NSDUH and MTF annual reports would increase the drugged driving knowledge base and provide annual data to track the prevalence of drugged driving. Making available to researchers the datasets would allow them to use the micro-data with geographic identifiers.
  3. Improve Drugged Driving Education. There are six specific groups for which best practices in drugged driving education should be identified and developed. These include drivers convicted of Driving Under the Influence (DUI) as well as repeat DUI offenders, new drivers, older adults, law enforcement and the general public. Research is needed to identify and study best practices in drug and alcohol education and highway safety among these groups, resulting in innovative programs. As education programs are developed they should be evaluated for effectiveness through outcomes monitoring.
  4. Identify and Evaluate Promising Models for Drugged Driver Identification. Research is needed to identify best practices in the identification of drugged drivers and to manage and treat drugged driving offenders, including but also extending beyond Drug Recognition Experts (DRE). Conducting a survey of police agencies on the practical aspects of collection of specimens from impaired driver suspects would identify best practices. Evaluating programs that manage impaired driving offenders with a specific focus on substance use monitoring and its impact on recidivism would also be valuable. Research is needed to determine if offenders who use treatment to succeed in monitoring have more stable post-monitoring outcomes than those offenders who do not use treatment.
  5. Standardize Drugged Driver Testing. Fundamental research efforts are needed to assist in effective drugged driver detection, deterrence and data collection. Research is needed to optimize point of contact oral fluid technology which has been used successfully in other countries. Professional organizations in the toxicology community have taken steps to standardize drug testing in drugged driving investigations; those efforts should be supported through study, research and outcomes assessment. Research is needed to determine current practices in drug testing casework and the degree of compliance with published recommendations. Selecting states with good FARS alcohol compliance rates and appropriate laboratory infrastructure to participate in a comprehensive data collection of drug use by drivers would permit examination of different driver populations and demonstrate the use of best testing practices to provide both baseline and time series data to assess the effectiveness of interventions, education and deterrence campaigns. This document does not reflect Federal policy or the views of NIDA. 6
  6. Conduct Drug Impairment Research. Case-control drug risk studies could demonstrate e the value of enacting per se drugged driving laws. A series of new research studies of the drugs most frequently encountered in drugged driver and fatally injured populations for their impairing effects would build the currently inadequate knowledge base. Quantitatively assessing new prescription drugs for their effects on skills critical to safe driving would allow both patients and prescribers to assess a new medication with the highest therapeutic value and low driving risks consistent with individual patient needs. In addition, studies might be conducted to improve computerized warning systems for drug interactions that have implications for driving.
  7. Conduct Drugged Driving Behavioral Research. New research is needed to determine the complex relationship between knowledge of drug risks and driving behaviors. This research could determine the role of education in reducing prescription-based drugged driving through changes in prescription drug warnings, physician education, regulating pharmacies and educating pharmacists. As drugged driving law enforcement measures change, research will be needed to determine how general deterrence laws and enforcement impact the prevalence of drug-using drivers on the road and the frequency of drug-involved crashes.
  8. Conduct Related Treatment Research. As drugged driving offender management programs evolve, the role of treatment in maintaining sobriety should be studied. Conducting research on the use of Screening, Brief Intervention and Referral to Treatment (SBIRT) with first-time and repeat DUI offenders could be of value to both drugged driving enforcement and to substance abuse treatment. As more drugged drivers are identified, prosecuted, and managed, research will be needed to improve the testing and evaluation of SBIRT and contingency management models with this population of drugged drivers. The use of Behavioral Triage to select which DUI offenders to mandate into treatment might be studied because this strategy has the potential to manage treatment costs.

Their CONCLUSIONS? The evidence that drugged driving is a serious public health and safety problem in the US is strong, as is the evidence that current efforts to combat it are grossly inadequate. Now is the time to expand the drugged driving knowledge base to inform the development of more effective policies, laws and programs. A successful response to the problem of drugged driving holds the promise of improving highway safety, creating an important new path to long-term recovery and improving the effectiveness of all drug abuse prevention and treatment.

As a result of these types of studies, State legislatures have added statutory language  proscribing operation of motor vehicles by "illegal drugs," or "impairing substances." Many States have supported the establishment of programs within their State and local police, and the training of special Drug Recognition Experts (DREs). 17 States have taken the initiative to enact driving under the influence of drugs (DUID) per se laws (Arizona, Delaware, Georgia, Iowa, Illinois, Indiana, Michigan, Minnesota, North Carolina, Nevada, Ohio, Pennsylvania, Rhode Island, South Dakota, Utah, Virginia, and Wisconsin).  Washington State has a Per Se Marijuana limit of 5ng, but otherwise no other drug limits are set, rather it is an “affected by” State.  Meaning there are three principal types of drugged-driving laws:

  1. Statutes that require drugs to render a driver "incapable" of driving safely;
  2. Statutes requiring that the drug impair the driver’s ability to operate safely or require a driver to be "under the influence" or "affected by" intoxicating drug; and
  3. "Per se" statutes that make it a criminal offense to have a drug or metabolite in one's body/body fluids while operating a motor vehicle (often referred to as "zero tolerance" laws) at a proscribed limit (.08 is a per se alcohol law, and 5ng is a per se marijuana law).

With respect to the issue of Ketamine and treatment for depression: Like the treatment of Medical Marijuana patients, those who suffer from depression and use Ketamine are more likely to be caught up in the drugged driving enforcement push, simply for having the drug in their system and/or in their system at low levels that do not render them incapable of safe operation of a motor vehicle. This summer, July 1, 2016 Medical Marijuana Patients will be required to register into a database. This begins a slippery slope of forcing all medical patients to one day register. All medical patients to be known to law enforcement to be prescribed any number of drugs, all of which are within the 7 categories focused on by law enforcement in the new push to detect and prosecute "drugged driving."

No one can argue that such prosecutions of those actually affected by the drugs or medications is a bad thing. However, those caught up in the aggressive enforcement of it and who are wrongfully arrested and prosecuted is wrong, and is a bad thing. If you think that this will never happen, then you are mistaken. I represent people currently and previously that are not over the legal alcohol limit. Likewise I represent those not over the per se Marijuana limits, as well those that have medication in their system (that can in high doses affect the ability to drive) but in numerous such case have levels nowhere near level that affects the ability to drive, nevertheless, they are prosecuted. As a result, it is not unusual for new therapy and breakthrough uses of traditionally abused and misused drugs will create different problems for users.