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A BRIEF HISTORY OF TOXICOLOGY

 

The foundations of modern toxicology are built upon the significant milestones and discoveries of chance and crude experimentation. Throughout the ages, toxicological science has provided information that has shaped and guided society.

Rapid advancements in modern toxicology has resulted in some astonishing scientific milestones and innovations, from our understanding of the complex processes of drug metabolism to advanced technologies that are capable of detecting compounds at a level of specificity and accuracy that the early pioneers in the field could not have possibly imagined.

The field has also produced its fair share of dubious “quasi-science” and has been exploited for financial gain by some, which has resulted in numerous headlines about the meteoric rise and spectacular fall of a few toxicology labs.

One of the more spectacular falls involved one of toxicology’s brightest stars, Millennium Health. There are countless editorials describing the sordid details of a culture rooted in greed and a pervasive attitude among the Company’s leadership of thumbing its nose at standard business acumen and regulatory boundaries.

In five short years, the company had grown into the largest urine drug testing lab in the nation. That growth had been fueled by a highly aggressive sales approach, targeting doctors and medical groups and signing them up to have patient’s urine samples tested by Millennium.

Millennium’s growth was also fueled largely by its billing practices, later deemed questionable by authorities. The Company used a “custom profile” when it signed up doctors, which approved testing for many drugs at a time. Some of those did not meet patients’ medical needs and were not reasonable, according to the government. With the custom profiles, tests that would normally cost $25 for a single drug ballooned to as much as $450 for the panel.

Millennium also gave away POC drug testing cups that had testing strips in them to instantly analyze the specimens. In return, doctors agreed to send the specimens to Millennium for confirmatory testing, a direct and blatant violation of federal anti-kickback laws.

That reckless approach to business is always short-lived and Millennium is yet another example of that. The company was found guilty of multiple charges by the Justice department and agreed to pay $256 million to the government to settle the false billing claims, and also agreed to resolve numerous whistleblower lawsuits filed by former employees and doctors around the country over. The Company has many other legal challenges ahead and its future, not surprisingly, is uncertain.

At Southwest Labs, we want to set the standard for superior performance, technological advancement, innovation and most importantly, to establish the benchmark for the highest ethical level of conduct in the industry.

INDUSTRY OVERVIEW

INTRODUCTION

Toxicology testing is the process of identifying traces of substances in samples such as urine, hair, blood, and oral fluids. Results obtained from such testing enable effective prescription drug monitoring by clinicians and the implementation of regulations and guidelines by various regulatory bodies, in an attempt to control and deter substance abuse.

The steady increase in the abusive consumption of controlled substances and illicit drugs has prompted increased legislation by government bodies that require clinicians to implement comprehensive prescription drug monitoring for their patients.

Competition has increased due to the availability of relatively low-cost drug testing instruments and combinational automated toxicity detection technologies. These, among other factors, are driving considerable growth in the toxicology laboratories market.

By sample type, North America toxicology laboratories market is segmented into the following matrices; urine, blood, hair, and oral fluid. The urine sample matrix is expected to emerge the highest revenue generating segment through 2022. This is due to its non-invasive nature and ease of sample collection, which is promoting its frequent application.

By country, the U.S. market has been estimated to remain dominant with over 83% share of the North America market. This is expected to result from increasing consumption of controlled substances and active regulatory controls to curb the illicit use of regulated drugs.

MARKET DRIVERS

The use of Urine Drug Testing (UDT) and toxicology laboratories in medication management is an important protocol that physicians are rapidly adopting. The reasons behind the increase are varied and numerous: America’s addiction epidemic; the increase in prescription-related overdoses; mass drug diversion statistics; and, for the first time in a decade, a dramatic increase in failed drug tests by employees.

While all of these issues factor into the toxicology boom, physicians have a more personal stake in ensuring that their patients are in compliance with their prescribing instructions: legal liability. According to an article in American Medical News, published by the American Medical Association (AMA), attorneys nationwide are seeing an alarming increase in the number of physicians held liable for negligence. According to Alfred F. Belcuore, a medical liability defense attorney in Washington, “Doctors have to be vigilant to make sure the patient is not abusing the prescription, not selling drugs and not overusing.”

According to the CDC, during 2015, drug overdoses accounted for 52,404 deaths in the United States including 33,091 (63.1%) that involved an opioid. Deaths from synthetic opioids, including illicit fentanyl, rose 73 percent to 9,580.

Prescription drug abuse is the fastest growing drug problem in the United States. The increase in unintentional drug overdose death rates in recent years has been driven by increased use of a class of prescription drugs called opioid analgesics.

Depressants, opioids and antidepressants are responsible for more overdose deaths (45%) than cocaine, heroin, methamphetamine and amphetamines (39%) combined.

in 2007, the Drug Enforcement Administration found that abuse of the painkiller Fentanyl killed more than 1,000 people that year in the US. Fentanyl is thirty to fifty times more powerful than heroin.

New Mexico is ranked as one of the most adversely affected states in the nation, and the numbers are increasing at an alarming rate. New Mexico requires the use of the State’s Prescription Drug Monitoring Programs (PDMP) by all physicians who prescribe controlled substances.

Because of rampant abuse and misuse of prescription medications, strict protocols of accurate patient testing are imperative, and the PDMP is an important part of this process. However, knowing what a patient is prescribed is only half the information – practitioners need to know what their patients are taking. This is the role of the toxicology laboratory. And not all tests are created equal.

In spite of the PDMP, drug overdose deaths continue to increase at alarming rates throughout New Mexico. In 2010, New Mexico had the second highest drug overdose death rate in the Nation. The number of drug overdose deaths increased by 66.3 percent in Bernalillo County (our State’s most populated district) in 2011 over the previous year.

Of the 521 drug overdose deaths statewide in 2011, nearly 40 percent occurred among Bernalillo County residents. In 2011, Bernalillo County’s age-adjusted drug overdose death rate was 29.6 per 100,000. From 2010 to 2011, drug overdose death rates decreased for cocaine, heroin, benzodiazepines/depressants, antidepressants, and antipsychotics – but during the same period, drug overdose death rates increased for those deaths attributable to prescription opioids.

Drug use can result in overdose death and is also associated with other societal problems including crime, violence, homelessness, loss of productivity and spread of blood-borne disease such as HIV and hepatitis.

Unintentional drug overdose is the largest subset of total drug overdose death, accounting for 80-85% of drug overdose deaths in New Mexico. Poisoning has been the leading cause of unintentional injury in New Mexico since 2007, surpassing motor vehicle crash deaths, largely as a result of increased unintentional drug overdose deaths associated with prescription drug use.

During 2010-2014, 53% of drug overdose deaths were caused by prescription drugs, while 33% were caused by illicit drugs, and 14% involved both types. Medical examiner data indicate that the most common drugs causing unintentional overdose death for the period were prescription opioids (e.g., methadone, oxycodone, morphine 48%), heroin (34%), tranquilizers/muscle relaxants (23%), cocaine (17%), methamphetamine (16%) and antidepressants (12%) (not mutually exclusive).

In New Mexico and nationally, overdose death from prescription opioids has become an issue of enormous concern. Interventions are currently being formulated, assessed and implemented in New Mexico and in communities across the country, and may be contributing to decreases in death in the most recent data available.

Hispanic men had the highest total drug overdose death rate during 2010-2014. The rates of total drug overdose death and unintentional drug overdose death among men were roughly 1.5 times that of women. Among women, drug overdose death from prescription drugs was more common than from illicit drugs across the age range. Illicit drugs were the predominant drug type causing death among males across the age range, and the rates were highest among males aged 25-54 years.

BUYER PURCHASE CRITERIA

Buyer purchase criteria consists of all the information that is needed for a customer to make a buying decision.

For toxicology services, it generally includes the following:

Cost of the Service; Market share; Brand image; Quality of service; Recommendation from a doctor; Recommendation from pharmacists; Recommendation from satisfied customers; Breadth of services provided; Types of insurance accepted; Service safety record; Security of personal information; Speed in delivering results; Company location(s); Quality and cleanliness of the facilities; Perceived adherence to CLIA, HIPPA, ICD-10 and OSHA standards.

These criteria help the customer make a quick and confident buying decision.

INDUSTRY TRENDS

The number of industry competitors is decreasing through M&A or closings however, entry barriers are falling and new entrants with different capabilities will likely enter. Turnaround times are becoming a key differentiator so providing the services quickly is of increasing importance to customers.

In some parts of the world, there is a movement to unionize medical laboratories, including toxicology labs. Global M&A activity in healthcare is leading to larger and more specialized healthcare providers with an increasing trend to build their own lab testing capabilities. Consumers and patients are taking on a greater role in their own health management, including preventive measures that include periodic toxicology testing and self-service testing.

TECHNOLOGY TRENDS

The rapid growth in mobile devices continues to raise customer expectations for leveraging their use and HL- 7 Electronic interchange of clinical, financial & admin data among health care oriented computer systems. Artificial Intelligence (AI) and Big data solutions with pattern recognition technologies are increasingly being used for competitive advantage.

Social media is increasingly changing buyer information flows and the buying process among providers. AI is also facilitating the growth of telehealth, telemetry and telemedicine related technologies and they are growing in use, functionality and importance to the overall continuum of care. The increasing functionality and affordability of urine and oral testing equipment designed for home use, is fueling broader adoption.

ADDITIONAL INDUSTRY INFORMATION

Back-office lab focused on a growing list of tests and providing data visualizations is being fueled by low-cost, cloud-based technologies. All-in-one medical testing lab franchises (i.e. ArcPoint), are also growing as a powerful substitute to simple toxicology labs.

TYPES OF ABUSED PRESCRIPTION DRUGS

Prescription drugs that are taken for recreational use include the following major categories:

  • Depressants: Often referred to as central nervous system (brain and spinal cord) depressants, these drugs slow brain and brain stem function. They include sedatives (used to make a person calm and drowsy) and tranquilizers (intended to reduce tension or anxiety).

  • Opioids and morphine derivatives: Generally referred to as painkillers, these drugs contain opium or opium-like substances and are used to relieve pain.

  • Antidepressants: Psychiatric drugs that are prescribed to address depression.

  • Stimulants: A class of drugs intended to increase energy and alertness but which also increase blood pressure, heart rate and breathing.

WHY TEST?

Many leading experts encourage wider and “smarter” use of drug testing within the practice of medicine and beyond that, broadly within American society. Smarter drug testing includes increased use of random testing rather than the more common scheduled testing. In addition, smarter testing means testing based upon clinical indication for a broad and rotating panel of drugs rather than only testing for the traditional five-drug panel (the “SAMHSA-5”), that was designed not by practicing physicians or researchers, but by the federal government for government-mandated testing such as that required of commercial drivers.

Smarter testing includes improved sample collection and detection technologies to decrease sample adulteration and substitution. Designing appropriate steps to respond to the efforts of individuals trying to subvert the testing process must be considered when evaluating the costs/benefit ratio of different testing matrices, recognizing that such countermeasures may have a dramatic impact on the usefulness of testing.

Smarter drug testing also means carefully considering the financial costs of testing in relationship to the value and in many cases, medical necessity, of the test results. It also means considering the advantages and limitations of the many testing technologies available today.

SMARTER DRUG TESTING:

  • Reduces the reliance on physical observation of aberrant behavior to trigger a UDT which may miss more than 50% of those individuals using un-prescribed or illicit drugs.

  • Can inform clinical decisions on a patient’s substance use that may affect other medical conditions.

  • Can inform clinical decisions about pharmacotherapy, especially with controlled substances.

  • Increases the safety of prescribing medications by identifying the potential for overdose or serious drug interactions.

  • Prevents dangerous medication interactions during surgery or other medical procedures.

  • Identifies women who are pregnant, or who want to become pregnant, and are using drugs or alcohol.

  • Identifies at-risk neonates.

POC VS. IMMUNOASSAY SCREEN VS. LCMS

In the 1970’s, the development of sensitive and automated immunoassay (IA) technologies conducted in laboratories permitted large scale urine drug testing in addiction treatment and in the criminal justice system. IA technology is widely used today in some circumstances as a stand-alone technique either through laboratory or point-of-collection (POC) options. Immunoassay methodologies were the first drug testing technology to be automated, permitting high volume testing and lower costs per test.

The second generation of drug testing, IA testing with presumptive positive results confirmed by gas chromatography-mass spectrometry (GC-MS), was introduced in the military in the early 1980’s and shortly thereafter adopted by private industry, the federal government, and federally regulated industries (e.g. commercial drivers).

Within the past few years an additional confirmation testing option has emerged, with highly improved specificity and accuracy, liquid chromatography-mass spectrometry (LC-MS) or tandem mass-spectrometry (LC-MS/MS). LC-MS/MS, is being utilized increasingly as an alternative to GC-MS to identify specific drugs or metabolites that are present in a specimen through a POC or laboratory IA test. GC-MS and LC-MS/MS tests "confirm" drugs that were identified on the initial IA test.

Definitive testing methods using LC-MS/MS offer significant advantages over screening strategies.

The IA and GC-MS paradigm of workplace drug testing worked reasonably well in medical settings in the 1990’s, when nearly all patients with substance use disorders used a fairly limited menu of drugs. As a growing array of prescription drugs and designer drugs became available, the drug testing challenge was no longer to identify a handful of drugs, but rather to identify the scores of continually evolving compounds taken by drug users.

The development of IA drug tests to identify all of these new drugs is not commercially feasible, nor is GC-MS easily adaptable to detection of the wide range of emerging drugs of abuse. This new trend in drug use and the challenges it poses to drug testing are in their early stages and LC-MS/MS technology provides significant advantages over other types of testing.

POC VS. IMMUNOASSAY SCREEN VS. LCMS

CITATIONS

 

Intro to the Toxicology Market

i. North America Toxicology Laboratories Market is Anticipated to Increase to US$ 198.2 Mn by 2022, Owing to Growing Demand for Toxicity Testing of Controlled Substances http://www.persistencemarketresearch.com/mediarelease/north-america-toxicology-laboratories-market.asp
ii. North America Market Study on Toxicology Laboratories: Increasing Usage of Toxicology Testing Services in Crime Investigation is Expected to Drive the Growth of Toxicology Laboratories http://www.persistencemarketresearch.com/market-research/north-america-toxicology-laboratories-market.asp
iii. Toxicology Laboratories Market: Global Industry Analysis and Forecast 2015 – 2021 http://www.persistencemarketresearch.com/market-research/toxicology-laboratories-market.asp
iv. Toxicology Laboratories Market: New Market Research Report https://www.medgadget.com/2017/05/toxicology-laboratories
v. Toxicology Laboratories: Market Research Report https://www.ibisworld.com/industry-trends/specialized-market--research-reports/life-sciences/laboratory-services/toxicology-laboratories.html

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