The Emergence of Psychedelic Drugs & the Need for Their Quality Testing

Biospecimen Management Software @IBS 2022 Virtual Symposium

February 24, 2022

Mental health conditions plague our planet. The tragic number of people who suffer from anxiety, depression, post-traumatic stress disorder (PTSD), and addiction is staggering. Of the 7.9 billion inhabitants of Earth, 1 in 13 people has anxiety (> 600 million people), with only about one-third of those people receiving treatment. The World Health Organization (WHO) reports that 300 million people suffer from depression, and this mental health condition can be so debilitating, that it has been rated to be in the same disability category as terminal stage cancer. Anxiety and depression can coincide with PTSD and the US Department of Veterans Affairs reports that PTSD affects approximately 6% of the population. An estimated 1.45 billion people who have experienced war have also been diagnosed with PTSD. Substance abuse can develop from a catastrophic mixture of all three of these mental health conditions. The United Nations Office on Drugs and Crime reports that 36 million people across the globe suffer from drug addiction.

These numbers portend disastrous consequences for the human race, and it should be understood that there are likely many more sufferers of these conditions that have not sought treatment, and therefore, many may not be a part of the statistics.

Challenges with the Traditional Ways of Treating Mental Illness

The traditional ways that modern medicine has tried to treat these conditions can be problematic. Pharmaceutical drugs may take a long time to work and may be addictive (e.g., methadone). Psychotherapy is a long-term venture as well, and the manifestations of these conditions may cause many people to feel like they are running out of time. What’s needed is a paradigm shift in the way that we look at mental healthcare, and, excitingly, several psychedelics are showing monumental promise.

Enter Psychedelics

Coined by Humphrey Osmond in 1957, the term “psychedelics” includes psychoactive, non-addictive substances that alter perception, mood, and affect other cognitive processes. There is an encouraging body of scientific literature demonstrating the power of psychedelics like ketamine, psilocybin, lysergic acid diethylamide (LSD), ecstasy, dimethyltryptamine (DMT), or 5-MeO-DMT for rapidly weakening the effects of debilitating mental illnesses and addiction. Despite this evidence, some of these molecules are still classified as Schedule I drugs at the federal level in the United States.

The US Food & Drug Administration (FDA), however, has labeled esketamine and psilocybin as “breakthrough therapies.” The ketamine derivative has been granted approval to be fast-tracked by the FDA for treatment-resistant depression. While many conventional treatments typically take 4 to 8 weeks to produce any results, ketamine can start working in 1 day.

Magic mushrooms have been available for millennia, but interest in psilocybin and psilocin has led to decriminalization in places like Denver, Colorado; Seattle, Washington; Washington D.C.; and Canada. Oregon fully legalized psychedelic mushrooms for therapeutic use in November 2020.

Here Comes the Data

The illegality of these molecules has likely led to much less scientific inquiry than what might have otherwise occurred, but with increasingly relaxed regulations, this will change as research groups, pharmaceutical companies, and wellness companies will require lots of data to understand their given active product ingredient(s) and how they interact with our bodies, and how to best implement these molecules to better aid humankind.

That means that in-house and 3rd party analytical laboratories will be developing and validating spectroscopic and chromatographic methods to qualitatively and quantitatively assess chemical structures and purities, identify impurities, design products, and pinpoint effective dosages to ensure standardized, reproducible products every time.

All that Data Needs a Good LIMS

This wealth of data will need to be processed and analyzed, and compared to past or future results. Finding an effective way to organize, file, and store the data will significantly aid in making sense of all that’s generated. This can be achieved using a robust Laboratory Information Management System (LIMS).

A LIMS can manage all of the analytical data and can offer the added benefit of accountability for regulatory guidelines that require tracking the samples, especially when they contain Schedule I molecules.

Using a LIMS, a lab can:

  • Manage calibration and validation data
  • Schedule preventative maintenance
  • Manage standard operating procedures
  • Track changes to the data including who made the changes
  • Manage training requirements and reports

Conclusion

With so many people suffering from debilitating mental health conditions, the timing of psychedelic-based treatments couldn’t be better. Although the early reports are definitely a cause for excitement, there is still so much that we don’t know about these substances. As we learn, we’ll generate loads of data that help us unlock the full potential of psychedelics, and help us effectively utilize these substances in pursuit of happier, healthier qualities of life.

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