Drug research stigma holds back new therapies


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The therapy is turning to drugs that were previously known as illicit party substances. But there’s no reason to abandon proper testing, says Malcolm Hopwood, in part three of a series on psychedelics and mental health. Read parts one and two here Y here

A variety of new therapies for mental illness were previously considered unthinkable: party drugs including ketamine, medical cannabis, and psychedelics such as MDMA, psilocybin, and DMT.

With mental health disorders a growing cause of disability in our communities, the need is acute. But the question is whether the desire for new approaches will see short cuts from the usual process of drug testing and regulation.

All drugs require careful review of efficacy and safety before being used publicly. A healthy balance between caution and necessity can avoid missing important opportunities for new treatments. A process that enables scientists to safely investigate drugs needs a structured approach supported by national regulatory and research bodies to enable the development of new therapies and protect patients.

Typically, this process involves multiple phases of clinical trials prior to general release. These trials will initially demonstrate safety, establish efficacy, dosage, and place in therapy. All trials will need ethical approval, informed consent and independent review before regulators will consider broad approval. Early consultation between investigators and regulators can be helpful in establishing what trials are needed to establish the appropriate place in therapy and safety.

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Party drugs have been around for decades, and some psychedelics have been around for centuries, they’re not new. But its use in clinical practice is. As a therapy, they still require evaluation with clear ethical frameworks and standard research practice.

Each of these new therapies has a proposed rationale for its usefulness. Ketamine and its molecular sister esketamine increase the effect of glutamate, the most widespread natural chemical stimulant in the brain. Cannabis binds to a series of receptors for its active ingredients, tetrahydrocannabinol and cannabidiol, in the brain. Psychedelics are known to act on multiple brain chemical systems that can create altered mental states. In psychotherapy, this has been harnessed to make mental breakthroughs.

The availability of medical cannabis is an example of the need for careful evaluation before it is released onto the open market. Medical cannabis has become more available based on evidence supporting its use in chronic pain and some forms of severe epilepsy. But it has also been promoted as a treatment for a variety of mental health conditions despite poor quality evidence.

Careful research is beginning to show that cannabidiol, one of the components of cannabis, may have benefits for anxiety. But medical cannabis production in Australia and its regulation are inconsistent. It does not appear to be subject to the same promotional standards as traditional medicines produced by large pharmaceutical companies and must meet strict national standards, particularly on claims of its medicinal benefits. It is not clear why these compounds should be treated differently and their high promotion has created the risk of ineffective treatments being tested and more effective ones being delayed. That is, a compound with inadequate evidence that may not be effective will be used by an individual first in preference to established treatments with known efficacy. Delay in treating mental illness is generally associated with worse outcomes.

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The use and regulation of ketamine and psychedelics for medical purposes are also complex. the LSD abuse In some mental health care settings in the 1960s, a stigma around the potential for substance abuse has been established. This perception has been difficult to correct even with evidence of trials showing that the risks of abuse are very low, especially in carefully monitored environments.

As a researcher, these challenges create tension around participation in this area; Do I want my name or reputation associated with an area that may draw criticism and is potentially difficult to fund?

This area can also be easily confused with the purported benefits of psychedelics in enhancing normal thinking and creativity. It’s the contemporary equivalent of 1960s psychologist Timothy Leary’s famous phrase, “turn on, tune in, drop out.” The main focus of the research should be on its treatment capabilities, looking at its applications and whether it is safe and effective.

The history of medicine, including mental health, is replete with examples where treatments have been hastily received and trumpeted before careful evaluation at significant human cost, such as the historical use of insulin coma, malaria therapy in mental health or thalidomide in more recent years. medical care.

And while some hope that these long-established drugs will be free from the often-alleged conflicts of interest of traditional big pharmaceutical companies, this is not automatically true. All pharmacological health treatments are invented, produced, and marketed by someone who likely has a personal and financial interest in their widespread use.

Stigma in all its forms has long surrounded mental illness and its treatments. A lot of evidence tells us that stigma leads to the risk of bad practices and more suffering. In this area, the stigma of mental illness and illicit drug research threatens to impede research into whether these drugs have uses in mental health treatment.

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The emphasis is to give value to mental health research that has long been given to other areas of health research, such as oncology. Research into new therapies for mental health should be funded in proportion to the disability that mental illness causes, whether or not they were ever party drugs. And only a good process will allow us to find the therapies that we so badly need.

Malcolm Hopwood is a professor at the University of Melbourne. He is one of Australia’s leading researchers in translational research in mood and anxiety disorders. He leads a research team based at the Albert Road Clinic, a private psychiatric hospital in Melbourne.

Does not declare any conflict of interest.

Originally posted under creative commons by 360 information™.

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