Issues with the self-report during R & D of novel treatments and therapeutics for mental illness. A need for objectivity presents itself.

Looking back at the history of health research a clear increase in the reliance of the self-report can be observed. Prior to 1895 the only way an assessment on the severity of internal injuries was to ask the patient if it hurt (or cut them open!). It was only really during the 20th century that objective measures were developed and widely used, these measures not only improved treatment, but they also improved the effectiveness of R and D into novel health treatments.

In the 1994 publication “The Science of Self-report: Implications for Research and Practice” Author Wendy Baldwin reminds readers that even a straightforward question such as asking someone for their address can be fraught with potential for misunderstanding. After making such a cynical observation Baldwin then goes on to explain that in some cases the self-report should not be thought of as just a proxy for other more effective assessment methods because in some cases there are no better methods. She goes on to give past sexual behaviour and historical drug use as an example of instances requiring a self-report. Unfortunately for Baldwin this is the type of thinking that can keep ineffective and outdated practices in use for far longer than they need, the absence (or at least the perceived absence) of better methods does not immediately render the only option available useful.

In a mental health setting research into the efficacy of a treatment has always been overshadowed by issues associated with the self-reporting of research subjects, some of the key issues were outlined by  Kristalyn Salters-Pedneault, PhD on June 19, 2020 on the website www.verywellmind.com. They included Honesty; subjects may make the more socially acceptable answer rather than being truthful. Introspective ability; the subject may not be able to assess themselves accurately, and finally, the interpretation of questions; the wording of the questions may be confusing or have different meanings to different subjects.

The highly competitive and expensive pharmaceutical development industry has recognised these issues, in response during 2018 two of the world’s largest companies Pfizer and Astrazeneca dropped their mental health R and D departments. Who can blame them? developing a new prescription medicine that gains marketing approval is estimated to cost drug makers $2.6 billion according to a recent study by Tufts Centre for the Study of Drug Development and published in the Journal of Health Economics. With margins like this flimsy efficacy protocols such as the self-report can cost investors billions, this has led companies to be wary of spending time and money developing new psychiatric pharmaceuticals and poured them into oncology and immuno-oncology where 38% of global pharmaceutical R and D funds are spent.

Will more objective assessment options into the efficacy of mental health treatments lure some of these large industry players back to this space in a big way? Only time will tell.

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