Editorial: Drug Industry, Psychopharmacology, and Mental Health Care Needs: Where Do We Go from Here?
Segman, Ronnen, Weizman, Abraham, The Israel Journal of Psychiatry and Related Sciences
The pharmaceutical industry has recently been challenged with much public concern, despite its generally impressive success in promoting health care technology over the last decades. Pharmaceutical companies play a central role in new drug development, designing of randomized controlled trials (RCTs) that provide the data required to support efficacy and safety of novel treatments, initiating requests for labeling indications and safety warnings, and influencing consumer patterns of new products by health care providers and the public. As these are for-profit organizations, making huge capital investments that carry substantial risks, market forces and commercial interests must govern decision-making aspects in all these processes, and these may not always overlap with public health benefit. We briefly review the extent of the predicaments that have evolved, and conclude by summarizing unmet needs and outlining some possible directions for change.
The pre-marketing approval average cost for developing a new drug has recently been estimated at over US$800 million (1). The high cost of investment bars government and academia, leaving mostly the pharmaceutical industry to develop drugs for profit, with the consequence that new drug development priorities are largely determined by financial opportunity considerations rather than public health needs. The high cost of investment also translates into a high inducement for marketing, motivating drug development and marketing strategies that have recently attracted much criticism. Offering hope to the large proportion of patients who do not respond well to currently available drugs requires the discovery of novel mechanisms of action. However, the development of new compounds that emulate a known drug's mechanism of action, with some technical improvement (adverse effect profile, duration of action, etc.), tends to be more cost effective, and therefore predominates over investment in compounds with novel mechanisms. This is well exemplified in the field of psychotropic drugs, where the new generation drug revolution beginning in the late 1980s includes almost no novel mechanism agents. Instead, several drug companies have chosen to compete for the development of similar replica agents revolving around few known mechanisms, producing overlap in place of innovation. If public health needs were to guide new drug development, the overwhelming percentage of patients who do not achieve remission with current psychotropic agents, old and renewed (2-4) would have dictated increasing the relative percentage of investment into innovative compounds possessing added or unique efficacy or tolerability.
High cost marketing strategies applied to increase drug product sales have lately been the subject of heated critique. The majority of available evidencebased data on the efficacy and safety of drugs comes from phase III randomized controlled trials (RCTs). The prohibitive cost of conducting large scale RCTs contributes to the fact the majority of available evidence-based data are derived from studies conducted and funded by pharmaceutical companies. Industry-funded drug trials for assessing safety and efficacy are largely designed to comply with federal authority labeling approval requirements, and to affect consuming patterns, rather than to guide clinical practice by addressing real life clinical dilemmas (e.g., such as head-to-head comparisons of longterm safety and efficacy, against available treatment alternatives) as would be mandated by pertinent public health interest. One systematic evaluation reviewed comparative data on the efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder, concluding that although over 46 head-to-head short-term RCTs were examined, the quantity and quality of the evidence was generally found to be inadequate to allow actual quantitative comparisons, illustrating the limited relevance of industry-funded drug trials for guiding real life clinical decision making (5). …