Peering into the pharmaceutical “pipeline”: Investigational drugs, clinical trials, and industry priorities

Abstract

In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry’s investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding – and often problematic – role of pharmaceuticals in society. To access the pharmaceutical industry’s pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2,477 different drugs in 4,182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline were being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered.

“Just Advil”: Harm reduction and identity construction in the consumption of over-the-counter medication for chronic pain

“…Illnesses such as depression (Lakoff 2004; Applbaum 2006), Erectile Dysfunction (Lexchin 2006; Moynihan et al 2002), and Pre-Menstrual Dysphoric Disorder (Smirnova 2012) are defined, promoted, and effectively “sold” by pharmaceutical companies (Martin 2006a; Healy 2006; Kirmayer 2002; Fisher et al 2014; Abraham 2010). Chronic pain, alternatively, is unique in that its experience as well as available treatments remains incompletely or ambiguously medicalized (Crowley-Matoka and True 2012).…”

Uso racional de medicamentos, farmaceuticalização e usos do metilfenidato

“…The initiatives for the construction of protocols for the public dispensation of methylphenidate are part of an initial movement in attempt to rationalize use and minimize inappropriate use of the medication [23][24][25][26] . Nonetheless, there are still uncertainties about who would benefit from the treatment and about the challenges to the establishment of diagnosis, which therefore challenge the construction of solid guidelines for the rational use of the medication.…”

“…Therefore, there is no way to establish any sort of control for prescriptions that result from this professional practice, which makes it possible that the medication be approved for one objective and prescribed for another one, which can be completely different from the uses tested in clinical trials 23,24 . In the case of methylphenidate, the leaflet registered at Anvisa gives the prescriber the responsibility to determine doses and treatment schedules.…”

“…Unlike the rational use (RUM), there are parallel non-rational "practices and desires" developed for the use of pharmaceutical substances by individuals and populations" 25,26 . The outreach and popularity of a medication is not only based on its capacity to achieve an ef- fect, but on its interaction with cultural and social pressures that define a condition as worthy of pharmaceutical resolution 20,23 . Busfield 4 suggests a typology that considers five types of inappropriate use: a) not receiving medicines that are clinically necessary (benefits would compensate for the risks); b) receiving/ using medicines that are not efficient for the condition being treated (risks exceed benefits); c) receiving/using medicines with no appropriate clinical need (risks exceed any benefits); d) receiving/using a specific medicine, but in wrong doses or schedules or in combination with another incorrectly prescribed medicine (which would change the risk-benefit equation); e) receiving/ using expensive medicines, while there would be an equally efficient and cheaper alternative.…”

“…Such limitations required the inclusion of two other combinations: (Pharmaceuticalization OR Pharmaceuticalisation) AND "Label" (off-label) 20,21 , (Pharmaceuticalization OR Pharmaceuticalisation) AND "Mental Illness" 22,23 . It is important to note that, being a neologism, the word Pharmaceuticalization, in English, may be written with S or with Z, which was controlled in the research with the use of the Boolean operator "OR".…”