A Recent study of productivity in the workplace revealed that workers spend on average eight percent of their workday doing nothing. This statistic takes on greater significance when we find that health problems impact employee productivity loss by an even greater percentage. In light of this discovery, a group of leading experts from the emerging field of health and productivity research argues that the expansion of health care benefits represents a substantial investment opportunity for employers.
 
 Health and Work Productivity presents state-of-the-art health and productivity research that suggests interventions aimed at prevention, early detection, and best-practice treatment of workers along with an informed allocation strategy can produce significant cost-benefits for employers. Contributors cover all the major aspects of this new area of research: approaches to studying the effects of health on productivity, ways for employers to estimate the costs of productivity loss, concrete suggestions for future research developments in the area, and the implications of this research for public policy. 

To explore the impact of a drug on productivity is not the same thing as to attempt to come up with an FDA-approved labeling claim based on productivity. If a pharmaceutical company wishes to measure the likely effect of a drug, then any of the questionnaires could be utilized (with an emphasis on choosing the measure that is likely to be most responsive). If, at a later date, a confirmation of the exploratory research results is desired, then a more in. depth appraisal of options should occur. In comparison, if the purpose of the research is to obtain a labeling claim from a regulatory body, then the questionnaires must be examined in great depth. As Stang and coauthors report in chapter 12 of this volume, though the FDA has yet to give firm guidance on productivity research, the future for productivity claims is potentially promising. With regard to pharmaceutical companies that are interested in select ing an appropriate measure for productivity research, some lessons may be learned from the field of health-related quality-of-life assessment. The FDA has been reluctant to accept the claim of improved quality of life because few interventions affect all areas of life. Instead, the FDA is more likely to permit claims of a prespecified set of items in a domain; e.g., physical functioning) (Burke 2001). Therefore, it may be anticipated that the FDA will also take a similar stance with productivity assessments. But researchers should pro ceed with caution. While some existing questionnaires essentially measure productivity as a single item, the FDA has cautioned that single items may not be sufficient to provide evidence of a benefit (Burke 2001). In addition, the FDA may also require that the productivity question naire be field-tested in two well-controlled pivotal trials, with the productivity measure as a primary endpoint. This stipulation brings into question whether a pharmaceutical company will truly want to obtain a labeling claim. The easiest way to obtain the claim would be to piggyback the productivity as- The Pharmaceutical Industry and Productivity Research (237 these trials represent a stylized world of clinical practice because of artificial inclusion and exclusion criteria as well as controls demanded by the protocol that can greatly hinder the generalizability of the trial results (Bombardier and Maetzel 1999). In other words, results based on such a stylized sample may fail to meet the needs of the industry's target audience, workplace decision-makers who want information particular to their situation. For example, a manufacturing labor union is unlikely to be interested in the results of a study conducted primarily on white collar workers. This desire for situa tionally specific data creates a substantial challenge for the design of experi- mental treatment trials aimed at documenting effects on productivity. Based on the above considerations, a naturalistic or effectiveness trial is likely to be a more appropriate trial design for demonstrating the value of an intervention based on improvements in worker productivity. A naturalis. tic study reflects realworld treatments by loosening the restriction on patient inclusion and exclusion criteria and by permitting routine medical practice (for instance, by permitting the titration or augmentation of medications), Although this study design would not, in most cases, reach the FDA stan dards of "substantial evidence," it does have the considerable virtue of rele. vance to the decision-maker. Of course, the ability of a pharmaceutical com pany to promote productivity messages based on a trial becomes more limited. Strictly speaking, a company can cite only productivity information that was truly unsolicited and unprompted

 

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Should the FDA make worker productivity a mandatory measure for approval?

 

400 words no plagiarism no bullet points please