Accountable care organizations and the allergist: challenges and opportunities.

For decades, health care policy experts have wrestled with ways to solve problems of access, cost, and quality in US health care. The current consensus is that the solution to all three lies in changing financial incentives for providers and delivering care through integrated systems. The currently favored vehicle for this, both in the public and private sectors, is through Accountable Care Organizations (ACOs). Medicare has several models and has fostered rapid growth in the number of operative ACOs. At least an equal number of private ACOs are in operation. Whether or not these organizations will fulfill their promise is unknown but there is reason for cautious optimism. Allergists can and should be part of the process of this transformation in our health care system. They can be integral to helping these organizations save money by reducing hospitalizations and improving the quality of allergy and asthma care in the populations served. In order to accomplish this, allergists must become more involved in their medical communities and hospitals.

Regulatory immunotoxicology: does the published evidence support mandatory nonclinical immune function screening in drug development?

Recent immunotoxicity guidance documents from the EU CHMP and the US FDA apply significantly different weightings to immune function testing; whereas the former mandates (as a starting point) incorporation of immune function tests (IFTs) to screen for immunotoxic potential in sub-chronic rodent toxicity studies, the more cautious 'for cause' FDA approach recommends the use of IFTs only when warranted by evidence obtained from conventional nonclinical and/or clinical studies. Conclusions from detailed evaluations of several key drugs, including salmeterol and some opioids, challenge the notion that data on these examples support the need for IFTs to detect unintended immunosuppression. Given the virtual absence of convincing pharmaceutical examples and the rarity of unintended immunosuppression, routine immune function testing of all new pharmaceuticals is not considered justified. Resources currently being employed in this manner in an attempt to detect a seemingly rare phenomenon would appear to be better applied to the development of reliable predictive assays for drug hypersensitivity, which is known to cause significant patient morbidity. Any moves towards a globally harmonised guideline that recommends the use of concern-based IFTs, need ideally to be accompanied by the establishment of appropriate historical control reference intervals and interpretation criteria to support a reliable weight-of-evidence approach to data evaluation.