Persistence is the Twin Sister of Excellence

Persistence is the twin sister of excellence. One is a matter of quality; the other, a matter of time.Marabel Morgan Consider 2011 as the culminating year for the decade of clinical trials seeking to alter immune-mediated destruction of β-cells in type 1 diabetes. Emphasizing this past decade is not meant to diminish earlier studies (1), or the seminal trial in 1984 demonstrating the effects of cyclosporine on preservation of β-cell function (2); indeed it was the sobering results from the latter study (i.e., better insulin secretion but worsening renal function) that pushed the field to test new approaches aimed at achieving some sort of tolerance—i.e., a safe, short-term intervention that would enable a “reset” of the immune system away from self-destruction and provide long-term clinical benefits. To achieve such a goal would not be easy, but would require a remarkable degree of persistence. To this end, in 2002 and 2005 reports from two trials using modified anti-CD3 antibodies hinted at the promise for such a new approach (3,4). Since then, early evidence has been reported that therapies of similar therapeutic purpose but targeting completely different mechanistic pathways (e.g., antigen based with GAD65-alum, anti-B lymphocyte) may have also beneficially altered the disease course after type 1 diabetes onset (5–8). But 2011 is a key year not only because results of a number of major clinical trials will be reported from nonprofit- or federally funded studies, but it represents the year that results will be disclosed from studies involving “big pharma,” often in association with biotech companies. And it is with this notion that we will build our case for the …