correspondence

times per week for the first week, weekly for the Camillo Ricordi, M.D.
first month, every other week through 4 months, University of Miami
and monthly for the remainder of the first year. Miami, FL 33136
We also acknowledge the comments regarding Bernhard J. Hering, M.D.
the potential risk of nephrotoxicity from the com- University of Minnesota
bination of sirolimus and tacrolimus. However, as Minneapolis, MN 55455
underscored by the long-term data generated by 1. Ryan EA, Shandro T, Green K, et al. Assessment of the sever-
Ojo et al., all recipients of organ transplants who ity of hypoglycemia and glycemic lability in type 1 diabetic sub-
jects undergoing islet transplantation. Diabetes 2004;53:955-62.
receive long-term calcineurin-inhibitor therapy are 2. Paty BW, Ryan EA, Shapiro AMJ, Lakey JRT, Robertson RP.
at risk for a decline in renal function and, thus, for Intrahepatic islet transplantation in type 1 diabetic patients
the need for dialysis.4 We may conclude, therefore, does not restore hypoglycemic hormonal counterregulation or
symptom recognition after insulin independence. Diabetes 2002;
that the immunosuppressive drugs currently used 51:3428-34.
in islet transplantation are far from ideal. 3. Clarke WL, Cox DJ, Gonder-Frederick LA, Julian D, Schlundt
D, Polonsky W. Reduced awareness of hypoglycemia in adults
A.M. James Shapiro, M.D., Ph.D. with IDDM: a prospective study of hypoglycemic frequency and
University of Alberta associated symptoms. Diabetes Care 1995;18:517-22.
Edmonton, AB T6G 2C8, Canada 4. Ojo AO, Held PJ, Port FK, et al. Chronic renal failure after trans-
shapiro@islet.ca plantation of a nonrenal organ. N Engl J Med 2003;349:931-40.

Financial Relationships of Institutional Review Board Members

To the Editor: Campbell et al. (Nov. 30 issue)1
provide valuable data on financial conflicts of in-
terest of members of institutional review boards
(IRBs). However, they do not address potentially
more problematic conflicts of interest inherent in
the IRB system. Industry-sponsored protocols are
reviewed and approved by IRBs consisting almost
entirely of employees of the academic medical cen-
ter, many of whom may be involved in the con-
duct of industry-sponsored research. Disapproval
of such protocols means that less money will flow
into the institution and its clinical-trials opera-
tion, with a potential deleterious financial effect.
Consider, for example, a placebo-controlled trial
evaluating an investigational (“me too”) drug with
a minimal change from a standard drug. Such a
trial arguably lacks clinical value, thus failing to
justify exposing patients to placebo.2 Are IRBs pre-
pared to reject such protocols when their mem-
bers know that industry sponsors can go to other
academic medical centers with IRBs that are
more industry-friendly? Institutional conflicts of
interest are just one reason favoring the use of re-
gional ethics review committees as an alternative
to IRBs.3
Franklin G. Miller, Ph.D.
National Institutes of Health
Bethesda, MD 20892-1156
fmiller@nih.gov
The views expressed in this letter are those of the author and
do not necessarily reflect the policy of the National Institutes of
Health, the Public Health Service, or the Department of Health
and Human Services.
1. Campbell EG, Weissman JS, Vogeli C, et al. Financial rela-
tionships between institutional review board members and in-
dustry. N Engl J Med 2006;355:2321-9.
2. Miller FG, Shorr AF. Ethical assessment of industry-spon-
sored clinical trials: a case analysis. Chest 2002;121:1337-42.
3. Wood A, Grady C, Emanuel EJ. Regional ethics organizations
for protection of human research participants. Nat Med 2004;
10:1283-8.
The authors reply: It seems likely that institu-
tional conflicts of interest of the type that Miller
describes could arise at medical schools and teach-
ing hospitals around the country. In the focus-
group and individual interviews performed for our
study, participants voiced concern about this very
issue. However, to our knowledge, there are no na-
tional, quantitative data demonstrating how fre-
quently such conflicts of interest occur and the ex-
tent to which IRBs are unwilling to reject a study
of questionable scientific value because to do so
would result in a loss of research funding for their
institution. We believe future research should ex-
plore this issue before new policies are made re-
garding the use of regional ethics review commit-
tees in lieu of traditional IRBs.
Eric G. Campbell, Ph.D.
Christine Vogeli, Ph.D.
Joel S. Weissman, Ph.D.
Massachusetts General Hospital
Boston, MA 02114
ecampbell@partners.org

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