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Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorPhil B.FontanarosaMD, Executive Deputy EditorIndividualAuthor
To the Editor: In their Commentary, Drs Davis
and Lantos1 make a common mistake when they
state that, "the PIP improved immunization rates" may have produced "untoward
effects." They attribute these effects and "ethical problems involved in policy
evaluation" to the evaluation rather than to the policy itself. In Georgia,
it was the coercive statewide policy that improved immunization rates and
may have had adverse effects. By adding a small temporarily exempt control
group, the PIP2 merely increased the ethical
quality of an otherwise uncontrolled, potentially unethical statewide policy
experiment. When an agency laudably uses a randomized delayed control group
to make a policy's effectiveness (or ineffectiveness) more measurable, it
also makes other aspects of the policy, such as coercion and adverse effects,
more evident. The challenge for ethicists, researchers, clinicians, and policy
makers is to find ways to increase the linkage of policies to evidence, including
ethics-related evidence. This can be better achieved by praising randomized
policy trials for increasing visibility of ethical issues than by criticizing
them for ethical aspects of the policies they are evaluating.
Our views are based on experience with our randomized policy trial.
British Columbia's publicly funded drug benefit program, Pharmacare, introduced
a cost-saving policy in 1999 that restricted coverage of nebulized medications.
As usual, there was no informed consent and some theoretical risk of potential
adverse effects. Ten percent of physicians were randomly allocated to an optional
6-month exemption. This is an inversion of Zelen's randomized consent design3,4 in which consent is sought from
subjects in the treatment arm after randomization. In our trial, only the
474 privileged controls were given the option of withholding their consent.
Only 1 physician with patients receiving nebulized medication asked to withdraw
from the control group. A university ethics committee approved our delayed
controls but had no authority over the policy itself. Yet, as advisors who
helped implement the policy, 2 of us (M.M., B.C.) were aware that the control
group increased scrutiny of the policy from an ethical perspective. We found
that this increased the sensitivity to ethical issues and helped produce a
better policy. We believe randomized delayed controls can often increase the
ethical quality of restrictive or coercive policies.
Maclure M, Carleton B, Schneeweiss S. Effects and Ethics of Sanctions on Childhood Immunization Rates. JAMA. 2000;284(16):2056–2057. doi:10.1001/jama.284.16.2053
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