Re: Barbiturates regulated in Germany
Dear colleagues,
I applaud your efforts to improve drug use, and acknowledge your
serious concerns about the dangers of barbiturates. However, I think
we must be very cautious about feeling completely satisfied with
product withdrawals alone as a solution to the underlying drug use
problems represented in this example without sufficient evidence that
all the effects of limiting access to barbiturates were positive ones.
My areas of concern are the following:
1. Patients use drugs, and doctors prescribe them, for real reasons,
both medical and non-medical. The drugs may be the "wrong" ones
biomedically, but they nonetheless are serving a real purpose.
Suddenly removing drugs can have both intended and unintended
consequences. It is important to critically assess these consequences
-- both the medical consequences and, especially in cases like this,
the psychosocial ones -- to fully understand the impacts of product
withdrawal.
2. Preventing the choice of specific products does not necessarily
make doctors better prescribers. The products they select as
substitutes -- and they will indeed substitute other products -- may be
as harmful, or more so. Compared to older drugs like barbiturates,
they will certainly be more expensive. Unless doctors are educated in
WHY withdrawn drugs were not indicated, and what the DESIRED
ALTERNATIVES might be, the market as a whole (and specific
patients) might not be better off. There are numerous papers from our
group at Harvard and elsewhere that have demonstrated specific examples
of this.
3. When widely-used products are withdrawn for safety reasons, both
the companies and the national regulatory authority have the
responsibility to adequately educate both prescribers and consumers
about the reasons for withdrawal, and also the preferred alternative
therapies.
I urge you to evaluate in more depth the impacts of discontinuing
barbiturates in Germany, to examine changes in utilization of the
barbiturate products which remain on the market (especially regarding
use for unlisted indications), and to ensure that the appropriate
education of prescribers and consumers is carried out.
Good luck, and please keep us informed about your progress.
Dennis Ross-Degnan
Assistant Professor
Drug Policy Research Group
Harvard Medical School