Intended for healthcare professionals

Editor's Choice

Is drug regulation failing?

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7477.0-g (Published 25 November 2004) Cite this as: BMJ 2004;329:0-g

Scientific Credibility is based upon Transparent Debate

I savored the comments of Albert Figueras in response to Kamran
Abbassi’s editorial (1). To paraphrase Dr. Figueras, he suggested that
individual practitioners consider accepting a greater role and
responsibility in airing their clinical observations to protect the
regulatory process of drug approval and post-marketing surveillance. He
added that individual and collective ‘whistle-blowing’ could enhance the
accumulation of scientific evidence---and therefore should not be the
exception to the process, but the rule.

I concur. Scientific credibility is powered by transparency but
disemboweled by conflicts of interest. In the debate about drug safety,
those political, cultural and/or financial alliances that exist other than
for the purpose of protecting and improving the public welfare are at odds
with the pursuit of scientific discipline and the rigorous honesty that is
necessary for its success.

This debate reminds me of a quote attributed to Dorothy Thompson
(b.1893), an early-mid 20th century American political commentator and
journalist. She said, “There is nothing to fear except the persistent
refusal to find out the truth, the persistent refusal to analyze the
causes of happenings. Fear grows in darkness; if you think there’s a
bogeyman around, turn on the light.”

I’m guessing that both Abbassi and Figueras agree that turning up the
lights in order to curtail ignorance and misinformation is a good thing.
It is---with one clarification.

Earlier this evening, I spoke with two colleagues who work for our US
Food and Drug Administration (FDA). They are out of the spotlight and in
the trenches. They are hurting because they have persevered under the
umbrella of suspicion while certain administrative members and/or legal
counsel to the FDA have been the target of media censure. Not unlike
their counterparts at agencies such as the MHRA, many--if not most--of
these scientists have done what’s asked of them, with conviction and
diligence.

Their dedication should not go unnoticed. Optimistically, the
efforts of these exemplary men and women can be more fully realized when
vigorous and transparent leadership returns to steward the protection of
our foods and pharmaceuticals.

1. Abbassi K. Editor’s choice. Is drug regulation failing? BMJ 2004;
329 (27 November), doi:10.1136/bmj.329.7477.0-g

Competing interests:
None declared

Competing interests: No competing interests

04 December 2004
Stefan P. Kruszewski, M.D.
Psychiatrist
Harrisburg, Pennsylvania USA