Intended for healthcare professionals

Rapid response to:

Editor's Choice

A tough nut to crack

BMJ 2005; 330 doi: (Published 27 January 2005) Cite this as: BMJ 2005;330:0-h

Rapid Response:

Protecting Editorial Integrity through Responsibility and Resolve

The BMJ must be steadfast in its resolve as a ‘tough nut to
crack.’(1) The reasons are simple and timeless. The products,
treatments, therapies and pharmaceuticals derived from research and its
applications are only as safe and effective as their honest and
reproducible scientific discipline.

Research science can be corrupted at any step of the research
process. It is the very reason behind the passion that drives the
arguments for full disclosure and transparency. Since this is not a
theoretical exercise, but one from which human lives are held in the
balance, the stages of the process are worth reiterating: If basic science
is corrupted, clinical protocols can not accurately proceed. If the
results of an early clinical trial are misreported, the basis for larger
trials is skewed. If negative data or adverse effects are hidden, the risk
-benefit questions cannot be addressed. If the positive conclusions are
embellished, the marketing and advertisement are at risk. If the
regulatory bodies do not perform their tasks in an independent and
unbiased manner, the approval process is corrupted. (2) If any facet of
the pharmaceutical ‘diamond’ is not etched carefully or any person who
chooses to make decisions about the process is not scrupulously clear
about the reasons and responsibilities that they have undertaken, the
entire process suffers as a result. The consequences for that
interruption of the scientific process violate the Hippocratic Oath, our
common welfare and can harm an uninformed public.

That said, kudos to Kamran Abbasi for having the courage and
opportunity to assert and defend his positions, as he writes in his recent
Editor’s Choice remarks. (1) What he does must be the mainstay of
responsible editing, not the exception.

He and his editorial staff must expose published studies whose
conclusions are not corroborated by the research results; where
statistical analysis is simply a means to achieve a positive result rather
than a meaningful analysis of benefit and reward; and when sloppy and
uncontrolled clinical research designs merit neither statistical analysis
nor publication.

The freedom and responsibility to speak out are the cornerstones of
obligatory medical reporting since it that duty that protects the
integrity of scientific debate. Editor Abbasi must not only remain
impervious to retreat from those essential endeavors, but must continue to
safeguard his editorial and investigative reporters: Susan Mayor, Ray
Moynihan, Lynn Eaton, Owen Dyer, Tony Sheldon and Jeanne Lenzer, and so
many others----who brilliantly share that burden and exemplify that
responsibility. (3, 4, 5, 6)

I’m going to be corny, but I believe what I’m saying to my soul. The
current day courageous medical editors and writers are not unlike other
freedom fighters who fought for lofty ideals: Lech Walesa’s pro-democratic
Solidarity efforts in the Gdansk shipyards prior to the collapse of the
Soviet Union; Nelson Mandela’s struggles and sacrifice against apartheid
in South Africa; and, Rosa Park’s refusal to sit at the back of the bus in
a segregated 1955 Montgomery, Alabama. Like them, freedom fighters for
ethical and honest medical reporting must be protected and nurtured. The
search for scientific truth can be precarious, but the goal is keen.

1. Abbasi, K. A Tough Nut to Crack. BMJ 2005; 330: 7485.O-h (29

2. Spiers, Alexander. Save the FDA.BMJ 2005; 330:308 (5 February),

3. Mayor, S. Rofecoxib caused excess heart disease. BMJ 2005; 330:
212 (29 January)

4. Dyer, O. Surgeon is struck off for failing to mention disciplinary
action. BMJ 2005;330:274 (5 February), doi:10.1136/bmj.330.7486.274-a

5. Sheldon, T. Pfizer found guilty of breaching code.
BMJ.2005;330:162 (22 January), doi:10.1136/bmj.330.7484.162-b

6. Lenzer, J. Public interest group accuses FDA of trying to
discredit whistleblower. BMJ 2004; 329: 1255( 27 November)

Competing interests:
None declared

Competing interests: No competing interests

05 February 2005
Stefan P. Kruszewski
Harrisburg, Pennsylvania USA