Intended for healthcare professionals

Rapid response to:

Papers

Are these data real? Statistical methods for the detection of data fabrication in clinical trials

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7511.267 (Published 28 July 2005) Cite this as: BMJ 2005;331:267

Rapid Response:

Benford's Law [very large data set number-analysis] not needed in approaches that work

Let not this debate become lost in statistical complexities and keep our focus on results.

The authors compared 2 trials, one wonderfully well done, the MRC trial [MEDLINE 2861880] where in 85,572 years of observation with beta-blockerordiuretic in mildly hypertensive patients [diastolic
90-109 mm Hg], the difference in deaths at trial end vs. placebo was 5, one death per roughly 8500 years of drug use. Everything, even in hind sight, was perfect and that should have been the end of 2 drugs if mortality is an endpoint in such patients. But was it?

The later trial of 1992 [MEDLINE 1586782] lacked statistical rigor but it was an intriguing study in only 406 patients with suspected acute myocardial infarction in which 17 (44%) fewer patients died on the intervention diet.
There are questions but when many drugs don't save lives even in the best run mega-trials, one should repeat the trials that do find mortality benefit.
Paraphrasing Harvard's Dr.
Alexander Leaf
in 1999 Circ. concerning an equally surprising
diet trial with similar benefits, the Lyon Diet Heart Study: "first
let's find an effect and then figure out what caused it".

When a prevention approach actually produces results in the time frame of a single human being, others should replicate such trials especially if it takes patient numbers only in the hundreds. This should have been the value of BMJ publishing this kind of study, preferably with
an editorial, in the first place. vos{at}health-heart.org

Competing interests:
None declared

Competing interests: No competing interests

09 August 2005
Eddie Vos
maintains health-heart.org
Sutton (Qc) Canada J0E 2K0