Healthy Skepticism Library item: 19931

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Publication type: Journal Article

Hamet P
Reply from author of STONE study
BMJ 1997 Dec 13; 315:1621-1622

Abstract:

Editor – I have been sent a copy of Blondeel’s letter about the advertisement for nifedipine (Adalat). He comments on the STONE study and Bayer’s advertisement for the drug, which has the heading “Research for the future: STONE study”. As the senior author of the study and the author of the sentence depicted in the advertisement and sentence depicted in the advertisement and quoted in Blondeel’s letter, I would like to make several comments.

I appreciate that Blondeel carefully read the report of the STONE study and noted shortcomings, which my colleagues and I mentioned in the paper. It is surprising that Blondeel has picked up only on the shortcomings, which we discussed openly to make readers aware of the study’s entire content.
Unfortunately, Blondeel has missed all the positive points, which we also underlined in a balanced way. The STONE study is the first prospective controlled trial that tested this new type of drug against placebo; it concluded in a strong, unambiguous way that treatment with nifedipine is better than placebo, protecting against stroke and overall cardiovascular events.

The STONE study is not weaker than the original Veterans Administration study 1; it is similar in design and shortcomings – which we discussed. The Veterans Administration study was a landmark proving that hypertension treatment is worthwhile. We believe that the STONE study is also a landmark study giving doctors the opportunity to rely on newer classes of drug. We scrupulously and openly discussed in our paper the study’s strengths and weaknesses; this is usually not done, and frequently only other analyses review weaknesses.

Naturally, we must await the results of further studies to confirm our findings. From what was presented at the last European meeting on hypertension, it seems that studies such as the systolic hypertension in Europe studies will have the power to address the question of whether the STONE study was the first to show that nifedipine is a proved agent able to reduce morbid events. Despite Blondeel’s comments, I believe that openness and criticism by authors should be kept as a standard, should not be used to diminish the value of the data, and serve to facilitate proper weighing of the evidence.