{"id":44822,"date":"2019-06-14T11:42:59","date_gmt":"2019-06-14T10:42:59","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=44822"},"modified":"2019-06-21T11:11:17","modified_gmt":"2019-06-21T10:11:17","slug":"jeffrey-aronson-when-i-use-a-word-biomarkers-advantages-and-disadvantages","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/06\/14\/jeffrey-aronson-when-i-use-a-word-biomarkers-advantages-and-disadvantages\/","title":{"rendered":"Jeffrey Aronson: When I use a word . . . Biomarkers\u2014advantages and disadvantages"},"content":{"rendered":"<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/12\/jeffrey_aronson.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-32935\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/12\/jeffrey_aronson-223x300.jpg\" alt=\"jeffrey_aronson\" width=\"106\" height=\"131\" \/><\/a><a href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/06\/07\/jeffrey-aronson-when-i-use-a-word-biomarkers\"><span style=\"font-weight: 400\">Last week<\/span><\/a><span style=\"font-weight: 400\"> I suggested that many terms, such as \u201cbiological markers\u201d, \u201csurrogate markers\u201d, \u201cintermediate markers\u201d, \u201csurrogate response variables\u201d, \u201csurrogate endpoints\u201d, \u201cintermediate endpoints\u201d, \u201cbiomarker endpoints\u201d, and \u201cintermediate marker endpoints\u201d, could be replaced by a single term, \u201cbiomarkers\u201d, defined, as Robin Ferner and I have <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/28779556\"><span style=\"font-weight: 400\">proposed<\/span><\/a><span style=\"font-weight: 400\">, as follows:<\/span><\/p>\n<table>\n<tbody>\n<tr style=\"border: 1px solid black\">\n<td style=\"border: 1px solid black\"><span style=\"font-weight: 400\">biomarker, n. \/\u02ccb\u028c\u026a\u0259\u02c8m\u0251rk\u0259r\/ A biological observation that substitutes for and ideally predicts a clinically relevant endpoint or intermediate outcome that is more dif\ufb01cult to observe. [ancient Greek \u03b2\u03b9\u03bf- combining form, life + Old English mearc, a boundary, a limit +-er suf\ufb01x]<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400\">I also summarized the various uses of biomarkers.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Clinical biomarkers are simpler and less expensive to measure than \ufb01nal clinical endpoints, and they can be measured repeatedly and over shorter time spans. For example, it is easier to measure the blood pressure than to use echocardiography to measure left ventricular function, and much easier to use echocardiography than to measure long-term morbidity and mortality from hypertension.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Biomarkers allow clinical trials to be performed with fewer subjects than might otherwise be possible. For example, a randomized placebo-controlled crossover <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22815989\"><span style=\"font-weight: 400\">study<\/span><\/a><span style=\"font-weight: 400\"> of the effects of a once-daily Polypill containing amlodipine 2.5 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg, and simvastatin 40 mg on mean systolic blood pressure, diastolic blood pressure, and LDL cholesterol was completed within a year. It would have taken several years to show that this resulted in reduced morbidity and mortality. Large observational studies have shown that changes in these biomarkers predict those outcomes, justifying the use of the intervention.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Biomarkers are also useful for avoiding ethical problems associated with the measurement of clinical endpoints. For example, N-acetylcysteine has never been subjected to a randomized placebo-controlled clinical trial in the treatment of paracetamol (acetaminophen) overdose, with liver damage as an endpoint; instead, the plasma paracetamol concentration, a pharmacological biomarker of the risk, is <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21508044\"><span style=\"font-weight: 400\">used<\/span><\/a><span style=\"font-weight: 400\"> to predict whether treatment is required.<\/span><\/p>\n<p><span style=\"font-weight: 400\">However, a major problem in using biomarkers is failure to understand the relation between the pathophysiology of the condition and the mechanism of action of the intervention. For example, smoking causes lung cancer, and a trial of the bene\ufb01t of education in preventing lung cancer might use smoking as a biomarker rather than the occurrence of the cancer itself. On the other hand, if chemotherapy is used to treat lung cancer, smoking is of no use as an indicator of outcome, since smoking is irrelevant to the action of the intervention. This is self-evident, but other cases may be less obvious.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Here is an example of the importance of understanding the relation between the pathophysiology of the condition and the mechanism of action of the intervention. Because ventricular arrhythmias cause sudden death and antiarrhythmic drugs prevent ventricular arrhythmias, it was assumed that antiarrhythmic drugs would prevent sudden death. That assumption was wrong. The results of the Cardiac Arrhythmia Suppression Trial (<\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/1900101\"><span style=\"font-weight: 400\">CAST<\/span><\/a><span style=\"font-weight: 400\">) showed that the antiarrhythmic drugs encainide and \ufb02ecainide increased sudden death signi\ufb01cantly in patients with asymptomatic ventricular arrhythmias after myocardial infarction. The mechanism remains unde\ufb01ned.<\/span><\/p>\n<p><span style=\"font-weight: 400\">It is perhaps unfortunate that this example, and a handful of others like it, has been used as an argument against mechanistic reasoning in clinical medicine, and in promoting the view that the results of randomized trials trump mechanisms. But the problem with the arrhythmia example was not that the hypothesis was wrong, which it was, but that it was for a long time assumed to be correct and that a trial was not needed. The lesson from this case is not that mechanisms are not useful, but that a priori mechanistic reasoning in the absence of supporting clinical evidence is hypothesis generating and should not be regarded as proof of concept. The assumption that it was so in this case is estimated to have led to more deaths than among US soldiers killed in wars such as those in Korea or Vietnam (Figure).<\/span><\/p>\n<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/06\/aronson_disadvantages.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-44823 alignnone\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/06\/aronson_disadvantages.jpg\" alt=\"\" width=\"608\" height=\"430\" srcset=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/06\/aronson_disadvantages.jpg 608w, https:\/\/blogs.bmj.com\/bmj\/files\/2019\/06\/aronson_disadvantages-300x212.jpg 300w\" sizes=\"auto, (max-width: 608px) 100vw, 608px\" \/><\/a><\/p>\n<p><em><strong>Jeffrey Aronson<\/strong>\u00a0is a clinical pharmacologist, working in the Centre for Evidence Based Medicine in Oxford&#8217;s Nuffield Department of Primary Care Health Sciences. He is also president emeritus of the British Pharmacological Society.<\/em><\/p>\n<p><strong>Competing interests:<\/strong>\u00a0None declared.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Last week I suggested that many terms, such as \u201cbiological markers\u201d, \u201csurrogate markers\u201d, \u201cintermediate markers\u201d, \u201csurrogate response variables\u201d, \u201csurrogate endpoints\u201d, \u201cintermediate endpoints\u201d, \u201cbiomarker endpoints\u201d, and \u201cintermediate marker endpoints\u201d, could be [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/06\/14\/jeffrey-aronson-when-i-use-a-word-biomarkers-advantages-and-disadvantages\/\">More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":38359,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5762],"tags":[],"class_list":["post-44822","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-jeff-aronsons-words"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Jeffrey Aronson: When I use a word . . . 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