{"id":3643,"date":"2005-02-01T00:00:00","date_gmt":"2005-02-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/index.php\/2005\/02\/01\/pmn42-article04\/"},"modified":"2019-02-18T18:08:30","modified_gmt":"2019-02-18T18:08:30","slug":"pmn42-article04","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn42-article04\/","title":{"rendered":"Numbers, Math and Communicating Risk"},"content":{"rendered":"<p>Numbers, Math and Communicating Risk        &#8220;You want numbers? You can&#8217;t handle numbers!&#8221;<br \/>The FDA would like more risk information to be presented in direct to consumer (DTC) drug advertising (see &#8220;<a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmn32-article03.html\">FDA Draft Guidance for Print DTCA: Less than Feared<\/a>&#8220;). Some DTC experts want the drug industry to take the lead in communicating risk.  <\/p>\n<p> To make sense of trial data and risk information in DTC ads, you need to look at numbers. As pointed out in a recent Washington Post article, &#8220;many people don&#8217;t demand the same kinds of numbers [as they do with money matters] when judging medical findings.&#8221; To paraphrase Jack Nicholson in the 1992 movie A Few Good Men, &#8220;You want numbers? You can&#8217;t handle numbers!&#8221; <\/p>\n<p> This article examines the numbers from Vioxx trials to illustrate how difficult it may be to communicate risk and benefit to consumers. <\/p>\n<p> <b>Take the <a href=\"http:\/\/www.surveymonkey.com\/s.asp?u=41030875328\">CLINICAL TRIAL BRAIN TEASER<\/a>.<\/b> <\/p>\n<p> Sometimes, not all the critical data from a trial are available and you need to do some math to calculate risk. Here&#8217;s an example from a recent article published in the press (I won&#8217;t reveal the source because I want you to do the math).   <\/p>\n<ul type=\"CIRCLE\">\n<li>There were 2,643 people in a study comparing naproxen to Celebrex. 702 took naproxen, 1057 took placebo, 704 took Celebrex. <\/li>\n<li> <\/li>\n<li>There were a total of 70 cardiovascular events among all the study participants. <\/li>\n<li> <\/li>\n<li>The proportion of people having an event was 50% higher in the naproxen group compared to placebo. <\/li>\n<li> <\/li>\n<li>There was no increased risk for people taking Celebrex compared to placebo. You can assume that the Celebrex risk was the same as the placebo risk. <\/li>\n<\/ul>\n<p> <b>Q1: Calculate the likely magnitude of the naproxen risk, i.e., what percent of people taking naproxen experienced a cardiovascular event compared to people taking placebo? <\/b><\/p>\n<p> Q2: What would these numbers be if no (0) people taking Celebrex in this trial experienced a cardiovascular risk? <\/p>\n<p> Think you know the answers?<br \/><a href=\"http:\/\/www.surveymonkey.com\/s.asp?u=41030875328\">Click Here To Take The Test<\/a><br \/> There you will also find the CORRECT answers. <\/p>\n<p><b>Read this article now. It&#8217;s FREE&#8230;<\/b> <\/p>\n<p><b><a href=\"http:\/\/www.news.pharma-mkting.com\/pmn42-article04.pdf\">Download PDF file<\/a><\/b><\/p>\n<\/p>\n<hr\/>\n<p><b>Update<\/b> (December 2011): See the blog post and article below for a follow up on this issue. Also, to address a requirement of the 2010 Patient Protection and Affordable Care Act  (Affordable Care Act), FDA may be required to revisit this issue (see &#8220;<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?t=67028\">FDA Summary of Drug Benefits vs Risks<\/a>&#8220;).&#8211;&gt;<\/p>\n<p>  PMN42-01<br \/> Issue: Vol. 4, No. 2: February 2005<br \/> Word Count: 1257  <\/p>\n<p> <b>Find other articles in related Topic Areas:<\/b>  <\/p>\n<ul>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNbrandingReprints.htm\">Brand Marketing<\/a> <\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNrmReprints.htm\">Relationship Marketing<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This article examines the numbers from Vioxx trials to illustrate how difficult it may be to communicate risk and benefit to consumers.<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[54,6],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - 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