{"id":19370,"date":"2017-03-20T09:00:43","date_gmt":"2017-03-20T13:00:43","guid":{"rendered":"http:\/\/pmedicine.org\/epatients\/?p=19370"},"modified":"2017-03-21T00:54:50","modified_gmt":"2017-03-21T04:54:50","slug":"e-patient-perspective-on-evolocumab-that-new-cholesterol-study-beyond-the-headlines","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2017\/03\/e-patient-perspective-on-evolocumab-that-new-cholesterol-study-beyond-the-headlines.html","title":{"rendered":"e-Patient perspective on evolocumab (that new cholesterol study): beyond the headlines"},"content":{"rendered":"<p><a href=\"https:\/\/www.amgen.com\/media\/news-releases\/2017\/03\/landmark-outcomes-study-shows-that-repatha-evolocumab-decreases-ldlc-to-unprecedented-low-levels-and-reduces-risk-of-cardiovascular-events-with-no-new-safety-issues\/\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-19371 alignright\" style=\"border: 1px solid black;\" src=\"https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2017\/03\/Evolocumab-press-release-screen-capture.jpg\" alt=\"\" width=\"376\" height=\"147\" srcset=\"https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2017\/03\/Evolocumab-press-release-screen-capture.jpg 861w, https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2017\/03\/Evolocumab-press-release-screen-capture-300x117.jpg 300w, https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2017\/03\/Evolocumab-press-release-screen-capture-768x301.jpg 768w\" sizes=\"auto, (max-width: 376px) 100vw, 376px\" \/><\/a><em><span style=\"font-size: 85%; line-height: 125%;\">Please cite this post as &#8220;by Dave deBronkart, Marilyn Mann and Peter Elias MD&#8221; or, on Twitter, &#8220;@ePatientDave, @MarilynMann &amp; @PHEski.&#8221; Our blog software only allows listing one author but they provided 2\/3 of the content.<\/span><\/em><\/p>\n<p>The medical news is abuzz &#8211; and your newspapers will be abuzz &#8211; with coverage of a study released Friday. Understanding it properly requires several things that we\u2019ve blogged about here in the past, not least of which is understanding statistics, especially these\u00a0key points:<\/p>\n<ul>\n<li style=\"font-weight: 400;\"><strong>Avoid<i> relative<\/i><\/strong><span style=\"font-weight: 400;\"><strong> risk reduction<\/strong> (headlines about percentages)<\/span><\/li>\n<li style=\"font-weight: 400;\"><strong>Look instead for <i>actual <\/i><\/strong><span style=\"font-weight: 400;\">(absolute) numbers of patients helped<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><strong>Figure out the NNT<\/strong> &#8211; the number needed to treat. It&#8217;s the number savvy people look for.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">I\u2019m not involved in cardiac issues, so I first heard about it on ABC\u2019s evening news, where, sure as you\u2019re born, all they talked about was relative risk: \u201clowers the risk of heart attack, stroke, etc by 15-20%.\u201d That\u2019s good news, of course, but you can\u2019t tell <\/span><i><span style=\"font-weight: 400;\">how <\/span><\/i><span style=\"font-weight: 400;\">good it is unless they dish up the <\/span><i><span style=\"font-weight: 400;\">absolute <\/span><\/i><span style=\"font-weight: 400;\">numbers. (For example, a study of 1000 patients on a new drug could show a 20% reduction in relative risk from 5 to 4 patients or from 50 to 40. Both are 20% reductions, but there\u2019s a tenfold difference in how many were helped!) <\/span><\/p>\n<p><span style=\"font-weight: 400;\">The graphic above is from the company\u2019s press release. Surprise: relative risk! What if that\u2019s all a news outlet reads? Will their coverage be what you need? (Plus, some news outlets also post the company\u2019s press release as is, <\/span><a href=\"http:\/\/www.abc6.com\/story\/34937742\/landmark-outcomes-study-shows-that-repatha-evolocumab-decreases-ldl-c-to-unprecedented-low-levels-and-reduces-risk-of-cardiovascular-events-with-no\"><span style=\"font-weight: 400;\">like this<\/span><\/a><span style=\"font-weight: 400;\">. Consumer beware!)<\/span><!--more--><\/p>\n<p><span style=\"font-weight: 400;\">One reason this is a big problem is that if the public doesn\u2019t understand this, doctors say they\u2019re beset with people asking for a drug based on something they saw poorly reported on TV. Another reason <\/span><i><span style=\"font-weight: 400;\">was <\/span><\/i><span style=\"font-weight: 400;\">covered in the news I saw: insurance companies have been hesitant to pay for this drug, which costs $14,000\/year<del>month<\/del>. Are they scrooges?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">How should patients and clinicians look at this drug? This post is edited by several members of our Society: Peter Elias MD (a retired physician and member-at-large of our board), Marilyn Mann, who moderates a community of <\/span><span style=\"font-weight: 400;\">familial hypercholesterolemia (FH)<\/span><span style=\"font-weight: 400;\"> patients and their family members, and Casey Quinlan, cancer survivor and board member of <a href=\"http:\/\/thennt.com\" target=\"_blank\">TheNNT.com<\/a>, a superb resource that analyzes literature on diseases and treatments, particularly turning relative risk into the real bottom-line number: how many patients need to take a drug, for one of them to benefit?<\/span><\/p>\n<h2>The specifics<\/h2>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The new drug is currently approved only for patients with FH, a genetic cholesterol disorder, and patients who already have heart disease, have had a stroke, or have peripheral artery disease. <\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">It\u2019s a BIG study &#8211; 27,000 patients. That\u2019s good: bigger studies are far less likely to give shaky results.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Major heart problems or strokes happened to 11.3% of patients WITHOUT the new drug, and 9.8% of patients WITH the new drug. In other words, 1.5% of patients avoided a problem event, but 9.8% still experienced a problem event despite taking the drug. <\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Since 1.5% of the population had this benefit, it means on average, 1 patient in 67 benefits from the drug. <strong>That\u2019s the NNT<\/strong> &#8211; the number of patients to treat, for one to get any benefit.<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Note, though, that the drug saved no lives: the same percent died whether or not they got the drug. So it prevented 1.5% of these major cardiac events, but didn\u2019t alter death rates &#8211; at least not during the time of this study.<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The drug costs $14,000\/year, and these patients were watched a median of 2.2 years, so the cost was about $30,800 per patient.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The 67:1 ratio means each prevented heart attack etc came at a cost of 67 x $30,800 = <strong>$2.06 million. <\/strong><\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">No new side effects were discovered. That\u2019s good &#8211; many new drugs bring new risks too. (But Marilyn points out what savvy patients know: this study was pretty short, so more news about side effects may come out later.)<\/span><\/li>\n<\/ul>\n<h2>What to make of it?<\/h2>\n<p><span style=\"font-weight: 400;\">Obviously, neither the press release headline nor the ABC Evening News coverage gives the information that a patient and clinician would need to make an informed choice. <\/span><\/p>\n<p>In the Facebook thread, Marilyn Mann\u2019s perspective contributed the most resources:<\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">NPR\u2019s Shots blog: <\/span><a href=\"http:\/\/www.npr.org\/sections\/health-shots\/2017\/03\/17\/520516314\/pricey-new-cholesterol-drugs-effect-on-heart-disease-is-more-modest-than-hoped\"><span style=\"font-weight: 400;\">Pricey New Cholesterol Drug&#8217;s Effect On Heart Disease Is More Modest Than Hoped<\/span><\/a><span style=\"font-weight: 400;\"> by noted cardiologist Harlan Krumholz &#8211; a great balanced perspective<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Krumholz also writes from a different angle on Forbes: <\/span><a href=\"https:\/\/www.forbes.com\/sites\/harlankrumholz\/2017\/03\/17\/with-trial-results-amgen-should-reconsider-its-pricing-for-repatha\/#7acc8077ccce\"><span style=\"font-weight: 400;\">With Trial Results, Should Amgen Reconsider Its Pricing For Repatha?<\/span><\/a>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">This one rounds down the numbers and comes at a similar estimate: \u201cabout $1.4 million for every event averted.\u201d<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">It also includes this great summary of the many aspects of the pricing problem: \u201cAmgen has done heroic work to bring this drug to market and test it appropriately in a rigorous scientific trial. Perhaps the pricing would account, for some period of time, for that effort to break new ground and provide bonus pricing for a couple of years. Such an approach may represent an innovation bonus based on the novelty of the approach and what was required to produce it. We do need to figure out how to continue to reward risk and innovation in producing breakthroughs. But in the end the question is\u2026how does what the drug cost square with what it provides?\u201d<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Health editor Matthew Herper, also on Forbes: <\/span><a href=\"https:\/\/www.forbes.com\/sites\/matthewherper\/2017\/03\/17\/amgen-drug-prevents-heart-attacks-not-deaths-disappointing-experts\/#197c6fa7117c\"><span style=\"font-weight: 400;\">Amgen Drug Prevents Heart Attacks, Not Deaths, Disappointing Experts<\/span><\/a><span style=\"font-weight: 400;\">, a deep look at the complexities of assessing the drug\u2019s trial, benefits and costs, including some human cases.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">CardioBrief: <\/span><a href=\"http:\/\/cardiobrief.org\/2017\/03\/17\/fourier-shows-new-cholesterol-drugs-work-but-are-they-worth-it\/\"><span style=\"font-weight: 400;\">FOURIER Shows New Cholesterol Drugs Work, But Are They Worth It?<\/span><\/a><span style=\"font-weight: 400;\"> Subhead: <\/span><i><span style=\"font-weight: 400;\">Doctors and patients now must wrestle with a modestly effective but expensive drug.<\/span><\/i><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">ICER, a nonprofit that evaluates evidence on the value of medical tests and treatments: <\/span><a href=\"https:\/\/icer-review.org\/announcements\/pcsk9-new-evidence-update\/\"><span style=\"font-weight: 400;\">Institute for Clinical and Economic Review to Produce \u201cNew Evidence Update\u201d<\/span><\/a><span style=\"font-weight: 400;\">, saying they\u2019ll update their recommendations by mid-May.<\/span><\/li>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.tctmd.com\/news\/fourier-evolocumab-reduces-risk-cvd-events-15-compared-placebo\"><span style=\"font-weight: 400;\">tctMD\u2019s piece<\/span><\/a><span style=\"font-weight: 400;\"> leads off with the absolute benefit (1.5%) and quotes the study\u2019s lead author on an important point Herper noted: did the study stop too soon, in its haste to get published? \u201cWe\u2019ve seen this for all the statin trials as well. It takes time for LDL lowering to translate into healthier arteries.\u201d In other words, 3 years from now will we discover \u201cWait &#8211; in the long run it\u2019s lots better than we thought back then\u201d? There\u2019s no way to know without waiting.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">A <\/span><a href=\"http:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2544639\"><span style=\"font-weight: 400;\">2016 article in JAMA<\/span><\/a><span style=\"font-weight: 400;\"> that concludes the price of such drugs would have to drop 70% to meet a common measure of value.<\/span><\/li>\n<\/ul>\n<h2>What can we learn? What\u2019s the impact?<\/h2>\n<p><span style=\"font-weight: 400;\">Did I hear someone saying patients should stay off the internet? This list of great resources was pulled together (on Facebook!), within a day after the study was published, by Marilyn, who has no medical degree: she\u2019s a highly motivated participant from the <\/span><i><span style=\"font-weight: 400;\">patient <\/span><\/i><span style=\"font-weight: 400;\">perspective. The rules for who can contribute to this work have changed forever. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Healthcare works better when clinicians and e-patients are both well informed, and that means digging past the headlines, which are designed to catch attention rather than inform. (Plus, these days headlines are often written NOT by an article\u2019s author, but by separate people who are trained to write for clicks, not for accuracy &#8211; <\/span><a href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2013\/05\/when-bad-heads-go-viral-how-a-malformed-headline-is-skewing-medicines-view-of-the-patients-role-in-decisions.html\"><span style=\"font-weight: 400;\">example<\/span><\/a><span style=\"font-weight: 400;\">.)\u00a0<em>(Addition: my college friend Stephen Owades notes that this is no different from tabloid headline writers, whose job was to write in a way that grabbed the eye of newsstand customers.)<\/em><\/span><\/p>\n<p><span style=\"font-weight: 400;\">Peter adds a superb observation: Both patients and their clinicians should not be distracted by arguments in the media about whether or not a new treatment is worth it, because care must go on. \u201cWorth it\u201d is the wrong question and a distraction from the real issue: patients still have problems and need to decide what to do. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Medicine is full of challenges like this, he says &#8211; some more expensive and some less, some with big and some with small consequences. \u00a0We need to stop thinking in terms of a global \u2018this is good\u2019 or \u2018this is bad\u2019 evaluation and think in terms of \u2018how can we support patients who are making decisions in conditions of uncertainty?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Marilyn responded with a related note: this study included very high risk patients, and if your risk isn\u2019t as bad, then the benefits of the drug would not be comparable. You\u2019d be much less likely to benefit, so the NNT for patients like you would be much larger. <\/span><\/p>\n<h2>e-Patient takeaway: the details are tricky but the basics are manageable.<\/h2>\n<p><span style=\"font-weight: 400;\">It takes knowledge and savvy to do this, but notice: even without Marilyn\u2019s list of great articles, the bottom line issues (mostly that $2 million number) were figured out from knowing these e-patient basics:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><b>Ignore <\/b><b>percentages (relative risk reduction, \u201cRRR\u201d)<\/b><span style=\"font-weight: 400;\"> when making decisions. <\/span><b>Look for the <\/b><b>absolute <\/b><b>numbers<\/b><span style=\"font-weight: 400;\">. (Problems were experienced by x% with the drug, and y% without.) <\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">In this study it was 9.8% vs 11.3%, so 1.5% of patients got a benefit during the length of this study.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\"><b>From that, figure the NNT.<\/b><span style=\"font-weight: 400;\"> That\u2019s 100 divided by the absolute number: in this case,100 \/ 1.5 = 67 people. \u00a0So a user of the drug has a 1 in 67 chance that it will help (<\/span><span style=\"font-weight: 400;\">if <\/span><span style=\"font-weight: 400;\">they\u2019re like the people in the study, as Marilyn says).<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Notice: from the headlines saying\u00a015% reduction, you don\u2019t have a clue what the NNT is.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\"><b>Look at the study\u2019s endpoints<\/b><span style=\"font-weight: 400;\"> (what they were monitoring) to answer an important question: \u201cSpecifically <\/span><i><span style=\"font-weight: 400;\">how <\/span><\/i><span style=\"font-weight: 400;\">might this help?\u201d Marilyn and Peter both point out that while it\u2019s important to reduce heart attacks etc, the overall chance of dying was not helped.<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\">Teach others to watch out for this too. Do not respect any coverage that only talks percent.<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">One last tip: these journalistic hazards and many more are taught on the great <\/span><a href=\"http:\/\/healthnewsreview.org\"><span style=\"font-weight: 400;\">Health News Review<\/span><\/a><span style=\"font-weight: 400;\"> site, which we\u2019ve <\/span><a href=\"http:\/\/www.e-patients.net\/?s=%22health+news+review%22\"><span style=\"font-weight: 400;\">blogged about here<\/span><\/a><span style=\"font-weight: 400;\"> for years. It\u2019s an essential e-patient resource.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Please cite this post as &#8220;by Dave deBronkart, Marilyn Mann and Peter Elias MD&#8221; or, on Twitter, &#8220;@ePatientDave, @MarilynMann &amp; @PHEski.&#8221; Our blog software only allows listing one author but [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[3586,4236,226],"tags":[164,7979,219,7403,158,7999,7998,7707],"coauthors":[],"class_list":["post-19370","post","type-post","status-publish","format-standard","hentry","category-research-issues","category-shared-decision-making","category-understanding-statistics","tag-cost","tag-coverage","tag-innovation","tag-marilyn-mann","tag-medical","tag-nnt","tag-subhead-doctors","tag-understanding-statistics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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