{"id":12569,"date":"2011-10-13T13:49:32","date_gmt":"2011-10-13T17:49:32","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=12569"},"modified":"2011-10-17T15:57:02","modified_gmt":"2011-10-17T19:57:02","slug":"national-lipid-association-expert-panel-has-many-deep-ties-to-industry","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/10\/13\/national-lipid-association-expert-panel-has-many-deep-ties-to-industry\/","title":{"rendered":"National Lipid Association Expert Panel Has Many Deep Ties To Industry"},"content":{"rendered":"

[Editor’s note: see here for a reply post <\/a>to this news story by Chrstopher Seymour, MBA, Executive Director of the National Lipid Association].<\/p>\n

An \u201cexpert panel\u201d assembled by the National Lipid Association (NLA)<\/a>\u00a0is recommending a dramatic expansion in the use of new biomarkers for the diagnosis and management of cardiovascular disease. The recommendations, if widely adopted, would significantly increase not just the use of these diagnostic tests but also lead to much greater use of lipid-lowering drugs. But every member of the panel \u00a0has extensive ties to industry, and the \u201cconsensus conference\u201d that led to publication of the guidelines was funded by an array of diagnostic and drug companies that stand to gain from the new recommendations.<\/p>\n

The NLA panel recommends a greatly expanded role for 5 out of 6 new biomarkers\u2013\u00a0CRP, Lp-PLA2, Apo B, LDL particle number, and Lp(a). (HDL or LDL subfractions did not receive an expanded recommendation.) However, these same biomarkers received a much more critical review in\u00a0the ACCF\/AHA guidelines for cardiovascular risk assessment<\/a>\u00a0and in the USPSTF<\/a>\u00a0guidelines. The ACCF\/AHA guidelines, for example, allow a very modest role for CRP; the other biomarkers are simply\u00a0not recommended:<\/p>\n

Measurement of lipid parameters, including lipoproteins, apolipoproteins, particle size, and density, beyond a standard fasting lipid profile is not recommended for cardiovascular risk assessment in asymptomatic adults.<\/p><\/blockquote>\n

Panel members, along with the NLA itself, have a dizzying number of industry relationships. The chair of the panel,\u00a0Michael Davidson<\/strong>, \u201chas received research grants from Abbott Laboratories, Daiichi Sankyo, GlaxoSmithKline, Merck & Co. and Roche\u2026 has received consulting fees from Abbott Laboratories, Aegerion Pharmaceuticals, Amgen, AstraZeneca, Atherotech Inc., Daiichi Sankyo, DTC MD, Esperion, GlaxoSmithKline, Intelligent Medical Decisions, Kinemed, LipoScience, Merck & Co, Novo Nordisk, Roche, Sanofi-Aventis, Synarc, Takeda Pharmaceuticals, and Vindico Medical Education\u2026. has received honoraria related to speaking from Abbott Laboratories, GlaxoSmithKline and Merck & Co\u2026. [and] has served on the Board of Directors of DTC MD, Omthera, Professional Evaluation Inc., and Sonogene.\u201d<\/p>\n

Chrystie Ballantyne<\/strong>, a co-chair of the panel, has a disclosure list even longer than Davidson\u2019s. Another member of the panel,\u00a0W. Virgil Brown<\/strong>, is the editor of the\u00a0Journal of Clinical Lipidology<\/a><\/em>,\u00a0the NLA journal in which the expert panel appears. He \u201chas received consulting fees from Abbott Laboratories, Amgen, Anthera, Genzyme, Pfizer Inc., LipoScience, and Merck & Co\u2026. [and] \u00a0has received honoraria related to speaking from Abbott Laboratories, LipoScience, and Merck & Co.\u201d<\/p>\n

One of the 17 panel members, James McKenney<\/strong>, had no disclosures in the paper, but this may not tell the entire story. A Pharm.D, \u00a0McKenney is a former president of the NLA, and\u00a0a faculty disclosure statement<\/a>\u00a0online indicates that McKenney has had extensive ties with industry in the past.<\/p>\n

An\u00a0NLA webpage about the document<\/a>\u00a0includes the statement that \u201ccontributors to this paper have provided full disclosures and their thoughts on this matter were discussed in advance and the contributors have affirmed that their participation has not been influenced by bias or commercial interest…\u201d<\/p>\n

The authors acknowledge financial support to produce the document in the form of \u201cunrestricted grant funding\u201d from 9 companies, all of whom stand to benefit from the changes endorsed by the panel:\u00a0Abbott Laboratories, Atherotech Diagnostics Laboratory, Berkley Heart Lab, Inc., Boston Heart Diagnostics, diaDexus, Inc., LipoScience, Merck & Co., Inc., and Spectracell Laboratories. After thanking the companies for their support the authors then assert that the document is free from commercial influence:<\/p>\n

The NLA would like to thank each company for its support of this endeavor. In accordance with the National Lipid Association Code for Interactions with Companies, the NLA maintained full control over the planning, content, quality, scientific integrity, implementation, and evaluation of the consensus conference and this inflammatory markers and advanced lipoprotein testing consensus document. All related activities are free from commercial influence and bias.<\/p><\/blockquote>\n

At least one company has already gone ahead and started to use the document to promote its product. Even before the paper had a chance to receive wide distribution, LipoScience, which markets a test that measures LDL particle number (LDL-P), issued\u00a0a press release\u00a0announcing the publication<\/a>, and trumpeting the new indications for its product:<\/p>\n

The consensus panel recommends that the use of LDL particle number for initial clinical risk assessment of CVD is reasonable for many patients at intermediate risk, including patients with a family history of coronary heart disease (CHD) and recurrent cardiac events. In addition, LDL particle number should be considered in the risk assessment of selected patients with known CHD or CHD risk equivalent.<\/p>\n

The panel also recommends that LDL particle number for on-treatment management of CVD risk is reasonable for many patients at intermediate risk, including patients with coronary heart disease, a CHD risk equivalent and in patients with recurrent cardiac events. LDL particle number should be considered in the management of selected patients with a family history of CHD.<\/p><\/blockquote>\n

Here\u2019s another question worth asking:\u00a0how much of the paper did the expert panel actually write?<\/strong><\/em>\u00a0The end of the paper acknowledges \u201cBiofortis-Provident Clinical Research for writing and editorial assistance.\u201d This company has extensive connections with the NLA and the lipid community (some of its current employees were also involved with an\u00a0Abbott marketing study that was published in the\u00a0American Journal of\u00a0Cardiology<\/em><\/a>). \u00a0In fact, two \u201cnon-panel scientists\u201d who are listed as co-authors of the expert panel paper are\u00a0Kevin C. Maki, PhD and Mary R. Dicklin, PhD. In addition to their numerous other relationships with industry, the disclosures section of the paper states that they receive \u201csalary support from Biofortis.\u201d In fact, they are employees of the company, and a cursory look at Maki\u2019s resume reveals that he\u00a0is the President and Chief Science Officer of Provident Clinical Research.<\/p>\n

A recent study in\u00a0BMJ<\/em><\/a>\u00a0examined the role of conflict of interest in published guidelines for diabetes and cardiovascular disease over the past decade and found numerous problems with the way most organizations manage conflicts of interest on these panels. But, says Mt. Sinai\u2019s\u00a0Jennifer Neuman, lead author of the study, the NLA paper is an egregious example of these problems:<\/p>\n

The Institute of Medicine has made a number of recommendations on how to manage conflicts of interests on guideline panels in order to limit potential bias, and the NLA appears to have disregarded most of these recommendations. This flies in the face of national and international efforts to improve the credibility of the guideline development process.<\/p><\/blockquote>\n

See articles about the NLA from earlier this year on CardioBrief.org<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

[Editor’s note: see here for a reply post to this news story by Chrstopher Seymour, MBA, Executive Director of the National Lipid Association]. An \u201cexpert panel\u201d assembled by the National Lipid Association (NLA)\u00a0is recommending a dramatic expansion in the use of new biomarkers for the diagnosis and management of cardiovascular disease. The recommendations, if widely […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[1015],"class_list":["post-12569","post","type-post","status-publish","format-standard","hentry","tag-nla"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/12569","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=12569"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/12569\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=12569"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=12569"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=12569"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}