October 13th, 2011

National Lipid Association Expert Panel Has Many Deep Ties To Industry

[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 “expert panel” assembled by the National Lipid Association (NLA) is 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  has extensive ties to industry, and the “consensus conference” 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.

The NLA panel recommends a greatly expanded role for 5 out of 6 new biomarkers– CRP, 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 the ACCF/AHA guidelines for cardiovascular risk assessment and in the USPSTF guidelines. The ACCF/AHA guidelines, for example, allow a very modest role for CRP; the other biomarkers are simply not recommended:

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.

Panel members, along with the NLA itself, have a dizzying number of industry relationships. The chair of the panel, Michael Davidson, “has received research grants from Abbott Laboratories, Daiichi Sankyo, GlaxoSmithKline, Merck & Co. and Roche… 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…. has received honoraria related to speaking from Abbott Laboratories, GlaxoSmithKline and Merck & Co…. [and] has served on the Board of Directors of DTC MD, Omthera, Professional Evaluation Inc., and Sonogene.”

Chrystie Ballantyne, a co-chair of the panel, has a disclosure list even longer than Davidson’s. Another member of the panel, W. Virgil Brown, is the editor of the Journal of Clinical Lipidology, the NLA journal in which the expert panel appears. He “has received consulting fees from Abbott Laboratories, Amgen, Anthera, Genzyme, Pfizer Inc., LipoScience, and Merck & Co…. [and]  has received honoraria related to speaking from Abbott Laboratories, LipoScience, and Merck & Co.”

One of the 17 panel members, James McKenney, had no disclosures in the paper, but this may not tell the entire story. A Pharm.D,  McKenney is a former president of the NLA, and a faculty disclosure statement online indicates that McKenney has had extensive ties with industry in the past.

An NLA webpage about the document includes the statement that “contributors 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…”

The authors acknowledge financial support to produce the document in the form of “unrestricted grant funding” from 9 companies, all of whom stand to benefit from the changes endorsed by the panel: Abbott 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:

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.

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 a press release announcing the publication, and trumpeting the new indications for its product:

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.

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.

Here’s another question worth asking: how much of the paper did the expert panel actually write? The end of the paper acknowledges “Biofortis-Provident Clinical Research for writing and editorial assistance.” This company has extensive connections with the NLA and the lipid community (some of its current employees were also involved with an Abbott marketing study that was published in the American Journal of Cardiology).  In fact, two “non-panel scientists” who are listed as co-authors of the expert panel paper are Kevin 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 “salary support from Biofortis.” In fact, they are employees of the company, and a cursory look at Maki’s resume reveals that he is the President and Chief Science Officer of Provident Clinical Research.

A recent study in BMJ examined 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’s Jennifer Neuman, lead author of the study, the NLA paper is an egregious example of these problems:

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.

See articles about the NLA from earlier this year on CardioBrief.org.

10 Responses to “National Lipid Association Expert Panel Has Many Deep Ties To Industry”

  1. William Priester, BA, MD says:

    I wish I could say I am suprised. It is astonishing how industry has infiltrated the practice of medicine. I wonder if this same group is behind the recent hit job on simvastatin.

  2. Ruth Strauss, MD says:

    BRAVO LARRY HUSTEN !!!!! this is the kind of reporting and self-policing we should ALL be paying attention to–I am so glad that someone (Dr. Husten) as used their time so ethically to call this to our attention; additionally, as pointed out by Dr. Husten, the American College of Cardiology Guidelines always go with best medical practice and evidence-based medicine, without, thank goodness, it seems, these types of conflicts of interest. Again, THANK YOU, Dr. Husten!

  3. How can you put together a panel of international experts who also have no conflicts of interest? I submit that this is impossible.

    Davidson and Ballantyne are big league experts in lipidology. As a consequence of their expertise, they are courted by industry. To imply that their council is compromised by their industry ties is silly. They have relationships with so many different companies that their conflicts almost neutralize each other.

    So lets get a panel of “experts” who have never done clinical research, never worked in a consultant role, and have never lectured on lipid topics. Don’t forget to exclude anyone in academia as the institutions in which they work get industry money which is ultimately used to pay their salaries.

    The result would be a poorly informed panel who lack knowledge and experience in the subject for which they are writing guidelines. They could come up with ill informed positions and bad suggestions which can result in un-diagnosed disease and avoidable death and disability. We could call them the USPSTF.

    Competing interests pertaining specifically to this post, comment, or both:
    Although I have had no industry ties for over two years, in years past I have received honoraria from GSK, Abbott, and Pfizer.

  4. VAZHA AGLADZE, MD., PhD says:

    Honest trials with honest scientists – that’s the question!!!!

    Competing interests pertaining specifically to this post, comment, or both:

  5. David Powell , MD, FACC says:

    A bettter way to do guidelines: assemble a group with no links to the lipid industry. This would include medical statisticians, clinicians, and clinical trialists (but in other areas). They review all the literature and discuss. They can call on any “experts” to provide further insight, but they will know the “experts'” COIs and challenge them.

    Interesting about not recommending GGE…particle size… I agree that number trumphs size and HDL is a quagmire of fiindings. But wouldn’t Berkely Labs be a loser here?

    Competing interests pertaining specifically to this post, comment, or both:
    I have talker for Pfizer remotely.

  6. Dan Hackam, MD PhD says:

    Guidelines are years behind new evidence in most cases. Look at JNC VII and ATP III. Both are completely out of date. Both imminently releasing updates. Both updates will be outdated the moment they are released, given how fast new data appears (AHA, ESC, ACC, ISC, ADA etc).

  7. Anil Virmani, MD, DRM says:

    Bravo ! And we talk about “Evidence-based” medicine, and following guidelines.We must always remember that guidelines are like lampposts, to be used only for illumination and not as crutches for support. No amount of guidelines can replace sound clinical judgement based on clinical experience !

    Competing interests pertaining specifically to this post, comment, or both:

  8. You can’t assemble a panel of experts in this day and age who don’t have ties to industry. The best and the brightest attract the funding from Industry for their talks and their research and their opinion. They are also the ones I wish to hear from.

    I have disappointingly few ties.

  9. Saying that there are no experts without industry ties is crude, have a look at various the ACCF/AHA guidelines first, and you will notice several eminent investigators without prominent industry ties.

    On the remarks that ties to several companies offset each other, it really depends on the type of study. For a head to head comparative effectiveness stuy; maybe. However, in this case a whole bunch of tests and drugs are at one side and no-intervention is at the other side. So, I believe the conflicts stand in their place firmly!

    Dr Powell’s recommendation is nice,as is the idea implemented at Yale to cut the direct tie between the industry and investigators (they are doing it for BMP-2). It is okay that industry pays for a meeting but there should be no direct contact with reviewers or authors… .

    Competing interests pertaining specifically to this post, comment, or both:

  10. Mark Perlroth Mark, md says:

    Excellent summary of the pitfalls of industry-related experts offering industry-favorable advice.

    The alternative of uninvolved trialists/statisticians assessing the data and including estimates of the number needed to treat to avoid a single death would be more helpful and acceptable.

    Competing interests pertaining specifically to this post, comment, or both: