Part 1: The National Lipid Association and the FH Guidelines

Editor’s Note: This is the first of a three-part series on the National Lipid Association. This first part focuses on the NLA’s publication of a series of papers offering expert guidance on familial hypercholesterolemia (FH) and raises serious questions about the role of industry in the documents. The second part explores additional questions about the NLA’s relationships with industry and the management of the organization. In the third part the NLA answers questions sent to them about some of the issues raised in this series.

In conjunction with its annual meeting in New York City, the National Lipid Association (NLA) is publishing in its own Journal of Clinical Lipidology a series of clinical guidance papers authored by “expert panels” on the subject of familial hypercholesterolemia (FH). With the help of a public relations campaign, the NLA hopes to focus more attention than usual on this group of genetic lipid disorders.

Lipid experts– NLA supporters and critics alike– agree that FH is a serious disorder that can cause premature coronary artery disease and death in nearly everyone with the disease who is left untreated and that efforts should be increased to identify and treat more people with FH. But critics say that the NLA recommendations are misguided in at least one key point and, more significantly, the guidelines, and the NLA itself, are deeply tarnished by the NLA’s extensive connections with industry.

The most newsworthy recommendations from the NLA involve increased screening for FH. Specifically, the expert panel recommends universal screening for all children between the ages of 9 and 11 and, for children with a family history of elevated lipids and coronary disease, screening beginning at age 2.

Outside experts told CardioBrief that the recommendations are another example of “disease mongering.” But in an interview the chair of the NLA expert panel, Dr. Anne Goldberg, was passionate about the need for better screening and treatment of FH. She said that “no one else is doing it, there’s kind of a vacuum there, and we have a group of people well versed in lipids. We thought we were the right organization to come out with recommendations.”

But the NLA is not the only organization working on FH guidelines. The NHLBI’s Pediatric Cardiovascular Risk Reduction Initiative is scheduled to be released in the fall. One of the co-authors, Patrick McBride of the University of Wisconsin, told CardioBrief that he is not opposed to the NLA recommendation for universal screening of children between 9 and 11 but that he strongly opposes screening children with a family history beginning at the age of 2. McBride supports universal screening in the older group because its alternative, targeted screening, “will miss about about half of the kids with FH.” But he opposes testing children at age 2 with a family history because, he says, if you test them, “what are you going to do differently? Presumably a parent already has it so the family should be eating to reflect that, and medications are not recommended” for children that age.  (Because the NHLBI document has not been published yet McBride’s comments represent his personal views.)

Critics have expressed concern about the role of industry in the NLA FH guidelines. They note that the published papers include a disclosure of industry support:

The January 2011 NLA familial hypercholesterolemia
recommendations conference was supported by unrestricted
grant funding from the following companies: Abbott Laboratories,
Aegerion Pharmaceuticals, Daiichi Sankyo,
Genzyme, Kaneka Pharma America LLC, and Merck & Co.
The National Lipid Association 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 recommendations conference
and this familial hypercholesterolemia recommendations
paper. All related activities are free from commercial
influence and bias.

Each of these companies would benefit from increased screening and treatment of FH and some, such as Keneka, Aegerion, and Genzyme have a huge portion of their future invested in FH. In addition, it appears that the promise of high ethical standards in this statement has been seriously compromised. More than a month ago, on April 15, the chief scientific officer of Aegerion Pharmaceuticals, one of the sponsors of the conference listed above, sent an email to physicians with PDFs of all the papers. Here is the letter she sent:

Dear Dr. XXX:

As part of Aegerion’s initiative to support educational efforts and improve awareness of the diagnosis and treatment of familial hypercholesterolemia (FH), we wish to highlight 7 publications in the April 2011 Journal of Clinical Lipidology (attached) that summarize the consensus opinion of the National Lipid Association’s Expert Panel on Familial Hypercholesterolemia based on their experience as lipid specialists and evaluation of the scientific evidence.

These publications illustrate the need for wide-spread screening and early diagnosis and treatment of FH, describe the complexity of diagnosing FH due to the presence of multiple causative genetic defects, and summarize clinical criteria that will improve diagnosis and treatment of these patients.  Special attention is given to the use of age-specific LDL-C thresholds to diagnose patients with FH, with de-emphasis of genetic testing, a perspective that we at Aegerion share. [emphasis added]

We look forward to the public dialogue and improvements in the identification and treatment of patients with FH that will result from these publications.


Diane L. Tribble, Ph.D., M.M.Sc., Chief Scientific Officer, Aegerion Pharmaceuticals

Aegerion is a pharmaceutial company with a drug in late phase development that is intended for the treatment of FH. Goldberg, the chair of the expert panel, said she did not know how the documents were acquired by Aegerion “while we were still working on the PDFs.” She continued: “the fact that someone just jumped the gun doesn’t change the fact this is an important piece of work. People are dying because they’re not being treated…” [Editor’s note: in part 3 of this series the NLA clarifies that the papers were inadvertently published online early in April. In an email to CardioBrief, the president of Aegerion, Will Lewis, wrote that the documents had been available for purchase on the journal website “prior to the date of the email.”]

In addition to Aegerion’s letter, ISIS pharmaceuticals, which is developing the FH drug mipomersen in conjunction with Genzyme, is promoting the NLA documents on its website. Clearly industry is not just aware of the documents but is taking efforts to promote them.

In fact, the fingerprints of industry involvement with the NLA FH documents are all over the place. The executive summary of the papers includes disclosures from all of the authors, and all the authors list industry ties, and all but two of the authors disclose multiple relationships with industry  (see below). Nearly all had ties with the companies that sponsored the conference. In an interview, Goldberg, told me that “we believe in transparency” but that, unlike organizations like the ACC and the AHA, “we have not taken people off of committees because of any ties with industry.” (The ACC and the AHA now require that the chair of guideline committees and at least half of the committee have no relevant ties to industry. In addition, committee members are not allowed to participate in decisions about areas in which they have a conflict.)

The NLA document stands in sharp contrast with the upcoming NHLBI guidelines, which of course is not supported by corporate funding. A glance at the disclosures on the NHLBI website shows that the authors had much less interaction with industry: of the 14 authors 8 had no relevant financial interests and in general the ties to industry appear modest. By contrast, the relationships of the NLA authors (see below) with industry are deep and pervasive. It is hard to see how the NLA can claim it is “free from commercial influence and bias” when every single member of the expert panel had ties to industry.

Click here to read part 2 of this story.

Click to enlarge the image below:


  1. “will miss about about half of the kids with FH.”

    Thank G*D for small mercies. I can’t imagine the horror of children on statins.


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