Editor’s Note: This is the final installment of a three-part series on the National Lipid Association. The first part focused on the NLA’s publication of a series of papers offering expert guidance on familial hypercholesterolemia, and raised questions about the role of industry in the documents. The second part explored additional questions about the NLA’s relationships with industry and other issues concerning the organization’s management. In this installment, the NLA answers questions sent to them about some of the issues raised in this series. The following material is reprinted without editing from the NLA response.
1. Did the NLA seek to work with the AHA, the ACC, or other organizations in the development of the FH recommendations?
The National Lipid Association (NLA) Expert Panel on Familial Hypercholesterolemia (FH) has released recommendations for the screening, diagnosis and treatment of FH in children and adults. The recommendations will be published in the May 2011 issue of the Journal of Clinical Lipidology.
It was important that the publication of the FH recommendations coincide with the NLA Scientific Sessions held in New York City from May 19 – 22, 2011. The NLA shared the recommendations with AHA and ACC for their review and endorsement. Both organizations were supportive of the NLA on its efforts, but require a specific level of review time, which NLA could not accommodate to achieve a May 2011 publication date.
2. How much money did the NLA receive from the sponsors of the January 2011 conference, and what role did those supporters play in the conference and the development of the guidelines? Was the January 2011 conference a public meeting? What was the agenda of this conference?
The January 2011 conference was organized to help finalize the recommendations for FH. The conference had two sessions. In the first session, expert panelists presented scientific data in their area of expertise. This session was open to the public and anyone could attend, including supporters.
The second session was closed format and only NLA panelists could participate. During this session, panelists deliberated and worked to finalize the recommendations. The process from this deliberation onward, including the review of drafts and the finalization and publication of the recommendations, was closed to panel members only.
It’s important to note that all activities were conducted in accordance with the National Lipid Association Code for Interactions with Companies (http://www.lipid.org/pages/Code_for_Interactions_%28NLA%29.pdf). The NLA maintained full control over the planning, content, quality, scientific integrity, implementation, and evaluation of the FH conference and resulting recommendations, as well as the FH public education campaign. All related activities are free from commercial influence and bias.
Also, the NLA and the contributors to this paper have provided full disclosures and avow that their thoughts on this matter have not been influenced by bias or commercial interest. All disclosures were circulated in advance by all panelists taking part in the conference.
The conference was funded by multiple sources, including the NLA, the Foundation of the NLA, and unrestricted grants from pharmaceutical companies, including Abbott Laboratories, Aegerion Pharmaceuticals, Daiichi Sankyo, Genzyme, Kaneka Pharm America LLC, and Merck & Co. We requested funding from all industry supporters and received a total of $112,500 in grant support. The unrestricted educational grants helped pay for the January conference and the journal supplement, which contains the recommendations for the screening, diagnosis, and treatment of FH.
Copies of NLA tax forms and financial statements can be found in the disclosures section of the NLA website, http://www.lipid.org/pages/disclosures.php.
3. How did Aegerion gain access to the early PDFs of the guidelines? What response did the NLA have to the circulation of these PDFs by the company?
NLA did not share the embargoed recommendations with Aegerion. However, Elsevier, the publisher of the Journal of Clinical Lipidology, posted the recommendations on their website, in error. As soon as NLA was made aware of this mistake, it asked Elsevier to remove the recommendations immediately. Unfortunately, several related publication websites in Elsevier’s distribution network had already added the recommendations to their own catalog and although we tried, we were unable to get them removed entirely. This is a matter of concern for the NLA and has been addressed extensively over the past month with the publisher.
We were further disappointed to learn that Aegerion pre-empted our embargo. It is clear Aegerion was not notified of the embargo by Elsevier. We were not contacted, nor did we know about Aegerion’s press release until Friday, May 13. We immediately reached out to Aegerion to understand how they obtained the recommendations. Algerion explained they secured the recommendations at the Elsevier site.
4. Can the NLA amplify its conflict of interest policy? Why is the policy for guideline writers significantly less restrictive than the policy adopted by the ACC and the AHA?
Our conflict of interest policy is clearly stated in our Code for Interactions with Companies, found here: (http://www.lipid.org/pages/Code_for_Interactions_%28NLA%29.pdf)
Please remember the recommendations for the screening, diagnosis, and treatment of FH are not guidelines. Further, we are not aware of all policies adopted by ACC or AHA and are not clear how they compare to NLA policies. We are confident and proud of our adherence to policies that ensure the Association remains free from commercial influence and bias.
5. There appears to be a very close linkage between the NLA’s certification programs and the NLA’s commercially supported CME programs, so that anyone seeking certification is almost forced to utilize these programs. Is this appropriate?
The NLA is an organization formed to support clinical lipidology and we are proud and well suited to offer physicians the opportunity to strengthen their medical training in the management of lipid disorders through a variety of CME courses. Certification is not restricted to NLA members and candidates can be credentialed independent of the NLA, including through many other organizations offering CME in dyslipidemia. There is no requirement of membership to be certified and the certifying boards make no qualification of membership in any organization, including NLA.
An early goal of the NLA was to establish lipidology as a subspecialty of internal medicine equal to other disciplines such as cardiology, endocrinology, etc. This is a long-term goal, which requires the establishment of a regimented exam and certification program. The NLA Board and the Examination Board meet independently and have independent bylaws, budgets and procedures. The Examination Board measures competence, while the NLA Board focuses on training lipidologists.
6. What percentage of NLA revenue is derived from industry support?
The disclosure section of our website provides all necessary information about our revenue. It can be found here: http://www.lipid.org/pages/disclosures.php. You’ll find board disclosure, tax returns, copies of audits and policies. We have always worked hard to be completely transparent. We have never hidden that we have been funded by industry.
It is important to note that many not–for-profits rely on contributions from individuals and companies to continue doing their very important work. However, making those contributions does not give those organizations unfair access or influence.
A strategic goal in 2008 and reaffirmed in 2010 demonstrates our commitment to greater self reliance. The strategic plan can be found at http://www.lipid.org/pages/strategic_plan_recom.pdf
7. What is the role of Compass management and other entities involving Christopher Seymour? How much money do these companies receive from NLA, and what is this money for?
Compass Management is an Association Management Company (AMC). Compass is contracted to perform services for the NLA, and its Foundation. There are a variety of management models for associations and professional societies and for many organizations, large and small, association management companies can provide the most efficient model. Information on management services and general expenses can be found in the disclosures area of the website and are specifically contained in the 2010 auditor’s report, which is posted.
1. Specifically, the papers mention a January 2011 conference. Can you clarify for me the purpose of that conference? It seems unlikely that the papers could have been written in such a short time after the conference.
The majority of the FH recommendations were drafted and edited in advance of the January 2011 conference. The conference was designed to assemble expert lipidologists to present the drafts, create dialogue and debate, and finalize the recommendations for publication. The recommendations were finalized after the January meeting, reviewed by the Journal and submitted in April for publication in time for the May NLA Scientific Sessions of the NLA.
2. I’m writing to seek clarification regarding the Aegerion email message. I asked Aegerion to explain where they obtained the PDFs. As you can see from the company’s response below, they say the documents were available on the Journal website. However, in my interview with Dr. Goldberg last Friday, she stated that on April 15, the date of the Aegerion email, the documents had not yet been finalized. Any help you can provide in resolving this discrepancy would be greatly appreciated.
The summary recommendations were complete on April 1, 2001, but we did not declare them final until we had responses from those we asked to endorse the paper, which we received about April 15, 2011. Elsevier, the publisher of the Journal of Clinical Lipidology, made the recommendations public on their website, in error, sometime in or around April 15. As soon as the NLA was made aware of this mistake, they requested that Elsevier remove the recommendations immediately. Unfortunately, some of the associated journal distributors had also added the recommendations to their website. We attempted to have it removed by Elsevier and were told it was removed, only to find it wasn’t. Apologies abound from Elsevier, but the articles have unfortunately been in print on various websites beyond the main Elsevier site, despite our embargo and at the publisher’s mistake.
3. How were the recommendations assembled?
It was a tremendous effort that has been in the works for several years. The group prepared drafts and had discussions regarding the content well before the January 2011 conference. At the January 2011 conference, we gathered to present and review drafts of the recommendations. We discussed, modified and referenced each piece at the conference and circulated drafts over the next several weeks.
4. Why did the NLA focus on FH?
The NLA is a non-profit membership association dedicated to healthcare providers who manage patients with lipid disorders and cardiovascular disease. The FH Recommendations are germane to the mission and to help reduce deaths related to high cholesterol. The NLA identified FH as a condition that is rarely discussed, yet is more common than well-known conditions, such multiple sclerosis, Down Syndrome, and type 1 diabetes. Far greater attention from the medical community and improved awareness among the general public was warranted. You will find volumes about cholesterol management in the medical literature, but little about FH in the U.S. The issue of FH has not been discussed by any major related organization, and certainly not in great depth.
FH is an inherited disease that causes high cholesterol, typically starting in childhood. FH affects more than 600,000 Americans. Unlike other genetic disease, it is treatable. It’s critical that diagnosis and treatment are improved because the cardiovascular consequences of untreated cholesterol can be devastating and lead to early heart attack and death. Currently, only about 20 percent of patients with FH are diagnosed and, of those, less than half receive appropriate treatment.
NLA is proud of its commitment to patient advocacy and will continue to identify and bring awareness to various lipid disorders.
5. Why did the NLA issue guidelines about FH?
To be clear, they are not guidelines, but are recommendations. The NLA issued recommendations about the screening, diagnosis and treatment of FH in children and adults and encourages the NHLBI to consider these recommendations as they develop and issue the guidelines for the Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel IV or ATP IV), which are expected to be available for public review and comment in the fall of 2011 or spring of 2012.