Residual Risk Reduction Initiative: promotion or education? Reply

Cardiologists and other physicians have reported receiving an email lately from an organization called the Residual Risk Reduction Initiative. Here’s how the organization describes itself:

The Residual Risk Reduction initiative (R3i) is a worldwide, academic, multidisciplinary, non-profit, Swiss-law Foundation established by international researchers and clinicians who recognize the importance of the high risk of fatal and non-fatal macro- and micro-vascular complications occurring in patients with atherogenic dyslipidemia who are already receiving the current standards of care.

It sounds like a worthy program. Who could be against efforts to further reduce cardiovascular risk? Unfortunately, R3i, in reality, is something more (or less) than an altruistic organization: it’s a keystone in the promotional efforts of Abbott to sell more of its fenofibrate drugs (TriCor and TriLipix) and to “spin” the negative ACCORD trial into a positive message for fenofibrate. ACCORD, you will recall, was a negative trial that failed to demonstrate the benefits of fibrates in type 2 diabetics already taking statins, although there was a possible benefit in the subgroup of patients who had both high baseline triglycerides and low HDL cholesterol (interaction p=0.057).

By way of background, as far as I’ve been able to piece together, R3i first surfaced in a supplement in the American Journal of Cardiology in November 2008: The Residual Risk Reduction Initiative: A Call to Action to Reduce Residual Vascular Risk in Patients with Dyslipidemia. The supplement was sponsored by Solvay Pharmaceuticals (which has since been acquired by Abbott). The R3i website explains Solvay’s involvement this way:

As a pioneer sponsor, initial seed funding was provided by Solvay Pharmaceuticals which has enabled the R3i Foundation to launch a series of research and education projects in 2008. The policy and programs of the R3i are developed and overseen by the Board of 3 Trustees and an independent International Steering Committee comprised of 26 recognized researchers in vascular diseases from across Europe, North America and Asia.

However, I can find no explanation or discussion about current funding for the site. A number of questions remain hanging: What is the current source of funding for R3i? What role does Abbott play now? How was the board of trustees and the “independent” steering committee chosen? What role did Abbott, or any company hired by Abbott, play in the organization, planning, and management of R3i? What is a “Swiss-law foundation” and what are the obligations of R3i to respect FDA limitations on off-label marketing in the US?

A large part of the website is devoted to spinning ACCORD. For instance, the board of trustees of R3i– consisting of Jean Charles Fruchart, Frank Sacks, and Michel Hermans– write in an editorial on the R3i website that “there is a risk that the positive and clinically important results seen in ACCORD Lipid will be lost in the context of ACCORD being seen as a ‘negative’ study.”

What they don’t say is that many other experts believe there is an equal and perhaps greater danger in spinning a “negative” study as positive, and that the beneficial effects of fibrates have not yet been conclusively demonstrated in any population. Unfortunately, ACCORD did nothing to alter the truth of this statement.

According to the R3i website, the research component of the R3i initiative is composed of two international epidemiological studies known as the Realist research program, which is looking “to establish the magnitude of dyslipidemia defined by low HDL and high TG or both” in ACS and type 2 diabetic patients and “to assess the relative risk in this population of developing” coronary events or microvascular complications. Now this may well be a worthy research project, but I feel compelled to point out that it could also be viewed as an extremely valuable tool for Abbott to define the largest possible patient population for their fenofibrate products.

Let’s be clear: this is pure promotion in the guise of an educational “initiative.” Any genuine educational or research “initiative” with legitimate academic credentials would need to consider  alternative perspectives and opinions. It can’t just be a mouthpiece for the perspective favored by a commercial interest. Further, there must also be a certain degree of transparency and accountability. Unfortunately, R3i lacks any of these characteristics . Rather, R3i appears to be an impressive monument to the ingenuity of pharma marketing.

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