The Office of Lilly CME is planning a sepsis educational program for the fall.

The symposium will focus on "newer approaches to the treatment of sepsis." The timing of the symposium may coincide with the approval of Lilly's pending recombinant activated protein C agent Zovant for sepsis. The BLA was submitted in late January with a six-month priority review deadline.

The Office of Lilly CME, a division of Eli Lilly and Company, is accredited by the Accreditation Council for Continuing Medical Education as a provider of continuing medical education.

Lilly is also working with outside CME providers to update practitioners on sepsis therapies. Under an unrestricted educational grant from Lilly, Medscape put on a sepsis CME event in October 2000, when the Zovant pivotal trial data were released.

The accreditation of pharmaceutical companies as CME providers was criticized in an editorial in the April 18 Journal of the American Medical Association as an example of the trend towards increasing influence of pharmaceutical companies in CME (¹ Also see "ACCME Certification Of Rx Firms Challenged In JAMA, Defended By PhRMA" - Pink Sheet, 23 April, 2001.).

The April 18 JAMA also contains an advertisement for Lilly's "sepsis.com" website. The website includes a slide kit and presentation on sepsis and the role of activated protein C in treating the syndrome.

Lilly CME's website includes a discussion of its CME policies and highlights that "the Office of Lilly CME is accredited by the Accreditation Council for Continuing Medical Education," and "must adhere to the same rigorous ACCME Essentials and Standards that medical schools and teaching hospitals do."

"We maintain a continuous effort to determine educational needs and possible interventions to maximally satisfy those needs," the website states.

However, Lilly CME acknowledges, "the OLCME Mission Statement provides that our educational programming will follow the therapeutic and scientific focus of Lilly."

Lilly CME notes that it also pursues a broader scope of CME activities. "We have recently co-sponsored with various medical schools several live activities centered on improving clinical trial site quality and compliance."

The faculty included "representatives from medical schools, Lilly Research Labs, other pharmaceutical companies and FDA," Lilly CME said.

OLCME points out that its educational programs are frequently co-sponsored. Recent collaborations include Duke University, the University of Michigan, University of California-San Francisco and the AMA, and "faculty in our activities have included faculty members from the previously mentioned universities as well as FDA," the website adds.

Lilly CME's projects include an online CME course on diabetes, co-sponsored by the American Medical Association, and an upcoming series on genomics, co-sponsored by Harvard University.

Lilly CME does provide educational grants but only "to support an activity in which we are a co-sponsor. As a general rule we do not supply grants for activities where we have no participation other than grantor."

Lilly CME stresses that it has taken steps beyond ACCME requirements to protect the educational value of its programs. All content of its educational programs is reviewed by "an independent external advisory panel composed of educators and physicians from several therapeutic areas who are also experts in CME."

The "FAQ" section of Lilly CME's website poses a question and answer on whether it is ethical for Lilly reps to distribute CME information.

"My Lilly representative gave me a brochure for one of your educational programs. Is this legal?"

The answer states that it is not OLCME's policy, in accordance with the ACCME, to use "the Lilly sales force as the sole or major source of publicity" for CME activities. "However, it is acceptable ethically and legally for a sales representative at the request of this office to assist in publicizing the activity," OLCME maintained.

Lilly CME is one of 12 accredited CME providers that are affiliated with manufacturers of FDA regulated products, ACCME said.

Lilly Sepsis CME Programs Include In-House And Medscape Organized Events

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