Washington Briefs:

Letter Sent to ESA Manufacturers:

(Sent via fax)

December 21, 2007

Roger M. Perlmutter, MD, PhD

Executive Vice President, Research & Development

Roy Baynes, MD, PhD

Vice President, Global and Clinical Development, Oncology

Amgen                                                                                                                 

Alex Zukiwski, M.D.

Vice President

Johnson & Johnson Pharmaceutical Research and Development             

Dear Colleagues,

We are writing this letter as a group of patient advocates representing both individuals and advocacy organizations.  As such, we are increasingly concerned about the use of erythropoiesis-stimulating agents (ESAs) in cancer patients.

We recognize that companies have legitimate reasons for maintaining confidential information and, in the past, we have honored your collective privacy.  However, at this point, our concerns have been heightened by the recent PREPARE and GOG 191 results.  Thus, we feel that in the interest of keeping patient safety first, the ‘next steps’ of the pharmacovigilence program must include an unusual degree of transparency.

We need to reassure our communities that ESA manufacturers and marketers are providing enough resources to answer the most critical safety questions and that high-quality clinical trials and basic research are being done in a timely way. We believe that your interests are also well served by better and more detailed communication with the public.

In order to achieve transparency without disruption to your research enterprise, we ask that you include respected, technical patient advocates in the process.  For example:

• Include patient advocates as members of your clinical trial design teams
• Create seats for patient advocates on the Data, Safety and Monitoring Boards (DSMB) of your new and on-going ESA clinical trials.

Additionally, we ask that you provide detailed information to the community about:

• The design of new and proposed ESA clinical trials, including hypotheses, patient entry criteria, endpoints and data elements, as well as information about where the trials will be conducted, trial timeline and data ownership
• The questions being addressed by basic research
• Your expectations of how long it will take to obtain answers to critical ESA basic science and safety questions

We realize that this level of patient advocacy participation in your research programs and your business may be unusual. However, this is an unusual situation.

We have raised a number of concerns and questions with the FDA; however, there are legal restrictions on the information the FDA is allowed to disclose.  Therefore, it is up to you to fill the information gap. Your acceptance of experienced patient advocate involvement in your research process will only serve to strengthen your credibility and begin to rebuild the trust you have recently lost with many in the cancer patient advocacy community.

We would like to have your response and come to agreement on the path forward as soon as possible.  To that end, we would like to schedule a conference call during the first week of January.  Please contact Carlea Bauman at Carlea.Bauman@FightColorectalCancer.org or 703-548-1225 ext. 11 with your availability for such a call.

Thank you for your serious consideration of our requests, and we look forward to speaking with you soon.

Cordially,

American Cancer Society

American Cancer Society Cancer Action Network (ACS CAN)

C3: Colorectal Cancer Coalition

Lung Cancer Alliance

Marti Nelson Cancer Foundation

Ovarian Cancer National Alliance