Last Thursday, the historic review of the IDSA 2006 Lyme guidelines was held in Washington, D.C. Eighteen people presented arguments for and against the guidelines. We don’t know how the IDSA panel will act in the face of this deluge of previously suppressed information, but we do know that we have grown enormously as a community and that the skill-sets we developed on this project will continue to have a positive effect in the future.

I want to share with you a little of the background of the action and acknowledge people who have joined in this massive undertaking over this period. Many others have contributed, and I apologize if I have overlooked anyone’s contribution to this effort.

Last Thursday, the historic review of the IDSA 2006 Lyme guidelines was held in Washington, D.C. Eighteen people presented arguments for and against the guidelines. We don’t know how the IDSA panel will act in the face of this deluge of previously suppressed information, but we do know that we are have grown enormously as a community and that the skill-sets we developed on this project will  continue to have a positive effect in the future.

I want to share with you a little of the background of the action and acknowledge people who have joined in this massive undertaking over this period.  Many others have contributed, and I apologize if I have overlooked anyone’s contribution to this effort.

After I became ill with Lyme, and with the encouragement of many in the community like Pat Smith, I turned to legal advocacy.  Since 2005, the antitrust effort has been my passion project.  During the roughly 4 years intervening, I lost my husband and sent my two children off to college.  In Fall of 2005, I received a call from my husband who was attending a high school reunion in Texas.  He was having coffee with an old high school friend, Richard Wolfram, an antitrust attorney based in New York. My husband set his cell phone on speaker and placed it in the middle of the table, saying, “I think you two need to talk about antitrust and the IDSA.” With that began a collaborative effort between Richard and me to develop the antitrust theory that would become the basis for the investigation.

Three months into the project, my husband died and Richard relentlessly prodded me to continue with the project. With the antitrust legal framework in hand, we needed to capture the interest of an Attorney General who had the vision and intestinal fortitude to launch an investigation. Time for Lyme, which had assisted with the Connecticut Attorney General Lyme hearings in 2004 contacted their office and arranged a meeting for Richard and me to discuss a potential investigation.  From developing the theory and working out the factual base to fielding issues in the settlement, including panel selection, presenter selection, timeframes, and even viewing issues for the hearing, we could not have undertaken this effort without Richard’s assistance.

My legal efforts on the project were provided without charge as a CALDA volunteer. Richard donated an enormous amount of time at no charge and his other legal costs were provided at a substantial discount. The legal costs were borne by CALDA, Time for Lyme and the national Lyme Disease Association and these organizations were the initial complainants against the IDSA. The three groups worked closely together throughout the process with public health officials and coordinated publicity surrounding the event.  Shortly after, ILADS joined these organizations in support of the effort, and Dr. Dan Cameron became a central voice in the process.  Time for Lyme worked hand-in-glove with me with the Attorney General’s Office throughout the process.

The document submission process alone was Herculean, with submissions from third parties in addition to the ILADS submission. Under ILADS’ aegis, we submitted roughly 280 pages of scientific analysis of the guidelines and over 1,300 pages of peer-reviewed research contesting the guidelines recommendations—so much for the notion that there is “no science” supporting our viewpoints. Those who contributed to the document submission put in long hours, with regular group meetings developing themes and reviewing work and concepts. This group included authors Drs. Betty Maloney (who wrote 5 of the 12 articles), Ray Stricker (2 articles), Steve Phillips (an 81 page article), Ken Liegner, Dan Cameron, Leila Zackrison, and Chris Green and statisticians Liu Tao, Ph.D., Allison DeLong, MS, and Barbara Blossom. In addition, Drs. Bob Bransfield and Joe Burrascano generously contributed to the group process. Barbara Blossom coordinated the extraordinary organizational effort and was supported by the Ridgefield Lyme group and Phyllis Mervine. Dr. Maloney and Barbara Blossom served as my wing-men on the documentation SWAT team, helping to pull research and carefully orchestrate, edit, and suggest revisions and additions to the process.

Once presenters were selected, efforts focused on dividing up the list of contested recommendations and pulling together outlines and PowerPoint presentations. Again, regular meetings helped hone this group process and a trial run-through of the presentations was held in New York, with Drs. Richard Horowitz, Maloney, and Burrascano participating as well as Pat Smith and Ellen Lubarsky. Time for Lyme managed the logistics for the meeting and Jennifer Weis-Monsky provided the facilities for the session. This meeting was funded by CALDA, the national Lyme Disease Association, Time for Lyme and ILADS.

The day of the hearing, we were fortunate to have in attendance the NIH Program Director, representatives of Congressman Christopher Smith (NJ-R) and Senator Christopher Dodd (CT-D), the HHS Inspector General’s office, and the CDC. Pat Smith was largely responsible for bringing this august group to the hearing. We were also blessed that independent researchers, Drs. Brian Fallon (Columbia), Ben Luft (Stony Brooke) and David Volkman (formerly of the NIH) raised their voices to challenge the guidelines.  Dr. Sam Donta and Tina Garcia (LEAP) also provided strong challenges for the panel.

Tom Feldman, Dr. Ray Stricker, Sandy, and Lucy Barnes provided behind the scenes support for the process. And others, such as Miguel Perez-Lizano, Kris Newby, and Barbara Blossom helped develop the factual support for the project. Many others who prefer to remain anonymous also provided moral and financial support and encouragement along the way.

Last, but not least, we are thankful for finding an honest man who was willing to help patients take on Goliath, CT Attorney General Richard Blumenthal, with special appreciation to Tom Ryan and Michael Cole.