Lyme Policy Wonk

Over 6,100 responded to our IDSA survey within one month! That’s YOU being engaged. Everyone who has worked on this project has been deeply touched by your responses. In addition to answering our survey questions, over 1,700 patients offered their thoughts in a tiny comment box. I have to say, I was unprepared for the depth of responses offered. I know that those of us who reviewed the comments teared up. You may too.

In March, the Infectious Diseases Society of America provided a 30-day window for the public to comment on its plan to revise the Lyme disease guidelines. The deadline was April 9. However, the IDSA has just extended the time to file comments. If you have not yet done so, you now have until April 24th.

LymeDisease.org and the national Lyme Disease Association filed comments on behalf of 67 patient groups across the nation. LymeDisease.org also launched a patient survey on March 28 to solicit patient views. It drew more than 5,500 responses. We included findings from the survey in the formal comments we filed with the IDSA.

Raise your voice with ours–and let’s be heard as a community! The IDSA guideline revision process is very important to patients. The guidelines panel is required to consider outcomes that are important to Lyme patients. But it has excluded them. This survey is your opportunity to tell the panel what outcomes are important to you.

For the past 11 years, the IDSA has refused to include patients (as well as researchers and physicians who are not like-minded) on its Lyme guidelines panels. The group has also fought against patient representation on federal and state advisory boards. On March 9th, they announced a new guideline development process. This time, they have included a patient representative. Why the sudden change? And, more to the point, should patients rejoice or weep?

In August last year, I blogged about new FDA guidance on laboratory developed tests and how these might restrict access to diagnosis and care for Lyme patients. Many patients with Lyme disease rely on laboratory developed tests, for example, the IGeneX western blot. Since that time, I have met with the FDA twice and LymeDisease.org conducted a survey which drew close to 8,000 responses. The results of that survey were presented to the FDA in our meetings and by Dr. Elizabeth Maloney at the FDA public hearing in January. On January 29th, LDo submitted official public comments to the FDA proposal.

Lyme disease is a controversial illness—as anyone with the disease knows. The controversy arises because there is medical uncertainty about the best way to diagnose and treat the disease, poor quality diagnostic tests, and very little treatment research. Out of this uncertainty, two approaches to treating the disease have emerged: one advanced by the Infectious Diseases Society of America (IDSA) and the other advanced by the International Lyme and Associated Diseases Society (ILADS). But both of the approaches are not equal in the eyes of patients. One leaves patients without treatment options when short term therapy fails, as it does all too often. The other provides patients with the option of receiving additional care.

In the final days waiting for Governor Cuomo to sign the Lyme bill in New York that would ensure Lyme patients access to diagnosis and care, Slate magazine ran what can only be called a Lyme bashing piece designed to kill the legislation. LymeDisease.org responded with this letter to the editor.

LymeDisease.org has launched a new survey regarding the FDA’s proposed regulation of Lyme lab tests. We need your views on this very important topic. This is extremely time sensitive so please respond quickly! We will use this information to assess patient views and to inform our meetings with the FDA. Our last survey drew over 6,000 responses and was published this year. We need your input now!