IDSA Lyme disease review panel date set for July 30th! New calendar attached

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.

I was reading a book today about the power of small groups. The book is called Microtrends. It is by Mark Penn. One of the things he said stuck with me: “It only takes 1% of the people making a dedicated choice—contrary to the mainstream—to create a movement that can change the world.” What he is talking about is the increasing fragmentation of America (the world, in fact) brought about by the internet and the collapse of normal distribution channels. Very small groups of people can now connect and be effective through the internet. And, the normal channels of distribution used to control information flow have collapsed. You see this in television where there are no longer three networks to choose from but over 200 channels. That’s fragmentation.

Merrill Goozner at Gooznews cites a recent JAMA article by Tricoci showing that nearly half of the recommendations in treatment guidelines are not based on clinical trials, but rather, are based on no more than the expert opinion of those on the panel. This leads to the rather obvious conclusion that evidence based medicine is largely bankrupt. Only 11% of recommendations for heart disease were based on multiple randomized trials.

I wanted to post a piece of poetry that captured the spirit of the Lyme community to ring in the New Year. I found this great Jack Kerouac poem about people who create change. Then I found out it was not by Jack Kerouac, but actually was an ad for Apple computers. Still, it is a great piece that captures the essence of a community that tirelessly swims against the current trying to change the status quo. And now for that poem. . .

Have you ever wondered how many patients with Lyme disease have a rash? You would think the answer would be straight-forward. It’s not. Estimates range from 27-80%.

CALDA has just sent a letter to National Institute of Allergy and Infectious Diseases (NIAID) asking them to pull the plug on an experiment that threatens to harm Lyme patients. The study involves allowing live tick larvae to feed on patients. It is impossible to ensure that ticks are truly sterile and do not carry unidentified pathogens. In addition, tick saliva as well as Borrelia burgdorferi suppress the immune system of patients. Both factors place patients who enroll in the study at risk. Because of this, we feel the study is unethical and could harm patients. Keep reading for details. . .