The IDSA leadership, staff, and I are extremely grateful for the words of encouragement members sent us following the announcement of our agreement with the Connecticut state attorney general regarding our Lyme disease guidelines. The most important reason why IDSA entered the agreement ending the antitrust investigation is that we believe it is in the best interest of our patients, the Society, and evidence-based medicine to ensure that the proper treatment of Lyme disease remains a medical issue and not a legal one. The support from members has been heartening. (For more information on the agreement, our press release is online.)
We have always found puzzling the attorney general’s charges that the guidelines panel had conflicts of interest, because no infectious diseases physician had anything to gain from recommending against long-term antibiotic therapy—the central issue in this controversy. The guidelines recommend against this treatment because it provides no demonstrated benefit yet carries significant risks. However, we write our guidelines to advise clinicians, not to dictate to them. Nothing substitutes for a clinician’s judgment. The real issue for proponents of this unproven treatment is that many insurance companies will not cover it. What the insurance companies will cover is up to them, not us.
The attorney general also claimed that the panel excluded competing viewpoints, but this simply is not the case. The panel considered evidence presented by proponents of “chronic” Lyme disease and long-term antibiotic therapy and weighed it alongside all the other evidence. We have complete confidence in the panel’s conclusions. We hope that the additional review of the guidelines set forth in the agreement will demonstrate to our critics that our recommendations are sound.
I would like to extend my sincere thanks to the panel members for their steadfast dedication throughout the investigation, and especially to panel chair Gary Wormser, MD, FIDSA, and Eugene Shaprio, MD, FIDSA, who as IDSA’s leading experts on Lyme disease have borne the brunt from very early on. Thanks also to Standards and Practice Guidelines Committee Chair Thomas File, MD, FIDSA, for his wise counsel during the negotiation of the agreement.
The next step will be to convene the review panel. IDSA will be looking for open-minded individuals versed in evidence-based medicine to examine the data and recommend whether any changes to the guidelines are necessary. Your participation will be crucial. A request for panel applicants will be arriving by e-mail soon.
The distractions of the Lyme disease investigation have not kept IDSA from moving forward on issues of the utmost importance to our members and our patients. We continue developing guidelines that provide clinicians with the best recommendations that medical science has to offer their patients. This year, the Society took the reins of the Seasonal and Pandemic Influenza meeting after two years as co-sponsor. This forum brought together the world’s top leadership in research, clinical care, industry, and government for an update and to exchange ideas. And our “Bad Bugs, No Drugs” advocacy campaign continues, highlighting the rising threat of antimicrobial resistance and the shortage of new drugs.
In a major development on this front, we are pleased to report that, following years of steady prodding from the Society and its members, the Food and Drug Administration (FDA) is at last updating breakpoints for some clinically important antibiotics. This month, FDA lowered the breakpoints for vancomycin for use against Staphylococcus aureus, an increasingly resistant organism. Last month, FDA raised the breakpoints for penicillin for use against pneumonia caused by Streptococcus pneumoniae, which in this setting still responds well to this safe and effective drug.
In another encouraging sign, FDA held a meeting last month to hear testimony on how to move forward with other key issues in antimicrobial resistance. The agency has been stalled on these issues for years. IDSA was a leading voice at the meeting and submitted a comprehensive plan of action.
After spending nearly two years and nearly half a million dollars responding to the Lyme disease guidelines investigation, IDSA is happy to be closing this chapter and moving on. We thank you again for your support and look forward to your input on the review panel. And we pledge to continue to serve as leaders across the entire field of infectious diseases.
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