LYMEPOLICYWONK: Dr. Paul Duray Resigns from IDSA Panel Due to Family Illness–Implications unknown

Recently, a group that writes guidelines asked for my input about the role of patients in the development of Evidence Based Medicine guidelines. With universal healthcare now ‘the law of the land’, treatment guidelines have become even more important. Preserving the integrity of the guideline development- process is what matters most. It is essential that patients play a role in the process that can so affect their lives. The question posed to me was why should those developing guidelines involve patients? My response follows.

I don’t know about you, but I have watched wide-eyed and breathless as the Centers…

When studies fail to take heterogeneity into account, researchers can leap to the wrong conclusion. In a recent open-access article, Dr. Fallon and colleagues describe the four NIH trials, the Krupp Stop-LD study, the Klempner seronegative study, the Klempner seropositive study, and Fallon neurologic study and make a key point. There are considerable differences between chronic Lyme patients (so-called patient heterogeneity) that need to be addressed in study design to improve what he calls the signal to noise ratio. If a study does not address heterogeneity, the results may simply reflect “garbage in, garbage out.”

This is a chart of the relative importance of different stakeholders to big Pharma. (Click chart to enlarge.)
I was really struck by how little weight patients were given (9%) compared to specialists (47%) and compared to key opinion leaders (21%).
So if you take specialists and add key opinion leaders to that, 68% of drug companies thought that key opinion leader who are specialists would have the
most influence on their company over the next 2 years. Wow! And, look at the lowly role of the general practitioner

Yesterday, I was honored to speak at the US Department of Health and Human Services’…

Finally, the Institute of Medicine (IOM) came out with its agenda for their “State of the Science Hearing”after much hemming and hawing. Patient groups (including CALDA) who asked for transparency in the study process received a mere “no comment” response. Well, we never got transparency, and we only got the agenda after it was finalized and released to the public. So, here’s the score: its 3 for 3 in the ‘Final Inning’ in favor of the IDSA.

Four of the 6 IOM panel members are IDSA members.

10 of the 14 physician speakers were authors on the IDSA guidelines or the copycat guidelines issued by members of the IDSA panel or members of the IDSA.

Zero ILADS physicians have been chosen to speak. Let me repeat: ZERO, zip, nada, not a single ILADS physician was chosen to speak!

Dr. Gary Wormser, poster boy of the Connecticut IDSA antitrust investigation, is kicking off the game.

Oh, there’s window dressing to be sure. A personalized tour of the Agenda after the great leap forward. . .