#IDSAFail

That's a "hashtag" on Twitter now. I don't know if it was used before, but I saw it fly into action last week after the IDSA (Infectious Disease Society of America) made this announcement:

After nearly two years, a special independent Review Panel has agreed that no changes need be made to IDSA’s 2006 Lyme disease guidelines at this time.

I'm slow getting to this due to momentous things happening for me, right now, however I can't let it pass.

I'd like to say I was shocked, but I wasn't.

I wasn't shocked because, from the beginning of their antitrust settlement  (link to PDF of the agreement is near the bottom of the page) with the CT Attorney General, they made it clear that they weren't taking the need to reconsider their position seriously. Though the Attorney General said this:

This agreement vindicates my investigation -- finding undisclosed financial interests and forcing a reassessment of IDSA guidelines," Blumenthal said. "My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA's guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.

the President of the IDSA said this:

IDSA's signing the agreement was not, as he alleges, an admission of guilt, but an effort to end a fruitless investigation that was costing our organization (and presumably Connecticut taxpayers) thousands of dollars.

Denial, denial, denial. All this denial of conflict when we know that some members worked with the CDC to develop a Lyme vaccine and we know that some had consulting contracts with the insurance industry. Both of these areas of work have a significant influence of whether patients can get testing treatment. Yet, they were allowed to police themselves.

In light of that, let's look at the recent announcement more closely. The sentence above is their home page summary of the fuller announcement. It's one sentence, with so much packed into it. Let's start with the depiction of the review panel as "independent".

How "independent" was that panel? When the IDSA announced their selections for the  panel - oh, wait...  They got to select who would be on the panel to review themselves? Is that "independent"? When I'm accused of a crime, may I pick my jury members, please?

But I digress. When they made the announcement, they gave the professional background of the person they appointed as Chair:

She is a past president of the National Foundation for Infectious Diseases (NFID) and IDSA.

Past president of IDSA? Doesn't that constitute a conflict of interest? Somehow, I don't see someone, whose own professional background could be tainted by a negative finding, as independent. Even if she was not on the Lyme Guidelines Panel, the reputation of the entire IDSA, and certainly any officer, is at stake here. After all, if the guideline process was as flawed as the AG says it was, how did the IDSA allow a panel with conflicts of interest and a bullying approach to scientific review to exist? If they didn't self-police the ethics of that panel, how many of their other panels have similar issues? There is an institutional need to vindicate the Lyme Guidelines Panel, isn't there?

It boggles the mind. Why didn't the antitrust settlement state that the members of the panel had to be free of past associations with the IDSA? At least at an officer level or having held any prominent position?

I don't see this panel as independent. They were selected by and paid for by the IDSA and chaired by a past president of the IDSA.

Onto the other assertion in that announcement: Did this panel recommend no changes? Actually, if you read through the report, they did recommend some changes. As the announcement states, they didn't direct the IDSA to make the changes "at this time" but said they should make for the next release of guidelines in 2012. Since these recommendations directly impact whether a patient can get testing or treatment, it seems negligent to wait. I'll give one example of what I mean.

Perhaps, the lengthiest discussion section in the review panel's report had to do with one piece of the Executive Summary of the Guidelines:

Clinical findings are sufficient for the diagnosis of erythema migrans, but clinical findings alone are not sufficient for diagnosis of extracutaneous manifestations of Lyme disease or for diagnosis of HGA or babesiosis.  Diagnostic testing performed in laboratories with excellent quality-control procedures is required for confirmation of extracutaneous Lyme disease, HGA, and babesiosis

By "extracutaneous", they mean a case of Lyme where the patient did not present the erythema migrans rash.

There is a lot of back and forth in the discussion. I'll point out one bit:

On the other hand, the Panel felt that in clinical practice, the presence of certain classic complications of Lyme disease such as aseptic meningitis, AV nodal block, inflammatory arthritis, and cranial or peripheral neuropathies, in a patient with epidemiologic risk of Lyme disease and in whom alternative diagnoses have been excluded or are unlikely, may be sufficiently convincing as to constitute an exception to the statement in the Executive Summary.

In other words, there are cases where clinical judgment is appropriate for diagnosing an extracutaneous manifestation of Lyme.

If that's true, shouldn't that be updated immediately?! I have a case of Lyme where I am unaware of ever having a rash. It took me years to get anyone to run tests other than the ELISA, which is known to miss up to half the cases of Borrelia, due to a lack of sensitivity. I'm "lucky" because, once I did pay for more testing (out of pocket, because insurance wouldn't cover it due to these IDSA guidelines) my test results came back definitively positive. They continue to do so. And I continue to be negative for anything else. But because of the required 2-tiered testing system laid out by these guidelines, I was two years delayed getting a diagnosis.

That's two years while I'm having trouble walking, getting lost in my own house, having seizures, unable to bear light and sound, losing feeling in my fingers and feet and so much more. I have verified peripheral neuropathies. So, my case fits the type they are discussing here. How can they make anyone else suffer like that when they know that the guidelines are wrong? Why wait 2 years? I simply don't get it.

If the guidelines acknowledged this possibility, when my peripheral neuropathies were confirmed, y doctor could have, based on the fact the I lived in New England and walked two dogs in the woods all the time, have made a clinical diagnosis without fear of the insurance companies reporting her and the state board threatening her license. Instead, she was trained that patients like me are crazy. And that's what she told me. I fired her that day and found a new doctor. One who recognized that something was wrong. She still felt constrained by the system, but she supported me seeking out an avenue to get to the bottom of it. I was "lucky".

Patients like my shouldn't have to get lucky to get treatment. This review panel knows it. So, why aren't those guidelines changes immediately? Who is it serving to wait.

I could go on about things that have a suspicious nature in this review process. They were supposed to have 9 members to avoid a tie and the IDSA didn't make a timely announcement when one member left the panel. One of the votes ended in a tie.

All of the other votes are unanimous. Its a hotly contested subject. There are no definitive studies to back the IDSA's opinions, which is what these guidelines are: the opinions of those on the panel. They turn to two small and very limited studies about long-term antibiotics, where the patients were all diagnosed in early stage and didn't have co-infections, and base all their opinions on that. The review panel admits there are clinical observations that need fuller studies to be confirmed and the studies haven't been done. So, how is it that all the votes are unanimous? As Dr. Stephen Phillips noted:

...he's never seen a scientific panel reach a unanimous finding, which, he said, raises the question of whether the panel was interested in science, or "simply the rubber-stamping on an intransigent ideology.

The investigation by the Attorney General was never about him or his office having an opinion on the science. It was about the ethics of the guidelines panel. He reported that their process was clouded with ethical improprieties that effect the business system for researching, testing for and treating Lyme Disease. Seems to me, if you want to get rid of that shadow from that cloud, you need to have impeccable ethics in your process of exonerating yourself.  Such is not the case here. There are far too many places in which sunshine was not allowed to penetrate the cloud, leaving us all in the dark and rendering everything they say and do suspect.

I'm not a doctor or a scientist or a lawyer, but when something smells fishy, the fish is already rotten.

Hence the prevalence of the #IDSAfail hashtag in the Lyme-related Twitter stream.