#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.

Double Duty

As May is Tick-Born Disease Awareness Month, I find myself with double writing duty. I'm a member of a small team at DailyKos (a web site for progressive democratic political activism with over 200,000 subscribers and millions of page views) who keep the community there apprised of the issues surrounding Lyme Disease. We post sporadically throughout the year, but May is more intensive.

Thus, I may be cross-posting and putting what I write for DailyKos here. I simply don't think I can keep up with two sets of writing. There will be posts here that are not on DailyKos, though. So, stay tuned.

Thank you for your understanding.

May is Lyme Disease Awareness Month

I prefer to think of it as Tick-Borne Disease Awareness Month. I know. It's a mouthful. But, the truth is, all too often, those generous little ticks like to share more than one microscopic critter with us. When we think about Lyme, we also need to be thinking about Babesia, Bartonella, Erlichiosis, Rikketsia and others. You can see a full list here.

Here's a fun little chart:

Click on the chart to see a fancier version, with pictures for identifying the ticks.

There you have it. Many of us get two or more of these. This is why I'd like to change the name "Tick-Borne Disease Awareness Month."

Tech-i-nical Difficulties

Please forgive me being so slow to follow up. The short of it is this: while there is an experience to relate, the treatment went well enough that it was deemed I could continue. However, since then I have felt as though a truck ran me over.

I had two small social things to host this weekend and it was all I could do to appear functional and tolerate the stimulation. Sunday morning I lay in bed for hours unable to move. The full body pain was intense, as if everything had simply seized up into one giant cramp.

A little better today.

Will write more soon.

Thank you for your patience.

Treatment: Day 1 pt 1

I thought I might be able to "live-blog" yesterday, but it didn't work out that way. With all the time in the car (3 hrs each way), I needed to know how to post from my phone and I hadn't looked into that. As it turned out, I wasn't able to do much while sitting for the 4 hours of the infusion, either. So, I offer this report after a good night's sleep:

It was a fairly uneventful 3+ hour drive down. We did run into some traffic on The Turnpike and had to call to let the clinic know we would be late. No big deal. As is usual for me, these days, I was disoriented most of the time. Before we even got to the highway, I was asking, "Where are we?!" After 5 years, this is still disturbing to me. I used to be so good at navigation. Just one more reason to appreciate my iPhone. (a recent acquisition, so I'm still in the honeymoon phase with it.)

I had been told that I needed to be well-hydrated with electrolytes, so we had a couple of big bottles of Recharge on hand and a bag of sea-salted chips. I was also told that I could eat during the transfusion, so we stopped and picked up lunch at Rein's Deli, our favorite stop anytime we're heading south on I-84. As a ex-New Yorker, I miss the delis in Manhattan and Reins offers me a moment of 'saudade'. (wow. what *isn't* on the internet any more?! I can give a link to explain 'saudade', that's awesome.) While I'll often indulge in a Reuben, yesterday I got an egg salad sandwich. Yum.

I wasn't in the mood to talk much. Early mornings are really difficult for me and getting in the car with the roaring of the tires, all the sounds of traffic, the morning sun burning my eyes, etc leaves me very unsociable. Add to that the anticipation and anxieties of heading to a first intravenous treatment and I was downright curmudgeonly with not the slightest amount of grace about getting the worst cup of tea. Ever. (ya know, tea won't steep if you put the cream in right way?! and it really won't be palatable if its only lukewarm to begin with. ugh. sigh. Yes, I still adore Rein's but they need a tea education.) I buried my self in a fantasy book. (I'm not sure how I feel about starting a story with at least 13 volumes. Will I feel unsatisfied with such a long term of incompletion? Or will I enjoy having this world to be absorbed in? Sometimes, I actually grieve a little when I finish a book or a series, having loved the experience and the characters I'd been drawn into.)

We arrived at about 11:20 for an 11:00 appointment and were told it would be another 15 minutes. I love my doctor and I admire that everyone working there seems to be in good spirits and enjoying their work. I can't stand the new offices, particularly the waiting room. Buzzing green fluorescent lights, tight space with video arcade machine and wide screen TV, a door that slams shut when not closed with care and the receptionist window which slides on ball bearings to make a sound which feels like your brain is being ripped open with a zipper pull. I have to manage the growing rage that comes with the ongoing sensory onslaught. You'd think a neurologist would have more sensitivity to this. I do realize that as a doctor who has opted out of the insurance game and is doing all he can to treat patients in desperate need, that he likely can't afford opulent office space and is keeping his overhead costs down. That's the rational part of me, appreciating his devotion and sense of mission. My lizard brain doesn't process it that way.

I brought knitting, but couldn't really focus on what needed to be done next because it required some thinking and planning, so I just wove in ends. There were plenty of ends to weave in and that's a tedious task, so this was a good use of that time.

"That time" was considerably more than 15 minutes. I was finally called back into the infusion room at about 12:30.

Things were lively, nearly hectic, in the infusion suite. Two people were already in the room filled with reclining chairs. Each with their own satellite tower holding their personal container of fluid, connected to them via long, supple tubing. Another woman was getting a 'midline' installed and receiving her operating instructions and being oriented about what to expect when the nurse comes to her house once a week. She was cheerful, but clearly a bit anxious and seemed overwhelmed. I'd be overwhelmed, too. They handed her a box that was about 30" cubed full of supplies which have to be refrigerated. If I had to put all that in my fridge, there'd be no room for food. We joked about the infusion diet, but you could tell hers was nervous laughter.

I waited for the nurse to finish up with her and to prepare my setup. I was informed that it was standard practice to give the patient Tylenol and Benadryl before an immunoglobulin infusion. There was concern that my system is very sensitive. The two nurses talked to each other about what to do and then one of them went to talk to the doctor. It was decided that I would have Claritin, instead of Benadryl. I've never taken either, as I don't recall ever using an antihistamine, so I have no idea why Claritin would be better than Benadryl. I simply complied and swallowed.

At Least They Published This

Before I continue critiquing news articles that fraught with journalistic fail, I'd like to acknowledge that after printing one of these articles, the Star Tribune in Minneapolis/St. Paul did, at least, print this follow-up opinion piece:

Elizabeth Maloney: We've much to learn about Lyme disease

Given that Dr. Maloney opens with a rather scathing criticism of the paper itself, I give kudos to them for having the forthrightness to publish it:

The April 12 article about the resolution passed by the Minnesota Board of Medical Practice ("Activists and doctors divided over Lyme disease treatment") brought many questions to mind, including: "When did the Star Tribune morph into Fox News?" The article used buzzwords and themes known to inflame physicians, and it misled readers regarding the professional credentials and capabilities of physicians who recognize that persistent/chronic Lyme exists.

One of my main criticisms of the journalism surrounding Lyme Disease is exactly what she points out here: all too often, proponents of the Infectious Disease Society of America (IDSA) and their "guidelines" are presented as the only ones who have professional credentials and the prestige of a legitimate medical association behind them. Those who recognize the persistence of the disease are presented as "Lymies" who are not professional, or, if they actually quote a doctor, the impression is given that this is a rogue outlier and they are not linked to the larger association of medical professionals who recognize this truth: the International Lyme and Associated Diseases Society. Any reader who is not already educated on the subject is likely to discount the word of a "Lymie", don't you think?

I'm not sure why the Star Tribune has taken a step in the right direction by publishing Dr. Maloney's piece. I would like to think that their own sense of integrity was intact. Perhaps, it is. Perhaps, they got enough letters and comments from people after their April 12th piece that they felt compelled to publish it. If they really wanted to do the right thing, though, they'd do a more well-researched, in depth news piece that gives the public a more serious look at the issue.

We're talking about a topic that effects the lives of tens of thousands, perhaps hundreds of thousands, or people. If the news industry is really interested in doing the public a service, perhaps they could begin by focusing on one question: how is it that after the IDSA has been shown to have had major conflicts of interest -  that is, ethical issues -  it was allowed to essentially police itself, hire a past president of the IDSA to chair the policing, and then violate the terms of the antitrust settlement which set the rules for the policing? When do we stop seeing them as a credible source of information and strip away their rights to authority? When do we start talking about them as the "Lyme Deniers"? How blatant does someone's lack of integrity have to be?

It doesn't take much digging to see what's gone on behind the scenes regarding Lyme Disease. There are books on the subject. One by an acclaimed science journalist: "Cure Unknown". Others laying out the history, too, such as "Beating Lyme".

So, I applaud the Star Tribune for publishing Dr. Maloney's opinion piece. Still, it doesn't carry the same weight as a news piece. It doesn't begin to help the public see that we have one more case in this country of anointing someone one or some group with authority, which has been abused. That it is up to us, to stand up to that abuse and to stop allowing folks with serious integrity issues to rule the day.

Can't Focus. Tomorrow is Big.

I had planned to post a review of a piece that the Minnesota Public Radio posted on its site yesterday. I've begun the draft, but I can't focus.

Then the IDSA announced that their review committee (that one where those folks who are accused of ethics violations get to oversee the review of themselves and then violate the antitrust agreement which outlined the voting procedure of the review.  You know, that one.) has voted to make zero changes to their guidelines. That warrants a significant response. But, I can't focus.

Tomorrow I start my Intravenous Immunoglobulin (IvIg) treatment.

That seems like a simple statement, right?

Yet, there is so much packed in there. I first went to a doctor because I was feeling "poisoned" all the time in 2005.

I have a plethora of emotions and myriad questions. I'm ecstatic and anxious and hopeful and cynical. Will I tolerate it? Will it work? How long will it take? What will it be like to be well again? Will my daughter like who I am when I'm healthy? What will I pursue to earn a living when I regain my health? What if it doesn't work? How depressed will I get?

Can I knit for the 4 hours the Iv line is in my arm? Can I walk around? Can I eat? Will it be cold? Or hot? Will it wear me out or energize me? Will my symptoms get worse before they get better?

Will I be able to perform on the violin?

Okay. Old joke.

So, what does any erstwhile compulsive personality do when she's feeling so overwhelmed? She organizes her sock and underwear drawers. Oh yeah.

I think I've done other stuff today. Not sure, though. I'm nursing a big headache and nausea over sounds or making an effort to think or trying to have a conversation. Very strong burning all over my skin. Worst on my ankles and lower legs. Non-stop yawning. Walking the dog nor caffeinated tea helped.

So, I think I'm checking out for the eve.

Hmmm. Maybe I'll liveblog my treatment.....