Lorraine Johnson: Good morning. I’m Lorraine Johnson, a Lyme patient and an advocate. I have a JD from Loyola University and an MBA from USC. I am the Chief Executive Officer of the California Lyme Disease Association, and I serve on the professional advisory board of the National Lyme Disease Association. I am an officer and a director of ILADS. Over the past five years, I’ve focused on the medical, legal, and ethical issues relating to Lyme disease and I’ve published articles in this area. I’ve spoken before state legislators, the CDC, and before the Canadian Consensus Hearings on Lyme disease.

Prior to being infected with Lyme disease, I was Chief Operating Officer and general counsel of international entertainment companies, negotiating highly complex deals in the hundreds of millions of dollars.

In 1996, I became ill--too ill to work: I quit my job. Too ill to attend to my family--I took to my bedroom. I lost my life as I knew it, and my five and seven year old children lost their mom. My multi-systemic symptoms included fatigue, shortness of breath, cognitive impairment, neuropathy, arthralgias, and depression. I bounced from specialist to specialist, lost to the system, and was ultimately misdiagnosed with depression and treated with 54 different combinations of psychotropic drugs. Nothing worked, and I got worse. I was sick, undiagnosed, disabled, and untreated.

It was not until seven years later that I was diagnosed with Lyme disease based on a positive blood test, though not by CDC standards. Descending into depression and cognitive impairment felt as though I was sitting in the room of my house, watching the lights go out one by one. And my pre-treatment SPECT scan shows extensive hypoperfusion; and it literally does look as though the lights went out.

It was two years after extensive antibiotic treatment that my SPECT scan showed marked improvement and I was largely restored to my cognitive functioning. However, under the IDSA

guidelines, I would not have been diagnosed, treated, or restored to my functionality. Lyme disease was not even on the differential diagnosis of my doctors during those seven years.

Patients want treatment guidelines that restore them to health. Dr. John Eisenberg, identifies the key question for medical quality: Did people get better? Was disease or disability reduced? Was it reduced as much as it could have been? Under the IDSA guidelines as you will hear today from Dr. Stricker, the failure rates are unacceptably high, ranging from 5% to 40% for early Lyme and exceeding 65% for late Lyme.

The same IDSA physicians who say that the IDSA guidelines are not mandatory testify against physicians who treat and don’t comply with the IDSA guidelines. And, the IDSA opposes state legislation that would provide physician protection. This legislation has passed in three states – Connecticut, California, and Rhode Island. The fact that these guidelines are highly restrictive, that they’re regarded as mandatory by third parties and that they are enforced by the IDSA itself has had a devastating effect on patient care.

I hear from Lyme patients everyday about the hardships that these guidelines cause. And a recent survey by CALDA of over 3,000 patients with chronic Lyme confirms that these guidelines make it very difficult for patients to receive early diagnosis and treatment.- they force them to travel long distances for medical care; they put the cost of medical care beyond reach; and they leave patients sick and unable to function. Although not intended as high science, CALDA’s survey shows that 58% of those treated under the IDSA guidelines remained ill, and 60% of those improved with additional treatment.

Treatment failure rates under the IDSA guidelines are too high to deny seriously ill patients access to the only treatment option that may restore their functionality additional antibiotic therapy.

And opposition to these guidelines is growing. Forty thousand people have signed the LDA’s petition opposing these guidelines and other physician groups have joined ILADS in opposing these guidelines or supporting physician protection legislation which as I have mentioned has been passed in California, Rhode Island, and Connecticut.

Does this sound familiar? Think of the breast cancer legislative drive in 17 states to obtain access to treatment options then regarded as unnecessary by the medical establishment. And the reason for the opposition to the IDSA guidelines is simple. The IDSA guidelines extend well beyond what is known in science and they restrict clinical care based on expert opinion.

This hearing arises from the antitrust investigation by the Connecticut Attorney General that found that the IDSA 2006 panel had widespread commercial conflicts of interests, and refused to consider dissenting views and the science supporting those views.

Patient groups are here today because we believe that patients and the physicians who treat them should be central to any guideline development process. But we are concerned. Why? We’re concerned about bias because the hearing is run by the IDSA which selected the panel and the presenters and excluded from the panel physicians who treat chronic Lyme; and excluded from presenting a physician who authored 40% of ILADS submission, Dr. Maloney.

Under the antitrust settlement agreement, the panel is charged with determining whether each of the recommendations in the guidelines is medically, scientifically justified in light of all of the evidence. Any contested recommendation will require a 75% super majority vote by this panel to stand.

Guidelines that restrict clinical judgment and deprive patients of treatment options should not exceed their evidence-base. A recent JAMA article describes the authority-base for evidence-

based guidelines as evidence-based, not opinion-based. This authority-base stops where science is unknown, because opinion, even expert opinion is not science. Accordingly, this panel must determine whether the science supporting each of the guideline recommendations is complete and adequate or whether the science is emerging and, incomplete, and subject to legitimate dispute--to distinguish what we know from what we don’t know.

Science and Lyme disease is limited, uncertain, and emerging. Here are just two examples: first, there are no good biological markers for this disease and according to neurologist Israel Steiner, this means that clinical treatment trials in Lyme try to solve one equation with too many unknown variables and makes every attempt to address clinical questions in the realm of PLD doomed almost by definition to leave unanswered the very definition of the disease,its diagnostic criteria, its pathogenesis, optimum treatment durations, research endpoints, and the role of persistent subjective complaints – and aren’t these the same issues that we’re here to discuss today? And won’t they necessarily remain open until we have a good biological marker for this disease?

Consider this, there are over 100 strains in the United States that have been identified so far, yet none of the clinical treatment trials have taken strain variation into account. And strain variation may explain why some patients test positive for Lyme disease and some do not. And it may also explain why some patients respond well to shorter term courses of antibiotics and others require more extensive treatments.

Despite these unknowns--and I have raised just two--the IDSA guidelines extend well beyond their science-base. Guidelines should not restrict clinical judgment unless known science so dictates because uncertain science requires clinical flexibility and because the risk of getting it wrong based on opinion is too great when the patients are suffering.

Guideline panels for other illnesses defer to clinical judgment and provide treatment options where science is uncertain, where different treatment options exists, where treatment outcomes are variable, and where the quality of life implications are significant. For example, prostate cancer guidelines offer four treatment options, watchful waiting, radiation, surgery, hormone suppression; and other examples include breast cancer, ischemic heart disease, back pain, and hormone replacement, to name a few.

These guidelines assume that research studies should preceed any clinical treatment of patients, but this puts the cart before the horse because patients need care today and because evidence gaps are abundant in medicine. More than half of all medical treatments have not been validated by clinical trials and stopping treatment pending research would simply shut down most medical care in the United States today. Because of this, guidelines must default to treatments that reflect individualized medical judgment not no treatment.

So, what is our goal? What do patients want? We want guidelines that accurately reflect the state of the science and that are open to emerging science. Scientific evidence in Lyme disease is uncertain. Different diagnosis and treatment options in Lyme disease do exist. Treatment outcomes in Lyme are highly variable and quality of life trade offs in Lyme are very significant. Accordingly, the Lyme guidelines should be revised to accurately reflect the state of the science and the uncertainty there – to acknowledge legitimate scientific controversy regarding the diagnosis and treatment of this disease, to permit flexibility and clinical judgment, and to provide treatment options to patients who are trying to restore themselves to functional lives.

Today, you will hear a lot of viewpoints about the Lyme guidelines, which are viewed by the IDSA as beyond reproach. The controversy has relegated Lyme to a political disease with black and white viewpoints--when the truth is nuanced and uncertain. Because of this, the key studies must be read critically to determine whether the conclusion of the study is supported by its findings or whether it’s more reflective of the politics of this disease.

You will hear bold assertions from presenters for the IDSA about the state of the science, which others will refute. It may sound like ‘he says, she says.’But this is not an esoteric debate. These guidelines have a devastating impact on patients trying to restore their health. This panel must separate ideological stance from fact, science from opinion. You must determine whether reasonable scientists and physicians can disagree with the assertions in these guidelines based on the science and refrain from limiting clinical judgment and treatment options unless the evidence is certain.

In law, we say your position depends on where you sit. And you will need to assess the impact of the commercial influences on presenters here today. I think, we can all agree that while the role of the treating physician is primary to medical care, the role of outside industry influences such as vaccines, Lyme test kits, and insurance should play no role in determining patient care because these interests place maximizing profits above patient care.

Today, the nation and indeed the world is watching. We urge you to fulfill your duties with the highest degree of professionalism in good faith because patient lives and those of their families hang in a balance.

Thank you.

Dr. Baker: Thank you for your testimony. Before I turn this over to the other panelists, Ms. Johnson, would you mind answering, clarifying something that I thought you said that I may have misheard? This present Panel did I hear you say that there were no Lyme disease treating doctors on the panel?

Lorraine Johnson: I said that there are no doctors who treated chronic Lyme disease.

Dr. Baker: Thank you for clarifying that. Are there questions? Dr. Medoff?

Dr. Medoff: I’m just interested in how you would revise the guidelines. Are you saying that we should not be using expert opinion when there are no studies to support whatever that opinion is or are you saying that we should put different points of view in the guidelines?

Lorraine Johnson: I think that the important - something that would be very important because people do have different viewpoints here – would be to acknowledge that there are different viewpoints. I mean, right now, there is no acknowledgement– you could read the IDSA guidelines and believe that there was no controversy going on; that nobody held a divergent viewpoint. So, I think it would be important to acknowledge the controversy that exists, to acknowledge that there are other organizations that have different guidelines--that have different treatment approaches, and this would provide patients with, you know, the type of information necessary to make an informed consent about the treatment that they want to pursue. And it would also, I mean providing treatment options and clinical judgment would make these guidelines take away this mandatory nature of the guidelines. Those are the two things that would help take that away and if you take that away, then you are going to start seeing more insurance coverage. You are going to start seeing less of the medical board actions, and you know, that’s really where I think the heart of the problem lies.

Dr. Baker: Yes, Dr. Parsonnet.

Dr. Parsonnet: Thank you for your presentation. I have a question for you, in your talk, you said that the guidelines are, I think the word you were using we "enforced by IDSA itself". And, I mean, I think there’s two issues. One is what’s in the guidelines and then what is done with the guidelines by others, some of which is certainly not under the jurisdiction of IDSA. So, when you said the guidelines are enforced by IDSA itself, what do you mean?

Lorraine Johnson: What I mean is I mean that IDSA physicians go in and they testify against physicians who are not complying.

Dr. Parsonnet: Is that IDSA or is that individual members? Do you consider this to be a systematic effort by IDSA to enforce guidelines or just individual physicians?

Lorraine Johnson: I wouldn’t know the answer to that. I don’t know if the IDSA has a policy on it but I know that it –- the fact of the matter is that whether it’s because the IDSA members are reading the guidelines and taking them as sacrosanct or whether it’s because they believe that they are under a directive to do that, they are doing it.

Dr. Parsonnet: You know, you’re the lawyer and I am not, but, when you say that IDSA enforces it – I think it implies that the organization is enforcing these guidelines rather than what you seem to imply now that its individual members of IDSA, who independently might be testifying individual cases. I wonder whether that just doesn’t add a little bit to the…

Lorraine Johnson: Well, it may, I mean, you know organizations work through their members, you know, an organization is a, you know, it’s a separate distinct legal entitiy. It can’t walk, it can’t talk, you know, so it acts through its members and if the IDSA wanted to have its members not testifing against physicians who didn’t comply, they could easily hold back on that one and ask their members not to do it.

Dr. Parsonnet: Well, I, as a member, I would never do what my organization tells me to do. I do treat patients for the Lyme disease and with chronic symptoms. And I’ll do what I think is in the best interest of the patient regardless of what my society says. So…

Dr. Baker: Dr. Lantos?

Dr. Lantos: Thank you for your presentation. I um – I’ve come across a number of clinical scenarios in which I’ve had to treat patients with Lyme disease in manners that are not specifically addressed the guidelines. The most common being when patients have preexisting allergies to antibiotics that are recommended. So, alternatives need to be chosen or recommendations that exist in Europe for treatment of European Lyme disease need to be applied to American patients and I have never found that I was compelled to follow the letter of theIDSA guidelines when it seemed contraindicated in a particular patient. Do you find that the

sense that the IDSA guidelines are mandatory applies specifically to the chronic Lyme disease scenario and not the other aspects of Lyme disease?

Lorraine Johnson: Well, I think it’s – I think it is particularly is focused in the chronic Lyme scenario. It may apply in the earlier stages, but I don’t think that the controversy is as heated in the early stages of the disease in terms of treatment. I wanted to address the insurance issue that was raised earlier if that would be okay.

One of the things that I did – in preparing but I didn’t have enough time to bring the slide on it. was I took a look at the independent medical review that our state has and many states have, which says that if your insurance denies you then you can go to what they call an independent medical review. And the independent medical review send out whatever cases are being appealed for review. And my experience has been that they are routinely referred out for review to ID physicians; they’re sent out to specialists in the ID area. And so what happens with Lyme patientsis – is say, on a regular disease, you would have 39% of the patient’s who appeal, succeeding on that appeal. What happens with Lyme patient is its 9%. So, the impact of the guidelines and the way that they are brought to I mean this is sort of what I mean when I’m talking about the mandatory nature of the guidelines. I mean part of it is, it is a societal influential aspect which you know, I would say that this society has got so much power and so much influence that the obligation to use it responsibly is much greater than it would be on a normal medical society.

Dr. Baker: May I ask on the clarification on the 39% and 9%? Is that in California or is that throughout the United States? Where does that data come from?

Lorraine Johnson: I happen to do that in California because California happens to actually have this all on a database so it makes it very easy to do, but I would be surprised if the statistics vary.

Dr. Baker: So, that information was from the State of California?

Lorraine Johnson: That’s true.

Dr. Baker: Okay. In view of time, again, I’m going to move on to our next presenter but I will reiterated if we have time in afternoon, we may want to have some of the presenters come back to the podium to answer questions from the panel. Thank you so much for your presentation.