The issue is not whether or not "Chronic Lyme" exists. Clearly, there is no evidence to suggest that chronic infection from borreliosis persists after adequate (that is, in most cases, three weeks) of antibiotic treatment. On the other hand, the symptoms that patients feel, including fatigue, joint pain, and muscle ache, are indeed real, as, by definition, all symptoms are. Obviously, something is going on from a pathophysiology standpoint to cause such abnormal symptoms, but we can't say, in 2008, what that process is. It may some undetectable infectious or inflammatory process, it may be related to pain perception and neurologic pathways, or it may be related to psychological phenomena, or perhaps even black bile. Regardless, we clearly do not have the capability to diagnose the etiology of these symptoms with our current medical knowledge base and armamentarium of testing. That is nothing for the medical community to be ashamed of -- someday we'll figure it out.

No, the real issue is whether or not the use of longterm antibiotics is of any use in treating whatever it is that is causing these symptoms. Because that it is what is at the root of the cottage industry that has sprung up around the country to treat this malady. Western Medicine is based on science, and it is indeed specious science to draw the conclusion that antibiotics are the correct modality of treatment for this disorder when there is no evidence beyond anecdotes and pure conjecture that infection plays any role in the development of the syndrome which some, in this day and age, refer to as "Chronic Lyme". It's pure faith healing, and people are spending a great deal of their emotional, temporal, and financial means pursuing it. It is up to the scientific community to determine if this is indeed good medicine, or, rather, predatory behavior by some physicians who view this as a way to make a good living on the earnest gullibility and hopefulness of the infirmed.

That is why, while the ultimate goal is the development of adequate diagnostic modalities to determine the underlying cause of this peculiar syndrome, the most immediate step should be to do exactly what the author of this article proposes -- to run a double-blind, randomly controlled trial of long-term antibiotic use for the treatment of Chronic Lyme. It will not necessarily show cause and effect, but it will allow us to know if there is reason for the cottage industry of so-called "Chronic Lyme" medicine to continue to exist in its current incarnation.

To wit, there are certainly individuals who can cite chapter and verse from their own experiences about the efficacy of these treatments, using their resolution of symptoms as a very real personal data point. But individual anecdotes are not what science is built on, and despite what some in this country would have us believe, science is still the motor that drives the progress of our society, and most certainly, the progress of Western Medicine.

As an aside, as it exists now, the treatment of Chronic Lyme with longterm intravenous antibiotics, in the face of a lack of evidence to support it, can be seen as a specific sub-group of alternative medicine, more closely aligned with the anecdotally-based doctrines of homeopathy, herbal medicine and faith healing than with biomedical science. There is, of course, nothing wrong with this, but certainly one cannot expect those professional societies that represent the evidence-based approach to medicine that serves as the foundation of Western Medicine to sign off on such practices in good faith. It would be like asking a Darwinist to sign off on the introduction of the Creation story in to science class. The dogmas can exist side by side, but are definitely exclusive of each other.

"Clearly, there is no evidence to suggest that chronic infection from borreliosis persists after adequate (that is, in most cases, three weeks) of antibiotic treatment."

This statement is incorrect. There is plenty of evidence from animal models and human studies to support persistent infection with Borrelia burgdorferi after "adequate" (that is, short term) antibiotic therapy. Based on this incorrect premise, the rest of the post falls like a house of cards.

I whole-heartedly agree. However, the NIH has spent >$8M on four placebo-controlled clinical trials, all of which indicate that extended antibiotic therapy is not beneficial for the treatment of "chronic Lyme disease" (Amer.J. Med. 121: 562-564, 2008). It is just that those who advocate such treatment do not accept the results of these published, peer-reviewed studies. Since they still persist in advocating an unproven approach, it is incumbent upon them to provide convincing evidence to the contrary by conducting their own clinical trials. I challenge them to do so.

I apologize, as in my haste to write such a long post, I did not make my initial statement clearly enough at the beginning of my first message. There is some evidence to suggest that detectable, albeit low levels of b. burgdorferi have been found in patients (mostly animals) after treatment with antibiotics. There is, however, no evidence to show that CLINICALLY RELEVANT INFECTION persists beyond antibiotic treatment, that is, that the low level of persistent PCR-detected borrelia has any causal relationship to the syndrome at hand. Some patients with the syndrome have low levels of persistence, the majority do not. Similarly, the presence of funguria in febrile hospitalized patients with foley catheters does not intimate that the funguria is the cause of fever. Sometimes it is, most often it is not. To draw a causal relationship here is indeed specious science. As such, the point remains that the central tenet of the cottage industry of Chronic Lyme medicine is not based in scientific evidence, as there is of yet no cause and effect relationship shown between low level PCR detection of b. burdorferi and the clinical syndrome of Chronic Lyme (as the vast majority of patients with the syndrome do not have detectable levels of borrelia), and there is no evidence for the efficacy of antibiotic treatment in eradicating the symptoms of the syndrome.

If you can show me a study that gives a statistically significant causal relationship between borrelia and Chronic Lyme syndrome, then your point will hold more water than it does, but until that time, the lack of evidence dwarfs the specious science here.

That being said, don't get me wrong -- I'm not denying the existence of "Chronic Lyme". What I am saying is that the term "Chronic Lyme" suggests that the disease is caused by persistent borrelia infection, and that has not been shown. I think that someday we will know the cause of this syndrome, and it may end up being borrelia infection, and we may someday show that longterm antibiotics are helpful, but as of 2008, that is certainly not the case. Please tell me how that is wrong, and, as other responders to you have asked, please provide scientific evidence for either a causal relationship between borrelia and chronic lyme or for the efficacy of antibiotic therapy.


Believe me, if it were out there, the medical community would gladly, GLADLY accept it.

Look, I understand that this is a contentious issue, and I think that the medical field has fallen short in its bargain with patients by often quickly dismissing the claims of those with this syndrome, but there has to be hard evidence, otherwise the scientific community will not embrace the definitions of disease and treatment modalities as they currently stand. You cannot fault them for that. The advances in medicine have been based in hard science, not in semi-blind faith.

Before anybody jumps on me, I realize that funguria and fever example I gave above is not a completely analagous scenario here -- I was using it to show the true-true and unrelated nature of many laboratory findings in the setting of clinical scenarios. So, lay off!

Readers of this debate on the so-called “evidence” that long-term antibiotics don’t help chronic Lyme patients need to understand Dr. Phil Baker’s financial conflicts in the context of this discussion.

Of the four double-blind placebo-controlled studies cited in this debate, the $4.2M “Klempner Study” is the **only** antibiotic trial that definitively concludes that antibiotics don’t help chronic Lyme patients. This study was rife with controversy from the beginning. The awarding of this grant was so contentious, that a GAO investigation was initiated (B-274269). The study was terminated early, and the sloppy conclusions were rushed into publication for political reasons. (For an excellent autopsy of the flaws in this study, read Pam Weintraub’s book, “Cure Unknown.”)

In this online discussion, let’s shine the Lyme-light on Dr. Baker’s financial conflicts. Dr. Baker fails to mention that he was the project officer of this controversial NIH Klempner study (www3.niaid.nih.gov/news/newsr­eleases/1996/lyme.htm), and now, upon retiring from the NIH, he was just hired by the same old boys club (ALDF) who profited from this $4.2M grant. This is classic revolving door scenario—a revolving door that shuffles former federal employees into jobs as lobbyists, consultants and strategists.

The root of the Lyme problem is that the science is being tightly controlled by a small group of researchers with a commercial agenda and too much power over what gets published and who presents new findings at conferences. These are conclusions reached independently by the Attorney General of Connecticut, author Pam Weintraub, and our Lyme documentary, UNDER OUR SKIN.

The unbiased science says that Lyme disease causes chronic conditions that we don’t fully understand yet, and that antibiotics ease the suffering of chronic Lyme patients. Let’s do the humane thing and give these patients lifesaving antibiotics until we develop more accurate tests and more effective treatments.

For your information, Mr. Kris Newby, my salary as a government employee is the only compensation that I have ever received for my efforts on Lyme disease. I resent your false accusations.

Life-saving antibiotics? WTF?

You guys can take whatever you want, as long as somebody will prescribe it for you. On the other hand, without scientific evidence to support its benefit, you cannot expect biomedical scientists and their professional societies to support the use of such medicines. Neither can you expect insurance companies to pay for such treatments when their is no scientific data to support their use.

Look, hot cocoa makes a lot of people feel better. It may soothe your sore throat when you have a cold. That doesn't mean Medicare should pay for your supply of Swiss Miss.

Stop conflating the issues.

Someone who compares withholding antibiotics to hot cocoa when treating late stage neuroborreliosis, simply hasn't read the worldwide body of literature on this disease.

The scientific evidence is there, but in the case of the NIH-funded Klempner Study on "post Lyme syndrome," all the evidence has not been disclosed to the public.

Read this excerpt from "Cure Unknown" (pg 274) on undisclosed findings associated with the Klempner Report:

"...the NIH agreed to make the rhesus monkey treatment regimen exactly the same as the treatment regimen used by Klempner on his human patients--except that instead of relying exclusively on [indirect] tests like Western blots for antibodies and PCR for DNA, they would also sacrifice the monkeys and look for the spirochetes themselves. Thus, Philipp would be performing a sort of fact-check of Klempner's works... While Philipp is mum on the results pending publication, as this book goes to press, word from a number of academic insiders is that he's replicated in monkeys the mouse studies done by Barthold at Davis and the dog studies done by Straubinger at Cornell, posing a challenge to the NIH conclusions that have determined patient care for years... Increasingly evidence suggests that low-level infection in some patients can cause the kind of "pro-inflammation" that may be at the root of the pain and fatigue that chronic patients report."

Why has it taken the NIH over ten years to publish the mirror-study monkey evidence that shows that six weeks of IV antibiotics doesn't eradicate Lyme bacteria from a primate's brain, and that these bacteria may go on to cause chronic disease? Why is the existence of chronic Lyme such an "inconvenient truth" for the NIH and the CDC?

To Dr. Baker: The former director of the American Lyme Disease Foundation (ALDF) was paid a salary of $100,000 a year. Are you saying that you receive absolutely no compensation for running this organization?

Again, and this is getting kind of ridiculous, so I'm going to stop commenting on it, you are CONFLATING THE ISSUES. DO YOU UNDERSTAND THE DIFFERENCE BETWEEN NEUROBORRELIOSIS AND CHRONIC LYME DISEASE? We are talking about the syndrome known as CHRONIC LYME.

There is a documented disease of neuroborreliosis -- it occurs when lyme infection has gone untreated and infects the CNS. It can cause multiple neurologic and psychiatric symptoms and can be diagnosed with readily available diagnostic techniques, and a cause and effect relationship has been established. Furthermore, it has been shown to be treatable with antibiotics.

Chronic Lyme disease manifesting as fatigue, depression, malaise, myalgia, arthralgia, etc. is not the same as neuroborreliosis. It is often seen in patients with no documented evidence of ever having been infected with Lyme. It has no evidence suggesting efficacy for antibiotic therapy. ANTIBIOTICS DO NOT SAVE LIVES IN CHRONIC LYME DISEASE.

Furthermore, I have to point out that, since the symptoms of the syndrome that we currently call "Chronic Lyme" are only relatable from patient to physician by the use of language and not by objective evidence, there is very little to be learned from any animal study, including the simian study that you cite above, as symptomatology cannot be ascertained from a monkey.

I will presume that you are not a physician, otherwise you would understand the difference.

There IS NOT A SINGLE CASE IN ALL OF MEDICINE WHERE A PROFESSIONAL SOCIETY, GOVERNMENTAL HEALTH ORGANIZATION, OR THIRD PARTY PAYOR WILL ACKNOWLEDGE THE EFFICACY OF TREATMENT BASED ON ANIMAL STUDY.

The treatment of Lyme Disease is a science. The treatment of Chronic Lyme is not a science. Someday it may be. Until then, why should it be recognized as such by any scientific body?

What's so hard to understand about that?

There is no evidence that hot cocoa is inferior to antibiotics in treating CHRONIC LYME DISEASE, not NEUROBORELLIOSIS. And that is because there is no evidence for antibiotic efficacy over placebo.

Do you really think that if there were scientific evidence to treat Chronic Lyme syndrome with antibiotics that physicians and professional societies wouldn't embrace it? Who does that benefit? Certainly not physicians, and certainly not pharmaceutical companies. If anything, the medical community overuses medication in situations where evidence is scanty at best.


You guys are very passionate about this. I understand. It's a frustrating thing. But at this point you're grasping at straws.

Have faith. At some point we will understand this syndrome, its cause, and its effective treatments. It may be in five, ten, twenty, or fifty years. But we'll get it. It's not like nobody's interested in finding it out.

Until then, why not think rationally?

"There is, however, no evidence to show that CLINICALLY RELEVANT INFECTION persists beyond antibiotic treatment, that is, that the low level of persistent PCR-detected borrelia has any causal relationship to the syndrome at hand."

So patients with culture-positive or PCR-positive symptomatic Borrelia infection following failure of short-course antibiotic therapy do not have "clinically relevant infection"! Now we are really back in the Stone Age.

"There IS NOT A SINGLE CASE IN ALL OF MEDICINE WHERE A PROFESSIONAL SOCIETY, GOVERNMENTAL HEALTH ORGANIZATION, OR THIRD PARTY PAYOR WILL ACKNOWLEDGE THE EFFICACY OF TREATMENT BASED ON ANIMAL STUDY."

We are not looking at efficacy of treatment in animal models. We are looking at failure of short-course antibiotic therapy. All those animal models (gerbils, hamsters, mice, dogs, monkeys, horses) demonstrate failure of the IDSA treatment approach and the need for extended therapy in Lyme patients with persistent "clinically relevant infection".

One other point in addition to what Dr. Stricker wrote. Physicians don't practice science, they practice medicine. For most of my life, that meant that they were free to use their best clinical judgment in deciding what illness a person had and how it should be treated. Obviously those judgments were formed by their understanding of the underlying science.

But in cases where science did not yet have the answers, as it does not with regard to chronic Lyme disease, doctors were free to use their clinical judgment as long as it was supported in some manner by scientific evidence and clinical success. In the case of chronic Lyme, not only do you have science that suggests persisting infection, but you have overwhelming anecdotal success in clinical practice.

Unfortunately, scientists who have yet to find the answers to chronic Lyme, and the insurance industry who underwrites them, have turned this whole concept inside out. Now, doctors are not allowed to use their clinical judgment in the absence of absolute scientific proof because it offends the powers that be, and costs the insurance companies money.

Meanwhile, patients who found the one treatment that works for them have it and the doctor who prescribed it ripped away from them and are told to go suffer and die because the science hasn't caught up with the clinicians.

Kris Newby: Your response(s) to Baker were right on the money. Thank you for all the time you have put into investigating the politics of Lyme disease, and your willingness to stand up to corrupt propagandists like Phil Baker, a man who, when he was put in charge of Lyme disease at NIH, was described to me as "the dumbest man in the room." Perfect qualifications to head the ALDF.

For those who believe that medical practice is based primarily on science, I refer you to Johnson L, Stricker RB. Treatment of Lyme disease: a medicolegal assessment. Expert Rev Anti Infect Ther. 2004 Aug;2(4):533-57, in which the authors point out that in 1992, the Institute of Medicine estimated that only 4% of medicine was supported by strong evidence. A more recent estimate pegs the number at 20% of medicine being supported by rigorous clinical trials, Johnson said in her 2004 presentation to the annual International Lyme and Associated Diseases Society meeting in New York. Lyme disease is clearly not one of the better studied areas.

According to Johnson, this creates an enormous evidence gap—roughly 80%-- if you set the evidence bar at controlled studies. To the extent that insurers can take advantage of this gap, they increase profits by denying care. They tend to pick on the weakest areas—those without strong consensus.

Johnson also pointed out that the IOM and other commentators [such as Rosenbaum S, Kamoie B. Managed care and public health: conflict and collaboration.J Law Med Ethics. 2002 Summer;30(2):191-200. Review.] have noted that the lack of strong evidence creates the potential for inappropriate treatment vacuums if the evidence levels are set too high.

In my view it is unreasonable to expect very ill patients to wait [years] for more clinical trials to be performed, when a number of studies and anecdotes support longer term treatment. If antibiotics are dangerous, well then so are chemotherapy and
radiation, but no one is talking about cutting cancer patients off from one of their few effective therapies.

Yes. That's exactly what I am saying. I serve without compensation.

Yes. I receive no compensation as Executive Director of the ALDF. I do this purely in the interest of educating the public about Lyme disease based on the evidence derived from basic and clinical research.