Persistence of the Organism is Well-Accepted

From Steven Barthold, professor in the Department of Pathology, UC-Davis, and published researcher in veterinary science:

We've been working with looking at Lyme disease for well over 25 years in my laboratory. And what I am most interested in is the biology of this organism in the immune competent host and we use a mouse model for the most part to do that. And what comes across very clearly is that this bacteria is very good at persisting for the, literally, the lifespan of the animal. And we see this persistence in otherwise immune responsive hosts, in mice and rats and hamsters and guinea pigs and gerbils and dogs and monkeys.

Source: The Diane Rehm Show, 2-29-12

http://thedianerehmshow.org/shows/2012-02-29/diagnosing-and-treating-lyme-disease/transcript

Who are the Denialists?

In the September issue of The Lancet, several authors known for their research into tick-borne disease attacked those patient advocates, researchers and clinicians who favor treating severe cases of Lyme disease with long courses of antibiotics. Equating them with those who deny that HIV causes AIDS, they used psychologist Seth Kalichman's words in Denying AIDS to describe them:

"'They are deeply skeptical of science and untrusting of government and big business. Some are surely misguided and others seem to foolishly believe that they understand everything there was to know...'.

Then they go on to re-define what Kalichman calls antiscience by including:

"we will define this antiscience outlook to also include the promotion of pseudoscience and science that has weak credibility or validity because of fundamental flaws in its design or poor reproducibility."

The article goes on to use innuendo, ad hominem attack, ad populum arguments, lack of citations for factual statements, and other logical fallacies to say that long-term treatment advocates must be wrong. But is this what Kalichman says?

1. He defines HIV denialism as a mutation of the first stage of mourning, denying the severity of the illness and the need for aggressive therapy. "The most extreme case of maladaptive denial is malignant denial, during which people completely ignore their physical condition, with potentially irreversible damage (p. 3)." This description does not define the Lyme disease advocates in the Lancet editorial. Rather, these advocates admit to a serious illness and seek therapy.
   
2. Kalichman encourages patient questioning. "Research has shown that patients who actively engage in their care and probe their providers with challenging questions actually survive longer than those who remain passive (p. 4)." "Science has made great advances when pushed by outside thinkers (p. 160)." Lyme advocates may not know everything about science or health, but many have spent years studying one subject: tick-borne disease. On the other hand, the articles of the Lancet article have also said that symptoms after short-term treatment are "the aches and pains of daily living (p. 1115)," largely a problem for women, and largely all in their heads. Who are the denialists here?
   
3. Kalichman points to the malignancy of the science/denialist debate as becoming personal: "The bickering goes on to this day....The exchanges are personal and bear no resemblance to scientific debate (p. 37)." As in the article in Lancet.
   
4. Kalichman's solution to the debate is not more debate (p. 161). Rather, it is trust. "Making science and medicine more accessible to the public will help people distinguish between real science and that which masquerades as science. Trust is also established when doctors, nurses, and other health care providers listen to their patients (p. 162)."
   

Certainly, there are extremists on both sides of the Lyme debate, as there are in almost every controversy. It is time to get past the rhetoric and on to settling some of the basic questions concerning diagnosis and treatment of tick-borne diseases. According to the Institutes of Medicine, there are still plenty of questions. Solutions will put the need for advocacy to rest.

Kalichman, S. (2011). Denying AIDS: Conspiracy Theories, Pseudoscience, and Human Tragedy. NY: Copernicus Books.

More on the Patient-Clinician Partnership

Lyme patients aren't the only ones being given short shrift in medicine. They also aren't the only ones reaching out for medical advice on the Internet. Dave deBronkart found out about an experimental treatment for his cancer by speaking to other patients online, and he talks about it on Ted.com . Yes, the treatment was successful.

In The Widening Circle, Lyme pioneer Polly Murray wrote,

The preponderance of support groups and of patients acting individually as their own advocates is symptomatic of a health care profession that has become so stressed and fractured that the opportunity for a successful doctor-patient relationship has been compromised.

She goes on to quote Dr. Howard M. Spiro:

The more medical science advances, the more the art of medicine seems to decline...

And finally, she cites Dr. Richard J. Baron:

We must learn to hear our patients as well as their breath sounds; after all, what are we listening for?

When the diagnosis is bleak, and when perhaps there are more cutting-edge treatments out there than one's local doctor or hospital knows, reaching out to that great Internet "cloud" can reap rewards, if only to lend an ear of sympathy. If clinicians aren't providing that service anymore, then they should not be surprised that patients will look elsewhere to find it.


Murray, P. (1996). The Widening Circle: A Lyme disease Pioneer Tells Her Story. NY: St. Martin's Press, p. 289.

Spiro, H.M. (1986). Doctors, Patients, and Placebos. New Haven, CT: Yale University Press, p. 28.

Baron, R.J. (1985). An Introduction to Medical Phenomenology: I Can't Hear You When I'm Listening, Annals of Internal Medicine 103, p. 609.

Patient Advocacy, Micro and Macro

Michael Lockshin, MD and his patient Alida Brill wrote a book about the physician-patient partnership -- how it feels to be a clinician and a patient working together in empathy to decide on patient care. In this case, the patient (Ms. Brill) was suffering from the autoimmune disease Wegener's Granulamatosis. I recommend their book as a good one to understand how to engage in a dialogue, not a monologue, over treatment.

But Dr. Lockshin also spent some time working at the National Institutes of Health on policy, and he had something to say about how the dialogue with patient advocates can help or hinder the advancement of their goals:

I also learned the politics of policy. I should have known, but did not at the time, that in policy decisions, when convictions are deeply held, truth does not matter unless it can be cogently sold. I repeatedly watched people present their cases truthfully but poorly and thereby lose arguments that they should have easily won. I saw people who were untruthful and wrong speak fervently and compellingly and win, and I saw that, as a result of these false arguments, misdirected policy would ensue. During my stay in Bethesda Lyme disease, breast implants, fibromyalgia, and animal research advocates and detractors found themselves unable to negotiate positions civilly. The resulting policy was at times incoherent and often ignored. (page 141)

Whether it is a dialogue between doctor and patient, or between advocate and legislator, we must strive to work together in partnership, or we might be left out of the collaboration altogether.


Brill, A. and Lockshin, M.D. (2009). Dancing at the River's Edge: A Patient and her Doctor Negotiate Life with Chronic Illness. Tucson: Schaffner Press.

Chronic Fatigue, Major Discovery

Please take the time to read the blogs from Pamela Weintraub on Psychology Today's website (she is the author of the 2008 Lyme book, Cure Unknown), and Hillary Johnson's blog (she is the author of the book on the investigation into chronic fatigue syndrome, Osler's Web). They talk about a recent discovery, published in the October issue of Science magazine (reported online at Medical News Today, that pinpoints a retrovirus as a major cause, perhaps the cause, of chronic fatigue syndrome (also called myalgic encephalomyelitis).

Remember chronic fatigue syndrome? It was called the "yuppie flu" 20 years ago. People who had it were called malingerers or worse.

Today, some researchers want to lump chronic Lyme, chronic fatigue, fibromyalgia, and Gulf War syndrome under one label: chronic multisymptom illness. As Ms. Weintraub points out, if chronic fatigue seems to have an infectious origin, might not these other conditions also? Could a retrovirus be a player in chronic Lyme? Yes, there is evidence that retroviruses can be tick-borne, though a link between Ixodes ticks and this particular retrovirus has not yet been made. It is just one more intriguing piece of the puzzle.

Dr. William Schaffner of Vanderbilt University told the New York Times,

"My first reaction is, ‘At last,’ ” Dr. Schaffner said. “In interacting with patients with chronic fatigue syndrome, you get the distinct impression that there’s got to be something there."

Upon hearing so many similar histories from chronic Lyme patients, I would tend to say the same thing.

Grady, D. (2009). Virus is found in many with chronic fatigue syndrome [Electronic version]. New York Times, October 8, p. 18. Retrieved October 11, 2009 from
http://www.nytimes.com/2009/10/09/health/research/09virus.html?_r=1&em

Edited for accuracy, I hope

The official webcasts, transcripts, and supporting documentation from the IDSA Lyme guidelines testimonies are now available on the IDSA website. If the little I looked at is any indication, the webcasts are quite understandable, but the official transcripts are awful.

I read the first page of the first speaker (Tina Garcia) while listening to the webcast, and found at least 10 errors on the first page of the transcript. Some of these errors affect the meaning of the presentation, and other times they affect its impact. On 3 occasions on the first page of the text, the transcriptionist decided the speech was "indiscernible," yet I had no trouble understanding what was said in all three instances, while listening on my computer without watching the video and without wearing the hearing aids that correct my mild-to-moderate hearing loss. In Tina's transcript, the transcriptionist could not discern the words "egregious," "I awoke feeling as though" and "bicillin."

Later in the document (p. 3), the phrase, "that bring them close to death's door" became "that bring then close to death store." On yet another page (p. 2), her description of what infectious diseases doctors were saying about long-term treatment was taken out of quotes, making it look as if she herself thinks that long-term treatment is "of no benefit and may be harmful."

My observations are based on just one text. I hate to see what is in the rest. Someone at IDSA should review the transcripts for accuracy. I think we all would expect nothing less of an 8,000-member organization representing the scientific and medical communities. Let me be clear: I am glad for the webcasts, but disappointed in the "official" transcripts.

There is plenty to disagree about when it comes to tick-borne disease, but reasoned discourse is not possible when misrepresentations abound. I truly hope this post becomes obsolete as IDSA notes their error and takes steps to correct it.

Whose evidence is it based on?

One of the arguments that continually came up in the IDSA Lyme guidelines hearing was that of using evidence-based medicine (EBM) in the treatment of Lyme disease. Part of EBM requires the healthcare professional to be apprised of the most authoritative studies for the treatment of a particular condition, in order to give the best patient care. This is laudable in all of healthcare, including Lyme disease. But it is only part of what EBM is. According to the Centre for Evidence-Based Medicine, EBM is a fusion of:

• best research evidence, especially that derived from relevant patient studies
• clinical expertise, emphasizing the healthcare professional's experience with the disease and with the patient
• patient values, which may include variables such as personal preference, lifestyle needs, religious convictions, literacy, compliance, and cost

Dr. David L. Sacket, one of the fathers of EBM, and his associates had this to say about the practice of EBM:

The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice.... Evidence based medicine is not "cookbook" medicine. Because it requires a bottom up approach that integrates the best external evidence with individual clinical expertise and patients' choice, it cannot result in slavish, cookbook approaches to individual patient care. External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all...

When it comes to an emerging diseases such as tick-borne illness, true evidence-based medicine would be welcome, but it should be noted that the current few studies using too few patients with only a few treatment options might not pertain to the many ways in which a patient may manifest the disease or respond to treatment. According to EBM, in such cases, the clinician's judgment and the patient's values should be allowed to prevail.

Sacket, D.L., Rosenberg, W.M.C., Gray, J.A.M., Haynes, R.B., and Richardson, W.S. (1996). Evidence based medicine: what it is and what it isn't, British Medical Journal 312, 71-72. Retrieved September 7, 2009 from http://www.bmj.com/cgi/content/full/312/7023/71 (free registration required).

See also Dr. Daniel Cameron's testimony at http://idsociety.org/Content.aspx?id=15026 and his article, "Generalizability in two clinical trials of Lyme disease" in the October, 2006 edition of Epidemiologic Perspectives and Innovations.

To Each His Own Summit

I had the opportunity to speak with Ed Webster, who had climbed Mount Everest, including an assault without oxygen or sherpas, in the 1980's. We talked for awhile about his climbs, the last of which resulted in the loss of several fingers and toes, due to a moment of taking off his outer mittens to take a photograph. It called to mind how often the punishment does not fit the crime in life.

Ed is now living in Maine, and we got to talking about Lyme disease. He was truly moved to hear about a family member of mine who has struggled, and mentioned that he had two friends who have also been afflicted. This man, who has had to completely work around his own physical loss, and I'm sure is reminded of it daily, had compassion for others who struggled daily with a disease. We shook hands, we hugged, and I am a little more thankful for the things that I have today.

Happy Independence Day.

Webster, Ed. Snow in the Kingdom: My Storm Years on Everest. 2000

The Heart of Healthcare

With all the interest in healthcare reform these days, I found this quote from the Annals of the New York Academy of Sciences in 1994 most interesting. It was written by Robert O'Brien, CEO of Empire Blue Cross and Blue Shield of New York. He writes:

The art of medicine as practiced by the excellent physician is not just the recall of technical data from medical texts and journals. It is the synthesis of this information, the power of deductive reasoning, and the skill of active listening in a physician-patient encounter. The excellent physician has the intelligence, intuition, and interpersonal skills and respect for the patient that no battery of tests or detailed medical records or clinical protocols can replace. When the physician brings all these attributes to the encounter, medical quality outcomes can then be measured: early and accurate diagnosis, appropriate medical treatment, effective use of resources, and continuity of care after the initial encounter.

Cost-effective medicine is bound by excellent physicians knowing their patients. And superceding cost-effectiveness is successful outcome -- the patient is healed -- also bound by knowledgeable healthcare practitioners knowing the science and knowing the patient.



O'Brien, R. (1994). The doctor-patient relationship. Beyond the Crisis: Preserving the capacity for Excellence in Health Care and Medical Science, Annals of the New York Academy of Sciences 729, 22-26.

Science, Bent

Thomas O. McGarity and Wendy E. Wagner wrote Bending Science: How Special Interests Corrupt Public Health Research, to describe how scientific research can be corrupted before, during, and after the study is designed and completed in order to skew the results toward a particular point of view. Unfortunately, it is difficult for judges, legislators, and the public to tell when medical studies, reviews, and guidelines are being manipulated for a biased purpose.

The authors describe how research can be bent:

Shaping Science -- ..."Commission research designed to
produce a particular outcome"

Hiding Science -- "suppress the unwelcome
findings"

Attacking Science -- "launching ilegitimate attacks on
damaging research"

Harassing Scientists -- "a full-scale assault on the
integrity of the researcher"

Packaging Science -- "commissioning review articles that
purport to summarize existing research on a topic but... portray existing
research in the light most favorable to the sponsor."

Spinning Research -- "portraying damaging research as
'fatally flawed'...to generate pressure on decision-makers to discount
it." (p. 39-40)

The authors recognized that big business and advocacy groups could both be at fault for bending the science to meet their pre-conceived ideas. When looking at Lyme medical information, we have to constantly ask, Who is telling me this? How do they know this? Do their definitions of the disease and its treatment fit with what is known?

When presented with the facts, we need to adjust our thinking, not the data.


McGarity, T.O. and Wagner, W.E. (2008) Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press.

Paul Farmer on Infectious Diseases

Pulitzer Prize-winning author Tracy Kidder wrote Mountains Upon Mountains in 2003, tracing the work of Dr. Paul Farmer, anthropologist and epidemiologist, winner of the MacArthur "genius grant," who has worked with some of the poorest patient populations in the world, as well as some of the most prosperous in Boston.

Statements made about tuberculosis treatment in the book are most interesting.

From Chapter 13:

Meager incomes don't guarantee abysmal health statistics, but
the two usually go together....One-third of humanity, have TB bacilli in
their bodies, but the disease tends to remain latent. It multiplies into
bone-eating, lung-consuming illness in only about 10 percent of the
infected. The likelihood of getting sick increases greatly, though, for
those who suffer from malnutrition or various diseases...

Though I wouldn't necessarily equate Lyme patients in the US with Tuberculosis patients in Haiti, a few similarities are present. Both diseases seem to be latent in many patients, coming out due to malnutrition or coinfection. (Many Lyme patients seem to lack vital nutrients, perhaps due to the infection itself.) And with Lyme patients unable to get diagnosed or treated, due to our healthcare system and the disbelief in chronic Lyme, Americans are often healthcare poor when it comes to Lyme disease.

What is the answer? In Haiti, the answer to TB is antibiotics. When the disease is resistent to a single course of one antibiotic, then multiple stronger antibiotics are given, for as long as two years.

So what is the answer for Lyme patients?

Kidder, T. (2003). Mountains upon Mountains. NY: Random House.

Those pesky healthcare advocates

In the college paper, the Yale Daily News (12/3/08), Leslie P. King, MD PhD wrote an article critical of Lyme advocacy groups, entitled "Watch Out for Lyme Disease," in which she wrote:

"Most scientists and researchers vehemently deny the existence of chronic Lyme disease, citing numerous studies that demonstrate no biological evidence for its existence. Patient advocacy groups dispute the scientific evidence and often enjoy outsized influence over policymakers."

My reply:

Dr. King, I appreciate your comments. I would agree that climate change and the proliferation of deer contribute to the rise in tick-borne disease, and these problems should be addressed.

I disagree, however, that patient advocacy has led to poor science and poor public health policy. Historically, Lyme advocates who have insisted on disease persistence have often been ignored by scholarly reviews, guidelines, and editorials, despite evidence that advocates may be correct that Borrelia persist after treatment in other forms outside the bloodstream (see Hodzic et al, 2008; Norman et al, 2008; and Miklossy et al, 2008 for 3 recent examples).

The IDSA guidelines and insurance companies have also largely ignored the major double-blind, placebo controlled studies that suggest that long-term antibiotics contribute to severe fatigue management (Krupp et al, 2003) and pain relief (Fallon et al, 2007), and that chronic Lyme disease is not "the aches and pains of daily living" (IDSA guidelines, 2006) but rather a debilitating condition of the magnitude of congestive heart failure (Klempner et al, 2001).

In the wake of the CT Attorney general's investigation into possible conflicts of interest and anti-trust violations, many ground-breaking articles have come to print. Is it the result of advocacy, new technologies, or the natural progress of research? Perhaps all three. But clearly, new research is validating what patients have reported all along, and advocates all over the country are welcoming thorough science, wherever it leads.

(See also an excellent reply from Yale Associate Professor Preston Wiles, MD on the importance of patient advocacy groups.)

The Medium is the Message

Marshall McCluhan made famous the phrase, "The medium is the message," meaning that the way by which a message is sent is as important, if not more important, than the message itself. In the news media, for example, a headline article "above the fold" on the front page of a newspaper is deemed to be more important than if that same article were buried in the B section on page 9. How often a topic is covered also contributes to how important we perceive it to be.

A study called Medicine in the Popular Press: The Influence of the Media on the Perception of Disease demonstrated that students consistently ranked diseases that had media exposure as more severe than lesser-known diseases with similar symptoms. Students ranked Lyme disease as more severe than babesiosis, even though they are both tick-borne and were described with similar symptoms.

The researchers wrote:

...individuals will consider high media frequency disorders to be more serious and pose more of a threat than equally serious underrepresented infectious diseases.... Given the results presented in this paper, it is imperative that we fully understand the effects of the media on public perceptions of disasters and disease epidemics. In this age of television and internet media it is important to consider the impact of media reporting on public perception of risk, and public health in general...

West Nile Virus strikes fear when it is mentioned, but Lyme often does not. Yet West Nile Virus occurs much less often than does Lyme, and both can be severe or even fatal. Does that mean that West Nile should not be mentioned? No, but by keeping Lyme in the public eye, people may take it more seriously, seek treatment sooner, and pay attention to prevention strategies.

The Patient-Doctor Partnership

There are two very different skill sets at a typical primary care visit:

• the doctor's skill set: a huge overview of many body systems and body types, and experience with many common presentations of disease, and probably several unusual ones
• the patients' skill set: varying amounts of understanding of the human body, but a good understanding of what is normal and not normal in their own bodies

What may be missing in this scenario is very specific information about the specific symptomology the patient is experiencing. If the symptoms cluster points to something common, or something the clinician dealt with before, no problem. But what if it belongs to something less common, such as late-stage Lyme disease?

In emerging diseases, where research is still ongoing, it would be impossible for every doctor to keep up with every new finding on every disease. Even specialists have their sub-specialties. But patients have only one set of symptoms to understand -- their own. If they are healthy enough and literate enough to research their own symptoms, they can assist in their own diagnosis.

But patients have more than ever to gain by decoding the latest health news and researching their own medical care.

“I don’t think people have a choice — it’s mandatory,” said Dr. Marisa Weiss, a breast oncologist in Pennsylvania who founded the Web site breastcancer.org. “The time you have with your doctor is getting progressively shorter, yet there’s so much more to talk about. You have to prepare for this important meeting.”

There is the potential for a new model of patient care, where decision-making is transparent and both sides contribute information, and the final decision is left to the patient.

“We need to help them sort through it, not discourage the use of information,” he said. “We have to acknowledge that patients do this research. It’s important that instead of fighting against it, that we join them and become their coaches in the process.” -- Dr. Shalom Kalnicki, chairman of Radiation Oncology at the Montefiore-Einstein Cancer Center

Parker-Pope, T. (2008, September 29). You're sick. now what? knowledge is power [Electronic edition]. New York Times. Retrieved October 12, 2008 from http://www.nytimes.com/2008/09/30/health/30pati.html?ref=healthspecial

Congressional Brouhaha over Lyme

On September 27, things got a little testy in the House of Representatives. Frank Wolf (R-VA) had just attended a lunch presentation 3 days before on Lyme disease, hosted by the National Capital Lyme and Tick-Borne Disease Association. He saw Frank Pallone (D-NJ) on the floor presenting bills that could be passed quickly by consensus, and decided to confront him on the Lyme bill, HR741. The exchange soom involved Chris Smith (R-NJ), the author of the bill.

A transcript of the exchange is below in its entirety. To see the video of the exchange, see
the archives at C-Span or http://www.lymerights.org/Pallone_v3.wmv

Speaking:

Rep. Frank Wolf, R-Virginia, 10th District
Rep. Frank Pallone, D-New Jersey, 6th District, Head of the Health Subcommittee of the Energy and Commerce Committee
Rep. Chris Smith, R-New Jersey, author of HR741
Speaker of the House
Rep. John Sullivan, R-Oklahoma, 1st District

[NOTE: I have removed from the transcript things such as stammers, interruptions, or procedural moments. They are removed for the sake of clarity, even while knowing that that such things yield clues to meaning and intent (as do body language and voice inflection). I would refer the reader to a video of the proceedings for further clarity.]


Speaker of the House: Gentleman from Virginia is recognized.

Rep. Wolf: Thank you, gentlemen, and ask for unanimous consent, that I can revise and extend. I was watching this meeting and resolution in my office today, and I support it, I think it’s a good issue. But I want to say to the gentleman from New Jersey: I don’t understand why you’ve boxed up for months and years the bill that Congressman Chris Smith had that deals with Lyme disease. Now, I was at a national Lyme disease conference this week. Lyme disease is spreading through our nation. Lyme disease is spreading through my congressional district. Lyme disease is spreading through New Jersey -- it’s spreading through the gentleman’s district, spreading through Mr. Smith’s district. And if I could get the gentleman’s attention rather than whispering back and forth, I would like to know, I would like to know if we are going to do resolutions like this and take them out of the committee, why Mr. Smith’s bill, which has been pending in your committee for a long time, cannot be considered. If you watched the movie the other day, the number of people that have been impacted by Lyme disease is very serious. This is spreading -- it’s in Pennsylvania, I would tell the person that is chairing the House. It is spreading throughout the United States, and yet the bill is boxed up, locked up, in your committee, and I want to know, because I’ve had enough of seeing this thing go time after time after time, and you’re keeping the bill from coming out, so if I can yield to the gentleman, tell me: what do you plan on doing about Lyme disease? Why won’t you get that bill out? What is the status of it, and what would we tell somebody who happens to have Lyme disease today to know that the bill is pending in the committee? I yield to the gentleman.

Rep. Pallone: Well, as I’ve discussed with the gentleman, ‘cause we have actually talked about this, on several occasions, I believe. We are now doing what we call consent bills, in other words, bills that have the consent, meaning are basically agreed to, not only by the Democrats and Republicans, but also by the members of the subcommittee and the members of the House in general, because as you know you have to have a two-thirds vote to pass these bills or do them by unanimous consent. We do not have anything near consensus on that legislation. It would have to go through regular order, have a hearing, go through subcommittee. The problem is that, many (probably the majority but I won’t venture to say, you know, whether it’s the majority or minority, but many people) do not agree with the protocol, if you will, that is suggested if not mandated by that legislation. In other words, right now, you know the majority of the doctors treat Lyme disease, you know, in a certain fashion. Those who advocate for that legislation suggest a different protocol; and frankly I have tried very hard, as chairman of the House subcommittee not to mandate or make decisions for physicians as to what kind of protocols they use, in this case the protocol is very different from the overwhelming majority of the doctors, and so it’s a very controversial issue that needs to have a lot of debate, so there’s absolutely no way that we could do something like that on a consent calendar, because many of the members simply don’t support it.

Rep. Wolf: Reclaiming my time, then why hasn’t the gentleman had hearings on it?

Rep. Pallone: Well, we can certainly have hearings on it, and as I’ve discussed with the gentleman I would like to have hearings, not only on that bill but on the issue of Lyme disease research and treatment and we will certainly do that in the next session. But we’re obviously not doing this today, in the context of the consent calendar.

Rep. Wolf: Well, reclaiming my time, I will take you at your word that you are going to have hearings. Is that accurate, early in the year?

Rep. Pallone: What I said is that I would like to have hearings on the issue related to Lyme. We can certainly take up the issues that are raised in that legislation in the context of that. But as I would say to the gentleman again, the protocol in that legislation is very controversial. It’s certainly one of the many things that we would have to consider in the context of research and treatment of Lyme disease.

Rep. Wolf: Reclaiming my time, we’re not going to let this issue go away, I want to tell the gentleman from New Jersey, even if I have to come up into New Jersey and go throughout the state, if this bill is being boxed up. Just so members know: incidents of Lyme disease are rapidly rising in Virginia, in my Congressional district, but across the country. According to the Centers for Disease Control and Prevention, from 1993 to 2007, reported cases of Lyme in Virginia have risen 909%, and this committee has done nothing. In the same time frame, reported cases are up 235% nationwide. Lyme disease is frightening. Picture boy scouts and girl scouts camping during summer months; or children playing in their back yard; or joggers on bike paths through tree-lined neighborhoods, sharing the outdoors with a minute insect that can bring monumental health problems. The Congress needs to get serious, so I just want to say I was watching this, and I think you have boxed it up. (You know, when the gentleman was speaking I listened to him, and if you would look at me I would just appreciate it.) I want to tell the gentleman that we’re going to hold you to this with regard to hearings. I will come and testify. But if this issue is boxed up next year, we’re going to deal with it in many ways. I would ask for unanimous…if you’re going to say something, I’ll wait.

Rep. Pallone: Well, I would just say this, you know, it does bother me, because the gentleman is sort of suggesting that you and I haven’t had conversations about this. We’ve actually had many conversations about this. I told you the same thing I’ve just said here on the floor, and I really don’t understand why the gentleman is giving the impression that somehow we haven’t discussed this because we have.

Rep. Wolf: Reclaiming my time, I never said. We’ve discussed it twice. What I’m saying is, that you’ve boxed the bill up, you’ve boxed Chris Smith’s bill up, there have been no hearings, and there are a lot of people around the country that are suffering with Lyme disease, and you appear to be the roadblock, and so what we’re asking for is hearings next year…

Rep. Pallone: Would the gentleman yield?

Rep. Wolf: …give us an opportunity for people of all sides to be heard.

Rep. Pallone: Would the gentleman yield?

Rep. Wolf: I yield.

Rep. Pallone: First of all, I resent the fact that the gentleman has suggested that we’ve been boxing this up. I would point out to the gentleman that the problem of Lyme disease has been around for many years, and the gentleman and his committee, the Appropriations Committee, were in the majority for what, at least twelve years before the last two years of the Democrats have been in the majority. Certainly the gentleman had plenty of opportunity, and still does, to do something about this himself.

Rep. Wolf: Reclaiming my time, I was going to offer the Chris Smith amendment to the Appropriations bill. The Appropriations bill hasn’t met and had the hearings for months. Your side has prohibited any amendments being offered. But I will tell the gentleman, next year, if you don’t move this bill, I am going to offer it to the Labor H bill next year and we will have to deal with it on the floor.

Speaker of the House: Gentleman from New Jersey yields back his time. Gentleman from Oklahoma reserves his time. Chair recognizes the gentleman from New Jersey.

Rep. Pallone: I would just point out that, on this and so many other issues, it is amazing to me that the gentleman who was in the majority for so many years and had so many opportunities to raise this and other issues is somehow now suggesting that the Democrats are boxing it up. You know, Lyme has been around for a long time, the people who are concerned about this issue have been trying to address it for a long time. The bottom line is the gentleman knows that this is a very controversial issue. We’ll certainly raise it. But he had ample opportunity over the many years that he was in the majority to raise it and it just didn’t happen. I yield back the balance of my time.

Rep. Wolf: Would the gentleman yield back to me another minute?

Speaker of the House: New Jersey wants to yield back his time or reserve his time?

Rep. Pallone: I reserve my time.

Speaker of the House: Gentleman reserves his time. Gentleman from Oklahoma has 8 ½ minutes remaining.

Rep. Johnson: Okay Mr. Speaker, I’d like to give Mr. Wolf some more time.

Rep. Wolf: Thank you. This is a growing issue. It is becoming a more important issue and a new issue. If you look at the statistics, it is growing around the nation. It has now become an epidemic, and so when I now see an epidemic taking place in my Congressional district, in your Congressional district, through New Jersey, through Connecticut (if you talk to Senator Dodd, he will tell you), through Connecticut, through Massachusetts, all up and down the east coast, it is time to deal something. And so I think it is time to deal with. And I see the gentleman from New Jersey here. You have blocked this bill for a long period of time, and I will tell you I will not permit you to block it, and next year I will offer amendment after amendment after amendment and do whatever I can to make sure, to make sure the people that are impacted by this, to make sure the people who do not even know what may very well be threatening them will not be threatened. And I urge my gentleman, the gentleman from New Jersey, I yield to him, to also make some comments about this.

Rep. Smith: Mr. Speaker, first of all, I want to thank Mr. Wolf for raising this. I didn’t know he was going to be doing this…

Rep. Wolf: I didn’t know I would be doing it, until I saw the gentleman, Mr. Pallone, standing up and taking himself under suspension.

Rep. Smith: …so I appreciate the gentleman yielding. Let me just say, to clarify the record, this legislation, which would seek to get and lay bare the science about Lyme disease, the fact that, I believe, we do have an epidemic. The fact that it often goes misdiagnosed, under-diagnosed. It is called the “great pretender.” There’s so many people have it and don’t know it, that often masquerades as other different kinds of anomalies manifesting in a person’s body, and it’s not until it gets to a chronic state, very often causing severe disability, including neurological damage, that people finally realize that they have Lyme disease. There’s been, unfortunately, a significant (and I believe it’s a) cover-up of the fact that chronic Lyme exists. The gentleman knows that we have asked him repeatedly – the gentleman from New Jersey, my good friend, Mr. Pallone. This legislation has been pending in his subcommittee. He told Pat Smith (no relation to me)…

Rep. Pallone: Will you yield?

Rep. Smith: …(let me finish), who runs a Lyme disease organization, that this would get a hearing and would be marked up. It has not been marked up, and meanwhile, this epidemic is growing. Now let me just say for the enlightenment of my colleagues: the Infectious Diseases Society of America, which creates (and often does a very laudable job) the definitions, the parameters of what constitutes a certain disease, has looked at Lyme and said that chronic Lyme does not exist. Unfortunately, many of us have raised serious concerns about that, because of what we believe to be conflicts of interest on the part of the panel members that made up of that panel. Chris Dodd is the prime sponsor of the legislation that I’ve introduced on the House side, we work cooperatively on the legislation, so we have a companion bill on the Senate side. The legislation has over 110 (I think it’s 112) co-sponsors, totally bi-partisan, Democrats and Republicans alike, rallying around this legislation. The problem with the Infectious Diseases Society of America is that these conflicts of interest, we believe, have crowded out or caused them to come to the conclusion that chronic Lyme doesn’t exist. We don’t know absolutely if that’s the truth, but Attorney General Richard Blumenthal from Connecticut finally took a look at this and came back with a scathing, insightful report, that there were conflicts of interest. The red flags should go up everywhere. What does my legislation do? As Mr. Pallone knows, the legislation does not prescribe a protocol, as he has suggested. It simply calls for an advisory committee that will take a good long look at Lyme disease, and determine what is fact and fiction, and finally, for the sake of all those who are suffering immensely from this disease, and their families, say what we need to be doing to mitigate and hopefully stop the spread of Lyme. Whether it be long term and very heavy antibiotic treatment, which I believe probably is the case (based on clinical practitioners who have suggested that to be the case). But we want an honest look! As Mr. Pallone knows, we did not get an honest look from the Infectious Diseases Society of America, and I find that appalling. Conflicts of interest with the insurance companies has no place in modern medicine, and regrettably, and it’s been, again, the full weight of the attorney general’s report clearly suggests (Richard Blumenthal of Connecticut) that there were significant conflicts of interest on the part of the panel members. Our legislation says, let’s go where the science takes us. If the science says chronic Lyme exists, then all those patients and the insurance companies which need to be providing the wherewithal to get the coverage, to get the intervening medicines and the like, like the antibiotics, because what has happened, as my friend knows, because of this exclusion of chronic Lyme as a problem in the definition, the insurance companies say, “We don’t have to pay.” So when a patient presents with a bill of a hundred thousand dollars or some excessive amount of money, the insurance companies say, “Not us, we’re not gonna pay for it.” And they go right back to the – what I believe to be – a false definition that precludes chronic Lyme as a condition. Now, you might think that chronic Lyme doesn’t exist, I say to my friend, the chairman. But let’s go where the science takes us. We need this advisory committee, and we need it now. All points of view, as our legislation clearly suggests, has to be a part of this group. We want a robust debate! Not something that is engineered by the insurance companies. Finally, the legislation would authorize $100M over five years, $20M each year. Frankly, if that drops off, it’s only an authorization – I’d like to see it go forward, we’re not spending enough on Lyme. And it is, as Mr. Wolf said so aptly, it is growing exponentially. CDC admits we’re missing most of the cases on Lyme, maybe as many as 90% of the cases go unreported. Our state, Mr. Pallone, as you know, is number 3, according to CDC numbers, and they are probably very much understated in terms of the prevalence of Lyme disease. So I would make the appeal again, as I have made to my friend from New Jersey, as I have made to Mr. Dingle, as I have made to Mr. Barton, and everyone else, this legislation ought to be on this floor, it ought to be on the floor today. It is truly bipartisan! There ought to be a consensus to go where the science takes us. And again: an advisory committee, a blue-ribbon panel, that would be configured under this legislation, would finally end, hopefully, this contentious debate, and tell us what it is and what it is not. And let me also say, too, I have known dozens of people who have had chronic Lyme. Now, you might say it doesn’t exist, Infectious Diseases Society says it doesn’t exist. They’ve got the spirochete. They have been ruled in, in terms of having this very, very dangerous disease, and they have suffered neurological damage, severe joint damage, and many, many other problems. There is a new book called Cure Unknown, that I would recommend to the body. I read it in one sitting, because it is so incisive in finally breaking through the fog on this disease. People are walking around with Lyme and they don’t even know it. We need to bring the forces to bear of the US government, that an advisory committee of this kind would do – a blue-ribbon panel – a 9/11-type panel, of scientists, of the best people we can put together, to say, “Put aside the egregiously flawed Infectious Diseases Society of America’s finding, which Blumenthal (and I urge members to read Blumenthal’s – and I’ll put it into the record, so members can read it) his findings, were atrocious! Conflicts of interest, everywhere! This legislation ought to be on the floor; it ought to be on the floor today.

Speaker of the House: All time from the gentleman from Oklahoma has expired. The gentleman from New Jersey has 16 minutes remaining.

Rep. Pallone: Thank you, Mr. Speaker, and I yield myself such time as I may consume. First of all, I want to say to the gentleman from New Jersey: he’s made a lot of statements about my views on this subject which are simply not true and I do not appreciate them. I have no intention of yielding to the gentleman because of the disrespect that he has shown. Now secondly, let me also say this: I do appreciate the fact that the gentleman from Virginia, Mr. Wolf, has on several occasions come up to me in the last few months and talked to me about this legislation, and we’ve had very reasoned conversations about the legislation. But I will also point out that the gentleman from New Jersey has not. The gentleman from New Jersey has not spoken to me at all about this legislation, and certainly not, in my recollection, in the last year. So if you thought it was so important, the way the gentleman from Virginia did, and has, he certainly had many opportunities to come up to me and talk to me about it. He has not. And I see the gentleman from New Jersey all the time, on the floor, at home, on various occasions. He has not spoken to me. So I want to thank the gentleman from Virginia for at least saying that he has taken the time, had some reasoned discussions about it. That is not true of my colleague from New Jersey, which is why I deeply resent the fact that he is on the floor here today talking about it, ‘cause it’s the first time I ever recollect him talking to me about it. Now, let me say a few other things. First of all, as far as the science is concerned, the science is in the Infectious Diseases Society and the CDC, not with the Attorney General and some political grandstanding that he’s doing in Connecticut, nor with my colleague from New Jersey who’s grandstanding here today. I am very concerned about Lyme disease. I’ve been working with the CDC to address the issue. We’re awaiting answers from the agency on how best to address this. I have in fact talked to many of my constituents about this, even though my own colleague hasn’t talked to me about it from New Jersey. And I would also like to say this: as far as the Infectious Diseases Association, they basically are the majority opinion. Many doctors, including my neighbors who are physicians in my home town, very much agree with the Infectious Diseases Society and don’t think that this should be treated with these antibiotics for a long period of time because they’re concerned about the impact on people about whether they would be seriously injured or even die from the antibiotics. There is a lot of controversy that involves this issue. It’s very involved, and it’s very controversial. It shouldn’t be considered today on a consent calendar. And that was the only point I was trying to make to my colleague from Virginia: that we need to have hearings. And we will have hearings on the issue in general, and we can include this bill as part of that in the next session. But to bring this up today on the consent calendar when they know very well that there’s not agreement on this and we couldn’t possibly get a UC, or have this on the suspension calendar -- it’s really very upsetting, and particularly coming from my colleague from New Jersey, who has never talked to me about this at all. And with that, Mr. Speaker, I yield back the balance of my time.

[End 1:44 pm Eastern]

[1:57 Eastern]

Rep. Sullivan: I yield such time to the speaker from New Jersey, to address another concern.

Rep. Smith: Thank you. I do rise in strong support of House 906, the Mercury Market Minimization Act of 2007, Mr. Speaker. I just, again, I didn’t get a chance when Mr. Pallone was here, to correct the record. We did contact Congressman Frank Pallone and Nathan Deal by way of letter, on May 18, 2007, and wrote at the time, “As co-chairs of the Congressional Lyme Disease Caucus we are writing to respectfully request that you mark up and report HR741. HR741, the Lyme Disease, Tick-borne Disease Prevention, Education, and Research Act of ‘07 would work toward the goals of prevention, accurate diagnosis and effective treatment of Lyme,” then we went on to explain the bill. We pointed out that, at the time, we had 77 co-sponsors – that’s now over 112, and it is totally bipartisan. We also pointed out, significantly, that Lyme is the most prevalent vector-borne disease in the United States today. More than 220,000 Americans develop Lyme each year, and that’s according to CDC that’s only 10% of the cases that meet its surveillance criteria. Our reported cases that fall outside of the surveillance criteria are not even considered anywhere statistically. If not diagnosed and treated early, Lyme disease can lead to chronic illness, and can effect every system in the body, including the central nervous system and cardiac systems. Later symptoms of Lyme disease include arthritis, neurological problems such as facial paralysis, memory problems, extreme weaknesses of the extremities, seizures, heart block and inflammation, and even blindness. And on the second point – so we sent that back in May 18th, 2007, and I say that with respect to my colleague. Let me also point out, and I just will read a very small portion of Attorney General Richard Blumenthal, the Attorney General of Connecticut. This is his statement: “Attorney General Blumenthal today announced ( and this is May 1st, 2008) that his anti-trust investigation has uncovered serious flaws in the Infectious Diseases Society of America’s process in writing its 2006 Lyme disease guidelines, and the IDSA has agreed to reassess them with the assistance of an outside arbiter. (And that has gone very, very slow.) The IDSA guidelines have sweeping (this is Blumenthal speaking) have sweeping, significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care, and are also strongly influence treatment decisions by physicians. Insurance companies have denied coverage for long-term antibiotic treatment, relying on those guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is non-existent.” Blumenthal goes on to say, “This agreement vindicates my investigation, finding undisclosed financial interests, and forcing a reassessment of IDSA’s guidelines.” Blumenthal said, and I quote, “My office uncovered undisclosed financial interests held by several (several) of the most powerful IDSA panelists. The IDSA 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 IDSA’s Lyme disease guideline process lacked important safeguards, requiring complete re-evaluation of its ’06 Lyme disease guidelines; in effect, a comprehensive reassessment through a new panel.” Blumenthal, and I will put this in the record, talks about conflicts of interest with the insurance companies, and again, I would think this Congress would want to get to the science. Find out does chronic Lyme exist, and whether or not this cover-up is indeed a cover-up. Yield back and I thank my friend for yielding.

[End]

Thinking Out of the Box

Wouldn't it be great if every patient presented according to a textbook? It would be easy to recognize a set of symptoms, and choosing a treatment plan would be obvious. Unfortunately , there are so many variables from patient to patient that such simplified medicine is not always possible. Yet doctors have to start somewhere, so they rely on the medical expertise of others, the textbooks and the guidelines, to guide them. Quoting James Lock, chief of cardiology at Boston Children’s Hospital, James Groopman wrote in How Doctors Think:

“The big problem is that most people assume that once [a medical treatment protocol is] made up, it’s actually real. Especially the people who make it up themselves. Then they think it came straight from God…. Not everyone in medicine can be constantly making calculations about the value of the information. You’d go crazy. But if you are in a subspecialty field, as you train, you not only need to know what people know, but how they know it. You have to regularly question everything and everyone.” p. 135

If medicine worked like a cookbook, there would be little need for doctors. We could look up our symptoms ourselves and know the diagnosis and the treatment. (In this age of managed care and short doctor appointments, perhaps that explains why there is a proliferation of diagnostic sites for patients on the Internet.) But we are hoping that the extra training that goes into making physicians will enable them to begin with the textbook, but expand to include the patient.

Groopman, J. (2007). How Doctors Think. New York: Houghton Mifflin Company.

Walmart medicine

From MedPage Today, a doctor-reviewed medical news source, comes information that patients are going to "retail medical clinics," such as those operated by Walmart, for their common complaints, more often than they would go to a primary care physician.

http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/tb/10882

Their study, reported in the September/October issue of Health Affairs, also disclosed that 61.3% of retail clinic patients (SE 0.04%) had no regular primary care physician....those 18 to 44 years old, were a disproportionate share of retail clinic patients.

Young adults, most likely not to have health insurance, are going to walk-in clinics for basic care, and if those clinics were not available, they wouldn't go to anyone. Apparently, Lyme patients are not the only population underserved by the medical community.

Enthralled by Research

There is always a concern that medical research not be indulged in merely to learn knew things, but that it should first concentrate on things that are of help to the patient. From the book, Hospital: An Oral History of Cook County Hospital comes this quote:

Then there's how medical science works. We had another site visit, and at one point this mean-spirited site inspector said, "You all have to understand, NCI [National Cancer Institute] funds research to stop cancer, it doesn't provide patient care." And another doctor, Richard Cooper, said, "Maybe that's why the rate of cancer has gone up."

Overly simplified? Yes. But worth remembering.

Lewis, S (1994). Hospital: An Oral History of Cook County Hospital. NY: The New Press.

Seeing the Whole Picture

From The Widening Circle by Polly Murray, her thoughts about her first meeting with the Yale doctors:

"As I was drifting off to sleep that night after my meeting at Yale, it occurred to me that perhaps something inherent in the way medicine is practiced restricts physicians’ thinking about new medical problems. Perhaps, being outside of the medical world, I had more freedom to see new possibilities; I had nothing invested in being an expert or in maintaining the image of the all-knowing doctor. For many doctors it may be easier to make up a diagnosis or blame the patient when she does not fit into an established entity. Some physicians may become complacent in the status quo, not wanting to challenge current disease classifications for fear of being wrong or opening a Pandora’s box. Another problem is that many doctors are very specialized, so they may see only part of a given problem, therefore missing connections between different aspects of a complicated disease.

"It is an unusual physician who says that he will listen to all in search of an answer and who acknowledges that perhaps the person living with the disease may be able to provide valuable clues. The doctor who listens and hears is a good doctor."

Murray, P. (1996). The Widening Circle: A Lyme Disease Pioneer Tells her Story. NY: St. Martin’s Press. p. 103.

How the Medical Establishment Thinks

Best-selling author and Harvard Medical School professor Jerome Groopman said in How Doctors Think (2007, p. 5):

"To establish a more organized structure, medical students and residents are being taught to follow preset algorithms and practice guidelines in the form of decision trees. This method is also being touted by certain administrators to senior staff in many hospitals in the United States and Europe. Insurance companies have also found it particularly attractive in deciding whether to approve the use of certain diagnostic tests or treatments….

“Clinical algorithms can be useful for run-of-the mill diagnosis and treatment – distinguishing strep throat from viral pharyngitis, for example. But they quickly fall apart when a doctor needs to think outside their boxes, when symptoms are vague, or multiple and confusing, or when test results are inexact.”

It is helpful in emerging diseases for doctors and researchers to think methodically, and to build on the solid work of others. But it is also necessary to be ready for the unexpected, both in symptoms and response to treatment, in order to put together the entire picture of pathology and to be of best assistance to the patient.

Groopman, J. (2007). How Doctors Think. New York: Houghton Mifflin Company.