IOM Articles

16 October 2010

The Aftermath

Well, the IOM workshop on Lyme and related tick-borne infections has ended and the combatants have left the field to ponder some new strategies. The IOM, evidence-based medicine, and peer-reviewed science remain intact after two days of verbal assaults and sorties. The battle probably won’t be joined again until early 2011 when the workshop report is released. Since many activists and their “Lyme literate” physicians have already denounced the IOM process and participants, it’s likely the report will meet the same fate. Still, the workshop speakers and committee members seem to have produced a consensus, or at least a short to-do list, of some potential interesting actions, which may appear in the report. Whether these ideas are financially and logistically possible is another matter. More about that at the end.

First, some quick observations from the meeting.

Three groups of activists staged a boycott of the meeting because they thought the IOM process and the participants were biased. They put out a press release and complained to a friendly congressman.

Despite their absence, the meeting was full of patient/activists, and ILADS and “Lyme literate” quacks, all of whom took advantage of every Q&A session to sermonize, pontificate, lecture, sound off, and in one case, and become hysterical. In effect, the Lyme activists got to have their cake and eat it too: they publicly denounced the IOM and called into question the integrity of the meeting while simultaneously attending the meeting to advocate for their beliefs in the hope those beliefs will be included in the forthcoming report. Politically, it was an effective stunt. But the meeting was about science, and science and politics don’t mix too well, especially after politics tries to embarrass science.

As expected, there was quite a bit of talk about how future technologies may shed light on post-infectious Lyme disease, and the diagnosis and treatment of other tick-borne infections. The lay audience seemed interested in these esoteric technologies, which included the use of biomedical informatics, microarrays, genomics and proteomics to diagnose disease and patient susceptibilities. The recently published work ofSchutzer and Luft was cited a number of times by activists as important research on Lyme disease, though I don’t think they realize how far from the bedside many of these bench science projects are.

It also was odd to hear such enthusiasm for basic science coming from a body of people who are largely anti-science and anti-vaccine in outlook, and have a general dislike for the entities that fund research on these cutting-edge technologies, (e.g., NIH, CDC). And while there was generally high praise for the quality and sophistication of the research presented, there was a distinct disconnect when these same researchers shot down some deeply held patient beliefs about Lyme disease. For example:

There is no such thing as seronegative Lyme.

The CD57 assay doesn’t work.

Bacteria do not form cysts.

B. burgdorferi does not form biofilms.

B. burgdorferi does not produce toxins or proteases.

B. burgdorferi is not an intracellular pathogen.

Ticks require days—not minutes or hours—to transmit B. burgdorferi.

People often confuse re-infection with relapse.

These plainly stated facts were met with blank stares and occasional looks of scorn. Such reactions reminded of last week’s USA Today story about the conflict between science and religion. The article referred to a 2006 Time poll that showed “a staggering 64% of Americans declared that if science disproved one of their religious beliefs, they'd reject that science in favor of their faith.” Evidently, a similar questioning of some of the tenets of the chronic Lyme catechism also leads to a rejection of facts in favor of myths. So how do Lyme activists expect to cooperate with researchers and advance the diagnosis and treatment of tick-borne infections when each new piece of information must first be judged to be either orthodox or heretical and then either accepted or rejected along with the bearer of that information?

Treatment and for-profit LLMDs were not on the IOM workshop agenda, but they kept getting dragged into the room. Cameron—a past president of ILADS and a remarkably inarticulate man whose relentless torturing of English grammar and syntax probably compels him to rely heavily on simple repetition (as in his often stated introductions, “I’m an epidemiologist.”) and sign language as regular forms of communication—asked one panel of scientists whether there should be a moratorium on LLMDs losing their medical licenses. It was a totally inappropriate question that elicited only silence from the panel.

Still, it turned out to be a recurring theme. One patient also mentioned the “targeting of our Lyme doctors,” and insisted “the targeting has to stop.” Again, this topic wasn’t a part of the IOM’s charge, but it is curious that activists would insist LLMDs are being targeted by….whom? The IDSA? Insurance companies? The Government? As far as I can tell from published news stories and filed lawsuits, it is the former patients of LLMDs or their families who are doing the “targeting.” In cases involving financial fraud or deaths, the “targeting” is done by state and federal prosecutors. So maybe activists and worried LLMD like Cameron should complain to these people and not try to weasel some kind of affirmation of a non-existent problem out of IOM panelists.

Another LLMD suggested chronic Lyme disease needed a “Manhattan Project” approach. The Bomb is everyone’s favorite metaphor for problem solving, but it’s usually applied wrongly to problems in science. The Manhattan Project was an engineering project to build a bomb. Everyone working on it knew what they wanted and how to achieve it; the only surprise would have been if there had been no Boom after the button was pushed. Science, on the other hand, isn’t engineering. It’s a trial-and-error process that often begins with assumptions that rapidly change as experimental trials and errors accumulate. In the case of chronic Lyme disease, there are lots of questions and lots of suggestions about how to proceed, but no clear understanding of what the end result will be. In other words, don’t expect a Boom.

There were repeated activist calls to change the CDC case definition of Lyme disease (which doesn’t have anything to do with “chronic” Lyme disease). They seemed to think the case definition had been written in stone three decades ago. It has been modified; the last time was in 2008 when it was broadened to capture “confirmed,” “possible” and “suspected” cases of Lyme. Has the activist/LLMD community ever drafted their own version of what a case definition should look like? It would be interesting to read though probably epidemiologically disastrous to follow.

There were audience comments about communication problems. I took this to mean two things. First, agencies like the CDC and the NIH are doing a terrible job of educating the public about Lyme disease. (Never mind that this is not the primary function of either agency.) This was a curious comment because activist groups and support groups always seem to be talking about how much they do to educate the public, educate the press, educate the schools, educate the doctors, and educate the politicians. Apparently, they’re doing a lousy job if everyone is still so unaware of the dangers of Lyme disease and the habits of backyard ticks.

Second, there seems to be a persistent lack of understanding about what is meant by many words commonly used by scientists. One woman in the audience nicely demonstrated this problem by stating “your persistence isn’t our persistence.” No, it’s not. And perhaps the meeting should have devoted some time to carefully defining what is meant by persistence, chronic, latent, infection, colonization, subclinical, relapse, asymptomatic, seropositivity, cure, late-stage, etc., and why the persistence of Borrelia in a mouse (the natural reservoir of Borrelia) should not be assumed to be a model for what happens in people.

Definitions aside, there were often stated demands that the IOM declare that “chronic Lyme exists.” Such an official-sounding declaration from the National Academy’s Institute of Medicine would not, in fact, alter the current state of knowledge or reality about Lyme disease, but it would provide a powerful justification for the practices and profits of Lyme quacks everywhere. This is not going to happen.

Finally, there was some small talk about how activists and scientists could work together and perhaps lower the levels of antagonism and suspicion. Toward that end, the lawyer for one group (how bad are things that one is compelled to bring a lawyer to an IOM meeting??) presented members of the IOM Committee with copies of a Lyme book and the DVD, “Under Our Skin.” The lawyer once must have trained as one of those famously two-handed economists that Truman used to complain about. With one hand he urged cooperation and respect, and with the other he distributed a Lyme propaganda film that depicts mainstream scientists and physicians as greedy, corrupt, and conflicted villains.

Maybe he doesn’t recognize irony or maybe he just never watched the video. He should hope the committee members don’t watch it either. It’s a video hatchet job that will leave them with a very negative impression of Lyme disease activism.

I think the lawyer also called for “less hubris” in Lyme research. I’m not sure who he thought had too much, but we certainly can expect the IOM report to note the need for less faith and more facts.

So what will the IOM report identify as gaps or needs in research related to Lyme and other tick-borne infectious diseases?

Many presenters and committee members felt a repository for serology and other clinical samples is badly needed in order to validate new diagnostics, and to study patients’ post Lyme complications and persisting symptoms in other infections.

Serology-based diagnostics in the acute stages of infections are obvious problems so there may be suggestions for doing away with IgM-based diagnostics and the attendant problems of false-positives and widespread positive background serology for many tick-borne pathogens. Aside from the acute phase and IgM questions, there were calls for more and better diagnostics for other emerging tick-borne pathogens.

There also seemed to be enthusiasm for establishing a multi-center clinical trials group modeled on the current AIDS Clinical Trials Group. It’s not likely such centers would fund additional antibiotic trials (4 NIH-funded trials showed no benefits), but other treatment trials for pain and immune modulation could be possible.

Of course, new research and new trials requires new money, and the 2011 Congress probably will be too busy with their own petty internal struggles to do anything thoughtful or useful. At least until the next election cycle.

Posted by Relative Risk at 09:11

Labels: IOM

15 October 2010

Mixed News from Nature

Scientists push for Lyme disease trials

October 15, 2010

Nature magazine

Doctors and researchers in the United States have spoken out about the lack of support provided by the Institute of Medicine (IOM) and the National Institutes of Health (NIH) when it comes to treating patients with chronic Lyme disease.

The remarks were made at a workshop organized by the IOM in Washington DC on 11 and 12 October.

"Our session wasn't supposed to talk about treating chronic Lyme," says Sam Donta, an infectious disease specialist at Falmouth Hospital in Massachusetts who spoke at the workshop. "But when we had our pre-session conference call and they said this is supposed to be about diagnosis and management, I said how can you talk about management without talking about treatment?"

"The IOM overly restrict[s] the definition of chronic Lyme disease," says Donta. "I hope now the IOM is finally listening."

[The IOM doesn’t have a definition of “chronic” Lyme and doesn’t have the authority to restrict anything.]

The IOM will issue a report on gaps in the prevention, amelioration and resolution of Lyme disease and other tick-borne diseases, which will help to guide agencies such as the NIH. Although the treatment of chronic Lyme disease has been controversial for decades, the IOM excluded the issue from their agenda at the request of the NIH.

There is widespread disagreement over what constitutes and causes the chronic disease, in which a range of symptoms persist after a patient has been treated for the initial bacterial infection. Names for the condition differ, but whether it's called chronic Lyme disease, post-Lyme disease syndrome (PLDS) or something else, patients can suffer from fatigue, pain, temporary paralysis, heart conditions and severe cognitive problems.

"Our patients with PLDS feel terrible, their lives have been disrupted immeasurably and they deserve answers," says Afton Hassett of the University of Michigan Medical School at Ann Arbor who spoke about biomarkers, which could be used to diagnose patients with chronic Lyme disease.

Many patients who have been diagnosed with chronic Lyme by their doctors do not meet the criteria set out by the Center for Disease Control and Prevention (CDC) for the disease.

Paul Mead, a medical epidemiologist at the CDC, says that he would welcome new insight that might contribute to better diagnoses and treatments for patients who don't meet the centre's current criteria. "There's no point in debating whether or not this is a real entity," he says. "The point is what is the best treatment."

But his words have not been met with financial backing. Controlled clinical trials testing long-term antibiotic therapy previously found that the antibiotic was no better than a placebo, and that intravenous antibiotic treatment might even be dangerous for some patients.

The Infectious Diseases Society of America recommends against treating chronic Lyme disease with antibiotics and some worry that the door to new trials has now been shut.

In his presentation, Brian Fallon of Columbia University in New York pointed out that, in the trial he led, patients in severe pain benefited from intravenous antibiotics. But, he added, those with low levels of pain fared no better than those given the placebo.

"This study has been significantly downplayed, and I think to the detriment of science because although it showed that IV antibiotics can cause significant risk, there was a greater improvement with the drug than with the placebo," he says. He added that more trials should focus on using safer antibiotics and non-antibiotic treatments.

[It got what it deserved: especially after spending so much public money on so few patients. “Treatment resulted in no sustained benefit. The authors [Fallon, et al.] concluded: “10 weeks of IV ceftriaxone followed by 14 weeks of no antibiotic is not an effective strategy.” More than one quarter of antibiotic-treated patients had significant adverse effects necessitating treatment termination.”

The NIH does not fund trials on treating chronic Lyme disease and the IOM are hesitant to push for further studies on antibiotic treatments, says Fallon, because the jury is still out on whether chronic Lyme disease results from an extended inflammatory reaction to the Lyme bacteria — Borrelia burgdorferi in the United States — after it has [been eradicated by a short course of antibiotics.

[Yes, NIH did fund treatment trials. See the list of trials here.]

Yet Borrelia infections often persist in animals, say researchers at the workshop. Linda Bockenstedt of Yale School of Medicine in Connecticut presented images of non-mobile bacteria remaining in the tissues of mice long after they had been treated with antibiotics.

[Which is why the mouse is the perfect reservoir host for Borrelia though in the case of Dr. Bockenstedt’s data, the Borrelia were dead from the antibiotic treatment.]

[snip]

Nonetheless, Monte Skall, executive director of the National Capital Lyme and Tick-Borne Disease Association, was pleasantly surprised that the IOM acknowledged chronic Lyme disease at the workshop. Three advocacy groups withdrew from the workshop before it started, accusing the IOM of bias against claims of chronic Lyme disease and the possibility that it can be treated with antibiotics. "It goes to show you, it's best to come to a conference like this with an open mind," Skall says. "We are hoping that out of this workshop comes a second workshop where we can talk about treatment."

[I think lawyer Skall is reading more into an alleged acknowledgment than is warranted, especially since no one knows what exactly “chronic” Lyme disease is or is not. As for talking about treatment, that happened in 2006 when the IDSA revised their treatment guidelines, and again in 2009 when those guidelines were re-reviewed.]

Posted by Relative Risk at 17:18 0 comments Links to this post

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06 October 2010

Don't like the Science, Call a Congressman (R)

From the whining section of Lyme Activism:

Research Gaps in Lyme disease Exposed in the Congressional Record Groups’ Withdrawal from IOM Prompts Changes in IOM Agenda

October 5, 2010 - In an effort to raise awareness about the difficulties facing patients with Lyme disease, on September 29,2010, Congressman Christopher Smith (NJ) introduced into the Congressional Record a report that exposes the research gaps in Lyme disease. The report was submitted by three of the nation's most influential Lyme disease organizations, the NJ based national Lyme Disease Association (LDA), the California Lyme Disease Association (CALDA), and Connecticut-based Time for Lyme (TFL). The report was originally commissioned by the Institute of Medicine (IOM) study group as part of a scientific workshop which was initiated through Congressional Appropriations language. The three groups objected to the IOM process which permits bias on the workshop committee and lack of transparency, and they asked the help of Smith to allow their concerns to be heard in a credible venue.

[A credible venue? The Congressional Record? It’s the most doctored, forged, altered, trivia-filled, vanity press in the Western World. No one takes anything in it at face value, except maybe the date, and only then if there are witnesses and videotape. Anyway, the three groups won’t be missed; there will be others there to represent patient/activist groups, though their presence isn’t likely to have much impact on charting new research directions for Lyme and other tick-borne infections.]

The report presents the patient viewpoint on gaps in the science of Lyme disease, and includes areas of biomarkers, proteomics, pathophysiology, patient oriented research, treatment options, strain variation, persistence and testing. Antiquated Lyme disease testing is the central issue which fuels the Lyme controversy. Unlike HIV, which had a gold standard test in less than 10 years, Lyme disease does not have one 35 years into the disease. Less than 50% of patients test positive with conventional antibody tests. Treating physicians have argued against over-reliance on testing for diagnosis and treatment, relying instead on clinical judgment with testing as an adjunct.

[Well, the HIV tests are antibody-based just like the 70 or so Lyme tests on the market. In both cases, one must wait for antibodies to develop. The 50% reliability figure is a standard lie among activists. As for Lyme quacks and LLMDs, I’m sure the last thing they really want to see is a better test for Lyme disease; undoubtedly it would show them treating patients for an infection they don’t have.]

Lyme advocacy groups saw a need to assess the state-of-the-science and advocated for a conference by the National Institutes of Health (NIH). NIH requires transparency and inclusion of all stakeholders and permits the exploration of broadly diverse scientific viewpoints. NIH policies also guard against bias on the planning committee.

[I’m not sure where they heard this nonsense…the NIH Fairy perhaps? It would be nice if NIH actually did operate like that, but it operates as one well-known division director once described it: “We appoint the committee members we want so we get the conclusions we’ve already decided on.”]

Instead of using its own process, NIH contracted the workshop out to IOM. The IOM's mission was to provide "independent, objective and non-partisan" advice to policy makers, yet the majority of the participants sitting on its Lyme disease panel belong to the Infectious Diseases Society of America (IDSA), a medical society with a known bias. The hearing panel ignored the Lyme advocacy groups' frequent requests for transparency and a balance of scientific viewpoints, as delineated in Congressional Appropriations language. The groups felt they had no choice but to protest the process integrity and withdrew their support of and participation in the program.

[So they think a federal agency (NIH) is open and honest, but an independent arm of the National Academy (IOM) is neither. Very odd. What to do? Complain (again) to one Republican congressman from NJ. One out of 535. We’ve really been over this time and again, but activists are deaf and have plenty of time on their hands to whine about the same things over and over and over again.]

The Lyme advocacy groups expressed their belief that this amount of bias would undermine the integrity of the scientific workshop and that its final report would reflect this lack of objectivity. Rather than participate in a process that the groups believe may harm patients, the groups had their report entered into the Congressional Record to ensure that its contents would be shared widely both with Congress and the public. See Congressional Record No.133 Book II Vol. 156 No. 133 E 1872 or go to: THOMAS - Congressional Record - 111th Congress

After the withdrawal of our advocacy groups, the IOM appears to have responded by commencing review of its agenda. We applaud this. It is noteworthy that Benjamin Luft, a leading investigator on the use of high throughput technologies to decipher the myriad manifestations of Lyme disease has been added after that review. Although this will undoubtedly bring new openness to the discussion, it is hoped that further modifications will be made to correct a flawed agenda.

[Yes, the agenda changed since not everyone originally asked to participate could do so.]

Although the groups are heartened to see movement in the right direction, they remain skeptical that the process will lead to a true understanding of the patient's needs.

[It’s not about the patients’ needs. It’s about gaps in the research.]

In a jointly prepared statement, the groups stated: "It's one step-but we are cautious. The IOM needs to commit to making this entire process unbiased so that the true state of the science can be explored, and we can make the type of progress on this disease necessary to develop diagnostic tools and treatments that help restore patients to health. That is what this should be about."

[Frankly, I’d like to see the Wonk’s idea of what an “unbiased” agenda looks like. Someone ask her to draw one up. If she’s got time to write to Smith or Blumenthal in an effort to smother science with politics then she’s got time to show the world what an unbiased agenda for research should look like.]

Posted by Relative Risk at 07:41 0 comments Links to this post

Labels: IOM

01 October 2010

More Wonkery

For someone who has no interest in attending the IOM meeting Lyme disease, the LymeWonk certainly spends a lot of time talking about it. Here’s some of the latest wonking:

This IOM process is called a “workshop”. Its “product” will be a “committee-authored” summary of the “presentations and discussions”. This summary will “contain only the opinions of those who attended and presented at the workshop”. A workshop summary “does not reflect the views of the IOM”. Ok, well, if the IOM workshop doesn’t represent its views, then whose views does it reflect really? If you answered the views of the committee, you would be correct.

[No, you would not be correct. It reflects the views of the invited presenters and the committee members (assuming they say or present anything), which subsequently are assembled by the IOM staff for the reviewers. One can examine this process and the IOM’s many published products by visiting: http://www.iom.edu/Reports.aspx.]

Recall that 4 of the 6 members of the IOM committee are members of the Infectious Diseases Society of America (IDSA), a group that has highly biased views on Lyme disease.

[I see only one IDSA member on the committee: Gordon Schutze, but the wonk is conveniently forgetting all of the presenters whose statements and presentations will form most of the committee report.

There are no patients and no members of ILADS on the committee.

Even if the panel members could write a neutral summary (possible, but how likely?), it could only be a sum of its parts—namely a conference headlined by the IDSA that categorically excludes physicians who belong to ILADS.

[I think this is the heart of the matter: no ILADS quacks on a panel that ultimately is organized by and representative of the U.S. National Academy of Sciences (of which the IOM is a part). And who can blame the NAS/IOM for wanting to keep their distance from a small collection of private practice doctors who run cash-based practices, have been disciplined by state medical boards or sued by former patients, and who lack any real world experience in basic or clinical research, which is the point of the IOM workshop in the first place: identifying research gaps and needs in Lyme and related tick-borne infections. The only things ILADS can bring to the table are self-serving excuses for their own practices. What they would walk away with is a report with their names in it, and which they would no doubt use as evidence of their expertise and knowledge to lure more naïve patients into their practices. I know several of these guys who are still listing on their CVs or websites decade-old federal and national meetings they have attended: as if attendance at a meeting is somehow proof of knowledge and skill, and not simply the ability to travel or pay the registration fee. I’m sure these guys would not hesitate to list an IOM report on their CVs as one of their own publications. If such a practice was appropriate or professional, I suppose I could list 12 to 15 such IOM publications.

I also should note that if the Wonk had come to the meeting she could have represented CALDAand ILADS since she’s a member of both. Though how one represents both Lyme patients and Lyme docs without creating a host of professional and ethical conflicts is a mystery to me.]

To my mind, this is a redo of the IDSA review panel without the protection of the Attorney General to make sure it is balanced in terms of presentation of the science. Only this time it is under the banner of the IOM—which will make people think it represents the views of the IOM. Another rubber-stamp process run by the IDSA without IOM accountability, but with what looks like (but isn’t?) the IOM official seal of approval of the process.

[No, this is not a re-do. The 2009 IOM review of its guidelines was about….its guidelines. This is about charting a course for future research on LD and other tick-borne pathogens. As for the guidelines review, I’m glad to see the wonk acknowledge that it was “balanced in terms of presentation of the science.” The IOM process will be too because of the variety of physicians and scientists among its committee members and presenters.]

Posted by Relative Risk at 09:17 0 comments Links to this post

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29 September 2010

Is there a secret handshake?

Last week, a couple of Lyme disease activist groups announced they were boycotting the upcoming IOM meeting on Lyme disease and related tick-borne infections. While some groups are boycotting, others are not. Various reasons for each action were announced, but it was an interesting reminder of the fractious nature of these different groups, their goals, and their uneasy relationship with the rest of the world (i.e., reality).

This week, the online group, LymeNet, closed their Internet discussion group to outsiders. Apparently, a number of I.P. addresses also have been blocked so anyone at CDC, NIH, various medical schools or a state public health lab probably will have trouble trying to read the daily postings. Perhaps it’s a symptom of the IOM boycott or just a growing sense of paranoia. Instead of a semi-open forum with spectator viewing, there is now a secret knock, a secret handshake and an oath not to identify any “Lyme Literate” docs or suggest anything that smacks of heresy. (All cults and theologies first demand obedience, then money, then exile you when you run out of both.)

In any case, it’s a welcome end to what was probably the most visible promotion of quackery and pseudoscience related to tick-borne infections. A colleague once complained that reading through the daily nonsense made his head feel like it was going to explode. Now fewer naïve people clicking around the Internet will stumble into this modern-day bedlam of cranks, quacks, and hypochondriacs, and may instead have a somewhat greater chance of finding some honest and accurate information about Lyme disease.

Perhaps LymeNet will go the way of the old newsgroup, sci.med.diseases.lyme, which once had several hundred members, but was depopulated by infighting and insults, leaving only a single madwoman in Connecticut who posts nonsense to herself under the online name of Mort Zuckerman.

The current boycotts and the online lock-outs should be a reminder to readers, reporters, and legislators that the public “battle” between scientists and Lyme activists is also a private battle among Lyme activists. Yes, it’s a lot like the Middle East, and in both theaters it’s hard to remember who’s fighting whom for what and why.

Posted by Relative Risk at 09:05 0 comments Links to this post

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26 September 2010

A little lyme with your tea?

Below is part of an announcement from a Lyme disease group in the Washington, D.C. area explaining their decision to attend an upcoming IOM workshop even as others intent to “boycott.”

September 23, 2010

National Capital Lyme & Tick-Borne Disease Association

Dear Lyme Community:

As you know, some Lyme advocates have chosen to pull out of the IOM Lyme Disease workshop. They are legitimately concerned that the agenda is heavily biased against the patients’ interest. We respect their concerns and their decision to pull out of the workshop. However, upon careful consideration, we have decided to participate in the IOM workshop to represent the Lyme patient’s perspective and show support for our presenters. While we have our own reservations, we are working hard to improve the agenda.

This is another example of yet another rift in the fractious and belligerent Lyme disease movement. I suppose it could be called a Tea Party with Lyme. That aside, the announcement went on to make a number of curious comments that merit some attention.

The announcement suggested if they don’t attend “the only perspective presented will be that of the IDSA.” The IDSA is a professional society of some 8,000 members who share a consensus about the most effective ways to treat a Lyme infection. This consensus is based on 35 years of basic research and clinical experience among hundreds of investigators and physicians, and thousands of successfully treated patients. Moreover, a similar consensus has emerged from many other professional societies and organizations in Europe and Canada. Some Lyme activists would take this similarly of conclusions to suggest collusion and conspiracy when in fact it is just the everyday workings of a process called science.

Despite all the hand-wringing about the IDSA, they actually will not be at the IOM table. There are no official representatives from the IDSA attending or participating in the meeting. There will be some MDs present who also are members of the IDSA, but they will be outnumbered by many more DVMs, PhDs, entomologists and immunologists, who are not members of the IDSA. The IDSA is a large, national organization of many people. But it’s not a cult.

Which brings me to another point raised in the announcement: the issue of “whose science is right or wrong.” One could write a book about this phrase and how wrong-headed it is. (Probably someone has.) Science isn’t a thing—it’s a process. There cannot be two sciences, or three, or a Protestant science and a Hindu science, a federal science or a communist science. (Apologies to all you Republican climatologists, Stalinist geneticists, modern-day AIDS denialists and Nazi physicists.) Imagine how chaotic and unknowable the world would be if there were a multitude of distinct sciences. Yet, the world is knowable because there a cogent process by which it can be interrogated and that process allows anyone to ask questions and get the same answers (sloppy technique aside) regardless of personal opinion, wishful thinking, or religious and political beliefs.

I suppose the problem with Lyme activists is they regard anecdote, opinion, desire and fervent belief as equal to scientific evidence. That’s the heart of the matter: an ignorance of what scientific evidence is and is not. Cherry-picking the literature, staging protests, writing to congressmen, and publishing argumentative letters-to-the-editor are not equally valid evidence or interpretations of data. Until this idea is more widely recognized there is not going to be much meaningful dialogue between scientists and activists. But then there isn’t much dialogue with anti-vaccine activists, anti-GM activists, AIDS and germ theory denialists, and various other conspiracy-minded peoples.

Finally, there is this statement: “If the situation warrants it, there will be time to write a minority report.”

The IOM workshop is intended to suggest some “critical needs and gaps” in Lyme and related tick-borne diseases research. It will be an IOM consensus document. I don’t know who among the activists would write a minority report or to whom they would give it, but the whole notion of such a report goes back to the earlier issue of “whose science is right or wrong.”

Edgar Allen Poe once wrote that science is a “vulture, whose wings are dull realities.” I always thought reality was pretty interesting in and of itself, but then I don’t have Poe’s imagination or pharmacy. If he was alive today, he might find the fight over the science of Lyme disease to be more like a screaming raptor, whose wings are bloody nightmares.

Yet for all the angst and ink about the IOM and its workshop, here’s the actually language defining that workshop and its final report:

At the request of the NIH, National Institute of Allergy and Infectious Diseases, the IOM will convene a committee to plan and conduct a scientific workshop to assess the state of the science of Lyme and other tick-borne diseases. The workshop will represent the broad spectrum of scientific views on Lyme disease and should provide a forum for public participation and input from individuals with Lyme disease as requested in congressional appropriations report language in House Committee Report 111-120 andSenate Committee Report 111-66. The product to be delivered will be a committee authored meeting summary that highlights workshop presentations and discussions. The project is sponsored by NIH. The approximate start date for the project is March 8, 2010. The workshop report will be issued at the end of the project in approximately 13 months.

Sounds pretty dull…as dull as only Congress and some federal agencies can make something.

Posted by Relative Risk at 13:24 0 comments Links to this post

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23 September 2010

Pity the IOM staff

From some cranky Lyme activists:

Congress asked for a state-of-the-science evaluation of Lyme disease. What the Institute of Medicine is offering, however, is a one-sided, biased presentation of the Infectious Diseases Society of America's point of view. Because the IOM refuses to allow speakers of comparable scientific weight to counter the IDSA viewpoint, three major Lyme patient groups have withdrawn their participation.

This is quickly becoming redundant. Lyme activists can bitch to each other all they want, but they have to explain to everyone else how a workshop that includes Lyme activists (e.g. Carl Brenner, Pam Weintraub), “Lyme Literate” docs (e.g., Brian Fallon, Sam Donta), and non-IDSA scientists (e.g., Janis Weis, Howard Ginsberg, Dave Walker) can be “a one-sided biased presentation.”

I suppose what they really want are some private practice physicians from the ILADS* money club to participate in the meeting. Though it’s not likely that any ILADS member could be described as a speaker of “comparable scientific weight to counter the IDSA viewpoint.” But let’s take a look at the potential ILADS line up.

There’s Ralph Stricker, former ILADS president, barred from receiving federal funds after falsifying research data. Fired from UCSF, he went to work for a clinic that did penis enlargements.

Robert Bransfield, current ILADS president, and infectious disease-practicing psychiatrist recently sued by a patient for $250,000, and whose bizarre writings and opinions even manage to offend other LLMDs.

Joseph G Jemsek, ILADS treasuer. “March 16, 2010. Joseph G. Jemsek, M.D., Applicant. Area of Practice: Internal Medicine (Charlotte, NC). Denial of Application for medical licensure. The [Maryland] Board found that the violations of unprofessional conduct in diagnosing and treating patients, failing to inform his patients adequately of the risks of his treatment and failing to conform to standards of acceptable and prevailing medical practice, for which he was disciplined in North Carolina, are violations of grounds of the Maryland Medical Act and constitute reasons to deny his application for licensure.”

Richard Horowitz, President of the International Lyme and Associated Diseases Educational Foundation (ILADEF), and founding board member of ILADS, and recipient of a NYS Board for Professional Medical Conduct “Non-disciplinary Order of Conditions” for continuing to practice medicine.

Joe Brruanscano, a director of ILADEF, but not currently practicing medicine, also had a run-in with the NYS Board in 2002: “The Review Board sustained the Hearing Committee's November 6, 2001 determination finding the physician guilty of negligence on more than one occasion and ordering excessive tests and/or treatment not warranted by the condition of the patient. The Review Board modified the Hearing Committee's penalty by extending the physician's term of probation from six months to two years.”

ILADS faculty member Bernard Raxlen, another infectious disease-practicing “psychiatrist who markets himself as a specialist in treating Lyme disease, has offices in New York City and in Greenwich, Connecticut. The Connecticut Department of Health has disciplined him twice.”

Nick Harris, ILADEF treasurer, and CEO of the Lyme specialty lab IGeneX. His lab has been the subject of several warnings previously mentioned here, here, and here.

“Comparable scientific weight”? Well, I could go on but you get the idea.

*In the late 1990s, Burrascano, Phillips, and other physicians organized the ILADS society to promote national and international awareness of chronic Lyme disease. ILADS states that chronic Lyme disease is being ignored by mainstream medicine. Physicians and patients who support ILADS have formed a network throughout the United States. This network includes physicians who practice in states where Lyme disease is not endemic (for example, Florida and Colorado). ILADS does not have a clear case definition of chronic Lyme disease or specific treatment recommendations, except that oral/intravenous antibiotic therapy may be needed for months to years.

Chronic Lyme Disease: A Survey of Connecticut Primary Care Physicians.

Johnson M, Feder HM Jr. J Pediatr. 2010 Aug 31

Posted by Relative Risk at 15:48 0 comments Links to this post

Labels: IOM

22 September 2010

More foot stomping in LymeLand

This is part of an internet notice from the Connecticut-based Lyme disease group, Time for Lyme (which, by the way, is a curious name for a group of people who don’t like Lyme disease). Anyway, they’re annoyed with the IOM because they were unable to “pack the court” with their supporters and quack doctors. No surprise really. The IOM is a serious place that draws in serious people to talk about serious things. They don’t really have the time for the kind of nonsense the activist community has been sending them. (See here, here, and here.) So here’s part of the notice:

In a move designed to protest the Institute of Medicine's upcoming Lyme disease workshop, three of the nation's largest and most influential Lyme groups have pulled out of the process. After much deliberation, speaker Diane Blanchard, co-president of the Time for Lyme (TFL- CT) has withdrawn from the panel. The national Lyme Disease Association (LDA- NJ) and the California Lyme Disease Association (CALDA), along with TFL, will not participate in the workshop and their IOM commissioned scientific paper will not be submitted.

Well, according to the agenda the only person designated to speak was Diane Blanchard from the TLC. The LDA and CALDA (a blonder, better tanned version of the LDA) are not on the agenda and were not asked (mercifully) to speak. Though I’m sure they would have butted in. So really only TLC is dropping out.

The scientific workshop was promoted by the Institute of Medicine (IOM) to be a conference about the state of the science regarding Lyme and tick-borne diseases. Despite the groups request for transparency and a balance of scientific viewpoints, as delineated in Congressional Appropriations language, neither the hearing panel nor the speakers selected by the IOM satisfy the Congressional intent or objectives.

The IOM has about 40 years of experience dealing with Congress. They know what they’re doing. And as previously noted, there will be a number of otheractivists and LLMDs at the meeting to voice other ideas and opinions.

A whole lot of drama for nothing.

Posted by Relative Risk at 22:26 0 comments Links to this post

Labels: IOM

15 September 2010

Letters to the IOM

The Lymewonk is whining again. Here’s today’s missive from the nut state:

LYMEPOLICYWONK: Spotlight on an IOM Speaker: Does the IOM Know the Difference Between Dogma and Science? Rumor Hassett They Don’t!

14 September, 2010

The IOM has slotted Afton Hassett to speak about “Potential Bio-Marker Applications for Lyme Disease: Aligning Multiple Symptoms with Biological Measures”. You might think he was a microbiologist or, or, or ? Well, it turns out that he is a Psy.D. What is a Psy.D.? It is a newish graduate degree in psychology. It does not focus on research or statistics, it focuses on the “soft” side of psychology….

[Odd that L.J. the wonk doesn’t know much about the origins or requirements of the Psy.D. degree. Odder still that she would object to someone who has written about the association of psychiatric co-morbidity in chronic Lyme cohorts when the current president of ILADS is a psychiatrist with no training in infectious diseases or research.]

[And speaking of the current ILADS president, here’s part of a letter he just fired off to the IOM about their ongoing study of Lyme disease. It’s really an amazing compilation of lies. Maybe it’s the result of treating so many people who think they have a chronic infection that can’t be eradicated except by walletectomy.]

I am writing on behalf of the International Lyme and Associated Diseases Society (ILADS) to express our disappointment with the lack of balance in the selection of the IOM panel and speakers for the “State of the Science” review of Lyme disease.

The science in Lyme disease has been a topic of great debate and polemic viewpoints. The two viewpoints are reflected in Lyme guidelines from the Infectious Diseases Society of America (IDSA) on the one hand and the Lyme guidelines from ILADS on the other, both evidence-based.

[Well no, they can’t both be evidence-based. This is something ILADS quacks regularly fail to do: define “chronic Lyme disease,” provide evidence of ongoing infection, and prove that long-term antibiotics eradicate said infection.]

In addition, IDSA has been investigated by the Connecticut Attorney General, who found extensive conflicts of interest and suppression of scientific evidence in the guideline development process. The fact that IDSA ultimately vindicated its own guidelines through a self-selected review panel that excluded treating physicians and was comprised almost exclusively of IDSA members should be no surprise given the bias of the review panel.

[That is so far from true it would take the above statements a week just to walk to the point of being false. This nonsense has been noted before here, here, andhere.]

There is a significant disconnect between IDSA and the community of physicians who treat Lyme disease.

[No there isn’t, as shown by a recent survey of private practice physicians in Ct.]

There is also an urgent need for transparency in recognizing the limitations of the existing Lyme research. The bulk of the research on Lyme treatment has been controlled by IDSA researchers. Their research is based on sample populations that do not reflect those seen in clinical practice.

[No again. The bulk of the research is controlled—or at least funded by—the NIH. NIH-funded clinical treatment trials were based on volunteer patients from private practices in the Northeast and NY.]

[snip]

We do not believe that the selection of the “State of the Science” panel or the speakers reflects the diversity of scientific viewpoints in this highly controversial area. This lack of balance and diversity will necessarily erode the integrity of the process and the results. We encourage you to revamp the process to address these issues.

Sincerely yours,

Dr. Robert Bransfield, MD, DLFAPA

President, ILADS

[Both the wonk and the shrink listed a number of so-called IDSA bad guys on the IOM committee, but they left off quite a few other people. For example, well-known LLMDs like Fallon and Donta who will be at the October IOM meeting. Others include Carl Brenner from the NRFTBD group and the Lyme activist Pam Weintraub; Robert Aronowitz, a professor of history and sociology of Science, and Diane Blanchard from the activist group Time for Lyme in Ct. Then there are various university-based scientists (and non-IDSA members) such as the entomologists Munderloh and Oliver, immunologists such as Janis Weis, and various veterinarians. The agenda and complete list of speakers is available online here. It’s a diverse group; it’s just not full of ILADS quacks.]

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Posted by Relative Risk at 17:23 0 comments Links to this post

Labels: IOM

29 July 2010

More IOM bashing

Well, I guess this is why Lyme Blogger Johnson has been (mercifully) silent of late. She’s been drafting letters for a couple of congressmen who don’t want to otherwise tie up their busy staffers with trivia. Here’s her note:

What do Representatives Chris Smith and Frank Wolf have in common? They know how to ask the right people hard questions. What do the IDSA, the NIH, and the IOM have in common? They’ve honed the skill of the artful dodger. Representatives Smith and Wolf want to know why the NIH “stepped back” from its charge to run a state of the science conference and handed that hot potato to the IOM. One big difference between the NIH process and the IOM process? The NIH process considers bias a conflict of interest, meaning IDSA folks wouldn’t be sitting on an NIH panel. But, drum roll. . .the IOM permits panels to be biased and coincidentally has a panel that consists almost exclusively of IDSA folks, 4 of 6 panel members. Oh, and one more thing, the IOM is not technically considered to actually be ‘the government’. This is a picture perfect example of plausible deniability. The NIH didn’t stack a panel. The IOM did with IDSA folks. But, hey, they like bias and they are not accountable, are they? A copy of the letter from Representatives Smith and Wolf to Dr. Francis Collins of the NIH together with Collins response can be downloaded……

I may be a little vague on my Dickens, but wasn’t the Artful Dodger a pickpocket and not a slippery lawyer like L. Johnson? Isn’t she “dodging” the issue of bias and conflicts with this tautological recital of lies? Here she is back in Junecomplaining the membership of the recent IOM meeting on Lyme and other tick-borne diseases “is composed almost exclusively of IDSA members, in what seems like a saga of deniable accountability.” And again, “the Institute of Medicine— which, also, surprise-surprise, is composed mostly of IDSA members (according to my sources 4 of 6 members), in what seems like a saga of deniable accountability.”

Readers need only look at the IOM panel membership list to find her claims just aren’t so.

For all her effort (a 5-page, single-spaced letter), all she and her colleagues got back was a clear repudiation from NIH. The National Academy of Sciences—of which the IOM is a part—has been has been giving the government advice since Lincoln was president. Johnson and her Lymee agitators are not going to change that with another redundant accusation…even if it is on congressional stationary.

The letter ends with the usual degree of paranoia exhibited by Lyme activists.“It is important that information be made public, including the identity of all reviewers, and that transparency exist to the maximum extent possible throughout the process.” That is, of course, the standard practice with Academy reports.

The IOM applies the National Academies’ rigorous research process, aimed at providing objective and straightforward answers to difficult questions of national importance. Our consensus studies are conducted by committees carefully composed to ensure the requisite expertise and to avoid conflicts of interest.

The committee’s task is developed in collaboration with the study’s sponsor, which may be a government agency, a foundation, or an independent organization. However, once the statement of task and budget are finalized, the committee works independently to come to consensus on the questions raised. In fact, while committees may gather information from many sources in public meetings, they carry out their deliberations in private in order to avoid any external influence.

As a final check for quality and objectivity, all IOM reports undergo an independent external review by a second, independent group of experts whose comments are provided anonymously to the committee members.

And finally, the IOM states, “the names and affiliations of the report reviewers are made public when the report is released.”

Of course, it won’t be clear which reviewer made which comments during the review process. Trying to match reviewer names to comments should keep Johnson and her paranoid company busy for a few weeks.

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Posted by Relative Risk at 19:41 0 comments Links to this post

Labels: IOM

10 July 2010

Survey says…..whatever you want it to say