21 Letter: Antiscience and ethical concerns associated with advocacy of Lyme disease

Well, it's time for a little commentary on a recent publication which has been making the rounds in the Lyme disease patient community - this time on a letter which has been published to the Lancet recently. The letter is basically about those who believe Lyme disease can be a chronic, difficult to diagnose disease are part of an antiscience movement, and how the media, politics, and advocacy groups have supported unorthodox views concerning Lyme disease and other tickborne infections.

I'll post the excerpts in full first, and then a second time with my commentary interspersed.

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Excerpts from: Antiscience and ethical concerns associated with advocacy of Lyme disease.

Auwaerter PG, et al. Lancet Inf. Dis. Aug 22 2011.

Aspects of Lyme disease advocacy are an important example of this antiscience movement. For the purposes of this Personal View, 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.

For two decades, many Lyme disease activists have portrayed Lyme disease, a tick-borne infection, as an insidious, ubiquitous, difficult to diagnose, and often incurable disease, which causes mainly non-specific symptoms such as chronic fatigue, musculoskeletal pain, and neurocognitive dysfunction that can be treated only through the use of antibiotics for months or years.

As with other antiscience groups, some Lyme disease activists have created a parallel universe of pseudoscientific practitioners, research, publications, and meetings, arranged public protests and made accusations of corruption and conspiracy, used harassment and occasional death threats, and advocated legislative efforts to subvert evidence-based medicine and peer-reviewed science.
Politicians, the media, and the public have been left trying to discern the scientific facts from the pseudoscientific ones, with many regarding both as equally valid as they try to be fair and balanced.

When such inappropriate and uncritical weighting occurs, public and government officials unknowingly come to accept or even endorse highly unconventional and sometimes dangerous theories and therapies.

Many individuals who represent themselves as Lyme disease activists and LLMDs hold and promote views of a tick-borne infectious disease that is inconsistent with credible scientific evidence. Although relatively small in number, their effect should not be underestimated.

Their unorthodox perspectives and resulting practices have contributed to injury and even deaths of patients. Millions of dollars have been spent refuting their claims, and thousands of hours have been spent responding to false allegations, legal threats, congressional queries, and other harassments.

At a time when unnecessary healthcare expenditures are being scrutinised and widespread bacterial resistance has been linked to overuse of antibiotics, it is particularly important that unsubstantiated treatments be avoided.

This situation is not likely to end anytime soon. As with other antiscience groups, many Lyme disease activists are well funded and often connected to influential political and media sources.

Treatment of Lyme disease with long-term antibiotics is profitable for LLMDs and can be falsely reassuring to patients, who believe that they have a debilitating chronic infection and thus do not seek diagnosis and treatment for other disorders.

There is no deficiency of either new patients or activists. The medical anthropologist Sharon Kaufman wrote that “Information technology has transformed the way trust and knowledge are produced”. Most people now find medical information on the internet, and the websites of LLMDs and activists are often viewed as legitimate and reliable sources of information, which they may not be.

Such misplaced trust has also contributed to a similar situation in Europe, with increasing pressure being brought on authorities there to sanction the use of prolonged antibiotic treatment for patients without credible evidence of Lyme disease by groups such as the German Borreliosis Society and Dutch Lyme Association. This ill-founded advocacy is being extended to other, less common, tick-borne infections (and to non-Ixodes tick-transmitted pathogens such as Bartonella).

In conclusion, activists, through public appeal and political lobbying, have managed to divert attention away from existing evidence-based medicine in their quest to redefine Lyme disease. There is a serious concern that they will further endanger the public’s health unless responsible physicians, scientists, government leaders, and the media firmly stand up for an evidence-based approach to this infection that is based on high-quality scientific studies.


The Above, With Camp Other Commentary

"Aspects of Lyme disease advocacy are an important example of this antiscience movement. For the purposes of this Personal View, 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 problem with a statement such as this is that the content is a mix of fact and opinion.

I have to admit, there are a heck of a lot of unproven alternative treatments for Lyme disease and its coinfections which are out there - salt and vitamin C, MMS, and Rife being some of the riskiest and most useless treatments being promoted.

I think the focus on such treatments has distracted others from investing more energy into petitions for and promotion of research on persistence, combination antibiotic treatments, immune dysregulation, and other topics which affect the outcome for patients with persisting symptoms.

And I think focus has to come back to the use of antibiotics and other antimicrobials in their effective treatment of Lyme disease and its coinfections, as such medicines have been studied for years for their effectiveness in treating such infections.

Not all patients, doctors, and researchers who are connected with Lyme disease advocacy are antiscience or avoid the facts, even when they do not align with what we wish they would be instead. Quite a number of us are in favor of more research and want independent research completed to help patients with persisting symptoms of post treatment chronic Lyme disease.

NIH research and private research on Lyme disease has been funded by Lyme disease advocacy groups. And some Lyme disease advocacy groups have even funded research to address the immune dysregulation component behind persisting symptoms, providing evidence that it is a misconception that all Lyme disease advocacy groups and patients are only interested in long-term antibiotic treatment alone.

I have heard mention by others that Lyme disease advocates and patients are any of a number of things -  anti-vaccination, conspiracy theorists, hypochondriacs, and gullible. Maybe some people are - and there are also such people in the general population.

But to characterize everyone - or even many people - with Lyme disease as having these qualities is ignoring the majority of us with Lyme disease who do not possess these qualities... It's like characterizing everyone or most people who are a microbiologist, pharmacologist, scientist, or family doctor as being a shill for Big Pharma. Neither characterization is either accurate, fair, or true.

If you only write about Lyme disease patients with certain qualities, then you have not managed to talk to us or acknowledge us all: Some of us have been quiet online and in public - we're very sick and just want to get better. Some of us are forward-thinking advocates who have always wanted more research. Some of us are inbetween. We aren't all the same.

If you have read my blog, you will know I have an issue with conspiracy theories. I don't even want to discuss them and demand credible evidence from anyone mentioning them. While I have not been particularly vocal on this issue before, I am in support of safe and effective vaccines - especially in the case of life threatening diseases.

 I am in many ways a skeptic and am hardly considered gullible, nor am I a hypochondriac.

If you think that those of us who are looking at and supporting "science that has weak credibility or validity because of fundamental flaws in its design or poor reproducibility", then it would be educational and informative if you would take these cases and studies point by point, and just lay it all out for those of us who want to hear your position on why the specific studies are flawed.

Instead, most of what the Lyme patient community hears in various media outlets and your own articles is the phrase "in our expert opinion, chronic Lyme disease is not a real clinical entity" without any specific explanation as to what reasoning and evidence supports that statement. (And then you go on to mention Post Lyme Disease Syndrome, and yet there is no solid clinical definition and are no biomarkers for this condition. I find this strange and inherently useless.)

Falling back on your position as expert is not cutting it for those who are ill with persisting symptoms - it's not enough when some of us have been ill for years and have lost a lot due to illness. Patients and advocacy groups need to know not just what your conclusions are, but how you reached them.

"For two decades, many Lyme disease activists have portrayed Lyme disease, a tick-borne infection, as an insidious, ubiquitous, difficult to diagnose, and often incurable disease, which causes mainly non-specific symptoms such as chronic fatigue, musculoskeletal pain, and neurocognitive dysfunction that can be treated only through the use of antibiotics for months or years."

I think the truth lies somewhere inbetween.

I don't think it's incurable, but I think standard treatment may be inadequate for some patients. I think Lyme disease is complex and the outcome is mixed for Lyme disease patients depending on a number of factors. Even the 2006 guidelines show up to 10% of early acute cases have treatment failures - so even if caught early, not everyone is better with early treatment.

Based on your own research, clinical microbiology texts, conference literature, medical school presentations, PubMed publications, and patents written by infectious disease experts, documentation states that Lyme disease can be easily misdiagnosed or mistaken for another medical condition. This is especially true in its early stages when serology is unreliable and a rash may not be visible or was missed due to its location. Because it's a multisystem disease, symptoms can be all over the map, and later stage untreated Lyme disease can be missed unless it's a clear case of Lyme arthritis.

I didn't learn this from other activists, though some of them have the same information on their own sites. I learned it from books, professional clinical journals, professional medical groups, and your own studies. I'm a stubborn sod and I do my own research, and question everything I read and hear. I occasionally even reread my own writing and question myself: "Do I still think this is true? And if not, why?" because I want to aim for getting as a clear an understanding of the issues as I can.  (I'm okay with being wrong, too, and correcting my position provided the evidence I'm given is convincing and there is no alternative hypothesis which has equally compelling evidence.)

Untreated Lyme disease leads to late stage sequelae that can be very serious and disabling.  You cite that patients mention "non-specific symptoms such as chronic fatigue, musculoskeletal pain, and neurocognitive dysfunction". Those symptoms can relate to conditions such as Lyme carditis (affecting the heart),  Lyme encephalopathy and neuroborreliosis, and arthritis (including chronic Lyme arthritis, which is hypothesized to be autoimmune in origin in patients with an HLA-DR4 allele).

Will everyone experience these symptoms who gets Lyme disease? No. Not everyone gets such serious symptoms. Do some people experience them? Yes. But then this is what we were always talking about, and why prevention is important. (Isn't this why, too, you have been working on various vaccines for Lyme disease over the years? Because the late stage sequelae are rough, and because no one wants their son to collapse from heart block caused by a tickborne infection?)

These non-specific symptoms could be considered clinical indicators of the presence of late stage Lyme disease - some are symptoms which arrive in early dissemination. Symptoms in and of themselves could be related to other conditions - but if the patient has a clinical history and symptoms pointing to Lyme disease, it needs to be considered in the differential diagnosis.

If the same symptoms arise in patients with Lyme disease who have been treated with a standard course of antibiotics, then a cause for those symptoms needs to be further investigated. At present - according to all the documentation I've read - the cause is unknown.

This means it is... unknown. Both the persisting infection model and autoimmune model are hypotheses. And there are variations on each of these models.

I don't understand why a third hypothesis isn't tested: that it is a combination of both infection and immune dysregulation that leads to persisting symptoms?

"As with other antiscience groups, some Lyme disease activists have created a parallel universe of pseudoscientific practitioners, research, publications, and meetings, arranged public protests and made accusations of corruption and conspiracy, used harassment and occasional death threats, and advocated legislative efforts to subvert evidence-based medicine and peer-reviewed science."

When patients have not been heard and their condition has not been adequately addressed - and when their condition has not been researched to the point where the cause is known and treatment path clear - patients are going to turn to whatever treatments are made available to them.

Some treatments will be evidence-based, some will be experimental and based on scientific hypothesis, and some of it will not have any evidence to base their treatment on at all and turn to anecdote.

What would anyone expect them to do? Nothing? 

One of the often cited pieces of advice given by you has been to see a doctor to rule out any other medical conditions. What if patients have already done so, some even having been to a few specialists - and have found no other cause for their symptoms but have evidence that suggests they have a tickborne illness?

They can choose to do nothing, treat their symptoms, or continue to look for another cause. I think right or wrong, most people are not going to sit there and do nothing.

Especially if they are bedridden. Especially if they have chronic pain and fatigue. Nobody wants to live like that. They want their old life back.

It's not that anyone wants to subvert evidence-based medicine or peer-reviewed science, per se. That's not it at all. The issue is that patients think that in this particular situation, your scientific research has failed to help them.

Some reasearchers are trying to conduct research which help patients find more effective treatment and an understanding of the disease process, but it is slow going.

The perspective of the average Lyme disease patient with persisting symptoms is probably not all that different from patients with chronic fatigue - or people with fibromyalgia not too long ago.

Patients have not only felt abandoned but judged and labeled. They have been told their pain is just "the aches and pains of daily living" when that has not been their experience - their lives have been limited if not entirely put on hold by their pain and fatigue. If symptoms were that mild, I think most of us would just shrug, pop some ibuprofen, and live with them. Go to work. Go to the gym. But for a significant number of us, they aren't mild. They're debilitating.

For just a moment, I want you to stop, look in the mirror and think: Why hasn't the Lyme disease patient community listened to me? Why are they angry?

I don't support the use of threats and do not like conspiracy theories. If there has been any corruption, I leave that to be handled by professional investigators and those who are aware of the corruption firsthand - I am not in a position to make that call and couldn't base my decision on hearsay, anyway.

All this aside, though: Patients are angry, and a letter like this does not make your position stronger. It's not a letter advocating for improved health and research to help patients. It's not a letter demonstrating the strength of the evidence supporting your own position. And it's not a letter about caring for and healing the sick.

On the surface, it's a letter condemning pseudoscience - which I find fault with, too. But on a deeper level, this is not what it is about. No. Patients are going to read it and see that it's a letter which condemns the organizations and doctors who have been there for them.  Not only been there for them - but have helped many of them get better.

While you can argue with some of the LLMDs' methodology, the truth of the matter is they have diagnosed cases of Lyme disease and other tickborne infections accurately and helped patients get better. Some of them have picked up the pieces after an urgent care or family doctor missed the diagnosis.

This is part of what I think you have trouble reconciling: That even as there are charlatans and bad doctors - even including a few bad LLMDs - there are good LLMDs out there who are correct in their diagnosis and their treatment is helping patients.

Whether or not you agree with what advocacy organizations and LLMDs do or not is besides the point here - hey, there are certain statements and practices I've heard LLMDs and organizations make which I disagree with, too. Anyway, this message here is really more about you, not them.

Here are your bullet points:

• You have not adequately addressed the needs and concerns of patients either through your communications involving them or by conducting research which is important to them on a practical level.
  
  
• Your 2006 guidelines seem to focus on discussion about people with persisting symptoms who do not have a previous history of Lyme disease rather than people who do, and lack citations for effective and beneficial ways to treat patients with persisting symptoms. The focus is almost entirely on what not to do.
  
  
• Patients are not likely to want to listen to you if you are characterizing their pain as minimal when their pain is moderate to severe, and patients are not likely to listen to you when you are characterizing them and their situations when you don't even know their story. It's called diagnosing at a distance.
  
  
• Given past history between patient organizations and your organizations, things are not looking good. Patients are not trusting you for various reasons, and part of it is already years of not being listened to and considered. At this point, you can change what you do to consider patients in the equation more - but honestly, I think third party work is the best place to go for everyone. 

"Politicians, the media, and the public have been left trying to discern the scientific facts from the pseudoscientific ones, with many regarding both as equally valid as they try to be fair and balanced."

Instead of making such a statement, can you provide evidence to back up what you consider to be scientific fact and what you consider to be pseudoscientific?

Maybe you should create a web site where you outline this information and let others read it and decide. So far, whatever arguments and evidence I've heard from your side that I've read is currently not that detailed or comprehensive in terms of presenting your view and is provided in terms of soundbites.

Right now you have an uphill battle. Whenever I google "Lyme disease" the percentage of web sites out there which are represented by your organization are outnumbered by a pretty wide margin by patients and advocacy groups.

And so far, very few web sites discuss the scientific evidence supporting either the persistence model or autoimmune hypotheses in a comprehensive and easily understood way - regardless of which side is presenting the information. Even fewer web sites get into the nitty gritty of why a particular aspect of a particular study has shortcomings (data lacking) or flaws (data analysis was faulty; method was incorrect).

Yes, there is research out there for both models - but it is distributed and piecemeal, some of the information is outdated and some of it is not easily accessible because it's behind a "pay for publication" wall.

I end up getting most of my Lyme disease information from Pubmed and textbooks - both of which I refer to pretty heavily on this site. I don't refer to either major advocacy organizations or your sites much because I am trying to look at the data directly and sidestep the controversy. I have to piece together this puzzle on my own.

The problem I'm seeing so far is that there isn't enough directed research that addresses the problems of someone with my condition, period.

"When such inappropriate and uncritical weighting occurs, public and government officials unknowingly come to accept or even endorse highly unconventional and sometimes dangerous theories and therapies."

Critical weighing of the evidence is necessary, and researchers, doctors, and patients need to all be involved in the process. Patients in particular, because they are the primary stakeholders in this situation.

In the end, it's about the PATIENTS.

Patients who need more research and have been waiting a long time to get it.

In the early days of Lyme disease, patients' voices were welcome at more scientific conferences just as they were at the October 2010 Institute of Medicine tickborne diseases workshop. Polly Murray was listened to before this, and the public health service took her reports seriously when she mentioned an outbreak of juvenile arthritis clusters in Connecticut back in the 1970's.

What happened?

Many individuals who represent themselves as Lyme disease activists and LLMDs hold and promote views of a tick-borne infectious disease that is inconsistent with credible scientific evidence. Although relatively small in number, their effect should not be underestimated.

I think I've already addressed the bulk of this statement.

Their unorthodox perspectives and resulting practices have contributed to injury and even deaths of patients. Millions of dollars have been spent refuting their claims, and thousands of hours have been spent responding to false allegations, legal threats, congressional queries, and other harassments.

How do you suggest patients improve their health and quality of life if they have persisting symptoms of post treatment Lyme disease?

Even conventional perspectives and practices in medicine have contributed to injury and death of patients - including denying antibiotics and antiprotozoals to patients who need them. Treating patients comes with risks, and not treating patients also comes with risks. What can you do to mitigate risks and improve the health of patients overall?

I'd like to see the hurling stop on both sides of the controversy. Hint: Not writing this letter and writing a different one about research that helps patients would have been one step towards stopping.

"At a time when unnecessary healthcare expenditures are being scrutinised and widespread bacterial resistance has been linked to overuse of antibiotics, it is particularly important that unsubstantiated treatments be avoided."

How do you know antibiotics are overused in individual patient cases? Perhaps in some situations additional antibiotics and antiprotozoal medications are necessary.

More research on the treatment of late stage Lyme disease and polymicrobial infection needs to be done, as well as the immune dysregulation factors leading to persisting symptoms.

More research on neuroborreliosis needs to be done. Dr. Fallon mentioned at the IOM workshop that there is a correlation between neuroborreliosis and the development of persisting symptoms. If you could prevent more cases of neuroborreliosis and treat existing ones effectively, then perhaps far fewer people will be trying longer courses of antibiotics. Many patients are concerned about Lyme disease because it can affect CNS and brain - if researchers address this issue effectively, more patients will be at ease.

If you tell me Dr. Fallon has misplaced concerns - or by extension I do - tell me why.

If you are absolutely sure that more antibiotics aren't going to help all patients in all situations where symptoms are persisting, and something else is going to help more - tell me why and tell me what helps. I am all ears.

To date, I have yet to hear a really convincing argument and be presented with evidence that supports this as being the case for everyone with persisting symptoms of post treatment chronic Lyme disease.

"This situation is not likely to end anytime soon. As with other antiscience groups, many Lyme disease activists are well funded and often connected to influential political and media sources."

And this letter is not addressing the issues which concern patients, once again.

"Treatment of Lyme disease with long-term antibiotics is profitable for LLMDs and can be falsely reassuring to patients, who believe that they have a debilitating chronic infection and thus do not seek diagnosis and treatment for other disorders."

Medicine is often profitable in general, and doctors of all kinds have been falsely reassuring to me and other patients.

Personally, I don't think my LLMD has been making money hand over fist off me. And this field is not a  uniform one - it is more profitable for some LLMDs than others for a variety of reasons. And some take insurance, some do not.

In the end they are all different, but most of them are doing the best they can to help people. And any statement you apply to an LLMD can be written to apply to other doctors and specialists for other situations and other forms of profit generation.

The questions I have as a patient are: Do they have any evidence to support their treatments for individual patients? Do they have solid case studies? Are people getting better? The proof is in the pudding.

And I'd also want LLMDs to avoid conflicts of interest as much as any researcher working on Lyme disease.

I'm not holding anyone up to different standards here. The problem is the way scientific and medical culture are now, how far do you have to go before you find some conflict of interest somewhere along the line with just about anyone?

This bit about not seeking out diagnosis and treatment for other disorders is an assumption, and it is incorrect.

I have sought diagnosis for treatment for other disorders. I have also had two specialists and one family doctor tell me to talk to my LLMD when they could not figure out why I kept getting fevers and other strange symptoms.

Make of that what you will - it reflects on them and the medical profession today. Either the doctors are stumped, or they trust the LLMD's judgment, or they just want me off their hands. I don't think the last item is entirely true, because when acute problems come up like a flu or an ingrown toenail, my family doctor is willing to treat it - I don't see an LLMD for every problem that comes up.

I suppose it's possible that I could have a chronic condition that has not been identified yet, but if so, I don't know who I would hold responsible for this because I have been thoroughly examined and tested.

"There is no deficiency of either new patients or activists. The medical anthropologist Sharon Kaufman wrote that “Information technology has transformed the way trust and knowledge are produced”. Most people now find medical information on the internet, and the websites of LLMDs and activists are often viewed as legitimate and reliable sources of information, which they may not be."

This is actually a hilarious statement to make.

Back in 1992, there were over 100 Lyme disease support groups and there were a sum total of 26 web sites on the internet. 

Most people outside of universities and the government didn't even have internet access yet.

Why did patients need that many support groups before 1992 and form them so readily without using the internet?

It's really simple: Because they already weren't getting the support or research they needed.

Yes, we have more access to information about Lyme disease online than ever. Think of how many cases may have been prevented by now because people spoke up about it, and it was the patients who did. Think about how many people are familiar about the symptoms and know what they are - and it was the patients who warned them.

Maybe not everything online is right, but there is a lot of information that is right that I can easily access now that I could not before - not without going to a university library and piling through books for hours. Some of us still do that because not everything can be found online.

The issue isn't the source but having a critical way of considering and weighing the information and being aware of the limits of one's own knowledge in a given area in order to consider the data presented.  There will always be a certain amount of information I won't immediately grasp - so that is why I talk to a professional such as a doctor, scientist, microbiologist, or other researcher I trust.

I turned to the internet, too, but because I am skeptical, I decided to look at what everyone had to say about Lyme disease. I still don't know the answers to some of my questions and I'm finding out that researchers aren't entirely sure, either. Where does that leave me then?

"Such misplaced trust has also contributed to a similar situation in Europe, with increasing pressure being brought on authorities there to sanction the use of prolonged antibiotic treatment for patients without credible evidence of Lyme disease by groups such as the German Borreliosis Society and Dutch Lyme Association. This ill-founded advocacy is being extended to other, less common, tick-borne infections (and to non-Ixodes tick-transmitted pathogens such as Bartonella)."

Why do you think this is happening? I suggest referring to my comments further upstream.

"In conclusion, activists, through public appeal and political lobbying, have managed to divert attention away from existing evidence-based medicine in their quest to redefine Lyme disease. There is a serious concern that they will further endanger the public’s health unless responsible physicians, scientists, government leaders, and the media firmly stand up for an evidence-based approach to this infection that is based on high-quality scientific studies."

It's funny to hear it from both sides. I don't even like that there are "sides" to this controversy. I just want to know the truth, and at the moment, I read the research directly and I see some of the points you make and agree - but I also disagree. And I see some of the points others make within the Lyme community and agree - but I also disagree.

This is why I want more research from independent parties who are not invested in the outcome financially or ideologically - but still care about patients and want to do right by them.

If you want to win the Lyme wars, change strategy.

What you're doing? It ain't workin'.

At this point, I just don't want to play.  I want to get better and go back to work and stop feeling like fatigue and pain is going to dog me forever. I have lost a good portion of my 30s to this illness - the most productive years of my career. How are you going to help me through my 40s? Or is disability it for me?

Addendum April 2012: A few rebuttal letters have been posted to Auwaerter et al's original letter published in The Lancet. See: http://campother.blogspot.com/2012/04/health-matters-magazine-and-lancet-anti.html

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