INFECTION- MULTIPLE SCLEROSIS, MOTOR NEURONS, PARKINSONS?

Rare infections mimicking MS
Vesna V. Brinar, Mario Habek
Received 28 March 2010; accepted 6 April 2010.
Abstract
The diagnosis of multiple sclerosis (MS), despite well defined clinical criteria is not always simple. On many occasions it is difficult to differentiate MS from various non-MS idiopathic demyelinating disorders, specific and infectious inflammatory diseases or non-inflammatory demyelinating diseases. Clinicians should be aware of various clinical and MRI “red flags” that may point to the other diagnosis and demand further diagnostic evaluation. It is generally accepted that atypical clinical symptoms or atypical neuroimaging signs determine necessity for broad differential diagnostic work up. Of the infectious diseases that are most commonly mistaken for MS the clinician should take into account Whipple's disease, Lyme disease, Syphilis, HIV/AIDS, Brucellosis, HHV-6 infection, Hepatitis C, Mycoplasma and Creutzfeld-Jacob disease, among others. Cat scratch disease caused by Bartonella hensellae, Mediterranean spotted fever caused by Riketssia connore and Leptospirosis caused by different Leptospira serovars rarely cause focal neurological deficit and demyelinating MRI changes similar to MS. When atypical clinical and neuroimaging presentations are present, serology on rare infectious diseases that may mimic MS may be warranted. This review will focus on the infectious diseases mimicking MS with presentation of rare illustrative cases.
http://www.clineu-journal.com/article/PIIS0303846710001137/abstract?rss=yes

This week CALDA blog posted here the San Jose Mercury News writes a follow-up story on Bart Fenolio, who last December was told he had two months to live. Fenolio has been in a nursing home since then, receiving Lyme treatment. Now he's well enough to go home.
Told he was dying of ALS, California man turns it around with Lyme treatment.

Many patients with Lyme Disease will already have heard about Dr Martz who in 2003 was also diagnosed with ALS Upper and lower known as Motor Neurons here in the UK. He found that infact he had Lyme Disease and on appropriate antibiotic treatment turned his life around, more details can be seen on CALDA blog here and on Can Lyme here

In June 2010 ILADS held their first conference in London and I was privileged to be asked to help out at reception. I was able to listen to some of the presentations all really amazing and ground breaking work. Dr Martz had travelled from USA to join other Lyme Doctors from USA, UK, Germany and France.

I had a particular interest in hearing Dr Martz' presentation because someone I know of locally had like me been diagnosed years before with Polymyalgia Rheumatica and I had passed a message on when my Polymyalgia Rheumatica had been found to be Lyme Disease to perhaps check it out. More recently this person developed Neurological symptoms and was diagnosed with Parkinson's. It transpired that he had history of tick bite, had worked in agriculture and had a rash on his shoulder that had been there a year and had mystified his doctors. I heard this week that he has in fact tested positive for Lyme Disease so fingers crossed that his antibiotic treatment will go some way to alleviate his symptoms.

Dr Martz at the ILADS conference not only talked about his experience but also about his findings from treating other patients with such illnesses as ALS/Motor Neurons, Parkinson's and Multiple Sclerosis after his recovery he had come out of retirement and opened a clinic treating patients with Lyme Disease. This is clearly just the start of researching into these illnesses and Borrelia or Lyme Disease as one of their possible causes. Sadly with the controversy caused by IDSA restrictive Guidelines and the tests not being very reliable most people will not be properly assessed to see if their Multiple Sclerosis, Parkinson's or Motor Neurons could be Lyme Disease.

After the London ILADS conference and at the end of a very tiring day I watched Dr Martz and his lovely wife walk away through Regents Park and thought what an amazing man, no one would ever have thought that just 7 years ago he had been given a death sentence.

CLINICAL JUDGMENT FOR MULTISYSTEMIC ILLNESS

The Need for Clinical Judgment in the
Diagnosis and Treatment of Lyme Disease


Elizabeth L. Maloney, M.D.



extract


The wide array of Lyme disease symptoms is consistent with Borrelia burgdorferi’s ability to infect multiple organ systems; nervous system involvement creates the potential for varied and atypical symptoms. Common symptoms include: EM rash, fever, fatigue, headache, neck pain, joint or muscle pain, paresthesias, memory impairment, weakness of facial muscles, mood disorders, neuropathic pain.



further extract


It is the multisystemic nature of the illness that provides physicians
with useful diagnostic information. In fact, with the exception of an
isolated EM rash or swollen joint, patients with symptoms restricted to
a single system are unlikely to have Lyme disease. Recognizing the
potential for disease is different from “seeing it everywhere.” Failure
to recognize Lyme disease may lead to serious harm, as antibiotics are
delayed and the infection is unchecked.


The nonspecific nature of many Lyme disease symptoms leads
some to suggest that such symptoms hold no diagnostic value. Lyme
disease is like many other illnesses that present with nonspecific and
often subtle symptoms—symptoms that may go unrecognized by
physicians. Examples include hypothyroidism, ovarian cancer, and
acute sub endocardial myocardial infarction. What gives the
individual symptoms of Lyme disease value is their occurrence in
clusters; a single symptom means little but four or five may, for all
practical purposes, make the case. Just as abdominal bloating, urinary
urgency, and pelvic pain raise “red flags” for gynecologists, the
combination of fatigue, paresthesias, arthralgias, and memory
complaints presenting in a single patient commands the attention of
physicians aware of these potential Lyme disease symptoms.


Steere et al. noted that patients with early Lyme disease who
lacked an EM rash presented with an average of four or more
symptoms. Fever, chills, malaise, and myalgia, all nonspecific, were
present in 46%-71% of the patients with definite Lyme disease alone.
In this group, it was the clustering of nonspecific symptoms in the
appropriate setting that led to the correct diagnosis of Lyme disease.


Logigian et al. also noted the nonspecific nature of identi-fying
symptoms: “The most common form of chronic central nervous
system involvement in our patients was subacute encephalopathy
affecting memory, mood, and sleep, sometimes with subtle
disturbances in language.


Diagnosis of this condition may be difficult
because the typical symptoms are nonspecific” [emphasis added].


To provide a clinical level of diagnostic sensitivity higher than two tier
testing, physicians need to recognize the symptom clusters and
maintain a high index of suspicion for Lyme disease.



To read the full article click here

SHAME ON OUR HEALTH CARE FOR IGNORING RESEARCH

I posted earlier Dr Bransfield's response to the IDSA decision over their review of the IDSA Lyme Disease Guidelines. click here

Presentations to IDSA review can be found on www.ilads.org

Stephen Phillips presented 25 studies of seronegativity and persistent infection, Phillips highlights on 18 occasions where IDSA 2006 authors were actually involved in that research confirming seronegativity and persistent infection yet failed to include it in their Guidelines. At the end of the presentations to review panel the chairwoman asked Steere to comment, what was his answer OPINION, Opinion is what is driving these guidelines and leaving thousands of patients the world over without diagnosis and treatment that can help.

How many people suffer from Arthritis, Muscle weakness, Neurological problems, fatigue, Psychosis, digestive problems, brain fog, cognitive difficulties and get diagnosed with ME/CFS, Fibromyalgia, arthritis, MS, MN, Parkinson's, ADHD, OCD without their doctors considering if it could be Lyme Disease.

Ticktalk Ireland has just posted a very useful link to a pdf on her blog that presents many studies on seronegativity and persistent infection, it highlights where the IDSA guideline authors were themselves involved in that research yet failed to include in their guidelines. click here

Whilst our health authorities cherry pick science to support their opinions patients suffer.

A LYME WARRIOR

Dr. Joe Jemsek “Speaks the Truth” Speech

Dr. Joe Jemsek (www.jemsekspecialty.com) discusses the controversy surrounding Lyme disease and what action needs to be taken to provide patients with better care.

Lyme Disease is more generally associated with Arthritis by the general public, that is if they think about it at all. In fact my main symptoms were arthritis and muscle weakness but as my illness progressed I developed various Peripheral Neuropathies. It is interesting to read what Dr Jemsek has to say about the Disease and the Patient.

THE DISEASE
A tick bite can expose a person to a variety of bacteria and other microorganisms that may make one sick. This can occur after a single bite or through multiple tick bites. In this overview, we will focus on the particular bacteria called Borrelia Burgdorferi (Bb) that is known to cause Lyme disease and is acquired from a tick bite. If antibiotics are not taken or are inappropriately administered soon after a bite from a Bb-infected tick, the patient is at higher risk for illness, which may occur suddenly or surface at a later time.
Finding the attached tick is difficult because the tick that carries this bacterium is very small and tick bites may occur where they are not easily seen. Often times, the tell-tale rash that can result from a tick bit, called erythema migrams, does not develop. Hence, a patient may not know they were bitten by an infected tick. They may soon begin to feel symptoms such as fatigue, muscle pain and spasms, sensory aversion, gut and bladder problems, bizarre neurological symptoms and memory loss. It is not unusual for cognitive difficulties to progress to the point that patients experience the inability to find their way home from everyday places, such as the grocery store and post office.

THE PATIENTS
Most patients that come to the Jemsek Specialty Clinic have seen 5 to 15 doctors for the symptoms listed above. They have seen neurologists, psychiatrists, rheumatologists, cardiologists, gastroenterologists, and internal medicine specialists. They have often been treated for one of more of their individual symptoms without knowing the cause of those symptoms. When treatment for their symptoms is stopped, the symptoms typically re-emerge. This is not unusual if one stops taking high blood pressure medicine, the blood pressure usually rises again.

On the matter of the IDSA review

http://www.jemsekspecialty.com/shownews.php?id=30

IDSA Review Panel Results Called Highly Suspect

"There is no justification for relying on flawed science for continuing its recommended guidelines and arming insurance companies to deny health benefits to insured Lyme victims. If the panel was not prepared to recognize the studies that support longer courses of antibiotic treatment for chronic sufferers, it should have included a call for continued scientific study of this topic among its suggestions. It is time for the IDSA doctors to stop defending their reputations and get back to the work of helping sick people to get well."

Although the above video was of 2009 Into The Light Gala I had not started this blog then and it is something I wanted to post about. I remember Dr Jemsek saying that of the top 20 chronic illnesses in the USA they only know the cause of two Helicobacter Pylori a bacterial infection causing stomach ulcers and HIV a viral infection.

How many patients went under the knife for a stomach ulcer unnecessarily and how many AIDS patients died before HIV was accepted? Already Lyme disease is a greater epidemic in the USA than HIV.

ME/CFS TIME LINE

In the early stages of my illness I was diagnosed with Fibromyalgia, I had migrating Arthralgias. As my symptoms deteriorated I was diagnosed with ME/CFS, then Arthritis and muscle Weakness and eventually Polymyalgia Rheumatica and put on steroids. Clearly steroids reduced the inflammation I had throughout most of my joints and muscles and enabled me to struggle on working although on very much reduced hours.



It wasn't until a chance course of antibiotics significantly improved my symptoms that led my GP to suspect Lyme disease. Later this was confirmed clinically by an expert and the recovery from chronic debilitating health on long term antibiotics has given me my life back again.



Because of my earlier ME/CFS diagnosis and the fact that many patients with ME/CFS are found to have Lyme Disease, I take an interest in this illness and the problems patients have.



A recent post on CFS Central blog found here gives an excellent catalogue of events A COMMOTION IN THE BLOOD by Mindy Kitei do visit this blog for a detailed read of what has been going on.

AUTISM VIDEOS

These excellent videos from Lymenaide are a must watch for parents with children suffering from Autism.

This Spring Lymenaide and And What Productions filmed an interview with Dr Chitra Bhakta.
Dr Bhakta is a DAN (Defeat Autism Now) and an LLMD. She spoke with us about Lyme Induced Autism, Lyme disease and treatment.

http://lymenaide.wordpress.com/

'When I started testing these (Autistic) children 8 out of 10 were testing positive for Lyme and Bartonella and other co infections of Lyme Disease.'

Dr Bhakta points out that Lyme is endemic throughout the World.

Her closing words are 'the tests are not the be all and end all.' (She had already pointed out that most of the tests for Chronic Lyme will turn out negative)

'Doctors are human beings and have fallibilities.'

'The best person is to have belief in yourself.'

For earlier posts on Autism and Lyme Disease enter Autism in the search in the right column or click here

IS IT REALLY AUTISM?

Dr Jones treats children with Lyme Disease many of those children present with symptoms similar to children with Autism and several of those children had been previously diagnosed with Autism. On long term antibiotics for their Lyme Disease there symptoms improve.

Below are extracts from the Hartford Advocate a well written article by Betsy Yagla


A 7-year-old boy named Timmy came in for an appointment.

At an earlier visit with Jones, five months prior, Timmy exhibited problems like low muscle tone and no expressive speech. Another doctor diagnosed him with autism when he was 2 years old. Timmy’s mom noticed that when he was on antibiotics, his behavior became better. He exhibited fewer symptoms associated with autism. After he went off his medication, though, his symptoms returned to full force.

Jones thought the boy had Lyme disease, not autism.
At that first visit, Jones says, he put his hands on Timmy’s cheeks and looked into his eyes: “I hope I have the key to unlock your brain,” he said. Timmy then squirmed out of Jones’s lap and began to run around the room.

At Timmy’s follow-up visit, one day after Jones received his punishment, Timmy “climbed into my lap, put my hands on his cheeks and said, ‘Thank you for giving me the key to unlock my brain.’” Jones says. “Then he hugged me.”

“That’s why I stayed in [medicine],” he says.


One of the reasons Jones is so controversial is because of patients like Timmy: Jones’ diagnoses and treatments call into question those of other doctors. While other doctors see autism or mental illness, Jones sees Lyme. Jones thinks one of the reasons he’s so disliked in the medical community is other doctors’ pride.

Sitting in a leather chair in his New Haven office, 81-year-old Jones does not look like a man who arouses passionate disputes. He’s wearing a blue Adidas tracksuit with his name embroidered on the back, and the type of black orthopedic sneakers you’d expect on a man his age.
Jones didn’t start out as a doctor — he was a divinity student at Boston University in the early 1960s. As an assistant minister with the Second Church Unitarians, Jones made house calls to people who couldn’t get out to go to church. Changing professions was a decision inspired by one of those visits: “I was in the home of an 80-year-old woman who was very badly stricken by arthritis. She grabbed my hand on the way out and said, ‘Please do something to help me in a real way,’ and that was it.”
He started focusing on cancer in New York, but moved to Hamden with his wife to raise a family and start a pediatric practice in New Haven. In the late ’60s, he noticed clusters of kids — several in a family — diagnosed with juvenile rheumatoid arthritis. Many had strep throat, he says. “When we treated them [for strep] with antibiotics, they got better. That was the beginning of it,” Jones says.

He saw more as time went on.

“It infected every part of the body, including the brain and the skin. We were treating them with six weeks of antibiotics. Then another six weeks if it didn’t work. There was a little boy, about 10 or 11, who was diagnosed with rheumatoid arthritis. We did several rounds of six weeks of antibiotics and a few weeks off. He did better on them, not off. He said to me, ‘If I’m better while I’m on the antibiotics, why don’t you keep me on them?’
“‘Well,’ I wondered ‘Why didn’t I think of that?’ He was on antibiotics for three of four years and now he’s in his late 40s and is perfectly well. From that point on, I started treating with antibiotics continuously until they were better and then for two months after that.”
That attitude is what’s turned Jones into the Pope of the Lyme disease community. It also turned him into a pariah of the academic and medical community.

To read the article in full from the Hartford Advocate click here

To read more about the controversy surrounding this Pioneering doctor have a look at CLADA website and there many blogs listed on the right hand side here

To read more of my posts on Autism enter Autism in the search engine on the right hand column on my blog or click here

To look at more information on Lyme Disease and Autism see the links in the right hand column of my blog or click here

To find out more about Lyme Disease visit the many links in the right hand column of this blog.

My own Arthritis and Muscle weakness improved significantly when given a chance course of antibiotics and this led my GP to suspect Lyme Disease. Many of the patients I talk with on Eurolyme had similar experiences so it was interesting to hear what Dr Jones says in the above article that many of his patients would improve on antibiotics and deteriorate when they stopped.

How many more children's Autism could be complicated or caused by a sneaky infection of Borrelia? Certainly at present this is something not widely researched or known by those doctors treating children with Autism.

The science is still evolving with Lyme Disease, Borrelia and it's many complex associated co infections, which currently are rarely tested for.

BBC NEWS LYME DISEASE WARNING

BBC NEWS York & North Yorkshire

Lyme disease threat to walkers on North York Moors

Walkers on the North York Moors are being warned to check their skin carefully after being out on the moors.
Ticks, from deer and sheep, infected with Lyme disease are said to pose a serious risk to health as Peter Lugg found out.

To watch the clip click here

Ticks can be found throughout the UK so it is important to be vigilant. It is easy to miss the sometimes poppy seed sized tick and not everyone gets the bulls eye rash. Not all ticks carry Lyme Disease, Borrelia, but ticks which feed off any small mammal such as rats, mice or birds etc., can carry a multitude of infections most of which are never even tested for. We can't exactly ask the tick if it picked up an infection in it's last feed and if so which infection. By the time we are really sick it is often too late to treat as an early stage infection and if that opportunity is missed then longer courses of treatment are sometimes needed to clear the infection according to the ILADS Guidelines.

It is good to see an increasing awareness in the media but so much more needs to be done. If only I had known 7 years ago that we could catch Lyme Disease in the UK, I had thought it unique to USA. If only the doctors I saw with bites, rashes , summer flu' like no other I had ever experienced, migrating arthralgias, not to mention the doctor I asked if it could be from an insect bite, who firmly said no with the shake of her head, if only they had known.

To think that all that arthritis pain and disability, muscle weakness, dysphargia, fatigue, peripheral neuropathies could have been avoided with more doctor and patient awareness. 6 1/2 years of chronic illness could have been avoided with just a few weeks antibiotics.

Shocking isn't it but what is more shocking is the children who suffer undiagnosed and untreated and they are the most vulnerable.

Thankfully there are a growing number of doctors here in the UK who are realising there is more to this controversy over Lyme treatment than they have been led to believe. Where I live in Guildford there are an increasing number of patients I am getting to know with Chronic Lyme Disease but also an increasing number of patients who are seeking and receiving early medical attention.

For more information look at UK charity website Lyme Disease Action

TWO HIDDEN EPIDEMICS

Many of you with ME/CFS and/or Lyme Disease will be following the duplicity which is unfolding since the discovery of XMRV and where better to hear what is going on than Hillary Johnson's blog Osler's web.

One of her latest posts a must read here

One of our Lyme Warriors Virginia Sherr MD had this to say to Hillary.

Dear Hillary, Your comments comprise a priceless treasure for the thousands of currently suffering CFS people and for those who will be added to their numbers in the future. Thanks for your guts and true grit. I am aware that you have knowledge of the current Lyme Wars, as well. One of many things that both of our groups have in common is that neither the leaders nor rank-and-file patients in either community has truly been allowed to be part of the solution. Instead, those afflicted are, against all human reasoning, offered only derision not compassion. And, patients are expected to remain in and accept as natural, their various states of agony. So familiar is this to what both the newly-named Lyme Complex as well as what CFS patients endure. As is taught in my field {psychiatry), here is what is typical of "psychopathy": perpetrators have a profound lack of compassion for any other’s feelings of misery and a total lack of empathy for their suffering. Yet this is what we see played out on the part of the very portion of the U. S. Government and its cooperating agencies that are sworn to care about the suffering of the citizenry on a public scale. So, added to CFS agony there is that of the hundreds of thousands of tick-bitten folks who have now late-stage Lyme, a Complex of persistent tick-borne infections but whose government’s only response is to continue to hide the epidemic. I wonder if our current President is aware of the magnitude of these larger-than-the-Oil Spill problems. Or is it as was true with our previous president’s personal Lyme infection, have his handlers hidden the epidemic from him too?
- Virginia T. Sherr, MD


Virginia Sherr has written many good articles on Lyme Disease some of which can be accessed here


More news on FDA/NIH STUDY from PNAS here at CFS Central

PHYSICIANS HEAL THYSELVES

An excellent article The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines written by Lorraine Johnson and Raphael Strickner. I posted earlier about it here

below is one of the comments posted on that article here

Insufficient Evidence and Poor Outcomes: IDSA Treatment Recommendations Rightly Ignored

Elizabeth Maloney (10 July 2010) None

Comments from IDSA president, Dr. Richard J. Whitley, suggest that he fully believes that “the best defense is a good offense”. Instead of addressing the shortcomings of the IDSA guidelines on Lyme disease, of which there are many, he assails Dr. Stricker and Ms. Johnson for not providing evidence that long-term treatments are valid.[1] He also tries to distract readers from considering the weak scientific underpinnings of the IDSA guidelines by raising the specter of unending courses of IV antibiotics and “life-threatening drug-resistant superbugs”; readers should not be fooled by such tactics. Organizations which create treatment guidelines are obligated to prove the validity of their recommendations. This requires them to disclose the strength of their evidence so clinicians can use this information to judge the merits of the treatment recommendations. Because the IDSA Lyme guidelines issued 72 graded recommendations, it is easy for clinicians to lose sight of the fact that 54% of these, including 17 strong recommendations, were based on panel opinion.[2] Other guidelines developers, such as the American Academy of Pediatrics, require that the strength of a recommendation be matched to the strength of the underlying evidence;[3] unlike the IDSA, AAP would not restrict treatment options, via strong recommendations, purely on the basis of panel opinion. The evidence strength ratings assigned by guidelines panels must be justifiable; even the pedestrian, IDSA-chosen review panel recognized that the strength of the supporting evidence had been stretched to reach the single-dose doxycycline prophylaxis recommendation.[4] And, evaluating the strength of an individual study requires more than a casual glance at the abstract and conclusion. When the article in question is written by a panelist on the 2006 guidelines, the examination should be especially vigorous so as to withstand charges of professional cronyism. This is also true when recommendations are issued to address areas of medical controversy. This clearly did not happen with the IDSA guidelines. Consider the issue of treatment duration for erythema migrans, a contentious topic. The IDSA guidelines panel cited 8 prospective studies to support its recommendation; of these, only 2 investigated doxycycline regimens employing brief, 10 day treatment durations. In the study by Mazzarotti et al, the authors claimed the 10-day doxycycline arm had a 95% success rate.[5] However, of the 22 patients randomized to and completing this treatment, 7 were immediately retreated with doxycycline or amoxicillin and another patient later required IV ceftriaxone. Thus, 10 days of doxycycline failed to cure 36% of the patients, not 5%. One would think that such a gross overstatement of treatment success would have been caught by a diligent guideline panel; panelist Steere, as one of Mazzarotti’s co-authors, may have been best positioned to prevent the inclusion of this study in the guidelines. The other study, by guidelines panelist Wormser, had excessive drop-out rates.[6] At the study’s completion 49% of the subjects were “unevaluable”; at the earlier 12 month evaluation, 29% of the patients were already “unevaluable.” Biostatisticians warn against drawing outcome conclusions when drop-out rates exceed 20%;[7] thus, the panel also erred in citing the study by Wormser as supportive. If these studies are representative of what the IDSA considers “sound scientific evidence”, perhaps it is premature to be making recommendations in the first place. After discovering a lack of support for the 10 day doxycycline regimen, I re-evaluated the data from the other 6 trials cited as supportive evidence for the early Lyme disease treatment recommendations.[8-13] During that process, I reanalyzed the outcome data using intent-to-treat methodology (ITT) as opposed to the complete-case(cc) or last-observation-carried-forward (LOCF) methods used in the original papers. ITT is the method preferred because CC and LOCF overstate treatment outcomes.[14] Differences in study designs and in the definitions of treatment success, improvement and failure make direct comparisons difficult but if success is defined as a return to the pre-morbid baseline without relapse during the observation period, then the overall success rates for doxycycline, amoxicillin and cefuroxime are roughly 65%. While this may seem incredulous to many, the review panel, which received my analysis in the course of its deliberations, suggested that future guidelines describe the first-line agents as “effective” rather than “highly effective”.[4] Dr. Whitley expressed concerns regarding the use of long-term antibiotics in patients with persistent symptoms. There can be no doubt that such approaches carry risks but those risks must be weighed in light of the situation for which they are employed; this is not a case of using sledgehammer to swat a fly. The disease burden in this group is quite high, as the retreatment trials demonstrated.[15-17] The IDSA guidelines also prohibit retreatment for patients with late neurologic Lyme disease who remain symptomatic following 30 days of ceftriaxone. This restriction is based on scant evidence. The guidelines cite only 4 trials, with a total of 96 patients representing a limited disease spectrum, which can be analyzed in terms of neurologic outcomes.[18-21] In this very small cohort, treatment successfully restored health in only 7 – 35% of the patients. Such a poor outcome is unacceptable for a patient group burdened with a disease causing a profoundly negative impact on the quality of their lives. While physicians are cautioned to do no harm, it is clear that for the majority of patients with late neurologic Lyme disease, doing nothing more is harmful. To appease those looking for a scientific basis for additional antibiotic therapy, I suggest they read the 1999 study by Logigian et al.[21] In that open label trial using 30 days of ceftriaxone, one patient (who was well at the 6 month evaluation) reported a relapse, supported by a deterioration in his verbal and visual memory, 2 months later. Based on that information, the authors retreated him with 30 additional days of ceftriaxone and he demonstrated sustained improvement. Given that Steere served on the original guidelines panel and co-authored this paper, it is curious that the IDSA recommends against retreatment. Given the poor outcomes to shorter treatment durations and the disease burden, it is unconscionable. Similarly detailed critiques can be made for the other major recommendations. Rather than shoot the messengers (Dr. Stricker and Ms. Johnson), Dr. Whitley should heed the message: the IDSA failed, in its initial and review efforts, to create impartial, conflict-free, evidence-based guidelines. Moreover, the errors of the guidelines panel were compounded by the review panel, which had an obligation to provide an unbiased review and right these transparent errors. Those of us who understand the situation lack mechanisms to resolve it. The duty remains with the IDSA members; physicians, heal thyselves. References 1. Whitley RJ. IDSA Response to Stricker and Johnson. http://www.peh-med.com/content/5/1/9/comments 2. Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, Krause PJ, Bakken JS, Strle F, Stanek G, Bockenstedt L, Fish D, Dumler JS, Nadelman RB. The clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006;43(9):1089-134. 3. American Academy of Pediatrics: Steering Committee on Quality Improvement and Management. Classifying Recommendations for Clinical Practice Guidelines. Pediatrics 2004;114;874-877. 4. Infectious Diseases Society of America: Final Report of the Lyme Disease Review Panel of the Infectious Diseases Society of America. April 22, 2010. http://www.idsociety.org/Content.aspx?id=16499 5. Massarotti EM, Luger SW, Rahn DW, et al.. Treatment of early Lyme disease. Am J Med 1992; 92:396–403. 6. Wormser GP, Ramanathan R, Nowakowski J, et al.. Duration of antibiotic therapy for early Lyme disease: a randomized, double-blind, placebo-controlled trial. Ann Intern Med 2003; 138:697–704. 7. Schulz K, Grimes D. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet 2002; 359: 781–85. 8. Luft BJ, Dattwyler RJ, Johnson RC, et al.. Azithromycin compared with amoxicillin in the treatment of erythema migrans: a double blind, randomized, controlled trial. Ann Intern Med 1996; 124:785–91. 9. Dattwyler RJ, Volkman DJ, Conaty SM, Platkin SP, Luft BJ. Amoxicillin plus probenecid versus doxycycline for treatment of erythema migrans borreliosis. Lancet 1990; 336:1404–6. 10. Eppes SC, Childs JA. Comparative study of cefuroxime axetil versus amoxicillin in children with early Lyme disease. Pediatrics 2002; 109:1173–7. 11. Nadelman RB, Luger SW, Frank E, et al.. Comparison of cefuroxime axetil and doxycycline in the treatment of early Lyme disease. Ann Intern Med 1992; 117:273–80. 12. Luger SW, Paparone P, Wormser GP, et al.. Comparison of cefuroxime axetil and doxycycline in treatment of patients with early Lyme disease associated with erythema migrans. Antimicrob Agents Chemother 1995; 39:661–7. 13. Dattwyler RJ, Luft BJ, Kunkel M, et al.. Ceftriaxone compared with doxycycline for the treatment of acute disseminated Lyme disease. N Engl J Med 1997; 337:289–94. 14. Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis. Hoboken, N.J. Wiley-Interscience, ©2004; pp 391-4. 15. Klempner MS, Hu LT, Evans J, et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med 2001;345(2):85–92. 16. Krupp LB, Hyman LG, Grimson R, et al. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology 2003;60(12):1923–30. 17. Fallon BA, Keilp JG, Corbera KM, Petkova E, Britton CB, Dwyer E, Slavov I, Cheng J, Dobkin J, Nelson DR, Sackeim HA. A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology 2008;70:992-1003. 18. Dattwyler RJ, Halperin JJ, Pass H, Luft BJ. Ceftriaxone as effective therapy for refractory Lyme disease. J Infect Dis 1987;155:1322–5. 19. Dattwyler RJ, Halperin JJ, Volkman DJ, Luft BJ. Treatment of late Lyme borreliosis—randomized comparison of ceftriaxone and penicillin. Lancet 1988; 1:1191–4. 20. Logigian EL, Kaplan RF, Steere AC. Chronic neurologic manifestations of Lyme disease. N Engl J Med 1990; 323:1438–44. 21. Logigian EL, Kaplan RF, Steere AC. Successful treatment of Lyme encephalopathy with intravenous ceftriaxone. J Infect Dis 1999;180:377–83.
Competing interests
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LYME DISEASE AWARENESS IN WALES

Well done BBC Wales for showing this program, thank you to Kathy and Louisa Morgan for raising awareness. Thank you Wendy Fox for her tireless efforts to raise awareness of this horrible illness. Wendy Fox is one of the founder members of BADA UK Charity, Borreliosis and Associated Diseases Awareness UK.

Also in the news recently

Wales On line article here below are two short extracts

WALKERS are being warned to take a series of simple precautions in a bid to prevent them contracting Lyme disease.
The incidence of Lyme disease, which is spread by infected ticks, has been steadily rising, but awareness remains low among the general public and employers.

It can cause a range of symptoms, the most common being a rash called erythema migrans, which has a distinctive bullseye pattern.
The rash can cover a large area and last for weeks if untreated. Some patients may also have flu-like symptoms.
The most common complications of untreated Lyme borreliosis affect the nervous system, usually within a few weeks to months of infection. They include facial palsy, viral-like meningitis and radiculitis, which is a nerve inflammation that can lead to pain, disturbance of sensation or clumsiness of movement.
Ticks acquire the bacteria when they feed on birds or mammals that carry the organism in their blood. Although deer do not carry Lyme disease they help to maintain tick populations because they are important feeding hosts for adult ticks.

Lyme disease can infact cause a multitude of symptoms affecting all areas of the body generally caused by inflammation, by following the many links on this blog you can learn more about the symptoms of Lyme Disease.

My own symptoms were mainly arthritis and muscle weakness but some Peripheral Neuropathies, twitching and tingling sensations and the scariest symptom swallowing difficulties, Dysphargia. I had a constant sore throat which lasted years with no let up but mainly on one side, most peculiar. All gone now since long term antibiotic treatment following ILADS Guidelines

GENES IN LYME DISEASE, ME/CFS

I had read that there was a genetic link involved in cases where patients had difficulty fighting chronic Lyme Disease. In my earlier post Genes, Microbes, Environment -Illness Dr Bransfield says 'Often this person has the HLA DR4 genotype'

I have also read that many patients with ME/CFS have been found to have the same gene.

A genetic component to ME / ICD-CFS is strongly suggested by HLA phenotyping analysis in the laboratory of Paul Terasaki at UCLA School of Medicine. Terasaki is one of the world's leading experts in HLA typing and he found 46% of ME / ICD-CFS patients were HLA-DR4 positive.

link here

Other illnesses such as Lupus and Rheumatoid Arthritis according to Wikepedia also have this genetic link.

Some research hypothesises that it is the cause of an auto immune reaction but more research needs to be done.

Although I don't and can't contradict this hypothesis, in my own experience I have improved on antibiotics and deteriorated off them.

I find it strange why my symptoms of Arthritis and muscle weakness have moved from area to area, why would a wonky immune system flit from place to place?

GENES, MICROBES, ENVIRONMENT -ILLNESS

Psychiatric Times

Below are extracts from an article written by Dr Bransfield the preseident of ILADS. For the full article click here.

Lyme Disease, Comorbid Tick-Borne Diseases, and Neuropsychiatric Disorders
By Robert C. Bransfield, MD 01 December 2007

Many recall the phrase "To know syphilis is to know medicine." Now Lyme disease (Lyme borreliosis), the new "great imitator," is the ultimate challenge to the breadth and depth of our knowledge. In psychiatry, we generally treat mental symptoms or syndromes rather than the underlying cause of a disorder. A greater awareness of immune reactions to infections and other contributors to mental illness enhances our psychiatric capabilities. Lyme disease, like syphilis, is caused by a spirochete with a multitude of possible manifestations and 3 stages: early with dermatological symptoms, disseminated, and late stage.

Unlike Treponema pallidum, the cause of syphilis, the causative agent of Lyme disease, Borrelia burgdorferi, can be much more difficult to eliminate, diagnostic testing is less reliable, and interactive copathogens are major contributors in the pathophysiology. B burgdorferi is highly adaptable with 6 times as many genes as T pallidum and 3 times as many plasmids as any other bacteria that allow rapid genetic adaptations. It is a stealth pathogen that can evade the immune system and pathophysiological mechanisms. Knowingly or not, most psychiatrists have at some point been perplexed by patients with late-stage psychiatric manifestations of Lyme borreliosis. Several factors are associated with the risk of infection as well as the different manifestations of Lyme borreliosis

The following composite case illustrates a number of problems that may make diagnosis and treatment of Lyme borreliosis anything but straightforward. The patient is in good health and enjoys outdoor activities. Often this person has the HLA DR4 genotype. He or she may acquire a small tick bite that goes unnoticed because the subsequent rash may not be of the classic bull's-eye type, may be easily overlooked in dark-skinned individuals, may be misdiagnosed, or may occur only with a second or subsequent infection. There may be flu-like symptoms with migratory musculoskeletal aches and pains. If a diagnosis of Lyme disease is made, the initial course of antibiotic treatment may not have been sufficient to eliminate the infection. (Although standardized by 1 set of guidelines, psychiatrists often see the failures of some of the "standard" treatments.) Low-grade symptoms may remit and periodically relapse over time. An accident, emotional stress, vaccination, or childbirth can trigger an exacerbation of symptoms.

The patient, who did not have psychosomatic symptoms and was not hypochondriacal in the past, now complains of an increasing number of somatic, cognitive, neurological, and psychiatric symptoms. Although Lyme disease may be suspected, the laboratory tests available to most clinicians often lack sensitivity and thus are read as negative for Lyme disease. Fibromyalgia, chronic fatigue syndrome, or multiple sclerosis (MS) may be erroneously diagnosed.

Treatment of some symptoms with corticosteroids may initially provide relief, but a more rapid decline often follows. The patient sees multiple specialists, each of whom restricts the examination to his area of expertise. Nothing is resolved, and the patient is frustrated that his symptoms cannot be explained. In view of the growing list of unexplained symptoms, including psychiatric symptoms, the patient is treated with tranquilizers and antidepressants with some benefit, but gradual decline persists.
The major complaints include fatigue, multiple cognitive impairments, depression, anxiety, irritability, head-aches, and a multitude of other symptoms. When general medical treatment fails, the patient may be referred to a psychiatrist for 3 reasons: the unexplained medical symptoms give the appearance of a psychosomatic or somatoform condition; complex mental symptoms are thought to require psychiatric assessment; and a psychiatrist is thought to be needed to more effectively manage psychiatric treatments.

General theoretical issues

The causes of most psychiatric illnesses are unknown. The catecholamine hypothesis does not adequately explain the cause of abnormal neurotransmitter functioning. Mendel stated that human traits are determined by individual genes that function independently of other genes and environmental influences. Koch believed that many human diseases are caused by microbes that exert their effect independently of other microbes, environmental factors, and genes. The cause of most mental illnesses cannot be explained by neurotransmitters, genes, or infections alone. Instead, as stated by Yolken,
most common human diseases are caused by the interaction of environmental insults and susceptibility genes.Many of the susceptibility genes are diverse determinants of human response to environmental factors, including infections, and prevention or treatment of the infections may result in the effective treatment of complex disorders.


Tick-borne diseases and chronic infectious diseases

B burgdorferi, the principal organism associated with Lyme borreliosis, is one of the most complex bacteria known to man. In addition, a tick bite can presumably transmit more than 1 disease-causing organism. Thus, 2 major clinical hurdles in diagnosis and management are the absence of a clear therapeutic end point in treating Lyme borreliosis and the potential presence of tick-borne coinfections that may complicate the course of the illness. The more common interactive coinfections may be caused by M fermentans, Mycoplasma pneumoniae, B microti, Ba- besia WA-1, Chlamydia pneumoniae, Ehrlichia, Anaplasma, and B henselae, and multiple viruses and fungi. When multiple microbes grow together, they can promote immunosuppressive effects and cause marked symbiotic changes that alter their functioning.

Neuroborreliosis is an infection within the brain; however, infections in the body that do not pass through the blood-brain barrier may also impact the brain indirectly via immune effects. All the clinical manifestations, acute or chronic, of infection with B burgdorferi are characterized by strong inflammation with the production of several proinflammatory and anti-inflammatory cytokineswith an aberrant innate proinflammatory response and inflammatory brain changes. Most of the dysfunction caused by these infections is associated with immune reactions.

All involved with late state Lyme disease agree there is a large amount of inaccurate information on this subject. This disagreement exists at every level – journals, scientific meetings, clinical practice, media outlets,etc. Some of this disagreement can best be viewed as the normal difference of opinion seen when scientists approach a very complex problem from a very different perspective. To fuel the intensity of these disputes, some approach these issues with a significant bias. The full recognition of this illness has implications, which could effect tourism, real estate values, disability, insurance company/managed care liability, workman’s compensation cases, motor vehicle issues, some criminal cases, and political issues. Bias issues can adversely effect patient care, research funding, and medical regulatory issues. Some of those previously impacted by bias now have difficulty approaching this disease with full-unhampered objectivity.

Lyme disease is clearly a very complex disease. When considering a similar spirochete disease, syphilis, it has been said, “To know syphilis is to know medicine.” However, to know Lyme disease is not only to know medicine but also neurology, psychiatry, politics, economics, and law.

Another interesting article by Dr Bransfield here

By entering Bransfield in the search box in the right hand column of this blog you come up with other posts that Dr Bransfield has been mentioned in, alternately click here

TICK BITE

I have only just come across this excellent article written in the Telegraph by a vet Peter Wedderburn. It is good to see more awareness in the media here in the UK.


Have you ever been attacked by a tick?

By Pete Wedderburn Health and lifestyle Last updated: May 13th, 2010



short extract

I’ve blogged about Lyme Disease before, and I’ve had lengthy comments from people who’ve suffered from the condition: they have a huge amount of concern about under-diagnosis of this disease, with many patients not being diagnosed, despite classical symptoms, until their body has been too badly damaged for treatment to be fully effective. It seems that in the UK, we’re far too casual about the risk of contact with ticks; in other European countries, there’s a much higher level of awareness of the disease threat.
Well, if you’ve read this blog, you’re that little bit more aware now. Please spread the word.



The full article can be read here



Pete's blog article can be seen here



and his blog link here



The person Pete refers to had a very similar experience to myself, my symptoms were mainly Arthritis, Muscle Weakness and Fatigue but with some Peripheral Neuropathies, Dysphagia being the scarriest symptom all gone now since following ILADS treatment on long term antibiotics.

RAMBLERS BEWARE OF TICK BITES

To Watch this tick in motion click here which will take you to the video on Lyme Disease Action Facebook page.

WILDLIFE EXTRA NEWS

see the full article here

Watch out for ticks & Lyme disease now the warm weather is here

07/06/2010 12:13:44

Lyme disease on the increase in the UK

Soon summer will be in full swing and many of us will be spending more time wildlife watching, walking, climbing, cycling and camping. Few, however, will be aware of, or indeed prepared for, the hidden danger of tick bites and what can come with them - Lyme disease.
The highest risk period for tick bites is from May to October when the tick is most active and feeding.
Ticks - tiny (the size of a full stop on an A4 page) blood-sucking parasites - are present in woods, moors and parks throughout the UK; London parks are no exception, and tick numbers are on the rise due to changing habitats and climate. Lyme disease, caused by the bite of an infected tick, is also on the rise, and is found throughout North America, across the UK and Europe, and Scandinavia - so it's important for everyone, at home and on holiday, to know what to look out for and to seek early treatment if necessary.

What is Lyme disease and what are its symptoms? Lyme disease is caused by the bite of an infected tick and causes a wide range of symptoms which may include a circular red "bull's eye" rash, headaches, a stiff neck, extreme fatigue, muscle and joint pain, and disturbances of sight, hearing, digestive system and sleep.

My comments on the above article included :-

It took 5 doctors and 3 Rheumatologist 4 years to diagnose me. I was diagnosed with ME/CFS, Fibromyalgia, Polymyalgia Rheumatica, Arthritis, Musculo skeletal disease, and eventually Lyme Disease. A chance course of antibiotics significantly improved my symptoms and led my GP to suspect Lyme Disease. There had been other cases of Lyme disease at my surgery. I had presented at the surgery at times of bites, bulls eye rashes, summer flu and migrating arthralgias before chronic illness and disability set in all had been documented on my records.

BORRELIA LIKES BRAIN TISSUE

This link is to part of an interview with Eva Sapi here



During the interview Eva Sapi talks about the nutritious requirements for Borrelia being quite significant, she says when we culture Borrelia in the lab, we need to use a very rich media.



She says the brain is an organism very juicy, perfect for Borrelia.



Dr Macdonald and Dr Judith Miklossy both found spirochetes in the brain especially on plaques (they also found the DNA for Borrelia in the brain's of patients that had died of Alzheimer's).



Dr Sapi talks about the many different forms of Borrelia at least 6 -7 forms. Spirochetes, cystic form, bio films, granular forms and countless pleomorphic forms.



Dr Sapi's team are looking at what infections ticks can carry and have found that Mycoplasma is carried by 84% of ticks. Treatment for Mycoplasma can be very many months. Another organism found in ticks is Filarial Nematodes.



Enough of my comments do watch the video

MORE CONFLICTS. ME/CFS, FIBROMYALGIA, XMRV, LYME DISEASE

I was diagnosed with ME/CFS, Fibromyalgia, Arthritis, Muscle weakness, Musculo Skeletal Disease, Polymyalgia Rheumatica and finally Lyme Disease, as my symptoms progressed over a number of years. On treatment following ILADS Guidelines, links in my side bar, long term high dose antibiotics, I have regained my health and my life.

I know many patients with ME/CFS also have Lyme Disease, this is well recognised by several experts in both fields but not by the medical establishments. Some patients with Lyme Disease have been found to have XMRV retrovirus as I have mentioned in earlier posts.

This latest news on research from CDC and NIH with XMRV retro virus is very disturbing. I have said before that many of the conflicts and controversies of ME/CFS are running parallel to what is happening in the world of Lyme Disease.

http://news.sciencemag.org/scienceinsider/2010/06/conflicting-papers-on-hold-as-xm.html

With Papers On Hold, Government Scientists Fuel Debate on Virus for Chronic Fatigue

It was just a snippet of news, reported by an obscure journal in the Netherlands. And yet it lit up the Internet. Twitter was all atwitter, scientists' mailboxes on both sides of the Atlantic began filling up, and dozens of bloggers started jubilating. "It's happened. I cannot tell you all how this changes the world as we have known it for 25+ years," one patient wrote on her blog. "Now to work on the vindication part!"
The reason for all the excitement? Scientists at the U.S. National Institutes of Health (NIH) and the Food and Drug Administration (FDA) were reported to have confirmed the link, first published in Science last year, between a human retrovirus and the elusive condition called chronic fatigue syndrome (CFS). Earlier this year, three other groups reported being unable to replicate such a connection. That federal scientists now confirmed it was huge mood-lifter for patients, many of whom are desperate to find a biological cause, and a cure, for their debilitating ailment.
But the story wasn't as simple as that. Science has learned that a paper describing the new findings, already accepted by the Proceedings of the National Academy of Sciences (PNAS), has been put on hold because it directly contradicts another as-yet-unpublished study by a third government agency, the U.S. Centers for Disease Control and Prevention (CDC). That paper, a retrovirus scientist says, has been submitted to Retrovirology and is also on hold; it fails to find a link between the xenotropic murine leukemia virus-related virus (XMRV) and CFS. The contradiction has caused "nervousness" both at PNAS and among senior officials within the Department of Health and Human Services, of which all three agencies are part, says one scientist with inside knowledge.
The debate over XMRV started in 2009 when a group of researchers led by Judy Mikovits of the Whittemore Peterson Institute (WPI) for Neuro-Immune Disease in Reno, Nevada, reported in Science finding traces of the virus in peripheral blood mononuclear cells, a type of white blood cell, of 67% of CFS patients. By contrast, only 3.4% of healthy controls were found to harbor the virus. The team also showed that XMRV could infect human cells and concluded that the virus—which had previously been linked to prostate cancer—might play a role in causing CFS (Science, 23 October 2009, p. 585).
Many scientists were skeptical, however, and in May, Science published three Technical Comments that tried to poke holes in the study, along with a rebuttal by Mikovits and first author Francis Ruscetti of the National Cancer Institute. By that time, two groups in the United Kingdom and one in the Netherlands had also published papers failing to find a link; in fact, they found little or no evidence of XMRV infection at all, either in patients or in healthy people. Three other groups, two from the United States and one from Europe, have also reported negative findings at meetings, says Kim McCleary, president of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America, a patient advocacy group.
The FDA-NIH paper would offer fresh hope that Mikovits is on to something after all, but so far, details about the work are scant. Ortho, a Dutch magazine about nutrition and food supplements, last week issued a press release saying that Harvey Alter, a renowned virologist at NIH's Clinical Center, mentioned the study when he gave a talk at a blood safety meeting in the Croatian capital Zagreb in late May. In his PowerPoint presentation, Alter wrote that the data in the 2009 study in Science "are extremely strong and likely true, despite the controversy." Another bullet point said: "We (FDA & NIH) have independently confirmed the Lombardi group findings." (WPI's Vincent Lombardi was the paper's first author.) But the presentation offered no detail beyond that tantalizing summary, and an NIH spokesperson says Alter is not available for comment.
Meanwhile, a group working with retrovirologist William Switzer at CDC, which has done an independent study, has held its cards closer to its chest. But Science talked to several scientists who say they have seen the data, and they are negative. Although it's not unprecedented for government scientists to be on opposite ends of a scientific debate, two contradictory press releases on a flashpoint issue like CFS would look odd, scientists say. With publication deferred, "they want to find out what's going on first," says one researcher who says he has been briefed about the controversy.
Last week, the AABB, an international association of blood banks, recommended to its members that they discourage CFS patients from donating blood. A special task force on XMRV conceded that the evidence was preliminary but decided it's "prudent" to err on the side of caution, says task force member Louis Katz, the medical director at the Mississippi Valley Regional Blood Center in Davenport, Iowa. "If [XMRV] turns out to be important," says Katz, "I don't want to be criticized for doing nothing when I could have done something."
(This story is adapted from a longer one in the 2 July issue of Science.)

http://www.sciencemag.org/cgi/content/summary/329/5987/18

Science 2 July 2010:Vol. 329. no. 5987, pp. 18 - 19DOI: 10.1126/science.329.5987.18

News of the Week
Chronic Fatigue Syndrome:
Conflicting Papers on Hold as XMRV Frenzy Reaches New HeightsMartin Enserink
Scientists at the U.S. National Institutes of Health and the Food and Drug Administration have been reported to have confirmed the link, first published in Science last year, between a human retrovirus and the elusive condition called chronic fatigue syndrome (CFS). Earlier this year, three other groups reported being unable to replicate such a connection. That federal scientists now confirmed it was a huge mood-lifter for patients, many of whom are desperate to find a biological cause, and a cure, for their debilitating ailment. But the story wasn't as simple as that. Science has learned that a paper describing the new findings has been put on hold because it directly contradicts another as-yet-unpublished study by a third government agency, the U.S. Centers for Disease Control and Prevention. That paper, a retrovirus scientist says, is also on hold; it fails to find a link between the xenotropic murine leukemia virus-related virus and CFS.
Read the Full Text

PHILOSPHY, ETHICS AND HUMANITIES IN MEDICINE

Ethics and Lyme Disease is something I have been discussing at length today and so I decided that it was a good day to link into this recent article written by Lorraine Johnson and Raphael Stricker.

http://www.lymedisease.org/news/lymepolicywonk/462.html

IDSA guidelines: A cautionary tale about development of clinical practice guidelines

http://www.peh-med.com/content/5/1/9

The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about development of clinical practice guidelines

Lorraine Johnson and Raphael B. Stricker

Philosophy, Ethics, and Humanities in Medicine 2010, 5:9doi:10.1186/1747-5341-5-9
Published:
9 June 2010

Abstract (provisional)
Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future.

http://www.peh-med.com/content/pdf/1747-5341-5-9.pdf

CONCLUSIONS
Attorney General Blumenthal’s investigation ‘exposed a deeply flawed process rife with conflicts of interest that improperly excluded alternative views and information’ [63]. The application of antitrust law was based on IDSA’s dominant position in the marketplace and the foreclosure of treatment options for healthcare consumers. IDSA’s response to the guidelines investigation reaffirmed the need for Attorney General Blumenthal to apply antitrust law to insure procedural fairness.
The recent calls for guidelines reform dovetailed with the issues giving rise to the IDSA antitrust investigation. Medical societies have an obligation to acknowledge legitimate controversy in treatment approaches, particularly when the controversy is fueled by a paucity of high-quality evidence. At a minimum, the guidelines issued by a dominant medical society should conform to fundamental rules of due process, fairness, and accuracy. It is critical that the interests of all stakeholders be given a voice, that legitimate controversies be acknowledged, and that treatment options be preserved. The application of antitrust law may provide a much-needed vehicle of
reform to prevent future abuses.
As we have argued elsewhere, the exclusion of competing evidence in treatment guidelines is clinically and ethically unacceptable [74,75]. Failure to disclose treatment options violates the principles of patient autonomy and informed consent, which require that treatment options
should be disclosed to patients and that treatment decisions should be made with the patient’s informed consent [76]. Treatment guidelines should not inhibit patient access to treatment options; rather, guidelines should describe treatment options and default to the clinical judgment
of treating physicians in order to maximize the ability of patients to get well.

I would particularly like to draw attention to page 29 and 30


On February 1, 2010, the Connecticut Attorney General, who was monitoring the panel review process, sent a letter to IDSA that expressed concern over an improper voting procedure adopted
by the panel [66]. The procedure used by the panelists essentially flipped a supermajority voting requirement to make revision of the guidelines less likely. For example, according to the letter by the Attorney General, the panel’s vote on whether laboratory tests, which ILADS contends
are flawed, should be required for a diagnosis of Lyme disease was deadlocked at 4 to 4, indicating that there was no consensus even on a panel that excluded divergent viewpoints [67].
However, the IDSA panel employed different voting requirements and initially concluded that this vote meant that the guidelines did not require revision. According to the Attorney General, the IDSA panel not only violated the voting procedure stipulated in the settlement agreement, it
also failed to comply with an internal IDSA memo directing the panel on the proper procedure for voting [67]. A copy of the letter from the Attorney General to IDSA and a copy of the internal memo from IDSA to the panel are included as Additional Files 3 and 4 to this article.
On April 22, 2010, the IDSA review panel released its report [68]. Despite the voluminous testimony presented by ILADS, the panel voted almost unanimously to uphold the guidelines without exception. Carol Baker, the panel chair and former president of IDSA, stated that for 69
guideline recommendations the panel found that each was “medically and scientifically justified in light of all the evidence and information and required no revision.” The panel report expressed concern that prolonged use of antibiotics puts patients in danger of serious infection while not
improving their condition. The report stated: "In the case of Lyme disease, there has yet to be a single high-quality clinical study that demonstrates benefit to prolonging antibiotic therapy beyond one month." As to the existence of a chronic persistent form of Lyme disease, the panel
concluded that "symptoms that are commonly attributed to chronic or persistent Lyme, such as arthralgias, fatigue and cognitive dysfunction, are seen in many other clinical conditions and are, in fact, common in the general population. It would thus be clinically imprudent to make the
diagnosis of Lyme disease using these nonspecific findings alone. [68]"
To deal with the testing issue where the panel vote was split, the final report concluded that testing was not a true recommendation and therefore did not fall within the parameters of the settlement agreement [68]. The guideline language at issue states: “Diagnostic testing performed in laboratories with excellent quality-control procedures is required for confirmation of extracutaneous Lyme disease.” Hence, although the panel originally voted on the testing recommendation with a split vote, when pressed to redo the vote in conformity with the agreement, the panel recharacterized the testing requirement as a “statement” that did not
constitute a recommendation. This seemingly transparent attempt to manipulate the vote to ensure a desired outcome, coupled with the exclusion of divergent viewpoints and other process irregularities, show how easy it is for political considerations, such as avoiding legal liability or
protecting organizational reputation, to trump impartial scientific review. The Attorney General's office has announced that it will "carefully and comprehensively assess the final report and the review process leading to that report to determine whether the IDSA fulfilled the requirements of our settlement. [69]"