BOSTON (CBS) – Dr. Alfred Miller is a Mayo Clinic trained physician with four decades of experience running a private practice. He believes that there may be a connection between Lyme Disease, ALS, and MS. Tonight, he joins Dan in studio (all the way from Texas!) to talk about his research and take some listener calls. Tune in to hear his perspective and find out about some of the cases he’s seen.
**Comment**
Great interview. Dr. Miller points out the insensitivity of current CDC 2-tier testing, the fact many patients with autoimmune diseases have undiagnosed Lyme, that other insects carry borrelia, the causative agent of LD, and the importance of going off immunosuppressive drugs for at least a month, taking at least 21 days of doxycycline to evoke an immune response, and then taking a Lyme test. (Please only work with a Lyme literate doctor. Contact your local support group for more doctor information)
A word of caution: while some LLMD’s use the CD-57, others do not.
https://heallyme.wordpress.com/2009/01/28/understanding-the-cd-57-test/ It is important to remember that the CD57 result is just a number; far more important is the patient’s clinical status. An old professor of mine used to say, “treat the patient, not the lab test!” There is still much we do not know about the CD57 marker and what other factors may lower or raise it.
Dr. Marty Ross rarely uses the CD-57 – here’s why: http://www.treatlyme.net/treat-lyme-book/cd-57-test-rarely/I rarely recommend a CD-57 test because in most situations it is not useful and has no real predictive or helpful value in charting the course of a person’s care. See why in this Lyme Byte from our webinar Conversations with Marty Ross MD on 09/10/13. The CD-57 is a type of a natural killer white blood cell that often is less than normal in chronic Lyme disease. Some other Lyme literate medical doctors recommend it as a way to see if a person has Lyme and to follow the course of his/her treatment.
Dr. Miller points out that doxycycline only kills the spirocheteal form and the L-form of Lyme and does not kill the cyst form so when people are given doxy only, they are not eradicating the organism. Most LLMD’s use a combination of antibiotics. Only uninformed practitioners use doxy only.
A Couple of points: Some patients NEVER test positive on any Lyme test and/or coinfection test for that matter. In fact a highly reputable LLMD in WI states the very sickest patients often never test positive. It truly helps to print and fill out Dr. Horowitz’s questionnaire. If you have a preponderance of symptoms, chances are high you have Lyme: https://madisonarealymesupportgroup.com/wp-content/uploads/2016/01/symptomlist.pdf
Please contact your local support group. Seriously, these people are the boots on the ground and are familiar with the lay of the land in your state. They know the good treating physicians, their costs, their regimens, and other helpful information. You do not have to go this alone.
We evaluated the QX200 Droplet Digital PCR (ddPCR™, Bio-Rad) system and protocols for the detection of the tick-borne pathogens Borrelia burgdorferi and Borrelia miyamotoi in Ixodes scapularis nymphs and adults collected from North Truro, Massachusetts. Preliminary screening by nested PCR determined positive infection levels of 60% for B. burgdorferi in these ticks. To investigate the utility of ddPCR as a screening tool and to calculate the absolute number of bacterial genome copies in an infected tick, we adapted previously reported TaqMan®-based qPCR assays for ddPCR. ddPCR proved to be a reliable means for detection and absolute quantification of control bacterial DNA with precision as low as ten spirochetes in an individual sample. Application of this method revealed the average carriage level of B. burgdorferi in infected I. scapularis nymphs to be 2291 spirochetes per nymph (range: 230–5268 spirochetes) and 51,179 spirochetes on average in infected adults (range: 5647–115,797). No ticks naturally infected with B. miyamotoi were detected. The ddPCR protocols were at least as sensitive to conventional qPCR assays but required fewer overall reactions and are potentially less subject to inhibition. Moreover, the approach can provide insight on carriage levels of parasites within vectors.
**Comment**
While this is a great start, there are many other pathogens to be concerned with besides Borrelia burgdorferi (Bb), the agent of Lyme Disease: https://madisonarealymesupportgroup.com/2017/07/01/one-tick-bite-could-put-you-at-risk-for-at-least-6-different-diseases/, and there are many more besides the six mentioned in this article. Bartonella has not been proven conclusively to be transmitted by ticks, but it is highly likely. It is also a frequent coinfection and can be spread by:
Arthropod vectors including fleas and flea feces, biting flies such as sand flies and horn flies, the human body louse, mosquitoes, and ticks; through bites and scratches of reservoir hosts; and potentially from needles and syringes in the drug addicted. Needle stick transmission to veterinarians has been reported. There is documentation that cats have received it through blood transfusion. 3.2% of blood donors in Brazil were found to carry Bartonella in their blood. Bartonella DNA has been found in dust mites. Those with arthropod exposure have an increased risk, as well as those working and living with pets that have arthropod exposure. 28% of veterinarians tested positively for Bartonella compared with 0% of controls. About half of all cats may be infected with Bartonella – as high as 80% in feral cats and near 40% of domestic cats. In various studies dogs have close to a 50% rate as well. Evidence now suggests it may be transmitted congenitally from mother to child – potentially leading to birth defects. https://madisonarealymesupportgroup.com/2016/01/03/bartonella-treatment/
Three premature infants in one neonatal intensive care unit (NICU) developed transfusion-transmitted babesiosis. Two of the infants developed high-grade parasitemia. All three affected infants were treated and cured with azithromycin and atovaquone. No infant required exchange transfusion. Clinicians should be cognizant that babesiosis may be acquired via blood transfusion.
___________________
**Comment**
Babesia is finally getting the press it deserves. Lately there has been much on transmission by transfusion as well as deaths in patients without spleens.
https://madisonarealymesupportgroup.com/2017/08/08/transfusion-transmitted-babesiosis-in-nonendemic-areas/ “Asymptomatic individuals with Babesia infection are able to donate blood in the United States because of the lack of specific blood donation testing. Blood products collected in Babesia-endemic areas are distributed nationally; thus, clinicians in nonendemic states may fail to include babesiosis in the differential diagnosis of a patient who had a recent transfusion history and a fever of unknown origin.”
https://madisonarealymesupportgroup.com/2016/01/16/babesia-treatment/ Dr. Horowitz, a nationally recognized LLMD, states Babesia is one of the most tenacious coinfections he sees in his patients and that treatment often takes 9 months to a year, particularly with those also infected with Lyme disease (borrelia).Treatment options in this link.
http://www.nejm.org/doi/full/10.1056/NEJM199807163390304When left untreated, silent babesial infection may persist for months or even years. Although treatment with clindamycin and quinine reduces the duration of parasitemia, infection may still persist and recrudesce and side effects are common. Improved treatments are needed.
https://madisonarealymesupportgroup.com/2017/06/28/concurrent-babesiosis-and-lyme-in-patient/ Dr. Horowitz warns that due to this immune suppression, patients with Rheumatoid Arthritis or Lupus and are on immunosuppressant drugs, if they have Babesia, could get much worse. The strain, B. divergens, causes a higher mortality rate and more severe symptoms, and if left untreated, this strain can develop into shock-like symptoms with pulmonary edema and renal failure.
In the USA an unprecedented anti-trust law suit of $57 million is being prepared against the CDC. They are accused of deliberately suppressing the use of an accurate DNA direct diagnostics for Lyme disease. You can read about the aim and potential impact of this lawsuit in this article.
“In the current situation, even in an endemic area like Connecticut, the first doctor a Lyme patient sees is an emergency room physician” – Dr. Sin Hang Lee at the 2017 ILADS conference in Paris, Europe
Introduction
Lyme disease belongs in the same health threat category as AIDS and cancer, while it is far more prevalent than Zika. With over 300,000 new cases annually in the USA alone, the incidence of Lyme is now six times the AIDS epidemic and it is twice as prevalent as breast cancer.
Early detection and treatment of Lyme disease is of utmost importance, but it is well known that typical antibodies are not detectable for 4-6 weeks after infection. The lack of diagnostic tests for early Lyme disease has caused untold pain and suffering worldwide as delayed diagnosis and treatment often leads to “chronic Lyme disease” or “Post Treatment Lyme Disease Syndrome”. The current situation has been framed as a human rights abuse on a global scale.
For decades, the reliability of Lyme diagnostics has been subject to critique. A few doses of doxycycline prescribed will almost guarantee a negative two tier serology test. Historically an indirect way of proving the causative pathogen for Lyme Borreliose (LB) has been used, since direct diagnostics such as microscopy, PCR and DNA testing were lacking. The current two-tier serological test system (with ELISA and Western Blot) seem to have many false-negative results. A recent meta-analysis showed that the number of false-negatives are over 500 times higher than with the two-tier testing on HIV.
Recently Dr. Becker, director of the Association of Public Health Laboratories, publicly admitted that “Lyme disease presently cannot be diagnosed based solely on a laboratory test because the tests still aren’t good enough.”
Fortunately, medical technology has evolved during the last three decades. DNA sequencing produces no false-positives and can measure the presence of the Borrelia beyond a reasonable doubt. This method works even with low bacterial density in the blood, provided that specific precautions are taken.
According to Dr. Lee, director of Milford Molecular Diagnostics, Connecticut, the CDC should launch a national competitive proficiency test program. The goal of this program should be to select the laboratory methods which can detect low density of borrelial spirochetes in whole blood samples for patient management. He had tried to work with them to achieve that goal.
Attempt at cooperation
On the Change.org petition of Carl Tuttle, the history of this effort is well described: Dr. Lee and David Shearer originally contacted the CDC for collaboration. Marty Schriefer of the CDC agreed to assist. Schriefer sent archived sera from the CDC’s Lyme disease repository for testing using Dr. Lee’s lab developed PCR/sequencing test in a CLIA-certified laboratory.
In 2013 the CDC provided 52 blind-coded archived serum samples – including 12 from post treatment and 20 pretreatment clinically suspect Lyme disease patients – and 20 negative serum samples to Milford Molecular Diagnostics.
These samples were provided for the purpose of evaluating the accuracy of a new diagnostic test for Lyme disease by Nested PCR and DNA Sequencing.
Dr. Lee’s technology uncovered a novel Borrelia in one of the serum samples tied to a patient in the Hudson Valley, who had been previously treated for neurologic Lyme disease (DNA sequence deposited in GenBank under accession number KM052618). Dr. Lee also found Borrelia miyamotoi in one of the CDC’s Lyme disease serum samples.
As a result, Dr. Lee informed the CDC that the nested PCR/16S rRNA sequence analysis has been shown to be an effective testing platform for accurate diagnosis of Lyme borreliosis at the spirochetemic stages of the infection, even for some chronic Lyme disease patients.
This is a serious problem and clearly identifies that there is no accountability at the CDC. It would appear that the serum repository for Lyme disease has many problems and that samples may also be wrongly coded.
Using these samples to determine the validity of future test kits is highly questionable, whereas nested PCR and Sequencing through Milford Molecular Diagnostics can detect different strains of bacteria causing Lyme borreliosis with as few as25 bacteria per mL of blood.
According to Dr. Lee, at a Telecom conference on Friday October 25, 2013 among Dr. Schriefer and Dr. Molins of the CDC, Dr. Shearer and Dr. Lee, the CDC agreed to organize a national study program to further evaluate and promote new diagnostic tests and encouraged researchers to develop direct test methods, including the 16S rRNA sequence analysis technology.
Based on this agreement a research protocol was initially drafted by Dr. Lee and Dr. Shearer, and submitted on December 19, 2013 to Dr. Molins and Dr. Schriefer for their review. Dr. Schriefer indeed had reviewed, commented and edited the protocol and returned the edited copy to Dr. Shearer for revision on December 26, 2013. Dr. Lee and Dr. Shearer returned the protocol revised according to Dr. Schriefer’s recommendations in January 2014 to be finalized and implemented.
The CDC commitment to the national study abruptly stopped with no reasons given. However, it appears the CDC is focusing on developing their own newly patented test rather than supporting a group of innovators that compete with the CDC patents.
As with serology, such a test is an indirect test, and does not directly detect the bacterium. In an open PubMed comment Dr. Lee characterized the metabolite measurement as “an unproven technology” which “has deviated from the classic teachings of diagnostic microbiology”.
The current law suit
The current legal case is unprecedented and complex. Due to “sovereign anti-trust immunity” to protect the US government from claims by its own people, the current claim against the CDC is a long and difficult process. According to the Federal Tort Claims Act, one can only sue the government or its employees for damage by submitting an SF-95 form with supportive documents for money compensation only.
Through the law firm of Moore Leonhardt & Associates LLC, Dr. Sin Lee of Milford Molecular Diagnostics has now submitted the SF-95 form with documents to support the $57 million damage claimed, based on a complaint of 16 pages and a file of Exhibits of 376 pages. This amount of $57 million is 10% of the annual Lyme testing dollar volume charged to the insurance companies by 7 large commercial laboratories in the United States.
The CDC is accused of violation of the antitrust law in suppressing a direct testing method to diagnose an emerging infectious disease (Lyme borreliosis), which the CDC itself has called the ‘fastest growing vector borne disease in the USA’.
One of the purposes of the current lawsuit is to make the Exhibits public, so that Lyme disease patients can ask their lawyer to use the Exhibits to file their own SF-95 form for damages due to delayed diagnosis.
If he wins his case, Dr. Lee intends to donate the money to a non-profit organization to set up nested PCR/16S rRNA sequence diagnostic laboratories in hospitals located in Lyme disease-endemic areas so that all Lyme patients can be diagnosed early within a few days of first symptomatic presentation and receive timely and proper treatment.
These diagnostic centers will further improve the sensitivity of the PCR procedure so that a very low density of spirochetemia in chronic Lyme patients can be diagnosed for further appropriate management. He also hopes that the insurance companies will pay for these tests, which should cost no more than the WB tests.
How to set up proper Lyme diagnostics?
In a letter to Jane Philpott, Federal Minister of Health of Canada, hand-delivered on August 22 2017, Dr. Lee explains how easy and cost-effective it would be to set up proper nationwide Lyme testing:
Establish one National Lyme Disease Diagnostic Laboratory with Sanger sequencing facilities. The equipment costs less than US $300,000. This Lab also serves as an educational and training center.
Set up 10 local PCR laboratories attached to the existent laboratories of regional hospitals located in Lyme disease endemic areas. Each of these laboratories will be equipped with one high speed micro-centrifuge to collect circulating spirochetes from platelet-rich plasma samples from suspected Lyme disease patients. The additional thermocycler, micro-centrifuge and PCR setup may cost about $15,000 at each site.
The DNA extracted from the pellet of the platelet-rich plasma will be amplified with comprehensive genus-specific borrelial nested PCR primers for 16S rRNA gene detection at the local laboratories.
The PCR results should be available within 2-3 working days after the patient’s visit. The PCR positive results are very accurate in the diagnosis of Lyme borreliosis for initiating timely treatment.
The positive PCR amplicons will be sent to the national Lyme diagnostic laboratory for Sanger sequencing final validation.
In a reply to Dr. Becker, Dr. Lee also wrote that “the excuses commonly used to suppress using and development of direct DNA tests for the diagnosis of Lyme borreliosis include potential sample cross contamination, false identification of target DNA and lack of sensitivity. However, these are technical issues which can be overcome by good laboratory practices.”
He made this proposal for a national proficiency test project in the USA to advance the diagnostics in this area, which you can find here. However, he does not believe that anything will happen in the USA due to the financial stakes in keeping the current situation as it is.
A precedent?
Since Dr. Lee is not a Lyme patient nor a victim of delayed diagnosis himself, he cannot claim damage as a patient. So he can only sue the government for damage to his business (in terms of dollars).
Both American Lyme patients and Medical Doctors are also able to use a SF-95 claims form, within two years since the date when CDC’s suppression of using an available 16S rRNA sequence analysis as a reliable direct test method for diagnosis of early Lyme borreliosis was made public, namely on July 20, 2017. It could achieve two things: individual compensation and collective financial pressure to show that the CDC suppression of direct testing has led to delayed diagnosis of Lyme disease or missed diagnosis of Lyme disease, and the resulting devastating effects on public health, loss of income, expenses, general quality of life and agross violation of basic human rights.
It is however not easy to sue the CDC, the European version ECDC or the Health Department of your national government, such as the RIVM in the Netherlands. You could be facing a long battle as – due to sovereign immunity protection – you may not be able to sue government employees. In the USA the exception is under Federal Tort Claims Act via the SF-95 form. You may need a lawyer to do this properly.
One cannot file a case in court until the Complaint is cleared with the federal agency (CDC) and the OIG. This means waiting for six months, if they do not rule. This is called “exhausting administrative remedies”. This legal option has been used so little by either patients or doctors that there are hardly any lawyers who are specialised in filing these claims.
As history of social revolution has shown over and over again, all effective action once started with a single try. As Dr. Lee puts it: “We have tried everything: reasoning, petitions, complaining, pleading. It’s time to change course. However, I am a lone wolf with one meagre voice. If a thousand patients are filing 1000 SF-forms, each demanding $1 million damage due to suppression of early diagnostics, the judge may think differently. Even if I lose the case and the patients win $100,000 per case, the CDC would have to change its Lyme policy. Someone has to try and we are given the opportunity now.”
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Peter L. Salgo, MD: What are we looking for going forward 10 years from now? What is the future of Lyme disease management, whether or not it be testing improvements?
Robert C. Bransfield, MD, DLFAPA: I would think, eventually, you see a trend towards more DNA-based testing platforms that may evolve. I think, eventually, there would be better testing that would help. The question of vaccines, that has been something that people have been struggling with for a long time. One interesting thing is vaccines against ticks themselves, because there have been a lot of problems with the vaccines so far. I think that of those different things that are being considered, that’s probably the best option. So, it has been very hard to develop a vaccine. Just like a vaccine against the common cold. It may not be possible. I would love to see it happen.
Samuel Shor, MD, FACP: One of the major problems is, even if you have a good vaccine for Borrelia, what do you do about the co-infections? And more and more ticks are co-infected.
Leonard Sigal, MD: That’s why, going back to your anti-tick idea, there’s a wisdom commonly shared: the more erythema, the more redness and inflammation you develop at a tick bite site, the less likely you are to actually get infection.
Samuel Shor, MD, FACP: More robust immune response.
Leonard Sigal, MD: And so, that goes back to your comment. If you could come up with a tick saliva vaccine, not only would you cover Borrelia burgdorferi, but you’d also cover coinfections as well.
Robert C. Bransfield, MD, DLFAPA: And I also think there’s a trend towards looking in the microbiome— the tick microbiome, the human microbiome—and that’s part of disease. It’s not like you can ever just get rid of all infection in the body. It’s the microbiome that’s within us, and that’s, I think, becoming a broader area in psychiatry and general medicine with chronic illness: to look at chronic infections and the microbiome, and some of these infections are good for us.
Peter L. Salgo, MD: We’re going to get guideline changes going forward?
Patricia V. Smith: Yes. I think we need to get guideline changes, and the reason that we need to is because, even though I know the IDSA is coming out with their guidelines in early 2018, my understanding is they didn’t last time—and I’m guessing that they won’t this time—include anything for patients with chronic disease or post-treatment Lyme, whatever you want to call it. And so, that is very problematic, the same way with the CDC MMWR article. The way they have, in a little box in the side of the article, put in that they do not recommend any antibiotic treatment or IVIG treatment for chronic Lyme because, of course, we know chronic Lyme doesn’t exist. So, now you leave a whole plethora of patients out there without any kinds of options. They’re not allowed to have alternative medicine and they’re not allowed to have extended antibiotics, which are not alternative medicine. Tuberculosis patients get treated for 2 years with IV antibiotics.
Leonard Sigal, MD: And there’s a reason for that, Pat. There’s a reason for that, and that is the lack of really rigorous science in support of those approaches.
Patricia V. Smith: I agree with you.
Leonard Sigal, MD: What I’d like to see is cooperation between the 2 ends of the spectrum, proper studies.
Patricia V. Smith: I’m totally in favor of that.
Peter L. Salgo, MD: I need to stop right here. I’m going to go around and everybody is going to get a last word. You’re going to get it, too. Dr. Bransfield, start. This is your shot.
Robert C. Bransfield, MD, DLFAPA: So, William Osler, the father of medicine, once said, “To know syphilis is to know medicine.” But I think we could look at that in terms of Lyme disease, and to know Lyme disease, you really have to know not just medicine, but also psychiatry, entomology, epidemiology, immunology, psychoimmunology, rheumatology, and politics.
Leonard Sigal, MD: Throw cardiology in as well.
Robert C. Bransfield, MD, DLFAPA: And cardiology. You need a broad capability that’s beyond the training of most people. So, the big thing we have to add is some humility. We can’t have arrogance. We have to know that a lot of the answers to this are outside our field of specialty, so we have to have open dialogue, open communication like we’re having here, and that’s what will help resolve this.
Peter L. Salgo, MD: Dr. Shor?
Samuel Shor, MD, FACP: Well, it’s important, I think, to recognize that chronic active Borrelia infection exists. What is most contentious is this post-treatment component, which I’ll get to in a second. But what is often disregarded are those who never get diagnosed and are untreated. We have an expanding tick population, and the percentage of ticks are increasing that are actually infected. The majority of patients never recognize they’ve been bitten by a tick. There’s a large percentage of them who don’t have the hallmark feature EM rash, and if they do, it’s often in a hidden place, or it may be atypical. They present with common symptoms—summer flu. Then, throw in the post-treatment group that can potentially present in similar manners with chronic disease. We’ve already alluded to that there’s good evidence of persistence after requisite antibiotics. Not everybody who’s chronically ill after treatment has active infection, but I would argue that a modest percentage do. And so, we need to be empathetic in dealing with this chronic fatigue, chronic pain, and cognitive impairment, this complex group of individuals who, unfortunately, because of poor lab testing and the politicization of this condition, are often peripheralized.
Peter L. Salgo, MD: Dr. Sigal?
Leonard Sigal, MD: In clinical medicine, have an open mind and an open heart. To rephrase what you were saying, we have to have humility, absolutely. We don’t know everything. We have to be open to the possibilities of it being Lyme disease, being another infection, being something else entirely, being immune meditated or inflammatory mediated. You have to be aware of all the potential mechanisms, and you have to be humble in the sight of all these competing potentials. You have to have an open mind and ultimately, even if I can’t make a diagnosis, the person who’s sitting in front of me is suffering. And to show that person the door without any sense of what we’re going to do next is cruel and should not be the practice of any physician. So, an open mind, open heart, clinical practice, and better science. We need to stop arguing with each other, and we need to stop pointing fingers, and we need to be able to move on and say, ultimately, that the only important thing is the patients are suffering. Ergo, I agree: power, I agree; money, I agree. We have to throw out those things and get beyond ourselves and sit down and come up with the studies, mutually agreeable studies, that will allow us to come up with biomarkers; better sero-confirmatory tests, they’re not diagnostic tests; and better approaches to therapy. Anything short of that is an abdication of our primary responsibility, which is to practice scientific and empathic medicine.
Peter L. Salgo, MD: And I promised you the last word.
Patricia V. Smith: You did.
Peter L. Salgo, MD: And I’m keeping my promise. Go ahead.
Patricia V. Smith: I want to speak to the fact that, for many decades now, patients and advocates have been left out of this process of Lyme disease. And by that I meant they’ve been excluded. Other diseases have had committees for years that have sat in Washington, and they’ve sat with these working groups, and they’ve been able to have input on their diseases. Patients have been totally excluded. It’s very frustrating for them. It has caused, in my opinion, some of this bad science, because the educated patients know what kind of studies they need to help them with their disease. They just want to get better. They don’t care about these arguments, they want to get better. They’ve never been able to sit down like this.
So, finally, I’m pleased to say that last year we were successful for the first time, after a lot of opposition from the IDSA and others over the years, in getting legislation passed and included in the 21st Century Cures Act. That provides a working group that—there’s a working group now in Washington—only includes federal officials at the table. They have been making all the decisions for patients. That is really outrageous. And so now, patients, because of the way we set this up, will have a seat at the table, perhaps an advocate, or a member of a Lyme organization will have a seat. Our treating physicians who have never had any input into this process—guess what they’re going to be doing. They’re going to be working with all the different agencies to find out what the resources are that are available for research, what kinds of studies need to be done, and it’s also going to be done in a transparent fashion, whereas now it’s behind closed doors. No one knows what research is selected until after it’s done, and then you have no say in the matter. I just say for Lyme patients, the time has come when they will get a seat at the table, to be able to have input about their disease.
Peter L. Salgo, MD: Alright. Well, thank you all for being here. You can all take off your flak jackets and your helmets. This has been a tremendous discussion, one of the best in my career, and I’m glad we all got at the same place at the same time to discuss what has been one of the most contentious issues in modern American medicine. On behalf of our panel, I want to thank you for joining us, and I hope you found this Peer Exchange® discussion to be useful and informative. I’m Dr. Peter Salgo, and I’ll see you next time.
Madison Area Lyme Support Group 