Why It Took So Long To Develop A New Vaccine For Lyme Disease
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In May, an article with the unprepossessing title Detecting Borrelia Spirochetes: A Case Study with Validation Among Autopsy Specimens was published in the medical journal Frontiers in Neurology. The deceased person in question was a sixty-nine-year-old woman who suffered from severe cognitive impairment. Fifteen years before her death she had been treated for Lyme disease, the most prevalent tick-borne illness in the United States, and was thought to have fully recovered. Yet, when her brain and spinal-cord tissue were examined, researchers found intact Borrelia spirochetes, the bacteria responsible for Lyme. If the womans cognitive decline did result from Lyme diseasewhich the paper suggested was a strong possibilitythen it was further evidence that the illness could persist and wreak havoc long after a tick bite, and long after treatment.
It was the first time an F.D.A.-licensed vaccine was removed because of a concerted public-opinion campaign, even as the number of infections were rising. People say, Why cant I do for myself what I can do for my dog? Well that, you know, is thanks to the people who brought down LYMErix, Mark Klempner, a professor of medicine at the University of Massachusetts and one of the vaccines developers, told me. It was a great disappointment to have worked all those years and feel successful at the end of it, only to see it pulled. It was a tragedy.
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Idsa Publishes New Lyme Disease Treatment Guidelines
The following is a press release from the Infectious Disease Society of America. Analysis from LymeDisease.org will be forthcoming.
New evidence-based clinical practice guidelines for the prevention, diagnosis, and treatment of Lyme diseasehave been developed by a multidisciplinary panel led by the Infectious Diseases Society of America, the American Academy of Neurology, and the American College of Rheumatology. Representatives from an additional 12 medical specialties and patients also served on the panel.
The guidelines provide practical recommendations for clinicians treating patients with Lyme disease, including, but not limited to, primary care physicians, infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists, and dermatologists.
These recommendations aim to serve as a meaningful resource for the safe, effective, evidence-based care of people with Lyme disease. They address clinical questions related to the prevention, diagnosis, and treatment of Lyme disease complications from neurologic, cardiac, and rheumatic symptoms disease expression commonly seen in Eurasia and complications from coinfection with other tick-borne pathogens.
The guidelines include 43 recommendations related to diagnostic testing, including testing scenarios detailed recommendations about Lyme carditis and a discussion of chronic Lyme disease.
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Determining Efficacy Of Drugs On Doxycycline Tolerant Persisters
The 106/ ml of Borrelia taken from log and stationary phase were cultivated with varying doxycycline concentrations of 2.5, 5 and 10g/ml. The doxycycline cultivated Borrelia cultures were incubated in 48-well plates for 3 days at 33°C with 5% CO2. Then the cultures were centrifuged for 10minutes at 13,000rpm. The remaining doxycycline tolerant Borrelia pellets were washed and incubated with 1ml of BSK-II medium containing drugs of varying concentrations for 7 days. As a control doxycycline tolerant Borrelia obtained were also resuspended again with doxycycline concentrations of 2.5, 5 and 10g/ml. After incubation for 7 days the cultures were pelleted, washed and resuspended in 0.5ml of fresh BSK-II medium. Then the semisolid plating was done by mixing cultures diluted in 0.5ml BSK-II medium with 10ml of BSK agarose and poured as top agar. The agar plates were incubated at 33°C with 5% CO2 up to 21 days. The white visible colonies were counted for generating persister curve. All the experiments were done atleast thrice with triplicates.
Chronic Lyme Dos And Donts
Chronic Lyme disease is an ongoing Borrelia burgdorferi infection that can involve any body system or tissue. The infection produces a wide range of symptoms and signs, which can be debilitating for some patients. Common symptoms include severe fatigue, migratory musculoskeletal pain, headaches, and impaired memory. Unfortunately, chronic Lyme disease is complex and often misunderstood, which means that many patients will struggle to obtain the care they need to regain their health. Every patient concerned about Lyme disease and tick-borne illness should know the following.
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For Depression And Anxiety
Both psychotherapy and pharmacotherapy have proven benefits for improving mood. Psychotherapy has many different types such as supportive, dynamic, cognitive behavioral, dialectical behavior therapy, transference focused psychotherapy each of which offers benefit. Pharmacotherapy also has many different types. For depression the first-line options usually are SSRIs, SNRIs, Tricyclics or other agents with more unique modes of action.
A few noteworthy tips on anti-depressant agents:
- Most anti-depressant agents also help in reducing anxiety. However the opposite isn’t necessarily true. Specific anti-anxiety agents such as clonazepam or diazepam may not necessarily help fight depression.
- Most anti-depressants take three to eight weeks before an effect is seen. Therefore, it is unwise to stop an anti-depressant after only three or four weeks, as staying on it another two to three weeks may lead to a good response.
- Dosage makes a difference. Some anti-depressants work fine at low doses some medications however are effective only at higher doses. Some medications are more effective as the dose is increased. Other antidepressants may have a therapeutic range one has to achieve at least a certain dosage .
New Antibiotics For Lyme Disease
Researchers in the Lyme disease community were aware that the commonly prescribed antibiotics for Lyme disease were ineffective against chronic Lyme, so they set out to identify more effective treatments. The goal was to repurpose already approved medications by screening medications from drug libraries. Testing already-approved medications with established safety profiles allow quick identification of effective treatments without developing new medications, attaining approval, and establishing safety in humans.
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Obtaining An Accurate Diagnosis
If you do not have a map, how do you get to where you want to go? Recovering from illness works the same way. An effective treatment strategy is only as good as the accuracy of the diagnosis. Nuances associated with Lyme disease lab tests create a challenge to getting an accurate diagnosis.
I only rely on reputable Lyme specialty laboratories to make a diagnosis. Testing for chronic viral infections, mold illness, heavy metal toxicity, digestive disorders, and more presents the same obstacle.
Conventional labs like LabCorp and Quest are fine for general markers like blood counts, chemistry panels, and thyroid hormones, but specialized labs need to be used for all the conditions mentioned above. Even within specialized laboratories, some provide more accurate data than others.
The labs that provide me with the best map change over time based on advances in testing and my clinical observations. If you tested for tick-borne infections or the above conditions over a year ago, the tests should be repeated because testing has improved. Its essential to know the current status of the results.
Potential Treatment For Lyme Disease Kills Bacteria That May Cause Lingering Symptoms Study Finds
Screening thousands of drugs, Stanford scientists determined that in mice, azlocillin, an antibiotic approved by the Food and Drug Administration, eliminated the bacteria that causes Lyme disease.
Deer ticks are vectors of Borrelia burgdorferi, the bacteria that causes Lyme disease.Scott Bauer/USDA Agricultural Research Service
For decades, the routine treatment for Lyme disease has been standard antibiotics, which usually kill off the infection. But for up to 20% of people with the tick-borne illness, the antibiotics dont work, and lingering symptoms of muscle pain, fatigue and cognitive impairment can continue for years sometimes indefinitely.
A new Stanford Medicine study in lab dishes and mice provides evidence that the drug azlocillin completely kills off the disease-causing bacteria Borrelia burgdorferi at the onset of the illness. The study suggests it could also be effective for treating patients infected with drug-tolerant bacteria that may cause lingering symptoms.
This compound is just amazing, said Jayakumar Rajadas, PhD, assistant professor of medicine and director of the Biomaterials and Advanced Drug Delivery Laboratory at the Stanford School of Medicine. It clears the infection without a lot of side effects. We are hoping to repurpose it as an oral treatment for Lyme disease. Rajadas is the senior author of the study, which was published online March 2 in Scientific Reports. The lead author is research associate Venkata Raveendra Pothineni, PhD.
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Antibiotics For Chronic Lyme Disease
If you have learned that chronic Lyme disease is the underlying cause of your symptoms, the next hurdle is finding effective treatments. The conventional medical model believes Lyme disease can only last short-term, and if symptoms persist following treatment, there is another cause. However, multiple research studies have demonstrated that the bacteria that causes Lyme disease can persist following treatment with antibiotics.
The antibiotics commonly prescribed for Lyme disease are ineffective against chronic or persistent Lyme disease. This article reviews research studies that identified antibiotics that are effective against the persistent forms of the bacteria that cause chronic Lyme disease.
Two Standards Of Care For Lyme Disease Treatment
There is significant controversy in science, medicine, and public policy regarding Lyme disease. Two medical societies hold widely divergent views on the best approach to diagnosing and treating Lyme disease. The conflict makes it difficult for patients to be properly diagnosed and receive treatment.
One medical society, the Infectious Diseases Society of America , regards Lyme disease as hard to catch and easy to cure with a short course of antibiotics. IDSA claims that spirochetal infection cannot persist in the body after a short course of antibiotics. The group also denies the existence of chronic Lyme disease.
In contrast, the International Lyme and Associated Diseases Society , regards Lyme disease as often difficult to diagnose and treat, resulting in persistent infection in many patients. ILADS recommends individualized treatment based on the severity of symptoms, the presence of tick-borne coinfections and patient response to treatment.
LDo believes that patients and their doctors should make Lyme disease treatment decisions together. This requires that patients be given sufficient information about the risks and benefits of different treatment options. Then, patient and health care provider can collaborate to reach an informed decision, based on the patients circumstances, beliefs and preferences.
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What Are Phase I Phase Ii And Phase Iii Studies
Determining the true benefit of a drug in a clinical trial is a difficult and lengthy process. Once a drug has been developed, there are three additional phases to obtaining FDA approval of the drug:
- The phase I study determines the safety of a drug candidate and its maximum tolerated dose that does not produce unacceptable side effects. Phase I studies offer little or no benefit to the volunteer subjects, who are typically healthy people who do not have Lyme disease. This phase takes approximately six to nine months to complete.
- The phase II study involves a drug candidate whose dose and side effects have been established in Phase 1. This phase will determine the drugs effectiveness. Does it help patients with Lyme disease get better? This phase will offer opportunities for Lyme patients to volunteer to participate if they meet study inclusion criteria. The timeline for this phase is roughly 18-24 months.
- The phase III study compares the new drug candidate against a commonly used drug, like doxycycline. Some volunteer subjects are given the new drug and some the commonly used drug. This phase will also offer opportunities for eligible Lyme patients to volunteer to participate. The timeline for this phase is roughly 12-24 months including time required for statistical analysis and submission of materials for FDA review.
New Drug Kills All Forms Of The Lyme Bacteria
Rajadas and Pothineni put together a team to study new drugs that could fight Lyme disease more effectively. Their study was recently published in Scientific Reports. They took thousands of existing drugs and chemical compounds and mixed them with Lyme. As results seemed promising, they created second and third tests to recheck those that showed positive results. Through this process, the team found a drug called azlocillin.
Azlocillin was previously approved by the FDA for the treatment of alcohol abuse disorder. Azlocillin appears to kill the morphed forms of the bacteria as well as the active. This could lead to a significant decrease in the need for extended treatment for Lyme disease. We are pleased to share that the treatment is now moving into human clinical trials.
An effective treatment for Lyme disease and the bacteria that cause it would be an astonishing scientific breakthrough. It could ease hundreds of thousands of people from the suffering that is associated with the disease. At Mosquito Squad of Southeastern Massachusetts, we are excited to share this promising news. Even still, we must remind you of one thing: Ticks are already out this year.
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Identifying New Drugs Against Borrelia
In 2016, researchers from Stanford University used high-throughput screening to identify compounds that were effective against Lyme disease. They started with over 4,000 compounds from various drug libraries and published their findings in the paper Identification of new drug candidates against Borrelia burgdorferi using high-throughput screening. The drugs were different in their pharmacological class, chemical structure, and mechanism of action to identify effective compounds.
One of the major challenges in the discovery of potent therapeutically effective drug molecules is the lack of availability of sensitive screening tools. Though the procedure becomes fairly simple with the availability of HTS methods and large collections of drug libraries, the development of drugs against slow-growing organisms still remains an uphill task. Though a number of drugs have been tested and approved against various spirochetes, the currently available drug therapies, such as amoxicillin and doxycycline, were unable to kill B. burgdorferi persisters in vitro.
The researchers discovered 150 compounds that inhibited over 90% growth of Borrelia. The top 20 compounds with significant growth inhibition, bacteria-killing capability, and safety history were further studied. The results were published in April 2016 in the paper Identification of new drug candidates against Borrelia burgdorferi using high-throughput screening.
Biorepositories And Research Cohorts
Well-characterized samples are an essential tool to help researchers develop and validate new diagnostic tests and to better understand the complexities of LD. Well-characterized sample sets can benefit medical providers, test developers, and the public at risk for LD . It is critical that sample users understand the criteria used to enroll participants, how samples were collected and stored, and what additional clinical and testing data may be available. Additional benefits can be realized when multiple sample users are using the same well-characterized sample sets. Current sample sets available for researchers include the CDC Lyme Serum Repository , the Lyme Disease Biobank , and samples from the Studies of Lyme Immunology and Clinical Events at Johns Hopkins University School of Medicine. Additionally, some investigators also have their own sample collections with, in some cases, blood samples, skin biopsy specimens and synovial fluid which form the basis for collaborative studies .
Lyme Disease Biobank
Lyme Disease Research Center
Long Island Outdoor Worker Cohort
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Testing Antibiotics For Persister Phase Lyme
In 2014, researchers from Johns Hopkins published the first study to assess the full spectrum of antibiotic susceptibility against persister phase Borrelia. The study, titled Identification of novel activity against borrelia burgdorferi persisters using an FDA approved drug library, screened over 1500 medications and identified 165 that had better activity against stationary Borrelia than doxycycline and amoxicillin.
The B31 strain of Borrelia was grown on a culture medium until the bacteria reached the stationary/persister phase between 6-7 days. The bacterias round body form characterizes the persister phase. This contrasts to the rapidly dividing phase early in infection when the bacteria is still in the spirochete form.
The 165 hits were narrowed to the top 27 drug candidates against stationary phase Borrelia. The antibiotics with the most significant activity against persister Borrelia bacteria were daptomycin, clofazimine, carbomycin, some cephalosporins, and some sulfa drugs. Daptomycin is an intravenous antibiotic and had the highest activity against the persister phase of Borrelia but was not effective against the growth phase. Doxycycline, amoxicillin, azithromycin, clarithromycin, and penicillin G had poor activity against Borrelia persisters.
Eradication Of Lyme Disease
I hope that it will continue moving forward in development and will become the first therapeutic to treat Lyme disease, Lewis says. It will be very important to see whether treating with hygromycin A will diminish the probability of developing chronic Lyme.
But the plans go even further: Lewis team has also shown that feeding hygromycin-laced bait to mice can eliminate Borrelia burgdorferi infections. Theoretically at least, putting out such bait could eradicate Lyme disease from entire areas or even entire countries.
This idea is not entirely new: A field trial with doxycycline baits was successful. But widespread use of this drug for that purpose is undesirable because it could lead to many microbes developing antibiotic resistance. In the case of hygromycin, however, Lewis studies indicate that it is extremely difficult for Borrelia burgdorferi to develop a resistance.
The first field trial against Borrelia burgdorferi is scheduled to start next summer. And Lewis team is also investigating whether hygromycin A can treat other diseases caused by spirochetes, such as syphilis, which is caused by the bacterium Treponema pallidum.
This article was translated from German.
Ticks a plague for humans and animals alike
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