Tag Archives: research

SEEKING VOLUNTEERS FOR POST-TREATMENT LYME SYNDROME STUDY AT COLUMBIA UNIVERSITY

Global Lyme Alliance grant recipient, Dr. Alla Landa is currently seeking volunteers for her study, “Reducing Chronic Pain in Post-Treatment Lyme Syndrome: a Brain Imaging and Treatment Study” at Columbia University’s Lyme and Tick-borne Diseases Research Center in New York City. This is one of the first-ever studies of chronic pain management in Lyme patients.

At least 5-15% of those with Lyme disease develop Post-treatment Lyme Syndrome (PTLS), which is marked by “debilitating residual symptoms that last months to years, even after having received antibiotic treatment.” These symptoms often include chronic muscle, joint and/or nerve pain.

Dr. Landa’s study explores how the brain processes pain signals in PTLS patients.
• Can PTLS patients benefit from medication that reduces central pain?
• Can PTLS patients benefit from D-Cycloserine: the FDA-approved tuberculosis treatment?
• Do PTLS patients have over-active central pain circuits in the brain?

If you are between 18 and 55 years old, suffering from Lyme disease and chronic pain, and would like to participate in this study, please contact Ellen Brown at 646-774-8100 or [email protected] for an initial eligibility screening.

For more information about the study please visit http://www.columbia-lyme.org/research/cr_research.html.

New Grant Awards Gla’s Largest Ever!

Request for Proposals (RFP)

The Global Lyme Alliance is pleased to issue a request for proposals (RFP) for research grants to be awarded in 2016.

The proposals must be aligned with GLA’s mission to study prevention, basic science, diagnostics and treatment of Lyme and other tick-borne diseases. We are interested in studies ranging from proof-of-concept that will potentially lead to federal funding, to research in areas of major deficiency. These include, but are not limited to:
• obstetrical and pediatric issues
• immune dysfunction
• animal models of tick-borne illness
• discovery of new antimicrobials and other treatment strategies for acute and chronic Lyme disease and coinfections

We welcome proposals from early-career investigators as well.

Guidelines for proposals are available here.

Proposals should be submitted via Grantmaker, an online portal that will become available on our website on June 1, 2016. The Grantmaker portal will be closed on September 15, 2016, and applications will not be accepted after that date. Awards will be announced in November 2016.

GLA Disagrees with NEJM Study Conclusions

The March 31, 2016 issue of the New England Journal of Medicine published a study of antibiotic treatment for long-term Lyme disease (Berende et al.). Individuals were treated with a two-week course of intravenous ceftriaxone, an antibiotic, followed by additional oral medications or placebo. The study concluded that longer-term antibiotic therapy for persisting symptoms does not confer additional benefits beyond short-term therapy.

We disagree with the conclusions of this study for the following reasons:

  1. This study compared shorter-term therapy (ceftriaxone followed by placebo) with longer-term therapy (ceftriaxone followed by more antibiotics), in patients with sustained symptoms. However, there was no “true” placebo group that was completely untreated. All three study groups reported significant, yearlong improvement in SF-36 scores, which measure health quality. The improvement could be attributed to the ceftriaxone given at the beginning, because even the group subsequently treated with placebo responded to the ceftriaxone after two weeks and beyond (Figure 2).
  2. Since they observed no significant difference in outcome in the various treatment groups, the study’s authors concluded that there was no benefit from continued antibiotics. However, with this study design, it is impossible to conclude that long term antibiotics are ineffective for treatment of chronic Lyme disease, as reported and distorted by the lay press.
  3. Doxycycline and clarithromycin, antibiotics used in two of the study arms, are poor at eradicating the antibiotic tolerant or persistent forms of Borrelia infection, which may be one cause of chronic Lyme disease (Feng 2015, Sharma 2015)
  4. Hydroxychloroquine is a drug used to treat autoimmune diseases. This was given along with clarithromycin to one of the three study groups. If persistent symptoms of Lyme disease are due to immune system malfunction, then we should have expected additional improvement, beyond that of the other two groups, after the three month treatment period. This did not occur.
  5. CDC diagnostic guidelines dictate that IgG, not IgM antibodies against Lyme bacteria indicate infection after the first 4-6 weeks. The patients in this study have had symptoms for more than two years. The authors do not explain why positive IgM was used as a criterion for inclusion into the study. These patients may be different than those who are positive for IgG.
  6. No consideration was given to co-infections by other tick-borne pathogens as the explanation for continuing symptoms which would not have responded to the oral antibiotics used in the study. Furthermore, the Borrelia species in Europe, where the study took place, differ in virulence and symptomatology from those in North America, limiting the study’s geographic relevance to that location.

Global Lyme Alliance (GLA) is disheartened by the inaccurate reporting and superficial reading of this study by the media and lay press. GLA has never blindly endorsed long-term antibiotic use for people with continued Lyme disease symptoms. In fact, GLA supports evidence-based, rigorous research into post-treatment Lyme disease in order to discover more effective antibiotic strategies. We are disappointed that this flawed study has been accepted without critical judgment.

The position of GLA is simple – Until there is an effective cure, the treatment of patients with tick-borne diseases should be in the hands of the physician.

For over 17 years, GLA and its predecessor organizations have supported research on behalf of the Lyme community. We have three major goals. The first is to reduce the number of new Lyme cases through awareness. The second is to reduce the number of patients who go on to suffer from chronic symptoms by funding research that will hopefully lead to better and earlier diagnostics, resulting in prompt treatment and fewer treatment failures. The third is to fund meaningful research leading to a better understanding of the chronic condition and effective therapies.

There are many unknowns in Lyme disease and other tick-borne illnesses. However, these facts are indisputable:

  1. There are over 300,000 new cases of Lyme disease every year in the United States, a number endorsed by the Centers for Disease Control and Prevention.
  2. At least 10% to 20% of these patients go on to experience chronic symptoms, including chronic pain, fatigue and neurological issues (Aucott J, SLICE 1). Chronic outcome is correlated with delays in treatment, truncated treatment, poor antibiotic choice, and a potentially inappropriate immune response to the pathogen. Even at the low end, this means 30,000 new chronic cases annually.
  3. Not every patient demonstrates a signature erythema migrans rash. We cannot rely on a rash to make the diagnosis.
  4. Current diagnostic tests may miss up to 60% of patients with acute Lyme disease. There is broad acknowledgement that the current diagnostic tests are unreliable.

In conclusion, we need truly controlled, well-designed clinical trials to identify efficacious therapeutic options for individuals with long-term symptoms attributed to Lyme disease. Unfortunately, the study by Berende et al. was not such a trial, and does not convincingly rule out long-term antibiotic therapy as a treatment for persisting Lyme disease. The search for effective therapies, which may include new antibiotic strategies, will continue.

New Grant Awards Gla’s Largest Ever!

GLA Awards Over $1 Million In New Grants!

Global Lyme Alliance (GLA), the nation’s leading nonprofit funder of Lyme and tick-borne disease research and education, announced today that it has awarded a record total of over $1 million in grants to eight researchers focused on post-treatment Lyme disease syndrome (PTLDS) or “chronic” Lyme.

“Although GLA’s scientific agenda—the identification, treatment and cure of Lyme and other tick-borne diseases—remains the same, this grant cycle we strove especially to award exceptional researchers advancing the science of post-treatment Lyme,” said Harriet Kotsoris, M.D., GLA’s Chief Scientific Officer. “Even with 21 to 28 days of antibiotic treatment, nearly 20 percent of Lyme patients exhibit persistent and debilitating symptoms such as fatigue and pain. We need to understand why.” In announcing the new grants, Dr. Kotsoris noted that GLA had received the most grant applications in its history—almost $3 million in funding requests.

“While we were pleased to receive so many quality grant applications this year, such a profusion underscores the fact that there are far more scientists competing for grants than there is funding to support them,”she said. “Federal funding of Lyme is, in fact, minuscule, yet the Lyme threat keeps growing. This speaks to the importance of GLA’s critical role in working with private donors to drive advancements in the field.”

The resulting GLA 2015-2016 grant portfolio is “outstanding,” Dr. Kotsoris said. “The quality of the proposals and funded grants continues to increase every year.”

The eight grants were awarded to: Armin Alaedini, Ph.D., Columbia University, NY; Nicole Baumgarth, D.V.M., Ph.D., University of California, Davis; Alla Landa, Ph.D., Columbia University, NY; Kim Lewis, Ph.D., Northeastern University, Boston, MA; Benjamin Luft, M.D., State University of New York, Stony Brook; M. Karen Newell-Rogers, Ph.D.,Texas A&M University; Eva Sapi, Ph.D., University of New Haven, CT, and Ying Zhang, M.D., Ph.D., Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.

“GLA is proud to support the innovative research being conducted by some of the best and brightest men and women in the field today,” said Dr. Kotsoris. “We believe that the exceptionally talented scientists being funded by GLA will greatly contribute to advances in identifying the causes of PTLDS, how to reverse it, and especially how to treat the persistent infection.”

Among the projects being supported by GLA is the first human clinical trial for pain and cognitive impairment in chronic Lyme sufferers. The trial will be conducted at Columbia University under the direction of Dr. Landa.

Researchers were selected following a rigorous evaluation process using guidelines established by the National Institutes of Health (NIH). Each proposal was evaluated by Grant Review Committee members of GLA’s Scientific Advisory Board and met the same scientific standards that NIH applies to its own grant review process. The resulting 2015-2016 grant awards represent projects judged to have exceptional prospects of delivering measurable advances.

Lyme disease is the most common vector-borne disease in the U.S. with some 329,000 new cases reported in the United States each year, according to the Centers of Disease Control and Prevention. There are no accurate diagnostic tests for Lyme, no tests to prove that Lyme bacteria are eradicated or that an individual is cured. Some 15 to 20 percent of individuals with Lyme end up with long-term health problems.

About Global Lyme Alliance

Global Lyme Alliance is the nation’s leading tick-borne disease organization dedicated to supporting Lyme and tick-borne disease research and education. The 501(c)(3) nonprofit is headquartered in Greenwich, CT. For more information, call 203- 969-1333.