“For the past two days I had a national team on my property and in my life to get to know me. They saw my room and watched as I took medicines, wrapped my IV up, prepared for a shower, wrote a new blog entry, visited my miniature horse, ate ice cream, and performed regular activities. Nothing about the experience was regular however. It was surreal having strangers going to and from and putting a microphone on you and following you around. I’m used to just doing my thing pretty quietly but there was nothing quiet about the new visitors.”

The show will air this Friday, 10 pm, on ABC News.

Click here to see Elaina’s blog and view her videos.

TOUCHED BY LYME is written by Dorothy Kupcha Leland, LymeDisease.org’s VP for Education and Outreach. Contact her at dleland@lymedisease.org.

.

A few days later I collapsed in the dining hall. When I came to, the camp nurse told me I’d had a low blood sugar reaction, something that had never happened to me before. She didn’t think to connect the incident with my mysterious rash, which by then had faded. She didn’t think to test me for Lyme disease, known for its tell-tale rashes. She didn’t think to test me for babesia, ehrlichia or bartonella, tick-borne parasites that consume oxygen in the red blood cells, which can first manifest as hypoglycemia. She didn’t think to do any of these tests, because she didn’t know the serious health threat that ticks pose in wooded areas.

I don’t blame the camp nurse for my misdiagnosis, but I do blame the lack of awareness surrounding tick-borne illness that led to her ignorance. It took eight years for a doctor to connect the dots of my burgeoning constellation of symptoms. By then the bacteria had spread to every system of my body, crossed the blood-brain barrier and invaded my central nervous system, and was replicating at a rate that evaded the strongest antibiotic treatment.

I was left bedridden, hooked up to an IV, for two years. The co-infections of babesia, ehrlichia and bartonella caused nightsweats, fevers, and neurological symptoms that demanded intense anti-malarial treatment.

This is the fate that awaits anyone who does not receive a proper diagnosis of tick-borne illness right away.

Our best defense against this health threat is Lyme literacy, not just amongst the general population but amongst doctors, too.

If you suspect you have a tick-borne illness and you feel that your doctor is not taking you seriously, please, remember my story, and find another doctor. Press on until you receive an accurate diagnosis and proper treatment. Doctors should test not only for Lyme disease but for co-infections that can complicate treatment. Because tests for tick-borne illnesses can be inaccurate, doctors also need to watch for clinical symptoms.

Thirty thousand cases of Lyme disease are reported by the Center for Disease Control each year. But because Lyme is often overlooked or misdiagnosed, the International Lyme and Associated Diseases Society estimates that only 1 out of every 10 cases of tick-borne illness is actually reported, and that the number of cases occurring each year has increased twenty-five-fold since the disease was first tracked in 1982.

If Lyme disease is diagnosed right away, a course of antibiotics may eradicate the disease. The problem is that not all bites come with a classic bull’s-eye rash. Often, bites happen in hard-to-spot places like the scalp or behind the ears. Symptoms of fatigue, joint and muscle pain and neurological impairments can be misdiagnosed as everything from the flu to anxiety.

I am living proof of the damage this gross illiteracy of tick-borne illness can cause. If my story can save one person the trouble of all that I have been through, the pain and suffering will have been worth it.

Jennifer Crystal is a masters of fine arts student at Emerson College in Boston. This article originally appeared on boston.com.

Other topics in this issue: Using TV for Lyme education…Wisconsin medical board backs down…Dr. Jones appeals to CT Supreme Court…How biofilms evade the immune system… Understanding the Western blot…and more.

If you are already a member, your copy of The Lyme Times is in the mail. If not, join today and have your subscription start with this issue. Regular membership is $35/year. Membership special: Join at the $50 level or above and receive a 2-DVD set with Dr. Joseph Burrascano.

.

.

.

.

From the US Food and Drug Administration:

FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

.

Date Issued: May 10, 2012

Audience: People with multiple sclerosis (MS), their families and caregivers; Neurologists; Interventionalists (Radiologists, Vascular Surgeons and Neurosurgeons); Clinical Researchers; other MS health care providers; and Institutional Review Boards (IRBs).

Medical Specialty: Neurology, Interventional Radiology, Vascular Surgery.

Purpose: The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved.

This communication is also intended to notify physicians and clinical investigators planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices.

Summary of Problem and Scope: MS is a progressive, immune-mediated disorder of the brain and spinal cord.  In this disorder, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms.

The underlying cause of MS is not known. Some researchers think that narrowing (stenosis) of specific veins in the neck and chest (internal jugular and azygos veins) may cause MS or may contribute to the progression of MS by impairing blood drainage from the brain and upper spinal cord. This narrowing of neck and chest veins has been called CCSVI.

Studies exploring a link between MS and CCSVI are inconclusive. Some studies have suggested a link exists, while others have found no such connection.  At this time, the FDA believes there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS. In addition, the criteria used to diagnose CCSVI have not been adequately established. Therefore, data to support CCSVI as a clinical entity on its own or its relationship with MS are inconclusive and at times, contradictory.

Some individuals, organizations and websites promote an experimental treatment of CCSVI that uses balloon angioplasty devices or stents to widen the narrowed internal jugular or azygos veins. This procedure is sometimes called “liberation therapy” or the “liberation procedure”.

The FDA believes that using these medical devices in CCSVI treatment procedures poses a risk to patients because:

• There is no clear diagnostic evidence that CCSVI exists as a distinct clinical disorder or is linked to MS.
• Venous stenoses seen on imaging tests may be normal variants that do not cause any symptoms or disease, since they are sometimes seen in healthy people.
• The safety and effectiveness of using balloon angioplasty devices or stents in the internal jugular or azygos veins have not been established for any clinical condition; nor has the FDA approved the use of these devices in these veins.
• There is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS or improves the quality of life for MS patients.
• It is possible that stent placement can worsen any venous narrowing. This is because further narrowing has been shown to sometimes occur within stents placed in veins, due to the body’s response to the implant.

The FDA encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures. Rigorously conducted, properly targeted research can provide a more complete understanding of the existence of CCSVI and any relationship between CCSVI and MS, which will help people with the disease and their clinicians make the best treatment decisions.

Adverse Events: CCSVI procedures have been associated with serious, even fatal, complications.  The FDA has received reports of one patient who died from bleeding in the brain and one patient who suffered permanent paralysis from a stroke after CCSVI treatment. Other serious complications of the CCSVI procedure reported primarily as individual incidents or case series in medical journals include: at least one death, stents migrating from their original location to another part of the body (including the heart), venous injury, blood clots forming in the jugular vein or in stents, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding. The frequency of these serious complications is not known.

Recommendations:

For People with Multiple Sclerosis:

• Be aware that there is lack of clear evidence of the existence of CCSVI. Furthermore, the link between CCSVI and MS and the safety and effectiveness of the CCSVI treatment procedure in MS patients has not been established.
• You should know that serious complications can occur as a result of CCSVI treatment procedures. Before you have any CCSVI procedure, discuss with your physician or other health care provider the signs and symptoms of such complications. If you have the procedure and you develop any of the signs or symptoms of a complication, contact your health care provider immediately.
• Before considering CCSVI treatment, discuss the potential risks and benefits with a neurologist or other health care provider who is familiar with MS and CCSVI (including the CCSVI procedures and their outcomes).
• If you decide to undergo diagnostic and/or treatment procedures for CCSVI, continue to follow the MS treatment plan outlined by your neurologist or the provider caring for your MS.
• If you are considering participating in a clinical trial for CCSVI, learn as much as possible about the clinical trial and ask questions of the health care team conducting the trial. Read the informed consent document carefully, and ask for an explanation of anything you do not understand.  You can find additional information and recommended questions to ask your health care team on the Understanding Clinical Trials page of www.clinicaltrials.gov.
• If you undergo treatment for CCSVI and experience a complication, we encourage you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

For Physicians and Care Providers:

• Inform patients of the following concerns:
  • there is conflicting evidence about CCSVI as a clinical entity;
  • CCSVI’s relationship to MS is scientifically unproven; and
  • consensus on the diagnostic criteria of CCSVI has not been reached.
• You should be aware the FDA has not cleared or approved any angioplasty device or stents for the treatment of CCSVI and use of such devices in treating CCSVI are considered off-label at this time. While the FDA does not regulate the practice of medicine and health care practitioners may choose to use a legally marketed device, based on their clinical assessment, for purposes other than the cleared or approved use, the FDA believes the safety issues observed to date warrant a communication on the subject.
• Discuss the risks of CCSVI treatment with potential patients, including both the adverse events generally associated with catheter-guided endovascular intervention and those related specifically to use of balloon angioplasty devices or venous stenting for CCSVI.
• If your patient experiences a complication following CCSVI treatment, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

For Clinical Investigators and Institutional Review Boards (IRBs):

• The FDA has determined that investigations of medical devices for use in CCSVI treatment are significant risk studies.  Clinical studies of significant risk medical devices, such as in the case of balloon angioplasty devices and stents to treat CCSVI, require approval through an IRB and the FDA’s Investigational Device Exemption (IDE) program. The IDE regulations help ensure the rights, safety and welfare of patients are protected during these studies and that the risks are as low as possible and are balanced by any potential benefits.
• The FDA encourages clinical investigators to discuss trial design with the FDA in the early planning phase, through both the formal pre-IDE process and less formal meetings and conferences.
• If a patient in an IDE study experiences a complication related to the CCSVI treatment, sponsors and clinical investigators must comply with applicable adverse event recordkeeping and reporting requirements under the FDA’s IDE regulations.

FDA Activities:

The FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without an approved IDE. Because the FDA currently considers clinical studies evaluating CCSVI treatment with balloon angioplasty devices and/or stents to be significant risk, this study was in violation of the FDA’s regulations. The sponsor/investigator has reported the study has been voluntarily closed.

The FDA will continue to monitor for adverse events related to medical devices commonly used in CCSVI treatment (e.g. angioplasty devices and stents) and take action when appropriate.

The FDA will continue to monitor this situation and keep the public informed as new information becomes available.

Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

She spent more than a year in a wheelchair. After 18 months of Lyme treatment, she can leave the chair behind and walk with a cane.

“When I got diagnosed I started a website to share my story & spread awareness,” she writes in an email. “Since then 5 people in my small town of 1,000 have realized they had Lyme through my site. I enjoy making videos as well.”

A little over a year ago she started LymeTeens, an online support group/social network that has grown to about 60 members. “We have teens from the US, Canada, Australia, Norway, & England. I thought it was hard trying to get treated for Lyme in the U.S.–but I’ve found the teens in the other countries have it even worse off.”

There are a lot of Lyme support groups on the internet, but Gabbi says there’s not much there for people her age. “It’s hard for us relate to our friends who are not sick & sometimes hard to relate to adult Lyme patients because we are at different stages in our lives. I have made many friendships through LymeTeens & it gives me the courage to keep going.”

One project that’s come out of LymeTeens is the following YouTube video made for Lyme Awareness Month.

Click here for more information about LymeTeens.

TOUCHED BY LYME is written by Dorothy Kupcha Leland, LymeDisease.org’s VP for Education and Outreach. Contact her at dleland@lymedisease.org.

“The IDSA’s 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests — in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies — to exclude divergent medical evidence and opinion.”

The IDSA guidelines are still in effect today, and are a major reason that Lyme patients are denied appropriate medical care. (Not just in the United States, either. The IDSA guidelines have been adopted in many other countries as well.)
The guidelines are listed on the National Guidelines Clearinghouse, an arm of the US government which advises doctors on the best way to treat patients for various illnesses. Even though the NGC’s own rules call for guidelines to be updated at least every five years (to reflect the latest scientific discoveries) the NGC gave the powerful IDSA a free pass. The stale-dated guidelines stay in effect, making life miserable for Lyme patients everywhere.

LymeDisease.org has launched a petition to urge:
1) The National Guidelines Clearinghouse to remove the guidelines as its listing rules require.

2) The IDSA to revise its guidelines in a transparent process that includes both patient advocacy representatives and physicians who treat chronic Lyme disease.

More than 21,000 people have signed this petition to date–a good start. We need more to make a stronger impact. Won’t you sign today, and urge family and friends to do so as well?

Click here to sign the petition.

TOUCHED BY LYME is written by Dorothy Kupcha Leland, LymeDisease.org’s VP for Education and Outreach. Contact her at dleland@lymedisease.org.

Austin, TX (PRWEB) May 02, 2012
A multinational panel of medical and scientific professionals met on March 24 and 25, 2012 in Austin, Texas at the 5th annual Morgellons Medical Conference entitled, “Searching for the Uncommon Thread” to discuss the latest findings on Morgellons disease.

Morgellons is a debilitating, systemic illness characterized by the formation of unusual fibers within the skin. In addition to slow-healing skin lesions, those afflicted by the illness also experience overwhelming fatigue, and an array of neurological deficits. Morgellons affects people of all ages and ethnic groups, worldwide.

Sponsored by The Charles E. Holman Foundation (CEHF), the two-day event boasted attendees comprised of doctors, scientists, Morgellons patients and supporters. Much of this conference was dedicated to refuting the conclusions suggested by the 2011 study by Hylwa et al, of the Mayo Clinic, and the January 25th, 2012 Center for Disease Control (CDC)/Kaiser Permanente Morgellons study.

Highlights of the two-day event included many educational and thought provoking presentations. Canadian microbiologist, Marianne Middelveen, reported on ground-breaking research that she and prominent San Francisco-based physician, Raphael Stricker, published recently in Clinical Cosmetic and Investigational Dermatology, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3257881. This research demonstrates similarities between Morgellons and a bovine spirochetal disease.

“The unusual filaments associated with Morgellons are likely composed of keratin and demonstrated photographic evidence that fibers stem from both pavement epithelial cells and hair follicles, tissues where keratinocytes are the predominant cell type,” stated Dr. Middelveen.

According to Middleveen “these findings conclusively debunk the erroneous theory that this disease is caused by delusional beliefs and that patients self-implant fibers or are intentionally mutilating themselves”. A second publication related to this subject authored by Middelveen, Stricker and other collaborating researchers, is currently in-press and scheduled to be published soon.

Australian Dermatologist Peter Mayne showed clear slides of fibers taken from some of his many Morgellons patients, noting that fibers are subdermal in origin and some originate in the hair bulb. Dr. Mayne is the first practicing dermatologist to thoroughly examine the tissue of Morgellons patients and acknowledge the disease’s unique pathological characteristics.

Mayne outlined differential diagnoses he considers in his Australian clinical practice. Dr. Mayne, along with Randy S. Wymore, PhD., Director of Research at the Center for the Investigation of Morgellons disease, reviewed the history of the CDC’s noninvolvement with Morgellons disease, and refuted the 2012 CDC/Kaiser study results.

A presentation on Institutional Cognitive Dissonance by CEHF Director, Cindy Casey, RN, in collaboration with Elizabeth Rasmussen, PhD, further demonstrated the repudiation by the CDC of its lawful responsibilities towards Morgellons patients as well as to their confused and bewildered medical care providers.

CEHF Associate Director Greg Smith, a pediatrician from Georgia, Dr. Amelia Withington, a Psychiatrist from Pennsylvania, Ginger Savely, DNP, a recognized authority in the medical management of Morgellons disease from Washington, D.C., and Carsten Nicolaus, MD, PhD from Augsburg, Germany, an esteemed medical provider for Morgellons patients in Europe, also gave informative presentations covering a broad range of Morgellons-related topics.

The Morgellons medical conference is an annual gathering in Austin, Texas of medical and scientific professionals and members of the Morgellons community. Sponsored by The Charles E. Holman Foundation in Austin, Texas, its purpose is to discuss the latest scientific discoveries in Morgellons research. The foundation was named for Charles E. Holman, a pioneer in the fight against Morgellons disease.

The official DVD of the conference is now available. To order a copy of the DVD, please visit http://www.thecehf.org.

A new study by Drs. Monica Embers, Stephen Barthold, Mario Phillip and colleagues has found that the bacteria that cause Lyme disease, Borrelia burgdorferi (Bb) persist in monkeys after antibiotic treatment. It is the latest in a number of studies that have demonstrated persistent infection in animal models despite treatment. The study also found that the C6 antibody test gave false negative results in all of those treated with antibiotics and in more than 50% of those untreated. This study contradicts most of the IDSA major tenents in their Lyme guidelines as set forth in the table below:

Embers Monkey Trials: IDSA Guidelines Implications

Mandatory Use of Antibody Laboratory Tests for Diagnosis

IDSA:“Clinical findings are sufficient for the diagnosis of erythema migrans, but clinical findings alone are not sufficient for diagnosis of extracutaneous manifestations of Lyme disease. . . . Diagnostic testing performed in laboratories with excellent quality-control procedures is required for confirmation of extracutaneous Lyme disease.”

Embers Monkey Trials:  The C6 antibody test failed to detect Lyme disease in 50% of monkeys with persistent Lyme disease over time even though direct evidence of the bacteria confirmed persistence. [This means the test is not sensitive enough to be required for diagnosis.]

Treatment of Early Disseminated Lyme Disease

IDSA:“Doxycycline, amoxicillin, and cefuroxime axetil are effective for the treatment of early Lyme disease. Most patients respond promptly and completely. Some individuals have persistent subjective complaints, despite receiving therapy that otherwise appears curative. Less than 10% of individuals do not respond to antibiotic therapy, as evidenced by the presence of objective clinical manifestations, and rarely is re-treatment required.”

Embers Monkey Trials:  All infected monkeys treated with this protocol failed to clear the infection. Early disseminated was defined as 4 months after inoculation. [This means short term protocols are expected to fail in monkeys with early disseminated Lyme disease.]

Persistence of Lyme disease bacteria (Borellia burdorferi)

IDSA:“There is no convincing biologic evidence for the existence of symptomatic chronic B. burgdorferi infection among patients after receipt of recommended treatment regimens for Lyme disease.”

Embers Monkey Trials:  Embers found direct evidence of persistence in all monkeys treated with 28 days of antibiotics and in 8 out of 11 treated with 90 day Klempner protocol.  [This means Bb persistence is the norm in monkeys.]

Effectiveness of Antibiotic therapy chronic Lyme disease

IDSA:“Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic (6 months) subjective symptoms after recommended treatment regimens for Lyme disease (E-I).”

Embers Monkey Trials:  Embers found that 3 of 11 infected monkeys cleared the infection using the 90 day Klempner protocol. [This means that 90 days of antibiotics worked in about 25% of the monkeys. It suggest that rather than being ineffective, the course of antibiotics used may be insufficient.]

Recommended modalities of treatment

IDSA:“Because of a lack of biologic plausibility, lack of efficacy, absence of supporting data, or the potential for harm to the patient, the following are not recommended for treatment of patients with any manifestation of Lyme disease: . . . .combinations of antimicrobials, pulsed-dosing (i.e., dosing on some days but not others), long-term antibiotic therapy. . .”

Embers Monkey Trials: “Finally, the use of variable and pulse-dosing regimens of antibiotics may improve efficacy [43] and this warrants testing in an appropriate model.” [This means that non-standard approaches may improve efficacy. Also note that 90 days was better than 28 in the Embers study.]

Mechanisms of persistence

IDSA:“Finally, Lyme disease lacks characteristics of other infections that justify longer treatment courses, such as infections in immunodeficient hosts, infections in which a pathogen is inhibited but not killed by antimicrobial therapy or in which available antimicrobials are minimally active in vitro, infections caused by an intracellular pathogen, infections involving a biofilm, infections on a heart valve, or infections involving a clinical site in which there is ischemia, a foreign body, a sequestrum, or frank pus [170]. The “cystic” forms of B. burgdorferi that have been seen under certain growth conditions in vitro have not been shown to have any clinical significance [320].”

Embers Monkey Trials: “The nature of the persistent organisms and the acquisition of tolerance to antibiotics are questions that need to be addressed. The B. burgdorferi spirochete is known to invade collagenous tissue as a possible mechanism of immune evasion.”
. . . .”The fact that organisms can persist in the presence of antibiotics such as penicillin and cephalosporins (ceftriaxone) that interfere with cell wall synthesis appears to stem from their ability to enter a dormant, non-dividing state [43,44], thus avoiding the need for cell wall synthesis to continue growth.”
. . . .”A ‘‘persister’’ phenotype may possibly be responsible for the recalcitrance of persisting spirochetes made evident by previous studies in mice and dogs [37,42,45], and by those presented in this report.” [This means there are lots of plausible mechanisms for persistence.]

Antibody Level Decline

IDSA:Additional compelling evidence against the hypothesis that persistent symptoms are the result of persistent infection is the fact that the concentrations of antibodies against B. burgdorferi in many of these patients diminish to undetectable levels [257, 286, 288, 318]. The panel is unaware of any chronic infection in which antibody titers diminish despite persistence of the causative organism.

Embers Monkey Trials:  In all of the infected animals, the C6 antibody index rose steeply within the first 5–8 weeks post-inoculation (PI). Thereafter, the responses fit into three patterns, depending on whether the animals were or were not treated with antibiotics. In the treated group, the response declined steadily during the treatment period and reached background levels at the endpoint in all animals. In contrast, the responses of the untreated group remained either largely unchanged (5 out of 12 animals,  or returned to background levels (7 out of 12 animals) but not in parallel with the kinetics of the treated group’s decline in specific antibody (Figure 2B).

This article is part of a series of reviewing the Embers findings for treatment of chronic and early disseminated Lyme disease as well as the effectiveness of the C6 antibody test. You can find these other posts here:

Part 1–New study shows Lyme persists in monkeys

Part 2–Treatment and Persistence

Part 3–IDSA 28-day treatment protocol fails to clear infection

Part 4–Lab tests fail to detect Lyme disease

Part 5–Of mice and men and monkeys

Read the journal article here.

You can sign the petition to have the IDSA antiquated Lyme guidelines removed from the National Guidelines Clearinghouse here.

References:

Embers ME, Barthold SW, Borda JT, Bowers L, Doyle L, Hodzic E, et al. Persistence of Borrelia burgdorferi in Rhesus Macaques following Antibiotic Treatment of Disseminated Infection. PLoS ONE. 2012;7(1):e29914. Available at: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0029914.

Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, et al. 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 Nov 1;43(9):1089-134.

The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org, formerly CALDA. Contact her at lbjohnson@lymedisease.org.