Medical panel keeps Lyme guidelines “as is”
Photo: Gary Wormser, MD, lead author of the IDSA guidelines, attributes many chronic Lyme symptoms to “the aches and pains of daily living.”
After reviewing 3,000 pages of evidence challenging advice in its 2006 Lyme disease medical guidelines, eight Infectious Diseases Society of America (IDSA) panelists voted to keep the 45-page document “as is.”
Dr. Robert Bransfield, the president of a group of community-based Lyme specialist physicians (ILADS) issued this statement in response:
“It’s a sad day for the health care system and for everyone who suffers from the Lyme disease epidemic. The IDSA’s flawed positions means patients will continue to suffer with incorrect diagnosis and improper treatment.”
“By and large, the people on the IDSA panel who made this decision are ivory tower researchers,” says Bransfield. “They’re not the doctors on the front lines looking into the eyes and faces of these very sick patients, performing exams and then assuming long term responsibility for dealing with patients suffering from chronic Lyme.”
Bransfield and ILADS point to a number of discrepancies and other concerns about the vote, including:
—68 out of 69 of the original 2006 recommendations under review were OK’d with unanimous votes. “How can there be such a total consensus with any scientific issue?” asked Bransfield. “It’s highly suspect and beyond comprehension.”
—If Lyme cannot be chronic, then why did the guideline’s authors acquire 200 Lyme disease patents and receive $76 million in Federal funds to study it?
—The original guidelines are not only controversial, but written back in 2006, are considered old and out of date.
—The CDC has also advised for many years that the disease should be diagnosed on clinical grounds and not by unreliable laboratory tests. The Lyme disease tests are inaccurate 50% of the time.
—The IDSA’s decision reinforces that doctors have little control when it comes to treating diseases such as Lyme. Researchers and insurance companies remain in the driver’s seat of diagnosis and treatment.
In May 2008, the IDSA agreed to re-evaluate its Lyme disease guidelines as part of a settlement agreement for an antitrust investigation by the Attorney General of Connecticut, Richard Blumenthal. The crew of the documentary, UNDER OUR SKIN, covered this investigation as it unfolded, and revealed some of the evidence alluded to in Blumenthal’s investigation, including the significant conflicts of interest among the original IDSA guidelines panelists, suppression of scientific evidence by panelists, and exclusion of panel members with opposing viewpoints.
During a telephone press conference on the IDSA’s announcement of the ruling, IDSA president Richard Whitley, MD, said he thought Blumenthal had been “misguided by the [Lyme] activists” and that the antitrust suit against IDSA wasn’t “justified or warranted.”
- To read the IDSA report, click here.
- To read the ILADS response, click here.
- To download a detailed history of the IDSA investigation, click here.
- To read the Attorney General’s release on the investigation, click here.
- To read UNDER OUR SKIN’s Jordan Fisher-Smith’s letter to the IDSA and learn what you can do, click here.
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“Shame on you IDSA” says UNDER OUR SKIN’s Jordan Fisher Smith
Jordan Fisher Smith, the eloquent park ranger featured in UNDER OUR SKIN and the author of the acclaimed naturalist book “Nature Noir,” has written this open letter to the Infectious Diseases Society of America (IDSA), in response to the society’s decision to make no changes to their controversial 2006 IDSA Lyme Disease guidelines.
___________________________________________
To the Infectious Diseases Society of America:
Almost twelve years ago, I was bitten by a tick at work, and contracted Lyme Disease and Babesiosis. Because of the job you’ve done at diminishing the perception of danger about tick-borne disease and pressuring doctors who treat it aggressively out of business, it took a year and a half and a nationwide search to find a doctor who would treat me.
By then I was dreadfully ill, and as a result I lost my job and my 21-year career. In my first year of antibiotic treatment I got worse. I pursued aggressive treatment for another six years, during which time I got steadily, if slowly better. During this time one of my two doctors was forced out of practice as a result of your work. Thanks to my heroic physicians, I am recovered after a nine-year battle with tick-borne disease. And I am now contributing to society, working, and raising my kids.
Your ineffectiveness and the extent of your compromise with the insurance and HMO businesses are noted. You and your work will be forgotten eventually, as we have forgotten the names of the opponents of Copernicus. Shame on you for the suffering you are causing on the way to your eventual obscurity as prideful scientists who called it tragically wrong. The monument to your life’s work is an unchecked epidemic.
—Jordan Fisher Smith, recovered victim of tick-borne disease
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The reevaluation of the IDSA Lyme guidelines was driven by an antitrust investigation led by Connecticut Attorney General Richard Blumenthal. During his 17-month investigation, Blumenthal found substantial conflicts of interest among the 2006 guidelines authors, who held commercial interests in Lyme-related diagnostic tests, vaccines, and insurance. In addition, he found that this panel had suppressed scientific evidence and excluded opposing views.
Lorraine Johnson, CEO of the Lyme patient advocacy group California Lyme Disease Association (CALDA), questions the integrity of the evaluation, saying that the IDSA “stacked the panel, paid the ethicist, ran the process, and achieved a foregone conclusion which ‘validated’ their guidelines.”
The Connecticut Attorney General Richard Blumenthal is currently reviewing the IDSA Lyme report to determine whether the IDSA has violated the Settlement Agreement.
If you would like to submit your feedback on how the IDSA Lyme disease guidelines have affected you and/or your family, emails can be sent here:
attorney.general@po.state.ct.us
To send a copy to the IDSA leadership:
Richard Whitley, MD, IDSA President: rwhitley@peds.uab.edu
Diana Olson, IDSA VP of Communications: dolson@idsociety.org
James M. Hughes, MD, FIDSA, IDSA President-Elect: jmhughe@emory.edu
Mark A. Leasure, IDSA Chief Executive Officer: mleasure@idsociety.org
Carol J. Baker, MD, IDSA Lyme disease panel chair: cbaker@bcm.edu
Photo by Jim Herrington
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Dr. Jones Update: Crime and Punishment in CT
Last week the Connecticut Medical Examining Board (CMEB) voted to discipline Dr. Charles Ray Jones, the 80-year-old pediatrician featured in UNDER OUR SKIN, for technical violations in the way he diagnosed and treated three children suspected of having tick-borne diseases.
The medical board’s final decision, which will be signed in March, specifies that Jones pay a $10,000 fine and finance four years of supervised probation by a licensed pediatrician. This is on top of another $10,000 fine and two years of probation specified in a 2007 ruling, which is currently in appeal.
Jones supporters question the fairness of the proceedings against this pediatric Lyme specialist, who has treated more than 10,000 children with tick-borne diseases over the course of his career. Dr. Jones’ lawyer, Elliott Pollack, believes that the undue harshness of the sentence is related to the heated controversy surrounding his use of long-term antibiotics in treating children with persistent Lyme disease.
The medical board, on the other hand, says that the most recent charges are not related to Lyme disease. The panel chairman, Dr. Richard Bridburg, elaborated: “For us, at least, this issue was perhaps because of the size and busyness of Dr. Jones’ practice, we thought that he takes shortcuts.” (Source: Hartford Courant)
While no one disputes that Dr. Jones took “short cuts,” a review of all CT Physician Disciplinary Actions 2009 rendered by the CT medical board raises questions about fairness of his punishment for these procedural issues.
Last year the medical board punished 43 physicians for serious charges such as substance abuse, sexual misconduct, mental illness, and negligence; not one of these physicians received a fine larger than $5,000. And only one other physician, accused of drug abuse, received a longer supervised probation period than Dr. Jones – though this drug-addict doctor did not receive the additional $20,000 in fines levied on Dr. Jones.
None of Dr. Jones’ treatments resulted in patient harm and his medical decisions were motivated by his desire to begin the treatment of these very sick children as soon as possible. The cases under investigation were:
Case 1: Dr. Jones ordered tick-borne disease blood tests for two siblings he hadn’t physically examined, in advance of an appointment, based on a phone interview with the children’s grandmother.
Case 2: Dr. Jones prescribed antimicrobial drugs over the phone for a child who had tested positive for Babesiosis, a serious tick-borne disease similar to malaria, before a physical exam. This was after interviewing the mother and a referring health care provider, and learning that the child had a history of a tick bite and a physician-observed Lyme rash.
Irrespective of whether the punishment fits the “crime,” the medical board’s six-year investigation into Dr. Jones has sent a headline-grabbing message to every pediatrician in Connecticut – If you treat children with Lyme disease with more than four weeks of antibiotics, you may lose your medical license and be treated as a pariah among your peers. So, with Connecticut Lyme cases skyrocketing up 118% from 2006 to 2008, and the state desperately needing every Lyme specialist it can get, the children of Connecticut are the ones receiving a potential life sentence of suffering, if they acquire one or more tick-borne diseases.
Whether they admit it or not, the Connecticut medical board has turned their hearing rooms into a virtual battlefield for the two standards of care in Lyme disease: the academics at IDSA (with “one-size-fits-all” antibiotic limits) v. the ILADS community-based physicians (who treat until the child is well). With the board’s expert witness list drawing from IDSA-friendly Yale and UConn, it’s no secret where the CT board’s loyalties lie. Given that the IDSA Lyme guidelines are under legal scrutiny by the Attorney General Blumenthal of CT, it’s time that the citizens of Connecticut ask their medical board, “Is justice being served here?”
To watch an interview with Dr. Jones, click here.
For the history of the Dr. Jones legal battle, click here.
To read a new statement by Dr. Jones, click here.
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While Oscar Fades, Fargo awards UNDER OUR SKIN top prize
UNDER OUR SKIN just received a “Best Documentary” award from the Fargo Film Festival, which will be held from March 2-6, 2010 at the newly restored Art Deco Fargo Theater. This is the sixth “Best Documentary” award that UOS has received at international film festivals, in addition to several top medical media awards.
Fargo Film Festival Chair Tom Brandau said the film won by a unanimous decision, and affirmed:
“UNDER OUR SKIN is a wonderful film and I know our festival goers will think so too. I also wanted you to know that the film is up for additional awards, which will be announced during the festival.”
As many of you may have heard, UNDER OUR SKIN didn’t make it into the Oscar finals, but we are honored to have made it to the top 15, and to be considered among so many excellent films. During our publicity campaign, thousands more learned about the hidden epidemic of Lyme disease.
In the meantime, we will continue our efforts to spread the word through film festivals, television broadcast, educational distribution, and community outreach. To learn more about hosting or attending a screening in your area, visit our website.
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Lyme film featured in People Magazine
Under Our Skin is featured on page 40 of the February 8, 2010 issue of People Magazine. (Cover image: Elizabeth Edwards.)
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More Delays in Lyme Guidelines Revisions
The Infectious Diseases Society of America (IDSA) has missed its target date of December 31, 2009 for rendering a decision on whether it will rewrite its Lyme disease medical guidelines, which according to a group of leading Lyme disease specialists, “mislead clinicians and result in poor patient care.”
Diana Olson, IDSA VP of Communications, said that the medical evidence review panel, which has met over a dozen times in 2009, is aiming to release recommendations “as early as possible in the new year.” If a rewrite is called for, the IDSA revision would be completed in “several months to a year or more”, leaving suffering Lyme patients in treatment purgatory for four years since the scientific integrity of the guidelines was first questioned.
The reevaluation of the IDSA Lyme guidelines was driven by an antitrust investigation led by Connecticut Attorney General Richard Blumenthal. During his 17-month investigation, Blumenthal found substantial conflicts of interest among the 2006 guidelines authors, who held commercial interests in Lyme-related diagnostic tests, vaccines, and insurance. In addition, he found that this panel had suppressed scientific evidence and excluded opposing views.
In December, Senator Chuck Grassley launched an investigation into the conflicts of interest of 33 other medical societies, saying in a press release, “These organizations have a lot of influence over public policy, and people rely on their leadership. There’s a strong case for disclosure and the accountability that results.”
During the 2.7 years since the IDSA Lyme guidelines investigation began, IDSA leadership has shown a consistent lack of concern, remorse or urgency in correcting possible inaccuracies and biases in the 2006 Lyme guidelines.
As soon as Blumenthal’s investigation was announced, IDSA’s conflict-riddled panel launched a far-reaching campaign to disseminate their 2006 recommendations across the U.S. medical information network through physician continuing education (CME), medical textbooks, infectious disease board certification courses, online resources, and medical school lectures. So, even if the IDSA guidelines are revised immediately, it could take a year or more to remove flawed diagnosis and treatment recommendations from the system.
Furthermore, rather than censuring the guidelines chairman, Gary Wormser, M.D., for violating the IDSA’s conflicts-of-interest policies by holding “a bias regarding the existence of chronic Lyme” and handpicking “a likeminded panel without scrutiny by or formal approval of the IDSA’s oversight committee,” the IDSA leadership awarded Wormser the IDSA’s 2007 Society Citation for being “a bold champion for rational, evidence-based medicine.”
To add insult to injury, three days after the mandated evidence hearing, which according to many observers was an evidence-based victory for Lyme patient advocates, former IDSA president Anne Gershon denied any IDSA wrongdoing, saying, “IDSA’s signing the agreement was not, as [Blumenthal] alleges, an admission of guilt, but an effort to end a fruitless investigation.”
Gershon went on to say, “The notion that the authors had financial conflicts of interest is absurd to anyone who has read the guidelines, which recommend generic tests and a short course of generic drugs.”
Lyme disease policy expert, Lorraine Johnson, J.D., M.B.A., explained why this IDSA statement is misleading: “People in the Lyme disease community know that conflicts of interest were a big issue in the Lyme vaccine. We also know that the narrow disease definitions that suited the vaccine trials the best, hurt patients by denying and delaying diagnosis to patients with Lyme.”
Johnson provided details on the author conflicts in a recent article in the Journal of Medical Ethics:
“The most influential panelists on the IDSA guidelines panel had commercial interests related to Lyme vaccines, diagnostic tests, and insurance. Some of the panelists had been involved in the development of the first Lyme vaccines—had run the clinical trials for these vaccines–vaccines which were withdrawn from the market after patients reported serious neurologic side effects. Some had been sued as part of a class action lawsuit or served as expert witnesses for the vaccine manufacturer. Some of the panelists acknowledged they owned Lyme diagnostic tests or were working on the second generation of Lyme vaccines, which are still under development.”
In the meantime, as the number of U.S. Lyme cases grows by about 30% per year, Lyme patients are trapped between a broken health care system and biased medical guidelines that are being used by insurance companies to deny treatment.
Here’s to hoping that Senator Grassley and CT Attorney General Blumenthal (who is now running for the Senate) will put some legislative teeth into making “non-profit” medical societies like the IDSA more accountable for patient welfare and less beholden to vaccine and drug manufacturers.
Photo caption: At the July 30, 2009 Lyme evidence hearing, ILADs submitted 300 pages of analysis and 1,300 pages of peer-reviewed research contesting the IDSA Lyme Guidelines recommendations.
For an overview of the Lyme controversy, watch the UNDER OUR SKIN trailer:
http://underourskin.com/watch.html
For a detailed timeline of the IDSA Lyme Guidelines investigation, IDSA_Investigation_Timeline.
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UNDER OUR SKIN in Tribeca Oscar semifinalists screening
UNDER OUR SKIN was one of six documentaries selected by New York’s Tribeca Film Institute for a special January 9th viewing marathon of the most promising films on the 2010 Oscars feature documentary short list.
We encourage UNDER OUR SKIN supporters in the New York area to pack the theater with friends to help generate a groundswell of public support for the final Oscar nominations, which will be announced on February 2, 2010.
For more information and tickets, visit http://www.tribecafilm.com/docseries/
Saturday, January 9 at 8:30pm
Tribeca Cinemas
54 Varick Street (Laight below Canal)
UNDER OUR SKIN continues to garner critical acclaim among the Oscar watch pundits. The film was selected as one of the “Best films of 2009” by the movie awards website InContention.com, which also predicted UNDER OUR SKIN would be among the five nominated documentaries. Our fingers are crossed as we enter the home stretch. Having an “Oscar nominated” label on the film will do more to boost awareness about Lyme disease than 1000 press releases. Keep up the good work. Spread the word.
Acclaim for UNDER OUR SKIN:
“Like a well-made thriller, gets under your skin…More deeply terrifying than any slasher film you’ll ever see.” - Michael O’Sullivan, Washington Post
“Fascinating…artful and compelling.” - Frank DiGiacomo, Vanity Fair
“Scary enough to make the faint of heart decide never to venture into the woods.” - Stephen Holden, New York Times
“Frightening, powerful stuff.” - Gary Goldstein, Los Angeles Times
“The most important documentary to come out this year.” - Molly Dedham, Sirius-XM Radio
“Stirs the deepest emotions and reveals the most unsettling truth.” - Justin Berton, San Francisco Chronicle
“Head-spinning…riveting…a rigorously researched and highly thorough piece of investigative reporting.” - Lauren Wissot, Slant Magazine
“Dramatically compelling…a ripping indictment of the medical establishment’s failure to uphold its oath.” - Dann Gire, Chicago Daily Herald
“A powerful film and cautionary tale…as significant an indictment of American medical practices as Michael Moore’s Sicko.” - Curt Schleier, Film Sound Off
“One of the most frightening horror movies I’ve seen. The evil in it springs from deer ticks and human ignorance, both of which seemed to be omnipresent.” - Lawrence Toppman, Charlotte Observer
“Infectiously persuasive…targets both the heart and brain.” - Sarah Sluis, Hollywood Reporter
“Rock solid…paced like a horror story.” - Susan Orlean, The Daily Beast
“Best Films of 2009″ - InContention.com
“Enlightening and alarming…Wilson takes us on a journey of discovery.” - Leonard Maltin, Film Critic
Recognition for UNDER OUR SKIN:
Audience Choice Award Finalist, Tribeca Film Festival
; Best Documentary, Houston International Film Festival
; Best Documentary, Sonoma International Film Festival;
Best Documentary, Durango Independent Film Festival
; Best Documentary, Okanagan International Film Festival;
Best Documentary, Camden International Film Festival;
Audience Favorite, Durango Independent Film Festival
; Audience Favorite, Okanagan International Film Festival
; Best Picture Silver Award, International Health Film Festival;
Best in Health & Science, CINE Golden Eagle Awards;
Best in Category, International Health & Medical Media Awards;
Best Cinematography, International Health & Medical Media Awards;
Chris Award, Columbus International Film Festival;
Best Documentary Silver Award, Asheville Film Festival
; Honorable Mention, Wild & Scenic Environmental Film Festival
; Audience Award Runner-up, Berkshire International Film Festival
; Best Socially Conscious Documentary Nominee, IFP/Fledgling Fund
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UNDER OUR SKIN makes the Oscar “short list”
The Academy of Motion Picture Arts and Sciences today announced that UNDER OUR SKIN was selected as one of the 15 finalists competing for “Best Documentary Feature” in the 82nd Academy Awards®.
Unfolding like a real-life thriller, UNDER OUR SKIN exposes the hidden epidemic of Lyme disease and reveals how our corrupt medical system is failing to address one of the most serious illnesses of our time. Open Eye Pictures is thrilled that the Academy has honored the courageous Lyme patients and physicians whose stories are told in this film. And we hope that this nomination will help spread awareness about this devastating disease and serve as a catalyst for fixing our country’s broken health care system.
The Documentary Branch Screening Academy Committee viewed all eighty-nine qualifying documentaries during the preliminary round of voting. Academy members will now select five nominees from among the 15 titles on the shortlist, and Academy Awards nominations will be announced on Tuesday, February 2, 2010.
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Lyme patients abandoned: Letters from “Under Our Skin”
We receive many letters from Lyme sufferers and occasionally we like to share them with the rest of the community. Frustrated by the impossibility of getting help, many reach out to their legislators, and some to the President of the United States. Here’s one story that recently came our way and was particularly poignant:
August 18, 2009
Dear President Obama,
I am 39-years old and writing to you about healthcare reform. I would like to share my story with you in the hopes of putting another human face to the healthcare crisis in America. I am a single woman who was very athletic, outgoing and involved in my community, family, church, career, and friends before becoming debilitated with late stage Lyme disease.
I am three chapters of my dissertation short of a second part of a double PhD in Psychology with areas of focus in Neurology and Forensics. I have a Masters degree in Psychology with the same areas of specialty, and an Addictions Certification which is the accumulation of 6,000 supervised work hours, ten graduated level courses and a State Board exam. I started working in the field of psychology at age 18 and continued until I was 33 years old when I could no longer work due to the level of debility from Lyme disease.
I was diagnosed in 1994 with Lyme disease, given a course of antibiotics and told I was cured. I was not cured and my health continued to decline.
I went from doctor to doctor searching for answers. After years and years of misdiagnoses, I was finally properly diagnosed in 2005 with late stage Neurological Lyme disease with many co-infections. Since that time I have been searching for a doctor who will take me on as a patient while the Lyme and other co-infections wreaked havoc on my body. I am not able to perform even the simplest of day-to-day tasks due to the chronic and severe level of physical pain.
I lost my health insurance and have not been able to get more due to pre-existing conditions. My finances are depleted from years of misdiagnoses and improper treatments. I have not been able to get the help I need due to financial restraints and a lack of knowledge about late stage Lyme disease here in Florida.
I now have a team of doctors who are willing to take my case, but the team of doctors resides on the West Coast and I live in Florida. All of this treatment is out of pocket. I do not have insurance as I have either been told I am ‘uninsurable’ or that the premiums will be so high I could not afford it.
I would like to know what your healthcare reform will do to help someone like me?
What can we do in this nation so people will not have to suffer as I am? What I am suffering could have been avoided if given the proper diagnoses and treatment in a timely manner. I am laying here literally dying a very slow, agonizing death, and without the medical help I need. I am a young woman, and have been told by many organizations that if I had a family of my own, if I was older, if I was a child, or if I was a minority . . . then resources would be available to me.
How, in a Nation of equality, is such an injustice permitted?
I understand that some of your staff has viewed the groundbreaking documentary film, UNDER OUR SKIN. This film depicts the growing epidemic and political controversy surrounding Chronic/Late Stage Lyme disease as well as the grave nature of the disease. This film has been instrumental in helping Lyme disease sufferers to gain understanding from family, friends, and the medical community as a whole. UNDER OUR SKIN helps to clear up the many questions related to timely diagnoses and effective treatment of Lyme disease. In light of your healthcare reform initiatives, I am begging you to personally watch this film and take action. Lyme disease is an epidemic of proportions unparalleled to most diseases that have swept this nation and the world. Please take a personal interest in Lyme disease and in using the film to help educate the American people about this widely misunderstood disease.
Please help me save my life and please help others in similar situations to save their lives. Do not allow us to continue to be a population who falls through the cracks.
Thank you for your time in reading my letter. I hope and pray with all of my heart that you will consider all I have shared and allow it to sink in with empathic understanding, following with some action taken to help.
Respectfully Yours,
Elizabeth C.
Boca Raton, FL
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Top LA Times awards critic Tom O’Neil roots for UNDER OUR SKIN
Can this Lyme disease exposé get under Oscar voters’ skins?
by Tom O’Neil, The Envelope, LA Times
Let’s hope the Oscars cite “Under Our Skin” next week when the academy unveils the shortlist of titles in the running for best documentary feature. It’s not only a compelling work of filmmaking; it’s important because of its shocking message: Lyme disease may be going undiagnosed as a greater and more widespread threat to Americans’ health than AIDS.
“Under Our Skin” has won more than a dozen top awards at film festivals (see the full list here at the docu’s website), but it still doesn’t have a U.S. distributor. It had its qualifying run in a Los Angeles theater to make it into the Oscar race — the week Michael Jackson died — but it still needs to be adopted by a major distributor to make sure it’s widely seen. This is one of those cases in which the Oscars can play a starring role in an urgent cause.
At a time when America’s leaders battle over how to fix the nation’s healthcare system, “Under Our Skin” is an illuminating anecdotal example of what’s ailing. Bravely, it spotlights many victims of a fast-growing epidemic of Lyme disease who go undiagnosed or misdiagnosed because of corruption in the healthcare biz.
“We’ve submitted this film at the Oscars because we want it to be seen by the largest number of people,” producer-director Andy Abrahams Wilson tells Gold Derby. “If we get into the Oscars, it might make a big difference toward creating changes in the medical and insurance industries needed to save lives.”
“Under Our Skin” has been a crusade for Wilson, who shot 400 hours of footage over five years while chasing suspicious medical and legal authorities to get justice for their victims: Lyme disease patients who can’t get proper care because the medical industry doesn’t see profit in it.
“We focus on several powerful cases,” Wilson says, “but there were many others we encountered along the way — some too tragic to include.”
See more about “Under Our Skin” at its website.
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Save Dr. Charles Ray Jones, Lyme Pediatrician
Dr. Charles Ray Jones, the 80-year old Connecticut pediatrician featured in UNDER OUR SKIN, has treated more than 10,000 children with Lyme disease over the course of his career. In addition to seeing patients six days a week, Dr. Jones has spent the last four years and hundreds of thousands of dollars defending himself against state medical board charges of “inappropriate” treatment of children with Lyme and other tick-borne diseases. This is despite the fact that the Connecticut House of Representatives just unanimously passed a bill that reassures doctors that they will not face retaliation if they choose to diagnose chronic Lyme disease and treat it with long-term antibiotics.
[To read details of this legal battle, click here.]
Is this justice, or politics-as-usual in Hartford, CT, the “Insurance Capital of the World“?
With Connecticut Lyme cases skyrocketing up 118% from 2006 to 2008 and the state desperately needing every Lyme specialist it can get, why is Dr. Charles Ray Jones still being dragged through the courts? Today his defense fund is depleted, and he needs $8,000 immediately, or his attorney will be forced to resign. This will deal a devastating blow to Dr. Jones and all the children he treats, and it will set a dangerous precedent for other Lyme physicians.
You can watch an interview of Dr. Jones here.
To help, please donate whatever you can by clicking below.
http://lymesite.com/Dr_Jones_use_paypal_to_make_donations_to_.htm
Or mail donations to:
Pullman & Comley Trust Account-for Dr. Charles Jones,
Elliott Pollack c/o Pullman & Comley, LLC90 State House Square, Hartford, CT 06103-3702. Note “gift” in the memo field.
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Report from Portland screening
Here’s a report from Anna from one of the Portland, OR UNDER OUR SKIN screenings. Feel free to share your stories with us too:
Hi Everyone,
Last Saturday’s opening event of “Under Our Skin” at the Hollywood Theatre in Portland, Oregon, was a complete success. About 240 people attended. The panel went well – it was succinct and informative. Dr. Martin Ross, Dr. Tara Brooke, Tamara Gebhardt, and Miguel Perez-Lizano provided some helpful and beneficial information for the audience. The feedback I received noted that the panel was the best part of the afternoon.
By far, the best thing the event did was to connect Lyme sufferers together. There was the couple from Grants Pass, Oregon, who mentioned they had never been around so many Lyme people before. They mentioned they have been in treatment limbo ever since their Lyme doctor retired.
Then there was the young man who is grappling with his inability to provide for himself. He looked so tired and hopeless. I just wanted to give him a big hug.
And then there was the young woman who was wrestling with how she was supposed to pay for any of the treatment.
“Is there a foundation that helps people out financially?” she asked.
“If there was, it would be tapped out by now,” I said.
Finally, there was the woman who attended on behalf of her cousin who has Lyme. The woman began to cry as she told me how devastating it was to watch her family member lose her job and spend her days on the couch. That’s the kind of love I like to see.
So many people and so many stories of pain, suffering, hopelessness, confusion, despair. Yet, when we share and collaborate and exchange stories – when we show up to events like these – these stories start to become full of hope and possibility, too. This is the beginning of something new!
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What’s Under Our Skin? New research on Lyme biofilms
At the end of UNDER OUR SKIN, Dr. Alan MacDonald presented a revolutionary new hypothesis – that Lyme bacteria are able to shroud their colonies with protective biofilms – and this may explain why these pathogens can be so difficult to eradicate with short courses of antibiotics. [1]
His collaborator, Eva Sapi, Ph.D., Associate Professor of Biology and Environmental Science at the University of New Haven, is exploring why and how these biofilms form, in hopes of developing more effective treatments for chronic Lyme sufferers.
[Click on this video clip to watch a Lyme biofilm colony in action. The green fragments on the screen are a fluorescent protein (GFP) gene that has been derived
from the bioluminescent jelly fish, Aequorin victoria. This gene has been inserted into the genome of Borrelia burgdorferi strain B31 as a visual marker. It fluoresces green light when excited by a blue or ultraviolet light attached to a microscope. In other words, it's like a bike light attached to the Lyme bacteria.]
Biofilms are made up of a polymeric jumble of DNA, proteins and polysaccharides. They are known to cause persistent, antibiotic-resistant bacterial infections for a number of reasons. [2] First, the polymeric “slime” protects the bacteria in the center of the medusa-like colony, and the inner organisms often shape-shift into energy-efficient forms that can survive months to years in a dormant state, only to reemerge when the host environment is free of chemical threats. Second, antibiotics typically don’t work as well when bacteria are in a dormant state.
Dr. Sapi’s lab is currently trying to identify the chemical messaging that the bacteria use to trigger the formation of a biofilm, with hopes of preventing the formation of this antibiotic-resistant matrix. And she is testing a variety of enzymes and techniques for breaking up existing biofilms. In addition, her preliminary research has found that that Lyme biofilms are comprised of an abundance of calcium crystals, which she thinks could cause some of the joint irritation experienced by many Lyme patients.
Medical professionals and researchers who want to learn more about Lyme biofilms can join Dr. Sapi at the Lyme Research Workshop that will be held at the MediTenth Annual Scientific Session: 21st Century Lyme Disease Treatment, October 24-25, 2009 in National Harbor, Maryland 20745.
The California Lyme Disease Association (CALDA) will reimburse up to $500.00 out-of-pocket expenses for any actively practicing MD, DO, ND, NP or PA (in any state) who wants to attend this conference. This offer is also available for the Lyme Disease Association (LDA) conference, which is held the day before this conference at the same location. CALDA grants are limited and are only available to those qualifying professionals who are attending the conferences for the first time.
To read more about Dr. Sapi’s research, visit her website at:
http://www.newhaven.edu/unhtoday/archive/UNH_09172007/pages/faculty_profile.html
[1] Sapi E, MacDonald, A. Biofilms of Borrelia burgdorferi in Chronic Cutaneous Borreliosis. Am J Clin Pathol 2008; 129:000-000.
[2] Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science 1999;284:1318-1322.
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UOS wins top award at International Health Film Festival
Andy Abrahams Wilson receives award from festival jury and town mayor
UNDER OUR SKIN was just awarded “Best Feature Film-Silver Award” at the 1st International Health Film Festival in Kos, Greece. The tiny island in the eastern Aegean sea was the home to Hippocrates, father of medicine. Over 80 films competed and were juried by industry professionals as well as physicians. It was another great triumph of recognition within the medical community of a disease too long ignored and a health system riddled with commercial conflicts. I was fortunate to be present to receive the award (a commemorative silver coin of Hippocrates and bust of the Greek goddess of health Hygieia), as my trip was graciously covered by the U.S. Embassy in Athens. The Q&A (at 2AM!) was especially contentious, with a few physicians in the audience asking challenging questions. I was very impressed by the Greeks’ natural and ancestral love of dialog and debate–and ability to genuinely listen to another viewpoint. This made it even more special and validating to be honored in the birthplace of medicine and the Hippocratic Oath, which reminds and challenges us some 2500 years later to do no harm to patients. One pledge stands out in particular as strikingly relevant in the Lyme disease arena:
“I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.”
And yet, Lyme-literate physicians (e.g. Dr. J. Jemsek and Dr. C. Jones) continue to be persecuted for upholding this oath. On the contrary, many physicians do untold harm by denying Lyme patients accurate diagnosis and effective treatment, so often telling them that their problems are “all in their head” or, as in Mandy’s case, “There’s no medicine for someone like you.” May this award serve as another clarion call to return to the essence of medicine, in full humility and for the good of the patient. The film festival jury explained its award choice to UNDER OUR SKIN…
“For advocating at the frontier of medicine. The film provides an activist challenge to the medical profession on ethical review standards, long term treatment and the necessary attentiveness to those who suffer from Lyme disease.”
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Lyme cases spike 77% from 2006 to 2008
Click to download a PDF image or spreadsheet of this data.
Lyme disease continued its steep rise in 2008, as the CDC posted a final tally of 35,198 reported cases, a 28% increase over the previous year. Looking at a two-year timeframe, cases increased by 77% from 2006 to 2008. According to CDC epidemiologists, these reported cases are underestimated 6- to 12-fold, due to inherent flaws in its passive reporting system. So, the actual number of new Lyme cases in 2008 may total upwards of 420,000. And many Lyme-literate physicians believe that the real numbers may be even higher.
In 2008 the CDC changed its Lyme reporting process to include both “confirmed” and “probable” cases in the total, and during this transition year, it’s difficult to tell how this affected the accuracy of the case count. Fifteen states failed to report any “probable” cases.
Here are the states with the most reported Lyme cases in 2008:
This change in the Lyme disease surveillance process was initiated in 2008 to reduce the burden of mandatory CDC Lyme reporting on resource-strapped state and local health departments. But it did nothing to address the fundamental flaws in the Lyme surveillance criteria—it is still based on an inaccurate blood test and an outdated list of Lyme disease symptoms. [1]
To compensate for the ambiguity caused by bad tests and diagnostic criteria, local health officials often must make time-consuming calls to treating physicians for clarification. In New Jersey, for example, the health department found that:
–Each Lyme case took health officials an average of 2 months to close
–24% of Lyme cases were never closed or counted
–The Lyme reporting process in New Jersey alone required 5 full-time employees to handle
(The overworked New Jersey health department quantified the absurdity of the Lyme surveillance process in their report, “Burden of Lyme Reporting.”)
To add insult to injury, the Lyme surveillance criteria, which were initially designed as analytical metrics for CDC epidemiologists to track the spread of the disease, are being used inappropriately for Lyme disease diagnosis. While the CDC officially says that this surveillance criteria should **not** be used for diagnosis, the organization is sending a mixed message to physicians and patients by officially endorsing the Infectious Diseases Society of America (IDSA) Lyme guidelines, which mandate that this overly stringent surveillance criteria be met before patients can be treated. And though the IDSA claims that these diagnostic guidelines are not mandatory, they have been used as legal hammers in challenging the medical licenses of both Dr. Charles Ray Jones and Dr. Joseph Jemsek, two prominent Lyme-literate physicians who diagnose based on symptoms, exposure, and a less rigid interpretation of the tests.
Meanwhile, as the number of Lyme sufferers continues to climb by double-digits the silence from both the CDC and mainstream medicine is deafening. If the CDC reported an increase of 77% for AIDS, wouldn’t it be on the cover of every newspaper and medical journal in America? So what’s going on with Lyme disease?
The problem is that most people and frontline physicians believe that Lyme disease is a trivial, over-diagnosed illness that can be cured with 2 weeks of antibiotics.
The reality is that untreated or undertreated Lyme disease can result in a serious neurological infection, similar to syphilis, for which we have no accurate tests and a poorly defined set of symptoms. Information and research on this disease has been controlled by a small group of academic researchers, operating under the legal protection of the IDSA, who have conflicts of interest in Lyme-related vaccines, test kits, and the very definition of the disease. (For more information on these conflicts, watch this clip from UNDER OUR SKIN, review the ruling from the Attorney General of Connecticut, and read the book, “Cure Unknown.”)
Much to the frustration of Lyme patient advocacy groups, the CDC has allied itself to the narrow IDSA view of Lyme disease, and has repeatedly refused to incorporate new diagnosis and treatment information onto its website.
Recently, new research has shown that the CDC-endorsed blood tests, which are based on a single Lyme strain from Shelter Island, NY, may not be detecting all the bacterial strains of the disease.
In the recent IDSA Lyme evidence hearings, initiated by the Attorney General of Connecticut, David Volkman, Ph.D., M.D., Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook, reiterated these evidence-based findings [3], saying:
–Persistent Lyme is well documented in mice, dogs, and man
–The current Lyme tests are unreliable
–The CDC surveillance case definition for Lyme is being misapplied
In light of this new evidence, it’s clear that the latest revision to the CDC Lyme surveillance criteria is akin to putting a butterfly band-aid on a cut to the femoral artery. The new regime at the CDC needs to look more accurate ways of tracking Lyme disease, such as the automated lab reporting system that they’ve funded for tracking Lyme disease in dogs, through Banfield pet clinics.
And with chronic disease accounting for 80% of our nation’s health care costs, our public health system needs to know how many of our citizens are suffering from both the acute and chronic forms of Lyme disease.
The tragedy of this broken reporting system is that it is ruining lives. Physicians make clinical decisions based on the CDC case numbers, and if they think that Lyme is rare in their area, they may not consider it as a differential diagnosis. Congress allocates research funding based on the CDC case numbers, too, and by underestimating these numbers by a factor of ten, grants will go to other diseases. (We hope that our documentary, UNDER OUR SKIN, has helped to raise Lyme disease awareness, and in turn, the accuracy of the Lyme case count.)
It’s time for the CDC to stop downplaying the magnitude of the Lyme epidemic and to put the truth back into the testing and the reporting system.
Below: Though the CDC shows a majority of cases in the Northeastern states, there is evidence that the CDC-endorsed Lyme tests may be missing the new Lyme strains emerging in the South and West. Click here to view/download this map.
[1] A review by Stricker and Johnson (2007) of North American case-control studies of commercial two-tier Lyme testing reached the following conclusion: “The two tier testing system endorsed by the Centers for Disease Control and Prevention (CDC) has a high specificity (99%) and yields few false positives. But the tests have a uniformly miserable sensitivity (56%)—they miss 88 of every 200 patients with Lyme disease.” An updated analysis including more recent studies found that the sensitivity of the two-tier test system was even worse (46%). This sensitivity is far below the 95% cutoff required for an accurate diagnostic test, and much worse than the 99.5% sensitivity of commercial HIV testing.
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“Fully loaded” DVD now available for pre-order
Finally, the “fully loaded” DVD of UNDER OUR SKIN is available for purchase. We are now accepting pre-orders, and the DVD will be shipped (hot off the press) in mid to late September. All consumer DVD orders placed in August will get a $5 discount and a free “Uncover the Epidemic” bumper sticker. Community group and educational purchases will receive a $15 discount. The DVD includes an hour of never-seen before footage (deleted scenes and additional characters, including Amy Tan and an appearance by U2’s The Edge); interviews with Mandy, Dana and the filmmakers; a director’s commentary; closed captioning; French, Spanish and English subtitles; theatrical trailer; and a special 32-page discussion guide.
‣ Pre-order the “fully loaded” DVD for home use only.
‣ Pre-order the “fully loaded” DVD for community groups and educational use.
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Join the Facebook movie movement
Facebook has been an unexpectedly useful tool for spreading awareness and creating community around the film and the issue. After six months, the UNDER OUR SKIN film page has over 3600 film fans, and hundreds and hundreds of fan comments. The page provides updates on screenings, events, calls to action, press, photos and other pertinent information to the film and the Lyme community. Below (and is a “window” to the film’s Facebook page wall. You can also embed the page on your own website and blog by cutting and posting the HTML code below. Thanks for joining us on Facebook and helping to create a movie movement.
To embed this Facebook window on your website or blog, copy and paste the HTML code below:
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A summary of the IDSA Lyme evidence hearing
On July 30, 2009, a newly formed panel from the Infectious Diseases Society of America (IDSA) heard 8 hours of testimony from 18 presenters representing various viewpoints on Lyme disease diagnosis and treatment. This was the first time the two sides of the Lyme controversy have been given equal time in front of a conflict-free evidence-review panel. And it’s the first time that a medical guidelines hearing has been broadcast over the Internet for all the stakeholders to hear, from patients to researchers to treating physicians.
Over the past decade, two opposing camps have emerged in the battle over this tick-borne illness. One camp is represented by the group of 14 academic researchers who wrote the 2006 IDSA Lyme guidelines. They maintain that Lyme disease is ‘hard to catch and easy to cure’ because the infection is rare, easily diagnosed and cured with two to four weeks of antibiotics. This group claims that chronic infection by the Lyme spirochetal bacterium, Borrelia burgdorferi, is rare or nonexistent.
The opposing camp is represented by the International Lyme and Associated Diseases Society (ILADS), led by a group of community-based physicians. Its members argue that Lyme disease is not rare and tick bites often go unnoticed, especially since commercial laboratory testing for Lyme disease is inaccurate. Consequently, the disease is often not recognized and may persist in a large number of patients, requiring prolonged antibiotic therapy to eradicate persistent infection with the evasive Lyme spirochete.
This hearing came about as the result of an antitrust settlement initiated by Connecticut Attorney General, Richard Blumenthal in 2007. During his investigation, the Attorney General found substantial conflicts of interest among the 2006 panel members, who held commercial interests in diagnostic tests, vaccines, and insurance. In addition, he found that this panel had suppressed scientific evidence and had excluded opposing views from the panel.
After watching the entire hearing, my overall impression was that the community-based ILADS physicians gained significant ground in the evidence-based debate with the 2006 IDSA guidelines authors. The most compelling takeaway messages were:
1. THE GUIDELINES ARE TOO RIGID GIVEN THE STATE OF THE SCIENCE.
The science on diagnosing and treating Lyme disease is still uncertain, and we need guidelines that allow physicians freedom to treat until this disease is better understood. Based on a national patient survey conducted by Lorraine Johnson of CALDA, it was found that 58% of Lyme patients remained ill after the IDSA’s recommended treatment and 60% improved with longer courses of antibiotics. Even though the IDSA Lyme guidelines are supposed to be voluntary, they are widely used by insurance companies to restrict physicians’ ability to exercise clinical judgment, depriving seriously ill patients of the only available treatment option (long-term antibiotics) that can get them back to leading normal lives.
2. LONG TERM ANTIBIOTICS HELP SOME PATIENTS.
A meticulous dissection of the 4 peer-reviewed studies used by the IDSA to deny longer courses of antibiotics showed that 2 of those studies had serious design flaws and the other 2 actually showed that patients improved after 6 weeks of IV antibiotics. Given that these 4 studies were based on a total of only 207 patients and a single antibiotic, it was clear that much more treatment research is needed. The other revision that most of the expert panelists seemed to back is Dr. Volkman’s strongly held belief that the “two pill Lyme cure” recommended in the IDSA guidelines fails 80% of the time, and it should be removed from the guidelines. (Volkman Ph.D., M.D., is an Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook.)
3. CHRONIC LYME IS CAUSED BY PERSISTENT INFECTION.
Benjamin Luft, MD, from SUNY Stony Brook presented compelling evidence showing that the Lyme bacteria can persist in the body beyond the IDSA-recommended 2 to 4 weeks of antibiotics. He cited the Barthold (UC Davis) mouse study and other studies that demonstrated the multiple strategies that the organism uses to escape detection by the immune system. Overall, the weigh of evidence for the existence of chronic Lyme far outweighed the IDSA “expert opinion” that the symptoms that linger beyond treatment are due to a “medically unexplained symptom” (MUS), labeled as “Post-Lyme Syndrome” by the IDSA authors.
4. MORE ACCURATE TESTS ARE NEEDED.
Dr. Ray Stricker, as well as a number of other presenters, showed that the two-tier surveillance Lyme test system endorsed by the IDSA, though highly specific, lacks the sensitivity required for an accurate diagnostic test, missing 88 out of every 200 Lyme patients. This results in thousands of Lyme patients being misdiagnosed and undercounted. (The CDC admits that U.S. Lyme cases are being underreported by 6- to 12-fold each year.) The CDC spokesperson, Barbara Johnson, Ph.D., however, stood by these tests, even though the expert panel seemed shocked that the CDC’s endorsement was based on a decade-old study that looked at a mere 26 patients.
During the hearing, the 9 expert reviewers listened intently and asked many astute questions. This panel will now spend a few months assessing all information submitted before and during the hearing to determine whether the existing guidelines should be maintained, modified or entirely rewritten. The panel expects to complete its review by the end of the year.
Although I’m optimistic that anyone listening to all eight hours of testimony will see the urgent need to rewrite the guidelines in a major way, I worry that the officers and lawyers running this commercially-driven medical society may water down the conclusions to protect the society from lawsuits. All of the panel’s conclusions could be reversed if the IDSA officers assign a biased team of writers to execute the recommendations.
Three days after the hearing, my worst fears were realized when the IDSA President, Anne Gerson, M.D., said this, as if the hearing never happened:
“The physicians and scientists who wrote the Infectious Disease Society of America’s (ISDA) guidelines thoroughly reviewed all the medical evidence and took great care to address the claims made by the small minority of physicians who advocate long-term antibiotic use.”
“The notion that the authors had financial conflicts of interest is absurd to anyone who has read the guidelines, which recommend generic tests and a short course of generic drugs.”
As the researcher for UNDER OUR SKIN who spent years uncovering the invisible conflicts of the 2006 IDSA guidelines authors, my conclusion is that the battle over these guidelines is not over conflicts surrounding the cure – a prompt course of off-patent antibiotics. (A curative dose of doxycycline or amoxicillin can be purchased at Walmart for $4.)
This conflict is all about a small group of academic researchers controlling every aspect of a disease for profit. They ignored or creatively interpreted new scientific data to protect their lucrative revenue streams from vaccine trials, arthritis/lupus/fibromyalgia clinical trials and government grants.
My impressions of the hearing and hopes for a happy ending were summed up nicely by Lorraine Johnson, the champion of the Lyme patients who organized much of the ILADS evidence:
“This hearing shows that the weight of the science falls on the side of providing patients with treatment options. The speakers supporting the 2006 guidelines relied heavily on conjecture, belief and reputation, advancing an unsubstantiated somatic disorder hypothesis for possible explanations of why patients remain ill. Hypothesis, conjecture and beliefs are not science and hopefully this panel will recognize that and gut these guidelines.”
And here is my favorite quote of the day, which came from Dr. Ken Liegner, a Lyme-literate physician from Armonk, New York:
“This is a formidable pathogen. We should be humble before this disease.”
Finally, on a possibly hopeful note, the IDSA just requested from Open Eye Pictures nine copies of UNDER OUR SKIN which will be given to each of the panelists. In addition, we offered to screen the film and speak with it at the October IDSA conference in Philadelphia. Though we’re skeptical this will happen, we’re happy and humbled that the film is proving its potential to affect policy and people’s lives.
You can view video footage of the hearing and download hearing presentations by clicking here.
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Tribeca Film Festival promotes UOS panel with Amy Tan
Amy Tan and Andy Abrahams Wilson at Tribeca Film Festival
Last year, when UNDER OUR SKIN had its world premiere (and was an Audience Award finalist) at the Tribeca Film Festival, it was one of three films selected to include a special “Behind the Screens” panel discussion. Bestselling author Amy Tan joined the panel (which also included filmmaker Andy Abrahams Wilson, Chief Science and Health Correspondent for NBC News, Robert Bazell, and LLMD Richard Horowitz, MD). Read the Tribeca press blog and watch the panel discussion in its entirety.
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Good Morning America revisits Lyme: The difference a year makes
We were disappointed that yesterday’s Good Morning America “Lyme rage” segment didn’t include footage from or mention of UNDER OUR SKIN in its report, despite what the producer had told us. But it was interesting (and auspicious) to watch GMA’s Dr. Marie Savard’s evolution in her thinking. Just last year, in GMA’s report about our movie, this same doctor dismissed Lyme as something that could be cured with “a single dose of antibiotics.” Now she talks about her own serious battle with it! Suddenly, it seems, the cat’s out of the bag, and many people are telling us that UNDER OUR SKIN has been instrumental in making this happen.
Compare last year’s GMA Lyme story and yesterday’s story.
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