Tuesday, July 17, 2012

3 NOTES: House Subcommittee Hearing On Lyme Disease

Here are some very rough notes from today's hearing on Lyme disease in Washington, DC. Please be aware that notes on about 5 minutes of testimony are missing towards the end of the day's hearing. If the webcast is archived, viewers may wish to refer to it to make their own notes.

House Committee on Foreign Affairs, Subcommittee on Africa, Global Health, & Human Rights hearing

2PM EDT
Tuesday, July 17, 2012
2172 Rayburn HOB
Washington, DC, USA

"Global Challenges in Diagnosing and Managing Lyme Disease - Closing Knowledge Gaps"

OPENING REMARKS

CHRIS SMITH - CHAIR - NJ Rep

We have a missed decade on Lyme disease research
Chris mentions chronic Lyme disease controversy
Mentions bill to establish tickborne disease committee and take fresh look at all the scientific approaches to Lyme disease
Mentions some history about Lyme disease including Borreliosis in Europe and discovery in Lyme, CT
2010 - 20,000 cases reported, but actual number of maybe 300,000 cases in US in 2010
North America Borrelia burgdorferi s.s.
Different species = different manifestations of disease
Clinical manifestations come in three stages
Mentions two distinct views of Lyme and research conflicting
Hard to catch, easy to cure vs. easy to catch, hard to cure
IDSA states short course of abx ok - anything else is risky
ILADS says the science is unsettled
One or more cause of chronic Lyme disease symptoms is possible, including persistent infection
Persistent symptoms could be due to a combination of persistent infection and immune problems

Three areas we need to took at:
1) diagnostics
2) post treatment symptoms
3) available treatments in light of science

CDC: 2 tier serological testing, but should be used for surveillance not diagnosis -unfortunately it is used for diagnosis by some doctors instead of clinical diagnosis
Europe: 8 immunoblots were shown to have a wide range of sensitivity and specificity
Bolen/NIAID: Lyme multistage disease is difficult to diagnose at any stage
Dr. Eshoo: Has exciting info on new diagnostic tools

Persistence: IDSA says Lyme disease cannot be persistent
Chris Smith says there is plenty of evidence that it can persist past antibiotic treatment
Mentions Barthold's studies and persistence in animal model studies
Mentions possible mechanisms of persistence studies: morphological changes (cell wall deficient, biofilms, etc)

Counterargument by IDSA: there are no convincing arguments that post treatment persistent Lyme disease infection is possible.
Chronic Lyme disease is a misnomer according to IDSA.
IDSA treatment guidelines should be based on best science - Smith argues they don't take into consideration possibility of persistent infection and deny patients needed treatment.

Chris Smith reports that the IDSA, NIH, and CDC were invited to the hearing today. The IDSA representative had scheduling conflict, and they were requested to testify at a very near future date before the subcommittee.

MS. BASS

Mentions the serious concern of missing early diagnosis
States few cases of LD in CA - MS. Bass says she thinks Lyme disease is under reported in CA especially in Central Valley
"Deer ticks" aptly named, as deer can carry 1000 ticks on their back on average.
But white footed mice are now known to be major carriers of the disease.
Other animals are now suspected including birds.
Need new solutions and explorations.
Changes in temperature, weather, and precipitation and their role in spread of Lyme disease should be examined.
Improved detection of early disease is contributing to higher reported numbers to some degree.
Local health departments are increasing awareness in spring and summer.
How can we improve awareness with limited budgets and resources?
Work with WHO to prioritize the disease esp in emerging areas such as Asia.

Rep. GIBSON

This is constituent driven. Major issue in upstate NY. (After he retired from army, so many people are suffering from LD and are confused and medical community is divided over its treatment. A Lyme disease task force would resolve this. Need more awareness about disease and diagnosis. Need to make sure money goes to right place. Money has gone into similar place before and the results were the same.

Most encouraging is research to be published in next year about role of confections in persistent symptoms.

WITNESS TESTIMONY

DR. STEPHEN BARTHOLD, UC DAVIS

Borrelia persists normally in immune competent host
i.e. mice rats hamsters gerbils guinea pigs dogs nonhuman primates
antibiotics are likely to fail under some circumstances if not many circumstances
finds self in contentious field - is somewhat of a pariah
we know in pre-immune stage animals can be cured
in immune stage, animals are not easily cured by antibiotics
Only a few places are really studying post antibiotic treatment Lyme - my group, Finland, NY, Louisiana... [?]
Ceftriaxone, Tigecycline, Amoxicllin, Zithromax: spirochetes are shown to survive these antibiotics in animal models
clonal population of Lyme disease spirochetes -> given antibiotic treatment -> results in non cultivable but living spirochetes
Transcribing RNA = metabolically alive spirochetes
exoplant -> carries infection from Bb infected animal to naive animal

Completed study, hope to publish it soon: 12 month post treatment resurgence of spirochetes found in mice.
what is significance of these spirochetes?
viruses can re-ignite and cause disease - question is: can spirochetes?
The answer is not known yet; something unique is going on with Bb and needs further study

DR. RAPHAEL STRICKER
San Francisco, CA - LLMD

speciality in internal medicine, ILADS Vice President
has 2,000 LD patients
number of patients has grown exponentially in past 15 yrs
patients all over the world Canada Brunei Costa Rica UK even NJ
reflects an increasing rate of LD around the world
Lyme disease is the most common TBD

patients develop muscle, joint, neurological, and cardiac symptoms
despite common disease, doctors are ignorant of how to diagnose and treat:
a bulls eye rash may be absent (50% not seen)
patient may be unaware of tick bite (some bitten by poppy seed size tick)
patients have a wide range of symptoms - doctors are often unaware of this wide range

testing remains problematic (not standardized and insensitive)
treatment has evolved in haphazard fashion (IDSA guidelines only address acute infection; standard guidelines ignore more chronic and severe form)
LD has become international medical disaster
thousands of patients suffer from undiagnosed and untreated Lyme disease
and even though it is all over media
the IDSA sits by and does nothing

State of California is grateful to state health board for forming a state Lyme disease advisory board
for requiring mandatory laboratory reporting of Lyme disease to Department of Health just like system for reporting STIs
California has a physician protection law which allows doctors to treat Lyme disease patients as they deem appropriate
Stricker thinks a model for a Lyme disease national advisory board could stem from CA state model

We need CDC and NIH to abandon failed Lyme disease research programs
need them to have targeted research for better tests just as they did for AIDS
need to have more research on treatment of chronic Lyme disease
need to get them to look at evidence and discard dogma about what chronic Lyme disease is
we need for them to listen to patients and how they are affected

Almost 2 decades ago Dr. Joe Burrascano testified before the Senate. He said, "The very existence of 100s of LD support groups, etc underscores many problems which exist in real world of LD." Two decades later and it's the same story.

DR. MARK ESHOO
IBIS Biosciences, Abbott Labs

Need to develop better diagnostic tests
number cases steadily increasing
Lyme disease is severely under reported
Babesiosis is also important
Babesiosis can be mistaken for malaria (Babesia looks similar to malaria under the microscope, too)
Other TBDs are also present

Lyme spread by ticks to mice, and then ticks infect more mice
mice become chronically infected with Lyme disease
bacteria evolved to evade immune system, especially immune privileged sites (e.g. skin, joints)
humans can have long lasting or chronic infection
those infected develop neurological and joint problems
best time to treat is early in infection
most typical early symptoms are bulls eye rash, flu-like, fatigue, aches

CDC 2 tier test - involves indirect detection of antibodies; has 3 problems:
1) can take Lyme patient more than 3 wks for immune system to detect infection
2) interpretation of 2 tier tests can be subjective and change outcome
3) even after treatment, patient can remain positive… controversy over how long to treat patient (weeks? months? years?)

Abbott Labs is looking directly at presence of DNA of pathogens
Sensitive direct assay of organism is historically very difficult because spirochetes are present in small numbers
Abbott made an assay with 8 independent tests to detect the presence of bacteria in blood
they use large volume of blood
and find way to amplify the presence of small numbers of bacteria (bacterial DNA) in blood

Eshoo et al did a study which could find organism very early in infection in doctor's office (refer to abstract) in 62% of patients

Another area of research Eshoo is working on:
variations of strains may determine type and severity of disease
need to study 100 different strains of Bb and what makes them different in terms of impact of disease

We need more government research and funding
- sensitive test for direct detection early in infection before dissemination (monitor responses to treatment
- find out cause of PTLDS. A direct diagnostic tool would be useful
- need to increase research into diff Borrelia strains differences and their role in human infection

PAT SMITH, LDA USA

LD called yuppie or housewife disease
patients have been referred to by some doctors as being paranoid, hysterical, hypochondriac, etc. without any evidence and without looking that something else could be wrong
many advocacy organizations in the world have been victimized in peer reviewed publications
Many patients confide they'd rather have cancer than Lyme disease due to the misunderstanding and controversy over the disease
Patients want studies which solve their dilemmas (such as doctors don't believe they're sick, answer the question "Why isn't the government doing anything?")
The outcome of small clinical trials/studies put a coffin the nail for treatment of chronic Lyme disease and for a number of reasons, these studies were inadequate.
The conclusion was that no treatment is effective for long term Lyme.

Lyme in the south - there are many myths. Myths that:
No lyme disease can be found in south or west
No reservoir hosts in the south
Deer ticks on lizards prevent Lyme disease in ticks all throughout the south
Deer ticks in south do not bite people (?!)
These claims are not scientifically backed.

Patients are overburdened with medical problems.
There are cutbacks in public health depts. so number of cases are unknown.
Pharmacists who won't fill prescriptions for Lyme disease patients in some places.
Munchausens by proxy charges are made toward mom's who treat kids with Lyme disease with long term antibiotics.

Guidelines that are written by researchers and not clinicians are problematic
IDSA is against any sort of treatment for CLD - either antibiotics, alternative treatment, or the use of supplements
CDC surveillance criteria for Lyme disease has formed basis of IDSA guidelines and this is problematic
patients can die of Lyme disease: study of 114 patients who had Lyme disease who died. After they died, most terminal events for which LD was known as the underlying cause have listed on their death certificate a reported cause of death which researchers stated were thought to be unrelated to Lyme disease. Only one patient was said to have died of complications of Lyme disease directly. Question that.

Has seen recorded 22 point IQ drop in kids with Lyme disease due to infection affecting brain
kids have killed themselves due to Lyme disease - due to pain and due to disbelief by peers and others of their having the disease

Pat Smith has had 2 daughters affected by Lyme disease

CDC, NIH, IDSA were absent at hearing and she thinks they are avoiding responsibility when they were invited to be part of the process to help patients.

EVAN WHITE, NYC
Patient - Had Chronic Lyme Disease

(wife just had baby, he is on SKYPE  - his life is now normal being part of point of his testimony)

20 yr advocate borne out of very tragic case of his own Lyme disease due to being given limited antibiotic treatment
at end he is now well because of conscientious doctors
today is father and practicing attorney and employer.

he says his case is an illustration: if not for long term treatment, none of this would be possible

so many people do not have benefits he had
if they had access to treatment, they would be contributing members of society
his story has happy ending
he is fighting for fellow Lyme patients to have same access to treatment
he is advocating for change in limited guidelines

his case study is that short term treatment did not work
long term treatment helped him recovered
he was ill at 11 yrs old
missed school due to flu-like symptoms
doctor did diagnose Lyme disease and he was given 1-2 wks of antibiotics
after 2 weeks he did not get better
the response to not recovering after 2 wks was that PT and psych therapy was needed after those 2 weeks
daily his condition deteriorated
he was a 12 yr old who trusted his doctor
but 6 months later so bad could not do anything
could not go to school, had trouble getting out of bed
blood test showed Lyme disease and confections were very much present months later

here is devastating result of un (or under treated) Lyme disease
6 months of no treatment sent him into tailspin
he vastly deteriorated, went from active athletic child to one who couldn't care for himself
had muscle atrophy, neurological problems
60 lbs at age 13, called a vegetable, and doctors were confused by his state
doctors put him in children's rehabilitation care
did brain scan
it revealed Lyme disease's affect in its passing the BBB: hypoperfusion
he had trouble reading and talking
and was surrounded by doctors who had no idea why he was in condition he was in
2 yrs bounced from hospital to hospital
6 months in children's hospital

went home and parents arranged for appt with LLMD
the LLMD "got it" and had their own personal experience with the disease - not just treating other patients
he had long road ahead for recovery but this was his turning point
he was on long term antibiotics coupled with supplements
2 year crawl to get out of that place
even if it were 10 yr crawl that would have been ok with him
stopped using wheelchair
got out of bed
began to take care of self
began to read again
began to be able to communicate again
got him on trajectory to become person he is today and fully recovered

hoping through this testimony that patients who are affected can get treatment they need to recover from chronic Lyme disease
the net effect of current guidelines restricting treatment deprives so many if not all from having health care option to seek long care treatment that does work for many patients so that they can recover and live long healthy lives

Rep. SMITH

intro Stella in UK

STELLA HUYSHE-SHIRES
Lyme Disease Action (UK)

UK doctors not taking patients seriously
Department of Health accreditation of Lyme Disease Action, Lyme Disease Action is now considered an unbiased source of information on Lyme disease in the UK
papers say Lyme Disease is overdiagnosed
public say it is underdiagnosed
what is the evidence?
we don't know incidence of Lyme disease in the UK
One GP practice finds it 20x greater than numbers which are reported
1300 cases found in one year may mean there are really more like 26,000 cases in UK

survey:
23% patients found ot have Lyme disease but the rest with similar symptoms were diagnosed with CFS
there is concern CFS patients are misdiagnosed and have Lyme disease
on the flip side maybe
100 people year in clinics in UK may be misdiagnosed with Lyme disease
But in a CFS clinic - 40% patients were misdiagnosed with CFS

Why is LD difficult to diagnose and what can be done about it?
we need unequivocal tests and clear guidelines
none exist in UK
most doctors haven't seen Lyme enough and rely on blood tests for diagnosis in UK

unreliable info on internet, certain labs, etc only part of story even if there is an element of truth in it
European challenge of more than one strain of Bb adds to complexity of test issue
Scotland uses more bands in its lab than other locations - leading to different line drawn for positive test results and access to treatment

Most treatment recommendations based on opinion not evidence
need other stakeholders to investigate Lyme disease
Lyme Disease Action (UK) is working with James Lind Alliance to engage doctors in more awareness of LD in patients and in general

The biggest challenge globally is recognition of unknowns in Lyme Disease
All across Europe there is a polarization of opinions along IDSA/ILADS poles
and there may be reluctance to climb out of one's entrenched view of Lyme disease

In Northern Europe doctors rely heavy on test results - similar issues found there.
In Central Europe, doctors have more experience: Lyme is a big problem, doctors say the tests are not good enough; doctors say they don't know how to effectively treat all patients.

Politics are a problem.
Uncertainty of the science is a problem.
Politics prevents recognition of the uncertainties.

QUESTION AND ANSWER SESSION (Rep Smith/Rep Gibson ask questions)

HUYSHE-SHIRES

A: HPA guidelines come from IDSA
Worse thing when patients are told symptoms are in their head
IDSA only recognizes visible arthritis then patient may get further tx
HPA does follow IDSA guidelines
indiv doctors sometimes make indiv clinical decision
case studies London school of hygiene (4-5 yr period) - some patients did not recover after initial course of abx, then some not after second, then some had a third. Between each treatment, patients were believed and found rising antibody levels.
Doctors will say adequate tx occurred, but it's adequate in terms of meeting guidelines but not in terms of effectively treating patient

BARTHOLD

Q: Are proposals being rejected for research at NIH?

A: Peer review is an issue. Peers are divided just are anyone else in Ld community
have direct exp in prejudicial statements in grant application reviews - peer view of applications does not get over the barrier
NIH is struggling to fund investigators
young people are not entering science, old people are leaving
in that environment combination of things - anything controversial having difficulty being funded
made NIH call for application on research on persistence after antibiotic treatment
only suggestion is his
we scientists are always looking for money. Follow the money.
NIH invests in biodefense then people gravitate towards biodefense research.

STRICKER

Q: Rep.brings up conflicts of interest and suppression of data in IDSA guidelines review.

A: IDSA hearing was organized by IDSA and no treating physicians were on the committee
Even though guidelines were flawed they were ruled acceptable.
Stricker encouraged by Dr Eshoo's research and development of advanced early testing.

["To date no antibiotic treatment treats biofilms." - attribution?]

Q: Rep comments to Barthold: issue of "mopping up" after antibiotics
host immune system must mop up remaining spirochetes... Explain.

BARTHOLD

A: using biofilm analogy: there is a population of microorganisms, some of which are dormant
dormant non-dividing bacteria are universally tolerant of antibiotics and are not dividing or active metabolically
Borrelia: we know it is dividing and disseminating and susceptible to antibiotics early on but during the immune phase in animals there is a 10 fold reduction in population (not necessarily in biofilms) and what is found are non-dividing spirochetes; they are dormant and antibiotics are not touching them
What is unique is they grow out but they cannot be cultured - they may be attenuated.


STRICKER

A: Borrelia has molecular machinery to make biofilms according to Dr. Stricker.
Stricker states cell wall deficient form evades antibiotics and it needs to be researched more.

Q: Rep. Asks Dr. Eshoo: How close are you to coming up w new test and why is Big Pharma not getting further involved?

ESHOO

A: It's a small market according to BP and takes lots of money and time to invest.
Lot of people in medical community say current test is good enough.

Eshoo thinks sensitivity needs to be improved and tests need to be improved to end the controversy.

Who wants to be infected for 3 weeks or more untreated waiting for a positive blood test? Nobody.

Rep. Q to Stricker:

Are there people outside the IDSA guidelines panel who notice there's a problem [with testing]?
Does Dr. Francis Collins (NIH director) say "What is wrong here? Why is this a persistent bone of contention?"

STRICKER

A: Blumenthal investigation found there are 14 people in the IDSA who control guidelines, testing, and diagnostic guidelines of Lyme Disease. The rest of the IDSA (8,000 people) defer to this group.

PAT SMITH, Lyme Disease Association

LDA has Scientific and professional review board
It is voluntary board
If issues need to be addressed or LDA is considering funding research, the board is asked to comment on it using their expertise
CALDA, LRA, etc also rely on this board

STRICKER

Q: Rep. [?]: you have 2,000 patients. What is your takeaway from this huge patient number and how are they when they find you?

A: Number of patients exceeds CDC reporting. That's one thing it tells me. Number of those affected may be 10 fold higher.
Many come after yrs of misdiagnosis and no treatment.
70% of patients get better. He finds this gratifying and he turns a deaf ear to the controversy because of outcome.
Uses long term antibiotic treatment.
Published study last year on neurological patients needing 6-12 months of antibiotic treatment to improve.

[5-6 minutes of testimony notes missing]


COMMENTS NEAR END

8.75 million dollar research fund Chris Smith says has been put forward. Chronic Lyme is supposed to be included in this research. How should the wording for the law be improved and how can there be better oversight to get money to the right place?

Barthold said: Follow the money.
If you enlarge the pot and spend it on research that's already been done, we get nowhere.
If we and NIH recognize persistence after treatment as an issue, then new research would be done on this issue.
A more narrowly focused call for applications would help if NIH would agree with that - research on chronic symptoms and the biology/pathology of the organism.

Dr. Eshoo said the field needs support to get off the ground and that RFAs must be specifically targeted toward solving narrowly defined problems.

PAT Smith has concern research money goes to post Lyme disease syndrome and not chronic Lyme disease - which is a different condition.
Patient perspectives on issues of the disease is important and knowing how it's affecting them is important.
Advocates, treating physicians, and patients need to be involved in the process of determining what needs to be researched.

Q: Rep. Gibson: How do you expand Lyme literacy among old and new doctors?

STRICKER

A: ILADS has preceptorship program. Can learn about diagnosis and treatment of Lyme disease. Program is funded privately. Mentor doctors who want to get involved sign up.

Stricker has trouble finding physicians willing to get involved due to controversy. This has had a chilling effect on mentorship.


Q: Rep Gibson: is that because state med board may censor them?

A: Yes. Though state has protection law, the risk censoring by board and other doctors may still go on.

Has 27 studies in table in written testimony (table 2) showing persistence in humans after IDSA guidelines-based treatment.

BARTHOLD

We need to know what is happening in humans but animals allow us to extrapolate models. Many people are using animals but looking only at acute early phase of infection. Not many people are looking at chronic persistent infection in animals. Fewer than five labs worldwide are studying this but it is the most important aspect of the disease.

HUYSHE-SHIRES

Borrelia has been isolated in patients after initial treatment - there are some cases recorded in published papers.
Some people improve after longer treatment
We need more investigation to determine how to better diagnose and treat Lyme disease

IDSA guidelines are accepted in the UK
Summary of recommendations for treatment by European Federation of Neurology Specialists (organization name needs fact checking) - make the point that in neurological Lyme there are no good trials of more than 28 days antibiotic treatment for neuroborreliosis.
They base this on opinion because there is no trial in Europe for longer term treatment of neuroborreliosis.

There are some trials which show good recovery, but at most 60-70% patients experience a good response. A patient does not consider 7 of 10 people responding to treatment as being a rate that is excellent.

PAT SMITH

Children are most affected by Lyme. They have more complications and are greatly impacted by their peers and teachers and what they are saying about them.

It is appalling what comments are being made about students who are ill with Lyme who cannot make it to school because they are too sick. No one wants to stay at home with their mother from school for four years.

One problem is inadequate early antibiotic treatment may lead to a poor antibody response and negative tests, which then put child at further risk for being disbelieved for having Lyme disease.

Some family services will take kids away from parents if those parents treat one child with antibiotics for chronic Lyme disease. This is serious and kids are psychologically damaged by the disease as well as the response from society and their community towards their illness.

We have the knowledge and tools in this country to stop this.

HUYSHE-SHIRES

1-3 people in UK are believed to have expertise on Lyme in UK, and those 1-3 apply IDSA guidelines and support them
NHS did not make any needed changes to their guidelines even though they should be made to suit the UK patient population

ETHAN WHITE

If sick, seek out people who will lead you to knowledgeable doctors who will offer treatment for Lyme disease.

SOME CLOSING COMMENTS

Barthold thinks people on both sides are good people, and he thinks we need to move past contentiousness and work together to help those affected by Lyme disease.

We need to work to get out of entrenched positions and get to the bottom of what's happening using science.

It's time for people to get together and show their cards and be willing to act in the best interest of patients and work past this contentiousness.



Comments:

Will be adding links relevant to this testimony soon.

If anyone who gave testimony at the hearing reads these notes and sees a correction that needs to be made, please request correction in comments and I will revise this post.

UPDATE - July 17:

Original testimonies are now available for download including additional materials from each of the witnesses. Scroll down this page for pdf files: http://foreignaffairs.house.gov/hearings/view/?1455

UPDATE - July 19:

Ustream has two streaming video archives of the hearing available at the following links:

http://www.ustream.tv/recorded/24058724

http://www.ustream.tv/recorded/24060689


3 comments:

  1. Thank you for taking the time to write this up.

    ReplyDelete
  2. Brilliant write up of the Hearing many thanks Camp

    ReplyDelete
  3. The testimonies can now be viewed through the original link

    ReplyDelete

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