Baker, Phil
Former NIH Lyme disease employee
Dr. Phillip Baker is now the
Executive Director of ALDF
Dr. Phillip Baker, Ph.D. has recently been named as Executive Director of the ALDF by a unanimous vote of the Board of Directors. "We are thrilled to have Dr. Baker bring his vast expertise and leadership to our organization," says Jeffery Black, acting Chair. Dr. Baker has more than 30 years experience as a research scientist for the National Institutes of Health and 10 years as the Program Officer for the Lyme disease research grants awarded to academic and medical research institutions by NIH. Dr. Baker is truly a scientific expert and knowledgeable of the facts about Lyme disease.
"At a time when misinformation is rampant, I am proud to continue to serve the interest of public health by heading the American Lyme Disease Foundation," states Dr. Baker. In his first official role as Executive Director, Dr. Baker has published a paper in the July issue of The American Journal of Medicine, rebutting the unsubstantiated claims of "chronic Lyme" among a small but vocal group of activists who challenge the results of mainstream medical research. con't.
Phillip Baker Quotes
"On the other side of the issue, Phillip J. Baker, executive director of the American Lyme Disease Foundation, said he was pleased by the outcome.
"I have always felt, and so did many of my colleagues, that the guidelines are based on firm and established evidence," Baker said.
Baker has sympathy for people suffering from the pain and fatigue associated with chronic Lyme disease.
"These people are suffering from something and no doubt they need proper medical care," he said. "But they are not suffering from a persistent infection that can be treated by long-term antibiotic therapy. They have something serious that needs to be treated, but it's not due to Lyme disease."
Full article HERE
National Institute of Allergy and
Infectious Diseases (NIAID)
FOR IMMEDIATE RELEASE
Friday, June 28, 1996
Media Contact:
John Bowersox
(301) 402-1663
NIAID Awards Contract for Post-Lyme Disease Syndrome Studies
The National Institute of Allergy and Infectious Diseases (NIAID) has awarded a five-year contract to the New England Medical Center (NEMC) in Boston, Mass., to study the pathogenesis and treatment of post-Lyme disease syndrome (PLDS). Mark Klempner, M.D., is the principal investigator of the $4.2 million study.
"This research will help us answer important questions regarding the nature of Lyme disease sequelae and the most effective treatment for individuals affected by this syndrome," saysNIAID Director Anthony S. Fauci, M.D.
Lyme disease is caused by infection with the tick-borne spirochete Borrelia burgdorferi. Since 1982, when the organism was first identified by NIAID scientists, more than 50,000 cases of Lyme disease have been reported in the United States. Patients usually are treated successfully in the early stages of the disease with a two- to four-week course of oral antibiotics. Additional treatment with intravenous antibiotics may be required in some cases. Several months after patients with the initial symptoms of Lyme disease have been treated, some of them develop PLDS, a condition also known as chronic Lyme disease and characterized by persistent musculoskeletal and peripheral nerve pain, fatigue and memory impairment.
"There is much uncertainty about the pathogenesis of PLDS. We don't know if it is caused by ongoing active infection withB. burgdorferi or another tick-borne pathogen, or if PLDS symptoms result from reinfection," says John R. La Montagne, Ph.D., director of NIAID's Division of Microbiology and Infectious Diseases. "Inflammatory or autoimmune responses occurring during early infection, prior to treatment with antibiotics, may also play a role in PLDS. We also have a lot to learn about its clinical manifestations. This contract will allow us to define this syndrome more precisely and develop rational strategies for treating it."
As contractor, NEMC researchers will work closely with NIAID staff, and collaborate with scientists at New York Medical College, the University of Minnesota School of Medicine, and Tufts University School of Medicine. Studies on the cause or causes of PLDS and the evaluation of potential therapies for patients with PLDS are planned. Treatment success will be measured with a variety of tests that assess symptoms, signs and laboratory manifestations of PLDS.
This contract award to NEMC follows a rigorous objective review process, during which all proposals received under an NIAID solicitation were evaluated and scored by non-government Lyme disease experts. The new study further expands NIAID's growing portfolio of Lyme disease research projects. NIAID currently supports a variety of investigator-initiated studies of the pathogenesis, diagnosis and treatment of Lyme disease. In addition, intramural scientists from NIAID and other institutes at the National Institutes of Health (NIH) are collaborating on Lyme disease studies.
According to NIAID's Phillip Baker, Ph.D., the project officer for the study, the NEMC researchers will work closely with NIH intramural investigators.
"Although these new studies will not supply all the answers with regard to the etiology and treatment of PLDS," says Dr. Baker, "they should provide meaningful information that can help us move toward the development of effective solutions to this problem."
NIAID, a component of the NIH, conducts and supports research to prevent, diagnose and treat illnesses such as AIDS and other sexually transmitted diseases, tuberculosis, asthma and allergies. NIH is an agency of the U.S. Public Health Service, U.S. Department of Health and Human Services.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site atwww.niaid.nih.gov.
The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
The FASEB Journal
Published online before print July 14, 2010 as doi: 10.1096/fj.10-167247.
http://www.fasebj.org/cgi/content/abstract/fj.10-167247v1
The FASEB Journal • Life Sciences Forum July 14, 2010
Chronic Lyme disease: in defense of the scientific enterprise
Phillip J. Baker
American Lyme Disease Foundation, Lyme, Connecticut, USA
Chronic Lyme disease: in defense of the scientific enterprise
Phillip J. Baker
E-mail contact: executivedir@aldf.com
There is no better example of a relentless attack on evidence-based biomedical research and the integrity of outstanding scientists than that associated with the treatment of a poorly defined condition called "chronic Lyme disease." Here, a scientifically naive general population, the lay press, and legislators, who in most instances are unable to evaluate and judge scientific evidence properly, have been misled by patient advocate groups to believe that extended antibiotic therapy is the best and only solution to this condition. This has resulted in the unprecedented intrusion of government and the legal systems into the practice of medicine and scientific research. Because there is no clinical evidence that this condition is due to a persistent infection, advocating extended antibiotic therapy is not justified and has been shown to be harmful and of no benefit.—Baker, P. J. Chronic Lyme disease: in defense of the scientific enterprise.
Full article:
http://www.fasebj.org/cgi/content/abstract/fj.10-167247v1
The FASEB Journal • Life Sciences Forum
Chronic Lyme disease: in defense of the scientific
enterprise
Phillip J. Baker- American Lyme Disease Foundation, Lyme, Connecticut, USA
ABSTRACT There is no better example of a relent-
less attack on evidence-based biomedical research and
the integrity of outstanding scientists than that associ-
ated with the treatment of a poorly defined condition
called “chronic Lyme disease.” Here, a scientifically
naive general population, the lay press, and legislators,
who in most instances are unable to evaluate and judge
scientific evidence properly, have been misled by pa-
tient advocate groups to believe that extended antibi-
otic therapy is the best and only solution to this
condition.
This has resulted in the unprecedented
intrusion of government and the legal systems into the
practice of medicine and scientific research. Because
there is no clinical evidence that this condition is due to
a persistent infection, advocating extended antibiotic
therapy is not justified and has been shown to be
harmful and of no benefit.—Baker, P. J. Chronic Lyme
disease: in defense of the scientific enterprise. FASEB J.
24, 000 – 000 (2010). www.fasebj.org
Key Words: evidence-based research antibiotic therapy
The peer review system of grants sponsored by the
National Institutes of Health (NIH), which supports
90% of all biomedical research in the United States,
is emulated throughout the world. It is responsible for
most of the many advances made in medicine and
biomedical research. Obtaining an NIH grant is an
extremely competitive process in which 20% of appli-
cations submitted are funded. Publishing the results of
NIH-sponsored research is likewise a demanding pro-
cess; manuscripts considered for publication must pass
the test of rigorous peer review. Investigators whose
work survives such scrutiny are rightly considered to be
among the very best the scientific community has to
offer.
Many are not only members, but also officers in
prestigious organizations such as The American Academy
of Sciences, The Institute of Medicine, The American
Society for Microbiology, The Federation of American
Societies for Experimental Biology, The American Asso-
ciation for the Advancement of Science, and the Infec-
tious Diseases Society of America (IDSA), to name but a
few. Since many of these outstanding and internationally
known investigators have documented achievements in
basic and/or clinical research on Lyme disease, they often
are invited to serve on NIH Study Sections, as well as Lyme
disease advisory panels; indeed, they represent a national
resource of reliable information for community physi-
cians, research investigators, and the public at large on
Lyme disease.
Despite the numerous achievements of this ex-
tremely rigorous and demanding enterprise, contro-
versy and misinformation abound concerning a poorly
defined condition called “chronic Lyme disease” (1).
This has caused some to question wrongfully the
integrity of many outstanding research scientists, as
well as the institutions to which they belong. During
a past session of the Maryland House of Delegates,
legislation was proposed that would have compelled
health insurance companies to pay for extended
antibiotic therapy for the treatment of chronic Lyme
disease, and prohibited local medical boards and/or
societies from disciplining physicians who administer
such therapy.
Similar legislation has been proposed
in other states (Pennsylvania, Connecticut, Massa-
chus et t s , Mi nnes ot a, New Hamps hi re, Vermont ,
Maine, and New York) where Lyme disease is en-
demic. These unwarranted legislative interventions
into the practice of medicine are unprecedented and
part of a well-organized campaign by Lyme disease
activists who, contrary to all published scientific
evidence, propagate the unproven view that chronic
Lyme disease is the result of a persistent infection
that requires long-term antibiotic therapy to cure.
Such legislation was proposed despite the facts that
there is no clinical evidence to support either of
t hes e c l ai ms ; t he publ i s hed r es ul t s of 4 NI H-
supported placebo-controlled clinical trials indicate
that extended antibiotic therapy is neither beneficial
nor safe (2– 4); and several peer-reviewed publica-
tions from Lyme disease referral centers indicate that
“most patients unresponsive to conventional antibi-
otic therapy never had Lyme disease, do not have it,
or were cured of their Borrelia burgdorferi infection”
(5).
Some practitioners accept undocumented testi-
monials from patients, whose condition is claimed to
have been improved after extended antibiotic ther-
apy. However, one should be skeptical of such iso-
lated reports, since the results of a rather large
placebo-controlled clinical trial on the efficacy of
extended antibiotic therapy for the treatment of
chronic Lyme disease showed a placebo effect as high
as 39% (2). Also, it has been shown that several
-lactam antibiotics used to treat Lyme disease, in-
cluding ceftriaxone, which is often used to treat
chronic Lyme disease, have profound neuroprotec-
tive properties that can ameliorate neurological
symptoms (6, 7); such a pharmacological effect,
rather than the elimination of a presumed persisting
infection, might account for the short-lived benefi-
cial effects sometimes seen.
At the behest of Lyme disease activists, an antitrust
investigation was launched against the IDSA for its failure
to cite, in its guidelines on the treatment of Lyme disease
(8), nonexistent evidence that chronic Lyme disease is
due to a persistent infection that requires extended
antibiotic therapy to cure. This unprecedented action,
which was resoundly condemned by distinguished attor-
neys and members of the medical profession (9),
prompted an extensive review of the published IDSA
guidelines by an independent review panel. That panel
issued a final report in which it unanimously approved all
of the recommendations made in the IDSA’s current
guidelines (10).
The review panel, which relied on 1000
published scientific papers in making its deliberations,
also affirmed that there is no published evidence to
indicate that extended antibiotic therapy is beneficial for
the treatment of chronic Lyme disease; there is “no
well-accepted definition of post-Lyme disease syndrome”;
and there is “no convincing biological evidence for the
existence of symptomatic chronic Borrelia burgdorferi infec-
tion among patients given recommended treatment reg-
imens for Lyme disease” (10).
It should be noted that the IDSA’s recommendations
for the treatment of Lyme disease are in agreement
with those of the European Federation of Neurological
Societies (11), the European Union of Concerted Ac-
tion on Lyme Borreliosis (12), the American Academy
of Neurology (13), the Canadian Public Health Net-
work (14), and the German Society for Hygiene and
Microbiology (15). They also are in agreement with
recommendations made by expert panels from 10
European countries, i.e., The Czech Republic, Den-
mark, Finland, France, The Netherlands, Norway, Po-
land, Slovenia, Sweden, and Switzerland. [An excellent
summary of these expert panel recommendations may
be found in the presentation by O’Connell in the
guidelines section posted on the American Lyme Dis-
ease Foundation (ALDF) website at http://www.aldf.
com.] None of these organizations or expert panels—as
well as the Centers for Disease Control (CDC) and the
NIH—recommends extended antibiotic therapy for
the treatment of chronic Lyme disease.
In contrast to the false and misleading information being propagated
on the Internet via Lyme disease patient support websites,
the IDSA guidelines (8), as well as websites sponsored
by the NIH (http://www.nih.gov), the CDC (http://
www.cdc.gov), and the ALDF (http://www.aldf.com),
are the best source of factual information extant on
Lyme disease for community physicians, medical prac-
titioners, and the general public.
Some Lyme disease activists continue to make the
astounding claim that this overwhelming consensus of
independent expert opinion is the result of conflicts of
interest and/or a vast conspiracy by a cabal to suppress
the truth. This is absurd, especially when such claims
are made by “Lyme-literate physicians” who profit im-
mensely from the prolonged treatment of chronic
Lyme disease. It should be noted that the composition
of the IDSA guideline review panel was approved by an
independent ethicist, who found no evidence of con-
flict of interest with respect to any member of the
review panel (10). Instead of casting doubts on the
reputation of distinguished scientists and the organiza-
tions to which they belong, those who disagree would
be well advised to do the following if they wish to gain
acceptance from the scientific and medical community
for their unproven views:
1) Develop a precise definition of what is meant by
“chronic Lyme disease” so that it can be distinguished
unequivocally from other medical conditions with sim-
ilar symptoms.
2) Provide direct and unequivocal evidence that a
patient suspected of having chronic Lyme disease really
has a persistent B. burgdorferi infection that justifies
antibiotic therapy.
3) Demonstrate, from the results of published, peer-
reviewed, randomized, placebo-controlled trials, that
extended antibiotic therapy is beneficial and safe for
the treatment of chronic Lyme disease.
The results of NIH-supported studies frankly ac-
knowledge that some patients with chronic Lyme dis-
ease experience significant pain and indeed have defi-
cits with respect to their physical health status (2).
Obviously, these patients require appropriate medical
attention and care. However, because there is no
evidence to indicate that their symptoms are caused by
a persistent Borrelia burgdorferi infection, antibiotic ther-
apy is neither a prudent nor a beneficial option. It is
time to discard this unproven approach and begin to
consider alternative causes and symptomatic treatment
options, if we truly wish to achieve common ground
and provide relief for these patients (16).
In this context, the results of a small pilot study indicated that
treatment with gabapentin alleviates the neurotropic
pain associated with chronic Lyme disease (17); since
the Food and Drug Administration has approved the
use of pregabalin (similar to gabapentin) for the treat-
ment of fibromyalgia, a condition with symptoms simi-
lar to those ascribed to chronic Lyme disease, this
approach requires further investigation. Other studies
indicate that psychiatric comorbidity and other psycho-
logical factors (e.g., the tendency to catastrophize pain)
distinguish chronic Lyme disease patients from those
with fibromyalgia and chronic fatigue syndrome and
were associated with poor functional outcomes (18). It
has been reported that antineural antibody activity is
significantly higher in patients with chronic Lyme dis-
ease than in post-Lyme disease healthy and normal
subjects; this exciting recent finding suggests the exis-
tence of a differential immune system response in
patients with chronic Lyme disease and offers new clues
about its etiopathogenesis that may be useful in devis-
ing novel and effective treatment strategies (19).
REFERENCES
1. Weissmann, G. (2007) “Chronic Lyme” disease and other med-
ically unexplained syndromes. FASEB J. 21, 299 –301
2. Klempner, M. S., Hu, L., Evans, J., Schmid, C. H., Johnson,
G. M., Trevino, R. P., Norton, D., Levy, L., Wall, D., Kosinski, M.,
and Weinstein, A. (2001) Two controlled trials of antibiotic
treatment in patients with persistent symptoms and a history of
Lyme disease. New Eng. J. Med. 345, 85–92
3. Krupp, L. B., Hyman, L. G., Grimson, R., Coyle, P. K., Melville,
P., Dattwyler, A. S., and Chandler, B. (2003) Study and treat-
ment of post Lyme disease (STOP-LD): a randomized double-
masked clinical trial. Neurology 60, 1923–1930
4. Fallon, B. A., Keilp, J. G., Corber, K. M., Petkova, E., Britton,
C. B., Dwyer, E., Slavov, I., Cheng, J., Dobkin, J., Nelson, D. R.,
and Sackheim, H. A. (2008) A randomized, placebo-controlled
trial of repeated IV antibiotic therapy for Lyme encephalopathy.
Neurology 70, 992–1003
5. Sigal, L. H. (2007) Misconceptions about Lyme disease: confu-
sions hiding behind ill-chosen terminology. Ann. Intern. Med.
120, S4 –S25
6. Domercq, M., and Matute, C. (2004) Neuroprotection by tetra-
cyclines. Trends Pharmacol. Sci. 25, 609 – 612
7. Rothstein, J. D., Patel, S., Regan, M. R., Haenggeli, C., Huang,
Y. H., Bergles, D. E., Jin, L., Dykes Hoberg, M., Vidensky, S.,
Cheng, D. S., Toan, S. V., Bruijn, L.I., Su, Z. Z., Gupta, P., and
Fisher, P. B. (2005) -lactam antibiotics offer neuroprotection
by increasing glutamate transporter expression. Nature 433,
73–77
8. Wormser, G. P., Dattwyler, R. J., Shapiro, E. D., Halperin, J. J.,
Steere, A. C., Klempner, M. S., Krause, P. J., Bakken, J. S., Strle,
F., Stanek, G., Bockenstedt, L., Fish, D., Dumler, J. S., and
Nadelman, R. B. (2006) 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. 43, 1089 –1134
9. Kraemer, J. D., and Gostlin, L. O. (2009) Science, politics, and
values. JAMA 301, 665– 667
10. Lantos, P. M., Charini, W. A., Medoff, G., Moro, M. H., Mushatt,
D. M., Parsonnet, J., Sanders, J. W., and Baker, C. J. (2010). Final
report of the Lyme disease review panel of the Infectious
Diseases Society of America. 51, 1–5
11. Mygland, A., Ljostad, U., Fingerle, V., Rupprecht, T.,
Schmutzhard, E., and Steiner, I. (2010) EFNS guidelines on the
diagnosis and management of European Lyme neuroborrelio-
sis. Euro. J. Neurol. 17, 8 –16
12. European Union concerted action on Lyme borreliosis. http://
meduni09.edis.at/eucalb/cms/index.php?langen
13. Halperin, J. J., Shapiro, E. D., Logigian, E., Belman, A. L.,
Dotevall, L., Wormser, G. P., Krupp, L., Gronseth, G., and Bever,
C. T. Jr. (2007) Practice parameter: treatment of nervous system
Lyme disease (as evidence-based review). Report of the Quality
Standards Subcommittee of the American Academy of Neurol-
ogy. Neurology 69, 91–102
14. Canadian Public Health Network, The laboratory diagnosis of
Lyme borreliosis: guidelines from the Canadian Public Health
Laboratory Network. (2007) Can. J. Infect. Dis. Med. Microbiol. 18,
145–148
15. Nau, R., Christen, H., and Effert, H. (2009) Lyme disease—
current state of knowledge. Dtsch. Arztebl. Int. 106, 72– 81
16. Baker, P. J. (2008) Perspectives on “chronic Lyme disease”.
Am. J. Med. 121, 562–564
17. Weissenbacher, G. P., Ring, J., and Hofman, H. (2005) Gabap-
entin for the symptomatic treatment of chronic neuropathic
pain in patients with late-stage Lyme borreliosis: a pilot study.
Dermatology 211, 123–127
18. Hassett, A., Radvanski, D. C., Buyske, S., Savage, S. V., Gara, M.,
Escobar, J. I., and Sigal, L. H. (2009) Role of psychiatric
comorbidity in chronic Lyme disease. Arthritis Rheum. 59, 1742–
1749
19. Chandra, A., Wormser, G. P., Klempner, M. S., Trevino, R. P.,
Crow, M. K., Latov, N., and Alaedini, A. (2010) Anti-neural
antibody reactivity in patients with a history of Lyme borreliosis
and persistent symptoms. Brain Behav. Immun. 24, 1018 –1024
Received for publication June 16, 2010.
Accepted for publication July 1, 2010.
3
DEFENSE OF SCIENCE
Department of Public Health Hearing
January 29, 2004
Public Hearing of the State of Connecticut, Department of Public Health, re: Lyme Disease. Held January 29, 2004 at 9:00 A.M. at the Legislative Office Building, 300 Capitol Avenue, Hartford, Connecticut.
Pg. 242- 255 Phil Baker's Testimony- currently Executive Director of the American Lyme Disease Foundation (ALDF).
ATTORNEY GENERAL BLUMENTHAL: Dr.
20 Baker?
21 DR. BAKER: Can you hear me?
1 ATTORNEY GENERAL BLUMENTHAL: yes.
2 DR. BAKER: Okay. Good afternoon.
3 I am Dr. Phillip Baker, the NI-- the Lyme Disease
4 Program Officer and the Anthrax Basic Research
5 Program Officer with the Division of Microbiology
6 and Infectious Diseases, National Institutes of
7 Allergy and Infectious Disease, NIAID, NIH, at the
8 Department of Health.
9 It is a pleasure for me to be here
10 today along with my colleagues from the CDC to tell
11 you what we are doing about Lyme Disease.
12 NIH has a long-standing commitment
13 to Lyme Disease that began more than 20 years when
14 the cause of the disease was not yet known. In
15 1981, NIAID-funded scientists identified Borrelia
16 Burgdorferi as a causative agent of Lyme Disease.
17 Since then, basic and clinical research efforts have
18 been expanded in scope to address a variety of
19 issues related to this disease. These activities
20 include both intramural and extramural research on
21 animal models, microbial physiology, molecular and
1 cellular mechanisms of pathogenesis, mechanisms of
2 protective immunity, vectors and disease
3 transmission, efficacy of different modes of
4 antibody therapy and the development of more
5 sensitive and reliable diagnostic tests for both
6 early, acute and late chronic Lyme Disease.
7 Other NIH institutes and centers
8 that conduct Lyme Disease research are the National
9 Institute on Aging, the National Institute of
10 Arthritis, Musculoskeletal and Skin Diseases, the
11 National Institute of Mental Health, the National
12 Institute of Neurological Disorders and Stroke, the
13 Fogerty International Center and the Center for
14 Research Resources.
15 I might also add that we have an
16 NIH Lyme Disease Advisory Panel that includes
17 representation from the CDC and we meet at least
18 once a year to discuss how we could work together to
19 accomplish our various goals related to research on
20 Lyme Disease.
21 Approximately 20 percent of
1 NIAID's extramural Lyme Disease grant portfolio is
2 devoted to the development of novel and more
3 sensitive diagnostic procedures. The NIAID also
4 regularly re-evaluates the effectiveness of
5 currently used diagnostic methods. In collaboration
6 with the CDC, the Institute plays a major role in
7 the development of new approaches for diagnosing for
8 Lyme Borrealiosis in the presence of co-infecting
9 agents, as well as in individuals who have been
10 immunized.
11 In addition, there is a strong
12 need to develop a procedure that will enable one to
13 distinguish those who are actively infected with B.
14 Burgdorferi from those who have either recovered
15 from a previous infection or have been immunized
16 with the Lymerex vaccine.
17 Since the genome of B. Burgdorferi
18 has now been completely sequenced, greater advances
19 are anticipated as this information is used both to
20 improve diagnosis and improve -- and provide greater
21 and newer insights on the pathogenesis of the
1 disease through the application of micro-array
2 technology and cardiometrics.
3 Co-infection looms as a major potential problem,
4 mainly because the ixodes ticks that transmit B.
5 Burgdorferi can carry and simultaneously transmit
6 other emerging pathogens, such as Ehrlichia species,
7 the causative agent of human granulocytic
8 Ehrlichiosis or HE, and Babesia Micro which causes
9 Babesiosis.
10 In Europe and Asia, ixodes ticks
11 are also known to transport tick-borne encephalitis
12 virus. Fortunately, this tick-borne viral infection
13 has not yet been reported in the U.S. Although,
14 co-infections with Powasson virus and deer-tick
15 virus have been reported.
16 Co-infection by some or all of
17 these infectious agents may interfere with the
18 clinical diagnosis of Lyme Borrealiosis and/or
19 adversely influence host defense mechanisms, thereby
20 altering landmark characteristics of the disease and
21 the severity of infection.
1 For example, studies conducted by
2 NIAID extramural researchers have shown that
3 co-infection with HGE increases the severity of Lyme
4 Borrealiosis.
5 The issue of co-infection and its
6 potential implications also has been examined in all
7 of NIH's clinically supported studies on Lyme
8 Disease.
9 Antibiotic therapy is another
10 aspect that we address. A clinical study on the
11 efficacy of antibiotic therapy for the treatment of
12 chronic Lyme Disease was completed in late 2000. It
13 was funded through a contract awarded through the
14 New England Medical Center in Boston. It involved
15 randomized, double-blind, placebo-controlled,
16 multi-center studies to examine the safety and
17 efficacy of Ceftriaxone and Doxycycline for the
18 treatment of patients with either sero-positive or
19 sero-negative chronic Lyme Disease.
20 The clinical protocols for these
21 studies which have been posted on the NIAID website
1 were developed through collaboration and extensive
2 discussions with Lyme Disease research experts, as
3 well as with NIAID Lyme Disease Advisory Panels
4 composed of patients with Lyme Disease, members of
5 patient advocacy groups, practicing physicians who
6 treat patients with Lyme Disease and basic research
7 scientists with experts in either infectious disease
8 or Lyme Disease.
9 This panel provided input on the
10 implementation of the protocols selected for the use
11 in the study, as well as on intramural clinical
12 studies that are also being done. In late 2001, the
13 Data Safety Monitoring Board, or DSMB, for the New
14 England Medical Center clinical trials conducted a
15 planned interim analysis of the data.
16 After its review, the DSMB
17 unanimously recommended that NIAID terminate the
18 treatment component of these studies. The
19 preliminary data analysis showed that after 90 days
20 of continuous antibiotic therapy, there were no
21 significant differences in the percentage of
1 patients who felt that their symptoms had improved,
2 worsened or stayed the same between the antibiotic
3 treatment and placebo groups in either trial. In
4 other words, we had an answer to a question we were
5 asking.
6 In addition, the DSMB further
7 recommended that the investigators continue to
8 follow the study patients to monitor their long-term
9 safety and to obtain additional information that
10 might have value in determining the underlying basis
11 of chronic Lyme Disease and in suggesting more
12 effective therapeutic approaches.
13 These extensive follow-up studies
14 are still in progress. No new therapeutic studies
15 are contemplated until these have been completed and
16 the results analyzed. The results of New England
17 Medical Center clinical trials were published in the
18 New England Journal of Medicine in the year 2001.
19 Both the intramural and extramural
20 studies mentioned above involve data collection as
21 well as the maintenance of specimen repositories.
1 Such specimens have been made available to other
2 investigators working on Lyme Disease and, thus,
3 have contributed significantly to the development of
4 improved and/or novel diagnostic procedures.
5 Animal models also have provided
6 considerable information on the transmission and
7 pathogenesis of Lyme Borreliosis as well as on the
8 mechanisms involved in the development of protective
9 immunity.
10 The NRAAID, in collaboration with
11 the National Institute for Neurological Diseases and
12 Stroke, has broadened these efforts to include
13 comprehensive studies on non-human, primate animal
14 models for experimental research on the neuro
15 pathology associated with chronic Lyme Borreliosis.
16 These studies will expand knowledge of those doctors
17 that contribute to the pathology associated with
18 persistent infection of the central nervous system
19 by B. Burgdorferi and ultimately will enable
20 researchers to devise more effective clinical
21 approaches for the treatment of chronic Lyme
1 Borreliosis in humans.
2 They also will supplement and
3 enhance the results of current clinical studies on
4 the efficacy of antibiotic therapies for the
5 treatment of chronic Lyme Disease and provided
6 precedence for use in the design of future clinical
7 studies.
8 Two pharmaceutical companies have
9 devoted considerable effort towards the development
10 of a vaccine for Lyme Disease. Double-blind,
11 randomized, placebo-controlled clinical trials
12 involving more than 10,000 volunteers in regions of
13 the U.S. where Lyme Disease is highly endemic were
14 conducted for each of two Borrelia Burgdorferi
15 recombinant outer surface lympho protein A or OSP-A
16 vaccines that were manufactured by Glaxo-Smith-Klein
17 and Pastor-Marieu-Konot.
18 These vaccines were found to be 49
19 to 68 percent effective in preventing Lyme Disease
20 after two injections and 68 to 92 percent effective
21 in preventing Lyme Disease after three injections.
1 The duration of their protective immunity generated
2 a response to the SKB vaccine which is called
3 Lymerex, which was licensed by the FDA in December
4 of 1998, is not known.
5 Although Lymerex was licensed for
6 use in individuals from 15 to 70 years of age, the
7 results of another study involving about 250
8 children from 15 to -- 5 to 15 years of age indicate
9 that Lymerex is well-tolerated and highly
10 immunogenic in children as well.
11 A larger pediatric study involving
12 more than 3,000 children from 4 to 14 years of age
13 showed that just two doses rather than the usual
14 three given to adults were enough to provide
15 protection. Only minor side effects were observed.
16 NIAID was not directly involved in
17 the design and implementation of these particular
18 vaccine trials. However, patents for cloning the
19 genes used for the expression of recombinant OSP-A,
20 as well as knowledge on the role of antibodies
21 against OSP-A and the development of protective
1 immunity, were derived from basic research grants
2 funded by the NIAID.
3 In April of 2003,
4 Glaxo-Smith-Klein announced that even with the
5 incidence of Lyme Disease on the increase, sales of
6 Lymerex declined from about 1.5 million doses in
7 1999 to a projected 10,000 doses in 2002.
8 Although studies conducted by the
9 FDA did not reveal that any reported adverse effects
10 were directly attributed to the vaccine,
11 Glaxo-Smith-Klein discontinued manufacturing the
12 vaccine for economic reasons.
13 The NIAID also is funding
14 pre-clinical studies on the development and testing
15 of other candidate vaccines. For example,
16 Decravining Protein A which is being produced by
17 MedImmune and Advanced Pharmaceuticals,
18 Incorporated. These companies reported that a
19 combination vaccine composed of Decravining Protein
20 A and OSP-A is far more effective than either one
21 given alone in preventing the development of Lyme
1 Disease in experimental animals.
2 On the basis of these encouraging
3 findings, both companies have entered into
4 agreements to develop a new, more effective
5 second-generation vaccine to prevent Lyme Disease in
6 humans.
7 In conclusion, as demonstrated
8 above, NIAID has a comprehensive Lyme Disease
9 research portfolio with the goal of advancing the
10 understanding of the disease and developing ways to
11 improve its diagnosis, treatment and prevention.
12 These efforts highlight several specific avenues of
13 investigation. Improving the ability to diagnose
14 Lyme Disease in the presence of the co-infecting
15 agents, evaluating the efficiency of antibiotic
16 treatment for Lyme Disease and assessing candidate
17 vaccines to replace the discontinued Lymerex
18 vaccine.
19 The NIAID is fully committed to
20 continuing to explore these and other
21 yet-undiscovered areas of research in the hope that
1 future research financed will provide important
2 clues to better understanding this painful disease.
3 Lyme Disease research will continue to be a priority
4 for the NIAID for the foreseeable future.
5 Thank you.
From Microbe magazine, July 2011.
The Film Under Our Skin and Lyme Disease
The film entitled Under Our Skin was produced in 2008 and premiered on 19 June 2009, at the IFC Center in New York. It depicts the plight of patients claimed to be suffering from a poorly defined condition called "chronic Lyme disease," and champions the unproven benefits of extended antibiotic therapy for its treatment. Since the guidelines for the diagnosis and treatment of Lyme disease, formulated by the Infectious Diseases Society of America (IDSA), neither recognize "chronic Lyme disease" as a distinct clinical entity nor advocate more than a short course of oral antibiotics for the treatment of Lyme disease, there is some public confusion surrounding this disease.
That confusion encouraged Richard Blumenthal, then Connecticut Attorney General (AG), to launch an antitrust investigation of the IDSA guidelines. This culminated in a detailed and extensive review of their validity by an independent panel approved by the AG. The independent review panel, which relied on more than 1,000 published scientific papers in rendering its decision, issued its final report in May 2010 (P. M. Lantos, W. A. Charini, G. Medoff, et al., Clin. Infect. Dis. 51:1-5, 2010). It unequivocally affirmed that: (a) there is no published evidence to indicate that extended antibiotic therapy is beneficial for the treatment of "chronic Lyme disease;" (b) there is no well-accepted definition of post-Lyme disease syndrome, also known as "chronic Lyme disease;" and that (c) there is no convincing biological evidence for the existence of symptomatic chronic Borrelia burgdorferi infection among patients given recommended treatment regimens for Lyme disease (Lantos et al., Clin. Infect. Dis. 51:1-5, 2010).
It was not surprising that the review panel unanimously upheld the IDSA guidelines since the IDSA's recommendations for the treatment of Lyme disease are in complete accord with those of the European Federation of Neurological Societies, the European Union of Concerted Action on Lyme Borreliosis, the American Academy of Neurology, the Canadian Public Health Network, the German Society for Hygiene and Microbiology, the British Infection Association, as well as those of expert panels from at least 10 European countries (P. J. Baker, FASEB J. 24:4175- 4177, 2010; British Infection Association, J. Infect. 62:329-338, 2011). To deny the existence and validity of such an overwhelming consensus of independent expert opinion, in the absence of convincing evidence to the contrary, is an interesting example of antiscience denialism. It should be noted that an independent appraisal and review of alternative guidelines proposed by the International Lyme and Associated Diseases Society (ILADS) by the British Health Protection Agency found them to be untenable and unsupportive of extended antibiotic therapy (independent appraisal and review of the ILADS 2004 evidence-based guidelines for the management of Lyme disease; general information reported by the Health Protection Agency, U.K. Furthermore, Borrelia burgdorferi, the spirochete that causes Lyme disease, does not form cysts or microfilms that render it resistant to conventional antibiotic treatment as suggested by a self-employed "scientist" featured in the film.
In view of these considerations, it is regrettable that some Public Broadcasting System (PBS) stations chose to air this deceptive film whose production was funded largely by contributions from Lyme disease advocates and "Lyme-literate physicians" to advance their unproven views. In so doing, it lends a semblance of credibility to a film that is now years out of date, and which recent events have shown its central message to be based on false assumptions. A partisan film such a this can only undermine public health by encouraging naive individuals to seek unproven remedies to relieve symptoms that, though deserving of appropriate medical treatment and care, may well have nothing to do with Lyme disease. This film was distributed by the National Educational Telecommunications Association to PBS for airing on their affiliate stations, free of charge. If that is the case, then PBS got exactly what it paid for-but at the cost of compromising its integrity.
Phillip J. Baker
Executive Director
American Lyme Disease Foundation
Foot in Mouth
"A major criticism raised by those who oppose the IDSA Guidelines is that they fail to provide evidence to support legitimate opposing views, namely, that extended antibiotic therapy is beneficial for the treatment of “chronic Lyme disease”. That is not a deliberate omission. The simple fact of the matter is that there is no published evidence -- derived from a well-designed placebo- controlled clinical trial-- to show that such therapy is both beneficial and safe. If that were the case, there would be no
controversy and we would not be here today discussing this matter."
"None of the four NIH-supported clinical trials – that cost >$8M to conduct --provided any evidence to indicate that extended antibiotic therapy is beneficial for the treatment of “chronic Lyme disease”, or that such a condition is mediated by a persistent infection by Borrelia burgdorferi or any other co-infecting pathogen transmitted by ticks (1,2,3)."
"In the absence of evidence of a persistent infection, extended antibiotic therapy clearly is not justified."
"Here we have two similar situations in which the results of government sponsored evidenced-based research are being discredited -- and the integrity of outstanding
scientists questioned -- simply because the results obtained conflict with the unproven views of a strident minority."
"To date, the published results of no less than four peer-reviewed, randomized, placebo-controlled clinical trials have shown that extended antibiotic therapy is not beneficial for the treatment of “chronic Lyme disease”. If those who disagree with these findings believe that these studies were flawed and that such treatment is beneficial and safe, it is incumbent upon them to design and conduct a randomized,
placebo-controlled trial -- one that will withstand the rigorous test of peer-review -- to demonstrate efficacy and safety."
"If that can be done, I am certain that the results would be accepted by the medical and scientific community and this controversy would come to an end. Until that is done, the current IDSA Guidelines for the Treatment of Lyme Disease -- with its more than 400 peer- reviewed reference citations-- should be considered the best
available and most comprehensive resource on the diagnosis and treatment of Lyme disease extant."
SOURCE- Phil Baker's- Testimony to be Presented to the Infectious Diseases Society of America (IDSA) Guideline Panel
(July 30, 2009)
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Phil Baker responding to Lyme Policy Wonk Blog article concerning a study confirming persistence that was missing for 12 years. It was funded and overseen by Phil Baker while at the NIH.
- chris powell on February 22, 2012 at 10:13 pm said:
- would it be possible for you to interview the authors and ask the reason for the delay?
- many thanks once again for your enlightening, thought provoking article.
- Reply ↓
- louon February 23, 2012 at 9:51 am said:
- Doubtful that the authors will want to answer this question. Embarrassing, leaves them open to retaliation. Means NIH will write them off, and put their institutions in the position of leaning on them to shut up. NIH is fully capable of refusing grant money to anyone who doesn’t follow the party line. They have been doing it for years. They have billions to bestow. Who is going to cross them if they ever want to get grant money or publish again?
- Reply ↓
- Phillip J. Baker on February 23, 2012 at 7:40 am said:
- I resent your incorrect, if not frankly false, accusation that either I — or the NIH– had anything to do with “delaying” or “suppressing” publication of the work reported in Embers et al. Everyone knows that data collected on a NIH-funded research grant is the intellectual property of the principle investigator of the grant, not the NIH; consequently, investigators are free to publish the scientific results they obtained, whenever they believe that the work is complete and ready for publication. I challenge you to ask both Drs. Philipp and Barthold to publicly affirm and substantiate your account that either I or anyone else at the NIH attempted to suppress publication of their research results.
- Reply ↓
- Rebeccaon February 23, 2012 at 4:02 pm said:
- 12 years? R e a l l y ? really?
- Reply ↓
- Kris Newbyon February 23, 2012 at 8:54 pm said:
- When I began interviewing Lyme experts for our documentary, I discovered that it was widely known among academic Lyme researchers that live, metabolizing Lyme bacteria were found in the autopsied brains of monkeys that were given the equivalent Klempner study antibiotic protocol for treating Lyme disease in humans. Yet this important evidence was not mentioned in Klempner’s NEJM article or in the IDSA Lyme guidelines for 12 years.
- Dr. Gary Wormser, a Klempner study participant and the lead author of the IDSA guidelines, told me that these live organisms were simply “zombie” organisms that were alive, but didn’t cause disease in humans. How could they possibly know this if they never autopsied the brains of the human subjects in their study?
- Truly open-minded scientists would’ve mentioned the mirror monkey study in the “Discussion” section of the NEJM article, as a question that needed to be addressed. As an avenue for further research. Not mentioning the primate results – which cannot be ignored because monkeys are our closest mammalian relatives – is a scientific sin of omission.
- So here is the central question: Did Phil Baker, the person who supervised the awarding and results of the $4.2M Klempner study, know about this evidence? Did he ignore it, suppress it, or simply not know about it?
- Either way, it’s an immeasurable tragedy.
- Reply ↓
- Phillip J. Baker on February 23, 2012 at 8:57 am said:
- I should have added in my previous posting that investigators are not required by the NIH to submit copies of manuscripts for approval prior to submission for publication or for oral presentation at scientific meetings. It is ludicrous for any one to imagine that I or anyone else connected with the NIH could have suppressed or delayed the publication of any scientific findings, even if we wanted to do so.
- Reply ↓
- Phyllis Mervine on February 23, 2012 at 12:24 pm said:
- Dr. Baker, when Carl Brenner and I were on the NIH Advisory Panel for the Klempner treatment trials, and you were the NIH Lyme Program Officer, we asked for longer treatment, but you said it would be too expensive. We were afraid the chosen protocol would prove not to be enough for such sick patients, but you assured us that Klempner would only prove that this particular treatment worked or didn’t work – and that it was just the first treatment trial of a series. We believed you.
- We were concerned that the study used only subjective methods to evaluate the patients, so we pushed for a parallel monkey trial to give us objective evidence to balance the scale. You funded Philipp’s study but we never saw the results – until now.
- After the results of Klempner’s aborted trial were published with such fanfare, the “Clinical Alert” on the NIH website blared, “Chronic Lyme Disease Symptoms Not Helped by Intensive Antibiotic Treatment.” NIH quotes Klempner as saying, “[W]e think it is unlikely that a longer course of treatment or different antibiotic combinations would result in greater improvement than what we found in these studies.”
- I asked NIH to change their headline to “90-Day Treatment Inadequate for Chronic Lyme Disease.” They – and you – ignored my request. And now you are asking us to believe that the NIH had nothing to do with the suppression of evidence of persistence for over a decade? What did you did to get these results out in the public? What did you do to control the damaging spin of the Klempner trials that has hurt patients enormously?
- Reply ↓
- Phillip J. Bakeron February 23, 2012 at 1:49 pm said:
- Phyllis
- For your information, I did not see the results of Philipp’s study as reported in Embers et al. until just a few days ago. So, How could I have been involved in suppressing/delaying its publication?
- You keep talking about the Klempner trial being ABORTED. Nothing of the kind happened. The protocol for both the seropositive and seronegative study, which you must have seen as a member of the panel since you and others approved it, called for an interim statistical analysis when 129 patients were enrolled. So, that’s exactly what was done, under the supervision of an independently appointed Data Safety Monitoring Board that included a biostatistician. It was THEIR decision to terminate the trial because the results obtained were conclusive and not likely to be different even if the study been continued until full enrollment was achieved.
- You forget, Phyllis that we were doing a placebo controlled study. For safety reasons, it could not have been longer due to the increased risk of sepsis — that could be life-threatening– in the placebo group. That is why we elected to do 30 days of IV ceftriaxone, followed by 60 days of oral doxycycline. If you look at the data for the Krupp and Fallon studies, that were of shorter duration than the Klempner study, you will see that the number of adverse events reported were more than Klempner found. This could have been due to better care provided by Klempner and the infusion company he hired to insert and manage the pic lines.
- Reply ↓
- Lorraine Johnson on February 23, 2012 at 12:36 pm said:
- Dr. Baker
- I actually say that you “deny” allegations of suppression, which you do. However, you were the person at the NIH who was responsible for overseeing this study, which was funded with taxpayer dollars. It was your job to make sure that the study was carried out and that the results were timely distributed to the public. You failed to do this. As a result, the real research that should have been done — how to best treat this persistent infection — has not been done because the issue wasn’t even on the agenda. I hope you understand what a staggering loss that is to patients debilitated with this disease and to the science of Lyme disease in general.
- Reply ↓
- Phillip J. Bakeron February 23, 2012 at 2:14 pm said:
- Actually, no one was more eager to learn of the results of Mario’s studies than I, and I contacted him repeatedly all during the time that his grant was active to find out what was happening. Initially, he told me that he was having technical problems with the strain of Borrelia that he had been using in all of his previous work. It appeared to have changed properties in that it was no longer as infective as it once was in previous studies. This necessitated re-deriving a new strain and then conducting a series of preliminary studies to standardize the dose to be used for infection in the planned definitive studies.Unfortunately, things like that sometimes happen and are a part of doing scientific research. Also, he told me that he was having difficulties getting adequate numbers of NHPs, mainly because of increased demands for such animals in research on HIV-AIDS. The long and short of the matter is that he had no conclusive results to report that closely resemble those reported in the Embers et al. paper before his grant expired.
- Furthermore, the significance of the results reported by Embers et al. with respect to human disease are far from clear and remain to be established. Sufficient information was not provided to indicate that the antibiotic regimen used was adequate to clear the disseminated infection, specially since ceftiofur — not ceftriaxone — was used. Since ceftiofur differs significantly from ceftriaxone in structure, one can not assume that it has the same PK/PD properties or even the same MID. Furthermore, ceftiofur has not been approved for use in human studies and its efficacy for the treatment of borreliosis — in humans and/or in animals– has not been established. More important, no evidence is provided to indicate that “persistors” — even those taken up by ticks in the xenodiagnosis experiments are infective and cause disease. On the basis of all these deficiencies, it is unclear why the work was accepted for publication by PlosOne in the first place.
- Reply ↓
- lou on February 23, 2012 at 1:45 pm said:
- Does anyone doubt the ability of the NIH to influence the direction of research? They have made sure, for instance, that more than 3 decades after the discoveries in Lyme,CT and many thousands of patients treated, we are still being told by the federal health agencies that chronic lyme does not exist. The people who have been funded for lyme research are more often those that will support the party line.
- Here is more than a billion reasons for NIH to get what it wants Not likely that any institution will want to cross the people who provide this kind of funding.
- http://www.medcitynews.com/2011/03/top-nih-grant-funding-by-institutions-states-for-2010/
- Reply ↓
- Phillip J. Bakeron February 23, 2012 at 3:27 pm said:
- Lou
- Sounds to me like what you are really trying to say is that if a study does not provide you with the results that you want to get, then it is biased and no good. To date, the NIH has spent millions of dollars to fund 4 clinical trials, none of which indicate that extended antibiotic therapy is beneficial for the treatment of “chronic Lyme disease”. So why do you think longer treatment with more or different antibiotics will help? I have no doubt that these people are suffering from something other than antibiotics is needed to cure. It is time to examine other possibilities, if one truly wishes to help these people.
- Reply ↓
- Claire on February 23, 2012 at 2:37 pm said:
- Thank you Phyllis and Lorraine for continuing support of Lyme disease patients. You’ve given us a very clear picture of what has gone in the past that has so negatively impacted so many of us and our families. What a shame that this study was not published at the appropriate time.
- Reply ↓
- Cindy on February 23, 2012 at 4:51 pm said:
- Dr. Baker,
- Perhaps the question should be, did you know the results of the monkey study? Did anyone at the NIH know the results of this study? If so, what did you, or others that knew, do to help set the record straight? To help direct more research to build upon the incredible results of the monkey study? To help correct the sweeping notion that Lyme disease can not persist after 90 of treatment?
- Reply ↓
- Freda on February 23, 2012 at 7:26 pm said:
- Dr. Baker,
- I have a question for you.
- If the monkey study was intended as confirmation of the Klempner treatment trial, and if it was approved by NIH with you at the helm as program director for Lyme disease, then how did you happen to approve a protocol you now say is so inadequate the reviewers at PLOSone should have rejected the study on that basis alone?
- It seems like a gotcha: If the study confirms Klempner, it validates you. If, as happened, it opposes Klempner, then you say that the protocol –which you funded– was, in retrospect, inadequate.
- It reminds me of “heads I win and tails you lose.”
- Freda
- Reply ↓
- barbara hower on February 23, 2012 at 8:18 pm said:
- ” I have no doubt that these people are suffering from something other than antibiotics is needed to cure. It is time to examine other possibilities, if one truly wishes to help these people.”–Dr. Baker
- Since there is ample evidence that there is some kind of persistent infection, then why has no other investigation been attempted? It seems to me that a logical extension of Klempner’s study (which I thought was criticized for numerous flaws) and Dr. Baker’s own observation quoted above would have been to have the NIH to serve its taxpayer-supported purpose by funding additional studies to investigate further. Why was this not done? Instead what we have had is a series of denials and a whole lot of excuses–very suspicious, if you ask me. So, prove those of us who believe in persistent borrelia infection wrong and provide the answers you claim are waiting in the wings. I dare you.
- Reply ↓
- barbara hower on February 23, 2012 at 8:31 pm said:
- What I may not have made clear is this: Any scientist worth his or her salt would want to know, “Well if it is not borrelia, then what the hell is it??” Why stop at borrelia–keep at it until we know what is causing this persistent infection, this cascade of worsening conditions. Why would a scientist not find it fascinating and be deeply curious? This is what makes me suspicious. Just when it gets interesting, the spigot is turned off. Why?
- So many denials, but I have yet to hear any kind of scientific hypothesis as to what else it could be.
- Reply ↓
Link here:
Phil Baker Letter to PBS Regarding the Film Under Our Skin
I have contacted you previously on behalf of the American Lyme Disease Foundation in opposition to showing the false and misleading film "Under Our Skin" on PBS stations. I call your attention to this news article that describes how this film is being used by those who profit from the use of unproven approaches to treat Lyme disease that they mistakenly feel is all pervasive. I truly hope PBS will not embarrass itself by showing this film on its stations.
Phillip J. Baker, Lyme, CT
Executive Director ALDF
http://www.pbs.org/ombudsman/2011/06/the_mailbag_once_again_pbs_is_the_wrong_addre_1.html
"Lyme disease can be difficult to diagnose, especially in later stages of infection when an individual’s antibodies can fall to very low levels."
NIAID Collaboration Yields New Test For Lyme Disease
ScienceDaily (June 21, 2001) — A new test developed with funding from the National Institute of Allergy and Infectious Diseases (NIAID) has been shown to be highly accurate and sensitive for detecting antibodies to Lyme disease. Produced by Immunetics, Inc. of Cambridge, Massachusetts, the new assay recently won approval from the Food and Drug Administration (FDA) for use as a diagnostic test for Lyme disease.
See Also:
It is the first diagnostic tool to use a synthetic product called C6, a hybrid chemical marker based on components derived from the surface of Borrelia burgdorferi, the tick-borne bacterium that causes Lyme disease. The C6 test is sensitive only to antibodies generated during an active infection.
Lyme disease can be difficult to diagnose, especially in later stages of infection when an individual’s antibodies can fall to very low levels. Laboratory testing showed the C6 approach resulted in a high rate of sensitivity to antibodies from both the early and late stages of Lyme disease. The kit also resulted in fewer false positive readings when compared with current screening methods. Significantly, no false positive readings were obtained when the kit was used to test people who had previously received Lymerix®, the Lyme disease vaccine. Another advantage is the test’s ability to detect antibodies specific to both U.S. and European strains of Borrelia.
“The C6 test is the result of years of collaboration in an ongoing effort to improve our ability to diagnose Lyme disease,” explains microbiologist Phillip Baker, Ph.D., NIAID’s Lyme disease program officer. “This new approach is an important first step in that direction.”
NIAID is a component of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, tuberculosis, malaria, autoimmune disorders, asthma and allergies.
Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
The National Institute of Allergy and Infectious Diseases is a component of the National Institutes of Health, U.S. Department of Health and Human Services.
http://www.sciencedaily.com/releases/2001/06/010619073530.htm
NIH Grants
Phil Baker was the NIH Lyme disease program officer who green-lighted the Klempner Study. After retirement, he went out the NIH's revolving door to work for the American Lyme Disease Foundation (ALDF), which appears to be run primarily by Dr. Gary Wormser and the IDSA Lyme disease guidelines authors.
It has been reported that $18,587,393.00 is the dollar total for Phil Baker's NIH grant to Klempner, from 1996 to 2001. Funds have been shared by Wormser & Weinstein too. Grants listed below.
1,288,246
3M01
RR000054-370634
1,409,153
3M01
RR000054-370635
1,671,471
5M01
RR000054-380634
2,008,745
5M01
RR000054-380635
1,827,311
5M01
RR000054-390634
1,592,660
5M01
RR000054-390635
1,705,308
3M01
RR000054-39S30634
2,079,636
3M01
RR000054-39S30635
2,204,914
5M01
RR000054-410634
2,284,251
5M01
RR000054-410635
28,333
5M01
RR000054-420634
487,365
5M01
RR000054-420635
Perspectives on “Chronic Lyme Disease”
The American Journal of Medicine (In Press)
Phillip J. Baker, Ph.D.
Executive Director
The American Lyme Disease Foundation
Post Office Box 466
Lyme, CT 06371
E-mail Address: inquire@aldf.com
Abstract
There is much controversy about the treatment of Lyme disease with respect
to two poorly defined entities, “chronic Lyme disease” and “post treatment
Lyme disease syndrome”. In the absence of direct evidence that these
conditions are due to a persistent infection, some mistakenly advo
cate extended antibiotic therapy (6 months or more) , which can do great
harm and has resulted in at least one death. The purpose of this brief report
is to review what is known from clinical research about these conditions to
assist both practicing physicians and law-makers in making sound and safe
decisions with respect to treatment.
During the 2007 session of the Maryland House of Delegates, legislation was
proposed that would have compelled health insurance companies to pay for
extended antibiotic therapy for the treatment of “chronic Lyme disease”, and
prohibited local medical boards from disciplining physicians who
administered such therapy. Similar legislation was proposed in
Pennsylvania, Connecticut, Massachusetts, and New York where Lyme
disease is endemic. This is all part of an orchestrated campaign by some who
mistakenly believe that “chronic Lyme disease” is due to a persistent
infection requiring 6 months or more of antibiotic therapy to cure. The
purpose of this document is to review what is known about “chronic Lyme
disease” and examine the impact of such therapy on the public health.
Lyme disease is easy to cure with a short course of oral antibiotics such as
doxycycline or amoxicillin. What is less well-recognized is that late
manifestations also are responsive to 3 to 4 weeks of treatment with
doxycycline, amoxicillin, or ceftriaxone. Despite the proven efficacy of these
regimens, there still is much controversy about the treatment of two poorly
defined entities, “chronic Lyme disease” and “post treatment Lyme disease
syndrome”, which occur in a small percentage (<5%) of individuals previously
treated for correctly diagnosed early Lyme disease. To address this issue, the
National Institutes of Health (NIH) funded three placebo-controlled clinical
trials on the efficacy of prolonged antibiotic therapy for these conditions; the
results obtained have been published in major scientific journals and thus
were subjected to rigorous peer review. Two large studies provided no
evidence that prolonged antibiotic treatment is beneficial 1. In the third
study, the score for severity of fatigue improved in both the antibiotic-treated
and the placebo groups 2; however, the improvement was greater by 13% in
those who received antibiotic (22% vs 9%). No significant benefit was found
for other symptoms and unblinding may have occurred. Because of the high
frequency of serious adverse effects noted, the investigators concluded that
“repeated courses of antibiotic treatment are not indicated for persistent
symptoms following Lyme disease, including those related to fatigue and
cognitive dysfunction…” 2.
Several key factors were considered in the design of these clinical trials. They
included:
• the susceptibility of Borrelia burgdorferi, the causative agent of Lyme
disease, to the antibiotics used,
• the ability of the antibiotics used to access the central nervous system
and to persist –at effective levels—during the course of therapy,
• the ability of the antibiotics used to penetrate mammalian cells, even
though there is much evidence to indicate that Borrelia are
extracellular, rather than intracellular, pathogens,
• the possibility that various co-infecting agents could influence the
expression and severity of symptoms, and
• the safety of patients enrolled in the trials.
Since the experimental protocols used addressed all of these issues, there is
no reason to believe that different results would be obtained using other
antibiotics – given singly or in combination by different routes—for longer
periods of time. The results obtained are consistent with the findings of more
than 20 years of basic research on the pathogenesis and treatment of Lyme
disease supported by the NIH and the Centers for Disease Control and
Prevention (CDC).
Despite the convincing results obtained, some continue to claim -- in the
absence of relevant peer-reviewed experimental data -- that “chronic Lyme
disease/post treatment Lyme disease syndrome” is due to a persistent
infection with Borrelia burgdorferi , requiring several months of antibiotic
therapy to be cure. Such a regimen, which is unprecedented for a disease that
is not life-threatening, is harmful and exposes patients to great risks that
may result in:
• death from fulminating fungal infections 3;
• obstruction of the gall bladder often requiring its removal 4;
• outbreaks of severe Clostrium difficile infections with significant
mortality 5; and,
• the generation of new antibiotic resistant strains of bacterial
pathogens that are an increasing and serious public health problem 6.
Obviously, extended antibiotic therapy for the treatment of “chronic Lyme
disease/post treatment Lyme disease syndrome” is not warranted unless
there is clear evidence of a persistent infection which proponents of this
view have yet to provide.
To be accepted by the medical and scientific community, the validity of any
therapeutic regimen proposed must be supported by the results of carefully
designed and critically reviewed clinical trials. This has always been the
norm and is the foundation of sound evidenced-based medical practice where
the burden of proof is on those recommending a particular therapeutic
approach. They must provide unequivocal evidence that their approach is
justified, effective, and safe. In this context, those advocating extended
antibiotic therapy for the treatment of “chronic Lyme disease/post treatment
Lyme disease syndrome” have failed to address the following key issues:
• “Chronic Lyme disease/post treatment Lyme disease syndrome” must
be defined in terms of well-established diagnostic criteria, so that it
can be distinguished from other non-infectious medical conditions with
similar symptoms, e.g., fibromyalgia, and chronic fatigue syndrome.
This issue was a matter of great concern in developing the criteria for
enrollment in the aforementioned NIH-supported clinical trials to
ensure that those enrolled had a high probability of having this
condition; otherwise, the results obtained would have been
inconclusive. In the trials conducted at the New England Medical
Center (NEMC), more than 1,500 individuals claiming to have chronic
Lyme disease were screened in order to obtain the 129 subjects (8.6%)
enrolled 1. An enrollment rate of about 5% was noted in another
treatment study 2. This indicates that “chronic Lyme disease/post
treatment Lyme disease syndrome” is not common.
• Direct evidence must be provided that “chronic Lyme disease/post
treatment Lyme disease syndrome” is due to a persistent bacterial
infection in patients being considered for treatment. Without such
evidence, prolonged antibiotic therapy is not justified, can result in
great harm, and contributes to the emergence of new strains of
antibiotic resistant bacterial pathogens.
• Evidence must be provided, from the results of placebo-controlled
studies, that prolonged antibiotic therapy is beneficial and safe.
Testimonial observations and anecdotal reports are not reliable, since
a placebo effect of 40% was noted in the published studies cited above
1, and other investigators have noted periodic improvements in the
symptoms of patients given only placebo during the course of their
studies.
• Adjustments must be made in the experimental design to compensate
for the unanticipated beneficial effects of antibiotics that are unrelated
to their antimicrobial properties. The anti-inflammatory properties of
macrolides, doxycycline and other tetracyclines are well-known;
however, these – as well as several other beta lactam and
cephalosporin antibiotics, including ceftriaxone often used to treat
“chronic Lyme disease/post treatment Lyme disease syndrome” – have
profound neuroprotective properties that might ameliorate
neurological symptoms 7,8,9. Such pharmacologic effects, rather than
the elimination of a presumed persisting infection per se, might
account for the short-lived beneficial effects sometimes seen. In the
absence of evidence for a persisting infection, some have suggested
treatment with gabapentin to alleviate symptoms associated with
“chronic Lyme disease/post treatment Lyme disease syndrome”.
Although promising results were obtained in one small clinical trial 10,
this approach requires much more study. Recently, the Food and Drug
Administration (FDA) approved the use of pregabalin for the
treatment of fibromyalgia, a condition with symptoms very similar to
those ascribed to “chronic Lyme disease/post treatment Lyme disease
syndrome”.
The results of NIH-supported studies acknowledge that some patients with
“chronic Lyme disease/post treatment Lyme disease syndrome” indeed have
deficits with respect to their physical health status 1. No doubt such patients
experience significant pain and therefore require appropriate medical
attention and care. However, since there is no evidence to indicate that their
symptoms are caused by a persistent Borrelia burgdorferi infection, other
options must be considered to determine their cause and how such patients
might be treated to relieve their symptoms. Without direct evidence for a
persistent infection, it is clear that extended antibiotic therapy is not the
answer; it remains an unproven and unsafe therapeutic approach that is
neither justified nor in the best interest of the public health. This is in accord
with the views expressed by many outstanding experts in infectious disease
11,12,13 .
References
1. Klempner MS, Hu, LT, Evans J et al. Two controlled trials of antibiotic
treatment in patients with persistent symptoms and a history of Lyme
disease. New Eng. J.Med. 2001; 345: 85-92.
2. Krupp LB, Hyman LG, Grimson et al. Study and treatment of post
Lyme disease (stop-LD): a randomized double-masked clinical trial.
Neurology 2003; 60:1923-1930.
3. Patel R, Grogg KL, Edwards WD et al. Death from inappropriate
therapy for Lyme disease. Clin. Infect. Dis. 2000; 31:1107-1109.
4. Shaffer EA. Gall bladder sludge: what is its clinical significance?
Current Gastroenterol. Reports 2001; 3: 166-173.
5. Owens, RC Jr Clostridium difficile-associated disease: an emerging
threat to patient safety: insights from the Society of Infectious
Diseases Pharmacists 2006; Pharmacotherapy 26: 299-311.
6. Moellering RC Jr, Graybill JR, McGowan JE Jr et al. Antimicrobial
resistance prevention initiative—an update: proceedings of an expert
panel. Amer. J. Med. 2007; 120: S4-25.
7. Domercq M, and Matute C. Neuroprotection by tetracyclines. Trends in
Pharmacol. Sci. 2004; 25: 609-612.
8. Rothstein JD, Patel S, Regan MR et al. β-lactam antibiotics offer
neuroprotection by increasing glutamate transporter expression.
Nature 2005; 433: 73-77.
9. Maier K, Merkler D, Gerber J, et al. Multiple neuroprotective
mechanisms of minocycline in autoimmune CNS inflammation.
Neurobiol. Dis. 2007; 25: 514-525.
10. Weissenbacher S, Ring J, and Hofman H. Gabapentin for the
symptomatic treatment of chronic neuropathic pain in patients with
late-stage Lyme borreliosis: a pilot study. Dermatology 2005; 211:123-
127.
11. Wormser, GP, Dattwyler RJ, Shapiro ED et al. The clinical
assessment, treatment, and prevention of Lyme disease, human
granulocytic anaplasmosis, ans babesiosis: clinical practice guidelines
by the Infectious Diseases Society of America. 2006; Clin. Infect. Dis.
43: 1089-1134.
12. Halperin JJ, Shapiro ED, Logigian E et al. Practice parameter:
treatment of nervous system Lyme disease (an evidence-based review).
Neurology 2007; 69: 91-102.
13. Feder HMJr, Johnson, BJB, O’Connell, S, et al. A critical appraisal of
“chronic Lyme disease” New Eng. J. Med. 2007; 357: 1422-1430.
http://www.aldf.com/Baker2008AJM.pdf
Poughkeepsie Journal Article Response
By Phillip Baker
Dear Editors,
In response to Mary Beth Peiffer’s article on Lyme disease, which appeared in the May 19th issue of the Poughkeepsie Journal, I respectfully offer the following response to counter-balance some of the distorted notions conveyed by that article. It is a perfect example of how one, unfamiliar with the complexities of the science and the actual events involved can “connect the dots” from about 7,000 old – and often disconnected -- e-mails to construct the illusion of a conspiracy. What’s even worse is how many people believe such “fiction” and embellish it with their delusions.
In 2006, I was invited by the Agency for Healthcare Research and Quality (AHRQ), the agency that posts clinical guidelines on its clearing house website, to discuss the results of NIH-sponsored clinical trials showing no benefit of extended antibiotic therapy for the treatment of “chronic Lyme disease” and their implications with respect to the International Lyme and Associated Diseases Society’s (ILADS) guidelines, advocating an opposing point of view. The meeting was chaired by the Assistant Secretary of Health, Department of Health and Human Services (DHHS).
At that meeting, I stated that the ILADS guidelines were deficient in that they: (a) did not provide a precise definition of “chronic Lyme disease” as a clinical entity, so that it could be distinguished from other non-infectious medical conditions (e.g., chronic fatigue syndrome, fibromyalgia, etc.) with similar symptoms; (b) failed to provide unequivocal clinical evidence to indicate that patients suspected of having “chronic Lyme disease” actually have a persistent borrelial infection that justifies antibiotic therapy; and (c) failed to demonstrate, from the results of published, peer-reviewed, randomized, placebo-controlled trials, that extended antibiotic therapy is not only beneficial but also safe for the treatment of “chronic Lyme disease”. The views that I expressed were later confirmed independently in much greater detail in a full report issued by the U.K. Health Protection Agency (see http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1294739293177 ).
It should be noted that the obviously flawed ILADS guidelines were removed from the guidelines clearing house, not as a result of any of the testimony presented at this meeting; rather, they were removed because ILADS failed to submit an updated version of their guidelines after they were posted for the allotted 5 year period of time. Obviously, the credibility of guidelines proposed by ILADS, a pseudoscientific organization with an undistinguished membership of about 300, as well as the similar views of those often referred to as Lyme Literate Physicians (LLMDs), should no longer be given credence and serious consideration.
The Infectious Diseases Society of America (IDSA), an organization composed of more than 8,000 outstanding scientists and physicians, independently developed and published their own guidelines on the prevention, diagnosis and treatment of Lyme disease; they were published in 2006. In contrast to the flawed ILADS guidelines, the IDSA guidelines do not recognize the poorly defined condition called “chronic Lyme disease” as a distinct clinical entity, and do not recommended prolonged antibiotic therapy. It should be noted that the recommendations of the IDSA Guidelines are almost universally accepted by experts engaged in basic and clinical research on Lyme disease and are in agreement with those of the European Federation of Neurological Societies, the European Union ofConcerted Action on Lyme Borreliosis, the American Academy of Neurology, the Canadian Public Health Network, and the German Society for Hygiene and Microbiology, as well as with recommendations by expert panels from 10 European countries including The Czech Republic, Denmark, Finland, France, The Netherlands, Norway, Poland, Slovenia, Sweden, and Switzerland. None of these organizations or expert panels, as well as the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) recommend the extended antibiotic therapy advocated by ILADS for the treatment of “chronic Lyme disease”.
Such unanimous support is precisely what one would expect to find when ones views are evidence-based and firmly supported by the facts; indeed, it would be ludicrous to suggest this represents collusion or favoritism, thereby challenging the integrity of outstanding scientists and the prestigious institutions that they represent. I am dismayed that The Poughkeepsie Journal would publish articles conveying such a distorted anti-science message. If patients can no longer believe and trust our very best research scientists, clinicians, and public health institutions, who have contributed significantly to the public health for the past many years, where should they go to get the advice and treatment they need? Obviously, not to ILADS or its disciples.
There is controversy about the existence of seronegative Lyme disease and the validity of the two-tiered diagnostic test that has been approved by the Food and Drug Administration (FDA) and recommended by the CDC for the laboratory diagnosis of Lyme disease. Much of the controversy is due to the failure to acknowledge two key observations. First, serological tests are not recommended for infections of less than 4 weeks, largely because detectable amounts of antibody are not likely to be present in the blood at that time, not because the tests being used are insensitive; this is the case, not only for Lyme disease, but also for other infectious diseases. It is an inherent limitation of virtually all serological tests, no matter how sensitive or specific they may be.
At such times, the presence of a bull eye (EM) rash and/or clinical symptoms in patients living in Lyme disease endemic areas, where the risk of exposure to infected ticks is high, is considered to be sufficiently diagnostic and justifies the recommended course of oral, antibiotic therapy. There is nothing to prohibit a physician from prescribing antibiotic under such circumstances and confirming the presence of an infection later by tests conducted on convalescent serum; that is usually done. Second, there is ample published evidence -- based on well-characterized patient populations-- to indicate that, beyond 4-5 weeks of infection, practically all patients are seropositive by two-tiered testing which by then has a sensitivity and specificity of almost 100%. So, if a patient is seronegative under such circumstances, it makes good sense to consider the possibility that their very real symptoms might be due, not to Lyme disease, but to other causes that certainly merit proper medical attention and care. Most competent physicians would do that.
About 2-3 years before I became Program Officer for the National Institute of Allergy and Infectious Diseases’s (NIAID) Lyme Disease Basic Research Program, the U.S. Congress mandated that NIH establish an NIH Lyme Disease Advisory Panel to facilitate the exchange of information and the development of co-operative interactions between those institutes of the NIH that support clinical studies and basic research on Lyme disease; representatives from the CDC and the FDA also were invited to serve on this
panel which is required to meet at least once per year and more often if needed. The minutes of all past meetings of the panel are on file and are available from the NIAID who took the lead in chairing the panel, simply because NIAID supports most of the research conducted on Lyme disease.
Therefore, it should not be surprising to discover that the NIH, CDC, and FDA work closely together on Lyme disease; not only have they been encouraged by the Congress to do so in this and other areas of scientific research (to avoid duplication of effort), but also it makes good sense for scientists and clinicians to share the results of their studies with others working on the same or related issues to accelerate progress. That’s just the way good science is done. This hardly constitutes collusion -- or a conspiracy-- as some naïve individuals believe to be the case. As a result of such close interactions, many of us have become better acquainted not only with each other, but also with scientists who actually do the research that is funded by grants from the NIH and other government agencies. As Program Officer for NIAID’s Lyme Disease Basic Research Program, I managed the grants and therefore had personal contact and direct interactions with almost every well-known and accomplished scientist doing research on Lyme disease; that was an integral part of my job and is considered to be entirely appropriate and ethical.
One reason why I have not been supportive of some of the Lyme disease bills that have been proposed almost annually by Congress is not that I don’t want to see more money spent on Lyme disease research; it is simply because what is being proposed in all of these bills duplicates work that is already being done by the NIH Lyme Disease Advisory Panel as part of its mandate. Because Congress seldom provides new money to implement the provisions of these Lyme disease bills, they then become essentially unfunded mandates; thus, if the NIH is mandated to create a Tick-Borne Diseases Advisory Panel, it must fund such a redundant activity from its current budget for research on Lyme disease. This would result in fewer grants to support much needed and important basic and clinical research on Lyme disease at a time when only the top 6-8% of grant applications are now being funded.
Lastly, with respect to the Banbury Conferences on the Laboratory Diagnosis of Lyme Disease, only individuals with well-documented experience (peer reviewed publications) in the development of diagnostic procedures and/or in assessing their strengths and limitations (specificity and sensitivity) were invited to participate. This was essential since these conferences were intended to focus specifically on diagnosis, rather than on a wide range of other clinical issues related to Lyme disease. I have no doubts that all of the right people were invited, and that these conferences were indeed “an in-depth and critical examination of the strengths and weaknesses of currently used diagnostic procedures and latest advances in the field”.
Although the proceedings were not published, the executive summaries of all past Banbury Conferences are on file with the NIAID as part of the public record. The recommendation and recent implementation of a reference specimen repository, funded by the NIH and managed by the CDC in collaboration with the FDA, is now in operation and will surely accelerate the development of new and more sensitive FDA-approved diagnostic procedures for the early detection of Lyme disease. These panels of reference specimens will be made available to all working on the development of new diagnostic methods so that they can
compare the results they obtain with their new assays to those obtained using existing conventional procedures. This is clearly a long awaited -- and much needed -- advance, and one that can help resolve many of the conflicts that have plagued the diagnosis of Lyme disease for so many years. It should be noted that the Banbury Conferences on the Laboratory Diagnosis of Lyme Disease were established in response to Lyme disease activists who falsely claimed that the NIH and CDC were doing nothing to improve diagnosis.
The work presented at these conferences attests to the fact that the NIH and CDC have made -- and will continue to make -- significant efforts to develop and implement new, more sensitive and specific procedures for the diagnosis of Lyme disease, especially during its early stages.
Dr. Dattwyler whose work is funded by a Small Business Innovative Research (SBIR) research grant, has a long-standing interest in the identification and use of specific and well-defined Borrelia peptides for the diagnosis of early Lyme disease. He has recently published a paper on the successful use of one such peptide for the diagnosis of early Lyme disease in an ELISA test; the results obtained compare well with those of the existing two-tiered procedure, as well as the C6-ELISA. He is now examining the possibility of combining 5 or more such peptides in a single one-step assay for the better detection of early Lyme disease. No doubt, the specimens in the reference repository will enable him to compare the results obtained with his peptides to those obtained using other assays to determine superiority. This is truly exciting, cutting edge research. I am indeed proud to have assisted Dr. Dattwyler, as well as many other NIH grantees, in getting support for the outstanding work that they are doing. Clearly, positive efforts such as these will provide the knowledge we need to solve these and other problems related to Lyme disease.
Finally, I can’t tell you how many vile, vicious, and profane telephone calls I received -- when I was Program Officer-- from various individuals who blame me, as well as the NIH and CDC, for all of the problems they’ve experienced over the past several years, including the enormous costs incurred from unproven therapies recommended by LLMDs. Although I always attempted to be as polite and responsive as possible, the same courtesies were not always extended to me. No public servant deserves to be treated in such an abusive manner, and there is no justification for such aberrant behavior. To characterize such individuals as “loonies” might be too kind a description.
During my long scientific career, I have had the privilege of knowing many outstanding and dedicated scientists who do excellent work and really care about the public health. I am extremely proud to have been associated with all of them. Your biased article does them and all that they have accomplished a great disservice.
Sincerely,
Phillip J. Baker Executive Director,
American Lyme Disease Foundation
P.O. Box 466
Lyme, C T 06371
NOTE- Paragraph spacing added for those with vision problems.
Link to Letter
http://www.aldf.com/Poughkepse_Journal_Letter_to_the_Editor.pdf
Response to Phil Baker at NIAID/NIH from IGeneX
February 26, 2001
Response to Phil Baker, NIAID, NIH, press release
IGeneX, Inc.
Re: Klernpner paper Am.J. Med. 110:217-219,2001
Over two years ago, Dr, Mark Klempner approached me. He was doing a
study of chronic Lyme disease funded by the National Institutes of Health and wanted to compare the Western Blot with the Lyme Urine Antigen Test (LUAT). IGeneX agreed to the study and told the New England Medical Center (NEMC), which was providing the samples, that certain handling requirements must be met for the samples, since improper handling can lead to flawed results.
IGeneX received the samples in late 1998, early 99. IGeneX scientists
sensed immediately that there was a problem with the samples. l called and spoke with a laboratory supervisor and shared our suspicion that we had received improperly handled specimens. This supervisor confirmed that the samples had not been kept frozen but were refrigerated for many months. (Our written requirements for the study were that samples must be frozen after collection in a 70C freezer and remain frozen prior to testing to test accurately.) l called and informed the laboratory manager at NEMC that I would not release the results due to the improper handling of the samples. He informed me that I must send the results anyway because NEMC had paid for them under an NIH grant. I sent NEMC the results (attachment #1) along with a letter to Dr. Klempner clearly stating that the results could not he considered valid due to improper storage and possible contamination.
Over a half-year later, Munich International Lyme Conference attendees
informed me that Dr. Klempner had presented the results of this study,
not even mentioning the contamination. I then personally called Dr.
Klempner and offered to have IGeneX pay for a repeat study involving an independent third party evaluator. He reported the offer to his Medical Officer (#2) at the NIAID, and I personally offered the same to Phil Baker, NIH Lyme Program Director. All three refused the offer. We informed our clients of the situation in September 1999 (#3).
Now two years later, Dr. Klempner has published study results using
samples that he was personally told by me were contaminated and improperly handled, Science is based upon conclusions drawn from data objectively obtained under controlled conditions so that the variables are reduced. If the controlled conditions of the study have not been met, the conclusions derived are questionable at best, since the study's basis in science has been lost.
The study should have been terminated, but since it has now been published with the flawed data, science itself requires that a repeat study be performed, and IGeneX again repeats the offer of a third party independent evaluator study for which IGeneX will pay the bill.
Nick Harris, PhD, IGeneX Reference Laboratory, Palo Alto, CA
cc:
The Honorable Aden Spector
The Honorable Joseph Pitts, attention Jeri-Lynn Wier
The Honorable Rick Santorum, attention Pete Stein
The Honorable Christopher Smith, attention Andy Napoli
Don Keller, GAO
Hoc Noble, New York Times
http://www.avonhistory.org/bug/r14.htm
National Institute of Allergy and
Infectious Diseases (NIAID)
FOR IMMEDIATE RELEASE
Tuesday, June 12, 2001
Media Contact:
Laurie K. Doepel
(301) 402-1663
Chronic Lyme Disease Symptoms Not Helped by Intensive Antibiotic Treatment
Results of the first randomized, placebo-controlled, double-blind trials testing antibiotics in patients with a stubborn form of Lyme disease-those whose symptoms persist after standard courses of antibiotics-validate that these patients suffer significant pain and other disabling symptoms. The two trials found, however, that a 90-day course of intravenous and oral antibiotics was no better than placebo at improving these chronic symptoms.
Because of their potential importance to Lyme disease treatment, The New England Journal of Medicine is publishing these findings today online at http://www.nejm.org. The report will appear in the July 12th print edition of the journal. The studies were funded by a National Institute of Allergy and Infectious Diseases (NIAID) contract to Mark S. Klempner, M.D., of Boston University School of Medicine.
"Our results suggest that we need to define the cause or causes of the debilitating, persisting symptoms experienced by some patients with Lyme disease. Understanding the origin of these symptoms should lead to more effective therapeutic approaches to ameliorate these symptoms," says Dr. Klempner. "Based on experience with other chronic infectious diseases caused by persisting bacteria-syphilis, tuberculosis, and ulcers, for example-we think it is unlikely that a longer course of treatment or different antibiotic combination would result in greater improvement than what we found in these studies."
Significantly, more than 700 different blood and cerebrospinal fluid samples were collected from the study volunteers. None of the samples showed evidence of persistent infection with the Lyme agent, Borrelia burgdorferi. This suggests, Dr. Klempner says, that researchers should investigate autoimmune and other processes to determine whether they play a role in a least some of the symptoms of chronic Lyme disease.
The trials were carried out by primary investigators and their staffs at three centers: New England Medical Center in Boston (Dr. Klempner's former affiliation); New York Medical College in Valhalla (Arthur Weinstein, M.D.); and Yale-New Haven Hospital in Connecticut (Janine Evans, M.D.) Volunteers were recruited through hundreds of screening clinics set up in schools, hospitals, and town halls located in these areas where Lyme disease is highly endemic.
A total of 129 volunteers enrolled in the two studies. All participants had well-documented Lyme disease and had previously received at least one course of recommended antibiotics. Despite prior antibiotic treatment, the volunteers currently suffered from persisting muscle or joint pains and complained of memory and thinking problems, often associated with fatigue.
Although both trials were identical in design, one trial enrolled 78 chronic Lyme disease patients who tested positive for antibodies to the Lyme bacterium, while the other trial enrolled 51 people with chronic symptoms but no evidence of antibodies.
In each study, volunteers were assigned at random to receive either antibiotic treatment or an inactive placebo. Treatment consisted of intravenous ceftriaxone, 2 grams daily, for 30 days, followed by oral doxycycline, 200 milligrams daily, for 60 days. The investigators evaluated symptom improvement based on the patients' responses to a health-related quality-of-life questionnaire given 90 days after they completed the course of antibiotic treatment or placebo.
An interim data analysis planned into the design of the trials was carried out last November by a Data and Safety Monitoring Board (DSMB), an independent group of doctors and researchers. The DSMB unanimously recommended that NIAID stop the treatment arm of both trials because the data showed no significant difference in the percentage of patients who received either antibiotic treatment or placebo who felt their symptoms had improved, worsened, or stayed the same: a little more than one-third felt better, about one-third felt worse, and slightly less than one-third felt the same. The DSMB's review suggested that even with continued accrual of another 131 patients, the number needed to reach full enrollment, there was only a slight chance a difference between the antibiotic treatment and placebo groups would be found. NIAID agreed with the DSMB's recommendation, as well as their recommendation that the investigators continue to follow the patients to monitor them for safety and to learn more about possible causes of chronic Lyme disease.
"Although we still have much to learn," says Dr. Klempner, "we know much more about chronic Lyme disease now than we did when these studies began." Besides the information obtained about the efficacy of intensive antibiotic treatment, the investigators found that the impact of Lyme disease on physical health was at least equal to the disability of patients with congestive heart failure and osteoarthritis. Some patient were also found to have cognitive impairment.
"The antibiotic treatment component is only one piece of NIAID's comprehensive clinical studies on chronic Lyme disease," adds Phillip J. Baker, Ph.D., who oversees NIAID's Lyme disease program. "These studies have yielded a considerable amount of new information. We intend to characterize the patients enrolled in the study as thoroughly as possible to learn more about the mechanisms involved in chronic Lyme disease," Dr. Baker adds. "The knowledge obtained from such studies should be of immense value in developing new, more promising approaches for treating this disease."
###
References:
MS Klempner et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. New England Journal of Medicine . vol. 345(2): July 12, 2001.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site atwww.niaid.nih.gov.
The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.