McSweegan and the new definition of a quack (& CDC & SmithKline)
Mort Zuckerman
lPick...@cdc.gov, Durlan...@yale.edu, Aa...@columbia.edu,
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Subject: McSweegan and the new definition of a quack (& CDC &
SmithKline)
Date: Jul 11, 2010 7:52 AM
ARTICLE BELOW
=======================================
The definition of a quack is: "someone who
can't tell us what OspA is/does."
Like Anthony Fauci, the head of NIAID.
Like all of IDSociety.org.
Like all of the AMA.
Like everyone at Yale.
You will notice that after I published
the Pam3Cys chapter of Cryme Disease,
no one said another word about an OspA
vaccine:
http://www.actionlyme.org/MCSWEEGAN_AND_DUMB_EUROPEANS.html
http://www.actionlyme.org/GARY_WORMSER_SUED.htm
Deploying the Hairballers:
http://www.actionlyme.org/SCIENTIFIC_FRAUD_WITH_INTENT.htm
IDSA CLAIMS: "We're not trying to claim that these people aren't
suffering, but we're not sure that what they have is Lyme disease,"
Baragona said. "They may travel to a doctor who doesn't know what's
wrong with them and we know that's frustrating for them and for their
doctors. If there's some kind of breakthrough in diagnostics, then
we'd embrace it, but right now we don't have evidence that what we're
looking at is long-term antibiotic therapy."
Uhm, lemme see. They want a breakthru
in diagnostics... yet they don't mention
that they know OspA suppresses the immune
system:
Gary Wormser reporting the blunting of the immune response in
vaccinated animals:
http://www.ncbi.nlm.nih.gov/pubmed?term=10865170[uid]&cmd=DetailsSearch
"OspA interferes with the response of lymphocytes to proliferative
stimuli including a blocking of cell cycle phase progression."
That's ^^^ the definition of a quack;
giving people a vaccine that they know
does not produce antibodies.
They're very funny, these guys.
Whenever they try to say something about
"Lyme Disease," just remind them that they
haven't told us what OspA is, yet.
Don't forget, Dearborn was where the disease
testing was designed around the vaccine. There
is no OspA/B in the CDC's current diagnostic standard
because testing for disease breakthru without the
vaccine antigen is standard practice.
To this day, the CDC can't admit what they
did at Dearborn, because Barbara Johnson's name is
all over those European patents with SmithKline
http://www.actionlyme.org/Dearborn_Who_Approved.htm
http://v3.espacenet.com/publicationDetails/description?CC=AU&NR=4392093A&KC=A&FT=D&date=19931230&DB=EPODOC&locale=
http://v3.espacenet.com/publicationDetails/biblio?CC=AU&NR=4392093A&KC=A&FT=D&date=19931230&DB=EPODOC&locale=
Publication number: AU4392093 (A)
Publication date: 1993-12-30
Inventor(s): GOLDE WILLIAM T; ROEHRIG JOHN T; BURKOT THOMNAS; PIESMAN
JOSEPH F; JOHNSON BARBARA J B; MAYER LEONARD W; KEEN MARK G; HUNT ANN
R + (WILLIAM T GOLDE, ; JOHN T ROEHRIG, ; THOMNAS BURKOT, ; JOSEPH F
PIESMAN, ; BARBARA J. B JOHNSON, ; LEONARD W MAYER, ; MARK G KEEN, ;
ANN R HUNT)
Applicant(s): SMITHKLINE BEECHAM CORP; US HEALTH +
So, keep reporting US crimes to the world.
All of America is one big quack.
Kathleen M. Dickson
http://www.actionlyme.org
======================================
To: Spin...@yahoogroups.com
Subject: [SpinLyme] Latest crap from McSweegan
Date: Jul 10, 2010 2:47 AM
http://www.quackwatch.org/01QuackeryRelatedTopics/lyme.html
Lyme Disease:
Questionable Diagnosis and Treatment
Edward McSweegan, Ph.D.
Lyme disease is the most common tick-borne disease in the United
States. In 2006, the Centers for Disease Control and Prevention (CDC)
recorded 17,002 cases [1]. The infection is caused by Borrelia
burgdorferi, a spiral-shaped bacterium (spirochete) named after Dr.
Willy Burgdorfer, the public health researcher who discovered it in
1982. The infection is often contracted during warm-weather months
when ticks are active. The spirochete enters the skin at the site of
the tick bite. After incubating for 3-30 days, the bacteria migrate
through the skin and may spread to lymph nodes or disseminate through
the bloodstream to organs or distant skin sites.
Lyme disease frequently presents with a skin rash called erythema
migrans (EM) and common flu-like symptoms of fever, malaise, fatigue,
and muscle and joint pains. The characteristic EM rash is a flat or
raised red area that expands, often with clearing at the center, to a
diameter of up to 20 inches. However, it does not always occur, which
can make the diagnosis more difficult, especially when the patient is
not aware of having been bitten by a tick. Other early signs may
include small skin lesions, facial nerve paralysis, lymphocytic
meningitis, and heart-rhythm disturbances. Early infections usually
are cured by two to four weeks of orally administered antibiotics
(amoxicillin or doxycycline). However, if untreated or inadequately
treated, neurologic, cardiac, or joint abnormalities may follow.
Worldwide, Lyme disease has been directly responsible for fewer than
two dozen deaths [2].
The disease is named after the town of Old Lyme, Connecticut, where
researchers recognized its nature in 1975. In Europe, associations
between tick bites and several skin diseases had been known for
decades, but it was not understood that various conditions were part
of a single illness. Since its nature was clarified, Lyme disease has
emerged as a significant source of public controversy [3]. Some people
claim to be persistently infected with B. burgdorferi and suffering
from debilitating symptoms as a result.
Many infectious agents can cause chronic infections or can be
difficult to eradicate with standard antibiotic treatments.
Unfortunately, it is often difficult to diagnose such infections and,
in the case of Lyme disease, it is difficult to know what percent of
cases persist in the form of chronic infections. Other possibilities
for persistent symptoms include: autoimmune-like reactions in which
the body attacks its own organs and tissues; physically damaged or
scarred organs and tissues from an earlier infection; another tick-
borne infection such as babesiosis or ehrlichiosis; and re-infection
by B. burgdorferi [4].
Of course, symptoms occurring long after the onset of Lyme disease
also can be coincidental. A long-term study of 212 Connecticut
residents suspected of having Lyme disease found incidences of pain,
fatigue, and difficulty with daily activities to be similar to 212 age-
matched controls without Lyme disease [5]. As noted in an accompanying
editorial:
After a median follow-up of 51 months, patients with a diagnosis of
Lyme disease that met the national surveillance case definition
developed by the Centers for Disease Control and Prevention (CDC) had
the same profile of symptoms and the same quality-of-life indicators
as age-matched controls without Lyme disease. Thus, recognition and
treatment of clear-cut Lyme disease resulted in a return to baseline
with no measurable sequelae. On the other hand, patients who were
reported to have Lyme disease but who did not meet the CDC's case
definition of Lyme disease had increased symptoms and worsening
quality-of-life indicators. The implication is that many of these
individuals really did not have Lyme disease and therefore did not
respond to the treatment [6].
Limitations of Laboratory Tests
The diagnosis of Lyme disease should be based primarily on an
evaluation of a patient's symptoms and the probability of exposure to
the Lyme spirochete. Laboratory evaluation is appropriate for patients
who have arthritic, neurologic, or cardiac symptoms associated with
Lyme disease, but it is not warranted in patients who have nonspecific
symptoms, such as those of chronic fatigue syndrome or fibromyalgia
[7].
Matthew J. Rusk, MD, and Stephen J. Gluckman, MD, of the University of
Pennsylvania summarized the diagnostic situation, noting that "A true-
positive test result consists of a positive enzyme-linked
immunosorbant assay [ELISA] or immunofluorescent assay [ILA] followed
by a positive Western blot. However, positive results do not prove
that [the] patient has Lyme disease and have little predictive value
in the absence of characteristic symptoms" [8].
The FDA agreed and outlined a two-step algorithm for laboratory
testing [9]. In a 1997 FDA Public Health Advisory, it advised
physicians that:
"The results of commonly marketed assays for detecting antibody to
Borrelia burgdorferi (anti Bb) . . . may be easily
misinterpreted . . . . Although package inserts for some commercial
assays describe their intended use 'to aid in the diagnosis of Lyme
disease,' this statement does not fully reflect current
knowledge . . . and many such assays yield potentially misleading
results. . . . Assays for anti-Bb frequently yield false-positive
results because of cross-reactive antibodies associated with
autoimmune diseases or from infection with other spirochetes,
rickettsia, ehrlichia, or other bacteria such as Helicobacter pylori."
Several years ago, a diagnostic laboratory marketed a one-step Lyme
Antigen Urine Test [LUAT], data for which were presented at Lyme
advocacy meetings and published in the journal of a Lyme advocacy
group. The LUAT, however, was found to return a high rate of false-
positive test results and has been discredited [10].
In February 1999, the FDA approved the PreVue B. burgdorferi Antibody
Detection Assay, an "in-office" test that provided results within an
hour. The test results are similar in accuracy to those of the ELISA
test, but must be confirmed with a Western blot test done by a
laboratory.
In May 2001, the FDA approved another ELISA test called C6. It was the
first diagnostic tool to use a synthetic hybrid molecule derived from
the surface of the Lyme spirochete. A positive C6 test appears to
correlate well with acute cases of Lyme disease [11]. In addition, it
detects all B. burgdorferi genotypes, but does not appear to cross-
react with a related tick-borne pathogen, B. lonestari, which is
associated with a Lyme-like infection called (Southern Tick-Associated
Rash Illness (STARI) [12].
In 2005, concerns about inappropriate laboratory testing prompted the
CDC and FDA to issue a warning about "commercial laboratories that
conduct testing for Lyme disease by using assays whose accuracy and
clinical usefulness have not been adequately established. These tests
include urine antigen tests, immunofluorescent staining for cell wall-
deficient forms of Borrelia burgdorferi, and lymphocyte transformation
tests. In addition, some laboratories perform polymerase chain
reaction tests for B. burgdorferi DNA on inappropriate specimens such
as blood and urine or interpret Western blots using criteria that have
not been validated and published in peer-reviewed scientific
literature" [13]. The CDC noted, "patients are encouraged to ask their
physicians whether their testing.was performed using validated methods
and whether results were interpreted using appropriate guidelines."
Some private practice physicians incorrectly diagnose Lyme disease in
patients and subsequently treat them with inappropriate and
ineffective regimens. Some of these treatments are described below.
Malariotherapy and ICHT
Malaria is a parasitic disease that typically involves bouts of fever
that may reach 40°-41°C (104°-106°F). Before the antibiotic era,
patients in the late stages of syphilis were sometimes given malaria
in the hope that a high fever would kill the spirochetes responsible
for syphilis. The practice was never subjected to controlled studies
and was abandoned decades ago when antibiotics became widely
available. Over the years, some Lyme patients have allowed themselves
to be injected with blood containing a malaria parasite, Plasmodium
vivax [14]. Persons seeking such treatments usually had to travel to
Mexico. However, in one case, a Texas resident acquired P. vivax-
contaminated blood from an unknown source, injected himself, then
treated himself with the antimalarial drug chloroquine [15]. There is
no evidence that malaria cures Lyme disease (or any other disease for
that matter). Moreover, patients who receive malaria-containing blood
face significant risks of serious illness or death caused by malaria
itself, transfusion reactions, or an infection by other pathogens that
might be in the blood. Malariotherapy is far more dangerous than a
common case of Lyme disease.
Another form of fever therapy administered to patients who are alleged
to have chronic Lyme disease is intracellular hyperthermia therapy
(ICHT). A chemical such as 2,4-dinitrophenol (DNP) is administered to
the patient. According to one Web site devoted to Lyme disease and
ICHT:
The net result of ICHT uncoupler therapy causes the mitochondria to
be converted from efficient "powerhouses" of energy production to
"chemical furnaces", heating cells from the "inside-out." The Lyme
spirochetes are subjected to such an amount of heat over a prescribed
time that they cannot survive. In essence, ICHT maybe considered a
form of therapeutic "pasteurization."
Unfortunately, DNP is a metabolic poison that can result in severe
weight loss and even death.
Hyperbaric Oxygen Therapy (HBOT)
High-pressure (hyperbaric) oxygen is legitimately used to treat deep
sea divers suffering from decompression sickness ("the bends") and
smoke inhalation, and to help treat several other conditions. There
are 300 hyperbaric facilities in the United States. Some of these
facilities have been used to treat AIDS, chronic fatigue syndrome, and
Lyme disease. The Lyme patients subjecting themselves to long hours in
these small chambers apparently hope that high-pressure oxygen will
enhance oxygen-dependent immune mechanisms and kill spirochetes
lurking beyond the reach of antibiotics.
Is HBOT effective against Lyme disease? At far as I know, it has not
been subjected to clinical testing for that purpose. One Lyme patient
writing on the Internet said, "After 30 hours of therapy [at $4,000]
in 90-minute doses I had no positive results for chronic Lyme
treatment." Another online patient wrote, "The director of the clinic
is refusing to refund . . . me. This money was for some of the dives I
was scheduled to take, but was unable to because I was sick." At best,
HBOT is an experimental treatment for some infectious diseases. It is
one of several treatments not recommended by the Infectious Diseases
Society of America (IDSA) [16].
Colloidal Silver
Many colloidal silver and silver salt preparations have been touted as
cures for AIDS, chronic fatigue, herpes, TB, syphilis, lupus, malaria,
plague, acne, impetigo, and many other diseases. Lyme disease is just
the latest target. A 1996 Federal Register notice stated the "FDA is
not aware of any substantial scientific evidence that supports the use
of . . . colloidal silver ingredients or silver salts for these
disease conditions." The same notice stated that "human consumption of
silver may result in argyria-a permanent ashen-gray or blue
discoloration of the skin, conjunctiva, and internal organs" [17].
Despite these warnings, some websites devoted to Lyme disease or
colloidal silver products display misleading reports about laboratory
experiments in which colloidal silver killed spirochetes. One such
report is a letter from Dr. Burgdorfer, the discoverer of the Lyme
spirochete. The letter merely reports on a pilot study using colloidal
silver to kill spirochetes in a test tube and states that additional
laboratory and human studies are underway. Many silver and Lyme
advocates have used the letter to suggest that colloidal silver has
been proven effective against Lyme disease. However, no study has
shown that colloidal silver is safe or effective for treating people
with Lyme disease (or anything else).
Rife Machines
A quack electromagnetic frequency device from the 1930s also has been
resurrected for use in treating Lyme disease. These rife machines are
marketed through the Internet. As one website claims, "rife machine
therapy is an affordable, life-saving treatment option. Lyme Literate
Medical Doctors (LLMDs) often refer their patients to rife machines if
antibiotics fail." These devices are based on the false notion that
disease-causing agents and diseased tissues emit radio-like
frequencies that can be detected and cured by matching their
frequencies.
Dangerous Injections
Other quack treatments for Lyme disease include injections of hydrogen
peroxide, and bismacine. In 2006, the FDA issued a warning about the
use of "bismacine" for treating Lyme disease. The situation came to
the FDA's attention after a patient died as a result of bismacine
treatment. The errant doctor, John R. Toth, M.D., of Topeka, Kansas,
surrendered his medical license in 2005 and is serving a 40-month
prison sentence for manslaughter related to the death [18]. FDA
inspectors eventually uncovered a network of shady practitioners who
were making bogus diagnoses of Lyme disease and using illegal "dietary
supplements" to treat their victims. The situation came to light in
December 2008 when Toth; Robert W Bradford; C.R.B., Inc. (d/b/a
American Biologics); and C.R.B.'s chief operating officer Brigitte G.
Bird were charged with a total of 25 counts of conspiring to violate
federal food and drug laws and defraud individuals seeking medical
care. The indictment states that Bradford, C.R.B., and Bird marketed
bogus Lyme disease products and a microscope falsely claimed to
diagnose the disease and that Toth had used the system in his office.
In 2009, Carole Bradford was added as a co-defendant. In a separate
case, Carl E. Haese, owner/operator of The Haese Clinic of Integrative
Medicine in Las Cruces, New Mexico, has been charged with fraud in
connection with using Bradford's system [19].
Overuse of Intravenous Antibiotics
Many Lyme disease activists insist Lyme disease is a difficult-to-
treat, chronic infection that requires long-term consumption of
powerful antibiotics. (See common beliefs about Lyme disease at the
American College of Physicians.) Although decades of medical practice
and recent clinical trials suggest otherwise [20], many Lyme patients
still undergo expensive, long-term intravenous antibiotic treatments.
Outpatient intravenous therapy is a multi-billion-a-year business. It
remains largely unregulated and can cost patients thousands of dollars
per week. Price gouging, drug markups, kickbacks, and self-referral of
patients by physicians with financial ties to infusion companies have
occurred. In 1995, for example, Caremark, Inc., pled guilty to mail
fraud charges for entering into illegal contracts with physicians by
paying them to refer Medicaid patients to use Caremark's infusion
products [21]. In Michigan, prosecutors charged a physician and
Caremark employees with scheming to over bill Blue Cross/Blue Shield
for drugs and equipment for patients with Lyme disease [22].
More recently, Forbes magazine reported on the dangerous and expensive
practices of so-called "Lyme Literate Doctors" (LLMD) who rely on
powerful, long-term antibiotics to treat patients for presumptive Lyme
disease [23].
The long-term intravenous antibiotic therapy administered to Lyme
patients sometimes has disastrous results. During the early 1990s, the
CDC described 25 cases of antibiotic-associated biliary complications
among persons with suspected disseminated Lyme disease [24]. All
patients had received intravenous ceftriaxone for an average of 28
days for suspected Lyme disease. (Ceftriaxone can form precipitates in
the presence of bile salts. The resulting "sludge" can block the bile
duct.) Twelve patients subsequently developed gallstones. Fourteen
underwent cholecystectomy to correct bile blockage. Twenty-two
developed catheter-associated bloodstream infections. Yet most of the
patients lacked documented evidence of disseminated Lyme disease or
even antibodies to B. burgdorferi.In 2000, physicians reported the
death of a 30-year-old woman who died from an infected intravenous set-
up that had been left in place for more than two years. She was being
treated for a case of "chronic Lyme disease" that could not
unsubstantiated [25].
The risks and costs associated with such treatments were analyzed in a
1993 report whose authors concluded that for most patients with a
positive Lyme antibody titer and only symptoms of fatigue or
nonspecific muscle pains, the risks and costs of intravenous
antibiotic therapy exceed the benefits [26]. Yet fourteen years later,
these conclusions continue to be ignored by patients and physicians
alike.
In an Internet newsgroup posting, a woman described being on
intravenous antibiotic, Rocephin, for 4 weeks, developing gallstones,
and switching to another antibiotic regimen for three more weeks. She
also described a sudden high fever, anemia, low white cell count,
systemic pain, heart rhythm disturbance, and neurologic symptoms. Such
descriptions are common among devout Lyme patients and provide an
unsettling view into the desperate and dangerous measures some people
will take to treat suspected Lyme disease. The woman ended her account
by writing that she had switched her medication to ciprofloxacin. This
is a powerful antibiotic with side effects that may include acute
psychosis and other neuropsychiatric reactions [27]. Other online
"antibiotic addicts" have confessed to using veterinary and aquarium
antibiotics when they could not get physician prescriptions [28].
Another patient writing on the Internet said he was treated at a
Mexican clinic where the doctor admitted that he and his staff knew
little about Lyme disease. The patient wrote, "I started on IV
Rocephin (two grams a day), and later added oral azithromycin. My
symptoms did improved, but I soon hit a treatment plateau. We then
tried IV doxycycline, but this made me sick to my stomach." He went on
to describe a long list of other drugs (IV Claforan, Cefobid/Unisyn,
Premaxin, a second round of Cefobid/Uisyn, and IV Zithromax), followed
by bouts of "severe diarrhea" and phlebitis. Three months and some
$25,000 later, DMSO was added to another infusion of Zithromax.
Yet, the drug-seeking behaviors of self-described chronic Lyme
patients and the prescribing practices of many "Lyme Literate doctors"
remain at odds with published research. Investigators carried out two
treatment trials of patients claiming to suffer from chronic Lyme
disease. They reported that "treatment with intravenous and oral
antibiotics for 90 days did not improve symptoms more than
placebo" [29]. Additional studies in Europe and the U.S. similarly
found that: oral doxycycline is as effective as intravenous
ceftriaxone in treating late-stage central nervous system infections
[29,30]; and additional antibiotics are not beneficial in improving
cognitive function in patients with post-treatment chronic Lyme
disease [31].
In October 2006, the Infectious Diseases Society of America published
guidelines for effective intravenous (and oral) antibiotic regimens to
treat various manifestations of Lyme disease [16]. The European
Concerted Action on Lyme Borreliosis (EUCALB) also has published
recommendations for treating Lyme disease with various oral and
intravenous antibiotics.
Published treatment guidelines provide important navigation aids for
both physicians and patients. If you don't like the guidelines,
however, there is nothing to stop you from making up your own. That's
what one group of doctors did recently. They posted a set of Lyme
disease diagnosis and treatment guidelines on a website, and then
proceeded to follow the guidelines they had drafted. They referred to
their guidelines as "evidence-based," but there is no evidence that
the rationale for the guidelines has ever been validated in clinical
trials or published in the professional literature, and there is no
evidence that the guidelines have been endorsed by recognized medical
societies such as the American Academy of Pediatrics or the American
College of Physicians.
Indeed, the composers of these guidelines (copies of which they
offered for $15) are a handful of private practice physicians and Lyme
patient advocates. Some of these doctors have been disciplined by
their state medical licensing boards. Many are not trained in
infectious diseases and most have no research experience with Lyme
disease. Still, that did not prevent them from having their guidelines
listed in the National Guideline Clearinghouse or using that web
listing to suggest their guidelines are clinically appropriate and
professionally endorsed. (The Clearinghouse listing is a directory,
much like a phonebook, which neither endorses nor evaluates those
listed. Unfortunately, this fact is not readily evident to patients
looking for online information.)
"Herxing"
Many patients who believe they have a chronic or persistent Lyme
infection are willing to endure considerable discomfort in their
effort to get rid of their symptoms. This behavior is fostered, in
part, by the misguided belief that antibiotic therapies are not
working unless they make the patient feel worse. These patients
typically refer to this condition as "herxing," a colloquial term for
the Jarisch-Herxheimer (J-H) reaction. This reaction is an acute
response to the release of toxic or biologically active molecules from
certain types of bacteria in the presence of some antibiotics.
About 10% of patients treated for early Lyme disease experience a J-H
reaction involving chills, fever, muscle pains, rapid heartbeat, and
slight lowering of blood pressure during the first 24 hours of
antibiotic therapy. These symptoms usually last for several hours, and
require little more than aspirin and bed rest. Yet many Lyme newsgroup
participants write about a "herx" beginning days or weeks after the
start of antibiotic therapy, and "herxing" for weeks at a time-often
in a cyclic fashion." Herxing" events have even been likened to an
"exorcism" that is "a necessary evil to be endured." Some of these
patients are likely to be suffering from the side effects of their
inappropriately prescribed antibiotics. It is also safe to assume that
the mistaken belief that Lyme treatment involves temporary worsening
will lead some people to neglect other illnesses. Neurological
symptoms, blurred vision, gastrointestinal upset, vomiting, and
palpitations, for example, should be reported to a physician, not
posted on the Internet with a request for comments.
Tranmission Myths
Fear, ignorance and Internet rumors have also created an environment
for expanding the mythology of Lyme's protean properties far beyond
scientific fact or medical observation. For example, some Internet
postings and websites suggest that Lyme can be acquired through sexual
contact.
"I think that Lyme is also a STD [sexual-transmitted disease]," said
one newsgroup poster. Another wrote, "I've talked to many couples who
claim they transmitted to each other through sexual contact. I believe
I gave it to my wife."
At least a few LLMD appear to be telling patients that Lyme is
sexually transmitted and therefore their family members should be
tested. One person reported to Quackwatch that a family member had
been tested and told that the test was positive and that a 4-5 month
course of antibiotics was necessary.
There is no basis for such advice or beliefs. Lyme infections are
acquired from the bite of an infected tick. People are "dead end"
hosts and do not spread Lyme infections to others.
The topic of pregnancy and Lyme is also rife with rumor and
unnecessary fear. A recent review of case reports and other research
found no specific patterns of fetal malformation or adverse events in
pregnancy [32]. In addition, the authors noted that "larger
epidemiological and serological series have consistently failed to
demonstrate an increased risk to pregnant women who develop Lyme
disease if they receive appropriate antimicrobial therapy." Attempts
to demonstrate venereal, transplacental and contact transmission of
Lyme spirochetes in hamsters also have failed [33].
The risk of acquiring Lyme disease from a blood transfusion is also
very low. This was demonstrated in a study of patients in Connecticut
whose antibodies were measured six weeks after they received multiple
transfusions during cardiothoracic surgery. Of 155 subjects, 149
received a total of units of packed red blood cells and 48 received a
total of 371 units of platelets. No patient developed antibodies to B.
burgdorferi or clinical evidence of Lyme disease [34].
In contrast, a case of perinatal transmission of human granulocytic
ehrlichiosis (HGE) was reported in the New England Journal of Medicine
[35]. Like B. burgdorferi, HGE is transmitted by the Ixodes tick, and
simultaneous infections with both pathogens have been reported.
Political Aspects
The fact that Lyme disease is readily curable has not discouraged the
formation of over a hundred support groups and nonprofit foundations,
some with ties to intravenous services, Lyme diagnostic labs, and
physicians specializing in private Lyme disease practices. These
groups and their ardent followers have used the Internet and other
media to barrage politicians and the general public with
misinformation, dire personal stories, rumors, and exaggerated claims
about thousands of people being maimed, killed and bankrupted each
year by Lyme disease. The core message is that Lyme is a deadly
chronic disease that requires long-term antibiotic therapy paid for by
insurance companies.
Despite the alleged frequency of chronic Lyme disease, clinical trials
funded by the National Institutes of Health (NIH) were hampered by a
lack of patients who met evidence-based medical criteria for Lyme
disease. A third trial at Columbia University had to modify its
patient entry criteria in order to find enough patients to carry out
the study. The reality is Lyme remains a common bacterial infection
that is antibiotic-responsive, nonfatal, non-communicable, and
geographically- and seasonally-limited in range.
Still, support groups and individual patients have created numerous
websites that contain unsubstantiated claims, inaccurate medical
information, and personal testimonies for the dubious treatments
described above. Indeed, the Internet has provided a powerful
mechanism for organizing patients and presenting poorly documented
information to the public and the press [36,37]. And as the owner of
one Lyme diagnostic lab recently said, "Patients, because of the
Internet, have become my best salesmen" [23].
Internet newsgroups also have posted violent polemics against
physicians and researchers who disagree with their claims and
concerns. Research reports that run counter to the claims of Lyme
activists are denounced and their authors accused of incompetence and
financial conflicts of interest. Magazines and news organizations
whose stories on Lyme disease are not sufficiently hysterical are
barraged with e-mail complaints and urged to contact certain
organizations for "the truth." Protests have been organized to
denounce Yale University because, according to the protesters, Yale
"ridicules people with Lyme disease, presents misleading information,
minimizes the severity of the illness, endorses inadequate, outdated
treatment protocols, excludes opposing viewpoints, and ignores
conflicts of interest."
Researchers have been harassed, threatened, and stalked [38]. A
petition circulated on the Web called for changes in the way the
disease is routinely treated and the way insurance companies cover
those treatments. Less radical groups have had their meetings invaded
and disrupted by militant Lyme protesters. In October 2006, the New
Jersey-based Lyme Disease Association (LDA) led a series of protests
at NY Medical College to denounce the updated Lyme disease treatment
guidelines published by the IDSA. The LDA organized another online
petition against the guidelines, and a related LLMD organization
demanded the treatment guidelines be retracted. Evidently, they were
worried the guidelines would be accepted by insurance companies and
therefore cut into their private practice profits [23].
In November 2006, Lyme activists persuaded the Connecticut Attorney
General, Richard Blumenthal, to file a Civil Investigative Demand
(CID) to look into possible anti-trust violations by the IDSA during
the drafting of the treatment guidelines [39]. A few weeks later, the
activists persuaded Congressional Representative Chris Smith (R-NJ) to
write a letter to the CDC Director questioning the CDC's support of
the IDSA guidelines and suggesting CDC needed to show support for
alternative guidelines developed by activists and the private
practice, for-profit physicians who treat them.
The CDC declined to do so. Moreover, few lawyers and physicians
believe Blumenthal's quixotic use of anti-trust law to intimidate a
nonprofit professional society into changing or withdrawing voluntary
clinical guidelines is going to affect the treatment of Lyme disease.
Yet, these events demonstrate the power of Internet-connected
activists to mobilize political power in order to question evidence-
based medicine and peer-reviewed scientific research.
Not content to suppress evidence-based medicine through litigation and
legislation, some Lyme organizations also have tried to raise funds
for their own research on hyperbaric oxygen treatments, pregnancy-
related Lyme, and a clinical trial of chronic Lyme patients. Others
have organized "scientific" meetings and journals to present anecdotal
reports and opinions from physicians friendly to their cause.
Several years ago, a Lyme Disease Buyers Club marketed vitamin and
nutrient supplements (e.g., flax seed oil, evening primrose oil,
coenzyme Q10, garlic, B-complex) to Lyme patients. The club indicated,
"10 percent of each sale will go to Lyme disease research and advocacy
projects." However, the initial proceeds went to a Lyme disease
advocacy group (Lyme Alliance) in Michigan. The group filed an amicus
brief supporting a court appeal by Joseph Natole, Jr., M.D., whose
state medical board had sanctioned him for inappropriately managing
patients with actual or suspected Lyme disease. According to a report
on the Alliance's website: the court ruled against the doctor; his
license was suspended for three months; he was fined $50,000; and he
was subsequently indicted and pleaded guilty to federal charges of
over billing insurance companies.
The Alliance later circulated a petition stating that, "Lyme disease
can and does exist as a chronic illness with persisting infection, and
that the disease is greatly underdiagnosed and undertreated." The
petition demanded that, "Physicians who are on the front lines of Lyme
disease patient care not be harassed, persecuted or made to fear for
their medical practices because they do not adhere to the conservative
"short term" care for Lyme disease."
That defiant battle cry still echoes today. Activists continue to file
petitions and organize protests in support of any physician willing to
provide them with a positive Lyme disease diagnosis and long-term
access to antibiotics. Activists often attend state medical board
hearings in support of their physicians and flood state legislators
with demands for legislative protection of their doctors [40].
Currently, the Connecticut Department of Public Health is
investigating a doctor for violating "the applicable standard of
care," alleging that he diagnosed Lyme disease in children without
examining them, that he failed to consider other causes for their
symptoms, and that he improperly prescribed antibiotics. Since 2005,
several other so-called "Lyme Literate" doctors have been accused of
wrongdoing:
a.. A Kansas doctor was accused of murder after he gave one of his
patients bismacine injections to treat her Lyme disease. Bismacine
contains high amounts of bismuth, a metallic chemical that can be
poisonous and is not approved by the FDA.
a.. In South Carolina, the widow of a man who died of prostate
cancer filed suit against a Lyme doctor who gave her husband
intravenous hydrogen peroxide and falsely diagnosed him as having Lyme
disease. The doctor also prescribed testosterone, which caused his
cancer to rapidly advance, resulting in his death about six weeks
later.
a.. In North Carolina, the Medical Board suspended a physician's
license for one year after finding he departed from prevailing methods
of treating Lyme disease. The 12-member board also concluded he did
not adequately inform patients that his treatment method, which
includes months or years of intravenous antibiotics, is unorthodox.
Five patients, including the widower of a woman who died of morphine
poisoning while under his care, testified for the prosecution.
a.. In New Jersey, a doctor and former member of the Governor's Lyme
Disease Advisory Council took money from Lou Gehrig's disease patients
for a stem-cell treatment that she could not-and did not-perform,
according to a federal indictment. The doctor and her assistant were
charged with 11 counts of conspiracy, mail fraud, wire fraud and money
laundering.
a.. Another New Jersey doctor was indicted on charges of conspiracy
to defraud the United States, income tax evasion, and willful failure
to account for and pay IRS employee taxes at two Lyme disease
treatment centers.
Despite the deaths and the prosecutions, support for LLMDs remains
strong among activist groups, even as some of these doctors attempt to
expand the range of diseases that can be blamed on B. burgdorferi and,
therefore, treated with long-term antibiotics. Some of these diseases
include complex or degenerative illnesses such as autism, multiple
sclerosis and amyotrophic lateral sclerosis.
A Lyme Vaccine
After a decade of research, and pressure from patient advocates and
Congress [41], the FDA licensed the first vaccine for Lyme borreliosis
on December 21, 1998. The vaccine, called Lymerix, was derived from a
recombinant version of the bacterium's OspA lipoprotein. Lymerix was
intended for "at-risk" individuals between the ages of 15 and 70
years. Given in three separate injections, the vaccine appeared to be
effective in preventing infections.
Yet, after years of pre-license clinical trials and three years of
commercial sales, the manufacturer, GlaxoSmithKline, pulled the
vaccine off the market on February 26, 2002. The company cited poor
sales and a projected low demand [42] as the basis for their decision
to end production and distribution of Lymerix.
The demise of Lymerix has not ended research on new Lyme vaccine
candidates and vaccines against tick vectors. It may be difficult,
however, to field-test new vaccines due to anti-vaccination
organizations and the lingering hostility of Lyme activists to a
vaccine [43].
Ironically, many of the original advocates for a vaccine turned
against Lymerix as soon as it hit the market. Citing its less than
perfect efficacy and anecdotal evidence of vaccine-induced arthritis
and other injuries, they crowded FDA hearings with tales of personal
injury, flooded the Internet with anti-vaccine tautologies, and joined
lawsuits seeking compensation from Glaxo and Pasteur Mérieux
Connaught, the maker of a second, but never licensed vaccine [44].
Despite the lawsuits and the website tales of personal anguish,
repeated studies failed to find any evidence of specific adverse
events associated with Lymerix [45]. A CDC study published in the
February 2002 issue of Vaccine also failed to detect any "unexpected
or unusual patterns" of adverse reactions to vaccination [46].
(Reports of adverse reactions to Lymerix, and other vaccines, can be
searched for on the Vaccine Adverse Event Reporting System (VAERS)
website.)
It is interesting to note the results of a 2002 survey of parental
attitudes toward Lymerix [47]. The survey authors found that
respondents in Nassau County, New York indicated they would
"definitely" or "likely" request Lymerix for their children (23% and
65% respectively). The positive response to Lymerix may be because
most survey respondents got their information about Lyme disease and
the vaccine from a friend or an advertisement (49% and 44%,
respectively). The Internet was not identified as a source of
information. Yet, the survey found that most respondents were
"surprisingly misinformed" about Lyme infections. For example, they
considered Lyme infections to be a chronic, difficult-to-treat
disease.
"Chronic Lyme disease" remains the favored term of support groups and
patient advocates, but has no basis in medical fact or practice [7].
The endless public repetition of this misleading mantra may have
influenced parental opinions in favor of vaccination as a means of
preventing a chronic infection that does not exist. The option to
vaccinate ended on February 26, 2002.
Interestingly, a recent study of patients presenting with recurrent
signs of Lyme disease suggests that they are being repeatedly infected
and not "relapsing" from a persistent infection [4]. The study authors
noted, "People experiencing recurrent episodes [of Lyme] tended to
have frequent contact with vector ticks. Prompt administration of
standard antibiotic therapy.reliably eliminates persistent infection
and prevents relapse." This is just what the vaccine was designed to
do.
Reliable Resources
In 2004, two infectious disease specialists at the University of
Connecticut reviewed the quality of online information about Lyme
disease [36]. Most of the websites they surveyed contained inaccurate
or incomplete information. One of the authors, Henry Feder, told
Reuters Health, "The problem is that some of these sites may have had
an agenda other than education. They make the unusual seem common." As
the authors noted in their paper, "The challenge for medical providers
is to convince worried patients . . . that some of the Internet-
recommended testing and treatment . . . is inappropriate. This
convincing can take multiple visits, debate, compromise and time."
The steady flood of Lyme disease misinformation prompted Kent
Sepkowitz, the director of infection control at Sloan-Kettering, to
vent similar feelings in the New York Times (May 10, 2005). He wrote:
"The vast, lumpy terrain of Lyme disease is a confusing place for
doctor and patient alike. According to some, Lyme is able to cause any
imaginable symptom, yet laboratory diagnosis remains famously elusive.
This combination of plasticity and stealth makes it a convenient
explanation for any ailment that otherwise makes no sense."
Despite the Internet noise, fundraising letters from activists, and
intimidating lawsuits, it is not difficult to find accurate
information about Lyme disease. Most state health departments provide
free brochures or direct online information. Good sources include:
a.. U.S. Centers for Disease Control and Prevention (CDC)
b.. American Lyme Disease Foundation (ALDF)
c.. Infectious Disease Society of America's Lyme Disease Treatment
Guidelines
d.. University of Rhode Island's Tick Encounter Resource Center
e.. European Union Concerted Action on Lyme Borreliosis (EUCALB)
f.. Aetna Coverage Policy Bulletin 0215: Lyme Disease
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