Subject: "Lyme Disease" treatment "side effects" argument a lie
Date: Jul 17, 2010 8:41 AM
ARTICLE BELOW = More Lyme nonsense
from Yale/UConn's Peter Krause, Corruptor
of CT.gov DPH science.
============================================
Um, no. The "side effects" study
by Lenny (Munchmeister
http://www.actionlyme.org/MUNCHAUSENS.htm
Sigal demonstrated that whoever
performed gallstone surgery on his
New Jersey patients committed malpractice.
The "gallstones" from ceftrixone
are pseudogallstones:
http://www.actionlyme.org/DEBUNKING_THE_CEF_IS_BAD_STUDY.htm
11/1352 patients with a maybe problem equals 0.8%.
Feel free to do the math yourselves.
It was something less than 11 out of
1352 patients who ended up having
anything at all in their gallbladders.
It in fact, may have been none, if you
read the report carefully.
It was less than one percent. And at that
we don't even know if one case of surgery
for "ceftriaxone-induced gallstones" was
necessary, nor do we know if the micro-stones
were due to ceftriaxone. They could have been
there before treatment.
PICC line infections are *well* *below,*
percentage-wise, of people who pick up
hospital-acquired (MRSA) infections.
This, below, is yet another outright lie told
about Lyme by the people who tried to put out
an immune-suppressing vaccine that gave
people the New Great Imitator/activated,
opportunistic viral and fungal infections
that are "multisystem complaints characterized
by later presentations of Lyme."
It's only a matter of time before most
people come to understand that OspA was
the cause of the "disease." There is no
vaccine against tuberculosis. The
hysterical reactions performed by IDSA
all these years over what "Lyme Disease"
is and how it should not be treated amounted
to nothing.
All they got was lawsuits, legislated-over,
and we got to watch the fool Fauci giggle
his way thru the WaPo "On Leadership" series,
having been given an award for his incompetence
by none other than Mort Zuckerman:
http://www.washingtonpost.com/wp-dyn/content/video/2009/02/12/VI2009021203091.html
sponsor of the Lyme Cryme gang:
http://www.actionlyme.org/ALDF_BOARD.htm
ROTFL
Duh.
Kathleen M. Dickson
http://www.actionlyme.org
================================================
http://www.capecodonline.com/apps/pbcs.dll/article?AID=/20100717/NEWS/7170319/-1/NEWSMAP
Law clears aggressive Lyme disease therapy
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By Cynthia Mccormick
cmcco...@capecodonline.com
July 17, 2010
A new state law that spells out the rights of physicians to treat
chronic Lyme disease patients with long-term antibiotics is being
heralded as a victory by advocates of people afflicted by the tick-
borne illness.
The law is meant to prevent doctors who treat patients with
antibiotics beyond the 30 days recommended by some professionals from
billing insurance, said Brenda Boleyn, who chairs the Cape and Islands
Lyme Disease Task Force, a community organization comprised of local
government, agencies and Lyme disease patients.
Barnstable county rates drop
While cases of Lyme disease are climbing across Massachusetts, state
public health officials report a decline on Cape Cod, based on 2008
figures, the latest available.
For years, Barnstable County, which includes all of Cape Cod, has had
the third-highest incidence of the tick-borne disease in the state,
after Nantucket and Dukes counties. But in 2008, the latest year for
which the state Department of Public Health has figures, Berkshire,
Franklin and Plymouth counties topped the Cape for the most cases per
100,000 people.
Nantucket County and Dukes County on Martha's Vineyard maintained
their status as the Lyme disease capitals of Massachusetts with the
highest concentrations of the disease in the state.
Advocates for people with Lyme disease say many more people are
treated for Lyme than are reported to the state as confirmed cases.
Statewide, the number of Lyme cases jumped from 2,494 in 2006 to 3,946
in 2008, a leap of 58 percent.
CYNTHIA MCCORMICK
While short courses of antibiotics appear to work when Lyme is
detected in its early stages, more aggressive and longer treatment
seems to be the only solution for seemingly intractable cases of Lyme,
Boleyn said.
Advocates for people with Lyme have accused a physician group, the
Infectious Diseases Society of America, of discouraging insurers from
paying for aggressive treatment by saying that long-term antibiotic
treatment is not proven to be effective and may even be dangerous.
The society's guidelines say 95 percent of cases of Lyme disease are
cured with 10 to 28 days of oral antibiotics.
Last year, Connecticut passed a similar law, protecting physician
prescribers of long-term antibiotics from action by state health
regulators.
Nancy Wood of West Barnstable had Lyme disease that went undetected
for six to seven years. She required three to four years of oral
antibiotics to get better, said Wood, who chairs the Cape Cod chapter
of the Lyme Disease Association, a national nonprofit patient advocacy
group that, among other activities, supports long-term treatment.
"I'm doing great. I have my life back," she said. "So do a lot of
other people" who have been treated aggressively, said Woods, who went
to a physician in New York as well as one in Falmouth.
The original bill was filed four years ago by former state Rep.
Shirley Gomes, R-Harwich. She patterned it on a Rhode Island bill that
sought to protect doctors who treated chronic Lyme disease patients.
The Massachusetts bill ended up on the desk of Gov. Deval Patrick at
the end of June as an amendment to the state budget. Since Patrick did
not veto the language, it became law, said Jennifer Kritz,
spokesperson for the state Executive Office of Health and Human
Services.
Having non-physicians write law about how to practice medicine "is
kind of dangerous, I think," said Dr. Alan Sugar, who follows IDSA
guidelines and heads the infectious disease department at Cape Cod
Hospital.
"The problem is that antibiotics have side effects," said Dr. Peter J.
Krause, a senior research scientist at the Yale University School of
Public Health. He spoke on Nantucket last week at a conference on Lyme
disease.
People with persistent symptoms may no longer harbor the bacteria that
initially caused Lyme disease, meaning that antibiotic treatment won't
help, Krause said. Evidence suggests that something else may be
causing their immune reactions, he said.
But Dr. John N. Aucott, a physician at Johns Hopkins in Baltimore and
president and founder of the Lyme Disease Research Foundation, which
studies Lyme disease, said he believes no one knows what causes
chronic or late-stage Lyme.
"What we have here are professional disagreements," Boleyn said.
Until there is better testing, physicians have to be allowed to rely
on their own judgment in treating Lyme patients, she said.
HOME
KMDickson
Enbrel
Adverse Reactions in Adult Patients with RA, Psoriatic Arthritis,
Ankylosing Spondylitis, or Plaque Psoriasis
Enbrel® has been studied in 1442 patients with RA, followed for up to
80 months, in 169 patients with psoriatic arthritis for up to 24
months, in 222 patients with ankylosing spondylitis for up to 10
months, and 1261 patients with plaque psoriasis for up to 15 months.
In controlled trials, the proportion of Enbrel®-treated patients who
discontinued treatment due to adverse events was approximately 4% in
the indications studied. The vast majority of these patients were
treated with 25 mg SC twice weekly. In plaque psoriasis studies,
Enbrel® doses studied were 25 mg SC once a week, 25 mg SC twice a
week, and 50 mg SC twice a week.
Injection Site Reactions
In controlled trials in rheumatologic indications, approximately 37%
of patients treated with Enbrel® developed injection site reactions.
In controlled trials in patients with plaque psoriasis, 14% of
patients treated with Enbrel® developed injection site reactions
during the first 3 months of treatment. All injection site reactions
were described as mild to moderate (erythema and/or itching, pain, or
swelling) and generally did not necessitate drug discontinuation.
Injection site reactions generally occurred in the first month and
subsequently decreased in frequency. The mean duration of injection
site reactions was 3 to 5 days. Seven percent of patients experienced
redness at a previous injection site when subsequent injections were
given. In post-marketing experience, injection site bleeding and
bruising have also been observed in conjunction with Enbrel® therapy.
Infections
In controlled trials, there were no differences in rates of infection
among RA, psoriatic arthritis, ankylosing spondylitis, and plaque
psoriasis patients treated with Enbrel® and those treated with placebo
(or MTX for RA and psoriatic arthritis patients). The most common type
of infection was upper respiratory infection, which occurred at a rate
of approximately 20% among both Enbrel®- and placebo-treated patients
in RA, psoriatic arthritis, and AS trials, and at a rate of
approximately 12% among both Enbrel®- and placebo-treated patients in
plaque psoriasis trials in the first 3 months of treatment.
In placebo-controlled trials in RA, psoriatic arthritis, ankylosing
spondylitis, and plaque psoriasis no increase in the incidence of
serious infections was observed (approximately 1% in both placebo- and
Enbrel®-treated groups). In all clinical trials in RA, serious
infections experienced by patients have included: pyelonephritis,
bronchitis, septic arthritis, abdominal abscess, cellulitis,
osteomyelitis, wound infection, pneumonia, foot abscess, leg ulcer,
diarrhea, sinusitis, and sepsis. The rate of serious infections has
not increased in open-label extension trials and is similar to that
observed in Enbrel®- and placebo-treated patients from controlled
trials. Serious infections, including sepsis and death, have also been
reported during post-marketing use of Enbrel®. Some have occurred
within a few weeks after initiating treatment with Enbrel®. Many of
the patients had underlying conditions (e.g., diabetes, congestive
heart failure, history of active or chronic infections) in addition to
their rheumatoid arthritis. Data from a sepsis clinical trial not
specifically in patients with RA suggest that Enbrel® treatment may
increase mortality in patients with established sepsis.9
In patients who received both Enbrel® and anakinra for up to 24 weeks,
the incidence of serious infections was 7%. The most common infections
consisted of bacterial pneumonia (4 cases) and cellulitis (4 cases).
One patient with pulmonary fibrosis and pneumonia died due to
respiratory failure.
In post-marketing experience in rheumatologic indications, infections
have been observed with various pathogens including viral, bacterial,
fungal, and protozoal organisms. Infections have been noted in all
organ systems and have been reported in patients receiving Enbrel®
alone or in combination with immunosuppressive agents.
In clinical trials in plaque psoriasis, serious infections experienced
by Enbrel®-treated patients have included: cellulitis,
gastroenteritis, pneumonia, abscess, and osteomyelitis.
In global clinical studies of 20,070 patients (28,308 patient-years of
therapy), tuberculosis was observed in approximately 0.01% of
patients. In 15,438 patients (23,524 patient-years of therapy) from
clinical studies in the US and Canada, tuberculosis was observed in
approximately 0.007% of patients. These studies include reports of
pulmonary and extra-pulmonary tuberculosis.
Malignancies
Patients have been observed in clinical trials with Enbrel® for over
five years. Among 4462 rheumatoid arthritis patients treated with
Enbrel® in clinical trials for a mean of 27 months (approximately
10000 patient-years of therapy), 9 lymphomas were observed for a rate
of 0.09 cases per 100 patient-years. This is 3-fold higher than the
rate of lymphomas expected in the general population based on the
Surveillance, Epidemiology, and End Results Database.10 An increased
rate of lymphoma up to several fold has been reported in the
rheumatoid arthritis patient population, and may be further increased
in patients with more severe disease activity11, 12. Sixty-seven
malignancies, other than lymphoma, were observed. Of these, the most
common malignancies were colon, breast, lung, and prostate, which were
similar in type and number to what would be expected in the general
population.10 Analysis of the cancer rates at 6 month intervals
suggest constant rates over five years of observation.
In the placebo-controlled portions of the psoriasis studies, 8 of 933
patients who received Enbrel® at any dose were diagnosed with a
malignancy compared to 1 of 414 patients who received placebo. Among
the 1261 patients with psoriasis who received Enbrel® at any dose in
the controlled and uncontrolled portions of the psoriasis studies
(1062 patient-years), a total of 22 patients were diagnosed with 23
malignancies; 9 patients with non-cutaneous solid tumors, 12 patients
with 13 non-melanoma skin cancers (8 basal, 5 squamous), and 1 patient
with non-Hodgkin’s lymphoma. Among the placebo-treated patients (90
patient-years of observation) 1 patient was diagnosed with 2 squamous
cell cancers. The size of the placebo group and limited duration of
the controlled portions of studies precludes the ability to draw firm
conclusions.
Among 89 patients with Wegener’s granulomatosis receiving Enbrel® in a
randomized, placebo-controlled trial, 5 experienced a variety of non-
cutaneous solid malignancies compared with none receiving placebo.
Immunogenicity
Patients with RA, psoriatic arthritis, ankylosing spondylitis, or
plaque psoriasis were tested at multiple timepoints for antibodies to
Enbrel®. Antibodies to the TNF receptor portion or other protein
components of the Enbrel® drug product were detected at least once in
sera of approximately 6% of adult patients with RA, psoriatic
arthritis, ankylosing spondylitis, or plaque psoriasis. These
antibodies were all non-neutralizing. Results from JIA patients were
similar to those seen in adult RA patients treated with Enbrel®.
In PsO studies that evaluated the exposure of etanercept for up to 120
weeks, the percentage of patients testing positive at the assessed
time points of 24, 48, 72, and 96 weeks ranged from 3.6%- 8.7% and
were all non-neutralizing. The percentage of patients testing positive
increased with an increase in the duration of study, however, the
clinical significance of this finding is unknown. No apparent
correlation of antibody development to clinical response or adverse
events was observed. The immunogenicity data of Enbrel® beyond 120
weeks of exposure is unknown.
The data reflect the percentage of patients whose test results were
considered positive for antibodies to Enbrel® in an ELISA assay, and
are highly dependent on the sensitivity and specificity of the assay.
Additionally, the observed incidence of any antibody positivity in an
assay is highly dependent on several factors including assay
sensitivity and specificity, assay methodology, sample handling,
timing of sample collection, concomitant medications, and underlying
disease. For these reasons, comparison of the incidence of antibodies
to Enbrel® with the incidence of antibodies to other products may be
misleading.
Autoantibodies
Patients with RA had serum samples tested for autoantibodies at
multiple timepoints. In RA Studies I and II, the percentage of
patients evaluated for antinuclear antibodies (ANA) who developed new
positive ANA (titer ≥ 1:40) was higher in patients treated with
Enbrel® (11%) than in placebo-treated patients (5%). The percentage of
patients who developed new positive anti-double-stranded DNA
antibodies was also higher by radioimmunoassay (15% of patients
treated with Enbrel® compared to 4% of placebo-treated patients) and
by Crithidia luciliae assay (3% of patients treated with Enbrel®
compared to none of placebo-treated patients). The proportion of
patients treated with Enbrel® who developed anticardiolipin antibodies
was similarly increased compared to placebo-treated patients. In Study
III, no pattern of increased autoantibody development was seen in
Enbrel® patients compared to MTX patients.
The impact of long-term treatment with Enbrel® on the development of
autoimmune diseases is unknown. Rare adverse event reports have
described patients with rheumatoid factor positive and/or erosive RA
who have developed additional autoantibodies in conjunction with rash
and other features suggesting a lupus-like syndrome.
Other Adverse Reactions
Table 10 summarizes events reported in at least 3% of all patients
with higher incidence in patients treated with Enbrel® compared to
controls in placebo-controlled RA trials (including the combination
methotrexate trial) and relevant events from Study III. In placebo-
controlled plaque psoriasis trials, the percentages of patients
reporting injection site reactions were lower in the placebo dose
group (6.4%) than in the Enbrel® dose groups (15.5%) in Studies I and
II. Otherwise, the percentages of patients reporting adverse events in
the 50 mg twice a week dose group were similar to those observed in
the 25 mg twice a week dose group or placebo group. In psoriasis Study
I, there were no serious adverse events of worsening psoriasis
following withdrawal of study drug. However, adverse events of
worsening psoriasis including three serious adverse events were
observed during the course of the clinical trials. Urticaria and non-
infectious hepatitis were observed in a small number of patients and
angioedema was observed in one patient in clinical studies. Urticaria
and angioedema have also been reported in spontaneous post-marketing
reports. Adverse events in psoriatic arthritis, ankylosing
spondylitis, and plaque psoriasis trials were similar to those
reported in RA clinical trials
Read more: http://www.drugs.com/sfx/enbrel-side-effects.html#ixzz0uNvmJAXY
On Jul 17, 8:43 am, Mort Zuckerman <morph...@yahoo.com> wrote:
> To: dwhe...@forbes.com, ca...@drcarolgoodheart.com,
> lPicker...@cdc.gov, Durland.f...@yale.edu, A...@columbia.edu,
> gary_worm...@nymc.edu, scientificintegr...@ostp.gov,
> pkrug...@princeton.edu, Stanley.f...@fiu.edu,
> emcswee...@niaid.nih.gov, afa...@niaid.nih.gov,
> SpinL...@yahoogroups.com, kshep...@calea.org, fitz...@gmail.com,
> patrick.fitzger...@usdoj.gov, modelt1...@sbcglobal.net,
> jdra...@nejm.org, lett...@courant.com, Jgerberd...@cdc.gov,
> michael.c...@po.state.ct.us, conn...@po.state.ct.us, executive-
> edi...@nytimes.com, managing-edi...@nytimes.com, news-
> t...@nytimes.com, biz...@nytimes.com, fore...@nytimes.com,
> natio...@nytimes.com, dv...@cdc.gov, brigidcalla...@optonline.net,
> t...@hotmail.com, illinoisl...@aol.com, jlen...@courant.com,
> tinajgar...@yahoo.com, jhornber...@fff.org, thomas.car...@usdoj.gov,
> thomas.r...@po.state.ct.us, kur...@washpost.com,
> georgew...@washpost.com, p...@allegorypress.com,
> commissioner....@po.state.ct.us, bransfi...@comcast.net,
> vtsh...@comcast.net, o...@po.state.ct.us, freethin...@charter.net,
> scott.mur...@po.state.ct.us, governor.r...@po.state.ct.us,
> attorney.gene...@po.state.ct.us, randall.samb...@usdoj.gov,
> Robert.shil...@yale.edu, edi...@greenwich-post.com,
> harold....@yale.edu, sedmo...@nswbc.org, rrmcgov...@aol.com,
> fr...@nytimes.com, dpr...@stmartin.edu, saint.mich...@sbcglobal.net,
> ksulli...@rockpointe.com
> Cc: fran...@ucia.gov, dr-ahmadine...@president.ir,
> eugenerobin...@washpost.com, afa...@niaid.nih.gov,
> bmil...@newstimes.com, t...@hotmail.com, rastr...@aol.com,
> billcurr...@gmail.com, amcgui...@rms-law.com, rjmur...@aol.com,
> paulcraigrobe...@yahoo.com, criminal.divis...@usdoj.gov,
> karla.dobin...@usdoj.gov, christopher.chris...@usdoj.gov,
> richard.Le...@yale.edu, harold....@yale.edu, james.phill...@yale.edu,
> inqu...@aldf.com, l...@idsociety.org, meganmcar...@theatlantic.com
>
> Subject: "Lyme Disease" treatment "side effects" argument a lie
>
> Date: Jul 17, 2010 8:41 AM
>
> ARTICLE BELOW = More Lyme nonsense
> from Yale/UConn's Peter Krause, Corruptor
> of CT.gov DPH science.
>
> ============================================
>
> Um, no. The "side effects" study
> by Lenny (Munchmeisterhttp://www.actionlyme.org/MUNCHAUSENS.htm
> by none other than Mort Zuckerman:http://www.washingtonpost.com/wp-dyn/content/video/2009/02/12/VI20090...
> sponsor of the Lyme Cryme gang:http://www.actionlyme.org/ALDF_BOARD.htm
>
> ROTFL
>
> Duh.
>
> Kathleen M. Dicksonhttp://www.actionlyme.org
> ================================================
>
> http://www.capecodonline.com/apps/pbcs.dll/article?AID=/20100717/NEWS...
>
> Law clears aggressive Lyme disease therapy
> Text Size: A | A | A
> Print this ArticlePrint this Article Email this ArticleEmail this
> Article
> ShareThis
>
> By Cynthia Mccormick
> cmccorm...@capecodonline.com
Kathleen
http://www.actionlyme.org
I AGREE 100% with you....
You will notice that the Lyme
pricks haven't published anything
in a while. No one *believes* their
insane crap and they were de-funded,
LOL.
K