Re: Hey Phyllis, We're Waiting...

a_weisman_at_yahoo.com
Date: 01/03/05 

Date: 2 Jan 2005 18:29:11 -0800

pmerv@direcway.com wrote:
> Dear Mr. Weisman:
>
> Blaming the advisory committee for the outcome of the NEMC trial is
> like blaming a rape victim for being raped.

NO that is an entirely false and absurd analogy.

YOU sat by idly while a study design that could only produce two
outcomes, both bad for Lymeland, was adapted. It was entirely
forseeable, and forseen, the results. Totally predictable.

Did you speak out? Dissent? Did you KNOW what you could and could not
do as a panel member? What your authority was? What rules applied? Was
this a FACA committee? If so, does FACA provide any rights or
requirements that might have allowed you to use them to actually make a
difference?

Outcome #1: "Long term treatment" as prescribed in the study, does not
"cure" chronic Lyme disease (if there even IS such a thing?)

Outcome #2: "Long term treatment" as defined and prescribed in the
study, DOES cure chronic Lyme disease, and that is ALL the treatment
necessary (IF there is even such a thing as Chronic Lyme Disease).

So, 30 days of IV and sixty days of orals either doesn't work or it
does.

Wow!

So a totally unrepresentative group of patients either succeeds or
fails on a strawman test of what "long term treatment" is really in
Lymeland.

At the starting gate you had already conceded the race. YOu had already
allowed that Burrascano style treatment was not justified. Because he
might treat for months and months and months and years, but now 30 days
of IVs and 60 days of orals, either was or was not a cure.

Either way how COULD that have helped ANYONE with chronic Lyme disease?

How could it have helped the doctors treating a la burrascano?

Don't you get that Phyllis?

And Phyllis, AGAIN I am asking:

What DID you do? Attend some meetings? Did you speak up? Did you
prepare a written dissent? Did you circulate a critique of study
design? Go on record?

Did you speak out? Dissent? Did you KNOW what you could and could not
do as a panel member? What your authority was? What rules applied? Was
this a FACA committee? If so, does FACA provide any rights or
requirements that might have allowed you to use them to actually make a
difference?

Come on, you're a "leader."

Share with the "led."

Dish,girlfriend.

Be accountable.

Don't the people you claimed and still claim to represent, have a right
to know?
========================================================================

http://www.nlm.nih.gov/databases/alerts/lyme.html

Clinical Alert: Chronic Lyme Disease Symptoms Not Helped by Intensive
Antibiotic Treatment
National Institute of Allergy and Infectious Disease (NIAID)
12 June 2001

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
patients 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."

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.

--------------------------------------------------------------------------

Reference

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.

Last updated: 15 June 2001
First published: 12 June 2001
Metadata| Permanence level: Permanent: Unchanging Content

Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD
20894

National Institutes of Health, Health & Human Services

>people lied to us and
> things happened behind scenes that we were not privy to.

Well it was the REAL WORLD, Phyllis.

What did you expect? The people who disagreed with this to start were
being forced to do a study to prove themselves wrong, due to the
popular outcry, something they hate anyway--politics to them, NOT
science. So did you do any of the above Phyllis?

And don't you think that the fact that YOU were LIED to would stop you
and others from LYING to us now?

A point I've made previously. And, when you're just honestly wrong,
i.e, incompetent, and the truth is demonstrated to you, and you keep
repeating something you know or should know or have to know at THAT
point is wrong...well I have a problem with that. I thinkn at some
point what might start as incompetence, or malfeasance, let's say,
becomes a LIE, or let's say MISfeasance.

Either way it ain't pretty.

>Of course the
> outcome was predictable - that is easy to see in retrospect, and
> indeed, we suspected the outcome was predetermined.

Well MANY predicted it IN ADVANCE.

And the second part of your statement is AMAZING Phyllis.

You "suspected the outcome was predetermined"

You "suspected the outcome was predetermined"

You "suspected the outcome was predetermined"

You "suspected the outcome was predetermined"

And that is you defending what you did then? Or, rather, what you did
NOT do!

And Phyllis, AGAIN I am asking:

What DID you do? Attend some meetings? Did you speak up? Did you
prepare a written dissent? Did you circulate a critique of study
design? Go on record?

Did you speak out? Dissent? Did you KNOW what you could and could not
do as a panel member? What your authority was? What rules applied? Was
this a FACA committee? If so, does FACA provide any rights or
requirements that might have allowed you to use them to actually make a
difference?

Come on, you're a "leader."

Share with the "led."

Dish,girlfriend.

Be accountable.

Don't the people you claimed and still claim to represent, have a right
to know?
>the point is, if
> you are offered a slot on the advisory committee, do you accept and
do
> what you can, or do you refuse to take part (assuming anyone would
> care)?

Phyllis, if you are offered a "slot" (aka a "Seat at the table") you
need to make a choice, not automatically accept. And once you've
accepted, resigning (and perhaps making a PR statement WHY) has a power
of its own.

Phyllis, I think that you really were a lamb led to slaughter. What
bothers me is that shouldn't have taken the position if you weren't
prepared to do the job.

The job was NOT to just go along to get along. And I am willing to bet
that you had then and have now, no real idea of what you could have
done or should have done.

But, of course, I have no idea what you did do.

AGAIN I am asking:

What DID you do? Attend some meetings? Did you speak up? Did you
prepare a written dissent? Did you circulate a critique of study
design? Go on record?

Did you speak out? Dissent? Did you KNOW what you could and could not
do as a panel member? What your authority was? What rules applied? Was
this a FACA committee? If so, does FACA provide any rights or
requirements that might have allowed you to use them to actually make a
difference?

Come on, you're a "leader."

Share with the "led."

Dish,girlfriend.

Be accountable.

>I don't really have time to provide all the documentation you
> are asking for, besides, much of what I did does not have a written
> record (participation in meetings, phone calls, etc.). Besides, at
this
> point the NEMC trial is ancient history. We are now focusing on the
> results of the Columbia trial.

NO Phyllis. You absolutely do not "get it" do you?

Did YOU LEARN anything from the first trial?

Really?

If so what?

So of course "we" as in those who were lanbs and who led other lambs to
slaughter, are "focusing non the results of the Columbia Trial."

Are they really so great as you read them? How do they really help?

Has anything changed as a result, as happened after the Klempner study?

When's phase 2?

> I am also not willing to post on this forum information that could be
> termed libelous, however this information is known to the people I
work
> with, and determines who I am willing to work with in the Lyme
> community.

Well Phyllis, LIBELOUS has a meaning.

And, you might be suprised, But TRUTH is an ABSOLUTE DEFENSE.

And OPINION is PROTECTED SPEECH.

> Your continual attacks on me and others I respect do not dispose me
to
> inconvenience myself merely to satisfy your curiosity;

Still you do not "get it."

You CLAIM to be a LEADER.

Those you claim to LEAD have a RIGHT TO KNOW.

Leaders have to be accountable.

> also judging
> from your response to previous posts I have made, I doubt having more
> information would change your mind anyway.

It isn't only me who's asking Phyllis. I represent the people's right
to know.

Explain to us. Share with us. Dish. What happened? What did you learn?

>If there are any links on
> the internet to statements I have made, you can search for them.

You don't have a file yourself? Your entire repotorie consists of
advertisements for "the pat" and her evil Lyme empire?

>Unlike
> some people, I always use my real name.

What a tremendous accomplishment!

So freaking what Phyllis? If someone doesn't use their real name, does
that mean that what they have to say is invalid? Huh?

>You can find my critique of the
> NIH clinical trial under public documents on the calda.intranets
site.
> I sent it to NIH with my letter when the advisory committee was
> disbanded (with copies to various legislators, none of whom
responded).

No I cannot find it. Your site is dysfunctional. Try to click on some
of the links. It doesn't work.

And IF IN RETROSPECT you did (and WHEN did you?) write a letter upond
the disbanding of the committee, which was months and months after the
conclusion of the Klempner study, and no one responded, what did you do
about that?

Did you think, perhaps, of making that an issue? PUBLICLY? Put some
PRESSURE on them? Damage THEIR credibility?

Huh?

> You are welcome to visit our websites and see what CALDA has been
doing
> and download any materials that may be useful to you.

Gee thanks! First, you're inviting me to use the internet? Thanks, I
guess now that I have YOUR approval, it is like a cyber hall pass?

Feel free to use the internet Luke...

Thanks Phyllis!

And SECOND, your FREAKING WEBSITE DOESN'T WORK!

> Please don't
> expect me to respond in detail to any future questions/challenges
from
> you.

Well why would I expect you to respond? YOu haven't done it now nor
have you ever done so before.

So, like, what's new? You haven't answered, have no answers, don't
think you should have to answer, and just won't.

> You talk as though you offered good ideas that Lyme leaders rejected.
> You apparently interpret this as a personal rejection. If your
> communication style on this newsgroup is an example of your
> communication style in real life, I am not surprised.

I've already said that ideas were offered by MANY and no matter how
they were put they were rejected. Because YOU who knew then and know
now with great moral certainty that YOU KNOW BEST.

You're style of leadership has a name.

It is autocracy.

It is dictatorship.

> Phyllis Mervine, President
> California Lyme Disease Association
> Affiliate of the Lyme Disease Association, Inc.
> PO Box 1423
> Ukiah, CA 95482

How many people are "members" of CALDA, Phyllis. How many people do you
represent in that capacity? How did you come to be a "leader?" Is your
"leadership" subject to any vote, any review? Are you, in any way,
accountable to anyone?

Oh yeah, IGENEX. LOL

> Check our websites
> calda.intranets.com
> www.lymedisease.org
> www.lymetimes.org
>
>
> --
> Phyllis Mervine, President
> California Lyme Disease Association
> Affiliate of the Lyme Disease Association, Inc.
> PO Box 1423

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