Re: Urgent notice on Congressional letter

a_weisman_at_yahoo.com
Date: 01/15/05 

Date: 15 Jan 2005 11:40:24 -0800

GregGerber wrote:
> Weisman, why not wait until I get the documentation and information
in
> full. I am not saying you are wrong --though I think you are missing
> the exact history here, and are not precisely right; let us wait
until
> I have the material, and I will post it here. I believe this bill
> called for a report to be issued back to Congress on the
"instructions"
> or "recommendations," and I think NIH was instructed by this
launguage
> and did follow through. That is my information. But your questions
are
> valid and reasonable, I will nail it down to provide an answer.
Please
> wait until I do. You have raised legitimate questions, but there
simply
> is no more point in debating it until there are solid facts before
us.
> You have pointed to a dearth of documentation for what I have said,
and
> I agree; now let me get the documents and then we can talk further.
GG

Sure that is the most reasonable thing and admittedly some of the
details
in my story may be a bit off.

I still think the overall plot is about right.

But we'll talk more with a bit more information in hand.

I will say that this entire thread (or threads) have informed me
about some things I never knew about and/or forgot and all of this,
along with
the passage of time and a fresh, more fully informed view, gives me a
different
perspective on the NIH stud(ies).

I've had to rethink some of the autoimmunity stuff and rethink some of
the issues
of study design.

I was one of the few who thought from the beginning that the PCR
exclusion wasn't
an issue because it didn't seem to me to predispose the results. But on
rethinking
it I think the PCR exclusion does have (theoretical) importance (not
actual since as
you point out Klempner CLAIMS that there were no PCR positives).

But the ethical issue looks like an excuse; a distinction without a
difference and
then one thinks that maybe there is another reason behind the excuse.
That it didn't
perhaps predispose the results of antibiotic success or failure yes
but, and this is
informed by your points, that the selection of those more likely to be
"autoimmune" was
the REAL reason. At least from a study design standpoint.

In fact the study design on fuller reflection (informed by your
insights and those of Der
dritte mann and some of the comments at the time by Rita, and others
who spoke out)
was never about antibiotic treatment at all. Because if it were it
would have been a
multi staged study. If one month of IV and two months of orals didn't
work, the next
stage would have been two months of IV and four months of orals; the
next three months of IV
followed by six months of orals, until finally we were really testing
burrascano like
treatment--open ended and based on symptomatic response--an objective
look at the empiric
treatment, with follow up to see outcomes.

But the antibiotics were an excuse, a tease, a sop, a loss leader. To
get the patients
in the door and pay lip service to the Lyme community, where the real
study was all
about autoimmunity from start to finish not about persistent infection
or the optimal
treatment duration (another stage of the study would have looked for
optimal drug choice
using one month of Claforan followed by two months of biaxin; and then
two months of claforan
followed four months of biaxin etc, using one drug after another.

And there would have been close examination of the role of
coinfections.

But this was never an infectious disease study at all, was it? That was
a
stalking horse for autoimmunity.

And that's the real dirty truth behind Lyme disease research for all
these years;
it is about "auto immunity" not infection.

After all the paradigm for Lyme was created by rheumatologists NOT
infectious disease
doctors.

I dunno why there's ever been this much deference--usually each
speciality would claim
it for their own but here the rheumies were first and the id docs and
neurologists etc
have deferred to their "wisdom" (or distinct lack thereof).

The whole thing is so bizzare.

>
>
>
> a_weisman@yahoo.com wrote:
> > This is what LDF misrepresented as a "law". It was NOT. It never
was.
> > It was part of the language in a committee report. It was not
> identical
> > to the report of the House nor to that of the conference which was
> > created to resolve differences between language in the Senate
> > appropriations LAW and that of the House (this is part of the
> > legislative process, bills have to be passed indentically in both
> > houses, conferences are used to resolve differences in languge, see
> how
> > a bill becomes a law recently posted here)
> >
> > This language had no mandatory effect and little symbolic or
salutory
> > effect in that it is routinely ignored--look at the report in
> question
> > it contains provisions about many many pet causes of congressmen or
> > senators or both.
> >
> > And Lyme patients ran around telling doctors, insurance companies
and
> > legislators about this great new "law" and LDF in some desperate
> > attempt to prove that they still had some relevance to Lymeland and
> in
> > an attempt to "win" the battle of the two bills raging between ldf
> and
> > lda new jersey "the karen" vs "the pat"
> >
> > Well so this is it.
> >
> > You can probably tell from the language that there's nothing
> mandatory
> > about it. And as I said as a practical matter in the real world of
> NIH
> > and Congress this kind of stuff is routinely ignored.
> >
> >
>
-------------------------------------------------------------------------------------------------------------------
> >
> > LDFTF Jan 30 2002, 6:02 pm show options
> >
> > Newsgroups: sci.med.diseases.lyme
> > From: l...@aol.com (LDFTF) - Find messages by this author
> > Date: 31 Jan 2002 02:02:18 GMT
> > Local: Wed, Jan 30 2002 6:02 pm
> > Subject: New Federal Law could help Lyme Docs and Patients
> > Reply | Reply to Author | Forward | Print | Individual Message |
Show
> > original | Report Abuse
> >
> > Dear Friends
> >
> >
> > I am pleased to announce a new Federal Law (Public Law 107-116),
that
> > will have
> > a
> > major impact on the Lyme disease community, has passed the Senate
and
> > House,
> > and was signed by President Bush on January 10, 2002. We and others
> > have worked
> > on the
> > Lyme wording in this bill for over a year and know it will be of
> great
> > benefit
> > to
> > physicians and patients across the country. This is another way we
> are
> > helping our doctors in medical licensing hearings, insurance
> > reimbursement,
> > and other issues.
> >
> >
> > This law reinforces that the CDC's Lyme disease (LD) Case
> Surveillance
> > Definition is not a standard of care for the diagnosis and
treatment
> of
> > Lyme
> > disease. Sections of medical protocols that rely on the CDC LD Case
> > Definition for diagnostic or treatment standards are misusing this
> > protocol and should be invalid. A copy of the wording is on the
lower
> > part of
> > this
> > ***.
> >
> >
> > This Public Law Appropriations wording states, along with other
> things
> > about Lyme disease, that the CDC's case surveillance definition "is
> > reportedly misused as a standard of care for healthcare
> reimbursement,
> > product (test) development, medical licensing hearings, and other
> legal
> >
> > cases." This reinforces that protocols misusing this case
> definition
> > are
> > inappropriate standards of care. The wording then instructs the CDC
> to
> > correct this misuse. Other important wording includes concern about
> the
> > Lyme
> > vaccine, broadening of the Lyme Case Surveillance Definition, and
> > development
> > of an improved test.
> >
> >
> > I hope you join me in thanking Congress and the President for
> standing
> > up for
> > our rights and ask them to please help us with the next
step....Sign
> > onto the
> > LIFT Act in the Senate
> > (S969) and the House (HR 2118).
> >
> >
> > Sincerely,
> > Tom Forschner
> > Executive Director
> > Lyme Disease Foundation
> >
> >
> > Excerpts from Public Law 107-116 Signed by President Bush 1/10/02
> > Departments of Labor, Health, and Human Services, and Education,
and
> > Related
> > Agencies Appropriations Act 2002
> >
> >
> > Senate Appropriations Report Language - S.1536, SR.107-84.
> >
> >
> > This is the actual wording that was passed by the Senate (11/06/01,
> > 12/20/2001)
> > and
> > House (10/11/01, 12/19/01) and included as part of the final bill
> that
> > was
> > signed
> > into Public Law by President George Bush on January 10, 2002.
> >
> >
> > Centers for Disease Control and Prevention
> >
> >
> > Lyme Disease - The Committee is deeply concerned about the safety
of
> > the
> > Lyme disease vaccine (LymeRix). Over 1,000 adverse event reports
were
> > filed
> > with the Food and Drug Administration from December 1998 to October
> > 2000. The
> > Committee encourages CDC to work closely with the FDA to ensure
that
> > all
> > adverse event reports are thoroughly and expeditiously investigated
> to
> > ensure
> > public safety as the vaccine is being distributed. Investigators
> should
> > pay
> > particular attention to patients' reports of arthritis when
> evaluating
> > these
> > reports.
> >
> >
> > The Committee recognizes that the current state of laboratory
testing
> > for
> > Lyme disease is very poor. The situation has led many people to be
> > misdiagnosed and delayed proper treatment. The vaccine clinical
trial
> > has
> > documented that more that one third (36 percent) of the people with
> > Lyme
> > disease did not test positive on the most sophisticated tests
> > available. The
> > ramifications of this deficit in terms of unnecessary pain,
suffering
> > and
> > cost is staggering. The Committee directs CDC to work closely with
> the
> > Food
> > and Drug Administration to develop an unequivocal test for Lyme
> > disease.
> >
> >
> > The Committee is distressed in hearing of the widespread misuse of
> the
> > current Lyme disease surveillance case definition. While the CDC
does
> > state
> > that 'this surveillance case definition was developed for national
> > reporting
> > of Lyme disease: it is NOT appropriate for clinical diagnosis,' the
> > definition is reportedly misused as a standard of care for
healthcare
> > reimbursement, product (test) development, medical licensing
> hearings,
> > and
> > other legal cases. The CDC is encouraged to aggressively pursue and
> > correct
> > the misuse of this definition. This includes issuing an alert to
the
> > public
> > and physicians, as well as actively issuing letters to places
> misusing
> > this
> > definition.
> >
> >
> > The Committee recommends that the CDC strongly support the
> > re-examination and
> > broadening of the Lyme disease surveillance case definition by the
> > Council
> > of State and Territorial Epidemiologists. Voluntary and patient
> groups
> > should
> > have input into this process. Currently there is just one
definition
> > ('confirmed case') of seven possible categories. By developing
other
> > categories while leaving the current category intact, the true
number
> > of
> > cases being diagnosed and treated will be more accurately counted,
> > lending to
> > improved public health planning for finding solutions to the
> infection.
> >
> >
> >
> > The CDC is encouraged to include a broad range of scientific
> viewpoints
> > in
> > the process of planning and executing their efforts. This means
> > including
> > community-based clinicians with extensive experience in treating
> these
> > patients, voluntary agencies who have advocacy in their mission,
and
> > patient
> > advocates in planning committees, meetings, and outreach efforts.
> > Thomas E. Forschner
> > Executive Director
> > www.lyme.org