Re: Urgent notice on Congressional letter

a_weisman_at_yahoo.com
Date: 01/15/05 

Date: 15 Jan 2005 07:58:04 -0800

GregGerber wrote:
> Stony Brook got higher score on quality of experiment but Tufts was
> higher on cost ie it was cheaper but provided less. This made the
> scores equal, but the Stony Brook project was rated higher for its
> ability to answer the questions posed. Also, Tufts got extra points
for
> staff, ie they had Allen Steere on board and that is a big bonus in
> Lyme if you know what I mean. You need to read the fine print of the
> NIH documents not this report in Lymenet. Scores were equal but the
> section that scored the experiment itself gave the higher score to
> Stony Brook. You will need to to some digging of your own Weisman.
The
> importnat thing is the review of the proposals written by the
internal
> NIH evaluation panel. It isn't in this article.

I don't know that I have access to internal NIH documents absent a FOIA
request that I'm not personally prepared to file.

But thanks for sharing the information above, I'll trust your summary.

> It is possible I misused the word mandate, legally, who knows, as I
am
> not an attorney. These were recommendations in an appropriations
bill.
> They were recommendations that NIH apparently felt compelled to
follow.
> They did follow them.

Well thanks for clarifying that too.

Language in appropriations bills is almost never mandatory particularly
NIH appropriations bills.

Recently (a coupla years ago) LDF insisted that something was a "law"
that wasn't and it was language in appropriations bill committe reports
not even the appropriations bills themselves.

And, NO, NIH does not generally feel compelled to follow these
recommendations which aren't taken seriously because for the most part
they are just sops for various special interests and everyone knows
they have zero meaning.

LDF continued to INSIST that the language they cited was a LAW and had
patients running around saying so. They continued even after being
informed that it wasn't a law and that it was inaccurate and foolhardy
to say otherwise.

So this makes a big difference. Maybe it wasn't even language in an
appropriations bill but similar to the recent example, language in a
committee report and in that recent case not even the same language in
the Senate and House reports, and never adapted in a conference report.

And NIH doesn't follow it (at the risk of being called on the carpet
which just doesn't happen). THere is some sub silentio understanding
that Congress says this stuff but that it is really up to NIH how to
spend the money and even whether to spend it, some recognition that it
really is up to the scientists not the politicians to set scientific
priorities.

I'd suggest a speculative alternative explanation, Greg, and this is
NOT a conspiracy theory, but an informed political reality check, if
you will, though speculative because I'm still not looking at the
language and don't know the details of the history of the Rose De Lauro
language following up the 1993 Senate hearing (though she was a rep not
a sen).

Here it is: Every year NIH receives certain "language" which is
hortatory not mandatory and not generally taken seriously.

Some group, like say, Lyme patients, are being a particular thorn in
their side (and/or in the side of someone who matters at NIH or an
influential scientist, say an Allen Steere).

So there is a decision by NIH to take up the challenge, but no
intention to do what they're being told to do. And they take up the
challenge in such a way as to sabatoge the provacateurs. They even
enlist "patient advocates" and "leaders" of the disease advocacy group
or community and enlist "patient representatives" who are
scientifically naive and politically totally naive. And the "advocates"
and "leaders" and "representatives" are given a "seat at the table" and
actually legitimize the undertaking. In fact, they actively help and
recruit for this undertaking. They are effectively hoodwinked and
coopted. They legitimize the whole thing.

And then get hoisted by their own petard.

Remember, the NIH and those who work there particularly in policy and
managment may have a scientific background but the career folks are
also now experienced bureaucrats. They get to know their way around and
develop political sophistication because NIH is not just a "pure
science" environment but also a political place as is any large
bureaucracy or company. They guard their "turf" and know how to fight
turf battles. And use the bureaucracy to undermine what they choose to.

Lots of ways to do it.

So rather than feeling "mandated" they instead feel empowered to
finally get rid of or screw over someone or a group of someones who are
being a thorn in their side.

Gee sometimes it is even personal (e.g, McSweegan vs "the karen" and
"the tom."

So remembering that the NIH is filled with PEOPLE and if those people
have an agenda, personal and/or scientific and/or political, well they
know better than say Phyllis or Carl or "the karen" or "the pat" how to
go about achieving it.

Ruthlessly.

They might even dress it up like a gift, say like a Trojan Horse and
have the unsuspecting folks bring the enemy into their own walled
compound. Or vice versa, Carl and Phyllis and Steve McClain and "the
karen" and "the pat" might even lead the Lyme lambs to slaughter,
bringing their own unarmed folks into the walled compound of the enemy
to be hoisted by their own petards, burnt at the stake, slaughtered
like innocent lambs, or at least subject to multiple spinal taps,
giving valuable ammunition to the theories of autoimmunity of the
enemy. Maybe the enemy will even patent and profit. Who knows?

So maybe NIH wasn't "responding to a Congressional mandate" at all, but
to their own mandate, and the twain never met?

But ostensibly NIH can say that they DID respond to what the patients
asked for, begged for, pleaded for and DEMANDED.

And that the patients got what they asked for but are just sore losers
because it didn't turn out the way they wanted, but that is because
they were wrong in the first place and NIH was right all along and
maybe that sends a further message to congress not to try to mandate
things because after all NIH does know better.

See what I'm getting at Greg?

It is not a conspiracy theory at all but a little slice of reality in
government work.

Certainly if one judges retrospectively by the outcome this alternative
explanation seems to make some sense? And if one had thought it
through, this was all predictable from the get go and there were lots
of hints along the way too.
>
> Perhaps that is not a legal mandate but it was essentially taken as a
> mandate as far as I am concerned.

But maybe you're not considering the alternative?

WOuld you agree that the scenario I suggest is PLAUSIBLE? Even more
likely than what you suggest?

I'd be interested in what der dritte mann has to say too, as he
typically has good insights into this kind of thing.

And I guess the fishbrain will get out his soapbox and add some self
righteous moralizing or perhaps an incoherent or inane comment too?

LOL

a_weisman@yahoo.com wrote:
> > GregGerber wrote:
> > > reference to the appropriated money in lymenet. But this is not
> the
> > > primary source, I will post it when I get it.
> > > http://www2.lymenet.org/domino/nl.nsf/UID/4-18
> >
> > I don't see anything about the Congressional "mandate"
> >
> > Also if this is correct it says that the Tufts and SUNY SB
proposals
> > were scored EQUALLY by NIH; not that the SUNY SB proposal got a
> higher
> > score but was rejected anyway as you said recently.
> >
> > It said NIH then chose of the two equally scored studies the one
that
> > was cheaper.
> >
> > It also says that Alfonse D'Amato's office utilizing a GAO
> > investigation (it says hearing) put a hold on the funds and
> > investigated whether there was shenanigans at work or not.
> >
> > Apparently they didn't find or prove any.
> >
> > The author does make some seemingly valid points about other
benefits
> > of SUNY SB over Tufts and comparing the proposed researchers, in
> > particular pointing out (I don't know if it is accurate or not)
that
> > Klempner hadn't run a clinical study before.
> >
> > I don't know if you're right or if this contemperaneous and
seemingly
> > well informed thing is right. I know that YOU want to be accurate
now
> > and in the future in things you write.
> >
> > Right?
> >
> >
> > ------------------------------------------------------------------
> > IV. EDITORIAL: NIH Contracts and the "Universal Fudge Factor"
> > ---------------------------------------------------------------
> > Sender: Steven Gottschalk <RACEr91@aol.com>
> >
> > There was a running joke amongst my fellow engineering students
> during
> > my college years. If you couldn't arrive at the answer your
professor
> > was looking for, just add in the "Universal Fudge Factor". As
> humorous
> > as it was to us, I'm quite sure its use would have resulted in a
> > failing mark.
> >
> > Apparently, the same practice that would have flunked me out of
> > engineering school is an accepted practice at NIH when it comes to
> > awarding scientific contracts.
> >
> > BACKGROUND
> > ----------
> > In June, 1996, the National Institute of Health (NIH) announced
their
> > intention to award $4.2 million to Tufts/New England Medical Center
> > for a study on the use of longer term antibiotics for relieving the
> > symptoms of chronic Lyme disease. Many in the patient community
were
> > outraged at this selection. They could not understand, and rightly
> > so, how the NIH could have selected a team of investigators to
study
> > an issue that those same scientists have doggedly dismissed as
> > poppy*** for many years.
> >
> > Also outraged and crying foul was the primary competitor for the
NIH
> > contract, State University of NY at Stony Brook (SUNY/Stony Brook),
> > a far more open-minded and credible bunch when it comes to
admitting
> > the possibility of persisting infection (unlike the bunch at Tufts,
> > they have published articles proving the existence of persisting
> > infection). Stony Brook was certain they had real evidence of foul
> > play in the selection process and embarked, with the help of
Senator
> > Alphonse D'Amato's [R-NY] office, on making an appeal to the US
> > General Accounting Office (GAO). That resulted in a hold being
placed
> > on the study and a hearing being scheduled by the GAO. That
hearing
> > has now taken place.
> >
> > THE AWARDING PROCESS
> > --------------------
> > While I originally had had high hopes that justice would be served
by
> > this hearing, the resulting decision by GAO to deny all aspects of
> > Stony Brook's appeal has taught me just how easy it is for those
> > in power at NIH to corrupt the scientific process and get away with
> > it. To understand how easy it is, one must know a little bit about
> > how the NIH awards a contract of this magnitude.
> >
> > First, a secret panel of esteemed scientists is selected by NIH to
> > review all submitted proposals and rate them. The scientists are
> > then instructed to review and rate the proposals on 3 categories,
> > weighted as follows:
> >
> > "Scientific and Technical Approach" (50 percent)
> > "Personnel" (25 percent)
> > "Facilities/Resources" (25 percent)
> >
> > The scores for each of the above are tabulated and a total arrived
> at.
> > Then NIH awards the contract based on the ratings and
recommendations
> > of that panel.
> >
> > Sounds pretty reasonable so far, right?
> >
> > THE SUPERIOR PROPOSAL WINS?
> > ---------------------------
> > Specifically, in the case of the chronic Lyme extramural contract,
we
> > now know that both Tufts and Stony Brook were scored equally at 79
> > points by the panel. It was then up to NIH to break the tie, which
> > they did by selecting the lower cost proposal, which belonged to
> > Tufts ($4.2 million vs. $5.3 million).
> >
> > This seems pretty reasonable, assuming of course, as I once did,
that
> > the Tufts proposal was really better than or equal to the Stony
Brook
> > proposal. However, that is far from the truth. You see, Stony
> > Brook's proposal actually OUTSCORED Tufts' proposal (Stony Brook
> > scored higher in the ONLY category that dealt with the quality of
the
> > actual study design, that being "Scientific and Technical
Approach").
> >
> > This means that despite submitting a technically inferior proposal,
> > Tufts won the contract based on the panel's belief that their
> > personnel and facilities were superior to Stony Brook's. Am I the
> > only one who sees a little hypocrisy here? The very same
scientists
> > who failed to devise a scientifically superior study are rated
> > superior?
> >
> > THE SUPERIOR PERSONNEL?
> > -----------------------
> > To understand just how ludicrous this is, let's have a more
detailed
> > look at the personnel involved.
> >
> > The Tuft's team is led by Dr. Mark Klempner, who's credentials as a
> > researcher are quite good, but who has never, to my knowledge,
> > conducted a clinical trial. Most troubling to me is that Dr.
> > Klempner privately stated to me in a telephone interview that 3
> > months of antibiotics is twice what he believes is necessary for
> > Lyme disease and that he does not know of ANY infection that can't
> > be brought under control with 6 weeks or less of antibiotics (he
> > apparently hasn't studied tuberculosis, syphilis, leprosy or
> > hepatitis B/C - and obviously never had a case of zits). Is it
just
> > me, or does it seem odd that a team which is led by someone with no
> > experience at running clinical trials and holds a distinct bias
> > against the purpose of the study he is supposed to be conducting
> would
> > be rated superior to one who's leader, Dr. Ben Luft of Stony Brook,
> > appears to be far less biased about persisting infection and has
> > experience at conducting clinical trials?
> >
> > Another prominent figure on this team is Dr. Allen Steere, head of
> the
> > Tufts Lyme disease clinic. His credentials are well known. Dr.
> > Steere believes that Lyme disease is an overtreated and
overdiagnosed
> > "fad illness". For 21 years he has ridiculed, stepped on and
> > testified against those who believe differently than he does and
who
> > treat outside his protocols. His dogmatic denials of the benefits
of
> > longer term antibiotic treatments make him the LAST person one
would
> > want to have involved in a study that explores the value of such
> > treatment. Furthermore, he is on record as stating that the very
> > study NIH just awarded to him would be a waste of money and would
> never
> > have come about if the scientific community had any say in the
matter
> > (the money to study chronic Lyme disease was appropriated through
> > patient advocacy with the help of congressman Rosa DeLauro [D-NY]).
> >
> > Rounding out the team are Drs. Gary Wormser, Arthur Weinstein and
the
> > crew at Westchester Medical Center (WMC) in Valhalla, New York -
the
> > primary site for patient selection, evaluation and treatment. You
> may
> > recall them as the defendants in a $1.2 billion lawsuit for alleged
> > misconduct in the treatment of patients during the Connaught Labs
> Lyme
> > vaccine trials. Their alleged failure to recognize a relapse of
Lyme
> > disease in one of their patients resulting in his being confined to
a
> > wheelchair or walker due to neurological damage. They then,
> > allegedly, compounded their error by attempting to cover it up.
> > Yeah, this seems like a superior place to conduct a clinical trial
on
> > the diagnosis and treatment of patients with chronic Lyme disease,
> NOT!
> >
> > And these people outscored the scientists at Stony Brook? I find
> that
> > scary!
> >
> > ARTFUL USE OF THE UNIVERSAL FUDGE FACTOR
> > ----------------------------------------
> > One must ask themselves "how is it that a team of scientists who
> > produced an inferior proposal, could rate higher in the category of
> > personnel than one who produced a superior proposal?". Knowing a
> > little about the teams of researchers involved and the quality of
> > their proposals, the only answer that makes sense to me is the
> > "Universal Fudge Factor." Let's face it, the categories of
> "Personnel"
> > and "Facilities" are so subjective in nature that it'd be a piece
of
> > cake to add in a little fudge factor to get the score you want.
> >
> > So, let's say, hypothetically, that the secret scientific panel
> > includes a bunch of scientists like, say, Dr. Alan Barbour (rumored
> > to have been on the panel), who are friends of Dr. Steere's. And
> > those people really want Dr. Steere's team to get the contract.
And
> > maybe someone high up at NIH suggests to these panel members that
NIH
> > would be "more comfortable" working with Dr. Steere & Co. Well,
hey,
> > all they'd have to do is jack up Tufts' scores for personnel and
> > facilities so that the total score was equal to or better than
> > the Stony Brook score.
> >
> > And if they did do that, who could ever question it. The panel is
> > secret. The minutes of their meetings are secret. And what could
be
> > easier to defend than how you scored a category which is based
> totally
> > on opinion and judgment? Heck, why would anyone question the
scoring
> > to begin with. After all, the marks were arrived at by an elite
> panel
> > of PhD scientists. And we all know that these people are
tirelessly
> > devoted to truth and scientific fact. Right? RIGHT?
> >
> > This is the largest and most important Lyme disease contract ever
> > awarded by NIH and their first effort ever to delve into the
mystery
> > of persisting illness. The NIH had a mandate, according to the GAO
> > hearings, to select the technically superior proposal regardless of
> > its cost. In point of fact, they selected a technically weaker
> > proposal. The scoring on personnel and facilities allowed them the
> > subjective latitude to create a tie. They then justified the tie-
> > breaking selection by using the smokescreen of lower cost. I
believe
> > that NIH wanted this contract at Tufts and they found the loopholes
> > to make it happen (if you think this seems far fetched, read
"Osler's
> > Web", by Hillary Johnson).
> >
> > Whether I am correct in that assumption or not, one thing cannot be
> > denied. The NIH has publicly admitted that they funded an inferior
> > study design due to its lower cost. The NIH's actions display a
very
> > callous disregard for the very things that they are supposed to
stand
> > for - quality of science and commitment to public health. The
> decision
> >
> > process for a study of this importance is reprehensible.
> >
> > EPILOGUE - PUTTING THE CART BEFORE THE HORSE?
> > ---------------------------------------------
> > Many of you will be debating over the next few weeks about what the
> > Lyme community should do about this issue. Before you get too
hyped
> > up about switching the contract to Stony Brook, I'd like to pose a
> > question - Why are we conducting clinical trials of "longer term"
> > antibiotics when we have no reliable way of proving whether the
> > treatment used has provided a cure? Doesn't that seem like putting
> > the cart before the horse? Does anyone believe that treating
chronic
> > Lyme patients with 3 months of antibiotics will tell us anything of
> > importance?
> >
> > As much as I think Stony Brook has the better proposal, better
> > approach, better team and better facilities, the only thing our 4-5
> > million dollars will MAYBE buy us is the answer to whether 3 months
> > or so of antibiotics relieve symptoms based on neuropsych testing
> > and subjective ratings. In the end, we will be no closer than we
are
> > now to knowing whether the subjects' Lyme disease has been cured.
> > And we will then be arguing about whether patients should be
treated
> > for longer than 3 months.
> >
> > This money, in my opinion, should be used for research into better
> > testing methods, into animal studies of persisting infection, and
> into
> > pathological studies on humans believed to have lost their organs
or
> > lives to Lyme disease to see whether spirochetes were involved in
> those
> >
> > losses.
> >
> > I believe we should do everything in our power to see that the
> > extramural chronic Lyme disease contract is rescinded and the money
> > used for better research projects. And if the only choice we have
is
> > Tufts or "goodbye money", the latter choice is the only one that I
> > find palatable.
> >
> >
> > =====*=====

Quantcast