close

Вход

Забыли?

вход по аккаунту

?

NerveCenter VA scuttles Gulf War illness single-source contract reignites debate surrounding earmarking of funding for science.

код для вставкиСкачать
NERVECENTER
DECEMBER 2009
VA Scuttles Gulf War Illness Single-Source
Contract, Reignites Debate Surrounding
Earmarking of Funding for Science
One of the leading researchers studying neurological
symptoms in veterans of the 1991 Gulf War appears to
have lost his own battle with the Department of Veterans Affairs (VA).
After an ongoing impasse over a number of contract issues – most notably disagreements over data
ownership and patient confidentiality – the VA announced it will not renew the third year of a fiveyear, $75 million contract with noted researcher Dr.
Robert Haley, an epidemiologist at the University of
Texas-Southwestern Medical Center (UTSWMC), in
Dallas.
Haley has been studying neurological complaints in
Gulf War veterans since the mid-1990s. His team was
first to report elevated rates of amyotrophic lateral
sclerosis (ALS) among former combatants, as well as
more controversial claims of cholinergic differences in
the brains of veterans exposed to nerve agents and/or
concentrated pesticides. Their work also suggested
that many veterans with what is now called Gulf War
Illness (GWI) may have lower levels of paraoxonase, a
protective enzyme against toxins found in pesticides.
The cancellation was triggered by a report by the
VA’s Office of the Inspector General (OIG) that found
Haley and the UTSW in violation of provisions of a
2006 sole-source contract pertaining to ownership of
research and patient data, among other issues.
In October 2008, according to the report, Haley
“unilaterally changed” informed consent forms veterans
sign to participate in his studies, changes that prevented the VA from accessing some medical records.
The UTSW institutional review board approved the
changes at the request of Haley, who has asserted that
providing patient names and other medical data to the
VA might keep potential research subjects away, or be
used to deny them benefits.
The OIG’s office, however, said he lacked authority
to make such a change, and that his withholding of
patient and other study data breached the terms of the
contract.
In announcing its decision, the VA cited “persistent
noncompliance and numerous performance deficiencies” by UTSW.
A6
“Given UTSW’s continued refusal to comply with
the terms and conditions of the contract, UTSW has
given [the] VA no option other than to terminate the
contract for default,” the agency said in a statement.
In its response, UTSW said it “strongly disagreed”
with the VA’s characterization of the facts. “We were
surprised to learn of their action, especially since we
have been working diligently and in good faith with
the VA to resolve all areas of disagreement,” the school
said in a statement.
Haley would not comment on the VA’s decision,
nor would the VA or OIG officials.
John Walls, assistant vice president for public affairs at UTSW, told NerveCenter that talks between
the parties are ongoing, but he would not comment
on the nature of the discussions or the status of the
VA projects currently underway at the school.
The VA said it will continue to meet with UTSW
contract staff “to provide guidance for completing
work in progress and submitting adequate documentation to allow payment.”
UTSW will also be allowed to fulfill task orders
already in progress if all performance deficiencies are
amended, according to the agency’s announcement.
Asked if the cancellation carries any take-home
message for VA researchers at other institutions, an-
Dr. Robert Haley, University of Texas-Southwestern Medical
Center.
Annals of Neurology
December 2009
other University spokesperson, who asked not to be
identified, said, “My advice is simple — stick with
grants.”
Funds Going Elsewhere
The unusual sole-source contract was made possible
under an earmark added to a 2005 spending package
by Sen. Kay Bailey Hutchison (R-Texas). The provision provided at least $15 million per year for research
into Gulf War Illness for the five-year period, however
the VA was permitted to reconsider renewing the contract each year.
According to the University, an estimated $19.2 million has been accrued to date. It has sent approximately
$15.5 million in invoices and has been reimbursed
$9.1 million.
The VA said it will redirect the remaining funds
away from UTSW to support 2010 research projects at
other institutions. These include a genomic study to
identify susceptibility factors and markers of GWI;
studies of similarities and differences among veterans
with chronic fatigue syndrome and fibromyalgia; studies of new GWI diagnostic tests; efforts to identify subpopulations of ill Gulf War veterans, and studies of
potential new treatments.
One prominent scientist, who asked to remain anonymous, said that the problems with Dr. Haley’s research have been ongoing, and that a number of researchers have tried unsuccessfully to replicate many of
his findings over the years.
“I don’t think anything is lost by canceling the contract, even though he might turn out to be right somewhere down the road. Basically he has used the same
small group of subjects to publish papers over and over
again.”
The status of current GWI projects being conducted
by Haley and his staff is unknown; however, Tim
Doke, vice president for communications at UTSW,
told the Dallas Morning News that, without third-year
funding the University could not afford to continue
the research. He also said the University would like to
convert its contract with the VA into a more traditional research grant, and that Haley and his team will
attempt to get participating veterans to sign new consent forms acceptable to the VA.
“We are going to re-consent the veterans in the
study so the amount of information the VA needs is
available to them,” he told the Dallas Morning News.
“Everyone is working in good faith.”
Legislative Weigh-In
Congressional reaction to the VA’s announcement was
mixed.
Sen. Hutchison, who originally proposed funding
Annals of Neurology
December 2009
Dr. Roberta White, Boston University School of Public
Health.
the research, issued a statement critical of the agency’s
decision.
“Southwestern has worked to comply with all the
VA’s contractual demands but the VA bureaucracy apparently did not reciprocate in good faith,” she
charged.
Sen. Daniel Akaka (D-Hawaii), chairman of the
Senate Veterans Affairs Committee, voiced his support
for the decision in a letter to VA Secretary Eric Shinseki. Akaka asked him to “implement the recommendation to terminate the contract for default so that
VA’s funds can be directed to research projects that
will help those veterans affected by Gulf War Illness.”
Rep. Michael Burgess (R-Texas) also sent a letter to
the Secretary, asking him “to reconsider canceling the
funding for Dr. Haley’s breakthrough research.”
He said that despite the areas of disagreement, both
UTSW and the VA were attempting to act in the best
interest of veterans.
“I have no doubt these issues could have been mediated and I have been told that UT Southwestern was
committed to this end. When we are so close to the
finish line we should not pause in our efforts,” Rep.
Burgess wrote.
A ‘Critical Time’
Dr. Roberta White, professor and chair of environmental health, and associate dean for research at Boston University School of Public Health, also serves as
scientific director of the Congressionally-mandated
Research Advisory Committee on Gulf War Veterans’
Illnesses (RAC). A report issued by the RAC in November 2008 concluded that GWI is “a real condition” affecting at least one-quarter of all veterans who
served during the war and furthermore that the cause
of GWI was resulted from exposure to some combination of sarin nerve gas, oil smoke plumes, pyriA7
ANNALS OF NEUROLOGY
Dr. Haley’s Work
Dr. Robert Haley and his colleagues have been conducting research on GWI since the early 1990s, supported in part by a continuing grant from the Perot
Foundation. The Foundation would not comment on
the VA’s cancellation or the future of Dr. Haley’s
research.
In 1997, his team published three papers in the
Journal of the American Medical Association in
which they concluded that exposure to various combinations of chemicals during the Gulf War caused
brain damage in a small number of veterans. They
also linked different neurological syndromes to exposure to pesticide-containing flea collars, the insect
repellant DEET, low levels of sarin nerve gas, and
the use of pyridostigmime bromide anti-nerve gas
tablets taken by soldiers.
The papers drew a mixed response from the research community. Four out of seven letters published in the journal criticized the research, with one
author commenting that Haley’s team had “advanced from unmerited speculation to fantasy.”
Two years later, Haley’s team linked PON1 enzyme deficiencies to neurological disorders in
some veterans and, in 2001, reported that such
PON1 deficiencies affected chemical sensitivity
among veterans
In 2003, they reported in Neurology that a disproportionately high number of veterans had developed
amyotrophic lateral sclerosis (ALS), and that symptoms began in veterans at a much younger age than
in the general population. The consensus in the scientific community was that the ALS findings had
merit, and studies continue among vets with the disease.
As recently as March 2009, Dr. Haley’s team published new research funded under the VA contract in
the journal Psychiatry Research: Neuroimaging, in
which they reported abnormal activity in cholinergic
receptors on cells in different parts of the brains of
veterans with encephalopathies
dostrigmine bromide (taken by troops as a precaution
to potential nerve gas attacks) and pesticide use.
“Dr. Haley was following up on a lot of important
A8
neurological pieces, and I am very worried that some of
this data will be lost. We don’t know everything he
was working on, but a lot of money was spent. I just
hope this doesn’t turn into a piecemeal approach.”
An Elusive Consensus
The controversy over GWI, like the one that surrounded Agent Orange in the 1980s, has yielded more
questions than answers.
RAC, and the Institute of Medicine (IOM), also
charged with evaluating GWI research, have failed to
reach any consensus on the issue other than agreeing
that many Gulf War veterans have experienced a wide
range of neurological and other symptoms that might
be associated with exposure in the field.
Many researchers and government health officials remain skeptical or unconvinced of an association between service in the Gulf and most reported medical
problems because the same or similar symptoms have
also been reported by veterans who did not serve in the
Gulf.
In a 2006 report, an IOM panel of experts concluded that while research indicated elevated rates of
neurological and other illnesses, there was insufficient
evidence to support any specific “syndrome.”
In July 2009, the House Veterans’ Affairs Oversight
and Investigations Subcommittee conducted a hearing
to evaluate the differences between the findings of the
RAC and IOM, and how the VA uses the research to
formulate policy.
The IOM and the RAC disagree on the proper
methodologies to be used by researchers investigating
possible associations, notably they way diagnosed and
undiagnosed illnesses are evaluated and how animal
and human study findings are evaluated.
At the July hearing, Dr. Lea Steele, the former RAC
scientific director, testified, “The differences between
the RAC and IOM reports are not subtle, and are not
explained by minor variations in the review methods
used or how individual study results were interpreted
or weighed. Rather, they are the result of major differences in the scope of questions addressed by the reports, and the scope of the evidence used to answer
those questions.”
Kurt Samson
Annals of Neurology
December 2009
LONG AGO
in the Annals...
DEGRADATION OF MYELIN BASIC PROTEIN BY CEREBROSPINAL FLUID: PRESERVATION OF ANTIGENIC DETERMINANTS UNDER
PHYSIOLOGICAL CONDITIONS
ALVORD EC, HRUBY S, SIRES LR
DECEMBER 1979
ABSTRACT
Cerebrospinal fluid contains several proteolytic enzymes that can degrade myelin basic protein (BP) under physiological conditions into peptide fragments of various sizes which still contain antigenic determinants capable of binding antibodies to BP. These enzymes are optimally active in either acid (pH 4) or neutral (pH 7 to 8) conditions and
can be characterized by the nature of the BP peptide fragments produced. Proteinases resembling cathepsin D, thrombin, plasmin (fibrinolysin), or kallikrein are present in variable amounts in CSF. No relationship to any particular
disease has yet been established.
Annals of Neurology
December 2009
A9
Документ
Категория
Без категории
Просмотров
3
Размер файла
299 Кб
Теги
illness, earmarking, reignite, nervecenter, scuttles, war, funding, surrounding, science, debates, gulf, single, source, contract
1/--страниц
Пожаловаться на содержимое документа