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Agent Orange study findings
called flawed
Two scientists involved in
25-year, $140 million study say it may underestimate cancer risks
for Vietnam vets
By Clark Brooks
STAFF WRITER
A design flaw in the federal government's $140 million study of
the health effects of Agent Orange on Vietnam veterans has resulted
in a quarter-century of inaccurate findings, two scientists involved
with the study told The Greenville News.
Begun in 1978 to help settle compensation claims, the Air Force
Health Study will end this week as it began, in controversy, with
tens of thousands of veterans still seeking answers to chronic
illnesses they attribute to herbicides used during the Vietnam
War.
Agent Orange and other herbicides sprayed in Vietnam to destroy
enemy crops and jungle cover contained cancer-causing dioxin.
The U.S. Air Force, however, is closing up shop on the study having
found no increased incidence of a serious illness other than diabetes.
The study has compared airmen directly involved with the spraying
missions, called Operation Ranch Hand, to Air Force veterans who
served in Southeast Asia but had no role in spraying.
However, hundreds in the comparison group spent time in Vietnam
and may have been exposed to herbicides, too, said
Joel Michalek, who worked on the study from the
beginning and was its principal investigator for 14 years until
he left in May.
"It spoils everything," Michalek told The
News. "It's as if you're running a clinical trial
on a new medication, and you found out some of the people who
were in your placebo group were actually taking meds. That would
spoil your whole study. And that's what's going on here in this
study."
Michalek co-authored two articles published in the Journal
of Occupational and Environmental Medicine in 2004
and 2005 that found significant rates of cancer in the Ranch Hand
and comparison groups.
Air Force spokesman Ed Shannon declined to make officials available
for comment. Shannon was asked why Michalek's analysis published
in the Journal showing cancer
trends in the comparison group of veterans was not used in the
analysis for the final Air Force report published last year.
The Air Force noted in an e-mail reply that a "recently
published analysis" showed an increased cancer risk in Ranch
Hand and comparison veterans. Shannon said Saturday there would
be no further Air Force analysis.
In a follow-up e-mail, the Air Force said the final report included
only the veterans who attended the last round of medical tests
in 2002 and that all physical examination reports follow the same
basic analytical plan.
Michalek's finding of cancer in the comparison group was not
used in the analysis for the Ranch Hand report.
Michalek said he followed up on the cancer articles with an analysis
that allowed for the exposed control group and other factors and
found a doubling of cancer in the Ranch Hand group.
Further research needs to be done to strengthen these findings
and figure out what other diseases the Air Force scientists may
have missed because of the exposed comparison group, Michalek
said.
The comparison veterans, he said, are similar to average Vietnam
veterans, from nurses to truck drivers, who spent most of their
time in base camps. The comparisons' data also should be studied
further, he said.
The results could matter greatly to thousands of Vietnam War
veterans who've never received compensation for debilitating illnesses
that earlier Ranch Hand study findings said couldn't be linked
to Agent Orange.
A Department of Veterans Affairs analysis in 1998 found 92,276
Agent Orange claims for compensation had been
filed by veterans and their survivors. Of those, 5,908
had been approved.
The analysis was done before diabetes was added to the list of
diseases eligible for compensation, which would make both columns
much higher today, said Jim Benson, a VA spokesman.
The VA no longer tracks Agent Orange claims because many veterans
apply for more than one type of compensation per claim, he said.
The Ranch Hand study has followed about 1,000 Ranch Hand veterans
and some 1,300 comparison airmen who served in Southeast Asia.
Although the study will end Saturday for the Air Force, legislation
pending in Congress would turn over all the data and specimens
to the Institute of Medicine's Medical Follow-up Agency, which
would collaborate on analyses with scientists outside the government.
Michalek left his civilian Air Force job for the University of
Texas Health Science Center in San Antonio. He said he will apply
on behalf of the school to be a collaborator.
Greer soldier sprayed
The U.S. military sprayed more than 18 million gallons of herbicides
over 3.6 million acres of South Vietnam from 1962 to 1971. Nearly
two-thirds of it was Agent Orange.
Richard Leoffels of Greer saw the planes spraying overhead when
he was an Army infantryman with the 1st Cavalry Division in 1968-69.
Sometimes the wind blew it onto him and his buddies as they set
up for ambushes, he said.
He didn't give it much thought, he said, even as he occasionally
crawled through areas saturated with herbicides. He was more concerned
about the enemy.
"I didn't know anything about Agent Orange until I came
back, did some reading and saw a couple specials on TV,"
he said.
Red blotches appeared on his legs in 1969, just a minor annoyance,
he said. Later, he would suffer a litany of more serious conditions.
The Air Force has announced in periodic updates since 1984 that
the Ranch Hand veterans are about as healthy as the comparisons
and have no significant increase in cancer or heart disease or
any other serious illness except diabetes.
Ranch Hand and comparison veterans were thoroughly examined every
three to five years, beginning in 1982. The results were recorded
in thick Air Force reports.
The final one of those, published last year, presented the results
from the sixth and last round of testing, conducted in 2002. It
concluded the cancer analysis "did not suggest an adverse
relation between cancer and herbicide exposure."
Ron Trewyn, a biochemist and member of the Ranch Hand study advisory
committee, reviewed that report's cancer chapter.
He argued strongly during advisory committee meetings that the
cancer chapter should include all the cancer data used to write
the 2004 and 2005 articles in the Journal of Occupational and
Environmental Medicine. It didn't happen, he said.
"They referenced those papers, but they left all the data
out from those cancer papers that were done that showed the cancer
effects," he said. "It's huge, because then the conclusion
is there's no cancer effect, when as part of the study, the same
investigators, just analyzing the data in a different way, found
that when they did that, lo and behold, then there were significant
cancer effects.
"And so for the final report to say there's no cancer effect
when the investigators themselves published papers saying there
is a cancer effect, that's just flat scientifically wrong."
Without factoring in the new information about the comparison
veterans, Trewyn said, the Air Force got the same, predictable
results.
"When they use an exposed control group and they say the
two groups have roughly the same amount of cancer and so forth,
what is that finding good for? Nothing," said Trewyn, vice
provost for research and dean of the graduate school at Kansas
State University.
And it doesn't take a scientist to figure that out, he said.
"This is common sense now, a lot of it," he said. "It's
like now wait a minute. This just does not pass the smell test
or the common sense test."
Trewyn, who said he began wondering about exposures in the comparison
group in 1999, did cancer research for 20 years.
Because many comparisons were exposed to the same environmental
conditions as the Ranch Hand veterans, all major health outcomes
need to be re-examined, he said.
"There have been industrial studies related to dioxin where
as they looked back at it they thought they had a few exposed
in the control group and so the statistics went to hell,"
he said.
In the Ranch Hand study, it's more than a few. At least 600 members
of the comparison group spent time in Vietnam, Michalek said.
New rates found
Michalek said the breakthrough that led to the new data analysis
came when he started to look not just at the numbers but at the
men behind them. Where in Southeast Asia did the Ranch Hand and
comparison veterans serve? For how long?
He learned some Ranch Hand veterans didn't take part in spraying
because none was done while they were there, and those who served
earlier in the war had higher levels of dioxin.
When he factored in that information along with the exposed comparison
group, Michalek said he found a doubling of cancer among Ranch
Hand veterans with the highest dioxin exposures. He also found
cancer increasing with dioxin exposure, the first time such a
trend has been seen in the Ranch Hand study, he said.
Michalek said he also found a stronger showing than previously
for diabetes.
Advisory committee members wanted him to get the new cancer and
diabetes findings published in a scientific journal, and he told
them he intended to, according to minutes from the June 2005 committee
meeting.
However, Col. Karen Fox said during the committee's final meeting
this month in Rockville, Md., that the Air Force has no plans
to publish the new findings in any Air Force report or scientific
journal, The News reported earlier this month.
Fox, responding to extensive questioning from advisory committee
members, said the Air Force told Michalek to destroy the data.
Fox, who succeeded Michalek as principal investigator of the
study, declined to be interviewed by The News during breaks in
the meeting.
She said during the meeting the Air Force "tried to enter
into a relationship" with Michalek to write the cancer and
diabetes papers, but "he elected not to do that."
Michalek said the Air Force told him he would have to contract
with Science Applications International Corp., which does data
analysis for Ranch Hand study reports. He said he negotiated with
SAIC but wasn't hired.
Maurice Owens, a project manager for SAIC, told The News the
company decided it would be a conflict of interest to work with
Michalek because he had been a scientist for the Air Force.
There is precedent for such a hire, however. Col. George D. Lathrop,
who helped design the Ranch Hand study, moved to SAIC during the
1980s after he retired from the Air Force.
Owens said he couldn't comment on that.
Michalek said he began writing the cancer paper without pay.
He said he finally gave up when he got a letter from the Air Force
dated July 6, 2006, ordering him to delete the data.
Rick Weidman, who has monitored the Ranch Hand advisory committee
meetings for Vietnam Veterans of America, said he believes the
Air Force had no intention of letting Michalek write the cancer
paper on his own.
"They didn't want him to publish because they wanted to
be able to censor it," Weidman said. "That's just plain
as day to us."
Getting compensation
Because Ranch Hand study reports had said the health of the Ranch
Hand and comparison veterans was about the same, some members
of Congress sought other ways to settle compensation claims. The
Agent Orange Act of 1991 established a compensation list.
The first entries were non-Hodgkin's lymphoma, soft-tissue sarcoma
and chloracne, a skin condition. The act also authorized the National
Academy of Sciences to evaluate dioxin research from a host of
studies, mostly of civilians.
Using the results of that research, the Department of Veterans
Affairs has added nine diseases, mostly cancers.
Leoffels suffered his first of three strokes in 1998. They were
minor as strokes go, but for a time, he couldn't control his left
leg.
He was working as a letter carrier for the post office, a good
job, he said, but not one a person can stagger through.
"People were calling the post office and saying, 'Hey, the
mailman is walking around drunk,'" he said.
Circulatory disorders are on the long list of diseases and conditions
for which the NAS has not found enough evidence of a dioxin association
to be included for compensation.
Leoffels, 58, does receive compensation for type 2 diabetes,
he said, $112 a month. It's the one illness on the list that might
owe its spot to the Ranch Hand study, said David Tollerud, an
epidemiologist who headed the NAS research during the 1990s.
Spina bifida, a birth defect, is the only other condition on
the list that received an assist from the Ranch Hand study, he
said.
'Flawed design'
Tollerud, a professor of public health at the University of Louisville,
chaired the IOM panel that recently recommended the Ranch Hand
data and specimens be saved for study outside the Air Force.
He briefed the Ranch Hand advisory committee during a meeting
in February. He called the biological specimens accumulated over
25 years "a trove of valuable research material," according
to the minutes from that meeting.
Tollerud also pointed out some study limitations, including the
study's "flawed design and execution" and "potential
herbicide exposures in the comparison populations," the minutes
show.
In an interview with The News, Tollerud said his comments were
not meant to be condemning but to recognize limitations that future
researchers need to take into account.
As for the exposed comparison group, he said, "The general
result of that kind of a complication in a study design would
be to do what we call bias it toward the null, meaning that it
might make it less likely that you would observe findings that
were really there."
Leoffels said he is in favor of continuing the Ranch Hand study
as long as it is done outside the Air Force.
"Why throw away $140 million?" he said.
Leoffels said he lost his job as a letter carrier to post-traumatic
stress disorder. The VA compensates him for it, offsetting what
he believes he should be getting for Agent Orange damage, but
isn't.
He helps other vets navigate the VA, though many get discouraged
the first time they are turned down and never go back, he said.
Leoffels said it shouldn't be so difficult for veterans to get
the help they need.
"I think what the government wants is for us to die off
so they don't have to pay us anything," he said.
STORYCHAT
Poor Sheila. And thankyou, thank you, thank you Sheila for your
immense pain of efforts to obtain 'justice' from the VA. Before
I say more, let me say that the majority of the folks working
there in the VA, it's two faces to us vets; the med dept and the
benefits dept; are good people trying to do what they should for
us. The VA though, like every other 'bureau' of what masquerades
to us as the Constitutional Government of the United States of
America, is controlled by corporatist hacks put there by usaInc.
Their brazen craven corporatist (their codeword for fascist) "Contract
With America". Our real masters, if we but look away from
that corporate media programming screen we've been staring at
for 60 years, and see that it is indeed, in actuality, a wall,
which we do not percieve, beyond which our real masters operate.
Our masters they truly now are. Just kissed Habeas Corpus bye
bye didn't ya. Eight hundred years of a basic, agonizingly won,
foundation block of True Justice, Gone in an Evil Wind. The 'clinton
ring' killed it a decade and a half ago, chimpo just put the coup
de grace to it with his stinkin' pen. We The Sheeple. We vets
suffered in fields of shattered bone, shredded flesh, blood, #*%&,
flies, maggots, stink..Hope and Despair..for nuthin'. Thanks Greenville
News for allowing your staff reporter to write and you publish
this one. Not even the tip of the iceberg. Back on point, those
folks at the VA, docs on one end and bureaucrats on the other,
have their hands tied. Ferociously so. I've seen a couple of the
secret documents that are among the swords to their throats. They
can't, but in small ways, help us. We have to help ourselves.
See. Find the Real Facts. The True Fabric. Think for Ourselves.
Act. We Must. At heart of our problem as vets, is the Feres Doctrine.
A 'court' case 'decided' in the 50's stealing for them legal precedence
such that all 'courts' forthwith must decide all cases of such
provenance 'that way'. Not the Scale of Justice at work. Not news,
I'm sure. That 'decision' shielded those who control us from Negligence
towards those among us who serve us in our Armed Forces. Constitutionally
our Armed DEFENSE Forces. The Real Depth of this heinous 'legal
beagle' perfidy is that they use it to shield 'them' from any
liability criminally or civilly, for their actions against our
soldiers made by them with Malice, Forethought, Intent, Battery
to maim us or kill us. The list of horrors they have carried out
against us in our hundreds of thousands, secretly, though well
exposed now, the People just won't hear it, yet, is vast and incredible.
Radionucleides, poisonous chemicals and gasses, biologicals, psychoactives
and 'physics weapons'. For 70 years!! Do you not understand that
ultimately, the intent of these people is to use these on you!?
As they have tested them fatally and miserably on us? Rumdum and
one of his hobnailin' Air Force sycophants have repeatedly, recently,
publicly stated that they are itchin' to test their latest, and
horrifying secret 'physics weapons' on the US Citizenry, exercising
what was our inalienable right to peaceful dissent. Get it!? To
Arms!! Dammit!! They can 'hose' us with this kind of technology,
like a spotlite! You can run, but you can't hide. Their dream
come true. And Rick, comment two, Right On Bro!! Those who control
us completely now, held beyond our view and comprehension, have
been at this game for hundreds of years, they are very ruthless,
and patient, and yes, they simply deceive and obfuscate, the 'circus
spot lite' thrown here and there to the 'phoney issue of the day',
the dimmo or repug 'ring', so that we get our peanuts, are none
the wiser, and we brutalized vets unheard, impugned, shunned,
many many left homeless in gulleys and alleys, until we just 'fade
away'. Many of us in their now GULAGS. We die off from their 'slow
bullets' tearing though our flesh, and anguish, these decades.
End of problem. I must say this though about and to us vets, we
have no moral right to ask for rightful assistance from the 'government',
until we address and STOP, what they are doing to our children
serving us in what was our Armed Defense Forces, RIGHT NOW DAMMIT!!.
The same they did to us. Nothing has changed with all those 'tests'.
Just accelerated. The criminal harm done them now deeply outrageous.
You there 'joe citizen', mr status quo, you're next. Right Soon.
To you goose steppers at our throats, I offer this, from a man
who lived humbly and found within himself great wisdom, to our
spiritual profit, if we but read, as he wrote it to share it with
us. Henry David Thoreau 1817~1862 "The squirrel you kill
in jest, dies in earnest." Me, just an old soldier, one of
the few, an 'angel of the darkness', now spoken an 'angel of the
light'. (now don't you religiousities git' in an uproar, I speak
merely figuratively here, but quite accurately)
Regards, Bobby Baxter ~ Veteran & Marijuana Felon
Posted: Sat Sep 30, 2006 8:22 pm
I attended the IOM meetings
in Washington, DC. The tissue and blood samples stored for the Ranch
Hand Study must be kept safe and not destroyed.
The Vietnam Veterans deserve better. I am the widow of a Vietnam
Veteran and I have been fighting for 23 years.
It is ashame that the VA Department treats our heros and their
families in such a way but it is the TRUTH - they are hoping that
we all die so they don't have to work and pay our claims. My story
is one that is proof of this for the USCAVC found an issue not
adjudicate since l983 in their l998 ruling and trusted the Secretary
of VA to finalize it posthast. Some 8 years later, it has been
remanded back again 4 times and now the RO will not comply with
the latest Court remand of August 2003 and has closed the issue
and will not rule or comply with the Court's order.
The VA says there is still an administrative remedy for the ruling
and will not order the "equitable reflie" and the Court
will not compell the Secretary to answer a petition for writ of
mandamus, so the VA believes I am stopped in my tracks.
However, the Court will now have to rule as a non compliance
of its order for all issues were not addressed as my original
case. The VA usually does not rule while a case is at the Court,
but GUESS WHAT?
Yes, the RO ruled on the same issue that is at the Court on appeal,
without proper procedures. They as usually acting above the law,
ruled without asking the Court's permission to temporary jurisdiction
and again made a defective decision. So what is happening here
is I have another appeal coming back behind the one that the Court
is fixing to rule on which will make 6 times this is at the Court.
WHAT A WASTE OF TAXPAYERS MONEY - ERRORS BY FEDERAL EMPLOYEES
JUST IN A SYSTEM ESTALBISHED TO WAIT TIL WE DIE SO FINALIZE -
THEN IT IS FINALIZED AS "FILED IN STORAGE AS DISMISSED!"
Shelia Winsett
261 America Junction Road
Parrish, AL 35580
Posted: Wed Sep 27, 2006 9:11 am
YOU ARE SO RIGHT BROTHER,
I"VE BEEN TRYING TO GET COMPENSATION FOR THREE AND A HALF YEARS.
I WAS IN VIETNAM ON A GUIDED MISSLE DESTROYER, WE DID SEA DRAGGING
, BLUE UP ENEMY BUNKERS, ETC, WE WOULD GO BACK INTO DANANG HARBOUR
TO ANCHOR OUT , THEY DROPPED THAT AGENT ORANGE ON US LIKE SALT ON
A SNAIL. I HAVE HAD ELEVATED SUGAR LEVELS, SEVERE CRONIC BRONCHITIS,
PROSTATE CANCER, ALSO I WAS HURT REAL BAD ON MY SHIP, WHILE STATE
SIDE, NEARLY TO THE POINT OF DEATH. I DEVELOPED OSTEO ARTHRITIS
IN MY NECK , SHOULDER, AND LEFT ARM AND ELBOW. IF YOU THINK THE
VA GIVES A SHIT , THEY DON"T!
THANKS FOR LISTENING, RICK
Posted: Sun Sep 24, 2006 4:21 pm
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Sunday,
September 24, 2006