Agent Orange cancer findings won't get in report, Air Force says Study's chairman raises questions about decision to leave data out
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September 10, 2006 - ROCKVILLE, Md. -- Cancer findings described as potentially significant by the chairman of an advisory committee won't be in the final report of a 25-year government study of the effects of Agent Orange on Vietnam veterans.

The $140 million study of airmen who sprayed herbicides in a series of missions called Operation Ranch Hand was designed to be used as a basis for compensation for thousands of veterans. It ends Sept. 30.

The analysis showed a doubling in cancer rates among the highest-exposed veterans, according to information submitted to the advisory committee.

The Air Force has no plans to publish the new cancer findings in any Air Force report or scientific journal, Col. Karen Fox told the civilian advisory committee during a meeting in Maryland in response to spirited and sustained questioning during the panel's final meeting Thursday.

Fox said the Air Force instructed the scientist who conducted the analysis to destroy the data.

Michael Stoto, committee chairman and a professor at Georgetown University, said the new analysis included "some interesting and potentially important findings" about the health of airmen involved in herbicide spraying missions during the Vietnam War.

"Frankly," Stoto said at one point in the hearing, "when it shows a significant finding and it seems to have been suppressed, that doesn't add credit to the study." However, Stoto said later in the hearing he perhaps should not have used the word "suppressed."

In an interview during a break in the meeting, Stoto said the discussion was triggered by questions The Greenville News posed to him about the status of the unpublished data the week before the meeting.

The U.S. military sprayed 18 million gallons of herbicides over 3.6 million acres of South Vietnam from 1962 to 1971 to destroy enemy crops and hiding places and to clear areas for American base camps. The majority of it was Agent Orange, which contained cancer-causing dioxin.

Agent Orange and other herbicides, some of which also were tainted with dioxin, were named for the color of the stripe around their 55-gallon storage drums.

Sapp Funderburk, an Air Force veteran who lives in Taylors, recalls loading orange-striped drums on aircraft in 1969 when he was an air freight sergeant in charge of special handling at Phu Cat Air Base.

"They told us they were Agent Orange, so wear these gloves," he said. "They were big, heavy rubber gloves like you see in a science fiction movie."

Funderburk, who was diagnosed with cancer of the larynx in December 2001, said that in the tropical heat and humidity, the instant he lowered his hands, the gloves slid off.

He had to unscrew a plug to open a hole to relieve the pressure in the drums, he said, and Agent Orange sloshed over him.

Veterans complaining of health problems they said were caused by Agent Orange began filing claims in the late 1970s, and Congress funded the Ranch Hand study to investigate the health effects of herbicides. The study, also known as the Air Force Health Study, began in 1982.

Although the study is ending for the Air Force, the Institute of Medicine wants the government to preserve the data sets and frozen biological specimens of about 1,000 Ranch Hand veterans and 2,000 comparison airmen who did not spray herbicides.

A recent IOM report said the materials are valuable and should be

studied further. Legislation pending in Congress would turn everything over to the IOM's Medical Follow-up Agency, which would collaborate on analyses with other scientists and research centers.

The Air Force scientists never reported significant incidences of cancer in any of the study's periodic reports on the participants, who were examined every three to five years.

Nor has the Ranch Hand data ever yielded a finding of cancer increasing with dioxin exposure until the new analysis that was the topic of discussion at last week's advisory committee meeting.

That analysis showed a doubling of cancer among Ranch Hand veterans who have the highest blood-serum levels of dioxin. Committee members were aware of the findings because the work was done by Joel Michalek, a civilian scientist with the Ranch Hand study from the beginning and its principal investigator for 14 years.

Stoto said in an interview the week before the meeting that the cancer analysis, which Michalek presented to the advisory committee in a June 2005 meeting, "really needs to be published."

Michalek's data analysis, as detailed on slides presented at that meeting, shows cancer increasing with dioxin exposure. A separate analysis showed a stronger diabetes finding among Ranch Hand veterans than previously, Michalek said. Ranch Hand scientists reported a significant risk of diabetes among exposed veterans seven years ago.

Michalek, who did not attend the meeting, told The Greenville News he did the analyses before he left the Air Force in May 2005 for a job as a professor at the University of Texas Health Science Center at San Antonio. He said he wants to use a similar approach to examine a variety of other health outcomes in the Ranch Hand group.

In his cancer analysis, Michalek said he took into consideration that there were intervals during the war when no spraying was done, and that Agent Orange and other herbicides may have been more heavily contaminated with dioxin earlier in the war.

Fox, who succeeded Michalek as principal investigator, told the advisory committee she had doubts about his analyses.

"I don't think there was a hypothesis before he started crunching the data," she said.

Michalek disagrees.

"We tried to question all of our assumptions and incorporate external information about the war to once again test the underlying hypothesis that exposure to Agent Orange may be related to the risk of cancer," he said. "I hope the new custodian will find a way to give other researchers access to the study material so these methods and results can be peer-reviewed."

Fox, responding to questions from the advisory committee, said that in spite of her misgivings about Michalek's analyses, the Air Force tried to work with him on the cancer and diabetes papers after he left, but Michalek didn't follow through.

"We tried to enter into a relationship with him for him to write those papers," Fox said. "He did not do that."

Michalek said he negotiated with Maurice Owens, a project manager for Science Applications International Corp., which is under contract to do data analysis for Ranch Hand study reports. Owens, who attended the advisory committee meeting last week, told The Greenville News that SAIC decided working with Michalek would be a conflict of interest because he had been a scientist for the Air Force.

Michalek said he has since done as ordered and deleted the Ranch Hand data that was in his possession.

Fox declined to be interviewed during breaks in the meeting.

Ron Trewyn, a biochemist and member of the Ranch Hand study advisory committee, said during the meeting that if Michalek had left one university for another, he would have been able to complete unfinished research papers. He asked Fox why Michalek couldn't do that for the Air Force.

The scientist is "more than welcome" to talk to whatever entity winds up as custodian of the data and specimens, Fox said.

Trewyn, a Vietnam veteran, said in an interview that getting the new

cancer analysis published is important to veterans who are not yet being compensated for cancers and other illnesses related to their service in Vietnam.

The Agent Orange Act of 1991 established a compensation list. The first entries were non-Hodgkins lymphoma, soft-tissue sarcoma and chloracne, a skin condition. The act also authorized the National Academy of Sciences to evaluate medical and scientific data about the health effects of dioxin exposure from a host of studies, mostly in the civilian population.

Based on NAS research, the Department of Veterans Affairs has added nine diseases, among them diabetes and respiratory cancers, which include cancer of the larynx. Prostate cancer and multiple myeloma are also on the list.

Among those the NAS is studying that have not yet made the list are bone cancer, melanoma, testicular cancer, urinary bladder cancer, breast cancer and most leukemias.

The Department of Veterans Affairs no longer keeps statistics on Agent Orange claims because of variables such as veterans applying for more than one type of compensation per claim, said Jim Benson, a VA spokesman.

The San Diego Union-Tribune reported in 1998 that 92,276 Agent Orange claims had been filed by veterans and their survivors, and 5,908 of them had been approved.

Funderburk, the Taylors veteran, receives compensation in the form of monthly checks from the VA. But he thinks it's unfair that thousands of other Vietnam veterans with cancer are not getting help.

Trewyn, vice provost for research and dean of the graduate school at Kansas State University, said cancers caused by exposures in Vietnam could show up anywhere.

"Some people are going to be susceptible to one type of cancer versus another," he said. "Having done research on cancer, it doesn't surprise me at all that you find this at a whole host of different sites."