Feds' attempt to kill polycythemia vera investigation shows need for change
By SUE STURGIS Special to The TIMES NEWS
U.S. Rep. Brad Miller (D-N.C.), chaired a hearing earlier this month on failures of the federal Agency for Toxic Substances and Disease Registry, a branch of the Centers for Disease Control and Prevention, to protect public health from environmental contaminants.
The hearing revealed numerous problems at ATSDR including the fact that it tried to bury research on the polycythemia vera epidemic in the anthracite coal region.
Problems at ATSDR first came to the attention of Miller's Science and Technology Investigations and Oversight subcommittee after the agency's badly flawed health assessment for formaldehyde exposure in Hurricane Katrina and Rita victims living in FEMA trailers. Through a series of hearings, Congress learned that ATSDR had honored a request from FEMA which was facing litigation over the trailers' formaldehyde levels to calculate the risk posed by formaldehyde by assuming storm victims were exposed for less than two weeks, even though many had already been living in the units for more than a year.
"Government at all levels failed the victims of Katrina and Rita in many ways, but ATSDR's failure was perhaps the most unforgivable," Miller said in his opening statement. "ATSDR's health assessment certainly failed any test of scientific rigor, but ATSDR's failure was worse than just jackleg science. ATSDR's failure was a failure not just of the head but of the heart."
In the wake of its investigation into formaldehyde in FEMA trailers, the subcommittee heard about other problems with ATSDR's work. It also heard about what Miller referred to in his opening statement as the agency's "keenness to please industries and government agencies that prefer to minimize public health consequences of environmental exposures."
The hearing featured testimony from a number of sources who pointed to serious failings by the ATSDR that are putting people's health in danger. They included Dr. Ronald Hoffman, a blood cancer expert and professor at the Mount Sinai School of Medicine in New York (pictured in photo above, a still from the hearing webcast). He was part of the team of researchers who discovered a statistically significant cluster of polycythemia vera, a relatively rare blood cancer, in Schuylkill County and the fact that it might be related to the area's extensive environmental contamination.
Under oath, Hoffman told the Congressional subcommittee how ATSDR's management first tried to discourage his research and then to prevent the publishing of findings that suggested an environmental connection.
"My sense is that if the agency was left to itself, it would have preferred to ignore the problem," he said.
'An obvious attempt at intimidation'
Concerns about polycythemia vera first came to widespread public attention in 2006. That year, the Pennsylvania Department of Health released a public health assessment in Schuylkill, Luzerne and Carbon counties that found Schuylkill and Luzerne counties had unusually elevated rates of polycythemia vera, a relatively rare malignancy marked by the overproduction of red blood cells.
The specific genetic mutation involved in polycythemia vera has been linked to polycyclic aromatic hydrocarbons chemicals released during the burning of fossil fuels. The area in question has the nation's highest concentration of waste-coal-burning power plants, a significant source of PAHs. It is also home to numerous toxic waste sites, abandoned mines, coal ash dumps, and polluting industries that are also sources of health-damaging chemicals.
ATSDR got involved in the investigation at the state health department's request. Dr. Vince Seaman, an ATSDR epidemiologist and toxicologist, contacted Dr. Ronald Hoffman, who agreed to evaluate blood samples from subjects thought to have the disease using a new molecular test.
But to Hoffman's surprise, ATSDR's management was not only unwilling to provide funds for the tests but was resistant to having them done at all. He proceeded with funding from a private foundation.
Through his own research, Hoffman confirmed that there seemed to be an unusually high rate of polycythemia vera in the study area including an unusual number of cases along Rush Township's Ben Titus Road, which runs near a site that's home to an abandoned mine, an old toxic waste dumping and incineration site, a waste-coal-burning power plant, and a massive dump for waste-coal ash.
The two doctors wrote an abstract about their findings for a 2007 meeting of the American Society of Hematology. Despite the fact that the abstract had been reviewed by numerous ATSDR staff, the agency objected to its submission because it had not gone through a formal clearance process. Then amidst the controversy, ATSDR sent Seaman on a months-long assignment to Mozambique a move that angered study participants and that Hoffman thought "showed poor judgment."
Even more surprisingly, at an October 2007 community meeting in Hazleton to discuss the preliminary findings, an ATSDR spokesperson presented conclusions that in Hoffman's words "seemed at odds with the results summarized in our abstract." For example, the ATSDR claimed polycythemia vera cases were scattered throughout the study area in no predictable pattern, and it downplayed the extraordinarily high rate of the disease.
"As I drove back to New York that evening with my scientific colleague Dr. Mingjiang Xu we talked about the experiences of the day," Hoffman said in his written testimony. "We commented how we felt that the ATSDR had misinterpreted and prematurely drawn conclusions about the data that we had participated in generating. ... Also we questioned if there was some outside constituency who ATSDR was responding to that made them act like they just wanted this whole matter to go away."
Soon after, Hoffman learned that the abstract of his research paper with Dr. Seaman had been accepted for a presentation at the hematology meeting which led to more problems with ATSDR management. Agency officials made repeated requests that he not exhibit his maps suggesting a geographic relationship between the polycythemia vera cases and pollution sources. When he refused, the agency issued a press release disavowing the findings.
When Hoffman showed up at the meeting, he got repeated cell phone calls from ATSDR officials asking him to either withdraw the abstract, make a statement before his presentation that the agency disagreed with its conclusions, or present an abridged version of the data.
"I was intimidated by these frequent calls by government officials which created a great degree of stress and anxiety for me," Hoffman said. "I was also outraged at this obvious attempt at intimidation."
However, Hoffman was not intimidated enough by ATSDR's pressure to change course. His presentation was well received at the hematology meeting and his fellow scientists accepted the possibility that environmental contamination was a likely factor behind the unusual rate of polycythemia vera in the study area.
Hoffman and Seaman continued to refine their research. As part of that effort, ATSDR biostatisticians performed a sophisticated analysis that confirmed a statistically significant cluster of polycythemia vera in the study area. It includes Ben Titus Road, where multiple cases of the cancer were identified, as well as the borough of Tamaqua.
Hoffman's manuscript describing the cluster findings was eventually accepted by a peer-reviewed journal titled Cancer, Epidemiology, Biomarkers and Prevention and published last month.
But even then pressure to scuttle the reported findings continued. PADOH's chief epidemiologist, Dr. Stephen Ostroff who came to the agency from the CDC while Hoffman's study was underway was angry that the manuscript had been altered without his approval during the peer-review process.
Hoffman reports that Ostroff made "numerous calls" to top ATSDR officials to try to get them to discredit the manuscript. So far ATSDR has not done that.
"The scientific nihilism and lack of respect for the integrity of scientific investigation initially displayed by members of the agency surely compromises the stated mission of this agency," Hoffman said in his written testimony. "Their unwillingness to look objectively at the compelling data generated by our investigations is puzzling and disturbing to me."
This month, U.S. Sen. Arlen Specter (R-Pa.) announced that the Senate has approved an appropriations bill with $5 million for further study of the polycythemia vera cluster. But President Obama has yet to name a permanent head of the CDC to oversee ATSDR. After former CDC Director Julie Gerberding stepped down after the election, Obama appointed as a temporary replacement Richard Besser, a CDC insider and bioterrorism expert.
No word yet on when a final appointment will be made or what it might mean for the integrity of ATSDR's future scientific research. But as Hoffman's testimony made clear, changes are needed at the agency if it's to live up to its mission of safeguarding communities.
"We hope the new Obama administration will take a hard look at ATSDR," Miller said at last week's hearing. "The American people deserve better, and so do the many scientists at ATSDR who have dedicated their lives to protecting the public's health."
Labels: arlen specter, ATSDR, cancer clusters, carbon county, CDC, congress, luzerne county, Northeastern Power Co., PAHs, politics, polycythemia vera, public health, schuylkill county, waste coal burning