House Committee on Energy and Commerce
The Honorable Joe Barton, Chairman
The Honorable John D. Dingell, Ranking Member
The Honorable Nathan Deal, Chairman, Subcommittee on Health
The Honorable Ed Whitfield, Chairman, Subcommittee on Oversight and Investigations
2125 Rayburn House Office Building
Washington, DC 20515
Dear Representatives Barton, Dingell, Deal and Whitfield:
The Project On Government Oversight (POGO) is a politically-independent, nonprofit watchdog that promotes a government that is accountable to the citizenry. POGO is concerned about the quality of investigations by the Centers for Disease Control and Prevention (CDC). Our concern stems from cases of flawed investigations at the CDC, including the laboratory-caused infection of Dr. Ru-ching Hsia. Faulty CDC investigations could hinder responses to bioterrorism and result in weak oversight of laboratories' safety and security procedures for dangerous pathogens. The threat of bioterrorism and the 20-fold increase in biodefense funding gives this issue greater significance than before. POGO urges your Committee to investigate this incident, and the possibility of systemic investigative failures of the CDC.
As detailed in The Scientist's article, "Researcher alleges CDC cover-up," former United States Department of Agriculture (USDA) microbiologist Dr. Ru-ching Hsia claims that a CDC investigation was flawed. In December 2003, while working at the USDA's Produce Quality Safety Laboratory in Beltsville, Maryland, Hsia was infected with Escherichia coli O157:H7 (hereafter referred to as E. coli O157), a foodborne illness that kills an average of 60 people in the US each year. At the time of her infection, lab technician Santiago Rossi and his supervisor Yaguang Luo were conducting experiments with E. coli O157. Hsia developed severe gastrointestinal symptoms and then fell into a coma for nearly a month, until mid-January 2004. Hsia eventually recovered, but still suffers from short-term memory loss and recurring headaches. The CDC was called in to investigate.
Unfortunately, the investigation and resultant report contained serious errors. The CDC didn't take into account scientific evidence, administrative records, and testimony that was available and relevant at the time. For instance, prior to her infection, Hsia had repeatedly raised concerns about unsafe experiments and inadequate safety procedures with Rossi, his supervisor Luo, and others in the USDA lab. Furthermore, during early 2004, two other persons connected with the lab fell ill in episodes of intestinal disease. Hsia suspects that these episodes may be laboratory-acquired infections as well.
While CDC has admitted to some minor errors, other problems have been dismissed. Just some of the problems yet to be addressed are the CDC investigative team's lack of training in the handling of infectious disease agents; not considering institutional and personal incentives to distort facts or cover up damaging information; and discounting the infection by uncommon pathogens of two other individuals who were in the lab long after Hsia's infection and hospitalization – one of whom was Dr. Yaguang Luo who supervised the December 2003 experiment which resulted in Hsia's infection. These oversights warrant further critical inquiry.
CDC also erred in such a basic fact as who supervised the lab technician responsible for the accident. CDC's conclusion that Hsia was "officially supervising" Rossi was based on her seniority over Rossi and that she happened to share a lab with him. However, one of the co-authors of the CDC report, Dana Jones, said, "We knew [Rossi] didn't work for her." The actual supervisor was Luo or, in her absence, Kenneth Gross – both Hsia and Luo's boss.
The CDC investigative team's misinterpretation or misrepresentation of facts as basic as Hsia's role in the lab is extremely worrisome and casts into doubt their findings. It becomes more difficult to hold the right person(s) accountable for mistakes or to even know what mistakes were made. Even more concerning is the possibility that this type of failure by the CDC is typical, which would have serious implications for its ability to arrive at correct conclusions in cases of other accidents or bioterrorism.
In addition to problems with CDC's investigative abilities, as highlighted by the Hsia case, there are issues with CDC's ability to oversee infectious disease research. For example, the CDC does not have a mandate to monitor lab safety, and there is no comprehensive requirement to report lab accidents to the CDC. As a result, there is no way for the CDC to know how many lab infections or accidents occur at any particular lab or in total across the nation. This is troubling because the CDC is one of the most important entities in monitoring and preventing the threat from pathogens.
Two risks heighten the importance of adequately investigating not only the technical aspects of disease cause and transmission but the human factor, such as motives to cover-up lax safety as well. The first is that terrorists seek to develop and deploy infectious agents on Americans or others in acts of bioterrorism. While there is some disagreement over the exact nature of the threat and about the current and near-term capabilities of terrorists, there is generally agreement that the technology and knowledge enabling bioterrorism are spreading. Thus, the risks are increasing that Americans will be deliberately infected with harmful agents.
The second is the tremendous increase in the number of people and facilities with access to biowarfare agents as a result of biodefense research. This biodefense response, if not overseen properly, may actually exacerbate the chances of accidental or intentional infections.
The Hsia story is not directly about bioterrorism or biodefense. It is about laboratory safety and the investigative ability of the CDC. But the bioterror threat and the massive increase in the number of labs and persons with access to dangerous pathogens means that significant failures in safety, oversight and investigation are unacceptable.
We hope that you will exercise your oversight authority and determine what measures should be taken to remedy this troubling situation. POGO looks forward to working with you in the near future. Our staff would be happy to assist you in your investigative efforts in any way.
Project On Government Oversight
CC: Senate Committee on Health, Education, Labor and Pensions
The Honorable Mike Enzi, Chairman
The Honorable Edward Kennedy, Ranking Member
The Honorable Richard Burr, Chairman, Subcommittee on Bioterrorism and Public Health Preparedness
House Committee on Homeland Security
The Honorable Christopher Cox, Chairman
The Honorable Bennie Thompson, Ranking Member
The Honorable John Linder, Chairman, Subcommittee on Prevention of Nuclear and Biological Attack
Senate Committee on Homeland Security and Governmental Affairs
The Honorable Susan Collins, Chair
The Honorable Joe Lieberman, Ranking Member
The Honorable Norm Coleman, Chair, Permanent Subcommittee on Investigations
1. Another possible example is that of Bill Paliscak, a postal investigator showered in anthrax dust during the 2001 anthrax attacks. Dr. Gary J. Kerkvliet, an assistant professor at the Johns Hopkins medical school who has cared for Paliscak, fears the CDC "has its head in the sand" because it never classified Paliscak as having anthrax , despite strong reasons to classify him as a "suspect" case. See Shane, Scott. "After a Shower of Anthrax, An Illness and a Mystery," New York Times, June 7, 2005.
2. In fact, acts of bioterrorism may not even be recognized as such, as in the Rajneesh cult case during the 1980s. In that case, the CDC ignored evidence that over 700 cases of Salmonella infection from numerous restaurant salad bars in a compressed time period were the result of bioterrorism. See Miller, Judith, Steven Engelberg and William Broad. Germs: Biological Weapons and America's Secret War. New York: Simon & Schuster, 2001.: 23.