Bioweapons Infections Hit Texas A&M University Again (Q Fever)
- Accident Happened During Biodefense Experiments
- Q Fever Cluster Not Reported to the Centers for Disease Control
- Second Documented Violation of Federal Bioweapons Law by Texas A&M
- Further Sanctions under Texas Public Information Act possible
Three Texas A&M University biodefense researchers were infected with the biological weapons agent Q Fever in 2006. The infections were confirmed in April of that year, but Texas A&M officials did not report them to the Centers for Disease Control (CDC), as required by law. Instead, Texas A&M officials covered the infections up until now, illegally failing to disclose them despite freedom of information requests dating back to October 2006.
The Q Fever cluster is a separate incident than the 2006 infection at Texas A&M with the bioweapons agent Brucella, first reported this April by the Sunshine Project. Texas A&M is liable for $750,000 or more in federal fines ($1.5 million including the brucella incident) for failure to report, as well as possible charges under the Texas Public Information Act.
After a lengthy freedom of information battle, documents received by the Sunshine Project yesterday (June 25th) reveal that the infections were confirmed on 3 April 2006. On that day, Scott & White Hospital called A&M Professor James Samuel as well as Brent Maddox, the university’s institutional biosafety officer, to tell them that three of Samuel’s lab workers had tested positive for Q Fever (Coxiella burnetti). The mechanism of exposure is not stated in the records released; but the Samuel lab conducts aerosol challenges of pigs and other studies with the Q Fever bacteria.
"It is apparent that brucella was only the beginning of Texas A&M’s problems." says Sunshine Project Director Edward Hammond, "A&M’s infection of its staff and students with bioweapons agents and its serial violations of the Select Agent Rule demand law enforcement. If the US government fails to severely sanction Texas A&M, then the Select Agent Rule might as well be tossed in the trash can." Adds Hammond, "Unpunished, Texas A&M’s impunity reduces Bioterrorism Act to mere half-hearted suggestion, rather than the law of the land. Congress surely did not intend biology professors to consider law to prevent bioterrorism optional."
What prompted the infected individuals to visit the hospital is not stated in the documents received by the Sunshine Project. Yet three individuals from the same lab visited the hospital at the same time and had the same tests for a very unusual pathogen performed. Circumstances strongly suggest a lab accident that led the researchers to suspect (correctly) that had become infected. According to the A&M records, upon learning of the infections, the main action of the biosafety officer was to report the accident to the co-chairs of the Texas A&M Institutional Biosafety Committee, who include Thomas Ficht, the professor responsible for the researcher who contracted Brucella in February 2006. But no mention of a Q Fever accident appears in Texas A&M’s biosafety committee meeting minutes.
In fact, Texas A&M has produced zero documentation, such as accident reports, lab paperwork, lessons learned, modified operating procedures, or anything else except a few sparse e-mails for either the Q Fever or the Brucella accident. This is despite open records requests for such paperwork. "If Texas A&M’s replies under the Texas Public Information Act are to be believed," says Hammond, "then four people at the University have been infected with bioweapons agents without responsible A&M professors and other officials even bothering to file a simple incident report, much less alert the community or report to public health officials."
According to federal law, A&M was required to report the infections immediately upon their discovery and to file a federal report, called APHIS/CDC Form 3, within 7 days. It did not do so. Under the Texas Public Information Act, which includes civil and criminal penalties for false responses, Texas A&M has denied filing any report of the Q Fever infections. By not reporting the infections to the government, Texas A&M thus violated (again) the Select Agent Rule, the main federal law intended to protect Americans from biodefense research gone awry.
Samuel is a professor of Medical Microbiology and Immunology and teaches courses at Texas A&M’s Center for Homeland Security, which is funded by the US Department of Homeland Security. Samuel also receives biodefense funding from the National Institutes of Allergy and Infectious Disease (NIAID) and the NIH-funded Southwest Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research, managed by the University of Texas Medical Branch at Galveston. The records released to the Sunshine Project do not contain information concerning the treatment of the infected individuals.
Several freedom of information requests to Texas A&M remain unanswered. The Sunshine Project will continue to pursue these and other requests with Texas A&M until a satisfactory resolution, including federal and state government action, is achieved.
July 5th, 2007 at 10:56 am
标题:A&M disease research halted [by CDC]
CDC suspends A&M research on infectious diseases
http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/DN-a&m_02tex.State.Edition1.1577e7d.html
11:18 PM CDT on Sunday, July 1, 2007
By EMILY RAMSHAW / The Dallas Morning News
[email protected]
AUSTIN – The Centers for Disease Control and Prevention has indefinitely suspended all of Texas A&M University’’s federally sanctioned research on the most dangerous infectious diseases after the university’’s failure to report two 2006 cases of human exposure to biological agents.
Mike McKinney, chancellor of the Texas A&M System, said that before Saturday’’s decision, the CDC had already halted the university’’s research on one of the two agents the lab workers were exposed to. He said he supports federal authorities'’ decision to expand that research ban to all \"select agents\" monitored by the agency.
\"I'’m one of those who says, when you find a problem, you ought to take care of it,\" said Dr. McKinney, who says he didn'’t learn of the 2006 incidents until about a month ago. \"I have a whole bunch of frustration, but it’’s not with the CDC.\"
In a memo sent to the university Saturday, the CDC questions whether A&M meets biosafety standards and has an appropriate security plan. The memo says CDC officials plan to revisit the campus this month, and it demands dozens of records and interviews with key researchers.
The letter warns that the university could permanently lose the authority to work with select agents if researchers don'’t follow federal guidelines.
In a statement, A&M interim President Eddie Davis said the university takes the matter seriously and intends to comply with federal rules.
\"We plan to cooperate fully with the CDC and look forward to resolving this matter in an appropriate manner as quickly as possible,\" Dr. Davis said, \"so that we can move forward in our work supporting the nation’’s homeland defense initiatives.\"
News of the A&M incidents emerged last week when The Sunshine Project, an Austin-based bioweapons watchdog group, released records showing that three biodefense researchers were exposed to Q fever in April 2006. Just two months earlier, another lab worker fell ill after being infected with Brucella.
Edward Hammond, who directs The Sunshine Project, said this is the first time he’’s heard of such a CDC ban, one he’’s sure will send shockwaves through research universities across the country.
And he said it serves as a \"serious blow\" to A&M’’s campaign to host the new National Bio and Agro-Defense Facility, a major federal biological agents lab the Department of Homeland Security will award in 2008.
\"How could any government agency in good conscience put an institution in A&M’’s situation in charge of what’’s going to be one of the largest biodefense labs in the world?\" Mr. Hammond asked.
In the Brucella case, university officials acknowledge that they did not follow protocols for reporting such incidents to the CDC, but they dispute allegations that they broke the rules with the Q fever exposure. No one died from the diseases, which, while rarely fatal in humans, cause flulike symptoms that are difficult to cure. Neither is easily contagious among humans, so there was no widespread public danger.
Both incidents have been under investigation by the CDC and the U.S. Health and Human Services Department’’s inspector general since April, and Dr. McKinney said he expects some resolution by the end of the month.
Homeland Security link
Texas A&M heads the National Center for Foreign Animal and Zoonotic Disease Defense, one of 10 \"centers of excellence\" around the nation. The A&M center is funded by an $18 million U.S. Department of Homeland Security biodefense research grant.
A&M researchers have been studying vaccines for Brucella and Q fever, both of which are considered \"terror agents\" that could be used in biological warfare.
The Q fever case came to light after routine blood tests showed that three lab workers had elevated levels of certain antibodies, indicating they'’d been exposed to the agent. None of the researchers fell ill.
CDC officials say they never received documentation on the Q fever exposure. But university officials say that they contacted the CDC on the exposures and that the agency told them it wasn'’t serious enough to warrant a formal report. The university has since changed its policy to require reporting of exposures, even when there’’s no evidence of infection.
The Brucella infection occurred when a female lab worker climbed into a chamber used to expose mice to the agent in an attempt to disinfect it. She was home sick for several weeks before she was diagnosed with brucellosis, and she had to take two months'’ worth of antibiotics to fully recover.
An e-mail released by the university shows that at least one principal researcher knew the university was supposed to report the illness to the CDC, but the mandatory report on the Brucella infection wasn'’t sent for a year.
Consequences
Dr. McKinney said that the university has suspended that researcher in the Brucella lab pending the outcome of the investigation and that \"there are some other people who probably should'’ve been dealt with.\" He didn'’t indicate that anyone would be fired, though.
\"This is where I get mad, where I get extremely upset, because it looks like you'’re trying to cover something up,\" Dr. McKinney said. \"The responsibility on all of this stuff, it goes to the top. And you destroy your own credibility if you don'’t follow the rules.\"
Federal rules on select agents require researchers to inform the CDC of potential security breaches immediately and to file formal reports within seven days. Penalties include steep fines or loss of federal funding. Select agents are the most serious and infectious – including everything from the ebola virus to smallpox.
Dr. McKinney said that since he learned of the exposures, he has brought in a disease safety expert to examine the university’’s protocols and hired an attorney to get to the bottom of why the suspected infections occurred and weren'’t reported.
\"I want to name names, fix the blame,\" he said. \"I want the unadulterated, unvarnished truth.\"