Saturday, May 30, 2015

Iowa biosafety: Do lab mistakes risk public health?






Accidents and employee negligence at Iowa research laboratories have caused unnecessary biological risks or potentially exposed workers to bovine tuberculosis, pathogens and other dangerous viruses, according to records obtained by The Des Moines Register and USA TODAY.

The occurrences — mostly documented over the past three years in federal incident reports — are among hundreds of laboratory mistakes that were uncovered across the nation during a six-month investigation by Gannett newspapers.


UNAPPROVED STUDIES: Research on the Middle East Respiratory Syndrome virus — better known as MERS —was conducted for about five months in 2013 and 2014 prior to being approved by the bio-safety committee at the University of Iowa. MERS is a respiratory illness first reported in Saudi Arabia in 2012. It kills about 30 percent of people who contract it. The incident "was the result of negligence" of Stanley Perlman, a UI microbiology professor who headed the project, the report says.

ACCIDENTS: A postmortem examination on a cow with bovine tuberculosis resulted in an employee accidentally stabbed in the knee with a knife used in a September 2014 exam at the USDA's National Animal Disease Center in Ames. In another incident, a University of Iowa graduate student in January 2012 cut his finger after breaking a glass tube containing staphylococcus, a common cause of skin infections and respiratory disease. He wasn't wearing the required laboratory personal protective equipment, including gloves, the report shows.
The Register requested an interview with UI staff about the incidents. University spokesman Stephen Pradarelli responded to questions in writing, saying the incidents are typically self-reported by the researchers and involve little or no risk to human health or safety. He emphasized the importance of the university's research.

"Infectious diseases like Lyme disease and bird flu present unique challenges, and gaining basic understanding about their origins, behavior and transmission within and across species is critical to defining measures to reduce transmission and finding effective treatments," Pradarelli wrote.

Even the laboratory incidents that appear to be the most minor could have major consequences and deserve full disclosure, said Brady Allin, director of operations for the International Federation of Biosafety Associations, a Canadian-based watchdog group that advocates for improved bio-safety measures. The organization has struggled for years to fully document the problems associated with biolabs, he said.

"An accident that happens in a laboratory can result in someone going home, bringing it to their family and children and it can spread from there," Allin said.
The Register and USA TODAY identified nine bio-safety incidents at the University of Iowa lab reported to the National Institutes of Health and eight incidents at the USDA labs in Ames. The majority involved what were described as minor injuries involving things such as researchers cut with scalpels or stuck with needles.

The laboratories conduct research on some of the world's most serious and sensitive biological issues. The Ames labs, for example, include studies of the highly contagious avian influenza aimed at developing vaccines and other tools to prevent outbreaks such as those that are currently decimating the nation's poultry industry.

The University of Iowa refused to disclose the location, nature or number of biolabs it oversees, citing an internal policy and claiming such information is not public under Iowa law for security reasons.

The USDA laboratories were more transparent, posting the address and photos of the facility online along with a general description of their work and a listing of employees.

Allin said he has struggled for years to overcome the information obstacles associated with some biolabs. Part of the reason is money. Institutions known to have bio-security problems may have difficulty getting grants or government allocations to continue their work.

"It is very difficult to get at the data in some cases," Allin said.
Gannett news organizations encountered months of push back from some publicly funded laboratories in response to record requests for bio-safety meeting minutes and incident reports. In some cases, such as the University of Kansas, entire pages of minutes from public meetings were blocked from view.

USA TODAY filed a public records complaint with the National Institutes of Health in February over the university's attempt to charge nearly $400 for records at its two laboratories, a fee the news organization argued was excessive. The university later reduced the charges to $90.

A second public records complaint was filed against KU on May 14 over the redaction issue.

Some of the redacted entries involved precisely the information needed for public oversight and awareness, said Edward Hammond, a bio-science researcher and writer in Texas who filed an open records complaint against UI last year in an attempt to gather more information about the MERS incident.

The university also redacted safety committee minutes discussing inspections, sometimes to the extent it was impossible to determine who conducted the checks or what problems, if any, were found.

The inspection reports were related to research that involves so-called "select agents," a term used to describe hazardous materials that pose a severe threat to public health and safety, Pradarelli told the Register this week. The UI spokesman said federal guidelines allow the university to keep the information secret.

But Hammond said such heavily redacted documents are an example of how the public must too often rely on faith rather than facts when it comes to bio-safety.
"Don't take their claims at face value," Hammond said in response to conclusions laboratory officials sometimes provide without offering data or public records to support them. "These are people who are dedicated to making sure accidents don't happen, and they often downplay incidents."