A new analysis may provide some comfort to those who fear that studies US of dangerous pathogens multiply without control. Federal officials say that more than 8 years, they rejected two-thirds of proposals for some 0 studies that fall into a category of studies considered so risky to public health they need a special examination. But a spectator, although praising the results, said the definition of small studies should be expanded to include controversial flu experiments not now covered by the rules.
The report, published online Sept. 8 in the journal safety , sums up examinations by an office in the Centers for Disease Control and Prevention (CDC) in Atlanta. This office, the CDC Division of Select Agents and Toxins (DSAT), oversees the use and handling of certain viruses, bacteria and toxins that appear on a government list of "select agents" that could be used as weapons organic. In 05, in the wake of / 11 post-9 anthrax attacks, the federal government began requiring DSAT examine two types of select agent research.
One category consists in a selection agent resistant to drugs or chemicals. Researchers sometimes intentionally create this resistance to select clones of bacteria that carry a desired trait. (Those not bearing the desired trait are killed by the treatment, remove them from the study population.)
The second "limited experience" category implies adding a gene for a toxin of the selection agent to a microbe. This is often done in order to allow the bacteria to produce large amounts of a toxin, such as botulinum, for experimental purposes.
Both kinds of experiences involve risks, analysts say. If a resistant bug escapes the lab, for example, doctors may not be able to easily handle a person who becomes infected. And engineering of bacteria to produce toxins could be a first step towards the production of a stock of bioweapons.
From 06 to 2013, DSAT has received 618 applications for approval of limited experiences of 109 governments, universities and private organizations. DSAT found that most of the proposed experiments do not meet the definition example for limited purposes, because the toxin was not powerful or because other antibiotics can control the drug-resistant strain.
Of the 91 studies that did meet the definition, officials refused to approve 60 the reasons for rejection included with the laboratory equipment and inadequate biosecurity procedures, and no other medicine existed to treat a selection agent that would be designed to resist existing treatments.
All 61 of the studies involved rejected the inclusion of traits in drug-resistant bugs. In about half the cases, the agents were Burkholderia mallei or Brucella abortus bacteria, which can cause disease in livestock and humans.
Do the results mean scientists are being too cautious and ask DSAT for approval when they should not? DSAT director and co-author of the study Robbin Weyant said that prevention is better than cure. "It is a matter of due diligence," he said. "We encourage regulated entities that research activities involving any kind of selection or cloning component to go ahead and send their protocols for us. We try to be very fast and provide quick turnaround. "
the DSAT program is" a small bright spot "in the monitoring of the pathogens to the risk of the government, said the molecular biologist Richard Ebright of the Waksman Institute of Microbiology at Rutgers University Piscataway, New Jersey, who has long argued that regulation of these experiments is too lax. But Ebright would like to see federal officials to expand the definition of limited experiences so it covers a controversial type of experiment in which a high risk bird flu, the respiratory syndrome Middle East, or SARS virus are refined to make them more likely to spread and cause disease in the man. The government stopped financing these studies "gain of function" there is one year and is currently conducting a complex, long months of examination of their risks.
At present, however, it seems that most experiences pause would not require a DSAT examination. (But federal officials recently proposed the addition of the H5N1 avian influenza, the target of the break of funding, to the list of selected agents, regulated by the CDC.)
One reason for expand the definition of CDC, Ebright said, is that the select agent rules have the force of law and apply to all laboratories, even without federal funding. The downside, he said, is that the inter-agency high-level committee that advises on DSAT these experiences working behind closed doors
Weyant said it for a reason "The process is opaque." public disclosure "sensitive information" might "open the security risks to the institution that sent [the proposed experiments] for us," he said.
it should also be noted in the safety paper is that the number of entities or organizations registered with DSAT fell 15% between 06 and 2013, from 336 to 284 . Ebright suspect, 'the megaburst "biodefense funding after 9/11, more than initially focused on site laboratories" that could be housed, "and some have now moved to other research. But he says the modest decline does not allay concerns that the large number of labs that do work raises risk of biodefense a dangerous pathogen could escape into the environment
* Fixed: October 5, 24:05: An earlier version of this story badly told that the H5N1 bird flu virus is not listed as selected agents H5N1 viruses are currently on the list of selected agents regulated by the Ministry. of Agriculture of the United States. However, H5N1 viruses are not on the Department of Health and Human Services list of some agents that are regulated by the CDC.
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