Experts outline path forward in dual-use research conundrum

Two biosecurity experts who have called for civil debate and mutual understanding surrounding dual-use research of concern (DURC) issues yesterday proposed a framework for moving forward.

Writing in PLoS Medicine, Michael J. Imperiale, PhD, of the University of Michigan Medical School and Arturo Casadevall, MD, PhD, of the Albert Einstein College of Medicine in New York City said the discussion of DURC studies—so-called because their results could be used for good or bad purposes—has become polarized.

"The situation today is highly unsatisfactory," they wrote. They called the establishment of a definition of DURC in 2005 by the National Advisory Board for Biosecurity (NSABB) a step forward, but decisions about publishing DURC studies have largely fallen to journal editors. They also decried a lack of US government leadership.

Two controversial studies published in 2012 on experimentally modified H5N1 avian flu viruses brought the issue to a head, but no overall solution or clear path forward has been established since then, they said.

"To us, the essential questions are, what experiments does humanity truly need and which risks are we willing to accept?" they wrote, adding that answers are not clear-cut. "Scientists who are most closely associated with these experiments cannot make these determinations alone. A larger group of stakeholders must contribute, including the broader scientific community, public health experts, and ethicists, to name a few."

Their proposed approach for advancing the process includes five principles:

  1. Defining the medical and scientific problems that need to be solved to protect humanity from pandemic threats, such as understanding the relationship between virulence and transmissibility
  2. Acknowledging that research has inherent risks that can be minimized but never fully abolished
  3. Acknowledging that, although risks and benefits can be difficult to quantify, efforts must be made to assess them
  4. Developing new biosafety approaches, including safer laboratory strains, careful attention to protocol, constant improvement of infrastructure, and vaccines to protect laboratory personnel when possible
  5. Creating a national board to vet issues related to research with dangerous pathogens, possibly modeled after the Recombinant DNA Advisory Committee

In August 2014, Imperiale and Casadevall penned an editorial in mBio urging both sides of the debate to approach the issue "with consideration of the opposite view and with humility." They are both mBio editors and former NSABB members.
Apr 14 PLoS Med commentary
Aug 4, 2014,
CIDRAP news story on mBio editorial


Study says immune response to inhaled measles vaccine inferior

Although an aerosolized measles vaccine was immunogenic in children, their immune response was lower than the response to a traditional subcutaneous vaccine (measles shot), according to study results published today in the New England Journal of Medicine.

An international team of scientists administered an aerosolized (inhaled) vaccine produced by the Serum Institute of India to 1,001 unvaccinated Indian children from 9 to 11.9 months of age and the subcutaneous vaccine to 1,003 such children.

In the pre-protocol population, 85.4% of the kids in the aerosol group were seropositive after 3 months, compared with 94.6% in the subcutaneous group. Almost identical results were seen in the full-analysis set: 85.4% in the aerosol group and 94.7% in the subcutaneous group. No serious adverse events were noted in either group.
Apr 15 N Engl J Med study


US offers mixed news on drug resistance in foodborne pathogens

A pair of annual federal reports on antimicrobial resistance in pathogens found in poultry and meat brought a mix of good and not-so-good news this week.

The government's National Antimicrobial Resistance Monitoring System (NARMS) issued its retail meat report for 2012 and an interim report for 2013 that covers only Salmonella.

NARMS is a collaborative program of the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, and state and local health departments in 11 states. The annual reports focus primarily on Salmonella and Campylobacter.

On the Salmonella front, testing showed that multidrug-resistant strains decreased from 2011 to 2013. In 2012, 33% of retail chicken Salmonella isolates were resistant to three or more classes of antibiotics, which was lower than in 2011. The number dropped to 26% in the 2013 interim report.

There was good news on quinolone resistance: all Salmonella isolates from poultry and meat were susceptible to nalidixic acid and ciprofloxacin in 2012, and in 2013 all were susceptible to ciprofloxacin. (The 2013 report does not mention nalidixic acid.)

The 2012 report shows that third-generation cephalosporin resistance in retail chicken Salmonella isolates increased from 10% to 28% between 2002 and 2012, but the 2013 report shows it dropped to 19.7%.

As for Campylobacter, nearly half of C jejuni and C coli isolates from retail chicken were resistant to tetracycline in 2012, making tetracycline resistance the most common type among Campylobacter.

The report also said that monitoring has revealed no consistent changes in ciprofloxacin resistance among retail chicken C jejuni and C coli isolates since the FDA banned fluoroquinolone use in poultry production in 2005.

On the other hand, Campylobacter rarely shows resistance to multiple drugs, as only 26 of 620 poultry isolates were resistant to three or more antibiotic classes in 2012.
NARMS 2012 Retail Meat Report
NARMS 2013 interim report on Salmonella


WHO acknowledges 20 recent H7N9 cases in China

The World Health Organization (WHO) announced today that Chinese health officials on Apr 10 reported 20 more lab-confirmed H7N9 infections, 4 of them fatal.

Onset dates ranged from Feb 14 to Mar 21, with patient ages ranging from 32 to 80 years, with a mean of 55. Fifteen patients are men, and 18 had been exposed to live poultry. One person is a healthcare worker who also had poultry exposure. No clusters were reported.

The cases were reported from five of China's provinces, and half of the cases were in Zhejiang. The others are Anhui (3), Fujian (2), Guangdong (4), and Shandong (1).

The report didn't list China's cumulative H7N9 case total or the total so far this year.

In its latest monthly report on zoonotic flu activity, posted yesterday and covering most of March, the WHO said a total of 631 H7N9 infections, including 253 deaths, have been reported in China.

A running global case list compiled by FluTrackers from individual health department reports and other official sources puts the overall total at 656. FluTrackers is an infectious disease news message board. The cases China reported to the WHO appear to have already been picked up by FluTrackers.

The WHO indicated yesterday that the dynamics of H7N9 in China haven't changed. It said the virus is still being found in poultry near where human cases are occurring and that it still doesn't spread easily to humans.
Apr 15 WHO statement
FluTrackers H7N9 case count
Mar 31 WHO monthly influenza risk assessment

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