It was reported this week that the Presidents Council on Bioethics was disbanded. The Council, appointed by the Bush Administration, was often accused of taking a more ideological than scientific perspective in its reports and advice. In its place, President Obama will convene a new bioethics commission.
Today Science Magazine is reporting that the Army has banned all pathogen research at one of its labs at the Armed Forced Institute of Pathology (AFIP) in Washington, DC. This decision was made December 2, 2008 as a result of an earlier failed Biological Surety Inspection, and not made public.
Science reports that “officials found that lab managers ignored information about certain employees that could have disqualified them from having access to dangerous pathogens. The redacted version of the IG’s [Inspector General's] report released to Science does not divulge the nature of this so-called potentially disqualifying information, but it could be anything from alcoholism to mental instability.”
On October 28, 2008 AR 50-1 came into effect, stipulating a strict Biological Personnel Reliability Program for DOD employees as part of their Biological Surety Program. It includes and intense background investigation and interviews of employees as well as regulations regarding substance abuse and mental health.
In early February the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) also suspended its research on biological select agents and toxins when it was realized that there were problems with the system of accounting for high risk microbes and biological materials in the laboratories at Fort Detrick, MD.
Today at 1pm EST HHS secretary Kathleen Sebelius, DHS Secretary Janet Napolitano and acting Director of the CDC Richard Besser will be webcast answering questions about Swine Flu from the American people. The webcast will be available at www.hhs.gov and questions can be emailed to firstname.lastname@example.org.
The World Health Oraganization has now raised the Pandemic Alert Level to Phase 5 meaning that they believe there is a “strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short.” There currently have been 109 confirmed cases of Swine Flu in the US and one death. Continually updated information on the situation and statistics as well as fact sheets and interim guidance documents can be found on the CDC Swine Flu page at www.cdc.gov/swineflu.
SciecneInsider has the details surrounding an Ebola researcher who pricked her finger with a needle during an experiment last week. Virologists around the world are collaborating to try to save their colleagues life. An exposure to Ebola from a needle stick does not often lead to infection with the deadly illness, but a group of scientists immediately got together to discuss a long list of experimental vaccines and treatments that could possibly prevent infection or slow progression of the disease. As a result, the exposed researcher was given a vaccine that has previously been shown to provide protection in monkeys who had been exposed to Ebola. The incubation period of Ebola is typically between 4 and 21 days, and it has only been 6 days since the needle stick incident. Thus far there is no indication that the researcher has contracted an Ebola infection, but virologists are anxiously following her case.
On March 12 AAAS in partnership with the Center for Biosecurity of UPMC hosted a public briefing to discuss the current oversight of high-containment laboratories. The session was held to discuss the elements of H.R. 1225, the recently introduced Select Agent Program and Biosafety Improvement Act of 2009. This bill seeks to reauthorize the Select Agent Program by amending the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 and to improve oversight of high containment laboratories.
Michael Ehret from the Midwest Research Institute, a private laboratory, Michael St. Clair, from Ohio State University an academic laboratory, and Michael Pentella from the University of Iowa, a public health laboratory discussed the regulatory procedures associated with the operation of each of their facilities. Each spoke about the different agencies and number of inspections or audits that they face each year, the costs of these audits and staff training as well as additional personnel reliability programs in place at their institutions.
All three speakers expressed concern about the number of agencies, each with a unique set of regulations, responsible for oversight of their facilities and suggested that a harmonized approach to regulation was necessary. Each of the represented laboratories also had internal oversight committees to ensure a high level of safety and security.
During a ceremony at the White House today, President Obama signed an Executive Order to overturn President Bush’s 2001 restrictions on using federal funds for research on embryonic stem cells. The Executive Order is focused on stem cell research, but it signals a desire by the Obama Administration to return scientific integrity to its policy decisions. Accompanying the Executive Order will also be a Presidential Memorandum to ensure that the government’s scientific decisions are insulated from political influence. This is a welcome change after 8 years of the Bush Administration ignoring or distorting science to further its political agenda.
Yesterday Interfax news agency reported that experts estimate that over 30 nations have the capability to rapidly deploy biological weapons. The remarks were made by Natalya Kaverina of the Russian Academy of Sciences’ Institute of Global Economy and International Relations during a presentation for the Stockholm International Peace Research Institute on March 3. Kaverina suggested that the tempation to use such weapons had inreased due to global instability and economic uncertainty.
This weekend it was reported that 2 mice infected with Yersinia pestis, the causitive agent of plague, were missing from a lab at the University of Medicine and Dentistry of New Jersey (UMDNJ). In September 2005 it was also reported that 3 live mice infected with Y. pestis were missing from UMDNJ a lab. In this case however, the “missing mice” are actually the carcasses of mice who died during an experiment, were bagged and placed in a freezer for storage until the experiment was completed and they could be incinerated. It is believed that the missing bag of mice was accidentally sterilized along with another bag.
In both cases the FBI investigated and determined that there was no public health risk.
ScienceInsider is reporting that the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has suspended their research on biological select agents and toxins. Officials froze research last Friday when they realized that there were problems with the system of accounting for high risk microbes and biological materials in the laboratories at Fort Detrick, MD and have begun an inventory of select agents and toxins at the facility. Not coincidentally, this is the same facility that has been under intense scrutiny after the FBI named researcher Bruce Ivins as their main suspect in the 2001 anthrax letter attacks.
“The decision was announced by institute commander, Col. John Skvorak, in a 4 February memo to employees. The memo, which ScienceInsider has obtained, says the standard of accountability that USAMRIID had been applying to its select agents and toxins was not in line with the standard required by the Army and the Department of Defense. USAMRIID officials believed that a satisfactory accounting involved finding all the items listed on its database, the Army and DOD wanted the converse; that is, all select agents and toxins needed to be matched to the database.”
The Army is clearly clamping down on their select agent research programs with very strict accounting of biological agents and, personnel in direct response to the Ivins case. Of note, on October 28, 2008 Army Regulation 50-1 came into effect. AR50-1, outlines a strict Biological Personnel Reliability Program for all DoD employees with access to BSAT. In order to be cleared to work with or have access to BSAT everyone must go through intense screening. This includes an interview, personnel security investigation, personnel records review, medical evaluation (includes mental evaluation and any medications) and drug testing.
Today the National Academies of Sciences (NAS) and the American Association for the Advancement of Science (AAAS), released their survey of Attitudes and Actions on Dual Use Research in the Life Sciences. The survey was sent to AAAS members whose primary area of research was in the life sciences in order to assess their awareness of and attitudes toward “dual-use” research-studies undertaken for beneficial purposes that could also have harmful applications. The survey also explored actions the scientists might support to reduce the risk of misuse of research, as well as steps that scientists may already be taking in response to these concerns.
David Franz of the Midwest Research Institute and Ronald M. Atlas of the University of Louisville, two of the members of the committee which reviewed the survey results and wrote the final report presented the main findings. David Franz began by defining dual-use research and its importance within the life sciences community and Ronald Atlas discussed the primary findings of the survey. Atlas noted that a low response rate and uncertainty about whether the sample is representative of the broader life sciences community limits the ability to draw definitive conclusions. Nonetheless, the survey results are useful and informative and Atlas went on to explain that the results indicate that some respondents have already been so concerned about dual-use issues that they have altered their research or experiments. Even in the absence of guidelines or government restrictions some scientists have already taken action to try to avert misuse of biomedical research.
Copies of A Survey of Attitudes and Actions on Dual Use Research in the Life Sciences: A Collaborative Effort of the National Research Council and the American Association for the Advancement of Science are available from the National Academies Press.
Today’s presentation can be heard via podcast from the National Academies website.