Archive for January 2015
By: Sara Cassidy, M.S., Ph.D.
In a press release issued by the White House on January 15th, and reiterated briefly in the State of the Union address on Jan 20th, President Obama asked Congress to pass a bill providing 6 weeks of paid parental leave to all federal employees, a move which aims to fill “a notable gap in federal benefits,” that “can hamper federal agencies’ ability to recruit talented young people to join public service.” The president’s budget also proposes a $50 million State Paid Leave Fund to bolster states that choose to enact paid leave programs1. Currently there are only 5 states which guarantee paid leave to new parents; California, Hawaii, New Jersey, New York, and Rhode Island.
The issue of paid parental leave for federal employees is not a new one in the House. Since 2009, Representative Carolyn Maloney (D – N.Y.) has spearheaded a bill proposing to fund 4 of the 12 weeks of leave given under the Family Medical Leave Act (FMLA) for federal employees who are new parents. In its debut, H.R. 626 passed the House in a 276-to-146 vote but stalled in the Senate. Rep. Maloney has supported passage of this bill in every congress since 2009. The most recent iteration, H.R. 517 – Federal Employees Paid Parental Leave Act of 2013, never made it to a House vote2-4.
Offering paid parental leave to federal employees is a step in the right direction toward universal leave for all Americans. In practice, the U.S. is shockingly behind the times in supporting working families. A survey released in May 2014 by the United Nations’ International Labour Organization revealed that the U.S. is the only country in the developed world that does not offer government-mandated paid maternity leave. In fact, the U.S. is one of only 2 countries out of 185 surveyed that provide no cash benefits to women during maternity leave; the other country being Papua New Guinea5.
Science overwhelmingly supports the health benefits of parental leave for both parents and children. Research suggests that mandated leave increases the duration of breastfeeding, and breast milk protects against childhood infections, chronic diseases, and may prevent obesity6. Lack of access to paid parental leave may explain, in part, the poor statistics for breastfeeding in the U.S. compared to other developed countries where paid leave is a right7. Additionally, paid parental leave leads to better long-term health of the child and to lower rates of depression in mothers, according to the National Bureau of Economic Research10,11. Highlighting both positive health and economic benefits, a report on European leave policies found that paid leave is a cost-effective way to reduce infant mortality because it allows parents to better care for their child and monitor their child’s health16.
There are additional economic benefits of paid parental leave. Healthier parents and children incur fewer medical bills, which makes fiscal sense for government-supported healthcare programs, such as Medicare and health plans offered through the Affordable Care Act. And, according to the National Partnership for Women and Families, “Paid leave improves worker retention, which saves employers money through reduced turnover costs.13” The drive to retain highly trained workers in skilled fields, such as information technology (IT), may be the reason why some major players in IT have generous family leave policies. Susan Wojcicki, the CEO of YouTube (which is owned by Google), in a piece for the Wall Street Journal wrote, “When we increased paid maternity leave to 18 weeks from 12 weeks in 2007, the rate at which new moms left Google fell by 50%.8” Although 18 weeks of paid leave will likely never be offered to the majority of Americans, even short stints of paid parental leave can have positive economic benefit. The National Partnership for Women and Families cites a study that found 87% of businesses in California (where 4 weeks of paid state-supported parental leave is offered) reported no increased costs resulting from the state leave policy, and 9% reported cost savings in the form of reduced turnover and/or reduction of their own benefit costs13.
The importance of paid leave for new parents reflects a shift in the social and economic implications of raising a family in the U.S. According to the White House, “it is no longer the case that one parent is the breadwinner while the other is the caregiver. Women now make up nearly half of all workers on U.S. payrolls, and men and women are more evenly sharing care-giving responsibilities.1” Data from a 2012 survey by the Bureau of Labor Statistics report that among families with children, 59% have two working parents9. So, should the government be obligated to help support new families? On one hand, there exists a well documented of dearth of U.S. women in high-profile positions, despite the fact that there are equivalent numbers of men and women getting college degrees in nearly all fields of study. The choice to have children and a lack of subsequent maternity support is often cited as a reason for this imbalance. By that measure, better support for working women could be considered the next logical outgrowth of affirmative action policy, initiated by the Johnson administration in the 60s. However, the issue may be even more striking when considering single parent households and lower-income jobs. Many Americans cannot afford to take unpaid leave and, even if they could save enough for this to be an option, 40% of the American workforce is not covered by FMLA, so unpaid leave after the birth or adoption of a child is not their right. For these workers, mandated paid parental leave, even for only a few weeks, could be the difference between returning to a job or turning to welfare.
Americans from all political backgrounds overwhelmingly agree that it is time to better support working families, according to a poll by the Make it Work campaign, an advocacy organization pushing to make working family issues a priority in 2016, cited by the Washington Post15. But the likelihood of Congress moving on a bill to that effect anytime soon seems slim. The last time Congress passed legislation to support working families was FMLA in 1992, which took 10 years. The good news is that White House coverage of the topic has illuminated the need for better support of working parents. Ultimately, child rearing is a personal choice, but one that should be considered, as it is in other nations, an investment in the future.
- Guendelman S et al. 2009 123(1) pg.e38-e46
- Ruhm C.J. J. Health Econ. (2000) 19(6) pg931-960
By: Kaitlyn Morabito
On October 17th, the Obama administration announced a funding pause on new gain of function (GOF) research and a voluntary moratorium of current research on Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS), and both highly pathogenic and low pathogenic influenza viruses. The re-evaluation of the potential risks and benefits of federally funded GOF research will be pioneered by the National Science Advisory Board for Biosecurity (NSABB) and National Research Council (NRC) of the National Academies. These organizations will consult with the biomedical community and are responsible for developing a new policy on “dual use of research of concern” (DURC), which includes GOF research, using a deliberate process that is expected to be decided in 2015. Formation of the new policy will determine what DURC research can be done and whether the funding pause will be lifted. Although this funding pause is limited to MERS, SARS, and influenza, this policy will have implications for many other areas of research. While a discussion on the future of DURC is merited, the funding pause has broader implications that may affect our ability to prepare for potential pandemics.
When life science research has the potential to be used for malicious as well as beneficial intentions, it may fall into the category of DURC. Although a lot of the recent debate has surrounded GOF studies involving avian flu virus transmission, the definition of DURC is wide reaching. Infectious pathogen research is a major component of DURC, with a particular focus on agents and toxins which fall into the Federal Select Agent Program, including Ebola and anthrax among others. There are seven kinds of experiments that may be considered DURC and are generally referred to as GOF research. These involve creating mutations within the pathogen, allowing it to gain a function such as increased host range or tropism, transmissibility, or ability to be disseminated. Additionally, changes to pathogens that lead to resistance to prophylactic or therapeutic agents, or make a vaccine or natural immunity less effective, are considered DURC experiments. The final categories involve enhancing vulnerability of a host population and generation of new pathogens or regeneration of previously eradicated or extinct Select Agents. These experiments are considered to be biosecurity threats since modified agents can be used for bioterrorism or accidently released. There has been a lack of open discussion between researchers and policy makers regarding DURC research and there are four major issues that need to be addressed. What dual-use research should be allowed to be done? Should the public fund this research? Who should determine which research can and cannot be done? Should the details and results of these studies be published and available to the public? While these issues are important and need to be discussed and a DURC policy developed, the moratorium on GOF research is not the solution.
The major problem with the GOF moratorium is the overall vagueness of it. There is no end date to the moratorium in which a new policy has to be decided. The initial controversy regarding avian flu transmission studies appeared over two years ago; however, prior to the funding pause, NSABB has failed to hold any scientific meetings to work on DURC policy. Although they have already organized a meeting of scientists in December, without a deadline for the funding pause, there is no motivation to determine the policy. Additionally, the definition of the types of research that fall into this category is vague; the funding pause applies to any work by which researchers could “reasonably anticipate” an increase in pathogenicity or transmission. This definition could apply to nearly any research involving passaging or mutating these viruses.
The timing of this moratorium may hinder work on pandemic preparedness particularly in the case of the recently emerged MERS coronavirus. There is currently no small animal model for the pathogenesis of MERS. Animal models that recapitulate human disease are often developed by passaging a virus through a small animal such as a mouse. However, this type of research is not allowed under the funding pause because the virus may be gaining host range or pathogenicity in the animal. Animal models allow researchers to better understand the virus as well as test treatments and vaccines. Without these models, there is a real hindrance in the development of new prophylactics and treatments, which may prevent epidemics from becoming pandemics.
Another important aspect of pandemic preparedness is surveillance of naturally occurring genetic mutations in viruses. By collecting samples from sick patients or animals and then sequencing the viruses, a researcher can monitor the spread and mutation of different viruses throughout the world. This surveillance is a powerful tool in predicting outbreaks, drug susceptibility, and determining the contents of the influenza vaccine. However, monitoring genetic changes without understanding the level of functional changes is not very informative. This surveillance needs to be used in conjunction with reverse genetics in the laboratory to determine the effects of these changes on pathogenicity, transmission, drug susceptibility, treatment, and immunization. Using laboratory data to supplement surveillance is one aspect of the relationship between surveillance and GOF research. It is also very important to have the reverse relationship with laboratory research informing surveillance. Genetic mutation in viruses is fairly noisy, with many changes having little or no effect on the virus or a detrimental effect. Determining potential mutations in the laboratory that may increase pathogenicity can help determine signals above the noise. Without the ability to supplement knowledge gained by surveillance in the laboratory, the data obtained through surveillance is insufficient to understand the potential outcomes of genetic mutation in viruses.
When talking about DURC, it is impossible for one to avoid the debate swirling around two avian flu studies (1, 2), which involved increased transmission among ferrets. In these studies, an important aspect is often overlooked. Increased transmission among ferrets decreased the pathogenicity of these viruses, with fewer ferrets dying from the transmitted virus. So while this study increased one aspect of GOF, transmission, there was a compensatory loss of function since lethality decreased. This is an important aspect of DURC. By doing these GOF experiments, researchers can also discover loss of function (LOF) mutations, which can be exploited for drug development and also better understand the potential costs of these mutations to the pathogen.
The risk of dual-use research or accidental release of these altered pathogens is real. This moratorium comes on the heals of a number of highly publicized laboratory incidents including the discovery of a vial of smallpox in an FDA laboratory and the CDC’s distribution of anthrax that had not properly been inactivated. However, the pausing of new research and cessation of current research involving these viruses, which have the potential to cause pandemics, is a bigger threat. A new policy and guidelines for DURC and oversight of research is needed, but until that has been established, researchers should be trusted to determine which DURC should be done.