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Science Policy Around the Web – June 17, 2016

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Biomedical Research Funding

NIH gets $2 billion boost in Senate spending bill

The Senate approved a $2 billion dollar boost to the National Institutes of Health (NIH) budget for the 2017 fiscal year. This will increase the agency’s overall budget to $34 billion which represents a 6.2% increase from the previous year. This boost in funding represents an increase to NIH’s funding for the second year in a row after more than a decade of stagnate funding. NIH received an additional $2 billion last year.

The increase to NIH’s funding is the result of bipartisan negotiations between Senate Labor, Health and Human Services, and Education Appropriations Subcommittee Chairman Roy Blunt (R.-Mo.) and Ranking Member Senator Patty Murray (D-Wash.)

“Last year, for the first time in 12 years, we were able to have an increase in [funding to support] NIH research,” Blunt said at a subcommittee meeting to unveil the budget proposal. “We have worked hard to repeat that this year.” Adding that he hopes to establish a pattern of increases for health research funding, he further noted that “if you are going to have an annual pattern, year two is critical. So we’re proposing for the second year in a row we make a substantial commitment to NIH research.”

The bill will include $1.39 billion for Alzheimer’s disease research, a $100 million increase for Obama’s Precision Medicine Initiative, an additional $100 million for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) brain-mapping project, and $50 million in new spending for a federal initiative to combat antimicrobial resistance. Not mentioned is the $670 million proposal for Vice President Joe Biden’s proposed moonshot to double progress against cancer. (Jocelyn Kaiser, ScienceInsider)

Federal Accountability

House sharpens oversight of new NSF facilities

The U.S. House of Representatives approved bill H.R. 5049 by a vote of 412 to nine which would direct the National Science Foundation (NSF) to audit its major multi-user research facilities. This bill was passed in response to the problems that have plagued NSF’s National Ecological Observatory Network (NEON) under construction at dozens of sites across the country. Last December NSF fired the contractor, NEON Inc., citing a potential $80 million cost overrun and continued delays in completing the project.

The passage of the NSF Major Research Facility Reform Act of 2016 would direct the NSF to audit its major multi-user research facilities in order to prevent such cost overrun problems in the future. The Congressional Budget Office estimates that conducting these audits required by the legislation would cost about $2 million annually and $10 million over the 2017-2021 period. Specifically, the bill would require NSF to analyze how much every large research project would cost by the first year of the start of construction.

NSF officials remain concerned on how these changes in legislation would affect how audits are conducted and the use of management fees for a contractor. Such additional restrictions on management fees could potentially scare off some highly qualified would-be bidders for future projects. In addition, they believe that the proposed audits would not have caught the problems that NEON faced. (Jeffrey Mervis, ScienceInsider)

Infectious Diseases

Zika virus added to the FDA Priority Review Voucher Program Act

U.S. Senators Amy Klobuchar (D-Minn.) and Al Franken (D-Minn.) supported emergency funding to help stem the spread of the Zika virus in the United States. Over $1 billion in emergency funds passed the Senate today on a bipartisan basis to help mitigate the spread of Zika and respond to outbreaks of the virus.

“The Zika virus is a real threat, and we need action to curtail its spread and encourage the development of treatments and a vaccine,” said Franken. “This emergency support will help fight back against the disease, and now, we need to work with the House of Representatives and with President Obama to make sure that the funding measure becomes law. This is far too important of an issue to ignore.”

The Centers for Disease Control has reported that over 150 pregnant women in the U.S. have been diagnosed with Zika virus, which can cause a range of birth defects including devastating neurological defects. There are currently no known treatments or vaccines for the disease. The funds will be used to control mosquitos that carry the Zika virus, raise awareness of Zika virus disease, provide education on how to reduce risk of becoming infected, and accelerate development of a vaccine. (Congressional Research Service)

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June 17, 2016 at 9:00 am

Science Policy Around the Web – April 1, 2016

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By: Ian McWilliams, Ph.D.

photo credit: Matti Mattila via photopin cc

Federal Research Funding

House budget plan would rearrange and restrict federal research portfolio

Since the financial crisis of 2008, much attention has been given to the state of the economy. With recent optimism about the health of the economy, the president’s new budget plan for 2017, increases the NIH budget in FY 2016, and initiates new research spending for the Cancer moonshot. However, not all agencies are benefiting from the proposed budget. A report filed recently by the U.S. House of Representatives’ budget committee could curtail research spending for the National Science Foundation (NSF), the Department of Energy (DOE), and could lead to reshuffling sections of the Department of Commerce (DOC) into other agencies. Current DOE budget speculation is that there will be a decrease in funding for “several high-risk projects” that should be picked up in the private sector. While NSF biology, computing and information science, and math and physical sciences research directorates are to receive “stable funding”, the omission of specific plans for engineering, geoscience, and the social and behavioral sciences is ominous. It is unclear how the reorganization of the DOC will contribute to decreases in discretionary spending. The DOC is responsible for the research portfolios of the National Oceanic and Atmospheric Administration (NOAA), the National Institute of Standards and Technology (NIST), and the Census Bureau. (Jeffrey Mervis, ScienceInsider)

Science in the Public Eye

Controversial anti-vaccination documentary pulled from Tribeca Film Festival

In 2010, The Lancet retracted a highly controversial paper by Andrew Wakefield which proposed to link the Measles, Mumps, and Rubella (MMR) vaccine to autism. Since the original publication in 1998, this paper has been a cornerstone for the anti-vaccination movement, even after the paper has been discredited and retracted. Recently, Wakefield himself has directed and co-written a documentary titled “Vaxxed: from cover-up to catastrophe,” which claims that the CDC falsified and omitted crucial data linking vaccines to autism. This divisive film was to be screened at the Tribeca film festival , but was pulled, likely due to the backlash over screening the film. The original plan, put forth by Tribeca co-founder Robert De Niro, was to give an “opportunity for a conversation around the issue,” but he later decided after consultation that “we do not believe it contributes to or furthers the discussion I had hoped for.” In response, Wakefield and Del Bigtree, a producer for the film, released a statement that “We will be pressing forward and sharing our plans in the very near future.” With both sides pointing fingers, this argument will likely continue for some time to come. (Jason Ukman, StatNews)

Medical Devices and Testing

Study of Theranos Medical Tests Finds Irregular Results

The first peer-reviewed results of finger prick blood tests offered by Theranos have been published this week and bring more questions about the accuracy of its tests. Theranos, the medical start-up that provides direct-to-consumer blood tests, has come under increased scrutiny after an independent study found irregular results from tests offered by the company. The study, published in the Journal of Clinical Investigation, compared results from 22 different tests offered by Theranos to conventional blood test results from two national diagnostic laboratories, Quest Diagnostics and LabCorp.

Theranos has received much attention for their claims to offer blood tests that require small amounts of blood as a low-cost alternative to conventional laboratory testing. The company offers over two hundred different tests that require only a finger prick compared to vials of blood needed for conventional tests. Elizabeth Holmes, CEO of Theranos, touts the convenience and consumer experience of Theranos’s tests. However, the company has been reluctant to release data regarding their tests and has been mired in controversy after a Wall Street Journal article questioned the accuracy of the results of these tests. Furthermore, Theranos’ Newark, California laboratory has been cited by The Centers for Medicare and Medicaid Services for problems that “pose immediate jeopardy to patient health and safety.”

The current study used 60 healthy, adult volunteers who were tested at separate laboratories on the same day and found more measures outside of their normal range for Theranos’s finger prick blood tests when compared to measures from conventional blood tests. Results from Theranos were out of range for 12.2 percent of measurements compared to 7.5 and 8.3 percent for Quest Diagnostics and LabCorp, respectively. Although variability was seen in results from all three labs, Eric Schadt, one of the authors of the study, said that “Theranos was outside of range in ways that would impact clinical decision-making.”

Theranos’ laboratory directors responded to the study by sending a letter the journal calling the study “flawed and inaccurate.” They claim that a large blood draw from a vein could affect the results from a finger prick test and that the study authors did not attempt to determine which measurements were correct. (Andrew Pollack, New York Times)

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April 1, 2016 at 9:00 am

Science Policy Around the Web – February 23, 2016

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By: David Pagliaccio, Ph.D.

Kris Krüg via Photo Pin cc

Science in Schools

Climate confusion among U.S. teachers

Despite the vast agreement among scientists that global warming is occurring due to human activities, many difficulties persist in conveying this to middle and high school students. A new survey published in Science indicates that 74.3% of middle and high school science teachers discuss global warming but only at median rate of 1.5 class hours. Importantly, only 54% of teachers are clearly stating that fossil fuel use is a major cause of global warming rather than natural causes. The remainder presents a mixed message about the role that humanity plays in global warming vs. natural factors, denies humanity’s role, or does not present the causes of global warming. This may be due to several causes. Luckily, few teachers felt outside pressures from parents, school administrators, etc. to not teach about climate change. Instead, it appeared that a large percentage of teachers did not know the consensus among scientists and thus try to present a two-sided case about global warming. Further, less than half of teachers reported having formal training on climate change during their education though newer teachers were more likely to discuss the human causes of global warming. The authors also indicate a role for sociopolitical ideology where teachers with a more conservative view of the government’s role were less likely to emphasize teaching about the causes of climate change. The authors call for improved training, continuing education, and content materials, including updated textbooks, to aid in addressing this issue as well as trying to work to improve science literacy. (Eric Plutzer, Mark McCaffrey, A. Lee Hannah, Joshua Rosenau, Minda Berbeco, and Ann H. Reid, Science Education; USNews.com; NPR)

Science Funding

Budget 2017

President Obama has requested increased science funding in his fiscal year 2017 budget, yet people have concerns over the strategy for this and the likelihood of it passing Congress. Particularly, he requested an additional $825 million be allocated to the National Institutes of Health (NIH), but this money was set to come from mandatory funds. Further, $1 million of the NIH’s current budget was slated to be moved from regular appropriations processes to mandatory funds. There are concerns that Congress will not approve these mandatory funds, which require that a dedicated funding source be established. If approved, this new money would go to support new cancer initiatives, the Precision Medicine Initiative, and the BRAIN initiative with little going to the other NIH institutes. The Food and Drug Administration (FDA) would also not get much of a general increase in funding but would get money specifically for its role in Precision Medicine Initiative and the new cancer programs – also from mandatory funding. The President has also called for a $500 million increase in funding for the National Science Foundation (NSF) coming from both discretionary and mandatory spending streams. Again, there is doubt that Republicans will approve of allocation through mandatory spending streams that will require selling federal assets, which would leave only a small increase in NSF funding through discretionary spending. While there are many increases in science funding budgeted for, many people are disappointed in the means of funding allocation and are less than optimistic for passing this proposed budget. (Science News Staff, Science Insider)

Federal Regulations

Could FDA E-Cigarette Regulations Help More People Quit Smoking?

While e-cigarettes are generally expected to be safer than traditional cigarettes due to the lack of tar from burning tobacco, research is limited and major health organizations currently do not recommend using e-cigarettes to help people quit smoking. Despite the large and expanding market for e-cigarettes, there are essentially no federal rules or regulations regarding anything about the e-cigarette industry, including sales and advertising. Several attempts have been made to regulate e-cigarettes with the FDA first trying to regulate e-cigarettes as a drug-device combination in 2009. This was overruled by the courts, which deemed e-cigarettes a tobacco product in the next year. Further, the President’s Family Smoking Prevention and Tobacco Control Act allowed the FDA to regulate some tobacco products but did not specifically list e-cigarettes. In 2014, the FDA called for authority to specifically regulate e-cigarettes and is awaiting final approval. While no real federal regulations are in place, some states have enacted minimum purchasing age laws, tax e-cigarettes, or call for e-cigarettes to only be used in places where other tobacco products can be used. The science regarding the potential harms of e-cigarettes and any potential benefits to smoking cessation are lacking leading to much fractured debate over regulatory policy, which will continue as the FDA’s role continues to unfold. (Michael P. Eriksen, USNews.com)

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February 23, 2016 at 9:00 am

Science Policy Around the Web – February 5, 2016

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Environment, science and society

Congress approves bill to ban plastic microbeads in skin care products

Plastic microbeads used in a variety of personal-care products from soaps to face washes will be phased out starting in 2017. Microbeads are tiny plastic particles used as an abrasive in many beauty products such as facial scrubs, soaps, and toothpastes. These beads do not dissolve and can remain in the environment for decades.

The Microbead-Free Waters Act of 2015 was introduced by Congressmen Frank Pallone, Jr. (NJ-6), Ranking Member of the House Energy and Commerce Committee, and Fred Upton (MI-6), Chairman of the Committee. It is believed that “these tiny plastic particles that are polluting our environment are found in products specifically designed to be washed down shower drains,” said Pallone. “And many people buying these products are unaware of their damaging effects on the environment.” This view is in alignment with research that shows how these beads slip through wastewater treatment systems and into waterways. Sherri A. Mason, an environmental chemist at the State University of New York in Fredonia, estimates that 11 billion microbeads are released into the nation’s waterways each day.

At the state level, states such as Illinois and California already have passed microbead bans while more than half of the states are considering them. However, the growing number of state and local laws with conflicting restrictions and timelines helped to motivate the sponsor of the bill in the Senate. The federal legislation will prohibit the manufacture of products containing plastic microbeads as of July 1, 2017, and phase out sales of the product over the next two years. The federal law will take precedence over state laws that are starting to phase out microbeads over similar concerns. (Congressional Research Service)

CRISPR technology

UK scientists gain license to edit genes in human embryos

A team of British scientists has received permission to edit genes in human embryos for scientific studies. Although there is currently a voluntary moratorium observed by scientists worldwide on DNA alterations that could be passed down to subsequent generations, the proposed studies would not contradict them because the altered embryos will not be implanted into a womb.

On February 1st, the British regulatory agency that oversees reproductive biology, the Human Fertilization and Embryology Authority, approved an application by Kathy Niakan, of the Francis Crick Institute in London, to utilize a new genetic editing technique called Clustered regularly-interspaced short palindromic repeats or CRISPR (or CRISPR/Cas9) to alter human embryos. This CRISPR system enables researchers to precisely remove specific DNA sequences.

In the United States, Congress has banned the government from supporting research where a human embryo is destroyed. This ban, however, does not apply to privately or state funded researchers. “This type of research should prove valuable for understanding the many complex issues around germline editing,” said George Daley, a stem-cell biologist at Boston Children’s Hospital in Massachusetts. “Even though this work isn’t explicitly aiming toward the clinic, it may teach us the potential risks of considering clinical application.” (Ewen Callaway, Nature)

Federal Research Funding

White House wants $1 billion for Vice President Biden’s cancer moonshot. Where will it come from?

In his next upcoming budget, President Barack Obama will ask Congress for $755 million for cancer research. This will bring the total price tag of Vice President Joe Biden’s cancer “moonshot” to $1 billion. However, it is still not known if Congress will agree to this new funding proposal for 2017. In addition, it is also not known how much existing money will be reshuffled at the National Institutes of Health (NIH) in order to support this year’s moonshot plans.

Currently, the White House plans to immediately fund the Moonshot initiative with $195 million in “new cancer activities” at NIH for the 2016 fiscal year. Most of this spending is predicted to occur at the National Cancer Institute (NCI) which already received a $264 million boost in new money this year as part of the overall $2 billion NIH budget increase. Although researchers are “very excited and enthusiastic” about the initiative, they have questions about exactly where the money will come from, says Jon Retzlaff, managing director for science policy and government affairs for the American Association for Cancer Research in Philadelphia, Pennsylvania. Bolstering certain NCI programs partway into the fiscal year may force the institute to divert funds from other programs.

Currently, Biden plans to continue the moonshot’s financial momentum in the White House’s FY 2017 budget request to steer $75 million to the U.S. Food and Drug Administration for moonshot activities, and $680 million for NIH. If this request will be approved by Congress is still up in the air, Retzlaff notes. This is because the budget request calls for using “mandatory funds” to pay for these increases. Mandatory funds are not directed through the regular annual appropriations process, but instead the money comes from dedicated sources approved by Congress. Using mandatory funds preempts congressional oversight which is generally not supported by lawmakers. If approved, this additional funding will represent an increase of about 15% over what the federal government is already spending on cancer research, the nation’s second leading cause of death. (Jocelyn Kaiser, Science magazine)

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February 5, 2016 at 9:00 am

Science Policy Around the Web – November 3, 2015

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By: Danielle Friend, Ph.D.

Photo credit: photo credit: Grandfather Healing via photopin (license)

Healthcare Costs

Costs for Dementia Care Exceed Most Other Diseases

A recently study examining the cost of care for individuals suffering from dementia found that the cost of this care is exceeding the cost for caring for those that die from heart disease or cancer. In addition to costing more, the new study also reports that out-of-pocket spending for these patients and their families is 81 percent higher than for people without the disease and suggests that the economic burden is higher for individuals with dementia if the patient is black, has less than a high school education, or is widowed or unmarried. The study used data from Medicare recipients who died between 2005 and 2010 and found that the average cost for caring for these patients was $287,038 compared to $175,136 for those who died from heat disease or $173,383 for those who died from cancer. The increased costs for caring for an individual with dementia have been attributed to the fact that these individuals often require care for many years, that there are currently no treatments that effectively slow the disease, and that the care is not covered by insurance. For example, Medicare does not cover homecare service and non-rehabilitative nursing care, support often need for those with dementia. Additionally, individuals with dementia often need constant supervision as well as assistance with everyday activities such as eating, dressing, and bathing – again, care that is costly but not covered by Medicare. Certainly as the Baby Boomer population nears their elderly years concerns for how individuals pay for this much needed care will increase. (Gina Kolata, New York Times; Tara Bahrampour, Washington Post)

International Scientific Community

Canadian Scientists have High Hopes for Increased Government Support Following Election

Prior to Canada’s Election Day on October 19th, Canadian scientists made a rare push for federal science funding to be an issue in the elections. The Professional Institute of Public Service of Canada, a union made up of 15,000 scientists, aired radio ads accusing the governing Conservative Party of not supporting scientists.  However, with the ousting of the Conservative Party, which had held power for nearly 10 years and the election of Canada’s Liberal Party to a majority government led by Justin Trudeau, Canadian scientists are looking to the future with higher hopes for science. Since taking hold of leadership in 2006, the Conservative Party had eliminated the position of the national science adviser, a position that the Liberal Party states they will restore.  Additionally, the Conservative Party was also accused of ending climate and environment science programs and closing research libraries in government departments, as well as placing a greater emphasis on applied industrial research which left basic science lacking resources. In Canada, government support for science research is particularly important because private industry contributes proportionally less to research compared to other countries. If commitments are upheld by the new Liberal Party, Canadian scientists hope a new era of Canadian science will see a bright future. (Brian Owens, ScienceInsider)

Infectious Diseases

Ebola Virus Appears to be Long-Lived

As the number of new cases of Ebola appears to be dwindling, researchers are startled by new findings that the Ebola virus may leave traces in survivors that could contribute to new epidemics. Although researchers have known since 1999 that Ebola virus could be found in the semen of male survivors for months, new work published in The New England Journal of Medicine demonstrate that in 93 Ebola virus survivors, Ebola viral RNA could be found in semen samples from 46 men up to 9 months after contacting Ebola. Additionally, a second paper details the sexual transmission of the Ebola virus to a Liberian woman. The paper indicates that there were no cases of Ebola in the 30 days prior to the woman being diagnosed, however she reported having unprotected vaginal intercourse with an Ebola survivor prior to being diagnosed in March 2015. The male survivor had Ebola in September of 2014 but had tested negative in October 2014. However, a semen sample taken from the man in March tested positive for Ebola. Much more work will need to be done to definitely determine whether Ebola can be sexually transmitted and for how long after the survivor has recovered. The original articles detailing these findings can be found here and here.

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November 3, 2015 at 9:00 am

Science Policy Around the Web – May 1, 2015

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By: Rebecca A. Meseroll, Ph.D.

photo credit: Colours via pixabay

Consumer Safety Regulations

Senators seeks increased FDA oversight for personal care products and cosmetics

Despite the ubiquity of personal care products and cosmetics, federal regulations of these goods have not changed significantly since the Food, Drug, and Cosmetic Act was passed into law in 1938. A bill introduced by Senators Dianne Feinstein (D- California) and Susan Collins (R- Maine) would give new regulatory oversight of personal care products to the Food and Drug Administration (FDA). Under the current regulations, cosmetics manufacturers are not required to divulge adverse health effects of their products reported to them by consumers and the FDA can only request that manufacturers voluntarily disclose this information to the public. If the bill becomes a law, companies would be required to report serious adverse health effects of products, such as death, disfigurement, and hospitalization, to the FDA within 15 days of notification by the consumer. Less severe health effects would need to be reported annually. Furthermore, the bill would require FDA’s yearly evaluation of at least five personal care product ingredients to determine whether the ingredients are safe, to what concentration they are safe, and whether they should have consumer warnings. Some of the proposed ingredients on the list for the first round of evaluations are propylparaben, a preservative in many products including shampoos and lotions, an estrogen-mimicking compound which can act as an endocrine system disruptor, and lead acetate, an additive in hair dyes. In addition to its bipartisan sponsorship, the bill has broad support of several large associations and companies representing the personal care industry, as well as consumer protection groups. (Rachel Abrams, The New York Times)

Federal Research Funding

A call for a doubling of the NIH budget

Health care costs are on the rise, while federal funds for biomedical research have stagnated for more than a decade. Taxpayers already spend upward of a trillion dollars annually on Medicare and Medicaid, but perhaps these costs could be reduced, if cures or preventative measures could be identified for some of the more financially demanding illnesses. Given these observations, former Speaker of the House Newt Gingrich argued last week, in an op-ed published in the New York Times, that Congress should plan double the budget of the National Institutes of Health (NIH), as they previously did between 1998 and 2003. In this article, which he directs particularly toward fiscal conservatives like himself, Gingrich selects Alzheimer’s as a representative disease and describes in detail the skyrocketing financial burdens and human suffering the disease will inflict on the American public if better preventions or cures are not discovered. He contends that there is a great deal of possibility for breakthroughs in treatments and cures for Alzheimer’s and many other diseases, and that increasing NIH funding would be a step in the right direction toward achieving those breakthroughs. Recent discussions in the Senate indicate there is bipartisan support for increasing NIH funding above current levels, although how close it will come to Gingrich’s proposed doubling remains to be seen. There is also history to consider, since the previous NIH budget doubling (and subsequent abrupt end of funds) has lead to some of the problems in federal biomedical research today, such as low grant funding rates and an overabundance of young researchers struggling to get their first grant to even attempt the “breakthroughs” touted by Gringrich. A long-term commitment to sustained funding increases to the NIH could be the best of both worlds. (Newt Gingrich, The New York Times; Peter Sullivan, The Hill)

Lab Animal Rights

Court orders hearing in lab chimpanzee rights case

New York Supreme Court Justice Barbara Jaffe ordered Stony Brook University to appear in court on May 27, 2015 to respond to a petition by the animal rights group, the Nonhuman Rights Project (NhRP), that two evolution research chimpanzees, Hercules and Leo, are being unlawfully detained. NhRP initially filed three lawsuits in 2013 contending that chimps are too cognitively advanced to be kept captive lawfully, and ought to be moved from the lab to a chimpanzee sanctuary. NhRP’s legal strategy has been to petition the courts with a writ of habeas corpus, which is traditionally used to challenge human imprisonment. Prior to the current court order, which was issued in appeals, the lawsuits have been struck down, as the courts stated that the writ of habeas corpus does not apply to the chimps because they are not legal persons. Even the current court order has been amended to strike the writ of habeas corpus, indicating that the court has not granted personhood to the chimps. The upcoming hearing will determine whether Hercules and Leo are being unlawfully detained, and ScienceInsider reports that NhRP has plans to continue to petition for the release of other animals on the basis of personhood, regardless of the outcome of this case. (David Grimm, ScienceInsider)

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May 1, 2015 at 9:00 am