Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘Congress

Science Policy Around the Web – June 18th, 2019

leave a comment »

By Allison Dennis, B.S.

Source

Congress is debating-again-whether genes can be patented

The last time the U.S. government issued an official guidance on human gene patenting, it was from the Judicial Branch in 2013. By a unanimous decision, the Supreme Court ruled that two genes whose DNA sequence can be used to predict the probability of a patient developing breast or ovarian cancer, BRCA1 and BRCA2, could not be patented. Companies are still free to pursue patents manipulating or mitigating the effects of specific genes, but the ruling invalidated the patents held by Myriad Genetics for these two genes and opened the door for clinical labs to begin widely testing patient samples for mutations across a wide variety of disease predicting genes that might have otherwise been patented.

Insurance claims filed in 2004 indicate that only one in four women received a BRCA mutation test before being diagnosed with cancer. By 2014, more than 60% of these tests were administered diagnostically, allowing women confirmed to be at risk to pursue prevention and early detection of breast and ovarian cancer before developing either. The effect of the 2013 Supreme Court ruling to dramatically reduce testing costs in combination with technological developments and public health awareness have been attributed to this shift.

Now lawmakers in the legislative branch are weighing in. Senators Thom Tills and Chris Coons filed a bipartisan draft bill that would expand the types of inventions eligible for a U.S. patent to include previously restricted subject matter falling under “abstract ideas,” “laws or nature,” or “natural phenomenon,” which could be interpreted to include human genes. While Tillis has since made clear that it was “was never the intent” to again give companies ownership over single human genes, the changes could allow companies to limit examination of specific genetic variants like those most likely to cause disease. Supporters of the bill feel it is necessary to provide companies with sufficient intellectual property to incentivize their research into isolated natural products. Many point to less-restrictive patent codes abroad, which they feel put the U.S. at a disadvantage.  

Following two weeks of Congressional hearings, and a letter signed by 170 scientific organizations, nine nobel prize winners along with 74 leading physicians and scientists have weighed in by urging lawmakers to more carefully consider the proposed changes. The level of concern or eagerness expressed for the bill seems largely up to the interpretation of the reader, suggesting that much more work is needed for the bill to achieve its stated goal of reducing frustration and confusion generated by the Supreme Court rulings.

(Megan Molteni, Wired Magazine)

Federal Grants Restricted To Fighting Opioids Miss The Mark, States Say

Of the 70,237 drug overdose deaths captured by the CDC in 2017, nearly a third involved cocaine, psychostimulants, which include MDMA and methamphetamine, or both. The CDC cites “changes in the drug supply, mixing of substances with or without the user’s knowledge, and polysubstance use” as emerging threats. Yet the opioid-focused way grant money is allocated may be restricting the ability of states to adapt.

At the frontlines of the opioid epidemic are state officials dedicated to making the most of federal grants designed to offer struggling states a financial lifeline. For example in 2017, Arizona used funds from a State Targeted Response grant to train 9,197 individuals in Naloxone usage and purchase 8,798 Naloxone kits, allowing first responders to perform 5,649 overdose reversals. Many states are using the money to implement the hub-and-spoke model, first developed and demonstrated to be effective by Vermont, in which intensive addiction treatment is offered at a limited number of hubs connected by a local network of outpatient addiction programs and primary care physicians. Through this structure, the hub-and-spoke model can make at least one licensed mental health or addiction counselor accessible per 100 patients.

While the framework provided by the hub-and-spoke model may intuitively help address addiction beyond the specific use of opioids, they rely on Medication Assisted Treatment, an intervention that has only been approved for opioid addiction. Similarly the use of Novaxalone is only effective in reversing opioid overdoses, in the case of cocaine overdose it is ineffective. Additional research is underway to develop parallel treatments for other substances, but these efforts have been eclipsed by the national focus on opioids.  

In 2017, opioids accounted for less than half of the overdoses suffered in eleven states, including Pennsylvania, Texas, and California. This may point to the effectiveness in opioid specific treatment, but it also the persistent dangers of drug-use. Currently, the funding opportunities are insufficient to address the gaps in the mental health system needed to more completely help patients living with addiction. The pathways leading to drug-abuse, no matter the current drug of choice, may provide a common point of intervention resilient against the so called “emerging threats” of substance abuse.

However, similar to the shift seen as users transitioned from OxyContin to Heroin, public health fear that the next shift will turn to drugs not classified as opiods and therefore ineligible to be combated with the funds. In 2017, eleven states

(Carmen Heredia Rodriguez, Elizabeth Lucos, and Orion Donovan-Smith, Kaiser Health News)

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

June 18, 2019 at 5:22 pm

Science Policy Around the Web – May 10th, 2019

leave a comment »

By: Caroline Duncombe

Image by Steve Buissinne from Pixabay 

Drug prices will soon appear in many TV Ads

When watching an advertisement for a prescription drug on the television, a new addition will be added to that long list of side-effects: the product’s cost. On Wednesday, the health and human services secretary, Alex Azar, announced that the Trump administration will require pharmaceutical companies to state the priceof prescriptions in television advertisements in “legible” text, similar to the current standard of side effects. This policy will only apply to drugs whose whole-sale-price exceeds $35 per month.

            Such a change in policy has received substantial pushback from the drug industry. They claim that including the list price would confuse consumers who would potentially pay a different amount post-insurance (that is if you have insurance).  In addition, drug companies claim that such a requirement infringed on the companies’ First Amendment Rights. One of the driving forces behind the new policy change are the patient advocacy groups, who have pointed out that televised drug ads direct consumers to the higher priced medications.  The hope of such a policy is to potentially incentivize drug companies to lower their prices. Mr. Azar in a statement points out “If you’re ashamed of your drug prices, change your drug prices.” 

(Glenn Thrush and Katie Thomas, NYT)


Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 10, 2019 at 3:07 pm

Science Policy Around the Web – May 7th, 2019

leave a comment »

By: Allison Cross Ph.D.

Source: Flickr

Shake-up at NIH: Term limits for important positions would open new opportunities for women, minorities

Beginning next year, the NIH will be setting into motion a new policy implementing 12-year term limits for lab and branch chiefs in the NIH intramural program.  Currently, of the 272 chiefs overseeing the NIH intramural program, almost 20% of them have served in their position 20 or more years and, of those, over 5% have held their position for over 30 years.  

Individuals serving as lab and branch chiefs oversee administrative matters, mentoring, and recruitment for several labs or groups at NIH. With the current lack of turnover in chief positions, many feel it is hard to move up to a leadership position within NIH.  The new policy intends to change this, and to increase diversity among NIH leaders.  It is noted that women currently hold 26% of cheif positions, which is comparable to the percentage of women who hold tenured track positions at NIH.  

With implementation of the new policy, as many as half of the currently serving chiefs will be replaced in the next 5 years. The new policy indicates that the positions which become vacant will be filled through “open and transparent processes”.  To increase diversity of those holding these leadership positions, it will be important for NIH to have a diverse field of candidates capable of filling these positions. To help build the pool of candidates, the NIH is relying on the recently launched Distinguished Scholars Program, a program aimed at reducing the barriers to the recruitment and success of tenure-track female and minority faculty.

While some see the policy change as an opportunity to increase diversity in NIH leadership, others feel the change will have little impact, and still others question if leaders doing stellar jobs should really be replaced.  The current term limit policy change intended to take place next year will only affect the midlevel leadership positions, however, these changes may spread to higher level leadership positions in the future.   

(Jocelyn Kaiser, Science)


Senator’s queries prompt NIH and NSF to clarify how they monitor foreign research ties

There has been a recent increase in concern among members of Congress that foreign governments are taking advantage of open nature of the nation’s research enterprise. These concerns prompted senator Chuck Grassley (R–IA), chair of the Senate Committee on Finance, to send letters to the NIH, NSF, and DOD asking each agency to explain the practices they have in place to root out any illegal behavior.

These letters contain several questions for each agency to answer including 1) how the agency conducts background checks before awarding a researcher or institute a grant, 2) how much money is being spent “to identify and investigate potential violations of the rules concerning foreign affiliations and financial support for an investigator’s research, and 3) the number of institutions under investigation by the agencies “for employing individuals who failed to disclose contributions from foreign governments”.

Congress has received responses to these letters from NIH and NSF and is still waiting on a reply from DOD. Though both agencies that responded to the letter failed to answer all the questions from Senator Grassley, they used their responses to highlight changes being made to their grant application processes.  

In response to the question regarding background checks for grantees, both NIH and NSF explained that the agencies do no perform background checks.  In the NIH’s response to Senator Grassley, they explained that, in the last year, they reminded grantee institutions about their responsibility to notify NIH if a grantee is found guilty of scientific misconduct. Notably, the NIH currently requires that grantees disclose all “foreign components” of their research. The NSF used their response to explain the development of a web-based discloser form where researchers are to list “all sources current and pending support”. In a recent change by the NSF, they now also require all those applying for NSF grants to disclose if their proposal requests money for a foreign organization and, if so, to justify what the foreign collaborator offers that cannot be done at a US-based institution.   

With the responses from NIH and NSF leaving many of Senator Grassley’s questions unanswered, it is expected that further inquiries from Congress will continue.  

(Jeffrey Mervis, Science) 


Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 7, 2019 at 4:15 pm

Science Policy Around the Web – May 3rd, 2019

leave a comment »

By: Allison Dennis B.S.

Image by Ashley Smith from Pixabay

A More Humane Livestock Industry, Brought to you by CRISPR

Innovations sparked by germline editing in livestock are poised to help farmers make rapid improvements in the care and treatment of their animals by helping overcome inefficiencies genetically. Livestock industries use animals specifically bred to maximize their use and often require or prefer animals of a particular gender. Male cattle produce more meat. Female cows produce milk. Female chickens lay eggs. Known as “the dirty secret” of the dairy industry, farmers under financial pressure may kill male calves soon after birth to avoid the costs of raising them further. Every year, 6 billion male chicks, which hold no economic value for egg production, are killed within a day of hatching. The egg industry is seeking to prevent this, and in June of 2016, the United Egg Producers, a group that represents more than 95% of egg production in the United States, stated their goal of “eliminating the culling of day old male chicks by 2020 or as soon as it is commercially available and economically feasible.”

Scientists are racing to offer these industries solutions by harnessing the power of the gene editing technology CRISPR to genetically engineer animals to break the 50-50 gender rule. Mark Tisard, a geneticist at the The Commonwealth Scientific and Industrial Research Organization, Australia’s national science agency, is using CRISPR to engineer male eggs to glow red under fluorescent light, allowing farmers to repurpose male eggs for vaccines or feed production before the chick has developed. Across the world, the startup eggXYt in Israel is taking a similar approach, making male eggs glow yellow. Alison Van Eenennaam, an animal geneticist at UC Davis, is exploring the possibility of using CRISPR to produce all male herds of beef cattle from the point of conception.

While pre-determining gender remains a major goal, gene-editing has already been used to introduce a gene for slick hair that helps cattle handle heat better in warm climates. Scientists have successfully used CRISPR to produce pigs that are resistant to the PRRS virus, which causes respiratory disease and reproductive failure, costing farmers in the United States half a billion dollars a year. 


The reception of these technologies in the United States remains unclear. Most recently, in January 2017, the FDA drafted rules that would put genetically altered animal products through the same safety and efficacy testing undertaken for new drugs. However, since then, the USDA has clarified that plants produced through genome editing will not be subject to additional regulation if they could conceivably been developed through traditional breeding methods. Those looking to harness the power of these types of genetic modifications for livestock are hoping to see this attitude expanded to animal products.

(Gregory Barber, Wired Magazine)

House Democrats move to resurrect Congress’s science advisory office

At the helm of American society is a group of appointed representatives racing to keep abreast of a deluge issues stemming from technological innovation. A draft of the 2020 Legislative Branch funding bill that was approved by its subcommittee on April 30th offers potential relief in the form of re-establishing the Office of Technology Assessment (OTA). The OTA was originally established in 1972 to provide congressional staff with deep and comprehensive analysis of technical issues to aid in the crafting of public policy, independent from lobbyists and activists. At that time, Anti-Ballistic Missiles and Super Sonic Travel were the technologies stirring up media frenzies. However, the OTA was eliminated in 1995 to reclaim $21 million for the congressional budget. The $3.9 billion dollar proposed budget for 2020 included only $6 million for its revival.

Currently, the Congressional Research Service (CRS) is tasked with keeping Congress informed on technical issues ranging from gene editing to artificial intelligence. In January 2019, recognizing the need for greater technical assistance, the US Government Accountability Office (GAO) established the Science, Technology Assessment, and Analytics team to conduct technology assessments and provide technical assistance directly to Congress. The proposed budget would support these efforts by providing CRS and the GAO an additional $24 million and $26 million respectively. However, some believe that there is still a need for the OTA in spite of these new teams. Representative Sean Casten testified to fund the OTA as he believes there is still a need to “fulfill the forward looking, deep-dive, technical assessments of new scientific and technological developments once provided by OTA.” Representative Mark Takano also expressed support, stating “In the ecosystem of legislative support organizations, OTA plays a unique role. No other entity has the capacity and expertise to provide in-depth and forward-looking analysis of complex, technical issues informed by an understanding of how Congress works.” 

Former Congressman Rush Holt similarly tried to revive the OTA in 2015, only asking for 2.5 million dollars, but his amendment was defeated 248 to164. The 2020 funding bill next heads to the full House Appropriations Committee for markup before representatives get a chance to vote.

(David Malakoff, Science)



Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 3, 2019 at 11:20 am

Science Policy Around the Web – January 15, 2019

leave a comment »

By: Patrick Wright, Ph.D.

hierarchy-73338_640

Source: Pixabay

All Seven of the FDA’s Recent Commissioners Agree It Should be Independent—But Not on How to Accomplish It

From 2016 onward, former Food and Drug Administration (FDA) commissioners have called on Congress to make the FDA an independent agency that would no longer fall within the purview of the Department of Health and Human Services (HHS). The idea was initially proposed at the Aspen Ideas Festival in Colorado in 2016, which subsequently lead to the crafting of formal bipartisan white papers detailing the proposal to be used by current and upcoming administrations; these two companion white papers were recently released via the Aspen Institute and the January edition of Health Affairs.The co-authors of these white papers, seven former Commissioners of the FDA spanning 30 years of service, propose a new framework in which the FDA is reconfigured as an independent federal agency. The hope would be to make the FDA a cabinet-level agency (e.g. the Environmental Protection Agency) or an autonomous entity with powers similar to the Securities and Exchange Commission. These changes would help minimize the extent of bureaucracy (e.g. falling under HHS but funded as though it is part of the Department of Agriculture) and interference from other bodies. The FDA currently operates as one of eleven Operating Divisions under the HHS Secretary’s oversight, along with agencies such as the National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA).

The current structure allows other HHS agencies to have input on FDA policymaking, despite not necessarily having any familiarity with the innerworkings of FDA policy. David Kessler, the commissioner under George H.W. Bush and Bill Clinton, stated that there are “150 people in between the commissioner and the president, and they all think they’re your boss—that’s the problem”. A recent example of the results of external influence was in 2011 when the HHS Secretary at the time, Kathleen Sebelius, barred the decision by then-FDA Commissioner Dr. Margaret Hamburg to allow emergency contraception to be sold over the counter.

In the Aspen Institute white paper, the Commissioners state: “The goal of independence is to accommodate efficient, science-based decisionmaking by reengineering the processes through which FDA regulations and guidances flow from proposal to final form”. Many objectives that can be achieved with increased independence of the FDA as an entity are outlined in the paper, including the ability to enhance transparency of the Agency and thus sustain public confidence and to ensure predictable decisionmaking exclusively grounded in scientific evidence. Given the breadth of the FDA’s regulatory umbrella, newfound independence would have profound implications on the agency’s ability to address public health issues.

(Ike Swetlitz, StatNews)

Bipartisan Bill on Sexual Harassment Signals Strong Interest by Congress

A recently introduced bipartisan bill, the Combating Sexual Harassment in Science Act of 2019 (H.R. 36, 116thCongress), directs the National Science Foundation (NSF) to implement a number of strategies to combat sexual harassment in STEM academic and research settings. It was introduced by Eddie Bernice Johnson (D-TX) and Frank Lucas (R-OK), leading members from the House Committee on Science, Space, and Technology.

The bill allocates $17 million to the NSF Director to award grants to expand research efforts to “better understand the factors contributing to, and consequences of, sexual harassment affect individuals in the scientific, technical, engineering, and mathematics workforce, including students and trainees”; collect relevant national survey data on the issue; update the report on responsible conduct of research by the National Academies to include evidence-based practices for fostering a climate intolerant of sexual harassment; and work with the National Academies to assess the influence of sexual harassment in institutions of higher education on the career advancement of individuals within STEM. The NSF implemented a policy in 2018 that requires institutions receiving NSF funds to disclose whether they have put a funded investigator on administrative leave pending the conclusion of a harassment investigation or have found an investigator guilty of sexual harassment. Under this NSF policy, funds will be reallocated to another investigator at the institution; decisions to terminate a grant to an investigator found guilty of sexual harassment would depend on the capacity of the institution to continue the research without the original investigator.

However, H.R. 36 currently does not outline appropriate actions that federal agencies should take upon receipt of information from institutions of any harassment. To address this, Representative Jackie Speier (D-CA), aims to reintroduce a bill she wrote in 2016 that would require agencies to consider any finding of sexual harassment against a research when deciding to award funding. These collective efforts point to an increased drive by Congress to tangibly address this issuethat has been plaguing the scientific research spectrum.

(Jeffrey Mervis, Science)

 

 

 

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

January 15, 2019 at 8:58 pm

Posted in Linkposts

Tagged with , , , ,

Science Policy Around the Web – August 9, 2016

leave a comment »

By: Thaddeus Davenport, Ph.D.

Infectious Diseases

Local Transmission of Zika Virus in Miami

Most of the world became aware of Zika virus earlier this year when doctors in Brazil noticed a correlation between Zika virus infection in pregnant women and microcephaly in their newborn children. Recent articles in the New York Times on July 29th and August 1st report a notable shift in the course of the Zika virus epidemic – local transmission of the virus within the United States. In the last year, there have been over 1600 cases of Zika virus detected in the United States, but nearly all of these were imported infections, in which individuals became infected while traveling in Zika-endemic regions or through sexual transmission of the virus from people traveling outside of the United States. Because the Zika-carrying mosquito species, Aedes Aegypti is resident in parts of the continental United States, many people expected that it was only a matter of time before Zika virus would be transmitted locally within the United States. On July 29th, the Centers for Disease Control and Prevention and the Florida State Department of Health reported that Zika virus was transmitted to at least four individuals in the Wynwood neighborhood of Miami. By August 1st, the number of individuals infected in the neighborhood had risen to fourteen, and the CDC issued a travel advisory discouraging pregnant women from traveling to the affected area. Though Congress went to recess last month without passing a bill to provide funding for the fight against Zika virus, perhaps, and hopefully, the news of local Zika transmission will motivate bipartisan action in Congress to fund mosquito control efforts and basic research on this still poorly understood virus. (Pam Belluck, New York Times)

Clinical Research

First CRISPR-based clinical trial set to begin this month

The gene-editing technique commonly referred to as CRISPR-Cas9 has received significant attention over the last year because of its impressive potential to target, cut, and modify nearly any sequence of interest within a genome. David Cyranoski reported for Nature News that scientists in China are poised to be the first to use CRISPR-Cas9 technology in a human clinical trial. The trial will enroll individuals with metastatic, non-small cell lung cancer, for whom other treatment options have failed. T cells, immune cells capable of killing infected, cancerous, or otherwise afflicted cells, will be removed from these individuals and modified using CRISPR-Cas9 to delete the gene for a protein called PD-1, which plays a role in downregulating the immune response. It is hoped that removing PD-1 will make the participants’ T cells better able to mount an immune response against cancer cells. As an additional measure of safety, the genome of modified cells will be sequenced in order to confirm that there are no off-target modifications outside of the PD-1 gene that might impact the safety or validity of the study. Initially the trial will test the safety of introducing CRISPR-Cas9-modified cells into ten individuals at three different dosages, while also monitoring the effect of the treatment on cancer progression. A similar trial is set to begin in the United States later this year. These will be important proof-of-concept studies to show that CRISPR-Cas9 can be applied safely and effectively in the treatment of disease. (David Cyranoski, Nature News)

Drug Development – Antibiotic Resistance

New Funding for Antibiotics Development

Bacterial resistance to antibiotics is a significant and emerging threat to public health. Methicillin resistant Staphylococcus aureus (MRSA) – a commonly reported and widely feared strain of S. aureus – is one example of a bacterium that was once readily treatable with penicillin and related antibiotics, but which became difficult to treat after acquiring resistance genes. As current antibiotics become less effective against pathogenic bacteria, doctors are running out of tools to treat infections. An important hurdle to addressing the problem of antibiotic resistance is obtaining the funding necessary to support basic research. Unlike drugs to treat chronic health problems, effective antibiotics designed to cure infections of limited duration, are not necessarily a good investment for pharmaceutical companies. Asher Mullard reported for Nature News that CARB-X – Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator- a public-private partnership supported primarily by the US government, Wellcome Trust, and the UK-based Centre for Antimicrobial Resistance hopes to provide US $350 million to motivate and accelerate the development of new antibiotics over the next five years. While many biotechnology companies support the initiative, some researchers, including Kim Lewis a researcher at Northeastern University, worry that CARB-X is too heavily focused on drug development instead of the discovery of novel antibacterial compounds. Despite their limitations CARB-X and other similar programs will likely provide valuable incentives for biotechnology and academic researchers to work towards better antibiotics for the common good. (Asher Mullard, Nature News)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

August 9, 2016 at 9:00 am

The Campaign to Battle Zika

leave a comment »

By: Melissa Pegues, Ph.D.

On February 1, 2016 the World Health Organization (WHO) declared the Zika outbreak a public health emergency, meaning that the response requires the coordination of global partners to detect infections, control mosquito populations, and develop vaccines and diagnostic tests to prevent the spread of the disease. With concerns that Zika will move into the US as summer begins, there is an urgent need to contain the epidemic. Congress, however, has been slow to respond and continues to debate how exactly to fund the fight.

Zika infection is rarely fatal and is commonly accompanied by symptoms such as rash, fever, and joint pain, but some do experience more serious symptoms including Guillain-Barre syndrome, a rare form of paralysis. However, Zika gained significant publicity when medical professionals in Brazil and other Latin American countries noticed a frightening association between Zika virus infection in pregnant women and babies born with microcephaly. Microcephaly is a rare birth defect where infants are born with underdeveloped brains and smaller than average head size. Although only considered an association for many months, studies of Zika infection in pregnant mice and monkeys have found evidence supporting the link between Zika infection and microcephaly. In support of the mounting evidence, Tom Frieden, the director of the Centers for Disease Control (CDC), recently stated that “It is now clear that the virus causes microcephaly.

While research moves quickly to demystify the Zika virus, the political system has failed to gain a foothold amongst the confusion. The White House had requested $1.885 billion towards the Zika fight in February, and in a rare bi-partisan effort, Marco Rubio (R-FL) and Bill Nelson (D-FL) topped Obama’s request with a $1.94 billion proposal that included $144 million for vaccine research that would also include funding for research into dengue fever and chikungunya. That proposal ultimately never came to a vote. The Senate has approved $1.1 Billion in emergency funds and the House of Representatives has offered a bill that would reallocate just $622 million from existing programs for the Zika response, but neither measure has been passed by both chambers.

The Capital Hill battle over Zika has revealed a number of underlying political viewpoints that each affect how politicians respond to this crisis. Republicans worry that abortions may increase due to the severe birth defects associated with Zika infections in pregnant women, and with evidence mounting that Zika can be sexually transmitted, Republicans are debating whether the better message is use of contraception or abstinence. Federal public health officials have countered that they do not believe their role is not to tell women if they should become pregnant, but rather focus on preventing spread of the disease. Pope Francis has weighed in and suggested that the use of contraception is acceptable to help prevent the spread of Zika.

On the other hand, Democrats have expressed concern over use of pesticides. In a proposal meant to help control mosquito vector populations, Senator John Cornyn (R-TX) suggested easing regulatory restrictions on pesticides. Democrats have accused Republicans of trying to exploit fears and countered that exceptions for use of pesticides already exist. The White House also commented that the Republican-led House’s proposal removes Clean Water Act protections that are not acceptable during this emergency. Democratic representatives Peter DeFazio (D-OR) and Grace Napolitano (D-CA) stated “Over the years, proponents of exempting pesticide spraying from the Clean Water Act have used the crisis of the day as the reason to support their legislation.”

While Congress debates how to best combat Zika, the CDC reports that the number of cases of pregnant women in the US with the virus has climbed to 279 as of late May, and multiple models are predicting the spread across the US. Furthermore, WHO chief, Margaret Chan, has cited a number of policy failures that allowed for lapses in mosquito control and the spread of Zika. At a recent World Health Assembly meeting, Chan said Zika took the world by surprise and revealed fault lines in the world’s collective preparedness. In addition, the spread of Zika, resurgence of dengue, and the emerging chikungunya threat are prices paid for “a massive policy failure that dropped the ball on mosquito control in the 1970s.”

With the outbreak of Zika spreading, many concerns have arisen over how to respond to Zika and prepare for other emerging threats. In a recent essay, Ronald A. Klain, the White House Ebola response coordinator from 2014 to 2015, urged Congress to put aside their differences and fund preventive measures for new epidemics. He stated that the threat of emerging disease is “not coming to the United States: It is already here.” In support of this, the Senate recently voted 93-2 to move forward with negotiations with the House of Representatives. Public officials have continued to urge politicians to focus on controlling the disease, but Chan stated that for now “all we can offer is advice. Avoid mosquito bites. Avoid pregnancy. Do not travel to areas with ongoing transmission.”

Written by sciencepolicyforall

June 15, 2016 at 9:00 am

Posted in Essays

Tagged with , ,

Science Policy Around the Web – April 12, 2016

leave a comment »

By: Amy Kullas, Ph.D.

A representation of the surface of the Zika virus is shown. A team led by Purdue University researchers is the first to determine the structure of the Zika virus, which reveals insights critical to the development of effective antiviral treatments and vaccines. (Purdue University image/courtesy of Kuhn and Rossmann research groups)

Funding the ongoing Zika pandemic

Shifting funds for Zika is a good start, but more money is still needed

Last week, the White House made the decision to redirect $589 million in unspent federal funds, previously allocated for an Ebola response, to cover costs associated with fighting and researching Zika. The White House is still advocating for additional funding for both the ongoing Zika pandemic and to replenish the money that was moved away from Ebola. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), informed ScienceInsider that ~$50 million of the reallocated funds will go to NIAID to fund Zika research. None of the redirected funds will come out of the money that NIAID had previously received for research on Ebola, as the vast majority of those funds have already been spent. Further, Fauci warns “That’s not enough to last me very long. We can start the work, but we can’t finish what we need to do.”

Dr. Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention revealed in a press conference on April 12, “Everything we know about this virus seems to be scarier than we initially thought.”

In February, the Obama administration had requested almost $2 billion to help thwart the Zika virus and its transmission. Unfortunately, the Republican-controlled Congress failed to act on this emergency funding request. White house officials are nevertheless still trying to persuade Congress to pass the emergency Zika funding. Fauci bleakly predicts, “If we don’t get all of the Zika money, that is when things start getting hurt,” alluding to the possibility of having to further shift critical NIAID funds away from ongoing malaria, influenza, and tuberculosis research. (Puneet Kollipara, ScienceInsider)

Mental Health

Solutions to mental health impairments require global collaboration

Globally, almost 1/3 of people will suffer from a mood, anxiety, or substance-use issue during their lifetime. In fact, these disorders are one of the leading causes of disability. The resources to assist people facing these problems are not only inadequate in the United States, but around the world as well. There are some countries in Africa, where people are extremely underserved leaving them particularly vulnerable because these countries have the fewest resources for mental-health care as they only one psychiatrist for the entire country. In fact, there are only 9 mental health providers per 100,000 people worldwide.

Importantly, support for mental health does not lack political backing. Both the World Health Organization and the World Bank will coorperate to broaden global efforts in mental health. This past September, mental health was included in the United Nations’ Sustainable Development Goals. Since 2011, new investments (estimated at ~$80 million US) have been made by the three largest funders of mental-health research in low- and middle-income countries: the US National Institute of Mental Health, Grand Challenges Canada, and the UK Department for International Development. Recently, research has focused on efficacy, effectiveness and implementation in the low- and middle-income countries. These local research teams often work or consult with colleagues in rich countries. Researchers, clinicians, and caregivers must unite to all work together because “when it comes to mental health, all countries are developing.” (Pamela Y. Collins & Shekhar Saxena, Nature Comment)

Vaccine shortage and Global Health

Dangerous shortage of yellow fever vaccine

Four. There are only four facilities worldwide that produce yellow fever vaccines: the Pasteur Institute, two government facilities in Russia and Brazil, and a French vaccine company Sanofi Pasteur. Unfortunately, their combined efforts have been failing the world’s demands and the ongoing outbreak in Angola only further emphasizes the escalating shortage. Jack Woodall, formerly of the Centers of Disease Control and Prevention and the World Health Organization, warns “another major outbreak…could be impossible to control.” He admits that this potential is something that he’s deeply concerned about.

Yellow fever is an acute viral hemorrhagic disease transmitted by infected mosquitoes. The ‘yellow’ in the name refers to the jaundice that affects some patients. Without treatment, up to half of severely affected people will die. Annually, there are an estimated 60,000-80,000 deaths attributed to yellow fever globally. There is no specific treatment for yellow fever, leaving vaccination the most important preventative measure.

When a yellow fever outbreak occurs in an urban setting, like the one in Angola, it is often relentless as the mosquitoes can easily transmit the virus person to person. William Perea, of the World Health Organization’s (WHO’s) Control of Epidemic Diseases department, stated that Angola has confirmed 490 cases and almost 200 deaths, the actual numbers could be 10 fold higher. Since February, a large vaccine initiative has been underway, reaching 6 million of Luanda’s estimated 7.5 million residents. Currently, yellow fever has stretched into 6 of the 18 provinces in the country. The global emergency yellow fever vaccine stockpile has been left empty, unlikely to be replenished anytime soon. (Kai Kupferschmidt, ScienceInsider)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

April 12, 2016 at 12:00 pm

Science Policy Around the Web – February 12, 2016

leave a comment »

By: Rebecca A. Meseroll, Ph.D.

Zika research funding

Obama requests $1.8 billion in emergency funds to fight Zika

President Obama issued a statement of intent to request $1.8 billion from Congress to develop resources to combat the spread of Zika virus both internationally and domestically.  Zika, which is transmitted by the Aedes aegypti mosquito, has spread rapidly around Central and South America, the Caribbean, and the Pacific Islands in the past year, and is an emerging public health threat, especially due to its possible link with congenital microcephaly, a severe birth defect, in children born to women infected with the virus during their pregnancy.  The funds requested by the president would be used for a variety of purposes in an aggressive effort to contain the spread of the virus, including mosquito control, research on the virus and a potential vaccine against it, public education campaigns, and support personnel and equipment for areas where the outbreak is ongoing.  Congress will have to decide whether to grant the funds, which would be part of the 2017 budget, later this year.  While there is much to be done to minimize the impact of Zika, health officials indicate there is no cause for alarm about large-scale spread of the virus in the United States at present, but women who are pregnant or considering becoming pregnant are advised to use caution when planning travel to countries affected by Zika. (Jon Cohen, ScienceInsider and Mark Landler, The New York Times)

Climate change policy

Supreme Court stays climate change regulations

The Clean Power Plan, developed by the U.S. Environmental Protection Agency (EPA) at President Obama’s behest last year, sought to reduce carbon dioxide emissions from power plants by 32% compared to 2005 levels.  The EPA’s rules would require states to create their own plans, due to the agency by September of this year, detailing how they would reduce emissions beginning in 2022.  This week, however, the US Supreme Court granted a request put forth by many states and power companies to put the regulations on hold on the grounds that they are outside of the purview of the EPA.  Thus the regulations are set up to endure a lengthy legal battle, as the case will not come up in appeals court until June, after which it will likely be appealed to the Supreme Court, who would not hear the case until 2017.  Although the Supreme Court did not give its reasons for granting the stay, experts suggest that the Court may be telegraphing its wariness about the legality of the regulations by making this decision before the case has gone through a lower court.  The Obama administration remains confident and environmentalists hopeful that the regulations will hold up in court, however it may be necessary in the future for Congress to pass climate change legislation before progress can actually be made. (Jeff Tollefson, Nature and Robert Barnes and Steven Mufson, The Washington Post)

HIV and organ transplantation

First HIV-positive organ transplants to occur in the United States

Years of advocacy led to the passage of the HIV Organ Policy Equity Act in 2013, which lifted a ban on research into organ donations between HIV-positive individuals, and now the life-saving promise of the law is about to come to fruition. Doctors at Johns Hopkins received permission from the United Network for Organ Sharing to perform the first kidney and liver transplants between HIV-positive donors and recipients in the US, and they are prepared to conduct the procedures as soon as the first patients are ready. Johns Hopkins will be the first in the world to perform liver transplants between an HIV-positive donors and HIV-positive recipients, however doctors in South Africa have had success with kidney transplants of this kind since 2008.  It has been estimated that organs from more than 500 potential HIV-positive deceased donors have gone unused each year because of previous prohibitions, thus this new source of HIV-positive donor organs for HIV-positive recipients is expected to improve wait-times for all patients hoping for an organ to become available.  The current HIV-positive transplants will utilize only organs from deceased donors, as more research must be done to determine the outcomes of kidney donation for HIV-positive patients. (Daniel Victor, The New York Times and Ariana Eunjung Cha, The Washington Post)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

February 12, 2016 at 9:00 am

New nutritional guidelines for 2015-2020 released after compromises with Congress, food industry

leave a comment »

By: Kimberly Leblanc, Ph.D.

Earlier this month, the Office of Disease Prevention and Health Promotion released the new nutritional guidelines, Dietary Guidelines for Americans, for 2015-2020. Many of the guidelines are familiar from previous versions, recommending a wide range of fruits and vegetables, at least 50% of grains being whole, fat-free or low-fat dairy, a variety of lean proteins, and limiting saturated fats, trans-fats, and sodium. One of the new recommendations was a stricter limit on sugar intake, with no more than 10% of daily calories coming from added sugar. The World Health Organization (WHO) has made similar recommendations, citing evidence that lowering added sugar could reduce the risk of obesity, heart disease, Type 2 diabetes and some types of cancer. In an article for Politico, Michael Jacobson, president of the Center for Science in the Public Interest (CSPI), said that the recommended limit is “a major step forward.” The biggest surprise in the guidelines was the recommendation that men and boys “reduce their overall intake of protein foods” such as meat, poultry and eggs, and add more vegetables to their diets.

The nutritional advice is updated every five years, and it has become mired in political controversy because of its impact on how the food industry does business and how Americans eat. Recommendations from the report guide decisions on the aims of food assistance programs, the content of school meals, the labeling and advertising of food products, and the advice given by health professionals. With billions of dollars at stake, food industry groups bristle at any potentially negative mention of their products. The interest groups unhappiest with the guidelines are likely to be sugar growers and food manufacturers, as a result of the government’s new recommended limit on added sugars. However, before the recommendations could make it to the new guidelines, they were met with strong opposition from a number of corporate and agricultural interest groups, the meat industry in particular.

One of the many recommendations made by the Dietary Guidelines Advisory Committee in their report that did not make it into the final version of the guidelines was for Americans to adopt a diet low in red and processed meat, which met with strong opposition from meat industry groups. The National Cattlemen’s Beef Association, the National Pork Producers Council, and the North American Meat Institute spent hundreds of thousands of dollars last year lobbying, with a part of their goal being “to get lean beef recognized in the final health dietary patterns statement.” “Those things should be part of, and remain part of a balanced diet, and there’s no reason to cut back,” said Dave Warner, spokesman for the National Pork Producers Council. That comment stands in stark contrast to the findings of the WHO last October, which classified the consumption of red meat as “probably carcinogenic to humans” and the consumption of processed meat as “carcinogenic to humans” based on “sufficient evidence in humans that the consumption of processed meat causes colorectal cancer.” The 2015 Dietary Guidelines Advisory Committee was more conservative in their report, stating, “moderate evidence reports inconsistent positive associations between colorectal cancer and the intake of certain animal protein products, mainly red and processed meat. Limited evidence shows that animal protein products are associated with prostate cancer incidence.”

Another recommendation that didn’t make the cut was the advice for Americans to consume more plant-based foods and less meat to help promote environmentally sustainable eating habits. That suggestion elicited intense lobbying and criticism from the food and meat industries, leading to a congressional hearing on the topic last year. In December of 2015, Congress passed a spending bill that contained a directive for the Obama administration to ignore environmental factors and focus solely on nutrients in the next revision of the guidelines. However, food production, and livestock in particular, has a significant negative impact on the environment. Livestock producers, which include meat and dairy farming, account for about 15% of greenhouse gas emissions around the world. That’s more than all the world’s cars, buses, boats, and trains combined. If you think regulating this would fall under the Environmental Protection Agency’s jurisidiction, think again. In December of 2015, Congress renewed a provision that prevents the EPA from requiring emission reports from livestock producers, making the meat industry the only major source of greenhouse gases in the country excluded from filing annual reports. Despite the evidence and the recommendations from the committee, the pressure from industry and farm state lawmakers has led USDA Secretary Tom Vilsack and HHS Secretary Sylvia Mathews Burwell to promise furious lawmakers that they would steer clear of recommendations concerning the environmental impact of the consumption of meat.

Nutritional issues were also a bargaining chip in the spending bill that was passed in December. In recent years, reforms to the school lunch and breakfast programs have allowed the USDA to improve critical nutritional standards. A study published in JAMA Pediatrics earlier this month concluded that the nutritional quality of school meals has increased by about 30 percent, and an analysis by the Centers for Disease Control and Prevention (CDC) documents improvements, too. Yet the School Nutrition Association (SNA), which represents cafeteria directors and receives financial support from food companies, has lobbied Congress to relax some standards, complaining that the sodium standards would be “extremely difficult to achieve” and that stricter nutritional standards have led to cafeterias losing money. Their demands were met in the congressional directives that were attached to the bill, which prohibits the federal government from requiring less salt in school lunches until more research is done and allows schools to obtain exemptions from whole-grain requirements. This despite the fact that the CDC found in 2014 that 90% of school-aged kids eat too much sodium, and that the USDA reports that 97% of all schools are already meeting the 100% whole grain rich rules. As of January 20th, 2016, the Senate Agriculture Committee has voted in support of a compromise plan in the re-authorization of the Healthy, Hunger-free Kids Act, which incorporates the SNA’s demands to table the sodium recommendations and allow exemptions to the whole-grain requirement. The SNA had also asked to relax the fruit and vegetable requirement, but lawmakers didn’t budge on this key tenet of the standards.

Nutritional research is constantly evolving, and our guidelines should evolve with new evidence as it comes out.  Debates over the scientific evidence for certain guidelines, such as the link between saturated fat and heart disease, are reasonable. That’s the point of having a Dietary Guidelines Advisory Committee made up of scientists and medical professionals review the evidence before submitting their recommendations. As a prime example, the committee reversed the recommended cholesterol limit of 300mg/day in the new guidelines “because available evidence shows no appreciable relationship between consumption of dietary cholesterol and serum cholesterol.” However, scientific evidence isn’t the only factor influencing our guidelines. Agricultural and corporate interest groups, due to their size and financial incentives, have the power to shape the nutritional guidelines based on economic interests rather than scientific evidence. This power, and the desire of certain politicians to cater to these groups, is troubling, especially in a time when childhood obesity has more than doubled in children and quadrupled in adolescents in the past 30 years and when type 2 diabetes accounts for 20% to 50% of new-onset diabetes case patients in youth.

Written by sciencepolicyforall

February 1, 2016 at 9:00 am

Posted in Essays

Tagged with , ,