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Science Policy Around the Web October 25th, 2019

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By Andrew Wright BSc

Image by Arek Socha from Pixabay 

NIH and Gates Foundation lay out ambitious plan to bring gene-based treatments for HIV and sickle cell disease to Africa

Following the launch of an initiative to boost gene therapy treatments of sickle cell disease last month, the National Institutes of Health (NIH) and the Bill and Melinda Gates foundation have announced a joint funding agreement of at least $100 million over the next four years to expedite a cure for both sickle cell disease and HIV and make it available in Africa. 

The current medical intervention for sickle cell disease is a bone marrow transplant, a treatment that is limited by the availability of genetically compatible donors and can be risky for adult patients. This new partnership aims to build on funding towards more effective treatments that are less restricted and more cost effective. While genetic intervention is being used in a limited clinical setting, it is still necessary to destroy a patient’s stem-cells via chemotherapy before reintroducing the patient’s genetically modified ones. Using burgeoning gene-editing techniques such as CRISPR, researchers for this initiative hope to modify targeted genes with a process more similar to a blood transfusion using replication-deficient viruses or nanoparticles to carry the molecular tools to where they need to be. This should theoretically make treatments much less expensive and more available to regions that have limited medical infrastructure and a high incidence of sickle cell disease such as sub-Saharan Africa. 

Since there is also a high incidence of HIV in sub-Saharan Africa, this initiative also aims to tackle HIV in the region using similar techniques. The current standard for treating HIV is anti-retroviral therapy, which can allow patients to live a normal life, but also must be taken every day, is expensive ($429-$10,896 per month), and does not eliminate the disease. The drive behind genetic intervention strategies comes from serendipitous case-studies when two men were cured of HIV following stem cell transplants that intentionally had white-blood cells with a weakened protein to treat their blood cancers. The NIH-Gates funding initiative will focus on strategies to weaken these proteins (called CCR5 receptors) and to directly destroy HIV genetic material.

(Jon Cohen, Science)

Evidence links poliolike disease in children to a common type of virus

Since 2014 more than 570 children have experienced a condition known as acute flaccid myelitis (AFM) where some suddenly lost limb control, had trouble swallowing or breathing, or ended up paralyzed. These symptoms routinely followed symptoms of a common cold, like a runny nose or fever. Up until now, the route cause behind AFM was not well understood, but recent studies of patients’ spinal fluid suggest the culprit is enterovirus. Infections from enteroviruses are common and rarely cause severe symptoms (although they can cause respiratory illness in asthmatic populations). 

Previous studies into the cause of AFM had examined enterovirus but found no trace of it in the central nervous system, where it would need to be in order to lead to loss of motor control. In the most recent study conducted by the University of California San Francisco, researchers sampled for elevated levels of antibodies in the central nervous system rather than the virus itself. They found that 69% of AFM patients had elevated antibodies against enteroviruses. There are still questions as to why only some children experience AFM when infected by enterovirus when most only experience typical symptoms.

Unfortunately, enterovirus-AFM is currently untreatable beyond post-infection physical therapy, although the lead author of the study suggests that immunoglobin therapy may help reduce the worst symptoms. Ultimately, the only way to completely prevent enterovirus-AFM infections, referred to by some as ”the new polio“,  will be a vaccine.

(Kelly Servick, Science)

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October 25, 2019 at 3:39 pm

Science Policy Around the Web October 22nd, 2019

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By Mohor Sengupta PhD

Image by truthseeker08 from Pixabay 

What’s Behind The Research Funding Gap For Black Scientists?

A recently published study by a group of NIH investigators has found possible reasons for the funding gap that exists between grant proposals submitted by black and white researchers. This gap was first revealed in a report published in 2011 that found that black applicants to NIH grants were awarded funding at a significantly lower rate than white applicants to the same grant. These data prompted the NIH to investigate the grant funding process.

In this paper, the authors analyzed keywords in grant application topics and found that some topics were four times more likely to get funded than others. Broadly, topics dealing with the mechanistic basis of science on a micro-level, such as genetics, or cellular mechanisms were more likely to grab the attention of grant reviewers than grants involving population sciences and community-oriented research. Grants on these subjects are more commonly proposed by African American applicants. 

The authors find that black researchers tend to pursue studies on topics that are more connected with their communities. Such topics include health disparities research, which unfortunately don’t figure as priority in grant reviewers’ radar, possibly because they don’t see things through the same lens when evaluating proposals. This may be because the grant reviewers didn’t have similar life experiences while growing up as a person belonging to a minority community might have. In the present study, only 2.4% of grant reviewers was black. 

In the study, self-reported demographic data of applicants was not visible to grant reviewers. As a next step, the authors will investigate if applicant anonymity decreases the existing funding gap. 

(Emily Vaughn, NPR)

Marijuana and Vaping: Shadowy Past, Dangerous Present

A severe lung disease has been affecting users of e-cigarettes with marijuana. So far nearly 1500 people have become sick, and 33 have died of the mysterious disease. Residents of 49 states and the District of Columbia have reported the vaping-related illness. While the cause of the disease remains unknown, experts say that THC, the chemical in marijuana that makes people feel high, produces different components when burned in rolled joints versus when aerosolized in vaping devices. The latter may have unknown harmful chemicals. 

However in addition to THC, vaping oils contain additives, solvents and flavor enhancers. It is unclear which of these ingredients is the culprit, but vitamin E acetate is a likely candidate for the illness. The obscurity surrounding illness-causing vaping components in part exists because of restrictions imposed on cannabis research by the federal government. The reason behind this is the high abuse potential of cannabis, which classifies it as a controlled substance not available for research. 

This rule annoys scientists and industry experts alike. Lack of hard science and awareness among the vaping community is made worse by the many cheaper products freely available in black markets, both in states where vaping THC is illegal and legal. As counterfeit cartridges are much cheaper than the tested and taxed licensed products, these have many consumers. Vaping cartridges sold on the black market are not tested.

Considering the recent illnesses taking a toll on people who use e-cigarettes to smoke cannabis, the government should allow investigation into the chemical underpinnings of the disease. 

“I’m not able to take products we think are potentially harmful and do analysis. I can buy a vape device around the corner, but I can’t bring it into the lab and test it,” UCSF researcher on nicotine and vaping, Dr. Neal Benowitz said. Benowitz has sent a letter to the congress about the hugely popular and unstudied practice of vaping. 

(Matt Richtel, The New York Times)

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October 22, 2019 at 4:09 pm

Science Policy Around the Web – June 7th, 2019

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By: Mary Weston, Ph.D.

Source: Pixabay

Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world?

Last Tuesday, the Washington Post reported that the biopharmaceutical company Pfizer had hints that their rheumatoid arthritis drug Enbrel might reduce the risk of Alzheimer’s disease, but chose not to report these findings to the public.

In 2015, after analyzing hundreds of thousands of insurance claims, a team of Pfizer researchers observed that their anti-inflammatory drug Enbrel might also decrease the risk for Alzheimer’s by 64%. They recommended that the company conduct a costly clinical trial to prove the link but, after several years of internal debate, the company decided not to pursue the lead.  The question remains: why did Pfizer not release these findings to the scientific community?

Pfizer claims they did not pursue the research due to scientific considerations – they argue that since Enbrel cannot cross the blood-brain barrier and directly reach brain tissue, it is unlikely to prevent the debilitating neurodegenerative disease. Further, Pfizer claimed that they did not to report the research because the statistical findings did meet “rigorous scientific standards” and were concerned about misleading researchers down a false path. However, Pfizer is also losing its patent protection on Enbrel soon, meaning that generics will become available and the drug will be much less profitable, reducing any financial incentive for further research or clinical trials (likely to cost around $80 million).

Some in the scientific community are questioning Pfizer’s justification. Keenan Walker, an assistant professor of medicine at Johns Hopkins, argues that the scientific community benefits when the data is available, stating that ““[w]hether it was positive data or negative data, it gives us more information to make better informed decisions.’’

Several scientists argue that Pfizer’s results should be release because they could provide clues to combating the disease and slowing cognitive decline in its earliest stages. Specifically, recent research is hinting that inflammation may promote Alzheimer’s disease. Further, neurodegenerative research is notoriously challenging and there are no major drugs that treat Alzheimer’s. Even several recent phase 3 clinical trials have been halted because the drugs were not effective. Due to a lack of progress in the field, a couple large pharmaceutical companies, including Pfizer, have just closed their neurology-related research programs.

 (Christopher Rowland, Washington Post)

Trump administration halts fetal-tissue research by government scientists

The Trump administration has announced that government scientists will stop using human fetal tissue for research and is placing new limitations on researchers in academic settings who use federal funding from the NIH.

It is not entirely known how many research projects will be affected by the new regulations. Government scientists will be allowed to continue their current work, but are prohibited from acquiring new tissue samples. Current extramural research at universities and privately funded work can continue but any new grant proposals or renewals of existing projects must be approved by an ethics advisory board that will be formed.

In addition to halting government fetal tissue research, the administration has decided to cancel an ongoing HIV research contract with the University of California San Francisco, effectively ending a 30-year partnership. The project involves using fetal tissue to develop mouse models with human-like immune systems to develop new HIV therapies.

Use of fetal tissue is essential to for studying certain human biological processes, such as kidney development. Often biomedical research uses mice as substitutes of people, but in this case, murine kidney development is too different from their human counterparts to be of use. Some researchers fear that these new restrictions will set back certain research for years to come. Important areas of research that depend on using fetal tissue including HIV, neurodegeneration, human organ growth and regeneration, Zika (determining how/why the virus affects developing fetuses so severely), and certain types of vaccine development.

POLITICO reports that this decision was made after much debate between the White and the Department of Health and Human Services (HHS), which wanted a less restrictive policy. In a statement released Wednesday, HHS said that “promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration.” HHS is now reviewing whether sufficient alternatives to human fetal tissue exist and will be supporting the development and validation of these models. However, good alternatives for certain fetal tissue research are elusive and many scientists say that the tissue is essential for some fields.

 (Sara Reardon, Nature)

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June 7, 2019 at 6:11 pm

Science Policy Around the Web – May 10th, 2019

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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)


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May 10, 2019 at 3:07 pm

Science Policy Around the Web – May 7th, 2019

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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) 


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May 7, 2019 at 4:15 pm

Science Policy Around the Web – January 15, 2019

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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)

 

 

 

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January 15, 2019 at 8:58 pm

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Science Policy Around the Web – January 4, 2019

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By: Saurav Seshadri, Ph.D.

united-states-2361405_1280

Source: Pixabay

U.S. shutdown begins: ‘It’s disheartening, … discouraging, … deflating’

As the third government shutdown of 2018 enters its third week, the extent of its impact on the scientific community is still unclear. The shutdown affects about a quarter of the federal government, including agencies such as the EPA, NIST, and NASA.  While some agencies, such as the NIH and CDC, have budgets approved through 2019 and can operate normally, many others have had to halt activities and place non-essential employees on leave without pay.  Such employees can’t even use their official email addresses until the government reopens. One of the hardest hit agencies is the National Science Foundation (NSF), whose current contingency plan only retains sixty out of about two thousand employees.  NSF has been forced to stop grant reviews and payments, and will have to reschedule many of its deadlines, which has real consequences for investigators – following a 16-day shutdown in 2013, NSF stated outright that because of the lapse in funding, ‘scientists experienced setbacks in furthering their research objectives’.  Other agencies are less affected; for example, drug reviews conducted by the FDA are largely funded by pharmaceutical companies and will continue without disruption.  However, the American Association for the Advancement of Science (AAAS) summarized many scientists’ concerns by stating that ‘any shutdown of the federal government can disrupt or delay research projects, lead to uncertainty over new research, and reduce researcher access to agency data and infrastructure’.

With their party’s majority in the House of Representatives made official on Thursday, Democrats immediately passed spending bills that would fund the government through early February.  However, these bills do not include $5.6 billion in funding for a border wall, and are therefore unlikely to end the shutdown: President Trump has insisted upon this figure, and Senate Republicans have indicated that they will not move forward any legislation that doesn’t meet Trump’s approval, despite previously supporting the same stopgap bill.  Post-holiday media coverage of struggling furloughed workersand lapsed public services has started to stoke public pressure, which will ultimately force an end to the shutdown.  But for now, both sides are more deeply entrenched in their positions than ever, and important science is falling by the wayside.

(Science News Staff, Science)

Brain circuits of compulsive drug addiction identified

Misuse of prescription opioid painkillers has reached epidemic proportions in America, and was declared a public health emergency by the Department of Health and Human Services in 2017.  According to recent estimates, there were 72,000 opioid overdose-related deaths that year, a 10% increase over the previous year.  The National Institute on Drug Abuse (NIDA) reports that about 20-30% of people prescribed opioids misuse them, and about 10% develop a disorder.  These statistics highlight the desperate need to understand the neurobiology of addiction, and specifically, how it can be reversed.  A recent study published in Nature makes significant progress in this direction.

The authors began by modeling a core feature of human addiction: compulsive behavior, or drug seeking in the face of negative consequences.  Mice were allowed to stimulate the release of dopamine (the neurotransmitter that signals ‘reward’ in response to drugs of abuse) by pressing a lever, which sent a laser pulse through an optical fiber to light-sensitized dopaminergic neurons in their brain.  Within a few days, mice were functionally addicted, and were self-stimulating up to 80 times per hour.  At this point, mice started to receive punishing electric foot shocks on every third stimulation.  This intervention caused the mice to split into two groups: those that stopped self-stimulating (40%, ‘renouncers’) and those that continued (60%, ‘perseverers’).

Having thus identified mice that showed characteristics of compulsive behavior, the authors turned their focus to the underlying circuitry.  They traced a neural pathway connecting the orbitofrontal cortex and the dorsal striatum, regions involved in decision making and action selection, which showed opposite patterns of activity in renouncers and perseverers.  Remarkably, reducing activity  in this pathway caused persevering mice to temporarily renounce stimulation, and weakening the connection itself extended this effect (up to about six days).

While the validity of comparing brain stimulation to drug abuse remains to be established, these results are still highly encouraging.  They provide a physical basis for aspects of addiction that are often poorly understood and harshly judged by society: why some addicts engage in seemingly irrational compulsive behaviors, and why individuals differ in their ability to break self-destructive cycles of addiction. Since several methods for modulating brain activity already exist, pinpointing exactly which circuits to target to combat addiction, as this study does, may be the key to recovery for many patients.

(Patricia Janak, Nature)

 

 

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January 4, 2019 at 10:01 am