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Archive for February 2018

Science Policy Around the Web – February 23, 2018

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By: Janani Prabhakar, Ph.D.

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Climate Change

Permafrost experiments mimic Alaska’s climate-changed future

In Denali National Park and Preserve, you will find ecologist Ted Schuur near Eight Mile Lake on an endeavor to answer some of the toughest questions in climate change research. His “laboratory” is situated in the middle of a tundra, filled with many instruments to measure changes in carbon dioxide. A gas-sensing tower can detect carbon dioxide levels a quarter mile away. Polycarbonate chambers at the top of this tower traps CO2 as it drifts through the air and measure its amount. Using a clever manipulation, he seeks to determine how rising temperatures will impact this region’s CO2 emissions.

The key to understanding the impact of rising temperature is to understand the dynamics between carbon dioxide, plants and soil. Microbes in the soil release CO2. Plants absorb more CO2 than they release, keeping it out of the atmosphere. Critically, microbes release CO2 all year while plants absorb CO2 only during growing season. For a perfect balance, there should be enough microbes in the soil that release CO2 throughout the year and enough plants in the environment to absorb it during growing season. How do rising temperatures impact this balance? Schuur measured CO2 from two different plots of land: one that was surrounded by snow fences and the other that was unfenced. Snow fences catch the cold drift and as a result, the ground they surround is 3 to 4 degrees Fahrenheit warmer than the unfenced plot. This amount of warming is significant because Alaska is projected to see an additional 4 to 5 degrees of warming by 2100. So, Schuur has created an environment within the fenced plot that mimics the projected environment of 2100.

Schuur finds that due to the warmer temperatures, slumping permafrost causes the land to lower by several feet. This, in turn, causes the depth to which the soil thaws in the summer to be deeper, allowing the permafrost layer to add more organic matter to the soil. The result is that more organic matter produces more plant growth, which means more CO2 is absorbed in these warmed fenced plots than the cooler unfenced plots. But, this only happens during the growing season. Since the deeper soil also sees more microbial growth, more CO2 is released from the soil all year around in the fenced than unfenced plot. Schuur finds that the amount of CO2 released in these warmer plots is not offset by what is absorbed by the plants in the growing season, despite the extra plant growth.

Altogether, this news is not good. Given the current rate of temperature rise, this imbalance between CO2 absorption and release may only grow. By the end of the century, the amount of carbon transferred from the thawing permafrost to the atmosphere could reach 1 billion tons, as much as present-day emissions of Germany and Japan.

(J. Madeleine Nash, Wired)

Healthcare

Synergy Between Nurses And Automation Could Be Key To Finding Sepsis Early

Sepsis is the body’s reaction to overwhelming infection and causes about a quarter of a million deaths in American each year. If caught early, it can be treated. But, healthcare workers struggle to identify sepsis in patients in a timely manner. Blood tests cannot specifically test for it, and there is nothing to search for under a microscope. Dr. David Carlbom, a pulmonologist at Harborview Medical Center in Seattle, devised a system to help healthcare providers identify sepsis symptoms and provide timely treatment. His system uses day to day electronic health records to detect subtle clues and send warning flags for impending sepsis. It helps to capture patterns in symptoms, including high or low temperatures, low blood pressure, fast breathing, and high white blood cell count. The system is implemented at nursing stations in the hospital. After a patient is admitted, a red box appears in the patient record, prompting the nurse to answer questions about symptoms and determine whether they point to early signs of sepsis. If the nurse determines that they do, a provider is paged and responds within a half hour. Altogether, the system is intended to ensure the patient is seen within three hours.

While this is a much more precise and efficient method than prior practice, there are circumstances that lead to false alarms. For example, faster breathing may be due to multiple factors, including simply walking down the hall. Or, symptoms such as high white blood cell count may not be due to sepsis, particularly in patients being seen for other health issues like cancer. One way to reduce false alarms is built into the system: the red box appears only every 12 hours. This ensures that providers are not paged throughout the day for false alarms. Furthermore, if nurses determine that the patient is not experiencing sepsis, they must report why and provide an explanation for the symptoms the patient is experiencing. This allows for thoroughness, accountability, and precision. It also ensures that nurses keep a close eye on their patients. The effectiveness of this system has been seen in the reduction of mortality rates since it was installed in 2011.

Despite the reduction in mortality rates, entering vital signs manually could have its shortcomings. Sepsis symptoms can arise quickly and affect the body rapidly. Nurses may miss these symptoms within the 12-hour window if they are not vigilant. Recent efforts have begun to address this issue. Dr. Matthew Churpek at the University of Chicago is partnering with a company to create a device that will go under a patient’s mattress to continuously calculate heart rate and respiratory rate. This will reduce false alarms and allow researchers to use an evidence-based approach to clinical practice. They can generate algorithms based on data to predict early onset of sepsis. Critically, this approach will allow clinicians to focus on preventative efforts rather than treatment.

(Richard Harris, NPR)

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February 23, 2018 at 10:43 pm

Clinical Trials Policy Revision: For Better or Worse

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By: Jenn L. Nguyen, Ph.D., M.P.H.

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As the largest public funder of biomedical research in the United States, the NIH wants to ensure that conducted trials are relevant to health priorities of the US, trials are conducted efficiently and are not duplicates of previously conducted trials, and trials contribute to scientific knowledge. In an editorial in 2016, NIH leaders noted a need for quality and efficiency improvements to clinical trials. NIH has introduced several initiatives, to enhance clinical trials stewardship by addressing accountability, transparency, efficiency, and dissemination. However, along with the widely acknowledged improvements some recent changes may hinder the pursuit of scientific knowledge.

To address accountability, all investigators and staff conducting and overseeing clinical trials must take the Good Clinical Practice (GCP) training. The training is mandatory for individuals involved with the design, conduct, oversight, or management of clinical trials. While the training may not be sufficient by itself, it does provide a standard of knowledge, a base of knowledge, standards, and guidelines for all clinical trials.

The second change requires that all grant applications for clinical trials be submitted under clinical trials specific funding opportunity announcements (FOA). Investigators interested in conducting a clinical trial can no longer submit under parent funding announcements, which made identifying clinical trials more difficult in the past. The FOAs will list specific review criteria for reviewers to consider clinical trials-related information, such as focus on the rationale, design, and operational and analysis plans. This new policy will increase NIH accountability and efficiency, as it will ensure that required information is submitted with each clinical trial application, allow staff to better track clinical trial proposals and study, and allow staff to uniformly apply appropriate review criteria.

A substantial change, however, is the limited eligibility of trainees to conduct interventional social science research, Institutional training (T) awards, which provide money to institutions for workforce training, do not allow money to be given to trainees involved in clinical trials (the exception is for D43s and K12s), Fellowship (F) awards, which support individual trainees,  do not support trainees involved in independently conducted clinical trials, but trainees can propose a research experience with a sponsor/co-sponsor.  For Career Development (K) awards, applicants may apply to either FOAs that specify “clinical trials required” or FOAs that are for “no independent clinical trials.” Scientists are concerned this may limit postdocs and students to get support for their fellowships and adequate career training.

To further address efficiency and accountability, applications must be submitted using a clinical trials protocol template that consolidates information from multiple forms, has structured data fields, and will collect information at the study level. This requirement will ensure that all investigators will submit the same information. In addition, the forms will contain fields forcing investigators to be clear and concise about their analytical and dissemination plans.

Addressing efficiency, NIH now requires use of a single Institutional Review Board (IRB) to review multisite studies. Prior, each institute involved with the study required duplicate or multiple IRB reviews, which involved the redundant assembly of experts to assure that the same proposed study was in line with the rights and protections of human and animal research subjects. Multiple reviews resulted in delays and at times, conflicting reviews. Guidance to establish a single IRB on record has been published.

Finally, there are significant changes for registration and reporting of clinical trials to address accountability, transparency, and dissemination. Investigators are now required to register their clinical trial(s) in the ClinicalTrials.gov database within 21 days of enrollment of the first participant. NIH makes the argument that this effort may help reduce the number of trials that fail, as it will require scientists to disclose their results even if the studies do not support their hypotheses urthermore, all investigators must adhere to the NIH policy on Dissemination of NIH-clinical trials. There have been longstanding concerns that investigators are not reporting all results (especially negative or non-significant results, not reporting results in a timely manner, and even sometimes, deviating from their own research protocol.

Along with these initiatives, The National Institutes of Health (NIH) broadened what was considered a clinical trial: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” Adaption of this updated definition did not take effect until earlier this year and has alarmed some scientists. Clinical trials have been traditionally understood as experiments or observations for/in clinical settings to answer three questions: 1) Does the proposed treatment/intervention work? 2) Is the proposed treatment or intervention more effective than other treatments? 3) Are there side effects?

Scientists critical of the new definition first and foremost recognize and appreciate the motivation for NIH to increase transparency and replicability, specifically efforts for pre-registration, data sharing, and protocol sharing of trials. Yet, many scientists who conduct basic and behavioral research disagree agree that their work and studies should now be considered clinical trials. These scientists, and even scientific associations, remarked that the new clinical trials definition is too broad and traditional criteria to evaluate a trial might be inappropriately applied to their proposal. There is also concern that these changes will increase the administrative and bureaucratic burden for many scientists, specifically for exploratory scientists. To address and alleviate concerns, NIH released a set of case studies to help scientists identify and understand what is considered a clinical trial and must adhere to all the changes in the policy. While this effort provided clarification, many scientists are calling for NIH to hold further conversation with the extramural community.

While scientists recognize the need and laud NIH’s effort to address clinical trials stewardship, many of the same scientists are worried that these benchmarks set the wrong standards for success and rigor. Scientists are also worried about the additional administrative burden these changes will bring. As NIH enforces the policies, they have promised to monitor trouble issues and work with the community to find a solution without compromise.

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February 20, 2018 at 3:52 pm

Science Policy Around the Web – February 16, 2018

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By: Mohor Sengupta, PhD

Health Bacteria Cell Infection Microbiology Black

source: Max Pixel

Antibiotic discovery

A potentially powerful new antibiotic is discovered in dirt

Antibiotics have been in an ongoing, constant battle with the pathogens they are aimed to eliminate. Bacteria constantly mutate their genetic material to acquire resistance to anti-microbial drugs, making multi-drug resistance a global concern. Misuse or overuse of antibiotics contributes to this phenomenon. To address the issue of multi-drug resistance, a team of microbiologists at the Rockefeller University, NY, have conducted a large screen of natural products produced by soil-dwelling bacteria. According to Dr. Sean Brady, who heads the group, only a small fraction of the bacterial biodiversity is cultured in the lab and only a tiny fraction of chemicals produced by these bacteria are detectable. Identification of naturally produced chemicals by bacteria that have never been cultured in the lab provides a promising new direction towards anti-microbial therapies.

Dr. Brady’s group adopted a “culture-independent”, metagenomics approach to analyze chemicals secreted by unknown bacteria from soil samples. Their aim has not been to identify the bacteria in the samples but to look for DNA signatures associated with calcium dependent antibiotic properties. This means that the chemical they are looking for will act against bacteria only in the presence of calcium. After the identification of a gene potentially encoding a calcium dependent antibiotic, the researchers cloned it and made a laboratory grown bacteria (S. albus J1074) express it. The gene product is a new class of antibiotics that have been named “malacindin”. Dr. Brady’s research has shown that malacidins act by interfering with bacterial cell wall formation and have shown this antibiotic to be effective against a range of superbugs, including methicillin-resistant Staphylococcus aureus (MRSA). Calcium dependent antibiotics are believed to make it more difficult for the target bacteria to evolve resistance. Dr. Brady’s research was published in Nature Microbiology on February 12.

Conventional methods to isolate new antibiotics from laboratory cultured bacteria often lead to the same antibiotics being found over and over again, resulting in abandonment of such approaches in recent times. The novelty of Dr. Brady’s work lies in the use of natural sources, like soil, sewage, water etc. to isolate the genetic blueprint encoding anti-microbial chemicals, made easier with the use of metagenomics and large-scale sequencing. Researchers elsewhere are also using this approach to identify new antibiotics from natural sources. In the modern scenario of increasing deaths due to multi-drug resistance, this type of research is critical to rapid discoveries of novel antimicrobial therapies. Of course, getting the newly discovered drug into the market will not be fast, as Dr. Brady warns, yet this is an ingenious solution to discovering clinically useful antibiotics.

(Sarah Kaplan, The Washington Post)

Risk assessment

He Took a Drug to Prevent AIDS. Then He Couldn’t Get Disability Insurance

Pre-exposure prophylaxis (PrEP) is a practice of taking a drug to prevent HIV infection in persons with high risk of contracting it. In the year 2012, the F.D.A. approved Truvada, a drug originally approved for HIV treatment a decade earlier, for prevention of HIV infection (PrEP). Since then PrEP has become increasingly popular and as of 2017, an estimated 136,000 people in the United States were on PrEP. Several studies have shown that Truvada is highly effective in preventing HIV infection. However in the initial days of Truvada use,  some thought that individuals taking prophylaxis might overestimate its level of protection, leading them to engage in risky behavior they otherwise would have avoided. This belief is prevalent even today, as several insurance companies across the United States regularly deny disability and life insurance to men on PrEP on the basis that this treatment is indicative of an increased level of personal risk.

The repercussions of this policy, was exemplified when Dr. Philip J. Cheng of Brigham and Women’s Hospital at Harvard accidentally cut himself while preparing an HIV positive patient for surgery. The responsible behavior in this situation is to immediately take steps to prevent infection. Dr. Cheng did just that, by enrolling into PrEP. However, when he applied for a disability insurance, he was denied coverage because he was taking Truvada. He could not get the insurance company to cover him even after agreeing to sign a waiver of benefits in case he got infected.

Disability insurance is usually applied for by people whose livelihood depends on their income. For people like Dr. Cheng this insurance will guarantee him his lifetime of income in the case of a disability. Use of Truvada has not shown any adverse side-effects till date. In fact, it is said to be safer than aspirin, whose long term usage causes gastro-intestinal bleeding. It is a consensus among AIDS doctors across the USA that PrEP is necessary for individuals at high risk of contracting HIV. Denial of insurance to PrEP users by insurance companies has been likened to denying insurance for using car seat-belts by Dr. Robert M Grant, whose group led the clinical trial that established the importance of PrEP. Even more perplexing is the fact that life insurance companies are regularly providing insurance to people with other conditions that are managed by regular medications, like diabetes and heart diseases. Even former alcoholics who are now un-addicted are not denied.

Mr. Bennet Klein, a lawyer with Boston based GLAD, an organization of legal advocates and defenders of GLBTQ community has asked several insurance companies the reason for denying insurance to men on PrEP. In most interviews with various insurance companies he and others have heard a range of answers, some ambiguous. The general understanding is that insurance companies are increasingly following this trend because they suspect potential high-risk behavior in PrEP users. The crux here is that regardless of risky sexual behavior, PrEP is highly protective. A prominent work of research published in The New England Journal of Medicine in 2010 showed that tenofovir, one of the chief components of Truvada reduced the risk of HIV infection by 95 percent. The famous HPTN 052 clinical trial of 2011 also showed the efficacy of PrEP.

Because of the prevalence of insurance denials, several people, like Dr. Cheng have stopped using PrEP. It is critical that this trend is reversed, in the light of clear benefits of taking PrEP. While there are insurance companies that do provide disability and life insurance to PrEP users, cases like Dr. Cheng’s result in disappointment and eventual withdrawal from using PrEP.

(Donald G. McNeal Jr, The New York Times)

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February 16, 2018 at 4:58 pm

Science Policy Around the Web – February 13, 2018

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By: Saurav Seshadri, PhD

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Experimental drugs

Trump Endorses “Right to Try” for Terminally Ill Patients

Proponents of the ‘right to try’ received some encouragement from President Trump’s recent State of the Union address, in which he announced his support for such legislation at the federal level.  Right to Try laws are designed to allow terminally ill patients to obtain unapproved but possibly lifesaving drugs directly from pharmaceutical companies, without involving the FDA.  While such laws already exist in 38 states, they are currently superseded by the Food, Drug, and Cosmetic Act; a bill that would eliminate this legal conflict was passed by the Senate last August, but has yet to be approved by the House of Representatives.

In general, Right to Try laws permit terminal patients, with their informed consent, to access investigational treatments if recommended by a physician.  However, they do not mandate that the manufacturer provide the drug or that insurance cover it, and in some cases, they absolve drugmakers and physicians from liability for adverse outcomes.  In addition, the FDA already offers a path to treatment for terminal patients under its ‘expanded access’ program, in which patients are treated as clinical trial participants and their doctor’s office becomes a satellite site, with appropriate regulatory oversight.  Opponents of Right to Try legislation, including FDA Commissioner Scott Gottlieb, argue that bypassing such oversight would critically undermine the clinical trial process (for example, a patient death from a drug obtained under a Right to Try law would not factor into the FDA’s consideration of that drug for approval).  They also suggest that these laws provide false hope for desperate patients – experimental drugs need only clear the safety phase of FDA trials, meaning no data exists on their efficacy – and open patients up to risks of physical harm and medical fraud.

Despite these concerns, Right to Try laws have gained momentum on the strength of anecdotal success stories, and politicians’ unwillingness to appear heartless towards patients suffering from terminal diseases.  Yet in reality, without securing financial support for patients, these laws are likely to result in some patients going bankrupt. Without requiring that treatments be demonstrated to be beneficial and at least safe, these laws are likely to result in patients pursuing ineffective treatments, while reducing their quality of life by enduring side effects, risking complications, and forgoing hospice care.  The future of Right to Try legislation may be influenced by new Health and Homeland Security Secretary (and former Eli Lilly executive) Alex Azar, who seems likely to support Trump’s agenda, though he didn’t mention the right to try in his response to the State of the Union address.  Ideally, the final bill will prioritize the existing drug review process, ensuring safety for the majority of patients while still providing hope for the sickest.

(Ike Swetlitz, STAT news)

Chemical safety

The truth about glyphosate may be getting lost in the weeds

The World Health Organization (WHO) kicked off a massive controversy in 2015 with its report labeling glyphosate, a component of an herbicide marketed by Monsanto, as ‘probably carcinogenic to humans’.  The report has faced stiff opposition from Republican Representatives on the US House Science, Space, and Technology Committee, largely fueled by a pair of Reuters reports suggesting that key data was suppressed by the WHO to support its conclusion.  Now Dr. Christopher Wild, Director of the group that conducted the research (the IARC, International Agency for Research on Cancer) has sent a detailed response to the Committee to rebut these criticisms and defend its original finding.

The response, which was presented at a recent Committee hearing by Democratic Representative Suzanne Bonamici, specifically addresses two issues raised by Reuters.  First, that a senior scientist failed to disclose data that would have exonerated glyphosate: the data was unpublished and therefore didn’t meet IARC’s criteria for consideration.  Second, that the published version of the report had several changes from an earlier draft, all of which involved deleting or revising statements that cast doubt on glyphosate’s link to cancer.  Dr. Wild claims that most of these changes were related to a single review article, whose conclusions were reconsidered when it was found to have been ghostwritten by a Monsanto scientist, and that its drafts are works in progress and therefore confidential.  Still, the response doesn’t explain the IARC’s discrepancy with other regulatory agencies: the European Food Safety Authority (EFSA) and US Environmental Protection Agency (EPA) have both found glyphosate to be safe, and claim their review processes are more transparent than the IARC’s.

The IARC’s stance on glyphosate puts it in a delicate position with the US government, from which it receives ‘valuable support’, especially as the topic becomes more partisan.  Republican lawmakers have already threatened to pull funding to the IARC, ostensibly over its refusal to provide a witness for the hearing (Dr. Wild invited them to visit his facility in France instead).  On the other side, the EPA’s assessment has been called into question by the discovery that an EPA official may have colluded with Monsanto to ‘kill’ investigation into glyphosate, leading Democratic Representative Ted Lieu to request a probe into the issue.  In the midst of a heated debate on climate change, the glyphosate story may initially seem to be another case of Republicans denying science to fight regulations and side with big business; however, the reality may be more complicated.  A recent protest in Paris by farmers, opposed to a proposed ban on glyphosate, highlights how those most affected by such policies must balance their economic stability against potential health risks.  Ultimately, though lawmakers may earn political points by siding with these individuals, if the price is discrediting accurate science and eroding public trust in regulatory agencies, no one wins.

(Corbin Hiar, E&E News)

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February 13, 2018 at 6:01 pm

Science Policy Around the Web – February 9, 2018

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By: Rachel Smallwood Shoukry, PhD

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Ethics

Big tobacco’s offer: $1 billion for research. Should scientists take it?

A controversial debate has arisen in recent years about whether scientists should accept funding from sources that have interests at odds with improving the human condition and promoting health. Specifically, should researchers accept research money from tobacco companies? This practice used to be generally accepted up until a couple of decades ago, but as the harmful effects of smoking have become more clear, as well as evidence of the tobacco industry’s attempts to cover-up and misdirect the public from becoming aware of those effects, the scientific community has become reluctant to partner with “big tobacco” and is more aware of conflicts of interest.

The tobacco company Philip Morris International (PMI), makers of Marlboro and other cigarette brands, is looking to invest in research of illegal cigarette trade and smuggling. It recently established a partnership with the University of Utrecht (UU) in the Netherlands to investigate this phenomena, but UU has now pulled out of the deal after a large amount of backlash. However, PMI is still looking to fund research on the tobacco industry, setting up the potential for more controversy.

There is additional concern about this possibility due to PMI’s funding of the Foundation for a Smoke-Free World. The foundation has stated that its goals are related to smoking cessation and preventing smoking deaths through several approaches. However, many fear that the foundation is simply a front for PMI to be able to distribute funds under a better-sounding name while continuing to fund research that can be presented in a misleading way to distract from legitimate health concerns. Several top institutions have denounced the Foundation for a Smoke-Free World for using PMI’s funds, and many have vowed that they will not seek grants from or collaborations with the foundation.

Proponents of allowing the funding via the tobacco industry are interested in research of cigarette alternatives aimed at harm reduction, arguing that little is known about their long-term health implications. They say there is little funding outside of the tobacco companies for these types of studies and don’t know where else to turn. They are also worried about the climate surrounding the topic, after the response UU received when accepting research dollars from PMI. But opponents do not believe that PMI and other companies are seeking harm reduction or to hide the truth about tobacco’s health effects through their research activities and marketing tactics. This ethical debate is sure to continue as PMI disclosed that it has had over 50 applications for funding.

(Martin Enserink, Science)

NSF

US science agency will require universities to report sexual harassment

The NSF has announced it will implement a new requirement that institutions receiving grants must report grant-funded investigators who have sexual or other types of harassment claims against them and whether they were put on leave pending investigation. Many are welcoming this step as movement toward a code of conduct that has been called-for in recent years. It is also coming on the heels of several research initiatives into sexual harassment in STEM fields and other organizations implementing policies to expose and prevent harassment. Although the #MeToo movement only brought sexual harassment claims to the forefront of our culture a few months ago, the STEM field had its own bombshell revelation followed by the unveiling of many stories of sexual harassment a couple of years ago when a renowned astronomer resigned after an investigation revealed years of sexual misconduct and harassment. This new policy is also likely related to the US Congress commissioning the Government Accountability Office to look into sexual harassment by individuals funded by federal scientific agencies.

The notice the NSF sent out also directs the recipient institutions to have clear policies on what constitutes harassment and what is appropriate behavior, as well as giving clear instructions to students and employees on how to report harassment. The institutions themselves will be responsible for conducting investigations and deciding repercussions. Until now the NSF has had an option to voluntarily report sexual misconduct of award recipients, but it was rarely used. The notice states that the NSF can remove the responsible personnel from the grant or even suspend or terminate the grant following the mishandling of a report.

Despite the general positive view of this attempt by the NSF to deter harassment and establish serious consequences, some have expressed concerns at the potential implications and logistics of implementation. It was suggested that this step may discourage universities from undertaking investigations of sexual harassment, since universities benefit from grant money and reputation just as the investigators do. Another aspect to consider is that universities have different policies on sexual harassment and misconduct, and what may be allowable at one institution may be a severe breach at another. It was not immediately clear from the notice how decisions will be made with regard to the grant following investigations. While perhaps not perfect, this policy by the NSF is a first step in the right direction to ensuring everyone can pursue their scientific endeavors in a harassment-free environment.

(Alexandra Witze, Nature)

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February 9, 2018 at 4:01 pm

Science Policy Around the Web – February 6, 2018

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By: Liuya Tang, PhD

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Cancer treatment

Breast cancer treatments can raise risk of heart disease, American Heart Association warns

Common cancer treatments include surgery, chemotherapy and radiation therapy. Chemotherapy and radiation therapy are always applied before or after surgical removal of a tumor, or applied to cancer patients when surgery cannot be performed. Not only will they attack tumor cells, chemotherapy or radiation therapy will also damage normal cells at the same time, which increases risks for other diseases. A recent report in the journal Circulation said that breast cancer treatments can raise risk of heart disease. It has been noticed that “breast cancer survivors who are 65 and older and were treated for their cancer are more likely to die of cardiovascular problems than breast cancer.” The possible cardiovascular consequences of breast cancer treatments may not be new to oncologists, but new cancer treatments have complex side effects which may not fully understood as they work differently from conventional cancer treatments. For example, the newly-developed cancer treatment, immunotherapy, stimulates the patient’s immune system to attack tumors, but sometimes the surging immune response can overshoot its target and attack healthy tissues and organs.

It is not a good idea to stop cancer treatment due to side effects, as saving ones life from a dangerous cancer is critical. But for this double-edged sword, how to make one edge blunt while keeping the other edge sharp? This requires surgeons and oncologists to work together to make a personalized treatment plan. As suggested by Dr. Deanna Attai, a breast surgeon at the University of California at Los Angeles, the patients with less-aggressive tumor may skip chemotherapy based on the test results on the cancer’s risk of recurrence. In addition, adopting different ways to deliver chemo drugs and developing more-targeted radiation can reduce the risks of cardiac damage for breast cancer patients.

It is not solely a doctor’s responsibility to monitor the side effects of cancer treatments, patients also need to be aware of what types of treatments and what the possible side effects are. Wrong treatments of side effects can aggravate symptoms, which may lead to severe problems. The new emerging immunotherapy presents a big challenge to the health care system as the side effects are not thoroughly understood. Doctors’ organizations and nonprofit groups are joining information campaigns to narrow the knowledge gap on immunotherapy, which will help patients better understand procedures of cancer treatment and manage any side effect if it occurs.

(Laurie McGinley, The Washington Post)

 

Drug development

Racing to replace opioids, biopharma is betting on pain drugs with a checkered past

The opioid epidemic has become a significant problem in the US, as 116 people died every day from opioid-related drug overdoses in 2016. To resolve this issue, biopharma continues to develop pain drugs. The class of drugs are called NGF inhibitors, which were halted by FDA in 2010 due to their severe side effects. NGF is short for nerve growth factor, which is a neuropeptide. When an injury occurs, the production of NGF is increased, which helps the brain perceive the pain. Theoretically antibodies that specifically bind NGF before it reaches cell receptors could be a good choice to inhibit NGF function, therefore treating people with chronic pain. But it was found that NGF antibodies are not suitable for a subset of patients with osteoarthritis, for whom treatment lead to dramatic joint deterioration. To obtain FDA’s approval of entering further clinical trials, drug companies showed that NGF drugs will probably be safe for patients not at risk of joint deterioration and shouldn’t be taken with nonsteroidal anti-inflammatory drugs such as Advil. So the clinical study was resumed in 2015. Will it become a replacement drug of opioids? Will the benefits outweigh its risks? The results will be put on table this year after drug companies finish their Phase 3 studies.

 

The severity of the opioid epidemic and the high need of non-addictive painkillers have kept drug companies optimistic about developing NGF drugs despite the side effects. However, there are opposite voices. The watchdog group Public Citizen criticized that the side effects are obvious and “further pursuit of testing in humans was an unreasonable course of action”. Criticisms also come from the business side. Leerink analyst Geoffrey Porges has warned Regeneron’s NGF drug would carry “all of the liabilities” of the past and scolded their continuing to pour money into the project. The failure has already been seen in the development of fulranumab, which is one type of NGF antibody. Even if NGF antibodies were approved by FDA, doctors would have concerns for prescribing a medication with potentially dangerous outcomes for patients with certain conditions.

(Damian Garde, STAT News)

 

 

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February 6, 2018 at 10:53 pm

The impact of the growing student loan burden on graduate education

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By: Rebecca McPherson, Ph.D.

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source: pixabay

Every individual has his or her reason for pursuing a graduate degree. For many, a graduate degree is a path to a specific career; for others, it is simply a personal goal; and at times, it is a requirement for job advancement. Although the benefits of a higher degree are as numerous as the types of degrees and disciplines offered, there is one unifying theme across higher education: rising and often unavoidable student loan debt. Forbes reported that in 2017, the student loan debt in the U.S. had reached an astonishing $1.3 trillion. Of the 44.2 million U.S. borrowers with some type of student loan debt, over 2 million owe at or more than 100,000 dollars. At the top of this mountain of debt are U.S. graduate students, a quarter of whom will borrow close to $100,000 to complete their education,  while a tenth will end up borrowing upwards of $150,000.

Educational debt can extend beyond the typical student loan programs. While tuition poses a major cost to the student, many may not be able to make enough money through stipends or part-time work to meet their cost of living. The Report on the Economic Well-Being of U.S. Households in 2016-May 2017 showed an increase in the rate of borrowing for educational related expenses. Although student loans remain the primary source of borrower debt, credit cards, home-equity loans, and private loans also make up a portion of the total educational debt burden.

With a climate of ever-increasing educational costs and associated debt, many current, past, and future students are left asking, what is being done to curb the impact of mounting educational debt? The Institute for College Access & Success (TICAS) is responsible for enacting and overseeing the National Agenda for the Student Debt Policy in the U.S. Currently, TICAS focuses on risk-reduction strategies for student borrowers, including developing income-driven repayment plans, increasing access to Pell grants, and streamlining student borrower application processes.

The growing concern surrounding the ever-increasing student debt load is also being tackled at the state level. In recent years, several individual states have introduced policies aimed at protecting the student borrower, especially from predatory private student loan lenders. The Private Student Loan Transparency and Improvement Act was passed in Oklahoma in 2013 and requires private and alternate student loan providers to be transparent in the lending and repayment conditions. The state of Connecticut followed by being the first state to implement a borrower’s bill of rights in 2015. Several states offer student loan forgiveness and repayment incentives to entice student loan debt holders to work in specific regions.

What does the rising burden of student debt mean, and what are the ultimate costs to the borrowers? Ultimately, the price of student debt means that many young adults will have to put off major life decisions. Among graduate student borrowers, 43 percent state difficulty in regularly meeting student debt repayment obligations, 61 percent  say they are unable to save for retirement due to debt load, and 45 percent lack the means to save for an emergency fund. The costs of tuition has substantially increased since the early 1990’s and continues to grow; this initial rise in costs was caused by a decline in state support to colleges and universities.   Although there are no exact numbers showing the impact to low income students, the pursuit of a higher degree may, for many students, be out of reach.

Although several policies at both the state and national levels exist, there are gaps in how to deal with and resolve the mounting student debt crisis, and questions remain as to the impact on future training.  TICAS has indicated several areas of the lending and repayment process in need of continued improvement, such as enhancing educational tax benefits, preventing predatory lenders, and promoting student borrower awareness.

Students pursuing advanced degrees – beyond a bachelor’s degree – shoulder the bulk of the student debt burden. At times, wage outcomes fall below borrower expectations in certain fields of study. This can have a serious economic impact for borrowers who are unable to meet loan repayment requirements. Borrowers who have completed a higher level of education at a not-for-profit institute, and consequently have a higher burden of debt (i.e., $100,000 or more) are less likely to fall behind or default on payments.  Counter to this, student borrowers who have attended a for-profit institute or did not finish their degrees are more likely to fall behind on repayments or default on their student loans.  Additionally, those seeking advanced degrees will find that they have a greater ability to borrow from the federal loan program, which often has high caps and few or no credit checks required before borrowing. This leads some to put the blame for the student debt crisis on the federal government, arguing that unchecked borrowing causes educational institutions to continually raise tuition and fees for graduate education.

As of February 2018, no new federal laws regarding the student loan debt burden have been passed. However, several initiatives have been proposed by the current administration in an effort to tackle the expanding costs of the student debt. One such recommendation is the expansion of the income-based repayment plan (IBR), which would consolidate all loans into a single repayment of 12.5 percent of income with loan forgiveness after 15 years. Other recommendations include lowering federal loan interest rates; eliminating the Public Service Loan Forgiveness (PSLF) program, which would instead give focus to the proposed IBR; and a pushing for tuition reduction by imposing educational institutes to cut administrative costs.  On the upcoming 10 year anniversary of the start of PSLF, many argue that cutting the program would dissuade many young professionals from entering into the lower paying public health service.

Ultimately, the impact of the student loan debt burden may negatively affect graduate level training. There are calls to protect borrowers from predatory lenders and proposed legislation to tackle the debt crisis. The willingness to take on large debt and possibly delay major life decisions lies with the individual. For now, the student debt debate continues.

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Written by sciencepolicyforall

February 6, 2018 at 12:13 pm