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Science Policy Around the Web – August 16, 2018

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By: Sarah Hawes, Ph.D.

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Scientific Discoveries

Ambitious ‘Human Cell Atlas’ Aims To Catalog Every Type Of Cell In The Body

You’ve no doubt heard of the Human Genome Project – a 15-year long endeavor to sequence the total human genome, fueled by 3 billion dollars and completed in 2003. But have you heard of the Human Cell Atlas Consortium? MIT biology professor and member of the Broad Institute Aviv Regev has led this collective of hundreds of international scientists since its foundation in 2016.

Just as the intent of the Human Genome Project was to sequence all our genetic material, the intent of the Consortium is to identify every single type of cell in the human body so that they can be investigated and understood independently, and in the complex context of cell-cell interactions, and their role in our physiology. This is a huge endeavor. We currently lack even a rough estimate of how many cell types exist. “People guess anything from the thousands to the tens of thousands. I’m not guessing,” Regev says. “I would rather actually get the measurements done and have a precise answer.”

And how does one delineate cell types in a meaningful way, to take these measurements? This is done by determining which genetic material a cell activates, i.e. which genes it mobilizes from quietly bundled DNA to RNA, and from there into a meaningful protein product to carry out the particular cellular functions defining a heart cell, or a lung cell, or a glial cell in the brain. The technology enabling description of a cells’ genetic character is called single-cell RNA sequencing.

In 2014, Aviv Regev, together with Steve McCarrol, and David Weitz at Harvard, improved on this process to substantially speed it up. “All of a sudden, we moved from something that was very laborious and we could do maybe a few dozen or a few hundred, to something where we could do many, many thousands in a 15- to 20-minute experiment,” Regev says. “We said, ‘That’s at the right scale that we could actually do the human body.’ And this is what they have set out to do.

Today, after just two years and 200 million in NIH funding, the Human Cell Atlas Consortium is beginning to bear fruit.

The first major Human Cell Atlas finding was published this month and simultaneously confirmed by a separate lab at Harvard Medical School. Both papers are published in the journal Nature, and report the definition of a new cell type in the windpipe which is responsible for creating a faulty protein linked to cystic fibrosis. Previously it was believed that the faulty protein originated in common cells lining the windpipe. Discovery of the new and rarer cells, dubbed ‘pulmonary ionocytes,’ will improve scientists’ ability to target faulty protein production by targeting the pulmonary ionocytes, thereby speeding up the development of treatments for cystic fibrosis.

A second consortium-related discovery appeared last week in the journal Science, in which British consortium members published the finding that childhood kidney cancer begins in a cell type which is distinct from the cells giving rise to kidney cancer in adults.

“We knew the lessons from the Human Genome Project were [that] rallying together the entire community would really let you get a full answer to a question. And that full answer will empower everyone to do better and faster and higher-resolution biology,” says Regev. Together, cataloguing all human cell types is predicted to take just another five to ten years. Discoveries building off this catalogue will dramatically enhance medical progress globally, and in perpetuity.

(Karen Weintraub, NPR)

Science and Innovation

It’s ‘Shark Tank’ For Global Health Inventions

A fascinating program to bolster innovation in global health, and particularly for impoverished mothers and children, is coming from a union between government agencies in the US, Norway, Korea, and the UK together with the Bill & Melinda Gates Foundation. This program, called Saving Lives At Birth: A Grand Challenge For Development, hosted a special conference in Washington, D.C. last week to empower global health inventors with the gift of pitch.

Nearly 500 applicants were winnowed down to ten participants, each of which presented global health innovations before a panel of judges rating them not on their science, but on their business plan – including target market, competition and revenue model.

Prior to presenting, each participant worked with consultants to enhance their slides and speeches. Rachele Haber-Thomson, one of the consultants, explained that many participants came from academia or non-profits. She said that while they knew how to write a grant, they needed help to capture the attention of investors looking for compact, business-savvy strategies.

Presentations were compact, seven-minute pitches on practical advances – describing a health problem, a solution, and convincing details on its implementation – all before taking questions from judges on feasibility, marketing, etc. The advances presented included an oxygen concentrator powered by running water, a medicine pouch to prevent transmission of HIV from mother to infant, a new subcutaneous contraceptive, and a system to generate disinfectant from salt and water. The winning pitch came from Gradian Health Systems, and was for a network of mobile medical training centers to enhance quality of care in areas with few physicians.

The prize for a winning pitch was not funding (though the audience included potential backers). Each participant had already been awarded $250,000 to $2 million from Saving Lives At Birth to develop their ideas prior to the conference. Instead of direct funding, the winner was given a choice between competing in a similar sales-pitch show-down in Berlin or else receiving free business-consulting.

As Sofia Stafford of USAID and Saving Lives At Birth puts it, “if these global health projects want to scale up, they need to know how to communicate their vision, grab investors’ interest and attract more funds.” Bearing this in mind, the July conference invokes the proverb “give a man a fish and he’ll eat for a day; teach a man to fish and he’ll eat for a lifetime.” Saving Lives At Birth does both.

(Vicky Hallett, NPR)

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August 16, 2018 at 4:31 pm

Science Policy Around the Web – August 10, 2018

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By: Leopold Kong, PhD

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The Scientific Workforce

Top US biomedical institute settles gender-discrimination lawsuits

In a joint statement on August 7, 2018, senior cancer researchers Katherine Jones and Victoria Ludblad agreed to drop all charges against the Salk Institute for Biological Studies in La Jolla, California for sexual harassment and gender-based discrimination.  The statement reads: “[…] productive conversations have led to a resolution of all claims between these parties that will enable us to put our disagreements behind us.” However, the settlement does not impact similar allegations against Salk by a third plaintiff, molecular biologist Beverly Emerson, whose contract was not renewed in 2018.  Her lawyer said, “Dr. Emerson intends to proceed until justice is fully achieved.”

All three lawsuits were initiated in July 2017, alleging several discriminatory practices at Salk. These include being excluded from retreats and social events with opportunities to network with donors, being assigned smaller lab spaces than male colleagues, being allocated fewer lab staff than male colleagues, and being paid less than male colleagues. The lawsuits also singled out Salk faculty member Inder Verma, a renowned geneticist who also served as the editor-in-chief of the prestigious research journal Proceedings of the National Academy of Sciences. Lundblad’s suit alleged that Verma made “overtly derogatory comments” about women. Furthermore, in reports going back to 1976, eight women alleged that Verma “grabbed their breasts, pinched their buttocks, forcibly kissed them, propositioned them, and repeatedly commented on their physical attributes in professional settings.”  “It was on everybody’s mouth that he was a harasser,” said molecular and cell biologist Monica Zoppè, who claimed she was forcibly kissed by Verma when she was a postdoctoral scientist in his lab.  Although Verma issued a statement to Nature that he had never used his position to take advantage of others, he resigned from the Salk earlier this year.

“Gender discrimination is everywhere,” says Christine Williams, a sociologist at the University of Texas at Austin. “But what makes the experience unique among scientists is their almost unflappable belief in objectivity and meritocracy.” To change the situation, some universities have become more transparent about salaries, promotions and funding.  In the United Kingdom, Athena SWAN (Scientific Women’s Academic Network) program collects information from over 140 institutions and rank them in terms of how well they attract and advance women. “There has been so much progress,” Nancy Hopkins, a molecular biologist at the Massachusetts Institute of Technology told Nature, “but the progress is uneven.”

(Amy Maxmen, Nature)

Vector-borne diseases

Dengue rates plummet in Australian city after release of modified mosquitoes

In 2016, there were over 2000 cases of dengue fever in Australia, reaching a 20-year high. The mosquito that spreads dengue, Aedes aegypti, can also carry the zika virus, and there were 59 confirmed cases of zika in Australia that same year.  When left untreated, dengue fever has a mortality rate of over 20%.  Since October 2014, researchers have been testing a new strategy to combat mosquito-borne diseases in Townsville, Australia.  Over many months, the researchers released around 4 million Aedes aegypti mosquitoes carrying a strain of the Wolbachia bacteria that blocks the transmission of dengue, zika and other disease-causing viruses.  Wolbachia are bacteria that can live inside insect cells, and are estimated to infect more than 60% of all insect species. One strain of Wolbachia is known to have the ability to halve the adult lifespan of Aedes aegypti and stimulate the mosquito’s immune system to make it more effective against disease causing viruses such as dengue. Wolbachia may also compete with disease causing viruses for the limited resources inside the mosquito.  According to the recently posted results in Gates Open Research, in the 44 months after the release of the mosquitoes, there were only 4 locally acquired dengue cases compared with 54 locally acquired cases over the 44 preceding months.  Similar studies with Wolbachia are ongoing in Yogyakarta, Indonesia, Rio de Janeiro, Brazil and Bello and Meddlin, Colombia, where dengue is a major health burden. Earlier this year, Wolbachia carrying Aedes aegypti mosquitoes were released in Vietnam and Pacific islands such as Fiji, Vanuatu and Kiribati.

(Ewen Callaway, Nature)

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August 10, 2018 at 1:22 pm

Science Policy Around the Web – August 3, 2018

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By: Cindo O. Nicholson, Ph.D.

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Drug Control

D.C. has had more than 300 synthetic marijuana overdoses in 2 weeks

A synthetic marijuana (cannabinoids) known as K2 is suspected to be the cause of more than 300 overdoses in Washington D.C. What is happening in D.C. is a microcosm for what is occurring in multiple states across the country. Recently, the U.S. Food & Drug Administration (FDA) has posted a statement on reports of deaths and severe illnesses from the use of synthetic cannabinoids.

Synthetic cannabinoids are different from natural marijuana. Synthetic cannabinoids are designed to stimulate the same receptors stimulated by natural marijuana. However, the contents of synthetic cannabinoids are not consistent; each batch can differ in the concentrations of active ingredients and there are even variations within batches. Furthermore, there can be other toxic ingredients like brodifacoum which is a vitamin K antagonist and a compound used in rat poisons. It is believed that that brodifacoum is added to synthetic cannabinoids in order to extend the duration of euphoria or “high”. However, brodifacoum’s antagonism of vitamin K can cause severe bleeding.

The components and concentration of active ingredients in these synthetic products are not regulated, unlike drugs sold in the pharmacy. The FDA has worked with the Drug Enforcement Agency in the past to put several of these synthetic cannabinoids into Schedule I of the Controlled Substances Act. However, producers of these substances have counteracted these efforts by changing how they’re distributed and by changing the chemical structure of these substances just enough to circumvent state and federal requirements.

Consumers of synthetic marijuana need to be mindful that these drugs are not the same as natural marijuana, and the contents of these drugs could contain toxic substances like brodifacoum that can cause severe illness or death. While there are public health laboratories with the expertise to isolate and classify new ingredients that show up in these synthetic compounds, it is a challenge for law enforcement to make the new ingredient illegal on the sole basis that it fits into a class of chemicals that are hazardous to human health.

(Marisa Peñaloza, NPR)

Clinical Trials

Controversial US ketamine trial sparks ethics complaints

The consumer advocacy group Public Citizen has filed a complaint to the U.S. government because of two clinical studies where ketamine was administered to patients without their consent. Both clinical studies were conducted in Minneapolis, Minnesota by researchers at the Hennepin County Medical Center (HCMC). In both studies, agitated patients were administered either ketamine or another sedative by paramedics.

In the first study, the HCMC conducted a previous trial to compare the ketamine to the sedative haloperidol and found that the percentage of patients that developed respiratory issues requiring a breathing tube after ketamine administration (39%) was almost 10 times the percentage of patients administered haloperidol that needed a breathing tube (4%). These findings were published in the journal Clinical Toxicology.

In June 2017, the HCMC proceeded with a second clinical trial where the administration of ketamine to agitated patients was compared to the drug midazolam. This trial was halted in June 2018 when it was reported that Minneapolis police encouraged paramedics to use ketamine on troublesome patients, some of whom were already physically restrained. Many of these patients breathing and heart rate stopped and had to be resuscitated at the hospital. The HCMC released a statement on its website denying that paramedics involved in the study could be directed by the police in this manner. Furthermore, the hospital states that paramedics were instructed that using ketamine or another sedative on a patient has to be a medical decision.

The Food & Drug Administration (FDA) ethics guidance for clinical trials on occasion allows trials to proceed without patient consent if it is known that there is minimal risk to the patient (The 21st Century Cures Act, 2016). The HCMC found from their first study that patients sedated with ketamine had a greater risk of serious respiratory complications, but their Institutional Review Board (IRB, an internal ethics oversight body) allowed a second clinical trial without requiring patient consent. The HCMC has responded to Public Citizen’s complaints and intends to participate in both internal and independent reviews of their study.

(Sara Reardon, Nature)

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August 6, 2018 at 10:50 am

Science Policy Around the Web – July 31, 2018

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By: Patrice J. Persad, PhD

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Science and Society

The ethics of computer science: this researcher has a controversial proposal

As a computer scientist with good intentions, it is only natural for him/her to be optimistic about the societal implications of his/her discoveries or findings. Unfortunately, this naivety, or lack of foresight, regarding secondary uses and repercussions of computer applications in/on everyday life can be damaging. As illustrations of unpremeditated consequences, automated tasks based on machine learning algorithms may be time efficient but steal jobs from millions of workers. Also, seemingly unlimited data storage capabilities and potent graphical processing unit (GPU) processing permit building prediction models of consumers’ behavior. This unrestricted data access and use can infringe on individuals’ privacy and question the voluntary nature of the consent process.

In order to magnify the importance of all computer applications’—notably, artificial intelligence’s (AI’s)—shortcomings in relation to society, Dr. Brent Hecht of Northwestern University has a plan. Instead of lauding their findings’ positive influences on society, computer science researchers must disclose negative implications of their research in publications and other press-related media.

The Future of Computing Academy (FCA), which Hecht oversees and which is a branch of the Association for Computing Machinery (ACM), promotes this duty of negative impact disclosure during the peer review process. Motivation for such a proposal stems from fostering accountability of researchers to the general public; this emphasizes the computer scientist’s role not as a mindless mass producer but as a mindful protector of the public’s welfare. Acknowledging the cons of works/applications pushes discussing plus implementing solutions. This deepening of accountability also revitalizes the public’s trust in the computer science community. As expressed by Hecht, here is what fellow computer scientists, as authors and peer reviewers, can do right now to contribute to these efforts of recognizing negative societal impacts:

  1. As an author, include a section entitled “Broader Impacts” or “Societal Impacts,” which discloses negative impacts in addition to positive impacts. Readers are not expecting the authors to be seers; in the context of pre-existing literature, discussing secondary uses with possible dastardly effects on citizens should be a start (if not sufficient).
  2. As a peer reviewer, outright ask, if unlisted in the submission, “What are the work’s negative societal impacts?” Stress that disclosing such information will not warrant rejection of the manuscript. (On the other hand, if negative impacts outweigh positive ones, funding agencies can use their discretion in supporting projects.)
  3. When communicating with the press, remember to mention negative societal impacts, and be prepared to address relevant questions/comments.

(Elizabeth Gibney, Nature)

Bioethics

Did a study of Indonesian people who spend most of their days under water violate ethical rules?

At the heart of any study involving human subjects, the potential for an ethical dilemma to arise is strong in the face of unclear and/or inaccessible research policies and regulations. Or, to put it bluntly, there churns the following question that torments the researcher when ethical matters cross over into legal waters: “Will I go to jail if I unknowingly breach research protocol (no matter if that protocol is under debate or revision)?” The ethical dilemma is imminent especially when principal investigators are foreign and from developed countries, but the proposed study’s focus is on indigenous populations in developing nations. Consider the research presented in the April 2018 Cell article “Physiological and Genetic Adaptions to Diving in Sea Nomads” by Dr. Melissa A. Ilardo and colleagues. The investigation’s results demonstrated that genetic variation in PDE10A is associated with a larger spleen size in the Bajau people, Indonesian “Sea Nomads” who have practiced extreme breath-hold diving for over a thousand years. The Ministry of Research, Technology and Higher Education (RISTEK) in Indonesia granted the team a permit to pursue the study. However, the bona fide ethical conflict stems from:

  1. local organizations’ claims that the team did not receive approval from at least one Indonesian research ethics commission/committee (see Council for Internal Organizations of Medical Science, CIOMS, guidelines).
  2. failure to procure approval from the Indonesian National Institute of Health Research and Development to transport human DNA samples out of Indonesia.
  3. lack of research involvement on the part of Indonesian scientists, especially geneticists.
  4. inadequate presentation of overall research results to study populations, including the Bajau, before publication.

In defense of Ilardo and colleagues, supporters point out that the Indonesian government has not reprimanded any team members for their research indiscretions, and Cell finds no issues with the group’s provided documents from said government. As for engaging more with Indonesian scientists regarding local research projects, Ilardo’s unanswered e-mails to several local professionals prior to data and specimen collection are proof of involvement attempted. In hindsight (or perhaps coincidence), RISTEK in early July organized an online portal where foreign researchers can easily gain access to all protocol/documentation for permits.

Foreign researchers are urged to realize that these presented ethical concerns—among them, governmental/national organizations’ approval, or consent, and transfer of biological specimens out of developing countries—are not trivial. Scientists should not be alarmed at just the prospects of jail time. Research cooperation with other nations’ institutions/entities can impact international relations between nations and local denizens’ trust in foreign researchers. Both international relations and trust influence the success of future research endeavors in developing and other nations.

(Dyna Rochmyaningsih, Science)

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July 31, 2018 at 4:56 pm

Science Policy Around the Web – July 27, 2018

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By: Emily Petrus, Ph.D.

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Innovation

Artificial Intelligence Has a Bias Problem, and It’s Our Fault

While computer and data scientists are working to create systems which can reason and perform complex analysis, groups of ethicists, lawyers and human rights advocates express increasing concerns about the impact artificial intelligence will have on life. It is becoming apparent that human bias regarding race, gender and socioeconomic position also influence algorithms and data sets used to train machine learning software.

Most artificial intelligence (AI) systems are trained on data sets culled from the internet. This results in skewed data which over-represents images and language from the United States. For example, a white woman in a white dress results in algorithms labeling a picture as “bride” or “wedding”, while an image of a North Indian bride is labeled as “performance art”. If that seems like a harmless hiccup, think about algorithms designed to detect skin cancer from images. A recently published study did a decent job detecting dark moles on light skin, but only 5% of the data set depicted dark skinned people, and the algorithm wasn’t even tested on that data set. This bias could skew accurate diagnoses for already underserved minority populations in the United States. Finally, AI will have a huge impact on financial markets beyond the replacement of humans to do jobs, particularly in manufacturing. Decisions on loan eligibility and job candidate hiring decisions are being filtered through AI technology, which is guided by data which may be biased.

It is apparent that computer scientists must make concerted efforts to un-bias data training sets and increase transparency when they develop new AI systems. Unfortunately, these common-sense suggestions are just that: suggestions. Before Obama left office in Fall 2016, a roadmap was created by the administration to guide research and development of AI systems. There’s no teeth in policy dictating fairness and inclusivity in AI development, but private and academic institutions are making gains in this arena. The Human-Centered AI project at Stanford University and Fairness, Accountability, Transparency, and Ethics (FATE) in AI research group at Microsoft are two examples of these types of efforts. Both groups seek to increase inclusivity in AI algorithms and reduce bias – human and computer generated. AI can also be trained to detect biases in both training data and the models by conducting an AI audit. An effort of developers in academia and private industry will be necessary to produce and prove their AI is unbiased, and it is unlikely that federal regulations would have the power or dexterity to administer any concrete regulations regarding this technology. Like most other scientific advances which bring significant monetary gains, the pace is breakneck but corners should not be cut. Legislation is unlikely to be able to keep up with the technology, but incentives to keep the playing field fair should come from within the AI community itself.

(Ben Dickson, PC Mag)

Scientific oversight

NIH delays controversial clinical trials policy for some studies

How does the brain process images of faces? How do we respond to frustrating situations? What does the mind of a sociopath look like in an MRI? These are all basic science questions in brain research which may discover treatment options for future studies. But for the moment, no drugs or interventions are being tested in many basic research labs funded by the National Institutes of Health (NIH). This means they’re not clinical interventions, or by definition, clinical trials, right? Maybe…

Basic researchers studying the healthy human brain sigh a breath of relief as the NIH decided to delay new rules applying to the classification of human trials. At issue is the re-classification of research which can be considered a clinical trial. The intent of the new guidelines was to increase reproducibility and transparency in government funded human research, for example requiring more rigorous statistical practices.  In practice, investigators will be required to upload their studies to clinicaltrials.gov, take mandatory trainings, and produce significantly more paperwork to continue receiving funding for their basic research. In addition, researchers were concerned that this would create more confusion in the public, as their research would be inaccurately represented as a clinical trial.

After the announcement last year, professional societies and academics sent letters of complaint to NIH, prompting congress to delay the implementation of the requirements to September 2019. This delay also gives leniency to basic researchers who apply to funding opportunity announcements seeking studies labeled as clinical trials, meaning they would not be immediately disqualified from being scored. Although many researchers hoped the NIH would drop all requirements for basic research, the delay is welcome for now. “This delay is progress because it gives them more time to get it right, and in the interim people aren’t going to be in trouble if they get it wrong,” said Jeremy Wolfe, a cognitive psychologist at Harvard Medical School.

(Jocelyn Kaiser, Science)

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July 27, 2018 at 4:51 pm

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Science Policy Around the Web – July 24, 2018

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By: Janani Prabhakar, Ph.D.

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The Scientific Workforce

Has the tide turned towards responsible metrics in research?

Quantifying progress and success in science has long been a challenging task. What is the correct metric to use? Mathematics can provide insight on the general impact of journals or calculate the productivity based on publication rate of an individual researcher. But, predictive statistics are much less common. Predictive statistics and machine learning approaches are used in other industries and sectors quite often. For example, as this article points out, predictive statistics and modeling are used in baseball to identify new talent. Why not in academia? There are private companies that provide such statistics like Academic Analytics. They offer a version of multiple existing metrics to measure potential success, including citations, H-indices, impact factors, and grant income. The desire for such statistics come from those making hiring decisions within academia to policymakers when making budgetary decisions. The need for quantifying potential success is apparent, but when, where, and how is still in hot debate, as well as how to do so ethically. The San Francisco Declaration on Research Assessment (Dora) called for an end to using journal impact factors in funding and hiring decisions, and focus on other metrics instead. UK has made some strides to ensure that any metrics used still cohere to the principles of science and reflect ‘responsible metrics.’ These metrics include robustness, humility, transparency, diversity, and reflexivity. A recent report evaluates the success of these metrics and implementations over the last five years. Out of 96 UK universities and research organizations, 21 have already agreed to follow these metrics. Some universities have begun to implement their own policies beyond those outlined in Dora. This has led to increasing data on good metrics and practices for Universities to begin to shift policy to improve the academic environment, reduce abuse, and to employ responsible management practices. This data is a great resource for making change in Universities at the global level.

(James Wilsdon, The Guardian)

Psychology

Confronting Implicit Bias in the New York Police Department

After a long history of police brutality towards black men, the role of racial bias has fallen front and center in the American dialogue. Implicit bias reflects the kinds of biases that are unintentional, unconscious, and more pervasive than racial bias alone. Erasing such biases requires overcoming one’s own stereotypes and using facts to make rational decisions. As part of Mayor Bill de Blasio’s police reform efforts, a training program on implicit bias will run through next year, conducted by Fair and Impartial Policing, a Florida company that provides such training programs for many police departments. While this program will cost the city $4.5 million, there is no data, yet, to assess the training’s effectiveness. The lack of objective data is troubling to policy makers and researchers, given the spread of this training across many police departments. Dr. Patricia G. Devine, a professor at the University of Wisconsin, has stated that we need to first know more about officers’ unintentional biases to determine whether the training has a significant effect. Furthermore, the longevity of the training effects need to be determined both in terms of changes in officer behaviors as well as the extent to which the community has benefitted. Despite the lack of such data, feedback from trainers suggests that over the course of the training period, initial hesitance in police officers turns to a better appreciation for the role of stereotypes in action selection. For many police officers, the training is an opportunity to reflect upon their own behaviors and make meaning out of them from the perspective of their own tendencies to racially stereotype. The training isn’t meant to cure officers of their biases, but rather to help them confront and manage their own biases. Police officers are shown case studies of situations where biases result in differences in the way police officers confront white versus black individuals, allowing them to appreciate the real-world consequences of implicit biases. Police officers are then taught strategies to reduce and manage their biases, and to recognize biases in others. Part of the process is to also help police officers make “unhurried decisions” so they have time to think, strategize, and make appropriate choices. Without metrics, the long-term viability may be questioned, but from the perspective of many participants, it is a big step in the right direction as it acknowledges underlying prejudices that may not have otherwise been realized.

(Al Baker, The New York Times)

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July 25, 2018 at 5:23 pm

Science Policy Around the Web – July 20, 2018

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By: Mohor Sengupta, PhD

Skeleton Tools Medicine Technology X-ray Medical

source: Max Pixel

Innovation

3-D Color X-Rays Could Help Spot Deadly Disease Without Surgery

Traditional X-ray or CT (computerized tomography) scanners pass X-ray beams through the body and detect the transmitted radiation. Dense tissues, that have absorbed the X-ray, appear white and softer tissues, which have transmitted most of the X-ray beam, appear darker. Dr. Anthony Butler from University of Otago in NZ, along with his father Phil Butler, has made a crucial breakthrough in this imaging technique. They have applied the principle of a pixel detecting tool that is used in the Large Hadron Collider at CERN, in modeling their scanner. Their tool basically records the change in the X-ray wavelength once it passes through sub-atomic particles and assigns the new wavelength a pixel (smallest individual unit of a digital image) of a certain color. This colored pixel identifies the particle the X-ray beam has passed through. For example, if the X-ray passes bone, the calcium atoms in the bone will alter its wavelength, which will then be recorded as certain color, say pink, which is different from the color assigned to the altered wavelength of the X-ray beam if it passed another tissue. The tool then translates this data into a 3D color image.

This imaging technique can provide very high-resolution images of tissues without any invasive procedures. Its developers have detected minute details of various tissues like cartilage, bones, adipose tissue etc. in scanned ankles and wrists. They plan to scan the entire human body eventually. Since this imager can take pictures of areas deep inside the body, it will hopefully uncomplicate the diagnoses of many hard-to-detect medical issues, like cancer, heart abnormalities and blood disorders. “It’s about being able to first find the explanation for somebody’s symptoms, like a tumor, and then find the best way to reach it with the least amount of detours and misadventures,” said Dr. Gary E. Friedlaender, an orthopedic surgeon at Yale University.

Aurélie Pezous is a knowledge transfer officer at CERN. She promotes outside uses of research techniques developed by the organization. Of the recent applications of the pixel detecting tool in medicine, she said, “This is the beauty of it: Technology that was first intended for the field of high-energy physics is being used to improve society. It’s very exciting for CERN”.

In the coming months, clinical trials will enroll orthopedic and rheumatology patients to test the novelties of the 3D color X-ray scanner.

(Emily Baumgaertner, New York Times)

Drug pricing

Trump administration to explore allowing drug imports to counter price hikes

In February last year Bernie Sanders, along with many of his democratic colleagues introduced a legislation in the House and Senate to allow drug importation from Canada, to rein in rising drug prices in USA. Drugs are cheaper in many countries because of government regulations on pricing. Since that legislation, this idea has been championed by Sanders and Trump alike.

Steep and regular drug price hikes pursue American consumers constantly. This is particularly true for an off-patent drug produced by a single manufacturer. The case of Martin Shkreli, who became infamous for having hiked the price of Daraprim, an AIDS drug, to 5000 percent of its original price after his company Turing Pharmaceuticals acquired its manufacturing rights in 2015, was cited as an example of blatant abuse of the current system. It has been suggested by Alex Azar, secretary of Health and Human Services, that in such situations an effective solution could be to import drugs from a reliable foreign source and effectively introduce competition in the local manufacturing arena, and curb prices within the United States in the process. As the federal law on drug importation currently stands, it is illegal to import foreign approved medicines except for meeting shortages in supply, something that happened after the hurricanes in Puerto Rico last year.  FDA commissioner Scott Gottlieb has likened the situation of steep price hikes to that of drug shortages, as it creates similar public health consequences for consumers and he believes that a temporary importation of foreign approved drugs could be helpful, at least until competition resumes and prices are brought down.

Yesterday, Gottlieb criticized makers of high priced medicines for stalling manufacture and availability of alternative low-priced versions of the same compounds. The focus of the federal government here is the importation of medically necessary drugs approved in other countries as a reasonable substitute for the FDA approved version in USA. If the import legalization comes about, it will be a major disappointment for pharmaceutical companies at home which have strongly opposed the move, along with the Republicans.

Shortly after the legislation introduced by Sanders in 2017, four former commissioners of the FDA issued an open letter to members of the Congress, citing the dangers of exposing Americans to imported drugs that have not undergone the established standards of scrutiny that the FDA has in place for American-made drugs. Irrespective of the criticisms, the proposed importation of foreign approved drugs seems to be encouraged by the federal government, which is good news for many consumers and a blow to the monopoly of local drug-makers.

(Laurie McGinley, The Washington Post)

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July 20, 2018 at 4:01 pm