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Posts Tagged ‘research ethics

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 – April 24, 2018

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By: Kelly Tomins, BSc

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NASA

Trump’s NASA Nominee, Jim Bridenstine, Confirmed by Senate on Party-Line Vote

The senate has confirmed Jim Bridenstine, republican Oklahoma congressman and former navy pilot, as the new administrator of NASA. The senate confirmed Bridenstine along party lines, with 50 republicans for and 47 democrats and two independents against. His confirmation concludes 454 days NASA has operated without a permanent leader, the longest period in the organizations history. Despite Bridenstine’s long-time interest in space, his lack of technical expertise and bureaucratic leadership experience has left many legislators skeptical of his ability to run a $18.5 billion dollar agency.

Bridenstine’s background differs greatly from past NASA administrators. He is a three-time Oklahoma congressman and the first elected official to ever hold the top position at NASA. Bridenstine’s science experience is limited to sponsoring the American Space Renaissance Act, an unpassed outline of the future of NASA, and serving for two years as the executive director of the Tulsa Air and Space Museum and Planetarium. The NASA administrator under Barack Obama, Charles F. Bolden, Jr., was an astronaut for 14 years at NASA before returning to the Marine Corp. Current acting administrator, Robert M. Lightfoot, is a mechanical engineer who has worked for NASA for nearly 20 years. Bridenstine will be only the third of 22 NASA administrators or acting administrators without previous NASA experience or formal science/engineering training. In addition, Bridenstine has no experience running a government bureaucracy and has come under fire for questionable dealings during his brief tenure at the Tulsa museum.

Democratic senator Bill Nelson of Florida was one of the most outspoken opponents of the confirmation, denouncing Bridenstine’s political background as a potential conflict of interest. Bridenstine has made controversial and conservative statements in the past, including criticisms of climate change funding and opposition to same-sex marriage. Even republican Marco Rubio expressed concerns regarding Bridenstine’s lack of science expertise, and was only swayed to vote yes after the current acting NASA administrator announced his retirement.

Bridenstine’s confirmation follows the trend within the current administration to appoint non-scientists to lead scientific agencies. Rick Perry was appointed as Secretary of Energy despite his lack of scientific expertise, his questioning of climate change, and having once proposed eliminating the agency as a whole. The current administrator of the EPA, Scott Pruitt, entered the position without scientific background. Additionally he was a well known critic of the EPA, demonstrated when he sued the agency more than a dozen times during the Obama presidency.

NASA is a historically nonpartisan agency, and its best interest would not be served by swaying political ties. There has historically been little partisan divide over the NASA administrator appointment, and both administrators under Barack Obama and George Bush were unanimously confirmed by the senate. Despite Bridenstine’s unconventional political background, Bridenstine assured the senate during his confirmation hearing that he “want[s] to make sure that NASA remains, as you said, apolitical”. Let’s hope that’s the case.

(Kenneth Chang, New York Times)

 

Ethical Research

African scientists call for more control of their continent’s genomic data

New guidelines published by the Human Heredity and Health in Africa Initiative (H3Africa) hope to clarify ethical standards of studies, give African scientists more autonomy, and ensure that Africans benefit from the research they participate in. The African continent contains a wealth of human genetic diversity and overseas researchers are increasingly utilizing this diversity to discover more about our species history and health. Despite the wealth of information African samples can provide, there is a lack of infrastructure to support African scientists. African genomic samples are often shipped to the global north to be analyzed, a practice driven by superior computational facilities and faster computing times. African scientists often have to collaborate with researchers overseas, reducing their autonomy. In addition, there are ethical questions regarding the use of African biobank data for secondary use by researchers not involved in the original study.

H3Africa is an NIH funded health-genomics consortium that works to increase the genomic infrastructure by funding African-led projects and train bioinformaticians. These new guidelines were written by an ethics working group aimed at all stakeholders involved in the design, participation, and regulation of genomic research throughout Africa. The guidelines four core principles are summarized as:

  1. Research should be respectful of African culture
  2. Research should benefit the African people
  3. African investigators/ stakeholders should have intellectual leadership in research
  4. Research should promote fairness, respect, equity, and reciprocity

H3Africa hopes that these guidelines will help guide research-ethics committees to promote the best practice for research in Africa, and eventually spark the creation of national regulations for genomics research and biobanks. Brenna Henn, a population geneticist at the University of California, Davis, is optimistic about the framework guidelines, although somewhat worried of heightened tensions with western scientists. She states, “The guidelines could be a rude awakening for scientists who seem to believe they can fly into an African country, study a genetically unique population and export the samples in a few months”. It is definitely a necessary awakening that African populations should not be exploited for their genomic data, and hopefully these guidelines will pave the way for more ethical, consensual, African-led research studies.

(Linda Nordling, Nature)

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April 24, 2018 at 10:21 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 – October 31, 2017

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By: Michael S. Tennekoon, PhD

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Forensic DNA testing

Using DNA to Sketch What Victims Look Like; Some Call it Science Fiction

CSI on Steroids”. That is how the latest forensic tool used by law enforcement agencies has been described. It is called phenotyping. But is it all that it promises to be?

Phenotyping is a technique that uses human DNA, from materials such as skin or blood, to predict an individual’s appearance. By analyzing the genetic sequence, scientists can look for genes that code for physical characteristics such as skin color, eye color, geographic ancestry, and many others. This information is then plugged into a computer algorithm to predict an individual’s appearance. Today, dozens of law enforcement agencies from New York to Louisiana use phenotyping for cases where traditional forensics has resulted in no leads.

However, critics argue that this technique is reaching far beyond its means, especially as there is a lack of peer-reviewed research to back up its claims. Indeed, Parabon Nanolabs, one of the pioneering companies that offers phenotyping to law enforcement agencies, has yet to publish the methods underlying its techniques. Furthermore, Dr. Yaniv Erlich, a computer scientist that studies genetics at Columbia University, states that apart from basic predictions like human ancestry, phenotyping of faces is “on the verge of science fiction.”

In addition to concerns about the reliability of phenotyping, there are other ethical and legislative concerns. For example, the New York Civil Liberties Union points out that using ancestry to identify potential suspects in a criminal case will place many innocent people without any connection to the incident under suspicion. Theoretically, this could be used in a similar way to ‘stop and frisk’. These concerns are in addition to the already well-documented susceptibility of DNA testing to human error and bias.

States are still in the process of establishing laws and guidelines to regulate DNA testing, including phenotyping, for use in criminal cases. For example, in New York, one must have authorization from state officials before DNA testing is done.

Ethical issues not withholding, supporters such as Deputy Chief Katranakis, who is the commander of the New York Forensics Investigation Division believe that phenotyping offers more benefits than drawbacks, especially for cases where there are no other alternatives. However, as the use of phenotyping becomes more prevalent, caution must still be urged when weighing the contribution of phenotyping to criminal cases.

(Ashley Southall, The New York Times)

 

 

Research Misconduct

The Cookie Crumbles: A Retracted Study Points to a Larger Truth

Generously, the chances for a PhD student to get a job in academia are less than 15%. Therefore, the pressure to publish has never been higher. Some would argue that, because of this pressure to publish, there is an increased quantity of lower quality research. Perhaps unsurprisingly then, there is a big problem of researchers failing to replicate studies in the social sciences, and there has been a sharp increase in the number of the papers that have been retracted over the past decade.

On Friday, October 20th, another study which appeared to offer a cheap and simple tool for the fight against national obesity has just been retracted as well. The study suggested that simply placing cartoon Elmo stickers on apples could nudge more children to pick an apple over cookies when offered the choice. However, other researchers noted discrepancies with the numbers in the paper, which led to the submission of a replacement article by the original authors. However, the problems continued when it became known that the study was actually performed on children much younger than originally reported (3-5 years old rather than 8-11 years old, as reported). This situation is exacerbated by the fact that these concerns may also have impacted other published reports from the same lab.

Studying ways to change complex eating behaviors in children is no easy task. Children are considered a vulnerable population and there are several additional regulatory requirements for doing work specifically with children. Examples include parental permission, working on school premises, and getting additional approval from Institution Review Boards to name but a few. However, these hurdles are no excuse to bypass scientific rigor. Given the ease by which scientific findings can reach the masses through social media and the press, scientists must take on the responsibility to be extra vigilant to ensure their findings are accurate, or risk losing the public’s trust and ultimately public funding for the wider scientific community.

(Aaron E. Carroll, The New York Times)

 

Climate Change

Fighting Poverty Might Make it Harder to Fight Climate Change

At first glance, the goal of tackling poverty appears noble and completely unrelated to tackling climate change. However, new research shows that eradicating poverty may indeed make it harder to tackle climate change. Why? If extreme poverty is eradicated, people may travel more and increase their energy consumption, thus creating a larger carbon footprint.

Given this potential conflict, researchers from the University of Maryland in College Park modeled what the impact of eradicating poverty would be on climate change. The authors found that eradicating extreme poverty (i.e. increasing income from less than $1.90 a day to between $1.90 and $2.97 a day) would not jeopardize current targets for tackling climate change. However, lifting everyone to the next income level (the global middle-income level defined as living on $2.97-8.44 per day) would have a significant impact (an extra 0.6°C of warming) on climate change.

This leaves the global society in the precarious moral position of deciding what level of poverty is acceptable to ensure the sustainability of the planet. If we not only want to eradicate poverty, but also wish to bring everyone to the middle class, we would need to dedicate almost 7 times more resources than we are currently towards tackling climate change.

However, all hope is not lost. Clean energy, if it becomes cheaper than fossil fuels, would be a viable option for developing nations to use to fuel economic growth and hence would reduce future carbon emissions. There are some encouraging signs that this may be a possibility. In recent years, while the global economy has grown, carbon-dioxide emissions have not followed suit. Amazingly, emissions in the United States, Europe and China have actually fallen—though the amount of carbon-dioxide accumulated in the atmosphere has increased. In the meantime, however, the authors of the current study call for lifestyle changes, such as taking public transportation, living in smaller houses, and eating less meat.

(Allie Wilkinson, Science Magazine)

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October 31, 2017 at 8:43 pm

Science Policy Around the Web – October 27, 2017

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By: Cindo O. Nicholson, Ph.D.

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The Opioid Crisis

Engulfed in opioid deaths, Ohio turns to science

The state of Ohio has been the most plagued by the opioid scourge in the United States. It suffered the most opioid-related overdoses in 2014, and the number of opioid overdoses have since increased by 32% according to the state’s health officials. The increase in opioid-related overdoses is not due to a lack of effort on Ohio’s part. In fact, the state spent nearly $1 billion on measures like prevention, law enforcement, and treatment, but all to no avail.

In May of this year, the state of Ohio has embraced a new strategy to curb its opioid crisis – technology. The state has passed a request for $20 million to boost the development of new technologies that will stem the tide. While the three-phase, prize-base Ohio initiative is still accepting applications, technologies vying for funding can be broadly grouped into two categories, non-opioid compounds or devices for treating pain and chemical compounds that effectively reduce the withdrawal symptoms of those already gripped by addiction. Non-opioid technologies for pain treatment that are seeking funding include, an implantable mesh of a special polymer, loaded with sufficient doses of non-opioid pain relievers, allowing the controlled delivery of pain medication and a wearable device that uses electric pulses to calm nerves that are sending pain feedback to the brain.

A compound that has already been FDA approved for use in helping recovering addicts manage withdrawal symptoms that could be immediately put to use in Ohio is Probuphine. Probuphine is an implant that consists of a partial opioid receptor agonist buprenorphine linked to a polymer. When worn, the Probuphine implant provides a low dose of the chemical over a six-month period.

These measures are not a “cure-all” as their success will be dependent on patients’ adherence to strict drug regimens. Also, patients will need to resist the urge to discontinue their follow-ups with doctors upon having early success with these interventions. Nevertheless, there is hope that more research and development of effective non-opioid pain therapies and therapies that can minimize the withdrawal symptoms will significantly reduce opioid overdoses in Ohio. The success of this approach in Ohio will serve as model for other states and countries, and show how policies in support of scientific research can benefit communities.

(Alfonso Serrano, Scientific American)

Genomics Policy

The Navajo Nation is considering a new policy to allow genetic research

Tribal leaders of the Navajo Nation are considering put in an end to a fifteen-year moratorium on studying the DNA of its people. The Navajo Nation is an independent Native American territory occupying 71,000 square kilometers (27,413 square miles) of land on portions of Arizona, Utah, and New Mexico. Like many Native American Nations, the Navajo were concerned about the potential for misuse and privacy infringements of genetic research performed by scientists from outside the community. Additionally, in the early 2000s the Navajo Nation’s department of health did not feel they had enough expertise to pursue genetic research and wished to develop their own research policies.

Now, the Navajo Nation will open its first oncology center in Tuba City, Arizona. This will be a major help to Navajo people living on the reservation who currently have to drive hundreds of kilometers to get specialized care. It also has also elicited a reconsideration of the moratorium on genetic research. If the moratorium on genetic research is lifted, it would allow the collection of blood and other tissue samples for further study. The Navajo Nation’s department of health is collaborating with traditional leaders, tribal officials and other delegates to draft a policy that would allow approval of genetic research, and maintain control of DNA samples.

Being able to collect genetic material and maintain them on the reservation would allow research to be conducted on the reservation which now has tribe members that are geneticists, bio-ethicists and other types of medical experts. Lifting the moratorium would allow Navajo scientists and medical experts to research genetic and environmental factors underlying other diseases exhibited by members of the Navajo population.

Ultimately the success of whatever new policy adopted by the Navajo Nation should increase the availability of specialized and personalized care for its people. It would lay the groundwork for regulating the use of genetic material requested from Navajo repositories by scientists outside of the territory. In addition, the success of a new policy for genetic research would serve as a model for other Native American territories seeking to establish their own policies on genetic research.

(Sara Reardon, Nature)

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October 27, 2017 at 5:05 pm

Science Policy Around the Web – June 27, 2017

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By: Sarah Hawes, PhD

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Influenza

An Arms Race with Nature

H7N9, a new bird flu emerging in China, has infected roughly 1,500 people and killed 40% of them. The virus is contracted directly from infected birds but is not yet easily transmissible between humans, however researchers at The Scripps Research Institute have evidence H7N9 could potentially become transmissible between humans fairly easily. They examined a fragment of the virus that interacts with receptors on animal cells to gain entrance, and identified three minor mutations that could cause the fragment to shift from preferentially entering avian cells to preferentially entering human cells. If these mutations were to occur, it could rapidly result in a pandemic.

Tests in a viral fragment do not prove functionality in the intact virus; that would require mutating H7N9 itself. A 2014 moratorium on mutating three types of viruses (SARS, MERS, influenza) to more dangerous forms is expected to lift when the Department of Health and Human Services finishes current work drafting a new policy establishing reviews designed to assess benefit/risk ratios before funding research.

The subject is divisive, even among scientists in the field. Stanford researcher David Relman says he would support efforts to test mutations in a weakened strain of flu, but not in the H7N9 virus.  Bioterrorism expert Thomas Inglesby opposes increasing the contagious lethality of a virus, and opposes publishing such procedures due to concern that less benevolent actors would be enabled to replicate the process. NIH funded researcher, Ron Fouchier in the Netherlands, whose alteration of H5N1 to become highly contagious between ferrets (the animal model for humans) in 2011 influenced the moratorium, believes examining dangerous virus mutations in a controlled lab environment is important to identify potential pandemic viruses.

Many of these topics were discussed at the recent Immunology and Evolution of Influenza Symposium, and are sure to be a hot topic at the July 16 – 19 Centers of Excellence for Influenza Research and Surveillance meeting. With policy guidance needed on benefit/risk, potentially safer models, security, and publication limitations, the new HHS policy will be critical. (Nell Greenfieldboyce, NPR)

Conservation

Modeling with Dough – Pick your Species

The Supreme Court found the Endangered Species Act was “intended to halt and reverse the trend toward species extinction—whatever the cost.” Today, in light of the cost, conservation policy makers are being invited to triage species extinctions. Fish and Wildlife Service representatives recently met with ecologist Dr. Leah Gerber to discuss her proposed use of an algorithm guiding conservation funding.

A self-proclaimed environmentalist, Gerber says her model suggests that defunding “costly failures,” including the spotted owl, golden-cheeked warbler and gopher tortoise, could help save about 180 other species. Gerber says policy makers may opt to continue to support species that her algorithm rejects, as was done for the koala in Australia where algorithm triage has been used. In this case, a popularity contest may determine who lives and who goes extinct.

Details of the algorithm are not explicit, but Dr. Gerber’s recent publication in PNAS is a straightforward return-on-investment calculation analyzing the mathematical relationship between funds requested, spent, and species success or decline.  Gerber finds “the cost–success curve is convex; funding surpluses were common for the species least likely and most likely to recover” so it’s not simply ‘money in – species out’. Other factors – endemism, keystone status, level of species risk – are also important, though Gerber acknowledges they are not currently included.

While proponents call use of the equation “doing the best you can with what you have,” lack of data on its predictive validity make it a frightening policy tool governing something as permanent as species extinction. What if region affects costs, population growth is slower in species reaching sexual maturity later, a break-through in understanding one species’ requirements is just around the corner or we haven’t yet discovered the significance of the niche occupied by another species? What if business or political interests conflict with a species’ needs? What if the algorithm developer seeks intellectual property legal status, as is happening now with a proprietary algorithm used in parole and sentencing situations? Algorithms impacting public policy should be vetted by multiple experts in germane disciplines, validated, and kept publicly accessible for healthy scrutiny. (Sharon Bernstein, Reuters)

 

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Written by sciencepolicyforall

June 27, 2017 at 11:42 am