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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  While such laws already exist in 38 states, they are currently superseded by the Food, Drug, and Cosmetic Act; a bill that would eliminate this legal conflict was passed by the Senate last August, but has yet to be approved by the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

Source: pixabay

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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June 27, 2017 at 11:42 am

Science Policy Around the Web – June 06, 2017

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By: Kseniya Golovnina, PhD

Source: Flickr, by USDA, via Creative Commons     (CC BY 2.0)

Food Security

What if Food Crops Failed at the Same Time?

When one group of people is fighting with climate change and another considers it “mythical”, researchers specialized in the study of social-ecological systems are developing food supply risk assessment models. Food crops are one of the most important sources of human being existence, and less than one-fourth of the planet (“breadbaskets”) produces three-fourth of the staple crops that feed the world’s population. In fact, climate change could cause crop losses in most of the breadbaskets.

Two important factors included in the models are shocks to major land crop production and economy. Shocks like droughts and heat waves in Ukraine and Russia in 2007 and 2009 almost wiped out wheat crops, and caused global wheat prices to spike. And demand assessments project that food production may have to double by 2050 to feed a growing population. Together, the potential environmental and economic stresses are making the world food production system less resilient, and will affect both rich and poor nations. To measure the fragility of the system, researchers developed scenarios of small shocks (10 percent crop loss) and large shocks (50 percent crop loss). These were then applied to corn, wheat or rice output using an integrated assessment model, the Global Change Assessment Model, which was developed by the U.S. Department of Energy.

Among the critical findings are that “breadbasket” regions respond to shocks in different ways. For example, South Asia, where most of the arable land is already in use, is quite unresponsive to shocks occurring elsewhere in the world, because the total amount of land in agricultural production cannot be changed significantly. In Brazil the situation is opposite, it has a lot of potential to bring new land into production if large shocks occur. However, cleaning Brazil’s forests requires significant effort and would add significantly to global climate change. Within the research agenda of the Pardee Center, these risks and preventive actions are discussed in more detail. The warning is clear: humankind needs to be aware and prepared for potential multiple “breadbaskets” failure if we want to reduce the potential for catastrophe. (Anthony Janetos, The Conversation)

Reproducibility in Science

Research Transparency: Open Science

Increasing amounts of scientific data, complexity of experiments, and the hidden or proprietary nature of data has given rise to the “reproducibility crisis” in science. Reproducibility studies in cancer biology have revealed that only 40 % or less peer-reviewed analyses are replicable. Another large-scale project attempting to replicate 100 recent psychology studies was successful in replicating less than 50% of the original results.

These findings are driving scientists to look for ways to increase study reliability, and make research practices more efficient and available for evaluation. A philosophy of open science, where scientists share their primary materials and data, makes analytical approaches more transparent and allows common research practices and standards to emerge more quickly. For scientific journals and associations, open science methods enable the creation of different ways to store and utilize data. Some journals are specifically dedicated to publishing data sets for reuse (Scientific DataJournal of Open Psychology Data), others require or reward open science practices like publicly posting materials and data.

The widespread use of online repositories to share study materials and data helps to store large data sets and physical materials to help mitigate the problems of reproducibility. However, open science practice is still very much in development, and faces some significant disincentives. Habits and reward structures are two major forces work against. Researchers are used to being close, and hide their data from being stolen. Journal editors tend to favor publishing papers that tell a tidy story with perfectly clear results. This causes researchers to omit “failed” studies that don’t clearly support their theories.

While efforts to overcome these obstacles are difficult, development of fully transparent science should be encouraged, as openness helps improve understanding, and acknowledges the truth that real data are often messy. (Elizabeth Gilbert and Katie Corker, The Conversation)

 

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June 6, 2017 at 9:00 am

Science Policy Around the Web – December 13, 2016

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By: Allison Dennis, BS

Source: pixabay

Whistleblowers in Science

Keep your reviewers close and your online, anonymous, post-publication reviewers closer

A recent ruling by the Michigan Court of Appeals has ruled that anonymous online scientific reviews are a protected form of speech. Fazlul Sarkar, a former researcher at Wayne State University, had sued the site PubPeer in 2014 in an attempt to reveal the identity of several anonymous online reviewers to mixed success. Sarkar claimed that the defamatory and public nature of several online reviews posted anonymously to PubPeer had cost him a forthcoming tenure position at the University of Mississippi, one that came with a $350,000 a year salary. These reviews brought into question the validity of several images found in his published works.

While the initial ruling in March of 2015 largely sided with PubPeer to protect the anonymity of their online posters, a follow-up just two weeks later compelled PubPeer to reveal the IP address of a user who had gone as far as to repost quotes from an email response from the Senior Executive Assistant to the President of Wayne State University confirming their knowledge of the online allegations.

PubPeer filed an appeal of the decision by the end March, which garnered the collective support of science and internet moguls, Bruce Alberts, and Harold Varmus, Google, and Twittter in addition to the ACLU who filed amicus briefs in support of online anonymity. The summer brought more trouble for Sarkar as thirteen of his papers were retracted.

On December 9, 2016, the Michigan Court of Appeals found upon further review that Sarkar was “not entitled to unmask the identities of any speakers on pubpeer.com” citing “anonymity protections afforded by the First Ammendment.” Although this ruling does not dismiss Fazlul Sarkar’s case against John and Jane Doe, the protection of anonymity makes the suit moot. (Adam Marcus and Ivan Oranksy, STAT)

Federal Funding

Bipartisan cure found for stalled 21st Century Cures Initiative

In an end of the year push, the House and Senate passed the 21st Century Cures Initiative, a bill aimed at bringing legislation and regulation up to speed with biomedical research. At the end of November, a draft of the bill emerged from negotiations that were largely palatable to both Republican and Democrats across the House and Senate. A previous draft of the bill had successfully passed the House in July. However agreement over the source of funding could not be reached, arresting any further progress of the bill. The passing months brought Fred Upton, the Republican Representative who had originally spearheaded the bill close to the term limit afforded, as the chair of the Energy and Commerce Committee. The results of the recent elections seemed to be enough to incentivize compromise for Democrats in the final months of the Obama administration. Both parties returned to negotiations settling on a combination of funds derived from the selling of petroleum reserves and the Affordable Care Act.

In the end, the bill won 392-26 in the House and 94-5 in the Senate. Highlights of the bill under the title of Development include the accepted substitution of “data summaries” for full clinical trials when a new indication is to be added for a previously approved drug and expansion of off label-uses. The FDA has been tasked with evaluating evidence from the real world in an effort to speed-up and improve patient access. Highlights under the title of Discovery include a $4.8 billion boost to the NIH budget and a $1.8 billion power pack for Joe Biden’s Cancer Moonshoot. A complete play-by-play of the winners and losers of the final version of the bill can be found in Sheila Kaplan’s article on STATnews. (Sheila Kaplan, STAT)

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December 13, 2016 at 10:38 am

Science Policy Around the Web – June 21, 2016

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By: Fabrício Kury, MD

Photo source: pixabay.com

Personalized Medicine Costs

The Paradox of Precision Medicine

Precision medicine has been hailed by President Obama as a multi-hundred-million “moonshot” meant to revolutionize medicine in a way never seen before. Its rationale derives from the recent field of research called Genome-Wide Association Studies (GWAS), which seeks to discover, in large and accelerated scale, the genetic basis of disease, novel targets for drugs, and what treatments work for which patients and at what moments and doses. This very rationale, however, can be self-limiting in a capitalist market where economics of scale is required to provide patients with access to otherwise prohibitively expensive treatments. In this lucid review, Janeen Interlandi from Scientific American demonstrates that old-fashioned, non-personalized treatments have recently been demonstrated not only be tremendously cheaper than “bespoke” drugs, but also just as clinically effective. (Janeen Interlandi, Scientific American)

Research Ethics

Scientists Are Just as Confused About the Ethics of Big-Data Research as You

Dubbed “the fourth paradigm” of science (book available for free download here), big data research poses novel ethical questions that might not be appropriately addressable by the current paradigm of ethics centered on the Common Rule and oversight by Institutional Review Boards (IRBs). A study can be ruled exempt from IRB approval if it only utilizes publicly available data – but what is it “publicly available,” exactly? In this article, Sarah Zhang from Wired magazine reviews recent cases of controversy in utilization of large datasets for studies, such as the Facebook Emotion Experiment, and suggests that IRBs might need new sets of skills to safeguard human subjects in the evolving landscape of research. (Sarah Zhang, Wired)

Data Science

The Doctor Who Wants You to Be a Research Parasite

After the editor-in-chief of the New England Journal of Medicine published in January, 2016 a stingy editorial affirming that some clinical researchers regard data scientists as “research parasites,” a wave of controversy exploded and culminated with personalities such as U.S. Chief Data Scientist DJ Patil and National Academy of Sciences President Marcia McNutt publicly using the hashtag #IAmAResearchParasite in defiance. In this article, Taylor Mayol from Ozy introduces Dr. Atul Butte, recently-appointed head of Clinical Informatics at the University of California, who sustains a bold call for more “research parasites” in health care, while additionally characterizing lack of entrepreneurship among academics as “a tragedy” because it is “the right way to truly change the world, by going beyond writing papers.” (Taylor Mayol, Ozy)

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June 21, 2016 at 9:00 am