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Archive for February 2019

Tackling scientific misconduct in academic research

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By: Jenny Kim, Ph.D.

Source: Pixabay

In recent years, scandals surrounding scientific misconduct have gained significant media attention. In 2018, the Washington Post reported the resignation of Dr. Brian Wansink from Cornell University. At Cornell, Wansink headed the Food and Brand lab which examined factors that influence people’s food choices. Following an internal investigation, it was determined that Wansink had encouraged his trainees and collaborators to manipulate data to achieve viral, media-worthy results. According to Retraction Watch, 18 of Wansink’s papers have been retracted and 15 papers corrected. Similarly, last year the New York Times published an exposé on Dr. Piero Anversa, a professor at Harvard Medical School, whose work examined the use of stem cells to repair damaged heart muscle. Anversa’s prolific research was able to secure millions of dollars in federal grant funding and even led to clinical trials. Investigation of Anversa’s scientific misconduct began in 2013 after collaborators accused his research group of falsifying data and photoshopping images in scientific publications. The investigation concluded 31 papers affiliated with Anversa should be retracted. In 2017, Harvard Medical School and Brigham and Women’s Hospital settled to pay $10 million to the federal government following the accusations of data falsification in the Anversa lab. While these cases of scientific misconduct are extreme examples, they highlight a larger problem in academic research: a lack of oversight on research integrity.

The National Institutes of Health (NIH) requires all trainees receiving support from an NIH training, career development, research education, or dissertation research grant to receive education pertaining to the responsible conduct of research (RCR). RCR training covers broad subject matters including conflict of interest, peer review, research misconduct and policies for handling misconduct, and responsible authorship and publication. The National Science Foundation (NSF) has similar RCR requirements for all trainees supported by their grants. While most universities and research institutions provide RCR education for their trainees, RCR instruction can vary greatly across research programs. The most effective RCR curricula tend to focus on real-world ethics cases, use of multiple types of practice exercises, contain more than 9 hours of coursework, and facilitate significant instructor-student interaction. However, not all research institutions are able to offer in-person, intensive RCR instruction, rather opting for online workshops instead. Several factors contribute to this discrepancy in RCR training across research programs. Financial constraints may prevent universities and research institutions from hiring instructors to create and teach RCR curriculum. For some, focus on promoting research integrity may not be a top priority for their program. Regardless, it is clear that significant restructuring and standardization of RCR education must occur across research institutions to enhance research integrity in an effort to prevent scientific misconduct.

In 2017, the National Academies of Science, Engineering, and Medicine (NASEM) published a report recommending the formation of a Research Integrity Advisory Board (RIAB) at the national level. The RIAB would aim to work with stakeholders (e.g. researchers, research institutions, funding agencies, and journals) “to share expertise and approaches for addressing and minimizing research misconduct and detrimental research practices.” If an RIAB were established, it could serve as a central resource that stakeholders could use to develop RCR training at their respective institutions to bolster research integrity. By using resources offered by an RIAB, RCR training can be standardized across universities and research institutions to ensure all trainees receive the same level of high quality RCR education. This is especially crucial given that universities often do not have prior knowledge or exper

ience to efficiently investigate these cases, potentially due to the relatively low incidence of reported gross scientific misconduct. Through consulting on these types of cases, the RIAB could act as a central repository for best practices on handling misconduct allegations; this would enable the promotion of research integrity to be more uniform across all research disciplines.  

Improvements in RCR training and the formation of an RIAB will not be as effective without the promotion of scientific rigor and research integrity from research faculty and staff. Trainees interact with their research mentors on a daily basis and use them as a guide to navigate the research environment. If research faculty and staff are not well-informed on current research policies or do not promote discussion of or encourage RCR in the laboratory, this could negatively impact a trainee’s understanding of research integrity. Even after his numerous retractions, Brian Wansink defends his research. He admits to poor record keeping but does not believe he conducted improper statistical methods or misreported his data. An internal review by Cornell confirmed Wansink used problematic statistical techniques. Former trainees of Wansink say he strongly encouraged p-hacking, or analyzing data in multiple different ways to discover a desired result, in the lab. Wansink’s trainees knew for years he used questionable research practices, but, under Wansink’s instruction, they continued to manipulate data and re-run analyses until they reached an interesting story. It is important that universities and research institutions provide assistance in identifying dubious practices and protection to trainees that subsequently report scientific misconduct. It would also be beneficial for universities and research institutions to require research faculty and staff to participate in RCR training and gain knowledge on leading RCR instruction. Preparing senior research personnel to have an open discussion of RCR in the research setting would help promote a culture of ethical research.

As scientific research continues to advance, RCR training will need to adapt to stave off potential threats to the conservation of scientific integrity. The creation of a central organization, like an RIAB, will allow for the development and maintenance of effective, efficient, high quality training in scientific rigor and research integrity for current and future researchers. Furthermore, encouraging the participation of senior researchers in RCR training and instruction will have important implications for improving education and communication with mentees in the research setting. When stories of gross scientific misconduct steal the headlines in mainstream media, the reliability of science falters. If the general public does not have confidence in science research, this can lead to difficulty in implementing science-based public policies. Improving RCR training across multiple disciplines at universities and research institutions can be a possible mechanism to promote research integrity and prevent incidents of scientific misconduct.

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Written by sciencepolicyforall

February 28, 2019 at 8:09 pm

Science Policy Around the Web – February 26, 2019

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By: Jennifer Patterson-West, Ph.D.

Source: Ellsworth Airforce Base

Scientists Release Controversial Genetically Modified Mosquitoes In High-Security Lab

Malaria is a parasitic disease that affects more than 200 million people each year.  Symptoms can range from mild to severe, and include high fever, chills, and flu-like symptoms.  These symptoms are more dangerous to children under the age of 5, which account for 77% of related deaths.

The life cycle of malaria requires two hosts: humans and female Anopheles mosquitoes.  It is important to note that not all species of Anopheles mosquitoes are good vectors, in fact, only 30-40 of the approximately 430 species transmit malaria in nature. The life cycle of malaria is also dependent on additional environmental factors including ambient temperature and humidity. Together these factors account for the geographic distribution of malaria. Although malaria is found more than 100 countries, transmission is most prevalent in Sub-Saharan Africa and in parts of Oceania including Papua New Guinea. 

In the past decade, major gains have been made to control the disease in developing nations thanks to increased funding. Current preventative measures include insecticide-treated netsindoor residual spraying, and intermittent preventative treatment for individuals at increased risk including pregnant women and infants.

In early February, a high-security laboratory in Terni, Italy launched a study to evaluate a new powerful weapon against the mosquito vector.  This new weapon is a genetically modified mosquitothat can spread a genetic mutation lethal to its own species. Researchers targeted the gene “doublesex” to producing female mosquitos that are sterile and have mouths resembling male mosquitos, which are unable to bite.  

The goal is to dramatically crash or reduce the local population of the main species of malaria spreading mosquitoes, Anopheles gambiae. To increase heritability of the mutation, researchers utilized CRISPR technology to engineer a “gene drive” into the genetically modified species. Gene drive inheritance ensures that nearly all progeny inherits the mutation.

Despite the need for new methods for reducing malaria, activists and other scientists warn that the technology can have unforeseen effects on the environment.  The environmental group, Friends of the Earth, is part of international coalition protesting the use of these new genetically modified organisms. Jim Thomas of the ETC group, has noted concern that gene drive technologies can also be used to develop biological weapons.  

To reduce the risk associated with releasing the gene-drive mosquitoes, the project plans years of additional study that will methodically and cautiously evaluate the mosquitoes and their potential environmental impacts with close consultation from other scientists, government officials, and local residents in Africa.

(Rob Stein, NPR)

With one manufacturer and little money to be made, supplies of a critical cancer drug are dwindling

Bacillus Calmette-Guerin (BCG) is a potent immunotherapy for the treatment of fast-growing bladder cancer.  BCG was initially used in 1921 as a tuberculosis vaccine.  In the 1970s, BCG was shown to stimulate the immune system to attack tumor cells when administered through a catheter into the bladder of cancer patients. Since then, BCG has become a potent treatment for intermediate and high-risk non-muscle invasive (NMI) urothelial cancer (UC) of the bladder.

Bladder cancer is the nation’s sixth most prevalent cancer with approximately 80,000 new cases each year.  About 20% of these patients are diagnosed with a type of bladder cancer that can be treated with BCG.  Although BCG doesn’t work for all eligible patients, the response rate is more than 70%.

Despite the established potency of BCG, there is a critical national shortage.  Supplies of BCG have been erratic since 2011, when the United States Food and Drug Administration (FDA) promptly shut down the Sanofi manufacturing lab after a failed inspection.  After continued regulatory issues, Sanofi stopped production of BCG in 2016. Merck is now the only manufacturer of BCG for the Unite States and European markets.

Merck has acknowledged short supplies and indicated that they are currently working at capacity.  Tyrone Brewer, the vice president of global oncology marketing at Merck, has indicated that the company intends to continue producing BCG for “the foreseeable future.”

During shortages, chemotherapies, such as mitomycin, can be used as alternative therapies.  However, they have lower efficacy and a higher price tag than BCG. During the 2014 BCG shortage, the cost of mitomycin increased by 99% further exacerbating the financial burden of these alternative therapies. 

In response to erratic supply of BCG, the Southwest Oncology Group has launched a clinical trial (S1602) to compare the TICE BCG strain currently used in the United States to the Tokyo Strain.  The FDA will consider the results of this trial as critical information for approving the Tokyo strain for use in the United States. 

In the meantime, urologists have begun to divide dosages into thirds to prolong supplies.  However, a recent literature review indicated that a large scale, well-designed, prospective study is need to establish a standard dose and maintenance instillation for reducing recurrence rate since the efficacy of lower dosage is unclear from existing data.

The University of Utah Drug information Service reported that in 2015 approximately 265 generic drugs were in short supply in the United States.  Of potentially greater concern than the current shortage of BCG are generic drugs that can have immediate life and death consequences. For instance, a retrospective study of the norepinephrine shortage in 2011 indicated a 10% higher mortality rate during hospitalization when the alternative vasopressor, phenylephrine was used.

A recent perspective from Davies et al. argues that current policy efforts have not sufficiently prevented supply disruptions of important generic drugs.  A major consideration for dealing with generic drug shortages are the unintended consequences of current policies. For instance, the 2003 Medicare Modernization Act, which sought to protect consumers by limiting the cost increase for generic drugs to 6% above the Medicare average sale price (ASP). This restriction may not provide manufactures with sufficient proficient to invest in production facilities.  

Further compounded these issues is the fact that manufacturers face few negative consequences during shortages, whereas an excess in supply cuts in to profit margins. To provide additional incentive for maintaining reliable supplies of generic-drugs, Davies et al. suggested that the FDA prioritize the review of future generic-drug applications from companies that “maintain generic drug production without quality-control problems”.  In November, the FDA issued a news release about efforts to address drug shortages, which included remedying the underlying problems when a shortage arise within their current authorities.  In today’s political climate, any policy reform or expanse to FDA’s authority to mitigate future shortages and provide incentives for the production of generic medications will require cross-party support. 

(Meghana Keshavan, STAT news)

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February 26, 2019 at 1:44 pm

Science Policy Around the Web – February 22, 2019

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By: Janani Prabhakar, Ph.D.

Source: Pixabay

China Uses DNA to Track Its People, With the Help of American Expertise

Recently, global attention fell on China and its treatment of its Uighur people, a predominately Muslim ethnic group who live in the far west region of China and have enjoyed a fair degree of self-autonomy from the Chinese government. In an attempt take control of this ethnic group and region, the Chinese government has used intense surveillance, oppression, and detainment through “re-education” camps. In addition, the Government has been collecting DNA samples from this ethnic group to generate a comprehensive database of Chinese Uighurs. What is unknown is how the Chinese government intends to use this database in its oppression of Chinese Uighurs. To complicate matters, collection of DNA samples has been bolstered by equipment and data from US-based companies and researchers. For example, Thermo Fisher supplies technology to support DNA data collection and analysis. Yale geneticist, Dr. Kenneth Kidd, provided genetic material from global populations to Chinese researchers. In both cases, the US parties were unaware of how their contributions were used. This brings to bear larger questions about culpability, adherence to scientific norms, and the role of scientific collaborations at a global scale. China has included these DNA samples in global databases, but it does not seem that proper consent was received for these samples. In some reports, individuals were called by police for mandatory health screening and medical checkup, suggesting that the samples were obtained through coercion. It is unclear whether inclusion of these samples in databases or during collaborations reflects tacit acceptance of China’s surveillance program of Uighurs.

Researchers including Dr. Kidd have hosted Chinese researchers in their labs to gain techniques in analyzing DNA material. The output of these collaborations has resulted in publications that provide methods to distinguish between ethnic groups, wherein Chinese researchers utilize DNA samples obtained from collaborators as a comparison group to Uighurs. Chinese officials state that this would be useful to identify individuals at a crime scene, which on the surface, is not an incorrect application or use of the data. However, in light of the allegations on the Chinese government in their use of this technology to oppress certain minority groups, the role of scientific collaboration becomes murky. In addition to collaboration is the question about US corporate involvement. Thermo Fisher recently announced that they would stop selling their products that have been integral to forensic DNA analyses in Xinjiang, where the campaign to suppress Uighurs has been most intense. This is striking given that 10 percent of Thermo Fisher’s $21.9 billion-dollar revenue comes from China. While this is a big step, monitoring how technology and science is being used in this global environment must be a central focus given the large human rights implications.

(Sui-Lee Wee, New York Times

The Energy 202: One of world’s biggest coal miners caps production amid climate 

In response to increasing public pressure, Glencore, one of the world’s largest mining companies, has announced that it will cap the amount of coal it mines. Evidence of private companies responding to this global pressure to reduce greenhouse gases has emerged around the world. Most recently, the Tennessee Valley Authority voted to shut down two aging coal-fired power plants. These actions reflect big shifts in an industry that has largely debunked climate change theories, particularly when President Trump has promised to bring back coal.  The pressure on private companies came from more than 200 institutions worldwide that targeted the world’s largest emitters. This has led to a wave of corporations like Glencore to make similar reduction pledges. These commitments are multi-pronged. Glencore has agreed to limit coal production (and not increase it) annually, in a shift away from its original production trends. In addition, the company has considered tying executive pay with meeting these goals as well as ending partnerships with coal lobbies.

This move towards reduction has also come from a waning coal market and its economic promise for companies like Glencore. While many countries like the United States and other advanced economies have reduced their coal use, Asian countries like India and China have increased it. Glencore exports most of its coal to coal-using countries in Asia. As a result, it is actually in the economic interest of private coal companies to reduce coal production:  restricting supply as demand wanes will increase coal prices and increase Glencore’s revenue. Important to climate change activists, increase in coal prices would lead over time to a reduction in coal use. In this way, private companies can work in partnership with efforts to reduce greenhouse gases without compromising their own interests.

(Dino Grandino, New York Times

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February 22, 2019 at 2:08 pm

Science Policy Around the Web – February 19, 2019

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By: Mohor Sengupta Ph.D.

Source: Maxpixel

New AI fake text generator may be too dangerous to release, say creators

Artificial intelligence. In a Beijing competition last year, it identified patterns in brain MRI scans from hundreds of individuals and diagnosed their conditions far more accurately than human doctors. In modern journalism, AI is being trained by humans to scan financial reports and dish out an immediate news story with pertinent facts and figures. Bloomberg uses the bot “Cyborg”, which helps it compete against its rival, Reuters, in financial journalism. The Washington Post uses “Heliograf”, which covered the 2016 Olympics and the 2016 US elections. But, AI can create a completely fake human image by teaching itself from several real images. It can produce a completely fake video by literally putting words in a person’s mouth. And, owners of the nonprofit research company, “OpenAI”, realized, to their concern, that a new AI text generator called GPT2, created by its researchers, is so smart that it can make up connected and logical sentences following a random one-liner input. 

Take this example. When fed with the opening line of George Orwell’s Nineteen Eighty-Four – “It was a bright cold day in April, and the clocks were striking thirteen” – GPT2 comes up with this: “I was in my car on my way to a new job in Seattle. I put the gas in, put the key in, and then I let it run. I just imagined what the day would be like. A hundred years from now. In 2045, I was a teacher in some school in a poor part of rural China. I started with Chinese history and history of science.” It recognizes the futuristic reference in the input. It had an interesting and obviously fake statement to say about UK Prime Minister Theresa May when fed with an unfinished line from a Guardian article about Brexit. In short, GPT2 is quick and creative. 

It is not difficult to imagine the mischief this kind of groundbreaking technology can create. Generating fake news is one that comes to the mind easily. 

Take for example, this false and incomplete phrase presented to GPT2 by a group of humans at MIT: “Russia has declared war on the United States after Donald Trump accidentally”.

OpenAI chillingly demonstrated how it can be a lethal hoodwinker by completing that phrase into this: “Russia has declared war on the United States after Donald Trump accidentally fired a missile in the air. Russia said it had “identified the missile’s trajectory and will take necessary measures to ensure the security of the Russian population and the country’s strategic nuclear forces.” The White House said it was “extremely concerned by the Russian violation” of a treaty banning intermediate-range ballistic missiles. The US and Russia have had an uneasy relationship since 2014, when Moscow annexed Ukraine’s Crimea region and backed separatists in eastern Ukraine.”

Don’t panic, none of that is true!

Machine learning was used to train GPT2 on a dataset containing about 10 million articles, selected by scouring the social news site Reddit for links with more than three votes. “We need to perform experimentation to find out what they can and can’t do,” said Jack Clark, policy director of OpenAI. “If you can’t anticipate all the abilities of a model, you have to prod it to see what it can do. There are many more people than us who are better at thinking what it can do maliciously.” For now, the company has decided to keep GPT2 behind closed doors until such a time when they know the bot’s full potential. Only a simpler version will be made publicly available. 

While there are skeptics of AI, there are also critics of the skeptics. They argue that humans can produce fake news as well as an AI. But take a moment to think of the number, variations, creativity and logical or factual supports that can be weaved in seconds by a bot like GPT2. How is it possible that any human can outsmart a program that has learnt 10 million articles about current and past politics, about wars, about famous fictional characters, about sports, about celebrities, about nature and about anything under the sun, and beyond? 

Downsides of a technology cannot confine it behind closed doors. We have learnt that from the past. AI is becoming increasingly necessary in many areas, for example, identifying medical conditions from MRI as mentioned above. Nature Medicine recently published an article where an AI accurately diagnosed common childhood diseases by analyzing digital and electronic health records. But like any revolutionizing technology, AI can be misused for malicious purposes. And it will be used for that, sooner or later. The idea here is to prepare the world for what is about to become mainstream in a few years. Clark calls this an “escalator from hell”. 

(Alex Hern, The Guardian)

Searching Tardigrades for Lifesaving Secrets

In the series “Cosmos: A Spacetime Odyssey”, Neil deGrasse Tyson talked about five cataclysmic events, separated by eons, that wiped out almost all life on Earth. Every time this happened, a miniscule proportion of existing life escaped and adapted to the new environment. Among this population there is an organism that survived ALL five purges. This animal is the size of a sand particle and it dwells in moisture. It is called a Water bear, or a Moss piglet, or Tardigrade.  

It is not entirely clear how these organisms survive extreme environmental conditions, but research on their physiology suggest involvement of certain proteins that protect its cells from dehydration. In an event of environmental emergency, the tardigrade can desiccate itself within minutes into a firm, curled-up ball called a “tun”, only to resume normal functions within minutes of sensing moisture. This remarkable feat is called anhydrobiosis in scientific jargon. A group of scientists from Japan have found certain heat-soluble proteins that help tide over the anhydrobiosis period. Separately, another group of scientists from USA and Italy have found intrinsically disordered proteins (IDPs) specific to tardigrades (TDPs) to confer to them the protection against desiccation.  

A team of three scientists at Harvard Medical School and are now using computational biology and machine learning to design TDPs tailored to slow down metabolism in human cells. “It really started out as a wacky, high-risk idea,” said Pamela Silver who spearheads the project. In 2008 Dr. Silver came across a grant challenge posted by the US military seeking novel solutions to stabilize hemorrhage of personnel in war zones. Together with her bioinformatician colleague and machine-learning expert Roger Chang and computational biologist Debora Marks, she set out to engineer novel TDPs that would lower the metabolism in eukaryotic cells during a state of shock. This is akin to “slowing biological time”, only to return back to normal pace when the critical period has passed. Although it is still unclear how these proteins might work, Dr. Chang has suggested that they might form a biological glass that physically immobilizes everything inside the cell during the stress period. 

The group was recently awarded a five-year cooperative agreement by the Defense Advanced Research Projects Agency (DARPA) to pursue the idea. If it works, the engineered TDPs could be a benchmark in modern medicine, revolutionizing current understanding of not only trauma management, but also address several pressing issues, like, long-term transportation of protein-based drugs or to-be-transplanted organs and keeping the egg cell viable without freezing it. 

(Steph Yin, New York Times)

Embryo ‘Adoption’ Is Growing, but It’s Getting Tangled in the Abortion Debate

In Vitro Fertilization (IVF) has changed the way people understand reproduction. It has made conceiving a reality for many women who are not able to conceive naturally for medical or social reasons. During the IVF process, sperm from a male donor are used to fertilize an egg cell from a female donor (generally the would-be biological parents). Usually, more than one embryo results from such a process, but only one is transplanted in the recipient’s uterus. Commonly, when a biological child is desired, donor and recipient are the same woman. In a relatively new trend, couples other than the donor are “adopting” these extra embryos. While this may seem as a very uncomplicated way of giving new life and a great option for many women, it is fraught with problems arising from religious and social issues. 

Monica Broecker is a woman in her mid-forties who found out that she couldn’t conceive, after repeated miscarriages. She decided to adopt an embryo and approached National Embryo Donation Center, based in Knoxville, Tennessee, which is also the largest embryo donation clinic in USA. Despite being financially stable, Ms. Broecker was turned down by the agency because she is a single woman. 

Some of the better-known embryo adoption agencies are funded by a grant by the Department of Health and Human Services (HHS), called the “Embryo Awareness Adoption Program” which has had $1 million in annual funding since 2003. To date, all the grant recipients, barring two, are affiliated with anti-abortion or Christian organizations. 

Ms. Tyson, who works for Snowflake Embryo Adoption, one of the recipient agencies of the HHS grant, says that her clients are mostly Christian. In almost all embryo donations, the donor family selects the recipient. Ms. Tyson has had a difficult time finding donors for single women, LGBTQ people or people from diverse religious practices and atheists. She usually refers such recipients to Embryo Donation International, an agency that is not affiliated to any religious organization. Unsurprisingly, Embryo Donation International doesn’t receive the HHS grant. 

On an average, embryo donation costs much less than a single round of IVF. Increasingly, many women wanting to become mothers are seeing this approach as a perfect synergy of their requirements and giving life to an embryo rather than it being frozen indefinitely. Matching with a donor is the biggest problem that many of them are experiencing. Although all grant recipients deny that they consider religion, sexual orientation or marital status while considering clients, statistics show a different picture. The government should look more carefully into its grant applicants and take measures to diminish bias in granting the awards. 

(Caroline Lester, New York Times)

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February 19, 2019 at 4:19 pm

Science Policy Around the Web – February 15, 2019

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By: Saurav Seshadri Ph.D.

Source: Pixabay

Hundreds protest against Washington state vaccine bill that would require measles shots

With over 58 people infected so far, the measles outbreak affecting the Pacific Northwest since January is a genuine public health emergency.  Still, local lawmakers are finding that they may have an even bigger challenge to overcome in preventing the next one.  The epicenter of the outbreak, Clark County, has one of the lowest vaccination rates in the country, with fewer than 80% of children receiving the recommended two doses of the measles-mumps-rubella (MMR) vaccine (far below the herd immunity threshold of 93-95%).  A bill sponsored by state Rep. Paul Harris, which aims to rectify this by limiting vaccine exemptions for non-medical reasons, was recently met with stiff opposition from anti-vaccination activists, who are particularly prominent in the region and turned out in the hundreds to protest.  Activists argue that the legislation would force parents to expose their children to risky medical procedures.  Such opposition, from groups such as Informed Choice Washington, prevented a similar bill introduced in 2015 from even making it to a vote.

However, while activists have been the most vocal and visible opponents of the bill, they may not be representative of the parents who are actually opting not to vaccinate in Clark County.  Portland is home to a large number of families from the former Soviet Union, many of whom are wary of vaccines for cultural or religious reasons.  Some Russian-language schools have vaccine exemption rates of over 50%.  The strain of measles in Clark County is the same one that recently sickened over 40,000 people in Ukraine, suggesting that the current outbreak may have originated within this community.  Any legislative solution may therefore have to tread carefully to avoid singling out a specific ethnic group.  

Furthermore, it’s unclear whether the proposed bill would be effective in promoting vaccination.  After a measles outbreak in 2015 that sickened 147 people, California eliminated ‘personal belief’ exemptions in both public and private schools; since then, medical exemptions (often issued with little justification and/or in exchange for a fee) have more than tripled.  While old studies linking vaccines to autism have been thoroughly debunked, their core message, that vaccines are inherently unsafe, has been tougher to eradicate.  This is partly because it bears a grain of truth: the CDC acknowledges that side effects of the MMR vaccine can include seizures and brain damage, and lists several scenarios in which its administration is contraindicated.  Despite these risks, in the wake of a potentially deadly outbreak, many will likely agree that public health must be prioritized and voluntary vaccination will resume.  If not, parents who truly fear the consequences of vaccination may be left with no other option but to educate their children at home.

(Ashley May, USA Today

Antidepressant based on party drug gets backing from FDA advisory groupT

Since 2006, scientists have known that the anesthetic ketamine is shockingly effective in treating depression.  Moreover, it can improve mood within hours, and is mechanistically distinct from existing antidepressants, meaning it can potentially help patients who are currently suicidal or whose depression is treatment-resistant.  While ketamine itself has been used as an anesthetic since the 1960s and cannot be patented, these findings were promising enough to motivate several drug companies to try to develop marketable variants.  One such compound, esketamine (produced by Johnson and Johnson), has just gotten a step closer to FDA approval: an independent advisory panel has voted to recommend its use for treating depression, based on the results of five phase III trials and several other supporting studies. The drug had previously received a Breakthrough Therapy Designation by the FDA, and an official decision from the agency is expected by early March.     

Ketamine is also a hallucinogen, a club drug known as Special K, a potential drug of abuse, and described by the DEA as ‘sometimes used to facilitate sexual assault crimes’.  Its transition to respectable pharmaceutical is therefore somewhat surprising, and could be indicative of a change in how such compounds are perceived by the government and society in general.  Medical marijuana is often prescribed to treat seizures, and last year, the FDA approved the first drug containing an active (though not psychoactive) ingredient derived from marijuana.  A more relevant example may be psilocybin, the active component of magic mushrooms.  The DEA describes psilocybin as a hallucinogenic drug of abuse, whose side effects include panic attacks, psychosis, and death; yet the FDA recently granted Breakthrough Designation to psilocybin therapy for treatment-resistant depression (a large-scale clinical trial, conducted by COMPASS Pathways, will take place this year).    

While the overall clinical efficacy reported by J&J for esketamine was modest, at least some panelists were convinced to approve the drug based on patient reports that its effects were worth any side effects.  As we enter the seventh decade since the discovery of the last novel antidepressant (or antipsychotic), such feedback may play a larger role in convincing regulatory bodies to try new treatments, even if they have been previously stigmatized or their mechanisms of action are unclear.  By allowing supervised administration, patient registration, monitoring, and research, bringing such drugs out of the shadows could provide welcome relief for people suffering from mental illness.  

(Sara Reardon, Nature)

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February 15, 2019 at 3:23 pm

Intellectual property theft and its effects on US-China trade relations

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By: Neetu Gulati, Ph.D.

Source:Wikimedia

China and the US are currently in the midst of a trade war that, if not resolved my March 1, 2019, will lead to another increase in tariffs by the US. This trade war, which started over the US accusing China of stealing intellectual property from American companies, has already affected the economy of the two countries and could have global effects. The US has evidence that information including biomedical research breakthroughs, technological advances, and food product formulations have been stolen. In response to these illicit trade practices, the US imposed tariffs on Chinese imports, leading to the beginning of the trade war.

So how did we get here? 2019 marks forty years of diplomatic relations between the United States and China, which officially began on January 1, 1979. Since relations began, the two countries have benefited from ongoing trade, and China has become the largest goods trading partner with the US. Bilateral economic relations have increased from $33 billion in 1992 to over $772 billion in goods and services in 2017.  Despite strong economic ties, relations between the two countries have come under strain in recent years. The US State Department has identified concerns over military conflict in the South China Sea, counter-intelligence and security issues, and the trade deficit, among other issues. These issues came to a head in April 2018 when President Donald J. Trump issued a statement that China had stolen America’s intellectual property and engaged in illegal trade practices. In response, the US imposed additional tariffs on approximately $50 billion worth of Chinese imports. China then countered with tariffs on US imports, and thus a trade war between the two countries began.

To understand how intellectual property, or IP, fits into the trade war, it is important to first understand what it is. According to the World Intellectual Property Organization, IP “refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce.” More simply, IP is something created or invented through human intellect, but not necessarily a tangible product. These products often have important scientific implications, as the umbrella of IP can cover genetically engineered crops, newly developed technologies and software, and new therapeutics, just to name a few. IP is legally protected through means such as patents, trademarks, and copyright, which allow people to gain recognition and financial benefits from their creations. These protections are country-specific, and the US Patent and Trademark Office gives guidance about protecting IP overseas, including in China. The process of transferring IP from the creator to another entity, often for distribution purposes, is known as technology transfer. This process is at the heart of the accusation of theft of American IP.

According to a seven-month long investigation done by the United States Trade Representative (USTR), China’s unreasonable technology transfer policies meant they did not live up to the commitments made when joining the World Trade Organization. The report found that Chinese laws require foreign companies to create joint ventures with domestic Chinese companies in order to sell goods within the country. The investigation by USTR found that “China’s regulatory authorities do not allow U.S. companies to make their own decisions about technology transfer and the assignment or licensing of intellectual property rights.  Instead, they continue to require or pressure foreign companies to transfer technology as a condition for securing investment or other approvals.” By pushing for technology transfer, these laws opened up American companies to theft of their IP. Stolen IP has included things like software code for a wind turbine, genetically modified corn seeds, the idea behind a robot named Tappy, and even the formulation for the chemical that makes Oreo filling white.

Beyond stealing information for goods entering China, it is also possible that Chinese workers in the United States may be stealing IP and sending it back to their home country. For example, a Chinese scientist known as ‘China’s Elon Musk’ was accused by his former research advisor of stealing research done at Duke University and replicating it in China for his own gain. A former assistant director of counterintelligence at the FBI suspects that the Chinese scientist was sent by the Chinese government intentionally to steal IP. This was not an isolated incident, either. According to a report from an advisory committee to the National Institutes of Health (NIH), research institutions in the US may have fallen victim to a small number of foreign researchers associated with China’s “Talents Recruitment Program,” which the National Intelligence Council identified as an effort to “to facilitate the legal and illicit transfer of US technology, intellectual property and know-how.” This comes mere months after the NIH announced that it had identified undisclosed financial conflicts between US researchers and foreign governments. Without giving details of specific countries, NIH Director Francis Collins reported to a Senate Committee hearing that “the robustness of the biomedical research enterprise is under constant threat.” Nevertheless, these threats should not hinder the research enterprise. During a hearing in April 2018, House Science Committee Chair Lamar Smith remarked, “on the one hand, we must maintain the open and collaborative nature of academic research and development. On the other, we must protect our research and development from actors who seek to do us harm.”

The balance between research collaboration and theft is delicate. Information sharing is increasingly necessary as scientific pursuits become more interdisciplinary in nature, and can lead to more productivity in research. However, voluntary collaboration is different from unwilling or coerced transfer of ideas. The ability of US scientists and entrepreneurs to innovate and create new IP is an important driver of the American economy, and further allows for the ability to research new scientific pursuits. Not only does IP theft undermine the incentive and ability for Americans to innovate, it has had drastic negative effects on the American economy, with annual losses estimated to be between $225 billion and $600 billion according to a report put out by the IP Commission. These losses directly affect those who own and/or license IP, as well as those who are associated with these companies or individuals. This can then lead to downsizing or cutting jobs, further harming American science and technology industries. It is for this reason that the US responded so strongly against the evidence of IP theft.

In response to the accusations from the US, Chinese President Xi Jinping promised to resolve the “reasonable concerns” of the US regarding IP practices. The Chinese government announced punishments that could restrict Chinese companies from state funding support due to IP theft and at the G20 Summit in December 2018, the Presidents of the two nations agreed to a 90-day financial truce, which will end March 1, 2019. 

The two countries are currently working on a trade deal to end the escalating tariffs, which would lessen tensions between the world’s two largest economies. The US wants China to commit to buying more American goods and services, and to agree to end the practice of requiring American companies to give technology transfers in order to do business in China. Without hashing out details, China has agreed to increase imports of U.S. agriculture, energy, industrial products and services. Delegations from the two countries will meet again in mid-February in China to continue negotiating. Trump was optimistic that the two nations would be able to make a deal before the deadline, saying, “I believe that a lot of the biggest points are going to be agreed to by me and him.”  

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Written by sciencepolicyforall

February 7, 2019 at 9:39 pm

Science Policy Around the Web – February 5, 2019

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By: Neetu Gulati, Ph.D.

Source: Pixabay

Macedonia name change paves way for science cooperation with Greece

Greece and the Republic of Macedonia have been at odds for decades over the name of the latter country. After the dissolution of Yugoslavia in the early 1990s, the nation known colloquially as Macedonia was founded. However, because a region in northern Greece shares a name with the republic, Greece has disputed the country’s name, and tried to bar its entry to international organizations such as NATO and the UN. The Prespa Agreement, ratified by the Republic of Macedonia on January 11, 2019 and Greece on January 25, 2019, is set to relieve tensions by changing the disputed country name to ‘The Republic of North Macedonia,’ and the short name of ‘North Macedonia.’

The Prespa Agreement not only ends the political stand-off between the two nations, but also opens the door for strategic partnerships in many ventures, including science. While some people opposed the Agreement, scientists in both nations welcomed the change, commenting that political tensions and bureaucratic procedures will hopefully no longer hinder collaboration. “Science is done by people, and many people were affected by the mutually negative spirit among the two countries that prevailed in the past years,” commented Ioanna Chouvarda, a Greek scientist.

Many are hopeful that the name change will positively impact scientific and diplomatic ties between the two nations. A spokesperson for the Republic of Macedonia’s science ministry commented that they hope the agreement will lead to more formal scientific and technological cooperation between the two nations. Greek Alternate Minister for Research & Innovation Costas Fotakis commented, “scientific diplomacy is an effective tool that can strengthen the relations between Greece and North Macedonia, as well as the Western Balkans in general. This agreement is very timely, especially considering that several research themes are of mutual interest in both countries.” 

(Julianna Photopoulos, Nature)

The modern tragedy of fake cancer cures

The news media can sometimes sensationalize and overclaim the results of scientific advances. This is especially dangerous when results have yet to be vetted by the peer-review process, as was the case when the Dan Aridor, chairman of a small biotechnology company in Israel claimed, “we believe we will offer in a year’s time a complete cure for cancer.” The story, published by the Jerusalem Post, made bold and likely unattainable claims that the new technology would have no side-effects, be less expensive than current therapies, and be “effective from day one.” However, the new treatment has so far only been tested in a single study in mice. Furthermore, it has not yet been published and therefore has not been scrutinized or validated by other scientists in the field of cancer research. 

The claims made by Aridor may just his optimism and faith in his product, but if taken at face value they are completely unbelievable. For one thing, the original article points out that the company has not yet started clinical trials, which would take years to complete, negating the hope of a cure within a year’s time. But even those clinical trials are not likely to succeed. The odds that a cancer therapy will successfully pass clinical trials is 3-5%, according to data from MIT and the Biotechnology Industry Organization. However, even the hurdle of getting from animal studies to clinical trials is not to be overlooked, which can easily take over five years.

Cancer therapies are still worth the investment of time and money. Successful drugs like Keytruda have made a large impact on those suffering from the cancer. However, therapies do not perform the same in every patient, and ‘cancer’ is not just one disease. Often, proper dosing of cancer therapies involves a balance between the effectiveness of the treatment and the harm of the side effects. Thus, it is unlikely that a single treatment will cure all cancers without a hitch, as boldly claimed by Aridor. It is much more realistic that some treatments will work for particular types of cancers more effectively than others, with limited side effects. Speaking more conservatively about the new treatment, the CEO of the company, Ilan Morad, commented that while the company believes their therapy will cure cancer, “we still have a long way to go.”

(Matthew Herper, STAT)

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Written by sciencepolicyforall

February 5, 2019 at 12:22 pm