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Science Policy Around the Web – February 26, 2019

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By: Mary Weston, Ph.D.

Source: Wikimedia

A Century-Old Debate Over Science Patents Is Repeating Itself Today

In 1923, after the economic devastation of World War I, the Italian senator Francesco Ruffini wanted to bolster scientific research by giving scientists ownership of their discoveries. His scheme would have awarded scientists a patent of sorts on the laws of nature they found. Although he had reasonable scientific support and the backing of the newly formed League of Nations, ultimately scientists around the world strongly rejected the plan for various reasons. Recent proposed changes to scientific discovery patent law possess a striking similarity to these events and proposals nearly 100 years ago.

Ruffini, desiring to increase scientific research, argued that scientists should be able to receive “scientific property” for a discovery, similar to patents awarded for inventions. He cited the example of “Hertzian waves” (i.e. radio waves) as something that resulted in many valuable products. The proposal was a large deviation from the existing law, where patents could only be assigned for inventions – artificial things made by humans, like machines – but not for discoveries of the natural world. Ruffini “was clear that scientific property would not prevent all uses of a natural law. But only practical commercial applications”.

In 2017, the American Intellectual Property Law Association (AIPLA) and the American Bar Association’s Intellectual Property Section (ABA’s IP) both submitted proposals to change current laws (Amendment 35, Section 101) and allow for patents on scientific discoveries. Motivation for change stems from recent Supreme Court decisions regarding patents for medical techniques (use of the BRCA1/2 gene for detecting breast cancer and a blood diagnostic test to fine-tune autoimmune disease treatments). Currently legislators, specifically Senators Thom Tillis and Chris Coons, are revisiting these guidelines and roundtables were held in both January and February of this year. 

The demise of the previous 1920s proposal was due to details in implementation, very similar to the problems current proposals face today. These include how to:

  • attribute scientific property when there are many contributors to one discovery (i.e. who “discovered” electricity? Benjamin Franklin? George Ohm?). 
  • deal with unexpected liability, potentially requiring some sort of scientific property insurance scheme. 
  • deal with the scope of some scientific discoveries, possibly being so large that it leads to tremendous and costly amounts of ligation. 
  • write the patents with the specificity required without being too vague and/or speculative. 

Edward S. Rogers, a Chicago lawyer who assisted Ruffini with his proposals in the 1920s, ultimately warned against it in 1931, saying that while the plan was appealing, “the whole scheme seems impractical.”

If changes to the patent law are to occur, the same issues that prevented change nearly 100 years ago will need to be solved – a daunting and challenging task.

(Charles DuanSlate

Japanese Spacecraft Successfully Snags Sample of Asteroid Ryugu

The Hayabusa2, a Japanese asteroid-sampling spacecraft, just successfully retrieved surface pieces from Ryugu, a 3000-foot wide asteroid. To obtain the sample, the probe fired a 0.2 ounce tantalum “bullet” into the boulder-covered surface at close range, and then collected disturbed particles using a “sampling horn” located on the underside of the machine. 

The Japanese Space Agency (JAXA) launched the Haybusa2, Japanese for Peregrine Falcon, in December 2014. They told CNN that even reaching the asteroid, 180 million miles from earth, is the “equivalent of hitting a 2.4-inch target from 12,400 miles away”. Upon arrival, the probe circled the small asteroid for 1.5 years collecting data. Then, last September, two probes were successfully released to image and document the asteroid surface. 

The goal of this exploration journey is to better understand the early history and evolution of the solar system. Ryugu is a C-type asteroid, the category that ~75% of known asteroids falls into, and is thought to contain water and other organic materials. One theory suggests that much of earth’s water and organic compounds may have been delivered by asteroids and comets. This will be the first time scientists have visited and collected samples from this type of asteroid and evaluation of its composition may “clarify interactions between the building blocks of Earth and the evolution of its oceans and life,” JAXA described

JAXA is planning two additional sampling expeditions in the next couple of weeks. This second mission will collect additional surface material. The third will use a copper projectile to create a surface crater in order to obtain samples from beneath the asteroid’s surface, which has been weathered by deep-space radiation. The Haybusa2 will depart the asteroid in December 2019 and should arrive back to earth in December 2020.

(Mike WallSpace.com)

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March 1, 2019 at 12:58 pm

Publications and Patents: Laying the foundation for future innovation and economic growth

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By: Xavier Bofill de Ros, Ph.D.

thought-2123970_1920.jpg

Source: Pixabay

 

Many hours on the laboratory bench made me wonder: What is the real impact of our science? How do the thousands of publications appearing in scientific magazines every month and the funds poured into research benefit our society? We all know history; Fleming’s research on mold resulted in the discovery of penicillin and saved millions of lives ever since, and GPS systems rely heavily on basic trigonometry. These examples embody the power of science as a driver of technological progress and motivates – public policies to support scientific research. For example, NIH receives $37 billion  annually to fund intramural and extramural biomedical research[1]. Some of this investment in research generates intellectual property, bringing back to the system private money derived from license agreements. For instance, the NIH Technology Transfer Office had an income of $138 million from royalties in 2015[2]. However, many critics are quick to point out that basic research rarely pays off in practical R&D.

To understand where we are we need to know where we are coming from. A big part of the current legislation that governs the intellectual property derived from publicly-funded research is inspired from the Patent and Trademark Law Amendments Act, also known as the Bayh–Dole Act passed in 1980. This act established that the ownership of inventions made with federally-funded research projects by universities, small business and non-profit institutions is entitled to them in preference to the government. Prior to that act, the government accumulated ownership to large numbers of patents derived from the $75 billion per year of funding dispersed through different agencies, however fewer than 5% of those patents were licensed[3]. In exchange for this new source of revenue, public money receiving institutions  are required to educate the research community about the patenting procedures and to protect the government’s interests on funded inventions among other requirements. Despite the criticisms for forcing consumers to “pay twice” for patented products, the economic impact of the Bayh-Dole Act has been important. Recent reports suggest that academic licenses to industry contributed between $148 to $591 billion per year to US gross domestic product (GDP)[4].

Besides economic performance, other approaches to assess the impact of scientific publications on intellectual property come from the bibliometric analysis of the prior art on issued patents. A recent study from Kellogg School of Management analyzed the content of 4.8 million patents and 32 million research articles to find out how research is connected to inventions[5]. By analyzing the prior art references of patents, and the references of these references, the authors revealed that 80% of research articles linked to a future patent. This connection is often indirect, since direct citations of research articles in patents only account for about 10%, but it quickly accumulates to 42% and 74% when second degree and third degree citations are included. This indicates that the vast majority of the publication corpus ends up in the pool of knowledge where inventions arise. The analysis of the distance between research articles and patents also revealed differences between fields of research. Areas such as “Computer science”, “Nanotechnology” and “Biochemistry and Molecular Biology” depict a more immediate impact on patents compared to others less easily applicable. The authors of the study also went on to address which institutions yield research articles with a more significant impact on patents. To this aim, they compared the publications from universities, government laboratories and publicly traded firms. Consistent with previous studies, firms’ scientific production is the most directly linked to patent production. However, universities and government publications follow at a very close distance, despite generally engaging with more long-term research goals.

Other less tangible contributions from academic research and industry take place through the open access of data, reagents or knowledge[6]. Examples of these are The Cancer Genome Atlas (TCGA) with genomic data from more than 11,000 patients, the Jackson Laboratory (JAX) collection and distribution of mouse strains of human diseases, or the Addgene repository, with a collection of more than 67.000 plasmids. Similarly, collaboration agreements like CRADAs (Cooperative Research and Development Agreements) allow industry to partner with academic labs[7]. Under such agreements, which can last years, researchers from academic labs and companies can engage with joint ventures by providing each other with resources, skills and funds. In these partnerships the ownership of any coming intellectual property is discussed upfront as well as first option rights for licensing. Such collaboration formulas have a positive impact on the market readiness of the technologies developed, when not directly shortening the pathway to market through the same industrial partner. Similarly, there’s also specific agreements allowing for to joint clinical trials, specifically for rare diseases, or to transfer research materials.

Overall, this illustrates that public investment can be used to generate innovation and economic growth through the right policy measures. Contrary to the belief that technological and scientific advances move independently, there’s a well-connected flow of ideas that permeate between patented inventions and scientific articles. There are already good incentives to the research communities to facilitate the collaboration between academia and industry. However, there’s still room for novel policies to further leverage what can be achieved through the public investment on research.

[1]https://www.nih.gov/about-nih/what-we-do/budget

[2]https://www.ott.nih.gov/sites/default/files/documents/pdfs/AR2016.pdf

[3]GAO/RCED-98-126 Transferring Federal Technology. Page 3.

[4]The Economic Contribution of  University/Nonprofit  Inventions in the United  States: 1996-2015. Biotechnology Innovation Organization and the Association of University Technology Managers

[5]Ahmadpoor M, Jones BF. “The dual frontier: Patented inventions and prior scientific advance”. Science. 2017 Aug 11;357(6351):583-587.

[6]Bubela T, FitzGerald GA, Gold ER. Recalibrating intellectual property rights to enhance translational research collaborations. Sci Transl Med. 2012 Feb 22;4(122).

[7]Ben-Menachem G, Ferguson SM, Balakrishnan K. Beyond Patents and Royalties: Perception and Reality of Doing Business with the NIH. J Biolaw Bus. 2006 Jan 1;24(1):17-20.

 

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November 28, 2018 at 10:41 am

The Trans-Pacific Partnership and its Impact on Pharmaceutical Affordability

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By: Shakira M. Nelson, PhD, MPH

        For many, the Trans-Pacific Partnership (TPP) was a point of great debate during the 2016 Presidential primaries and election. As a simplified explanation, the TPP is a free-trade agreement involving the United States, Canada, Australia, Japan, New Zealand, Mexico, Chile, Peru, Brunei, Malaysia, Singapore and Vietnam, intended to “level the trading playing field” through the elimination of tariffs and other laws that create trade barriers. In its final form, the TPP would impact up to one-third of world trade and 40% of the global gross domestic product. Many who debated the ramifications of the TPP did so in the context of foreign policy interests. Although aligned with foreign policy, a major part of the TPP deals with intellectual property protection, and pharmaceutical drug development. If implemented, the effects of the TPP could greatly diminish public access to affordable medicines, both domestically and internationally. Moreover, the stronghold the TPP places on intellectual property could limit the development and marketing of less expensive options.

Intellectual property can be divided into two categories: industrial property and copyright. Patents, trademarks, and industrial design fall under industrial property. Patent development is a large part of scientists’ work, seen as almost a necessity to incentivizing innovation. Many argue that, without the ability to patent inventions and significant findings, scientists would not be able to generate profits used to sustain research and development; within the pharmaceutical industry, patents are the proverbial bread-and-butter. When in place, patents create a stronghold around the release of new chemical drugs, which prevents competition by generic brands. The standard length of time of a patent for a chemical drug is 20 years, which starts from the time the drug is invented.

Many new medicines under development today fall under the category of ‘biologics’. As the name suggests, biologics are treatments made from biological sources, and are very different from chemical drugs. Created to treat a multitude of diseases, including Ebola and cancer, biological sources include vaccines, anti-toxins, proteins, and monoclonal antibodies. Given their structural complexity compared to traditional drugs, and use of recombinant DNA technology, biologics are more difficult, and costlier to make. Moreover, manufacturers have a greater burden in ensuring product consistency, quality, and purity over time. This is done through certifying that the manufacturing process remains the same over time. Because of this, it is estimated that the price to manufacture biologics cost on average more than 22 times the price of chemical drugs. Current laws state that generic biologic development, known as biosimilars, cannot be approved until 12 years after the branded product has been approved – this is known as an exclusivity period. This was enacted under the Biologics Price Competition and Innovation Act of 2009, by the Food & Drug Administration (FDA).

The challenge with current policies is establishing a period-of-time that balances the need for companies to generate profits and cash flows, which will incentive them to conduct more research and compensate them for the extensive manufacturing processes, with the need to provide greater access through launching generic drugs and biosimilars. The trouble with the proposed policies of the TPP agreement is that they seem to embolden the pharmaceutical companies by introducing changes that would prevent competition from generics and biosimilars for longer periods of time than the current basic terms. The implications of this are far-reaching, as it may lead to a significant increase in the current costs of pharmaceutical drugs and biologics, hindering the health of the patients who rely upon these treatments.

Critics of the current system of patent length and biologic exclusivity periods fear that rather than incentivizing innovation, companies are being rewarded through their ability to charge higher amounts for drugs without the fear of competition on the market. Health policy experts concur, identifying policies such as the Hatch-Waxman Act of 1984 in allowing for the creation of drug monopolies, and “going too far in compensating the pharmaceutical industry at the public’s expense”. A report released in 2009 by the Federal Trade Commission stated that biosimilar development was more difficult to achieve than traditional generic drugs. For example, development requires comparisons to the original biologic, to prove efficacy and equivalence. Biosimilars must share the same mechanism of action, with no clinically significant differences in terms of safety or potency for the approved condition of use. The steps necessary to achieve this are significant, and therefore imposing a 12-year exclusivity period on biologics may be unnecessary. US Congressmen have pushed to compromise, floating an amendment to the TPP that would lower the exclusivity period to 8 years. However, critics and patients who rely upon drug competition to lower market prices, have protested this amendment stating that costs of new drugs and biologics are too high, and 8 years is too long of a length of time to wait for affordable generics and biosimilars to come on to the market.

The impact of decreasing the length of time it takes for biosimilars to come onto the market can be seen with Neupogen, a leukemia drug that was first approved by the FDA in 1991. Delivered via injection, Neupogen costs patients $3,000 for 10 injections. With injections needed daily, this drug could carry a price tag of well over $100,000 per year. It wasn’t until recently, however, that the first biosimilar was approved on the US market. The biosimilar, Zarxio, was approved as a leukemia drug and is priced at more than $1000 less than Neupogen. This pricing has the potential to decrease the yearly costs of this drug from $100,000 with Neupogen to $55,000-$75,000. Further evidence of these financial savings was provided by the Rand Corporation, which predicted a savings of over $44 billion over 10 years with an increased approval of biosimilars, for patients who rely upon these specific cancer treatments.

Internationally, the policies of the TPP also have far reaching effects on the availability and costs of pharmaceuticals. The 12-year exclusivity period would be imposed upon the other countries involved in the TPP, where currently for some, such as Brunei, there is no current exclusivity protection. By imposing the 12-year period, global competition could become restricted. Additionally, the TPP proposes other key patent protections that play a bigger role on the international market. One protection, known as evergreening, allows drug companies to request patent extensions for new uses of old drugs. The immediate effect of this is an extension of monopolies on drug sales for minor reasons. The second protection allows pharmaceutical companies to request patent extensions if it takes “more than 5 years for an application to be granted or rejected.” Advocacy groups fear that the price of drugs would undermine the efforts of health initiatives, such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria. These initiatives rely upon price competition to manage costs, with the availability of cheap generics helping drive costs down.

Although the current administration has ended the USA’s association with the Trans-Pacific Partnership, it is important to note that other countries may try to implement some of the policies, affecting the availability and affordability of drug treatments. To decrease this burden, the US could work to assist in negotiating exceptions for the poorer and smaller countries, to help them meet any challenges they may come up against. Within the US itself, it is important for policies, laws and any future trade agreements to be modified, with more of a focus on the affordability and regulation of drugs and biologics. Imposing price controls may offer a modest benefit, but may not be a long-term solution. A focus on lowering the patent length for new drugs and biologics can be an immediate step. Although the push back from pharmaceutical lobbyists will be substantial, alleviating the financial burden on families afflicted with cancer and diseases should be the focus.

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Science Policy Around the Web – February 17, 2017

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By: Thaddeus Davenport, PhD

Source: pixabay

CRISPR

Decision in the CRISPR-Cas9 Patent Dispute

This week, Heidi Wedford from Nature News reported that the United States Patent and Trademark Office (USPTO) made a decision on the disputed patents for the gene editing technology known as CRISPR-Cas9 in favor of the Broad Institute of MIT and Harvard. The CRISPR-Cas9 system has been widely publicized, and this publicity is arguably not out of proportion with the potential of this technology to simplify and accelerate the manipulation of DNA of both microbial (prokaryotic) and higher order (eukaryotic) cells for research and therapy. A simplified, programmable version of CRISPR-Cas9 for use in gene editing was initially described by Charpentier and Doudna, and it was rapidly translated for use in eukaryotic cells by Zhang and colleagues at the Broad Institute in parallel with Doudna, Charpentier, and others.

The USPTO decision follows a dramatic and ongoing dispute over whether the patent application submitted by the University of California on behalf of Doudna and Charpentier – which was submitted before that of the Broad Institute, and described the technology in broad terms as a method of cutting desired DNA sequences – was sufficient to protect the CRISPR-Cas9 intellectual property when the Broad Institute later filed a fast-tracked patent application describing the use of CRISPR-Cas9 for use in eukaryotic cells. Because the Broad Institute’s application was expedited, it was approved before the University of California’s application. In January of 2016, the University of California filed for an ‘interference’ proceeding, with the goal of demonstrating to the USPTO that Doudna and colleagues were the first to invent CRISPR-Cas9, and that the patent application from the Broad Institute was an ‘ordinary’ extension of the technology described in the University of California application.

On February 15th of this year, the USPTO ruled that the technology described in the Broad Institute’s application was distinct from that of the University of California’s. The importance of this decision is that the patents granted to the Broad Institute for the use of CRISPR-Cas9 in mammalian cells will be upheld for now. It also creates some complexity for companies seeking to license CRISPR-Cas9 technology. Because of the overlapping content of the CRISPR-Cas9 patents held by the University of California and the Broad Institute, it is possible that companies may need to license the technology from both institutions. The University of California may still appeal the USPTO’s decision, but this is a significant victory for the Broad Institute for the time being. For many scientists, this dispute is a dramatic introduction to the inner workings of the patent application process. We would do well to familiarize ourselves with this system and ensure that it works effectively to accurately reward the discoveries of our fellow scientists and to facilitate the transfer of technology to those who need it most, without imposing undue economic burden on companies and consumers. (Heidi Wedford, Nature News)

Scientific Publishing

Open Access to Gates Foundation Funded Research

Also this week, Dalmeet Singh Chawla reported for ScienceInsider that the Bill and Melinda Gates Foundation had reached an agreement with the American Association for the Advancement of Science (AAAS) that will allow researchers funded by the Gates Foundation to publish their research in the AAAS journals Science, Science Translational Medicine, Science Signaling, Science Immunology, and Science Robotics. This agreement follows an announcement in January in which the Gates Foundation decided that research funded by the foundation would no longer be allowed to be published in subscription journals including Nature, Science, and New England Journal of Medicine, among others, because these journals do not meet the open access requirements stipulated by the new Gates open-access policies. The new Gates Foundation policy requires its grant recipients to publish in free, open-access journals and to make data freely available immediately after publication for both commercial and non-commercial uses. A similar policy is being considered by the nascent Chan Zuckerberg Initiative.

In the agreement with AAAS, the Gates Foundation will pay the association $100,000 in order to make Gates-funded published content immediately freely available online. Convincing a journal as prominent as Science to make some of its content open-access is a step in the right direction, but it is perhaps more important as a symbol of a changing attitude toward publishing companies. Michael Eisen, co-founder of the Public Library of Science (PLoS) open-access journals, was interviewed for the ScienceInsider article and noted, “[t]he future is with immediate publication and post-publication peer review, and the sooner we get there the better.” This sentiment seems to be increasingly shared by researchers frustrated with the hegemony of the top-tier journals, their power over researchers’ careers, and the constraints that subscription-based journals impose on the spread of new information. Funding agencies including the Gates Foundation, Howard Hughes Medical Institute, and the National Institutes of Health are in a unique position to be able to dictate where the research they fund may be published. A collective decision by these agencies to push the publishing market towards an improved distribution of knowledge – through open-access publishing and post-publication peer review – and away from the historical and totally imagined importance of validation through high-tier journal publication would enrich the scientific ecosystem and accelerate innovation. In this regard, the efforts by the Gates Foundation are laudable and should be extended further. (Dalmeet Singh Chawla, ScienceInsider)

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February 17, 2017 at 12:44 pm

Science Policy Around the Web – December 23, 2014

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By: Agila Somasundaram, Ph.D.

photo credit: pennstatenews via photopin cc

Workforce Development – Federal Policy

Yes, you can attend that career event, says the U.S. government

Whether a graduate student or a postdoc aspires to hold an academic position, or transition to a career away from the bench, developing skills other than those required at the bench are important. However, some principal investigators express reservations about sending their trainees to career development events; they consider it breaking the law, since they believe that federally funded trainees are meant to be doing research. The National Institutes of Health (NIH), the National Science Foundation, and several other agencies approached the Office of Management and Budget (OMB) requesting a policy clarification, which has resulted in the Council on Financial Assistance Reform (under the U.S. OMB) stating that graduate students and postdocs, even when supported by federal funds, are authorized to spend time away from the lab to develop career-related skills, since they hold “dual roles” as trainees and employees. Vanderbilt University postdoc, Lindsey Morris, says that without specialized career training, “you get to the end of your postdoc, and what do you do? You haven’t spent any time building those really critical career development skills, and you’re left without a job.” Though the OMB statement does not specifically state how much time a trainee can spend on career-related activities outside of lab, the guidelines “say very clearly that trainees are permitted to go and seek these opportunities. … You cannot misunderstand the language. There are no two ways of interpreting it”, says Ambika Mathur, Dean of the graduate school at Wayne State University in Detroit, Michigan. How the clarification and its implementation play out will be closely monitored over the next few years, to determine if further modifications are needed, says Michelle Bulls, director of the NIH Office of Policy for Extramural Research Administration, who worked on the statement. She says, “It will take about 3 years to figure out if this is good, bad, or indifferent.” (Rachel Bernstein, Science)

 

Stem Cells

European court clears way for stem-cell patents

The European Court of Justice ruled on December 18 that human embryonic stem (ES) cells made from unfertilized eggs can be patented, on the basis that these cells lack the capacity to develop into a human being. These cells are created through parthenogenesis, a form of asexual reproduction in some animals, but one that does not result in normal development in humans. This ruling counters the general ban imposed by the court in 2011, banning patents on human ES cells. The original ruling banned patents that involved destroying cells capable of forming human embyros, as well as patents on ES cells made from unfertilized eggs. The ruling had met with opposition from many scientists. “We have known for a very long time that parthenogenetic embryos are not capable of developing very far after implantation”, says Robin Lovell-Badge, a stem-cell scientist at the National Institute for Medical Research in London. In a press release, the European court said: “The mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regarded as a human embryo.” A couple of patents filed by the International Stem Cell Corporation, a biotechnology company in Carlsbad, California, for methods to generate corneal tissues from ES cells made from egg cells, had been rejected by the UK, and now it’s up to the UK courts to decide if these cells are eligible for patent protection. The ruling “is generally good news”, says Clara Sattler de Sousa e Brito, lawyer based in Munich, Germany. She adds that though it opens up space to argue that human ES cells obtained from other methods like cloning, are not capable of developing into a human being, and thus should be patentable, arguing scientifically that ES cells from spare human embryos do not have this capability would be harder. (Ewen Callaway and Alison Abbott, Nature)

 

Environmental Policy

The Arctic keeps warming, and polar bears are feeling the heat

 The air temperatures in the Arctic are increasing twice as fast as temperatures in the lower latitudes, says a federal report, released on Wednesday, co-authored by sixty-three scientists from thirteen countries. The report was peer reviewed by the Arctic Monitoring and Assessment Program of the Arctic Council and released in San Francisco at an annual gathering of the American Geophysical Union. The effect of the Arctic temperature rise, a result of global warming, can be seen in many different places. Alaska has recorded temperatures nearly 20 degrees higher than the January average. The amount of snow in Eurasia in April was at its lowest since 1979, and snow in June in North America was the third lowest on record. “Snow disappeared three to four weeks earlier than normal in western Russia, Scandinavia, the Canadian sub-Arctic and western Alaska due to below average accumulation in winter and above normal spring temperature,” said Jacqueline A. Richter-Menge, a senior research engineer for NOAA’s Cold Regions Research and Engineering Laboratory. Geoff York, senior director of conservation at Polar Bears International, wrote that the polar bear population declined from about 1,200 to 800 in the western Hudson Bay area of Canada between 1987 and 2011, though there might be some good news for bears in other parts of the Arctic. Overall, the findings from this report highlight an observation made by University of Virginia environmental professor Howard Epstein last year: “The Arctic is not like Vegas. What happens in the Arctic doesn’t stay in the Arctic.” (Darryl Fears, The Washington Post)

 

 

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December 23, 2014 at 12:34 pm

Science Policy Around the Web – April 21, 2013

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By: Jennifer Plank

photo credit: limowreck666 via photopin cc

photo credit: limowreck666 via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

FDA’s rejection of generic OxyContin may have side effects – With the patent on the original OxyContin ending, the FDA has declared that they will not approve generic versions of the drug. In order for drug developers to compete in the prescription pain relief market, they will have to develop abuse resistant forms of the drug. In 2010, Purdue Pharma LP, the developer of the original OxyContin, produced a form of the drug that includes a polymer that makes it impossible to snort and inject the drug. The patent on the drug resistant form expires in 2025.  (Nancy Shute and Audrey Carlsen)

Stereotype threat for girls and STEM – According to Facebook executive and author Sheryl Sandberg, women are being held back by what social scientists call a “stereotype threat”- an idea that suggests that the more we are aware of the stereotype, the more likely we are to act in accordance with it. Sandberg suggests that the stereotype threat is what is responsible for preventing women to pursue leadership roles and careers in highly technical field, such as computer science. A recent study looking at author gender and gender typing of projects suggests that publications from male authors were more highly regarded scientifically. The author also presents many links aiming to encourage interest in STEM. (Chris Gunter)

Gene patents are sabotaging the future of medicine – A case currently being debated by the Supreme Court, Association of Molecular Pathology v. Myriad Genetics, has the potential to influence how clinicians can report the results of genome wide sequencing to their patients. Currently, Myriad holds the patents on the BRCA1 and BRCA2 genes, which are associated with the onset of breast and ovarian cancers. Therefore, Myriad has a monopoly on all diagnostics and therapeutics related to the BRCA genes. The Association for Molecular Pathology states that a person has a right to know their own genetic code and should not have to have permission from patent holders to know the sequence of their own genes. The Supreme Court will rule on the case in late June. (Daniela Hernandez)

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April 21, 2013 at 8:17 pm

Science Policy Around the Web – December 7, 2012

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photo credit: Christopher Chan via photopin cc

photo credit: Christopher Chan via photopin cc

By: Jennifer Plank

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Supreme Court to Decide if Gene Patents are Legal
On November 30, the Supreme Court announced that it would hear the case of ACLU vs. Myriad Labs regarding patenting human genes. Myriad Labs patented the BRCA gene, therefore, they are the only company allowed perform medical research on the BRCA genes. Because no other companies can test for the BRCA1 or BRCA2 mutations, the testing remains very expensive for patients (approximately $5000, insurance companies pay a percentage of the test). The ACLU contends that naturally occurring genes should not be able to be patented. Myriad Labs disagrees by stating that without patents, it is not financially viable to conduct medical research. The Supreme Court will hear the case in early spring 2013. (Lynda Altman)

Genome Sequencing For Babies Brings Knowledge and Conflict – Whole genome sequencing can be used to decipher an individual’s genetic code and to screen for thousands of conditions that may impact the individual later in life. As the technology improves and becomes more common, whole genome testing will become more affordable for patients. Additionally, whole genome sequencing can be used to diagnose babies at birth. However, this use of the technology raises many questions regarding the handling of the results. For example, many adults who have had their genomes sequenced have decided to not receive results relating to the risk of incurable diseases such as Huntington’s or Alzheimer’s disease while newborn babies are unable to voice their desire to know the results. This article outlines many of the ethical issues facing whole genome sequencing for babies. (Rob Stein)

Research Grants: Conform and be Funded – Between 2002 and 2011, the National Institutes of Health (NIH) funded over 460,000 research grants, and the labs supported by these grants have produced numerous medical advances. However, it is unclear if the most influential researchers are funded by NIH grants. A survey of publications since 2001 suggests that approximately 60 percent of the most influential scientists (those who published papers that have been cited more than 1000 times) do not have NIH funding. This finding suggests that the NIH is not meeting their goal to fund the “best science by the best scientists.” (Joshua Nicholson and John Ioannidis)

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December 7, 2012 at 11:55 am