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Archive for March 2018

Science Policy Around the Web – March 27, 2018

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By: Patrick Wright, Ph.D

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source: pxhere

Right to Try Drug Access

Why Can’t Dying Patients Get the Drugs They Want?

The United States House of Representatives passed “Right to Try” legislation last week (HR 5247, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018”), which allows terminally ill patients access to experimental drugs that are only required to have completed Phase 1 of a clinical trial, bypassing approval of the Food and Drug Administration (FDA). These patients are those with life-threatening illnesses who have exhausted approved treatment options and are not eligible to participate in a clinical trial (e.g. due to not meeting inclusion criteria) designed to evaluate the desired drug. However, this access still requires cooperation and permission from the drug companies themselves. Hesitation on the side of these companies can be rooted in the potential risk of jeopardizing ongoing clinical trials and the long process of bringing a drug to market. Furthermore, drug companies often do not have a sufficient extra supply of a product to provide to patients. The logistics of granting access could slow efforts to get the drug approved. Opponents of this legislation cite patient safety concerns and the failure to address the fundamental issue of pharmaceutical company denial of access as the most significant problems that still must be addressed.

Some companies acknowledge the importance of FDA oversight and would continue to seek FDA permission even if a Right-to-Try bill becomes law. Dr. Joanne Waldstreicher, the Chief Medical Officer of Johnson & Johnson, said “In our view, the FDA plays a really important role.” It has “information that we don’t have necessarily; they see safety and efficacy information on products that may be similar.” The legislation includes language that could potentially encourage companies to participate, including preventing the FDA from considering the experiences of patients using the drug when approving drugs. The FDA itself already approves 99 percent of applications to its expanded access program for access to investigational drugs for patients facing serious illnesses.

The Right to Try campaign was initiated by the Goldwater Institute, a libertarian, free-market public policy research and litigation organization, and championed by Vice President Mike Pence. Currently, Right to Try legislation has been enacted by 38 states. Victor Riches, president and Chief Executive Officer of the Goldwater Institute said the passing of this bill “is a win for patients. Millions of Americans who have been told they are out of options and it’s time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first.”

In August 2017, the United States Senate unanimously also passed a Right to Try bill (S 204); notably, it was passed under pressure by Ron Johnson (R-WI) who threatened to hold up a five-year reauthorization of FDA user fee programs if he did not get a vote on the bill. However, the narrower House bill has key differences compared to the Senate version, with House Energy and Commerce Committee Chairman Greg Walden (R-OR), along with FDA Commissioner Scott Gottlieb and other interest groups, having specified additional provisions including limiting the types of patients who can access the pathway and giving the FDA more information regarding the use of the pathway. Because the House bill differs from the earlier Senate bill, the Senate must vote on this revised version. Last week, Senator Minority Leader Chuck Schumer (D-NY) blocked Ron Johnson’s attempt to secure unanimous consent in the Senate to pass the House version of the bill. Senator Schumer stated that the Senate had already passed its version and that he wanted to work on a compromise bill.

(Katie Thomas, The New York Times)

Animal Welfare

Congress Orders USDA to Restore Transparency, Completeness, to Animal Welfare Reports

The U.S. Department of Agriculture (USDA) blacked out a public database containing animal welfare inspection reports and records of enforcement actions that the USDA carried out against violations of the Animal Welfare Act in early 2017. The records were often later reposted after varying levels of redaction, eliciting resistance and objection from proponents of animal research and animal welfare activist groups. Last week, Congress released a report that accompanied the USDA’s 2018 spending bill. It stated that these redactions and the obfuscation in accessing USDA information on inspections and their subsequent enforcement violates previous congressional direction and that “the online searchable database should allow analysis and comparison of data and include all inspection reports, annual reports, and other documents related to enforcement of animal welfare laws.”

On the same day that the report was released, the Humane Society of the United States (HSUS) filed a lawsuit against the Animal and Plant Health Inspection Service (APHIS), the USDA entity responsible for conducting animal welfare inspections. HSUS had requested documentation (e.g. inspection reports) for three puppy breeding facilities (“puppy mills”) via the Freedom of Information Act (FOIA) and were, in response, provided reports by APHIS with significant contents redacted. The USDA’s FOIA office wrote that because the requested reports were about businesses that operated out of an individual’s private home, they could not be disclosed without that person’s consent. This is not the first lawsuit in response to the blackout that has been filed by animal welfare groups against the USDA. The Animal Legal Defense Fund as part of a coalition with other animal activist organizations (Stop Animal Exploitation Now, Companion Animal Protection Society, and Animal Folks) previously filed a lawsuit in February 2017 against the USDA’s handling of inspection report transparency and availability (Animal Legal Defense Fund v United States Department of Agriculture) that was dismissed by federal Judge William H. Orrick on the grounds that FOIA provides an “adequate, alternate remedy”. The coalition has since appealed the decision.

To explicitly describe the approach and process underlying the blackout and redactions, APHIS states on its website: “APHIS, during the past year, has conducted a comprehensive review of the information it posts on its website for the general public to view. To conduct the review, the entire agency search tool database, along with additional documents, was taken off line. As a result of this review, APHIS has removed certain personal information from APHIS’ website involving the Horse Protection Act and the Animal Welfare Act. APHIS recently reposted certain inspection reports and research facility annual reports that were determined to be appropriate for reposting.” It also states “The agency will continue to review records and determine which information is appropriate for reposting. Those seeking information from APHIS regarding inspection reports not currently posted to the website, regulatory correspondence, and enforcement related matters may submit FOIA requests for that information.”

It appears that the language in the new Congressional report, part of the new omnibus spending bill that was just approved by Congress and President Donald Trump, has support among the animal welfare community. Cathy Liss, president of the Animal Welfare Institute, based out of Washington, D.C., stated “The Animal Welfare Institute applauds Congress for forcing USDA to lift its veil of secrecy.” Similarly, Kathleen Conlee, vice president for animal research at HSUS said she is “very pleased” with the report and that the “HSUS has been working closely with Members of Congress over the past year to address USDA’s outrageous purge and redaction of these vital documents.”

(Meredith Wadman, Science)

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March 27, 2018 at 12:27 pm

Ask your doctor: This drug might be right for you

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By: Jennifer Patterson-West, Ph.D.

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source: Mike Licht via flickr

Direct-to-consumer advertising (DTCA) of prescription drugs is currently only legal in the United States and New Zealand.  In the United States, DTC advertising is regulated by the Office of Prescription Drug Promotion (OPDP) within the Food and Drug Administration (FDA).  The stated mission of the OPDP is to “protect public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated.”

From patients to consumers

The first DTCA was a print ad for Pneumovax vaccine in 1981. A couple years later, the first broadcast advertisement aired for Rufen, a prescription brand ibuprofen.  In 1985, in response to initial DTCA, the FDA published a notice claiming jurisdiction over the regulation of DTCA. The FDA’s authority would hold DCTA to the same standards as previously established for advertisements to health care providers.  These standards required that advertisement contain a “fair balance” and “brief summary” that notes every risk described on the drug’s label.  Following the release of these standards, DTC print advertisements became prevalent with annual DTCA spending rising from $12 million (1980) to $340 million (1995).

The FDA loosened standards in 1997 by replacing the requirement of a “brief summary” with a “major statement” that only requires inclusion of the major risks associated with a drug and an adequate provision for consumers to obtain additional drug information, such as a toll-free number or website.  By no longer requiring drug companies to buy enough air-time to read the fine print, these new standards removed the fiscal constraint previously restricting the use of broadcast DTCA.  In fact, by the following year, annual spending on DTCAs increased to $1.2 billion annually and peaked at $5 billion in the mid-2000s.  It has been estimated, that on average, Americans now watch 9 drug advertisements per day, which equates to approximately 16 hours per year.  This level of contact far exceeds the amount of time patients typically spend with medical professionals.

Persuasive or informative? Are DTCAs truthful, balanced, and accurate?

Surprisingly, the debate around DTCA is balanced with respect to advocates and critics with considerable evidence supporting both positions.  However, the focus of those on the two sides of the debate differ considerable.  Advocates focus on the benefits associated with DTCA, whereas critics highlight examples of DTCA that are in direct subversion of established regulations and the stated mission of OPDP.

Advocates assert that DTCA empowers consumers by informing them about different treatment options, reduces associated stigmas, prompts dialogue with health care providers, and improves patient compliance.  Improved dialogue with healthcare providers is supported by a 2004 FDA survey in which 73% of physicians reported that they thought DTC advertisements helped patients ask more thoughtful question.  In the same survey, 77% of physicians declared that DTCA improved awareness of new drugs, whereas 33% of physicians agreed that the advertisements increased patient adherence.  In addition to these advantages, proponents suggest that DTCA drives competition, thereby reducing prescription costs.  However, no verifiable evidence is available to support this claim.

In contrast, critics proclaim that DTCA misinforms patients, medicalizes natural conditions, and strains patient-physician relationships.  In the same survey mentioned above, 60% of physicians believed that DTCA did not provide sufficient information regarding risks and 58% of physicians thought DTCA inspired patients to overestimate the efficacy of a particular drug.  These sentiments indicate that advertisements did not adequately communicate a balance of risk and benefit related information.  A recent study by Klara et al. found that 13% of ads within their study section suggested off-label uses, which are prohibited under current regulations. None of the evaluated ads quantified risk.  Another major critisim, is the medicalization of normal conditions such as hormonal changes associated with menopause or variability in sexual performance.  Proponents claim that medicalization heightens patient discontent with “symptoms” ultimately promoting the over utilization of pharmaceutical interventions that consequently contributes to rising medical costs.  Manufacturing of disease states is another example of advertisement practices that are in direct opposition of the stated OCPC mission which promotes the communication of truthful and accurate information.

The argument outlined by critics is likely contributing to the overall sentiment of physicians toward DTCA despite stated benefits.  In a 2013 survey by CMI/Compas that probed the opinion of physicians with respect to the current levels of DTCA, 52.9% supported a scale back, 18.3% felt it should be eliminated, 26% indicated that it should continue as is, and only 2.9% agreed with the expansion.

Maximizing benefit, while limiting risk

The unfavorable effects of DTCA can be lessened by the strict enforcement of current regulations and a careful assessment of advertisement strategies that interfere with truthful, balanced, and accurate communication of drug infomation.  However, since 2010, there has been a sharp decline in enforcement activity by the OPDP.  This decline follows the 2011 Supreme court ruling in Sorell v. IMS Health, which established that pharmaceutical marketing is protected under the Freedom of Speech Clause of the First Amendent.

Despite extensive critisms, it is unlikely that broad restrictions will be implemented in light of this and other juridical rulings that favor increased protection of commercial speech.  Additional measures have been proposed to minimize the risks associated with DTCA and maximize the benefits of engaging and educating consumers.  These include: (1) restricting advertisement of new drugs for a set number of years following approval, (2) pre-clearance of DTCA materials by the FDA or an unbiased entity, (3) mandating that all materials be presented at an 8th grade literacy level, and (4) requiring the inclusion of quantitative information regarding both the potential benefits and risks.  However, additional guidelines that focus on restricting or controlling the messaging of DTCA are unlikely to be upheld when they are challenged in court, due to the recently set precident.

An alternative approach to restrict DTCA has been focused on increasing the associated financial burden.  In 2002, U.S. Representative Jerrord Nadler (D-NY) introduced a measured called Say No To Drug Ads Act that would eliminate the use of tax deductions by pharmaceutical companies for DTCA costs.  Ultimately, this bill was not passed.  Recently, U.S. Representative Rosa DeLauro (D-CT) introduced the Responsibility in Drug Advertisement Act with a similar aim.  Although financial restrictions of DTCA are not in opposition to the constitution or current juridical rulings, this bill is also not expected to progress due to the current political climate.

Based on established precedents within the courts and the current political climate, mitigating the risk associated with DTCA may fall to consumer advocate groups or a public education campaign that informs patients about how to properly evaluate the risks and benefits of prescription drugs.  The success of FDA’s “The real cost” campaign emphasizes the potential benefit of public health campaigns and their impact on consumer behavior.

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March 26, 2018 at 11:20 am

Posted in Essays

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Science Policy Around the Web – March 20, 2018

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By: Leopold Kong, PhD

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source: pixabay

Psychology

Science Finds Once Again That Violent Video Games Don’t Turn People Into Rage Monsters

Since the recent mass shooting in Florida, the old question of whether playing violent video games can be a factor towards violent behavior has become relevant to the public again. In a recent interview with the Los Angeles Review of Books, Alfie Brown, author of The PlayStation Dreamworld, argued that video games are powerful vehicles of indoctrination and possible behavior modification: “Like a dream and unlike books and television, a video game is experienced actively, as if each player has a role in determining its events and outcomes.” Brown further elaborates in recent article published in the Guardian:

“Although affected by context, video games have long focused on the expulsion of “aliens” (Space Invaders to XCOM), fear of impure infection (Half-Life to The Last of Us), border control (Missile Commander to Plants vs Zombies), territory acquisition (Command & Conquer to Splatoon), empire building (Civilization to Tropico), princess recovery (Mario to Zelda), and restoration of natural harmony (Sonic to FarmVille) . . . video games put the user to work on an instinctual level, making the gamer feel impulsive agreement with these ideologies. Playing Resident Evil is not equivalent to watching the movie, because the controller-wielding gamer experiences the desires of the game as their own desires – not as the desires of another.”

However, a recently published study in the Nature journal Molecular Psychiatry did not find any significant behavioral changes from playing violent video games for 2 months. The study recruited three groups of volunteers (77 total, mean age= 28 years, 48 females) who were given questionnaires assessing levels of aggression, sexist attitudes, empathy, interpersonal competencies, impulsivity-related constructs such as boredom proneness, mental health and executive control functions before and after the study. The study consisted of playing a violent video game (Grand Theft Auto V), playing a non-violent video game (The Sims 3) or playing no game at all for 2 months on a daily basis. The study found no significant differences before and after playing games, and no differences between the groups. Chris Ferguson, a psychology professor at Stetson University in Florida who studies how video games affect societies commented that:

“It’s small in terms of sample size, but it’s otherwise well-done and pretty unique in that it looks at long term exposure…I think that this is an important piece of evidence that should guide us to rethink our beliefs about whether violent video games do or do not influence aggression.”

(Ed Cara, Gizmodo)

International Science Policy

Africa is the home to 15% of the world’s population, and yet produces only 3% of the global GDP and suffers 25% of the global burden of disease. Recent numbers suggest Africa accounts for only 2% of the world research output, and holds only 0.2% of the patents worldwide. In a recent study from the African Academy of Sciences, these challenges and disparities are analyzed, and possible approaches to closing these gaps through implementation of science technology and innovation (STI) policy changes are presented. The key issues and findings of the study are:

  • In 2016, fewer than half of African countries had adopted STI policies. For those countries that did, most did not focus on funding technology development, but instead on basic science.
  • Low implementation of STI policies could be attributed to low policy literacy, weak human literacy, insufficient monitoring and accountability and inadequate budget. One interviewee said: “like many previous African plans, strategies and many programs for millennium development goals did not say much if anything about research, science and technology”.
  • Information and Communication Technologies (ICT) has expanded and has driven economic growth across multiple sectors in Africa. Africa has developed an entrepreneurial class from urban incubators to remove villages, leveraging mobile-based technologies to solve logistics and infrastructure challenges unique to Africa.
  • In comparison to ICT, growth of biotechnology has been limited. Adoption of genetic modification in commercial agriculture has been inconsistent and potentially undermines potential genetic modification applications in African in the future.
  • Cooperation in international research and innovation is often short-term, based on the interests of individual scientists, and lack institutional and government support

The study made these key recommendations moving forward:

  • Ensure executive accountability for implementation of STI policy frameworks to meet national targets on gross domestic expenditure on R&D (GERD) through developing greater political and legislative oversight, establishing partnerships with international institutions such as the United Nations Educational, Scientific and Cultural Organization (UNESCO) and the International Council for Science (ICSU) capacity building.
  • Improve policy literacy through development of educational and guidance material.
  • Collaborate with African educational institutes to develop graduate courses on innovation and technology management, as well as STIP policy.
  • Establish pan-African mechanisms to fund and coordinate research and innovation initiatives with partners such as the Bill and Melinda Gates Foundation.
  • Develop platforms to foster science-business-society dialogue.

With the global shift to knowledge-based economies, Africa may be poised for growth by leveraging a more centralized and technology-focused STI framework.

(African Academy of Sciences, Report)

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March 20, 2018 at 4:33 pm

Science Policy Around the Web – March 13, 2018

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By: Roger Mullins, Ph.D.

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source: modified from openclipart

International Science Policy

Key science agencies brace for change as leaders discuss new policies

Important changes to science policy are looming in key areas of the globe that drive a large portion of scientific publications; namely China, the European Union, and the United States of America. As international collaboration, publication, and sharing results make science a notably cosmopolitan enterprise, these developments will affect informed researchers outside of these regions as well.

China began their annual assembly of the Chinese People’s Political Consultative Conference earlier this March, during which they drafted policies to direct their development of science and technology. The latest 5-year plan that resulted placed a high priority on brain science, deep ocean exploration, conservation, stem cells, and pollution. Currently rivaling the US in terms of publications, the effect of any adjustments made within China’s centralized, top-down system of fostering science as a national priority will be of interest to the science community in general.

In the European Union, Robert-Jan Smits has handed his role over as the director-general of the European Commission’s research directorate to Jean-Eric Paquet. Smits eight-year tenure as director was marked by efforts to promote science and innovation in the EU, including the Horizon 2020 research programme and the prospective Framework Programme 9. In an interview with Nature, he outlines his ideas of what future EU research plans will include; specifically supporting research in poorer member states, potential defense research, supporting innovative companies and start-ups, and the ever-present issues of climate and health.

In the United States, Rep. Lamar Smith is expected to retire from Congress later this year. This move includes stepping down from the House of Representatives Committee on Science, Space, and Technology which he has held since 2013. While his replacement has not yet been determined, this change presents an opportunity for scientists to address lingering issues of maintaining world leadership in science via our national priorities, tackling disparities in the scientific workplace, and promoting scientific integrity and respectability.

Even so early in the year, these events signal substantial upheaval of the scientific community in several influential regions of the globe. It will be imperative for scientists in these communities to make their voices heard and set priorities for the advancement and integrity of their profession.

(David Cyranoski, Nature)

(Allison Abbot, Nature)

(Andrew A. Rosenberg, Scientific American)

Science Communication

Fake news spreads faster than true news on Twitter—thanks to people, not bots

Besides, as the vilest Writer has his Readers, so the greatest Liar has his Believers; and it often happens, that if a Lie be believ’d only for an Hour, it has done its Work, and there is no farther occasion for it. Falsehood flies, and the Truth comes limping after it; so that when Men come to be undeceiv’d, it is too late; the Jest is over, and the Tale has had its Effect…”

This observation from Jonathan Swift in 1710 is likely timeless, as shown by a new Science article about the undeniably human tendency to latch on to exciting and novel but false stories and perpetuate them. With recent news about the role of automated “Bots” in spreading false information, this study found that the lion’s share of the blame actually rests on uncritical social media users.

A key finding of this study was that Tweets containing misinformation reached other users approximately six times faster than similar-but-truthful information. For their part, the Bots themselves actually disseminated roughly equal amounts of true and false information. This is attributed to a higher degree of novelty in the false tweets and their emotional valence. False tweets that were spread more rapidly and widely were those that contained both novel and emotionally manipulative reactions, especially for those that elicited strong emotions of surprise and disgust.

How this relates to scientists whose work is written about by journalists should be apparent, as sensational misinterpretation of results is of great concern. In these times one can also expect that stories will be picked up and shared on social media as well as on the traditional web, which may only lead to faster tragic miscommunications with the public.

(Katie Langin, Science)

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March 13, 2018 at 5:05 pm

Science Policy Around the Web – March 6, 2018

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By: Cindo O. Nicholson, Ph.D.

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source: pixabay

Artificial Intelligence & Ethics

Artificial intelligence could identify gang crimes-and ignite an ethical firestorm

Today, many industries and our favorite gadgets use some form of artificial intelligence (AI) either to make better predictions on user/consumer behavior. AI is also being adopted by police departments to highlight areas where crime is likely to occur thus helping patrol officers prevent crimes before they occur (i.e. predictive policing). Recently at the Artificial Intelligence Ethics & Society (AIES) conference in New Orleans LA, researchers presented a new algorithm that could classify crimes as gang-crimes based on partial information. In particular, the new algorithm can identify gang crimes using only 4 pieces of information: the primary weapon used, the number of suspects, the neighborhood and location (street corner vs. alley for example) where the crime took place.

Many agree that the findings presented (published by the AIES) could change the way the police approach and respond to crimes by classifying the crime beforehand as gang-related. However, not all in attendance were convinced that the new algorithm would be any better than an officer’s intuition and experience. In fact, there were those who believed that there could be unintentional, negative consequences of relying on such an algorithm. A point of contention at the conference was the appearance that the research team did not give sufficient consideration to whether the training data was controlled for bias, or what would happen if individuals were misclassified as gang members.

AI is a powerful technology, and its use can be applied to solve problems in fields like ecology and conservation, public health, drug development, and others. However, like all powerful technology its development must keep pace with its regulation, and the consideration of its potential misuses and unintended consequences.

(Matthew Hutson, Science Magazine)

Science Education

Florida’s residents could soon get the power to alter science classes

The possibility that the public can make recommendations on what instructional materials are used in science classes is moving closer to reality. Two education bills are being considered by Florida’s legislature that would grant Florida’s residents the means to recommend what instructional materials are used in the classrooms of schools in their district.

The education bills being considered would add to a law enacted in June 2017 that grants Florida’s residents the right to challenge the topics educators teach students. In particular, the bills under consideration will allow Florida’s residents to review instructional materials used in class, and suggest changes to the materials. However, the final decision on whether recommendations from residents are accepted would still rest with the school board.

Among the concerns of the scientific community is that these laws would provide a mechanism for creationists, climate-change deniers, and flat-earth proponents (commonly referred to as “flat-earthers”) to insert their non-scientific viewpoints into scientific lesson plans. On the other hand, State Representatives in support of these bills contend that highlighting different viewpoints are important and would allow for debate and drawing one’s own conclusions.

While engaging the public on the content of educational curricula could have its merits, it could have negative consequences when public opinion overrides curricula that have been developed from knowledge gained and refined by rigorous, scientific interrogation over several decades. If more education bills that allow the public to challenge instructional materials are going to be approved, it will be imperative that individuals with scientific backgrounds be a voice of reason on school boards.

(Giorgia Guglielmi, Nature Magazine)

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March 7, 2018 at 11:28 am

Science Policy Around the Web – March 2, 2018

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By: Patrice J. Persad, PhD

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source: pixabay

The Environment

Plastic Pollution Is Killing Coral Reefs, 4-Year Study Finds

Plastic, plastic everywhere / Disease of corals on the flare. A large-scale investigation surveying coastal regions of the Asia-Pacific, including parts of Myanmar, Thailand, Indonesia, and Australia, found that approximately 11.1 billion pieces of plastic littered coral reefs. Given that the populous China and Singapore were omitted from the analyses, the bona fide count may be higher than this published value. Supporting the hypothesis that plastic, a manmade product, may find it’s way into coral reefs proximal to regions with more humans and with less developed waste management systems, the less densely populated Australian locations had the smallest numbers of plastic items while heavily populated Indonesian sites had the largest numbers.

Although quantification of plastic occupying the seas, especially on the visible surface, were pursued by other research groups, a link between plastic and the physiological state of the corals beneath was understudied and, thus, never established. Upon viewing diseased phenotypes of coral reefs imprisoned by plastic, Joleah B. Lamb and colleagues constructed regression models to determine if coral disease presence was associated with the presence of plastic debris. The likelihood of having skeletal eroding band disease, white syndromes, or black band disease increased significantly in the onslaught of plastic debris. The team also noted differences in disease likelihood for coral anatomy/morphology categories; the massive coral morphology, the most intricate coral structure, had the highest disease likelihood when engulfed with plastic items (although this category had the lowest likelihood of plastic waste encounters).

How does plastic precisely contribute to coral disease? Researchers are not completely sure. However, there are several hypotheses. Plastic debris cloak coral reefs and bar contact with the sun’s rays. Solar interaction is vital because coral species—those involved in reef generation—have a symbiotic relationship with the photosynthetic algae, zooxanthellae. The algae nurture these corals and assist with the formation of the reef’s calcium infrastructure. Another sea of thought is that the plastic items on reefs may be gouging coral tissue and allowing pathogenic microorganisms from surrounding waters to creep in. A third explanation is that the chemical compounds constituting plastic itself may incite disease outbreak on coral reefs.

The coral reef is an ecosystem with brilliant biodiversity rivaling that of the terrestrial tropical rainforest. Like the mangrove forest and seagrass communities, the coral reef is both a nursery and asylum for various fish and invertebrate species. If these facts on the mere ecological worth of protecting coral reefs do not compel citizens, then the economic worth might. These natural underwater marvels rake in billions of dollars from tourism, aquaculture, and fishing. Coral reefs prevent beach battery in the midst of titanic tempests. The oceans and waterways are interconnected, along with the ecosystems and accompanying food webs. Even though the Asia-Pacific was the center of Lamb et al.’s study, citizens everywhere can engage in recycling plastics or diminishing use of non-biodegradable plastic items.

(Christopher Joyce, National Public Radio)

Wildlife Conservation

China’s lust for jaguar fangs imperils big cats

One fang, two fangs, three fangs, four / Of the jaguar gone in gore. Imagine you are a police officer in Bolivia. Your duty is monitoring wildlife trafficking and apprehending any individuals who are exploiting native species. Recently, you have encountered several decapitated jaguars, an endangered species, in local canals. Aside from these decapitated jaguars, other retrieved cadavers were fangless if not headless. After communicating with colleagues in neighboring Brazil and Belize, you learn that these are recurring patterns in jaguar fatalities. The next week, you discover pamphlets and posters advertising payment for a single jaguar fang: $120 – $160 USD. Your division confiscates almost 200 jaguar fangs. During a briefing with your supervisor, you gravely state, “Sergeant, I think this [wildlife trafficking] is getting bigger than we thought.”

From the above scenario, why are jaguar fangs such a popular commodity? For generations, tiger body parts, such as bone, teeth, and skin, have been important components of traditional Chinese medicine. Fortunately, authorities are successfully limiting the tiger parts trade. As a result, many in China are now directing attention, unfortunately, to another big cat, the jaguar, as a proxy. However, the jaguar is not the only big cat grievously affected by this shift. As one case in Belize features, poor species recognition by poachers ended an ocelot’s life. As the wildlife trade is highly profitable around the globe—superseded by only weapons and drugs—the conservation front in the form of law enforcement can gain little economic or corporal support. In fact, consequences for those who violate wildlife trafficking laws rarely involve incarceration. Prominent ecologist, Vincent Nijman, feels this may stem directly from the international society’s indifference to the fate of poached species, especially if the immediate reward of killing or capturing species brings in more money than saving them.

The jaguar’s plight—the species’ decimation—emerges from more than China’s hunger pangs for fangs. Urbanization has down-sized this big cat’s habitat, a range of tropical rain forests and savannas. Because of losses in sanctuary and hunting grounds, the jaguar may prey upon cattle and other agricultural animals. Consequently, irate farmers lash out by killing these feline threats. Agricultural stakeholders have several options to share the land peacefully: incorporating guard animals into herds, securing baby farm animals in complexes/shelters, granting loans on the basis of cattle/agricultural animal management history, and deterring predators with innocuous barriers, such as moats and man-made lights.

The exploitation of the jaguar, South America’s prime big cat, impacts other species’ survival and spawns from previous misdeeds against other species. Many sets of individuals are responsible for and partake in such a transgression against the jaguar. Cooperation among international conservation organizations and law enforcement agencies will be needed given the scope of wildlife trafficking and the low-key sense of emergency from society. Perhaps a beautiful friendship will cultivate between the International Criminal Police Organization’s (INTERPOL’s) environment crime division and the International Union for the Conservation of Nature (IUCN) or TRAFFIC (if such a bond has not already deepened).

(Barbara Fraser, Nature News)

 

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March 2, 2018 at 9:34 pm

Hold the Mayo: Supreme Court Ruling Blocks Patent Protection for Important Medical Diagnostics

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By: Jon Nye, Ph.D.

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source: George Hodan, via publicdomainpictures.net

In President Obama’s 2015 State of the Union Address he announced the Precision Medicine Initiative. This study will follow 1 million or more volunteers over a long period of time at a cost of $215 million. The goal of this ambitious initiative is to fundamentally change the way we diagnose and treat patients by moving from a “one-size-fits-all” approach to one that tailors disease prevention and treatment based on each individual, factoring in differences such as genetic makeup, lifestyle, and environment. As we move forward into the era of precision medicine and gain a better understanding of the complex underlying mechanisms that contribute to disease, we will require the development of diagnostic tests that allow caregivers to identify the specific causes of each individual patient’s disease, leading them to select an appropriate treatment. Although the future market for diagnostic tests looks bright, recent Supreme Court rulings that will prevent companies from obtaining patent protection threatens to hamper the development of these important tools and may adversely affect patient care.

Mayo Collaborative Services v. Prometheus Laboratories

The purpose of the patent system is to encourage research and innovation by rewarding inventors with a temporary government-granted monopoly. This system has been around since the founding of our country and stems from Article I of the Constitution in which it says, “The Congress shall have power … To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries”. However, in the medical diagnostics field, recent court rulings have dramatically narrowed what is considered to be patent eligible. The most notable being the 2012 Supreme Court case Mayo Collaborative Services v. Prometheus Laboratories. This case centered on a method for determining the proper amount of a specific drug to give to patients by measuring the levels of a drug metabolite in their blood. This test provided a way to individualize dosing so that doctors could maximize the drug’s effectiveness while minimizing the side effects of receiving too much. In a unanimous decision, the Supreme Court ruled that this patent was invalid based on the fact that the test stated a “law of nature”.

“Prometheus’ patents set forth laws of nature – namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.”

In other words, any patent claim based on a test that measures compounds, metabolites, or any other marker specific to disease was now patent ineligible simply because they measure processes that occur in the human body. This extremely broad definition of what can be considered a natural law led to widespread rejection of most diagnostic tests, now referred to as a Mayo rejection.

Aftermath of the Mayo Decision

A recent study has analyzed the effect that the Mayo decision has had on the medical diagnostic patent landscape in the United States. In this study, the authors looked at 31 patents that contained either diagnostic or prognostic claims and were filed in both the US and the European Union. This revealed a huge discrepancy in the two systems. Indeed, in the EU, which has no legal equivalent to the Mayo rejection, 30 out of 31 applications had either received a patent or were still pending. On the other hand, 29 of 31 applications in the US were abandoned or were still pending after receiving a Mayo rejection. This study highlights the profound and possibly unintended consequences that the Supreme Court ruling in the Mayo case has had on medical diagnostic patent eligibility.

Surprisingly, recent federal court rulings have supported the notion that in the wake of Mayo, current guidelines are too restrictive and prevent even well-deserved new diagnostics from patent approval. Most notably was the recent case Ariosa Diagnostics, Inc. v. Sequenom, Inc. This case involved a patent on a new technique for non-invasive genetic testing of a fetus. Sequenom’s diagnostic relied on two novel findings. First, their test used fetal DNA that was found to be circulating in the mother’s blood which was previously discarded as useless. Second, they developed a method to selectively amplify DNA from the fetus apart from the mother’s by focusing on the paternal DNA contributions. Although this technique was referred to as, “a paradigm shift in non-invasive prenatal diagnosis”, by the Royal Society in the United Kingdom, multiple US courts ruled that it was patent ineligible based on Mayo. In fact, these court rulings were unanimous and all of the judges remarked that based on the Supreme Court’s guidelines their hands were tied, even though some judges believed that this novel test merited a patent. Judge Linn from the Federal Circuit Court wrote:

“This case represents the consequence—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.”

These lower court rulings had many people hopeful that the Sequenom case would make it to the Supreme Court and allow them to refine the broad language in Mayo. However, the case was declined later that year, signaling that the solution to this problem was unlikely come from the courts. Instead, congress would have to act.

A Path Forward

In the wake of the Sequenom case, it was clear to many that the only way to change the restrictive patent guidelines in the medical diagnostic field was to pass legislation that would supersede the Supreme Court ruling. In order to gain momentum and start a discussion about what a bill like this would entail, a conference was held at Berkeley. It was attended by leading industry experts, scholars, policymakers, and a retired jurist. From these discussions, it was agreed that the current patent guidelines were inhibiting research and development in the diagnostics field by undercutting incentives. Consequently, at least in the bioscience field, the current system is no longer fulfilling the original intent of the patent system which was, “To promote the Progress of Science and useful Arts”. The consensus was that future legislation should expand patent eligibility to include conventional applications of scientific discovery. This general framework for a bill is consistent with current guidelines in the EU and also consistent with the spirit and intent of the patent system outlined in the Constitution. With the continued focus on tailored individualized treatment of patients it will be important to promote research and development in this area. Therefore, changing current guidelines should be a priority before they negatively affect patient health.

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Written by sciencepolicyforall

March 1, 2018 at 7:45 pm