ORGANS ON A CHIP IS A MILITARY ----DARPA RESEARCH GOAL-------
If the goal is simply finding chemicals which when passing through an organ tissue lining can cause harm or death-----ORGAN ON CHIP will do that. The claims these research are BETTER because they eliminate animal testing is FAKE HUMANITARIANISM. The goals of GMO HUMAN ----building a body system organ by organ to create an artificially built human----IS THE ONLY GOAL in these ORGANS ON A CHIP technology.
'The original purpose of these chips to be a newer, better way of drug testing, but it can also be used to
test the toxicity of chemicals that could potentially be used harm others. Pharmaceutical companies may have no interest in such chemicals, but companies that create weaponry may be interested in using organ chips as a tool for creating new chemicals for wartime use'
By using the organ chips for purposes such as creating new drugs, we are promoting the health and welfare of the general public, but by using the organ chips to develop wartime weaponry, we are not upholding the safety, health, or welfare of the public.
BRAIN ON A CHIP
PHARMA was tired of PRETENDING to be doing clinical trials and public safety procedures----so they are creating a FAKE reason not to do ANY TRIALS.
GLOBAL PHARMA SAYS------US CLINICAL TRIAL AND PUBLIC HEALTH SAFETY POLICIES TAKE AWAY FROM OUR PROFITS-----THEY MUST DISAPPEAR.
Jul 31, 2012, 12:50pm
Military's 'Body-on-a-Chip' Could Fast-Track Pharmaceuticals
Katie Drummond
Contributor
I write about things that raise eyebrows. Or singe them right off.
The military's prepping a new weapon in their war against bio-threats and infectious ailments -- and it could, one day, transform the entire realm of pharmaceutical development.
DARPA, the Pentagon's ambitious research arm, last week announced a $37 million grant for the development of an array of "organs on a chip" designed to facilitate the study of human physiology, in particular the rapid testing of new pharmaceutical agents.
Led by a research team at Harvard's Wyss Institute for Biologically Inspired Engineering, the program will fund the creation of ten different "organ" micro-chips. All of them will be linked together by micro-channels flowing with a blood surrogate, and networked to an automated instrument capable of analyzing their functions and reactions. "With this tool, we'll be able to study how drugs interact with different organs," Dr. Don Ingber, founding director of the Institute and one of the project's leaders, tells me. "There's a unique capacity here to see cells behave the way they would inside the body."
Already, Ingber and co. have developed chip versions of a human lung (portrayed in the video above) as well as a human gut. Under the DARPA program, the team now hopes to develop additional organs, including the heart, liver, kidney and even chips that mimic human skin and muscle. In an interview with NPR this week, Ingber offered a prime example of how the body-on-a-chip program might one day work:
"So, for example, you might deliver an oral drug to the gut, see it absorbed, watch it metabolize by the liver. It's being peed out by the kidney, and you're looking for its toxicity on the heart."
Of course, given the vast complexity of a human organ, creating micro-chip versions isn't exactly an easy task. The "lung-on-a-chip," for instance, about the size of a computer USB stick, involved the creation of two tiny different channels -- one lined with airway lung cells, the other with capillary cells -- divided by a flexible membrane. The chip also contained a layer of flowing red blood cells, as well as side channels, powered by pumps and vacuums, that mimicked the stretch-and-relax rhythms of human breathing.
DARPA's interest in these novel devices is, obviously, oriented towards national defense: The agency, in recent years, has been on a mission to fast-track the development of pharmaceuticals tailored to thwart specific biological threats and curb potential pandemics. "A technological solution to increase the speed and adaptability of vaccine production is urgently needed to match the broad biological threat," the agency noted just last week, when they announced the successful creation of 10 million doses of H1N1 vaccine using plant-based production techniques.
The successful creation of these micro-chip organ mimics would further accelerate this kind of pharmaceutical development, by fast-tracking tests of a drug's human safety and efficacy. It remains to be seen just how rapidly the micro-chips could work, but DARPA does have lofty ambitions where timing is concerned. Their plant-based vaccine manufacture program is trying to turn a conventional one-year vaccine development process into a four-week one, and the agency's also funding a separate project that aspires to, as I wrote in 2010, "a vaccine to address any pathogen, developed in seven days and ready for injection shortly after."
Military applications aside, however, Harvard's micro-chip organ program could spur myriad improvements in other areas of drug development, by replacing costly, years-long lab and animal-based tests.
"Our ability to validate drugs and get them to humans is incredibly limited," Ingber says. "Right now, animal testing is the only option. And aside from time, cost and ethical issues, it isn't even necessarily accurate."
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For several hundred years of AGE OF ENLIGHTENMENT---I AM MAN having our 99% WE THE PEOPLE as CITIZENS---as educated and taking part in REAL domestic economies ------with KANT/LOCKEAN MORALS AND ETHICS humanist philosophy guiding STEM research -----DO NO HARM---HIPPOCRATIC OATH----we saw over those several centuries universities with academics tied to BIOETHICS writing the PROS and CONS of all medical research with universities having IRBs with medical officials actually tied to PUBLIC BENEFIT/SAFETY deciding whether any medical product could be released to PUBLIC.
These few decades have seen our BIASED ---FOR-THE----PUBLIC GOOD BIOETHICS departments filled with global banking corporate officials who say anything global medical corporations do to earn profits is SOCIAL/PUBLIC GOOD. The academic writing from universities now working as global corporate private research departments means------
NO ETHICAL OR MORAL DISCUSSIONS AS CRITIQUE OR CONS OF ANY MEDICAL GOAL.
The only place we saw with any attempt at creating a critique ------were global banking 1% OLD WORLD KINGS -------FAKE RELIGIOUS FREEMASONRY universities such as TRINITY INTERNATIONAL UNIVERSITY/GEORGETOWN UNIVERSITY. Both are tools of global banking 1%-----
So, what do these two 'VERITAS-------NOT' institutions find wrong with ORGAN ON A CHIP? Remember, the religious right fought stem cell research---fought the idea of MESSING WITH GOD'S CREATION-----AKA ----genetically modified or artificially created humans.
The only negative theses BIOETHICS departments could find is
THIS TECHNOLOGY WOULD BE BAD IF USED BY MILITARY.
Jul 31, 2012, 12:50pm
Military's 'Body-on-a-Chip' Could Fast-Track Pharmaceuticals
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Sanchez 4:00L10
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University of Pittsburgh, Swanson School of Engineering12014-10-28
ETHICS OF ORGANS ON CHIPS
Allen Wang (axw5@pitt.edu)PURPOSE AND DILEM
Allen Wang2
The original purpose of these chips to be a newer, better way of drug testing, but it can also be used to test the toxicity of chemicals that could potentially be used harm others. Pharmaceutical companies may have no interest in such chemicals,but companies that create weaponry may be interested in using organ chips as a tool for creating new chemicals for wartime use. Organ chips which were originally created with the hopes of solving issues such as a lack of good models for drug testing can lead to ethical issues such as where do the cells you are using come from and how are you planning on using the organ chips.
National Institute of Health and the Defense Advanced Research Projects Agency are funding are working on will have the ability to replace animal models. The organ chips will mimic the actual human organ and will use primary human cells. Primary cells are cells that mimic the physiologic state of cells in the actual organism. Even though this new technology shows promise, it still raises some ethical issues such as where do the cells come from and how are you going to use the organ chips.
GETTING CELLS
The purpose of organ chips is to allow research institutions and pharmaceutical companies to test new drugs in a more accurate and ethical manner. However, in order to use the organ chips, human cells are required and in order to build a lot of chips, lots of human cells will be needed. However, it is not always easy to get these cells because human cells used in labs are often those of donors [1]. If you are working in a pharmaceutical company and your supervisor asks you to prepare a large number of chips for a very important drug that they have produced, and you do not have the cells to prepare that many chips, what should you do? One solution is to go to the hospital that supplies you and take the cells you need and use them without the patient’s permission. The cells can be obtained from patients who needed a portion of the organ removed and they gave consent to use their organ for research purposes. By taking the cells without the permission of the patient, you are acting deceptively, irresponsibly, and unethically. First, you are deceiving the patient and the hospital by taking the cells without permission. This action is also unethical because you need the patient’s permission before ever using their cells. Second, you are acting irresponsibly because you did not let your supervisor know that you do not have any cells to build the chip with. Even if the new drug is extremely important, it is even more important to act ethically and to wait to receive new cells before proceeding with the experiment.
You are violating the BMES Code of Ethics by not considering the right of the patient and using their cells without consent as an engineer working in the field of healthcare and as a researcher. By taking cells from a patient without their consent, we bring up legal issues and shame to you, your company, the hospital that supplies your company, and the engineering profession.The code of ethics from both the NSPE and BMES are very useful in reaching a final decision on what you must do as an engineer.
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We will discuss more in detail why today's MEDICAL DATA surrounding the 'successes' and future 'successes' of ORGAN ON A CHIP are FAKE NEWS---FAKE DATA with goals of simply installing a DEVELOPMENT stage totally eliminating all clinical research both animal and human to allow these SHORT-CUT studies to be used by the FDA to release these medical PHARMA and products to mainstream patient care having done absolutely no REAL research on animal/human organ systems.
These ORGAN ON A CHIP are NOT anywhere near the same functioning natural human organ system -----it is widely believed there will NEVER be any ORGAN/BODY ON A CHIP which will be able to mimic a fully functioning HUMAN ORGAN. At best, these ORGAN ON A CHIP can tell when any experimental CHEMICAL PHARMA introduced past a protective ORGAN TISSUE LINING-----will harm or kill that organ/human.
This is where concerns about goals of these ORGAN ON A CHIP tied to MILITARY RESEARCH has a goal of HARMING/WAR ZONE BIOWARFARE techniques rather than PRACTICAL CIVIL PUBLIC INTEREST MEDICINE.
What almost all research analysis indicates is this-----ORGAN ON A CHIP will never replace today's real clinical trials in animals and humans----it is a procedure being created by global banking 1% and global private military corporations to understand how human organs react to chemicals.
There is NO BASIC SCIENCE saying these ORGAN ON A CHIP will ever be able to be made to mimic functional human organs.
The Ethics of Organoids: Scientists Weigh in on New Mini-Organs
By
Edd Gent
-
Jan 27, 2017
Growing organs in the lab is an enduring sci-fi trope, but as stem cell technology brings it ever closer to reality, scientists are beginning to contemplate the ethics governing disembodied human tissue.
So-called organoids have now been created from gut, kidney, pancreas, liver and even brain tissue. Growing these mini-organs has been made possible by advances in stem cell technology and the development of 3D support matrices that allow cells to develop just like they would in vivo.
Unlike simple tissue cultures, they exhibit important structural and functional properties of organs, and many believe they could dramatically accelerate research into human development and disease.
For developmental biologists, these structures offer unprecedented insight into how cells self-organize to become organs. For those developing drugs, they provide a far more nuanced understanding of how the human body will react to certain compounds and could potentially reduce the need for research on animals or risky early trials on human volunteers.
Organoids grown from a patient’s stem cells could be used to repair damaged organs or personalize their treatment by testing how they react to different drugs. Earlier this year, a Dutch university spin-out partnered with an insurance company to launch a €3 million trial into using organoids to determine patients’ responses to new cystic fibrosis drugs.
On the face of it, it’s hard to see the downsides, but a review of the field published in Science last week highlights that things may not be as clear-cut as they seem. For a start, the authors point out that organoids are unlikely to do away with human and animal testing.
They still fail to replicate important features of real organs, such as blood vessels, nerves and immune cells, and also can’t replicate the interactions between organs that a body, animal or human would. A DARPA-funded “body-on-a-chip” could solve the latter problem by connecting organoids with a blood substitute, but the approach is still experimental.
It may make it harder to justify animal research, shifting the onus onto researchers to justify why they need to test on animals rather than organoids. And as organoids can be grown from organ-specific adult stem cells and induced pluripotent cells--adult cells that have been reprogrammed into stem cells--they could reduce the need for controversial experiments on embryonic and fetal tissue.
In the short term, though, the technology could actually lead to an increase in the use of human embryonic material, the researchers say. Currently, many organoid approaches rely on embryonic stem cells. In addition, validating organoid models will most likely require comparison to gold standard embryonic stem cell models.
If the technology takes off and is put to use for precision medicine, the lines between research and medical care may also start to blur, which may put a strain on current approaches to ethical review and have broad implications for which medicines insurance providers should cover.
Maintaining a steady supply of organoids for both medicine and research will require the creation of biobanks stocked with donated tissue, which will raise complicated challenges regarding donor consent and ownership.
It is not yet clear what patients’ attitudes towards organoids grown from their tissue will be and what they will be prepared to let happen to them. The authors also point out that for many, organoids may not be a morally neutral alternative to embryos.
An editorial in Nature points out that there will be pressure to ensure these kinds of self-organizing tissues provide the best developmental model possible. But in the extreme, this drive could lead to complete human embryos engineered from pluripotent stem cells. No embryonic material was used in its creation, but is it materially different from a human embryo?
There are many shades of gray in between. Work on mini-brains has delivered organoids that spontaneously generate electrical activity, producing brain waves. You would be hard pressed to convince anyone they were thinking as we understand it, but as these technologies get more advanced, where do you draw the line?
It’s hard to say exactly when a collection of cells becomes a living being and what the ethical implications are as you near this demarcation. As the author of the Neuroskeptic column in Discover puts it, “The funny thing is, doing this kind of research is probably the only way we’ll ever work out whether it’s ethical or not.”
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Remember, over the past 20th century whether tied to CHEMICAL TOXICITY of industrial chemicals---or to trillions of dollars in human medical research where every chemical known to man has been involved in various medical research. Indeed, most medical research done by corporate R AND D do not pass the PATIENT---SAFETY tests. Without coincidence, much research done at PUBLIC MEDICAL institutions DID end in useful medical treatment. That is because PUBLIC MEDICAL institutions BEFORE CLINTON -ERA took several decades to research and develop medical treatments. LOTS AND LOTS OF LAB RESEARCH AND LOTS AND LOTS OF CLINICAL TRIAL RESEARCH kept the public safe.
Below is typical BIOETHICS article this one from GEORGETOWN claiming that there is a need for FAST-TRACKING chemical damage done to human tissues----as if that has not already been done. Then these FAKE BIOETHIC articles tout the ending of ANIMAL TRIALS as the SOCIAL BENEFIT.
So, if one is against ORGAN ON A CHIP one is pro-HARMING ANIMALS with medical research. OH, REALLY????
As left social progressives have ALWAYS been against medical animal research done inhumanly.
KNOW WHAT??
WE DO NOT NEED 99% OF WHAT PHARMA PUSHES ON PATIENTS DISGUISED AS HEALTH CARE.
That is the problem with too many animals harmed in medical research.
Which Chemicals Are Harmful to the Human Body?
by Stanford Advanced Materials | May 21 2018
There are about 8 million chemicals in the world, of which more than 70,000 are commonly used, and thousands of new chemicals are produced every year. There are many toxic chemicals in a wide variety of chemicals, which can be harmful to the human body in the process of production, use, storage, and transportation, causing catastrophic accidents. Therefore, it is necessary to master the basic knowledge about the harm of toxic chemicals.
So, here is yet another FAKE RELIGIOUS FREEMASONRY institution giving shelter to what is the absolute worst MEDICAL POLICY they know having only the goal of ending all our modern CLINICAL TRIAL PUBLIC HEALTH SAFETY procedures.
What happened to our RELIGIOUS INSTITUTIONAL STANCE OF NOT MESSING WITH GOD'S NATURAL PROCESSES VIA HUMAN BODY?
Bioethics Blogs
If I Only Had a Brain?
Tissue Chips Predict Neurotoxicity
Caption: 3D neural tissue chips contain neurons (green), glial cells (red), and nuclei (blue).
To take this confocal micrograph, developing neural tissue was removed from a chip and placed on a glass-bottom Petri dish.
Credit: Michael Schwartz, Dept. of Bioengineering, University of Wisconsin-Madison
A lot of time, money, and effort are devoted to developing new drugs. Yet only one of every 10 drug candidates entering human clinical trials successfully goes on to receive approval from the Food and Drug Administration (FDA) [1].
Many would-be drugs fall by the wayside because they prove toxic to the brain, liver, kidneys, or other organs—toxicity that, unfortunately, isn't always detected in preclinical studies using mice, rats, or other animal models. That explains why scientists are working so hard to devise technologies that can do a better job of predicting early on which chemical compounds will be safe in humans.
OH, REALLY?????????????
As an important step in this direction, NIH-funded researchers at the Morgridge Institute for Research and University of Wisconsin-Madison have produced neural tissue chips with many features of a developing human brain. Each cultured 3D “organoid"—which sits comfortably in the bottom of a pea-sized well on a standard laboratory plate—comes complete with its very own neurons, support cells, blood vessels, and immune cells! As described in Proceedings of the National Academy of Sciences [2], this new tool is poised to predict earlier, faster, and less expensively which new or untested compounds—be they drug candidates or even ingredients in cosmetics and pesticides—might harm the brain, particularly at the earliest stages of development.
Read more at directorsblog.nih.govThe views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.
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Today's FDA is filled with staff working for global INDUSTRIAL TECHNOLOGY corporations representatives and have been behind calling far-right wing global banking FAKE GREEN REVOLUTION----left environmental------they have been behind calling far-right wing global banking FAKE NEW GREEN DEAL ----left environmental-----
The FDA has over these few decades transitioned our Federal government from being PUBLIC INTEREST in areas of food, health products, land use------to GLOBAL BIG AG-----GLOBAL BIG MEAT-----GLOBAL ONE WORLD ONE ENERGY/TECHNOLOGY GRID all of which has devastated EARTH and humanity.
So, when the FDA embraces EMULATE as a global corporation saying it will determine what is toxic or not in our human bodies ---knowing that EMULATE as a global private corporations has only ONE GOAL----MAXIMIZING PROFITS and MARKET SHARE with any product it PATENTS........
We are losing all of our US developed nation---modern medical DO NO HARM HIPPOCRATIC OATH------health care protections.
THIS IS GATEWAY MEDICINE OPENING THE DOOR TO TRILLIONS OF DOLLARS IN MEDICAL PROFITS ENDING WITH NO HEALTH/DISEASE VECTOR GAINS.
FDA to Use Emulate's Organ-on-a-Chip Technology for Toxicology Testing
Genetic Engineering & Biotechnology News –
Emulate said today it will partner with the FDA to evaluate and qualify the company’s Organs-on-Chips technology for toxicology testing to meet regulatory standards for products that include foods, dietary supplements, and cosmetics.
Through a multiyear Cooperative Research and Development Agreement (CRADA) with the FDA’s Office of Foods and Veterinary Medicine, Emulate and the agency will carry out the testing using the company’s Human Emulation System™, consisting of Organ-Chips as well as instrumentation and software apps.
“We are excited to begin this relationship with FDA as a potential first step toward accelerating the adoption of our Human Emulation System for broad application as a new testing platform for a wide range of products that are reviewed and approved by regulatory authorities to protect and improve human health,” Geraldine A. Hamilton, Ph.D., Emulate’s president and CSO, said in a statement.
Emulate has developed Organ-Chips that emulate the lung, liver, brain, and kidney. Organ-Chips are living, microengineered environments designed to recreate the natural physiology and mechanical forces that cells experience within the human body. Each Organ-Chip contains tiny hollow channels lined with tens of thousands of living human cells and tissues and is approximately the size of an AA battery.
“Each chip has three microfluidic channels,” Dr. Hamilton told GEN in 2015. “The central channel has a porous, flexible membrane that can be coated with extracellular matrix protein, providing a scaffold to anchor cells in the organ. We then seed the cells in the chip.”
FDA and Emulate researchers will initially use the company’s human, dog, and rat Liver-Chips to conduct studies aimed at assessing cross-species differences in toxicology data between humans and animal species. The partners plan to publish the data and findings from the CRADA studies, Emulate said.
Looking Beyond the Liver
The CRADA collaboration agreement—whose value was not disclosed—allows for future expansion to additional Organ-Chips, including the Intestine-Chip, Lung-Chip, and Cardiac systems. Emulate said it may conduct further training of FDA researchers on the Human Emulation System depending on the evolution of the research and additional areas of interest.
The FDA will review and provide feedback on the performance and application of the Human Emulation System for agency research. Emulate will be able to use information obtained from the FDA for further development and improvement of the system.
The Human Emulation System is designed to provide a predictive model of human response to diseases, medicines, chemicals, and foods by recreating the natural physiology of specific human tissues and organs—with greater precision and detail than other preclinical testing methods, according to the company.
Privately held Emulate holds a worldwide exclusive license from Harvard University to the IP portfolio for the Organs-on-Chips technology and related systems. The company’s founding team pioneered the Organs-on-Chips technology at the Wyss Institute for Biologically Inspired Engineering at Harvard University, from which Emulate was spun out.
Since 2012, the FDA has also worked to develop Organs-on-Chips through a public–private collaboration with the federal Defense Advanced Research Projects Agency (DARPA) and the NIH’s National Center for Advancing Translational Sciences (NCATS).
The agencies’ Tissue Chip for Drug Screening program has worked to develop 3D human tissue platforms (or “chips”) modeling the structure and function of human organs—such as the lung, liver, and heart—and then combining these chips into an integrated system that can mimic complex functions of the human body. NCATS says the program aims to improve the translational science process for predicting whether drugs will be safe and effective in humans.
Last month, researchers at Northwestern Medicine published a study in Nature Communications detailing their development of EVATAR, a miniature female reproductive tract made with human tissue as part of the public–private effort. EVATAR consists of divided compartments, each of which contains a 3D model of a different part of the reproductive tract, such as the ovaries, fallopian tubes, uterus, cervix, vagina, and liver.
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Below we see what is an UNDERSTATEMENT------no, these ORGANS ON A CHIP will never be able to model MACROSCALE ORGAN BIOLOGY-------but, global banking 1% PHARMA and MEDICAL DEVICE corporations and the FAKE DATA will say these devices confirm any new PATENTED PHARMA actually does what these ORGAN ON A CHIP say they do.
'these models may not be appropriate to model the macroscale organ biology, for example, aorta or veins and therefore, different tools may be needed for such investigations'.
What is the process goal? PERSONALIZED MEDICINE where patients CONSENT to allow organ harvesting of primary cells to build a personal ORGAN CHIP being told this chip will tell doctors what chemicals to use in treating any one disease vector.
Don't worry----there will be plenty of FEDERAL MEDICARE AND MEDICAID funding to augment the PROFITS for these ORGAN ON A CHIP corporations.
'youtube.com
IF I ONLY HAD A BRAIN ~ Wizard of OZ
Ray Bolger as the Scarecrow sings "If I Only Had a Brain" from the timeless classic hit movie Wizard Of Oz'.
WIZARD gives SCARECROW an HONORARY DEGREE as his brain------well, we know how those degrees are full of HOCUS-POCUS these few decades as well.
Emerging trends in multiscale modeling of vascular pathophysiology:
Organ-on-a-chip and 3D printingAuthor links open overlay panel
KarliGoldaAkhilesh K.Gaharwarabc
AbhishekJainahttps://doi.org/10.1016/j.biomaterials.2018.07.029
However, there are still some limitations in the current microfluidic designs that restrict the extent to which vascular disease pathophysiology can be reconstructed. Virtually most published literature on organ-on-a-chip is based on the use of polydimethylsiloxane (PDMS) as the material of fabrication. The process of fabrication with PDMS, called soft lithography, is simple and adoptable to most lab environments. With soft lithography, multi-chamber microfluidic devices separated by thin film membranes to support tissue co-cultures can be designed with high fidelity. PDMS is also biocompatible, transparent, and permeable to gases, making it very suitable for cell culture.
However, a major drawback of PDMS is that the material adsorbs small hydrophobic molecules, therefore making it very difficult to assess pharmacokinetics of drugs and toxins.
For example, if the drug is absorbed by the PDMS, then its net concentration is lower, and potential therapeutic effect or toxicity might be underestimated.
Thermoplastic materials are potential alternatives that have been used to make microfluidic chips, but they often auto-fluoresce during imaging, do not permit oxygen diffuse (making it harder for cells to survive for long durations), and can be very expensive for a high-throughput setting.
Another potential limitation is that organ-on-a-chip models are subsets of the whole living organ.
For example, the blood vessel-on-a-chip models published so far lack connective tissue, containing fibroblasts between the epithelium and endothelium, which may regulate vascular homeostasis and pathogenesis. In addition, pericytes or SMCs may need to be integrated under the endothelium for a complete biological output from these models. This is not necessarily a drawback because scientists can design the simplest model and then add additional complexity until the required combination is achieved for solving the problem of interest. For example, blood flow in arteries is pulsatile and will be a very interesting addition to vascular organ-on-a-chip technologies in the future. A major hurdle that still exists is that the cells used in these model systems may not always represent the phenotype of the local environment of the human disease or patient, and therefore, standardization of the cell-lines and growth protocols is necessary [30,82,83].
In addition, given the planar and thin (<1 mm in thickness) cellular arrangement, modeling drug-tissue interactions may be inaccurate and require careful scaling up due to varied drug pharmacokinetics and pharmacodynamics [35,56,[84], [85], [86], [87]].
Also, organ-on-a-chip models may not always include the same cellular arrangements as in vivo. They are often designed as overlaying or side-by-side rectangular channels which make them unable to recapitulate the exact flow inside a cylindrical blood vessel. This may also alter endothelial function and affect the contractility-related mechanisms of cells.
Finally, despite promising use of organ-on-a-chip, these models may not be appropriate to model the macroscale organ biology, for example, aorta or veins and therefore, different tools may be needed for such investigations.
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'The paper concludes that predatory publishing is a growing phenomenon that has the potential to greatly affect both bioethics and science at large'.
Where are many ORGAN ON A CHIP corporations taking off? BUSH----WHACKING TEXAS for one--------FAKERY LLC
Medicine, Health Care and Philosophy
June 2017, Volume 20, Issue 2, pp 163–170 | Cite as
The false academy: predatory publishing in science and bioethics
Open Access
Scientific Contribution
First Online: 07 October 2016
Abstract
This paper describes and discusses the phenomenon ‘predatory publishing’, in relation to both academic journals and books, and suggests a list of characteristics by which to identify predatory journals.
It also raises the question whether traditional publishing houses have accompanied rogue publishers upon this path. It is noted that bioethics as a discipline does not stand unaffected by this trend. Towards the end of the paper it is discussed what can and should be done to eliminate or reduce the effects of this development. The paper concludes that predatory publishing is a growing phenomenon that has the potential to greatly affect both bioethics and science at large. Publishing papers and books for profit, without any genuine concern for content, but with the pretence of applying authentic academic procedures of critical scrutiny, brings about a worrying erosion of trust in scientific publishing.
Introduction: the false academy
Researchers today are under strong pressure to publish. The old slogan “Publish or perish” is probably more to the point than ever before, nowadays further underlined by the increasingly common practice of letting bibliometric data steer the allocation of faculty funding at universities, which means that apart from the individual’s career-interest in publishing, there is additional pressure to publish from one’s department.
Partly made possible by the IT revolution, an entire industry has grown up to cater to this need, mainly based on online publication, but also offering an extensive supply of conferences (Bowman 2014). The explosion of open access (OA) journals in recent years has brought with it increased opportunities to find decent journals to place academic work in. But not all actors are interested in promoting science while making their money. Rogue publishers serve their own economic interest, while creating dubious merit for scholars publishing with them.
Some scientists may wish for an exit strategy when traditional academic publishing is perceived as slow, somewhat arbitrary in its evaluation of manuscripts, and sometimes only moderately interested in one’s work (Lagoze et al. 2015). Some might search for a short-cut to getting published, while being aware that they have chosen a journal that does not live up to acceptable academic standards. Others might get fooled and publish in a non-serious journal, inadvertently subjecting themselves to criticism afterwards—what was meant to become an academic merit might become the very opposite. Those researchers are victims of what we may call the false academy: dubious or downright fraudulent operators who strike gold from luring the young and inexperienced (Xia et al. 2015) or from researchers trying to usurp merit as effectively and with as little effort as possible (Truth 2012).
In this paper, we describe the false academy with a particular focus on “predatory publishing”, raise the question whether traditional publishing houses have entered the same path as rogue publishers, note that bioethics is a discipline affected by this trend, and, towards the end of the paper, discuss what should be done to eliminate or reduce the effects of this development.
Predatory journals
One obvious actor in the false academy is journals (Butler 2013). That academic journals have varying quality is widely known. But with the advent of open access, new opportunities have risen. Open access journals make their money from charging publishing fees, usually over 1000 euros per published paper, sometimes double that amount. Instead they usually do not charge anything for access, which means that the content of the journal is available without subscription. Modern publishing tools make this model both effective and highly profitable.
The great economic potential in this type of publishing has attracted all sorts of actors to start up professional journals (Schöpfel 2015), though quite a few with limited competence in high-quality academic publishing. Many of these questionable journals originate from India or Nigeria and primarily attract authors from developing countries (Xia et al. 2015).
Typical cases are publishers whose only business idea is to accept as many papers as possible. This they are trying to achieve by offering swift review and comparatively low fees, while mimicking the academic ambitions of serious publishers. But there are also examples of outright fraud by “cyber criminals” who hi-jack established journals by using an exact replica of the original journal’s website online, except for the account to which the fee is sent (Beall 2016; Dadkhah and Borchardt 2016; Tin et al. 2014).
Apart from the moves from printed journals to electronic publications, and from subscription fees to publication fees, open access publication introduced another important change:
in order to make money with traditional publication of subscribed journals, it was important to make sure that the journal was perceived as of reasonable quality in order for sufficiently many libraries to make the decision to pay for a subscription.
With open access journals, quality no longer plays the same role—instead the important thing, in order to make money, is to find sufficiently many willing to pay to get published. Here, lack of genuine quality does not necessarily stand in the way of success, as long as appearances are kept up to some extent.
Many researchers easily recognize so-called predatory journals when an e-mail shows up offering space for an article or providing an invitation to act as editor of a special issue. For those who don’t, it can be costly to realize that they have been caught in the web of a non-serious journal and then trying to get out; for instance, to retract an article from the predatory publisher OMICS (see below for more about them) can result in over 400 dollars in administrative fees! (Beall 2015a) Sometimes it is difficult also for the experienced to distinguish the serious journals from the not-so-serious. For a long time, Bentham Science Publishers attracted a lot of scientists to send in OA papers and act as peer reviewers and on editorial boards, by the functionality and graphic design quality of their web pages and journals. Then, for several years, the stories started to build up a picture of a questionable publisher that could publish articles without peer-review and that spammed scientists with e-mails asking for papers. Eventually, in 2008, this (and other reasons) led to the creation of the Open Access Scholarly Publishers Association (http://oaspa.org/), which strives to set standards and organize the serious open access publishers (Eysenbach 2008; Grant 2009a).
Alarming development also concerns bioethics
We have seen an alarming development in predatory publishing since then (Shen and Björk 2015) and noticed how colleagues start turning up in some of these journals. This reflects how predatory publishers increasingly target social scientists (Beall and DuBois 2016).
Not surprisingly, the field in which this journal trades, bioethics, now has its own share of predatory journals. In a recent blog, we list approximately 25 predatory journals that deal in bioethics or related subjects (Eriksson and Helgesson 2016). We have probably missed some, and we expect the number to rise unless we can discourage bioethicists from lending themselves to such journals.
For those working in other fields, a good start when trying to identify the journals to avoid is a list maintained by Jeffrey Beall, an American academic and librarian who lists potentially rogue journals and publishers (available at http://scholarlyoa.com/). On the list are about nine hundred single, independent magazines, but if one adds to them all the journals published by larger publishing houses (sometimes actually more of garage operations, as Beall has revealed many times), the number of journals is over eight thousand (Shen and Björk 2015). So this industry is not insignificant!
One way to find the proper journals is to take a look at a list of recognized open access journals, the Directory of Open Access Journals (http://www.doaj.org). Obviously, there may be journals not found in either this whitelist or in Beall’s blacklist, or it might happen that a journal is incorrectly classified. Thus, researchers about to submit manuscripts also need to look into the matter themselves.
Some of the typical signs of predatory publishing include undisclosed fees, editorial boards with unknown or apparently non-existent members, flawed functionality and design of the website, and the choice of strange partners when it comes to indexing and impact calculations (Canadian Association of Research Libraries 2015; Clark 2015; Prater 2014). For a more extensive list, see Table 1.
Table 1
Characteristics of a predatory journal
Note that the idea with this list is not to say that any journal fulfilling any of the points below is a predatory journal. But the more points on the list that apply to the journal at hand, the more sceptical you should be
The publisher is not a member of any recognized professional organisation committed to best publishing practices (like COPE or EASE)
The journal is not indexed in well-established electronic databases (like Medline or Web of Science)
The publisher claims to be a “leading publisher” even though it just got started
The journal and the publisher are unfamiliar to you and all your colleagues
The papers of the journal are of poor research quality, and may not be academic at all (for instance allowing for obvious pseudo-science)
There are fundamental errors in the titles and abstracts, or frequent and repeated typographical or factual errors throughout the published papers
The journal website is not professional
The journal website does not present an editorial board or gives insufficient detail on names and affiliations
The journal website does not reveal the journal’s editorial office location or uses an incorrect address
The publishing schedule is not clearly stated
The journal title claims a national affiliation that does not match its location (such as”American Journal of …” while being located on another continent) or includes”international” in its title while having a single-country editorial board
The journal mimics another journal title or the website of said journal
The journal provides an impact factor in spite of the fact that the journal is new (which means that the impact cannot yet be calculated)
The journal claims an unrealistically high impact based on spurious alternative impact factors (such as 7 for a bioethics journal, which is far beyond the top notation)
The journal website posts non-related or non-academic advertisements
The publisher of the journal has released an overwhelmingly large suite of new journals at one occasion or during a very short period of time
The editor in chief of the journal is editor in chief also for other journals with widely different focus
The journal includes articles (very far) outside its stated scope
The journal sends you an unsolicited invitation to submit an article for publication, while making it blatantly clear that the editor has absolutely no idea about your field of expertise
Emails from the journal editor are written in poor language, include exaggerated flattering (everyone is a leading profile in the field), and make contradictory claims (such as “You have to respond within 48 h” while later on saying “You may submit your manuscript whenever you find convenient”)
The journal charges a submission or handling fee, instead of a publication fee (which means that you have to pay even if the paper is not accepted for publication)
The types of submission/publication fees and what they amount to are not clearly stated on the journal’s website
The journal gives unrealistic promises regarding the speed of the peer review process (hinting that the journal’s peer review process is minimal or non-existent)—or boasts an equally unrealistic track-record
The journal does not describe copyright agreements clearly or demands the copyright of the paper while claiming to be an open access journal
The journal displays no strategies for how to handle misconduct, conflicts-of-interests, or secure the archiving of articles when no longer in operation
Beware that the latest trend is for predatory publishers to buy old, serious journals. In one go, they get access to former reputation, indexing, etc. For instance, the infamous “predatory” publisher OMICS bought the journal La Prensa Medica, which now asks bioethicists to submit anything publishable in the medical field (such as “calendars, case-reports, corrections, discussions, meeting-reports, news, orations, product reviews, hypotheses, and analyses”) for fast and efficient publication (quote from spam e-mail received). Another example of an established journal bought by OMICS is the Electronic Journal of Biology (http://ejbio.imedpub.com/), which can boast of being indexed by Thomson Reuters and DOAJ and thus makes it even harder to understand its true nature. Another example reported on is the journal Experimental & Clinical Cardiology (Spears 2014).
Erratic peer reviewA problem with these journals is their claim to have proper peer review of articles before they get accepted, although they often do not.
Pre-publication peer review is broadly perceived to be the golden standard in science and although new models are gaining ground (such as post-publication review), the sub-standard journals want acceptance and international recognition and thus assure their authors that submitted articles will go through a thorough and efficient peer review. If you have high quality reviewers available, that promise might come to be, but this is seldom the case.
In an effort to reveal this state of affairs, some critically-minded researchers have been putting the journals to the test. For example, an anonymous researcher from Eastern Europe sent a fictional nonsense article to a publisher named AICIT. Very quickly the publisher wrote a fake review, accepted the article, and sent an invoice to the researcher; something that then could be revealed to all and sundry (Beall 2015b). Such disclosures have been made several times in the last few years (see e.g. Segran 2015; Stromberg 2014).
There is a more general problem with false peer review. Biomed Central (BMC) discovered in November 2014 that about fifty articles were carrying false reviews. Soon they found more cases in their portfolio of journals, scattered across different journals, authors, and topics. They suspected that there must be a number of firms behind this, selling false reviews, and therefore started an investigation. The withdrawal of articles accepted on grounds of fabricated reviews is in progress, at BMC as well as in other journals (Haug 2015), and the retracted article count is now well over three hundred.
Sometimes the authors themselves provide journals with fake peer reviewers in order to secure a positive response. A consequence of this is that some journals are now reconsidering the (fairly recent) practice of asking authors for suggested reviewers (Ferguson et al. 2014). However, predatory journals unfortunately cannot be expected to put much effort into exposing such illegitimate practices, since it is not in their interest.
Manipulation of impact scores
Journals are usually indexed and receive impact points on the basis of how frequently their articles are cited in other articles. No questionable journals of the kind discussed here would get decent scores in such calculations if properly made, but figures can be manipulated. One way to do this is to create citation cartels, in which a number of journals enter into an agreement to quote each other’s articles to an excessive extent, i.e., by choice of the editor rather than by what the researchers find scientifically justified. Thus, they may all receive a higher impact (Bowman 2014; Sipka 2012).
Some magazines invite authors to help out with the manipulation of impact figures. For example, the Thammasat International Journal of Science and Technology gives the following instructions: “Please kindly give some citations related to your written article from any articles published in TIJSAT in order that the TIJSAT’s impact factor can be raised to a higher level.” (Ferguson 2015).
Another available strategy is to work with an indexing firm whose business idea is to improve journals’ official citation indexes. When the indexing service Copernicus rated a journal titled Acta Myologica to have superior impact to Nature and Science (with an astonishing impact of 53), Beall and others reacted on the peculiar calculation methods employed by this service, and have since exposed many more (Gutierrez et al. 2015).
One of the authors of this article was recently offered to write in a bioethics journal, but something did not feel right, so it was examined more closely. The publisher, which turned out to be the OMICS Group, described on their website how one of the benefits of publishing with them was that they are skilled at manipulating impact:
OMICS Group international journal’s [sic] are among the best open access journals in the world, set out to publish the most comprehensive, relevant and reliable information based on the current research and development on a variety of subjects. This information can be published in our peer reviewed journals with impact factors and are calculated using citations not only from research articles but also review articles (which tend to receive more citations), editorials, letters, meeting abstracts, short communications, and case reports. The inclusion of these publications provides the opportunity for editors and publishers to manipulate the ratio used to calculate the impact factor and try to increase their number rapidly. (OMICS 2015)
At least they are honest!A peculiar way to tamper with the impact system was displayed by a company in the genetics sector that actually payed scientists if they cited their journals in their papers (Goldacre 2015). So citing scientists got some money while the company assembled citations. The higher the impact of the journal where you manage to cite the company’s papers, the more you are paid!
Authorship for sale
Another way to get fake academic credit is by buying authorship. Science made a real scoop when they revealed what they called “China’s Publication Bazaar” on November 29, 2013. By mistake a journalist working at the magazine was offered to buy himself a place as author of an article that would be published in a rather reputable journal: International Journal of Biochemistry & Cell Biology. The journalist could play along with this scheme and follow the process from within; it turned out that four others who had received the offer actually went through with it. The actual price of getting this publication in one’s CV was the neat sum of 14,800 dollars! This was not a single, isolated event: In China there are outright paper brokers who sell access to more or less legitimate academic articles, Science’s investigation found (Hvistendahl 2013).
Not that we researchers in the West should point the finger at other parts of the world. A while ago a Canadian firm, Cloud Consulting Company, based in Toronto, advertised for thesis writers. For up to 100,000 dollars a year, the writers can devote themselves in their own home to sit and write theses for their “clients” (Coyne 2015).
The selling of authorship might occur with greater frequency in predatory publishing than in established journals, we don’t know, as predatory publishers are utterly uninterested in addressing such problems. The problem does reflect a more general trend towards profiteering on the needs and vulnerabilities that exist in a highly competitive research world (publish or perish).
Rogue book publishers
Not only journals fool researchers. Rogue book publishers also want to make money even if what they produce does not forward science one iota. For instance, the publisher IGI Global specializes in publishing large edited collections (Bogost 2008; Weber-Wulff 2007). They press a few dozen copies that cost maybe 500 euros each.
The idea seems to be that the editor of the book, a researcher craving more academic merits, gets a nice item to add to the publication list, while the publisher draws money from selling a few mandatory library copies. Ultimately the public pays the salaries of these questionable publishers, while those sections of the public truly in need of good edited collections (such as scholars from low and middle income countries who can’t afford access to many journals) stand to benefit nothing. Nor is the book likely to have any impact whatsoever on scientific development.
This market idea is just one instance of a more widespread trend called “vanity publishing”. It aims to get authors to publish at their own cost in order to give an impression of having created a solid scholarly work, although it is accepted by some “publisher” (or dressed-up printing service) for financial rather than academic reasons (Beall 2014).
Traditional publishing houses turning to the dark side?
We suggest that there is a worrying trend that practices common among predatory publishers are becoming increasingly common also among traditional publishers. If we are right, scientific publishing is becoming increasingly compromised in quality and, thus, harder to trust.
A first example is that the familiar piracy practice of spamming researchers’ email boxes with offers to submit papers in areas they know little or nothing about (like offering a bioethicist to publish papers on radiology, gene sequencing, or whatever) seems to have spread to some legitimate journals. We have numerous times been invited to write scientific papers in journals from established publishers that focus on biology, epidemiology, etc., without any acknowledgement that our expertise lays elsewhere.
Also the practice of collecting large volumes, such as extensive anthologies, sold very expensively to libraries rather than being aimed at a broad scientific audience, seems to have spread outside predatory circles.
We recently were informed by a well-known publisher that an article of ours were to be included in such a volume, which were to be printed in 175 copies that would retail for over 400 £ each. The editor was someone we had never heard of, and we had no say in the matter. While the publisher could not afford to give us any complimentary copies, the collection would be “an invaluable resource for university libraries worldwide, especially in countries where academic holdings are relatively less comprehensive” (from the e-mail informing us about the publication).
Our experience does not seem like an isolated event (Anonymous academic 2015; Askey 2009; Bogost 2008; Paul 2016; Weber-Wulff 2007).
While most traditional journals have long been profit-driven, the competition from OA as well as their own forays into the world of OA have made it painfully clear that they sometimes put revenue before all else. They typically charge considerably higher fees than most predatory journals (Ahmed 2015; Bauer 2013; Butler 2016; Cofactor 2012; Graziotin et al. 2014) and frequently turn into “hybrid” journals, which is to say that they are both subscription-based and charge individual authors willing to pay for publishing open access. In adopting strategies such as these, the major publishing houses frequently draw criticism for primarily trying to maximize revenue at the expense of scientific exchange and openness (Bohannon 2014; Shen and Björk 2015; The Cost of Knowledge 2016).
A typical sign of predatory publishing is a stubborn refusal to engage with retractions, corrections or assisting in misconduct investigations.
Recently some of the most prestigious journals in the medical field were criticized by Ben Goldacre on the COMPARE website for e.g. not accepting corrections to misleading articles or giving access to protocols when fraud is suspected (COMPARE 2016). Others have recently criticised one of the biggest open-access publishers, PLOS, for not providing authors with page proofs and then not publishing corrections for the resulting formatting errors (Chawla 2016).
Also, fake or lousy reviews, or editors disregarding thorough negative reviews, are not exclusive to predatory journals. When Bohannon wrote his famous fake papers and sent them to 304 publishers, Elsevier, Sage, Wolters Kluwer, and several university-based publishers were among those who accepted the papers (Bohannon 2013). Some journals count Nobel laurates among their contributors, yet reportedly accept papers after insanely fast peer review (Nature News article comments 2014).
Perhaps the most noteworthy example of reputable publishers engaging in questionable practices is the much-discussed case of Elsevier. They notably issued several journals that basically served as adverts for unnamed drug companies while appearing as peer reviewed medical journals, with no disclosure of sponsorship (Grant 2009b; Singer 2009).
Elsevier is also criticized for high subscription costs that exasperate even wealthy universities such as Harvard: “We faculty do the research, write the papers, referee papers by other researchers, serve on editorial boards, all of it for free … and then we buy back the results of our labour at outrageous prices,” a Harvard library director complained to The Guardian (Sample 2012). Elsevier then in several instances charged readers for access to articles already paid for by the authors to make the articles open access (Jump 2014; Mounce 2015).
It is obvious that the greed of publishing houses may conflict with scientific goals and standards. It is troublesome if predatory publishers influence traditional publishers to increase focus on profit and feel more forgiving to quality-reducing shortcuts.
What can we do?
What is so serious about the development we now see is that trust and confidence in academic publishing is undermined. To curb this trend, an increased awareness of the false academy must be disseminated among researchers and those who assess researchers (Tin et al. 2014; Think, Check, Submit 2016).
To date, it has primarily been individual activists and journalists (this often coincides) that have worked hard to reveal this phenomenon and to get research institutions, funders, and journals to pay attention to the problem and take action.
Just to mention one example, Scientificspam.net is a niche DNSBL (which stands for a DNS-based Black List) that lists spammers targeting scientists by retrieving e-mail addresses from PubMed and similar sources, in order to get mailing lists for sending unsolicited bulk email.
A noteworthy recent institutional response is the US Federal Trade Commission charging OMICS, iMedPub and some other “predators” with having deceived researchers about their services (Federal Trade Commission 2016). This case will then be decided in court. This is very welcome, but a thorough response requires several additional actions to be taken. We propose the following actions (as a first input to the discussion):
Researchers all over the world are today finding new ways to share their experiences of predatory publishing practices, through blogs, commentary fields, twitter, etc. If their reports about academic publishing are only half-true, the observed behaviour threatens the scientific record by further swamping the literature with poor or misleading papers. If disguised as proper publishing, those practices will be even harder to unmask.
Therefore it is due time to start spreading information on this phenomenon and to take measures to reveal the extent of shoddy practices and false merit. We welcome further bioethics community debate and the reporting of experiences, both in this journal and at our blog on where to publish and not to publish in bioethics (Eriksson and Helgesson 2016).
Conclusions
Predatory publishing is a growing phenomenon that affects bioethics as well as science at large. The publishing of papers and books for profit, without any genuine concern for content, but with the pretence of applying authentic academic procedures of critical scrutiny, brings about an erosion of trust in scientific publishing. These concerns relate to so-called predatory journals and book publishers, and possibly also to more traditional publishers. The gravity of the problem calls for action. We have described some present endeavours and suggested further desirable actions. Maybe a greater change is required in the longer run, where commercial and career interests are forced to take a backseat and publishing again becomes primarily a matter of furthering scholarly exchange and scientific development (Poss et al. 2014; Parsons 2016). Even though there are interesting initiatives, such as Ubiquity Press (http://www.ubiquitypress.com/), it remains to be seen how that can be accomplished on a greater scale.1
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If the goal is simply finding chemicals which when passing through an organ tissue lining can cause harm or death-----ORGAN ON CHIP will do that. The claims these research are BETTER because they eliminate animal testing is FAKE HUMANITARIANISM. The goals of GMO HUMAN ----building a body system organ by organ to create an artificially built human----IS THE ONLY GOAL in these ORGANS ON A CHIP technology.
'The original purpose of these chips to be a newer, better way of drug testing, but it can also be used to
test the toxicity of chemicals that could potentially be used harm others. Pharmaceutical companies may have no interest in such chemicals, but companies that create weaponry may be interested in using organ chips as a tool for creating new chemicals for wartime use'
By using the organ chips for purposes such as creating new drugs, we are promoting the health and welfare of the general public, but by using the organ chips to develop wartime weaponry, we are not upholding the safety, health, or welfare of the public.
BRAIN ON A CHIP
PHARMA was tired of PRETENDING to be doing clinical trials and public safety procedures----so they are creating a FAKE reason not to do ANY TRIALS.
GLOBAL PHARMA SAYS------US CLINICAL TRIAL AND PUBLIC HEALTH SAFETY POLICIES TAKE AWAY FROM OUR PROFITS-----THEY MUST DISAPPEAR.
Jul 31, 2012, 12:50pm
Military's 'Body-on-a-Chip' Could Fast-Track Pharmaceuticals
Katie Drummond
Contributor
I write about things that raise eyebrows. Or singe them right off.
The military's prepping a new weapon in their war against bio-threats and infectious ailments -- and it could, one day, transform the entire realm of pharmaceutical development.
DARPA, the Pentagon's ambitious research arm, last week announced a $37 million grant for the development of an array of "organs on a chip" designed to facilitate the study of human physiology, in particular the rapid testing of new pharmaceutical agents.
Led by a research team at Harvard's Wyss Institute for Biologically Inspired Engineering, the program will fund the creation of ten different "organ" micro-chips. All of them will be linked together by micro-channels flowing with a blood surrogate, and networked to an automated instrument capable of analyzing their functions and reactions. "With this tool, we'll be able to study how drugs interact with different organs," Dr. Don Ingber, founding director of the Institute and one of the project's leaders, tells me. "There's a unique capacity here to see cells behave the way they would inside the body."
Already, Ingber and co. have developed chip versions of a human lung (portrayed in the video above) as well as a human gut. Under the DARPA program, the team now hopes to develop additional organs, including the heart, liver, kidney and even chips that mimic human skin and muscle. In an interview with NPR this week, Ingber offered a prime example of how the body-on-a-chip program might one day work:
"So, for example, you might deliver an oral drug to the gut, see it absorbed, watch it metabolize by the liver. It's being peed out by the kidney, and you're looking for its toxicity on the heart."
Of course, given the vast complexity of a human organ, creating micro-chip versions isn't exactly an easy task. The "lung-on-a-chip," for instance, about the size of a computer USB stick, involved the creation of two tiny different channels -- one lined with airway lung cells, the other with capillary cells -- divided by a flexible membrane. The chip also contained a layer of flowing red blood cells, as well as side channels, powered by pumps and vacuums, that mimicked the stretch-and-relax rhythms of human breathing.
DARPA's interest in these novel devices is, obviously, oriented towards national defense: The agency, in recent years, has been on a mission to fast-track the development of pharmaceuticals tailored to thwart specific biological threats and curb potential pandemics. "A technological solution to increase the speed and adaptability of vaccine production is urgently needed to match the broad biological threat," the agency noted just last week, when they announced the successful creation of 10 million doses of H1N1 vaccine using plant-based production techniques.
The successful creation of these micro-chip organ mimics would further accelerate this kind of pharmaceutical development, by fast-tracking tests of a drug's human safety and efficacy. It remains to be seen just how rapidly the micro-chips could work, but DARPA does have lofty ambitions where timing is concerned. Their plant-based vaccine manufacture program is trying to turn a conventional one-year vaccine development process into a four-week one, and the agency's also funding a separate project that aspires to, as I wrote in 2010, "a vaccine to address any pathogen, developed in seven days and ready for injection shortly after."
Military applications aside, however, Harvard's micro-chip organ program could spur myriad improvements in other areas of drug development, by replacing costly, years-long lab and animal-based tests.
"Our ability to validate drugs and get them to humans is incredibly limited," Ingber says. "Right now, animal testing is the only option. And aside from time, cost and ethical issues, it isn't even necessarily accurate."
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For several hundred years of AGE OF ENLIGHTENMENT---I AM MAN having our 99% WE THE PEOPLE as CITIZENS---as educated and taking part in REAL domestic economies ------with KANT/LOCKEAN MORALS AND ETHICS humanist philosophy guiding STEM research -----DO NO HARM---HIPPOCRATIC OATH----we saw over those several centuries universities with academics tied to BIOETHICS writing the PROS and CONS of all medical research with universities having IRBs with medical officials actually tied to PUBLIC BENEFIT/SAFETY deciding whether any medical product could be released to PUBLIC.
These few decades have seen our BIASED ---FOR-THE----PUBLIC GOOD BIOETHICS departments filled with global banking corporate officials who say anything global medical corporations do to earn profits is SOCIAL/PUBLIC GOOD. The academic writing from universities now working as global corporate private research departments means------
NO ETHICAL OR MORAL DISCUSSIONS AS CRITIQUE OR CONS OF ANY MEDICAL GOAL.
The only place we saw with any attempt at creating a critique ------were global banking 1% OLD WORLD KINGS -------FAKE RELIGIOUS FREEMASONRY universities such as TRINITY INTERNATIONAL UNIVERSITY/GEORGETOWN UNIVERSITY. Both are tools of global banking 1%-----
So, what do these two 'VERITAS-------NOT' institutions find wrong with ORGAN ON A CHIP? Remember, the religious right fought stem cell research---fought the idea of MESSING WITH GOD'S CREATION-----AKA ----genetically modified or artificially created humans.
The only negative theses BIOETHICS departments could find is
THIS TECHNOLOGY WOULD BE BAD IF USED BY MILITARY.
Jul 31, 2012, 12:50pm
Military's 'Body-on-a-Chip' Could Fast-Track Pharmaceuticals
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Sanchez 4:00L10
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University of Pittsburgh, Swanson School of Engineering12014-10-28
ETHICS OF ORGANS ON CHIPS
Allen Wang (axw5@pitt.edu)PURPOSE AND DILEM
Allen Wang2
The original purpose of these chips to be a newer, better way of drug testing, but it can also be used to test the toxicity of chemicals that could potentially be used harm others. Pharmaceutical companies may have no interest in such chemicals,but companies that create weaponry may be interested in using organ chips as a tool for creating new chemicals for wartime use. Organ chips which were originally created with the hopes of solving issues such as a lack of good models for drug testing can lead to ethical issues such as where do the cells you are using come from and how are you planning on using the organ chips.
National Institute of Health and the Defense Advanced Research Projects Agency are funding are working on will have the ability to replace animal models. The organ chips will mimic the actual human organ and will use primary human cells. Primary cells are cells that mimic the physiologic state of cells in the actual organism. Even though this new technology shows promise, it still raises some ethical issues such as where do the cells come from and how are you going to use the organ chips.
GETTING CELLS
The purpose of organ chips is to allow research institutions and pharmaceutical companies to test new drugs in a more accurate and ethical manner. However, in order to use the organ chips, human cells are required and in order to build a lot of chips, lots of human cells will be needed. However, it is not always easy to get these cells because human cells used in labs are often those of donors [1]. If you are working in a pharmaceutical company and your supervisor asks you to prepare a large number of chips for a very important drug that they have produced, and you do not have the cells to prepare that many chips, what should you do? One solution is to go to the hospital that supplies you and take the cells you need and use them without the patient’s permission. The cells can be obtained from patients who needed a portion of the organ removed and they gave consent to use their organ for research purposes. By taking the cells without the permission of the patient, you are acting deceptively, irresponsibly, and unethically. First, you are deceiving the patient and the hospital by taking the cells without permission. This action is also unethical because you need the patient’s permission before ever using their cells. Second, you are acting irresponsibly because you did not let your supervisor know that you do not have any cells to build the chip with. Even if the new drug is extremely important, it is even more important to act ethically and to wait to receive new cells before proceeding with the experiment.
You are violating the BMES Code of Ethics by not considering the right of the patient and using their cells without consent as an engineer working in the field of healthcare and as a researcher. By taking cells from a patient without their consent, we bring up legal issues and shame to you, your company, the hospital that supplies your company, and the engineering profession.The code of ethics from both the NSPE and BMES are very useful in reaching a final decision on what you must do as an engineer.
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We will discuss more in detail why today's MEDICAL DATA surrounding the 'successes' and future 'successes' of ORGAN ON A CHIP are FAKE NEWS---FAKE DATA with goals of simply installing a DEVELOPMENT stage totally eliminating all clinical research both animal and human to allow these SHORT-CUT studies to be used by the FDA to release these medical PHARMA and products to mainstream patient care having done absolutely no REAL research on animal/human organ systems.
These ORGAN ON A CHIP are NOT anywhere near the same functioning natural human organ system -----it is widely believed there will NEVER be any ORGAN/BODY ON A CHIP which will be able to mimic a fully functioning HUMAN ORGAN. At best, these ORGAN ON A CHIP can tell when any experimental CHEMICAL PHARMA introduced past a protective ORGAN TISSUE LINING-----will harm or kill that organ/human.
This is where concerns about goals of these ORGAN ON A CHIP tied to MILITARY RESEARCH has a goal of HARMING/WAR ZONE BIOWARFARE techniques rather than PRACTICAL CIVIL PUBLIC INTEREST MEDICINE.
What almost all research analysis indicates is this-----ORGAN ON A CHIP will never replace today's real clinical trials in animals and humans----it is a procedure being created by global banking 1% and global private military corporations to understand how human organs react to chemicals.
There is NO BASIC SCIENCE saying these ORGAN ON A CHIP will ever be able to be made to mimic functional human organs.
The Ethics of Organoids: Scientists Weigh in on New Mini-Organs
By
Edd Gent
-
Jan 27, 2017
Growing organs in the lab is an enduring sci-fi trope, but as stem cell technology brings it ever closer to reality, scientists are beginning to contemplate the ethics governing disembodied human tissue.
So-called organoids have now been created from gut, kidney, pancreas, liver and even brain tissue. Growing these mini-organs has been made possible by advances in stem cell technology and the development of 3D support matrices that allow cells to develop just like they would in vivo.
Unlike simple tissue cultures, they exhibit important structural and functional properties of organs, and many believe they could dramatically accelerate research into human development and disease.
For developmental biologists, these structures offer unprecedented insight into how cells self-organize to become organs. For those developing drugs, they provide a far more nuanced understanding of how the human body will react to certain compounds and could potentially reduce the need for research on animals or risky early trials on human volunteers.
Organoids grown from a patient’s stem cells could be used to repair damaged organs or personalize their treatment by testing how they react to different drugs. Earlier this year, a Dutch university spin-out partnered with an insurance company to launch a €3 million trial into using organoids to determine patients’ responses to new cystic fibrosis drugs.
On the face of it, it’s hard to see the downsides, but a review of the field published in Science last week highlights that things may not be as clear-cut as they seem. For a start, the authors point out that organoids are unlikely to do away with human and animal testing.
They still fail to replicate important features of real organs, such as blood vessels, nerves and immune cells, and also can’t replicate the interactions between organs that a body, animal or human would. A DARPA-funded “body-on-a-chip” could solve the latter problem by connecting organoids with a blood substitute, but the approach is still experimental.
It may make it harder to justify animal research, shifting the onus onto researchers to justify why they need to test on animals rather than organoids. And as organoids can be grown from organ-specific adult stem cells and induced pluripotent cells--adult cells that have been reprogrammed into stem cells--they could reduce the need for controversial experiments on embryonic and fetal tissue.
In the short term, though, the technology could actually lead to an increase in the use of human embryonic material, the researchers say. Currently, many organoid approaches rely on embryonic stem cells. In addition, validating organoid models will most likely require comparison to gold standard embryonic stem cell models.
If the technology takes off and is put to use for precision medicine, the lines between research and medical care may also start to blur, which may put a strain on current approaches to ethical review and have broad implications for which medicines insurance providers should cover.
Maintaining a steady supply of organoids for both medicine and research will require the creation of biobanks stocked with donated tissue, which will raise complicated challenges regarding donor consent and ownership.
It is not yet clear what patients’ attitudes towards organoids grown from their tissue will be and what they will be prepared to let happen to them. The authors also point out that for many, organoids may not be a morally neutral alternative to embryos.
An editorial in Nature points out that there will be pressure to ensure these kinds of self-organizing tissues provide the best developmental model possible. But in the extreme, this drive could lead to complete human embryos engineered from pluripotent stem cells. No embryonic material was used in its creation, but is it materially different from a human embryo?
There are many shades of gray in between. Work on mini-brains has delivered organoids that spontaneously generate electrical activity, producing brain waves. You would be hard pressed to convince anyone they were thinking as we understand it, but as these technologies get more advanced, where do you draw the line?
It’s hard to say exactly when a collection of cells becomes a living being and what the ethical implications are as you near this demarcation. As the author of the Neuroskeptic column in Discover puts it, “The funny thing is, doing this kind of research is probably the only way we’ll ever work out whether it’s ethical or not.”
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Remember, over the past 20th century whether tied to CHEMICAL TOXICITY of industrial chemicals---or to trillions of dollars in human medical research where every chemical known to man has been involved in various medical research. Indeed, most medical research done by corporate R AND D do not pass the PATIENT---SAFETY tests. Without coincidence, much research done at PUBLIC MEDICAL institutions DID end in useful medical treatment. That is because PUBLIC MEDICAL institutions BEFORE CLINTON -ERA took several decades to research and develop medical treatments. LOTS AND LOTS OF LAB RESEARCH AND LOTS AND LOTS OF CLINICAL TRIAL RESEARCH kept the public safe.
Below is typical BIOETHICS article this one from GEORGETOWN claiming that there is a need for FAST-TRACKING chemical damage done to human tissues----as if that has not already been done. Then these FAKE BIOETHIC articles tout the ending of ANIMAL TRIALS as the SOCIAL BENEFIT.
So, if one is against ORGAN ON A CHIP one is pro-HARMING ANIMALS with medical research. OH, REALLY????
As left social progressives have ALWAYS been against medical animal research done inhumanly.
KNOW WHAT??
WE DO NOT NEED 99% OF WHAT PHARMA PUSHES ON PATIENTS DISGUISED AS HEALTH CARE.
That is the problem with too many animals harmed in medical research.
Which Chemicals Are Harmful to the Human Body?
by Stanford Advanced Materials | May 21 2018
There are about 8 million chemicals in the world, of which more than 70,000 are commonly used, and thousands of new chemicals are produced every year. There are many toxic chemicals in a wide variety of chemicals, which can be harmful to the human body in the process of production, use, storage, and transportation, causing catastrophic accidents. Therefore, it is necessary to master the basic knowledge about the harm of toxic chemicals.
So, here is yet another FAKE RELIGIOUS FREEMASONRY institution giving shelter to what is the absolute worst MEDICAL POLICY they know having only the goal of ending all our modern CLINICAL TRIAL PUBLIC HEALTH SAFETY procedures.
What happened to our RELIGIOUS INSTITUTIONAL STANCE OF NOT MESSING WITH GOD'S NATURAL PROCESSES VIA HUMAN BODY?
Bioethics Blogs
If I Only Had a Brain?
Tissue Chips Predict Neurotoxicity
Caption: 3D neural tissue chips contain neurons (green), glial cells (red), and nuclei (blue).
To take this confocal micrograph, developing neural tissue was removed from a chip and placed on a glass-bottom Petri dish.
Credit: Michael Schwartz, Dept. of Bioengineering, University of Wisconsin-Madison
A lot of time, money, and effort are devoted to developing new drugs. Yet only one of every 10 drug candidates entering human clinical trials successfully goes on to receive approval from the Food and Drug Administration (FDA) [1].
Many would-be drugs fall by the wayside because they prove toxic to the brain, liver, kidneys, or other organs—toxicity that, unfortunately, isn't always detected in preclinical studies using mice, rats, or other animal models. That explains why scientists are working so hard to devise technologies that can do a better job of predicting early on which chemical compounds will be safe in humans.
OH, REALLY?????????????
As an important step in this direction, NIH-funded researchers at the Morgridge Institute for Research and University of Wisconsin-Madison have produced neural tissue chips with many features of a developing human brain. Each cultured 3D “organoid"—which sits comfortably in the bottom of a pea-sized well on a standard laboratory plate—comes complete with its very own neurons, support cells, blood vessels, and immune cells! As described in Proceedings of the National Academy of Sciences [2], this new tool is poised to predict earlier, faster, and less expensively which new or untested compounds—be they drug candidates or even ingredients in cosmetics and pesticides—might harm the brain, particularly at the earliest stages of development.
Read more at directorsblog.nih.govThe views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.
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Today's FDA is filled with staff working for global INDUSTRIAL TECHNOLOGY corporations representatives and have been behind calling far-right wing global banking FAKE GREEN REVOLUTION----left environmental------they have been behind calling far-right wing global banking FAKE NEW GREEN DEAL ----left environmental-----
The FDA has over these few decades transitioned our Federal government from being PUBLIC INTEREST in areas of food, health products, land use------to GLOBAL BIG AG-----GLOBAL BIG MEAT-----GLOBAL ONE WORLD ONE ENERGY/TECHNOLOGY GRID all of which has devastated EARTH and humanity.
So, when the FDA embraces EMULATE as a global corporation saying it will determine what is toxic or not in our human bodies ---knowing that EMULATE as a global private corporations has only ONE GOAL----MAXIMIZING PROFITS and MARKET SHARE with any product it PATENTS........
We are losing all of our US developed nation---modern medical DO NO HARM HIPPOCRATIC OATH------health care protections.
THIS IS GATEWAY MEDICINE OPENING THE DOOR TO TRILLIONS OF DOLLARS IN MEDICAL PROFITS ENDING WITH NO HEALTH/DISEASE VECTOR GAINS.
FDA to Use Emulate's Organ-on-a-Chip Technology for Toxicology Testing
Genetic Engineering & Biotechnology News –
Emulate said today it will partner with the FDA to evaluate and qualify the company’s Organs-on-Chips technology for toxicology testing to meet regulatory standards for products that include foods, dietary supplements, and cosmetics.
Through a multiyear Cooperative Research and Development Agreement (CRADA) with the FDA’s Office of Foods and Veterinary Medicine, Emulate and the agency will carry out the testing using the company’s Human Emulation System™, consisting of Organ-Chips as well as instrumentation and software apps.
“We are excited to begin this relationship with FDA as a potential first step toward accelerating the adoption of our Human Emulation System for broad application as a new testing platform for a wide range of products that are reviewed and approved by regulatory authorities to protect and improve human health,” Geraldine A. Hamilton, Ph.D., Emulate’s president and CSO, said in a statement.
Emulate has developed Organ-Chips that emulate the lung, liver, brain, and kidney. Organ-Chips are living, microengineered environments designed to recreate the natural physiology and mechanical forces that cells experience within the human body. Each Organ-Chip contains tiny hollow channels lined with tens of thousands of living human cells and tissues and is approximately the size of an AA battery.
“Each chip has three microfluidic channels,” Dr. Hamilton told GEN in 2015. “The central channel has a porous, flexible membrane that can be coated with extracellular matrix protein, providing a scaffold to anchor cells in the organ. We then seed the cells in the chip.”
FDA and Emulate researchers will initially use the company’s human, dog, and rat Liver-Chips to conduct studies aimed at assessing cross-species differences in toxicology data between humans and animal species. The partners plan to publish the data and findings from the CRADA studies, Emulate said.
Looking Beyond the Liver
The CRADA collaboration agreement—whose value was not disclosed—allows for future expansion to additional Organ-Chips, including the Intestine-Chip, Lung-Chip, and Cardiac systems. Emulate said it may conduct further training of FDA researchers on the Human Emulation System depending on the evolution of the research and additional areas of interest.
The FDA will review and provide feedback on the performance and application of the Human Emulation System for agency research. Emulate will be able to use information obtained from the FDA for further development and improvement of the system.
The Human Emulation System is designed to provide a predictive model of human response to diseases, medicines, chemicals, and foods by recreating the natural physiology of specific human tissues and organs—with greater precision and detail than other preclinical testing methods, according to the company.
Privately held Emulate holds a worldwide exclusive license from Harvard University to the IP portfolio for the Organs-on-Chips technology and related systems. The company’s founding team pioneered the Organs-on-Chips technology at the Wyss Institute for Biologically Inspired Engineering at Harvard University, from which Emulate was spun out.
Since 2012, the FDA has also worked to develop Organs-on-Chips through a public–private collaboration with the federal Defense Advanced Research Projects Agency (DARPA) and the NIH’s National Center for Advancing Translational Sciences (NCATS).
The agencies’ Tissue Chip for Drug Screening program has worked to develop 3D human tissue platforms (or “chips”) modeling the structure and function of human organs—such as the lung, liver, and heart—and then combining these chips into an integrated system that can mimic complex functions of the human body. NCATS says the program aims to improve the translational science process for predicting whether drugs will be safe and effective in humans.
Last month, researchers at Northwestern Medicine published a study in Nature Communications detailing their development of EVATAR, a miniature female reproductive tract made with human tissue as part of the public–private effort. EVATAR consists of divided compartments, each of which contains a 3D model of a different part of the reproductive tract, such as the ovaries, fallopian tubes, uterus, cervix, vagina, and liver.
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Below we see what is an UNDERSTATEMENT------no, these ORGANS ON A CHIP will never be able to model MACROSCALE ORGAN BIOLOGY-------but, global banking 1% PHARMA and MEDICAL DEVICE corporations and the FAKE DATA will say these devices confirm any new PATENTED PHARMA actually does what these ORGAN ON A CHIP say they do.
'these models may not be appropriate to model the macroscale organ biology, for example, aorta or veins and therefore, different tools may be needed for such investigations'.
What is the process goal? PERSONALIZED MEDICINE where patients CONSENT to allow organ harvesting of primary cells to build a personal ORGAN CHIP being told this chip will tell doctors what chemicals to use in treating any one disease vector.
Don't worry----there will be plenty of FEDERAL MEDICARE AND MEDICAID funding to augment the PROFITS for these ORGAN ON A CHIP corporations.
'youtube.com
IF I ONLY HAD A BRAIN ~ Wizard of OZ
Ray Bolger as the Scarecrow sings "If I Only Had a Brain" from the timeless classic hit movie Wizard Of Oz'.
WIZARD gives SCARECROW an HONORARY DEGREE as his brain------well, we know how those degrees are full of HOCUS-POCUS these few decades as well.
Emerging trends in multiscale modeling of vascular pathophysiology:
Organ-on-a-chip and 3D printingAuthor links open overlay panel
KarliGoldaAkhilesh K.Gaharwarabc
AbhishekJainahttps://doi.org/10.1016/j.biomaterials.2018.07.029
However, there are still some limitations in the current microfluidic designs that restrict the extent to which vascular disease pathophysiology can be reconstructed. Virtually most published literature on organ-on-a-chip is based on the use of polydimethylsiloxane (PDMS) as the material of fabrication. The process of fabrication with PDMS, called soft lithography, is simple and adoptable to most lab environments. With soft lithography, multi-chamber microfluidic devices separated by thin film membranes to support tissue co-cultures can be designed with high fidelity. PDMS is also biocompatible, transparent, and permeable to gases, making it very suitable for cell culture.
However, a major drawback of PDMS is that the material adsorbs small hydrophobic molecules, therefore making it very difficult to assess pharmacokinetics of drugs and toxins.
For example, if the drug is absorbed by the PDMS, then its net concentration is lower, and potential therapeutic effect or toxicity might be underestimated.
Thermoplastic materials are potential alternatives that have been used to make microfluidic chips, but they often auto-fluoresce during imaging, do not permit oxygen diffuse (making it harder for cells to survive for long durations), and can be very expensive for a high-throughput setting.
Another potential limitation is that organ-on-a-chip models are subsets of the whole living organ.
For example, the blood vessel-on-a-chip models published so far lack connective tissue, containing fibroblasts between the epithelium and endothelium, which may regulate vascular homeostasis and pathogenesis. In addition, pericytes or SMCs may need to be integrated under the endothelium for a complete biological output from these models. This is not necessarily a drawback because scientists can design the simplest model and then add additional complexity until the required combination is achieved for solving the problem of interest. For example, blood flow in arteries is pulsatile and will be a very interesting addition to vascular organ-on-a-chip technologies in the future. A major hurdle that still exists is that the cells used in these model systems may not always represent the phenotype of the local environment of the human disease or patient, and therefore, standardization of the cell-lines and growth protocols is necessary [30,82,83].
In addition, given the planar and thin (<1 mm in thickness) cellular arrangement, modeling drug-tissue interactions may be inaccurate and require careful scaling up due to varied drug pharmacokinetics and pharmacodynamics [35,56,[84], [85], [86], [87]].
Also, organ-on-a-chip models may not always include the same cellular arrangements as in vivo. They are often designed as overlaying or side-by-side rectangular channels which make them unable to recapitulate the exact flow inside a cylindrical blood vessel. This may also alter endothelial function and affect the contractility-related mechanisms of cells.
Finally, despite promising use of organ-on-a-chip, these models may not be appropriate to model the macroscale organ biology, for example, aorta or veins and therefore, different tools may be needed for such investigations.
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'The paper concludes that predatory publishing is a growing phenomenon that has the potential to greatly affect both bioethics and science at large'.
Where are many ORGAN ON A CHIP corporations taking off? BUSH----WHACKING TEXAS for one--------FAKERY LLC
Medicine, Health Care and Philosophy
June 2017, Volume 20, Issue 2, pp 163–170 | Cite as
The false academy: predatory publishing in science and bioethics
- Stefan Eriksson
- Gert Helgesson
- Stefan Eriksson
- Gert Helgesson
- 1.Centre for Research Ethics and Bioethics, Department of Public Health and Caring SciencesUppsala UniversityUppsalaSweden
- 2.Stockholm Centre for Healthcare Ethics, Department of LIMEKarolinska InstitutetStockholmSweden
Open Access
Scientific Contribution
First Online: 07 October 2016
Abstract
This paper describes and discusses the phenomenon ‘predatory publishing’, in relation to both academic journals and books, and suggests a list of characteristics by which to identify predatory journals.
It also raises the question whether traditional publishing houses have accompanied rogue publishers upon this path. It is noted that bioethics as a discipline does not stand unaffected by this trend. Towards the end of the paper it is discussed what can and should be done to eliminate or reduce the effects of this development. The paper concludes that predatory publishing is a growing phenomenon that has the potential to greatly affect both bioethics and science at large. Publishing papers and books for profit, without any genuine concern for content, but with the pretence of applying authentic academic procedures of critical scrutiny, brings about a worrying erosion of trust in scientific publishing.
Introduction: the false academy
Researchers today are under strong pressure to publish. The old slogan “Publish or perish” is probably more to the point than ever before, nowadays further underlined by the increasingly common practice of letting bibliometric data steer the allocation of faculty funding at universities, which means that apart from the individual’s career-interest in publishing, there is additional pressure to publish from one’s department.
Partly made possible by the IT revolution, an entire industry has grown up to cater to this need, mainly based on online publication, but also offering an extensive supply of conferences (Bowman 2014). The explosion of open access (OA) journals in recent years has brought with it increased opportunities to find decent journals to place academic work in. But not all actors are interested in promoting science while making their money. Rogue publishers serve their own economic interest, while creating dubious merit for scholars publishing with them.
Some scientists may wish for an exit strategy when traditional academic publishing is perceived as slow, somewhat arbitrary in its evaluation of manuscripts, and sometimes only moderately interested in one’s work (Lagoze et al. 2015). Some might search for a short-cut to getting published, while being aware that they have chosen a journal that does not live up to acceptable academic standards. Others might get fooled and publish in a non-serious journal, inadvertently subjecting themselves to criticism afterwards—what was meant to become an academic merit might become the very opposite. Those researchers are victims of what we may call the false academy: dubious or downright fraudulent operators who strike gold from luring the young and inexperienced (Xia et al. 2015) or from researchers trying to usurp merit as effectively and with as little effort as possible (Truth 2012).
In this paper, we describe the false academy with a particular focus on “predatory publishing”, raise the question whether traditional publishing houses have entered the same path as rogue publishers, note that bioethics is a discipline affected by this trend, and, towards the end of the paper, discuss what should be done to eliminate or reduce the effects of this development.
Predatory journals
One obvious actor in the false academy is journals (Butler 2013). That academic journals have varying quality is widely known. But with the advent of open access, new opportunities have risen. Open access journals make their money from charging publishing fees, usually over 1000 euros per published paper, sometimes double that amount. Instead they usually do not charge anything for access, which means that the content of the journal is available without subscription. Modern publishing tools make this model both effective and highly profitable.
The great economic potential in this type of publishing has attracted all sorts of actors to start up professional journals (Schöpfel 2015), though quite a few with limited competence in high-quality academic publishing. Many of these questionable journals originate from India or Nigeria and primarily attract authors from developing countries (Xia et al. 2015).
Typical cases are publishers whose only business idea is to accept as many papers as possible. This they are trying to achieve by offering swift review and comparatively low fees, while mimicking the academic ambitions of serious publishers. But there are also examples of outright fraud by “cyber criminals” who hi-jack established journals by using an exact replica of the original journal’s website online, except for the account to which the fee is sent (Beall 2016; Dadkhah and Borchardt 2016; Tin et al. 2014).
Apart from the moves from printed journals to electronic publications, and from subscription fees to publication fees, open access publication introduced another important change:
in order to make money with traditional publication of subscribed journals, it was important to make sure that the journal was perceived as of reasonable quality in order for sufficiently many libraries to make the decision to pay for a subscription.
With open access journals, quality no longer plays the same role—instead the important thing, in order to make money, is to find sufficiently many willing to pay to get published. Here, lack of genuine quality does not necessarily stand in the way of success, as long as appearances are kept up to some extent.
Many researchers easily recognize so-called predatory journals when an e-mail shows up offering space for an article or providing an invitation to act as editor of a special issue. For those who don’t, it can be costly to realize that they have been caught in the web of a non-serious journal and then trying to get out; for instance, to retract an article from the predatory publisher OMICS (see below for more about them) can result in over 400 dollars in administrative fees! (Beall 2015a) Sometimes it is difficult also for the experienced to distinguish the serious journals from the not-so-serious. For a long time, Bentham Science Publishers attracted a lot of scientists to send in OA papers and act as peer reviewers and on editorial boards, by the functionality and graphic design quality of their web pages and journals. Then, for several years, the stories started to build up a picture of a questionable publisher that could publish articles without peer-review and that spammed scientists with e-mails asking for papers. Eventually, in 2008, this (and other reasons) led to the creation of the Open Access Scholarly Publishers Association (http://oaspa.org/), which strives to set standards and organize the serious open access publishers (Eysenbach 2008; Grant 2009a).
Alarming development also concerns bioethics
We have seen an alarming development in predatory publishing since then (Shen and Björk 2015) and noticed how colleagues start turning up in some of these journals. This reflects how predatory publishers increasingly target social scientists (Beall and DuBois 2016).
Not surprisingly, the field in which this journal trades, bioethics, now has its own share of predatory journals. In a recent blog, we list approximately 25 predatory journals that deal in bioethics or related subjects (Eriksson and Helgesson 2016). We have probably missed some, and we expect the number to rise unless we can discourage bioethicists from lending themselves to such journals.
For those working in other fields, a good start when trying to identify the journals to avoid is a list maintained by Jeffrey Beall, an American academic and librarian who lists potentially rogue journals and publishers (available at http://scholarlyoa.com/). On the list are about nine hundred single, independent magazines, but if one adds to them all the journals published by larger publishing houses (sometimes actually more of garage operations, as Beall has revealed many times), the number of journals is over eight thousand (Shen and Björk 2015). So this industry is not insignificant!
One way to find the proper journals is to take a look at a list of recognized open access journals, the Directory of Open Access Journals (http://www.doaj.org). Obviously, there may be journals not found in either this whitelist or in Beall’s blacklist, or it might happen that a journal is incorrectly classified. Thus, researchers about to submit manuscripts also need to look into the matter themselves.
Some of the typical signs of predatory publishing include undisclosed fees, editorial boards with unknown or apparently non-existent members, flawed functionality and design of the website, and the choice of strange partners when it comes to indexing and impact calculations (Canadian Association of Research Libraries 2015; Clark 2015; Prater 2014). For a more extensive list, see Table 1.
Table 1
Characteristics of a predatory journal
Note that the idea with this list is not to say that any journal fulfilling any of the points below is a predatory journal. But the more points on the list that apply to the journal at hand, the more sceptical you should be
The publisher is not a member of any recognized professional organisation committed to best publishing practices (like COPE or EASE)
The journal is not indexed in well-established electronic databases (like Medline or Web of Science)
The publisher claims to be a “leading publisher” even though it just got started
The journal and the publisher are unfamiliar to you and all your colleagues
The papers of the journal are of poor research quality, and may not be academic at all (for instance allowing for obvious pseudo-science)
There are fundamental errors in the titles and abstracts, or frequent and repeated typographical or factual errors throughout the published papers
The journal website is not professional
The journal website does not present an editorial board or gives insufficient detail on names and affiliations
The journal website does not reveal the journal’s editorial office location or uses an incorrect address
The publishing schedule is not clearly stated
The journal title claims a national affiliation that does not match its location (such as”American Journal of …” while being located on another continent) or includes”international” in its title while having a single-country editorial board
The journal mimics another journal title or the website of said journal
The journal provides an impact factor in spite of the fact that the journal is new (which means that the impact cannot yet be calculated)
The journal claims an unrealistically high impact based on spurious alternative impact factors (such as 7 for a bioethics journal, which is far beyond the top notation)
The journal website posts non-related or non-academic advertisements
The publisher of the journal has released an overwhelmingly large suite of new journals at one occasion or during a very short period of time
The editor in chief of the journal is editor in chief also for other journals with widely different focus
The journal includes articles (very far) outside its stated scope
The journal sends you an unsolicited invitation to submit an article for publication, while making it blatantly clear that the editor has absolutely no idea about your field of expertise
Emails from the journal editor are written in poor language, include exaggerated flattering (everyone is a leading profile in the field), and make contradictory claims (such as “You have to respond within 48 h” while later on saying “You may submit your manuscript whenever you find convenient”)
The journal charges a submission or handling fee, instead of a publication fee (which means that you have to pay even if the paper is not accepted for publication)
The types of submission/publication fees and what they amount to are not clearly stated on the journal’s website
The journal gives unrealistic promises regarding the speed of the peer review process (hinting that the journal’s peer review process is minimal or non-existent)—or boasts an equally unrealistic track-record
The journal does not describe copyright agreements clearly or demands the copyright of the paper while claiming to be an open access journal
The journal displays no strategies for how to handle misconduct, conflicts-of-interests, or secure the archiving of articles when no longer in operation
Beware that the latest trend is for predatory publishers to buy old, serious journals. In one go, they get access to former reputation, indexing, etc. For instance, the infamous “predatory” publisher OMICS bought the journal La Prensa Medica, which now asks bioethicists to submit anything publishable in the medical field (such as “calendars, case-reports, corrections, discussions, meeting-reports, news, orations, product reviews, hypotheses, and analyses”) for fast and efficient publication (quote from spam e-mail received). Another example of an established journal bought by OMICS is the Electronic Journal of Biology (http://ejbio.imedpub.com/), which can boast of being indexed by Thomson Reuters and DOAJ and thus makes it even harder to understand its true nature. Another example reported on is the journal Experimental & Clinical Cardiology (Spears 2014).
Erratic peer reviewA problem with these journals is their claim to have proper peer review of articles before they get accepted, although they often do not.
Pre-publication peer review is broadly perceived to be the golden standard in science and although new models are gaining ground (such as post-publication review), the sub-standard journals want acceptance and international recognition and thus assure their authors that submitted articles will go through a thorough and efficient peer review. If you have high quality reviewers available, that promise might come to be, but this is seldom the case.
In an effort to reveal this state of affairs, some critically-minded researchers have been putting the journals to the test. For example, an anonymous researcher from Eastern Europe sent a fictional nonsense article to a publisher named AICIT. Very quickly the publisher wrote a fake review, accepted the article, and sent an invoice to the researcher; something that then could be revealed to all and sundry (Beall 2015b). Such disclosures have been made several times in the last few years (see e.g. Segran 2015; Stromberg 2014).
There is a more general problem with false peer review. Biomed Central (BMC) discovered in November 2014 that about fifty articles were carrying false reviews. Soon they found more cases in their portfolio of journals, scattered across different journals, authors, and topics. They suspected that there must be a number of firms behind this, selling false reviews, and therefore started an investigation. The withdrawal of articles accepted on grounds of fabricated reviews is in progress, at BMC as well as in other journals (Haug 2015), and the retracted article count is now well over three hundred.
Sometimes the authors themselves provide journals with fake peer reviewers in order to secure a positive response. A consequence of this is that some journals are now reconsidering the (fairly recent) practice of asking authors for suggested reviewers (Ferguson et al. 2014). However, predatory journals unfortunately cannot be expected to put much effort into exposing such illegitimate practices, since it is not in their interest.
Manipulation of impact scores
Journals are usually indexed and receive impact points on the basis of how frequently their articles are cited in other articles. No questionable journals of the kind discussed here would get decent scores in such calculations if properly made, but figures can be manipulated. One way to do this is to create citation cartels, in which a number of journals enter into an agreement to quote each other’s articles to an excessive extent, i.e., by choice of the editor rather than by what the researchers find scientifically justified. Thus, they may all receive a higher impact (Bowman 2014; Sipka 2012).
Some magazines invite authors to help out with the manipulation of impact figures. For example, the Thammasat International Journal of Science and Technology gives the following instructions: “Please kindly give some citations related to your written article from any articles published in TIJSAT in order that the TIJSAT’s impact factor can be raised to a higher level.” (Ferguson 2015).
Another available strategy is to work with an indexing firm whose business idea is to improve journals’ official citation indexes. When the indexing service Copernicus rated a journal titled Acta Myologica to have superior impact to Nature and Science (with an astonishing impact of 53), Beall and others reacted on the peculiar calculation methods employed by this service, and have since exposed many more (Gutierrez et al. 2015).
One of the authors of this article was recently offered to write in a bioethics journal, but something did not feel right, so it was examined more closely. The publisher, which turned out to be the OMICS Group, described on their website how one of the benefits of publishing with them was that they are skilled at manipulating impact:
OMICS Group international journal’s [sic] are among the best open access journals in the world, set out to publish the most comprehensive, relevant and reliable information based on the current research and development on a variety of subjects. This information can be published in our peer reviewed journals with impact factors and are calculated using citations not only from research articles but also review articles (which tend to receive more citations), editorials, letters, meeting abstracts, short communications, and case reports. The inclusion of these publications provides the opportunity for editors and publishers to manipulate the ratio used to calculate the impact factor and try to increase their number rapidly. (OMICS 2015)
At least they are honest!A peculiar way to tamper with the impact system was displayed by a company in the genetics sector that actually payed scientists if they cited their journals in their papers (Goldacre 2015). So citing scientists got some money while the company assembled citations. The higher the impact of the journal where you manage to cite the company’s papers, the more you are paid!
Authorship for sale
Another way to get fake academic credit is by buying authorship. Science made a real scoop when they revealed what they called “China’s Publication Bazaar” on November 29, 2013. By mistake a journalist working at the magazine was offered to buy himself a place as author of an article that would be published in a rather reputable journal: International Journal of Biochemistry & Cell Biology. The journalist could play along with this scheme and follow the process from within; it turned out that four others who had received the offer actually went through with it. The actual price of getting this publication in one’s CV was the neat sum of 14,800 dollars! This was not a single, isolated event: In China there are outright paper brokers who sell access to more or less legitimate academic articles, Science’s investigation found (Hvistendahl 2013).
Not that we researchers in the West should point the finger at other parts of the world. A while ago a Canadian firm, Cloud Consulting Company, based in Toronto, advertised for thesis writers. For up to 100,000 dollars a year, the writers can devote themselves in their own home to sit and write theses for their “clients” (Coyne 2015).
The selling of authorship might occur with greater frequency in predatory publishing than in established journals, we don’t know, as predatory publishers are utterly uninterested in addressing such problems. The problem does reflect a more general trend towards profiteering on the needs and vulnerabilities that exist in a highly competitive research world (publish or perish).
Rogue book publishers
Not only journals fool researchers. Rogue book publishers also want to make money even if what they produce does not forward science one iota. For instance, the publisher IGI Global specializes in publishing large edited collections (Bogost 2008; Weber-Wulff 2007). They press a few dozen copies that cost maybe 500 euros each.
The idea seems to be that the editor of the book, a researcher craving more academic merits, gets a nice item to add to the publication list, while the publisher draws money from selling a few mandatory library copies. Ultimately the public pays the salaries of these questionable publishers, while those sections of the public truly in need of good edited collections (such as scholars from low and middle income countries who can’t afford access to many journals) stand to benefit nothing. Nor is the book likely to have any impact whatsoever on scientific development.
This market idea is just one instance of a more widespread trend called “vanity publishing”. It aims to get authors to publish at their own cost in order to give an impression of having created a solid scholarly work, although it is accepted by some “publisher” (or dressed-up printing service) for financial rather than academic reasons (Beall 2014).
Traditional publishing houses turning to the dark side?
We suggest that there is a worrying trend that practices common among predatory publishers are becoming increasingly common also among traditional publishers. If we are right, scientific publishing is becoming increasingly compromised in quality and, thus, harder to trust.
A first example is that the familiar piracy practice of spamming researchers’ email boxes with offers to submit papers in areas they know little or nothing about (like offering a bioethicist to publish papers on radiology, gene sequencing, or whatever) seems to have spread to some legitimate journals. We have numerous times been invited to write scientific papers in journals from established publishers that focus on biology, epidemiology, etc., without any acknowledgement that our expertise lays elsewhere.
Also the practice of collecting large volumes, such as extensive anthologies, sold very expensively to libraries rather than being aimed at a broad scientific audience, seems to have spread outside predatory circles.
We recently were informed by a well-known publisher that an article of ours were to be included in such a volume, which were to be printed in 175 copies that would retail for over 400 £ each. The editor was someone we had never heard of, and we had no say in the matter. While the publisher could not afford to give us any complimentary copies, the collection would be “an invaluable resource for university libraries worldwide, especially in countries where academic holdings are relatively less comprehensive” (from the e-mail informing us about the publication).
Our experience does not seem like an isolated event (Anonymous academic 2015; Askey 2009; Bogost 2008; Paul 2016; Weber-Wulff 2007).
While most traditional journals have long been profit-driven, the competition from OA as well as their own forays into the world of OA have made it painfully clear that they sometimes put revenue before all else. They typically charge considerably higher fees than most predatory journals (Ahmed 2015; Bauer 2013; Butler 2016; Cofactor 2012; Graziotin et al. 2014) and frequently turn into “hybrid” journals, which is to say that they are both subscription-based and charge individual authors willing to pay for publishing open access. In adopting strategies such as these, the major publishing houses frequently draw criticism for primarily trying to maximize revenue at the expense of scientific exchange and openness (Bohannon 2014; Shen and Björk 2015; The Cost of Knowledge 2016).
A typical sign of predatory publishing is a stubborn refusal to engage with retractions, corrections or assisting in misconduct investigations.
Recently some of the most prestigious journals in the medical field were criticized by Ben Goldacre on the COMPARE website for e.g. not accepting corrections to misleading articles or giving access to protocols when fraud is suspected (COMPARE 2016). Others have recently criticised one of the biggest open-access publishers, PLOS, for not providing authors with page proofs and then not publishing corrections for the resulting formatting errors (Chawla 2016).
Also, fake or lousy reviews, or editors disregarding thorough negative reviews, are not exclusive to predatory journals. When Bohannon wrote his famous fake papers and sent them to 304 publishers, Elsevier, Sage, Wolters Kluwer, and several university-based publishers were among those who accepted the papers (Bohannon 2013). Some journals count Nobel laurates among their contributors, yet reportedly accept papers after insanely fast peer review (Nature News article comments 2014).
Perhaps the most noteworthy example of reputable publishers engaging in questionable practices is the much-discussed case of Elsevier. They notably issued several journals that basically served as adverts for unnamed drug companies while appearing as peer reviewed medical journals, with no disclosure of sponsorship (Grant 2009b; Singer 2009).
Elsevier is also criticized for high subscription costs that exasperate even wealthy universities such as Harvard: “We faculty do the research, write the papers, referee papers by other researchers, serve on editorial boards, all of it for free … and then we buy back the results of our labour at outrageous prices,” a Harvard library director complained to The Guardian (Sample 2012). Elsevier then in several instances charged readers for access to articles already paid for by the authors to make the articles open access (Jump 2014; Mounce 2015).
It is obvious that the greed of publishing houses may conflict with scientific goals and standards. It is troublesome if predatory publishers influence traditional publishers to increase focus on profit and feel more forgiving to quality-reducing shortcuts.
What can we do?
What is so serious about the development we now see is that trust and confidence in academic publishing is undermined. To curb this trend, an increased awareness of the false academy must be disseminated among researchers and those who assess researchers (Tin et al. 2014; Think, Check, Submit 2016).
To date, it has primarily been individual activists and journalists (this often coincides) that have worked hard to reveal this phenomenon and to get research institutions, funders, and journals to pay attention to the problem and take action.
Just to mention one example, Scientificspam.net is a niche DNSBL (which stands for a DNS-based Black List) that lists spammers targeting scientists by retrieving e-mail addresses from PubMed and similar sources, in order to get mailing lists for sending unsolicited bulk email.
A noteworthy recent institutional response is the US Federal Trade Commission charging OMICS, iMedPub and some other “predators” with having deceived researchers about their services (Federal Trade Commission 2016). This case will then be decided in court. This is very welcome, but a thorough response requires several additional actions to be taken. We propose the following actions (as a first input to the discussion):
- The forming of committees for each research field to keep track of rogue actors.
- A forum for continuous sharing of experiences of the false academy (preferably financially supported by several research-promoting government agencies).
- Further use in the research area of laws prohibiting deceptive acts or practices against consumers.
- A widespread policy among universities and research funders that individuals regularly involved in activities relating to predatory publishing should not be permitted to apply for positions, promotion, or funding.
- Other actions taken by universities, individually or jointly, in order to reduce the number of publications in predatory journals, such as blacklists.
- The allocation of funds for research on the false academy.
- Software development for fast tracking of false or dubious merits in publication lists.
Researchers all over the world are today finding new ways to share their experiences of predatory publishing practices, through blogs, commentary fields, twitter, etc. If their reports about academic publishing are only half-true, the observed behaviour threatens the scientific record by further swamping the literature with poor or misleading papers. If disguised as proper publishing, those practices will be even harder to unmask.
Therefore it is due time to start spreading information on this phenomenon and to take measures to reveal the extent of shoddy practices and false merit. We welcome further bioethics community debate and the reporting of experiences, both in this journal and at our blog on where to publish and not to publish in bioethics (Eriksson and Helgesson 2016).
Conclusions
Predatory publishing is a growing phenomenon that affects bioethics as well as science at large. The publishing of papers and books for profit, without any genuine concern for content, but with the pretence of applying authentic academic procedures of critical scrutiny, brings about an erosion of trust in scientific publishing. These concerns relate to so-called predatory journals and book publishers, and possibly also to more traditional publishers. The gravity of the problem calls for action. We have described some present endeavours and suggested further desirable actions. Maybe a greater change is required in the longer run, where commercial and career interests are forced to take a backseat and publishing again becomes primarily a matter of furthering scholarly exchange and scientific development (Poss et al. 2014; Parsons 2016). Even though there are interesting initiatives, such as Ubiquity Press (http://www.ubiquitypress.com/), it remains to be seen how that can be accomplished on a greater scale.1
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