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Archive for the ‘Legal Issues Genetic Medicine’ Category

Who won this years Nobel science prizes? – The Economist

Thursday, October 8th, 2020

Oct 8th 2020

OCTOBERS FIRST week is a nervous time for scientists with serious accomplishments under their beltsfor this is when the phone might ring from Stockholm. Those who give out the Nobel science prizes (the Karolinska Institute for the physiology or medicine award, and Swedens Royal Academy of Science for the awards in physics and chemistry) are known neither for offering the winners more than an hour or twos notice of the public announcement of their success, nor for respecting time zones. New laureates in North America receive the news in the dead of night. That, though, is normally reckoned a small price to pay for what is still seen as sciences most prestigious honour.

Britain being in a more convenient time zone from the Swedish point of view, Sir Roger Penrose, of Oxford University, was not actually asleep when his own phone rang. But he was, he says, in the shower. He was one of three winners of the physics prize, the others being Andrea Ghez and Reinhard Genzel, of the University of Californias Los Angeles and Berkeley campuses respectively. Their prize was for the theoretical explanation and subsequent discovery of some of the strangest objects in the universe: black holes.

Black holes are, famously, so dense that nothing, not even light, can escape their immense gravitational pull. A black holes centre is thought to be a point of infinite density, called a singularity, where the known laws of physics break down. Though the possibility that they existed was hypothesised a century ago, as a consequence of Einsteins general theory of relativity (which is actually a theory of how gravity shapes the structure and contents of the universe), early work suggested that they could form only from the collapse of perfectly symmetrical stars or gas clouds. That is hardly realistic, and Einstein himself doubted that they actually existed.

They therefore remained a theoretical curiosity until 1965, when an as-yet-unknighted Dr Penrose worked out the specifics of how real matter could collapse in a way that would form one. He showed, using a mathematical concept which he called a trapped surface, that even asymmetric, clumpy stars and dust clouds could become black holes. This work provided the tools needed by observational astronomers to go out hunting for them.

By definition, it is impossible to see a black hole directly. Instead, physicists glean insights into them by studying the effect of their gravity on the motion of their stellar neighbours. Dr Ghez and Dr Genzel used this idea to gather evidence that Sagittarius A*a bright source of radio waves at the centre of the Milky Way, Earths home galaxyis actually a supermassive black hole around which all the stars in the galaxy, the Sun included, orbit.

Dr Ghez and her team employed the Keck Observatory telescope, in Hawaii, with its ten-metre-wide primary mirror, to make their observations. Dr Genzels group used a series of eight-metre-wide telescopes high in the mountains of the Atacama desert, in Chile, for theirs. These instruments were all sensitive enough to peer through the clouds of dust that otherwise obscure the heart of the Milky Way.

Over three decades both sets of researchers, working independently, tracked around 30 of the brightest stars at the galactic centre (see chart). A star called S2, for example, takes 16 years to complete an orbit of Sagittarius A*, and, at its closest approach, comes within 17 light-hours of it. These measurements have permitted astronomers to piece together a picture of Sagittarius A* as a black hole of around 4m solar masses, packed into a region of space that is about the size of the solar system.

April 2019 saw the release of the first-ever image of a black hole (Sagittarius A*s local equivalent at the centre of a galaxy called M87, 53m light-years from Earth). This was taken, in radio frequencies, using the Event Horizon Telescope, a collaboration that links eight existing radio telescopes all around Earth and thus permits far higher resolution than any single instrument could manage. As technology improves, the Event Horizon Telescope could also one day provide a more detailed image of the region around Sagittarius A*.

As is often the way, the chemistry prize went for a discovery that might equally well have been handed out for medicineCRISPR-Cas9 gene editing. The winners were Emmanuelle Charpentier of the Max Planck unit for the science of pathogens, in Berlin, and Jennifer Doudna of the University of California, Berkeley.

CRISPR-Cas9 is derived from a bacterial defence mechanism that snips small sequences of DNA from viral interlopers and copies them into a bacteriums own genome, thus creating a scrapbook by which to recognise such aggressors, should they come again. The laureates prize is not, though, for the mere discovery of a novel bacterial immune system. It is for the adaptation of that discovery into the most important gene-editing tool yet inventedone that is already helping to design disease-resistant crops and new therapies for cancer, and which may, perhaps, end hereditary disease in human beings.

If an organisms collective DNA can be thought of as the book of its life, CRISPR-Cas9 allows for any specific sequence of words within that book to be identified, selected, removed and replaced. This is done by creating a molecule called a guide RNA, which matches a target DNA sequence, and pairing it with an enzyme, Cas9, that is capable of snipping the DNA helix at this point. Then, if so desired, a new piece of DNA can be inserted.

The laureates path to Stockholm began at a caf in Puerto Rico in 2011. That was when Dr Charpentier, who had discovered intriguing and unexplained RNA fragments in a bacterium, engineered a meeting with Dr Doudna, an expert in the DNA-snipping capability of Cas proteins. Since this collaboration bore fruit in 2012, progress has been rapid. By February 2013 Feng Zhang of the Broad Institute in Cambridge, Massachusetts and George Church of Harvard Medical School had independently demonstrated the techniques effectiveness in mouse and human genomes, paving the way for the treatment of human diseases. Clinical trials are now under way to test its power against sickle-cell anaemia and certain cancers, with animal experiments showing promising results in the treatment of muscular dystrophy.

There has also been controversy. In 2018 He Jiankui of the Southern University of Science and Technology, in Shenzhen, China, announced the birth of twin girls whose embryos he had edited with the help of CRISPR-Cas9. Dr Hes stated goal was to induce immunity to HIV, by disabling the gene for a protein which that virus uses to gain admission to cells. This was too much for the authorities. Even ignoring the issues of consent involved when a procedure is carried out on an embryo, making genetic edits so early in life means that they will be incorporated into germ cells, and thus passed down the generations. That raises serious ethical questions, and what Dr He did was declared illegal by the Chinese government. Dr He is now in prison.

Nor is germ-line editing the only controversy surrounding CRISPR-Cas9. A further complication concerns who gets the patents that will monetise it. The University of California and the Broad have been involved for years in a legal battle over the matter. By giving the prize to Dr Doudna and Dr Charpentier the Royal Academy of Science may have put its thumb on the scales. In picking them it has also, for the first time, awarded a Nobel science prize to an all-female group. Dr Charpentier, via a phone link to the room where the announcement was made, said I hope this provides a positive message to young girls. Women in science can also be awarded prizes. But more importantly, women in science can also have an impact.

Regardless of which category it truly fits into, the creation of CRISPR-Cas9 was a high-end piece of technowizardy. The actual prize for medicine, however, went for a piece of old-fashioned medical detective workthe identification of hepatitis C, a virus that causes life-threatening liver infections and is passed on by exposure to contaminated blood. Though other widespread diseases, such as malaria and HIV/AIDS, gain more attention, the World Health Organisation (WHO) reckons that around 70m people are infected with hep C and that it kills 400,000 people a year. Hep C has also, in the past, turned the business of blood transfusion into a lottery, since there was no way to tell whether a particular batch of blood harboured it. That this is no longer the case is, in no small measure, thanks to the work of this years laureatesHarvey Alter, Michael Houghton and Charles Rice.

Dr Alters work came first. In the 1960s he was a colleague of Baruch Blumberg, who discovered the hepatitis B virus (for which he won a Nobel prize in 1976). Hepatitis viruses are labelled, in order of discovery, by letters of the alphabet. A, a waterborne pathogen, causes an acute infection that passes after a few weeks and induces subsequent immunity. The effects of B and C, though, are chronic and may result eventually in cirrhosis and cancer. Blumbergs discovery led him to a vaccine for hep B, and also meant that blood intended for transfusion could be screened. But it became apparent that such screened blood still sometimes caused hepatitis, albeit at lower rates. Since hep A was also being screened for by this time, that suggested a third virus awaited discovery.

In 1978 Dr Alter, then working at Americas National Institutes of Health, proved this was true by injecting into chimpanzees blood from recipients of transfusions screened for the known viruses who had nevertheless developed hepatitis. These animals sometimes then went on to develop the illness. It took until 1989 to clone the new virus. That was done by Dr Houghton, who was then working at Chiron, a Californian biotechnology firm subsequently bought by Novartis, a Swiss pharmaceutical giant.

Dr Houghton amplified viral genetic material drawn randomly from chimpanzees infected with the as-yet-unidentified virus and tested this against antibodies from infected humans. Antibodies are proteins crafted by the immune system to stick specifically to parts of particular pathogens. By looking at which chimpanzee-derived material the antibodies in question attached themselves to, Dr Houghton was able to isolate the virus and identify it as a type of flavivirus, a group that also includes yellow fever and dengue. He also thus provided a way of screening blood intended for transfusion.

Dr Rice, working at Washington University, in St Louis, Missouri, eliminated lingering uncertainties about whether the flavivirus Dr Houghton had identified was the sole cause of hep C. Attempts to use cloned, purified versions of it to infect chimpanzees had not worked, leading to doubts about whether it was acting alone. Dr Rice identified part of the viral genome which looked crucial to the process of infection, but was highly mutable. He suspected that this mutability was hindering successful infection in the laboratory, and was able to eliminate it by genetic engineering. The stabilised virus was, indeed, infectious to chimps.

The consequence of all this is that blood for transfusion can now be screened routinely for hep C, and drugs to treat it have now been developed. Unfortunately, this has not stopped the march of the illness. Those in rich countries have benefited. Deaths in Britain, for example, fell by 16% between 2015 and 2017. But the wider picture is grim. Some countries, such as Egypt, have recently done well. Others, less so.

One reason is that, besides transfusion, hep C is spread by drug users sharing needles. It can also be spread sexually. This stigmatises it in the eyes of some. And unlike HIV/AIDS, which spreads in similar ways but quickly developed a political lobby to find a treatment once it was discovered, no one spoke up at the beginning for those suffering from the effects of hep C.

That is starting to change. In 2016 the WHO published a strategy for the elimination of all forms of hepatitis. The tools are there to do this. Whether the will to use them also exists remains to be seen.

This article appeared in the Science & technology section of the print edition under the headline "They walked in looking like dynamite"

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Who won this years Nobel science prizes? - The Economist


Patent and Patient Rights in COVID-19: Is the Right to Exclusivity a Hamlet Question? – The Leaflet

Thursday, October 8th, 2020

Today the judicial authority may be faced with balancing patent rights and patients rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life, writes J. PRABHA SRIDEVAN.

THERE cannot be a better moment than now, the year of COVID-19, to place my argument, that the right to health and ergo the right to a life with dignity is way ahead of the right that the patented invention obtains to the owner. An open letter has been addressed by heads of States and others to the World Health Organization (WHO), Our world will only be safer once everyone can benefit from the science and access a vaccine and that is a political challenge.Now is not the time to allow the interests of the wealthiest corporations and governments to be placed before the universal need to save lives, or to leave this massive and moral task to market forces. It is equally a judicial challenge.

I argue that the right to life which logically means the right of access to medicine and the right to health, inheres in every human being and is not bestowed under any grant, and is unlimited by time. But the patent right is one granted by the State to the inventor as a quid pro quo allowing the owner to enforce and protect his right for a period at the end of which the owner shall transfer the technology and the invention comes to the public space.

In a patent litigation between the right of access to medicine and the right to property, the judge must be the sentinel on the qui vive, not just a sentinel on the alert, but literally qui vive Who shall live or Whose side are you on? Whose entitlement is heavier? Today when even the survival of the world as we know it today, depends literally upon who gets the medicine, I say the right to life is heavier.

Public interest is not an either-or factor in (Indias) Patents Act. The General Principles mentioned in the Act as being applicable to working of patented inventions, unmistakably mentions public health. The criteria for granting compulsory license are also grounded in public interest; compulsory licence can be granted in circumstances of national emergency and extreme urgency; and patents can be acquired by the State for a public purpose. Every country has similar provisions and they have been successfully employed both by the North and the South.

By creating a higher bar for determining non-obviousness, India made sure that incremental innovations did not get canonized as patents and its Section 3(d) stands out as a model of how to use the flexibilities in a way that facilitates access to health. The Supreme Court of India said (W)e shall see how the Indian legislature addressed this concern and, while harmonizing the patent law in the country with the provisions of the TRIPS Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the Developing Countries and the Least Developed Countries). The State contracts with the patentee to enforce and protect the patent rights in return for technology transfer and promotion of technological innovation, for the benefit of not just the owner but also the user, and for the enhancement of social and economic welfare.

The argument of the patent rights holder is that the exclusivity is the reward for the knowledge contributed to the world by their invention. And they must be allowed to recoup it. It is the Money, money, money in Swedish pop group ABBAs words. It is argued that without monetary incentive there will be no innovation. It is argued that the owners have the right to maximise their profits. And since the creators right is a human right too and has been recognised as such, it is not bound to give way to right to health.

Even in the text of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the social objectives like health needs and access to medicine are inbuilt. But however good a covenant or instrument may be, if those who are implementing it are not good, it will prove to be bad. However bad that covenant or statute may be, if those implementing it are good, it will prove to be good. And it is the wise judge who weighs in these objectives in the balance.

The United Nations Human Rights Council has confirmed the primacy of human rights, such as the right to health over trade, intellectual property rights and other bilateral investment or trade agreements. Resolution 32/L.23 reaffirms the importance of access to medicines for all human beings as one of the fundamental human rights and stresses that improved access could save millions of lives every year.

The Constitution of every country contains implicitly or explicitly an assurance that there is a fundamental right to life. This must be expansively construed. The right to life, we acknowledge, encompasses several rights each one of them being basic and fundamental. The(y) are the right to live with dignity, the right to shelter and the right to health. The State is obligated to ensure that these fundamental rights are not only protected but are enforced and made available to all citizens.

How far can the Court stretch its arm to help? Rejecting the argument that courts can only issue declaratory orders, the South Africa Court said, The nature of the right infringed and the nature of the infringement will provide guidance as to the appropriate relief in a particular case. Where necessary this may include both the issuing of a mandamus and the exercise of supervisory jurisdiction.

It is basic that the power to grant carries with it the power not to grant. But without going to that extreme, the judiciary has enough aids to facilitate access.

The Costa Rica-initiated COVID-19 Technology Access Pool (C-TAP) aims to make vaccines, tests, treatments and other health technologies to fight the virus accessible to all. This indicates the importance of access. If the vaccines and other health technologies are manufactured in developed countries, and made available only to the people there, and even within those countries, only to those groups who have access, it would be inviting disaster of a pandemic proportion.

The Nagoya Protocol can be used as a tool. What has been overlooked in the ongoing discussions on IP issues and COVID is that the Nagoya Protocol and its obligations require sharing of benefits arising from the use of genetic resources. Thus, any commercialisation of COVID- related treatment and/or prevention can be argued to be bound by this protocol and its benefit- sharing provisions.

The judicial authority faced with balancing right to life against right to exclusivity and monetary gains has several tools to employ and to innovate solutions.

It is clear that TRIPS had the pious intent of balancing public health. Even if it had got skewed midway, the course can be corrected now. There is sufficient compass guidance within TRIPS for the judicial authority to rule in favour of access.

It is undeniable that adequate access to affordable medicine or treatment to the stricken cannot be facilitated just by a judicial fiat. It needs executive will, and there are bilateral treaties and other tangential statutes that may come in the way of the TRIPS flexibilities having full play. The initiative and the incentive that a willing generic manufacturer can show is another issue. Even the generics, it is feared, may sing the same song. Sales of drugs will naturally be incentivized to focus on those who can pay more, rather than the vast masses who cannot afford much. This not only unnecessarily raises prices, but reduces the possibility of weak patents being challenged. What effect will the present economic slow-down have on the generic manufacturers? This is, in the words of Prof. Shamnad Basheer a decision that calls into consideration issues of economic and political viability. In other words, the problem of access moves beyond the realm of the purely legal into the realms of economics and politics.

The judicial authority will have to choose life. Forced to choose between protecting the essential right to life an unalienable right assured by the Constitution (Art.5) or over ruling it in favour of secondary or financial interests of the State, I understand, as this dilemma is set out, that judicial ethics dictate to the judge only one possible option: to decide in favour of the undeniable right to life. While intellectual property right (IPR) has been termed as a human right, it is undeniably a granted right, and can be ungranted. The right to life and the right of access to health is a far superior right. It is a right we are born with, like the right to dignity, and we cannot be disrobed of that right.

The time has come to innovate and find an alternative to the present patent system, one which does not rest solely on access-denying exclusivity, but one where innovation and access can co- exist. A monopoly today could literally kill millions. Commenting on the judgment of the Australia High Court in DArcy v. Myriad Genetics, it is observed, This judgment raises the question whether a patent regime should allow quality of life to be the commodity of a monopoly.16

Today that commodity will not be just the quality of life but the very continuance of life. The consequences of a pandemic cannot be geographically limited if supply of the cure is so limited. Even a superficial scan of the demography of the most vulnerable argues the case in favour of access. Therefore, the South should present an alternative where both rights can be harmonised without jeopardising lives or diminishing the quality of lives.

This has happened earlier and the South has resisted such corporate and political hegemony that has facilitated the capitalization of health in various forms, and has been of vital importance and ha(s) won significant victories, but ha(s) not managed to transform or reverse the structural appropriation of health by capital.

The judicial authority must infuse itself with a spirit of constitutionalism that depends upon an interpretive, non-technocratic hermeneutics and has emerged as a democratic counter weight to logics of multinational pharmaceutical capital. It shall weigh in the huge public interest factor when orders of injunction are sought for and cannot ignore it. There are dismal examples of when it should not have been granted. One might convincingly argue that a patent right is predominantly a commercial or market-oriented property interest and is therefore compensable in monetary terms. And commercial interests can never take precedence over saving lives.

There is no acceptable data correlating the expenses incurred in inventing a drug and the price at which the drug is sold. The poser of whether there will be any invention without the rights being enforced and monetized is an arguable one. Assuming without conceding that it is so, it is possible to devise a different model of remuneration than the present one. The exclusive private ownership model lends itself to predatory tactics.

Instead we may have other innovative methods like a patent pool working in cooperation with not just countries and international organizations but also the hundreds of researchers, innovators, companies and universities involved. This will help in combating the crisis and earning collectively. It may be time to think of a pervasive compensatory liability regime. It is not that this tension between the two rights has gone unnoticed. The Sub-Commission on the Promotion and Protection of Human Rights adopted Resolution 2000/7 on Intellectual Property Rights and Human Rights which has an antagonistic approach to TRIPS.

The relationship between the private rights and the public health rights should be spatially expanded in tune with the constitutional aspirations rather than narrowly viewed as a private grasp of the patent owning few. The Court shall explore the various models of rewarding or compensating the inventor, but the Court shall and is bound to defer to the always superior claim of the right to health over right to exclusivity. Today Hamlets question must be answered in favor of life.

(Justice Prabha Sridevan is a former Judge of the Madras High Court and Chair of the Intellectual Property Appellate Board of the Government of India. Views are personal. The article was first published in SouthViews.)

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Patent and Patient Rights in COVID-19: Is the Right to Exclusivity a Hamlet Question? - The Leaflet


FDA Oversight of Laboratory-Developed Tests Continues To Evolve – JD Supra

Thursday, October 8th, 2020

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administrations (FDA) oversight of laboratory-developed tests (LDTs). The administration declared that LDTs, which are a subset of in vitro diagnostic tests (IVDs) developed and used in-house by clinical laboratories, would not be subject to premarket review by the FDA absent formal agency rulemaking. This announcement reversed the position that the FDA staked out in late February 2020, when it issued a guidance document for the industry on the development of IVDs to diagnose COVID-19.

The February guidance set expectations regarding the analytical and clinical validation of IVDs used to address the pandemic and included most complex LDTs intended to diagnose the disease. The FDA published a second policy in March allowing for independent authorization of LDTs by states and expounded on these policies again in May.

The FDAs oversight of LDTs in the context of COVID-19 promulgated with little fanfare given the exigencies of the pandemic represented yet another turn in the agencys mercurial relationship with these controversial diagnostics that dates back more than four decades. Because the administration and the Department of Health and Human Services has now rescinded the FDAs prior guidance, laboratories must decide whether to voluntarily seek an emergency use authorization from the FDA for their LDTs, which would provide the tort protections associated with all such authorized countermeasures, or to proceed without it. Longer term, the future and degree of FDA oversight of LDTs will remain uncertain until either the FDA undertakes a formal rulemaking process or Congress takes legislative action.

IVDs are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, according to the FDA. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. The FDA began regulating them as medical devices when Congress amended the Food, Drug and Cosmetic Act in 1976 to create the comprehensive regulatory scheme providing for the risk-based medical device classification system and premarket review process that exists today. Components of IVDs, such as antibodies, specific receptor proteins, ligands, nucleic acid sequences and other analyte-specific reagents, are also subject to FDA oversight as medical devices. Most of the hundreds of IVDs on the market today have been cleared by the FDA as Class II medical devices, which are sold to laboratories across the country.

The disconnect in this area is that, at the same time the FDA developed a robust regulatory process for premarket review of IVDs, it adopted a decidedly laissez faire approach to regulation of LDTs, a subset of IVDs that are designed, manufactured and used within a single laboratory for clinical use. The FDA perceived LDTs as low risk due to their limited number and primary use in rare disease contexts. Accordingly, LDTs were not subject to the agencys robust premarket evaluations of analytical and clinical validity. Analytical validity focuses on whether a test can accurately and reliably measure what it claims to measure, whereas clinical validity focuses on whether the measurement is predictive of a certain state of health. The result is a bifurcated market, in which IVDs developed for commercial sale are held to rigorous FDA standards while homegrown tests developed for the same uses inside the developers lab are not.

The FDAs oversight of laboratory-developed tests in the context of COVID-19 represented yet another turn in the agencys mercurial relationship with these controversial diagnostics that dates back more than four decades.

Medical and technological advances over the past four decades have driven the development of LDTs to cover a wide range of conditions, including human papillomavirus, Lyme disease, whooping cough, certain cancers and heart disease. The growth of the LDT industry has led to concerns among stakeholders about whether current regulatory oversight of LDTs, led primarily by the Centers for Medicare and Medicaid Services (CMS), is sufficient to ensure their safety and effectiveness. Reports of inaccuracies in cervical cancer testing led to the enactment of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which extended federal regulations to all laboratories performing testing on human specimens for the purpose of diagnosis or treatment. Under the CLIA, CMS evaluates the analytical but not clinical validity of LDTs during accreditation surveys of laboratories. These surveys are conducted on a biennial basis, so it may take up to two years after an LDT has been offered for clinical use before its analytical validity is confirmed by regulators.

In July 2010, the FDA announced its intent to reconsider its long-standing policy of enforcement discretion with respect to LDTs after identifying issues with several high-risk LDTs and hosted a public workshop to gather feedback from industry stakeholders. Four years later, the FDA issued draft guidance proposing a regulatory framework for LDTs. It followed up a year later with a report on 20 case studies of potential and actual patient harm arising from inaccurate or unreliable LDTs that supported the need for increased LDT oversight. Members of the lab and diagnostic industry pushed back against the FDAs new position, asserting the FDA had no right to regulate LDTs in the first place. They argued LDTs were clinical rather than medical devices and that regulation would constitute an intrusion into the practice of medicine. Industry stakeholders were also concerned that FDA oversight would stifle innovation, raise costs for laboratories and limit patient access to LDTs they deemed vital to public health.

In January 2017, the FDA announced it would not finalize the guidance and invited Congress to address the issue. To advance the discussion, however, the FDA published a position paper synthesizing feedback it received from stakeholders as well as its own views on appropriate oversight that would balance the need for innovation with the need for assuring the safety and effectiveness of LDTs. The FDA proposed an approach in which agency oversight would be phased in over several years based on risk. The proposal would grandfather tests already on the market and exempt from most oversight LDTs that are low risk or intended for rare diseases, forensic use, public health surveillance and so-called traditional tests that use components that are legally marketed for clinical use and whose output is the result of manual interpretation by a qualified laboratory professional, without the use of automated instrumentation or software for intermediate or final interpretation. All other tests, including modified versions of grandfathered tests, would be subject over time to adverse event and malfunction reporting, premarket clearance and approval, and CLIA-based quality requirements. The FDA reserved the right to take action against any LDT, even those exempted from the phased-in requirements, in the event of deceptive promotion or inadequate validation.

Many stakeholders interpreted the FDAs announcement as a retreat to the long-standing position of enforcement discretion while it turned the issue over to Congress to resolve. The reality was less clear, however, as the agency continued to assert its jurisdiction over LDTs in certain circumstances. In October 2018, FDA issued a guidance warning that many genetic tests on the market that claim to predict a patients response to specific medications had not been reviewed by the agency and might not be supported by requisite scientific or clinical evidence. In April 2019, the FDA issued a warning letter to Inova Genomics Laboratory alleging that its genetic tests, which were offered for the same purpose, were adulterated and misbranded, and posed a significant public health concern because they had not been adequately validated. Notably, the FDA rejected Inovas assertions that the company was operating within an LDT Exemption by explaining that no exemption existed and that the agency never created a legal carve out from its premarket review processes for LDTs. The agency also asserted that it retained the discretion to take action against LDTs when appropriate despite its long-standing policy of exercising enforcement discretion. The FDAs unpredictable approach toward LDTs left members of the lab and diagnostic industry unsettled and anxious about federal challenges to the legality of their tests.

Facing the COVID-19 pandemic, the FDA took another step toward more complete oversight when it included LDTs in its polices for other IVDs intended to diagnose the disease. The position was no doubt fueled by the FDAs desire to ensure a measure of analytical and clinical validity for all complex tests used to diagnose the disease, given the obvious exigencies and public health equities at issue. However, the Trump administrations August 19 announcement formally rescinds guidance and other informal statements from the agency concerning premarket review of LDTs. The move frees developers of LDTs to act without FDA pre-review, which offers a measure of clarity for the market but also triggers concern from public health experts who believe now is the time for more oversight, not less.

Against this backdrop, there may be greater pressure than ever on Congress to take up the issue. Lawmakers have made several attempts at determining the future of LDT regulation. A draft bipartisan bill released in March 2017 outlined a regulatory framework for LDTs based in part on a proposal by the Diagnostic Test Working Group, a coalition of industry stakeholders. After feedback from the FDA, lawmakers unveiled a new bill, the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act, in December 2018. On March 5, 2020, lawmakers introduced a revised VALID Act with bipartisan sponsorship.

The VALID Act would create a new regulatory framework to govern the development and use of all in vitro clinical tests (IVCTs), which would include both IVDs and LDTs. The proposal would replace the three-tiered system used to regulate other medical devices with a two-tiered system consisting of low- and high-risk tests (although the legislation would allow the FDA to develop special controls for certain high-risk tests, which could evolve into a third tier of moderate-risk devices). The legislation would require premarket evaluation and compliance with quality system regulations unless an exemption applied. Like the FDAs 2017 proposal, the act would exempt low-risk tests such as those intended to treat rare diseases and some LDTs that are already in use. Current LDTs not eligible for grandfathering under the act would be handled under special transitional provisions. The legislation also includes a precertification program intended to reduce regulatory burdens and provide priority review/breakthrough concepts. The program is modeled after those that exist today for other medical products to support expedited development and review of novel tests or tests intended to treat a life-threatening or irreversibly debilitating human disease or condition.

Whether and when Congress will act on the legislation is unclear. The current controversy surrounding COVID-19 testing is sure to put a spotlight on this issue, and the VALID Act has bipartisan support in committees of jurisdiction in both chambers. But the United States is heading toward another presidential election, and the current Congress has been notably partisan. The Medical Device User Fee Amendments must be renewed in September 2022, and that must-pass legislation is a likely vehicle for enactment of the VALID Act if it is not taken up beforehand. Some form of the legislation certainly could move in the next year, but the window is tight given the election and the other pandemic-related causes, which will take priority.

In the meantime, industry stakeholders should closely monitor developments in the LDT space. LDTs and related genetic tests play a significant role in health care decision-making, and a new regulatory framework will have major implications for the future of these products. But critical questions remain, including whether Congress will take action and whether the FDA will eventually act if Congress does not. Whether the FDA intends to respond to the August 19 announcement by initiating a rulemaking or formally modifying its 2017 position is unclear. The FDA likely will wait for the outcome of the election and take stock of its options then. Regardless of how, if at all, a more defined regulatory framework for LDTs ultimately crystallizes, the latest announcement makes clear that lasting guidance is necessary for all parties to navigate the world of LDTs with some measure of certainty, both during COVID-19 and beyond.

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FDA Oversight of Laboratory-Developed Tests Continues To Evolve - JD Supra


One Sperm Donor. 36 Children. A Mess of Lawsuits. – The Atlantic

Tuesday, September 15th, 2020

I discussed the case of Donor 9623 with Dov Fox, a professor of health law at the University of San Diego. Fox covered the lawsuits in his book, Birth Rights and Wrongs, and he has spent the past year diving even deeper into the case of Donor 9623interviewing parents who were deceived, children coming to terms with their genetic inheritance, and eventually the donor himself for a new Audible podcast.

Read: IVF mix-ups have broken the definition of parenthood

Fox and I have spoken before about the ways embryo mix-ups and other examples of reproductive technology gone awry confound the law and the very notion of parenthood. Tens of thousands of babies are born with the help of reproductive technology every year in the U.S., yet fertility clinics and sperm banks remain surprisingly unregulated. Mistakes, when they happen, have deeply existential consequences. Before the podcasts release last week, we talked again about Donor 9623 and how courts try to make sense of the uncomfortable idea of wrongful birth, a term that he argues makes no sense.

This interview has been edited for length and clarity.

Sarah Zhang: In your book, you covered several cases where reproductive technology gone wrong poses these really hard questions: white parents who were inseminated with the wrong donor sperm and ended up with a Black child, parents who had aborted based on an incorrect fetal diagnosis, a surrogate who didnt want to relinquish the child. What specifically drew you to this case of Donor 9623 so much that you wanted to do a whole podcast about it?

Dov Fox: I thought this case was really gray. It wasnt that there was just an obvious loophole in the legal framework or the law hadnt caught up to the advances in technology. It raised really deep, hard, fundamental questions about human existence, with an eye to the future of gene editing and embryo screeningwhat it means to be a parent and what is reasonable for would-be parents to expect. Thats an uncomfortable place for judges and for lawmakers.

This was one of the very largest and most international sperm banks that shipped to tens of thousands of parents in dozens of countries all over the world. This is an especially popular donor for more than a decade. And there were so many parts of his history that were concealed or misrepresentedhis health and his criminal record and his educational background.

Zhang: You say this is an uncomfortable place for judges and lawmakers, and while wrongful-birth lawsuits get a lot of attention, they havent been very successful in court in the U.S. Why is that?

Fox: A lot of courts that say no to wrongful-birth claims say its about protecting the individual children. And theres intuitive appeal to this idea. God, how awful would it sound to the child to learn that their life, their existence, is wrongfulthat their parents didnt want them, dont want them, wanted a different kid instead, dont love them. Thats not what parents intend, but that doesnt necessarily mean that it doesnt express that, whether to their kids or to other groups who have the very condition that their kids have.

One Sperm Donor. 36 Children. A Mess of Lawsuits. - The Atlantic


Poaching pressure mounts on jaguars, the Americas’ iconic big cat –

Tuesday, September 15th, 2020

In late November 2019, authorities in Peru found two jaguar cubs in a house in Chanchamayo, in the countrys central Amazonian region. The cubs were so young that they still had part of the umbilical cord attached; their mother was nowhere to be found. Legal proceedings were opened against the alleged poachers, and although the cubs were taken to a specialized zoo, they died within a few weeks. Separation from the forest and their mother can be fatal for jaguar cubs.

The cubs were among 86 seizures associated with the species by Peruvian authorities between 2015 and 2020. In addition to live animals, authorities have recovered fangs, skins, skulls and other body parts, according to the National Forest and Wildlife Service (SERFOR). Studies by SERFOR and the Wildlife Conservation Society (WCS) indicate that the nine jaguar-related items seized in 2019 represent less than 10% of what can be found in some illegal markets around the country.

The seizures effectively amount to the tip of the iceberg when it comes to the illicit trade in parts and live specimens of jaguars in Peru, which is home to the second-largest population of the big cat in South America, behind only Brazil. The total wild population of the species is about 163,000, according to 2018 estimates by the Venezuelan Institute for Scientific Research (IVIC) and the big cat conservation NGO Panthera.

In this investigative series, Mongabay Latam starts out with a regional snapshot of the plight of the jaguar. We interview more than 10 scientists to look at the threats and strategies to conserve this species in six countries: Bolivia, Ecuador, Guyana, Peru, Suriname and Venezuela.

163,098 The estimated jaguar population in South America is around 1.95 jaguars per 100 square kilometers an average disaggregated by South American country: Brazil / Peru / Colombia / Bolivia / Venezuela / Guyana / Suriname / Ecuador / French Guyana / Paraguay / Argentina

A four-month study by WCS and SERFOR in Peru shows that the illegal trade in jaguar parts is more common than previously thought. During visits to 21 locations in Iquitos, the capital of the Amazonian region of Loreto, researchers found 96 jaguar parts for sale in markets, handicraft shops, piers and even hotels. Jaguar fangs and claws were found embedded in necklaces and bracelets, while skins were hung up on show along public highways, almost like paintings or carpets.

Their investigation also covered two other cities in the Peruvian Amazon Pucallpa (in the Ucayali region) and Puerto Maldonado (in Madre de Dios) as well as Puno in the Andes. In total, they found 102 jaguar parts for sale publicly: 45% of these comprised skins, 37% fangs, 14% claws, and the remaining 4% were jaguar fat and skulls. Three-quarters of these parts were incorporated into handicrafts. The price of fangs, depending on the buyer, ranged from 30 to 1,000 soles ($9 to $280).

We have normalized animal trafficking; in Latin America we are used to seeing these kinds of scenes, says Liliana Juregui, an expert in environmental justice at the IUCN NL. Her organization has coordinated investigations in Bolivia and Suriname, countries where the first evidence of the rise of international trafficking of jaguar parts to Asia was uncovered seven years ago.

Despite the seriousness of the problem, data for seizures of jaguar parts in these countries have not been recently updated. In Bolivia, cases stopped being counted in early 2019, as attention focused on environmental emergencies such as massive forest fires, as well as the political upheaval that led to a change of government, according to ngela Nez, a biologist specializing in jaguars who researches trafficking as part of Proyecto Operacin Jaguar (Operation Jaguar Project) in Bolivia.

Since 2014, we have seized around 700 fangs, including a seizure in China [of fangs] that originated from Bolivia, Nez says, emphasizing the need to continue monitoring this environmental crime. According to the Bolivian Ministry of Environment and Water, there have been more than 20 legal actions taken related to the illegal trafficking of fangs, with five of the cases resulting in criminal sentences.

Research conducted by the IUCN NL also found that the demand for jaguar parts in Bolivia began in 2013 and was advertised through radio stations and posters distributed in rural areas. Between 2014 and 2016, the trafficking problem was underway in earnest, with 300 jaguar parts found in 16 postal packages, 14 of them sent by Chinese citizens working in Bolivia.

The facts that link the trafficking of jaguar parts to Asia, particularly China, are sensitive, considering that the most affected countries, such as Bolivia and Suriname, have sought to diplomatically resolve the problem by establishing alliances with the Chinese community within their territories.

But if there is one thing scientists in the six countries agree on, its the link between jaguar trafficking and the presence of companies engaged in Chinese-backed infrastructure projects in areas of high biodiversity, such as the Amazon. A study published in early June by the journal Conservation Biology examined the relationships between trafficking of wild cats and Chinese investments in South and Central America.

Among the main findings were that trafficking has been increasing and that the Chinese citizens involved in illegal activities dont belong to the Asian communities already established in these countries, but are instead workers who travel to the Amazon to work on the megaprojects such as new dams and roads. Chinese companies have invested heavily in developing countries, first in Africa and then in South America, says Guyanese geographer Anthony Cummings, who also investigates the trafficking of jaguar parts in his country. While we are not trying to stigmatize, it is important to be aware of the connection.

In Suriname, for example, the IUCN has found evidence of trafficking since 2003, when a former forest service employee there was contacted by the owner of a Chinese supermarket in the capital, Paramaribo, who was looking for jaguar fangs and claws. Esteban Payn, regional director of Pantheras northern South America program, says that due to the significant decline of tigers in Asia, demand for big cat parts used in traditional medicine seems to have been filled by parts from other big cats. Its suspected that this may be one of the reasons why trafficking of jaguar parts is growing in Latin American countries.

Large-scale illegal mining and logging have been observed in Surinames Brownsberg Nature Park. An estimated 40,000 people live within and around these mining camps, though only 18,000 people are formally registered. Links between this activity and wildlife trafficking are being investigated.

According to the IUCNs Juregui, this is an important hypothesis. We believe that there are links to illegal logging and its trade, or to gold routes. Trafficking routes are cross-border and take advantage of their porosity, she says, referring to how criminal groups use the same routes to traffic gold, timber and wildlife.

Although the trafficking of jaguar parts is the obvious threat, there are other clear dangers for the continents top predator. Cummings mentions two in Guyana: conflict between jaguars and ranchers or farmers, and with gold miners in the Guyanese jungle, as both groups kill the animals in retaliation for attacking their livestock, crops or pets.

Despite the cries for help from Latin American countries, it has not been possible [to vary their level of protection], says Rodrigo Medelln, a scientist at the Latin American Alliance for Jaguar Conservation. Even the leopard has been categorized as at risk of extinction, despite having a larger area of occupancy than the jaguar, he says of the big cat species found in Africa and Asia.

See related: Is Chinese investment driving a sharp increase in jaguar poaching?In Venezuela, Mara Fernanda Puerto, founder of Proyecto Sebraba, an NGO that studies jaguars, says there are no official numbers for seizures, and that jaguars are at constant threat from the use of their parts in Sanera, a popular belief system in some parts of the country, which has even attracted parishioners with political power. We have reports of local consumption of these animals, and that there is a risk of reporting when a jaguar or ocelot has been seized. Once it has been done, within a few hours [the report] disappears, Puerto says.

In her investigation into the threats to jaguars, she has encountered a prisoner incarcerated in southern Lake Maracaibo with a jaguar skin hanging in their cell as a symbol of power. It is on display there, despite it being a crime.

In other countries, such as Ecuador, where no significant evidence of trafficking of jaguar parts has been found, alerts continue to be triggered due to the strong pressure of deforestation and habitat loss. Galo Zapata-Ros, scientific director of WCS in Ecuador, says that in the countrys Amazon region, there has been a 30% loss of habitat.

In the Choc area, 90% has been deforested now due to the advancement of livestock and agriculture, such as the cultivation of African [oil] palm, he says. This area is an important jaguar corridor between Ecuador and Colombia. The growth of such monocultures near protected natural areas is also occurring in Peru and Brazil, where these areas play a crucial role in big cat conservation.

To protect a species, its important to understand it. This applies to the jaguar populations in each of the six countries in questions, where investigations began in 2013 after the first evidence of a rise in trafficking of jaguar parts in Bolivia appeared.

Key data on jaguars in South America. In this region there are 23 populations and 60 jaguar conservation units (JCUs). Sources: Jaguar populations: Antonio de la Torre, Jos F. Gonzlez-Maya, Heliot Zarza, Gerardo Ceballos and Rodrigo Medelln, 2018. Average number in jaguar conservation units: Data Basin/Panthera, 2010.

On the IUCN Red List, the jaguars conservation status is categorized as being near threatened, an assessment that many in the scientific community say doesnt reflect their concerns. As with many other species, the lack of information is a factor in whether the jaguar should be placed under one of the threatened categories: vulnerable, endangered, or critically endangered. Vania Tejeda, biodiversity officer for WWF in Peru, says its difficult to raise the alarm about the dangers faced by jaguars without investigations to demonstrate that they exist. It is difficult to push policies when there is no supporting scientific information, she says.

Recent findings, such as a 60% reduction in the species original habitat across South America, indicate that the threat is significant. Some range countries, aware of this problem, have begun to invest in the research necessary to categorize these species conservation status within their territory. For instance, the libros rojos de la fauna silvestre (wildlife red books) of Bolivia, Venezuela and Ecuador the national equivalents of the IUCN Red List assess the jaguar populations in the Amazon as being vulnerable, and the population inhabiting the Ecuadoran coast as critically endangered. In Peru, the species is listed as near threatened, but scientists led by Jos Luis Mena, director of the WCS Species Initiative in Peru, want to bring together studies carried out in recent years to improve their level of protection.

For scientists such as Rodrigo Medelln and Antonio de la Torre from the Latin American Alliance for Jaguar Conservation, there is already sufficient evidence to recategorize the jaguars conservation status at the continental level. De la Torre says that only by raising the status to vulnerable moving it from near threatened into a threatened category will it be possible to increase resources for its conservation, in turn drawing public and political attention to its care. The call for attention of an international organization may be heard more than that of local biologists and conservationists, he says.

However, there is one more step that must be taken along with the categorization, and for which more studies are also needed: the protection of habitats.

See related: A jaguar nicknamed Short-Tail is the first known to cross between Belize and Guatemala

In Peru, says Jos Luis Mena, five jaguar conservation units, or JCUs, have been identified in recent years. These are spaces that should be protected by law as important jaguar habitats, but have not been recognized as such by the state.

We must identify which are the priority areas for this conservation, as [jaguars live] in protected areas, Mena says. There is also an analysis of which spaces these corridors should support.

Peruvian scientists have begun to collect information in the northern jungles of Loreto and the southern ones of Madre de Dios. But the countrys central forests and the Ucayali region still need to be covered, Mena says. In these latter locations, in particular, cases of trafficking of jaguar parts have been detected, with six of the 11 seizures recorded between 2019 and 2020 occurring in these areas.

The lack of data in Bolivia is also evident, with many questions still unanswered: Where are the jaguars? How many are there? What spaces should be protected? According to Nez from Proyecto Operacin Jaguar, studies have focused mainly on two protected areas: Madidi and Kaa-Iya national parks in the Gran Chaco region. Outside the protected areas, where the jaguar is most at risk, not many studies are carried out on the species, she says.

Even in protected spaces such as Tariqua National Flora and Fauna Reserve, where jaguars move freely, there is no clear idea of how many there are, Nez says. The need for information becomes more urgent against the increase in oil and gold extraction and hydroelectric activities within the parks and reserves. Operation Jaguar, an IUCN NL project carried out in Bolivia, Guyana and Suriname, aims to conserve the big cats by identifying the most vulnerable areas to focus on.

Across South America, jaguar populations face very similar dangers, with little difference between the various range countries. Ecuador also has to contend with a lack of information, and has started updating its national jaguar conservation plan to identify existing research and determine who will be involved in new studies.

Jessica Pacheco, from WWF Ecuadors forest and freshwater program, says theres already information on the jaguar population in Cuyabeno Fauna Production Reserve, but not, for example, on the population that moves through the Achuar Indigenous territory along the border with Peru. Pacheco is especially interested in studying the latter area since, she says, It is not a national protected area but has still maintained high levels of wildlife conservation.

To this list of areas to explore, Galo Zapata-Ros of WCS adds the Andean foothills and the corridors that connect them to the Ecuadoran Amazon. We know very little about what happens in these areas and there are records of the jaguar above 2,000 meters [6,600 feet], he says, adding that WCS will start a project in these places in 2021. Zapata-Ros says cross-border corridors, such as those that link Yasun and Cuyabeno with La Paya Natural National Park in Colombia or with Geppi National Park in Peru, should not be forgotten. Jaguar conservation must have a transboundary approach, he says.

In Venezuela, to reaffirm the importance of the connection between jaguar populations, Proyecto Sebrabas Mara Puerto uses satellite imagery to identify routes that can link Sierra de Perij Park with Cinagas de Juan Manuel. Esteban Payn of Panthera says that to complete the puzzle, it would be ideal to revive the proposal for a park that would link Colombia and Venezuela, in the area of Sierra del Perij, where jaguars are known to move through.

But Puertos enthusiasm is tempered by the reality of the political situation in Venezuela. The corridor that links to Colombia should be protected, but there has already been a rejection of this proposal by the Ministry of Environment of Venezuela, she says, adding that theres no national plan for jaguar conservation in her country.

For 12 years, Puerto has concentrated her work in Cinagas de Juan Manuel National Park, south of Lake Maracaibo in Zulia state, where she estimates there are up to 3.37 jaguars per 100 square kilometers. This is an important number considering that the jaguar population density for the whole of Venezuela is an estimated 1.97 per 100 km2 with around 11,500 of the big cats in the grasslands alone according to a study by Wlodzimierz Jedrzejewski and other scientists from IVIC and Panthera.

Further research on jaguars in Venezuela may include the region of Los Llanos and the state of Amazonas. In Guyana and Suriname, research has focused primarily on threats to jaguar populations. According to Jedrzejewskis study, there are an estimated 11,500 jaguars in both countries, though there arent enough studies yet to confirm this.

Further research on jaguars in Venezuela may include the region of Los Llanos and the state of Amazonas. In Guyana and Suriname, research has focused primarily on threats to jaguar populations. According to Jedrzejewskis study, there are an estimated 11,500 jaguars in both countries, though there arent enough studies yet to confirm this.

In Guyana, biologist and geographer Cummings has been studying jaguars in his native country since 2014. He says the Guyanese government, represented by the Management and Conservation of Wildlife Commission, is currently interested in systematizing the data generated by studies, such as one hed been conducting on the animals situation in four Indigenous communities a few months ago through camera traps and drones. However, this study has been halted due to the quarantine, though there are hopes for it to be resumed before the end of the year.

At the end of 2018, 14 of the 18 countries that are home to jaguars joined forces to launch the Jaguar 2030 Plan, a road map for the conservation of the animal and the 30 landscapes it inhabits. This plan highlights priority areas to ensure the survival of the species, such as the JCUs, corridors that link territories both inside and outside the countries, and, above all, the importance of protecting natural areas that are part of their habitat.

Protected natural areas are those that will prevent human-made threats, says Vania Tejeda from WWF Peru. She adds that a recent WWF study of protected areas in Peru, Ecuador and Colombia has verified the effectiveness of such areas in keeping jaguar populations stable and ensuring the forests are healthy.

There are examples throughout South America: in Bolivia, Rob Wallace, a scientist who has studied jaguars for more than 20 years, highlights the Tambopata-Madidi transboundary landscape that encompasses natural areas in Peru (Tambopata National Reserve and Bahuaja-Sonene National Park) and Bolivia (Madidi National Park and Piln Lajas Biosphere Reserve).

Since the beginning of 2000, together with colleagues Guido Ayala and Mara Viscarra, Wallace has carried out research using camera traps that revealed a density of 0.5 jaguars per 100 km2 in 2001. By 2008 the density was up to 2, and by 2014 between 5 and 6. Since then, however, hunters have put severe pressure on the species. In 2019, the scientists carried out new monitoring that will more reliably depict the big cats current situation.

Wallace highlights the importance of joint work between countries and uses South Americas jaguar subpopulation map as evidence. According to research carried out in 2018 by Antonio de la Torre and other scientists from the Latin American Alliance for Jaguar Conservation, 26 of the 34 subpopulations are located in cross-border areas. This was also one of the main reasons outlined in the Convention on the Conservation of Migratory Species of Wild Animals (CMS) for the jaguar to be included in Appendices I and II. This would oblige each country to boost conservation efforts for the species and work with other range countries on cross-border protection.

Positive and negative factors are converging in the fight for the survival of this feline, says Rodrigo Medelln from the Latin American Alliance for Jaguar Conservation. Although the pressures of trafficking and habitat loss are evident, he notes that international conservation strategies, such as the Jaguar 2030 Plan, along with growing interest in expanding studies and taking actions to protect jaguars, have increased under the IUCN and global wildlife trade treaty CITES. Medelln says each country must also commit to start concerted actions in the next five years.

One of these actions is the Jaguar Corridor, a Panthera initiative that forms part of the Jaguar 2030 Plan and seeks to preserve genetic continuity between the JCUs through key cross-border sections. The area it covers spans 6 million km2, about three times the size of Mexico. As Pantheras Payn says, The Jaguar Corridor should act as a layer to generate better sustainable decisions for South Americas development. This means understanding where to build a road and where to permit areas for agriculture.

WWF Ecuadors Pacheco says countries should consider the sociocultural situations of the communities near the areas where jaguars are found as part of their conservation strategies. In updating the national conservation plan, we are taking this link with the communities into account. The process must be observed holistically, while also considering the educational side and exchange of information, she says.

Sometimes it can be difficult to sell the concept of conservation to local populations, even with animals as charismatic as the jaguar. But for Guyanese scientist Cummings, its necessary to start with everyday situations. If we know that having water is directly linked to the presence of jaguars in the forests, we might see it differently: that the environments health is directly connected to my health, that when an animal is wiped out, it has implications for my quality of life.

Banner image credit: Kipu Visual.This story was first reported by Mongabays Latam team and published here on our Latam site on June 17, 2020.

Read more Mongabay stories about jaguars here and big cats in general, including lions and tigers, here.

See original here:
Poaching pressure mounts on jaguars, the Americas' iconic big cat -


Nebraska Medical Bill initiative blocked from entering the November ballots – Cannabis Health Insider

Tuesday, September 15th, 2020

Gray mold on cannabis plants is a sign of a fungal disease called Botrytis blight. It appears as a thick blanket of webs on the plants and causes severe damage to the buds during growth and even after harvest.

In most cannabis plants, gray mold starts growing on the inside of a bud before appearing on the outside. One of the preventative measures that cultivators can take early on is to protect the buds from moisture. Using tents or greenhouse to cover plants can help to attain this.

Other than this, there are a number of other techniques that can help to stop the infection from damaging the plants. Here is a complete guide to prevent and control the infection.

Typically, gray mold causes a discoloration of plant buds and a lot of moisture retention in the leaves. This causes lesions to appear on the plant, advancing into a rot in later stages. The final stage that follows after this is the appearance of the mycelium, or gray mold in the affected plant.

According to experts, if an infection appears to be gray on the outside, it is most probably gray mold. For confirmation, examining a microbial infection under a microscope can provide solid answers.

The good news for cannabis cultivators is that although gray mold is a fairly common fungal disease, it is not aggressive. It does not harm any healthy plant tissue to progress further. In fact, the disease enters the plant through pruning cuts, damages caused by insects or dying tissues of spent leaves.

As mentioned earlier, Botrytis blight does not damage healthy tissue. It enters plants through wounds created by insects. Therefore, one of the first steps to ensure protection from gray mold is to inhibit insects and diseases from attacking the plants.

Like most fungal infections, Botrytis blight flourishes in humid and dark conditions. Just 12 hours of wetness and 90% humidity levels can set the infection in motion.

This is one of the major reasons of mature plants getting infected. The dense leaf and flower growth in mature plants inhibits ventilation, creating ideal conditions for the sporadic growth of the infection.

Opening up plants for more sunlight absorption can discourage the spread of the fungal infection in plants.

Using water management techniques like drip irrigation and proper drainage can be helpful in controlling this problem. Experts also suggest the use of a couple of humidity meters in cultivation facilities for maximum control.

In addition, small tips like watering the plants early in the morning and maximizing time between watering can ensure moisture control in the plants.

End users of cannabis usually consume the plant through inhalation or smoking. This is why using commercial fungicides on the crops for treatment is highly discouraged.

One of the primary ingredients for treating fungal infections is Myclobutanil. A number of studies have found that it turns into Cyanide gas while smoking, posing serious threat to the health of the end user.

Using organic fungicides is an alternate option for crop growers. Using potassium bicarbonate, bacillus amyloliquefaciens and Tetra Crop Control can help to stop the spread of infection if it is spotted early enough.

It is noteworthy that some cannabis strains are naturally mold resistant. Being inhabitants of wet and humid climates, these strains naturally have naturally developed resistance to the infection.

To curb the spread of gray mold, there are a number of techniques that can be applied by growers of cannabis plants.

Removing moldy buds and sterilizing the plants can inhibit the growth of gray mold on other parts.

Sterilizing equipment used in pruning damaged plant parts will ensure infection containment. Proper disposal of damaged parts after solarization will also ensure that the pathogens have been completely destroyed.

Botrytis has a tendency to feed on dying leaves. Therefore, removing any possible habitat can assure the infection does not thrive.

Plucking fan leaves off the plant can also be a possible step towards maintaining ventilation and humidity in its surroundings.

For assuring the best possible mold free harvest, it is important to consider the environment of the drying rooms of the harvested crops.

More often than not, buds are put in drying rooms that are humid or have a polluted airspace. In other cases, storing them while they were not completely dry starts the development of the mold.

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Nebraska Medical Bill initiative blocked from entering the November ballots - Cannabis Health Insider


‘There is a sense of being robbed’: Olympian Caster Semenya loses appeal on testosterone rule – The World

Tuesday, September 15th, 2020

South African Caster Semenya won the 800-meterrun at the Rio Olympics in 2016.

But a rulingfromthe Swiss Supreme Court on Tuesday means Semenya won't get to defend her title at next year's Olympics unless she takes medication to lower her testosterone levels.

Semenya, a two-time Olympic champion,has a genetic condition known as hyperandrogenism that elevates the level of male sex hormones in her body. A new rule institutedin 2018 by World Athletics, an international governing body, disqualifies her from competing internationally because of that condition. Semenya has been fighting that rule since it was passed, and with Tuesday's decision, she lost her second appeal.

Semenya's longtime attorney, Gregory Nott,has said theymay challenge the judgment in Swiss and European courts. He joinedThe World's host Marco Wermanfrom Johannesburg.

Related:So what if some female Olympians have high testosterone?

Gregory Nott: Look, we were very disappointed, naturally, to get the ruling that we have. However, the past has shown us that 7% of CAS [Court of Arbitration in Sports] rulings have been overturned by the [Swiss] Supreme Court. And so the odds were stacked against us. Yes, we were disappointed. Were we completely flabbergasted? No.

I mean, at the end of the day, this is the dignity of Caster. And would a judgment like that be found against a male runner? Would it be found against, let's say, a European runner? Would we find ourselves in the same position?

She's very positive. She spoke this is her quote: The doors are closed, but not locked. And so, she sees an opportunity, whether it be legal means alternatively, track means, athletic means of still fighting back, still making her presence felt among competitors.

Well, very simply put, it was seen as an advantage.

So, that particular ruling was to negate or try to create fairness within the complete section of runners under a women's race. And for that reason, a particular level a cutoff, as it were, [was established]. Anyone above that level had to have hormonal or surgical interventions to ensure that their testosterone levels were dropped.

Now, one would argue, did [Michael] Phelps have to have his feet cut off because he had bigger feet than the other swimmers?

[Caster] was born as a woman. And she has she competed as such.

Well, partly. And a large part of the appeal was the human dignity and human rights of Caster, and the effects of these regulations upon her dignity, upon her self-image and a whole variety of other human rights issues as well.

Never. She won't do it, period. That's ... never... you'll never find her do it.

She's absolutely strong-willed, and there's absolutely no way that she will take any medicine or hormonal interventions at all, physically.

She testified as much and she said as much publicly. So you won't find her doing that. No.

I see the will of Caster. I see her indomitable spirit. I see her as a person, as a human being. And I think that really strikes a chord. It resonates, and I identify with her in so many ways. I see the love of our country for her.

You know, the one thing I really hate are bullies and I've always hated them since I was a young schoolboy. So, I can't stand it, and I don't like the lean on her. Quite frankly, I've seen the lean on her since I first represented her 10 years ago, and that really riles me up. And you know, I was involved in activist law many years ago, decades ago. And its within my very being. And Caster, for me, resonates.

And she's not only a client, but a family friend, and part of the family. So, for me, I'm very passionate about her. I love the way she holds herself and carries herself. And if you knew South Africa, and where she came from, and the fight that she's actually had to do and take, [that] would be an extraordinary story that she has told. And it deserves telling, because there's such an example for others and not only others in South Africa, but others who want the opportunity and the rest of the world. You want to see justice done at the end of the day and you want to see fair play. So, there is a sense of being robbed.

This interview has been edited and condensed for clarity.

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'There is a sense of being robbed': Olympian Caster Semenya loses appeal on testosterone rule - The World


Global Microbiome Sequencing Market Growth Drivers, Demands, Business Opportunities and Demand Forecast to 2026|Clinical-Microbiomics A/S; Diversigen;…

Saturday, September 5th, 2020

A new research study from Data Bridge Market Research with title Microbiome Sequencing Insights 2019, Global Analysis and Forecast to 2026 provides an in-depth assessment of the Microbiome Sequencing including key market trends, upcoming technologies, industry drivers, challenges, regulatory policies, key players company profiles and strategies. Some of the leading key players profiled in this study:BIOLOG; Cosmosid Inc; Illumina, Inc.; Metabiomics Corp.; Oxford Nanopore Technologies; BaseClear B.V.; BGI; BioMathematica; Charles River; CoreBiome, Inc.; Clinical-Microbiomics A/S; Diversigen; Eurofins Scientific; LABCYTE INC.; Leucine Rich Bio Pvt Ltd.; Microbiome Insights; MICROBIOME THERAPEUTICS, LLC; Thermo Fisher Scientific Inc.; Molzym GmbH & Co. KG; Norgen Biotek Corp.; Phase Genomics Inc.; QIAGEN; Resphera Biosciences, LLC; Shoreline Biome; StarSEQ GmbH; Viome, Inc.; Zymo Research among others.

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Global microbiome sequencing marketis expected to rise to an estimated value of USD 3455.33 million by 2026, registering a healthy CAGR in the forecast period of 2019-2026. This rise in market value can be attributed to the focus of various researchers on utilization of this technology in the development of personalized medicine and dietary applications.

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Global Microbiome Sequencing Market Growth Drivers, Demands, Business Opportunities and Demand Forecast to 2026|Clinical-Microbiomics A/S; Diversigen;...


Legal and Regulatory Issues in Genetic Information …

Monday, August 31st, 2020


With the onset of the Human Genome Project, social concerns about 'genetic information discrimination' have been raised, but the problem has not yet been highlighted in Korea. However, non-medical institutions' genetic testing which is related to disease prevention could be partially allowed under the revised "Bioethics and Safety Act" from June 30, 2016. In the case of one domestic insurance company, DTC genetic testing was provided for the new customer of cancer insurance as a complimentary service, which made the social changes related to the recognition of the genetic testing. At a time when precision medicine is becoming a new standard for medical care, discipline on genetic information discrimination has become a problem that can not be delayed anymore. Article 46 and 67 of the Bioethics Act stipulate the prohibition of discrimination on grounds of genetic information and penalties for its violation. However, these broad principles alone can not solve the problems in specific genetic information utilization areas such as insurance and employment. The United States, Canada, the United Kingdom, and Germany have different regulations that prohibit genetic information based discrimination. In the United States, Genetic Information Non-Discrimination Act takes a form that adds to the existing law about the prohibition of genetic information discrimination. In addition, the range of genetic information includes the results of genetic tests of individuals and their families, including "family history". Canada has recently enacted legislation in 2017, expanding coverage to general transactions of goods or services in addition to insurance and employment. The United Kingdom deals only with 'predictive genetic testing results of individuals'. In the case of insurance, the UK government and Association of British Insurers (ABI) agree to abide by a policy framework ('Concordat') for cooperation that provides that insurers' use of genetic information is transparent, fair and subject to regular reviews; and remain committed to the voluntary Moratorium on insurers' use of predictive genetic test results until 1 November 2019, and a review of the Concordat in 2016. In the case of employment, The ICO's 'Employment Practices Code (2011)' is used as a guideline. In Germany, Human Genetic Examination Act(Gesetz ${ddot{u}}ber$ genetische Untersuchungen bei Menschen) stipulates a principle ban on the demand for genetic testing and the submission of results in employment and insurance. The evaluation of the effectiveness of regulatory framework, as well as the form and scope of the discipline is different from country to country. In light of this, it would be desirable for the issue of genetic information discrimination in Korea to be addressed based on the review of related regulations, the participation of experts, and the cooperation of stakeholders.

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Legal and Regulatory Issues in Genetic Information ...


The legal aspects of genetic testing – Medical Defence Union

Monday, August 31st, 2020

Interpretation of genetic test results

It is important that cytogenetic and molecular genetic test results are correctly interpreted to ensure that patients receive accurate information about their risks, particularly where different mutations in the same gene may result in a different phenotype, risk or the need for a particular type of follow-up.

New generation tests may not only identify mutations in genes which we expect or predict to find in a patient, but also other changes which may be more difficult to interpret. Careful thought has to go into whether or not patients or prospective parents are informed of these findings. This can create a very difficult situation for healthcare professionals, where there may be no way of knowing the significance of the finding. It is possible that the incidental finding is a variation of normal and therefore of no consequence to the patient.

On the other hand, the genetic change may be of significance, in which case patients may need to be told that a change has been observed, but with no information to inform them of what this might mean. This could be particularly difficult in prenatal testing where any concern raised about the foetus genome is likely to cause a great deal of anxiety.

With new genome sequencing it is hoped that medical care will become more personalised, allowing earlier and more accurate diagnosis to be made and better care to those with conditions like cancer. It is hoped that treatment will be more effective as it will be individualised for the patient's needs and the use of specific medication and their dosages will be tailored to the particular patient. This will all depend, of course, on the correct interpretation of results.

It is obviously a patient's choice as to whether they want to have genetic testing done. Whether or not it is offered may depend on their risk, and of course that the risk is identified at the outset. A patient may have an increased risk of a particular condition for a number of reasons, including their family history, environmental factors or their age.

A claim for clinical negligence could arise where a risk has not been identified and testing or screening not offered, and that patient suffers as a consequence. For example, a female patient presenting in early pregnancy may disclose a strong family history of mental retardation. If the clinician is not alert to this, the offer of appropriate referral to genetics services and testing for mental retardation syndromes (such as Fragile X syndrome) will not be made available to the patient.

This is clearly a problem that can arise for any type of test, not just results of genetic tests. A patient may come to harm where results are requested but not returned, or returned and not acted upon. It is important that there are robust systems in place to ensure that when a test is requested, it is followed up appropriately and any necessary action taken in a timely manner.

Failing to advise patients of the outcome of genetic tests may result in them missing out on vital preventative screening or being offered the option of prophylactic surgery. Similarly, prospective parents may go ahead with their plans to start a family, unaware of the fact that there is a risk of an inherited genetic condition in their offspring.

Where prenatal testing has taken place, there is the possibility of claims arising from misinterpretation of results or the failure to offer testing where appropriate. 'Wrongful birth' claims arise where a prospective mother is not advised of a condition that might affect a future pregnancy, or may be affecting her current pregnancy, and therefore is not given the option of deciding whether to conceive or to continue her pregnancy. If a child is subsequently born with a disability as a result of the condition, a claim may be pursued.

Genetic and genomic medicine is a constantly changing and developing field. As patient care becomes more personalised - with pharmacogenetics, for example, where medications are prescribed based on a patient's individual genome - there is the potential for more medico-legal and ethical questions to be raised. The MDU will continue to assist members in managing any risks as they arise.

Medico-legal adviser


Kathryn has been a medico-legal adviser with the MDU since 2007 and is a team leader, trainer and mentor in the medical advisory department. Before joining the MDU, she worked in paediatrics gaining her MRCPCH in 2002 and did her specialty training in clinical genetics. She has an MA in Health Care Ethics and Law, a Bachelor of Law and a Professional Doctorate in Medical Ethics. She is also a fellow of the Faculty of Forensic and Legal Medicine and has previously been an examiner and Deputy Chief Examiner for the faculty exam. Kathryn is currently a member of the faculty's Training and Education Subcommittee.

The legal aspects of genetic testing - Medical Defence Union


Their view: Now is not the time to legalize marijuana – Wilkes Barre Times-Leader

Monday, August 31st, 2020

August 26, 2020

Food and Drug Administration Commissioner Steven Hahn, having been battered around for his egregiously inaccurate endorsement Sunday of a purported COVID-19 treatment pushed by President Donald Trump, walked that endorsement back Monday and Tuesday.

It isnt enough. Hahn has damaged his credibility, possibly beyond repair, and taken the credibility of the FDA down with him at a crucial moment when the agencys trustworthiness may be more important than at any time in its 114-year history.

He has behaved like a Trump sycophant rather than the head of an independent, science-based arm of the federal government, and for that he has to go.

I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma, Hahn tweeted Monday, at the start of an apology round that also took him to CBS This Morning. The criticism is entirely justified, he tweeted. What I should have said better is that the data show a relative risk reduction, not an absolute risk reduction.

On CBS, he said, I could have done a better job and should have done a better job at that press conference explaining what the data show.

Lets take a closer look at what this is all about, and why Hahns most recent statements are insufficient.

The issue involved convalescent plasma, which is blood fluid taken from patients who have recovered from COVID-19. Its then transfused into new COVID-19 patients, with the aim of allowing antibodies the original patients developed during their illness to fight the infection in the new patients.

Sundays White House press conference was called to announce that the FDA had issued an emergency use authorization for convalescent plasma in COVID-19 cases. This move isnt tantamount to FDA clinical approval and has little practical effect, since researchers already were using the substance in clinical trials.

But it does raise the possibility that the general public will think that the FDA has concluded that it works for COVID-19 patients, for which there is still no evidence.

In short, the FDAs announcement benefited no patients or researchers. It smacked of being timed to coincide with the start of the Republican National Convention, which opened Monday with Trumps renomination. Hahn denies that the timing was anything but coincidental.

Convalescent plasma has been used for about 100 years as treatment for other diseases. It has never been a miracle drug or a breakthrough, as Trump has described it. Though researchers have seen some evidence that it may help seriously ill COVID-19 patients, medical experts strongly doubt that it will be a breakthrough drug now.

That brings us to Hahns original error.

As I reported, at a White House press conference Sunday, Hahn stated in Trumps presence that for patients treated with convalescent plasma there was a 35% improvement in survival, which he called a significant clinical benefit. He tried to explain what he meant by adding that, of 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.

None of that is true. The Mayo Clinic study on which his remarks were based says nothing of the kind. It says that preliminary results from its trial show that patients given convalescent plasma with a high concentration of antibodies and receive it within three days of diagnosis with COVID-19 have a 35% better survival rate than those given plasma with a low concentration of antibodies and who receive it four days or more after diagnosis.

The best one could say is that five out of 100 people in the trial but really only three out of 100 would have better survival rates. Even that conclusion is dubious, however, because the Mayo study doesnt compare the patients who received plasma to those who didnt receive it at all it merely compares those who receive different versions of the plasma and on different schedules to each other.

From that, its impossible to tell what benefit convalescent plasma has on COVID-19 patients, if any. Two studies, in China and the Netherlands, that actually tested convalescent plasma against a placebo were both ended early because of safety concerns. But neither showed any positive effect before they were curtailed.

Hahns statement instantly drew a pushback from medical experts. Jonathan Reiner of George Washington University medical school called it shockingly wrong. Eric Topol, head of the Scripps Research Translational Institute in La Jolla, California, called it not only blatantly wrong (but) an egregious public statement.

Hahns original statement was so profoundly wrong that his walkback Monday and Tuesday cant help but increase public confusion.

This is just blatantly wrong and misleading to the public, Topol told me. Millions of people now think that this is a breakthrough miracle treatment, but theres no data to support that. He has to say that there has been no survival advantage established for convalescent plasma, period, stop.

Hahns apology doesnt help, because its couched in technical language. The public doesnt understand the nuances of relative and absolute risk. Until he says that there is no survival advantage established, the public wont get it, Topol says. And he has to say it in public not through Twitter, and not through an exclusive CBS This Morning interview.

As for that interview, Hahn didnt err on Sunday by doing a bad job explaining the data. He completely misrepresented the data. On CBS he described the Mayo Clinic data in a way that was so confusing and incomplete that the lay viewer could still come away with the impression that theres solid evidence for plasmas positive effect. Thats completely unacceptable.

Of the FDAs emergency use authorization, Hahn told Gayle King of the CBS program, I can assure the American people that this decision was made based upon sound science and data.

Can that assurance be taken at face value? Unfortunately, no.

The importance of the FDAs credibility at this moment cant be overstated. At some point within the next year, the agency will be called on to validate the safety and efficacy of any vaccines for COVID-19 that emerge from clinical testing.

In an era in which conspiracy theories animate resistance even to vaccines of proven safety and efficacy, doubts about a new vaccine against a novel disease will threaten public health if they prompt people to refuse immunization. By appearing to truckle to Trumps political demands, Hahn is making it impossible to trust the FDAs judgment on COVID-19 vaccines.

Thats tragedy in the making. Hahns performance this weekend started out shamefully, and has only gotten worse.

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Their view: Now is not the time to legalize marijuana - Wilkes Barre Times-Leader


Weighing up the potential benefits and harms of comprehensive full body health checks – Croakey

Monday, August 24th, 2020

Most people are familiar with the concept of undergoing general health checks. This might mean that your doctor talks to you about your medical history and lifestyle including diet, physical activity, alcohol intake and smoking history. This is part of providing holistic care to identify and address risk factors to prevent disease. Health checks are also performed as part of national screening programs, such as the national cervical cancer screening program, which aim to detect and treat disease early.

However, a less familiar form is the general or full body health check that not only involves a comprehensive clinical assessment, but also includes performing a whole battery of laboratory, genetic and imaging tests in a person who does not feel ill and has not sought care. General health checks are a common element of health care in some countries and purport to be able to detect disease early, prevent disease from developing, and provide reassurance. In Australia this type of comprehensive full body health check-up may be offered to company executives or directly advertised to the general public, targeting the worried well.

But do these full body check-ups truly deliver on their stated aims and are there any potential downsides?

In the article below, Dr Romi Haas and Professor Rachelle Buchbinder describe how testing asymptomatic people to screen for a range of diseases as part of these types of general health checks can be dangerous. They outline what people need to know before consenting to such checks and suggest improved regulation of public advertising could help in ensuring the judicious and informed use of screening.

This article is published as part of theTOO MUCH of a Good Thingseries, which is investigating how to reduce overdiagnosis and overtreatment in Australia and globally, and is published as a collaboration betweenWiser HealthcareandCroakey.

To follow the series, bookmarkthis link, and follow#WiserHealthcareon Twitter.

One-page advertorials are appearing in Australian and regional newspapers for something called HealthScreen, with the headline The future of medicine is here now. HealthScreen is a direct-to-consumer service that conducts a variety of assessments that search or screen for signs of disease in people who are not displaying any signs or symptoms (asymptomatic).

These general health checks offered by HealthScreen cost AU$2,000 and include Magnetic Resonance Imaging (MRI) scans for 20 of the most common cancers, coronary heart disease and stroke risk assessments, genetic screening, laboratory tests and sleep health evaluation. The $2,000 cost is not covered by Medicare or private health insurance. It is also only an initial cost: it does not include the associated cost of the inevitable additional tests as well as treatments that will follow for many people.

A quick Google search has revealed that HealthScreen is not alone in offering comprehensive general health checks. In Melbourne alone, similar services are also offered by Epworth HealthCheck, Life First, Mens Health Melbourne and National Institute of Integrative Medicine.

HealthScreens promotions say they aim to identify medical conditions that are likely to reduce life expectancy before the onset of symptoms or any indication of a problem. They promise their clients will know they are doing everything possible to take control of your health and longevity. Framed this way, parting with $2,000 to future-proof your life might sound quite appealing to those who can afford the cost. But can it truly be this easy or is it too good to be true?

This type of screening is highly likely to lead to further tests. This is because screening tests like these are not designed to be diagnostic, but rather to identify people who are at higher risk of developing a disease so they can have further diagnostic testing. Positive screening tests require confirmatory tests to definitively rule in or rule out disease.

In fact, in December 2019, HealthScreen reported that so far the doctors have found hidden problems in every patient.

So what is the evidence that finding hidden problems is beneficial in future-proofing your life?

This is not simply a question of cost. Before consenting to undergo such general health checks, it is important to be fully informed about both the potential benefits and the potential harms of undergoing such a comprehensive check-up.

The best available evidence evaluating the benefits and harms of these types of health checks indicates they are unlikely to be beneficial. A recent update of a Cochrane review included 17 trials, 15 of which reported outcome data from more than 250,000 people in total. As well as a comprehensive clinical assessment, the trials assessed various combinations of blood, urine and lung function tests, electrocardiograms, cancer screening, and vision and hearing assessments.

It found high-certainty evidence that general health checks have little or no effect on either overall mortality or death from cancer, and moderate-certainty evidence that they probably have little or no effect on fatal or non-fatal heart attacks or strokes. General health checks offered by various organisations are therefore not evidence-based; they have not been shown to increase life expectancy.

As well as being unlikely to be beneficial, full body general health checks in asymptomatic people can potentially be harmful. The main harms are overdiagnosis, detrimental psychological effects, negative effects on health behaviours (for example, failure to quit smoking due to reassurance of good health), complications related to follow-up tests, and unnecessary treatments.

No screening test is one hundred percent accurate. There is always a trade-off between sensitivity (correctly identifying when you do have a problem) and specificity (correctly identifying when you dont have a problem). Tests with high sensitivity but low specificity have a higher chance of false positive results (saying you have the disease when you dont).

A positive screening test always requires further confirmatory or diagnostic tests. A false positive result cannot help you because you do not have the disease but it can harm you from unfounded worry and stress. Tests with high specificity but low sensitivity have a higher chance of false negative results (missing people who have the disease). False negative results can provide false reassurance, delay detection of disease, lead to legal action and reduce public confidence in screening programs.

Overdiagnosis is another harm that should be considered when weighing up the potential harms and benefits of full body general health checks. This occurs when a test leads to a diagnosis that would never have caused any symptoms or problems within a persons lifetime.

In cancer testing, for example, this can happen because a tumour may grow so slowly that a person dies of something else before it starts to cause symptoms, a tumour may not grow at all or a tumour may even disappear without treatment. In each of these cases the diagnosis has no direct benefit since no treatment is needed.

However, the diagnosis can cause harm through unnecessary psychological distress, adverse effects associated with unnecessary further testing (overtesting) and unnecessary treatment including surgery (overtreatment), and unnecessary medical costs. A recent study has estimated that in Australia nearly one in five cancers diagnosed in men and one in four cancers diagnosed in women are overdiagnosed cancers.

HealthScreen uses state-of-the-art medical imaging such as MRI and CT scans to look for hidden problems in people. While these types of tests were not evaluated in the trials included in the Cochrane review, paradoxically, the use of such sensitive testing technology has been identified as a major source of overdiagnosis.

Because they are so sensitive, they can detect minute tissue changes that may not ever cause any symptoms. For example, there is evidence to suggest that very small thyroid papillary tumours are being overdiagnosed and overtreated in people who have no symptoms but have been tested for some other reason with a CT scan, MRI scan or ultrasound.

These scans also detect degenerative findings that commonly occur with age. For example, degenerative changes in the low back, knee and shoulder are seen with ageing in people with and without symptoms, and are mostly benign. If full body checks find these changes in people without symptoms, it can lead to unwarranted diagnoses, cause worry and lead to unnecessary treatment.

There is also concern that screening the genes of healthy people may cause a whole new wave of unnecessary diagnoses. This is because genetic testing is often unable to determine if a person will show symptoms or whether the condition will progress over time.

One example of harm that may arise from full body general health checks is treating high levels of uric acid detected in the blood in people without symptoms. While allopurinol is the mainstay of treatment for gout (a form of arthritis causing painful joints), prescribing this treatment solely on the basis of a high uric acid is not recommended.

In a large population-based study, people taking allopurinol were 10 times more likely to end up in hospital because of a severe skin reaction than in those who did not take allopurinol. And two out of every 10,000 of these people died from the reaction.

It seems HealthScreen is not alone in advertising the benefits of their services without adequate consideration of the potential harms.

A recent project by Professor Ken Harvey at the Monash University School of Public Health and Preventive Medicine known as the whack-a-mole project has resulted in a considerable number of individual complaints against claims made about therapeutic goods and services being upheld. This means that the manufacturer or service provider had made claims for a product or service which were not supported by evidence.

Greater regulation of direct-to-the-public advertising for whole body health checks in Australia may be needed. At the very least, companies such as HealthScreen should ensure their advertising includes outline of the potential harms as well as the potential benefits of participating in their services.

Healthscreens Medical Director, Dr David Badov, was invited to address the concerns laid out in this article. His response can be found here.

Dr Romi Haas is a Postdoctoral Research Fellow at the Monash Department of Clinical Epidemiology, Cabrini Institute, part of the Monash University Department of Epidemiology and Preventive Medicine. Her research focuses on understanding and developing ways to reduce overdiagnosis and overtreatment of musculoskeletal conditions.

Prof Rachelle Buchbinder AO is an Australian NHMRC Senior Principal Research Fellow and Director of the Monash Department of Clinical Epidemiology at Cabrini Institute and Monash University. She is a rheumatologist and clinical epidemiologist who combines clinical practice with research in a wide range of multidisciplinary projects relating to arthritis and musculoskeletal conditions.

This article is part of an ongoing series that is published as a collaboration between Wiser Healthcare

The series investigates how to reduce overdiagnosis and overtreatment in Australia and globally. The articles are also available for republication by public interest organisations, upon request.

Bookmark this link and follow #WiserHealthcare on Twitter.

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Weighing up the potential benefits and harms of comprehensive full body health checks - Croakey


Soon, India will have its dedicated vaccine portal: ICMR –

Monday, August 24th, 2020

By Priyanka Sharma

New Delhi: In a first in India, the country's top medical research body is working to create an Indian Council of Medical Research (ICMR) vaccine portal, as a repository for all information related to vaccine development in India. The ICMR vaccine portal would be made public by the next week.

In the first stage, the ICMR vaccine portal will reflect the information on COVID-19 vaccine in India. However, with time, the web portal will be strengthened with data available for all the vaccines used to prevent various diseases.

"The Central government along with the ICMR is making all best efforts to combat coronavirus pandemic. Wearing masks, hand-hygiene and social distancing are preventive measures but at the same time vaccine development is another important aspect which will be updated on the ICMR vaccine portal," said Dr Panda.

The scientist added that the ICMR vaccine portal will be made public by the next week.

It may be noted that three COVID vaccine candidates are in India which are in different phases of the clinical study.

The first is--inactivated virus vaccine, which is the 'Bharat Biotech Vaccine', being developed in collaboration with Indian Council of Medical Research (ICMR).

Similarly, the second is a 'DNA vaccine' of pharma giant called Zydus Cadila.

According to the scientist, the ICMR vaccine portal will have sections like-COVID-19 vaccine, India's initiative, International Symposium and FAQ for the general public (which would be presented in regional language).

The vaccine portal will also fetch the information related to COVID-19 vaccine from the World Health Organisation (WHO) as available on their website.

So far, India has reported 29,75,702 coronavirus cases with 55,794 people died due to the infection. In the last 24 hours, the country has seen 69,878 cases and 945 deaths as per the Union Health Ministry data.

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Soon, India will have its dedicated vaccine portal: ICMR -


Two Families, Two Fates: When the Misdiagnosis is Child Abuse – The Marshall Project

Saturday, August 22nd, 2020

My baby is not breathing, Josue Santiago told the Racine, Wisconsin, 911 operator. Oh my God, man, please send somebody. Please. Elihu. Elihu, he said, repeating his sons name.

Until moments before the call, April 11, 2017, had been unremarkable in Santiagos household. He got home from his night shift at a foundry and took over child care from his girlfriend, the babys mom, Glendalyz Galarza, as she went to work. He spent the day feeding and playing with Elihu, walking the dogs, drinking coffee, and texting with Galarza. Take the meat out of the freezer, she reminded him. Santiago worried about Elihu, though, texting Galarza that the baby was sleeping a lot and wasnt hungry. In the afternoon, he took a photo of Elihu, and remembers thinking the four-month-old didnt look like himself, looked too serious.

Then, just before 5 p.m., Santiago flopped down on his and Galarzas bed to sleep and pulled Elihus bassinet close. I lay down, he told me when we spoke last year. Something told me, Get up. His voice slowed and lowered. And when I get up and look at him, hes pale. His lips were purple. As he talked, Santiago clasped and unclasped his hands, his eyes wet. He was shaking.

Santiago picked him up, ran downstairs, and splashed water on the babys face: no response. He called 911, and an ambulance sped Elihu to a hospital.

Several months later and one state over, in a quiet Illinois suburb, Molly Hayes, a dentist, and Daniel Namie, an engineering salesman, brought their three-month-old son, Alex, home after four weeks in the hospital.

Theyd thought they were being overly cautious when they first brought him to the ER, after he started wheezing and seemed to swallow milk wrong. Doctors didnt know what the problem was, but it was getting worse.

Hayes and Namie were praying in a waiting room when doctors stepped out of Alexs hospital room. The babys heart had stopped, they said. Hayes collapsed to the ground. Namie made himself enter the room, a priest accompanying him. I thought that was it, Namie told me. I kissed him on the forehead, and I was so happy to feel that he was still warm when I kissed him. The priest quietly baptized the baby with a syringe of water. Namie stumbled out and joined his wife on the ground in the waiting room, praying.

A few minutes later, the doctors came out. Hayes thought they were going to say the time of death. They didnt. Alexs heart was beating, slowly.

Doctors transferred Alex to Lurie Childrens Hospital in Chicago, where he underwent a battery of treatments. About a month later, on October 20, Alex was stable enough to go home, although with a feeding tube, an oxygen machine, and instructions for how to monitor his oxygen levels. Hayes had recently gone back to work at the dental practice, while Namie had quit his job to care for Alex. But on October 26, Alexs oxygen levels plummeted, and he was rushed to a local hospital.

Within hours of bringing their children to the hospitals, each familys life would change. Both sets of parents would eventually lose custody of their child. One parent would be jailed. One baby would live. One baby would die. And both childrens cases would turn on the diagnosis of a child-abuse pediatrician, an increasingly powerful medical specialty. These doctors are trained in diagnosing child abuse, in writing reports meant to hold up in court, and in providing testimony on behalf of state prosecutors. Many of their salaries are paid, in part, by the child-welfare departments charged with separating parents and children. The doctors opinions can be subjective and powerful, even overruling other specialists. But none of the parents knew that child-abuse pediatricians existednot even as they talked with them, unwittingly sharing information that became a part of a case against them.

Every word we used showed up in court, Hayes told me.

Child abuse is a pervasive and complex problem: Few children or abusers report harm themselves, so its up to other authorities, such as medical personnel and teachers, or bystanders, such as neighbors, to report suspected abuse. Some 3.5 million children in America were reported as being suspected victims of child abuse in 2018, the most recent year for which data are available; about 680,000 were ultimately determined by authorities to have been abused or neglected.

When suspected abuse has a medical component, like an injury or a bruise, child-abuse pediatricians step in to examine injuries, rule out causes other than abuse, such as a disease, and consider the familys explanations. They are trained in what types of fractures generally stem from abuse, and what bleeding patterns in the brain can be caused by shaking. With an abuse expert on staff, the thinking goes, regular pediatricians dont need to worry about overreacting to an innocent bruise, or missing warning signs because parents are convincing liars. Child-welfare workers also rely on this expertise as they consider removing children from their homes. The American Board of Pediatrics certified the first group of child-abuse pediatricians in 2009; there are now 344 such specialists nationally, stationed in all but three states.

A review of dozens of cases, including thousands of pages of medical records, child-welfare agencies records, and testimony, along with court decisions, contracts, and emails from child-abuse pediatricians, shows that these doctors can have near-unilateral power in labeling abuseeven though their conclusions are sometimes at odds with the opinions of specialists like orthopedists and hematologists. Their judgments are echoed, amplified, and often unblinkingly accepted by investigators. Indeed, instances in which medical professionals make reports to child-welfare agencies are 40 percent more likely to be substantiatedmeaning the agencies found that abuse occurredthan reports by nonmedical professionals, according to a Marshall Project analysis of the National Data Archive on Child Abuse and Neglect.

But child-abuse pediatricians may have a conflicted perspective. Many are paid in part by child-welfare departments and work directly with state lawyers in cases where the state is removing children from homes, and end up shaping arguments against parents, testifying in court, and working within a system that parents dont understand is stacked against them. This is particularly problematic because child-removal cases play out in family court, where the states burden of proof is low and parents have limited legal rights.

The first time I started to hear what parents are going through, I was shocked, Maxine Eichner, a family-law professor at the University of North Carolina School of Law, told me. There should be a role for child-abuse pediatricians, she said, but many are going well beyond their medical expertise and wielding the power of the diagnosis in ways that are really harmful for children and families.

After Alexs oxygen levels plummeted and he was rushed to the hospital, Hayes and Namie were anxious for updates. His earlier condition had been diagnosed as acute respiratory distress syndrome; Lurie staff said that a number of things could have caused it, such as aspiration pneumonia, meaning that milk had built up in his lungs rather than going to his stomach. Hayes and Namie were prepared for another round of trading off shifts at the hospital with Alex and at home with their 19-month-old, Mara. Then an X-ray showed that Alex had clavicle and rib fractures. An earlier X-ray from Lurie, however, had shown no fractures. I was seriously so unconcerned with this. I was like, What is going on with his lungs? Hayes said. Im so naive. Im a mandated reporter. I should have known.

Mandated reporter: As a dentist, Hayes, like any medical professional, is required to call a child-welfare hotline if she has any suspicion of child abuse.

The doctor transferred Alex back to Lurie, where a social worker told Namie that a child-welfare case had been opened. When Namie told Hayes, I was like, Good. I want to talk to somebody about this, she said, still focused on Alexs lungs and thinking maybe an incident of rough handling during the earlier hospital stay had caused the fractures.

According to Hayes and Namie, nurses, a hospital social worker, and a child-welfare caseworker told them that a pediatrician named Dr. Narang would get to the bottom of what was wrong with Alex. Soon after that, Narang spoke with Namie. Namie assumed that Narang was treating his son, and answered Narangs questions about Alexs history and their family.

That evening, the caseworker told Hayes and Namie that they couldnt be at home unsupervised with Mara, because there were concerns about her safety. They hastily arranged for Mara to spend the night with a friend of theirs.

The next morning, Narang talked with Hayes alone. We were so honestI said something about Alex being unplanned, and I didnt mean it like that, Hayes told me. Soon after, Narang told Hayes and Namie that the hospital had found more fractures.

Sandeep Narang, a child-abuse pediatrician who started out as a lawyer, has given lectures nationwide on being an expert witness. (A Lurie spokesperson, as well as lawyers for Narang and the hospital, declined to comment for this article.) He received Alexs case when the local doctor said it was beyond his expertise to speculate on any cause of the fractures, according to case notes, and Lurie ER doctors were concerned about abuse.

Other investigators would repeatedly defer to Narangs knowledge, records show, interpreting his opinions, even when he hedged them, as hard facts. Before Narang had drawn a firm conclusion about the cause of Alexs fractures, the child-welfare agencys notes show a caseworker reporting that the doctor thought the injuries were indicative of abuse. When Narang requested that the agency hold off on assuming protective custody of the children until more test results came in, the agency agreedbut then asked the parents to place Mara with the family friend, because the agency thought parental care was unsafe, per case notes.

Narang thought that the fractures looked fairly newmeaning they likely had occurred when Alex was at home. By October 30, hed told child-welfare workers that the team is still leaning towards non-accidental trauma, a term for abuse, but he needed other tests. The caseworkers didnt wait, asking that the parents agree not to see Alex and Mara without supervision, because the fractures appear[ed] suscipious [sic] for abuse.

Scrambling, the couple asked Namies parents to take the children. The child-welfare agency, without entering the couples house, had determined it injurious, so they rented an apartment for the children and their grandparents to stay in.

Youre guilty before proven innocent in this stuff, and its awful, Namie told me. Indeed, even before the child-welfare investigator got to the hospital, the agency opened a case against the parents with this note: **ACTION NEEDED** Allegation 9; Child at hospital with perpetrators present.

In March 2018, Narang, with all the requested tests back, gave his final opinion: Most probably the result of trauma, with non-accidental trauma being the most probable subset.

Worried about missing potential abuse, child-abuse pediatricians screen for a wide variety of physical issues, along with, of course, emotional and sexual abuse. At two Chicago hospitals, a contract requires child-abuse teams to screen any child under 3 who presents with a wide range of issues, from burns to bruises. In Florida, children 5 and younger who have bruises anywhere must be assessed. A presentation on the University of Utah School of Medicines website advises that children may be at risk for abuse if their parents have young age, low education, single parenthood, large number of dependent children, low income.

A familys background is an important factor in whether a child is screened for abuse. To be certified, child-abuse pediatricians must understand the influence of caregiver characteristics, such as young parental age and military service, on abuse risk, along with family poverty and family race and ethnicity, according to an American Board of Pediatrics examination guide for the specialty obtained by The Marshall Project.

Doctors overdiagnose abuse in children they perceive as being lower-income or nonwhite. In a 2017 study, researchers gave child-abuse pediatricians cases of potential abuse with certain socioeconomic cues about the victims families, such as unemployed caregivers. When researchers reversed those cuesfor example, by telling the doctors the caregivers were professionalsthey found that diagnostic decisions changed in 40 percent of cases. A 2002 study showed that hospitals are more likely to report Black, Hispanic, and Native children for potentially abusive fractures, while other studies show that lower social class leads to more screening for abuse.

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Cases referred to child-welfare agencies by medical professionals are much more likely to be substantiated than those referred by almost all other reporters, including teachers and social workers. Though the National Data Archive on Child Abuse and Neglect does not track referrals from child-abuse pediatricians specifically, an analysis by The Marshall Project found that from 2009, when the first specialists were certified, to 2018, the most recent year for which data are available, the number of reports by medical professionals grew by 55 percent, twice as fast as the growth of all reports during that time. In 2018, child-welfare agencies substantiated one in four reports by medical professionals, versus one in six reports by all other sources.

Once a child-abuse pediatrician diagnoses abuse, that assessment can take on a life of its own in family court.

In 1970, when Eli Newberger was a first-year pediatric resident at Childrens Hospital in Boston, child abuse had become a growing concern after an academic paper on the topic made waves, and every state passed a mandatory-reporter law. A hospital social worker asked Newberger to assess a 4-year-old boy who had been discharged from the hospital the week before with a fractured femur and referred to the Massachusetts child-welfare agency for possible abuse. The agency had relayed that the child might be at risk of being reinjured.

I said, Sure, it sounds serious. We could do this today if you like, Newberger told me. The social worker checked with the agency, which said the assessment could wait until the following week. Not knowing any better, Newberger said, he agreed to hold off. On Monday, the social worker paged him and, crying, told him that the child had died of widely disseminated scald burns over the weekend.

Later, Newberger would learn that those burn patterns likely meant a plunge into scalding bathwater. If only I had insisted: Call the police. Bring this child in. But, of course, I didnt know what I didnt know, Newberger said.

That day, he retrieved hospital records for all the children whom the hospital had reported to the child-welfare agency in the past year. To my horror, he said, four of the 39 had returned with new injuries. Newberger alerted the hospitals chief physician, who asked Newberger to find out how other hospitals handled suspected abuse cases.

Newberger learned that the few hospitals handling suspected abuse formally brought in pediatricians, social workers, or child-welfare representatives to review cases and make safe discharge plans. Newberger formed a team at Childrens to do so. In 1973, he published a study in the influential journal Pediatrics describing how the group had reduced the reinjury rate from 10 percent to just over 1 percent, while cutting hospital costs. Newberger was suddenly a pioneer in the child-abuse field, advising doctors and officials around the country.

By the 1990s, a group of pediatricians focused on child abuse was considering whether child abuse should be a medical subspecialty, requiring additional training and an exam.

That was a bad idea, Newberger thought. Hed become uncomfortable with child-abuse investigations, whose focus transformed into a very much criminalized approachless, primarily, on understanding and help than on the developing of an evidentiary base for prosecution and pursuing perpetrators, he said. Newberger thought making child abuse a subspecialty would move the focus further in that direction, and wouldnt necessarily help children or their families. He was outvoted.

Newberger, who is 79, closed his office at Childrens in 1999 but remained on staff until 2019. He now serves as an expert witness, analyzing cases for defense teams, consulting in cases where families were badly treated and mistakes in diagnoses were made, he said, and also for prosecutors and plaintiffs, when he believes abuse did occur. He said he gets a call from a parents lawyer requesting help about once a week.

The idea that the state should take custody of children is centuries old: The Elizabethan Poor Law of 1601 allowed English authorities to take poor children from their parents if they felt parents were unable to keepe and maintaine theire Children. This doctrine, called parens patriaeparent of the countrywas established in the American legal system via an 1839 Pennsylvania Supreme Court decision. May not the natural parents, when unequal to the task of education, or unworthy of it, be superseded by the parens patriae? the court wrote.

Courts elsewhere delivered their own parens patriae decisions, while reformers created institutions for children whose parents were deemed inadequate. The institutions handled mainly poor and immigrant children removed from their homes, and inculcated Protestant, middle-class values. Those efforts became the basis of the modern child-welfare system, and of family courts.

The first juvenile court in the United States was established in 1899. The court setup was communal, based on the parens patriae idea. Through the 1970s, the approach was to bring the family, the social worker into chambers and say, Were not here to accuse anybody of anything, says Richard Krugman, a pediatrician who treated abuse cases during that time. Many parents agreed to attend voluntary classes or accepted support from child-welfare services, and the child usually stayed with the family.

Under the Reagan administration, however, an attorney general directed prosecutors to charge and try abuse cases. And in 1997, under the Clinton administration, the Adoption and Safe Families Act shifted child-welfare agencies priorities from letting children stay in foster careand ultimately reunifying familiesto terminating parental rights and encouraging adoptions.

Today, parents in child-welfare cases dont have the protections that defendants in criminal cases have, because their cases are heard in family courts, where the burden of proof is low: States must show clear and convincing evidence of abuseor, in some jurisdictions, a preponderance of evidence, meaning, basically, that abuse or neglect is more likely than not. Some states have no requirement that low-income parents be provided with a free lawyer if they cant afford one. It can therefore be hard to put on a vigorous defense case, says Judge John J. Romero Jr., the childrens-court division judge in Albuquerque, New Mexico, and a former president of the National Council of Juvenile and Family Court Judges. In a recent abuse case, Romero says, one defense expert charged $300 an hour, and court administration would cover only $90.

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Even if a parent can mount an aggressive defense, doing so might antagonize the child-welfare worker deciding whether to reunite her with her child. If you put up a fight, its going to look worse, says Aaron Goldstein, the head of the civil division of the Cook County, Illinois, public-defenders office. Child-abuse pediatricians are not required to identify themselves as such, or to notify parents or caregivers that theyre being interviewed as part of a potential child-abuse case. Parents flustered conversations might become for-the-record statements without their realizing it. Child-abuse pediatricians consider it suggestive of abuse when parents cant explain an injury, or when their explanation changes. Unaware that theyre being formally questioned, parents may offer ideas about the cause of the injury, and the pediatrician may see this as a shifting account.

Once a case is referred to a child-welfare agency, the caseworker tends to accept the pediatricians assessment without question. In a 2019 case in Brooklyn, a mother told an ER doctor that her daughter spilled hot noodle soup on her stomach today, causing a burn. An off-site child-abuse pediatrician reviewed photos and decided the childs burns were most consistent with a burn from a heated implement like an iron.

The police were called. The mother told them that she didnt own an iron. The girl told them her mother made her noodles and the noodles fell down and got on her flowered shirt. Police photographs from the apartment show a Cup Noodles container and noodles in the garbage, and a stained flowered tunic. No iron was found. Police did not pursue the case. But the child-welfare caseworker, guided by the opinion of the child-abuse pediatrician, did. After the girls father left his job in another city to be with her, and her mother took months of parenting and anger-management classes, the agency agreed to dismiss the case. Everyone gets to back away quietly from the crisis situation of Are we going to have a screaming match about how absurd this call that this doctor made was? says Emma Alpert of Brooklyn Defender Services, who specializes in medically complex cases and worked on this case.

In a 2013 Brooklyn case, a child-abuse pediatrician conducted a cursory record review, in a judges words, to diagnose child abuse of a four-month-old who presented with fractures. The specialist didnt speak with the babys parents, her grandmother, her foster-care parent, her pediatrician, or doctors who had examined and treated her. At hearings, a child-welfare worker testified that the childs guardians were loving and have done all that has been asked of them, as the judge later wrote. But the agency removed the child from her guardians custody based on the child-abuse pediatricians assessment. The judge ordered the girl home after shed been separated from her family for a year. (The child-abuse pediatrician could not be reached for comment.)

A power imbalance between child-welfare caseworkers and child-abuse pediatricians makes it difficult for caseworkers to question the doctors. An entry-level caseworker job typically requires just a two- or four-year degree, and can pay less than $40,000 a year. Someone who second-guesses a doctors opinion, and a specialist working regularly with her department at that, could derail her career.This means that a second independent investigation of the case often doesnt take place, even though child-abuse pediatricians believe it does. Our partners, law enforcement and child-protective services, are the ones who actually make that final decision: Theyre the ones who do the investigation and talk with everyone in the family, go into the home, Suzanne B. Haney, the chair of the American Academy of Pediatrics Council on Child Abuse and Neglect, told me.

But in reality, it doesnt always happen that way. As a child-welfare worker testified in a 2015 Pennsylvania hearing, We have to go based upon the statement from the medical professional.

In November 2017, a family court held a custody hearing in Alex and Mara Namies case. A family-court judge decided that at least for the moment, the children werent safe with their parents.

Family court is where states can file to take temporary or permanent custody of children from parents if abuse is suspected; prosecutors can also pursue a separate criminal case. With a judges approval, a child-welfare caseworker makes arrangements for foster care, parental visitation, or parenting classes. But a state or child-welfare lawyer might take it further and argue for separation, culminating in a termination-of-parental-rights proceeding, where a judge makes the final decision.

The Illinois child-welfare agency decided to pursue separation; meanwhile, Hayes and Namie tried to make life as normal as possible for their kids. They burned through their savings, paying for lawyers and the new apartment. They saw the children daily, with Namies parents present. Hayes felt ripped with jealousy hearing other parents unthinking complaints. Friends were saying, I just want a break, and I welled up.

In court, Hayes watched as her statements were repeated on the standthat Alex had been unplanned, that she was back at work while Alex was cared for by his father and Mara by a nanny. Then there was a caseworkers testimony that when the department took custody of Alex and Mara, Hayess affect seemed a little flat. She didnt seem upset. She wasnt crying. (A spokesperson for Illinois child-welfare agency did not respond to requests for comment.)

Throughout a deposition and a court appearance, Narang maintained that hed ruled out explanations for Alexs fractures aside from abuse. But the parents lawyers focused on a specific report in the hospital records. A kidney specialist had examined Alex to see if he might have an underlying bone disease (irregular kidney function can signal problems with bones) and noted that Alexs earlier treatments at Lurie had put him at increased risks of fractures, and his bones appear thin throughout. Narang, who is not a kidney or bone specialist, had ordered follow-up tests, which ruled out most genetic bone diseases.When Steven Peskind, Hayess lawyer, asked Narang about the kidney specialists assessment that Alexs bones were thin, he replied, I wasnt convinced that that was true, adding that he didnt know why the specialist felt like those [earlier treatments] were correlated to the thinning bones.

At a later hearing, Narang adjusted a key fact. Doctors can backdate fractures based on X-rays showing when bone healing began. Narang had posited that Alexs fractures had occurred seven to 10 days before his second admission to Lurie. But when a lawyer asked Narang if it was more common for healing to start 10 to 14 days after a fracture, Narang said, Correct. Where was Alex in that time frame? the lawyer asked. He would have been back at Lurie, Narang replied.

By March, the parents lawyers had hired a pediatric orthopedist to review Alexs records. Alex did have thin bones from the earlier Lurie treatments, according to the orthopedist, so even mild handling, such as putting in an IV, could have caused the fractures. In April, that doctor testified that he believed Narang had been wrong. The same month, Hayes and Namie gave away Alexs now too-small baby clothing, much of it unworn.

Many people believe that science, including medical science, is a binary process, the family-court judge said as she gave her decision in May 2018. Its not that easy, she said. The case boiled down to the opinions of Narang and the orthopedist, the judge said, and she found the orthopedist more convincing, since he was a bone expert and Narang wasnt. The judge dismissed the states petitions. That day, the parents brought their children home, and bought champagne to celebrate. But Hayes didnt want it; she took her kids on a routine outing instead. It was the first time Id ever pushed my two kids in a Target cart, she said.

These days, Mara, red curls in a bun, climbs in and out of her parents arms. Alex moves around so much, he seems motor-powered. A third child, a girl named Ruthie, was born last August. The kids fluorescent scribbles cover the fridge. Hayes and Namie filed a lawsuit last year against Narang, Lurie, and a child-welfare worker; on Tuesday, a judge dismissed the case against Narang and Lurie, but kept the lawsuit against the caseworker active.

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There has to be reform, Namie said.

It was jalapeo coffee that brought Elihus parents together. In 2016, Josue Santiago went to a friends house one evening. Glendalyz Galarza, whom hed known when they were teenagers in Chicago, was there, and they talked all night. The next morning, Santiago tried to impress her with his signature cinnamon coffee, but he accidentally used ground jalapeo. Galarza choked it down anyway. They began dating.

Santiago had moved around a lot as a kid, living in Puerto Rico, Connecticut, Indiana, Wisconsin, and Chicago. When he eventually moved out on his own, to sleep on flour sacks at the bakery where he worked, his dad said, Oh, youre not gonna be nobody, Santiago recalled. In 2012, Santiago had a son, followed by two daughters. After splitting with their mother, he took the children on weekends. He got a solid job at the foundry and made extra money by tattooing friends and acquaintances.

When Galarza got pregnant, the couple was shocked but happy. In December 2016, they had Elihu. He looked just like his mother, they thought.

On April 11, 2017, after Santiago called 911 for Elihu, Galarza came home from her bank-teller job just as an ambulance arrived. At a local hospital, doctors assessed Elihu and thought his convulsions had occurred naturally, but he needed a higher level of care; they transferred him to Childrens Hospital in Milwaukee. There, the doctors said the baby showed retinal and brain hemorrhagingand they didnt seem to think it had occurred naturally. Their questions seemed to focus on Santiagos role, pretty much like they saw him and they automatically assumed he did something to the baby, Galarza told me. Santiago thought a lot about how he looked, as a Puerto Rican man with tattoos in a state whose population is almost entirely white; later, when a photo of him was posted online, people commented: Hes MS-13, and look at the teardrops in his eyes, he told me. I dont even have fucking teardrops in my eyes. These are stars.

Behind the scenes at Childrens, a nurse in the intensive-care unit requested an abuse consultation. Angela Rabbitt, a child-abuse pediatrician, questioned the parents and examined Elihu. She didnt tell them she was a child-abuse pediatrician, Galarza and Santiago said. The most common cause of this constellation of injuries can be seen when a child is violently slammed, shaken and/or thrown, Rabbitt wrote in a medical report, and in the absence of a severe bleeding disorder or plausible accidental mechanism these findings are diagnostic for abusive head trauma. She documented an unusual finding in Elihus blood labs, and suggested further testing to rule out congenital problems that could cause excessive bleeding.The night after he entered Childrens, on April 12, child-welfare workers took custody of Elihu. His parents couldnt be alone with him anymore. When the police arrived at the hospital, instead of interviewing Galarza and Santiago, they talked to Rabbitt. She specifically stated that this type of bleeding in the brain is not from any type of fall and would be consistent with a shaking motion, the police wrote.

The morning of April 13, doctors told Galarza and Santiago that Elihu had become unresponsive. That afternoon, police questioned the couple separately for six hours at a police station. Santiago told police repeatedly that he hadnt hurt the baby, asked if running down the stairs with him couldve done it, said he wanted to help. Left alone in the room, Santiago prayed aloud in Spanish. Padre, s que somos inocentes, Padre . Qu haces? (Father, I know that we are innocent, Father What are you doing?).By that time, Rabbitts analysis had become a hard fact. Its medical records telling us this, you know, an investigator told Santiago. I just talked to Dr. Rabbitt up at Childrens again, and theres only a couple ways this happens, right? the investigator said: car crashes, and in head-trauma cases, where sometimes parents lose their shit. The couple handed over their cellphones. Police photographed their house. They had Santiago reenact, with a doll, how hed found Elihu. My sons dying in the hospital, he said, his voice sounding charred. Elihu died on April 16.

On April 20, Rabbitt got back tests showing that Elihu had had a Factor VII blood deficiency, a bleeding issue not uncommon in head trauma, she wrote, adding that she would discuss additional tests with the hematology department. No further mentions of bleeding issues or tests occur in the hospital or child-welfare records. (Rabbitt declined to comment; a Childrens spokesperson said that medical evaluations are an important factor in the process, but the role of law enforcement and state agencies is to decide when and how to proceed on cases.)

Santiago told various peopleincluding investigatorsthat there was a history of bad blood, as he put it, in his family. But the investigators would shove it to the side, Galarza said.

The police and child-welfare officials seemed to accept Rabbitts assessment without question.On April 27, Santiago, whose record amounted to two driving-without-a-license violations, was arrested and charged with murdering his son. He would stay in jail for more than a year and a half.

Rabbitts opinion formed the legal basis for the arrest. Dr. RABBITT stated that this type of bleeding is the result of a traumatic brain injury, an investigator wrote. One of the public defenders representing Santiago questioned this: The conclusion, then, that you made that Mr. Santiago was somehow responsible for this injury was because of Dr. Rabbitts opinion, correct? Mindy Nolan asked a police investigator at a preliminary hearing.

The information that she gave us is what led us to the conclusion that we came to, the investigator answered.

A similar exchange occurred with child-welfare services. A caseworker met with a hospital social worker and Rabbitt, and wrote in her report: They believe that CPS needs to get involved and figure out what actually happened to Elihu. But instead of doing that, the child-welfare worker removed Elihu from Galarza and Santiagos custody per the report completed by Dr. Rabbitt. Though the worker filed follow-up reports and conducted interviews, nothing in the records suggests she did anything with that information. (A Wisconsin child-welfare spokesperson said state law prohibited the department from commenting on specific cases.)

The medical examiner, too, relied on Rabbitts assessment when he ruled Elihus death the result of non-accidental head injuries.

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In document after document, Wisconsin officials essentially cut-and-pasted Rabbitts technical findings as evidence of abuse, without context or analysis. As a detective told Santiago, Its science.

A review of contracts and correspondence from several states shows a close relationship between child-welfare departments and child-abuse pediatricians.

Child-abuse pediatricians can have the majority of their salary paid by child welfare. Take Houstons UTHealth: Last year, the Texas child-welfare department covered 62 percent of the lead child-abuse pediatricians salary, or about $113,000, plus $24,000 in benefits, $13,000 in travel for her team, and supplies such as computer disks. Contractually, the child-abuse-pediatrics team must assess cases, testify, and send the child-welfare agency monthly progress reports.

Child-abuse pediatricians are financially dependent on contracts like these, along with academic institutions or grants, since little of their work with patients is billable. In a 2019 contract, a child-abuse pediatrician at Comer Childrens Hospital, in Chicago, got 75 percent of her salary paid by Illinois child-welfare agency, via an organization coordinating child-abuse pediatricians work. It also paid for most of her team, a total of more than half a million dollars a year. Narang, the Lurie doctor, received about $45,000 of his $233,000 salary from Illinois child-welfare agency via that coordinating organization in 2018.

Once theyve diagnosed abuse, child-abuse pediatricians basically become prosecution witnesses rather than independent investigators. This is clear in e-mails obtained by The Marshall Project between Florida child-abuse pediatricians and the states child-welfare department: A child-welfare lawyer emails a Miami child-abuse pediatrician to get his thoughts on medical records that I received from the parents attorneys. A St. Petersburg pediatrician warns a child-welfare lawyer to look out for a doctor whos been providing irresponsible testimony in child-abuse cases.

The doctors legal sophistication adds to their authority. In recordings of trainings for child-abuse pediatricians reviewed by The Marshall Project, doctors learn about law-school topics such as Frye and Daubert evidentiary hearings, and how certain doctors need to be in order to use the term reasonable degree of medical certainty in courtall you really mean is youre pretty sure youre right, according to the law professor instructing the doctors.

Child-abuse pediatricians defend their work as important and nuanced. Shalon Nienow, a child-abuse pediatrician in San Diego, told me that every consultation takes a minimum of one to two hours, and she often rules out abuse when families descriptions are inconsistent with the injury: Sometimes people assume that a history is inconsistent, and its because they havent taken the time to ask the right questions, she said. Haney, of the American Academy of Pediatrics Council on Child Abuse and Neglect, who is an Omaha child-abuse pediatrician, said that we really understand the ramifications of erring either way, whether it means a child whos returned to a risky situation, or a child who is removed from a loving home.

Spurred by press coverage of questionable child removals, some lawmakers are thinking about ways to fix the system. In Texas, after an NBC News/Houston Chronicle series, legislators are considering asking child-welfare services to get a second medical opinion before removing children, or asking courts to appoint independent experts to evaluate medical assessments.

Another solution starts with analysis of outcomes in previous cases. In instances of missed abuse, who missed it and how? In cases where a pediatrician diagnosed abuse, what happened later? Krugman, a professor at the University of Colorado School of Medicines Kempe Center, a pediatric-abuse division, recently co-founded an organization to fund research on and raise awareness of child abuse.

I cant think of any other field, he says, where they practice without having any idea what the outcomes of their practice are.

Eli Newberger also urges data-based efforts. Doctors make mistakes all over the place, but in this area of practice, theres no review, he said.

In jail, his baby dead, Santiago bought sleeping pills: a few at a time, collecting enough to kill himself.

Galarza, on the outside, wasnt faring much better. I didnt go upstairs at all, where Elihus room was, she said. Shed drive by railroad tracks and imagine driving into an oncoming train.

One of Santiagos older brothers, a truck driver, who lived with the couple, insisted that Galarza come with him on the road so he could keep an eye on her. He would make a little bed in the middle and I would sleep there til the next day, she said.

In jail, Santiago fell out of contact with his older children; their mother brought them to visit just once, he said. He lost joint custody and missed thousands of dollars in child-support payments, which hed never been late on before. Unable to afford the Racine house, Galarza and Santiagos brother gave it up, sold furniture, gave away Santiagos dogs, and moved into an RV. Santiagos brother asked him what to keep from his house. I just told him, save at least my sons clothes and his crib, Santiago said.

After more than a year and a half in jail, Santiago was released on bond in December 2018. From the start, Mindy Nolan and his other lawyer, Erin Preston, had raised the possibility of genetic issues. But testing Galarzas and Santiagos blood took months. In the spring of 2019, Nolan and Preston received the results. Both parents had markers to indicate a Factor VII abnormality: They lacked a clotting agent that Elihu appeared to have lacked too. The lawyers consulted a bleeding expert. He said that Elihu had likely inherited the Factor VII deficiency, which can cause excessive bleeding and strokes.

The prosecutor took these results to the medical examiner and Rabbitt. The medical examiner changed his mind, saying he believed Elihu had had a congenital bleeding disorder that could have caused his death. Rabbitt altered her position only slightly, now saying it was likely that Elihu had been abused, rather than by a reasonable degree of medical certainty, the prosecutor wrote in a letter to the judge.

In June 2019, three weeks before trial, the prosecutor dropped the case. Judge Wynne P. Laufenberg, in granting the prosecutions motion, advised Santiago to undergo genetic counseling or parental counseling and education before you are to bring another child into this world with Galarza. She advised Santiago to express his gratitude for his public defenders work by never causing yourself to be charged with another felony.

A few weeks later, Santiago and Galarza sat in her parents house in Humboldt Park, Chicago, where the couple now live. Her mom was in the kitchen, making chiles rellenos, and oil sizzled and popped as they talked. Santiago was unemployed; hed been working since he was 16, and had nothing to show for it. He was living with his girlfriends parents. His son was gone. I lost everything, he said.

The year improved. Galarza went to work as a dental assistant. Santiago got an overnight shift printing labels for yogurt. They saved up for their own place. And, in December, they had a healthy baby girl. They named her Glendalyz Santiago. So shell have something from her mother, her father, and her brother, they gave her the middle name Elih.

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Two Families, Two Fates: When the Misdiagnosis is Child Abuse - The Marshall Project


Ron Evans steals a trick from I/O, and points the way to a transformational diabetes therapy – Endpoints News

Saturday, August 22nd, 2020

Salk Institute scientist and serial biotech entrepreneur Ron Evans showed new mouse work yesterday that could point to a long-sought holy grail for diabetes treatment.

The study, published in Nature,involved a new approach for islet cell transplant, a diabetes therapy where dysfunctional insulin-producing cells on the pancreas are replaced with functional ones. The treatment has been around for a while and new ones are in development, but theyve been hampered by the fact that patients will reject the cells unless they go on immuno-suppressive drugs.

But, working with iPSC stem cells and tricks from immunotherapy, Evans and his team developed what they called immune-evasive clusters of cells essentially mini pancreases. Placed into mice, these cells secreted proper amounts of insulin without coming under fire from immune cells, pointing the way toward a similar approach in humans.

Most type 1 diabetics are children and teenagers, Evans said in a statement. We hope that regenerative medicine in combination with immune shielding can make a real difference in the field by replacing damaged cells with lab-generated human islet-like cell clusters that produce normal amounts of insulin on demand.

Evans, who most recently co-founded and sold to Astellas the exercise-in-a-pill biotech Mitobridge, and his co-authors are hardly alone in this race. ViaCyte has received major backing from both private donors and the Juvenile Diabetes Research Foundation for their own stem cell-derived islet cell transplant. Flagship also launched Sigilon earlier this year with $80.3 million in Series B funding. With technology from Robert Langer, the company is developing polymers that can encase cells for transplant. A diabetes program is in the IND-enabling phase with Eli Lilly.

Four years ago, Evans and his team figured out how to make functional pancreatic beta cells for the first time, using a series of molecular switches to get them to not only produce insulin but do so in response to glucose, as normal cells do. But that still left questions about how to go from individual cells into pancreas-like clusters, and how to get those cells to avoid the immune system when transplanted.

To cluster the cells, Evans lab figured out that a protein involved in embryonic development called WNT4 could trigger the same molecular mechanisms that created the functional beta cells. Adding that protein led to the creation of 3-D clusters of cells similar to what would be seen in a humans. They called them human islet-like organoids, or HILOs.

To make those organoids, Evans and Eiji Yoshihara, a scientist in his lab, stole a trick from another field: immuno-oncology. Using short pulses of a protein called interferon gamma, Yoshihara got the cells to express PD-L1.

The PD-L1 had the opposite effect of the PD-L1 inhibitors used in cancer. Rather than making sure T cells saw a tumor, they made sure T cells didnt see the islet cells.

This is the first study to show that you can protect HILOs from the immune system without genetic manipulation, Michael Downes, an author on the paper, said. If we are able to develop this as a therapy, patients will not need to take immune-suppressing drugs.

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Ron Evans steals a trick from I/O, and points the way to a transformational diabetes therapy - Endpoints News


Contact tracing apps may be ineffective for reducing Covid-19 spread: Study –

Saturday, August 22nd, 2020

Illustration / Peter Hamlin;LONDON: Contact tracing apps are unlikely to contain the spread of Covid-19 without proper public health control measures such as physical distancing and closure of indoor spaces, according to a review of studies.

The systematic review, published in the journal Lancet Digital Health on Thursday, shows that evidence around the effectiveness of automated contact tracing systems is currently very limited.

The research suggests that large-scale manual contact tracing alongside other public health control measures -- such as physical distancing and closure of indoor spaces such as pubs -- is likely to be required in conjunction with automated approaches.

They analysed these to understand the potential impact these tools could have in controlling the Covid-19 pandemic.

"Across a number of modelling studies, we found a consistent picture that although automated contact tracing could support manual contact tracing, the systems will require large-scale uptake by the population and strict adherence to quarantine advice by contacts notified to have a significant impact on reducing transmission, said lead author Isobel Braithwaite from UCL.

In total, 4,033 papers published between January, 2000 and April, 2020 were reviewed, which allowed researchers to identify 15 papers with useful data.

The seven studies that addressed automated contact tracing directly were modelling studies that all focused on Covid-19.

Partially-automated systems may have some automated processes, for instance in determining the duration of follow-up of contacts required, but do not use proximity of smartphones as a proxy for contact with an infected person.

Analysis of automated contact tracing apps generally suggested that high population uptake of relevant apps is required alongside other control measures, while partially-automated systems often had better follow-up and slightly more timely intervention.

"None of the studies we found provided real-world evidence of their effectiveness, and to improve our understanding of how they could support manual contact tracing systems, Braithwaite said.

The review shows that, at present, there is insufficient evidence to justify reliance on automated contact tracing approaches without additional extensive public health control measures.

"We currently do not have good evidence about whether a notification from a smartphone app is as effective in breaking chains of transmission by giving advice to isolate due to contact with a case of Covid-19 when compared to advice provided by a public health contact tracer, said Robert Aldridge from UCL Institute of Health Informatics.

We urgently need to study this evidence gap and examine how automated approaches can be integrated with existing contact tracing and disease control strategies, and generate evidence on whether these new digital approaches are cost-effective and equitable," Aldridge said.

If implemented effectively and quarantine advice is adhered to appropriately, automated contact tracing may offer benefits such as reducing reliance on human recall of close contacts, which could enable identification of additional at-risk individuals, informing potentially affected people in real-time, and saving on resources, the researchers said.

"We should be mindful that automated approaches raise potential privacy and ethics concerns, and also rely on high smartphone ownership, so they may be of very limited value in some countries, Braithwaite said.

Too much reliance on automated contact tracing apps may also increase the risk of Covid-19 for vulnerable and digitally-excluded groups such as older people and people experiencing homelessness, Braithwaite added.

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Global Microbiome Sequencing Market Size 2020 Review, Growth Strategy, Developing Technologies And Forecast By 2026|Charles River; CoreBiome, Inc.;…

Wednesday, August 19th, 2020

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Global microbiome sequencing marketis expected to rise to an estimated value of USD 3455.33 million by 2026, registering a healthy CAGR in the forecast period of 2019-2026. This rise in market value can be attributed to the focus of various researchers on utilization of this technology in the development of personalized medicine and dietary applications.

Few of the major competitors currently working in the global microbiome sequencing market areBIOLOG; Cosmosid Inc; Illumina, Inc.; Metabiomics Corp.; Oxford Nanopore Technologies; BaseClear B.V.; BGI; BioMathematica; Charles River; CoreBiome, Inc.; Clinical-Microbiomics A/S; Diversigen; Eurofins Scientific; LABCYTE INC.; Leucine Rich Bio Pvt Ltd.; Microbiome Insights; MICROBIOME THERAPEUTICS, LLC; Thermo Fisher Scientific Inc.; Molzym GmbH & Co. KG; Norgen Biotek Corp.; Phase Genomics Inc.; QIAGEN; Resphera Biosciences, LLC; Shoreline Biome; StarSEQ GmbH; Viome, Inc.; Zymo Research among others.

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Bill Jones: Working to create a culture of education – Wilkes Barre Times-Leader

Wednesday, August 19th, 2020

August 10, 2020

Democrats around the country will gather around computer screens and smartphones next week for a strange new version of a timeworn political ritual: their partys presidential convention.

They wont flood into Milwaukee and crowd into a noisy sports arena on Aug. 17 for four nights of hoopla. They wont hobnob with party elders, campaign donors or up-and-coming politicians. They wont even wave placards or cheer, except in their living rooms.

The COVID-19 pandemic has made those traditions impossible and the conventions will almost surely be better for it.

Ever since 1948, when convention proceedings were first broadcast on television, the quadrennial events have slowly morphed from authentic political gatherings into slickly produced infomercials.

This year, the conventions can finally be honest about what they are.

There will still be roll call votes, but theyll only be for show; the nominees were chosen months ago. The last time a convention included a serious parliamentary battle was 1980, when Sen. Edward M. Kennedy of Massachusetts unsuccessfully tried to wrest delegates from President Jimmy Carter.

The old-style conventions werent particularly good TV; they were live pageants adapted for the small screen, often awkwardly. The live action make that live inaction got in the way.

This year, at last, that pretense can be dropped. There will be almost no live sessions, only speeches and video segments.

These will be television shows, pure and simple.

Instead of lame infomercials pretending to be conventions, they will openly and proudly be giant infomercials, a quintessentially American art form.

As a result, I expect theyll be more watchable, and maybe even more informative, than when they were staged in sports arenas.

Theyre being designed to serve the viewers, not the delegates, Chuck Todd, the political director of NBC News, told me. That should make for better television.

The change might even make the traditional set-piece speeches better, in the view of Kathleen Hall Jamieson, a political communication scholar and director at the Annenberg Public Policy Center at the University of Pennsylvania.

A speech written for television is different than one for a live audience, she told me. With a live audience, you write for applause lines; you want to draw cheers. A speech for television can actually invite more reflection from the audience.

A made-for-video convention might even prompt broadcast and cable networks to scale back their habit of cutting away from speeches for analysis from pundits, she ventured.

Thats probably optimistic. Todd and other television planners said theyre largely adapting their traditional templates live coverage of major speeches, with punditry in between for the new format.

My fear is that theyre going to give us a lot of difficult choices, he said. Whats the line between serving the viewer, including the viewer who may want to cheer for his or her team, and simply screening an infomercial?

Making the infomercial so compelling that the networks want to keep it on the air is precisely what convention planners are aiming for.

Democratic strategists want their convention to reintroduce Joe Biden his biography, his family tragedies, his government experience to voters who have a blurry impression of him.

They will air a glossy biopic that emphasizes Bidens time as vice president under Barack Obama and his image as the nations most empathetic politician.

They express confidence that Bidens acceptance speech will dispel Trumps allegations that the 77-year-old candidate is, as the president put it recently, mentally shot an absurdly low bar he should clear without difficulty.

The online convention will feature a prime time appearance by Barack and Michelle Obama, and a tribute to the late Rep. John Lewis, D-Ga. Biden plans to give his acceptance speech from his home in Delaware.

Thats not only to protect Bidens health; its to emphasize another Democratic theme, their insistence on following medical recommendations to reduce the spread of the coronavirus.

Republican plans appear less certain beyond an in-person meeting of delegates in Charlotte, N.C., on Aug. 24 to formally nominate President Donald Trump.

Campaign officials say they will present granular details of Trumps plans for a second term, attack radical elements that they claim control Bidens team and present a nightly surprise.

Trump will deliver his acceptance speech on Aug. 27 possibly from the White House, he said last week. But he might also drop in (digitally) on one or two other nights; he did that in person at his 2016 convention in Cleveland.

The Trump team is also working on a biopic recounting his first four years. Its expected to argue that Trumps leadership prevented the pandemic from getting worse and echo his promise that the economy will boom as soon as hes reelected.

Both campaigns hope to produce a significant bounce in the polls that can serve as a springboard to victory on Nov. 3.

But like old-fashioned conventions, the bounce may be a thing of the past probably because, in a polarized age, fewer voters appear willing to change their views. In the four presidential elections from 2004 to 2016, the average post-convention bounce was only 3%.

Delegates, donors, journalists and others who once flocked to conventions may mourn the loss of the spectacle, the noise, and the chance to mingle at receptions and meals.

But the vast majority of voters, who never got invited, wont miss a thing.

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Bill Jones: Working to create a culture of education - Wilkes Barre Times-Leader


Whats next for abortion legislation in the U.S.? – PBS NewsHour

Friday, July 10th, 2020

The Supreme Court decision to strike down a Louisiana law on June 29 that would have restricted access to abortion in the state was broadly seen as a win for the reproductive rights movement. Some scholars and activists caution, however, that the narrow decision does not necessarily signal abortion rights will be protected by the high court in future cases.

In a surprise 5-4 decision, the conservative Chief Justice John Roberts joined liberal justices in striking down the law, which would have required abortion providers in Louisiana to have admitting privileges to a hospital within 30 miles. If upheld, the law could have shut down all but one abortion clinic in the state.

WATCH: What Supreme Court decision on Louisiana law means for U.S. abortion rights

I was sort of bracing for a defeat for the abortion providers, so in some respect, I was pleasantly surprised by Roberts joining the liberal justices in the decision, said Melissa Murray, an NYU law professor specializing in family law, constitutional law, reproductive rights and justice. But, she warned, I think its a much more muted victory than many perhaps appreciate. The chief justice is very clear that his views on abortion havent changed.

When Roberts served as an attorney in two consecutive Republican administrations those of Presidents Ronald Reagan and George H.W. Bush he helped author briefs arguing that Roe v. Wade, the landmark case that legalized abortion nationwide, was wrongly decided and should be overturned. But in his Senate confirmation hearing in 2005, he agreed that the case was settled law and said he would err toward respecting precedent.

Heres a look at the implications of the June 29 decision on June Medical Services LLC. v. Russo, and what it means for abortion rights and access in the U.S. going forward.

The Louisiana law blocked last week was the second so-called TRAP law or Targeted Regulation Against Abortion Providers to make its way to the Supreme Court within the last five years.

It was the first time an abortion case was heard since President Donald Trump filled the high courts vacancies by appointing two conservative justices, Brett Kavanaugh and Neil Gorsuch.

In reinstating the Casey standard, hes gutted Whole Womans Health. Were back to 1992.

The legal argument that TRAP laws hinge on is the idea that abortion is in some ways bad for women, according to Mary Ziegler, a law professor at Florida State University specializing in the legal history of reproduction and author of Abortion in America: A Legal History from Roe to the Present.

Ziegler said the idea behind these laws is that if abortion clinics have more stringent requirements, women will have better continuity of care. Its part of this general argument that abortion, and abortion providers, are unsafe, she said when speaking with the PBS NewsHour in February.

Kathaleen Pittman, a clinic administrator at Hope Medical Group in Louisiana and a plaintiff in the the Supreme Court case, told the NewsHour in March that the state had tried everything to decimate access to abortion care.

The situation here is already dire and this law would be the last straw for most of the remaining clinics. Were hopeful that the court will recognize how devastating this law would be for women in our state, Pittman said in March.

The Supreme Court did end up siding with the health clinic, largely because it had already ruled back in 2016 that a similar Texas rule requiring abortion providers to have hospital admitting privileges placed a substantial obstacle in the path of women seeking an abortion, constituting an undue burden on abortion access.

Citing this precedent set in the 2016 case, Whole Womans Health v. Hellerstedt, Chief Justice Roberts sided with the liberal justices in blocking the Louisiana regulation from taking effect, even though he had ruled against the Texas law while on the high court in 2016.

I joined the dissent in Whole Womans Health and continue to believe that the case was wrongly decided, Roberts wrote, citing the Texas law that was struck down in 2016. The question today however is not whether Whole Womans Health was right or wrong, but whether to adhere to it in deciding the present case.

Abortion opponents protested the Supreme Courts decision. Kristen Waggoner, the general counsel and SVP of the Alliance Defending Freedom, which signed an amicus brief in support of the Louisiana law, likened reproductive rights advocates argument that hospital admitting privileges actually endanger women to the fox guarding the hen house.

Were going to hold abortion to the same standard that we hold other doctors, Waggoner told the NewsHour. And I think the standard should be applied to protect women no matter where their feelings are on the abortion issue itself.

Louisianas Solicitor General, Elizabeth Murrill, who defended the law before the Supreme Court, also said that clinics such as the ones targeted in the June Medical Services case actually endanger womens health. Here we have a history of egregious health and safety violations by the clinics and by the doctors who work there, Murrill said in an interview with the NewsHour when the Supreme Court heard arguments for the case in March. She added that abortion providers had a vested interest in being less regulated and having less oversight.

While complications do arise from abortion in the U.S., severe consequences, such as death, are rare. A report released by the non-partisan National Academies of Sciences, Engineering and Medicine in 2018 found that abortion is largely a safe procedure. It noted, though, that TRAP laws and other regulations instituted by states such as waiting periods and pre-abortion ultrasounds can complicate and delay the procedure, making it less safe.

Even though another law targeting abortion has been struck down by the court for now, NYU Laws Murray cautioned that the narrow nature of Roberts opinion could actually galvanize anti-abortion activists to pursue more restrictive laws in the future. This is because he cited another 1992 abortion case, Casey v. Planned Parenthood, in his reasoning.

Murray noted that while the Casey decision affirmed the right to an abortion, it also lowered the standards by which courts review abortion legislation, and allowed states to put in place regulations to further the health or safety of a woman seeking an abortion, as long they do not impose an undue burden on a womans ability to obtain the procedure.

While the decision was a nominal victory for the anti-abortion side, Murray said it actually empowered states to continue restricting access to the procedure. She worries the same could happen following the June v. Russo decision.

In his opinion, Roberts wrote, the only question for a court is whether a law has the effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus. He encouraged courts not to weigh the specific benefits against the burdens of abortion laws, as the 2016 Supreme Court decision on the Texas law did, but rather to simply decide whether the proposed legislation poses an obstacle to women who are seeking abortions.

Murray called this a more amorphous standard. In reinstating the Casey standard, hes gutted Whole Womans Health, she said. Were back to 1992. And I think what you will see is states empowered to continue restricting access, and courts no longer tethered to weighing benefits against the burdens of abortion laws like the Louisiana one, she added.

The ADFs Waggoner, though, said she saw Roberts line of decision-making as a positive step for the anti-abortion movement, as it may allow states to regulate abortion providers in a way that protects women as long as theres a reasonable relation to a legitimate state interest.

While one Louisiana abortion restriction has been settled for now, the issue is by no means going away. There are some 15 abortion cases that are just one step away from making it to the Supreme Court, according to Planned Parenthood. While some of the restrictions in question are similar to the Louisiana law, many others ban abortion at various points in pregnancy, or on the basis of disability. Others ban specific types of abortion, such as dialation and evacuation.

These laws are part of a broader strategy by the anti-abortion movement to pursue a patchwork of legislation that gradually chips away at abortion access in the hopes of eventually overturning Roe v. Wade.

As of July 1, 22 states had banned abortion between 13 and 24 weeks from a womans last menstrual period, according to the Guttmacher Institute, a research institution that advocates for abortion rights. Three states Alabama, Louisiana and Utah had attempted to ban abortion at any point in a pregnancy, but those bills were blocked by the courts.

In mid-June, Tennessee lawmakers passed a bill that would ban abortions after a fetal heartbeat is detected, as early as six weeks into a pregnancy. The Iowa legislature passed a bill that same week that would require women to wait 24 hours before receiving an abortion, and Mississippi Governor Tate Reeves signed a law banning abortion based on race, sex or genetic issues on July 1.

Some states more recently tried to limit abortions due to the COVID-19 pandemic, with Texas, for example, declaring that abortion doesnt qualify as an essential surgery. While those bans are no longer in play today they have been blocked by the courts some could return as states respond to another spike in coronavirus cases.

The Guttmacher Institutes state policy director, Elizabeth Nash, said that she would not be surprised to see states emboldened by the June Medical Services decision pursuing more restrictions similar to the Louisiana law, with the thinking that the courts will be less stringent in weighing the benefits against the burdens of such requirements.

Abortion opponents read these cases very carefully and amend their strategy based on the rulings, Nash told the PBS Newshour. It would not surprise me to see abortion restrictions next year that look to these kind of restrictions. You may see states that have, say, counseling and waiting period laws look to make them more burdensome in some way.

Laws targeting abortion providers have affected access to clinics over the past decade. Between 2011 and 2017 the number of abortion clinics in the U.S. dropped by almost 4 percent, but states in the South were more heavily impacted, with a net decline of 50 clinics 25 in Texas alone. The Midwest lost a net 33 clinics in the same time period. Both regions had the largest share of new abortion restrictions in the country.

Catherine Glenn Foster, the president & CEO of Americans United Life, argued in an interview with the Newshour last fall that disparities in access are tied to the fact that abortion is a profit-making venture: There are large parts of the country that dont have a lot of people, and those are places where there arent many abortion facilities, but thats a business decision. She said she couldnt think of anything less feminist than the sentiment that we cant have an education, career, plan for families without legalized abortion.

But reproductive rights organizations view the issue differently, and already see state-level challenges to abortion as a blow to the reproductive rights movement.

The likelihood of the Supreme Court going out of its way this year to overrule Roe vs. Wade is fairly low, but it can do the exact same thing in terms of an actual persons ability to access abortion by making it harder and harder or impossible to challenge these laws, Andrew Beck, a senior staff attorney for the Reproductive Freedom Project at American Civil Liberties Union, told the NewsHour.

Guttmachers Nash said the increasingly conservative makeup of the Supreme Court could pose a serious challenge to abortion access in the coming years.

There is a real palpable threat to abortion rights at the Supreme Court, said Nash. Its clear from Roberts opinion that he would support abortion restrictions.

Courtney Norris contributed reporting to this story.

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Whats next for abortion legislation in the U.S.? - PBS NewsHour


No ethics when it comes to US enemies, even in the middle of a deadly pandemic – IOL

Friday, July 10th, 2020

By Shannon Ebrahim 16h ago

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After a week, she is having trouble breathing, but when she goes to the nearest hospital, there is a shortage of medical staff to process her admission as many have succumbed to the virus due to a lack of PPE (personal protective equipment). There are also no ventilators to assist her to breathe.

She knows this could spell the end of her life, and there will be no one to take care of the three children she has left alone at home.

This is what happens when the noose of sanctions are tightened on a country in the middle of a global health pandemic - a country that already had a collapsing economy thanks to unilaterally imposed US sanctions.

There are no ethics or conscience when it comes to US enemies, even in the middle of a deadly pandemic. If denying Venezuelans life-saving medicine and equipment might hasten the collapse of the Maduro regime, then the US is all for it.

US allies are too scared to fill the vacuum and deliver the desperately needed aid and assistance to Venezuela, even on a humanitarian basis, due to the threat of secondary sanctions on countries that buck the US economic blockade. It is only countries like China, Russia, and Cuba that have assisted the people of Venezuela in their fight against Covid-19.

Foreign Minister Jorge Arreaza was correct when he said in March that the US illegal and unilateral coercive measures against his country were a form of collective punishment.

Under the 1949 Geneva Convention, collective punishment is a war crime and a crime against humanity as defined by the UN International Law Commission. When countries refuse to send medicine and supplies to Venezuela in the middle of a global health pandemic due to the unilateral US sanctions regime, they too are complicit in a war crime.

The US has laid down the gauntlet - any firm that trades with Venezuelas public sector could face secondary sanctions.

But the health infrastructure in Venezuela is run by the state, which has made it virtually impossible to access medical equipment, supplies, Covid-19 testing kits and medicine.

Since the outbreak of the pandemic, airlines and shipping companies have been too afraid to go to Venezuela to deliver essential goods exported from countries that refuse to be cowed by US bully tactics.

As a result, Venezuelans are dying, and the US is under the misguided notion that this will put an end to the great Bolivarian revolution, and finally succeed in its regime change agenda - with a little help from Covid-19.

What is that notorious concept: Dont waste a good crisis?

This inhumanity has not escaped condemnation by senior UN officials. The UN High Commissioner for Human Rights, Michelle Bachelet, has called for sanctions to be eased or suspended during the pandemic.

Three UN Special Rapporteurs have called on the US to lift sanctions on Venezuela due to the severe impact on the human rights of its people.

We have to give it to the Americans: they dont even try to hide or nuance their intentions any more - they put them out there for us on a silver platter. In February, US Secretary of State Mike Pompeo told the Munich Conference that the US seeks to oust Maduro.

In March, at the onset of the coronavirus pandemic, the US tightened its sanctions on the country.

US President Donald Trump wasted no time in waving a red flag to a bull by stationing a naval detachment off the coast of Venezuela, to prove that the US is a very real and present danger.

In May, one of the highest- ranking members of the Republican party, Lindsay Graham, penned an article in the Wall Street Journal which said: The US must be willing to intervene in Venezuela the way it did in Grenada.

In 1983, the US had overthrown the legitimate government of Grenada through military intervention.

Graham went even further to say: If measures are not taken then, the US should move military assets to the region.

But such threats form only part of the range of techniques the US uses to undermine foreign governments it does not find palatable to its national interests. Its what is called a hybrid war.

Another favourite tactic is to pressure the International Monetary Fund to deny such governments much needed funds in the context of a suffocating sanctions regime. The US Treasury Department has pressured the IMF to deny Venezuela access to emergency funds to fight the Covid-19 pandemic.

When President Nicolas Maduro wrote to the IMF requesting a $5 billion loan from the Covid-19 emergency fund to strengthen Venezuelas detection and response systems, the request was flatly denied.

Whoever believed the mantra of the Western-controlled international financial institutions, We are all in this together?

What they should have said is, All lives matter as long as you are not Venezuelan, Cuban, Iranian, or North Korean.

* Shannon Ebrahim is the foreign editor of the Independent Media Group.

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No ethics when it comes to US enemies, even in the middle of a deadly pandemic - IOL


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