In a second research report published this year so far, investigators found that the U.S. Food and Drug Administration (FDA) is approving drugs faster than ever. Unfortunately, it appears that the agency is also approving those drugs on less data and weaker evidence.

The first study published in the journal SSRN was by researchers at Harvard University, the University of Texas at Dallas, and the Massachusetts Institute of Technology (MIT). It questioned if the FDA and other regulatory agencies worldwide dont rush certain approvals, particularly at the end of the year in a kind of desk-clearing activity.

The report notes, In the United States, the number of December drug approvals is roughly 80% larger than in any other month. Similar approval spikes occur at the end of each calendar month. Additionally, approvals spike before holidays, such as before Thanksgiving in the United States and the Chinese New Year in China (but not vice versa).

And more troubling is that there appears to be a correlation with more problems with these drugs. Lauren Cohen, a professor of finance and entrepreneurial management at Harvard Business School and one of the authors, told the Wall Street Journal, We see about twice as many adverse effects.

The second study appeared in the journal JAMA Network and was conducted by researchers with Harvard Medical School. The lead author, Jonathan Darrow, a lawyer with the medical schools Program on Regulation, Therapeutics and Law, told NPR, There has been a gradual erosion of the evidence thats required for FDA approval. He points out that patients and physicians should not expect that new drugs will be dramatically better than older ones.

The study notes that about half of recent drug approvals were built on a single pivotal clinical trial. Typically, two pivotal, Phase III trials were the norm. In addition, the study says that surrogate measures, which are utilized as stand-ins for presumed patient benefits, has grown. For example, in oncology drugs, what most patients would want are improvements in survival after receiving treatment. But some cancer trials use a surrogate measure of tumor shrinkage. Ideally, both would be taken into consideration.

Darrow and his research associates studied FDA approvals, changes in the law and regulations, and how the industry funds agency reviews from 1983 through 2018. They found that the average number of new drug approvals annually grew from 34 in the 1990s to 41 in the 2010s. In the 2000s, it dropped to 25 a year. But now they are increasing. For example, in 2019, the FDA approved 48 new molecular entities and new therapeutic biological products. That doesnt include vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or the numerous new indications approved for existing therapies.

Darrow, with Jerry Avorn and Aaron S. Kesselheim, both with the Division of Pharmacoepidemiology & Pharmacoeconomics at Brigham & Womens Hospital, found that faster approvals were related to legislative and regulatory modifications that started in the 1980s. Although there are probably several reasons for those changes beginning in that period, much of it is likely related to the beginning of the HIV epidemic and demands from patient populations and advocates to fund more research and get therapiesany therapiesto market faster.

Just some of those regulations include: the 21st Century Cures Act (2016), which authorized funds for the Precision Medicine Initiative and Cancer Moonshot; the Biologics Price Competition and Innovation Act (BPCIA, 2010), creating an abbreviated pathway for follow-on biologic products; Breakthrough Therapy designation (2012), for drugs that showed substantial improvement over existing therapies; the Hatch-Waxman Act (1984), which created an Abbreviated New Drug Application pathway for drugs approved after 1962; and the Pediatric Research Equity Act (2003), which required results from pediatric assessments to be submitted as part of New Drug Applications (NDAs).

Congress also passed the Prescription Drug User Fee Act in 1993, and that first year, FDA collected $29 million in fees. In 2018, the agency brought in $908 million in PDUFA fees. Or, as the study notes, industry fees were responsible for about 80% of the money spent on FDA employee salaries for drug reviews.

There is some concern about the incentives that this created within the FDA, Darrow told NPR. And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry.

Another factor that is related, is the concept of me-too drugs. These are basically drugs that are very structurally similar to approved drugs, with only minor differences. Thats not necessarily a bad thing, because they need to be at least as good as the drugs already on the market, and generally need to be betteralthough not necessarily by much. Which does mean a number of companies spend time on developing drugs that are only incrementally better than others on the market.

Joshua Sharfstein, former FDA Principal Deputy Commissioner, told NPR that there are more changes needed to ensure drugs are worthwhile for patients. Some of them are really great, and some of them [are] not so great. And a lot of them are very expensive.

Sharfstein is currently a professor at the Johns Hopkins Bloomberg School of Public Health. He wrote an editorial in JAMA that accompanied the newer study. In it, he suggests its time to reevaluate the FDAs expedited approval programs to determine which ones are working and which ones are increasing healthcare costs.

Weve kind of reached a point where it makes sense to pause and see whether we can do things better, Sharfstein said. And I think we can.

Read the original post:
The FDA Is Approving Drugs Faster, But That May Not Be A Good Thing - BioSpace

Recommendation and review posted by Bethany Smith

Austin was three years old and Max was a newborn when their mother, Jenn McNary, learned they had a rare genetic condition called Duchenne muscular dystrophy. The doctor painted a grim picture: Her boys would stop walking by age 12 or 13 and, shortly thereafter, they would require nighttime ventilation. They would each need a tracheotomy, a feeding tube, or both by their late teens. Death would come a few years later.

It hasn't worked out that way, thanks to two new drugs that became available after the boys' 2002 diagnosis. Exondys 51, a medicine that targets their genetic mutation, slows the disease's progression, and Emflaza, a corticosteroid, mitigates some of its symptoms. Thanks to these treatments, Austin now attends college and interns at a biotech company. Max attends his local high school in Newton, Massachusetts. Both are able to get around in wheelchairs, and neither needs ventilation. McNary just rented an apartment for her boys because they can function on their own with the help of an aide.

By all accounts, the drugs have been transformative, McNary said. But, she added, her boys "aren't going to be cured," and extending and improving their life for an unknown period of time comes at a high price. Emflaza came onto the market in 2017 at an annual cost of $65,000. Exondys 51 appeared in 2016 at $748,500. Neither of the drugs will help the young men walk again and, in the eyes of some U.S. health economists, the drugs are not worth the price.

That's why McNary hates the quality-adjusted life year (QALY, pronounced "qua-lee"), an economic calculation that attempts to quantify the value of a medical intervention, based in part on the quality of life it bestows on recipients.

First developed by U.S. economists in the late 1960s and early 1970s, variations of the QALY have been used for years by governments around the world to help determine what treatments citizens can obtain under public health care. In America's free-market health care system, however, QALY calculations have largely been avoided. As McNary and others like her are finding out, that's starting to change.

Advertisement:

As policymakers and insurance companies scramble to get a handle on skyrocketing health care costs, they are promoting the idea of paying for value. In this view, drugs designated as higher-value should be prioritized over lower-value treatments. But this raises a thorny question: Who gets to define "value"? Health economists and insurance companies who seek to use limited health care dollars judiciously? Or patients, parents, and doctors who want to receive the best health care for their situation?

Because the quality-adjusted life year threatens her sons' ability to get the medicine they need, McNary is clear about her answer. "To me, the QALY is a measurement that says that keeping my sons alive by providing incremental benefit but not totally curing them is never going to be valuable," McNary said. "Just mull that around in your head if you are less than perfect, you are worth less money."

* * *

In QALY math, a year of perfect health is equal to 1; death equates to 0. The value of other health states is derived from surveys of patients, caregivers, or the general public. Paralysis might be valued at .35, for example, and mild Alzheimer's disease at .52, depending on the survey. Those numbers can then be plugged into a formula that allows the relative cost-effectiveness of treatments to be compared to identify the best buys.

Economists developed the QALY concept more than 40 years ago to address a fundamental question: "Where should we spend whose money to undertake what programs to save which lives with what probability?' Richard J. Zeckhauser and Donald Shepard asked in a 1976 article describing the basic QALY formula. The next year, as U.S. health care spending topped $120 billion, Harvard health policy professor Milton C. Weinstein and his colleague, cardiologist William B. Stason, sounded an alarm bell. "It is now almost universally believed that the resources available to meet the demands for health care are limited," they wrote in the New England Journal of Medicine. "We, as a nation, will have to think very carefully about how to allocate the resources we are willing to make available for health care."

Their article cited by other authors more than a thousand times in the past four decades pointed out that resources were already being allocated by millions of individual decisions: hospitals rationing beds where they didn't have room for all patients, for example, and insurers agreeing to pay for some tests and treatments but not for others. Such decisions, they argued, were often inconsistent with the "societal objective of deriving the maximum health benefits from the dollars spent," an objective that could be achieved by putting the QALY to work.

In the intervening decades, some countries the United Kingdom, the Netherlands, and Sweden, for example have embraced QALY-based evaluations. In the U.K., cost-effectiveness studies are used, in part, to determine which therapies the National Health Service will provide for residents. The publicly-funded health system does not cover Orkambi, the first cystic fibrosis treatment that targets the cause of the disease, for example, because its cost-per-QALY far exceeds the U.K. cost-effectiveness threshold.

In the United States, however, QALY-based assessments have not gained traction until recently. "Perhaps the general reason is that we as patients and our providers don't want to be limited in the treatment options available," said Louis P. Garrison Jr., an economist in the Pharmaceutical Outcomes Research and Policy Program at the University of Washington.

In fact, QALY-based cost-effectiveness reviews are so controversial that the federal government has repeatedly quashed their use. In 1992, the Department of Health and Human Services rejected Oregon's attempt to use QALY-based cost-effectiveness assessments to determine what services its Medicaid program would cover. In 2010, as part of the Patient Protection and Affordable Care Act, Congress prohibited the use of QALYs by the Medicare program. It also banned the federal Patient-Centered Outcomes Research Institute from using QALY thresholds in its assessments of comparative treatments.

* * *

A QALY Primer

A QALY reflects quality of life and length of life. A year in "perfect health" is worth 1 QALY, death is worth 0 QALYs, and other health states fall between 0 and 1. The amount that a drug lengthens or improves the quality of life is calculated as "QALYs gained." The cost of getting a certain level of health improvement is the "cost per QALY gained," shown here for several interventions targeting asthma.

But more than half of U.S. residents are covered by private insurance companies, which are not prohibited from using QALY-based assessments to decide which medicines they will cover for their members. Traditionally, however, private insurers have generally not used QALYs explicitly in their decisions about what tests and treatments they will pay for, according to a recent report by the National Council on Disability. Instead, when major U.S. insurers decide to limit access to a given medication, they usually cite insufficient data to justify its use in a given situation.

Indeed, until recently, U.S. insurers did not have a source for QALY-based cost-effectiveness reports. That began to change in 2014, when the Institute for Clinical and Economic Review, a nonprofit research organization based in Boston, turned its attention to high-cost drugs. Founded in 2006 as a research project based at Harvard Medical School, ICER initially issued reports on broad topics such as obesity management and palliative care. But when Sovaldi, a drug for deadly hepatitis C, came on the market at the then-shocking price of $84,000 for a 12-week course of treatment, ICER kicked into action. Despite the high price, its assessment found that Sovaldi is cost-effective for some patients. Insurers took notice.

Since then, the organization has been churning out several drug-assessment reports each year. Each report includes its opinion of how much the drug is worth; drugs priced higher than that are deemed not cost-effective. ICER has no authority over anyone, but its reports have become popular reading for U.S. insurers. "If there is a drug of note being approved by the FDA, there's also likely going to be an ICER assessment of that drug that can factor into their decision-making," said David Whitrap, the research organization's vice president of communications and outreach.

* * *

U.S. health care spending has risen dramatically since Weinstein and Stason expressed concern in the mid-1970s. In 2016, the U.S. spent nearly 18 percent of its gross domestic product on health care, far outstripping the average of 11 percent for 10 other high-income nations. High prices for prescription drugs is one reason. "We're seeing price tags now of $1 million, $2 million," said Seema Verma, administrator for the federal Centers for Medicare and Medicaid Services, at a conference recently. "That's completely unsustainable for the system."

That's why Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, said cost-effectiveness analyses are needed more than ever. But there are many reasons for the resistance, Neumann and his co-authors wrote in the Journal of the American Medical Association, including "an inclination on the part of many individuals in the United States to minimize the underlying problem of resource scarcity and the consequent need to explicitly ration care."

Further, Ari Ne'eman, a disability rights activist and consultant to Partnership to Improve Patient Care, a coalition of advocacy groups, said the idea that two health conditions can be numerically compared to one another is simply wrong. "Proponents of the QALY will say it is this mathematically perfect measure that gives us a superpower ability to compare depression drugs to cystic fibrosis drugs to cancer drugs even though all of those drugs do different things because it lets you translate them back to this common measure," he said. "Our concern is that when you engage in that process of translation, you lose some significant nuance in terms of the amount of benefit that's being delivered."

The Partnership argues the QALY calculation is flawed because it assumes quality of life can be captured by a certain number, despite the fact that different surveys arrive at different numbers. For example, a 2006 quality-of-life survey in the U.S. assigns blindness/low vision as .69 on the 0-to-1 scale, while a 2011 survey in the U.K. gives blindness/low vision a score of .78.

Beyond the methodological issues, Ne'eman said, "there are all kinds of ethical problems with it." People with disabilities and chronic medical conditions may value a treatment that offers an incremental improvement in the quality or length of their lives, even though the "QALYs gained" are less than those for a treatment that prevents the loss of perfect health.

Former U.S. Representative Tony Coelho, a Democrat from California and a primary author of the Americans with Disabilities Act, is the Partnership's chairman. "I worry that more focus is being given to what is most cost-effective for the 'average patient' than creating a system that works for each individual patient," he wrote in 2018. "The medication I take for epilepsy isn't 'high value' for every patient. But it's the only one that works for me."

That's why, Ne'eman said, cost-effectiveness analyses must consider the fact that not all patients respond the same way to a drug. Some patients need drugs that aren't deemed cost-effective for the general population. It's important to account for that, he said. "Otherwise we're giving insurers a tool to deny care to people who need it."

When an insurer decides to cover a specific drug, that decision affects everybody who pays into the insurance pool. Michael Sherman, chief medical officer for the insurer Harvard Pilgrim Health Care, uses the example of a gene therapy that costs $1 million to treat a child who will die without it. Under the ACA, families will hit their out-of-pocket maximum at about $16,000, and many health plans have out-of-pocket maximums far below that. "The rest of that million dollars is going to be paid by everyone else that's the way it works in insurance," he said. When insurers see that kind of unanticipated budget impact, they raise premiums or out-of-pocket cost-sharing for everyone.

Like other proponents of the QALY, Neumann sees it as an imperfect but useful tool. "Any single number is never going to capture everything," he said.

"The problem is, if you're not going to use QALYs, what are you going to use?"

* * *

That's an urgent question, particularly now when there is a huge pipeline for rare-disease therapies, often called orphan drugs. By 2024, orphan drug sales are expected to reach $242 billion.

In the U.S., a rare disease is defined as one that affects fewer than 200,000 people. While these conditions are individually rare, in the aggregate, an estimated 25 to 30 million Americans that's about one in 10 live with a rare disease. Most rare diseases affect children, and many are fatal or disabling.

Historically, drugmakers spent little effort developing treatments for rare diseases, but that changed with the passage of the Orphan Drug Act of 1983, which provides tax credits and a seven-year marketing exclusivity to companies that develop rare-disease treatments. Hundreds of such treatments have won FDA approval in recent years, with more than 560 medicines in the works.

Those treatments are generally expensive. On average, the per-patient cost for orphan drugs in the U.S. is almost 4.5 times more than for non-orphan drugs.

In the two decades ending in 2017, the average annual cost for orphan drugs was $123,543, based on the price at the time the drug launched, compared to $4,961 for traditional drugs. For Duchenne alone, more than 30 orphan therapies are in development. None of them are going to cure patients, McNary said. But she hopes new treatments, generally used in combination, will help her sons live longer, healthier lives and completely change the disease trajectory for younger patients whose disease has not yet progressed as far.

The barrier she worries about is cost-effectiveness analysis. In August, the Institute for Clinical and Economic Review published its assessment of treatments for Duchenne, which affects about 400 to 600 boys born in the U.S. each year. Emflaza, the corticosteroid, appears to be as good as or better than prednisone, another corticosteroid approved to treat the disease, but it would need a price cut of at least 73 percent to be considered cost-effective.

Exondys 51 approved by the FDA for about 13 percent of the Duchenne population got a worse review. In the clinical trials used to seek FDA approval, no clinical benefit, including motor function improvement, was demonstrated. (The FDA approved the drug because some of the patients treated with Exondys 51 had a slight increase in dystrophin levels in skeletal muscle.) In light of that, Exondys 51 was not deemed cost-effective at any price.

But Jenn McNary said the drug works for her sons. Austin, who was not eligible for the Exondys 51 clinical trial, stopped walking at age 10. Max got in the trial and started taking the drug at age 9."They have the same mutation, they have been raised by the same mother, so one would expect they would progress similarly," she said. "But Max walked until he was 17."

Austin was already in a wheelchair when, at age 15, he started taking Exondys 51. He regained some upper-body strength that changed his life, according to his mother. "He's able to use a urinal on his own, which makes is possible for him to have a job and to go to college without an aide," she said.

The Medicaid program in Massachusetts, where the McNarys live, won't pay for Max's Duchenne therapies. For the time-being, the drugmakers are giving him the drugs free through a patient-assistance program. Austin, because he's enrolled in college, is eligible for student coverage through Blue Cross Blue Shield of Massachusetts. The insurer, by policy, does not cover Exondys 51 for patients who can no longer walk. His mother appeals the insurance denial. Every six months, she sends a video of Austin in action, along with a letter from his doctor and so far, his medicines have been covered.

The payers made their coverage policies before the quality-adjusted life year analysis was published. Now, insurers who have been covering the Duchenne treatments have an independent analysis with which to rethink that decision.

For now, there is one thing that QALY supporters and critics agree on. "Very promising drugs are coming, and they're going to be very expensive," said Neumann, the health economist at Tufts. Increasingly, the QALY appears poised to influence how American health care money is spent.

* * *

Lola Butcher is a health care business and policy writer based in Missouri.

This article was originally published on Undark. Read the original article.

Read more here:
Is the medication you're taking worth its price? - Salon

Recommendation and review posted by Bethany Smith

For Immediate Release: January 28, 2020

This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world. To date, the FDA has approved four gene therapy products, which insert new genetic material into a patients cells. The agency anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area. The FDA believes this will provide patients and providers with increased therapeutic choices.

In that spirit, today, the FDA is announcing the release of a number of important policies: six final guidances on gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.

The growth of innovative research and product development in the field of gene therapy is exciting to us as physicians, scientists and regulators, said FDA Commissioner Stephen M. Hahn, M.D. We understand and appreciate the tremendous impact that gene therapies can have on patients by potentially reversing the debilitating trajectory of diseases. These therapies, once only conceptual, are rapidly becoming a therapeutic reality for an increasing number of patients with a wide range of diseases, including rare genetic disorders and autoimmune diseases.

As the regulators of these novel therapies, we know that the framework we construct for product development and review will set the stage for continued advancement of this cutting-edge field and further enable innovators to safely develop effective therapies for many diseases with unmet medical needs, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Scientific development in this area is fast-paced, complex, and poses many unique questions during a product review; including how these products work, how to administer them safely, and whether they will continue to achieve a therapeutic effect in the body without causing adverse side effects over a long period of time.

One of the most important steps the FDA can take to support safe innovation in this field is to create policies that provide product developers with meaningful guidance to answer critical questions as they research and design their gene therapy products.

The six final guidances issued today provide the agencys recommendations for product developers on manufacturing issues and recommendations for those focusing on gene therapy products to address specific disease areas. The six guidance documents incorporate input from many stakeholders and take a significant step toward helping to shape the modern structure for the development and manufacture of gene therapies. The agency is issuing this suite of documents to help advance the field of gene therapy while providing recommendations to help ensure that these innovative products meet the FDAs standards for safety and effectiveness.

The scientific review of gene therapies includes the need to evaluate highly complex information on product manufacturing and quality. In addition, the clinical review of these products frequently poses more challenging questions to regulators than reviews of more conventional drugs, such as questions about the durability of response, and these questions often cant be fully answered in pre-market trials of reasonable size and duration. For some gene therapy products, therefore, although they have met the FDAs standards for approval, we may need to accept some level of uncertainty around questions of the duration of the response at the time of marketing authorization. Effective tools for reliable post-market follow up, such as post-market clinical trials, are going to be key to advancing this field and helping to ensure that our approach fosters safe and innovative treatments.

The draft guidance on interpreting sameness of gene therapy products under the orphan drug regulations provides the FDAs proposed current thinking on an interpretation of sameness between gene therapy products for the purposes of obtaining orphan-drug designation and eligibility for orphan-drug exclusivity. The draft guidance focuses on how the FDA will evaluate differences between gene therapy products when they are intended to treat the same disease. As laid out in the draft guidance and our regulations, the agencys determination will consider the principal molecular structural features of the gene therapy products, which includes transgenes (the transferred gene) and vectors (the vehicle for delivering the transgene to a cell).

With the large volume of products currently being studied, gene therapy product developers have asked the agency important questions about orphan-drug designation incentives to develop products for rare diseases with very small patient populations. The draft guidance has potential positive implications both for product developers and patients by providing insight into the agencys most current thinking on the sameness of products, and thus, not discourage the development of multiple gene therapy products to treat the same disease or condition. For patients, this policy could help lead to the development and approval of multiple treatments, creating a more competitive market with choices. We encourage stakeholders to provide their comments.

In sum, these policy documents are representative of efforts to help advance product development in the field of gene therapy. We will continue to work with product innovators, sponsors, researchers, patients, and other stakeholders to help make the development and review of these products more efficient, while putting in place the regulatory controls needed to ensure that the resulting therapies are both safe and effective. We also encourage developers of new gene therapy products to make full use of our expedited programs available for products intended to address unmet medical needs in the treatment of serious or life-threatening conditions. These programs include breakthrough therapy designation, regenerative medicine advanced therapy designation, and fast track designation, as well as priority review and accelerated approval. Developers should pursue these programs whenever possible to help bring the benefits of important advances to patients as soon as possible. We believe our work will help advance innovations in a way that assures their safety and effectiveness, provides new therapeutic choices to patients and providers and continues to build confidence in this novel and emerging area of medicine.

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

Read more from the original source:
FDA Continues Strong Support of Innovation in Development of Gene Therapy Products - FDA.gov

Recommendation and review posted by Bethany Smith

Aperio Clinical Outcomes, a leading clinical research organization (CRO), announced today that Jonathan Yusi, an expert in the coordination and management of cell and gene therapy clinical trials, has joined the company as Senior Clinical Trials Manager to support their biotechnology clients in the immuno-oncology space.

Yusi has been managing immune-based therapy trials for over seven years. Prior to joining Aperio, he was a program manager for CAR-T studies and oversaw the first CAR-T program at a large CRO. He has provided independent trial management consulting for CAR-T trials, and his expertise has resulted in lasting KOL relationships within the immuno-oncology space. In addition to his adoptive cell therapy knowledge, Yusi brings over 20 years of clinical research experience to Aperio, with a focus on trial logistics, management, and monitoring of targeted and immune therapies in oncology trials.

Says Suzanne Kincaid, Aperios COO and an oncology industry veteran herself, "FDA expects to see over 200 INDs for cell and gene therapies in 2020, so it is imperative that our biotech clients have expertise like Jonathans to manage their trials. He has a strong understanding of the complexities of cell and gene therapy studies and can break down the components for ideal study set-up. We are so excited to have Jonathan help our immuno-oncology clients as they explore these groundbreaking treatments."

"Cell and gene therapy trials are a logistical maze, and one missed endpoint can be catastrophic to the study," says Yusi. "These programs allow me to utilize everything Ive learned about clinical research and oncology, and my medical and scientific background brings an understanding to the science behind the treatments. The bulk of my career has involved oncology trials, so as the treatments have evolved and become more personalized, my experience has evolved as well. These are life-saving breakthroughs, and Im happy to bring this experience to Aperio and our immune-based therapy clients."

About Aperio Clinical Outcomes

In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: http://www.aperioclinical.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200131005540/en/

Contacts

Heather Newbold: +1 919-604-5704heather.newbold@aperioclinical.com

Follow this link:
Aperio Hires CAR-T Trials Expert Jonathan Yusi to Support Cell and Gene Therapy Studies - Yahoo Finance

Recommendation and review posted by Bethany Smith

Gene therapy developers targeting the US market have a clearer idea of what it will take to win approval thanks to new guidance documents issued by the FDA.

The US regulator set out its expectations for developers in six documents published last week. There are final guidance documents on gene therapies for hemophilia, retinal disorders and rare diseases.

In addition, there are final guidance documents on chemistry, manufacturing and controls (CMC), observational studies and on the assessment of gene therapies that use retroviral vectors.

Image: iStock/Piotrekswat

There is also draft guidance explaining how the FDA will interpret sameness when deciding whether to award orphan drug status.

The agency said that when assessing two gene therapies targeting the same disease it will consider both the gene itself and the viral vector.

To date only four gene therapies that introduce new genetic material into a patients cell have been approved by the FDA.

However, many more gene therapies are on the way according to the agency which said it anticipates more approvals in the coming years based on the 900 investigational new drug (IND) it has received.

FDA Commissioner Stephen Hahn said, The growth of innovative research and product development in the field of gene therapy is exciting to us as physicians, scientists and regulators.

These therapies, once only conceptual, are rapidly becoming a therapeutic reality for an increasing number of patients with a wide range of diseases, including rare genetic disorders and autoimmune diseases.

This was echoed by Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, who stressed the importance of effective gene therapy regulations.

As the regulators of these novel therapies, we know that the framework we construct for product development and review will set the stage for continued advancement of this cutting-edge field and further enable innovators to safely develop effective therapies for many diseases with unmet medical needs.

Marks cited the rapid pace of scientific development as a challenge for the agency, explaining that assessing the safety, efficacy and long-term impact of gene therapies is highly complex.

Read more here:
US FDA predicts gene therapy surge - Bioprocess Insider - BioProcess Insider

Recommendation and review posted by Bethany Smith

With more than 900 investigational new drug (IND) applications for ongoing clinical studies related to gene therapies, and with the number of advanced therapy medicinal products at clinical stage worldwide exceeding 1,000, the US Food and Drug Administration (FDA) this week released a number of policies.

The policies, addressed to developers and manufacturers, include six final guidance documents on gene therapy manufacturing and clinical development of products, following up to respective draft guidance documents released in 2018, and a draft guidance related to orphan drug designations for therapeutic candidates.

Scientific development in this area is fast-paced, complex, and poses many unique questions during a product review, commented Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, adding The framework we construct for product development and review will set the stage for continued advancement of this cutting-edge field.

Regarding the draft guidanceInterpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations, the agency explained that it focuses on how the FDA will evaluate differences between gene therapy products when they are intended to treat the same disease.

The final guidance titled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) aims to inform sponsors on how to provide sufficient CMC information, in order to assure product safety, identity, quality, purity, and strength (including potency) of the investigational product and to be able to claim market authorization from the regulatory body.

Addressed to developers and manufacturers of retroviral vector-based human gene therapy products, the second document titled Testing of Retroviral Vector-Based Gene Therapy Products for Replication Competent Retrovirus (RCR) during Product Manufacture and Patient Follow-up determines testing for RCR during manufacture, as well as the regulations for follow-up monitoring of patients who have received such treatments.

Titled Long-Term Follow-Up After Administration of Human Gene Therapy Products, the third document includes recommendations by the FDA regarding the design of long-term follow-up studies for the collection of data on delayed adverse events.

Specifically, the FDA suggests that, as a result of long-term exposure to an investigational gene therapy, patients may be at increased risk of undesirable and unpredictable outcomes, and therefore they may be monitored for an extended period of time past the active follow-up period. The document outlines several factors based on which a risk assessment should be performed to determine the necessity of long-term monitoring for each product.

Another guidance of the FDA is focused on Human Gene Therapy for Hemophilia, and it provides recommendations regarding the clinical trial design for such therapies, as well as addressing discrepancies between Hemophilia A and B coagulation factors activity assays.

Focusing on Human Gene Therapy for Retinal Disorders, the fourth FDA guidance includes recommendations related to product development, preclinical testing, and clinical trial design for such gene therapy products.

Finally, the guidance on Human Gene Therapy for Rare Diseases, with suggestions on the clinical design for such products, is needed, according to the FDA, due to the limited study population size and potential feasibility and safety issues. Moreover, the FDA cites issues related to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the product.

Visit link:
FDA guidance on gene therapies development and manufacturing - BioPharma-Reporter.com

Recommendation and review posted by Bethany Smith

Abstract / Synopsis:

Research is finding key patient benefits to gene therapy as a promising treatment strategy for Leber's hereditary optic neuropathy (LHON).

This article was reviewed by Patrick Yu-Wai-Man, FRCOphth, FRCPath, BMedSci, MBBS, PhD

Data from two clinical studies of Lebers hereditary optic neuropathy (LHON) showed substantial visual improvements in patients with both disease durations of less than six months and between six months and one year. The improvements resulted from a unilateral injection of a gene therapy vector (GS010) and remarkably, the viral vector seemed to be carried over to the untreated eye.

The mechanism of action for these unexpected results need to be clarified with further experimental work.

Related: Research targets precision dosing for gene, cell therapy

LHON is the most common cause of mitochondrial blindness with a minimal prevalence of one in 30,000 individuals in the population. It causes blindness mostly in young adult men with a peak age of onset in the third decade of life. It is invariably a bilateral disorder in which the fellow eye becomes affected within three to six months after disease onset in the first eye.

Both eyes are affected simultaneously in about 25% of patients, according to Patrick Yu-Wai-Man, FRCOphth, FRCPath, BMedSci, MBBS, PhD, an academic neuro-ophthalmologist with faculty positions at the University of Cambridge, Moorfields Eye Hospital, and the UCL Institute of Ophthalmology, in the UK.

Three primary mutations within the mitochondrial genome cause about 90% of cases worldwide, namely, m.3460G>A, m.11778G>A and m.14484T>C, with m.11778G>A being the most common mutation by far, accounting for over 70% of those affected with LHON. Unfortunately, most affected patients remain legally blind with vision worse than 1.3 logarithm of the minimum angle of resolution (logMAR) or 3/60 in Snellen equivalent.

Given the poor prognosis, there is an urgent clinical need to identify effective treatments for this blinding optic nerve disease.

Related: LHON gene therapy: Deciphering phase III data

TreatmentGene therapy is obviously a very attractive treatment option, because the underlying pathophysiology is due to insufficient amount of the wild-type protein, Dr. Yu-Wai-Man said. Therefore, if the defective gene is replaced, we should be able to rescue the retinal ganglion cells, preserving function and improving the visual prognosis.

He described the principles of allotopic gene expression that involves inserting the mitochondrial gene of interest, in this case MTND4, into the nuclear genome with a modified viral vector. The wild-type protein produced has a specific mitochondrial targeting sequence that directs it to be imported into the mitochondrial compartment.

The use of an intravitreal injection is a big advantage for this treatment approach as it is a relatively straightforward procedure that provides direct access to the inner retina. Previous preclinical work indicates that allotopic expression is able to rescue the retinal ganglion cells from the deleterious effects of the m.11778G>A mutation.

Related: Gene therapy offering hope for retinal, corneal patients

Read the original here:
Studies target unilateral gene therapy injection - Ophthalmology Times

Recommendation and review posted by Bethany Smith

Investment Thesis

Objective: Wealth-building of an always fully-invested portfolio via repeated near-term (weeks or months) capital gains from careful, diversified, odds-on issue selection and timely price opportunity capture.

The stocks compared here are Sarepta Therapeutics, Inc. (NASDAQ:SRPT) and Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR). SRPT was inadvertently omitted from the Biotech Developer review recently published. Rather than picture it by itself, ARWR is provided here as a best-ranked alternative.

These market pros have insights you and I can't have because their everyday job is to satisfy investment organizations running billion-dollar portfolios who want to adjust their holdings in multi-million-dollar trade transactions. These market-makers [MMs] have to round up sellers when their clients want to buy, and buyers when they want to sell. That's hard to do when most investors will hold off to get better prices, whether they are buying or selling.

And when lots of money is involved in each trade, the players get pretty careful about what they want to do and when they will do it. But the big-money types work hard to be on top of developments, following some issues intently, anticipating what is likely to be happening to stock prices in the near future. Depending on what they know, or think they know, and what they think others believe is likely to happen, they may take surprising postures. Often their holding-period horizons are months, not years. Or even less.

So, the MMs have to respond when a big-money house says "sell a bunch of this and buy a lot of that, and do it in the next 15 minutes, or you can forget about keeping us as a good repeat-order client".

The MMs will round up any of their other clients who they know have holdings in the stocks or appetites (at a price) to initiate, expand or contract holdings in the issues involved. It's rare when a "cross" can be made with enough "other side of the trade" exists at acceptable prices to "fill" the trade order without having to put some of their own firm's capital at risk in order to balance buying demand with selling supply.

As market-makers, they will provide the balancing position when they can set up a hedge deal to protect the market risk involved in their "facilitation" of the trade's being completed. If they can't, then the trade order gets killed, not filled, to wait for a time when the market is more accommodating.

But what it takes to buy that market risk price-change protection for the MM tells what the players on both sides of the "insurance" market believe can happen to the stock's price during the limited lives of the derivative contracts for options, futures, swaps, or other highly leveraged involved instruments used in the hedge.

That's where we find the balances between forecast upside price gain prospects and price drawdown exposures today and can compare them with what has been seen day by day over the past couple of decades. That is what supports the opening statements above about +15% to +30% gains in specific stocks. Those are fact-based histories of all prior real-market experiences from forecasts made before the fact, not just blown smoke over some after-the-fact single illustration of convenient history.

"Sarepta Therapeutics, Inc. focuses on the discovery and development of RNA-based therapeutics, gene therapy, and other genetic medicine approaches for the treatment of rare diseases. The company offers EXONDYS 51, a disease-modifying therapy for Duchenne muscular dystrophy (DMD). Its products pipeline include Golodirsen, a product candidate that binds to exon 53 of dystrophin pre-mRNA, which results in exclusion or skipping of exon during mRNA processing in patients with genetic mutations; and Casimersen, a product candidate that uses phosphorodiamidate morpholino oligomer [PMO] chemistry and exon-skipping technology to skip exon 45 of the DMD gene. In addition, the company's pipeline comprises SRP-5051, a peptide conjugated PMO that binds to exon 51 of dystrophin pre-mRNA. It has collaboration agreements with Nationwide Children's Hospital to advance micro-dystrophin gene therapy program under the research and license option agreement; Galgt2, a gene therapy program for the treatment of DMD; and Neutrophin 3, a gene therapy program to treat Charcot-Marie-Tooth neuropathies. The company also has a license agreement with Lysogene to develop LYS-SAF302, a gene therapy for mucopolysaccharidosis IIIA; a license and option agreement with Lacerta to develop treatments for CNS-targeted and lysosomal storage diseases; and research collaboration and option agreement with Genethon to develop micro-dystrophin gene therapy products. In addition, it has a research agreement with Duke University to advance gene editing CRISPR/Cas9 technology for restoring dystrophin expression; a collaboration agreement with Summit (Oxford) Ltd. to commercialize products in Summit's utrophin modulator pipeline; a strategic collaboration with Paragon Bioservices; and a strategic collaboration with CENTOGENE for the identification of patients with DMD in the Middle East and North Africa region. Sarepta Therapeutics, Inc. was founded in 1980 and is headquartered in Cambridge, Massachusetts."

Source: Yahoo Finance

SRPT's and ARWR's recent daily price ranges over the past 6 months are shown in Figures 1 and 2, along with measures of their current forecast price up-to-down balances. Also shown are the odds of long position gains being earned in the couple of months subsequent to points in time in the past 5 years when MMs had the same kind of outlook they have today.

Figure 1

source: Author

Figure 2

source: Author

As a contrast, here is what MM forecasts for the "market-index" ETF of SPDR S&P 500 Trust (SPY) looks like at this time:

Figure 3

source: Author

How effective the MMs have been in forecasting for these stocks is a matter of market records, when conditions of uncertainty similar to today's are examined. That was done in the row of data between the graphics of Figures 1-3. For ease of comparison, they are repeated and slightly expanded in Figure 4.

Figure 4

source: Author

As explained in the prior Biotech Developer revue featuring ARWR, the SRPT Range Index [RI] of 23 produced 108 of 124 net gain %Payoffs under TERMD of +30.1%.

A comparison of the +30.1% payoffs with the present forecast of +23.1% suggests an exceptional profit achievement with a degree of credibility for the current outlook of 1.30, as indicated at column [N] of Figure 4.

So much for the "good side" of a buy proposition; what about the "bad side"?

As we condition the credibility of the upside price change forecast by comparison with actual experience, so too do we look to see how bad the downside might get. But with concern only during those "long" holding periods when committed capital would be at risk under the TERMD discipline. All other periods are irrelevant, shocking as they may be.

Figure 1's data row tells what the worst case price drawdowns have been (an average of them) during all of each actual exposure period when they were to be held. What matters is how bad a fear of loss may get induced any time, not just whether or not it existed at the end of the holding. Investors will have varied reactions to the exposures, so there is no way to evaluate potential risk impact by historic outcomes. But some useful guidance may be provided by having knowledge of the maximum degree of intensity possibly becoming present.

One logically-simplified way to address the combination of stock price risk and reward is to weight each part by its probability and combine the two. The "Win Odds" of profitable position odds here for SRPT of 108 out of 124, or 87 out of 100 offer such a probability. One minus those odds, or 100 - 87 provides the loss probability weight. Thus 0.87 times +30.1% plus 0.13 times -8.7% produces a weighted net payoff of +25.1%.

To make this style of evaluation more comparable between varied investment opportunity situations, an integration of the likely holding periods used in the calculation is helpful. For SRPT, the average number of market days required by all 129 positions of the sample was only 40 out of the maximum 63 possible, because of the high proportion of upside target prices reached.

A standard evaluation measure used in many capital planning decision situations is the expected net payoff stated in "basis points" of 1/100ths 1%, per day of capital involvement. On a 365-day calendar year +19 bp/day when sustained for a year doubles the original capital, or a CAGR of +100%. When a smaller-count of 252 market days makes up a relevant year, the fewer days are each proportionally more powerful, so only 14 bp/mkt day does the 100% equivalent.

Comparison is the essence of evaluation. If the investing objective is to make capital as productive of future spend-able amounts as possible, using an odds-weighted bp/d yardstick can be helpful.

To that end, Figure 4 includes the relevant MM forecasts and their prior outcomes for ARWR and the market-index proxy of the SPDR S&P 500 Index ETF (SPY). Also, the average of some 2,700 current-day MM price-range forecast issues, and a ranked set of the day's likely 20 best of those near-term wealth-building stocks under TERMD portfolio discipline.

All of these comparisons in Figure 4 have the same basic data as included in the row of Figure 1 for SRPT. That is expanded by the columns [O] through [R] to provide for odds-weighted bp/day price-prospect evaluation comparisons.

Competition from the market-index alternative SPY at this point in time is rather limited because of an unenthusiastic upside target outlook of only +5.5% at a CAGR of only +9% and an Odds-Weighted net prospect [Q] of +0.8%. That is better, though, than the overall population of 2,711 where MM forecasts are a modest net decline (-2.2%).

Sarepta Therapeutics, Inc. and Arrowhead Pharmaceuticals Inc. both offer outstanding prospects for capital gains with strong odds for achievement in short periods of holding. SRPT has the larger potentials, but ARWR appears historically to have quicker achievement prospects. Payoff potentials in basis points per day are exceptional. For further information, please check my blog here on Seeking Alpha.

Disclosure: I/we have no positions in any stocks mentioned, but may initiate a long position in SRPT over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: Disclaimer: Peter Way and generations of the Way Family are long-term providers of perspective information, earlier helping professional investors and now individual investors, discriminate between wealth-building opportunities in individual stocks and ETFs. We do not manage money for others outside of the family but do provide pro bono consulting for a limited number of not-for-profit organizations.We firmly believe investors need to maintain skin in their game by actively initiating commitment choices of capital and time investments in their personal portfolios. So, our information presents for D-I-Y investor guidance what the arguably best-informed professional investors are thinking. Their insights, revealed through their own self-protective hedging actions, tell what they believe is most likely to happen to the prices of specific issues in coming weeks and months. Evidences of how such prior forecasts have worked out are routinely provided in the SA blog of my name.

See the original post:
Sarepta Therapeutics, Inc. And Arrowhead Pharmaceuticals Now Top-Ranked Biotech Stock Buys - Seeking Alpha

Recommendation and review posted by Bethany Smith

Microsoft announced a new five-year, $40 million artificial-intelligence initiative geared toward global health challenges and research.

Dubbed AI for Health, the program will work to equip academia and non-profit research organizations for their medical research efforts, including the development of diagnostics, treatments and preventive measures. It also aims to address global health crises and healthcare disparities.

"We know that putting this powerful technology into the hands of experts tackling this problem can accelerate new solutions and improve access for underserved populations, Microsoft President Brad Smith said in a statement.

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

The tech giant hopes to tackle the uneven distribution of data science expertise as well: Microsoft estimates that less than 5% of the worlds AI professionals work in healthcare and non-profit organizations.

The new program will build upon the companys previous collaborations, like individual efforts focused on sudden infant death syndrome, leprosy and diabetic retinopathy, as well as its work on developing a secure system for sharing biomedical data.

AI for Healths first set of grantees include the Novartis Foundation, Fred Hutchinson Cancer Research Center, Seattle Children's Research Institute, PATH, Intelligent Retinal Imaging Systems and the international development organization BRAC.

RELATED: Novartis to put AI on every employee's desk through Microsoft partnership

"Countries like Bangladesh, where BRAC was founded, have made enormous strides in health equity in the last three decades. Unfortunately, at least half the world's population still lacks access to essential health services," said BRACs executive director, Asif Saleh. "Across our outreach areas in Asia and Africa, we see massive potential in using advanced data analytics and AI to bridge the gap between 'health for some' and 'health for all,' and we welcome Microsoft's commitment in making this happen."

Last year, Microsoft signed on to a wide-ranging partnership with Novartis to help put AI tools on the desk of each of the drugmakers research associates. That five-year project will also establish a joint innovation lab tasked with upgrading the Big Pharmas R&D, clinical trials and manufacturing efforts.

It will also take on research projects in macular degeneration and irreversible blindness, cell and gene therapy manufacturing efficiency and expediting the design of new drug compounds. Meanwhile, Microsofts new work with the companys foundation will focus on limiting the spread of disease.

"Leprosy is one of the oldest diseases known to humans, but today an estimated 2 to 3 million people are still living with the disease," said Ann Aerts, head of the Novartis Foundation. "Around the world, we are working to accelerate efforts to eliminate leprosy by focusing on interventions that aim to interrupt transmission. The use of AI is transformative and a game-changer in how we can accelerate progress and scale our work to reach the people in need."

Read the original here:
Microsoft launches 5-year, $40M AI initiative in global health - FierceBiotech

Recommendation and review posted by Bethany Smith

The Discovery Labs and Deerfield Management Company have formed The Center for Breakthrough Medicines, a contract development and manufacturing organization (CDMO). The CDMO is occupying over 40 percent (680,000 sq. ft.) of The Discovery Labs' 1.6 million square foot biotech, healthcare and life sciences campus in King of Prussia, PA.The CDMO provides preclinical through commercial manufacturing of cell and gene therapies and component raw materials. It offers process development, plasmid DNA, viral vectors, cell banking, cell processing, and support testing capabilities all under one roof. The company said the $1.1 billion facility will provide instant capacity as the largest known single source for accelerating the delivery and affordability of lifesaving and life-changing therapies from the bench to the patient's bedside.The company has initiated a substantial hiring effort, expecting to hire over 2,000 team members within the next 30 months.In addition to developing the world's largest single-point cell and gene therapy manufacturing facility, The Discovery Labs is establishing THE COLONY which will provide custom built discovery labs, breakthrough funding, sponsored research agreements, housing and relocation for the world's leading iconic experts in cell and gene therapy.THE COLONY will seek to work hand in hand with scientists from both academic and pharmaceutical institutions to unlock and expedite groundbreaking therapies.Marco A. Chacn, founder of Paragon Bioservices and chairman of The Discovery Labs said, "Musicians, artists, members of religious communities and great thinkers throughout time have formed colonies where freedom of thought and expression combined with unlimited dreams and potential have resulted in the world's greatest accomplishments. The United States of America is a perfect example. The goal of THE COLONY is to unshackle the potential of the world's greatest scientific minds."Audrey Greenberg, board member and executive managing director, The Discovery Labs, said, "The Center for Breakthrough Medicines will be serving companies from the earliest stages through commercialization. Its exceptional scale and offering will quickly relieve the production bottleneck for advanced therapies by reducing the time, complexity, and cost of commercializing vitally needed gene and cell therapies.The addition of this end-to-end manufacturing capability is expected to significantly enhance the offerings of The Discovery Labs in an area that has become one of the largest life sciences hubs in the world. Renovations are underway to construct a total of 86 plasmid, viral vector production, universal cell processing, CGMP testing, process development and cell banking suites. The viral vector and cell processing suites will be fully compliant with both U.S. Food and Drug Administration and European Medicines Agency standards. All suites will offer the flexibility to meet client-specific workflows and will be able to adapt quickly to meet demand. The company is in the process of reserving capacity now for late 2020."Today brilliant scientists are advancing an unprecedented number of gene and cell therapy drug candidates. The real tragedy, however, is a scarcity of manufacturing know-how, which is complex and expensive," said Alex Karnal, partner and managing director, Deerfield Management and a board member of the Discovery Labs. "With its visionary business model, it is hoped that The Center for Breakthrough Medicines will help realize the promise of cell and gene therapies in time to treat the many patients who need them."The Discovery Labs provides a central campus where the world's greatest scientists can collaborate on new therapeutic discoveries to eradicate diseases affecting small and large segments of the global population. The Center for Breakthrough Medicines will work with these leaders, life sciences companies, large pharmaceutical companies, and academic and government institutions.This new manufacturing capability is a transformational addition to The Discovery Labs market offering and dovetails with The Discovery Labs biotech incubator, Unite IQ. Unite IQ offers immediate space to emerging life sciences companies and scientists giving them the ability to grow from startup to enterprise company on one campus. The incubator and accelerator space at Unite IQ provides a comprehensive home for startups with every resource needed to initiate business operations. Unite IQ tenants are expected to utilize the discovery, development, testing, and manufacturing capabilities of the Center for Breakthrough Medicines with seamless forward integration of processes and analytics, and seamless tech transfer from research lab to large scale production.

Continued here:
Cell & Gene Therapy CDMO Begins Operations - Contract Pharma

Recommendation and review posted by Bethany Smith

Photo Submitted

Dr. Mahendran Mahadevan, a professor in the Department of Obstetrics and Gynecology at the University of Arkansas for Medical Sciences, willspeakfrom 3-4 p.m. Monday, Feb.3, in Room D2 of the Food Science Building, 2650 N. Young Ave. His presentation, "Food, Health, and Disease,"is open to everyone.

Mahadevan's presentation will focus on how different types of food and beverages plays a role in human body's health defense systems (Angiogenesis, stem cells/regeneration, microbiome, DNA protection, and immunity). This basic biological knowledge related to foods will be useful for better understanding about the effects of foods on the prevention and management of human diseases.

Mahadevan's research interests include: 1) roles of genetics, obesity, nutrition, food supplements, nutraceuticals, physical activity and other environmental/life style factors on prevention/public health and maternal, fetal, and child health; 2) tissue banking; 3) embryo and stem cell culture/expansion (particularly culture medium/conditions); and 4) gene therapy and stem cell gene therapy particularly in cancer and genetic diseases.

Mahadevan received his Veterinary medicine degree in 1975 from University of Ceylon Peradeniya, Sri Lanka and his doctoral degree in Reproductive biology from Monash University, Australia in 1982. His academic experience includes faculty positions in the Department of Physiology, School of medicine at the University of Ceylon and in the Department of Obstetrics and Gynecology at the University of Arkansas for Medical Sciences.

View original post here:
UAMS Professor to Present Relationships Among Food, Health, and Disease in Food Science Seminar - University of Arkansas Newswire

Recommendation and review posted by Bethany Smith

DUBLIN, Jan. 31, 2020 /PRNewswire/ -- The "Global Healthcare Market Outlook, 2020" report has been added to ResearchAndMarkets.com's offering.

Research and Markets Logo

Amid rising global trade tensions and sluggish global economic outlook for 2020, the global healthcare market is expected to cross the $2 trillion mark in 2020.

Healthcare will be among the top two priorities for voters in the 2020 presidential election in the US. In the European region, looming BREXIT indecision is likely to have a strong impact on Europe's biggest digital health market (UK). Globally, 2020 will be a reality check for long-pending national healthcare policies and regulatory reforms that must re-invigorate future strategies.

The new vision for healthcare for 2020 and beyond will not just focus on access, quality, and affordability but also on predictive, preventive, and outcome-based care models promoting social and financial inclusion. Social Determinants of Health (SDOH) will emerge has a big theme across progressive health systems to proactively engage the right patients and improve health outcomes to help healthcare organizations meet quality standards. In 2020, consumer-driven models of healthcare will gain more market traction, as they stand to better bridge the gap of what consumers want and what healthcare can deliver.

Continued steps will be taken by retail (Walmart, Costco, Amazon, Ali Health), and consumer tech (Google, Apple, Microsoft, and so on) companies globally; to make further headway (intrude) into vetted healthcare space. In 2020, the convergence of Artificial Intelligence (AI), Blockchain, and the Internet of Things (IoT) will further catalyze the space of innovation adoption and related applications in the healthcare realm. For example, while Blockchain will improve data liquidity to empower AI and analytics vendors/applications to digest a large amount of data, AI can manage Blockchain systems more efficiently than humans.

Research Scope

Every year, the team of futurists, analysts, and consultants at the publisher's Transformational Healthcare Group come together to render a comprehensive analysis to predict the themes, technologies, and global forces that will define the next 12 to 18 months (future) for the healthcare industry.

As a part of this research deliverable, the publisher provides bold perspectives and predictions for the global healthcare market in 2020. The sectors covered include pharmaceuticals and biotech, in-vitro diagnostics, medical technologies, medical imaging, and healthcare IT. The analysis captures sectoral and regional trends and provides predictions for the upcoming year. The study provides guidance on where to find the greatest opportunities for expansion.

Predictions for the global healthcare market in 2020 include:

Key Issues Addressed

Key Topics Covered

1. Executive Summary

2. Revisiting 2019 Predictions

3. Global Healthcare Market Outlook for 2020

4. Key 2020 Healthcare Market Predictions

5. Regional Predictions 2020

6. Sector Outlook 2020

7. Key Conclusions

For more information about this report visit https://www.researchandmarkets.com/r/o8dr1g

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

View original content:http://www.prnewswire.com/news-releases/global-healthcare-market-study-2020-perspectives--predictions-for-the-pharmaceuticals--biotech-in-vitro-diagnostics-medical-technologies-medical-imaging-and-healthcare-it-sectors-300996869.html

SOURCE Research and Markets

Read the original:
Global Healthcare Market Study 2020: Perspectives & Predictions for the Pharmaceuticals & Biotech, In-Vitro Diagnostics, Medical Technologies,...

Recommendation and review posted by Bethany Smith

The Sulfur Palletized Plant And Granulator Market study offers an in-depth analysis of the current market trends influencing this business vertical. The study also includes market valuation, market size, revenue forecasts, geographical spectrum and SWOT Analysis of the industry. In addition, the report depicts key challenges and growth opportunities faced by the industry bigwigs, in consort with their product offerings and business strategies.

A collective analysis of Sulfur Palletized Plant And Granulator Market offering an exhaustive study based on current trends influencing this vertical across various geographies has been provided in the report. Also, this research study estimates this space to accrue considerable income during the projected period, with the help of a plethora of driving forces that will boost the industry trends during the forecast duration. Snippets of these influences, in tandem with countless other dynamics relating to the Sulfur Palletized Plant And Granulator Market, like the risks that are predominant across this industry along with the growth prospects existing in Sulfur Palletized Plant And Granulator Market, have also been charted out in the report.

ThisPress Release will help you to understand the Volume, growth with Impacting Trends. Click HERE To get SAMPLE PDF (Including Full TOC, Table & Figures) at https://www.futuremarketinsights.co/reports/sample/REP-GB-4244

One of the most dynamic points that makes the Sulfur Palletized Plant And Granulator Market report worth a purchase is the widespread synopsis of the competitive range of the vertical. The study proficiently separates the Sulfur Palletized Plant And Granulator market into

key players and products offered

Potential and niche segments, geographical regions exhibiting promising growth

A neutral perspective on market performance

Must-have information for market players to sustain and enhance their market footprint.

NOTE All statements of fact, opinion, or analysis expressed in reports are those of the respective analysts. They do not necessarily reflect formal positions or views of Future Market Insights.

According to the competitive hierarchy. These firms have been competing with one another to gain a near-dominant status in the industry.

Get Access To TOC Covering 200+ Topics athttps://www.futuremarketinsights.co/toc/REP-GB-4244

The report provides extensive data concerning the market share that each one of these companies presently gather throughout this business, followed by the market share that they are anticipated to acquire by the end of the predicted timeframe. Also, the report expounds on details relating to the goods manufactured by these firms, that would help new industry participants and major stakeholders work on their competition and portfolio strategies. In addition, their policymaking process is likely to get easier since the Sulfur Palletized Plant And Granulator Market report also enumerates an idea of the trends in product prices and the revenue margins of all the major companies partaking in the industry share.

Queries that the Sulfur Palletized Plant And Granulator Market report answers in respect of the regional landscape of the business domain:

The geographical landscape, according to the report, is divided into North America, Europe, Asia-Pacific, South America & Middle East and Africa. Which among these regions is more likely to amass maximum market share over the forecast duration

How much is the sales evaluations of each market player in question Also, how are the revenue statistics regarding the present market scenario?

How much profit does each geography hold at present?

How many proceeds will every zone including North America, Europe, Asia-Pacific, South America & Middle East and Africa account for, over the projected timeframe?

How much growth rate is each region estimated to exhibit by the end of the estimated timeline?

Request Customized Report As Per Your Requirements athttps://www.futuremarketinsights.co/customization-available/REP-GB-4244

Significant takeaways from the study:

The Sulfur Palletized Plant And Granulator Market report hosts excess deliverables that may be highly advantageous. Say for instance, the report emphasizes information regarding market competition trends extremely essential data subject to contender intelligence and the current industry drifts that would enable shareholders to compete and take advantage of the biggest growth opportunities in the Sulfur Palletized Plant And Granulator Market.

Another vital takeaway from the report can be accredited to the industry concentration rate that could help stakeholders to speculate on the existing sales dominance and the probable trends of the forthcoming years.

Additional deliverables mentioned in the report include details pertaining to the sales channels deployed by prominent sellers in order to retail their status in the industry, including direct and indirect marketing.

About UsFMI is a leading market intelligence and consulting firm. We deliver syndicated research reports, custom research reports and consulting services which are personalized in nature. FMI delivers a complete packaged solution, which combines current market intelligence, statistical anecdotes, technology inputs, valuable growth insights and an aerial view of the competitive framework and future market trends.

Contact Us616 Corporate Way, Suite 2-9018,Valley Cottage, NY 10989,United StatesT: +1-347-918-3531F: +1-845-579-5705T (UK): + 44 (0) 20 7692 8790

Continue reading here:
Gene Therapy Market Segments and Key Trends 2019-2029 - Melanian News

Recommendation and review posted by Bethany Smith

Cannabis, and what it might be able to do for human health, inspires me. And I think it can do the same for other scientists and scientists to be.

Newlegal frameworksandemerging clinical researchhave opened the door to research on cannabis and the compounds it makes. In just a few years, weve gone from having a rudimentary understanding of the plants compounds to discoveringcrucial connectionsamong cannabinoids and human physiology. Our broader understanding of these plant compounds is boosting the STEM job market.

Weve only begun to scratch the surface of clinical research for the medical and health applications of cannabis. This exploration cant happen without collaboration between organic chemists, biologists, botanists, agronomy experts, medical doctors, pharmacologists, and experts in clinical trials, drug formulation, and therapeutic product design.

The potential for new and innovative medications and wellness products derived from cannabis could be huge. Promising applications include reducing or relieving pain, quelling nausea, and easing seizures or the symptoms of Parkinsons disease. Researchers are investigating myriad other conditions that may respond well to cannabinoids.

Theres no question that the cannabis industry needs scientists. But it looks as though scientists need the cannabis industry as well.

Read the original post

Read the original post:
'We've only begun to scratch the surface': How the cannabis boom opens the door to new medicines and wellness products - Genetic Literacy Project

Recommendation and review posted by Bethany Smith

TMRR in its latest research report states that the global market size of Gene Therapy and Antisense Drugs market was $XX million in 2018 with XX CAGR from 2014 to 2018, and is expected to reach $XX million by the end of 2029 with a CAGR of XX% from 2019 to 2029.

Global Gene Therapy and Antisense Drugs Market Report 2019 Market Size, Share, Price, Trend and Forecast is an intuitive and exhaustive study on the current and future prospects of the global Gene Therapy and Antisense Drugs industry. The key insights are elucidated as under:

Request Sample Report @ https://www.tmrresearch.com/sample/sample?flag=B&rep_id=500&source=atm

There are 4 key segments covered in this report: machine segment, product type segment, end use segment and regional segment.

Competitive landscape of Gene Therapy and Antisense Drugs market has tier 1, tier 2 and tier 3 players and provides a dashboard view of their strategies and intensity mapping.

Segmentation

On the basis of therapeutic area, the gene therapy and antisense drugs market is segmented into cancer, anemia, rheumatoid arthritis, cardiovascular diseases, HIV/AIDS, cystic fibrosis, diabetes mellitus and obesity, and renal diseases.

By gene transfer method, ex vivo gene transfer and in vivo gene transfer are the segments of the market. The former involves the transfer of cloned genes into cells, i.e., cells are altered outside the body before being implanted into the patient, whereas the latter involves the transfer of cloned genes directly into the patients tissues. The outcome of in vivo gene transfer technology mainly depends on the general efficacy of gene transfer and expression.

Global Gene Therapy and Antisense Drugs Market: Regional Outlook

The global gene therapy and antisense drugs market is segmented into North America, Asia Pacific, Europe, and Rest of the World. Amongst these, North America holds the leading position in the market followed by Europe. The increasing incidence of cancer and other fatal diseases, unhealthy lifestyle practices such as excessive smoking and excessive consumption of high fat content food, and increasing research efforts for treatment against cancer are the major factors driving the gene therapy and antisense drugs market in these regions.

Asia Pacific is expected to emerge as a significant market for gene therapy and antisense drugs. The high population density including a large geriatric population, expeditiously increasing demand for technologically advanced therapeutics, and increasing government support for improved healthcare infrastructure in the region is driving the growth of this regional market. Furthermore, favorable reimbursement policies and tax benefits on newer therapies will further fuel the growth of the Asia Pacific gene therapy and antisense drugs market.

Major Companies Mentioned in Report

Some of the leading companies operating in the global gene therapy and antisense drugs market are GenVec Inc., Avigen Inc., Genome Therapeutics Corp., Tekmira Pharmaceuticals Corporation, Isis Pharmaceuticals, Cell Genesys Inc., and others. These companies are profiled for their key business attributes in the report.

Customize This Report @ https://www.tmrresearch.com/sample/sample?flag=CR&rep_id=500&source=atm

For regional segment, the following regions in the Gene Therapy and Antisense Drugs market have been covered

Reasons to Purchase this Report:

We also can offer customized report to fulfil special requirements of our clients. Regional and Countries report can be provided as well.

Request For Discount On This Report @ https://www.tmrresearch.com/sample/sample?flag=D&rep_id=500&source=atm

See the original post here:
Gene Therapy and Antisense Drugs Market size and Key Trends in terms of volume and value2018 2028 - Dagoretti News

Recommendation and review posted by Bethany Smith

The latest iteration of Gwyneth Paltrow's controversial lifestyle brand has landed on Netflix, and hoo boy there is a lot to unpack.

Like anyone with a penchant for evidence-based medicine, I went into the series, The Goop Lab, with a sceptical eye (but an open mind).

Goop has a reputation for making unfounded health claims, and ahead of the show's release, health professionals expressed concern that it could spread pseudoscientific information and encourage a distrust in medical experts.

While Goop is careful to start each episode with a disclaimer that the show is designed to "entertain and inform not provide medical advice", it goes on to present alternative therapies (some with very limited evidence) as a treatment for various ailments, often without much-needed context.

Each episode of the six-part series generally follows the same formula: Paltrow and Goop executive Elise Loehnen sit down with a couple of experts (genuine or otherwise), discuss a health-related intervention, and send off Goop employees (or sometimes themselves) to test said intervention.

Despite being described as a "lab", the series is fairly light on science where it does have it, it tends to exaggerate and instead relies heavily on testimonials and anecdotes.

There is, however, one episode that really gets it right. So let's start there.

Goop's record on women's health is not strong (I'm looking at you, vagina steaming), so I was naturally apprehensive going into the episode on female sexuality and pleasure.

You can imagine my surprise (and utter delight) to find 35 minutes of vulva anatomy, body positivity and frank discussions about women's sexual health and autonomy.

The success of this episode is, in large part, thanks to Betty Dodson, a 90-year-old feminist sex educator and her colleague, Carlin Ross, who run workshops that aim to empower women with knowledge about their bodies.

Dodson notes that many women feel shame or embarrassment when it comes to sex, and most of the episode is spent trying to counter this.

Sex educators Carlin Ross and Betty Dodson are a highlight of The Goop Lab.

(Netflix)

Sex educators Carlin Ross and Betty Dodson are a highlight of The Goop Lab.

We get a rare and welcome glimpse of diverse, naked female bodies of all ages, and, more radically, a montage of vulvas, to demonstrate the diversity of female genitalia.

There are discussions about how porn has created unrealistic expectations about sexuality, and how women are increasingly turning to cosmetic surgery to change the appearance of their genitals.

The episode culminates in Dodson coaching Ross to achieve an on-camera orgasm, in a way that is educational, realistic, and not fetishised.

The whole approach is unabashed, yet sensitive, and feels genuinely refreshing. It left me wishing Goop would do this all the time: promote the message that vaginas and vulvas are great just as they are.

The only down-side to the episode was discovering Paltrow didn't know the difference between a vulva and vagina. To be fair, this is not uncommon.

But for someone selling products to put inside the vagina, I'd say that's a fairly major anatomical oversight.

There are a handful of episodes in the series which attempt to explore topics of genuine scientific interest, but struggle to execute them with much credibility.

Let's take the first episode, which focuses on psychedelic medicine, as an example.

In recent years, there has been a renaissance of research into the possible therapeutic effects of drugs like MDMA and psybicilin (magic mushrooms), and there are currently studies underway in Europe, the US and Australia investigating their potential to treat depression, trauma, and anxiety at the end of life.

While psychedelic-assisted psychotherapy is a genuinely promising area of research, what drug researcher Mark Haden makes clear in the episode is that the use of psychedelics in research is "completely different" to recreational use and "at no point are [researchers] advocating that people start taking MDMA or LSD or anything else".

In 2018, Gwyneth Paltrow's wellness company was estimated to be worth $250 million.

(Netflix)

In 2018, Gwyneth Paltrow's wellness company was estimated to be worth $250 million.

But Goop ignores this advice and sends four employees to Jamaica to trip on magic mushrooms under the guidance of "psychedelic elders" anyway.

A good portion of the episode is dedicated to watching the four Goopers (technical term for Goop staff) drink mushroom tea, hallucinate at the sight of the sky, and cry to themselves.

In typical Goop fashion, we hear very positive reviews: "I feel like I went through five years of therapy in about five hours".

What we don't hear is any of the side effects or risks associated with drug taking. Or how participants in clinical trials are heavily screened, and there are some mental health disorders for which psychedelic drugs are advised against.

Similarly, in episode two, the personal experience of Goop staff is favoured over scientific analysis, when we're introduced to Wim Hof, a Dutch athlete known for his ability to withstand freezing temperatures.

In the middle of winter, Hof takes a group of Goopers out to Lake Tahoe to learn his eponymous controlled breathing and cold-therapy method, which he claims can make the human body more resilient to physical and psychological stress.

Dutch athlete Wim Hof teaches Goop employees yoga in the snow at Lake Tahoe.

(Netflix)

Dutch athlete Wim Hof teaches Goop employees yoga in the snow at Lake Tahoe.

After learning to hyperventilate, meditate, and plunge into extremely cold water, one woman with a panic disorder claims to not have panic attacks any more.

Another man, not on the Goop bootcamp, says the Wim Hof method helped cure him of his auto-immune disorder.

As noted in the episode, a small 2014 study found the combination of meditation, breathing techniques and exposure to cold resulted in a temporary anti-inflammatory immune response.

However, the episode fails to include another 2014 study which suggests Hof's ability to tolerate extreme cold may come down to his genetics and high brown-fat levels.

There's interesting science to be explored around the mind-body connection and biofeedback, but we don't get much of it here.

In the fourth episode, the Goop team sets out to explore anti-ageing regimens, and this is where we really start to veer off the scientific road, so to speak.

Elise Loehnen gets facial acupuncture in The Goop Lab.

(Netflix)

Elise Loehnen gets facial acupuncture in The Goop Lab.

In a bid to reverse their "biological ages", Paltrow, Loehnen and fellow Goop executive Wendy Lauria adopt one of three diets: vegan, pescatarian or the "fast mimicking" diet (an alternative to fasting).

At the end of the episode, we learn Paltrow, who undertook the latter for five days reduces her so-called biological age the most: by 1.7 years.

While there is legitimate research investigating the connection between fasting and longevity, and evidence that calorie restriction can improve the biomarkers of ageing in animals, there is limited evidence so far that it can influence the biology of ageing in humans.

We also see in this episode Paltrow, Loehnen and Lauria undergo various cosmetic facial procedures.

The treatments which include injecting blood into the face, acupuncture needles, and inserting metal threads through cheeks (in what is ostensibly a face lift) are described by Loehnen as "a little bit more natural".

More natural than what? It's not clear.

You know how I said that at episode four, we start to veer off the scientific road? Well, in the final two episodes of The Goop Lab, the road seems to completely disappear underneath us; we are now freefalling in the Goop universe.

Episode five, titled The Energy Experience, is centred on the idea of "energy healing".

We meet John Amaral, a chiropractor and "body worker" to the stars, who claims to influence how energy moves through the body.

John Amaral supposedly works with people's energy fields moving his hands through the air as their bodies squirm below.

(Netflix)

John Amaral supposedly works with people's energy fields moving his hands through the air as their bodies squirm below.

As Julia Belluz notes in Vox, "energy" is presented uncritically as "an amorphous catch-all cause, and treatment for, so many our ailments", from psychological distress to physical pain.

At one point, Amaral invokes quantum physics, specifically the double-slit experiment which suggests the act of observing a particle has an effect on its behaviour to effectively prove that what he's doing is real.

I was *very* sceptical about the veracity of this claim, but I called Ben Buchler, a professor of quantum physics at the Australian National University, just to be sure. His response?

"It's unequivocal crackpottery."

(For context, Professor Buchler says the double-slit experiment does raise interesting questions about the nature of reality, but that it doesn't provide any scientific basis for "energy healing".)

A better way to assess the evidence for Amaral's work would be to look at studies on reiki, which are largely inconclusive.

A randomised control trial suggests the effects of energy therapy are likely to be a placebo which, should be noted, can be very powerful.

In the final episode of The Goop Lab, we meet psychic medium Laura Lynne Jackson, who, according to Goop, "gives a powerful, unexpected reading and invites the Goop gang to open up energetically".

My energetic response to this episode was mostly laughter, but that may have been because I was not wearing Goop's "psychic vampire repellent" spray.

As Goop reminds us each episode, "you should always consult your doctor when it comes to your personal health". I'd say that's sage advice.

Read more:
The Goop Lab exaggerates science and speculates, but shines on women's health - ABC News

Recommendation and review posted by Bethany Smith

Good stockmanship comes naturally to the Adam family, who have been farming at Newhouse of Glamis, near Forfar, for almost 100 years.

Bob Adams grandfather moved to the 550-acre farm in 1937 and the familys passion for pedigree cattle started with the formation of an Aberdeen-Angus herd, followed by the introduction of Beef Shorthorns in the 1950s.

The Aberdeen-Angus herd was dispersed in 1979 to make way for Limousin cattle, and Beef Shorthorns were dispersed in 1969 to make way for Charolais.

Now, 40 years later, Bob and Kay Adams sons, Andrew, 21, and James, 19, are preparing to sell the first pedigree bull from a new Aberdeen-Angus herd at Newhouse at this weekends Stirling Bull Sales.

Kay says the Aberdeen-Angus renaissance at Newhouse is entirely driven by her two sons the fourth generation of the Adam family at the farm who have funded much of their new enterprise with money earned from their pedigree flock of Bluefaced Leicesters.

Andrew, who works full-time at the family farm, said: We wanted to do something of our own to bring to the farm and we bought our first Angus in 2016 when we got a yearling heifer from Tonley for 4,000gn.

Their first purchase Tonley Emiline is the dam of the junior bull on offer at United Auctions this weekend. Named Newhouse Endeavour, he is a June-2018 born son of Gretnahouse Blacksmith.

Other foundation females purchased by Andrew and his brother James, who is undertaking an agricultural engineering apprenticeship with AL.

Agri, include Wolflaw Edwina, which traces back to original Newhouse Aberdeen-Angus genetics, and a Wedderlie heifer purchased as a 21st birthday present for Andrew.

The brothers also paid 7,000gn for Retties Diana from Perth breeders Richard and Carol Rettie when she stood female champion at Stirling in October 2016. They also purchased two Blelack cows, which are due to calf in the spring, from the Massie family at Firmarron, Aboyne.

The brothers bull joins a line-up of seven other Newhouse bulls being offered for sale at Stirling. These include six Limousins from the familys 75-cow herd and one Charolais from its 25-cow herd.

The Limousin entry comprises three black bulls and three red bulls. All three black Limousins are sired by Westhall Jammy, which has bred sons to 11,000gn.

The family also keeps a small herd of commercial cattle and flocks of North Country Cheviot and Blackface sheep at Auldallan Farm, near Kirriemuir, which is run with the help of shepherd Richard McArdle.

See original here:
Brothers unite in revival of Aberdeen-Angus herd - The Courier

Recommendation and review posted by Bethany Smith

With high levels of moisture saturating soils throughout the Red River Valley and parts of the Assiniboine River basin going into winter, there is a high likelihood the region will experience flooding come spring.

How much and how damaging will depend on the amount of precipitation we get over winter and how quickly it melts.

Herbicide-resistant Palmer amaranth. (University of Arkansas / Associated Press files)

While Manitoba farmers are no strangers to overland flooding, speakers at the annual round of extension updates this winter are warning to be on the lookout for some troublesome pests hitching a ride into fields on that water.

Officials have been watching the northward migration of two plants that have been wreaking havoc with weed-control efforts south of the border over the past decade: herbicide-resistant Palmer amaranth and its genetic cousin waterhemp. Palmer amaranths arrival in Manitoba is pending, and waterhemp is already here, ready to make its next move.

Theyve been dubbed "superweeds" because they so rapidly evolve to survive virtually all forms of herbicide control. Once they develop resistance to one herbicide, they quickly figure out how to overcome stacked combinations of other herbicides too.

Researchers trying to understand how they do it have zeroed in on their sex lives. These particular species are dioecious, which means a field population contains both female and male plants. Most Amaranthus species contain male and female flowers on the same plant.

The dioecious plants more rapidly outcross, which gives them an advantage in the evolutionary race. As well, they are prolific seed producers, with one plant able to produce up to a million seeds. So not only do they develop resistance more rapidly, they are really good at spreading it around.

Farmers are easily caught off guard because there are lots of reasons why they might see a few weeds left here and there after spraying. It could have been a plugged nozzle on their sprayer; it could have been too hot, too cold or too windy.

Farmers are advised to assume herbicide resistance and do whatever it takes mow, till or pull to prevent those patches from going to seed.

Researchers hope that a better understanding of how these plants reproduce will open the door to new tools, for example, genetically modifying the plants so all the offspring are male, thereby collapsing the local weed population.

Herbicide-resistant weeds arent the only waterborne threat farmers need to monitor.

Clubroot is a strange beast in the world of crop protection. It is a protist, which means it is a parasite with plant, animal and fungal characteristics. It needs a living host to grow, which means it can quickly take hold if farmers grow canola in the same field year after year.

When it moves into a canola field, it can cripple production, and there is no treatment for it. In a badly infected field, farmers only tool is starving the organism by not growing susceptible crops for as many as 10 years. With canola being the No. 1 cash generator on most Prairie farms, the cure is almost worse than the disease.

In Alberta, clubroot has spread from field to field on contaminated soil that clings to equipment as farmers go about their work.

The pathogen has gradually made its way eastward and is now showing up in Manitoba fields.

However, whereas the clubroot infections in Alberta tend to show up first in field-entry points, Manitoba extension workers have noted the main path of transmission appears to be via waterways. That means farmers need to change their scouting practices to monitor for it.

The thing with most of these crop production challenges, whether they are resistant weeds or diseases, is that they force farmers to diversify their strategy for dealing with them.

In most cases, they have lots of tools to pick from, ranging from improved genetics to tillage, to various crop-protection technologies.

The problems arise when they keep doing the same thing over and over. When the pests take over, sometimes the only option is taking that field out of annual crop production.

Thats why the pressure is on for farmers to avoid getting the problem in the first place.

Laura Rance is vice-president of content for Glacier FarmMedia. She can be reached at lrance@farmmedia.com

Laura RanceColumnist

Laura Rance is editorial director at Farm Business Communications.

Read full biography

More:
Superweeds, pests on the move - Winnipeg Free Press

Recommendation and review posted by Bethany Smith

Claim

The term "spinster" became an epithet thanks to resentment toward women who earned their own way rather than having to depend on a man around the house to bring in money.

Reporting

The word spinster generally conjures up a mental picture of mean little old ladies who have never been married, glaring at young people from behind their living room curtains (which are lacy and yellowed with age, naturally) with their mustachioed mouths puckered in disapproval at all the goings-on outside. At its very least, it is a word that carries connotations of pity.

An April 2018 entry on Tumblrhas gone quietly viral since it was first posted, putting the lie to that trope by delving into the origins and history of the term and tracing how it became an epithet. In it, user systlin wrote:

I honestly always find the termspinster as referring to an elderly, never-married woman as funny because you know what?

Wool was ahugeindustry in Europe in the middle ages. It was hugely in demand, particularly broadcloth, and was a valuable trade good. A great deal of wool was owned by monasteries and landed gentry who owned the land.

And, well, the only way to spin wool into yarn to make broadcloth was by hand.

This was viewed as a feminine occupation, and below the dignity of the monks and male gentry that largely ran the trade.

So what did they do?

They hired women to spin it. And, turns out, this was a stable job that paid very well. Well enough that it was one of the few viable economic options consideredrespectable outside of marriage for a woman. A spinster could earn quite a tidy salary for her art, and maintain full control over her own money, no husband required.

So, naturally, women who had little interest in marriage or men? Grabbed this opportunity with both hands and ran with it. Of course, most people didnt get this, because All Women Want Is Husbands, Right?

So when people sayspinster as inspinster aunt, they are TRYING to conjure up an image of a little old lady who is lonely and bitter.

But what I HEAR are the smiles and laughter of a million women as they earned their own money in their own homes and controlled their own fortunes and lived life on their own terms, and damn what society expected of them.

The claim has bounced around social media in bits and pieces for many years, but this particular entry seemed to strike a chord with readers; it was shared on the platform more than a hundred thousand times.

According to the old reliable standby Merriam-Webster, the term did indeed originally describe occupation, and its definition has evolved since it was first used sometime in the 14th century:

Definition of spinster1: a woman whose occupation is to spin2a archaic : an unmarried woman of gentle familyb: an unmarried woman and especially one past the common age for marrying3: a woman who seems unlikely to marry

The site also offered a page from the editors delving into the words etymology, which appeared to back up the original Tumblr post:

Whenspinsterfirst entered English in the mid-1300s, it referred to a woman who spun thread and yarn. Our earliest use comes from the allegorical poemPiers Plowman: And my wyf Spak to e spinsters for to spinne hit softe (and my wifespoke to the spinners to spin it soft).

Two historical facts led tospinstersevolution: the fact that most spinners in the Middle Ages were women, and the fact that it was common in legal documents to use ones occupation as a sort of surname (which is why we have Smiths and Bakers and Tanners and so on). Women who spun yarn or thread were given the titleSpinsterin legal documents.

The jump from spinner to single lady is likely an economic one. Some scholars suggest that during the late Middle Ages, married tradeswomen had greater access to raw materials and the market (through their husbands) than unmarried woman did, and therefore unmarried women ended up with lower-status, lower-income jobs like combing, carding, and spinning wool. These jobs didnt require access to expensive tools likelooms, and could be done at home. By the 17th century,spinsterwas being used in legal documents to refer to unmarried women.

The Online Etymological Dictionary also draws a clear line from the work-related origin of the word spinster and its later derogatory connotations, pointing out that it was supposed to be exactly the sort of work with which unmarried women were supposed to occupy themselves, at least in England, by the 1600s:

However, there seems to be little historical indication that this was ever a particularly lucrative trade; industries relegated to womens work have been characterized by intermittent labor and low pay throughout the centuries. Spinning and carding wool, even for the most gifted women in the Middle Ages, was no different. Which is not to say that it brought in no money at all. Poet and writer Christine de Pizan, who was born in 1364 and became one of the first women in Europe to support herself through her prolific writing, was an early advocate for womens equality. Medieval researcher and former Queens College professor Diane Bornstein summed up her advice in her book The Lady in the Tower: Medieval Courtesy Literature for Women, which indicated that spinning and carding did not always necessarily pay pittance wages:

The lady who lives on her estates must be wise and must have the courage of a man. She should not oppress her tenants and workers but should be just and consistent. She should follow the advice of her husband and of wise counselors so that people will not think she is merely following her own will. She must know the laws of warfare so that she can command her men and defend her lands if they are attacked. She should know everything pertaining to her husbands business affairs so that she can act as his agent in his absence or for herself if she should become a widow. She must be a good manager of workers. To supervise her workers, she needs a good knowledge of farming. She will be sure to have adequate supplies for the spinning and weaving of cloth for the wise housekeeper can sometimes bring in more profit than the revenue from the land.

That was not the only reference to spinning (and weaving) cloth as a way that women could findfinancial independence. But as with all of history, the true stories are always more nuanced and complex than the claims.A 2004 paper by Middle Ages historian Ruth Mazo Karrasnotes that even as textile production became regarded more as a prestigious and skilled occupation, meaning that men eventually took over its distribution and excluded many women from guilds in the process, spinning wool (which was at the time in great demand) remained the domain of the women:

With the continuing development of towns in the high and later Middle Ages craft guilds began to take control of production, and in northwestern Europe womens labor was largely excluded or relegated to spinning or other less skilled and less remunerative stages of the clothmaking process, although in the Mediterranean region women may have been included for longer. As David Herligy describes the situation by the thirteenth century, Guilds and governments as yet had made no effort to limit womens work or to reserve or preserve jobs for men. In cloth making as in many other trades, women and men worked alongside one another without visible rivalry. The central Middle Ages remained a period of free enterprise and of open access to employment for both sexes. Herligy paints too glowing a picure here, for (as he points out) even where men and women worked together in a craft men tended to do the more skilled parts of the job and to be paid more.

Karras goes on to point out that it is still difficult to parse how much work was done by women on behalf of men, rather than working on their own account:

By the fourteenth and fifteenth centuries craft guilds had come to dominate skilled labor and women were for the most part excluded. In a few places Paris, Rouen, Cologne there were female guilds, partcularly in luxury textile crafts like silkworking, but these were rare. In other places, like London, women did most of the wilk work but did not achieve the dignity of a guild structure. The male guilds of weavers, dyers, fullers, and others those who worked in wool, which was more lucrative because of greater demand attempted to exclude women other than widows of guild members (and sometimes daughters of guild members if they married men of the craft). Thus, although women may have done a good share of the textile work, as members of households, it was not conceived of as womens work, but rather as women helping men with their work. Individual female spinners or carders might be employed by male weavers, as York wills indicate.

It is true that some spinners and weavers were recognized as highly skilled, such as a group of women in 15th century London who spun and wove silk rather than wool, but whose experiences as tradeswomen followed a common trajectory:

The silkworkers of London, then, serve as a somber reminder of how some medieval notions of community worked to the disadvantage of women. Since most skilled work prone to gild organization was done by men, most gilds were male dominated, and if women were tolerated within them, they were second-class members. They enjoyed some of the religious, social, and charitable benefits of gild membership, but they were firmly excluded not only from its political perquisites but also from many of its more important economic and social privileges. Although some womens crafts and trades had sufficiently high status or sufficiently skilled workers to make gild organization possible, few gilds were actually formed. In some towns, such as Rouen, Paris, and Cologne, such women did form gilds, but even these were less autonomous than the gilds of men. In most other towns, like London, such women did not organize into gilds and were thus vulnerable to competition and loss of trade.

But even though the labor of women, even highly skilled women, was assigned lower value than that of men, it still offered a path to financial independence that lasted cor centuries, but it did not come without a social cost:

Jackie M. Blountcalls spinsters gender transgressors, women who managed to find lives of independence and autonomy in their work as educators. Hired because of their singleness, not despite it, spinsters were at first considered high-minded, upstanding pillars of the community and eventually became cultural icons. But when social hygiene and the study of sexuality came into vogue at the turn of the twentieth century, spinsters came under fire. Suspected of lesbianism and accused of suppressing frustrated sexuality, Blount writes, spinsters were increasingly viewed as standing outside their conventional gender roles as procreating women. Admiration turned into villainization as women were forced to defend their single status in a workplace that once welcomed them.

Though many spinsters doubtless fell on the LGBTQ spectrum or were simply unable to find a mate, there was another reason to stay single.Zsuzsa Berendwrites that contrary to modern-day beliefs that spinsterhood was the dismissal of traditional marriage values, many nineteenth-century spinsters in fact chose not to marry because they adhered strongly to ideals about traditional marriage. As marriage was elevated and spiritualized, Berend writes, women looked for vocations and occupations rather than betray their own principles about love.

But once again, a theme appears in the historical studies of spinsters, one that appears to have been missed by critics of the original Tumblr posts. Its true that spinning wool (and other textiles) was a stable and lucrative career in Europe during the Middle Ages, and indeed its true that it remained so for centuries. Cloth production was regarded as womens work, but eventually it was economically dominated by men who often tried to exclude women from guilds and unions. But it remained an way for women who by choice or by circumstances lived outside of their cultural and social norms to freely choose their own economic destinies and their own fates, relying on their own skills and talents to do so. For many women, freedom from such cultural pressures and the ability to steer their own fate is priceless by their own admission, a sentiment reflected in early writings of the time. The term started be used to describe unmarried women in the 1700s, but it did not becomederogatory until centuries later, when social hygiene was swept into vogue during the eugenics craze of the early 1900s; by 1903, United States President Theodore Roosevelt was vividly and dramatically describing what he thought of as low birthrates among white Americans as race suicide:

The growing scientific field of genetics led some political leaders to embrace the notion of controlled breeding to favor advanced races. White Americans feared an infertility crisis in their neighborhoods. President Theodore Roosevelt warned in 1903 that immigrants and minorities were too fertile, and that Anglo-Saxons risked committing race suicide by using birth control and failing to keep up baby-for-baby.

In one speech, Roosevelt said: The chief of blessings for any nation is that it shall leave its seed to inherit the land. The greatest of all curses is sterility, and the severest of all condemnations should be that visited upon willful sterility.

That meant that white women (and to a lesser degree, men) who chose to remain single were suddenly regarded as especially suspect, adding a eugenicist twist to the term spinster and giving it a whiff of louche disreputability for failing to uphold the white race:

The tendency of single women to remain unmarried seemed to pose an enormous threat to the traditional gender order where women served men.

In response, a series of intellectual developments emerged in the 1800s and early 1900s that were employed to counter the threat. First, the medical profession grew intensely interested in the broad field of human sexuality. The subject became a matter of heightened concern, and much of the research conducted was heavily influenced by religions beliefs. Any deviations from conventional procreative male-female relationships came under increased scrutiny and eventually were regarded as pathological (Bullough, 1974).

Second, in an era of rapidly increasing social diversity, the social hygiene movement emerged in the early 1900s and saw as its role the proper direction of sexuality toward the advancement of the White race. School and college hygiene classes assisted young White men and women in mastering gender-appropriate behaviors, and in finding worthy spouses who could best assure fit offspring and therefore the improvement of the race.

[]

[I]n the early decades of the twentieth century, single women increasingly were viewed as standing outside their conventional gender roles as procreating women. In time, spinsterhood even became conflated with lesbianism, then an unspeakable social transgression.

Over centuries, then, the term spinster went from describing an occupation, to describing an unmarried women, to describing an unmarriageable one, reflecting the social attitudes, trends, and finally the race-based moral panics of the times. At one point, working as a spinster was indeed regarded as a stable and sometimes lucrative profession that was open to women, particularly throughout Europe in the Middle Ages, just as described in the original Tumblr post. While admittedly history is far more nuanced and complex than it is often presented, and while women were still earning less on average than the men who often controlled the means of production, the historical record shows that spinning and other aspects of textile production were considered appropriate and common ways for women to earn a living and support themselves and their households without having to depend on others to do so. Therefore, we rate this claim True.

The rest is here:
Origin of the Word 'Spinster' - Truth or Fiction

Recommendation and review posted by Bethany Smith

A silent assasin is stalking us more virulently than ever, especially our young, but to quote from Aleksandr Solzhenitsyns Cancer Ward, you can have eyes and still not see. Its cancer, the second leading cause of death after cardiovascular diseases in India. Going by an estimate deduced from registered incidences since 2004, cancer cases in all age groups in the county is expected to reach 819,354 by the yearend. But the scarier bit, a cause of concern, is that cancer among adolescents and young adultsthose between 15 and 29 years generally, and bundled under the abbreviation AYAhas risen over the years. An exact number isnt available as data is still being collected. The volume could be significant because in a country of nearly 1.3 billion people, about 55 per cent of the population is below 35, and around 30-40 per cent of them are in the adolescent bracket.

Cancer in the AYA group is unique in the distribution of types as well as what it does to patients psychologically. As per Globocan 2018, International Agency for Research on Cancer, World Health Organization (WHO), the commonest cancers in this group are leukaemia (blood), germ cell tumour of the ovary, thyroid, oral, Hodgkins lymphoma, testicular, female genital tract malignancies, and bone sarcomas. A study from 2011 to 2014 on cancer patterns among 1,077 AYA cases at a tertiary care in northern India and published in South Asian Journal of Cancer in 2017 found that the most common was head and neck (32 per cent), followed by breast (14.2 per cent). Cancer has the greatest impact on individuals from this group because it occurs when they are most productive. They suffer from adverse psychosocial effects because most of their potential years are spent battling cancer. This also puts a large economic burden on society, says Ravi Mehrotra, chief executive officer, India Cancer Research Consortium.

Problem is cancers in the AYA group are often mistaken initially for infectious diseases. Thus diagnosis and treatment get delayed. Thats because people hardly suspect a kid could have the disease, although oral cancer is most common in this group in India. On the positive side, Dr Anurag Srivastava, professor and head, department of surgical disciplines, AIIMS, Delhi, says the survival of adolescents with leukaemia and lymphomas has dramatically improved over the past decade.

Our modern lifestylesedentary and unhealthy practices like smoking, drinking and binge-eating processed food et alis perhaps the biggest cause of cancer. Citing their national study published in Lancet in 2018, preventive oncologist Mehrotra says tobacco-use among young adults would be the single-most preventable cause because a smoker, for instance, may not have cancer at a young age but is at the highest risk in a couple of decades of smoking. Other than tobacco, alcohol and areca nut or supari are some specific reasons, particularly in urban and semi-urban areasSomething people dont talk about is obesity as a cause. The number of younger obese children, as young as 10 or 15 or even younger, is something to be noted. When we have obesity, we are automatically about 12 or 13 times more susceptible to cancer. Obesity is linked to oesophagus, colorectal and breast cancers, among others.

Some experts are non-committal on the reported spurt in cancer cases among the young and arent quite sure if poor lifestyle is a cause. Ramandeep Singh Arora, paediatric oncologist at Max Super Specialty Hospital, explains that increase in recognition of a disease, diagnosis and access to healthcare have contributed to better reporting of cancer cases. The younger you are the impact of lifestyle is negligible. But as you grow older, the impact of lifestyle and environment is more. In the case of AYA, the impact is a combination of environment and genetics, he says.

Whatever may be the cause, experts are worried about the rise in cancer cases. The incidence of cancer in India is unfortunately on a rising trend, the highest being in the states of Kerala and Mizoram. A committed epidemiological and scientific research is the need of the hour to find the cause of this alarming rise and prompt measures need to be initiated for prevention rather than therapy, particularly in the context of a developing country with limited resources, says Dr M.I. Sahadulla, chairman and managing director, KIMS Global Cancer Care, Thiruvananthapuram.

According to the WHO, 30-50 per cent cancers are preventable. Experts state that prevention offers the most cost-effective long-term strategy. They prescribea healthy lifestyle, regular physical activity, a good body mass index and weight, a nourishing diet considerably reduce susceptibility to cancer and other diseases. Diets high in fruits and vegetables may have an independent protective effect against many cancers. Quitting smoking can prevent cancers of the lung, oesophagus, larynx, mouth, throat, kidney, bladder, pancreas, stomach and cervix. Smokeless tobacco like khaini causes oral, oesophageal and pancreatic cancers. Avoiding excessive exposure to the suns carcinogenic UV rays and use of sunscreen can prevent skin cancers such as melanoma. Vaccination against the hepatitis B virus reduces the risk of liver cancer, while the vaccine for the human papilloma virus (HPV) helps decrease the risk of cervical cancer.

Actress, author Lisa Ray is a cancer survivor. She was diagnosed with multiple myeloma in 2009, aged 37 then.

Breast cancer is the commonest among women, accounting for 24.2 per cent or about 2.1 million cases worldwide, according to Globocan 2018. India had 162,468 new breast cancer cases in 2018. Dr Rajan, director of clinical services, KIMS in Kerala, reveals that Indian patients with breast cancer are a decade younger compared to counterparts in developed countries, where it is in the 55-65 age group normally. We dont know the reason for this spike and early prevalence, the specialist says. Dr Anurag Srivastava of AIIMS, Delhi, has a similar revelation. According to him, an ICMR study has found that the annual rise in breast cancer cases among women aged 15 to 34 is 4.24 per cent, 1.6 per cent and 0.80 per cent in Nagpur, Mumbai and Chennai. Whereas the increase for the 3544 age group is from 0.37 per cent to 2.97 per cent. In our own data, we had 7.1 per cent women below 30 years, he says.

Dr M.I. Sahadulla, CMD, KIMS Global Cancer Care

Several risk factors for breast cancer are known, including inherited genes and reproductive aspects such as early menarche, shorter menstrual cycle, late menopause besides nulliparity, child birth at a young age. The reproductive factors are linked to greater lifetime exposure to endogenous ovarian hormones. These ovarian hormones initiate breast development and may also lead to growth of mutated cells, Srivastava says. Dietary factors like excessive intake of saturated fat, carbs and red meat, and weight gain during adulthood, increase breast cancer risk. There is substantial evidence that alcohol consumption also heightens the risk.

Srivastava says AIIMS is taking the fight against breast cancer beyond the OPDs, labs and wards. It is imparting training to medical officers and auxiliary nurses and midwives from all states in collaboration with the governments National Health Mission. The institution also conducts a breast cancer screening camp, aside from a weekly clinic at the National Institute of Cancer Prevention and Research in Noida. Awareness in rural areas is spread through an animated movie that AIIMS had made and got it dubbed in multiple languages. It tells about symptoms and the right way to do self-examination of the breasts. AIIMS has started a super-specialisation course in breast and endocrine diseases, which is an established speciality in the West.

Cancer cure has surely improved in the past decades. The newest hope is genome. Dr B.S. Ajaikumar, chairman and CEO of HealthCare Global Enterprises Limited, feels cancer genomics research has enormous, untapped potential. Genomics research is the basis for genomic medicine, which is a relatively new branch of medicine, where doctors use a persons genetic information to choose the best possible line of treatment and cancer care. The need for innovative approaches is getting a new thrust. The India Cancer Research Consortium (ICRC) offered in October funds up to Rs 1.5 crore for three years to invite best research ideas in six thematic areasprevention and epidemiology, diagnostics, therapeutics, palliative care, basic biology and innovation. The objective is to produce outcomes that can be put into practice. A breakthrough, no doubt, will be a boon to thousands of patients and their families. Until then, to quote Siddhartha Mukherjees The Emperor of All Maladies, cancer will remain a pathological mirror of our own.

View original post here:
Leukaemia To Breast Cancer, Why The 15-29 Age-Group Has Become Most Vulnerable - Outlook India

Recommendation and review posted by Bethany Smith

When it became known that NXIVM was under investigation by the FBI, Keith Alan Raniere, Clare Bronfman, Lauren Salzman, Allison Mack, Nicki Clyne and several others fled the United States and went into hiding in Mexico.

On March 26, 2018 the Mexican Federal Police captured Raniere and turned him over to the FBI.

On April 19, 2018, a three-count indictment was unsealed in the EDNY charging Defendants Raniere and Mack with sex trafficking, sex trafficking conspiracy and conspiracy to commit forced labor.

On July 23, 2018, a superseding indictment was unsealed charging Raniere, Clare Bronfman, Mack, Kathy Russell, Nancy Salzman and Lauren Salzman with racketeering conspiracy, forced labor conspiracy, wire fraud conspiracy, sex trafficking conspiracy, sex trafficking, attempted sex trafficking,and conspiracy to commit identity theft.

On March 13, 2019, a Second Superseding Indictment was unsealed. The Second Superseding was similar to the first except for the dismissal of Nancy Salzman as a result of her guilty plea.And Raniere, Bronfman, Mack, Russell, and Lauren Salzman were charged with racketeering conspiracy, and racketeering; and four predicate racketeering acts were added, including two acts of sexual exploitation of a child, and one act of possession of child pornography, [Cami] and one act of visa fraud.

The child porn and sexual exploitation of Cami spooked all the codefendants of Raniere and in shot order they all took plea deals.

On April 8, 2019, Mack pled guilty to racketeering conspiracy, and racketeering. She admitted committing racketeering acts of state law extortion; and forced labor.

Now she is facing a civil lawsuit.

Many think the former actress is a victim and has been punished enough already. But the civil lawsuit, much like testimony in the trial of Keith Alan Raniere, paints a different picture of Mack, other than an abused victim.

She comes across as a sex-slaver

The case is SARAH EDMONDSON; TONI NATALIE; MARK VICENTE, JANE DOES 1-13, JANE DOES 15-39, JANE DOES 41-60; JOHN DOES 1-17, and JOHN DOES 19-20,

v. : KEITH RANIERE; NANCY SALZMAN; CLARE BRONFMAN; SARA BRONFMAN; LAUREN SALZMAN; ALLISON MACK; KATHY RUSSELL; KAREN UNTERREINER; DR. BRANDON PORTER; DR. DANIELLE ROBERTS; DANIELLA PADILLA BERGERON; ROSA LAURA JUNCO; LORETA J. GARZA DAVILA; MONICA DURAN; NICKI CLYNE; NXIVM CORPORATION; EXECUTIVE SUCCESS PROGRAMS, INC.; ETHICAL SCIENCE FOUNDATION; and FIRST PRINCIPLES,

[Ed. Note: Although I know the identity of some of the Jane and John Does, I will honor the anonymity provision of the lawsuit, except where the victims have already gone public. A few have testified in the trial of Raniere and I may identify them as they were identified in the trial.]

So with all those defendants where does the comely actress fit in?

Sadly for her fans, not too well

She was a leader of DOS, which began in 2015.

According to the lawsuit, it was headed by Raniere and Mack, Lauren Salzman, Rosa Laura Junco, Daniela Padilla Bergeron, Loreta J. Garza Davila, Monica Duran, and Nicki Clyne, the First Line Masters.

The lawsuit alleges quite a bit about DOS, which our readers are familiar with:

Of course, as readers know, and as the lawsuit,alleges, DOS recruits were required to provide collateral to prove their trustworthiness.

Collateral consisted of

We know the story:

As the lawsuit alleges, After supplying collateral. DOS was revealed to the recruits. But to their surprise and dismay, they were told that now, before they could learn about the structure and nature of this sisterhood, they had to provide additional humiliating and damaging collateral. Thus, before knowing anything about the internal workings of DOS, they were trapped, fearful that if they did not do precisely as instructed, the collateral that they had already provided would be released.

This, of course, is a point that might be debated. After giving the first collateral, which some could argue was stupid to begin with, you learn that there is a master slave relationship.

That might be a good time to stop. But it turns out that the DOS First Line Masters, including Mack, were not terribly forthcoming. No, in fact they lied.

The lawsuit alleges that it was only after the second batch of collateral was given that the recruiter/master revealed a little more about DOS: that it was a pyramid of master/slave relationships, explained as no different from a guru and disciple or a mentor-mentee relationship, which would strengthen women by testing and challenging their boundaries but would require absolute trust and obedience by slaves to their masters.'

But the slaves were never told that Raniere created and ran DOS.

When asked, the First Line Masters denied Ranieres involvement and did not tell the slaves that the collateral was intended to coerce women into a lifetime of personal servitude; and that the ultimate objective of DOS was to recruit and groom women for sexual slavery under their grandmaster Raniere.

DOS was, the lawsuit alleges, created to develop a pipeline of attractive young women for Raniere.

The lawsuit also paints a picture of what life was like in DOS.

As the lawsuit alleges, slaves were acutely aware of the ultimate punishment hanging over their heads: the very real threat that their collateral would be released.

And Slaves were in a constant state of near-starvation, sleep deprivation, forced to physically exert themselves and push themselves well beyond exhaustion, always anxious and fearful that anything they said or asked might be interpreted as rebellious and subject them to punishments, both mental and corporeal.

Not a single DOS member, the lawsuit alleges, understood when she gave that first collateral that she was signing up for a life of servitude and sexual slavery under a cruel grandmaster [Raniere] and his circle of mistresses.

The lawsuit describes it as a secret ceremony, [where DOS slaves] were forced to disrobe, read from a script stating they requested to be branded, lie down on a table, and submit to branding with a cauterizing iron in their pubic region. No anesthesia was administered during this procedure, which was extremely painful. The ceremonies were recorded, thereby creating an additional piece of collateral. They were told that the brand was a symbol representing the elements of nature. Only later did they come to realize that they would be carrying Keith Ranieres initials around with them for the rest of their lives.

In the lawsuit, almost all of Allisons alleged offenses involve her role in DOS.

They involve Jane Does 2, 3, 4, 9, 10, 11, 28 and Sarah Edmondson and quite frankly others not named.

Allison Mack was specifically mentioned as perhaps the most ruthless of the First Line Masters who reported directly to Raniere.

The lawsuit mentions that Mack recruited her own slaves, who were required to recruit their own, as well. All the women in Macks line of slaves were obligated to serve her and comply with her directions. This was true of each First-Line Masters line of slaves.

And again,When the slaves defected, many of them wrote to Mack, as well as Lauren Salzman, Nancy Salzman, and Clare Bronfman, pleading for their collateral to be returned or destroyed. Lauren Salzman would pass such pleas along to Clare Bronfman.No collateral was ever returned or destroyed.

Jane Doe 2 was recruited into DOS, [then referred to as The Vow] by a slave [India] of Macks.

Jane Doe 2 provided collateral and did unpaid work for the DOS slave [India] and Mack.

I dont think we are revealing too much by saying that Jane Doe 2 is Jaye who testified in the Raniere trial.

The Lawsuit alleges: Jane Doe 2 had frequent direct communications with Defendant Raniere, both in person when she visited Albany and through text messages, wherein among other things he promised that, if she moved to Albany, she could start an ethical t-shirt business with him (a ploy he had previously used on others to draw them closer to him).

[The ploy, of course, was to promise to start a company, which he would help fund and provide his unique genius.]

Unsurprisingly, the t-shirt company and all of its equipment was owned by Clare Bronfman.

The lawsuit continues, After Jane Doe 2 moved to Albany and gave collateral several times, Defendant Mack instructed her to have sex with Raniere, stating that this was a special assignment that would help her get over trauma from past [sexual] abuse.

Mack further insisted that Jane Doe 2 photograph the encounter, and she told Jane Doe 2 that she had Macks permission to enjoy the experience.

The language which follows was used not only for Jane Doe 2 but for the other sex slaves trafficked by Mack.

Eventually, the shame and humiliation of what she had to do as part of The Vow was more than she could bear, and Jane Doe 2 informed Mack that she was repudiating her Vow and requested that her collateral not be released. Paralyzed by the dual fears of release of hercollateral and the Defendants infamous abusive legal tactics, Jane Doe 2 left the NXIVM community and kept silent about her experience.

Now this next part will not come as a surprise:

Subsequent to her departure from NXIVM, Defendants Raniere and Clare Bronfman directed a co-conspirator [I believe this to be Alex Batancourt] to cause false criminal charges to be lodged against Jane Doe 2.

Raniere and Clare Bronfman then instructed an attorney to send Jane Doe 2 a letter threatening legal action if she told anyone about what Defendants did to her. That letter and the charges have never been rescinded, and thus Jane Doe 2 is still subject to thisintimidation.

As a result of Defendants scheme, criminal acts, and misrepresentations and omissions, Jane Doe 2 was emotionally and financially harmed.

Also, as part of Defendants scheme, Jane Doe 2 performed uncompensated labor, working for many hours without compensation for the benefit of the Defendants.

Jane Doe 3 was recruited into DOS, then referred to only as The Vow, by a DOS slave of Macks.

Throughout her time in DOS, Jane Doe 3 was given direction and commands directly from Mack.

After Jane Doe 3 moved to Albany and gave collateral several times, she was instructed to have sex with Raniere. Jane Doe 3 acquiesced out of fear of punishment and release of her collateral.

Unlike Jaye [Jane Doe 2], this unfortunate woman actually had sex with the beastly one.

If you want a picture worth a 1000 words as to why this is a serious crime and worthy of significant financial recompense look at what she had to touch. Imagine the fear and loathing combined.

Allison Mack had her collateral and coerced her to have sex with this odious and malodorous creature.

Like Jane Doe 2, Clare and Keith and El Duce went after her to lodge false criminal charges and send threatening letters.

The lawsuit alleges, The letters caused her to experience tremendous fear and intimidation, and instead of coming forward and speaking with an attorney or authorities, she went into hiding and avoided contact with authorities for a period, even after learning that the FBI was investigating the Defendants and others. Those letters and charges have never been rescinded.

Jane Doe 4 worked for Mack and Ranieres The Source, NXIVMs purported curriculum for actors.She taught 2-hour long classes three times a week.Mack recruited Jane Doe 4 herself .

Sneaky Mack required Jane Doe 4 to provide collateral.After she got collateral, Mack revealed their relationship would be master and slave, and Jane Doe 4 was required to continue giving collateral, which Jane Doe 4 provided out of fear that her previously provided collateral would be released if she did not comply with all of Macks demands.

Mack assigned Jane Doe 4 to establish contact with Raniere and do whatever he told her. Mack informed her that if she failed, there would be punishment.Raniere demanded that Jane Doe 4 engage in sexual acts with him.

Out of fear of punishment and release of her collateral, Jane Doe 4 unwillingly acquiesced to Ranieres demands.e Defendants.

I believe Jane Doe 4 is none other than Nicole, who testified in the trial of Keith Alan Raniere most effectively and was the cause of his sex trafficking conviction

Jane Doe 9 was recruited into DOS by a DOS slave who was slave to one of other the DOS First-Line Masters.

But Mack spoke directly with Jane Doe 9 and helped recruit her.

Later, the lawsuit alleges, when another DOS slave told Jane Doe 9 that she was leaving NXIVM and showed Jane Doe 9 her brand, Jane Doe 9 quietly left DOS and NXIVM.

This slave was saved by the Frank Report; they read about the branding and happily Jane Doe 9 was not branded. I have interviewed Jane Doe 9 in the past.

Jane Doe 10 was recruited into DOS.When she wanted to leave, Jane Doe 10 requested the return of her collateral from Mack and Raniere, which she never received.

A resident of California. Jane Doe 11 enrolled in and paid for NXIVM curriculum based upon Defendants false, material representations that Rational Inquiry provided a scientific, patent-pending technology that would lead to a successful career and self-fulfillment.

Contrary to Defendants representations, Rational Inquiry was neither scientific nor patentable. Defendants also failed to disclose a material factthat Rational Inquiry was actually a pseudo-scientific hodgepodge of psychotherapeutic methods which, when practiced byunlicensed and unqualified lay-people, subjected its participants to an unreasonable risk of serious psychological injury and emotional distress.

Jane Doe 11 was recruited into DOS by Allison Mack and another person.

She was required to participate in 24/7 readiness drills, send a private message to her master each morning and night, and provide services to her master.

And we are not done yet.

A resident of California, Jane Doe 12 enrolled in and paid for NXIVM curriculum.Jane Doe 12 was recruited into DOS, by Mack.

Mack required Jane Doe 12 to obtain her permission to travel, meet with people and eat, and to report her whereabouts every hour. Mack put Jane Doe 12 on a restricted calorie diet which caused Jane Doe 12 to develop medical conditions including a hormonalimbalance.

Mack gave Jane Doe 12 an assignment which required her to establish contact with Raniere and acquiesce to his demands. Mack informed her that if she failed, there would be punishment. Raniere demanded that Jane Doe 12 engage in sexual acts with himself on numerous occasions.

Mack also instructed Jane Doe 12 to recruit other women to DOS and told her that she would be punished if she did not.

After giving several rounds of collateral, Jane Doe 12 was coerced into being branded. She later discovered the brand contained Ranieres initials.

Eventually, the shame and humiliation was more than she could bear, and Jane Doe 12 left DOS.

[I think this might be India.]

***

So Mack worked directly with Raniere to create and run DOS. Within the DOS structure, Mack was a First Line Master, where Jane Doe 2, Jane Doe 3, 4, 11, 12 and 15 were slaves in her line.

A little more for Mack.

It appears DOS had a precursor, TEN C, which Mack, Clyne, Nancy Salzman and Raniere started.

It was aimed at procuring young women from college sororities for Raniere.The young women were promised opportunities to build character through NXIVM curriculum and programs, and develop a sorority in their age group within NXIVM, mentored by Mack, Clyne, and Raniere.

The Defendants also offered these female students jobs working at a t-shirt company owned by Raniere and Clare Bronfman.

Privately, with sexual partners, Raniere referred to himself as TEN C, which stood for The Emperor has No Clothes.

Ultimately, this effort to procure young women for Raniere failed. Subsequently, Mack and Clyne and others created and ran DOS with Raniere.

Another of the Companies Mack was involved in was the Knife of Aristotle (The Knife), founded in 2014 as a purported news outlet.

The key officers included Mack, Rosa Laura Junco and Nicki Clyne.

Ranieres stated purpose for creating The Knife was the scientific analysis of existing media, including fact checking, so that subscribers could cut through abundant fake news and get to the truth, the lawsuit alleges. The truth, of course, meant Ranieres spin on everything, and the Knife was just one more way in which Raniere isolated his followers from outside influences.It enabled him to shield members from bad press about NXIVM because members of the NXIVM community received their news solely from The Knife. To get news from anywhere else meant that one was rebellious and jeopardizing the community.

Loyal Allison Mack was right there supporting him in everything.

Jane Doe 3, 6, 13, 21,41, 43, 51, Mark Vicente and John Doe 16 worked for the Knife.

Sarahs branding session video was release because she spoke out about Nxivm and DOS.

Read the original here:
Allison Mack Accused of Being Sex-Slaver in Nxivm Civil Lawsuit - Frank Report

Recommendation and review posted by Bethany Smith

DNA sequencing can unlock a whole new understanding but also holds some risks and ethical questions.

Genomics has been the most transformative biotechnology of the 21st century to date. It is one that has caused significant debate amongst medical professionals and regulators since direct-to-consumer (DTC) genetic testing entered the market in the early 2000s, allowing consumers to access limited genetic information without the involvement of a physician.

As DNA sequencing costs have plummeted, the number of DTC genetic tests available through companies like 23andMe and Ancestry.com have risen rapidly. At present roughly 30 million customers have embraced DTC. It has been predicted that by 2021, over 100 million people will have utilized such analyses. In 2018, it was estimated that there were 75,000 genetic tests on the market with ten being added each day.

Affluent families are active planners and assessors of risk. With direct-to-consumer DNA testing becoming so prolific, it seems logical to examine whether these families can use genomics to their advantage when it comes to embracing human capital issues and enhancing the health and well-being of various family members.

Can these at-home DNA tests assist in determining the possibility of illness and taking steps to mitigate this risk? Should the information they provide be factored into succession decisions? Are they the missing piece of the puzzle when it comes to achieving longevity?

To answer these questions first requires a basic understanding of the current state of direct-to-consumer genetic testing in comparison to medical versions, the information these provide and what inferences can be drawn from these types of tests.

Understanding genetic testing

The human genome is made up of over 6 billion elements grouped into thousands of genes that carry hereditary information about a persons traits, including things like hair and eye color. This information is based on the way specific molecules that make up genes are arranged.

Genetic testing examines these arrangements or variations. The results are used to determine the risk of disease development, screen for and diagnose rare diseases and, in some cases, may be used to determine medical treatment when predicting things like drug responses. In a clinical setting, the results of these tests are used to inform medical treatment decisions.

Ronnie S. Stangler, M.D., physician, psychiatrist and founder of Genome Advisory, helps families of wealth navigate the field of genomics from practical functional applications, its risks and ethics, to the dreamspace of aging-reversal.

Dr. Stangler comments, I often share with my clients that DTC genetic testing products typically capture less than 0.01% of their DNA. For example, 23andMe only tests for three of over 1,000 BRCA mutations, known to contribute to the development of breast and ovarian cancer. Thus, 90% of participants who carry a BRCA mutation would be grossly mislead by todays 23andMe test.

Direct-to-consumer genetic tests offer a variety of limited health information. This includes their calculations of risk of developing certain diseases, carrier status for certain conditions (these indicate whether a person carries a gene for a recessive disease that may be passed on to their offspring), and predictions on how a person will respond to certain drugs. Some recreational tests offer non-disease related information such as ancestry, eye-color, propensity to blush based on earlobe size and a host of other infotainment data.

Unlike clinical genetic tests, DTC tests, even those manufactured by 23andMe, which have FDA approval to market, are not intended for diagnostic purposes as they provide risk information based on a limited set of conditions. These tests not only have varying levels of evidence to support their claims, but different companies also test different variants. This can lead to contradictory results for the same condition.

Clinical studies have shown that 40% of the raw data direct-to-consumer tests use can yield false positives, which may cause unnecessary stress and anxiety in users. These tests can also produce false negatives, as Dr. Stangler noted earlier, which may put users minds at ease even though they are unknowingly still at risk.

Of course, genes are not the sole determinant of a persons ultimate destiny. Lifestyle, experience and environment are powerful factors as well.

Privacy and ethical considerations

Besides the apparent shortcomings of current DTC genetic tests, another issue for wealthy families to consider is privacy.

Beyond the medical risks associated with direct-to-consumer genetic testing, I have grave concerns about privacy and security. In its current state, DTC is a privacy and security minefield.

Direct-to-consumer DNA companies not only share their data with government and law enforcement, but some may even sell it, compromising confidentiality.

Private health information splashed across the tabloids is not only a personal nightmare, but it could also have far-reaching organizational ramifications for those in family offices. Does the extended family deserve to know about the specific health risks of other family members? What if board members suddenly discover the companys founder or their future successor has a chance of developing a mental illness or debilitating disease? Will decisions be made based on this information, or will it influence decisions?

Thus, affluent families need to consider how the information made available through these tests could potentially impact other family members and influence their roles within the company as well as succession decisions.

In other instances, users may have the option to share their DNA data openly, allowing them to locate and connect with distant relatives. In ultra-wealthy families, younger members may inadvertently become targets of unscrupulous individuals and be exploited via these avenues.

Still Dr. Stangler believes there is tremendous value in understanding our genes. She explains, As a source of raw genetic information, whole genome sequencing, which analyses the entirety of our genetic makeup, has profound advantages over DTC products. It is a highly regulated medical service with legal standards that ensure accuracy, safety and far better privacy. This is critical for families of wealth.

How clinical genetic tests can be used to a familys advantage

From the above discussion, it is evident that clinical genetic testing is far superior to direct-to-consumer versions at present.

According to Dr. Stangler, Whole genome sequencing is just the beginning of the genetics journey. We use the DNA science of genomics to help individuals and global families with strategic decisions regarding health, risk and legacy. Preeminent families have already embraced planning.

With this information in mind, environmental and lifestyle factors that could contribute to the development of certain diseases can be discussed and appropriate steps, if necessary, can be taken to minimize these risks and thereby increase the odds of longevity. This can be done for each member of the family, young and old.

The relevance of this form of risk mitigation to those in family businesses and family offices goes without saying. As much as economic and financial risks can be anticipated and planned for, today the same may be said for genetic ones.

The social, behavioral, interpersonal and ethical dilemmas that arise from knowledge of ones genes are best resolved with the help of experts who are familiar not only with the complex science of genomics, but with the multitude of unique and challenging issues and non-financial risks faced by affluent families and the systems that support them. Families of wealth and their trusted advisors require a working knowledge of genomics in order to shape their most powerful legacy and future.

Read the original here:
DNA Testing And Families Of Wealth - Forbes

Recommendation and review posted by Bethany Smith

Survey finds 23andMe Health + Ancestry results motivate customers to make positive lifestyle changes.

NEW YORK, Jan. 30, 2020 /PRNewswire-PRWeb/ -- At-home DNA testing service 23andMe is more than just a tool to discover ancestry - it also offers insight into how genes can impact overall health and wellness. 23andMe offers a wealth of reports that provide genetic health information that can help customers be more proactive about their health. Recently, 23andMe Genetics Trends Expert, Madeline Lynch, and customer Michelle Martinez, teamed with YourUpdateTV to discuss.

A video accompanying this announcement is available at: https://youtu.be/VAKAywAd4VY

A recent survey of 23andMe's Health + Ancestry Service customers found that more than three-quarters reported that after receiving their personalized genetic reports they made at least one positive change in their health behavior. Designed by 23andMe and M/A/R/C Research, researchers asked 23andMe Health + Ancestry customers about the overall impact of their 23andMe experience, regardless of their results.

51 percent of respondents reporting they've set future goals to be healthier. Changes included eating healthier, getting more sleep, and exercising more, among others. Of those who responded to the survey:

For more information and to get started, visit 23andMe.com

Madeline Lynch: Madeline Lynch is the Genetics Trends Expert at 23andMe. She serves as a subject matter expert and company spokesperson for media engagements, the analyst community, online communities, and the general public at large. Her responsibilities on the customer care team include providing input on prioritization and resolution of customer-facing issues and working directly with cross-functional teams to influence and support development of new and existing communications materials and messaging from the perspective of the customer. She holds a BA from University of California, Davis.

About Michelle Martinez: Michelle Martinez is a 51-year-old lab assistant from Arlington, Texas. Michelle was inspired to order a 23andMe Health + Ancestry kit to help prepare for any potential genetic health risks, due to several serious health risks running in her family. When she opened her Genetic Weight wellness report, she saw that she is genetically predisposed to weigh less than average. She thought, "I've been denying my genetics and just falling into bad habits. I'm not being my best self." That report, along with the knowledge of lifestyle and environmental factors that affect one's health, inspired Michelle to make better lifestyle decisions like eating healthier. She has since lost more than 50 pounds and gained confidence in being in her own skin. She believes that her weight loss journey is one of patience and acceptance with and of herself -- no matter her size.

About 23andMe: 23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand and benefit from the human genome. The company was named by TIME as a "Genius Company" in 2018 and featured as Fast Company's #2 Most Innovative Health Company in 2018. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 23andMe, Inc. is located in Sunnyvale, CA. More information is available at http://www.23andMe.com.

About YourUpdateTV: YourUpdateTV is a social media video portal for organizations to share their content, produced by award-winning video communications firm, D S Simon Media (http://www.dssimon.com). It includes separate channels for Health and Wellness, Lifestyle, Media and Entertainment, Money and Finance, Social Responsibility, Sports and Technology.

SOURCE 23andMe

Here is the original post:
How Genetic Testing with 23andMe Can Improve Your Health - Yahoo Finance

Recommendation and review posted by Bethany Smith

By Layal Liverpool

Guy Smallman/Getty

I am black and mixed-race, but it remains unclear to me whether these are social identities or biological classifications. Luckily, I can turn to Adam Rutherfords latest book, How to Argue with aRacist, to reveal the current scientific understanding of race, ancestry and genetics. It also tells us how to argue effectively against the idea that certain populations of people are biologically inferior.

From the beginning, Rutherford is clear that although he uses the term race frequently, he does so only because the word is widely used: it isnt scientifically valid, yet it exists so must be addressed. Race is a social construct. This does not mean it is invalid or unimportant, writes Rutherford.

How to Argue with a Racists strongest suit is to encourage a general conversation about race, informed by the latest science on the reality and origins of racism. Researching ethnicity has often been career death, but Rutherford says scientists shouldnt shy away from the field. Nor should writers, to judge by his mission.

For many, race is a cry for identity and belonging. In 2018, when groups of neo-Nazis in the US chugged milk to supposedly demonstrate their superior, genetically encoded ability toprocess lactose, they were trying to assert their white identity, writes Rutherford.

He rather undermines such anassertion by revealing that thegene mutations that enable lactose processing arent unique to people of European descent. They also exist today in Kazakhs, Ethiopians, Tutsi, Khoisan and in many places where dairy farming took off as part of agriculture.

Chugging milk is a theatrical gesture, but as Rutherford points out, we increasingly turn to ancestry and genetic testing toreaffirm our human tendency to seek meaning and identity.

I can relate to this. My surname, Liverpool, comes from an ancestor on my fathers side, forcibly shipped from West Africa to the Caribbean via Liverpool, UK, during the transatlantic slave trade. But as Rutherford points out, the number of children produced by sex between enslaved peoples, and between the enslaved and their owners, makes it virtually impossible for a genetic test to establish an African country of origin for the descendants of slaves.

Instead of arguing against thelogic of marrying identity toancestry, Rutherford elegantly uses a bit of mathematics to showhow our whole way of thinking about ancestry is wrong.

He assumes generational time is 25 years and that the number ofancestors for each person in every generation has doubled. Sowe each have two parents, fourgrandparents, eight great-grandparents, and so on. In 500years, or 20 generations, that is 1,048,576 ancestors. Go back 1000 years, and each of us has more than a trillion ancestors: 10 times more people than ever existed.

The notion of a family tree isnt the most scientifically accurate metaphor, he writes, because trees only ever branch, but family trees contain loops, with the same person appearing at multiple positions in the tree, for example, as a result of first cousins having children. Understanding that we are all more closely related to one another than we think is a pretty strong argument against racism.

Is any of this enough to convince hard-liners? Maybe not.As Rutherford writes: Thecommercial genetic testsremain scientifically unconvincing. Regardless, the utility of consumer genetic testing is now a major and significant part of white supremacy discourse.

But in many ways How to Argue with a Racist isnt really about arguing with hard-liners. Its target is the surprisingly prevalent set of racist beliefs, from men of certain groups having larger or smaller penises than average to people from different racial groups being more or less intelligent than average. The way we generally speak about races does not align with what we know about those innate differences between people and populations, says Rutherford.

For example, the largest study of penis size, including more than 15,000 men, found no evidence that the organs length or girth correlates with any particular population, racial category or ethnicity, while intelligence is a complex trait influenced by a score of genes and their interaction with our environment.

Rutherford hunts widely to account for the persistence of suchracist ideas. But in the end, hefaces down the biggest issue atthe core of many of these raciststereotypes: is race truly abiological classification?We are constantly told that it is asocial construct, but scientists muddy the waters by appearing tocontradict this as they perhaps carelessly mention both race and ethnicity in their research papers.

Rutherford is clear that the majority of geneticists think genetic differences between ethnic groups are meaningless interms of behaviour or innateabilities. But he also acknowledges the contradiction because scientific papers are still published in which genes for complex traits like intelligence seem stratified along racial lines.

Race science is pseudoscience, but genetics and evolutionary research are inextricably tied up with race, and are often used by racists to justify themselves. Rutherford accepts that the field ofhuman genetics has a dark history, founded by racists in a time of racism, but also argues that genetics has demonstrated the scientific falsity of race.

He writes that scientists reluctance to express views concerning the politics that mightemerge from human genetics is a position perhaps worth reconsidering. After all, he argues, those who misuse science for ideological ends show no such restraint, and embrace modern tech to spread their messages.

More on these topics:

Original post:
How to Argue with a Racist smashes race myths that plague society - New Scientist News

Recommendation and review posted by Bethany Smith

Amid concerns over gene mutations going undetected due to the variety of medical devices and test reagents in use, a Japanese organization has drawn up guidelines for standard procedures and frameworks to ensure that genetic tests are reliable.

The Japanese Committee for Clinical Laboratory Standards published the guidelines after studying international standards as well as guidelines and articles at home and abroad. The guidelines stipulate what staff are required, the records that need to be kept and the correct way to check instruments and reagents.

JCCLS consists of representatives from companies and academic societies with a focus on disease diagnosis and treatment.

The guidelines also call for hospitals and other medical facilities analyzing test results to compare the results with those from other institutions to ensure precision.

The move comes as an increasing number of people are opting to have their genes checked on being diagnosed with an intractable disease or in order to select an appropriate cancer treatment.

In collaboration with the committee, the Japan Accreditation Board, which evaluates abidance to international standards across various fields, has launched work to recognize institutions that carry out genetic testing in line with the new guidelines.

Accreditation is subject to passing on-site investigations and practical exams.

"Producing a correct result is key to safe, secure medicine," said Hayato Miyachi, a Tokai University professor who is involved in crafting the guidelines. "I believe the guideline will play a major role."

Read the original:
Organization crafts genetic testing guidelines to ensure reliability - Japan Today

Recommendation and review posted by Bethany Smith