is APEC to Bring a New Vision in 2020 By www.apec.org Published On :: Thu, 23 Jan 2020 17:58:00 +0800 APEC’s 21 member economies will finalize in 2020 a new vision for the forum’s next phase, said the APEC Secretariat’s Executive Director Dr Rebecca Sta Maria. Full Article
is ABAC Release: Achieving Integration and Inclusion in the Age of Disruption By www.apec.org Published On :: Tue, 18 Feb 2020 13:50:00 +0800 Business leaders from around the Asia-Pacific met in Sydney last week to discuss the year ahead Full Article
is APEC Announces Postponement of Upcoming Ministerial Meetings By www.apec.org Published On :: Tue, 17 Mar 2020 15:51:00 +0800 Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year. Full Article
is APEC Ministers Responsible for Trade Issue Statement on COVID-19 By www.apec.org Published On :: Tue, 05 May 2020 13:34:00 +0800 Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community. Full Article
is RE: CDRH PREMARKET REVIEW SUBMISSION COVER SHEET By connect.raps.org Published On :: Wed, 06 May 2020 04:30:41 -0400 From : Communities>>Regulatory Open ForumHello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007. Then for the publication date, I do put the latest version when published so would be April 2010. Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet. I would also rely a bit on the Recognized Standards list the FDA publishes: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm to list [More] Full Article Discussion
is RE: Traditional 510(k) RTA checklist By connect.raps.org Published On :: Wed, 06 May 2020 04:34:51 -0400 From : Communities>>Regulatory Open ForumYes, I think there were some previous posts where people uploaded Word versions you can get; just need to look around a little. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------ Full Article Discussion
is RE: New: Take the RAC Exams Online this Summer! By connect.raps.org Published On :: Wed, 06 May 2020 08:06:38 -0400 From : Communities>>Regulatory Open ForumGreat! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States --------------------------------- Full Article Discussion
is RE: Traditional 510(k) RTA checklist By connect.raps.org Published On :: Wed, 06 May 2020 16:49:37 -0400 From : Communities>>Regulatory Open ForumThis message was posted by a user wishing to remain anonymous Why not use Adobe to fill out the form? You will need it to compile the submission anyway. Full Article Discussion
is RE: Medical Device Submissions - Worldwide By connect.raps.org Published On :: Thu, 07 May 2020 08:53:43 -0400 From : Communities>>Regulatory Open ForumThis message was posted by a user wishing to remain anonymous Have you looked into PRA Health Sciences? Full Article Discussion
is RE: Traditional 510(k) RTA checklist By connect.raps.org Published On :: Thu, 07 May 2020 17:08:07 -0400 From : Communities>>Regulatory Open ForumThis message was posted by a user wishing to remain anonymous When this was first issued we printed it out, filled in the answers with careful handwriting and then scanned it back in - which seemed to be perfectly acceptable. Since then we've converted their form to a fillable PDF. Full Article Discussion
is RE: New: Take the RAC Exams Online this Summer! By connect.raps.org Published On :: Fri, 08 May 2020 17:21:00 -0400 From : Communities>>Regulatory Open ForumAnnie: Thank you for sharing this news. I am curious whether the Board considers this a limited exception or a potential new normal option going forward? Scott ------------------------------ Scott Bishop Houston TX United States ------------------------------ ------------------------------------------- Original Message: Sent: 04-May-2020 08:50 From: Annie O'Brien Subject: New: Take the RAC Exams Online this Summer! The RAC board has been working hard to find solutions offering more flexibility [More] Full Article Discussion
is SOP Revision, SWAT-Style By polarisconsultants.blogspot.com Published On :: Tue, 22 Mar 2016 13:59:00 +0000 By Laurie MeehanSOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.The SWAT TechniqueLast month, we worked with a company to revise a set of SOPs using a technique we call SWAT. (Any edgy appeal that name might have otherwise had will be immediately dulled by its acronym expansion: “SOP Working Analysis Team.” It’s the best we could do. Don’t judge.)The goal of the SWAT technique is to revise the most documents in the least time, while preserving friendships, sobriety, and original hair color. The heart of SWAT is an immersive, multi-day working session in which participants discuss SOP revisions and incorporate them in real time. Careful planning, thorough preparation, and commitment from management and participants are keys to keeping the SWAT session productive.It’s Not For EveryoneUp front, we need to say that SWAT won’t work for every organization. While the size of the company may not be important, the size of the working team needs to be fairly small. Also SWAT won’t work for every set of SOPs. The documents need to be part of a natural grouping – a set of similar procedures – and not a random collection.But in the right situations, SWAT works very well. Last month, we conducted a 2-day SWAT session with a client’s QA department to revise a set of 10 auditing SOPs. We’ve also successfully used the technique with ClinOps teams, for example, to revise sets of monitoring SOPs.SWAT Planning and PreparationThe SWAT process begins with central planning. A coordination team selects a logical grouping of SOPs to revise, and assembles a list of specific revisions to be made. Where it’s not possible to provide specific revisions, instructions and guidelines are developed, such as “remove audit report distribution details” or “update to reflect new file safeguarding practices.”Each SWAT participant is assigned an SOP from the revision set. The participant doesn’t need to be the author of record, but must be knowledgeable enough to “represent” the SOP – to learn the document well and understand how it’s similar to the other SOPs in the revision set and in what ways it’s unique. Based on this understanding, prior to the SWAT session, participants make applicable revisions to their individual documents using the information received from the coordination team. Participants should also note questions and any open issues appropriate for SWAT discussion using inline comments. SWAT SessionThe result of the SWAT session is a set of approval-ready SOPs. The precise structure of the SWAT session to get you there depends on a variety of factors, such as how similar or dissimilar the SOPs are, the extent and complexity of the revisions, and whether subject matter expertise is concentrated or distributed among the group. But all successful SWAT sessions we’ve conducted share these attributes:Duration of 2 to 3 days. Just long enough to accomplish the aggressive goal, just short enough to keep everyone from diving out the window.Real-time revision. The “SOP of the hour” is projected on a screen while participants sit in front of PCs and update their assigned SOPs accordingly.Rigorous facilitation. It’s natural for discussions about company procedures to morph into other topics, such as business strategy or staffing requirements. Discussion *will* get off topic. When it does, the facilitator must act quickly to table it. You can maintain a list of tangent topics on a flip chart, schedule a meeting to discuss the most pressing items, ring a cowbell, blow an air horn, or drop a quarter in the “Diversion Jar” and move on, but keep those conversations out of your SWAT session. Save the war stories for dinner.Commitment to the process. Scheduling the session is one thing, but remaining dedicated to the session is an act of will. It’s so ridiculously easy for outside work to creep in. Management and participants must be committed to carving out the time and keeping the barbarians at the gate.Of course: Plenty of caffeine and yummy treats.If you’ve ever worked on SOPs, you know there’s a big difference between done and almost done. To help ensure you emerge from the SWAT session with the former, time must be allotted for participants to format, polish, and conduct a quality review. If it’s possible to scare up some on-site administrative support, that could help expedite the process.SWAT BenefitsWhen you look on your team’s Outlook calendar and see 3 entire days blocked out, it can seem like an awful lot of time devoted to SOP revision. But SWAT really doesn’t take any longer than the usual process, it’s just more obvious. Does SWAT take significantly *less* time? Mmmm, not sure, but SWAT brings with it other benefits.SWAT produces a more consistent set of SOPs. Since every document is compared to every other, it’s easy to notice and correct incidental differences.SWAT is a cross-training opportunity. Participants enter SWAT knowing their own SOP very well. They leave knowing the whole SOP revision set very well.SWAT gets it done. Auditors, how many times have you cited facilities for failure to revise their SOPs within the specified window? It’s not because there’s a willful disregard for SOP procedures. It’s because, in the real world of work, revising SOPs is seldom prioritized highly enough to get on anyone’s schedule until the end of the revision window encroaches or – oops – has passed. But schedule a SWAT and they will come. (And because the effort is so visible and so obviously resource-intensive, no one wants to be the one to drop the ball. Participants come prepared and the resulting documents are the better for it.)SWAT is a lot more fun. Revising SOPs on your own is really boring. Revising them in immersive sessions with colleagues is significantly more enjoyable. Gallows humor reigns supreme. Copious amounts of chocolate are consumed. Air horns are blown in celebration. Friendships, sobriety, and hair color remain intact. Participants live to write another day._______________________________________________________________________Photo Credit: Tenaciousme CoffeeArt, under Creative Commons License Full Article SOP revision SOPs
is When is a Customer NOT a Customer? By polarisconsultants.blogspot.com Published On :: Tue, 06 Dec 2016 13:36:00 +0000 While patients are consumers of healthcare services, they can’t be considered customers in the traditional sense. The same is true of students. Over many years of teaching, I’ve noticed this parallel between the healthcare and education professions; both require significantly more “customer participation” to achieve desired outcomes than other industries do. That’s one reason it’s difficult to measure the quality of these institutions and the skills of their practitioners. That’s also why both industries focus so intently on engaging our communities; we simply can’t be successful unless we do. “Can You Hear Me Now?”As the old joke goes, there are 3 types of people in this world: those who are good at math and those who aren’t. Many students believe themselves to be permanent denizens of the 2nd camp. They find mathematical concepts confusing and the terminology inscrutable, so they tend not to ask questions. They’re afraid they’re being judged, so they’re not always truthful. Tests and exams fill them with anxiety, and sometimes even panic (no doubt waking to nightmares of trains leaving stations at varying rates of speed). These are the students who need my help the most. Our success in overcoming these challenges together will depend heavily on the student/teacher connection we can establish, yet few students are actually able to choose the teacher with whom they are asked to connect. Sound like healthcare yet? So it’s no surprise that trends toward greater patient engagement in healthcare, and patient-centricity in clinical research, emphasize clear and compassionate communication. Doctors, like instructors, need to explain concepts in relatable terms, encourage and address questions, assuage unwarranted anxiety, and establish trust. Until that happens, a meaningful partnership isn’t even possible. When the Cat’s Away, Will the Mice Make Good Choices?You may remember that old college rule of thumb: 1 hour of class requires 3 hours of study. This means instructors have just 25% of their students’ time to inspire the behaviors and habits that will make a success of the other 75%. “Don’t be the Sage on the Stage,” the mantra goes, “be the Guide on the Side.” If you’ve ever taught in an academic setting, you know how challenging that can be. The role of lecturer is fairly obvious, but the role of coach is nuanced; it evolves over time and it’s different for everyone. And if a college instructor has just 3 hours of face time a week, a physician is lucky to have 3 hours of face time a year. That’s not much time to persuade, convince, and encourage the lifestyle choices and medication adherence essential to maintaining good health. And when you consider that a good part of each office visit is spent performing examinations and assessments, it’s easy to understand the excitement surrounding mobile health technologies. Beyond delivering real-time, real-world data, smartphone apps can send patients important reminders, make complying with diet and exercise recommendations easier, and make progress toward fitness goals visible.“And the Survey Says…?”Most service industries are rightly concerned with customer satisfaction – how to achieve it, how to measure it, and how to improve it. So last year, an article entitled “The Problem with Satisfied Patients” caught my eye. The Atlantic article concluded that higher hospital satisfaction ratings don’t necessarily correlate with better healthcare. A five-star student course evaluation can be similarly misleading. Pleasing a student is not the same thing as teaching a student, just as making people happy doesn’t make them well. That’s not to say that hospitals and colleges shouldn’t solicit feedback; of course they need to understand the perspective of the communities they serve. But healthcare facilities and schools should give satisfaction surveys their proper weight or they risk implementing changes that consume resources but do nothing to improve a patient’s health or increase a student’s proficiency. Outcomes-based EvaluationSo if outcomes are paramount in both medicine and academia, it follows that the quality of care and education would be best measured by evaluating those outcomes. Right? Well, it’s a good place to start, but since patients and students share responsibility for success with their doctors and teachers, an individual outcome may be misleading. An instructor can influence, but can’t control, whether a student works on practice problems, studies for tests, asks questions, or even pays attention. A doctor can’t control whether a patient takes a prescription, follows medical advice, or reports relevant symptoms. There isn’t always a straight line between quality of service and success rate.College instructors try to keep their students engaged by tailoring their coaching styles, offering a mix of delivery methods, seeking out fresh ideas to make the concepts relevant, and maintaining convenient office hours. Looking to improve patient engagement, healthcare systems have found that many people face situations that prevent them from keeping appointments and following medical advice. Some organizations are now providing copay assistance, arranging transportation, and employing patient care coordinators to place routine monitoring calls. None of these services are free, but they can be considerably less expensive than eating the costs associated with hospital readmissions.The Partnership Starts HereTeachers want their students to learn and healthcare providers want their patients to be well, but students and patients must actively participate in order to meet those goals. Handing out easy A’s and offering gourmet hospital menu items in response to survey responses won’t cut it.Success begins with clear, compassionate communication – communication designed to explain complex concepts, to build trust, and to encourage the behaviors that lead to positive results. Understanding the challenges students and patients face enables educators and medical professionals to offer practical, meaningful solutions that can actually improve outcomes.[In case you missed it, our last blog post was about the most common site inspection finding every year for the last decade: Protocol Deviations and How to Avoid Them.] Full Article engagement outcomes patient-centricity
is What Suprises GCP Auditors? By polarisconsultants.blogspot.com Published On :: Mon, 13 Aug 2018 14:56:00 +0000 Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-) It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.Standard Operating Procedures (SOPs)It’s quite common for auditors to encounter sponsors, CROs, and sites that lack an adequate set of SOPs to describe local procedures. There are several reasons for this. Sometimes it’s a lack of resources. Sometimes smaller, established organizations believe writing it all down is unnecessary, as “people know their jobs.” Sometimes newer companies are simply unaware that written procedures are required for particular operations. But when procedures are not documented, organizations are unable to demonstrate GCP compliance, cannot ensure that activities are performed correctly or consistently, and have difficulty training new staff members. (We’ll come back to training in a bit.)Frequently missing from a good working set of SOPs are procedures for Disaster Recovery, Handling of Suspected Fraud, and Management of Regulatory Inspections. These SOPs are not used for day-to-day operations, so perhaps that’s why they don’t garner as much attention. Nevertheless, the inability to recover from a disaster, protect the organization from fraud allegations, or pass a regulatory inspection can sink a company.A fourth SOP that is commonly absent from the set is the document that describes how to write, approve, distribute, revise, and retire SOPs. Also frequently missing from a working set of SOPs is our next topic: Training.TrainingTraining can be expensive and time-consuming, and companies increasingly have to do more with less. In-person training has largely been replaced by computer-based systems, on-site training has given way to distance learning, and mentoring has gone the way of the dodo.The good news is that study sites typically adhere to formal GCP training requirements. What’s often missing, though, is the training that connects GCP concepts to everyday activities. A trainee might correctly answer a multiple-choice question about audit trails, but without that “last mile” of coaching, use Wite-Out to correct a source document error. This is where SOPs come in. When training is conducted using well-written SOPs, it can help bridge the gap between standard GCP training and specific site operations.It is not uncommon for study-specific training to be lacking in CROs – protocol training, device training, computer systems user training. As part of their vendor oversight procedures (also an SOP!), sponsors should be making sure that CRO staff is adequately trained. Trial Master Files (TMFs) Whether paper or electronic, it’s common for TMF documents to be missing or expired. Replacements for these documents can usually be produced and filed at the time of the audit. Misfiled documents are another matter; they are already there but cannot easily be found. Locating and refiling them essentially doubles the time and cost of the original effort. For example, documents from multiple labs, such as certificates, credentials, vendor audit results, etc., are often mistakenly commingled. Documents must be sorted and refiled so that each facility listed on the 1572 has its own file or electronic folder. Another very common mistake is treating every document on letterhead as if it’s general correspondence. Search for the word “letter” in the DIA Reference Model and you can see how many opportunities exist for misclassifying correspondence. For example, an IND safety report sent by the sponsor on letterhead should be filed under “Notification of Safety Information,” Section 8.3.18 in ICH E6(R2), not “Relevant Communications,” Section 8.3.11. In an eTMF, an IRB approval letter belongs in 04.01.02, its designated DIA Reference Model position, not 04.04.01, which is reserved for general communication. The root cause of these misfilings? The filer does not know enough about the filing structure of the TMF and often is not familiar enough with clinical research to know the purpose of each document and where it belongs. The corrective action? Training. Training on the TMF plan, the TMF Management SOP, ICH GCP, and study operations in general.Technology to the Rescue?No doubt, CTMSs, eTMFs, eCRFs, ePRO, and other systems have improved clinical operations and reduced error. However, three decades of technological advances have done little to address the most common quality and compliance issues encountered by GCP auditors – and by extension regulators. Some might find that discouraging, but isn’t it also a little satisfying that the solution to our most persistent problems comes down to human communication?______________________________________________________________________A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites. Full Article audit findings auditing clinical research clinical trials eTMF GCP research sites SOPs study sites training
is FDA Puts Santa on the Naughty List! By polarisconsultants.blogspot.com Published On :: Sun, 09 Dec 2018 18:56:00 +0000 WARNING LETTERVIA UNITED PARCEL SERVICESIGNATURE REQUIREDDecember 1, 2018Mr. Kris Kringle, OwnerSanta’s Workshop, LLC1225 Santa Clause WayNorth Pole, Arctic Circle Dear Mr. Kringle:The U.S. FDA inspected your manufacturing facility, Santa’s Workshop, LLC at1225 Santa Claus Way, North Pole Arctic Circle, from April 2 to April 20, 2018.This warning letter summarizes significant violations of CGMP regulations for finished product. See 21 CFR, parts 210 and 211. During our inspection, our investigators observed specific violations including, but not limited to, the following.CGMP Violations 1. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a) and 211.28).Many members of your Enterprise Labor Force (ELF) unit lacked sufficient prior experience for designing and assembling (b)(4). At the time of our inspection, no ELF members had received training on CGMPs, and most were unaware of their responsibilities in the areas of cleanliness and proper attire. Hands and faces were often coated with chocolate, and bells on hats and shoes prevented protective apparel from attaining a proper fit. More generally, factory staff demonstrated an undisciplined, almost gleeful disregard for quality procedures. On three separate occasions, at critical stages of the manufacturing process, floor workers erupted into spontaneous song and dance.Your written response of May 18, 2018 is inadequate because it does not address these training and experience deficiencies. While endearing, the ability to “sit on a shelf” or “live in a hollow tree” does not constitute acceptable manufacturing experience. Candy coating does not qualify as protective covering. And sticking one’s hands in a nearby snowdrift is not a recognized sanitation procedure. “Pure as the driven snow” is not a thing. Especially with all those reindeer knocking about.2. Your firm failed to maintain a system by which the distribution of each lot of product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).Product distribution records were incomplete and, in the event of a recall, would be insufficient to identify all product recipients.Your written response of May 18, 2018 is inadequate. Santa’s Own Procedures (SOPs) are insufficient to capture the information required to conduct a thorough recall. Mr. Kringle may well know which customers are naughty and which are nice -- who’s good, who’s bad, who’s sleeping, and who’s awake, but this information is not written down and, in the opinion of our investigators, would be of limited value if it were. 3. Your firm failed to store product at an appropriate temperature to ensure the identity, strength, quality, and purity of the products are not affected (21 CFR 211.142(b)).Entire sections of the facility lacked effective air conditioning, resulting in destruction of all (b)(4) warehoused in two large storage rooms. A third inadequately cooled room was not in use, and except for some miscellaneous items – a couple hunks of coal, a corncob pipe, and a large, oddly sad puddle of water – the room was all but empty.Your written response of May 18, 2108 was inadequate. FDA isn’t really sure what to do with “that old silk hat we found” in your response package.4. Products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed (21 CFR 211.165(f)). While not strictly a violation of 21 CFR 211.165(f), the rejection and quarantining procedures your firm follows for products that fail to meet established criteria is concerning. While it’s appropriate to reject a (b)(4) that swims, a (b)(4) with square wheels, a (b)(4) that shoots jelly, and a (b)(4) that rides an ostrich, exile to a remote island ruled by a flying lion is, in a word, extreme. Your firm also rejected and exiled a (b)(4)-in-a-box for what was almost certainly an easily remediated labeling problem; reprocessing would have been a more appropriate course of action. Also, we just have to know. Seriously. WHAT WAS WRONG WITH THE DOLLY???5. Your firm failed to establish adequate acceptance criteria for sampling and testing necessary to assure that batches of product meet appropriate specifications as a condition of their approval and release (21 CFR 211.165(d)). Sampling procedures consisted of pulling each finished batch of (b)(4) out of a hot oven, taking a few nibbles, and declaring it “Jingle-icious.” Testers would frequently adulterate samples by submersing and saturating them with milk. These procedures are totally without scientific rigor. Furthermore, sampling was not restricted to members of the Quality Control Unit, but was extended to the entire plant floor. At times, sampling frequency was so high that there was very little, if any, of (b)(4) left to distribute. (On a personal note, our investigators would like to express their appreciation for the opportunity to participate in the testing activity. All the batches they sampled exceeded the strictest statistical quality control criteria, excepting the fruitcake, which could have benefited from additional stability testing and an earlier expiry date.)ConclusionViolations in this letter are not intended as an all-inclusive list. Typically the manufacturer is responsible for investigating violations, determining their root causes, and preventing their recurrence. However, in this case we’re going to make an exception. Though your methods and procedures are unconventional and frequently out of compliance with regulations, they are not wholly without merit. Our investigators have never experienced such a high level of workplace morale -- some calling it “downright merry” – and believe it warrants further observation. Investigators have suggested a series of mutually consultative visits to your workshop. Music, dance, batch samples, reindeer games, and the occasional adulterated eggnog are highly encouraged.Sincerely,/S/Holly BushDivision Director/OPQO Division INorth Pole District Office Full Article 21 CFR 211 CGMP GMP Santa FDA Inspection Santa GMP Inspection Santa Warning Letter
is Vertex boosts market cap on plan for cystic fibrosis 'triple combo' By www.bizjournals.com Published On :: Wed, 26 Oct 2016 11:18:33 +0000 Vertex Pharmaceuticals announced a plan late Tuesday to begin trials before the end of the year of the third in its so-called “triple combo” of pills designed to treat as much as 90 percent of the 75,000 patients worldwide who suffer from cystic fibrosis. That news, announced in conjunction with the Boston-based drugmaker’s third-quarter financial results last night, spurred a 6 percent stock increase after hours, implying the company’s market cap could increase by about half a billion dollars… Full Article
is Ra makes nine Mass. biotech IPOs, over $640M raised, this year By www.bizjournals.com Published On :: Thu, 27 Oct 2016 09:50:20 +0000 Wednesday’s initial public offering for Cambridge-based Ra Pharmaceuticals marked the ninth biotech startup to go public this year, tying the number in 2013 but still less than either of the two years since. Ra (Nasdaq: RARX), which has 40 employees in one of the former Pfizer buildings in Alewife, ended up with the third-largest IPO size for any Massachusetts-based biotech in 2016, with a total of $92 million raised from the sale of 7 million shares for $13 each. That’s more than the $86 million… Full Article
is Venture firm Third Rock raises $616M fund, names female partner By www.bizjournals.com Published On :: Mon, 31 Oct 2016 10:00:10 +0000 Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,… Full Article
is Online education for diabetes specialists on biosimilar insulins By www.gabionline.net Published On :: Fri, 08 May 2020 08:30:39 +0000 An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist. Full Article
is China publishes draft guideline for bevacizumab copy biologicals By www.gabionline.net Published On :: Fri, 08 May 2020 08:41:25 +0000 On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1]. Full Article
is McCaul on KRIV Discuss the Childhood Cancer STAR Act By childhoodcancer-mccaul.house.gov Published On :: Fri, 25 May 2018 04:00:00 +0000 Full Article
is New Bipartisan ChiPACC Act Provides Better Medicaid Coverage to Children in Need By childhoodcancer-mccaul.house.gov Published On :: Fri, 27 Jul 2018 04:00:00 +0000 WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage. The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee. “Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.” Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs. Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind. ### Full Article
is AskBio buys BrainVectis for early-stage gene therapies By www.biopharma-reporter.com Published On :: Mon, 27 Apr 2020 15:00:00 +0100 AskBio acquires gene therapy biotech working on treatments for neurodegenerative disorders. Full Article Markets & Regulations
is COVID-19 vaccine in one year ‘wishful thinking’ By www.biopharma-reporter.com Published On :: Mon, 04 May 2020 09:27:00 +0100 The likelihood of an effective vaccine being developed and scaled up in less than 12 months is unrealistic, suggests GlobalData analyst. Full Article Bio Developments
is Pfizer’s $308m buy-in for Lyme disease vaccine By www.biopharma-reporter.com Published On :: Mon, 04 May 2020 14:56:00 +0100 Pfizer partners with Valneva to progress Phase II-stage vaccine candidate for Lyme disease. Full Article Bio Developments
is Health Canada: We do not enforce the law when Canadians poison Americans By searchingforsafety.net Published On :: Thu, 11 Sep 2014 00:42:42 GMT Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) On September 8, we posted a blogspot about our recent article published in Health Law in Canada, in which we write that Canada is providing haven for internet pharmacies located on Canadian soil that advertise and sell unapproved medicines illegally. We called this a transnational transnational organized crime, which Canadian officials are knowingly facilitating. We offered example [...] Full Article Uncategorized
is Is India right on its processes but wrong on its drug quality? By searchingforsafety.net Published On :: Tue, 14 Oct 2014 03:31:12 GMT Posted by Roger Bate India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to li [...] Full Article Uncategorized
is Ebola is not the only health concern for Africans or Americans: how Egypt aims to improve its drug quality oversight By searchingforsafety.net Published On :: Thu, 30 Oct 2014 14:51:38 GMT Posted by Roger Bate Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad &ndash [...] Full Article Uncategorized
is A Conservative Legal Group Significantly Miscalculated Data in a Report on Mail-In Voting By tracking.feedpress.it Published On :: 2020-05-02T11:45:00-04:00 by Derek Willis ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. In an April report that warns of the risks of fraud in mail-in voting, a conservative legal group significantly inflated a key statistic, a ProPublica analysis found. The Public Interest Legal Foundation reported that more than 1 million ballots sent out to voters in 2018 were returned as undeliverable. Taken at face value, that would represent a 91% increase over the number of undeliverable mail ballots in 2016, a sign that a vote-by-mail system would be a “catastrophe” for elections, the group argued. However, after ProPublica provided evidence to PILF that it had in fact doubled the official government numbers, the organization corrected its figure. The number of undeliverable mail ballots dropped slightly from 2016 to 2018. The PILF report said that one in five mail ballots issued between 2012 and 2018, a total of 28.3 million, were not returned by voters and were “missing,” which, according to the organization, creates an opportunity for fraud. In a May 1 tweet that included a link to coverage of the report, President Donald Trump wrote: “Don’t allow RIGGED ELECTIONS.” PILF regularly sues state and local election officials to force them to purge some voters from registration rolls, including those it claims have duplicate registrations from another state or who are dead. It is headed by J. Christian Adams, a former Justice Department attorney who was a member of the Trump administration’s disbanded commission on election integrity. The report describes as “missing” all mail ballots that were delivered to a valid address but not returned to be counted. In a statement accompanying the report, Adams said that unaccounted-for ballots “represent 28 million opportunities for someone to cheat.” In particular, the organization argues that the number of unreturned ballots would grow if more states adopt voting by mail. Experts who study voting and use the same data PILF used in the report, which is from the Election Administration and Voting Survey produced by the federal Election Assistance Commission, say that it’s wrong to describe unreturned ballots as missing. “Election officials ‘know’ what happened to those ballots,” said Paul Gronke, a professor at Reed College, who is the director of the Early Voting Information Center, a research group based there. “They were received by eligible citizens and not filled out. Where are they now? Most likely, in landfills,” Gronke said by email. A recent RealClear Politics article based on the PILF report suggested that an increase in voting by mail this year could make the kind of fraud uncovered in North Carolina’s 9th Congressional District in 2018 more likely. In that case, a political consultant to a Republican candidate was indicted on charges of absentee ballot fraud for overseeing a paid ballot collection operation. “The potential to affect elections by chasing down unused mail-in ballots and make sure they get counted — using methods that may or may not be legal — is great,” the article argues. PILF’s report was mentioned in other news outlets including the Grand Junction Sentinel in Colorado, “PBS NewsHour” and the New York Post. The Washington Times repeated the inaccurate claim of 1 million undeliverable mail ballots. In a statement, the National Vote at Home Institute, an advocacy group, challenged the characterization of the 28.3 million ballots as missing. Of those ballots, 12 million were mailed by election officials in Colorado, Oregon and Washington, which by law send a mail-in ballot to every registered voter, roughly 30% of which are not returned for any given election. “Conflating voters choosing not to cast their ballots with ‘missing’ ballots is a fundamental flaw,” the statement reads. In an interview, Logan Churchwell, the communications director for PILF, acknowledged the error in the number of undelivered ballots, but defended the report’s conclusions, saying that it showed potential vulnerabilities in the voting system. “Election officials send these ballots out in the mail, and for them to say ‘I have no idea what happened after that’ speaks more to the investments they haven’t made to track them,” he said in a telephone interview. But 36 states have adopted processes where voters and local officials can track the status of mail ballots through delivery, much like they can track packages delivered to a home. Churchwell said there are other explanations why mail ballots are not returned and that state and local election officials could report more information about the status of mail ballots. “If you know a ballot got to a house, you can credibly say that ballot’s status is not unknown,” he said. The EAVS data has been published after every general election since 2004, although not every local jurisdiction provides complete responses to its questions. In the data, election officials are asked to provide the number of mail ballots sent to voters, the number returned to be counted and the number of ballots returned as undeliverable by the U.S. Postal Service, which provides specific ballot-tracking services. The survey also asks for the number of ballots that are turned in or invalidated by voters who chose to cast their ballots in person. It asks officials to report the number of ballots that do not fit into any of those categories, or are “otherwise unable to be tracked by your office.” Gronke described the last category as “a placeholder for elections officials to put numbers so that the whole column adds up,” and said that there was no evidence to support calling those ballots a pathway to large-scale voter fraud. Numerous academic studies have shown that cases of voter fraud are extremely rare, although they do occur, and that fraud in mail voting seems to occur more often than with in-person voting. Full Article
is Meet the Shadowy Accountants Who Do Trump’s Taxes and Help Him Seem Richer Than He Is By tracking.feedpress.it Published On :: 2020-05-06T04:00:00-04:00 by Peter Elkind, ProPublica, and Meg Cramer, WNYC, with Doris Burke, ProPublica Stay up to date with email updates about WNYC and ProPublica’s investigations into the president’s business practices. This story was co-published with WNYC. On May 12, after a six-week delay caused by the pandemic, the U.S. Supreme Court will hear arguments in the epic battle by congressional committees and New York prosecutors to pry loose eight years of President Donald Trump’s tax returns. Much about the case is without precedent. Oral arguments will be publicly broadcast on live audio. The nine justices and opposing lawyers will debate the issues remotely, from their offices and homes. And the central question is extraordinary: Is the president of the United States immune from congressional — and even criminal — investigation? Next week’s arguments concern whether Trump’s accounting firm, Mazars USA, must hand over his tax returns and other records to a House committee and the Manhattan district attorney, which have separately subpoenaed them. (There will also be arguments on congressional subpoenas to two of Trump’s banks.) Trump, who promised while running for president to make his tax returns public, has sued to block the documents’ release. The questions apply beyond this case. Trump has repeatedly resisted congressional scrutiny, most recently by vowing to ignore oversight requirements included in the trillion-dollar pandemic-bailout legislation. “I’ll be the oversight,” he declared. The president’s accounting firm has found itself at the center of this high-stakes fight. The American arm of a global firm, Mazars has portrayed itself as an innocent bystander in the war between Trump and his pursuers, dragged into the conflict merely for possessing the trove of subpoenaed records. It’s the firm’s first burst into the media glare apart from an unfortunate moment of tabloid coverage in 2016 after one of its New York partners stabbed his wife to death in the shower of their suburban home. (He pleaded guilty to manslaughter.) Mazars has said it will abide by whatever decision the court makes in the Trump matter. But Trump’s accountants are far from bystanders in the matters under scrutiny — or in the rise of Trump. Over a span of decades, they have played two critical, but discordant, roles for Trump. One is common for an accounting firm: to help him pay the smallest amount of taxes possible. The second is not common at all: to help him appear to the world to be rich beyond imagining. That sometimes requires creating precisely the opposite impression of what’s in his tax filings. Time and again, from press interviews in the 1980s to the launch of his 2016 campaign, Trump has trotted out evermore outsized claims of his wealth, frequently brandishing papers prepared by members of his accounting team, who have sometimes been called on to appear in person when they were presented, offering a sort of mute testimony in support of the findings. The accountants’ written disclaimers — that the calculations rely on Trump’s own numbers, rendering them essentially meaningless — are rarely mentioned. Trump’s accountants have been crucial enablers in his remarkable rise. And like their marquee client, they have a surprisingly colorful and tangled story of their own. It’s dramatically at odds with the image Trump has presented of his accountants as “one of the most highly respected” big firms, solemnly confirming his numbers after months of careful scrutiny. For starters, it’s only technically true to say Trump’s accounting work is handled by a large firm. In fact, Trump entrusts his taxes and planning to a tiny, secretive team of CPAs who have operated at various times from humble quarters in Queens and two Long Island office parks. That team, which has had two leaders with back-to-back multidecade terms, has been working for the Trumps since Fred Trump began using the firm back in the 1950s. It was eventually subsumed into Mazars USA, the American arm of a large international firm, through a series of mergers over decades. Listen to the Episode One theme has been consistent: partners and sometimes the firm itself have faced accusations of fraud, misconduct and malpractice on multiple occasions, an investigation by ProPublica and WNYC has found. That pattern dates to the 30 years during which the Trump accounting team was led by Jack Mitnick, whose pugnaciousness was exceeded only by his aversion to his clients paying the IRS. He was the architect of the notorious schemes, revealed by The New York Times, to dodge more than $500 million in gift and inheritance taxes and funnel hundreds of millions from Fred Trump to his children, helping keep Donald Trump afloat through four of his business bankruptcies. Mitnick was known as an accounting star — at least until 1996, when his partners threw him out of the firm amid accusations of fraud and malpractice. Years of turmoil followed. The firm operated without malpractice insurance for a period and was dogged by feuds — with current and former partners suing each other — and financial problems. And it ran afoul of regulators. In January of 2004 — one week after “The Apprentice” premiered on NBC — the Securities and Exchange Commission formally censured the firm for willfully aiding and abetting misconduct. The SEC suspended one partner from practicing before it for four years for what the agency called “highly unreasonable” and “improper professional conduct.” Since Trump’s accountants merged their practice into Mazars in 2010, they have been present for Trump’s scandals, too. Mazars accountants prepared the tax returns for the Donald J. Trump Foundation, forced to shut down and ordered to pay more than $2 million in damages after a New York attorney general’s investigation exposed a history of illegal self-dealing. And the Manhattan DA’s office, which is investigating whether the Trump Organization falsified its business records to cover up hush-money payments to adult film actress Stormy Daniels, subpoenaed not only Trump’s tax returns but also various internal records and assessments prepared by Mazars. Today, the CEO of Mazars USA is the same partner who was suspended by the SEC for four years for improper conduct. (Mazars defends its CEO, saying he meets all ethical and professional standards, and asserts that the firm has encountered no more sanctions or litigation than other comparable firms.) The choice of a formerly suspended accountant as CEO surprised former SEC Chief Accountant Lynn Turner, now a senior adviser at the Hemming Morse financial consulting firm. “In my opinion,” said Turner, “that speaks loudly with the respect to the confidence one would have in that firm — better yet, the total lack of confidence one would have in that firm. And it would certainly make me wonder about the culture of that firm and whether or not that firm acts with integrity.” Whether by design, or perhaps just coincidence, Trump’s accountants have occasionally displayed the sort of audacity often associated with their client. Consider this example involving New York City taxes back in the 1980s. Mitnick claimed that Trump was exempt from paying tax on profit he made by flipping a Trump Tower condo. He had acquired the unit at cost, $634,648, ostensibly for providing “consulting services” to his development partnership, then sold it 19 days later for $3 million. At an administrative court hearing, Mitnick defended deductions that he’d claimed offset any profits from Trump’s consulting business, even as he failed to provide any documentation or explanation for those expenses, according to the 15-page court opinion in the case. He went so far as to deny that he’d prepared the federal tax return for Trump that also claimed the deductions, even though his signature was on the document. The accountant evidently protested vociferously in the New York case, leading the administrative law judge to scoff, “The problem at issue is not one of double taxation, but of no taxation.” The total amount at stake was relatively modest — $87,693.57, including penalties and interest — but Mitnick, on Trump’s behalf, contested it for more than a decade before a city appeals panel finally put an end to the case, ordering Trump to pay up. Decades after he left the Trump account, Mitnick briefly surfaced in the press in 2016, after the Times reported that Trump’s 1995 tax return reported a $916 million loss. Mitnick, then 80, dismissed Trump’s boast that he was a tax genius for using the loss to avoid paying taxes for as much as a decade. “I did all the tax preparation,” the dour accountant told TV interviewers. “He never saw the product until it was presented to him for signature.” Mitnick added, with apparent pride: “Those returns were entirely created by us.” When ProPublica first sought to speak with Mitnick late last year, he asked, “What’s in it for me?” and said he’d discuss Trump only if he were paid for his time. (In a longer second call, where he also asked to be paid, he eventually offered brief responses to some questions.) An accountant and attorney, Mitnick first arrived at Spahr Lacher & Berk, the tiny firm later merged into Mazars, in 1963, at age 27. Mitnick soon took charge of the Trumps’ accounts. He would oversee them for the next 30 years. In its early years, Spahr was located in Jamaica, Queens, and employed just a handful of CPAs. The firm had been working with the Trump family, whose five-bedroom Tudor home was in tonier Jamaica Estates, at least since 1951, when Fred Trump cemented the relationship by hiring a Spahr partner as controller for his growing real estate business. Fred Trump was far and away Spahr’s biggest client. His cash-spewing rental apartment empire in Brooklyn and Queens required lots of accounting work, and Fred paid his bills in full and on time. By 1979, Spahr Lacher had moved into a nondescript suburban office park in Lake Success, Long Island, just beyond the Queens border and the reach of New York City taxes. By then Donald Trump had begun pursuing his big, risky and expensive ambitions: glitzy towers and hotels in Manhattan; three over-the-top Atlantic City casinos; his own airline; a massive yacht and a professional football team. In 1987, as his father had done, Donald hired his company’s controller from the ranks of his accounting firm. Trump’s accountants played a critical role in Donald’s survival through the 1980s and early ʼ90s, a period when many of his projects crashed and burned, requiring massive infusions of cash from his father. With Mitnick in charge, Spahr hatched the strategies that minimized both gift and estate taxes on the transfer of Fred’s wealth to Donald and his siblings. A 2018 Times investigation found that Fred Trump had funneled at least $413 million in current dollars to his son and that the Trumps’ tax-avoidance tactics, all told, had slashed their tax bill by about $500 million. The article described some of the tax moves as “outright fraud.” (Trump’s lawyer called that conclusion “100% false” and said the relevant authorities “fully approved all of the tax filings.”) A lynchpin of the strategy was the 1992 creation of a corporation, All County Building Supply & Maintenance, through which Fred Trump’s children charged their father’s business grossly inflated prices, then split the markup, allowing them to avoid gift taxes even as they reeled in millions from their father. The strategy was viewed as a major success inside the accounting firm. “I wish I could take credit for it,” Mitchell Zachary, a former Spahr partner who worked on the Trumps’ accounts for more than a decade, told ProPublica and WNYC. “It was brilliant, but it wasn’t mine,” Zachary said. “It was a team of accountants, partners at Spahr.” Zachary defended the firm’s practices for the Trumps as “aggressive” but “within the letter of the law.” Mitnick was viewed as “a tax god” inside the firm, said Zachary, who worked at Spahr Lacher from 1986 to 2002 and teamed with Mitnick on the Trumps’ accounts. The family “wouldn’t make a move” without checking with Mitnick, he said. Mitnick even made a cameo appearance (albeit with his name misspelled) in the first chapter of Trump’s 1987 book, “The Art of the Deal.” Mitnick pressed for every advantage on Trump’s behalf, ever urging Zachary to be bolder. A fundamental Mitnick principle: “If you can’t find me where the law says you can’t do it, you can do it.” Said Zachary: “He always took these very aggressive positions and would never back down. Never. He always felt, ‘I’ll just keep appealing.’” Mitnick’s team developed virtually all the Trumps’ tax-avoidance maneuvers, Zachary said. “I mean, it was all for their benefit in so many ways,” he said. “It’s not like they were going to question it.” Donald Trump’s accounting work was much more complex than that of his father. His business operated scores of separate entities, each requiring its own tax filings. Just preparing his annual personal return took three to four months. Diving into Trump’s personal finances, as Zachary did in the late 1980s, proved bewildering. Warned that his work for Trump was sure to face an audit, Zachary said he took special care to trace every asset, expense and receipt. When he finally finished, he was mystified. Zachary couldn’t find evidence that Trump, in fact, possessed any cash beyond a recent payment in a casino deal. “I went to Jack Mitnick, and I said, ‘Look, I must be missing something: There’s nothing here!’… I thought for sure I screwed up. I thought for sure I missed something big.” Zachary recalled Mitnick’s reply. “He just laughed and went: ‘Well, you just figured it out!’” Spahr took unusual steps to safeguard the confidentiality of Donald Trump’s returns. No work papers or documents could be left on a CPA’s desk overnight; everything had to be carefully locked up. The secrecy was imposed to hide the chasm between Trump’s public claims and reality, according to Zachary: “He bragged a lot. … More than any other individual that I’ve ever seen, he was very big at promoting that he’s this super-rich billionaire.” Trump was a difficult client. He demanded discounts on fees and took forever to pay his bills. “Collecting from Trump was awful,” Zachary said. Eventually Spahr agreed to give Trump a 50% discount and allow him 12 months to pay. Zachary said: “Donald always made it clear: ‘You get the privilege of saying you’re Donald Trump’s accountants, so you have to pay the price.’” Trump’s nearly $1 billion write-off for 1995 represented an aggregation of the enormous losses his business blunders had run up — and Spahr skillfully exploited them on Trump’s behalf. Trump paid no federal income tax in nine of the 11 years from 1984 through 1994, according to tax materials obtained by the Times and publicly released documents. It is true that the Trumps’ aggressive tactics drew virtually nonstop scrutiny from tax authorities. Indeed, they spent so much time examining the Trumps’ books, Zachary said, that Spahr Lacher had a special room permanently set aside for the IRS’s Trump auditors. (Zachary also cites this scrutiny, and the relatively modest resulting adjustments, as evidence that Spahr’s tactics didn’t cross the line.) Spahr’s focus on wealth-transfer strategies intensified in the early 1990s, after Fred Trump, a detail-minded workaholic, began suffering from poor health and dementia. One tactic was to divide legal ownership of Fred’s properties into separate family partnerships, so Fred lacked complete control. That helped justify lowball appraisals for tax purposes. “There was an appraiser out there that the IRS hated … because he was so aggressive. And that’s the guy we used,” Zachary said. That appraiser, he said, reduced the claimed values of Fred Trump’s properties by 35% to 40% — and occasionally dramatically more. By the time Fred Trump died in 1999, Mitnick was gone from the firm. His departure followed a series of troubling lawsuits and other setbacks relating to work for non-Trump clients. In one case brought over Mitnick’s administration of a tax-shelter investment involving coal mine leases, a federal appeals court wrote in 1985: “The record amply demonstrates that he committed fraud.” In a second case, longtime Spahr clients charged Mitnick and the firm with “a long-term coverup of Mitnick’s malpractice” on their family’s estate and audit work, accusing them of missing filing deadlines and making false statements to the IRS, which they claimed cost the family millions in taxes and penalties. They asserted that Mitnick and his team neglected them and “devoted most of their professional time to other clients, including Donald Trump and his enterprises.” After the trial judge found that Mitnick was “the primary wrongdoer,” the matter was eventually settled for about $500,000, according to Mitnick’s deposition testimony in yet another malpractice suit against both him and the firm. Mitnick, meanwhile, had his own problems with the IRS. He had filed three federal tax court cases between 1987 and 1990 challenging IRS levies against him and his wife on their personal taxes. He became an enigma to his Spahr partners. Mitnick often seemed oblivious to important deadlines. One partner recalls finding Mitnick, just hours before a critical tax filing was due, in the firm’s staff room with a hammer and screwdriver, fixing a broken chair. By the mid-1990s, the litigation had left Spahr Lacher unable to obtain insurance, threatening the firm’s continued existence. Partners, including Zachary, shifted their assets into their spouses’ names. Records show the Mitnicks’ home, located 2 miles from the firm’s office, was held in his wife’s name. In September 1996, the partners expelled Mitnick. They told clients that Mitnick, then 60, was retiring. Less than a year later, he became a tax counsel with a Long Island law firm, where he remained until 2014. Asked about these events, Mitnick, now 84, repeatedly declined to comment, saying he couldn’t discuss “confidential communications between myself and the client.” He added, “You’re going back to the dark ages.” Mitnick eventually fell on hard times. In 2007, after Citibank filed a foreclosure action on an unpaid $500,000 mortgage loan, Mitnick and his wife sold their $1.4 million Long Island home. Three years later the IRS slapped him with a lien for more than $155,000 in unpaid federal tax debts dating back to 2003. Mitnick and his wife relocated to a modest house in Palm Beach County, Florida. In May 2017 Mitnick and his wife were evicted after failing to pay $11,331 in assessments and penalties to their homeowners association. Their possessions were placed out on the street. Less than two years later, in March 2019, they were ejected again, this time evicted from an apartment for unpaid rent and, according to a court filing, “physically removed from the premises.” At the time Mitnick left the firm, partners feared his departure might cost them the Trump business, which Zachary estimates represented about a third of the firm’s total billings. But Trump agreed to stick with Spahr. Still, the firm’s existence was precarious. Unable to obtain malpractice coverage, Spahr’s eight partners, after being hit by another lawsuit settlement, learned they would have to dig into their own pockets to pay it. So they happily welcomed an acquirer: M.R. Weiser & Co., a midsize Manhattan accounting firm eager to establish a big presence on Long Island. Spahr’s leaders signed off on the deal only after again seeking Trump’s personal blessing. He gave it, Zachary said, after being assured his fees wouldn’t increase. As it turned out, Weiser had problems of its own. The firm had engaged in a disastrous buying binge aimed at transforming the firm into a regional powerhouse. The deals instead triggered what partners later described as a “crisis of finances and morale.” Just a year after swallowing Spahr, Weiser’s partners ousted the firm’s chairman, Stanley Nasberg, who then sued, demanding $5 million in damages and sending the dispute to an arbitration panel. (In an interview, Nasberg maintained he was “instrumental” in the rapid growth of the firm and recruitment of major clients. He blamed his ouster on the “greed” of his then-partners.) The 24-page report from the arbitration panel detailed a litany of “recriminations and factual and legal disputes.” The firm had suffered such “acute cash shortages” that some senior partners had delayed depositing their year-end paychecks in 1999; partner draws had been withheld altogether in early 2000. For years Weiser was roiled by factional conflicts, cash-flow problems and bitter litigation. “It became just a disjointed mess,” said Jeff Coopersmith, a partner who arrived in 1999 as the result of one merger and was frog-marched out six years later after the firm discovered his plans to start his own firm with two other partners (and take clients with him). Amid all this turmoil, the Trump group remained a constant. With Mitnick’s departure, the firm handed its leadership to a CPA who seemed even more single-mindedly dedicated to the mogul: Donald Bender. Bespectacled, bald and bookish, Bender had arrived at Spahr in 1981, shortly after earning his accounting degree at Queens College. He’s been there ever since. (Through a firm spokesman, Bender declined requests for an interview.) Bender had a monkish devotion to his work, and to Trump, who became his sole client. Bender remained single well into middle age, when he married a woman who’d worked at Weiser. Now 62, he still runs the Trump account and lives with his family in a drab townhouse, six minutes’ drive from his office. Bender’s dedication won Trump’s respect, said Zachary, who worked closely with Bender until leaving the firm in 2002. “He really devoted his life to Donald Trump,” Zachary said, enough to earn him an invitation to Trump’s wedding to Melania Knauss at Mar-a-Lago in 2005. After Mitnick’s departure, Donald Bender (seen in a photo from his firm’s website) assumed leadership of Trump’s accounting team. (Obtained by ProPublica) Operating from offices at one end of the accounting firm’s floor, Bender and his small Trump team kept to themselves. It had long been standard practice to maintain extraordinary security provisions for all of Trump’s electronic files, including barring anyone from viewing them without a special password. Bender’s group had a mystique within the firm. In a 2017 essay published on a literary website, a former junior accountant at Weiser, Henry Kogan, recounted meeting Bender — whom he referred to as “the other Donald” — in the firm’s cafeteria. “After I introduced myself and the small talk subsided he said, ‘Everything you say will be repeated.’… In my two years at Weiser LLP, I learned the other Donald didn’t talk much but when he did it was worth listening to.” Kogan described the knowledge of Trump’s financial world as “passed down from one generation to the next through a single, chosen accountant, orally.” As he put it, “You could sense the weight of this knowledge in the way [Bender] walked, the way he carried himself, carefully and with precision. Sometimes it seemed as if he were moving across a tightrope, invisible across the thickly carpeted office floor.” Bender’s “entire professional existence,” he wrote, “revolved around one client, that client’s organization, and the hundreds of entities represented inside an IRS form.” As Trump banked evermore on his image for breathtaking wealth, he enlisted his accountants to back his dubious claims. For example, struggling to avoid personal bankruptcy in 1994, Trump cooperated with a cover story in Vanity Fair promoting his “comeback.” “Piece by piece, deal by deal, a beautiful story is starting to emerge about me,” Trump declared, after picking up writer Edward Klein in his stretch limo. As they were driven to a black-tie dinner at the Waldorf-Astoria hotel honoring Trump as “Humanitarian of the Year,” Klein wrote, “he handed me a folder containing his personal financial statement, which had been prepared by the accounting firm of Spahr, Lacher & Sperber.” It showed $139,326,000 in cash and equivalents.” That figure seemed unlikely given that four of Trump’s companies had gone bankrupt during the early 1990s. Similar documents surfaced in 2006, after Trump was stung by a book written by Tim O’Brien that ridiculed his boasts of being worth as much as $6 billion. The book, “TrumpNation: The Art of Being the Donald,” cited three confidential sources “with direct knowledge of Donald’s finances” who said the number was actually between $150 million and $250 million. Looking to rehabilitate the image of his net worth — on Forbes’ annual list of billionaires — Trump enlisted his accountants. He summoned two Forbes reporters, according to one of them, Stephane Fitch. They arrived at his Trump Tower conference room to find a table piled with leather-bound volumes and stacks of manila folders, supposedly documenting how much Trump was worth. Also present, to help make the case: Bender and his Weiser partner Gerald Rosenblum. The two accountants sat silently as Trump and his deputies touted his wealth. Forbes ultimately pegged it at $2.9 billion — about half of what Trump claimed — but far higher than O’Brien’s assessment. Trump sued O’Brien for defamation, and in the litigation, too, the accountants and their work played a supporting role. A 25-page document, on Weiser letterhead, titled “Accountants Compilation Report” was produced during discovery. (“I do keep one actually on my desk, hidden,” Trump testified during the case.) A two-page disclaimer explained that the report (which claimed a net worth of $3.5 billion) was based entirely on “the representation of the individual whose financial statements are presented.” In other words, all the numbers came from Trump. Trump made clear just how unreliable that was, at one point testifying during his deposition: “My net worth fluctuates, and it goes up and down with markets and with attitudes and with feelings, even my own feelings.” Asked if he’d ever exaggerated in statements about his properties, Trump replied: “I think everyone does.” The disclaimer on the “compilation” noted that Weiser had done nothing to confirm the unaudited numbers, which included wholesale departures from generally accepted accounting principles (GAAP). In particular, the statement acknowledged counting future income streams that were in doubt; excluding much of Trump’s debt; failing to reflect whether Trump actually owned only a portion of the assets he listed; and ignoring both repayment obligations and whatever taxes he owed. Weiser did sometimes prepare GAAP-compliant audited financial statements for Trump, when required by some lenders and regulators. These statements revealed a lower net worth. So Trump shared the “compilation” documents with reporters instead. O’Brien’s lawyers deposed the two Weiser partners who worked on the Trump document. Asked to explain a memo he’d written calling Trump’s valuations on properties “subjective,” Bender demurred: “I don’t have the professional expertise to discuss valuations.” Rosenblum, who said he had been preparing such statements for Trump since the early 1980s, was more direct. “In the compilation process, it is not the role of the accountant to assess the values,” he testified. “The role is to accept those values and move them forward.” He acknowledged he made no attempt to corroborate any of the figures. (A judge granted O’Brien a summary judgment, later upheld by an appeals court, in Trump’s libel suit.) Trump continued to offer selective financial statements. If anything, the list of recipients seemed to grow, to include banks and insurance companies, according to congressional testimony last year by former Trump lawyer Michael Cohen, shortly before he went to prison. Cohen released copies of Trump’s financial statements for 2011, 2012 and 2013 and testified: “It was my experience that Mr. Trump inflated his total assets when it served his purposes, such as trying to be listed among the wealthiest people in Forbes, and deflated his assets to reduce his real estate taxes.” By this point, Mazars had become his accountants of record (the Weiser merger occurred in 2010) and the disclaimers in the financial statements had grown to exclude anything involving the finances of Trump’s large hotels in Las Vegas and Chicago. The 2011 and 2012 statements placed Trump’s net worth at $4,261,590,000 and $4,558,680,000, respectively. They included multiple false claims. As The Washington Post reported last year, the 2011 statement claimed Trump Tower was 68 stories tall (it’s 58); exaggerated the size of Trump’s Virginia vineyard (it’s 1,200 acres, not 2,000); inflated the number of lots approved for sale at his golf course in southern California (it was 31, not 55); and claimed a 212-acre Westchester County estate he’d bought in 1996 for $7.5 million was already “zoned for 9 luxurious homes” and thus worth $291 million. Local officials said the property was really worth about $20 million, and the project, which faced years of opposition from area residents, was never built. Trump took a tax write-off on the property instead. These false statements alone appear to have inflated Trump’s claimed wealth by hundreds of millions. Once again, when Trump announced his campaign for the presidency in gala fashion in 2015, he waved a financial statement that he said his accountants had prepared. This time the tally was $8,737,540,000. “To pay an auditor to say ‘we have not checked the numbers, and the numbers don’t follow any rules’ — you just don’t see that,” said George Washington University assistant accountancy professor Kyle Welch. “This is not a real financial statement. This is a promotional document.” Welch said the sweeping disclaimer protects the accountants from legal liability or industry sanctions. He doubts a larger firm would have been willing to affix its name to such statements. “I don’t think any of the Big Four would put their name on those financial statements,” Welch said. “I don’t think they could have been paid enough to get it done.” Not long after it acquired Trump’s accounting firm, Weiser came under investigation by the SEC. The matter was resolved in 2004, with an agreed settlement order: Two Weiser CPAs were suspended from practicing before the commission for “highly unreasonable” and “improper professional conduct.” The SEC also censured Weiser, ordering it to disgorge $39,679 and hire an outside consultant to review its policies and compliance procedures. According to the SEC, Weiser had failed to properly monitor its client, a financial advisory firm called Sagam Capital Management, that was already operating under a cease-and-desist order for securities fraud and thus, as Weiser knew, warranted “heightened scrutiny.” These failures, the SEC found, had “willfully aided and abetted” more misconduct. (Sagam’s CEO later went to prison for stealing millions from his customers.) Victor Wahba, the Weiser partner in charge of the assignment, was barred from SEC practice for a minimum of four years. (He didn’t admit or deny wrongdoing.) But Wahba remained at the firm, and was promoted, just one year later, to run its New York office. In 2012, 15 months after being reinstated by the SEC, Wahba was named co-CEO of Mazars. He became chairman and CEO of Mazars USA in 2015. Wahba declined requests for an interview, but Mazars provided a statement that read, in part: “Under Victor Wahba’s leadership, Mazars USA has become a national leader in tax, accounting and consulting. He is well recognized as a thoughtful and charitable CEO.” It noted that Wahba now “remains in good standing” with various industry and government regulators, including the SEC. Trump’s accounting firm faced other issues. In 2009, a partner received a three-year SEC suspension for secretly negotiating for a high-level job with a client he was then auditing. The SEC called the partner’s conduct “at a minimum, reckless.” He eventually left the firm. In separate, more recent cases, the U.S. attorney’s office in Manhattan prosecuted two other CPAs who worked at the firm for their involvement in illegal tax shelters. Ronald Katz, a partner at Weiser for five years starting in 2004, received a nine-month prison sentence in 2017 after pleading guilty to conspiring with a New York tax attorney in what federal prosecutors described as a “corrupt multi-year tax evasion scheme.” Katz had been indicted, among other offenses, on charges of failing to pay taxes on $1.2 million in fee income while at the firm. Internal firm financial documents show that for 2004, Katz billed $6.6 million in fees, far more than any other partner in the firm. Katz declined to comment. In August 2019, New York federal prosecutors settled a civil complaint against former Mazars senior manager Michael Schwartz. In legal filings, prosecutors said he had arranged for more than 100 taxpayers to claim “large phony tax losses,” cheating the government out of hundreds of millions of dollars in taxes. (The shelters dated back to 2002, but were already under court challenge by the government when Mazars hired Schwartz in 2008.) In 2010, a federal appeals court found that one of Schwartz’s transactions, which allowed a tech executive to shelter $60 million in stock gains with an investment of less than $1 million, was “specifically designed to create a massive tax loss devoid of economic reality.” Despite this, Schwartz remained at the accounting firm until 2015, just weeks before the IRS assessed him for $35.4 million for promoting unregistered fraudulent tax shelters. After filing for bankruptcy, Schwartz settled the IRS claim by agreeing to pay $650,000. (“This had nothing to do with WeiserMazar,” Schwartz said. “This was all activities done way before I joined the firm. They knew about it. But they hired me for my international tax expertise.”) In its statement, Mazars dismissed the notion that it had a troubling record. “Any suggestion that Mazars USA is an industry outlier with regard to its business practices or litigation history is false and misleading. Even a cursory review of the history of any large accounting firm or business will reveal the inevitability of litigation. Our history is no different than any other similarly situated firm.” Mazars declined to respond to a long list of questions regarding its work for the Trumps, citing the need to protect client confidentiality. Its statement noted, “Mazars USA prides itself on providing professional accounting, audit and consulting services in accordance with all professional and ethical standards, rules, and regulations.” Because it handles virtually all the tax and accounting needs for Donald Trump, Mazars has inevitably found itself immersed in more recent controversies surrounding its famous client. This extends to the Donald J. Trump Foundation, whose annual tax returns Bender has regularly prepared and signed. For 2016 and 2017, before the foundation’s dissolution, Mazars also audited its financial statements, filed with the New York attorney general’s office. Among these documents, there is no indication the firm did anything to spotlight or curtail the financial abuses that eventually forced the charity’s shutdown. The Mazars accountants were complicit in the foundation’s illegal practices, according to Marcus Owens, an attorney and expert in nonprofit law who ran the IRS’ exempt-organizations division for a decade. “I cannot fathom how they would not know,” he said. Owens called the firm’s role in the foundation’s misconduct “extraordinary. ... I’ve been practicing charity law for 45 years, including 25 at the IRS, and I’ve never seen anything like it.” Added Owens: “This is aiding and abetting someone doing something that is in clear violation of federal tax law. It really calls into question what’s going on with every other tax return that firm prepared.” Mazars’ role, if any, in the Stormy Daniels hush money scandal remains unclear. As ProPublica has reported, the Manhattan DA’s office is investigating whether the Trump Organization’s payments, falsely reimbursed to Michael Cohen as a “legal retainer,” represented an illegal falsification of the company’s books and records. It is not evident what Mazars, in preparing its tax filings and auditing its books, knew — or should have known — about this. But it is clear that the investigation by Manhattan DA Cyrus Vance extends far beyond the scope of that 2016 episode. Vance’s grand jury subpoena seeks tax returns, work papers, financial statements and communications dating back to 2011. If the Supreme Court affirms two federal lower court rulings that he should get them, Vance’s investigators will be free to look for evidence of other potential crimes. For all the anticipation about the documents being sought by both the criminal prosecutors and Congress, it is possible that the public may never see them even if the Supreme Court orders Mazars to turn over the records. In Vance’s investigation, requirements for grand jury secrecy will prevail unless the documents lead to criminal prosecutions. It’s also not clear whether the congressional committees would make public any Trump records. The greatest revelations also may not be contained in the tax returns themselves, which will lack detail about Trump and his businesses, but in the thousands of pages of other materials that Congress and the DA have also subpoenaed. These include the hundreds of corporate returns, also prepared by Mazars, detailing Trump’s investments, his debts, his sources of income and his partners. Equally important, the accountants’ work papers and communications with the Trump Organization could reveal unguarded internal assessments and exchanges about his finances. The Supreme Court fight may end with a whimper. On April 27, the court hinted that it may be looking for a way to punt at least part of the three cases involving Trump’s tax records: It asked the parties to submit supplemental briefs to answer effectively whether the court should even be trying to resolve the two cases in which Congress has subpoenaed the records. (This would not affect the third case, involving the Manhattan DA). The question, as Scotusblog characterized it, is “whether courts should stay out of the fight over the subpoenas because it is fundamentally a political dispute between the branches of government. If the justices were to conclude that the doctrine applies, they could dismiss the cases without ruling on the merits of the dispute — which might be a particularly appealing outcome for some justices in the lead-up to the presidential election.” Such a decision would clear the way for Mazars and Trump’s banks to comply with the congressional subpoenas if they chose to do so — but would provide no judicial means of enforcement, according to University of Texas law professor Stephen Vladeck, a Supreme Court expert. (Asked about such a Supreme Court outcome, a Mazars spokesman said the firm stands by its previous statement that it will “respect the legal process and fully comply with its legal obligations.”) That would provide for a much less stirring conclusion than, say, a unanimous high-court opinion declaring that the president is not above the law. But the court could still affirm the third case, in which federal courts ordered Mazars to turn over the returns to the Manhattan DA. If Mazars then complies with that subpoena, that will leave the firm in good graces with the court — but likely facing the wrath of its client of many decades, the president of the United States. Full Article
is How Safe Are Nursing Homes Near Me? This Tool Will Help You Find Out. By tracking.feedpress.it Published On :: 2020-05-06T18:00:00-04:00 by Charles Ornstein and Lena V. Groeger ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. Nursing home residents have been among those hardest hit by the new coronavirus. In some states, more than half of the recorded deaths have been long-term care residents. Some of the homes have been cited for putting residents at “immediate jeopardy” of harm or death, our analysis showed. And many of the affected homes have been previously written up for violating federal standards. That’s true in California, New Jersey and New York. We’re updating Nursing Home Inspect to include more information about nursing homes across the country, including past problems with infection control practices, and which ones have had cases of COVID-19 among residents or staff. We introduced this resource in 2012 as a way to search through tens of thousands of nursing home inspection reports to find problems and trends. You can easily compare the nursing homes in your state based on how many times they have been cited for violating infection control protocols in the past three inspection cycles (roughly three years). We’ve also added data from The Washington Post on homes with COVID-19 cases. Nursing Home Inspect also allows you to sort by the number of health deficiencies cited by regulators; the number of serious deficiencies per home (that is, deficiencies in which patients were put in immediate jeopardy of harm); the amount of fines imposed; and how often the government has suspended payments to the home for new patients, another type of penalty. Our data is from the U.S. Centers for Medicare and Medicaid Services (CMS), which has its own website called Nursing Home Compare. We’ve taken the information and organized it into an easy-to-use resource for families and residents, as well as researchers and other journalists. Our site includes: • State pages: Every state has its own section that allows you to compare all of the homes in a state on a variety of indicators. • Individual nursing home pages: Every home has a section listing all of the health deficiencies identified within the past three survey cycles (roughly three years). The full text of these deficiency reports, if available, can be accessed via links from this page to CMS. Each home’s page also has ownership status — whether for-profit, government-run or nonprofit — and whether the home has been labeled by the government as a Special Focus Facility, meaning that it has many more problems than other homes. We’ve also labeled Special Focus Facility candidates, which meet the criteria to be a special focus facility but haven’t yet been designated as one. (We only include health deficiencies, not fire and safety violations, in this database.) • State-by-state maps: The main page of the app shows how states compare in terms of the percentage of homes with at least one serious deficiency, the average fine paid by homes in the state, and the percentage of homes in each state with at least one infection-related deficiency. • Top 20 Lists: We’ve listed the homes that have paid the most in fines in the nation and those with the highest number of serious deficiencies. If homes violate federal standards, CMS may impose fines or suspend Medicare/Medicaid payments to the nursing home for new residents until the facility corrects the deficiency. If problems persist or are not fixed, CMS can end its agreement with the nursing home. Additional details about CMS’ approach to enforcement can be found here. Nursing Home Inspect continues to allow you to search through nearly 80,000 inspection reports by keywords, such as “choke” or “maggots,” to look for issues you care about. These search results can be sorted by date, city, state or severity of the deficiency. Nursing homes are inspected on both a regular schedule and when there is a complaint. Inspectors typically work for state agencies paid by Medicare. If they find problems, known as deficiencies, they rank them on a scale of A to L, the most severe. The vast majority are either labeled D or E. What you won’t find on these pages are self-reported quality measures for each home. Those can be found on Nursing Home Compare. We also don’t list the state sanctions imposed against homes because those are not centrally collected. For information on penalties within a given state, you should consult the state agency that regulates nursing homes. The federal government has a list of contacts available here. When reading through inspection reports, it is a good idea to keep in mind the caveats we’ve outlined previously. How We Combined Data Sources To compile our app, we used different datasets: a listing of all Medicare-certified nursing homes, inspection violations and penalties, and deficiency report narratives. We merged spreadsheets containing findings from routine inspections and those identified during complaint visits and kept only health violations, not fire safety violations. We used each home’s unique identification code to match penalties imposed to the dates of their corresponding inspections so we could display that data together for each home. (We also noted some cases in which a penalty date did not have a corresponding inspection in the database.) You can find the data we used on these sites: • For a list of nursing homes: https://data.medicare.gov/Nursing-Home-Compare/Provider-Info/4pq5-n9py • For penalties: https://data.medicare.gov/Nursing-Home-Compare/Penalties/g6vv-u9sr • For health deficiency information: https://data.medicare.gov/Nursing-Home-Compare/Health-Deficiencies/r5ix-sfxw • For deficiency report narratives (updated in April 2020): http://downloads.cms.gov/files/Full-Statement-of-Deficiencies-April-2020.zip Full Article
is On the Same Day Sen. Richard Burr Dumped Stock, So Did His Brother-in-Law. Then the Market Crashed. By tracking.feedpress.it Published On :: 2020-05-06T18:00:00-04:00 by Robert Faturechi and Derek Willis ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. Sen. Richard Burr was not the only member of his family to sell off a significant portion of his stock holdings in February, ahead of the market crash spurred by coronavirus fears. On the same day Burr sold, his brother-in-law also dumped tens of thousands of dollars worth of shares. The market fell by more than 30% in the subsequent month. Burr’s brother-in-law, Gerald Fauth, who has a post on the National Mediation Board, sold between $97,000 and $280,000 worth of shares in six companies — including several that have been hit particularly hard in the market swoon and economic downturn. A person who picked up Fauth’s phone on Wednesday hung up when asked if Fauth and Burr had discussed the sales in advance. In 2017, President Donald Trump appointed Fauth to the three-person board of the National Mediation Board, a federal agency that facilitates labor-management relations within the nation’s railroad and airline industries. He was previously a lobbyist and president of his own transportation economic consulting firm, G.W. Fauth & Associates. Burr came under scrutiny after ProPublica reported that he sold off a significant percentage of his stocks shortly before the market tanked, unloading between $628,000 and $1.72 million of his holdings on Feb. 13 in 33 separate transactions. As chairman of the Senate Intelligence Committee and a member of the health committee, Burr had access to the government’s most highly classified information about threats to America’s security and public health concerns. Before his sell-off, Burr had assured the public that the federal government was well-prepared to handle the virus. In a Feb. 7 op-ed that he co-authored with another senator, he said “the United States today is better prepared than ever before to face emerging public health threats, like the coronavirus.” That month however, according to a recording obtained by NPR, Burr had given a VIP group at an exclusive social club a much more dire preview of the economic impact of the the coronavirus, warning it could curtail business travel, cause schools to be closed and result in the military mobilizing to compensate for overwhelmed hospitals. The timing of Burr’s stock sales drew widespread outrage, allegations of insider trading, calls for his resignation and an FBI investigation. Gerald Fauth, Burr’s brother-in-law, was appointed by Trump to the National Mediation Board in 2017. (National Mediation Board via Wikipedia) Burr defended his actions, saying he relied solely on public information, including CNBC reports, to inform his trades and did not rely on information he obtained as a senator. Fauth avoided between $37,000 and $118,000 in losses by selling off when he did, considering how steeply the companies’ shares fell in recent weeks, according to an analysis by Luke Brindle-Khym, a partner and general counsel of Manhattan-based investigative firm QRI. Brindle-Khym obtained Fauth’s financial disclosure from the Office of Government Ethics and shared it with ProPublica. Government forms only require that the value of stock trades be disclosed in ranges. After the February sales, the total value of Fauth’s individual stock holdings appears to be between $680,000 and $2 million. Alice Fisher, Burr’s attorney, told ProPublica that “Sen. Burr participated in the stock market based on public information and he did not coordinate his decision to trade on Feb. 13 with Mr. Fauth.” She did not respond to a question about whether Burr discussed anything he learned as a senator with Fauth or any other relatives. A review of Fauth’s financial disclosure forms since 2017 show that he is not a frequent stock trader, but that he also had a major day of sales in August 2019. On Feb. 13, Fauth or his spouse sold between $15,001 and $50,000 of Altria, the tobacco company; between $50,001 and $100,000 of snack food maker Mondelez International; and between $1,001 and $15,000 of home furnishings retailer Williams-Sonoma. He also sold stakes in several oil companies, which have been hit particularly hard, including between $15,001 and $50,000 of Chevron; between $1,001 and $15,000 of BP and between $15,001 and $50,000 of Royal Dutch Shell. The finances of the Burrs and Fauths have intersected before. Federal Election Commission records show that Burr’s leadership PAC, Next Century Fund, has paid $120,348 since 2002 to his sister-in-law, Mary Fauth, Gerald’s wife, who serves as treasurer. The PAC has also paid $104,850 in rent and utilities over the same period to 116 S. Royal St. Partners, in which Gerald Fauth is a partner. Do you have access to information about stock trading by Trump administration officials or members of Congress that should be public? Email robert.faturechi@propublica.org or reach him on Signal/WhatsApp at 213-271-7217. Here’s how to send tips and documents to ProPublica securely. Update, May 6, 2020: This story was updated with new comment from Sen. Richard Burr’s attorney. Full Article
is How Climate Change Is Contributing to Skyrocketing Rates of Infectious Disease By tracking.feedpress.it Published On :: 2020-05-07T05:00:00-04:00 by Abrahm Lustgarten ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The scientists who study how diseases emerge in a changing environment knew this moment was coming. Climate change is making outbreaks of disease more common and more dangerous. Over the past few decades, the number of emerging infectious diseases that spread to people — especially coronaviruses and other respiratory illnesses believed to have come from bats and birds — has skyrocketed. A new emerging disease surfaces five times a year. One study estimates that more than 3,200 strains of coronaviruses already exist among bats, awaiting an opportunity to jump to people. The diseases may have always been there, buried deep in wild and remote places out of reach of people. But until now, the planet’s natural defense systems were better at fighting them off. Today, climate warming is demolishing those defense systems, driving a catastrophic loss in biodiversity that, when coupled with reckless deforestation and aggressive conversion of wildland for economic development, pushes farms and people closer to the wild and opens the gates for the spread of disease. Aaron Bernstein, the interim director for the C-Change Center for Climate, Health and the Global Environment at Harvard University’s T.H. Chan School of Public Health, said that ignoring how climate and rapid land development were putting disease-carrying animals in a squeeze was akin to playing Russian roulette. “Nature is trying to tell us something,” Bernstein said. Scientists have not suggested that climate played any direct role in causing the current COVID-19 outbreak. Though the virus is believed to have originated with the horseshoe bat, part of a genus that’s been roaming the forests of the planet for 40 million years and thrives in the remote jungles of south China, even that remains uncertain. Scientists have, however, been studying the coronaviruses of southern China for years and warning that swift climate and environmental change there — in both loss of biodiversity and encroachment by civilization — was going to help new viruses jump to people. There are three ways climate influences emerging diseases. Roughly 60% of new pathogens come from animals — including those pressured by diversity loss — and roughly one-third of those can be directly attributed to changes in human land use, meaning deforestation, the introduction of farming, development or resource extraction in otherwise natural settings. Vector-borne diseases — those carried by insects like mosquitoes and ticks and transferred in the blood of infected people — are also on the rise as warming weather and erratic precipitation vastly expand the geographic regions vulnerable to contagion. Climate is even bringing old viruses back from the dead, thawing zombie contagions like the anthrax released from a frozen reindeer in 2016, which can come down from the arctic and haunt us from the past. Thus the COVID-19 pandemic, even as it unfolds in the form of an urgent crisis, is offering a larger lesson. It is demonstrating in real time the enormous and undeniable power that nature has over civilization and even over its politics. That alone may make the pandemic prologue for more far-reaching and disruptive changes to come. But it also makes clear that climate policy today is indivisible from efforts to prevent new infectious outbreaks, or, as Bernstein put it, the notion that climate and health and environmental policy might not be related is “a dangerous delusion.” The warming of the climate is one of the principal drivers of the greatest — and fastest — loss of species diversity in the history of the planet, as shifting climate patterns force species to change habitats, push them into new regions or threaten their food and water supplies. What’s known as biodiversity is critical because the natural variety of plants and animals lends each species greater resiliency against threat and together offers a delicately balanced safety net for natural systems. As diversity wanes, the balance is upset, and remaining species are both more vulnerable to human influences and, according to a landmark 2010 study in the journal Nature, more likely to pass along powerful pathogens. The casualties are amplified by civilization’s relentless push into forests and wild areas on the hunt for timber, cropland and other natural resources. Epidemiologists tracking the root of disease in South Asia have learned that even incremental and seemingly manageable injuries to local environments — say, the construction of a livestock farm adjacent to stressed natural forest — can add up to outsized consequences. Around the world, according to the World Resources Institute, only 15% of the planet’s forests remain intact. The rest have been cut down, degraded or fragmented to the point that they disrupt the natural ecosystems that depend on them. As the forests die, and grasslands and wetlands are also destroyed, biodiversity sharply decreases further. The United Nations warns that the number of species on the planet has already dropped by 20% and that more than a million animal and plant species now face extinction. Losing species has, in certain cases, translated directly to a rise in infectious disease. Peatland fires in Indonesia in 2018 used to clear forests for palm oil plantations. Deforestation is one of the largest drivers of the emergence of new infectious diseases. (Wahyudi/AFP via Getty Image) Americans have been experiencing this phenomenon directly in recent years as migratory birds have become less diverse and the threat posed by West Nile encephalitis has spread. It turns out that the birds that host the disease happen to also be the tough ones that prevail amid a thinned population. Those survivors have supported higher infection rates in mosquitoes and more spread to people. Similarly, a study published last month in the journal Proceedings of the Royal Society B found that as larger mammals suffer declines at the hands of hunters or loggers or shifting climate patterns, smaller species, including bats, rats and other rodents, are thriving, either because they are more resilient to the degraded environment or they are able to live better among people. It is these small animals, the ones that manage to find food in garbage cans or build nests in the eaves of buildings, that are proving most adaptable to human interference and also happen to spread disease. Rodents alone accounted for more than 60% of all the diseases transmitted from animals to people, the researchers found. Warmer temperatures and higher rainfall associated with climate change — coupled with the loss of predators — are bound to make the rodent problem worse, with calamitous implications. In 1999, for example, parts of Panama saw three times as much rainfall as usual. The rat population exploded, researchers found. And so did the viruses rats carry, along with the chances those viruses would jump to people. That same year, a fatal lung disease transmitted through the saliva, feces and urine of rats and mice called hantavirus pulmonary syndrome emerged in Panama for the first time, according to a report in the journal Emerging Infectious Diseases. As much as weather changes can drive changes in species, so does altering the landscape for new farms and new cities. In fact, researchers attribute a full 30% of emerging contagion to what they call “land use change.” Nothing drives land use shifts more than conversion for farmland and feedstock — a result of the push to feed the planet’s 7.8 billion people. As the global population surges to 10 billion over the next 35 years, and the capacity to farm food is stressed further again by the warming climate, the demand for land will only get more intense. Already, more than one-third of the planet’s land surface, and three-quarters of all of its fresh water, go toward the cultivation of crops and raising of livestock. These are the places where infectious diseases spread most often. Take, for example, the 1999 Nipah outbreak in Malaysia — the true-life subject matter adapted for the film “Contagion.” Rapid clearcutting of the forests there to make way for palm plantations drove fruit bats to the edge of the trees. (Separate research also suggests that climate changes are shifting fruit bats’ food supply.) They found places to roost, as it happens, alongside a hog farm. As the bats gorged themselves on fruit, they dropped pieces of food from the branches, along with their urine, into the pigsties, where at least one pig is believed to have eaten some. When the pig was slaughtered and brought to market, an outbreak is believed to have been spread by the man who handled the meat. More than 100 people died. The U.S. Centers for Disease Control and Prevention says that fully three-quarters of all new viruses have emerged from animals. Even the 2014 Ebola outbreak in West Africa is believed to have begun when a boy dug into a tree stump that happened to be the roost of bats carrying the virus. As Christine Johnson, the associate director of the One Health Institute, an interdisciplinary epidemiological program at the University of California, Davis, puts it, global health policymakers have a responsibility to understand how climate, habitat and land use changes lead to disease. Almost every major epidemic we know of over the past couple of decades — SARS, COVID-19, Ebola and Nipah virus — jumped to people from wildlife enduring extreme climate and habitat strain, and still, “we’re naive to them,” she said. “That puts us in a dangerous place.” Once new diseases are let loose in our environment, changing temperatures and precipitation are also changing how those diseases spread — and not for the better. Warming climates increase the range within which a disease can find a home, especially those transmitted by “vectors,” mosquitoes and ticks that carry a pathogen from its primary host to its new victim. A 2008 study in the journal Nature found nearly one-third of emerging infectious diseases over the past 10 years were vector-borne, and that the jumps matched unusual changes in the climate. Especially in cases where insects like infection-bearing mosquitoes are chasing warmer temperatures, the study said, “climate change may drive the emergence of diseases.” A mosquito in a laboratory of the Friedrich-Loeffler Institute in Germany. Scientists say at least 500 million more people, including 55 million more Americans, will be susceptible to mosquito-borne diseases as the climate warms. (Steffen Kugler/Getty Images) Ticks and mosquitoes now thrive in places they’d never ventured before. As tropical species move northward, they are bringing dangerous pathogens with them. The Zika virus or Chikungunya, a mosquito-spread virus that manifests in intense joint pain, were once unseen in the United States, but both were transmitted locally, not brought home by travelers, in southern Texas and Florida in recent years. Soon, they’ll be spreading further northward. According to a 2019 study in the journal PLOS Neglected Tropical Diseases, by 2050, disease-carrying mosquitoes will ultimately reach 500 million more people than they do today, including some 55 million more Americans. In 2013, dengue fever — an affliction affecting nearly 400 million people a year, but normally associated with the poorest regions of Africa — was transmitted locally in New York for the first time. “The long-term risk from dengue may be much higher than COVID,” said Scott Weaver, the director of the Institute for Human Infections and Immunity at the University of Texas Medical Branch in Galveston. “It’s a disease of poor countries, so it doesn’t get the attention it deserves.” The chain of events that ultimately leads to a pandemic can be long and subtle, steered by shifts in the ecosystem. The 1999 West Nile outbreak in the U.S., for example, came after climate-driven droughts dried up streams and rivers, leaving pools of stagnant water where mosquitoes bred unhindered. It turns out the loss of water also killed off their predators — dragonflies and frogs that depend on large watering holes were gone. Coronaviruses like COVID-19 aren’t likely to be carried by insects — they don’t leave enough infected virus cells in the blood. But one in five other viruses transmitted from animals to people are vector-borne, said U.C. Davis’ Johnson, meaning it’s only a matter of time before other exotic animal-driven pathogens are driven from the forests of the global tropics to the United States or Canada or Europe because of the warming climate. “Climate is going to shift vulnerability to that,” Johnson said, “and I think some of these regions are not prepared.” The changing climate won’t just affect how the diseases move about the planet, it will also shape how easily we get sick. According to a 2013 study in the journal PLOS Currents Influenza, warm winters were predictors of the most severe flu seasons in the following year. The brief respite in year one, it turns out, relaxed people’s natural defenses and reduced “herd immunity,” setting conditions for the virus to rage back with a vengeance. Even harsh swings from hot to cold, or sudden storms — exactly the kinds of climate-induced patterns we’re already seeing — make people more likely to get sick. A study in the journal Environmental Research Letters linked the brutal 2017-18 flu season — which killed 79,000 people — to erratic temperature swings and extreme weather that winter, the same period in which a spate of floods and hurricanes devastated much of the country. If the climate crisis continues on its current trajectory, the authors wrote, respiratory infections like the flu will sharply increase. The chance of a flu epidemic in America’s most populated cities will increase by as much as 50% this century, and flu-related deaths in Europe could also jump by 50%. “We’re on a very dangerous path right now,” said the University of Texas’ Weaver. Slow action on climate has made dramatic warming and large-scale environmental changes inevitable, he said, “and I think that increases in disease are going to come along with it.” Twelve months before the first COVID-19 case was diagnosed, a group of epidemiologists working with a U.S. Agency for International Development project called PREDICT, or Pandemic Influenza and other Emerging Threats, was deep in the remote leafy jungle of southern China’s Yunnan province hunting for what it believed to be one of the greatest dangers to civilization: a wellspring of emerging viruses. A decade of study there had identified a pattern of obscure illnesses affecting remote villagers who used bat guano as fertilizer and sometimes for medicine. Scientists traced dozens of unnamed, emerging viruses to caves inhabited by horseshoe bats. Any one of them might have triggered a global pandemic killing a million people. But luck — and mostly luck alone — had so far kept the viruses from leaping out of those remote communities and into the mainstream population. The luck is likely to run out, as Yunnan is undergoing enormous change. Quaint subsistence farm plots were overtaken by hastily erected apartment towers and high-speed rail lines, as the province endured dizzying development fueled by decades of Chinese economic expansion. Cities’ footprints swelled, pushing back the forests. More people moved into rural places and the wildlife trade, common to such frontier regions, thrived. With every new person and every felled tree, the bats’ habitat shrank, putting the viruses they carried on a collision course with humanity. By late 2018, epidemiologists there were bracing for what they call “spillover,” or the failure to keep a virus locally contained as it jumped from the bats and villages of Yunnan into the wider world. In late 2018, the Trump administration, as part of a sweeping effort to bring U.S. programs in China to a halt, abruptly shut down the research — and its efforts to intercept the spread of a new novel coronavirus along with it. “We got a cease and desist,” said Dennis Carroll, who founded the PREDICT program and has been instrumental in global work to address the risks from emerging viruses. By late 2019, USAID had cut the program’s global funding. USAID did not respond to a detailed list of questions from ProPublica. The loss is immense. The researchers believed they were on the cusp of a breakthrough, racing to sequence the genes of the coronaviruses they’d extracted from the horseshoe bat and to begin work on vaccines. They’d campaigned for years for policymakers to fully consider what they’d learned about how land development and climate changes were driving the spread of disease, and they thought their research could literally provide governments a map to the hot spots most likely to spawn the next pandemic. They also hoped the genetic material they’d collected could lead to a vaccine not just for one lethal variation of COVID, but perhaps — like a missile defense shield for the biosphere — to address a whole family of viruses at once. (In fact, the gene work they were able to complete was used to test the efficacy of remdesivir, an experimental drug that early clinical trial data shows can help COVID-19 patients.) Carroll said knowledge of the virus genomes had the potential “to totally transform how we think about future biomedical interventions before there’s an emergence.” His goal was to not just react to a pandemic, but to change the very definition of preparedness. If PREDICT’s efforts in China had the remote potential to fend off the current COVID pandemic, though, it also offered an opportunity to study how climate and land development were driving disease. But there has been little appetite for that inquiry among policymakers. PREDICT’s staff and advisers have pushed the U.S. government to consider how welding public health policy with environmental and climate science could help stem the spread of contagions. Climate change was featured in presentations that PREDICT staff made to Congress, according to U.C. Davis’ Johnson, who is now also the director of PREDICT, which received a temporary funding extension this spring. And until 2016, leadership of New York-based EcoHealth Alliance, the research group working under PREDICT funding in Yunnan, was invited several times to the White House to advise on global health policy. Since Donald Trump was elected, the group hasn’t been invited back. “It’s falling on deaf ears,” said Peter Daszak, EcoHealth Alliance’s president. A White House spokesperson did not respond to an emailed request for comment. What Daszak really wants — in addition to restored funding to continue his work — is the public and leaders to understand that it’s human behavior driving the rise in disease, just as it drives the climate crisis. In China’s forests, he looks past the destruction of trees and asks why they are being cut in the first place, and who is paying the cost. Metals for iPhones and palm oil for processed foods are among the products that come straight out of South Asian and African emerging disease hot spots. “We turn a blind eye to the fact that our behavior is driving this,” he said. “We get cheap goods through Walmart, and then we pay for it forever through the rise in pandemics. It’s upside down.” Full Article
is The State Attorney General Is Scrutinizing This Assisted Living Facility Over Its Handling of COVID-19. Some Residents Are Suing It, Too. By tracking.feedpress.it Published On :: 2020-05-08T06:00:00-04:00 by Joaquin Sapien ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. This story is co-published with PBS Frontline. New York Attorney General Letitia James is looking into allegations that a Queens adult care facility has failed to protect residents from the deadly coronavirus and misled families about its spread, according to two lawmakers who asked for the inquiry and a relative of a resident who spoke to an investigator with the attorney general’s office. In a separate action Tuesday, three residents of the Queens Adult Care Center sued the facility in federal court over similar allegations. Both developments were prompted largely by ProPublica’s recent coverage of the facility, which houses both frail elderly residents and those with mental health issues. On April 2, we reported that workers and residents at the home were becoming ill with the coronavirus as residents wandered in and out of the home without any personal protective equipment. Family members later told ProPublica the management said no residents were sick with the virus at the time. On April 25, ProPublica published a story and a short film with the PBS series Frontline about the harrowing experience of Natasha Roland, who rescued her father in the middle of the night as he suffered coronavirus symptoms so severe he could barely breathe. Roland, in heart-wrenching detail, described how the management of the Queens Adult Care Center repeatedly assured her that her 82-year-old father, Willie Roland, was safe, even as the virus swept through the facility. She said workers were too scared to care for him, forcing his girlfriend, Annetta King-Simpson, to do so. King-Simpson later fell ill herself. Roland and King-Simpson are now suing the facility in federal court. Joe Singer and Katie Campbell/ProPublica In an interview, Assemblywoman Catalina Cruz, whose district covers Corona, Elmhurst and Jackson Heights, said she was troubled by what ProPublica reported. She said she hoped the attorney general can determine whether the Queens Adult Care Center had broken any laws. “It didn’t sit right with me. I thought something was off here. So I said let’s have the experts look at whether there was a crime or a civil violation,” she said. “Folks who live in this adult home deserve the same dignity as everyone else, and if their rights have been violated, someone needs to pay for that.” Cruz said she had been suspicious of the facility for several years and had come across a community Facebook page where people posted complaints about treatment of residents at the center. When she saw the ProPublica stories, she said she decided to take action, along with City Council member Daniel Dromm, who had already written to the New York State Department of Health and the office of Gov. Andrew Cuomo about the spread of the coronavirus in the facility on several occasions. “The plight of those living in adult care centers during this crisis was highlighted in a recent article published by ProPublica, which focused on the perils faced by the residents at the Queens Adult Day Care Center,” the lawmakers wrote in their April 27 letter to the attorney general and the governor’s office. “Failure to inform families about the health of loved ones, to lying and covering up deaths have become regular concerns we have received. We are aware that adult care centers are struggling to keep COVID-19 from affecting their residents and we also know that minorities have been disproportionately affected by the virus. It seems to us that management at this particular center have struggled to implement procedures and policies to protect the lives of its residents.” Cruz said she received an update from the attorney general’s office on May 5, saying it was looking into the matter but would not provide specific details. Days after the lawmakers sent the letter, Natasha Roland, 35, said she received a phone call from an investigator with the attorney general’s office. Roland said she recapped what she had previously told ProPublica: She began to worry about her father’s safety when nearby Elmhurst Hospital became a viral hot spot, but the management repeatedly told her there were no coronavirus cases in the facility. She said she only found out the truth weeks later when a worker she was friendly with advised her to come and pick up her father because the virus was raging through the facility and aides were becoming too scared to check on residents. In a subsequent interview, that worker denied telling Roland to pick up her dad. A spokesperson for the attorney general would not confirm or deny a specific, active investigation into the Queens Adult Care Center, but said James has received hundreds of complaints related to COVID-19 inside nursing homes and adult care facilities across the state and is investigating many of them. For its part, the Queens Adult Care Center has denied any wrongdoing and repeated its belief that Roland’s allegations are “baseless.” “Sadly, select elected officials and ProPublica have been intentionally misled with baseless assertions and utter fabrications crafted by the daughter of one of our long-term residents,” said Hank Sheinkopf, a crisis communications spokesperson hired by the facility. “We have strong reason to believe that this individual is seeking to use her father and other select residents as pawns in an attempt to extort the facility. We are considering our legal options.” He said the facility has “worked tirelessly” to protect its residents and is unaware of a “potential investigation,” but understood that “the AG’s office has contacted many nursing homes, adult care, and assisted living facilities seeking information. We are glad to be a resource to the AG’s office and have nothing to hide.” Bruce Schoengood’s 61-year-old brother, Bryan, lives in the facility and shared a room with one of the first residents to become infected with COVID-19 and subsequently die of the disease. Bruce told ProPublica he only learned that his brother’s roommate had died by happenstance during a casual conversation with his brother, and that he has complained for more than a month about a lack of communication from the facility. He said he had not yet heard from anyone with the attorney general’s office but would welcome such a conversation. In the meantime, Bryan Schoengood, Willie Roland and King-Simpson are suing the facility under the Americans with Disabilities Act. In a 59-page complaint, the group has asked a federal judge to appoint a special master to oversee the facility at the home’s expense to ensure that residents there are safe. The lawsuit argues that residents have experienced a “gross failure to provide the most basic level of care to safeguard their health and safety in the context of a global health pandemic. People with disabilities are exposed to high risks of contracting the virus with no or few preventative measures in place. Residents who fall sick are left to languish in their room without proper access to medical care.” The lawsuit claims that because the facility has failed to follow state and federal guidelines, “COVID-19 is rampant in the facility among residents and staff alike.” Alan Fuchsberg is the Manhattan-based personal injury and civil rights attorney representing the three Queens Adult Care Center residents. In an interview, he said that the facility may not have the resources to properly follow the guidelines, which is why a special master should be assigned to work with a team of outside experts to make sure it can. “Right now the residents are in a tinderbox,” he said. “And if you drop a match in there, all hell breaks loose. It should be run right. We don’t need dozens of people dying in all our nursing homes and adult care facilities. Some are running better than others and QACC sounds like a place that is not run up to standards.” He and Bruce Schoengood pointed out that they are not currently suing for damages, but rather to persuade a court to immediately intervene and offer support to the facility’s roughly 350 residents. Schoengood said the goals of the lawsuit are twofold. “I think it is both short term and long term,” he said. “Immediate intervention to put proper protocols in place to treat the sick and stop the spread of coronavirus and to communicate with family members. And in the long term I would like to see this facility much better prepared to handle another pandemic or a second wave.” Responding to the charges in the lawsuit, Sheinkopf again said that “the allegations are baseless and utter fabrications. Queens Adult Care Center (QACC) continues to meet all state issued guidelines.” Full Article
is Early Data Shows Black People Are Being Disproportionally Arrested for Social Distancing Violations By tracking.feedpress.it Published On :: 2020-05-08T18:22:00-04:00 by Joshua Kaplan and Benjamin Hardy ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. On April 17 in Toledo, Ohio, a 19-year-old black man was arrested for violating the state stay-at-home order. In court filings, police say he took a bus from Detroit to Toledo “without a valid reason.” Six young black men were arrested in Toledo last Saturday while hanging out on a front lawn; police allege they were “seen standing within 6 feet of each other.” In Cincinnati, a black man was charged with violating stay-at-home orders after he was shot in the ankle on April 7; according to a police affidavit, he was talking to a friend in the street when he was shot and was “clearly not engaged in essential activities.” Ohio’s health director, Dr. Amy Acton, issued the state’s stay-at-home order on March 22, prohibiting people from leaving their home except for essential activities and requiring them to maintain social distancing “at all times.” A violation of the order is a misdemeanor, punishable by up to 90 days in jail and a $750 fine. Since the order, hundreds of people have been charged with violations across Ohio. The state has also seen some of the most prominent protests against state stay-at-home orders, as large crowds gather on the statehouse steps to flout the directives. But the protesters, most of them white, have not faced arrest. Rather, in three large Ohio jurisdictions ProPublica examined, charges of violating the order appear to have fallen disproportionately on black people. ProPublica analyzed court records for the city of Toledo and for the counties that include Columbus and Cincinnati, three of the most populous jurisdictions in Ohio. In all of them, ProPublica found, black people were at least four times as likely to be charged with violating the stay-at-home order as white people. As states across the country attempt to curb the spread of COVID-19, stay-at-home orders have proven instrumental in the fight against the novel coronavirus; experts credit aggressive restrictions with flattening the curve in the nation’s hotbeds. Many states’ orders carry criminal penalties for violations of the stay-at-home mandates. But as the weather warms up and people spend more time outside, defense lawyers and criminal justice reform advocates fear that black communities long subjected to overly aggressive policing will face similarly aggressive enforcement of stay-at-home mandates. In Ohio, ProPublica found, the disparities are already pronounced. As of Thursday night in Hamilton County, which is 27% black and home to Cincinnati, there were 107 charges for violating the order; 61% of defendants are black. The majority of arrests came from towns surrounding Cincinnati, which is 43% black. Of the 29 people charged by the city’s Police Department, 79% were black, according to data provided to ProPublica by the Hamilton County Public Defender. In Toledo, where black people make up 27% of the population, 18 of the 23 people charged thus far were black. Lt. Kellie Lenhardt, a spokeswoman for the Toledo Police Department, said that in enforcing the stay-at-home order, the department’s goal is not to arrest people and that officers are primarily responding to calls from people complaining about violations of the order. She told ProPublica that if the police arrested someone, the officers believed they had probable cause, and that while biased policing would be “wrong,” it would also be wrong to arrest more white people simply “to balance the numbers.” In Franklin County, which is 23.5% black, 129 people were arrested between the beginning of the stay-at-home order and May 4; 57% of the people arrested were black. In Cleveland, which is 50% black and is the state’s second-largest city, the Municipal Court’s public records do not include race data. The court and the Cleveland Police Department were unable to readily provide demographic information about arrests to ProPublica, though on Friday, the police said they have issued eight charges so far. In the three jurisdictions, about half of those charged with violating the order were also charged with other offenses, such as drug possession and disorderly conduct. The rest were charged only with violating the order; among that group, the percentage of defendants who were black was even higher. Franklin Country is home to Columbus, where enforcement of the stay-at-home order has made national headlines for a very different reason. Columbus is the state capital and Ohio’s largest city with a population of almost 900,000. In recent weeks, groups of mostly white protesters have campaigned against the stay-at-home order on the Statehouse steps and outside the health director’s home. Some protesters have come armed, and images have circulated of crowds of demonstrators huddled close, chanting, many without masks. No protesters have been arrested for violating the stay-at-home order, a spokesperson for the Columbus mayor’s office told ProPublica. Thomas Hach, an organizer of a group called Free Ohio Now, said in an email that he was not aware of any arrests associated with protests in the entire state. The Columbus Division of Police did not respond to ProPublica’s request for comment. Ohio legislators are contemplating reducing the criminal penalties for violating the order. On Wednesday, the state House passed legislation that would eliminate the possibility of jail time for stay-at-home violators. A first offense would result in a warning, and further violations would result in a small fine. The bill is pending in the state Senate. Penalties for violating stay-at-home orders vary across the country. In many states, including California, Florida, Michigan and Washington, violations can land someone behind bars. In New York state, violations can only result in fines. In Baltimore, police told local media they had only charged two people with violations; police have reportedly relied on a recording played over the loudspeakers of squad cars: “Even if you aren’t showing symptoms, you could still have coronavirus and accidentally spread it to a relative or neighbor. Being home is being safe. We are all in this together.” Enforcement has often resulted in controversy. In New York City, a viral video showed police pull out a Taser and punch a black man after they approached a group of people who weren’t wearing masks. Police say the man who was punched took a “fighting stance” when ordered to disperse. In Orlando, police arrested a homeless man walking a bicycle because he was not obeying curfew. In Hawaii, charges against a man accused of stealing a car battery, normally a misdemeanor punishable by up to 30 days in jail, were enhanced to a felony, which can result in 10 years in prison, because police and prosecutors said he was in violation of the state order. The orders are generally broad, and decisions about which violations to treat as acceptable and which ones to penalize have largely been left to local police departments’ discretion. Kristen Clarke, president of the Lawyers’ Committee for Civil Rights Under Law, a legal organization focused on racial justice, said such discretion has opened the door to police abuse, and she said the U.S. Department of Justice or state governments should issue detailed guidelines about when to make arrests. That discretion “is what’s given rise to these rogue practices,” she told ProPublica, “that are putting black communities and communities of color with a target on their backs.” In jails and prisons around the country, inmates have fallen ill or died from COVID-19 as the virus spreads rapidly through the facilities. Many local governments have released some inmates from jail and ordered police to reduce arrests for minor crimes. But in Hamilton County, some people charged with failing to maintain social distancing have been kept in jail for at least one night, even without any other charges. Recently, two sheriff’s deputies who work in the jail tested positive for COVID-19. “The cops put their hands on them, they cram them in the car, they take them to the [jail], which has 800 to 1400 people, depending on the night,” said Sean Vicente, director of the Hamilton County Public Defender’s misdemeanor division. “It’s often so crowded everyone’s just sitting on the floor.” Clarke said the enforcement push is sometimes undercutting the public health effort: “Protecting people’s health is in direct conflict with putting people in overcrowded jails and prisons that have been hotbeds for the virus.” Court records show that the Cincinnati Police Department has adopted some surprising applications of the law. Six people were charged with violations of the order after they were shot. Only one was charged with another crime as well, but police affidavits state that when they were shot, they were or likely were in violation of the order. One man was shot in the ankle while talking to a friend, according to court filings, and “was clearly not engaged in essential activities.” Another was arrested with the same explanation; police wrote that he had gone to the hospital with a gunshot wound. The Cincinnati Police Department did not respond to ProPublica’s requests for comment. In Springfield Township, a small, mostly white Cincinnati suburb, nine people have been arrested for violating the order thus far. All of them are black. Springfield Township Police Chief Robert Browder told ProPublica in an email that the department is “an internationally accredited law enforcement organization” and has “strict policies ... to ensure that our zero tolerance policy prohibiting bias-based profiling is adhered to.” Browder said race had not played a role in his department’s enforcement of the order and that he was “appalled if that is the insinuation.” Several of the black people arrested in Springfield Township were working for a company that sells books and magazine subscriptions door to door. One of the workers, Carl Brown, 50, said he and five colleagues were working in Springfield Township when two members of the team were arrested while going door to door. Police called the other sales people, and when they arrived at the scene, they too were arrested. Five of them, including Brown, were charged only with violating the stay-at-home order; the sixth sales person had an arrest warrant in another state, according to Browder, and police also charged her for giving them false identification. Brown said one of the officers had left the group with a warning: They should never come back, and if they do, it’s “going to be worse.” Browder denied that the officers made such a threat, and he said the police had received calls from residents about the sales people and their tactics and that the sales people had failed to register with the Police Department, as required for door-to-door solicitation. Other violations in Hamilton County have been more egregious, but even in some of those cases, the law enforcement response has stirred controversy. On April 4, a man who had streamed a party on Facebook Live, saying, “We don’t give a fuck about this coronavirus,” was arrested in Cincinnati’s Over-the-Rhine neighborhood, the setting of a 2001 riot after police fatally shot an unarmed black man. The man who streamed the party, Rashaan Davis, was charged with violating the stay-at-home order and inciting violence, and his bond was set at $350,000. After Judge Alan Triggs said he would release Davis from jail pretrial because the offense charged was nonviolent, local media reported, prosecutors dropped the misdemeanor and said they would focus on the charge of inciting violence, a felony. The Hamilton County prosecutor’s office declined to comment on Davis’ case. In Toledo, there’s been public controversy around perceived differences in the application of the law. On April 21, debate at the Toledo City Council meeting centered around a food truck. Local politicians discussed recent arrests of young black people at house parties, some contrasting them with a large, white crowd standing close together in line outside a BBQ stand, undisturbed by police. Councilmember Gary Johnson told ProPublica he’s asked the police chief to investigate why no one was arrested at a party he’d heard about, where white people were congregating on docks. “I don’t know the circumstances of the arrests,” he said. But “if you feel you need to go into poor neighborhoods and African American neighborhoods, you better be going into white neighborhoods too. … You have to say we’re going to be heavy-handed with the stay-at-home order or we’re going to be light with it. It has to be one or the other.” Toledo police enforcement has not been confined to partygoers. Armani Thomas, 20, is one of the six young men arrested for not social distancing on a lawn. He told ProPublica he was sitting there with nine friends “doing nothing” when the police pulled up. Two kids ran off, and the police made the rest stay, eventually arresting “all the dudes” and letting the girls go. He was taken to the county jail, where several inmates have tested positive, for booking and released after several hours. The men’s cases are pending. “When police see black people gathered in public, I think there’s this looming belief that they must be doing something illegal,” RaShya Ghee, a criminal defense attorney and lecturer at the University of Toledo, told ProPublica. “They’re hanging out in a yard — something illegal must have happened. Or, something illegal is about to happen.” Lenhardt, the police lieutenant, said the six men were arrested after police received 911 calls reporting “a group gathering and flashing guns.” None of the six men were arrested on gun charges. As for the 19-year-old charged for taking the bus without reason, she said police asked him on consecutive days to not loiter at a bus station. With more than 70,000 Americans dead from the coronavirus, government officials have not figured out how to balance the threat of COVID-19 with the harms of over policing, Clarke said. “On the one hand, we want to beat back the pandemic. That’s critical. That’s the end goal,” she told ProPublica. “On the other hand, we’re seeing social distancing being used as a pretext to arrest the very communities that have been hit hardest by the virus.” Full Article
is I’m an Investigative Journalist. These Are the Questions I Asked About the Viral “Plandemic” Video. By tracking.feedpress.it Published On :: 2020-05-09T07:00:00-04:00 by Marshall Allen ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The links to the viral video “Plandemic” started showing up in my Facebook feed Wednesday. “Very interesting,” one of my friends wrote about it. I saw several subsequent posts about it, and then my brother texted me, “Got a sec?” My brother is a pastor in Colorado and had someone he respects urge him to watch “Plandemic,” a 26-minute video that promises to reveal the “hidden agenda” behind the COVID-19 pandemic. I called him and he shared his concern: People seem to be taking the conspiracy theories presented in “Plandemic” seriously. He wondered if I could write something up that he could pass along to them, to help people distinguish between sound reporting and conspiracy thinking or propaganda. So I watched “Plandemic.” I did not find it credible, as I will explain below. YouTube, Facebook and Vimeo have since removed it from their platforms for violating their guidelines. Now it’s available on its own site. Sensational videos, memes, rants and more about COVID-19 are likely to keep coming. With society polarized and deep distrust of the media, the government and other institutions, such content is a way for bad actors to sow discord, mostly via social media. We saw it with Russia in the 2016 election and we should expect it to continue. But what surprised me is how easily “Plandemic” sank its hooks into some of my friends. My brother also felt alarmed that his own church members and leaders in other churches might be tempted to buy into it. The purpose of this column is not to skewer “Plandemic.” My goal is to offer some criteria for sifting through all the content we see every day, so we can tell the difference between fair reporting and something so biased it should not be taken seriously. Here’s a checklist, some of which I shared with my friends on Facebook, to help interrogate any content — and that includes what we publish at ProPublica. Is the Presentation One-Sided? There’s never just one side to a story. I mentioned this point in 2018 when I wrote about my faith and the biblical basis for investigative reporting. One of my favorite Proverbs says, “The first to state his case seems right until another comes and cross-examines him.” So a fair presentation should at least acknowledge opposing points of view. I didn’t see this in “Plandemic,” so I called the filmmaker, Mikki Willis, who is also the film’s narrator, to ask him whether I had somehow missed the other side of the argument. I had not. “The other side of the argument plays 24/7 on every screen in every airport and on every phone and in every home,” Willis said. “The people are only seeing one side of the story all the time. This is the other side of the story. This is not a piece that’s intended to be perfectly balanced.” I asked Willis if it was fair to call his film “propaganda,” which the Oxford dictionary defines as “information, especially of a biased or misleading nature, used to promote or publicize a particular political cause or point of view.” He said he doesn’t feel there’s anything misleading in his film, but otherwise the definition fits. And based on that definition he feels 100% of news reporting is propaganda. “What isn’t propaganda these days?” he asked. “In that sense, what we’re doing is fighting fire with fire.” Is There an Independent Pursuit of the Truth? The star of “Plandemic,” medical researcher Judy Mikovits, is controversial. The magazine Science reports that it published and then retracted one of her papers in 2011. A search warrant provided to ProPublica by one of her former attorneys shows she was fired from her position at Whittemore Peterson Institute, a research center in Nevada, in September 2011. Then she allegedly stole notebooks and a laptop computer from the Institute, the search warrant said, leading to an arrest warrant for alleged possession of stolen property and unlawful taking of computer data. She was arrested on Nov. 18, 2011, but denied wrongdoing. The charges were dropped. But “Plandemic” ignores or brushes past these facts and portrays her as an embattled whistleblower. “So you made a discovery that conflicted with the agreed-upon narrative?” Willis says to Mikovits, introducing her as a victim. “And for that, they did everything in their powers to destroy your life.” A typical viewer is not going to know the details about Mikovits’ background. But as the primary source of controversial information being presented as fact, it’s worth an online search. The fact-checking site PolitiFact details her arrest and criminal charges. Clearly, there’s more to her story than what’s presented in “Plandemic.” That should give us pause when we assess its credibility. Is There a Careful Adherence to the Facts? In “Plandemic,” Willis asks Mikovits about her arrest: “What did they charge you with?” “Nothing,” she replies. “I was held in jail, with no charges.” Being charged with a crime is one of those concrete facts that we can check out. Science magazine reported Mikovits’ arrest and felony charge. I also found a civil lawsuit she filed against the Whittemore Peterson Institute in 2014 in the U.S. District Court for the Southern District of California. “Mikovits was arrested on criminal charges…” her complaint says in the case, which was eventually dismissed. I asked Willis about the apparent discrepancy, where she said in his film that she wasn’t charged, when court documents show that she was charged. After my inquiry, he said he spoke to Mikovits and now feels it is clear that she meant that the charges were dropped. I tracked down Mikovits and she said what she meant in the film is that there were no charges of any type of wrongdoing that would have led to her being charged with being a fugitive from justice. She admitted that all the controversy has been hard for her to sort out. “I’ve been confused for a decade,” she told me. She said she would try to be more clear in the future when she talks about the criminal charge: “I’ll try to learn to say it differently,” she said. This underscores the importance of careful verification, and it distinguishes the craft of journalism from other forms of information sharing. People often speak imprecisely when they’re telling their stories. It’s our duty to nail down precisely what they do and do not mean, and verify it independently. If we don’t, we risk undermining their credibility and ours. That’s in part why we at ProPublica and many other journalists often link directly to our underlying source documents, so you can verify the information yourself. Are Those Accused Allowed to Respond? Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is one of the nation’s leaders in the response to the coronavirus. In “Plandemic,” Mikovits accuses Fauci of a cover-up and of paying off people who perpetrate fraud, among other things. PolitiFact found no evidence to support the allegations against Fauci. Every time I write a story that accuses someone of wrongdoing I call them and urge them to explain the situation from their perspective. This is standard in mainstream journalism. Sometimes I’ve gone to extreme lengths to get comments from someone who will be portrayed unfavorably in my story — traveling to another state and showing up at their office and their home and leaving a note if they are not there to meet me. “Plandemic” doesn’t indicate whether the filmmakers reached out to Fauci for his version of the story. So I asked Willis about it. “We did not,” he told me. Are All Sources Named and Cited, and if Not, Is the Reason Explained? All sources should be identified, with their credentials, so viewers can verify their expertise or possible biases. If they can’t be for some reason, then that should be explained. “Plandemic” features unnamed people in medical scrubs, presented as doctors, saying they’re being wrongly pressured to add COVID-19 on people’s death certificates or are not being allowed to use the drug hydroxychloroquine to treat patients. But the speakers are not named, so we can’t really tell who they are, or even if they are doctors at all. That makes it impossible to tell if they are credible. I asked Willis why he didn’t name those people. He told me he was in a hurry to release the 26-minute version of “Plandemic,” but the doctors will be named in the final version. “We should have done that,” he said. Does the Work Claim Some Secret Knowledge? “Plandemic” calls itself a documentary that reveals “the hidden agenda behind COVID-19.” We are in the midst of a global pandemic where few people in the world can figure out what is happening or the right way to respond, let alone agendas. We have almost every journalist in the country writing about this. And if the truth about a conspiracy is out there, many people have an incentive to share it. But “Plandemic” would like us to think it’s presenting some exclusive bit of secret knowledge that is going to get at the real story. That’s not likely. Plus, to be honest, there were so many conspiratorial details stacked on top of each other in the film I couldn’t keep them straight. When I spoke to Willis I told him I was having a hard time understanding his point. Then I took a stab at what I thought was the main thrust of his argument. “Are you saying that powerful people planned the pandemic and made it happen so they could get rich by making everyone get vaccines?” I asked. It turns out Willis isn’t sure either. “We’re in the exploratory phase,” he told me. “I don’t know, to be clear, if it’s an intentional or naturally occurring situation. I have no idea.” Then he went on to say that the pandemic is being politicized and used to take away our civil liberties and leverage other political policies. “Certain forces” have latched onto the situation, he said. “It’s too fishy.” He had me at, “I have no idea.” That sums it up. This is a vast pandemic and massive catastrophe. Our country wasn’t prepared for it, and the response by our top leaders has been disjointed. We’re restricted to our homes. Many people have lost their jobs and some are afraid or sick or dying. That makes us vulnerable to exploitation by people who will present inaccurate or intellectually dishonest information that promises to tell us the truth. Perhaps “Plandemic” is guilty of sloppy storytelling, or maybe people really do believe the things they’re saying in the video. Or perhaps they’re being intentionally dishonest, or it’s a biased connecting of the dots rooted in personal and professional grievances. I don’t know because I can’t get inside their heads to judge their motives. Ultimately, we’re all going to need to be more savvy consumers when it comes to information, no matter how slickly it’s presented. This may be but a signal of what’s to come in the run-up to the 2020 presidential election, when memes and ads of unknown origin come across our social media feeds. There are standards for judging the credibility of the media we take in every day, so let’s apply them. Full Article
is Temple RA/QA Advertising Course By regulatoryrx.blogspot.com Published On :: Mon, 27 Jan 2020 14:41:00 +0000 It was just confirmed that I'll be teaching in Temple University's RA/QA MS program this spring. Specifically, I'll be teaching the ad-promo course.If you or anyone you know is interested, please reach out to me for information. The course will be taught out of the Fort Washington campus, but online enrollment is permitted.Here's the complete schedule of classes for the spring. Full Article RAQA teaching Temple University
is Pharmacies' dispensing increases by up to a third as a result of COVID-19, survey finds By feeds.pjonline.com Published On :: Tue, 21 Apr 2020 15:22 GMT Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association. To read the whole article click on the headline Full Article
is One in three pharmacists unable to access PPE, finds RPS survey By feeds.pjonline.com Published On :: Wed, 22 Apr 2020 14:05 GMT A third of pharmacists cannot obtain continuous supplies of personal protective equipment, according to a survey conducted by the Royal Pharmaceutical Society. To read the whole article click on the headline Full Article
is Myocardial injury associated with increased risk of death from COVID-19, research suggests By feeds.pjonline.com Published On :: Thu, 23 Apr 2020 11:37 GMT The development of myocardial injury in COVID-19 patients is associated with an increased risk of death, researchers have found. To read the whole article click on the headline Full Article
is Care home pharmacists redeployed, despite COVID-19 palliative care increase By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 10:22 GMT Exclusive: Pharmacy staff in care homes are being redeployed to cover other roles during the COVID-19 pandemic, even though demands on care homes are increasing rapidly, The Pharmaceutical Journal has learnt. To read the whole article click on the headline Full Article
is Pharmacists will not be automatically included in government COVID-19 life assurance scheme By feeds.pjonline.com Published On :: Tue, 28 Apr 2020 16:21 GMT Pharmacists will not be automatically eligible for a new government life assurance scheme for healthcare workers in England who die from COVID-19 during the pandemic. To read the whole article click on the headline Full Article
is Transcending boundaries: the role of pharmacists in gender identity services By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 14:42 GMT There has been a surge in demand for gender identity services in the UK over the past five years. Although the current role of pharmacists is limited, their potential contribution within a multidisciplinary team supporting transgender patients is beginning to emerge. To read the whole article click on the headline Full Article
is Community pharmacists will now be included in COVID-19 death-in-service scheme By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 15:30 GMT Community pharmacists are to be included in the government life assurance scheme for staff working on the frontline of the COVID-19 pandemic, the health secretary, Matt Hancock has announced. To read the whole article click on the headline Full Article
is NHS England advises pharmacies to 'risk assess' BAME staff for susceptibility to COVID-19 By feeds.pjonline.com Published On :: Wed, 6 May 2020 12:29 GMT NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background. To read the whole article click on the headline Full Article
is In Surprise Move, SCOTUS to Rule on Constitutionality of ACA Next Term By cohealthcom.org Published On :: Wed, 04 Mar 2020 22:22:16 +0000 March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […] Full Article Courts/First Amendment ACA Affordable Care Act Jon Bigelow sunshine act Supreme Court U.S. Supreme Court
is Rising Leaders Conference Set for Nov. 18-19: Reserve Your Place Today! By cohealthcom.org Published On :: Thu, 12 Mar 2020 16:23:00 +0000 March 12, 2020 —[Note: Due to the coronavirus epidemic, the Conference has been rescheduled from May.] Healthcare was already the top issue for voters—and the coronavirus pandemic only intensifies the focus heading into a hotly-contested election. Both parties want to “do something” about the cost of healthcare and especially drug prices, and what happens when […] Full Article CHC News
is Emergency Relief Package Yields Increased FDA Funding, OTC Revisions By cohealthcom.org Published On :: Mon, 30 Mar 2020 16:04:19 +0000 March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […] Full Article Legislative Congress Coronavirus COVID-19 emergency relief fda funding Jon Bigelow OTC regulation OTC user fees President Trump sunscreen
is CHC Endorses Request Calling for Veto of Maryland Tax on Digital Advertising By cohealthcom.org Published On :: Mon, 06 Apr 2020 19:23:10 +0000 April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […] Full Article Legislative chc coalition for healthcare communication digital advertising Gov. Larry Hogan HB 732 Jon Bigelow Maryland the advertising coalition
is FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims By cohealthcom.org Published On :: Mon, 13 Apr 2020 19:38:22 +0000 April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […] Full Article Regulatory/FDA clinical trials COVID-19 FDA FDA approval process FDA enforcement FTC Jon Bigelow promoting unapproved drug unapproved drug Warning Letter