Climate Change: Springtime in NYC: First a Snow Storm, then Sun and Flowers

 

The photo below was taken in the front gardens of our building in NYC showing the crocuses pushing through.

 

On this same morning we had a very cold snow storm, but by the time I was coming home in the afternoon, the sun was out and crocuses blooming.

 

First 2017 crocuses blooming in our front garden. © Joyce Hays, Target Health Inc.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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Sharing Patient Records Is Still a Digital Dilemma

Structure and basic components of the Austrian Electronic Health Records (ELGA)Source: Sebastian 19781, the copyright holder of this work, hereby publish it under the following licenses: Creative Commons Attribution-Share Alike 3.0 Unported license.

 

Privacy and Security, are still important issues connected with Electronic Health Records (EHR). EHRs allow providers to use information more effectively to improve the quality and efficiency of your care, but EHRs do not change the privacy protections or security safeguards that apply to health information. EHRs Personal Health Records (PHR) are electronic versions of the 1) ___ charts in doctor’s or other health care provider’s offices. An EHR may include one’s medical history, notes, and other information about one’s health including symptoms, diagnoses, medications, lab results, vital signs, immunizations, and reports from diagnostic tests such as x-rays. The information in EHRs can be shared with other organizations if the computer systems are set up to talk to each other. Information in these records should only be shared for purposes authorized by law or by individuals. There are privacy rights whether information is stored as a paper record or stored in an electronic form. The same federal laws that already protect health information also apply to information in EHRs.

 

As health care providers begin to use EHRs and set up ways to securely share health information with other providers, it will make it easier for everyone to work together to make sure that one gets the care they need. For example: Information about medications will be available in EHRs so that health care providers don’t perscribe another 2) ___ that might be harmful. EHR systems are backed up like most computer systems, so health information can be retrieved in the vent of a computer shutdown. EHRs can also be available in an emergency. If one is involved in an accident and are non-verbal, a hospital could retrieve personal information so decisions about emergency care can be faster and more informed. Doctors using EHRs may find it easier or faster to track lab results and share progress with patients. If doctors’ systems can share information, one doctor can see test results from another 3) ___, so the test doesn’t always have to be repeated. Especially with x-rays and certain lab tests, this means one is at less risk from radiation and other side effects. When tests are not repeated unnecessarily, it also means care costs less.

 

Most of us feel that our health information is private and should be protected. The federal government put in place the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to ensure one has rights over one’s own health information, no matter what form it is in. The government also created the HIPAA Security Rule to require specific protections to safeguard electronic health information. A few possible measures that can be built in to EHR systems may include: “Access control“ tools like passwords and PIN numbers, to help limit access to authorized individuals. Encrypting stored information means health information cannot be read or understood except by those using a system that can decrypt it with a “key.“ An audit trail feature, which records who accessed information, what changes were made and when. Finally, federal law requires doctors, hospitals, and other health care providers to notify patients of any breach. The law also requires the health care provider to notify the Secretary of Health and Human Services if a breach affects more than 500 residents of a state or jurisdiction. In that case, the health care provider must also notify media outlets serving the state or jurisdiction. This requirement helps patients know if something has gone wrong with the protection of their information and helps keep providers accountable for EHR protection.

 

How can electronic health records (EHR) and regulations be designed to positively affect doctors’ practices? The meaningful use program has been successful in “forcing the adoption of EHRs but they weren’t ready for prime time,“ said AMA President Steven J. Stack, MD, recently, during a town hall meeting on EHRs at the Swedish Medical Center in Seattle. This is the third AMA town hall on EHRs and was co-hosted by the Washington State Medical Association (WSMA). The focus of this special session was: What is wrong with current EHRs and how they could be designed to benefit physicians in practice. Earlier this month Centers for Medicare & Medicaid Services Acting Administrator Andy Slavitt said the agency is changing its culture to focus more on listening to physician needs and will implement better policy in place of the meaningful use program when the new streamlined Medicare reporting program is created. With this statement, there’s never been a better time to speak up and offer constructive solutions to regulatory missteps that have stolen time from physicians that they would rather have spent with patients.

 

Taking control: Regulations should not hinder care of 4) ___.

 

As it did in Boston and Atlanta last year, the physician voice resounded through Seattle during Tuesday night’s town hall, emphasizing that EHR design should be focused on usability and interoperability and the physician voice must be heard. “Administrative burdens are strangling medical practice and creating unnecessary and costly inefficiencies in health care delivery while adding stress to physicians and their teams,“ said WSMA president Ray Hsiao, MD, kicking off the discussion. “It can make a cynic out of the happiest people and can lead to discouragement, professional dissatisfaction and burnout, and even drive 5) ___ to leave the profession. We cannot let that happen.“ Regulations force physicians to do “a lot of busy work that has nothing to do with the quality of care we provide,“ said Jane Fellner, MD, a primary care physician at the University of Washington School of Medicine. “It needs to stop.“

 

How we can make EHRs more functional in practice

 

Speaking to what they really need from these tools to help them in their practices, many physicians offered solutions and suggestions for how 6) ___ should work for the end-users who depend on them daily. Interoperability proved top of mind as the current EHRs struggle to communicate. “My EHR does not necessarily have the tools to interoperate well with other EHRs,“ Dr. Fellner said. “But within the universe of the other medical centers who use the same software – it is magic. I can import an entire record from Florida in 20 seconds.“ If all EHRs could talk to each other in this way, it would have a very positive effect on the way physicians treat patients nationally, she said. “It has revolutionized the care I provide.“ Another focus for improvement during the discussion was the need for more data usage focused on population health to show physicians how their patients’ health compares to national trends. “What we don’t see is our information going in to create this big picture that we can then [see] in real time,“ said Reena Koshy, MD, a family physician in Seattle. This capability is currently available but not to everyone using EHRs. Dr. Koshy said it would be very helpful if national patient data coordination were available to all practices. Thomas Payne, MD, medical director of information technology services at the University of Washington School of Medicine and board chair of the American Medical Informatics Association, said he uses his EHR in every patient visit. “We need to address documentation because that is the source of a lot of unnecessary new time that [we] spend,“ he said. “Natural language processing is a great example. As we speak, as we are this evening we can use that same capability to communicate in the medical record and be able to record what kinds of care people have received.“ “When you’re searching for billing 7) ___, you have to type it exactly correct or it boots it out,“ said Carrie Horwitch, MD, a primary care physician in Seattle. She suggested physicians could work much more efficiently if EHRs had the same kind of spell-check and search option drop-down menus as Internet search engines.

 

U.S. taxpayers have poured $30 billion into funding electronic records systems in hospitals and doctors’ offices since 2009. But most of those systems still can’t talk to each other, which makes transfer of medical information tough. Technology entrepreneur Jonathan Bush says he was recently watching a patient move from a hospital to a nursing home. The patient’s information was in an electronic medical record, or EMR. And getting the patient’s records from the hospital to the nursing home, Bush says, wasn’t exactly drag and drop. “These two guys then type – I kid you not – the printout from the brand new EMR into their EMR, so that their fax server can fax it to the bloody nursing home,“ Bush says. We should be working off the same set of standards,“ says Dr. Karen DeSalvo, coordinator for information technology, Department of Health and 8) ___ Services. In an era when most industries easily share big, complicated, digital files, health care still leans hard on paper printouts and fax machines. The American taxpayer has funded the installation of electronic records systems in hospitals and doctors’ offices – to the tune of $30 billion since 2009. While those systems are supposed to make health care better and more efficient, most of them can’t talk to each other. Bush lays a lot of blame for that at the feet of this federal financing. “I called it the ?Cash for Clunkers’ bill,“ he says. “It gave $30 billion to buy the very pre-internet systems that all of the doctors and hospitals had already looked at and rejected,“ he says. “And the vendors of those systems were about to die. And then they got put on life support by this bill that pays you billions of dollars, and didn’t get you any coordination of information!“ Bush’s assessment is colored by the fact that the company he runs – AthenaHealth – is cloud-based, and stresses easily sharing electronic health records. The firm also got a lot of the federal cash. Dr. Robert Wachter, with the University of California, San Francisco, says sure – in hindsight, the government could have mandated that stimulus money be spent only on software that made sharing information easy. But, he says, “I think the right call was to get the systems in. Then to toggle to, OK, now you have a computer, now you’re using it, you’re working out some of the kinks. The next thing we need to do is to be sure all these systems 9) ___ to each other.“ Right now, the ability of the systems to converse is at about a 2 or 3 on a scale of 0 to 10, Wachter and Bush agree. Wachter is about to publish The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age, a book that assesses the value of information technology in health care. Up until now, he says, there has actually been a financial dis-incentive for doctors and hospitals to share information. For example, if a doctor doesn’t have a patient’s record immediately available, the doctor may order a test that has already been done – and can bill for that test. Keeping EMRs from talking to each other also makes it easier to keep patients from taking their medical records – and their business – to a competing doctor. It’s time for that to change, says Dr. Karen DeSalvo, the federal government’s health IT coordinator.

 

The billions of dollars a year the government pays to doctors, hospitals and other institutions for patients enrolled in Medicare is a pretty good motivator. Already, 10) ___ is starting to increase pay to doctors and hospitals that work together to streamline care and avoid duplicative tests, and to penalize those that don’t. Winning the new payments and avoiding the penalties increasingly require proving that all of a patient’s doctors, no matter where they are, are working together. That requires using good electronic records that can seamlessly move from one system to the next. Wachter says that consumers are now demanding better health information technology, too – “because we’re all used to our app stores and we know how magical it can be when core IT platforms invite in a number of apps.“ “So I think,“ he says, “that even the vendors and healthcare delivery organizations that have been fighting interoperability recognize it’s the future.“ He says a lot of IT companies are now eager come up with software that meets the demands of the health care industry and consumers. About a dollar of every $6 in the U.S. economy is spent on health care. A new IT boom in that sector means there are billions of dollars to be made.

 

The effort to change meaningful use and fix EHRs

 

Early last year, the Medicare Access and CHIP Reauthorization Act of 2015 repealed the sustainable growth rate formula and called for the new Merit-Based Incentive Payment System (MIPS), which is intended to sunset the three existing reporting programs and streamline them into a single program. The AMA and 100 state and specialty medical associations recently submitted 10 principles to guide the foundation of the MIPS, and the AMA provided detailed comments (log in) as part of its ongoing efforts on this issue and submitted a detailed framework for what needs to change. The AMA and MedStar Health’s National Center for Human Factors in Healthcare last year developed an EHR User-Centered Design Evaluation Framework to compare the design and testing processes for optimizing EHR usability. Visit BreakTheRedTape.org, the AMA’s grassroots campaign to advocate for ways to solve medicine’s regulatory and legislative challenges.

 

Sources: NPR’s reporting partnership with Montana Public Radio and Kaiser Health News; www.hhs.gov/ocr/privacy/

 

ANSWERS: 1) paper; 2) medicine; 3) doctor; 4) patients; 5) physicians; 6) EHRs; 7) codes; 8) Human; 9) talk; 10) Medicare

 

Stephan Wolfram (1959 to Present)

Stephen Wolfram at home. Source: Wikipedia

 

Target Health Inc. is an eCRO, that creates software for clinical trials and is interested in how Big Data is sorted through, especially for application to medical research, and clinical trials.

 

Wolfram Alpha (also: WolframAlpha and Wolfram|Alpha) is a computational knowledge engine or answer engine developed by Wolfram Research, which was founded by Stephen Wolfram. Stephen Wolfram is a brilliant computer scientist/physicist who thinks about the world and its issues, in a very Big way. Wolfram Research is an online service that answers factual queries directly by computing the answer from externally sourced “curated data“, rather than providing a list of documents or web pages that might contain the answer as a search engine might. Wolfram Alpha, which was released on May 18, 2009, is based on Wolfram’s earlier flagship product Wolfram Mathematica, a computational platform or toolkit that encompasses computer algebra, symbolic and numerical computation, visualization, and statistics capabilities. Additional data is gathered from both academic and commercial websites such as the CIA’s The World Factbook, the United States Geological Survey, a Cornell University Library publication called All About Birds, Chambers Biographical Dictionary, Dow Jones, the Catalogue of Life, CrunchBase, Best Buy,the FAA and optionally a user’s Facebook account.

 

Stephen Wolfram (born 29 August 1959) is a British-American computer scientist, physicist, and businessman. He is known for his work in computer science, mathematics, and in theoretical physics. He is the author of the book A New Kind of Science. In 2012 he was named an inaugural fellow of the American Mathematical Society. His recent work has been on knowledge-based programming, expanding and refining the programming language of Mathematica into what is now called the Wolfram Language. His book An Elementary Introduction to the Wolfram Language appeared in 2015 and Idea Makers appeared in 2016.

 

Stephen Wolfram was born in London in 1959 to Hugo and Sybil Wolfram. Wolfram’s father, Hugo Wolfram (1925-2015), a textile manufacturer born in Bochum, Germany, served as managing director of the Lurex Company, makers of the fabric Lurex, and was the author of three novels. He emigrated to England in 1933. When World War II broke out, young Hugo left school at 15 and subsequently found it hard to get a job since he was regarded as an “enemy alien.“ As an adult, he took correspondence courses in philosophy and psychology. Wolfram’s mother, Sybil Wolfram (1931-1993) was a Fellow and Tutor in philosophy at Lady Margaret Hall at University of Oxford from 1964 to 1993. She published two books, Philosophical Logic: An Introduction (1989) and In-laws and Outlaws: Kinship and Marriage in England (1987). She was the daughter of criminologist and psychoanalyst Kate Friedlander (1902-1949), an expert on the subject of juvenile delinquency, and the physician Walter Misch (1889-1943) who, together, wrote Die vegetative Genese der neurotischen Angst und ihre medikament?se Beseitigung. After the Reichstag fire in 1933, she emigrated from Berlin, Germany to England with her parents and Jewish psychoanalyst, Paula Heimann (1899-1982).

 

As a young child, Wolfram initially struggled in school and had difficulties learning arithmetic. At the age of 12, he wrote a dictionary on physics. By 13 or 14, he had written three books on particle physics. They were not published. Wolfram was a wunderkind. By age 15, he began research in applied quantum field theory and particle physics and published scientific papers. Topics included matter creation and annihilation, the fundamental interactions, elementary particles and their currents, hadronic and leptonic physics, and the parton model, published in professional peer-reviewed scientific journals including Nuclear Physics B, Australian Journal of Physics, Nuovo Cimento, and Physical Review D. Working independently, Wolfram published a widely cited paper on heavy quark production at age 18 and nine other papers. He continued to do research and to publish on particle physics into his early twenties. Wolfram’s work with Geoffrey C. Fox on the theory of the strong interaction is still used in experimental particle physics.

 

He was educated at Eton College, but left prematurely in 1976. He entered St. John’s College, Oxford at age 17 but found lectures “awful“, and left in 1978 without graduating to attend the California Institute of Technology, the following year, where he received a PhD in particle physics on November 19, 1979 at age 20. Wolfram’s thesis committee was composed of Richard Feynman, Peter Goldreich, Frank J. Sciulli and Steven Frautschi, and chaired by Richard D. Field. A 1981 letter from Feynman to Gerald Freund giving reference for Wolfram for the MacArthur grant appears in Feynman’s collective letters, Perfectly Reasonable Deviations from the Beaten Track. Following his PhD, Wolfram joined the faculty at Caltech and became the youngest recipient of the MacArthur Fellowships in 1981, at age 21. In 1983, Wolfram left for the School of Natural Sciences of the Institute for Advanced Study in Princeton, where he conducted research into cellular automata, mainly with computer simulations. He produced a series of papers systematically investigating the class of elementary cellular automata, conceiving the Wolfram code, a naming system for one-dimensional cellular automata, and a classification scheme for the complexity of their behavior. He conjectured that the Rule 110 cellular automaton might be Turing complete.

 

A 1985 letter, from Feynman to Wolfram, also appears in Feynman’s letters. In it, in response to Wolfram writing to him that he was thinking about creating some kind of institute where he might study complex systems, Feynman tells Wolfram, “You do not understand ordinary people,“ and advises him “find a way to do your research with as little contact with non-technical people as possible.“ In the mid-1980s, Wolfram worked on simulations of physical processes (such as turbulent fluid flow) with cellular automata on the Connection Machine alongside Richard Feynman and helped initiate the field of complex systems, founding the first institute devoted to this subject, The Center for Complex Systems Research (CCSR) at the University of Illinois at Urbana-Champaign and the journal Complex Systems in 1987. Wolfram led the development of the computer algebra system SMP (Symbolic Manipulation Program) in the Caltech physics department during 1979-1981. A dispute with the administration over the intellectual property rights regarding SMP – patents, copyright, and faculty involvement in commercial ventures – eventually caused him to resign from Caltech. SMP was further developed and marketed commercially by Inference Corp. of Los Angeles during 1983-1988. In 1986 Wolfram left the Institute for Advanced Study for the University of Illinois at Urbana-Champaign where he founded their Center for Complex Systems Research and started to develop the computer algebra system Mathematica, which was first released in 1988, when he left academia. From 1992 to 2002, Wolfram worked on his controversial book A New Kind of Science,which presents an empirical study of very simple computational systems. Additionally, it argues that for fundamental reasons these types of systems, rather than traditional mathematics, are needed to model and understand complexity in nature. Wolfram’s conclusion is that the universe is digital in its nature, and runs on fundamental laws which can be described as simple programs. He predicts that a realization of this within the scientific communities will have a major and revolutionary influence on physics, chemistry and biology and the majority of the scientific areas in general, which is the reason for the book’s title. Since the release of the book in 2002, Wolfram has split his time between developing Mathematica and encouraging people to get involved with the subject matter of A New Kind of Science by giving talks, holding conferences, and starting a summer school devoted to the topic.

 

In March 2009, Wolfram announced Wolfram|Alpha, an answer engine. Wolfram|Alpha later launched in May 2009, and a paid-for version with extra features launched on February 2012. The engine is based on natural language processing and a large library of algorithms, and answers queries using the approach described in A New Kind of Science. The application programming interface allows other applications to extend and enhance Alpha. Wolfram believes that as Wolfram Alpha comes into common use, “It will raise the level of scientific things that the average person can do.“ Wolfram|Alpha is one of the answer engines behind Microsoft’s Bing and Apple’s Siri answering factual questions. In June 2014, Wolfram officially announced the Wolfram Language as a new general multi-paradigm programming language. The documentation for the language was pre-released in October 2013 to coincide with the bundling of Mathematica and the Wolfram Language on every Raspberry Pi computer. While the Wolfram Language has existed for over 25 years as the primary programming language used in Mathematica, it was not officially named until 2014. Wolfram’s son, Christopher Wolfram, appeared on the program of SXSW giving a live-coding demonstration using Wolfram Language and has blogged about Wolfram Language for Wolfram Research. On 8 December 2015, Wolfram published the book “An Elementary Introduction to the Wolfram Language“ to introduce people with no knowledge of programming to the Wolfram Language and the kind of computational thinking it allows. Both Stephen Wolfram and Christopher Wolfram were involved in helping create the alien language for the film Arrival, for which they used the Wolfram Language. The significance that data has on the products Stephen creates transfers into his own life. He has an extensive log of personal analytics, including emails received and sent, key strokes made, meetings and events attended, phone calls, even physical movement dating back to the 1980s. He has stated “[personal analytics] can give us a whole new dimension to experiencing our lives“.

Sources: Wikipedia; Edge.org

 

Click here to read a short piece by Stephan Wolfram, written beautifully with great clarity, about his vision of artificial intelligence and how humans should deal with it, through a shared language, through personal analytics and more. To know more about shared language, all humans should read, the recently published: An Elementary Introduction to the Wolfram Language. If you saw the Academy Award nominee, Arrival, you would have heard a version of this shared language, which a human linguist, is finally able to understand.

 

Beauty is truth, truth beauty, – that is all

Ye know on earth, and all ye need to know.’

John Keats

 

TED talk by Stephan Wolfram Computing a Theory of Everything

 

Chimpanzee Adenovirus Vector Ebola Vaccine

 

The unprecedented 2014 epidemic of Ebola virus disease (EVD) prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant chimpanzee adenovirus type 3-vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species, that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation.

 

As a result, in a study published in the New England of Medicine (2017; 376:928-938), enrolled 20 healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2×1010 particle units or 2×1011 particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 8 weeks after vaccination; in addition, longer-term vaccine durability was assessed at 48 weeks after vaccination.

 

While no safety concerns were identified, transient fever developed within 1 day after vaccination in two participants who had received the 2×1011 particle-unit dose. Glycoprotein-specific antibodies were induced in all 20 participants; the titers were of greater magnitude in the group that received the 2×1011 particle-unit dose than in the group that received the 2×1010 particle-unit dose (geometric mean titer against the Zaire antigen at week 4, 2037 vs. 331; P=0.001). Glycoprotein-specific T-cell responses were more frequent among those who received the 2×1011 particle-unit dose than among those who received the 2×1010 particle-unit dose, with a CD4 response in 10 of 10 participants versus 3 of 10 participants (P=0.004) and a CD8 response in 7 of 10 participants versus 2 of 10 participants (P=0.07) at week 4. Assessment of the durability of the antibody response showed that titers remained high at week 48, with the highest titers in those who received the 2?1011particle-unit dose.

 

According to the authors, reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. At the 2?1011 particle-unit dose, glycoprotein Zaire-specific antibody responses were in the range reported to be associated with vaccine-induced protective immunity in challenge studies involving nonhuman primates, and responses were sustained to week 48. Phase 2 studies and efficacy trials assessing cAd3-EBO are in progress.

 

Blood-based NfL: A Biomarker for Differential Diagnosis of Parkinsonian Disorder

 

In order t0 improve the diagnostic workup of parkinsonian disorders, a study published online in Neurology (2017; 88:930-937), was performed to determine if blood neurofilament light chain (NfL) protein can discriminate between Parkinson disease (PD) and atypical parkinsonian disorders (APD) with equally high diagnostic accuracy as CSF NfL.

 

The study included 3 independent prospective cohorts: the Lund (n = 278) and London (n = 117) cohorts, comprising healthy controls and patients with PD, progressive supranuclear palsy (PSP), corticobasal syndrome (CBS), and multiple system atrophy (MSA), as well as an early disease cohort (n = 109) of patients with PD, PSP, MSA, or CBS with disease duration <3 years. Blood NfL concentration was measured using an ultrasensitive single molecule array (Simoa) method, and the diagnostic accuracy to distinguish PD from APD was assessed.

 

Results found strong correlations between blood and CSF concentrations of NfL (? > 0.73-0.84, p < 0.001). Blood NfL was increased in patients with MSA, PSP, and CBS (i.e., all APD groups) when compared to patients with PD as well as healthy controls in all cohorts (p < 0.001). Furthermore, in the Lund cohort, blood NfL could accurately distinguish PD from APD (area under the curve [AUC] 0.91) with similar results in both the London cohort (AUC 0.85) and the early disease cohort (AUC 0.81).

 

According to the authors, quantification of blood NfL concentration can be used to distinguish PD from APD, and that blood-based NfL might consequently be included in the diagnostic workup of patients with parkinsonian symptoms in both primary care and specialized clinics.

 

Mutual Recognition Promises New Framework for Pharmaceutical Inspections for United States and European Union

 

The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities. The amended agreement ?represents the culmination of nearly three years of U.S. FDA and EU cooperation as part of the Mutual Reliance Initiative and will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.

 

In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which gave the FDA authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements. Since May 2014, the FDA and the EU have been collaborating to evaluate the way they each inspect drug manufacturers and assessing the risk and benefits of mutual recognition of drug inspections. The FDA was invited to observe the EU’s Joint Audit Programme, in which two EU nations audit the inspectorate – the regulatory authority – of another EU country. The FDA first observed the audit of Sweden’s inspectorate by auditors from the United Kingdom and Norway. Since then, the FDA has observed 13 additional audits of drug inspectorates across the EU with more audit observations planned through 2017.

 

Smoked Paprika Hummus with Warm Pita or Flatbread

Several years ago, our son, Alex, introduced us to one of Manhattan’s best gourmet vegan restaurants, Candle79.  We all go for dinner there, each time he comes to Manhattan . We all love it, by the way. Our strategy at Candle79 (on East 79th Street), is to have 3 or 4 courses, each ordering something different – and sharing. This way, we all get to sample a wide variety of what this inventive restaurant offers. For the appetizer course, one of the dishes was “Smoked Paprika Hummus.“ This and a few other items on the menu, which we ordered, were so-o delicious, that I bought one of the restaurant’s cookbooks in order to try their recipes out at home. The recipes are not that difficult. We want to share with our readers, Candle79‘s “Smoked Paprika Hummus“ recipe, exactly as it appears in their cookbook.

 

Ingredients

1 cup dried chickpeas, or 2 (15.5-ounce) cans chickpeas, drained and rinsed (I use the canned chickpeas)

2 large cloves garlic, minced

1 teaspoon freshly squeezed lemon juice

1/4 teaspoon cayenne pepper

2 teaspoons smoked paprika, plus more for garnish

1/2 teaspoon sea salt (I don’t use the salt)

1/2 teaspoon freshly ground pepper

2 Tablespoons finely chopped fresh flat-leaf parsley (I also like to use cilantro instead of parsley, for a change of pace)

1/3 cup extra-virgin olive oil, plus more for garnish

1/3 cup tahini

Optional garnishes: roasted red bell peppers, roasted garlic, lemon slices, olives, mint or parsley sprigs

 

Instructions 

If using dried chickpeas, put them in a saucepan or bowl and add cold water to cover by about 2 inches. Soak in the refrigerator for at least 6 hours or overnight. Drain and rinse.

Put the chickpeas in a saucepan and add cold water to cover by about 2 inches. Bring to a boil, decrease the heat, cover, and simmer until the chickpeas are tender, 50 to 60 minutes. Drain and let cool, reserving 1/4 to 1/2 cup of the cooking water.

Combine the chickpeas, garlic, lemon juice, cayenne, paprika, salt, pepper, parsley, olive oil, and tahini in a bowl and stir to mix well. Transfer the mixture to a food processor fitted with the metal blade and process until well mixed. Add 1/4 cup of the reserved cooking liquid (or water or vegetable stock if using canned chickpeas) and process until smooth and almost fluffy. Add more liquid if necessary. Scrape down the sides of the bowl once or twice. Transfer to a serving bowl and refrigerate for at least 1 hour. (The hummus can be made up to 3 days ahead and refrigerated. Return to room temperature before serving.)

To serve, drizzle a bit of olive oil over the hummus and sprinkle a bit of paprika. Serve with desired garnishes.

 

Some of the ingredients — Serve with warm pita bread

 

In the food processer

 

 

Try stuffing chunks of cucumber with this paprika hummus, or mushrooms or deviled eggs.

 

On an informal Sunday night at home, we find that this hummus is so good, we heat up some pita bread, break out a bottle of our favorite white wine, and just sit at our kitchen table, with raw carrot, celery, and cucumber sticks (and a few olives) and eat this delicious repast with total satisfaction. Sorta like a picnic at home.

 

See below the wine we enjoyed with the paprika humus.

 

Orvieto is a lovely light Italian white wine that we usually drink in the summer, but it went well with the paprika hummus  For dessert we had fresh mango spears and fresh blueberries.

 

From Our Table to Yours !

 

Bon Appetit!