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April 15, 2019Target Healthy Eating
1 large head cauliflower, broken into florets
2 heaping Tablespoons fresh thyme, well chopped
1 large onion, chopped
2 and 1/2 Tablespoons unsalted butter, for cooking and oiling baking dish
3 anchovy fillets ground in mortar & pestle with 3 fresh garlic cloves
2 Tablespoons chickpea flour
1 cup heavy cream
1 heaping Tablespoon black mustard seeds, toasted
1 jalapeno, seeded, then chopped well
3/4 cup grated Gruy?re cheese
1/2 cup grated fontina cheese
7 additional fresh garlic cloves, sliced
1 pinch chili flakes
1 pinch black pepper
1 teaspoon turmeric
1/4 cup panko flakes
1 teaspoon curry
1 teaspoon cardamom
2 Tablespoons Parmesan, grated in your kitchen
1 Tablespoon olive oil
1. Preheat oven to 375- 400 degrees
2. Butter a large 2 to 3-quart glass baking dish.
3. Do all your chopping, slicing grinding, toasting now.
4. Transfer to a colander to drain and cool.
5. In a small saucepan, melt 2 Tablespoons butter over medium flame. Stir in the chickpea flour until you get a pale yellow paste. Figure about 2 minutes.
6. Next, stir in the heavy cream, anchovy/garlic paste, additional garlic, jalapeno and chili flakes. Let this mixture come to a simmer, stirring for about 3 minutes, until it thickens.
7. Remove the saucepan from the stove, stir in half the Gruy?re and half the fontina. Stir until well combined.
8. With paper towels, pat the cauliflower dry.
9. Put all of the cauliflower into the buttered baking dish. Then pour all of the cheesy sauce over the cauliflower and stir to coat.
10. In a small bowl, add the rest of the cheese, toasted mustard seeds, turmeric, curry, cardamom, and stir these ingredients together.
11. Top the casserole with the ingredients from the small bowl and bake for about 20 minutes. Bake until the casserole bubbles a little and turns golden.
12. While casserole is baking, get out another small bowl. Add the panko flakes, chopped fresh thyme, and the extra virgin olive oil. Stir well to combine.
13. Check oven to see if the casserole has turned golden. When it does, add all of the panko mixture over the top of the curry.
14. Put the casserole back into the oven. Bake for another 8 to 10 minutes, until the topping gets crisp, which is what you want.
15. Remove from oven and allow your cauliflower curry to cool down a bit (5 minutes or so) before you serve it
Serve with rice, quinoa, pasta, noodles, seafood, fish, poultry, lamb.
Or serve as an entree with a crisp salad, baguettee and a chilled glass of your favorite white wine.
From Our Table to Yours
Have a Great Week Everyone!
April 15, 2019Regulatory
The most common type of bladder cancer is transitional cell carcinoma, also called urothelial carcinoma. Bladder cancers are associated with genetic mutations that are present in the patient's bladder or entire urothelium (the lining of the lower urinary tract). Bladder cancer is the sixth most common cancer in the United States. Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer.
The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa using an FDA-approved companion diagnostic device.
The efficacy of Balversa was studied in a clinical trial that included 87 patients with locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations, that had progressed following treatment with chemotherapy. The overall response rate in these patients was 32.2%, with 2.3% having a complete response and almost 30% having a partial response. The response lasted for an average of approximately five-and-a-half months. About a quarter of patients in the study were previously treated with anti PD-L1/PD-1 therapy, which is a standard treatment for patients with locally advanced or metastatic bladder cancer. Responses to Balversa were seen in patients who had previously not responded to anti PD-L1/PD-1 therapy.
Common side effects reported by patients taking Balversa were increased phosphate level, mouth sores, feeling tired, change in kidney function, diarrhea, dry mouth, nails separating from the bed or poor formation of the nail, change in liver function, low salt (sodium) levels, decreased appetite, change in sense of taste, low red blood cells (anemia), dry skin, dry eyes and hair loss. Other side effects include redness, swelling, peeling or tenderness on the hands or feet (hand foot syndrome), constipation, stomach pain, nausea and muscle pain. Balversa may cause serious eye problems, including inflamed eyes, inflamed cornea (front part of the eye) and disorders of the retina, an internal part of the eye. Patients are advised to have eye examinations intermittently and to tell their health care professional right away if they develop blurred vision, loss of vision or other visual changes. Health care professionals are advised to check patients' blood phosphate level between 14 and 21 days after starting treatment and monthly, and to increase the dose Balversa in patients whose serum phosphate is below the target level.
Health care professionals are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment with Balversa and for one month after the last dose. Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with Balversa. Women who are pregnant or breastfeeding should not take Balversa because it may cause harm to a developing fetus or newborn baby. Balversa must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.
Balversa received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Balversa's clinical benefit and the sponsor is conducting or plans to conduct these studies. Balversa was also granted Breakthrough Therapy designation.
The FDA granted the approval of Balversa to Janssen Pharmaceutical.
April 15, 2019Dermatology
Congratulations to our friends and colleagues at Eli Lilly and Company.
Atopic dermatitis (AD), also known as eczema, is a chronic, non-contagious inflammatory skin condition characterized by dry, itchy skin that can weep clear fluid when scratched. People with eczema also may be particularly susceptible to bacterial, viral, and fungal skin infections. AD affects an estimated 30% of the U.S. population, mostly children and adolescents.
According to an article published in the Journal of the American Academy of Dermatology (April 2019), the efficacy and safety of baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, were evaluated in patients with moderate-to-severe AD. Janus kinase 1 and Janus kinase 2 modulate proinflammatory cytokine signaling,
The phase 2 study was a randomized, double-blind, placebo-controlled study, with 124 patients with moderate-to-severe AD. Prior to randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks, all study subjects applied topical corticosteroids (TCSs) for 4 weeks. Use of TCSs was also permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo.
Study results showed that at 16 weeks, significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37%; P = .027). The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%).
According to the authors, that while baricitinib use with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD, a TCS standardization period before randomization reduced disease severity, thus limiting the ability to compare results with those of baricitinib monotherapy. The authors added that longer studies are required to confirm baricitinib's efficacy and safety in patients with AD.
As a followup, on 4 February 2019, Eli Lilly and Company and Incyte Corporation announced today that baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe AD. In both investigational trials, compared to patients treated with placebo, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint at Week 16 defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1). These are two of five studies that will be part of the placebo-controlled data program intended to support global registrations.
April 15, 2019Public Health
Inappropriate antibiotic use increases bacterial resistance to these drugs, eventually making many infections difficult to treat.
Many companies offer visits in which patients can connect with physicians outside of their primary care practice through audio-video conferencing, often on their cell phones or personal devices. According to an article published in Pediatrics (4 April 2019), children are more likely to be overprescribed antibiotics for colds, sinus infections and sore throats during telemedicine visits than during in-person visits to primary care providers or urgent care facilities.
For the study, the authors compared antibiotic prescribing practices from the billing data of 4,604 telemedicine visits, 38,408 urgent care visits, and 485,201 primary care visits for children up to 17 years old with respiratory infections. Results showed that children were more likely to receive prescriptions for antibiotics during telemedicine visits (52%), compared to urgent care visits (42%) and visits with primary care providers (31%). Also, clinical guidelines for antibiotic prescriptions were less likely to be followed after telemedicine visits (59%), compared to urgent care (67%) or primary care visits (78%). These clinical guidelines are intended to prevent inappropriate use of antibiotics, such as to treat viral infections for which they are ineffective, and to guide selection of the most appropriate antibiotic for bacterial infections.
The authors hypothesized that physicians providing telemedicine visits may overprescribe antibiotics because they cannot closely examine patients or perform tests, potentially limiting their ability to distinguish between bacterial and viral infections.
April 15, 2019History of Medicine
Toxigenic fungi and mycotoxins entered human food supplies about the time when mankind first began to cultivate crops and to store them from one season to the next, perhaps 10,000 years ago. The storage of cereals probably initiated the transition by mankind from hunter-gatherer to cultivator, at the same time providing a vast new ecological niche for fungi pathogenic on grain crops or saprophytic on harvested grain, many of which produced mycotoxins. Grains have always been the major source of mycotoxins in the diet of man and his domestic animals. In the historical context, ergotism from Claviceps purpurea in rye has been known probably for more than 2000 years and caused the deaths of many thousands of people in Europe in the last millennium.
It is suggested that the outbreak of the ?plague' in Athens in the 5th century BCE was caused by moldy food containing immunosuppressive mycotoxins, including the irritant T-2 toxin produced by certain Fusarium micro-fungi. Attica, a small hilly, coastal city-state, had to import its cereal grains from overseas. However, because of the Peloponnesian war and the occupation of its port, Peiraeus, by enemy forces, scarcity of food may have forced the population of the overcrowded Athens to consume any food, even when moldy. This happened in the Orenburg district of the USSR during World War II, when an outbreak of ?alimentary toxic aleukia' caused a great number of fatalities. The Plague of Athens was an epidemic that devastated the city-state of Athens in ancient Greece during the second year of the Peloponnesian War (430 BCE) when an Athenian victory still seemed within reach. It is believed to have entered Athens through Piraeus, the city's port and sole source of food and supplies. Much of the eastern Mediterranean also saw outbreak of the disease, albeit with less impact. The plague returned twice more, in 429 BCE and in the winter of 427/426 BCE. Some 30 pathogens have been suggested as causing the plague.
Sparta and its allies, with the exception of Corinth, were almost exclusively land based powers, able to summon large land armies that were very nearly unbeatable. Under the direction of Pericles, the Athenians pursued a policy of retreat within the city walls of Athens, relying on Athenian maritime supremacy for supply while the superior Athenian navy harassed Spartan troop movements. Unfortunately, the strategy also resulted in adding many people from the countryside to an already well-populated city, introducing a severe crowding factor as well as resource shortages. Due to the close quarters and poor hygiene exhibited at that time Athens became a breeding ground for disease and many citizens died including Pericles, his wife, and his sons Paralus and Xanthippus. In the history of epidemics the ?Plague' of Athens is remarkable for its one-sided affliction and bias on the ultimate outcome of a war.
In his History of the Peloponnesian War the historian Thucydides, who was present and contracted the disease himself and survived, describes the epidemic. He writes of a disease coming from Ethiopia and passing through Egypt and Libya into the Greek world:
a plague so severe and deadly that no one could recall anywhere its like, and physicians ignorant of its nature not only were helpless but themselves died the fastest, having had the most contact with the sick.
In overcrowded Athens, the disease killed an estimated 25% of the population. The sight of the burning funeral pyres of Athens caused the Spartans to withdraw their troops being unwilling to risk contact with the diseased enemy. Many of Athens' infantry and expert seamen died, as well as their general Pericles. After the death of Pericles, Athens was led by a succession of leaders Thucydides described as incompetent or weak. According to Thucydides, not until 415 BCE had Athens recovered sufficiently to mount a major offensive, the disastrous Sicilian Expedition. Accounts of the Athenian plague graphically describe the social consequences of an epidemic. Thucydides' account clearly details the complete disappearance of social morals during the time of the plague. Thucydides states that people ceased fearing the law since they felt they were already living under a death sentence. Likewise, people started spending money indiscriminately. Many felt they would not live long enough to enjoy the fruits of wise investment, while some of the poor unexpectedly became wealthy by inheriting the property of their relatives. It is also recorded that people refused to behave honorably because most did not expect to live long enough to enjoy a good reputation for it. Another reason for the lack of civilized behavior was the sheer contagiousness of the illness. Those who tended to the ill were most vulnerable to catching the disease. This meant that many people died alone because no one was willing to risk caring for them. The dead were heaped on top of each other, left to rot, or shoved into mass graves. Sometimes those carrying the dead would come across an already burning funeral pyre, dump a new body on it, and walk away. Others appropriated prepared pyres so as to have enough fuel to cremate their own dead. Those lucky enough to survive the plague developed an immunity and so became the main caretakers of those who later fell ill. A mass grave and nearly 1,000 tombs, dated between 430 and 426 BCE, have been found just outside Athens' ancient Kerameikos cemetery. The mass grave was bordered by a low wall that seems to have protected the cemetery from a wetland. Excavated during 1994-95, the shaft-shaped grave may have contained a total of 240 individuals, at least ten of them children. Skeletons in the graves were randomly placed with no layers of soil between them.
Excavator Efi Baziotopoulou-Valavani, of the Third Ephoreia (Directorate) of Antiquities, reported that:
[t]he mass grave did not have a monumental character. The offerings we found consisted of common, even cheap, burial vessels; black-finished ones, some small red-figured, as well as white lekythoi (oil flasks) of the second half of the 5th century BC. The bodies were placed in the pit within a day or two. These [factors] point to a mass burial in a state of panic, quite possibly due to a plague.
The plague also caused religious uncertainty and doubt. Since the disease struck without regard to a person's piety toward the gods, people felt abandoned by the gods and there seemed to be no benefit to worshiping them. The temples themselves were sites of great misery, as refugees from the Athenian countryside had been forced to find accommodation in the temples. Soon the sacred buildings were filled with the dead and dying. The Athenians pointed to the plague as evidence that the gods favored Sparta, and this was supported by an oracle that Apollo himself (the god of disease and medicine) would fight for Sparta if they fought with all their might. An earlier oracle had warned that:
A Dorian [Spartan] war will come, and bring a pestilence with it .
Thucydides is skeptical of these conclusions and believes that people were simply being superstitious. He relies upon the prevailing medical theory of the day, Hippocratic theory, strives to gather evidence through direct observation. He notes that:
Carrion-eating birds and animals disappeared as a result, though he leaves it an open question whether they died after eating the corpses or refused to eat them and were driven away. All the birds and beasts that prey upon human bodies, either abstained from touching them (though there were many lying unburied), or died after tasting them. In proof of this, it was noticed that birds of this kind actually disappeared; they were not about the bodies, or indeed to be seen at all.
Historians have long tried to identify the disease behind the Plague of Athens. The disease has traditionally been considered an outbreak of the bubonic plague in its many forms, but reconsiderations of the reported symptoms and epidemiology have led scholars to advance alternative explanations. These include typhus, smallpox, toxigenic fungi, measles, and toxic shock syndrome. Based upon striking descriptive similarities with recent outbreaks in Africa, as well as the fact that the Athenian plague itself apparently came from Africa (as Thucydides recorded), Ebola or a related viral hemorrhagic fever has been considered. Given the possibility that profiles of a known disease may have morphed over time or the plague was caused by a disease that no longer exists, the exact nature of the Athenian plague may never be known. In addition, crowding caused by the influx of refugees into the city led to inadequate food and water supplies and a probable proportionate increase in insects, lice, rats, and waste. These conditions would have encouraged more than one epidemic disease during the outbreak. However, advancing scientific technologies may reveal new clues. Unfortunately, DNA sequence-based identification is limited by the inability of some important pathogens to leave a footprint retrievable from archaeological remains after several millennia. The lack of a durable signature by RNA viruses means some etiologies, notably the hemorrhagic fever viruses, are not testable hypotheses using currently available scientific techniques.
Recent research has led to our current understanding of the formation of aflatoxins in grains and nuts, due to the growth of Aspergillus flavus and its role, in synergy with the hepatitis B virus, in human liver cancer. During a period of climate change and greatly reduced crop diversity on a global basis, researchers tasked with monitoring the food system need to be aware of fungal toxins that might have been rare in their working careers that can reappear. Sources: NIH.gov (Schoental, R.); WebMD.com; Medline.com; Wikipedia
April 15, 2019Quiz
Bacteria's ability to develop antibiotic resistance is well known, but it turns out fungi are also evolving to withstand modern 1) ___. Now one such fungus is cropping up in hospitals all across the globe and killing half the people who contract it within 90 days. This is raising concerns about a new global epidemic, according to an alarming story by The New York Times (04/06/19).
To understand the enormous danger of fungi, look back 20 years, when many species of amphibians were literally wiped out by a strange 2) ___. Climate scientists speculated that global rising temperatures and vast increased moist areas, could be the cause. In 1999, a new species of chytrid (fungus) was described that infected the skin of amphibians and was named Batrachochytrium dendrobatidis or Bd for short. Although the name Batrachochytrium is hard for even many scientists to pronounce, it roughly translates to mean frog chytrid. Bd is unusual because it is the only chytrid that is a parasite of a vertebrate animal 3) ___ specifically. Bd is a very important chytrid fungus because it appears to be capable of infecting most of the world's approximately 6,000 amphibian species and many of those species develop the disease chytridiomycosis which is linked to devastating population declines and species extinctions. In fact, infection with Bd has been called the worst infectious 4) ___ever recorded among vertebrates in terms of the number of species impacted, and its propensity to drive them to extinction.
Amphibian population declines due to chytridiomycosis can occur very rapidly, sometimes over a period of just a few weeks and disproportionately eliminate species that are rare, specialized and endemic. Because of these characteristics, rapid progression of population declines and loss of very important amphibian species, urgent mobilization of efforts to preserve amphibian species are required. Fungi thrives in 5) ___ areas. Consider the devastating flooding, now occurring globally, due to climate change, and the new vast areas of moisture, that result.
Mycotoxins are fungal metabolites which when ingested, inhaled, or absorbed through the skin can cause disease or death in humans and domestic animals, including birds. By general agreement this definition excludes the toxins produced by macrofungi (the mushrooms), and compounds that cause disease only in plants or lower animals such as insects. Fungi produce a large number of metabolites, but only a few are classified as mycotoxins, meaning, they have been demonstrated to cause illness. Specific mycotoxins are produced only by specific fungi, usually by only a few species Despite a few excellent studies of disease caused by fungi in feeds and foods in the first half of the twentieth century, the significance of mycotoxins in human and animal disease came only more recently. The term mycotoxicosis was first used in 1952, in a study of animal disease. However, the discovery of aflatoxins, following the deaths of 100,000 young turkeys in the UK in 1960, was the start of modern mycotoxin research. Starting after this devastating epidemic, laboratory and field experiments showed that many common 6) ___ that cause both food spoilage and plant disease are able to produce a vast array of more or less toxic metabolites. Molecular structures of mycotoxins vary widely, so their effects on human and animal health also vary widely. The most commonly induced diseases include liver cancer, kidney failure, and effects on the brain or nervous system. Toxicity due to mycotoxins is almost always insidious, without any overt indication of effects on health in the short term. For this reason, the health effects of mycotoxins are among the most neglected areas of medical science. Although mycotoxin-induced diseases have been recognized for many years, even centuries, recognition of specific mycotoxins as causes of disease is a comparatively recent development. As a result, major knowledge gaps remain to be filled through research for many of the known mycotoxins, particularly the potential human health effects of low-level chronic exposure, identification of biomarkers of exposure, and the effects of mycotoxin interactions. Mycotoxins continue to attract worldwide attention because of their impacts on human and animal health, agricultural losses, and the potential effects of climate 7) ___change.
Medical focus on Candida auris began in 2009, when doctors in Tokyo swabbed the ear of a 70-year-old woman and found an unknown strain of fungus that can infect humans and, in severe cases, cause a blood infection in high-risk patients. This discovery was Candida auris. Now, according to the US CDC, 8) ___ ___ ___ ___, a decade after it was discovered, cases have been reported in more than 30 countries around the globe -- including the United States, Australia, India, Germany, Israel, Venezuela and South Africa. At this point, the origin of this fungus is still a mystery. While the fungus seems to have cropped up relatively recently, its genetics reveal distinct groups that evolved apart, on different continents. The CDC's Mycotic Diseases Branch is considering that Candida auris could go back thousands of years. And yet, when scientists went looking for C. auris in old samples -- knowing that earlier tests may have misidentified it or not picked it up -- it was hardly anywhere to be found.
Part of the mystery is why this particular fungus suddenly come to cause a problem at a similar time in different parts of the world? Could it be due to increased moisture due to climate change? Or, could it have to do with our use of antibiotics and antifungal drugs? Changes in the health care environment? Or perhaps it's some other evolutionary change. Or a combination of all of the above? There are an estimated 5 to 6 million different species of fungi. Only a few hundred cause human disease. This Candida fungus acts like a bacteria. The emergence of C. auris highlights the danger of antimicrobial resistance: the rise of superbugs that threaten to render many of our tried-and-true drugs powerless. But there's something different about this fungus. It's a yeast that acts like a bacteria. Other species of Candida already travel with us -- on our skin, in our guts -- and they don't tend to cause infections unless there's an imbalance. This can happen, for example, when antibiotics wipe out good bacteria with the bad, leaving a place for Candida to grow. When this happens in the mouth, it's commonly referred to as thrush. In the vagina, it's a yeast infection. But most Candida is not known to be transmitted in health care settings, and C. auris is.
According to the CDC, C. auris can travel through health care facilities by lingering on surfaces and medical equipment, or it can spread directly from one 9) ___ to another. In a study published in October 2018, British researchers found 70 cases of C. auris in Oxford University Hospitals over the course of roughly 2.5 years, from February 2015 to August 2017. All but a handful had been admitted to its neurosciences ICU. Until public health authorities put out alerts about the fungus and doctors began actively looking for it, no one was aware that Candida auris was so virulent. It was several months before medical professionals could contain the problem. They used protective gear, changed how they cleaned, scaled back on bedside equipment and took other measures to stop the spread. However, as they cleaned to stop the spread, they continued to see new cases. Scientists thought they had found the culprit: a probe for monitoring patients' temperatures. Doctors stopped using the probes, but the fungus lingered. Even though the main source was found, the fungus still remained for a few more months before the medical staff could get rid of it completely. Only a handful of patients had had invasive fungal infections, no deaths were directly linked to it, and they haven't had a problem since. However, it might not be as successful in the next location or hospital, especially if dealing with more resistant types of C. auris. Samples of the fungus sent to the CDC are often resistant to one or two key antifungal drugs, and it can develop resistance to another while a patient is being treated. When it becomes resistant, it stays resistant, even though other microbes may lose their resistance when those drugs are no longer used against it. C. auris is dangerous. It has become resistant to all three classes of antifungals, making it a superbug, making it really untreatable, because there is no drug that kills it. In the United States, 587 confirmed clinical cases have been reported in 12 states as of February 28, 2019, according to the CDC. Over 1,000 additional patients have been found to be colonized with the fungus through targeted screening in seven of these states. Most of the clinical cases have been found in New York, Illinois and New Jersey -- with 309, 144 and 104 confirmed cases, respectively.
C. auris is a hard-to-treat organism in a patient population that's already very challenging to treat the sickest of the sick. In Illinois, for example, in one facility, the patients are chronically ill people who acquired the fungus in long-term care facilities, where they received a number of other medical treatments. Fortunately, most of the cases seen have still been treatable with common antifungals, but the appearance of C. auris underscores why we need to use drugs like antibiotics and antifungals responsibly. It's not about using less antibiotics. It's about using the right antibiotic for the right diagnosis and for the right duration of time. When it comes to bacteria, drug-resistant infections affect 2 million people a year in the United States, killing at least 23,000. And drug-resistant infections more broadly could claim 10 million lives per year around the globe by 2050 -- up from today's 700,000, according to one estimate. Once the persistent pathogen, C. auris turns up, getting rid of it is incredibly difficult. According to the New York Times, the CDC claims that more than 90% of C. auris infections are resistant to at least one major antifungal drug, with 30% resistant to two or more, and some medical facilities have had to go to such extreme lengths as tearing out their floor and ceiling tiles to completely remove traces of the fungus from a hospital room. All though we live in a world that has been filled with antibiotics, WHO says that the global supply is running out; not to mention that we now have superbugs like Candida 10) ___, that are resistant to the strong drugs we do have.
READ MORE: A Mysterious Infection, Spanning the Globe in a Climate of Secrecy [The New York Times]
ANSWERS: 1) medicine; 2) fungus; 3) amphibians; 4) disease; 5) moist; 6) fungi; 7) change; 8) Centers for Disease Control and Prevention; 9) person; 10) auris
April 15, 2019What's New
No matter where we go on the planet, the minute ON TARGET is mentioned, all we hear are accolades for the Target Healthy Eating recipes. The name and website are the brainstorm of our CEO and co-founder of Target Health, Joyce Hays. Her expertise as the creative Executive Chef in our home has now been shared since 2012 with over 6,000 ON TARGET readers and countless visitors to the website.
Ms. Hays, founder of the ON TARGET company newsletter also does the Weekly Quiz, History of Medicine and all the photography for the Recipe. Each week, on our last page, we toast to our friends and colleagues:
From Our Table to Yours
Have a Great Week Everyone!
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. The Target Health software tools are designed to partner with both CROs and Sponsors. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor
April 8, 2019Target Healthy Eating
Spicy delicious recipes from Pakistan and India feature a liberal quantity of turmeric (Curcuma longa). In biryani, the spice is an essential part of the curry mixture that gives the dish its distinctive zing. In American mustard, it's turmeric that gives it that bright yellow color. In Japan, turmeric tea is one feature attributed to Japanese longevity.
Much research has been done on turmeric and the good news is that it's good for arthritis, Alzheimer's disease, cancer and other diseases. How much daily consumption, is not clear. With all the studies in mind, I've begun to include in my diet a mid-morning home-made concoction of fresh lemon juice, honey, freshly grated ginger root and 1 teaspoon of turmeric. I've gotten used to the zing of the ginger and look forward to this healthy snack. It adds up to about 1/4 of a cup. Next Autumn, I will switch to a cup of hot turmeric tea with the same ingredients.
The good news about this cross-cultural spice is that elderly villagers in India, who eat turmeric in their daily curries, have the world's lowest rate of Alzheimer's disease. That does not appear to be a coincidence. In a study at the University of California at Los Angeles, scientists fed curcumin, an active compound in turmeric tea, to rats prone to accumulate beta-amyloid plaque in their brains - the abnormality associated with Alzheimer's disease in humans. Curcumin blocked the plaque's accumulation. It also appeared to reduce inflammation related to Alzheimer's disease in neural tissue. The rats fed curcumin also performed better on memory tests than rats on normal diets.
Although, turmeric/curcumin cannot formally claim medical uses established by well-designed clinical research, the research continues. Studies have suggested turmeric has broad anti-inflammatory and anti-cancer effects as well. But few Americans eat enough curry to achieve these protective effects. Although Dr. Andrew Weil found a potential solution during one of his many trips to Okinawa, the island nation with the world's longest average life span, 81.2 years. Okinawans drink copious quantities of turmeric tea. Some brew it fresh, but others simply buy cans or powdered instant versions of unsweetened tea from their local stores. If you would like to try it, here's a recipe. Feel free to experiment with the ingredients and flavorings until you find a combination that suits your taste:
While grated ginger and turmeric versions are more convenient, it's worthwhile to experiment with freshly grated turmeric and ginger, for a more vibrant flavor. These distinctive, deep-orange roots are increasingly available in American grocery and natural food stores. One of the most comprehensive summaries of turmeric studies is published by ethnobotanist James A. Duke, PhD. Here are some of the diseases that turmeric has been found to help prevent or alleviate, according to Dr. Duke.
Alzheimer's disease: Duke found more than 50 studies on turmeric's effects in addressing Alzheimer's disease. The reports indicate that extracts of turmeric contain a number of natural agents that block the formation of beta-amyloid, the substance responsible for the plaques that slowly obstruct cerebral function in Alzheimer's disease. Arthritis: Turmeric contains more than two dozen anti-inflammatory compounds, including six different COX-2-inhibitors (the COX-2 enzyme promotes pain, swelling and inflammation; inhibitors selectively block that enzyme). By itself, writes Duke, curcumin - the component in turmeric most often cited for its healthful effects - is a multifaceted anti-inflammatory agent, and studies of the efficacy of curcumin have demonstrated positive changes in arthritic symptoms.
Cancer: Duke found more than 200 citations for turmeric and cancer and more than 700 for curcumin and cancer. He noted that in the handbook Phytochemicals: Mechanisms of Action, curcumin and/or turmeric were effective in animal models in prevention and/or treatment of colon cancer, mammary cancer, prostate cancer, murine hepatocarcinogenesis (liver cancer in rats), esophageal cancer, and oral cancer. Duke said that the effectiveness of the herb against these cancers compared favorably with that reported for pharmaceuticals.
Sources: Andrew Weil MD, DrWeil.com, by Brad Lemley; Wikipedia
From Our Table to Yours
Have a Great Week Everyone!
April 8, 2019Regulatory
Breast cancer is rare in males with only 2,670 cases of male breast cancer estimated in 2019 - less than 1% of all cases of breast cancer. Men are more likely to be diagnosed at an older age, with a more advanced stage of disease. The majority of breast tumors in male patients express hormone receptors.
Metastatic breast cancer is breast cancer that has spread beyond the breast to other organs in the body (most often the bones, lungs, liver or brain). When breast cancer is hormone-receptor positive, patients may be treated with hormone therapy (also called endocrine therapy) or chemotherapy. Endocrine therapy slows or stops the growth of hormone-sensitive tumors by blocking the body's ability to produce hormones or by interfering with effects of hormones on breast cancer cells. There are several FDA-approved endocrine based therapies available for HR-positive metastatic breast cancer patients. Certain treatments are gender-neutral in their indication, but some therapies have been approved only for women, although they are often prescribed for male patients. According to the current clinical practice standards, male patients with breast cancer are treated similarly to women with breast cancer.
The FDA has extended the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients. Ibrance was initially approved in 2015. It is a kinase inhibitor, approved in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause and in men, or with fulvestrant in patients whose disease progressed following hormonal therapy. Pfizer provided the results of an analysis of real-world data (RWD) from electronic health records (EHRs) as additional supportive data to characterize the use of palbociclib in combination with endocrine therapy (aromatase inhibitor or fulvestrant) in male patients with breast cancer based on observed tumor responses in this rare subset of patients with breast cancer.
The most common side effects of patients taking Ibrance are infections, leukopenia (low levels of white blood cells), fatigue, nausea, stomatitis (inflammation of the mouth and lips), anemia (low levels of red blood cells), hair loss, diarrhea and thrombocytopenia (low levels of thrombocytes, also known as platelets, in the blood). Other common side effects reported are rash, vomiting, decreased appetite, asthenia (abnormal physical weakness or lack of energy) and fever. Health care providers are advised to monitor a patient's blood count for neutropenia (low levels of white blood cells called neutrophils). Patients should have their blood count checked prior to starting Ibrance and at the beginning of each cycle, as well as on day 15 of the first two cycles and as clinically indicated.
Because of the potential for genotoxicity (damage to cells), health care providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment with Ibrance and for three months after the last dose. Women who are pregnant or breastfeeding should not take Ibrance because it may cause harm to a developing fetus or newborn baby.
The FDA granted the approval of Ibrance to Pfizer.
April 8, 2019Neurology
Anhedonia is a diverse array of deficits in hedonic function, including reduced motivation or ability to experience pleasure. While earlier definitions of anhedonia emphasized the inability to experience pleasure, anhedonia is used by researchers to refer to reduced motivation, reduced anticipatory pleasure (wanting), reduced consummatory pleasure (liking), and deficits in reinforcement learning. In the DSM-V, anhedonia is a component of depressive disorders, substance related disorders, psychotic disorders, and personality disorders, where it is defined by either a reduced ability to experience pleasure, or a diminished interest in engaging in pleasurable activities.
Anhedonia is a risk factor for, and a symptom of, certain mental disorders and is predictive of illness severity, resistance to treatment, and suicide risk. While researchers have sought to understand the brain mechanisms that contribute to anhedonia, investigations on this condition have more commonly focused on adults rather than children. Importantly, previous studies often did not separate anhedonia from other related psychopathologies, such as low mood, anxiety, or attention-deficit/hyperactivity disorder.
According to an article published in the journal JAMA Psychiatry (15 March 2019), changes have been identified in brain connectivity and brain activity during rest and reward anticipation in children with anhedonia. The study, supported by the Emotion and Development Branch, part of NIMH's Division of Intramural Research Programs. sheds light on brain function associated with anhedonia and helps differentiate anhedonia from other related aspects of psychopathology.
For the study, fMRI data collected from more than 2,800 children (9-10 years old) were examined as part of the Adolescent Brain Cognitive Development (ABCD) Study. Some of the children included in the sample were identified as having anhedonia, low mood, anxiety, or attention-deficit/hyperactivity disorder (ADHD). fMRI data were collected while the children were at rest and while they completed tasks assessing reward anticipation and working memory. Analysis of brain connectivity at rest showed significant differences in children with anhedonia compared to children without anhedonia. Many of these differences were related to the connectivity between the arousal-related cingulo-opercular network and the reward-related ventral striatum area. These findings suggest that children with anhedonia have altered integration of reward and arousal compared to children without anhedonia.
When the authors examined brain activity during the tasks, they found that children with anhedonia showed hypoactivation of brain regions involved in integrating reward and arousal during the reward anticipation task, but not the working memory task. This hypoactivation was not seen in children with low mood, anxiety, or ADHD. In fact, children with ADHD showed the opposite pattern: abnormalities in brain activation during the working memory task, but the not the reward anticipation task. According to the authors, the study results suggest that children with anhedonia have differences in the way their brain integrates reward and arousal and in the way their brain activates when anticipating rewards. The authors added that anhedonia-specific alterations were found, such that youth with anhedonia, but not youth with low mood, anxiety, or ADHD, showed differences in the way they integrated reward and arousal and also showed diminished activity in reward-anticipation contexts.