FDA OK’s A Medicine Tablet That Monitors When It Is Consumed; It Then Reports to a Cell Phone!

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Imagine this: You suffer from schizophrenia – a chronic condition described by the National Institute of Mental Health as “a severe mental disorder that affects how a person thinks, feels, and behaves.” You’ve been prescribed medication to deal with the condition’s symptoms, but because of them, you aren’t always ‘religious’ about taking your meds when you are supposed to.

Not long ago, for a majority of schizophrenics, that could have posed serious problems for you – such as causing you to react to symptoms your meds would have controlled. A few years ago, though, the Food and Drug Administration (FDA) began overseeing tests of a new drug that sound like something straight out of science fiction: Called Abilify MyCite, it comes in tablets that contain an ingestible sensor that records – and sends to a skin patch – info on when the drug was taken. The skin patch can then transmit the information to a smartphone or computer.

But because there may be delays in transmission and/or reception of that information, specialists should not attempt to track Abilify MyCite in “real time”. Still, this is a remarkable medical advance that, earlier this week, was approved for general use by the FDA.

Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The FDA’s press release noted that roughly 1% of Americans have been identified as being schizophrenic. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. It, too, can be treated with Abilify MyCite.

The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

Abilify MyCite contains a Boxed Warning alerting healthcare professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify MyCite is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.

Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur. 

Schizophrenia is a chronic, severe and disabling brain disorder. About 1 percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

Abilify MyCite contains a Boxed Warning alerting healthcare professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify MyCite is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.

Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

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Canning Food is One Thing; Getting It Out Is Another Matter

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We take food-containing cans for granted these days. It wasn’t always thus.

The so-called ‘tin can’, or ‘tin’ in Britain-influenced parts of the world – so named because the original ones, created in the 1840’s, originally were an amalgam of wrought iron and tin, the latter being the part exposed to the food. In the early years, such cans were sealed with a tin-lead alloy, which could cause food poisoning. Thus, the long-time warning to not store foods in cans once they been opened.

As the science of making cans evolved, so did the science of opening them. In the beginning, a hammer and a chisel were the manufacturer-recommended approach.

Eventually (!), someone got the bright idea that there had to be a better way for accessing the contents of these storage vessels.

Smithsonian Magazine takes up the story:

How did the first tin cans get opened? A chisel and a hammer, writes Kaleigh Rogers for Motherboard. Given that the first can opener famously wasn’t invented for about fifty years after cans went into production, people must have gotten good at the method. But there are reasons the can opener took a while to show up.

  • Our story starts in 1795, when Napoleon Bonaparte offered a significant prize “for anyone who invented a preservation method that would allow his army’s food to remain unspoiled during its long journey to the troops’ stomachs,” writes Today I Found Out. (In France at the time, it was common to offer financial prizes to encourage scientific innovation–like the one that led to the first true-blue paint.) A scientist named Nicolas Appert cleaned up on the prize in the early 1800s, but his process used glass jars with lids rather than tin cans.

    Later that year,” writes Today I Found Out, “an inventor, Peter Durand, received a patent from King George III for the world’s first can made of iron and tin.” But early cans were more of a niche item: they were produced at a rate of about six per hour, rising to sixty per hour in the 1840s. As they began to penetrate the regular market, can openers finally started to look like a good idea.

    But the first cans were just too thick to be opened in that fashion. They were made of wrought iron (like fences) and lined with tin, writes Connecticut History, and they could be as thick as 3/16 of an inch. A hammer and chisel wasn’t just the informal method of opening these cans–it was the manufacturer’s suggested method.

The first can opener was actually an American invention, patented by Ezra J. Warner on January 5, 1858. At this time, writes Connecticut History, “iron cans were just starting to be replaced by thinner steel cans.”

Warner’s can opener was a blade that cut into the can lid with a guard to prevent it from puncturing the can. A user sort of sawed their way around the can’s edge, leaving a jagged rim of raw metal as they went. “Though never a big hit with the public, Warner’s can opener served the U.S. Army during the Civil War and found a home in many grocery stores,” writes Connecticut History, “where clerks would open cans for customers to take home.”

Attempts at improvement followed, and by 1870, the basis of the modern can opener had been invented. William Lyman’s patent was the first to use a rotary cutter to cut around the can, although in other aspects it doesn’t look like the modern one. “The classic toothed-wheel crank design” that we know and use today came around in the 1920s, writes Rogers. That invention, by Charles Arthur Bunker, remains the can opener standard to this day.

Please check out our other blog, Food Trade Trends.


 

Chile Broke Nazi Plot to Bomb Panama Canal

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USS Ranger traverses the Panama Canal during World War II.  (Wikimedia Commons)

More than 70 years after the end of World War II, several South American nations are continuing to deal in how they accepted, or at least turned a blind eye to, Nazis among them. Chile had a special unit called Department 50 that, according to newly declassified reports, neither ignored nor accepted the presence or activities of some of the most evil individuals to ever walk the earth: They went after them, with a vengeance.

One of the plots they foiled, Deutche Welle has reported, included an intended mission that could have altered the shape of the war and the world: The aim was to “destroy” the Panama Canal. The Germans clearly had figured out how critical that passageway was to the war effort, as it enabled the Americans the move troops, ships, and materiel westward, to stock the Pacific Theater, as the war intensified and, ultimately, reached its final conclusion there.

The rise of Department 50 marked an about-face for Chile, which resisted, until 1943, declaring war against the Axis (Germany-affiliated) nations. Deutche Welle said that South America-based spy rings monitored, on behalf of the Germans, Allied merchant ships, monitored Chilean naval communications and otherwise acted on behalf of Axis interests.

Prensa Latina reported this week that the newly-released documents “reveal the assistance provided by Nazi sympathizers in Chile by sending information to Germany about the routes followed by the Allies’ merchant ships.” Fortunately, the play to bomb the Panama Canal was thwarted – and two spy rings were broken up as a result of Department 50’s efforts. Prensa Latina said Chile eventually had 22 agents dedicated to working against the Nazis.

“If they had prospered in their objectives, it could have changed not only Chile’s history, but the history of the whole world,” said Hector Espinosa, the director general of the investigations police, during a ceremony to hand over the reports to Chile’s National Archives.

But much of Chile and South America’s past with the Nazis is less heroic. Christopher Klein at History.com reports that high-ranking Nazis, including Adolf Eichmann and Dr. Josef Mengele, found refuge in South America, along with at least 9,000 Nazi officers and collaborators who fled to Argentina, Chile and Brazil.

The Nazi connection to Argentina has also been in the spotlight recently. Just last week police found 75 significant Nazi-related artifacts in a hidden room in Argentina. Photographs indicated some of them may have even been owned or used by Hitler himself.

Ladybugs’ Wing-Folding Technique Uncovered! New-Style Umbrellas Could Result

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A Ladybug takes flight.  (Photo: U. of Tokyo)

Ladybugs are beautifully colored little creatures that, like bumble bees, seem to defy nature in that they fly with bodies far larger than logic, or perceived aerodynamic rules, would enable a living entity to become airborne under its own power.

Odd as that is, scientists have long pondered another mystery about the ladybug, a type of beetle: How they manage to corral fairly substantial wings into extremely tight folds, making them – the wings – virtually invisible when the, um, bugs are at rest.

Mystery solved! Not only have Japanese scientists at the University of Tokyo figured out how that’s done, they’ve suggested that the ladybug’s wing-folding system could give rise to a change in the shape of umbrellas, the design of which had essentially remained unchanged for more than 1,000 years.

Sarah Knapston, Science Editor at The Telegraph in London, described the finding recently. In a nutshell, it boils down to the fact that the folding wing lies beneath the colorful one that shields and protects the former.

To arrive at their conclusion, the Japanese scientists replaced the spotted forewing, known as an elytron, with a transparent piece of resin. What they learned could help engineers design foldable solar collectors or even a new type of umbrella.

Kazuya Saito, Assistant Professor at the University of Tokyo’s Institute of Industrial Science, designs foldable structures—so insect wings are a natural interest. “Compared with other beetles, ladybugs are very good at flying and frequently take off,” he tells Bryson Masse at Gizmodo. “I thought their wing transformation systems are excellent and have large potential for engineering.”

He and his team tried several methods to figure out how the ladybug folded its wing. They took high-speed images of the insect opening and closing its wings, but still couldn’t see the actual folding process under the opaque spotted forewings. They attempted to 3D print an artificial wing, but they couldn’t make one that was transparent enough to see thorough.

As Masse reports, the researchers’ secretary was the one who came up with a solution: clear nail art resin. After crafting the wing out of the resin, the team was able to observe how the insect folded and unfolded its wings.

The creatures use the edge of the elytron and abdominal movements to fold the wing along creased lines. Examination of the wings using a CT scan also revealed that they have springy veins similar to a tape measure that are rigid enough to allow the insects to fly, but elastic enough to fold up.

Saito tells Masse that the wings are unusual because “transformable structures” usually involve moving parts and joints. But the ladybug’s wing lacks those complications, completing a relatively complex task through flexibility and elasticity. The paper appears in The Proceedings of the National Academies of Science.

While the structure of ladybug wings may have applications for things like foldable solar panels for satellites and space ships, Saito seems most excited about its application to something much more domestic. “I believe that beetle wing folding has the potential to change the umbrella design that has been basically unchanged for more than 1000 years,” he tells Knapton. Collapsible umbrellas usually have multiple parts and are easily broken at the joints. But the ladybug umbrella could be made from”seamless flexible frames,” he says, making it indestructible in strong wind and quick to deploy using “stored elastic energy.”

Saito admits that he doesn’t have a design for the umbrella yet, but perhaps it will look something like this.


A Worm Enzyme Might Help Rid World of Some Thrown-Away Plastic

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Henderson Island beach. Photo: Jennifer Lavers, University of Tasmania

It is widely believed that is possible to rid ourselves of plastic items we no longer want by throwing them away. A study of Henderson Island, a 14.4 sq mile (37.3 sq km) spit of land in the Pitcairn Islands, which are far from anywhere else in the far reaches of the South Pacific, has demonstrated with frightening certainty that, as an old saying has it, “there’s no such place as away.”

Virtually every available surface, and too many buried ones to count on Henderson Island, are covered with bits of plastic, much of it from China, significant amounts also from Japan and Chile, according to scientists from the Institute for Marine and Antarctic Studies, University of Tasmania, and the Centre for Conservation Science, Royal Society for the Protection of Birds, in the UK. Some 37 million pieces in all have made Henderson Island one of if not the largest homes globally for parted-with plastic.

The scientists’ report, published in Proceedings of the National Academy of Science of the United States, said the plastics debris density on Henderson Island is higher than anywhere else on earth. While its accumulated 37 million pieces of discarded plastic is but a drop in the proverbial bucket of the 5 trillion plastic pieces – some 250,000 tons worth – littering the world. And its presence in this once pristine piece of property makes a mockery of the island’s status as a UNESCO-designated “World Heritage” site, as “one of the few atolls in the world whose ecology has been practically untouched by a human presence.”

That declaration was made as recently as 1988 – a mere 29 years ago.

Not only is the accumulated plastic an eyesore to those rare souls who approach close enough to uninhabitable Henderson to see it, it’s a real risk to wildlife on and near the island. As the plastic drifts closer to Henderson, which sits amidst what’s called the South Pacific’s ocean gyre, an enormous area comprising one of half a dozen major circulating areas for ocean currents, water from vast areas on either side of the Pacific contribute trash as well as water from diverse sources. (That’s why Henderson’s plastic comes from so far afield.) Sea creatures ingest or get tangled in plastic materials, which either kill them quickly or slowly choke the life out of them. Land animals, too, often become victims of plastic materials eaten because they smelled or appeared edible.

These problems are destined to become more widespread unless mankind, collectively, takes steps to reduce the creation and use of plastic materials.

That and finding, in the guts of a certain species of wax worms, the enzyme that enables it to “eat” plastic:That such an enzyme exists stems from findings of a part-time Spanish beekeeper, a day-job researcher who found that the worms, whose caterpillar parents like to munch on beeswax inside his hives, were able to eat their way out a plastic bag he’d put some in.

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A hole eaten through a plastic bag by a wax worm. (Photo: Federica Bertocchini, Paolo Bombelli, and Chris Howe

Great scientific answers, and solutions, have been launched from less auspicious starts than that! Who knows? In time a wax worm enzyme could, if replicated on a large enough scale, take a bite out of the world’s plastic waste problem. But don’t hold your breath: That kind of advance isn’t likely to happen with this, or even the next, decade or three.


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14,000-year-old human evidence found in Western British Columbia

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Photo: Joanne McSporran

A coastal strip of land in British Columbia has been occupied at least 14,000 years – back to the time of the last Ice Age, when warm water influences from the Pacific Ocean kept this area from freezing. A CBC report last month, detailing how a meters-deep excavation turned up evidence dating back at least that far, said the discovery lends credence to oral histories of the area by the Heiltsuk Nation, an aboriginal group there. The ancient site, uncovered last November, shows that people occupied this area long before the rise and fall of the Roman Empire and the creation of the Pyramids in Egypt, the Vancouver Sun said.

The Triquet Island settlement, reachable only by air or sea, has produced a hoard of valuable artifacts, including pieces of bent wood, compound fish hooks and assorted stone tools. The site is one of the oldest evidence of human habitation ever found in North America.

William Housty, a member of Heiltsuk Nation, told Smithsonian.com that the validation by “Western science and archeology” of his people’s long-time occupation of the area can help the Heiltsuk people as they negotiate with the Canadian government over title rights to their traditional territory.

Alaska Town Spends Bulk of Winter In One Building

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Turtle-like, Whittier AK pulls everything inside a single building – all the people, stores, services – as residents ride out Arctic-quality snow and cold every winter. Begich Towers originally was two buildings used to house military personnel and families during World War II. Then a third structure was added during the 1950’s, and a few years ago they were repurposed as a single entity intended to house nearly all of the town’s 218 full-time residents in condo-like units that are interspersed with such services as “a playground, a church, a post office, a clinic, two convenience stores, a police station, a video rental store, city offices and a laundromat all under the one roof,” Smithsonian Magazine reported in late March.

A school serves the community from across the street from Begich Towers.

‘Sounds like a setting made for the kinds of misunderstandings and mishaps forming the under-girding of Fawlty Towers, home to the British TV comedy of the same name. (John Clease created the show with his then-wife, Connie Booth, and both starred in it with Prunella Scales and Andrew Sachs. In 2000, it ranked Number One on a list of 100 Greatest British Television Programs.)

Basel Fawlty, a hotel keeper, regularly reacts (mostly inappropriately) to things his staff and guests do. He could have used a dose of the treatment given to “crabby” members of the Begich Towers’ community.


“If somebody’s crabby around here, we just tell them, ‘Alright I’ll see you later,’” June Miller, a full-time Towers resident told Smithsonian Magazine. “[We] let them go and take care of their issues.” After some time apart, she said, everything gets back to normal.

While that approach might have occasionally worked at Fawlty Towers, it probably wouldn’t have, because [1] Basel Fawlty was crabby beyond belief, and [2] that was the whole point of the BBC comedy!