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hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.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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To bison, a ‘discouraging word’ is a helicopter’s repeating ‘whoosh’

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Something wonderful may be on the hooves of happening in Colorado: There’s a move afoot to open land adjacent to Denver’s international airport – which occupies a calf-sized chunk of the 50 square miles (129.5 sq km) it occupies – to the US’s largest, and closest-to-being-extinct mammal – the bison.

Often erroneously called ‘buffalo’, these four-hooved monsters can weight more than 2,000 pounds (907 kg). They once roamed the Great Plains in the tens of millions. But over-hunting, aided by human population growth resulting from the westward expansion of what would become the transcontinental railroad, when “hunting by rail” was a popular sport, which left countless bison rotting where they were dropped, cut sharply into their numbers. The population decline persisted well into the second half of the 20th century. Then the federal government, recognizing (at long last!) that the nation’s ‘National Mammal’ was at serious risk of fading out if existence, placed restrictions on killing them, and slowly the population began to recover.

Now, thanks to several federal programs (including severe penalties for killing them) their numbers are continuing to increase – but at a rough count of around 30,000 in total, they continue to need all the protection they can get to return to something like their former majestic population.

The US Fish and Wildlife Service is coordinating efforts across several federal agencies to give the giants of the plains back land that was once all theirs. As much as 200 acres (81 hectares, abbreviated as 81 ha) of the Denver Airport property is expected to opened up to bison grazing through an expansion of their ‘reservation,’ as it were, the Rocky Mountain Arsenal Wildlife Refuge. No timetable has been established for the plan, but it has been noted by the feds that, while the local bison would no doubt by happy to have all that land to themselves, since they don’t need such a large grazing area (in addition to the land they already call home), their population is due to be supplemented by bison from elsewhere in the west.

Sadly, or fortunately, saving the bison isn’t the only aim of opening up more grazing land for them: They’re also seen as a tourist attraction – something to (hopefully) be visible to arriving and departing airline passengers.

It’s likely that some enterprising person will also arrange for helicopter flights over the area for paying passengers, for their photographing pleasure. Never mind the fact that some enterprising individual or company will overlook the fact that the helicopters’ whoop-whoop-whoop aural signature will tend to frighten the animals more than the railroad apparently did.

It’s sad how often man does something good, then shoots himself in the foot: Bison are used to a quiet environment. Having an airport as a neighbor is bad enough, but having helicopters flying the photograph-mad masses over their heads is likely to be more than some will be able to bare – causing them to go back where they came from: The far more peaceful Rocky Mountain Arsenal Wildlife Refuge.

Paper Towels As Hurricane Relief

paper towels to PR

Paper towels: Really? That’s what the president of the United States offers as ‘help’ to Puerto Ricans whose homes, whose whole island, was essentially destroyed by Hurricane Maria. That’s precisely what he threw, by the roll, to crowds in San Juan on his October 3rd visit to the island.

The 3.5 million people there – American citizens because this country saw the island as a good defense post and ‘adopted’ it in 1898 under terms of the Treaty of Paris — was devastated by Maria, leaving most of the main island, and its smaller related neighbors, with no electricity, no water, no properly functioning services of any kind.

In my youth, in my early 20’s, as a new resident of New York City, I developed an intense dislike of Puerto Ricans because I saw them as freeloaders seeking to suck the greatest possible amount of milk and honey from the ‘American dream’ and ship it back to PR.

Sometimes it’s hard, particularly when you’re young, to separate the people from the territory where they call home. It’s especially hard to make that distinction when you regularly hear how Puerto Ricans come to New York City, go on welfare (public assistance) and then, some months later, take the bulk of their hardly-earned, taxpayer-funded ‘loot’ back to their island paradise.

Well, Puerto Rico is hardly a paradise now. But it is home to some 3.4 million American citizens facing a serious crisis that will, in all likelihood, continue ceaselessly well into 2018. Imagine trying to survive with little or no drinkable water, no electricity, severe food shortages, and scarce medical services. (Hospitals depend heavily on electricity to accomplish their life saving missions.)

On my sole visit to Puerto Rico, in the late 1960’s, I met many hard-working, peace-loving citizens. I’ve met and worked many like them in the years since then. No longer an innocent youth, I have come to have more than a little sympathy for members of an island community entitled to pay taxes to Washington but not allowed to fully participate as American citizens – they have no voting rights for national officials (congressmen, senators or the president) so long as they remain on the island. But Puerto Ricans living on the mainland do have full voting rights. (Go figure!)

When President Trump told Puerto Rico aid in the face of their disaster was slow in coming “because we have to take care of Americans first,” he was not only wrong, he was insensitive. In other words, he was acting fully in character.

Paper Bag or … What? Plastic Ones Are Getting Banned

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Shoppers in Kenya use an estimated 100 million plastic bags a year, many of which wind up in landfills like this one in Nairobi. Credit: Ben Curtis/Associated Press

A few decades ago – sometime in the ’80’s – I attended a competition at an A&P supermarket on Eighth Avenue in Manhattan. It was a face off between baggers using paper versus plastic bags. The winner’s name (and bag type) is long lost to history. ‘Just as well, too, as the whole idea was ill conceived – as, it turns out, was the idea of introducing plastic bags in supermarkets.

An increasing number of American communities are, or are considering, banning them altogether. England instituted a 5p (pence) per bag charge a few years ago – resulting in a drop of more than 75% in the use of them within a year.

Then there’s Kenya. That country, with a population of 48.5 million, used to use something approaching 100 million plastic grocery bags a year. No more. It is now illegal to either manufacture in or import plastic bags to that country. Even visitors are required to leave plastic bags containing duty free goods at their port of entry – usually the international airport in Nairobi.

The accumulations of plastic bags in land fills had reached an alarming level. So had the death of cattle who’d ingested plastic bags.

The New York Times reported that, “The new rule, announced in March and put into effect on Monday August 28), also means that garbage bags will be taken off supermarket shelves and visitors entering Kenya will be required to leave their duty-free shopping bags at the airport.

Kenya joins more than 40 other countries including China, the Netherlands and France that have introduced taxes on bags or limited or prohibited their use,” The Times noted.

In Rwanda, plastic bags are illegal, and visitors are searched at the airport. As noted, Britain introduced a 5 pence charge at stores in 2015, leading to a plunge of more than 80 percent in the use of plastic bags. There are no nationwide restrictions on the use of plastic bags in the United States, though states like California and Hawaii ban nonbiodegradable bags.

Continue reading the main story

Fruit and vegetable sellers were at a loss for how to market their produce, and some residents mistook ordinary traffic controllers for law enforcement officials looking to punish consumers who violated the new law. In informal settlements, where most of the city’s residents live, plastic bags are used as “flying toilets” — holding human waste in the absence of a proper sewage system.

Judy Wakhungu, Kenya’s environment minister, tried to allay people’s fears, telling Reuters that the ban was primarily aimed at manufacturers and suppliers. “Ordinary wananchi will not be harmed,” she said, using a Kiswahili word for “common person.”

Kenya tried to ban the use of plastic bags in 2007 and 2011, but the limits were not put in place.

The new regulations call for a fine of $19,000 to $38,000 or a four-year jail term for those manufacturing or importing plastic bags in Kenya. Plastics used in primary industrial packaging are exempt, according to the National Environment Management Authority, although it said that the new regulation would prohibit retailers from selling garbage bags.

Kenyans have had several months to adjust to the idea of the new rules, a period during which big supermarket chains like Nakumatt and the French multinational retail giant Carrefour began offering cloth bags instead of plastic. The country’s High Court last week rejected a case filed by two plastic bag importers to drop the ban, saying that protecting the environment was more important than the companies’ commercial interests.

Please also check out our other blog, FoodTradeTrends.com. Between, them, these two blogs have reached at least 90 countries.

Cut the Cocoa, Add Jackfruit Flour, Result: Pretty Much the Same

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The bad news: Persistently low and volatile prices are raising fears that world demand for cocoa, the principal ingredient in the much-loved confectionery known as chocolate, could soon exceed availability. Aside from something called swollen shoot virus disease, the problem is, given the money, solvable: A shortage of warehouse storage capacity in the major cocoa productions of West Africa, South America, and Asia could relatively easily be overcome by, duh, building more facilities. But the funds to do so are lacking, so the risk of shortages is a real one.

The good news: Researchers in the UK and Brazil have found people identify a chocolate-like aroma in flour made from roasted jackfruit seeds, according to Food Navigator. Their studies hold promise for jackfruit’s ability to mimic the aroma of chocolate, making jackfruit, which has many of the same characteristics as cocoa, a potential stand-in for the real thing, providing consumers a taste and feel they like like in chocolate-like products.

The even better news: A study at the University of Malaysia has found that substituting a proportion of jackfruit flour for wheat flour in cake-making can result in a caloric reduction of more than 30% in the end product.

Food Dive reports that the International Cocoa Organization said about 4.7 million tons of cocoa are currently being produced worldwide, with total production expected to rise about 18% from 2016.

It’s still early as far as the jackfruit being used as a substitute for cocoa. Even if the fruit has many of the same characteristics as cocoa, if it does not mirror the taste or texture, it could instantly turn off consumers. It’s also uncertain how well the flour made from roasted jackfruit seeds would work with other ingredients used to make chocolate, or how much it would cost to produce the cocoa-like substitute. Figuring out these answers will go a long way toward determining whether it can displace cocoa in even a small amount of foods,” Food Dive says.

Developing additional U.S. markets for the popular jackfruit — now used in ice cream, smoothies, soups and side dishes — could stimulate new income streams, along with adding value and reducing widespread waste in places where it grows.

Jackfruit is the world’s largest tree-borne fruit, capable of reaching sizes of more than 80 pounds, growing both on branches and the trunks of trees native to South and East Asia. It’s botanically related to figs, mulberries, and breadfruit.

It also has a dual identity. If it’s left to ripen, it becomes amazingly fruity and has been rumored to be the inspiration for the flavor of Juicy Fruit gum.

The fruit is increasingly popular with U.S. consumers. Pinterest named jackfruit as the top food item people will be trying in 2017 based on a 420% increase in interest among users of the social media platform. Vegetarians and vegans are driving some of this interest because of jackfruit’s evolving role as a meat substitute, despite its relative lack of protein.

Jackfruit delivers a powerful nutritional package as a significant source of vitamin A, C and the B-complex vitamins, dietary fiber and several important minerals, particularly potassium, magnesium, manganese, and iron. Among its other assets, jackfruit contains no cholesterol and virtually no fat.

Please check out our other blog, FoodTradeTrends.com.

(Between them, these blogs have been view in 90 countries!)

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.


 

Official Stats: US Cops Kill 1,000, Wound 50,000, Every Year

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Photo: LA Times

In a fascinating article discussing the need and possible approaches to reducing police shooting of civilians in the US, the New York Times noted that every year, for the past several, at least, police in the US have killed close to 1,000 civilians and wounded some 50,000 others.

Many of these incidents involve traffic stops – situations where the law allows cops great discretion in how they approach stopped vehicles and in the ways they interact with stopped motorists. Hardly surprisingly, the author suggests ways stops can be reduced in number – more than 62.9 million U.S. residents age 16 or older, or 26% of the population, had one or more contacts with police during 2011 a sizable share of them in traffic stops, according to the US Department of Justice’s Bureau of Justice Statistics – and a couple of ways ‘stop procedures’ can be modified to reduce risks to the stoppers and the stopped.

But as a frightening number of incidents over the past couple of years have demonstrated, there are many other ways should-be-simple, mutually safe police/civilian encounters can turn deadly.

While some of them represent incidents where cops have, or think they have, legitimate reasons to fear the person they shoot, more often than not they result from poor police training and, it must be said, extreme reactions by civilians to the mere presence of a police officer or some action of that officer that was not necessarily, in-and-of-itself, threatening.

Sadly, a high proportion of individuals who are shot by a police officer are young African Americans – or members of other non-Caucasian minorities. The problem is so severe in some areas that African American parents feel compelled to have what they call “the talk” with their young men – advising them how to avoid confrontations with law enforcement officers and, if they are confronted, how to avoid having the situation escalate.

Young Philandro Castile, while ‘driving while black,’ was stopped at least 49 times, all for minor offenses, in a 13-year period before, on the last pull-over, he was shot and killed.

That is a sad commentary on attitudes and occurrences in the US, which has the unenviable reputation of being the most violent society, overall, in the world.

The Times article is well worth a read, as are the others we’ve linked to.