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hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.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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Concussed Kids Too Often Return Right Away To Playing Fields

 

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You can’t always protect people from themselves – but coaches of young footballers who return to play on the same day they’ve been concussed should be disciplined. Amazingly, more than a third do go back into action shortly after suffering a head injury, according to a study presented last Friday (Oct. 21) at the annual meeting of the American Academy of Pediatrics’ (AAP).

A HealthDay article noted that concussion guidelines and laws in all states discourage youth athletes from returning to play if they have any signs of concussion after a head injury. But, the findings from this study suggest those rules are often ignored.

Researchers looked at 185 young athletes treated for concussion at a Texas pediatric sports clinic in 2014. They were between the ages of 7 and 18. Forty-seven percent suffered a concussion while playing football and 16 percent while playing soccer, the researchers said.

The study found that 71 (38 percent) of the athletes returned to play on the same day they got a concussion. Those who immediately returned to play after their concussion reported less severe symptoms of dizziness and balance problems immediately after being hurt.

However, by the time they were seen in the clinic these patients were more likely to report the presence and increased severity of nausea, dizziness, balance problems, sensitivity to light and noise, feeling “slowed down,” pressure in the head, confusion, concentration problems and difficulty falling asleep.

While studies presented at meetings tend to be viewed as preliminary until they’ve been published in a peer-reviewed journal, this one strongly suggests “that we still have work to do to change behaviors to protect short- and long-term brain health of youth athletes,” study author Meagan Sabatino, a senior clinical research coordinator at Texas Scottish Rite Hospital for Children in Plano, said in an AAP news release.

“We need to emphasize the message: ‘When in doubt, sit them out — and keep them out — until full recovery,’ ” said study author Dr. Shane Miller, a pediatric sports medicine specialist at the hospital.

And while they’re out, it might be a good idea if they were required to read a ‘playbook’ on the long-term effects of concussion-type head injuries, as exemplified by NFL veterans and others.

 

Nose Cartilage Used To Repair Similar Material in Ten Patients’ Knees

 

Swiss doctors have demonstrated a way to use cartilage from a nose to repair damaged cartilage in a knee. Ten patients underwent the procedure two years ago, and MRIs taken recently showed new growth very similar to the knee’s own cartilage, and patients reported improvements in knee function, reductions in pain, and improvements in quality of life, it was reported on October 22 in The Lancet.

“We have developed a new, promising approach to the treatment of articular cartilage injuries,” said lead researcher Ivan Martin, a professor of tissue engineering at the University of Basel. The articular cartilage is the tissue that covers and protects the ends of the knee bones, and injuries to it can lead to degenerative joint conditions like osteoarthritis.

Although the results of this preliminary trial are encouraging, more research is needed before this technique could become widely available, Martin stressed.

“Before this can be offered to patients as a standard treatment, obviously it needs to be tested in a larger number of patients and in randomized trials with long-term assessment of clinical outcomes,” Martin said.

One joint repair expert welcomed the new approach.

“Treatment of cartilage injuries remains a significant clinical problem, and there is no gold standard treatment and no optimal treatment available,” said Dr. Nicole Rotter, vice chair of the department of otorhinolaryngology at Ulm University in Germany.

Using cells from the nose for joint repair is completely new, added Rotter, who co-wrote an editorial accompanying the study. “Nasal cartilage might be a great source for cartilage repair; however, further clinical studies are required,” she said.

For the study, Martin and colleagues took a small sample of cartilage cells from the patient’s nose bone, then grew more cells by exposing them to growth hormone for two weeks. All the cells were then placed in a membrane of collagen and cultured for two more weeks.

The engineered graft was cut into the right shape and used to replace damaged cartilage after it was surgically removed from the patient’s knee.

With the procedure, only a small sample of cells is taken from the nose, using a local anesthetic. After the knee is repaired, the patient is on crutches for six to eight weeks. It typically takes several months for a full recovery, the researchers said.

No bad reactions were reported, but two serious adverse events unrelated to the procedure occurred — an independent injury in the untreated knee and new cartilage damage in other areas of the treated knee, the researchers said.

Dr. Matthew Hepinstall, an orthopaedic surgeon at Lenox Hill Hospital Center for Joint Preservation and Reconstruction in New York City, welcomed the new findings.

Even small articular cartilage injuries can cause pain, limit walking and running, and restrict joint motion, Hepinstall told HealthDay. “Over time, surrounding healthy cartilage can deteriorate — resulting in arthritis,” he added.

A variety of surgical procedures have been developed to fill “potholes” in articular cartilage, with varying success, he said.

For the last two decades, surgeons have been able to take cartilage cells from the knee, grow them in a lab, and put them back into a patient’s knee, Hepinstall said.

But that procedure requires two operations, Hepinstall noted.

This new study demonstrates the plausibility of taking cartilage cells from the nose in a less invasive procedure that only requires a local anesthetic, he said.

Bomb-Related Radiation Less Harmful Than Feared — Over the Long Term

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Nagasaki, Japan, before the Atomic Bomb hit around 11 a.m. on Aug. 9, 1945.  Three days earlier, Hiroshima was similarly destroyed by the first-ever use of an Atomic Bomb.

In the short term, an atomic or hydrogen bomb detonated in a highly populated area will, without a doubt, kill a lot of people – instantly, or nearly so, in some instances. But in the long term, exposure to radiation levels generated by such bombs don’t affect people nearly as much as has long been feared.

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Nagasaki, Japan, after the Atomic Bomb hit around 11 a.m. on Aug. 9, 1945.

HealthDay News, reporting on an article appearing this month in the publication Genetics, said that:

Bertrand Jordan, a molecular biologist in France, analyzed more than 60 years of medical research on about 177,000 survivors and their children, as well as 20,000 people who were not exposed to radiation from the bombs. The United States dropped the bombs in August 1945, and 200,000 people died in the immediate aftermath.

Survivors did have a 10 percent to 44 percent added risk of cancer due to radiation exposure from the bombs. But they lived only a few months less, on average, than those not exposed to radiation, the study findings said.

No health effects or radiation-associated mutations have been detected in children of survivors, according to the findings published in the August issue of the journal Genetics.

Although more detailed tests might one day reveal subtle differences among survivors’ children, Jordan claimed the risk to their health risk isn’t as great as feared.

“Most people, including many scientists, are under the impression that the survivors faced debilitating health effects and very high rates of cancer, and that their children had high rates of genetic disease. There’s an enormous gap between that belief and what has actually been found by researchers,” Jordan said in a journal news release.

There are several possible explanations for the study findings, including historical context, Jordan said.

“People are always more afraid of new dangers than familiar ones,” Jordan said. “For example, people tend to disregard the dangers of coal, both to people who mine it and to the public exposed to atmospheric pollution. Radiation is also much easier to detect than many chemical hazards. With a hand-held geiger counter, you can sensitively detect tiny amounts of radiation that pose no health risk at all.”

But Jordan said his findings should not cause complacency about the threat of nuclear weapons and nuclear accidents.

The meltdowns that occurred in 2011 at a nuclear power plant in Fukushima, Japan, after an earthquake triggered a massive tsunami shows that disasters can occur even in a country like Japan that has strict regulations governing the nuclear industry, he said.

 

Electronic Health Records Are NOT Ready For Prime Time!

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Despite wonderful advances electronic health record (EHR) technology eventually will bring, today’s systems have some serious flaws. (See my earlier post here on one of them.)

I recently had a personal run-in with another not-ready-for-primetime EHR feature: The system used by a major health care facility – an ‘academic medical center,’ according to its website – is described by the office of at least one physician there as “the best way to interact with your medical team.” There’s a very good chance that would be so, if there were a way for [a] providers to be advised/alerted when a patient sends in a message, and [b] patients to be notified – ideally by email, alternatively by an automated phone call – when a message is sent to them, their chart is updated, or an appointment needs to be rescheduled. (The latter presently are handled by U.S. Mail, a slow, unnecessarily-costly approach to communications of this sort in the year 2016!)

Jim Schroeder, a pediatric psychologist – perhaps one of the least-known specialties in medicine! – had a lot to say on this EHR flaw and others in a recent by-lined article on the KevinMD.com website. The basic problem, he said, revolves around what’s called “meaningful use” – “defined as using EHR technology to improve quality, safety, efficiency, and reduce health disparities.”

“The promise,” he went on, “is that meaningful use will help improve patient and provider communication and increase coordination while maintaining the privacy and confidentially of patients.”

He says this is impacting his highly specialized practice, actually “decreasing efficiently and staff/patient communications,” as he put it. Imagine, then, the types, levels and degrees of communication breakdowns cited in the second paragraph (above) are having across the broad swath of specialties – not to mention the practices of primary care physicians (PCPs) where EHRs are being introduced and even mandated.

Even something as straight-forward  as this appointment-fixing system really breaks down, all too often, because neither the medical staff nor the patient is prompted – in a way suggested above – that ‘the other side’ is reaching out to effect a change. Complicating factors, Dr. Schroeder points out in his article, are instances where a medical practice staffer has been temporarily or permanently reassigned and no one is designated, in their absence, to check the incoming mail ‘bucket’.

And, he notes, it gets worse:

But beyond the purely practical issues, there are psychological factors at play that likely speak to increased stress, burnout, and turnover that many are experiencing.  The first issue is that we, the staff and providers, are increasingly being disjointed by all the options available.  Previously in our office the only place a staff member had to monitor for potential cancellations was the phone lines; now suddenly, there are multiple circuits that they are responsible for checking, which increases the already fragmented nature of the position.

Previously when patients wanted to send a message, it could only [be done] in person, by phone, or by fax (or mailed letter); now, the electronic avenues being utilized (or explored) are growing exponentially in addition [to] the traditional ones that [still] exist.

It seems wonderful for patients to be able to communicate through whichever way they desire.  That is, until the communication becomes so scattered and decentralized that it repeatedly breaks down.

A second principle of concern is what I will call the “psychological distance X amount of information received” ratio.  Basically described, the further removed a communication gets from a direct, face-to-face interaction, the more contacts [are likely to be necessary].  Effort also interacts with this principle, as the more effort a message takes, the less likely it will [accomplish the intended objective].

Take a simple illustration: Most patients do not show up at your office to convey a message.  A few might send a letter. Some will call.  But open the lines of electronic access, whether they be through a portal, email, text or otherwise, and what you will find is that your messages will only start increasing.  Thoughts/worries that patients may have not felt were significant enough issues to justify a phone call or face-to-face meeting will now much more likely be transmitted. …  Suddenly, everyone seems to have something to say!

Whereas people may have previously communicated a message to their friends through a few phone calls, now hundreds of texts might be sent.”

Dr. Schroeder says he wants his patients to be able to communicate with him effectively, for their health and his ‘quality of practice’.  But there is no way, he says, “[that]  I can sustain my professional and personal life the way I should if the messages only increase from what already exist.

“Meanwhile, as EHR is supposedly creating a more efficient circumstance for all providers, we are finding that internal medicine residents are spending an average of five hours per day on electronic charts.  Is this really patient-centered, person-centered practice and learning done more efficiently?

I appreciate many of the advantages that technology has provided at work and home.  But as EHR and other systems further develop, it seems that technology is guiding people instead of people guiding technology.  Simply because a capacity exists does not mean it is best practice, or should be employed at all.  Simply because we are a consumerist health care industry does not mean that patients should be afforded every means possible to dictate how they communicate their health care needs.  Sometimes, even the tedious act of calling an office to communicate a message or reschedule an appointment is way more important than we think, and more efficient than we realize.

I am not saying this just as a licensed psychologist.  I am saying this as a married father of six young children.  Because when we get to the heart of the matter, I am first and foremost responsible for the people I pledge to love, care for and work with.  Technology may just have to wait.

While I fully appreciate and empathize with Dr. Schroeder’s concerns, which are very real, increasingly more real ones, it’s hard to avoid thinking that, in a way, this doctor ‘doth protest too much’: Six young children? So much for his time stresses!

(The late comedian Groucho Marx had a radio, then televised, quiz program called ‘You Bet Your Life’. In its earlier days, it was broadcast live – dangerous at the best of times, where Groucho was concerned, as he was always prone to say the first thing that popped into his mind – or which effectively by-passed his mind on its way to his mouth.

(He once had a contestant, a woman, who said, responding to his general warm-up questions, that she had a lot of children. (The precise number is lost in the mists of time – and it’s irrelevant, anyway. Numbers as high as 14 have been tossed around.) She responded, “Because I love my husband.”

(Groucho, who nearly always had a trademark cigar in his face and a leer on his lips, said, without missing a beat, “I love my cigar, too, but I take it out of my mouth once in a while!”)

I envision a day, not too far in the future, when medical offices will have to have a staffer whose prime responsibility is capturing in-coming electronic messages, getting answers for them, and doing the responding doctors and nurses simply don’t have time to do – not to mention, electronic message-answering isn’t in their job description.

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I will be very appreciative if you will encourage your friends, family and colleagues to check out what my two blogs – Food TradeTrends.com and YouSayWhat.info – do in the interest of providing information you might, otherwise, never become aware of. You never know: Some of my research could prove useful, or possibly amusing, to you, and/or them.

2-Day-Old’s Kidneys Transplanted In China

 

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They were only 4 centimeters (1.57 inches) long, but surgeons in China nevertheless managed to transplant the kidneys of a two-day-old baby into a nine-year-old girl dying of chronic renal failure.

The procedure was performed recently in the Second Xiagya Hospital of Central South University in Changsha.

This teaching hospital, in central China’s Hunan Province, is big on transplants, even teeny tiny ones.

The kidney recipient, identified by the Chinese news agency Xinhau under the pseudonym Huang Jing, had kidney disease since she was a toddler, and her development was affected. Her new kidneys will, all being well, continue to grow for several months until they reach ‘normal’ size for her age.

After the surgery, ‘Huang’ said, “I am very happy and [I] want to go to school,” the news agency reported recently.

It went on to quote the head of the hospital’s transplant surgery team, Peng Longkai, that kidney transplants for young patients are a challenge due to the complexity of the operation and the tiny blood vessels involved.

The donor in this case died from anoxic encephalopathy, neonatal asphyxia and lung infection, and her parents decided to donate her kidneys to “let her stay in the world in another way.”

Take It Off! (Even A Little Bit of Weight-Loss Will Help!)

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For the one in three American adults who are obese, recommendations to lose substantial amounts of weight through a combination of diet and exercise can seem daunting and, at times, hopeless. But a new study should come as encouraging news for all those struggling to lose the extra pounds: even a modest goal of 5 percent weight loss delivers considerable health benefits.

In a National Institutes of Health-funded study, obese people who lost just 5 percent of their body weight—about 12 pounds on average—showed improvements in several risk factors for type 2 diabetes and heart disease. They also showed metabolic improvements in many parts of the body, including the liver, pancreas, muscle, and fat tissue.

While people who lost additional weight enjoyed further improvements in their health, the findings reported in the journal Cell Metabolism show that sometimes it really does pay to start small.

Doctors today often recommend that their patients who are obese lose 5 to 10 percent of their weight in accordance with current treatment guidelines. While these guidelines are quite helpful, many individuals find that loss of 10 percent is a very difficult challenge, and it’s been unclear how much of a boost patients might receive to their metabolism and heart health by aiming for the more achievable goal of 5 percent.

To find out, Samuel Klein of Washington University School of Medicine, St. Louis, and his colleagues randomly assigned 40 obese women and men to one of two groups. In one group, participants maintained their body weight. In the other, they cut their calories and ate “self-prepared foods” to lose 5 percent, 10 percent, or 15 percent of their weight. The participants, who initially weighed about 230 pounds on average, were told not to exercise. All had signs of insulin resistance, a condition in which the body produces insulin but cells don’t respond normally to it, putting them at risk for type 2 diabetes.

Of the 20 people in the weight-loss group, all but one (who dropped out of the study) reached the initial target of 5 percent weight reduction. Nine of the remaining 19 people went on to reach the most ambitious 15 percent weight-loss goal after more than 10 months of dieting.

After participants reached each of the three weight-loss targets, the researchers evaluated their heart health and metabolism, measuring their total body fat, blood pressure, heart rate, cholesterol levels, and insulin sensitivity (how well cells respond to insulin). They also looked for signs of inflammation, a possible contributor to metabolic problems, and examined the expression of genes in their fat tissue.

At 5 percent weight loss, study participants showed improved function in insulin-producing beta cells of the pancreas. They also showed increased insulin sensitivity in their liver, skeletal muscle, and fat tissue. The researchers were surprised to find that people who had lost just 5 percent of their weight showed nearly a 50 percent reduction in fat in their livers.

Those who went on to reach the 15 percent weight-loss goal continued to show improvements in the function of their pancreatic beta cells and insulin sensitivity. The researchers also observed progressive changes over the course of the study in gene expression within fat tissue, suggesting that this critical metabolic tissue is particularly responsive to weight loss.

The new findings are just the beginning of studies by Klein’s team to explore in great molecular detail why weight loss is so good for us and obesity can be so detrimental. They’d also like to examine the effects of weight loss in people with type 2 diabetes and in those following particular dietary interventions, such as a low-fat versus a low-carbohydrate diet.

These studies will yield a lot of interesting data in the years ahead. In the meantime, let’s hope these new findings will inspire those struggling with obesity to take steps, however small, toward a healthier weight.