Monday, 20 November 2017

FDA approves pill with sensor that digitally tracks if patients have ingested their medication

FDA approves Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.

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 smart phone. 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hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.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 health care 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 FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products".
In FDA News Release, 20th of November 2017. Find original article here.
FDA approves pill with sensor that digitally tracks if patients have ingested their medication, [https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm], last visited on the 20th of Nvember 2017, last update on the 13th of November 2017.
Post image kindly taken from The Mighty, [https://themighty.com/2017/11/fda-approves-abilify-mycite/].

Thursday, 16 November 2017

The very latest on Brexit - must read!

Brexit is proving to be a hardship process for all those involved. EU citizens like myself, living in the UK, have their lives suspended on a cold breath of oblivion. We know very little, the fresher news are all about egos and pertinent incompetence from a few politicians a lot more worried about becoming the next Prime-Minister rather than giving the British people, and consequently (if they're that altruistic) the EU citizens in the UK, the best deal possible out of a union that for over 50 years provided the longest period of peace and prosperity in the European continent.

Politics apart, we all crave news straight from the source, and not just mere opinions of Think-tanks that do lobby a lot and think very little about us, and OF US.

You can now subscribe to be passed on directly to your email the latest news from the British government on Brexit. I'd advise you to do it immediately as a ticking clock urges action.

Wednesday, 15 November 2017

What is it like to hear voices?

The video you are about to watch has been created by the charity Rethink alongside people who experience schizophrenia. It was made to help other people, like myself, who had no idea of what feels like to hear voices in your head. 

Since at least 1 in every 100 people will have to face this disease at some point in their lives, it is important to raise awareness to what it is like to experience this form of hallucination.

My advice is that you get your headphones and raise the volume so you can really feel the power of such disturbance. Then after listening to it once with your open eyes, try to close your eyes and listen again at the same volume (still with the headphones) - you'll realise that closing your eyes won't make it any better or any easier.

Share, as much as possible... and if possible... donate.


 

Abnormal calcium homeostasis in peripheral neuropathies

Any Sjogren's syndrome patient must be aware of abnormal neuronal calcium homeostasis as a condition that could potentially affect one as the disease progresses. 

It doesn't have to happen to everyone, but if it does it is important to seek medical advice. I for one know that many patients were able to control their tremors and their numbness simply by supplying themselves with a calcium supplement. In many cases this practice solved a problem that not only is pertinent physiologically speaking, but can be also very detrimental emotionally speaking. The fact that the mind starts looking for a name for the symptoms usually directs the affected people to consider themselves affected by early-stage Parkinsonism or even letting the mind escalate to more serious and incongruent diagnosis. 

Abnormal calcium channel expression/function results in what is known as cellular dyshomeostasis , an imbalance that will affect the plasma membrane calcium signalling and the intracellular calcium in those cells related to the peripheral nervous system [1]. For those who are not so familiar with how the human body works to the cellular level, I found an incredibly good image that will allow one to understand how calcium is so important in, for example, muscular fatigue:

[2]


In a web-article by Ryan Andrews (I have no idea who this bloke is or his professional proficiency - I'm just assessing what he said) one can find this image (see above) from the New York Times. The image explains that it is the in- and outflow of cellular calcium that controls the way muscles work, to a certain extent (just to make it simple enough for those unaware of the depths of cell biology). For contraction, calcium is 'expelled', and for relaxation, calcium is sent in to the cellular moiety. If this system is affected by the typical systemic alterations that in Sjogren's syndrome cause metabolic imbalance to the molecular level, then the patients will be prone to sense some detrimental effects on their peripheral nervous system.

But before we go any further let's just go back a little bit to understand what in fact is a peripheral neuropathy and also how is calcium involved in the symptoms produced in the affected body. 

Peripheral neuropathy, as the name so well indicates, is a problem affecting the peripheral nervous system, or in simpler words, the mesh of nerves that connect the central nervous system in the brain with the extremities of our bodies. The moment you are a Sjogren's patient and for a certain period of time, not so occasional as one might think, are affected by numbness or a tingling sensation, loss of balance, loss of coordination, muscular weakness, pain in the limbs, or abnormal sensitivity to touch [3], you have an alarm bell ringing. Because this is pretty much a list of symptoms that can be associated to a range of several other conditions, some of a more serious core, medical advice, as in any other medical situation, should be sought. 

The Sjogren's Syndrome Foundation published about three years ago a list of the Top 10 Peripheral Neuropathy and Sjogren's Facts [4] and I advise any Sjogren's patient to visit the website and have a good read. It will help deconstruct many monsters. 

In regards to resorting to medication, I personally avoid medication to the maximum possible because of side effects that can worsen, for example, xerostomia. And to be fair, in my personal case, a calcium supplement of 800 micrograms a day (2 tablets of 400 micrograms taken with my breakfast food) have corrected the problem entirely! If I'm not wrong the recommended daily dose for a man my age (38) is a gram a day, and then my vegetarian diet provides the subsequently needed calcium. Important to refer that because dairy products are, to a certain extent, to be avoided/controlled in regards to intake as they can be quite 'immunogenic' for the Sjogren's patient, my calcium really needs to be strongly controlled because I rarely have any cheese, I don't remember the last time I had cow's milk, and I don't eat any fish or meat, so...

The alterations I have produced in my life to my diet and behaviour have been working so far. I honestly need more discipline in accepting and applying all the alterations needed to really control the syndrome to a point I'll forget I even have it. So controlled that I can almost consider it 'cured'. There is a long way to go, but my changes have produced very positive effects.

I hope you can also improve, but if you suspect of peripheral neuropathy deriving from your condition, please seek medical advice before implementing any dietary changes.

Let's all get better!


[1] Fernyhough, P. and Calcutt, N. A. (2010). "Abnormal calcium homeostasis in peripheral neuropathies". Cell Calcium, 47(2), pp. 130-139. 

[2] All about vitamins and minerals, Precision Nutrition, [https://www.precisionnutrition.com/all-about-vitamins-minerals], last visited on the 15th of Novenber 2017, last update unknown.

[3] Can peripheral neuropathy be a defficiency issue?, Instant calmag-c, [http://calmag-c.com/peripheral-neuropathy/], last visited on the 15th of Novenber 2017, last update on the 14th of October 2016.

[4] Peripheral neuropathy and Sjogren's, Sjogren's Syndrome Foundation, [http://info.sjogrens.org/conquering-sjogrens/bid/358138/Peripheral-Neuropathy-and-Sjogren-s], last visited on the 15th of November 2017, last updated on the 20t of November 2014.

Post image kindly taken from beliefnet [http://www.beliefnet.com/columnists/aprescriptionforhealthyliving/2017/07/calcium-supplement.html]. 

Monday, 30 October 2017

Long-term opioid use does not increase risk of Alzheimer's disease

Following on the motto of this blog concerning not writing articles on topics that have already been fairly covered throughout different channels, I am again refraining from mentioning anything further on this matter. However, due to the medical relevance of this issue and our current easy access to hospital pain killers, prescription pills, the growing interest from pharmacovigilants has never been stronger, hence demanding a quick yet very important note.

A few days ago, the blog Science Mission posted a short summary to a really interesting topic of a classic doubt/suspicion that was on many people's heads. The public was concerned that opioids would be associated to higher incidence of Alzheimer's. When considering opioids, we don't immediately have to go for the hardcore street heroin; we can also look into its clinical cousin, the semi-synthetic opioid - diamorphine - used in hospitals. 

Scientists performed studies on the relationship between long-term use of opioids and incidence of Alzheimer's and came to the conclusion that a direct cause-effect cannot be established or any blame attributed to the opioid itself. Be it due to duration of usage or even due to the sum of the different doses used.

Let's take a look into Science Mission's post where you can also find links to the articles debated.

"Long-term opioid use does not increase risk of Alzheimer's disease

 Long-term opioid use does not increase risk of Alzheimer's disease

Opioid use is not associated with an increased risk of Alzheimer's disease, shows a recent study. Researchers did not find any risk neither for long-term use nor for higher cumulative doses. Opioids are powerful pain relieving drugs that act on the nervous system.

Published in Pain Medicine, the study is the most extensive one conducted on the topic so far. A previous study from the US reported an association between high cumulative doses of opioids and an increased risk of dementia, but the Finnish study does not confirm this finding.

However, several adverse effects are related to opioid use, such as drowsiness and reduced alertness, and for this reason, opioid use should be restricted to the most severe pain conditions only. Opioid use may also lead to addiction or tolerance to pain-relieving effects.

Opioid use was compared between Finnish persons with Alzheimer's disease and their control persons without the disease. The study was part of the nationwide register-based MEDALZ study and included 70,718 persons diagnosed with Alzheimer's disease in Finland during 2005-2011, as well as 282,862 control persons.

http://www.uef.fi/-/opioidien-pitkaaikaiskaytto-ei-lisaa-alzheimerin-taudin-riskia

https://academic.oup.com/painmedicine/article-abstract/doi/10.1093/pm/pnx210/4096544?redirectedFrom=fulltext
 Edited  
Original post from Science Mission @ http://sciencemission.com/site/index.php?page=news&type=view&id=health-science%2F-long-term-opioid-use&filter=8%2C9%2C10%2C11%2C12%2C13%2C14%2C16%2C17%2C18%2C19%2C20%2C27

Post image kindly taken from https://www.rcemlearning.co.uk/references/pain-management-in-adults/

Saturday, 28 October 2017

Manipulate DNA from your mobile with Adna's Lab

It is now possible to just sit down, relax and learn how to manipulate DNA the way professionals do it. This knowledge is no longer kept in secret with a few scientists, this is now available for you to download and have a go learning what materials and what techniques they apply to generate the crazy results they accomplish.

Have you ever thought of how mutated monsters that star in movies could actually be created? Have you ever tried to understand how that cousin's genetic test was performed? Have you ever thought how police can go from a tiny drop of blood to nailing that manic serial killer? It's all hidden in DNA and the information it carries. A knowledge usually at reach only for those proficient in molecular biology and genetics. 

However, SciBoard Games and Bind Up Technologies merged in this project to make this secret know to the world and available for free and for everyone. We present you Adna's Lab, the app that mimics a molecular biology lab where you are the scientist using the same tools, materials and techniques real scientists use.

The Game:

In this game you compete against the software to build up a chain of DNA by adding the DNA letters (A, C, T, G) to your chain or your opponent's chain. Then you can use different equipment and materials to apply restriction enzymes (slicers, shall we call them) to cut your opponent's DNA chain making it smaller. You can also use restriction enzymes to slice your own DNA, in case you want to get rid of contamination (RNA) your opponent inserted in your chain.

Cutting DNA:

It is very simple, you just need to match the sequence found in the restriction enzyme card to the sequence found in the DNA chain. Then, if you have the right conditions of temperature and buffers you will damage that DNA so hard they will have to work harder to catch up with you. Make sure you manipulate the thermometer to the temperature you need because different tools (weapons) are only active at certain temperatures.



The Hint:

This is a game based purely on knowledge. SciBoard Games do not apply luck or dice to their games as progression is made as you learn. So don't feel dismayed if the game looks hard in the beginning, make sure you read the card instructions very well and collect as many points as you can. Sometimes your opponent can get to the end of the chain faster that you do, but if you used a lot more tools and enzymes along the way, you'll be making a lot more points and passing on to the next level. There are many different levels and the idea is to learn as you play.

The Secret:

Try to place some DNA letters in your opponent's chain as you start to create a matching sequence corresponding to an enzyme you hold in your hand. Then, if he/she is very close to wining the game you play that enzyme at the right temperature and with the right buffer, and you will destroy is DNA and get loads of points.


Tuesday, 3 October 2017

Inflationary Theory Model


I've never seen or felt Neil deGrasse Tyson, the Physics Tycoon, as a comedian, or a funny guy to say the least. After watching the revival of the old Carl Sagan's Cosmos on Netflix, I honestly think he did a great job as a dynamic presenter... but still not funny.

However, living on the rays of the success The Big Bang Theory brought to all 'pimply' scientists, physicists and science nerds are nowadays a must for any scientific encounter or public engagement that really want to sound intelligent, genius or exquisite.

It is easy for Physicists because they work on matters that put the finger on a lively wound. But that doesn't take the merit from their capacity to astonish us tremendously when it comes to their mathematical geniuses.

Nevertheless, the reason I chose this video for the Toxic Humour label is because it is quite frankly, amazingly and surprisingly... funny! Neil really brought up the effects of deGrasse in this participation :P

And to a certain extent I relate to this supposedly fictional theory of us being the higher power science experiment... I really do.