Bipolar? Or Gifted? – The Modern Day Epidemic Of Medicated “Madness” .

Have I gone mad?” asked the Mad-Hatter. “I’m afraid so, you’re entirely bonkers”, Alice replied, “but I’ll tell you a secret… all the best people are.”

The exchange above is from Lewis Carroll’s notorious fictional story, Alice in Wonderland, which in my professional opinion stands with more validity than today’s psychiatric and mental health paradigms. In fact, Alice shares the same view as some of the greatest thinkers of all-time, such as Socrates who once declared: “Our greatest blessings come to us by way of madness, provided the madness is given us by divine gift.” Plato too referred to insanity as “a divine gift and the source of the chief blessings granted to men.”

So, to best understand bipolar disorder the modern day epidemic of medicated “madness”, down the rabbit hole we go…

Going back to our friend Alice, on the first page of the classic story, we find Alice is disinterested in the dull, boring, everyday existence in which she resides. She peers into her sister’s book to see it has no illustrations or even conversations, which to Alice has no use or interest. She ponders the idea of making a daisy-chain, but lacks the energy or motivation to take the time to pick the daisies. She is disinterested in ‘normal’ life. Then, suddenly, a talking white-rabbit runs past her; he appears to be late. Of course, Alice is curious about this bizarre occurrence and follows him down the rabbit hole — and most of us will be familiar with the rest of the story.

By today’s standards and diagnostic references, Alice’s disinterest in ‘normal’ life would very likely be diagnosed as a mental disorder. With this diagnosis, she would then be medicated for life, after a brief stay at a psychiatric hospital to stabilize her on the medications that are claimed to be capable of normalizing her mental sickness.

But, is Alice really sick? Or is she a creative, intelligent, deep-thinking, imaginative, or even gifted child? I would wager everything I own on the latter!

Bipolar disorder is one of the oldest recognized ‘mental disorders’, yet it remains one of the most misunderstood. As a psychiatric Registered Nurse, it is my belief that people with bipolar disorder are not “sick” – the real sickness lies in the treatment and medications they receive.

What is Bipolar Disorder?

Formerly known as manic-depressive disorder or manic-depression, bipolar disorder refers to the experience of opposing poles with regard to a person’s mood. Essentially, bipolar disorder is distinguished by the experience of polarity.

At one pole is mania, which includes intense energy, racing thoughts, feelings of euphoria, inflated grandiosity or sense of self, impulsiveness and risk-taking behavior. The other pole includes depression, which presents the opposite symptoms, such as fatigue (to the point of inability to get out of bed), moving or talking so slowly that others notice, a feeling of emptiness, loss of interest in things that were once enjoyable, difficulty concentrating or making decisions, and thoughts of self-harm.

It is important to understand the distinction between moods and emotions here. Moods are essentially emotional feelings that last for a period of time – typically for more than two or three days, which can be difficult to shift. While everyone has their ups-and-downs, bipolar disorder is far more disabling, with symptoms far more severe than a typical mood swing from happiness to sadness. The extremes of bipolar disorder can take you from feeling that you are omnipotent to the point of wanting to end your own life.

Inside The Bipolar Mind

It is no measure of health to be well adjusted to a profoundly sick society” ~Krishnamurti

Just as Alice does in the opening chapter of her story, many people with bipolar disorder realize that “normal life” is far too phony, boring and constrained. They realize that there is much more to this mundane existence than what is commonly suggested. So, with this insight, one can see how easily it would be to slip into a depressed mood with thoughts such as:

– Why would I want to go through with this life?
Nobody understands me!
– I am all alone.
Why am I the only one who thinks this way?
Maybe they are right, maybe I am crazy.
What is the point of it all?
– What reason do I have to keep going?

This depression sucks the life out of you, to the point that you lack the energy to even get up and pour a glass of water. If I got up, then I would have to find a glass, wait for the water to filter, and then put the glass away… it is not worth the effort. Furthermore, the person experiencing these thoughts realizes that this thought process is illogical, and destructive, which only creates a tidal-wave effect, inducing further feelings of sadness and dejection.

How Does Bipolar Come On?

At birth, we are free — we are born with a clean slate and we see the world is magical. But as we grow, things change. We are trained to behave a certain way; we are domesticated to a set of standards that our society has agreed are “normal”. We learn to create a mask and put it on every day; To  conform. We learn to use different masks for different groups of people, different occasions, and different times. We are taught that this is “normal life”, and that wearing these masks is “normal” human behavior.

And yet this mask, this image that we create and send out to the world, is our false self. It is a learned function of the ego. It is only behind the mask that we find our true self — our soul.

Manic episodes — those times of euphoria, grandiosity and impulsiveness — are triggered by the collapsing of the ego or mask. It is as though the soul is allowed to be free for the first time. Just like a dog that is tied to a chain its entire life and then finally breaks free, it runs wild, explores, and does whatever it can, because it can finally be the animal it was meant to be.

A spiritual awakening is much the same process. Like those times of mania, it involves taking off the mask and living as our true self for the first time. If treated as a spiritual dis-ease, this is the unexpected gift that bipolar disorder can offer — a short-cut to enlightenment. The mania pole can reveal to us our strongest and deepest desires, and exactly how our personal energy truly wishes to be expressed, while the depression pole shows us – in no uncertain terms – the areas of our lives that are not being lived in total alignment with our most honest truth.

But, like the dog that just got off its leash and is running wild without care, there can be great danger if those manic episodes that are not controlled. Experiencing and freely expressing the impulses of your true self for the first time, you may begin to test reality in life-threatening ways, such as trying to fly out a window, walking into the middle of traffic, etc. In contrast, if the dog (the soul) has always been allowed to roam freely, it learns not to run in traffic or to chase people, and knows how to regulate its natural energy and exuberance for life.

The key is balance; learning always to roam free, not just in moments of mania.

Bipolar Disorder: Science, Medicine, and Statistics

According to the National Institute of Mental Health (NIMH), 5.7 million Americans (or 2.6 percent of the population) have bipolar disorder.[1] This is the highest rate of any country in the world. The official position of the NIMH is also that bipolar disorder cannot be cured. As stated on the NIMH website:

“Bipolar disorder cannot be cured… Because it is a lifelong illness, long-term, continuous treatment is needed to control symptoms.” [2]

With the United States having the highest prevalence of bipolar disorder, which is deemed incurable by the mental health establishment, it would make sense that the United States would have the finest diagnostic tools and science available, wouldn’t it? However, contrary to popular belief, there is no science involved in the diagnosis of bipolar disorder, rather it is diagnosed from a subjective set of criteria. There are no scans or medical tests, nor is there anything scientific about the process. Patients are simply asked questions in a brief consultation, and someone with a license makes a subjective interpretation as to whether or not they have a “lifelong, incurable disease”.

The primary treatment for bipolar disorder is the prescription of psychotropic medication(s), mood-stabilizers, atypical antipsychotics, or antidepressant medications. A government study published in 2005 reported that just 11% of mental health facilities provided psychotherapy to all patients diagnosed with bipolar. [3]

Regrettably, the medical establishment’s preference for treating bipolar disorder with medication over psychotherapy has less to do with results than one would like to think. When it comes to this disorder, it would seem psychiatric pay-checks and pharmaceutical profits rate far more highly than patients’ needs. In the past, psychiatrists would tend to the needs of 40 to 50 clients at most, conducting 45-minute sessions with each one. Today, they see up to 1,200 clients, holding only 15-minute appointments that focus on refilling medication prescriptions.

Why Are So Many Diagnosed with Bipolar?

In 1955, about one in every 13,000 people was diagnosed with bipolar disorder or manic-depression. [4] Today, that number has skyrocketed to nearly one in every forty!

Are there really that many more people displaying symptoms of such a disease, or could there be another factor accounting for this sharp rise in diagnoses? Let’s look at some statistics:

  • In 1970, the U.S. Food & Drug Administration approved the first mood-stabilizer medication Lithium (although many U.S. physicians were already prescribing it in the late 1960’s without seeking an investigational new drug permit (IND) from the FDA, meaning its initial introduction to the U.S. population was entirely unregulated.) Following the official release of this new medication, an increase in the rate of official diagnoses of bipolar disorder naturally followed.
  • In 1995 Zyprexa was the first of the atypical antipsychotic medications approved for treatment of mania, and again, a surge in diagnosis ensued.
  • America is home to only 5% of the world’s population, yet it is currently prescribed more than 50% of all pharmaceutical drugs worldwide.
  • In 1976, Americans owned just 18.4% of the world market-share in pharmaceutical interests, but by the year 2000, that figure had climbed to 52.9%. [5]
  • In 2001, worldwide revenue for pharmaceutical drugs was around $390.2 billion U.S. Ten years later (2011), this figure stood at almost one trillion U.S. dollars.

With BIG money to be made from the prescription of pharmaceutical drugs, it’s not difficult to see why the mental health establishment’s treatment of bipolar disorder with psychotherapy waned — It was a question of financial incentive not effective treatment.

While United States has the highest rate of lifetime diagnosis of bipolar disorder, population-based surveys show that New Zealand is in second place [6], where a startling rate of almost 5% of the nation’s Maori (indigenous) population is diagnosed with bipolar disorder. Outside the U.S. and New Zealand, no other country even comes close.

Importantly, high bipolar rates are not the only thing these two countries have in common. In 1997, the United States became the second country — New Zealand was the first — to allow Direct-to-Consumer (DTC) advertising of pharmaceuticals, enabling drug companies to advertise their products directly to consumers. [7] By doing so, the U.S. FDA loosened the regulatory chains that previously kept drug companies in check, allowing them to advertise their “products” on television, radio and other media. This kind of marketing (like all mass-marketing) creates a sense of need where one previously did not exist; it allows the consumer to become familiar with the drugs available and their supposed “benefits”, to specifically ask their doctor for that medication, and if the doctor refuses, to find another doctor that will fulfil their request.

Of course none of this has anything to do with science. What it does involve is a multi-million dollar marketing scheme. And if you wonder why you never hear anything about this on the TV news, that’s because doing so would constitute a massive conflict of commercial interests for the media corporations that are heavily funded by pharmaceutical advertising. And despite the clear conflict of moral interests here, media corporations and the shareholders who ultimately benefit from this kind of direct-to-consumer marketing, prefer not to bite the hand that feeds them.

Are Prescription Drugs Actually Helping?

Psychotropic pharmaceutical drugs, like all drugs, can initially relieve symptoms of bipolar disorder, in the same way that alcohol or any number of illicit substances can be used to mask symptoms. Such substances artificially relieve us of unwanted feelings or states of mind, by affecting the brain’s chemistry. But as with all consciousness-altering drugs, relief is only temporary. You only get to ‘rent the relief’. In other words, everything that the drug gives you will eventually have to be paid back at some time.

The brain is always working to create balance – known as homeostasis – and when conditions change, the brain’s neurology also changes. Therefore the perceived positive effects of pharmaceutical intervention are therefore short-lived.

According to the reductionist medical and mental-health paradigms, a medication is deemed successful when the patients’s symptoms diminish. Although the do nothing to address theroot cause of psychosis, antipsychotic drugs can remove or mask the symptoms at first. This is the same principle that applies to alcohol, which can temporarily remove feelings of anxiety or depression — but it is by no means a long-term solution. In fact, what happens is that the brain quickly develops a tolerance to the substance and the individual taking it then needsmore of the drug in order to feel the same effects. Eventually, a threshold is reached at which the individual no longer feels any effect and cannot be prescribed an increased dosage; the drug becomes the ‘new normal’. Then, when you try to stop taking the drug, your body suffers serious physical, mental, and emotional effects, because it has grown dependent on it. The body then needs to create homeostasis again, to cope without the drug. This is what is known as withdrawal.

In an August 2014 letter to The Psychiatric Times, psychiatrist Sandra Steingard M.D. (the Medical Director of Howard Center and Clinical Associate Professor of Psychiatry at the University of Vermont College of Medicine in Burlington) compared a number of different studies that demonstrate just how those suffering bipolar disorder and other psychoses are actually more effectively treated without antipsychotic drugs. She compared studies of individuals who stayed on antipsychotic drugs with studies of those who stopped using the medications after a period of two years.

According to Dr. Steingard’s research, after two years the results were initially fairly even, with 74% of those who stayed on antipsychotic medications showing psychotic symptoms, compared with the 60% of individuals showing psychotic symptoms in the group that stopped taking their medications after two years. However, as time went on, the gap grew exponentially larger. At 4½ years, 86% of those who continued to take the medications displayed psychotic symptoms, compared to 21% of those who continued to abstain after the two year mark. And after 20 years, the difference was 68% compared to 8% respectively.[8] Says Dr. Steingard:

This raises troubling questions for psychiatry… Psychiatrists are assigned a powerful role in our society; we can force patients into treatment, and this sometimes includes forcing them to take these drugs… In taking on this task, it seems that psychiatry should be assiduous in assessing risk and utterly transparent in our disclosures. This risk includes not only the failure to treat but also the consequences of our treatments. Yet, this has not been our history. Our profession has been slow to address the limitations of our drugs. We were slow to acknowledge tardive dyskinesia [a neurological disorder that occurs as the result of long-term or high-dose use of antipsychotic drugs] and slow to address the metabolic impacts of the newer antipsychotics. Will we be equally slow in addressing their impact on long-term recovery?

Clearly, pharmaceutical intervention is no solution to mental health disorders such as bipolar. All drugs, legal or illegal, have adverse effects on the body’s chemistry. Yet, with the support of regulatory bodies such as the U.S. Food & Drug Administration, pharmaceutical companies label the desirable short-term effects as the “main” effects and the unwanted ones as “side effects.” But, as the science has clearly demonstrated, all antipsychotic drugs will bring about changes in the body that are unnatural and undesirable, which ultimately prolong the suffering of the patient.

Blaming The Patients, Not The Drugs

We’ve all seen those stories on mainstream news where someone has committed a heinous or violent crime, and we are subsequently informed that the cause of their violence was because the individual did not follow their medication plan. The diagnosis of ‘insanity’ and the individual’s failure to medicate is blamed as the cause for their psychotic behavior. But people in true psychosis are not typically violent; that perception is simply not true. It is generally once they stop taking their prescribed antipsychotic medications (perhaps due to the undesirable side-effects being experienced) that the withdrawal/side-effects create these suicidal or homicidal behaviors.

In other words, far from helping the patient, the taking of drugs as a “solution” to their condition actually leads to further problems, sometimes involving the tragic loss of life.

Drugging Adolescents and Children

Like all good product marketers, companies search for untapped markets and seek to create customers for life. This is known as ‘cradle to grave’ marketing; a corporate term that bears an eerie interpretation when viewed in the context of the medical and pharmaceutical industry.

In 1995, around 25 out of 100,000 adolescents aged 19 and under were diagnosed with bipolar disorder. By 2002, less than a decade later, that number had risen to 1,679 diagnoses out of 100,000 visits. [9] This increase is staggering! While the medical establishment shrugs its shoulders, unable to determine a scientific cause for such a sharp increase, realistically, the one factor that has actually changed in that time period is the ready availability and social acceptability of antipsychotic medications.

But this startling trend doesn’t stop with adolescents; there has also been a steady increase in the diagnosis of pediatric bipolar disorder. Yes, you read that right – infants! In my experience, diagnosis goes a little like this:

Does your child act silly and crazy at some times? Then other times are they sad or angry? They might have bipolar disorder. Our drug can help you stabilize your child.

In reality, these young children do not have a diagnosable mood disorder — they are four-year-olds! Four-year-olds are simply not meant to always sit still, pay attention to one thing for extended periods, or regulate their own natural moods and emotions the way “socialized” adults do. Adding to this problem, up to 40 percent of U.S. schools are now cutting back on recess — the time when children get to go outside and be children!

And yet, prescribing antipsychotics has become the overwhelming norm, being regularly prescribed for so-called “behavioral disorders” like ADHD and ADD. According to Dr. Michelle Kmiec, an holistic health practitioner and contributing writer for Wake Up World:

Since 1990, according to some estimates, there has been a 300% increase with pharmaceuticals used to treat children diagnosed with ADHD. Now doesn’t that statement alone scream that there is something wrong with our medical establishment? It seems the trend is not to question why so many children (and adults) are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), but instead to simply keep developing more drugs to counteract the “symptoms”.

Dr. Peter Breggin, a psychiatrist from Ithaca, N.Y., elaborates:

These drugs damage developing brains. We have a national catastrophe… This is a situation where we have ruined the brains of millions of children. In controlling behavior, antipsychotics act on the frontal lobes of the brain — the same area of the brain targeted by a lobotomy… These are lobotomizing drugs. Of course, they will reduce all behavior, including irritability.

It should also be noted that long-term use of the antipsychotic risperidone, commonly prescribed to young children, is associated with serious side effects including headache, uneven heartbeats, fatigue, insomnia, weight gain and increased risk for type 2 diabetes.

To complete this discussion today, I would like to share a personal account of my time with one of those 1,679 adolescents out of every 100,000 who are diagnosed as “mentally ill for life”.

Jacob’s Hope

“How can you say he is intelligent and gifted!?” shouts the mother of a 19-year-old adolescent,“He just tried to kill himself, talks crazy, and is emotionally unstable. Do not tell me he isintelligent!”

Jacob stormed out of the room, slammed the phone against the wall, and began pounding his fists into the corner of the room as if he were a caged animal begging to be set free. Quickly the entire hospital staff sprinted – following the culture and protocols of state hospitals – and Jacob was quickly restrained as though he were a criminal. Tears rolled down his cheek and onto the floor.

I was taken aback by what I just witnessed.

“They say I have bipolar disorder,” Jacob told me later that afternoon. “They tell me that I am sick, that I need to be locked up here, and take these medications. I do not think I am sick, but I am not allowed to say that.”

Believing he was a danger to himself and others, Jacob’s family committed him to a state psychiatric hospital following what they believed to be “bizarre” comments and behavior they had witnessed.

“I don’t think like them,” Jacob told me, “All they care about is money. Money is worthless. I do not want to go to college. College is just a façade. They charge thousands of dollars to have you memorize information. They teach you what to think, not how to think. Those who get good grades are just robots, all they do is repeat what the teacher has told them. But I think the government is corrupt. I do not trust them. I do not want to work for my Dad’s business. I want to travel the world, be a vagabond, read, write, and draw. I do not have any desire to work just to own material possessions. It is all phony.”

As this continued, I realized that nothing this child told me was bizarre. In fact, I admired his ability to think freely – outside the box – and respected his deep understanding of his own reality. Jacob is not sick; he is misunderstood, creative, and actually quite gifted.

Other gifted individuals such as Vincent van Gogh, Ernest Hemmingway and Kurt Cobain shared the same diagnosis of bipolar disorder, and gave us some of the greatest art of their respective times. Sadly, each of the aforementioned also ended their own lives due to the depressive pole of the bipolar complex, which brought about overwhelming suicidal tendencies upon which (sadly) they acted.

Jacob had once attempted suicide too.

“There are no people like me. No one understands me. Nobody gets it”, he told me when sharing the story of his suicide attempt, “So what is the point in being here? Everyone is living a fake life, chasing money to buy things they don’t need, to impress people they don’t like. That is not what life is about. I just need an escape from it all and sometimes it feels overwhelming.”

Jacob asked to be taken off his medications because they made him feel like a zombie, feeling nothing at all, just going through the motions of life. But in the psychiatric world, any patient who shares an opinion such as this is simply labeled “resistant to treatment”, and their medication dosage is increased. The only way to be successfully discharged from psychiatric institutionalization is to follow to the letter what the staff believes is best for you, entirely without your input.

For my own sanity, this is a game that I like to call “Saving Normal.” Society and psychiatry have decided what normal is, with no scientific basis or understanding of the human condition, and then we tell ourselves that we are saving people by returning them to a state of mentalnormalcy.

Understanding his own nature better than any of the so-called experts on staff, Jacob stated that his goals were to stop taking medications, to discuss his feelings with people he trusted which he believed would help to minimize his feelings paranoia. But the staff would not allow it! Jacob was instructed that he can no longer talk about such things as the corruption of government, so he followed his orders and played the game, simply to get discharged.

But is such a protocol really helping people like Jacob? No. We are merely attempting to condition people like Jacob to ‘be’ what they need to be, to meet the expectations of society and to please the people who are empowered by government to run his life for him. This is why no one actually heals in the mental health system. This is why they come back, as life-long customers of the system. And when they do, we repeatedly try to force-feed them our beliefs about ‘normal’, medicate them out of their minds, and punish and restrain them for expressing their most intimate truth.

“I would like to be taken off my medications,” Jacob presented to the staff, “I am not sick. You can keep me here longer to monitor me if you wish. The meds make me sick and all I am asking is for an opportunity. I was depressed because I felt alone and nobody understands me. But I am seeing that there are people out there like me, just not as many. I want to be myself, which is why I use drugs and alcohol – it sets me free. Then I get more depressed and feel that life is not worth living. It has nothing to do with a disorder, I have just felt rejected and keep being told that I am not normal. But that’s ok, too. I’m not even sure I would want to be normal.”

The psychiatric team told him they would consider what he had said, but as soon as he left of the room, they burst into collective laughter. I know this because I was there. I was horrified but not surprised.

During his stay, I befriended Jacob and felt a real connection with him. I found him to be a highly sensitive and intelligent young man. He realized he must do as they told him so he would be granted his discharge and move on with his life. He was doped up with medications that made him sleep all day and, rendered inactive by the drugs that were forced upon him, he gained 20 pounds in just a few weeks. Worst of all, he no longer talked about the things that brought him joy and energy.

As far as the psychiatric staff were concerned, Jacob no longer displayed “psychotic symptoms” which, in their eyes, meant that he was clinically making progress. As his symptom diminished, the staff patted themselves on the back for “curing” this poor child, and the family was happy to have ‘saved normal’.

As for me? I was furious! This was simply not right. This child was intelligent, bright, and naturally gifted, and the “mental health” establishment took that away from him, and outwardly congratulated themselves for doing so.

But, when we scratch the surface of psychiatric institutions, the sad reality is that most psychiatric physicians are inadequately trained even to prescribe the psychotropic medications they so commonly substitute for genuine care — and deep down, they know it.

Dr. Marianne Kuzujanakis, MD, MPH, is a pediatrician with a Masters in Public Health from Harvard, the Director of SENG (Supporting Emotional Needs of the Gifted) and a co-Founder of the SENG Misdiagnosis Initiative. In an article for Psychology Today she described this problem as follows:

Pediatric primary care physicians do much of the psychiatric diagnosis and prescribe most of the psychotropic medicine – but a recent survey showed that only 10% felt adequately prepared by their training to do so. They see these kids for very brief visits, and many are too influenced by drug marketing propaganda – as are parents and teachers. Over-diagnosis and over-treatment are commonplace.

Dr. Kuzujanakis went on to state that pediatric misdiagnoses of ADHD, autism, depressive disorders and bipolar disorder are often attributed to highly gifted individuals; and at the same time, other symptoms go unrecognized, such as learning disabilities in those who do genuinely have them.

Dr. Kuzujanakis also asserts that giftedness does not always equate to what our society deems “positive” experiences. In fact, up to 20% of gifted adolescents drop out of the school system, displaying such “symptoms” as talking a lot, high energy levels, and impulsive, inattentive, or distractable behaviours. [10] Notably, these symptoms of the gifted are remarkably close to the symptoms of a person experiencing the manic pole of the bipolar disorder. And they are the same behaviors I observed in young Jacob, whose only desire was “to travel the world, be a vagabond, read, write, and draw.”

Where Is Jacob Now?

Today, Jacob has a family of his own, lives in the country, spends time in nature and makes enough money to pay the bills. He spends most of his time with his beautiful children, teaching them about life and what he feels is most important. He did end up traveling the world, roughing it with almost no money in his pocket — and he got to experience how other cultures lived, as was his dream.

Jacob rarely sees his immediate family these days, other than at occasional family reunions at which he regularly hears condescendingly mutters about ‘how bad they feel for him and his family’. But Jacob is happy. He knows who he is, and although his family does not understand this, it is Jacob who feels badly for them. While he now enjoys all aspects of the life he has created for himself, they – like most of us – continue to live behind their masks of ‘normalcy’.

So I ask you… Who is the crazy one?

U.S. government begins human trials of genetically modified Ebola vaccine .

Just as predicted, vaccine companies are soon planning to unveil an Ebola vaccine in response to the manufactured Ebola outbreak that’s allegedly still spreading throughout West Africa. A genetically-modified (GM) Ebola vaccine that’s currently undergoing human clinical trials will be a spray rather than an injection, and its administration, according to one virologist, “…will not require trained medical personnel.”

Much like an inhaler, the novel GM Ebola vaccine will be delivered through a special “breathing device” that anyone can pick up and use without a doctor’s help. It’s made from a common respiratory virus known as human parainfluenza virus type 3, or HPIV3, that scientists artificially engineered to contain genes from the Ebola virus. These genes purportedly encode the proteins of Ebola virus on the outside of the HPIV3 virus, prompting an immune response.

Researchers publishing their work in the Journal of Clinical Investigation say the vaccine has already been tested on six rhesus macaques, whose respiratory tracts were deliberately infiltrated with the GM virus. One month later, these same monkeys were injected with a dose of Ebola virus that was 1,000 times higher than the level that would normally kill them, but they survived.

The GM virus in the vaccine apparently replicated in the monkeys’ respiratory tracts upon inhalation, which in turn caused their cells to produce multiple copies of the Ebola virus’s coat. Recognizing the resultant end product as a foreign invader, the monkeys’ immune systems attacked it, which researchers say is an indicator of success.

They’re now testing this experimental GM Ebola vaccine on a small group of humans in the next step towards eventual commercialization, with the National Institutes of Health (NIH) leading the Phase I trial. The goal is to confirm the safety and efficacy of the vaccine, which they expect to undergo another three years or more of safety testing.

Aerosolized GM Ebola vaccine provides airborne vector to unleash deadly disease outbreak

The researchers involved with the study claim the vaccine doesn’t show any signs of harmful side effects, but time will tell whether or not this is actually the case. The unmitigated replication of a genetically engineered virus inside the body can’t be a good thing, even if the body supposedly recognizes it as foreign and attacks it.

This particular vaccine also works differently from other vaccines in that it targets two types of immunity – “local” and system-wide. Local, in this case, refers to the immunity present in the mucous membranes of the respiratory tract, while system-wide immunity refers to the gamut of immune cells that normally circulate throughout the body.

How this alteration in immune stimulation will affect humans in the long term is currently unknown, though researchers don’t seem all that concerned about the potential for major autoimmune effects. Their only focus, it seems, is to rush this GM Ebola vaccine to market as quickly as possible and to make it as easy as possible for people to receive it, particularly in poorer areas of West Africa.

As with any aerosol-based vaccine, there’s also the potential for viral spread beyond the individual to whom it’s being administered. Like with live-virus influenza vaccines, virus “shedding” is a serious concern, as is the threat of a GM virus spreading like wildfire throughout a population and potentially causing an outbreak of disease.

“In other words, creating the vector Ebola hasn’t had yet – being airborne,” wrote one Gizmodo commenter about the potential for a major catastrophe stemming from this novel vaccine. “Giving it to strains that will have developed a resistance to the vaccine and then disseminating it worldwide. What could possibly go wrong?”

Learn more:

Cystic Fibrosis: New Hope for Gene Therapy?

Gene therapy to treat cystic fibrosis patients was associated with stabilization — but not improvement — in lung function, according to the results of a randomized, double-blinded phase IIb trial of the therapy in the U.K.

In a per protocol analysis, Professor Eric W.F.W. Alton, of Imperial College in London, and colleagues found a significant, but modest, treatment effect in cystic fibrosis patients treated with the nonviral, chemically designed gene-liposome pGM169/GL67A compared with those treated with a placebo of 0.9% saline (3.7%, 95% CI 0.1-7.3, P=0.046).

While a significant ANCOVA-adjusted effect was observed after 12 months’ follow-up, relative differences in FEV1 after 12 months of treatment were -0.4% (95% CI -2.8 to 2.1) for the treatment group compared to -4.0% (CI -6.6 to -1.4) for the placebo, they reported in The Lancet Respiratory Medicine.

The primary endpoint of the study was defined as relative percent change in forced expiratory volume (FEV1) after 12 months. The authors achieved that because while treatment with pGM169/GL67A did not improve lung function, it did not worsen it either.

Modest Benefit

“This study proves for the first time that copies of the normal CF gene delivered by aerosol inhalation can have a measurable beneficial effect on lung function, compared with placebo, in patients with cystic fibrosis,” senior co-author Dr. Alastair Innes, of Western General Hospital in Edinburgh, Scotland, told MedPage Today. He added that while the effect was statistically significant, he also described it as “modest.”

A small number of patients in both groups did experience improvements in lung function. The authors note that a post-hoc analysis showed 18% of patients (15 in the treatment group and six in the control group) showed an improvement in percent predicted FEV1 of 5% or more of their initial baseline values. By contrast, overall treatment effect in the 65 patients in the treatment group and 56 in the control group was 3.6% (95% CI 0.2-7.0,P=0.039). Of the 20 patients who did not complete the full treatment of one dose per 28 days for 12 months, they received a mean 3.7 doses (SD 1-9).

Patients were randomized into a number of stratified subgroups, but the authors attributed any treatment effect to a greater decline in FEV1 from the placebo group as opposed to greater improvement from pGM169/GL67A. Stratifying by baseline predicted FEV1 (<70% versus ≥70%) found that patients with a more severe disease (FEV1 49.6%-69.2% predicted) had a treatment effect of 6.4% (95% CI 0.8-12.1). By contrast, those with less severe disease (FEV1 69.6%-89.9% predicted) had a 0.2% treatment effect (CI -4.6 to 4.9, P interaction=0.065).

The authors also cited the post-trial and pre-trial changes in the placebo group (-4.9%) compared with the treatment group (1.5%) as contributing to the treatment effect. There were no differences observed by age, sex, or CTFR mutation.

The study also had a number of secondary outcomes, which achieved mixed results. Patients in the treatment group experienced greater improvements in forced vital capacity (FVC) and CT gas trapping, or the inability to exhale completely (P=0.031 andP=0.048, respectively) than the control group. But authors observed no treatment effect for other measures of lung function, imaging, and quality of life. Similar to the primary analysis, they did note that secondary outcomes tended to be more favorable for those with more severe disease.

The authors commented that patients with more severe disease seemed to experience an enhanced treatment effect, and saw this as an opportunity for further research.

“A larger trial with a stratified trial entry design, powered to assess subgroups, and that addresses the mechanisms of response heterogeneity will be important to verify or refute these data,” they wrote.

A total of six serious adverse events were recorded from the pGM169/GL67A group. The committee judged that they were unrelated to the treatment, though one may have been related to a trial procedure (bronchoscopy), the authors said. Two patients total discontinued treatment; one in the placebo group due to fatigue and one in the treatment group due to flu-like symptoms. There were no deaths during the study, and the authors saw no clinically relevant changes in patients throughout the study.

This randomized, double-blinded, placebo-controlled trial consisted of two cystic fibrosis centers in London and Edinburgh at 18 sites in the U.K. from June 12, 2012, to June 24, 2013. Participants were eligible if they were ages ≥12 years, had a FEV1 of 50%-90% predicted and had any combination of CFTR gene mutations. Of the 140 patients, 78 received pGM169/GL67A and 62 received a placebo. There were 116 patients (83%) completing the treatment and included in the per protocol analysis.


The most important limitation the authors cite is that the mean difference is at the lower end of clinical trials for gene therapy in patients with cystic fibrosis, mainly due to the reduction in FEV1 volume in the placebo group. They suggest several reasons for this, such as optimal respiratory health for patients at time of trial entry, enthusiasm for the trial leading to improvements in lung function during the recruitment period, and that the trial included all available data, even if the patients were unstable, while registry data only contains measurements from an annual review. They also note the trial’s heterogeneous response and that the fact that changes may be the result of a “non-specific response” to the pGM169/GL67A treatment.

The authors describe their conclusions as a “proof of concept” for nonviral CFTR gene therapy, calling it “another step along the path of translational cystic fibrosis gene therapy.”

Innes said that the efficiency of the gene uptake needs to be improved before the therapy is applicable to clinical practice, adding that the UK Gene Therapy Consortium is engaged in pursuing several lines of research.

“We are exploring whether increased or more frequent dosing would increase benefit, the possible additional benefit of combining gene therapy with other basic treatments which help the CF ion channel to remain open, and novel viral gene therapy vectors which may increase the efficiency of gene transfer,” he said.

This Common Activity Is Reducing Your IQ, According to Research

Lack of sleep affects intelligence

The performance gap caused by an hour’s difference in sleep was bigger than the gap between a normal fourth-grader and a normal sixth-grader. Which is another way of saying that a slightly-sleepy sixth-grader will perform in class like a mere fourth-grader. “A loss of one hour of sleep is equivalent to [the loss of] two years of cognitive maturation and development,” Sadeh explained.
There is a correlation between grades and average amount of sleep.

Via NurtureShock:

Teens who received A’s averaged about fifteen more minutes sleep than the B students, who in turn averaged fifteen more minutes than the C’s, and so on. Wahlstrom’s data was an almost perfect replication of results from an earlier study of over 3,000 Rhode Island high schoolers by Brown’s Carskadon. Certainly, these are averages, but the consistency of the two studies stands out. Every fifteen minutes counts.
Not only does it affect intelligence, lack of sleep also reduces impulse control.

Via NurtureShock:

A different mechanism causes children to be inattentive in class. Sleep loss debilitates the body’s ability to extract glucose from the bloodstream. Without this stream of basic energy, one part of the brain suffers more than the rest—the prefrontal cortex, which is responsible for what’s called “Executive Function.” Among these executive functions are the orchestration of thoughts to fulfill a goal, prediction of outcomes, and perceiving consequences of actions. So tired people have difficulty with impulse control, and their abstract goals like studying take a back seat to more entertaining diversions. A tired brain perseverates—it gets stuck on a wrong answer and can’t come up with a more creative solution, repeatedly returning to the same answer it already knows is erroneous.
And when we’re tired it’s actually harder to be happy. We can recall negative memories more than positive ones when we’re exhausted.

Do Not Email First Thing in the Morning or Last Thing at Night.“The former scrambles your priorities and all your plans for the day and the latter just gives you insomnia,” says Ferriss, who insists “email can wait until 10am” or after you check off at least one substantive to-do list item.
<strong>Do Not Agree to Meetings or Calls With No Clear Agenda or End Time</strong> “If the desired outcome is defined clearly… and there’s an agenda listing topics–questions to cover–no meeting or call should last more than 30 minutes,” claims Ferriss, so “request them in advance so you can ‘best prepare and make good use of our time together.’”

Do Not Email First Thing in the Morning or Last Thing at Night “The former scrambles your priorities and all your plans for the day and the latter just gives you insomnia,” says Ferriss, who insists “email can wait until 10am” or after you check off at least one substantive to-do list item.

Negative stimuli get processed by the amygdala; positive or neutral memories gets processed by the hippocampus. Sleep deprivation hits the hippocampus harder than the amygdala. The result is that sleep-deprived people fail to recall pleasant memories, yet recall gloomy memories just fine. In one experiment by Walker, sleep-deprived college students tried to memorize a list of words. They could remember 81% of the words with a negative connotation, like “cancer.” But they could remember only 31% of the words with a positive or neutral connotation, like “sunshine” or “basket.”

California legislators who passed SB 277 to force vaccines on children now want to do the same for adults with SB 792

Now that nearly all school-age children in California have been summoned into the state’s growing medical dictatorship through Senate Bill 277, corrupt politicians are now trying to pass a companion bill that would force adults to be vaccinated in accordance with the government’s prescribed vaccine schedule.

Introduced by California Senator Tony Mendoza of Senate District 32, Senate Bill 792 is the medical mafia’s latest attempt to force vaccines on individuals without informed consent. It would mandate that adults who work in settings where children are being cared for or educated to be jabbed with many or all of the same vaccines that the children are forced to receive, without the option for a personal or religious exemption.

Those who refuse the mandate would face criminal penalties for non-compliance, according to the bill’s verbiage, which takes it one step further than SB 277 in forcing people under duress to accept a medical treatment that they might otherwise refuse due to the risk of serious adverse events, including death.

“This bill would make California the first state to require mandated vaccinations for all childcare workers, including all private and public school early childhood education programs (Headstart, Private preK and preschools), family daycares, and daycare centers,” warns Vaccine Impact.

“This bill eliminates medical autonomy, crushes religious freedom, undermines personal freedom, and burdens quality providers with a non-optional series of medical interventions in the form of mandated vaccines that are not even 100 percent effective.”

SB 792 would force adults in childcare settings to get annual flu shots

If passed, SB 792 would require all qualifying adults to be vaccinated for influenza, pertussis, and measles beginning on September 1, 2016. These same individuals would also have to receive annual flu shots between August 1 and December 1 of each subsequent year, in perpetuity.

“This bill, commencing September 1, 2016, would prohibit a day care center or a family day care home from employing any person who has not been immunized in accordance with the schedule for routine adult immunizations, prescribed by the federal Centers for Disease Control and Prevention,” reads and excerpt from the bill.

“The bill would make conforming changes to provisions that set forth qualifications for day care center teachers and applicants for licensure as a family day care center. Because the bill would extend the application of a crime under the act, the bill would impose a state-mandated local program.”

Learn more:

New Drug Lowers Levels of Triglyceride Blood Fats: Study

An experimental drug dramatically lowers blood levels of potentially harmful triglycerides, a new study finds.

Triglycerides are a type of blood fat created by the food you eat. At very high levels, they can cause heart problems and pancreatitis, an inflammation of the pancreas.

“Current treatment for elevated triglyceride [levels] leaves a lot to be desired,” said researcher Dr. Joseph Witztum, a professor of medicine at the University of California, San Diego. “This drug holds the promise that it will be the most effective therapy we have.”

The new drug — called ISIS 304801 for now — lowers triglyceride levels by as much as 71 percent without unpleasant side effects, the study found.

Elevated triglycerides can be caused by genetics as well as obesity, smoking, drinking too much alcohol and a diet very high in carbohydrates, the American Heart Association says.

Normal triglyceride levels are less than 150 milligrams per deciliter (mg/dL). But some people have much higher levels, which is associated with insulin resistance,metabolic syndrome, diabetes, inherited high cholesterol and certain other disorders, the researchers explained. Metabolic syndrome is a combination of high blood pressure, high cholesterol, high blood sugar and excess body fat.

A blood test will show levels of LDL (“bad”) cholesterol, along with HDL (“good”) cholesterol, and one-fifth of your triglyceride level, according to the American Heart Association.

Current treatments for elevated triglycerides include eating a healthy diet rich in fish oil and taking niacin (Niaspan), also called nicotinic acid. Drugs called fibrates, such as TriCor, can help lower triglyceride levels, but some patients don’t respond to the usual treatments, Witztum said.

The new drug works by targeting a protein — called apolipoprotein C-III — that slows the breakdown of triglycerides. In effect, ISIS 304801 speeds up the breakdown of triglycerides, allowing the fat to leave the body quickly.

“The drug lowers triglyceride and probably manifestations of insulin resistance and metabolic syndrome,” Witztum said.

For the study, researchers treated 57 patients with the drug or an inactive placebo. Their triglyceride levels ranged between 350 and 2,000 mg/dL, and they received weekly doses of the drug over 13 weeks.

The study also included 28 people who had triglyceride levels ranging from 225 to 2,000 mg/dL, who had been receiving fibrate therapy. These patients also received the new drug or placebo.

Overall, the researchers found that ISIS 304801 reduced triglyceride levels 31 percent to 71 percent.

This trial was the second of three required for drug approval in the United States. Witztum said that phase 3 trials are underway, but the results will not be available for two to three years.

Initially, the drug is intended to treat people who suffer from conditions such as inherited chylomicronemia syndrome that cause very high triglyceride levels, he said. In this condition, the body doesn’t break down fats correctly.

In the long run, Witztum believes the drug will be used by a larger population to help prevent heart disease related to high triglyceride levels.

The trial was funded by Isis Pharmaceuticals, the drug’s maker, and the results were published July 30 in the New England Journal of Medicine.

Dr. Gregg Fonarow, a professor of cardiology at the University of California, Los Angeles, said the study findings appear promising.

However, “whether lowering of triglyceride levels will in and of itself result in reduction in cardiovascular events remains to be demonstrated,” he said.

Further studies are needed, Fonarow said, to evaluate the drug’s safety and effectiveness, and determine whether it can prevent problems caused by high triglycerides.

“While the patient population that may benefit from a safe and effective triglyceride-lowering medication is more limited than the very broad population that have been shown to benefit from statin therapy to reduce cholesterol, there remains an important, but still unmet, clinical need,” Fonarow said.

5 Ways to Avoid Discomfort After Your Gallbladder Removal .

If you have your gall bladder removed, watch your diet carefully afterward. It can help you adjust gradually to changes in your digestion with little discomfort.

Gall bladder surgery solves the problem of gallstones, hard deposits of digestive fluid in the gallbladder. As people age, they become more common. In fact, surgeons remove more than 600,000 gallbladders each year to eliminate the pain associated with this condition.

The gallbladder – a pear-shaped organ on your right side beneath your liver – isn’t vital. However, it does help you digest fatty foods. It stores, concentrates and secretes the bile your liver makes.

After surgery, your liver still makes enough bile. But you might have difficulty processing fatty foods – at least for a while. More than half of patients who have their gallbladder removed have trouble digesting fat.

Here are five tips to avoiding discomfort after gall bladder removal:

1. Add foods back into your diet gradually

For the first few days after surgery, stick with clear liquids, broths and gelatin. After that, gradually add more solid foods back into your diet.

2. Go for low-fat and smaller portions

I advise my patients to avoid fried foods, high-fat foods, foods with strong odors and gas-causing foods. You should also stick to small, frequent meals.

Overall, I tell patients who have gallbladder removal surgery to stick to a low-fat diet. Typically, fat calories should total no more than 30 percent of your daily intake. That means if you eat about 1,800 calories each day, you should consume no more than 60 grams of fat.

Read food labels carefully. Look for foods that offer no more than 3 grams of fat per serving.

3. Skip high-fat foods t0 help avoid discomfort

Eating the wrong things after gallbladder surgery can induce pain, bloating and diarrhea. To side-step this gastrointestinal discomfort, avoid eating high-fat or spicy foods, including:

  • French fries and potato chips
  • High-fat meats, such as bologna, sausage and ground beef
  • High-fat dairy, such as cheese, ice cream and whole milk
  • Pizza
  • Lard/butter
  • Creamy soups and sauces
  • Meat gravies
  • Chocolate
  • Oils, such as coconut and palm oil
  • Chicken or turkey skin
  • Spicy foods

4. Take it slowly as you reintroduce high-fiber foods

Consider adding these gas-producing foods back into your diet slowly:

  • Whole-grain bread
  • Nuts
  • Legumes
  • Seeds
  • Brussels sprouts
  • Broccoli
  • Cauliflower
  • Cabbage
  • Cereal

Slowly add small amounts of foods back into your diet. Re-introducing things too quickly can lead to diarrhea, cramping and bloating.

5. Keep a journal and watch for ill effects

It’s a good idea to keep a food journal after surgery. You can keep track of when you begin eating a food again and what the impact is. Doing so will help you know what you can and cannot eat comfortably.

Most people can return to a regular diet within a month after surgery. However, talk to your doctor if you experience these symptoms:

  • Persistent, worsening or severe abdominal pain
  • Severe nausea or vomiting
  • Jaundice
  • No bowel movements for more than three days post-surgery
  • Inability to pass gas more than three days post-surgery
  • Diarrhea that lasts more than three days post-surgery

After surgery, doing these things should help you feel more comfortable. As time goes on, take note of your tolerance for higher fiber foods and fats, especially healthy fats.

Facebook Is About to Test Its Enormous Solar-Powered Drone

CX Deck

AT AN AIRFIELD somewhere in the UK, there’s a drone with the wingspan of a Boeing 737. And it belongs to Facebook.

This enormous unmanned aerial vehicle is called Aquila—a nod to the eagle who carried Zeus’s thunder bolts in Greek mythology—and it’s part of Facebook’s rather ambitious effort to deliver Internet access to the more than 4 billion people on earth who don’t already have it. The idea is that Aquila will circle in the stratosphere, above the weather, wirelessly beaming Internet signals to base stations in underdeveloped areas of countries like Nigeria and India.

Earlier this year, the company tested smaller models of this aircraft, and now, according to Facebook’s Yael Maguire, who oversees the project, the company is ready to test the full-size Aquila prototype. “The aircraft is real,” he tells WIRED, before a briefing with other reporters at Facebook headquarters in Menlo Park, California.

Though as wide as a 737, the drone weighs hundreds of times less than the commercial airliner, thanks to a carbon-fiber frame. The goal, Maguire says, is to reach a point where the drone can stay aloft for 90 days at an altitude of between 60,000 and 90,000 feet. “We think this is a very ambitious goal, given that the world record, as far as we can tell, is about two weeks.”

Meanwhile, at a lab in Woodland Hills, California, another group of Facebook engineers is developing new laser networking technologies that can help the drone beam its Internet signals down to earth. According to Maguire, the group has designed and tested a laser that can deliver data at “10s of Gbits per second,” hitting a target the size of a dime at a distance of 10 miles.

Developed under the aegis of a researcher group dubbed the Facebook Connectivity Lab, the Aquila project is just one of many efforts to deliver Internet access from the skies. Google is testing its own solar-powered drones—crashing one earlier this year—and it’s designing enormous balloons that can already stay aloft at similar heights for upwards of 180 days. Facebook and others are also exploring satellites that provide Internet signals from higher altitudes.

At Facebook and Google, these projects carry ulterior motives. The companies believe that if they expand the reach of the Internet, they’ll expand the reach of their businesses. Neither company plans to operate their own sky-high Internet services; they plan on handing these aerials to existing providers such as Vodafone. But these projects still have a long way to go. “There are many challenges ahead,” says Phil Finnegan, an analyst with the Virginia-based research outfit The Teal Group, who specializes in unmanned aerial vehicles. “Technologies are improving, but we’re not there yet.”

Indeed, it seems that Facebook has yet to test its 737-sized drone, and Maguire says the company likely won’t reach its 90-day-aloft goal until the end of this year or early next. At 60,000 feet, the drones are indeed above the most violent weather—and the clouds—but they must still deal with a little wind and extremely cold temperatures.

Though these planes are light and can power themselves via solar energy, Facebook must also find ways for the drones to carry all the equipment needed to deliver Internet signals, says Danny Ellis, the CEO of drone company SkySpecs, who has closely followed the project. Added weight could affect speed, but he believes that Facebook’s goal of a 90-day flight time is very doable. “Long-term, this is definitely a feasible idea,” he says. “We’ve already seen similar aircraft that can fly around the globe.”

Of course, Facebook must also find ways of reliably beaming that Internet access down to earth. Though the company is claiming that its laser technology is 10 times faster than the state of the art, Maguire declines to discuss the particulars of this technology. George Papen, an optical networking researcher at the University of California, San Diego, says it’s difficult to comment on Facebook’s claims because the company is not providing specifics, but he says that many others are working on similar technology, and that speeds that exceed 10s of Gigabits are well within what’s possible today. “This is not science fiction,” he says.

The real trick is to create a networking technology that can deal with obstacles such as clouds. “Guess what? There are clouds between there and Earth,” Papen says. In so many ways, this is a complex project. But Maguire and Facebook are very much committed to making it happen. The company’s social network now serves 1.3 billion people worldwide. But there are so many more to reach.

First Artificial Ribosome Designed

Scientists at the University of Illinois at Chicago andNorthwestern University say they have engineered a tethered ribosome that works nearly as well as the authentic organelle that produces all the proteins and enzymes within the cell. The engineered ribosome may enable the production of new drugs and next-generation biomaterials and lead to a better understanding of how ribosomes function, according to the researchers.

The artificial ribosome, called Ribo-T, was created in the laboratories of Alexander Mankin, Ph.D., director of the UIC College of Pharmacy’s Center for Biomolecular Sciences, and Northwestern’s Michael Jewett, Ph.D., assistant professor of chemical and biological engineering. The human-made ribosome may be able to be manipulated in the laboratory to do things natural ribosomes cannot do.

When the cell makes a protein, mRNA is copied from DNA. The ribosomes’ two subunits, one large and one small, unite on mRNA to form the functional unit that assembles the protein (translation). Once the protein molecule is complete, the ribosome subunits, both of which are themselves made up of RNA and protein, separate from each other.

In a new study (“Protein synthesis by ribosomes with tethered subunits”) in Nature, the researchers describe the design and properties of Ribo-T, a ribosome with subunits that will not separate. Ribo-T may be able to be tuned to produce unique and functional polymers for exploring ribosome functions or producing designer therapeutics, and perhaps one day even non-biological polymers, point out Dr. Mankin.” We felt like there was a very small chance Ribo-T could work, but we did not really know,” he noted.

Dr. Mankin said he and Dr. Jewett and their colleagues were frustrated in their investigations by the ribosomes’ subunits falling apart and coming together in every cycle of protein synthesis. Could the subunits be permanently linked together? The researchers devised a novel designer ribosome with tethered subunits, i.e., Ribo-T.

“What we were ultimately able to do was show that by creating an engineered ribosome where the ribosomal RNA is shared between the two subunits and linked by these small tethers, we could actually create a dual translation system,” explained Dr. Jewett. “It was surprising that our hybrid chimeric RNA could support assembly of a functional ribosome in the cell. It was also surprising that this tethered ribosome could support growth in the absence of wild-type ribosomes.”

Turns out that Ribo-T worked even better than Drs. Mankin and Jewett believed it could. Not only did Ribo-T make proteins in a test-tube, it was able to make enough protein in bacterial cells that lacked natural ribosomes to keep the bacteria alive. The researchers were surprised by this. Scientists had previously believed that the ability of the two ribosomal subunits to separate was required for protein synthesis.

“Obviously this assumption was incorrect,” said Dr. Jewett. “Our new protein-making factory holds promise to expand the genetic code in a unique and transformative way, providing exciting opportunities for synthetic biology and biomolecular engineering.”

“This is an exciting tool to explore ribosomal functions by experimenting with the most critical parts of the protein synthesis machine, which previously were ‘untouchable,'” added Dr. Mankin.

New Immunosuppressive Approved for Kidney Transplant Recipients

The FDA recently approved Veloxis Pharmaceuticals’ tacrolimus extended-release tablets (Envarus XR) to prevent organ rejection in kidney transplant patients. Veloxis anticipates that the product will be available in the United States in the fourth quarter of 2015. The FDA’s approval was based on the results of several late-stage trials that demonstrated once-daily Envarus XR has a flatter pharmacokinetic profile and higher bioavailability than twice-daily, immediate-release tacrolimus (Prograf), the current leading transplant drug.

“We are very pleased to have a new treatment option available for kidney transplant recipients,” said Anthony Langone, MD, associate professor and medical director of the Medical Specialties Clinic at Vanderbilt University, in a press release. “Patients must receive immunosuppression as lifelong therapy, and Envarsus XR holds promise for kidney transplant patients and their physicians as a tacrolimus product with the convenience of once-daily dosing.

” Envarsus XR and other immunosuppressants are associated with an increased risk for developing serious infections and malignancies that may lead to hospitalization or death. Other risks related to Envarsus XR include acute or chronic nephrotoxicity and mild to severe hyperkalemia. Hypertension is another common adverse effect of the drug and may require antihypertensive therapy.