Day: 01/17/2015

Biosimilars in 2015 – What Can We Expect?

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On Wednesday, January 7th, the FDA Oncologic Drugs Advisory Committee unanimously recommended approval of Sandoz’s EP2006, a biosimilar for filgrastim (Neupogen). EP2006 is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments that deplete these necessary infection-fighting cells. If FDA-approved, this would be the first true biosimilar in the U.S. and would have a brand name of Zarxio. The FDA noted in their briefs that EP2006 was “highly similar” to the brand biologic and had “no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity, and potency”. The FDA stated that “robust” pharmacokinetic and pharmacodynamic comparative studies supported biosimilarity with the original filgrastim. Legal action over patent protection may still interfere with a launch any time soon.

I’ll admit, as a pharmacist the topic of biosimilars peaks my interest. Europe has been marketing biosimilars for 10 years now, and the Food and Drug Administration (FDA) is currently developing long-awaited standards so that this process can occur in the U.S. But I have many questions:

  • What is the current biosimilar status is in the U.S. and when will we see the first biosimilar?
  • What biologics are in line to be the first biosimilars?
  • Where will I find information about biologic interchange with biosimilars?
  • Can a pharmacist automatically substitute a biosimilar for a biologic?
  • Will a biosimilar still be as expensive as many of the biologics?
  • What lessons can we learn from the European Union biosimilar program?

The first true biosimilar may be approved in the U.S. soon. Here’s a few facts about biosimilars to get you up to speed.

Why Biosimilars?

The general process to approve generics for traditional (small-molecule) drugs, like Lipitor(atorvastatin) and Celebrex (celecoxib) is well-known. Consumers have enjoyed these savings for years, especially since 2012 when many top medications became available generically during the “patent cliff”.

In a nutshell, generic drug makers submit an abbreviated new drug application (aNDA) to the FDA in anticipation of, or after, a brand medication patent expiration. Based on the proven bioequivalence of the active ingredient(s), plus inclusion of the same use, dosage form, strength, route of administration, and labeling, generic manufacturers can bypass much of the expensive and time-consuming clinical studies done by the original manufacturer, according to the FDA. In other words — no need to reinvent the wheel. But the process for biologics and biosimilars is somewhat different.

Biosimilars are just that; similar because they do not have to be exact copies of the active ingredient, as with small-molecule drugs. The Biologics Price Competition and Innovation Act of 2009 (the BPCI Act) allowed the creation of an abbreviated licensure pathway for biological products that are shown to be interchangeable with an already FDA-approved biological product. Under the new law, a biological product may be demonstrated to be “biosimilar” if data show that the product is “highly similar” to an already-approved biological product. The BPCI Act aligns with the FDA’s longstanding policy of permitting appropriate reliance on drug science that has already been established, thereby saving time, resources and unnecessary duplication of animal testing or human clinical trials. Some clinicians and patients are concerned if a biosimilar is not exactly the same as its counterpart, how can they rely on its safety and effectiveness?

First things first: What exactly is a biological product?

According to the FDA, biological products can include a wide range of products including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and proteins. Unlike most traditional, small-molecule drugs that are manufactured through chemical processes, biological products are usually made from human and/or animal materials inside their cells. Biological products — for example, Enbrel (etanercept) or Humira (adalimumab) are referred to as “large-molecule” drugs because they are larger in structure and have a more complex structure than small-molecule drugs, Such products may also be derived from natural sources or produced synthetically.

What is a biosimilar?

A biosimilar is a biological product that is “highly similar” to a U.S.-licensed reference biological and for which there are no clinically meaningful differences between the biological product and the original branded product in terms of safety, purity, and potency of the product. However, a biosimilar is not considered a “generic” in the same way that a traditional drug is determined to be a generic. As with generics, cost savings for healthcare systems and the consumer are expected with biosimilars and will be significant. According to the RAND Corporation, biosimilars could save the U.S. health system close to $44 billion in the next ten years.

Biologics are complicated, and so is their manufacturing process.

It is much easier to create and analyze a generic for a traditional drug product because it consists of a pure chemical substance, but manufacturing large molecule biologics is a more complex task. Manufacturing changes will certainly lead to slight differences between biologics and biosimilars. Proteins can be altered when manufacturing processes change, and there is concern that this may alter how the biosimilar product performs clinically in the patient. Much debate centers around this issue.

FDA is addressing this problem. As noted by the agency “changes in the manufacturing process, equipment or facilities may require additional clinical studies to demonstrate the product’s continued safety, identity, purity and potency.” Makers of biosimilar drugs will also be responsible for proving to the FDA that their products have similar outcomes, and that switching back and forth between the brand and the biosimilar will be safe and effective for the patient. If these studies are not done, the product cannot be called a “biosimilar.” These types of transition studies are not typically conducted with small-molecule, non-biologic agents.

But wait, haven’t biosimilars been available in Europe for years?

Yes, several biologics have already lost patent protection in Europe. An established legal pathway for biosimilars has been in the European Union since 2005. Several biosimilars, including somatropins, filgrastims, and epoetins, have been licensed and marketed in the European Union (EU). Biologics that have already expired in Europe include Neulasta(pegfilgrastim), Remicade (infliximab), Mabthera (rituximab, known as Rituxan in the U.S.), andLovenox (enoxaparin).

Other top biologics facing future patent expiration include Humira (2018), Enbrel (2015), andAvastin (2019), all well-known brands in the U.S. According to IMS, the biologics market accounts for 27% of the pharmaceutical sales in Europe and is growing at 5.5% vs. total market growth of 1.9% between 2012 and 2013.

France was the first EU member-state to initiate automatic pharmacist substitution for biosimilars in February 2014.

Common concerns with biosimilars.

However, as learned from the European experience, there are concerns about product-related and clinical issues with biosimilars.

  • Immunogenicity can occur with biologics and biosimilars alike. Structural alterations in the biosimilar compound can lead to “immunogenicity”, inactivating the therapeutic effects of the treatment, and possibly causing side effects. Newly introduced substances during the manufacturing process with biosimilars may lead to immunogenicity not seen with its corresponding biosimilar.
  • Some clinicians express uncertainty about using biosimilars because they are not identical to the innovator product. However, even innovator biologics can have differences within the same batch, so this is not a new concept in biotechnology. Small differences can usually be picked up early on in manufacturing with sensitive testing, and may not be clinically significant.
  • Post-marketing, Phase IV safety studies should be initiated to actively monitor for previously unreported side effects.
  • Determination of valid endpoints measuring biosimilar activity in studies.
  • Use of biosimilars for unapproved or “off-label” indications based on extrapolated data may raise safety issues.
  • Concerns about automatic substitution at the pharmacy level due to differences in injection device, preparation, and handling of the biosimilar, which may increase the risk of a medication error or affect adherence to treatment.
  • Concerns over naming standards; biosimilars with the same exact name as the corresponding biologic may be assumed to be identical and automatically substitutable by health care provider or patient.

Are There FDA Biosimilar Standards?

Biological products are complex products and the pathway to approval is an even more complicated task. Since passage of the Affordable Care Act in 2010, the FDA has been establishing standards for licensure to ensure the safety and effectiveness of biosimilars. A working group consisting of members from both the Centers for Drug Research and Evaluation (CDER) and the Center for Biologics Evaluation and Research (CBER) are tasked with addressing product-specific review and issues relating to scientific methodology.

According to FDA, “scientists, clinicians, and other personnel at FDA are currently working out the details of the review and licensure process.” When the first biosimilar will be on the U.S. market is not known. It appears biologic brand products will have exclusivity for 12 years from the date of first licensure before a biosimilar can be approved.

In the U.S. roughly ten biosimilar products may be available for FDA review in the next decade due to patent loss. Examples include Neulasta (pegfilgrastim), Herceptin (trastuzumab), Rituxan(rituximab), Remicade (infliximab), and Aranesp (darbepoetin alfa). While the biologics Neupogen(filgrastim) and Granix (tbo-filgrastim) are both filgrastim products, they each went through the full BCPI Act approval process and therefore are not considered “biosimilar”. Companies such as Teva, Hospira and Sandoz are now developing biosimilar products; however, some manufacturers are awaiting the final FDA biosimilar standards for clarification.

In the U.S., will a pharmacist be able to automatically substitute a biosimilar for a biologic without contacting the prescriber?

According to the FDA, this can only happen if the products are deemed “interchangeable.” In general, biosimilar biological products cannot be dispensed in place of another biological product unless a physician or other healthcare professional prescribes the biosimilar product. However, if the product has been determined to be interchangeable, which means it is biosimilar to the reference product, and will produce the same clinical result as the reference product in any given patient, then they are substitutable. Interchangeable also means the original biologic and the new biosimilar can be switched back and forth in patients without a risk of diminished safety or efficacy. Pharmacists will be responsible for knowing which biological products are interchangeable.

The Purple Book

Once biosimilars are marketed, The Purple Book will be to go-to resource for pharmacists and other health care providers interested in making an interchange between a reference biologic and a biosimilar. Similar to The Orange Book used to compare generic products to their brand name counterparts, The Purple Book has been developed by the FDA to list each reference biological product and the corresponding biosimilar and interchangeable biological products. Those biosimilars designated as interchangeable will have no clinically important differences from the original product. However, variation in formulation, delivery device, indications, and routes of administration may be acceptable.

The Purple Book also lists information relating to exclusivity and patent protection of the reference biological product. The Purple Book will serve as a helpful resource to be able to determine the earliest date at which a biosimilar or interchangeable product could be licensed. The official title of the Purple Book is “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations”; the Purple Book is much easier, don’t you think?

The Question of Cost

The size of the molecule is not the only thing large about biologics. As reported in The Economist, biologics could encompass over 30 percent of total big pharma sales by 2023. Even though biologics are hard to make, they can be financially rewarding for a manufacturer when the product is a success. In fact, seven of the top 10 drugs by sales in the U.S. in 2014 were biologics, and understandably so.

Consider this — the average per patient revenue for Avastin (bevacizumab), a cancer treatment, was over $66,000 in 2014. AbbVie’s Humira for rheumatoid arthritis and other autoimmune conditions was the top selling biologic in 2014 with over $6 billion in revenue. Similar dollar figures pop-up for other biologics — Lantus, Enbrel, Remicade, Rituxan, Neulasta, and Avastin — all found in the top 10 drugs by sales for 2014, according to EvaluatePharma. Revenues in 2014 for these drugs ranged from $3 billion to $5.7 billion in sales. Couple that with the delay in biosimilar standards, and even biologics with a valid patent expiry still enjoy significant market share. Epogen (epoetin alfa) was first launched in 1989, with 2012-2013 patent expirations in the U.S., but it still sees no biosimilar competition.

How payors will handle the burgeoning cost of biologics and biosimilars is another question that is not yet fully answered. Insurance groups are pushing back on the price tags, and for patients who lack adequate insurance, potentially life-saving biologic therapy can be completely out of reach.

Future discounts on biosimilars are uncharted territory, as well. As reported by SeekingAlfa, Hospira has noted biosimilars in the U.S. will most likely will be sold “at discounts of 20 to 40 percent from the branded competitors, but some consultants put the discount closer to 10 to 20 percent.” A 10 to 40 percent discount for Avastin could reap $6,000 to over $24,000 annual savings per patient. That is significant in the healthcare system, but even with the largest discount, an Avastin biosimilar still might approach an annual sticker price of $42,000 per patient, hardly a bargain for the individual person.

Sources:

Leigh Anderson is a Senior Editorial Pharmacist at Drugs.com

Doctor: Pubic Hair Exists for a Reason — Our Obsession With Hairless Genitals Must End!

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I must have missed the declaration of war on pubic hair.

It must have happened sometime in the last decade because the amount of time, energy, money and emotion both genders spend on abolishing every hair from their genitals is astronomical.  The genital hair removal industry, including medical professionals who advertise their specialty services to those seeking the “clean and bare” look, is exponentially growing.

But why pick on the lowly pubic hair?  A few sociological theories suggest it has to do with cultural trends spawned by bikinis and thongs, certain hairless actors and actresses, a desire to return to childhood,  a misguided attempt at hygiene or being more attractive to a partner.  Surely human beings are not so naïve as to be susceptible to fashion trends and biases.

It is a sadly misconceived war.  Long ago surgeons figured out that shaving a body part prior to surgery actually increased rather than decreased surgical site infections.  No matter what expensive and complex weapons are used—razor blades, electric shavers, tweezers, waxing, depilatories,  electrolysis—hair, like crab grass,  always grows back and eventually wins.   In the mean time, the skin suffers the effects of the scorched battlefield.

Pubic hair removal naturally irritates and inflames the hair follicles left behind, leaving microscopic open wounds.  Rather than suffering a comparison to a bristle brush, frequent hair removal is necessary to stay smooth, causing regular irritation of the shaved or waxed area.  When that irritation is combined with the warm moist environment of the genitals, it becomes a happy culture media for some of the nastiest of bacterial pathogens, namely group A streptococcus, staphylococcus aureus and its recently mutated cousin methicillin resistant staph aureus (MRSA).   There is an increase in staph boils and abscesses, necessitating incisions to drain the infection, resulting in scarring that can be significant.   It is not at all unusual to find pustules and other hair follicle inflammation papules on shaved genitals.

Additionally, I’ve seen cellulitis (soft tissue bacterial infection without abscess) of the scrotum, labia and penis from spread of bacteria from shaving or from sexual contact with strep or staph bacteria from a partner’s skin.

Some clinicians are finding that freshly shaved pubic areas and genitals are also more vulnerable to herpes infections due to the microscopic wounds being exposed to virus carried by mouth or genitals.   It follows that there may be vulnerability to spread of other STIs as well.

Pubic hair does have a purpose,  providing cushion against friction that can cause skin abrasion and injury,  protection from bacteria and other unwanted pathogens, and is the visible result of long awaited adolescent hormones, certainly nothing to be ashamed of or embarrassed about.

It is time to declare a truce in the war on pubic hair, and allow it to stay right where it belongs.  We owe it to our patients to encourage them to let it be.

Scientists Officially Link Processed Foods To Autoimmune Disease

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The modern diet of processed foods, takeaways and microwave meals could be to blame for a sharp increase in autoimmune diseases such as multiple sclerosis, including alopecia, asthma and eczema.

A team of scientists from Yale University in the U.S and the University of Erlangen-Nuremberg, in Germany, say junk food diets could be partly to blame.

‘This study is the first to indicate that excess refined and processed salt may be one of the environmental factors driving the increased incidence of autoimmune diseases,’ they said.

Junk foods at fast food restaurants as well as processed foods at grocery retailers represent the largest sources of sodium intake from refined salts.

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The Canadian Medical Association Journal sent out an international team of researchers to compare the salt content of 2,124 items from fast food establishments such as Burger King, Domino’s Pizza, Kentucky Fried Chicken, McDonald’s, Pizza Hut and Subway. They found that the average salt content varied between companies and between the same products sold in different countries.

U.S. fast foods are often more than twice as salt-laden as those of other countries. While government-led public health campaigns and legislation efforts have reduced refined salt levels in many countries, the U.S. government has been reluctant to press the issue. That’s left fast-food companies free to go salt crazy, says Norm Campbell, M.D., one of the study authors and a blood-pressure specialist at the University of Calgary.

Many low-fat foods rely on salt–and lots of it–for their flavor. One packet of KFC’s Marzetti Light Italian Dressing might only have 15 calories and 0.5 grams fat, but it also has 510 mg sodium–about 1.5 times as much as one Original Recipe chicken drumstick. (Feel like you’re having too much of a good thing? You probably are.

Bread is the No. 1 source of refined salt consumption in the American diet, according to the Centers for Disease Control and Prevention. Just one 6-inch Roasted Garlic loaf from Subway–just the bread, no meat, no cheeses, no nothing–has 1,260 mg sodium, about as much as 14 strips of bacon.

How Refined Salt Causes Autoimmune Disease

The team from Yale University studied the role of T helper cells in the body. These activate and ‘help’ other cells to fight dangerous pathogens such as bacteria or viruses and battle infections. Previous research suggests that a subset of these cells – known as Th17 cells – also play an important role in the development of autoimmune diseases.

In the latest study, scientists discovered that exposing these cells in a lab to a table salt solution made them act more ‘aggressively.’

They found that mice fed a diet high in refined salts saw a dramatic increase in the number of Th17 cells in their nervous systems that promoted inflammation.

They were also more likely to develop a severe form of a disease associated with multiple sclerosis in humans.

The scientists then conducted a closer examination of these effects at a molecular level.

Laboratory tests revealed that salt exposure increased the levels of cytokines released by Th17 cells 10 times more than usual. Cytokines are proteins used to pass messages between cells.

Study co-author Ralf Linker, from the University of Erlangen-Nuremberg, said: ‘These findings are an important contribution to the understanding of multiple sclerosis and may offer new targets for a better treatment of the disease, for which at present there is no cure.’

It develops when the immune system mistakes the myelin that surrounds the nerve fibres in the brain and spinal cord for a foreign body.

It strips the myelin off the nerves fibres, which disrupts messages passed between the brain and body causing problems with speech, vision and balance.

Another of the study’s authors, Professor David Hafler, from Yale University, said that nature had clearly not intended for the immune system to attack its host body, so he expected that an external factor was playing a part.

He said: ‘These are not diseases of bad genes alone or diseases caused by the environment, but diseases of a bad interaction between genes and the environment.

 ‘Humans were genetically selected for conditions in sub-Saharan Africa, where there was no salt. It’s one of the reasons that having a particular gene may make African Americans much more sensitive to salt.

‘Today, Western diets all have high salt content and that has led to increase in hypertension and perhaps autoimmune disease as well.’

The team next plan to study the role that Th17 cells play in autoimmune conditions that affect the skin.

‘It would be interesting to find out if patients with psoriasis can alleviate their symptoms by reducing their salt intake,’ they said.

‘However, the development of autoimmune diseases is a very complex process which depends on many genetic and environmental factors.’

Stick to Good Salts

Refined, processed and bleached salts are the problem. Salt is critical to our health and is the most readily available nonmetallic mineral in the world. Our bodies are not designed to processed refined sodium chloride since it has no nutritional value. However, when a salt is filled with dozens of minerals such as in rose-coloured crystals of Himalayan rock salt or the grey texture of Celtic salt, our bodies benefit tremendously for their incorporation into our diet.

“These mineral salts are identical to the elements of which our bodies have been built and were originally found in the primal ocean from where life originated,” argues Dr Barbara Hendel, researcher and co-author of Water & Salt, The Essence of Life. “We have salty tears and salty perspiration. The chemical and mineral composition of our blood and body fluids are similar to sea water. From the beginning of life, as unborn babies, we are encased in a sack of salty fluid.”

“In water, salt dissolves into mineral ions,” explains Dr Hendel. “These conduct electrical nerve impulses that drive muscle movement and thought processes. Just the simple act of drinking a glass of water requires millions of instructions that come from mineral ions. They’re also needed to balance PH levels in the body.”

Mineral salts, she says, are healthy because they give your body the variety of mineral ions needed to balance its functions, remain healthy and heal. These healing properties have long been recognised in central Europe. At Wieliczka in Poland, a hospital has been carved in a salt mountain. Asthmatics and patients with lung disease and allergies find that breathing air in the saline underground chambers helps improve symptoms in 90 per cent of cases.

Dr Hendel believes too few minerals, rather than too much salt, may be to blame for health problems. It’s a view that is echoed by other academics such as David McCarron, of Oregon Health Sciences University in the US.

He says salt has always been part of the human diet, but what has changed is the mineral content of our food. Instead of eating food high in minerals, such as nuts, fruit and vegetables, people are filling themselves up with “mineral empty” processed food and fizzy drinks.

Study Source: This is the result of a study conducted by Dr. Markus Kleinewietfeld, Prof. David Hafler (both Yale University, New Haven and the Broad Institute of the Massachusetts Institute of Technology, MIT, and Harvard University, USA), PD Dr. Ralf Linker (Dept. of Neurology, University Hospital Erlangen), Professor Jens Titze (Vanderbilt University and Friedrich-Alexander-Universitat Erlangen-Nurnberg, FAU, University of Erlangen-Nuremberg) and Professor Dominik N. Muller (Experimental and Clinical Research Center, ECRC, a joint cooperation between the Max-Delbruck Center for Molecular Medicine, MDC, Berlin, and the Charite — Universitatsmedizin Berlin and FAU) (Nature, doi: http://dx.doi.org/10.1038/nature11868)*. In autoimmune diseases, the immune system attacks healthy tissue instead of fighting pathogens.

Shoe generates power from walking

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Smart shoe
The devices represent a trade-off between power generating capacity, size and other factors

German researchers have built shoe-sized devices that harvest power from the act of walking.

The technology could be used to power wearable electronic sensors without the need for batteries.

There are two separate devices: a “shock harvester” that generates power when the heel strikes the ground and a “swing harvester” that produces power when the foot is swinging.

They could also form the basis of a self-lacing shoe for the elderly.

Details of the advance are outlined in the journal Smart Materials and Structures.

“We have tried to power a wireless transmitter and to power a simple sensor,” said Klevis Ylli from HSG-IMIT, a research centre in Villingen-Schwenningen, Germany.

“One application we are working on is indoor navigation which means we have sensors within the shoe that measure the acceleration of the foot, the angular velocity – whether you’re turning the foot or not – and the magnetic field.

“From the data from these sensors, you could calculate how far you have travelled and in which direction. So imagine a rescue unit walking into a building they don’t know. They could then track which way they went on their handheld device.”

Smart shoe
The shock harvester sits snugly in the sole of a training shoe
Running shoe
The devices exploit the motion between magnets and coils to generate power

Both energy harvesting devices generate power by exploiting the motion between magnets and coils.

As the magnetic field of a moving magnet passes by a stationary coil, a voltage is induced and an electric current is generated.

The energy they generate is still relatively small – in the three to four milliWatt (mW) range at their peak.

That’s not nearly enough to charge a smartphone, for example, which would typically require about 2,000 mW. But it is enough to power small sensors and transmitters, opening up a range of new applications.

The devices represent a trade-off between power generation, size and other limiting factors. And Mr Ylli says his team’s approach offers certain key advantages.

“Some approaches of the past for example have tried to use a lever underneath the shoe to power a gear box and an electric generator as used in some electric torches. They could generate up to 250 mW, but were huge, heavy and had parts protruding from the shoe,” Mr Ylli told BBC News.

“Generated power scales with size, but if you want to be able to reasonably integrate such a device within a shoe sole, you have to work with strict constraints, like a small height and limited length of the device.

“We believe we have built comparatively small devices, considering the power output.”

He said the swing harvester was developed with the intention of making a self-lacing shoe for the elderly. The shoe would detect when a user stepped into it and lace itself up, as well as open up again when required. The harvesting device would generate the energy for the closing mechanism.

Seasonal flu vaccine only 12 percent effective in adults.

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The US’s seasonal flu vaccine was only 12 percent effective, according to a Centers for Disease Control and Prevention (CDC) estimate. Nearly 70 percent of flu viruses have “drifted” from the form used in the immunizations, the government body said.

The CDC states in its weekly Morbidity and Mortality Report, released Thursday, that: “Overall, the estimate suggests that the 2014-15 influenza vaccine has low effectiveness against circulating influenza A (H3N2) viruses.”

It stated that the seasonal flu shot offered less protection because of the widely varied nature of the flu viruses in the US. Seventy percent of flu viruses were a different strain or had “drifted” from the virus used to produce the vaccination.

“More than two-thirds of circulating A (H3N2) viruses are antigenically and genetically different (drifted) from the A (H3N2) vaccine component of 2014–15 Northern Hemisphere seasonal influenza vaccines,” the report said.

The news somewhat undermines the CDC drive to encourage the public to get vaccinated against the flu.

However, in a release published on the CDC website, it still professed the importance of getting a flu vaccine, saying it “reduced a person’s risk of having to go to the doctor because of flu by 23 percent among people of all ages.”

Reuters / Kham

Despite this, it conceded that: “Flu viruses change constantly and the drifted H3N2 viruses did not appear until after the vaccine composition for the Northern Hemisphere had been chosen.”

On Thursday, the CDC recommended that additional flu treatment measures be prepared, particularly with regards to more vulnerable patients.

“All hospitalized patients and all outpatients at high risk for serious complications should be treated as soon as possible with one of three available influenza antiviral medications if influenza is suspected, regardless of a patient’s vaccination status,” The Hill reported Joe Bresee, branch chief in the CDC’s flu division, as saying.

Among high-risk groups are children younger than five years old, “but especially children younger than two years old,” adults 65 years of age and older, pregnant women, American Indians and Alaskan Natives, and people who have preexisting medical conditions such as heart disease, asthma or a weakened immune system.

Those who benefited most strongly from receiving the vaccination were children below the age of 17. In this group it was 26 percent effective.

14-Year-Old Just Wrote The Most Significant Poem Of The 21st Century

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Derek Nichols recently tweeted a poem written by his 14-year-old brother Jordan. As you will see, Jordan is a talented and quite insightful young man. Here’s what the poem said: Our generation will be known for nothing. Never will anybody say, We were the peak of mankind. That is wrong, the truth is Our generation was a failure. Thinking that We actually succeeded Is a waste. And we know Living only for money and power Is the way to go. Being loving, respectful, and kind Is a dumb thing to do. Forgetting about that time, Will not be easy, but we will try. Changing our world for the better Is something we never did. Giving up Was how we handled our problems. Working hard Was a joke. We knew that People thought we couldn’t come back That might be true, Unless we turn things around (Read from bottom to top now) Reading from bottom to top, the poem reads: Unless we turn things around That might be true, People thought we couldn’t come back We knew that Was a joke. Working hard Was how we handled our problems. Giving up Is something we never did. Changing our world for the better Will not be easy, but we will try. Forgetting about that time, Is a dumb thing to do. Being loving, respectful, and kind Is the way to go. Living only for money and power Is a waste. And we know We actually succeeded Thinking that Our generation was a failure. That is wrong, the truth is We were the peak of mankind. Never will anybody say, Our generation will be known for nothing. The future of our society lies in its youth and the fact that such words can come out of a 14-year-old’s mouth shows that today’s youth can be brave and ambitious with big dreams for the world. After all, only the ones who are crazy enough to think they can change the world, are the ones who do.

Targeted Drug Delivery to Flow-Obstructed Blood Vessels Using Mechanically Activated Nanotherapeutics

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Obstruction of normal blood flow, which occurs in a variety of diseases, including thromboembolism in stroke and atherosclerosis, is a leading cause of death and long-term adult disability in the Western world. This review focuses on a novel nanotherapeutic drug-delivery platform that is mechanically activated within blood vessels by high-fluid shear stresses to selectively target drugs to sites of vascular obstruction. In vitro and in vivo studies have shown that this approach can be used to efficiently lyse clots using a significantly lower amount of thrombolytic drug than is required when administered in a soluble formulation. This nanotherapeutic strategy can potentially improve both the efficacy and safety of thrombolytic drugs, particularly in patients who are at high risk for brain hemorrhage, and thus provide a new approach for the treatment of many life-threatening and debilitating vascular disorders.

Scientists Just Created Crystals That Make Breathing Underwater A Possibility.

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Danish scientists are a step closer to helping those suffering from respiratory ailments thanks to a revolutionary new absorption crystal. Working out of the University of Southern Denmark the group has uncovered crystalline materials that are capable of pulling oxygen out of both air and water -which could eventually mark the end of the need to carry around large air tanks.

water

The revolutionary crystalline material can bind and store oxygen in high concentrations, then control its release time depending on what the user needs. This new discovery could even benefit deep sea divers, giving them superhero-like abilities to stay submerged for extended periods of time without an air tank.

The standard human body can function with only 12% oxygen in the air around us, but what if we needed it in higher concentrations?

The crystalline material changes color when absorbing or releasing oxygen.

This was the main subject of the study conducted at the University of Southern Denmark, with help from the University of Sydney, Australia.

Professor Christine McKenzie was the one who led the study, alongside Jonas Sundberg, Department of Physics, Chemistry and Pharmacy at the University of Southern Denmark.

The study involved about a bucket full (10 liters) of microscopic grains, and found them to be enough to completely suck the oxygen out of a room. Professor Christine McKenzie said:

“In the lab, we saw how this material took up oxygen from the air around us.”

The new material is smaller and lighter to carry than those currently used to obtain the same result. Professor McKenzie added:

“A few grains contain enough oxygen for one breath, and as the material can absorb oxygen from the water around the diver and supply the diver with it, the diver will not need to bring more than these few grains.

When the substance is saturated with oxygen, it can be compared to an oxygen tank containing pure oxygen under pressure – the difference is that this material can hold three times as much Oxygen.”

According to the study, the crystalline-made material was obtained by using x-ray diffraction, displaying the atomic behavior of the material while it’s full of oxygen – it was then emptied of it.

Professor McKenzie also revealed:

“An important aspect of this new material is that it does not react irreversibly with oxygen – even though it absorbs oxygen in a so-called selective chemisorptive process. The material is both a sensor, and a container for oxygen – we can use it to bind, store and transport oxygen – like a solid artificial hemoglobin.”

An unexpected aspect to the new development is the oxygen storing process, which turned out to be completely natural. The metal cobalt, which is the essential component in the new crystalline material, controls the process of absorption. It can provide the new material with the molecular and electronic structure that gives it the capability to steal oxygen from the air.

Christine McKenzie explains:

“It is also interesting that the material can absorb and release oxygen many times without losing the ability. It is like dipping a sponge in water, squeezing the water out of it and repeating the process over and over again.”

Professor Christine McKenzie also illustrated that there are many conditions that can influence the process, which may impact the time involved in the absorption process. The result will be different versions of the same material. That being the case, different options will exist to control the time of release. She added:

“When the material is saturated with oxygen, it can be compared to an oxygen tank containing pure oxygen under pressure – the difference is that this material can hold three times as much Oxygen.”

The potentiality of the absorbing crystal is virtually endless with its impact being felt in everything from the medical field to space exploration.

People Who Go to Bed Early Worry Less, According to Science

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Good news for those of you who like to tuck in early. Your friends may call you lame, but science says that people who go to bed early worry less. So actually, you’re probably happier than those night owl friends of yours anyway.

According to the study, which was published in Cognitive Therapy and Research, people who go to bed later tend to experience more ”persistent, negative thoughts” than those who turn in earlier. In the study, researchers asked 100 undergraduate students to fill out a survey that asked about when they typically went to sleep and about their worrying habits, such as how often they worried and what sorts of things they tended to worry about.

Because these are college undergraduates, the average bedtime was around 1a.m., though some students also stayed out as late as 5 a.m.. Still, others reportedly went to bed much earlier, around 10 p.m. (I’m betting those are the ones who either play sports or have an early morning job to get to). But it seems that the 10 p.m. crowd might be onto something. The later the students reported their typical bedtime to be, the more they reported worrying during the day.

In other words, don’t make fun of your early bird roommate. She might be onto something.

So how does all this work? Well, it most likely has to do with the prefrontal cortex, which is a part of the brain linked to attention, and which is particularly sensitive to sleep-deprivation. So not going to bed later — and likely getting less sleep as a result — makes you more likely to pay attention to your problems and less able to stop.

Or maybe being worried about stuff all the time just makes it harder to fall asleep. Or maybe both things — worrying and not getting enough sleep — just enable each other in a never-ending positive feedback loop that will eventually need to be solved with sleeping pills.

If you are having trouble sleeping and would like to fix the problem, you can check outthese tricks for falling asleep, or look up frequent causes of sleeplessness to figure out what’s keeping you up in the first place. There are even apps to help you get some sleep. Because sleep is great guys. You should have some.

Top Scientists, Experts and Philosophers Warn of Dangers of Artificial Intelligence .

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If it is ever achieved – and the current consensus is that it will be – the creation of a fully-fledged artificial intelligence could be the most major milestone in the history of humanity.

The technology has the ability to operate on a level currently inaccessible to humans, and potentially reap major rewards, but there are also massive dangers.

This is why several notable scientists, industry experts and technicians have banded together to deliver an open letter to the artificial intelligence developing community. They’re not asking for the research to stop, merely that there be some kind of oversight to mitigate the risks.

The open letter, which was devised by the Future of Life Institute and contains names such as Stephen Hawking, Elon Musk, Skype co-founder Jaan Tallinn, George Church, and Nick Bostrom, states:

There is now a broad consensus that AI research is progressing steadily, and that its impact on society is likely to increase. The potential benefits are huge, since everything that civilization has to offer is a product of human intelligence; we cannot predict what we might achieve when this intelligence is magnified by the tools AI may provide, but the eradication of disease and poverty are not unfathomable. Because of the great potential of AI, it is important to research how to reap its benefits while avoiding potential pitfalls.

The open letter also added that AI research was currently too preoccupied with simply making AI happen, but not arriving at it in the best possible way. It states technicians need to “focus research not only on making AI more capable, but also on maximizing the societal benefit of AI.”

The document also included a compiled report of research proposals which raised certain issues as well as outlining important factors that must be taken into account, including:

  • Verification – “Did I build this system right?”
  • Validity – “Did I build the right system?”
  • Security – “Is this system safe from manipulation?”
  • Control – “Ok, I built the system wrong, can I fix it?”

What are the dangers with Artificial Intelligence?

This?

Firstly, as mentioned in the opening, super-(or artificial)-intelligence will be unlike anything else humanity has ever created, and can affect the world in ways no other technology, including the wheel, internal combustion engine and internet, ever have. One of the co-signers of the letter, and member of the prestigious Oxford University’s philosophy faculty, Nick Bostrom has stated:

A prerequisite for having a meaningful discussion of superintelligence is the realization that superintelligence is not just another technology, another tool that will add incrementally to human capabilities. Superintelligence is radically different.

Bostrom also claims the biggest issue isn’t necessarily a Skynet scenario in which robots attempt to kill off humanity or launch nuclear bombs into the atmosphere, but one where a small elite group has control of a super-intelligence. In this way, a super-intelligence could be pre-programmed with human prejudices towards others.

Similarly, an error in programming could result in unforeseen consequences. He posits that a super-intelligence dedicated to the mundane task of manufacturing paper clips (and nothing else), could break beyond expected limits in order to maximize the output of paper clips. In this sense, capitalistic sensibilities of increasing production, output and profit, need to be controlled within an ethical framework. This is something humans innately do, but would have to be something carefully programmed into an AI. As The Atlantic states, if the robots kill us, its because it’s their job and we’ve programmed them that way.

But could robots really wipe out humanity? Well, Stuart Armstrong, a philosopher and Research Fellow at the institute, thinks it’s possible. In fact, AI might be the only technology capable of wiping us out.

One of the things that makes AI risk scary is that it’s one of the few that is genuinely an extinction risk if it were to go bad. With a lot of other risks, it’s actually surprisingly hard to get to an extinction risk… First of all forget about the Terminator. The robots are basically just armoured bears and we might have fears from our evolutionary history but the really scary thing would be an intelligence that would be actually smarter than us – more socially adept… When they can become better at politics, at economics, potentially at technological research.

Furthermore, the resources required to develop an AI means the feat will only be available to states and major corporations – entities with expressed agendas and attitudes towards certain people. Would the US allow its super-intelligence to mutually benefit all the world’s population on an objective basis? What if that means the AI diverts more resources away from the US? Perhaps even to unfriendly states? What if that benevolence falls foul of US foreign policy?

What if that AI is Johnny Depp?

The same is also true for corporations like Google. What if their AI suggests decreasing its profits in exchange for increasing social support? Would Google really allow that? In that sense, can we actually create a truly non-prejudiced AI?

But there is one more, terrifying, conclusion. An artificial intelligence could rob us of our most important possession: humanity.

More subtly, it could result in a superintelligence realizing a state of affairs that we might now judge as desirable but which in fact turns out to be a false utopia, in which things essential to human flourishing have been irreversibly lost. We need to be careful about what we wish for from a superintelligence, because we might get it.

What are the potential benefits?

But it is not all doom and gloom. AI can also potentially rid the world of many of our current problems.

It has been suggested that a fully-fledged super-intelligence could aid the development of space travel, unlock the secrets of creation, answer our fundamental questions, eliminate age and disease, calculate the best possible solution to issues, and if coupled with nano-technology, end environmental destruction and “unnecessary suffering of all kinds”.

These are all lofty and worthwhile goals, but they still rest one on major issue – that a benevolent AI is developed. Bostrom claims the only solution is to build a super-intelligence which is fundamentally and irreversibly imbued with a sense of respect towards ALL humans (regardless of race, creed or political leanings) and perhaps even all sentient life.

But once again, if the machine is created by inherently flawed humans and by organizations whose expressed agendas are often subtly, if not explicitly, contrary to the benevolence for all, is this possible?

Could an AI actually result in a world where social, economic and political divisions are more pronounced? One where we are divided by our access to super-intelligence (and its benefits) and those who do not. This would no longer be a simple division of the ‘First’ and ‘Third World’ or ‘Developed’ and ‘Developing countries,’ but something of a much greater magnitude, and potentially, danger.