New Combination of Targeted Therapeutics Approved For Melanoma .


Last week, the U.S. Food and Drug Administration (FDA) approved the use of cobimetinib (Cotellic) in combination with vemurafenib (Zelboraf) for treating certain patients with advanced melanoma that has spread to other parts of the body or that cannot be removed by surgery. Specifically, this combination of targeted therapeutics is approved to treat only those patients with melanoma whose tumors test positive for BRAF V600E or BRAF V600K gene mutations.

The combination of cobimetinib and vemurafenib is approved to treat only those patients with melanoma whose tumors test positive for BRAF V600E or BRAF V600K gene mutations.
The combination of cobimetinib and vemurafenib is approved to treat only those patients with melanoma whose tumors test positive for BRAF V600E or BRAF V600K gene mutations.

Melanoma is the most lethal form of skin cancer: It accounts for less than 2 percent of all U.S. skin cancer cases, but the majority of skin cancer deaths. The growth of about 50 percent of melanomas is fueled by a BRAF V600E or BRAF V600K gene mutation.

The anticancer therapeutics in this new treatment combination target two different components of the BRAF signaling pathway. Vemurafenib, which targets BRAF V600E and blocks the BRAF signaling pathway, was approved by the FDA in August 2011 for treating patients with melanoma positive for the BRAF V600E mutation. Even though vemurafenib benefits many of these patients, about half of the melanomas that respond to treatment become resistant to vemurafenib and disease progresses in about six to seven months.

Because several of the ways in which vemurafenib resistance arises involve reactivation of the BRAF signaling pathway, researchers looked to combine targeted therapeutics that block different components of the pathway. Cobimetinib targets MEK, which is downstream of BRAF in the signaling pathway.

According to the FDA announcement, its approval of cobimetinib is based on results from the phase III coBRIM clinical trial, which showed that patients with advanced melanoma positive for either the BRAF V600E or V600K mutation who received cobimetinib and vemurafenib had a delay in the amount of time it took for their disease to progress compared with those who received vemurafenib alone. Specifically, the median progression-free survival was 12.3 months among those receiving the combination versus 7.2 months among those receiving single-agent vemurafenib. In addition, patients who received the combination of targeted therapeutics were more likely to respond to treatment and to be alive 17 months after starting treatment.

The approval of cobimetinib for use with vemurafenib to treat BRAF mutation–positive advanced melanoma is not the first combination of BRAF- and MEK-targeted therapeutics to be approved for this use by the FDA. In January 2014, the FDA approved the BRAF-targeted agent dabrafenib (Tafinlar) and the MEK-targeted agent trametinib (Mekinist) for the same use.

Moreover, as our basic understanding of the biology of cancer continues to grow, it is highly likely that this recent announcement will not be the last combination of targeted anticancer therapeutics to be approved by the FDA.

Over 100 science journals accept hoax scientific paper for publication, zero quality checks conducted


Online academic journals are losing integrity. It has now been proven that many open access journals trade truthful scientific information for a mere profit, as they accept flawed scientific studies just to earn publishing fees. This is generating a lot of poisoned, misleading scientific articles that spread around the internet, causing misinformation.

157 JOURNALS EXPOSED IN STING

Several journals have been exposed, thanks to a recent sting led by journalist John Bohannon, who is a contributor to theScience journal.

Bohannon collaborated with Harvard contributors to write up a fake research article that looked and sounded official. They dumbed the paper down with basic errors in the data, method and conclusion. They even threw in a graph that was in direct contrast with the paper’s data. They sent the paper to 305 online journals for publication review. Shockingly, over sixty percent of the journals accepted Bohannon’s flawed, fake paper, asked for publication fees and published his bogus study in their respective journals.

To be exact, Bohannon received 157 acceptance letters for his flawed paper and only 98 rejections. Many of the acceptance letters came from India.

“I was expecting 10 to 15 percent, or worst case, a quarter accepted,” says Bohannan, but a stunning 61 percent of journals accepted his bogus piece! “Peer review is in a worse state than anyone guessed,” he said.

To view an interactive map of the journals involved in this sting, click here: http://scicomm.scimagdev.org.

ACADEMIA FLOODED WITH IMITATORS WHO PUT PROFIT BEFORE QUALITY PUBLICATION

With the internet spiraling with infinite information and growing conscious awareness, there is also a dark side. Fake gurus, imitators and greedy journals may collect fees from scientists who are just trying to get published. The wide acceptance of Bohannon’s fake paper proves that academia itself has lowered its standards just to bring in revenue.

Those researchers seeking truth may not find the whole truth from online open access academic sources, since many journals have sold out, publishing a bunch of flawed information in the process.
Some online journals may look official, with academic titles and expert gurus, but this may all be a sham. That’s why it’s important for researchers to remain skeptical and question all “scientific” studies jogging around the internet.

Bohannan’s experiment further shows that many online journals can’t even recognize fatal flaws in a paper, revealing that the publishers may even be lazy, treating the information they publish as mere digits that need to be moved to keep money coming in. Solid peer review that is aware and accountable is dying off, as journals publish papers that they neither understand nor care to double check.

Bohanna said that many of these online journals never even noticed flaws that should be spotted by anyone “with more than a high-school knowledge of chemistry.” He states, “[T]his sting operation reveals the contours of an emerging Wild West in academic publishing.”

Bohannan’s experiment also shows that greed is deeply involved. In some of the cases, reviewers pointed out mistakes with Bohannan’s flawed paper, but the journal’s publishers accepted the paper anyway, asking the author for thousands of dollars in publication fees.

BIG INDUSTRY MAY FUEL THE MISINFORMATION TO FURTHER THEIR SPECIAL INTERESTS

Online journals have a special responsibility to review scientific data. Under an incentive to publish relevant quantity to please subscribers, online journals may be letting big industry run loose in misinformation scams.

Traditional print journals had to abide by rigid constraints that screened out junk scientific information that may have been fueled by big industry studies that had a special interest slant. Online journals’ lack of review and motivation for profit may be allowing big industries to fuel misinformation to the public.

The misinformation spans across many professional fields. Drug companies can manipulate the medical community by influencing false studies that bolster their claims. Government officials may get behind a fake study to help support their policy. Researchers themselves may be misled altogether as the misinformation piles up. Lawyers rely on scientific citations in briefs and trials. As fake papers are accepted more often then not, the quality of scientific information may become completely contrived and supportive of big industry’s specials interests.

What can be done to hold online journals more accountable?

Introverts Aren’t Shy… They’re Just More Complex Than You


You never talked? You never went out in high school? You were such anintrovert.

The word slithers from their mouths, biting me with its innuendoes and connotations. It’s a jab, a smack, an insult that lies somewhere between “socially awkward” and “f*cking loser.”

Stocksy

What I’d like to say back to my high school peers, whom I refused to converse with at football games and parties, is that I wasn’t shy; I just didn’t like talking to them.

Contrary to their warped visions of my life, I didn’t spend my adolescence with closed lips. I didn’t sit at dinner with my family silent and uncomfortable. I didn’t ignore my friends or refuse to answer phone calls.

I went out. I told stories and jokes and shot the sh*t. I liked to be funny and obnoxious and have a good time. I liked to be spontaneous and reckless. I loved having fun… I just didn’t like having it with them.

There’s this horrible connotation placed on the word “introvert”; just as in high school, everyone uses the term as a put-down, simply because they don’t understand. They don’t understand why you wouldn’t want to be the center of attention, or why you wouldn’t say every thought that comes to your head.

They don’t understand why you’d rather stay home than spend a night out with people who don’t fulfill you. They don’t understand why you pick and choose so carefully who you let into your small world.

People have tried to define it, diagnose it and label it, coming up with medical terminology, symptoms and definitions that are supposed to categorize these unique individuals.

The Oxford Dictionary defines an introvert as “a withdrawn or reserved person.” Its verb form translates to, “to turn (the mind, thought, etc.) inwards upon itself; to direct (one’s thinking or effort) to that which is internal or spiritual.”

In Carl Jung’s 1971 theory of psychological types, he categorizes introverts as happy alone, with rich imagination and artistic tendencies. They often stand “aloof” from society and are, thus, misunderstood. Jung defines them as people who place importance on their subjective view of the world and make decisions based on internally-established beliefs.

Introverts are withdrawn because they are internal. They are reserved because they are pensive. They are quiet because they are listening. This is why they are artists and writers, creators and inventors.

A study by The Gifted Development Center reports that 60 percent of “gifted children” are introverts, compared to the 30 percent of society that’s deemed “gifted.”

The Center reports,

Introversion correlates with introspection, reflection, the ability to inhibit aggression, deep sensitivity, moral development, high academic achievement, scholarly contributions, leadership in academic and aesthetic fields in adult life, and smoother passage through midlife.

Introverts are the people who don’t feel the need to spend every minute of their life around others just to keep from feeling lonely. They are the people who grow into well-adjusted adults and independent leaders.

Unlike their extroverted counterparts, introverts can find solace in their own company and don’t need empty friendships to fill a void. They are content to sit around in their own thoughts, as scary and uncomfortable as they may be.

The Gifted Development Center also reports that introversion is misinterpreted by adults who usually try to correct the “behavior.”

Like bipolar disorder or ADHD, introversion has been misrepresented and misdiagnosed for years, with society scorning and condemning it as a personality function they don’t understand.

As of 2011, the American Psychiatric Association has even made motions to include introversion in the Diagnostic and Statistical Manual (DSM-5), deeming it a personality disorder.

Just because introverts would rather stay in their room — with their thoughts, in their world — doesn’t mean something is wrong with them. Just because they’d rather be alone, doesn’t mean they are problematic; sometimes it just means they don’t like you.

They hate leaving their own world

Introverts are usually very spiritual. They are introspective and reflective, with a tendency to enjoy their own world more than anyone else’s. In their world, they are comfortable, safe and at peace.

Being a stranger in another’s world is usually boring, uncomfortable or just a waste of time spent wishing they were back in their own. According to Jung, introverts’ both strong suit and weakness is their tendency to enjoy solitude over interaction.


They enjoy their own thoughts more than yours

According to Jung, introverts are not seeking outside approval, but rather, their own “subjective appraisal.”

Introverts are largely obsessed with fulfilling their own goals and passions. They are in sync with their innermost desires and have a tendency to care more about their own standards than anyone else’s. Caring about their own opinion more than those of others is often viewed as arrogant and pompous.


They have a hard time finding people they like

Introversion is a personality type. It’s a spectrum that includes certain tendencies and traits that only people on that end possess. Introverts, like extroverts, have strongly developed personalities that attract certain personality types.

However, because introverts frequently find happiness in their own mind, finding someone’s company they can enjoy as much as their own can take many years. They are selective about the people they include in their thoughts and with whom they share their “alone time.”

Introverts like people who share the same ideas and passions, and will make their self-reflection more engaging. Introverts are just the kind of people who would prefer to be around one good mind, rather 100 empty ones.