40% of Scientists Admit Fraud “Always or Often” Contributes to Irreproducible Research

TruthFact
Source: Nature.com
Monya Baker
May 25, 2016

More than 70% of researchers have tried and failed to reproduce another scientist’s experiments, and more than half have failed to reproduce their own experiments. Those are some of the telling figures that emerged from Nature‘s survey of 1,576 researchers who took a brief online questionnaire on reproducibility in research.

The data reveal sometimes-contradictory attitudes towards reproducibility. Although 52% of those surveyed agree that there is a significant ‘crisis’ of reproducibility, less than 31% think that failure to reproduce published results means that the result is probably wrong, and most say that they still trust the published literature.

Data on how much of the scientific literature is reproducible are rare and generally bleak. The best-known analyses, from psychology1 and cancer biology2, found rates of around 40% and 10%, respectively. Our survey respondents were more optimistic: 73% said that they think that at least half of the papers in their field can be trusted, with physicists and chemists generally showing the most confidence.

The results capture a confusing snapshot of attitudes around these issues, says Arturo Casadevall, a microbiologist at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. “At the current time there is no consensus on what reproducibility is or should be.” But just recognizing that is a step forward, he says. “The next step may be identifying what is the problem and to get a consensus.”

Failing to reproduce results is a rite of passage, says Marcus Munafo, a biological psychologist at the University of Bristol, UK, who has a long-standing interest in scientific reproducibility. When he was a student, he says, “I tried to replicate what looked simple from the literature, and wasn’t able to. Then I had a crisis of confidence, and then I learned that my experience wasn’t uncommon.”

The challenge is not to eliminate problems with reproducibility in published work. Being at the cutting edge of science means that sometimes results will not be robust, says Munafo. “We want to be discovering new things but not generating too many false leads.”

The scale of reproducibility

But sorting discoveries from false leads can be discomfiting. Although the vast majority of researchers in our survey had failed to reproduce an experiment, less than 20% of respondents said that they had ever been contacted by another researcher unable to reproduce their work. Our results are strikingly similar to another online survey of nearly 900 members of the American Society for Cell Biology (see go.nature.com/kbzs2b). That may be because such conversations are difficult. If experimenters reach out to the original researchers for help, they risk appearing incompetent or accusatory, or revealing too much about their own projects.

A minority of respondents reported ever having tried to publish a replication study. When work does not reproduce, researchers often assume there is a perfectly valid (and probably boring) reason. What’s more, incentives to publish positive replications are low and journals can be reluctant to publish negative findings. In fact, several respondents who had published a failed replication said that editors and reviewers demanded that they play down comparisons with the original study.

Nevertheless, 24% said that they had been able to publish a successful replication and 13% had published a failed replication. Acceptance was more common than persistent rejection: only 12% reported being unable to publish successful attempts to reproduce others’ work; 10% reported being unable to publish unsuccessful attempts.

Survey respondent Abraham Al-Ahmad at the Texas Tech University Health Sciences Center in Amarillo expected a “cold and dry rejection” when he submitted a manuscript explaining why a stem-cell technique had stopped working in his hands. He was pleasantly surprised when the paper was accepted3. The reason, he thinks, is because it offered a workaround for the problem.

Others place the ability to publish replication attempts down to a combination of luck, persistence and editors’ inclinations. Survey respondent Michael Adams, a drug-development consultant, says that work showing severe flaws in an animal model of diabetes has been rejected six times, in part because it does not reveal a new drug target. By contrast, he says, work refuting the efficacy of a compound to treat Chagas disease was quickly accepted4.

The corrective measures

One-third of respondents said that their labs had taken concrete steps to improve reproducibility within the past five years. Rates ranged from a high of 41% in medicine to a low of 24% in physics and engineering. Free-text responses suggested that redoing the work or asking someone else within a lab to repeat the work is the most common practice. Also common are efforts to beef up the documentation and standardization of experimental methods.

Any of these can be a major undertaking. A biochemistry graduate student in the United Kingdom, who asked not to be named, says that efforts to reproduce work for her lab’s projects doubles the time and materials used — in addition to the time taken to troubleshoot when some things invariably don’t work. Although replication does boost confidence in results, she says, the costs mean that she performs checks only for innovative projects or unexpected results.

Consolidating methods is a project unto itself, says Laura Shankman, a postdoc studying smooth muscle cells at the University of Virginia, Charlottesville. After several postdocs and graduate students left her lab within a short time, remaining members had trouble getting consistent results in their experiments. The lab decided to take some time off from new questions to repeat published work, and this revealed that lab protocols had gradually diverged. She thinks that the lab saved money overall by getting synchronized instead of troubleshooting failed experiments piecemeal, but that it was a long-term investment.

Irakli Loladze, a mathematical biologist at Bryan College of Health Sciences in Lincoln, Nebraska, estimates that efforts to ensure reproducibility can increase the time spent on a project by 30%, even for his theoretical work. He checks that all steps from raw data to the final figure can be retraced. But those tasks quickly become just part of the job. “Reproducibility is like brushing your teeth,” he says. “It is good for you, but it takes time and effort. Once you learn it, it becomes a habit.”

One of the best-publicized approaches to boosting reproducibility is pre-registration, where scientists submit hypotheses and plans for data analysis to a third party before performing experiments, to prevent cherry-picking statistically significant results later. Fewer than a dozen people mentioned this strategy. One who did was Hanne Watkins, a graduate student studying moral decision-making at the University of Melbourne in Australia. Going back to her original questions after collecting data, she says, kept her from going down a rabbit hole. And the process, although time consuming, was no more arduous than getting ethical approval or formatting survey questions. “If it’s built in right from the start,” she says, “it’s just part of the routine of doing a study.”

The cause

The survey asked scientists what led to problems in reproducibility. More than 60% of respondents said that each of two factors — pressure to publish and selective reporting — always or often contributed. More than half pointed to insufficient replication in the lab, poor oversight or low statistical power. A smaller proportion pointed to obstacles such as variability in reagents or the use of specialized techniques that are difficult to repeat.

But all these factors are exacerbated by common forces, says Judith Kimble, a developmental biologist at the University of Wisconsin–Madison: competition for grants and positions, and a growing burden of bureaucracy that takes away from time spent doing and designing research. “Everyone is stretched thinner these days,” she says. And the cost extends beyond any particular research project. If graduate students train in labs where senior members have little time for their juniors, they may go on to establish their own labs without having a model of how training and mentoring should work. “They will go off and make it worse,” Kimble says.

What can be done?

Respondents were asked to rate 11 different approaches to improving reproducibility in science, and all got ringing endorsements. Nearly 90% — more than 1,000 people — ticked “More robust experimental design” “better statistics” and “better mentorship”. Those ranked higher than the option of providing incentives (such as funding or credit towards tenure) for reproducibility-enhancing practices. But even the lowest-ranked item — journal checklists — won a whopping 69% endorsement.

The survey — which was e-mailed to Nature readers and advertised on affiliated websites and social-media outlets as being ‘about reproducibility’ — probably selected for respondents who are more receptive to and aware of concerns about reproducibility. Nevertheless, the results suggest that journals, funders and research institutions that advance policies to address the issue would probably find cooperation, says John Ioannidis, who studies scientific robustness at Stanford University in California. “People would probably welcome such initiatives.” About 80% of respondents thought that funders and publishers should do more to improve reproducibility.

“It’s healthy that people are aware of the issues and open to a range of straightforward ways to improve them,” says Munafo. And given that these ideas are being widely discussed, even in mainstream media, tackling the initiative now may be crucial. “If we don’t act on this, then the moment will pass, and people will get tired of being told that they need to do something.”

Read More At: Nature.com

Has Snopes Been Snoped? Will Retraction Watch Retract?

Has Snopes Been Snoped? Will Retraction Watch Retract?
Source: GreenMedInfo.com
Celeste McGovern
May 22, 2017

Originally published on CMSRI.org.

The NEVER-retracted vaccinated vs. unvaccinated study that revealed significantly higher odds in risks of chronic illness among vaccinated children is back online. But will Retraction Watch admit it launched the attack to discredit it? Will Snopes fact-check itself? If not, why not?

The first-ever study of vaccinated vs. unvaccinated American children (and a subset study) published two weeks ago in the peer-reviewed Journal of Translational Science have reappeared online after briefly disappearing while under fire from a small band of Skeptics and the staff at Retraction Watch, an organization that reports Science retraction news. Snopes, the fact-checking website, is still misreporting that the study has been retracted, even while it sits, published, in the science journal’s pages.

It is a troubling saga unfolding in the scientific publishing world, and it is worth paying attention to because it’s revealing of powerful forces in that realm that are trying to censor scientific research and to shield important data from public viewing. Not at all the methodical and logical sort of thing you would expect from modern scientific types.  It looks more like a secret 17th century Salem witch trial…interrupted.

Most readers here will be aware of Anthony Mawson et al.’s pivotal pilot study on the health of homeschooled American children. It is one of very few studies to examine the explosion of once rare disorders and conditions affecting modern children (all the millions of 21st century First World earaches, allergies, hayfever, ADD, neurodevelopmental disorders and autism, that is damaging young children’s brains in spiking numbers). And it is the only study (yes, the ONLY study to contain totally unvaccinated American subjects.) There are no other studies of American children who have never had a vaccine compared to kids with the motherload of CDC protection.

The researchers cautiously asked a logical, but unorthodox question: is it possible that all this immune –mediated disease has anything to do with the immune-mediating drugs that children are given in doses five times that of their parents?   (And yes, autism is brain damage but it is almost certainly the result of a damaged immune system). Could it have anything to do with the 50 doses of 15 immune-stimulating vaccines before age six compared to the three doses of three vaccines the last generation — that wasn’t so sick — got?

The researchers got some very troubling answers. They reported Odds Risk ratios similar to smoking and lung cancer for vaccination and immune-mediated allergic rhinitis, for example.  And a more than four-fold higher risk of vaccinated children having been diagnosed on the Autism Spectrum than unvaccinated children. We better have another study, the researchers concluded. A bigger and better study.

Round One: Suppressing the Study Results

Enter the Skeptics. When the Mawson paper was under review at Frontiers last year, a Skeptic named Leonid Schneider leapt into action.

“I pride myself to have caused the Frontiers anti-vaxx retraction with one tweet!” he tweeted. “The anti-vaxx paper was published as abstract, a reader alerted me, I tweeted, Frontiers got scared, pulled the paper.” Before it was published. It was never published. NEVER RETRACTED. Just tweeted away by Leonid and his Skeptic friends.

Most scientists are skeptical — they don’t like claims without evidence – but not all scientists are Skeptics. Skeptics are champions of objective scientific inquiry who fight against anything they see as irrational and unscientific, which is everything outside of pharmaceutical manufacturing interests. Functional Medicine is equal to Bigfoot to them.  They know the difference between Good Thinking and Bad Thinking and some theories (like evolution) they think are very good and some ideas, like God, are particularly bad. They don’t like religion, but Skeptics can be quite dogmatic themselves about some things. Like vaccines. According to them, all vaccines are safe and effective. No one is ever injured by vaccines. Every child is healthier because of vaccines. The epidemic of childhood disorders is caused by something that is not vaccines. Questioning vaccines is heresy.

Retraction Watch, which bills itself as “a window into the scientific process,” got a little more involved than window-watching and inaccurately reported that the study was retracted, based on a Tweet. It ignored that accepting science on its merits, and then rejecting it on Tweets from those who disagree, is in violation of the publishing code of conduct.  Not to mention that there is a big difference in the world of science between having a paper retracted – which implies scientific misconduct or gross scientific error – and having a paper declined because of disgruntled Tweets.

Frontiers publicly posts their retraction policy and affirms that they abide by the Committee on Publication Ethics (COPE) guidelines and recommendations in cases of potential retraction. Frontiers also abides by two other key principles, as recommended by COPE:

  • Retractions are not about punishing authors.
  • Retraction statements should be public and linked to the original, retracted article.

There was no retraction statement ever made or posted by Frontiers; therefore Retraction Watch’s statement about Dr. Mawson’s paper being retracted is inarguably false. This proven lie was used to interfere with and misconstrue Dr. Mawson’s research, resulting in a temporary removal of his article from The Journal of Translational Science pending an inquiry. Inquiry resolved, the articles have been reinstated on the journal’s website, demonstrating sufficient proof that the articles were never retracted as claimed by Retraction Watch.

Round Two: Discrediting the Study Results

Retraction Watch was again the first to misreport the retraction of the Mawson paper from the Journal of Translational Science last week. Rather than reporting on the facts, Retraction Watch took an activist role in the attempted takedown of Dr. Mawson’s research. Misconstruing and misrepresenting another scientist’s research is considered scientific misconduct. Retraction Watch still has (at the time of writing) an article posted that claims the paper has been doubly retracted. Their actions have a ripple effect, furthering the harm to Dr. Mawson and his younger colleagues, actions which are harmful to reputations, careers, and their future livelihoods. Snopes, the “fact-checking” entity, was still reporting that the papers were retracted because of methodological flaws, with only a tiny disclaimer at the bottom showing the papers restored to the Journal’s webpages. I pointed out the error to the editors and they updated the story today, without apology for inaccuracies.

Continuing to retain articles that are demonstrably and provably false on their website shows a lack of regard for the integrity and truth they espouse to protect. The public should be aware that their representations are not well researched and supported by the facts, and that the due diligence they claim to conduct in the interest of scientific integrity is not as it appears once you scratch the surface.

No answers have been forthcoming from Retraction Watch’s editor Alison Cook. She has not replied to my inquiries. Snopes founder David Mikkelson and managing editor Brooke Binkowski did not reply to messages. I did not receive explanations from the journal editors either.

The Digital Media Law Project publishes guidelines for publishing information that “harms the reputation of another person, group, or organization.” Injury to one’s reputation that stems from a falsehood is defamation, and claiming an article was retracted when it wasn’t is false, defamatory and should be corrected when notice and evidence has been provided to the author of the defamatory article. In the case of the Snopes article, the DMLP states “the republication of someone else’s words can itself be defamatory. In other words, you won’t be immune simply because you are quoting another person making the defamatory statement, even if you properly attribute the statement to its source.”

The DMLP also advises publications to “be prompt and give your correction the same prominent position that you gave the inaccurate information you previously posted.”

Can Snopes and Retraction Watch be Trusted? 

The whole ordeal puts scientific publishing into a bad light. Can it be so easy to push editors out of publishing? Is the code of conduct meaningless? Don’t the researchers have recourse to defend their work if there are allegations against it, in a scholarly manner? Has science stooped so low, so beneath accepted standards of professionalism, that it is time to call in lawyers?

This disturbing event leaves the public bewildered. Is there something to worry about for our children’s health or not? Why did these researchers find such a high risk of autism and other disorders in vaccinated children?  What are the possible mechanisms of immune system injury from vaccination in children?

The way the Mawson study was received undermines public trust in a system that is meant to be seeking better health for humanity. It will continue to erode so long as it fails to answer these questions that our children need answers to, now.

Read More At: GreenMedInfo.com
___________________________________________________________

The Children’s Medical Safety Research Institute (CMSRI) is a medical and scientific collaborative established to provide research funding for independent studies on causal factors underlying the chronic disease and disability epidemic.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.

Would The Government Let Jesus Cure Cancer?

TruthFact

Source: NoMoreFakeNews.com | JonRappoport.wordpress.com
By: Jon Rappoport
May 23, 2017

As I’ve been telling you for years, it’s easy to keep the public on your side if you regularly tout medical “breakthroughs” in the press. The latest innovation. The promise of a cure around the corner. The maybe-could-be discovery that will change the course of disease treatment forever.

In this case, a start-up called Tilos has one of those, for cancer. They say it’s an antibody their researchers came across while looking for a cure for MS. They stumbled on to it by accident. Aha.

Somehow, this antibody helps the immune system to recognize and wipe out cancer cells. It produces “a memory” in immune-system cells, and they are ready to go to war when cancer arrives. Or something. It’s hard to say.

The people at Tilos are, naturally, very enthusiastic.

So forthwith, I give you an assignment. Keep track of stories about this amazing antibody as time passes, and see whether it ever a) becomes a real cancer treatment, and b) does any good. Or c) disappears down the memory hole, never to be heard from again. I’m betting on c. Why? Because I’ve watched a number of these flashes dim out quickly and recede into nowhere land. And because, in this case, the company is very far from being able to fashion the antibody into a ground-level treatment. Of course, it’s possible that, on the basis of the recent gaudy announcement, Tilos could pick up some investor funding, but funding isn’t a disease treatment the last time I looked.

On the other hand, if a non-pharmaceutical company or researcher actually makes a promising discovery in cancer treatment (read about the troubles of Dr. Stan Burzynski, Dr. Willam Koch, Royal Rife, etc.), all hell breaks loose. The press immediately pounces on the researcher as if he’s working on an H-bomb in his basement. He must be an outright quack and charlatan, “because they all are.”

Corporate drug outfit=potential breakthrough.

Independent non-pharmaceutical researcher=Dr. Nazi.

Good press vs. bad press comes down to: how much can you pay; who do you know; how much advertising can you afford to buy; what official expert can you bring on board to vouch for you; is your product a drug rather than a detested natural non-patentable substance; can you do officially recognized clinical trials; are you connected with a favored group (university, research foundation, federal facility, pharma lab) who can obtain publication in a well-known medical journal.

Or are you a dreaded INDEPENDENT?

In the 1990s, I watched a federal trial in a Los Angeles courtroom. The defendant was charged with selling medical drugs without a license to practice medicine.

The defendant was prepared to argue that a) the substance he was selling was naturally produced in the body and b) it was effective.

The prosecution moved to exclude such testimony, on the grounds that it was irrelevant.

The judge agreed. Therefore, the trial was nasty, brutish, and short. The defendant was found guilty and sentenced to prison for several years.

This is how the federal bureaucracy operates. “Do you have a government-issued license to heal? No? You’re a criminal.”

I believe that if Jesus of Nazareth were walking the Earth today, in the United States, he would be arrested on the same grounds.

This would be particularly so if he were curing cancer.

Imagine this extreme case: in a stadium packed with 50,000 people who have been diagnosed with cancer, Jesus of Nazareth waves his hand and cures all of them in a few seconds.

Now he is threatening the profits of many companies, to say nothing of the power of the government, which backs the chemo-radiation-surgery monopoly to the hilt.

So he is arrested. He is put on trial. He opts to defend himself without an attorney. He tells the court that curing cancer is no crime.

The prosecuting attorney objects. “Your Honor,” he says, “whether or not this man has cured cancer is beside the point. He has no license to practice medicine. That is why we are here today. We are simply establishing that a) he was practicing medicine and b) he has no government-issued license. That is the scope of this proceeding.”

The judge agrees. The verdict is issued. Guilty.

Of course, on another front, the major media, who depend for their existence on pharmaceutical advertising, take the ball and run with it. The networks and major newspapers seek out “experts,” who emphatically state that what Jesus of Nazareth “performed” in the stadium was mere hypnotism. It was all a placebo effect. Whatever sudden “remissions” may have occurred are just temporary. Tragically, the cancers will return.

Not only that, these 50,000 people have effectively been sidetracked and diverted from seeking “real care from real doctors.” With chemo, with radiation, with surgery, they would have stood a chance of surviving and living long normal lives.

Other media pundits send up this flag: “Many of those present in the stadium were bitter clingers to their religion. They refuse to accept science. They are living in the past. They favor superstition over real medical care. In fact, they are threatening the whole basis of healthcare, since other confused and deluded Americans may now turn away from doctors and seek snake-oil salesmen and preachers for healing.”

From the highest perches of political power in this country, the word quietly goes out to the media: don’t follow up on those people who were in the stadium; don’t try to track them; don’t compile statistics on their survival rates; move on to other stories (distractions); let this whole madness die down.

But among the citizenry, an awareness spreads: the government is controlling healing through its issuance of licenses. That’s how the government is essentially protecting one form of “healing” and enabling it to become an all-encompassing cartel.

What would be the alternative or the adjunct to licenses?

Contracts.

Contracts are agreements entered into by consenting adults, who assume responsibility for the outcomes. In the case of healing, a contract would specify that people have a right to be wrong.

Let’s say two consenting adults, Jim and Frank, agree to allow Frank to treat Jim for his arthritis with water from a well on Frank’s land.

The two men acknowledge that no liability will be attached to the outcome. In other words, whether Jim get better or gets worse, no one is going file a suit. No one is going to go to the government for redress of wrongs.

The well water may be wonderful or it may be completely useless. Both men understand and acknowledge that. But they assert a right to try the treatment, because they are free.

Immediately people say, “This is ridiculous. Water can’t cure arthritis. Frank is cheating Jim. Jim is a victim. He needs to see a doctor. He needs to go on arthritis drugs.”

No, Jim doesn’t have to do anything. He is free.

To put it another way, Jim has the right to be right or wrong. It’s his decision, which is beyond the scope of any authority.

If government tries to remove that right from all of us, it is essentially saying it knows what is correct, it knows what is true, it knows what we need and require, and it’s going to give it to us even if it has to shove it down our throats. Does that sound like freedom to you?

If Jesus of Nazareth lived in the United States today, and if he went around curing cancer, he would be arrested. He wouldn’t be charged with blasphemy or treason. He would be charged with something much simpler and more mundane: practicing medicine without a license.

And he would be convicted and sentenced.

Because then and now, the government, in its throne of corruption, wants to protect its proprietary and illegal interests.

Read More At: JonRappoport.wordpress.com

Study: Safety Issues Plagued 1/3 of FDA-Approved Drugs from 2001-2010 Even as President Trump pushes for quicker drug approvals

drugs
Source: NaturalSociety.com
Julie Fidler
May 19, 2017

The U.S. Food and Drug Administration (FDA) is tasked with making sure that drugs and medical devices are safe and efficient for Americans to use. However, it appears that the agency doesn’t take its job seriously enough, because a new study shows that nearly 1/3 of medications approved from 2001 to 2010 had safety issues years after they were made widely available to patients, and some were quite serious. [1]

The study, published May 9 in JAMAshows that 71 of the 222 drugs approved during that time period were withdrawn, required a “black box” due to their side effects, or warranted a safety announcement about new risks.

Source: Center for American Progress

Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, says:

“While the [Trump] administration pushes for less regulation and faster approvals, those decisions have consequences.”

A 2015 independent analysis of drugs approved using the agency’s expedited approval process found that the trend of speeding approval “is being driven by drugs that are not first in class and thus potentially are less innovative.” [2]

But President Trump isn’t the first president to pressure the FDA to speed up its drug approvals.

On December 13, 2016, President Barack Obama signed the 21st Century Cures Act. The law provides speedier routes to approval by pushing the FDA to consider evidence beyond the normal 3 phases of clinical trials. The move upset many researchers who feared the law would allow the approval of drugs that haven’t been adequately studied.

Says Dr. Vinay Prasad, a hematologist-oncologist and professor at Oregon Health and Sciences University, who wasn’t involved in the study:

“I’m actually sympathetic to the idea that there are ways in which the FDA can be more streamlined and do a quicker job. The one place you don’t want to cut a corner is safety and efficacy prior to coming to market.”

According to the study, during the first decade of the millennium, the FDA approved drugs faster than the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA), the majority of clinical trials in drug approvals involved fewer than 1,000 participants, and lasted 6 months or less, according to the findings. [1]

On average, it took 4 years and 2 months after the drugs were approved for safety issues to emerge. The most troublesome drugs included psychiatric medications, biologic drugs, drugs granted “accelerated approval,” and drugs that gained approval at the tail end of the regulatory period.

But drugs that were granted accelerated approval had the worst track record. Dr. Nicholas S. Downing, an author of the study and a resident physician of internal medicine at Brigham and Women’s Hospital in Boston, says:

“The key message with all new drugs and technology is that there is an ongoing learning process that will continue through the lifetime of the drug.

Downing says that scientists need to continuously test drugs to make sure they work with a wide range of variables, and used aspirin as an example. The medication has been used for hundreds of years, yet “there are still countless new studies coming out, and we learn more about it all the time.” [2]

Read More At: NaturalSociety.com

Sources:

[1] Kaiser Health News

[2] CNN

Center for American Progress

New Safety Concerns Identified For 1 in 3 FDA-Approved Drugs


Source: News.Yale.edu
Ziba Kashef
May 9, 2017

Nearly one out of every three drugs approved by the Food and Drug Administration (FDA) have a new safety issue detected in the years after approval, says a Yale-led study. While most of the safety concerns are not serious enough to require withdrawal of a drug from the market, the finding highlights the need for ongoing surveillance of new drugs in the post-market period, said the researchers.

The findings were published May 9 in the Journal of the American Medical Association (JAMA).

To assess new drugs for safety and effectiveness, the FDA relies on premarket drug testing and clinical trials. Most of the trials involve fewer than 1,000 patients studied over a period of six months or less, making it difficult to detect safety issues that might be identified once more patients use the drug over a longer time period. To identify factors that might enhance patient safety and regulatory surveillance efforts, the Yale-led team analyzed data on new drugs approved between 2001 and 2010, with follow up through 2017.

The research team, led by associate professor of medicine and public health Dr. Joseph Ross, found that 32% of new drugs were flagged for a safety issue after approval. “That is very rarely a drug withdrawal, but more commonly a black box warning, or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,” said Ross.

The researchers also identified characteristics of drugs that were more likely to be associated with a safety concern, including biologic therapies and drugs that were approved through the FDA’s accelerated approval pathway.

While the study results point to the need for ongoing monitoring of newly approved drugs, they also demonstrate that the FDA’s current process is working. “The fact that the FDA is issuing safety communications means it is doing a good job of following newly approved drugs and evaluating their safety up in the post-market period,” Ross noted.

At a time when the FDA is under pressure to accelerate drug approvals, the study findings provide key information about the agency’s process. “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,” said Ross. At the very least, the study should inform ongoing debate about premarket drug evaluation, the researchers said.

Other authors on the study are Nicholas Downing, Nilay Shah, Jenerius Aminawung, Alison Pease, Jean-David Zeitoun, and Harlan Krumholz. All authors have completed the ICMJE Form for Disclosure of Potential Conflicts of Interest, which are detailed in the study.

There was no funding for this research.

Read More At: News.Yale.edu

Infographic: Vaccine industry science lies are nothing more than recycled Big Tobacco science lies

Big Tobacco
Source: NaturalNews.com
Mike Adams
May 17, 2017

You gotta love it when arrogant science devotees defiantly claim they alone have a monopoly on the “settled facts” of our reality. Throughout much of the 20th century, it turns out, these same sort of arrogant scientists claimed smoking was awesome for your health, too.

“More doctors smoke Camels than any other cigarette” was the headline of a full-page ad carried by the Journal of the American Medical Association. Doctors were paid by Big Tobacco to tout the amazing health benefits of smoking cigarettes, and any doctor who dared point out that smoking might be linked to cancer was subjected to the same industry blackballing, scientific censorship and verbal abuse that’s leveled today against honest researchers questioning the safety of GMOs or mercury in vaccines.

The real truth is that science never has a monopoly on facts, and science makes enormous mistakes (such as condoning smoking cigarettes) on a regular basis. Science is also for sale and easy corrupted by corporate interests.

Peer-reviewed science journals, too, are often little more than a collection of corporate-funded make-believe science tabloids. “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines,” writes the former editor of The New England Journal of Medicine, Marcia Angell.

“I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine,” she says in Drug Companies & Doctors: A Story of Corruption.

With that in mind, take a look at the similarities between Big Tobacco science lies and vaccine industry science lies:

Book Review: Origins of the Sphinx – Celestial Guardian Of Pre-Pharaonic Civilization by Robert M. Schoch Ph.D. and Robert Bauval | #SmartReads

OriginsOfTheSphinx
TheBreakaway | BreakawayConciousness
Zy Marquiez
May 7, 2017

Written in a cogent, easy to follow, and yet daring manner, the renowned scholars, Shoch and Bauval, are at it again. In Origins of the Sphinx the authors challenge Egyptology at its core: at the Great Sphinx.

Methodically, the authors sift through a wide assortment of data, which seeks to ascertain a more precise dating of the ancient monument.

Split up into two parts, the first half of the book covers seven different topics, which includes an epilogue, while the latter half covers nine different appendixes that finalize the last half of the book.

Each of the initial seven parts is written solely by one of the two authors. At first this choice seemed odd, but it probably was best in order to differentiate who’s bringing about what particular commentary and argument.

Sampling a wide data set, the authors take a cursory glance at the architecture, which includes the Valley and Mortuary Temples, with multi-ton megalithic blocks, as well as more. A gander is also taken at a few of the visitors and researchers that excavated and sampled the sight, such as Colonel William Howard Vyse and Giovanni Battista Caviglia, who had a penchant for the mysticism, the occult, and more. But the authors don’t stop there. Also covered are issues with the fragments of the beard of the Sphinx, geophysical techniques to view below the surface of the Sphinx enclosure, considerations on water erosion on the Sphinx, as well as an in-depth analysis of the Sphinx’s possible construction date.

Regarding the date, Shoch, after some extended analysis in the chapter Sands Of Time, infers:

“…using a linear “conservative” calibration and assuming a date of 4,500 years ago for the western end (which in my assessment is a minimum date; it could be older), then the original core body of the Sphinx is minimally 2.7 times older than 4,500 years ago, giving a date after rounding of circa 10,000 BCE. All in all, I suspect that the proto-Sphinx was in existence prior to the end of the last ice age (that is, prior to 9700 BCE) and was contemporaneous with other structures, such as the oldest portions of Gobekli Tepe in southeastern Turkey. Put simply, the seismic data are compatible with an initial date of circa 10,000 BCE (or even a bit earlier) for the core body of the Sphinx. There is no doubt in my mind that the seismic data alone, independent of any other evidence – such as the surface weather and erosion, which I discuss in chapter 7 – strongly support the hypothesis that the origins of the Great Sphinx predate dynastic times by many millennia.”[pp.78-79]

Such an assertion will undoubtedly send shockwaves through the orthodox Egyptology communities. Then again, such a hypothesis will not surprise many of those exploring other avenues of research in the alternative research community.

Be that as it may, another salient component of this mystery discussed by Bauval is whether Khafre couples with the Sphinx as conventional Egyptology dictates, or whether some other theory might make more sense. Also discussed is what took place with the Dream Stela, the inscription of the Great Limestone Stela of Amenhotep II, the Edfu Temple Texts, and much more.

This book really features a lot more intriguing information than that mentioned. The authors are not only erudite in their research, but make the information accessible for the lay person. That also doesn’t even begin to delve into the nine appendices, which also give a deeper glance that’s a bit technical, but helps shed light onto the situation. Each of the appendices is essentially its own article, and yet couple to the rest of the book rather seamlessly.

If you’re looking for an open-minded foray into the mystery of the Sphinx, that’s meticulously researched while also offering the tools for incisive individuals to come to their own conclusions, hesitate no longer. The approach taken by the authors, although unorthodox, should be considered at length, for if what they say is true, then the history that we’ve been brought up with is drastically different than what we’re being told. Time will ultimately tell, but my bet’s that the authors are pulling on a thread that goes a lot deeper than merely the Sphinx.

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Footnotes:
[1] Robert M. Schoch Ph.D. and Robert Bauval, Origins of the Sphinx – Celestial Guardian Of Pre-Pharaonic Civilization, pp.78-79.

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About The Author:

Zy Marquiez is an avid book reviewer, researcher, an open-minded skeptic, yogi, humanitarian, and freelance writer who studies and mirrors regularly subjects like Consciousness, Education, Creativity, The Individual, Ancient History & Ancient Civilizations, Forbidden Archaeology, Big Pharma, Alternative Health, Space, Geoengineering, Social Engineering, Propaganda, and much more.

His own personal blog is BreakawayConsciousnessBlog.wordpress.com where his personal work is shared, while TheBreakaway.wordpress.com serves as a media portal which mirrors vital information usually ignored by mainstream press, but still highly crucial to our individual understanding of various facets of the world.