So we all know about the missing trillions by now, but where is that money going? And what can Americans do to reclaim that money that is rightfully theirs?
Join Catherine Austin Fitts of Solari.com and James Corbett of The Corbett Report for this wide-ranging discussion on the most important topic of our time that no one is talking about.
There are three types of stress—physical, chemical, and emotional. Each of these stressors knocks the physical body out of its natural state of balance, otherwise known as homeostasis. Likewise, these three types of stress can be countered by balancing the physical, chemical, and emotional states back into order.
For years we’ve been teaching people how to shorten their emotional reactions by pausing between the stimulus and the response. When done effectively, this should diminish the very hormones of stress that push the genetic buttons which create disease. The problem is, many people get stuck in emotional states, and 70% of the time these states are derived from the hormones of stress. The longer one remains in these emotional states, the more the long-term effects of stress push the buttons of genetic disease.
One of our most popular and powerful meditations for bringing balance to the body is the Blessing of the Energy Centers, the purpose of which is to program the autonomic nervous system back into order. This series of meditations helps bring balance to people by having them rest their attention in each one of the energy centers of the body. Each of these centers has its own energy and frequency, and frequency carries information. Each center also has its own hormones, glands, chemicals, and plexuses of clustered neurons that are under the control of the autonomic nervous system. Essentially, each center is its own individual mini brain.
When the brain gets out of balance due to the hormones of stress, it creates incoherence, and as a result, each one of these little brains sends very incoherent messages to the cells, tissues, and organs in the body. By practicing a convergent focus, however, which means resting your attention in these centers – if where you place your attention is where you place your energy – you’re directing your energy to bring balance and order to the very center you are focusing on.
As you tune into the energy around these centers, you begin to create coherence in each of these little brains; that’s how people in our workshops have been responding to—and healing from—all sorts of medical conditions. Every time you create balance in each one of these centers, a coherent message is being sent to all the cells, tissues, and organs of the body.
The Value of Nutrition
Despite the fact that I have a background in nutrition, over the years I had been hesitant to talk about it, even though I have always provided nutritional consulting in my practices. The reason is that people tend to move to the extremity, believing that to change their inner state they need to make changes outside of them. The fact of the matter is, when we are less dependent on conditions in our outer world, we have more power and control over our lives. That’s not to undervalue the importance nutrition plays in bringing the body back to homeostasis.
In thinking about this, it occurred to me that, when we are putting our attention on each center and providing it with the proper instructions in the field, it would also be a good idea to provide the proper raw materials in the form of nutrition. As an example, a hormone is a protein made of amino acids, and amino acids—like box cars on a train—are the building blocks of complex proteins.
In addition, there are certain vitamins and minerals that are essential cofactors in helping to assemble, build, and create hormonal balance. By adding other important ingredients to help the body move back into chemical balance, and by providing more raw materials, we could say that the body is being given all the necessary components to make hormones. If we add natural herbs and plant-based products that have been clinically proven to create more hormonal balance, now we are providing the nudge of even more raw materials that the physical body is looking for.
But having all the necessary ingredients to cook a French dinner still doesn’t make the meal. We need instructions to prepare, organize, and cook the food.
And so I began researching many peer-reviewed articles to see what cofactors, vitamins, and minerals could help facilitate hormonal changes, in addition to other natural herbs and ingredients that could be beneficial in bringing more order to the body. It’s for this reason that I partnered with a company to create different amino acids that are correlated with different hormones related to each center. Thus, if you provide the raw materials to the body in the right amounts, and you provide the proper instructions in the field by blessing these energy centers, then the body has both the correct instructions and the proper nutrition to build healthy hormones.
So, while we’re teaching people how to create a high level of order and coherence in the field around each of these energy centers, we are creating very clear instructions to inform matter (chemicals and hormones). Why? Because coherent signals from coherent frequencies carry coherent information. By providing all of the raw materials to manufacture these hormones and chemicals, and teaching people how to organize energy in each energy center to instruct matter, then when the body is looking for those chemicals, they will be readily available. That being said, the thought occurred to me—why not provide the very raw materials that would help to create more hormonal and chemical balance?
Thus we are advancing the teaching of the Blessing of the Energy Centers by selecting the best ingredients for these products to help people who have health conditions—or at least want to perform better—so they can begin to program the different hormonal centers of the body into more chemical balance.
If you’d like to learn more about these products and when they will be available, please visit https://biosyntropy.com/.
Numbers are everywhere, all around us, especially in this modern digital age. From your smartphone to your smart fridge, electronic devices often tell us the time, and we may also notice numbers in car registrations, addresses, phone numbers and other data chunks. So, what does it mean if you keep seeing the same pattern of repeating numbers?
You’re probably aware of the 11:11 phenomenon – increasing numbers of people who believe they are seeing the number pattern 11:11 (as a time) or 1111 cropping up in daily life. In numerology, 11 is a master number, and is believed to signify a strong spirituality. Many people therefore consider 11:11 to be a sign of a spiritual awakening, and that if you are seeing this number repeatedly, you are being called to a spiritual pathway as a lightworker.
But 11:11 is not the only significant number pattern. Any sequence of three or four repeated numbers has numerological significance. People probably see 11:11 more than the others because 11:11 is the only four-digit sequence which can appear on our clocks, but 222 or 2222, 333 or 3333 and so on are also deeply meaningful.
If you think you’re starting to see number patterns regularly, you’ll find it helpful to keep a log or a diary recording when and where you see them. Of course, confirmation bias plays a part here, and a sceptic would suggest that you’re not seeing these patterns any more often than any other random pattern of numbers, but you’re just subconsciously choosing to notice the one you want to notice. We don’t remember the dozens of times a day we glance at a clock and it says some other time, but we do remember if it says 11:11. While there’s undoubtedly something in that concept, it doesn’t negate that the number patterns you choose to pay attention to may well have some significant symbolic message for you.
111, 1111, 1:11 or 1.11
As you might expect, the number one connects in numerology with the concept of a beginning. If you are repeatedly seeing a 1-based number pattern, it could be a sign from the universal consciousness that the time is right to make a fresh start. A new cycle is yours for the taking, but action on your part is needed to kick it off. Whether it’s a new business you want to launch, or a new relationship you’re seeking, pay attention to these cosmic nudges and take positive steps to get something new off the ground.
222, 2222, 2:22 or 2.22
Two is feminine energy which speaks of harmony, love and balance. If you’re repeatedly seeing a 2-based number pattern, ask yourself if everything in your life is as balanced as it should be. This may be your prompt to adjust your work-life balance for example, or to balance your responsibilities against some me time. The number two is also about feelings and emotions, especially in love and interpersonal relationships. If you’re looking for love, the cosmos may be telling you that a soul mate is on the way.
333, 3333, 3:33 or 3.33
The energy of the number three is all about self-expression and creativity. If you’re repeatedly seeing a 3-based number of patterns, you’re being prompted to step into your full power as a manifestor and co-creator of your life. Set your imagination free and know that your thoughts create your reality. Perhaps it’s time for you to express who you really are instead of fitting into someone else’s boxes. Speak up, create, express yourself and don’t hold back.
444, 4444, 4:44 or 4.44
Four in numerology is about stability – think of the stability of a solid square. The energy of this number manifests itself in matters to do with our home life – our own source of stability – and issues around security, both physical and emotional. If you’re seeing a 4-based number pattern on a regular basis, the cosmos may be urging you to stay put or to have patience. Wait a while before making dramatic changes. While you’re waiting, work on nurturing yourself so that you feel safe and in control.
555, 5555, 5:55 or 5.55
If the energy of four is stable, the energy of the number five is unstable, inviting – if not demanding – change. Change can be daunting at the best of times, but if you’re repeatedly seeing a 5-based number pattern, it’s heading your way, like it or not. Prepare for this change in the first instance by embracing it. The number five asks that you surrender or let go of all that no longer serves you. This may feel like a big ask, and a risk, but this is a necessary step before a new cycle can begin.
666, 6666, or 6.66
The energy of the number six is all about duty, responsibility and service. If you are repeatedly seeing a 6-based number pattern, ask yourself whether you’re truly living up to your responsibilities – or perhaps at the other end of the scale whether your responsibilities are drowning you. The number six can bring worry and feelings of fear or angst, so seeing this pattern may be a nudge from the cosmos that you need to take better care of yourself. You can’t care for others unless you are well yourself. If you’re seeing this pattern regularly, get health niggles checked out.
777, 7777 or 7.77
The energy of number seven is about intuition and instinct. Christians believe that number seven is a lucky number, because it was on this day during creation that god rested. In Chinese numerology, however, number seven, like number four, is intensely unlucky. Forget notions of either luck or bad luck and instead understand that you make your own luck, based in large part on whether or not you listen to your instincts. If you’re seeing a 7-based number pattern regularly, the cosmos wants you to listen to your gut. Trust yourself and don’t be deceived by what others tell you.
888, 8888 or 8.88
Eight is a powerful number which tends to bring transformation and growth. It looks similar to the symbol for infinity and it is a reminder that however bad things have been, and however long the journey, you have it within your power to direct your own life. If you’re repeatedly seeing an 8-based number pattern, you have probably been through a tough time recently. This pattern is the universal consciousness telling you that you will emerge into better times if – and it’s a big if – you can trust the process.
999, 9999 or 9.99
Here in the UK, we are conditioned to associate the sequence 999 with an emergency or crisis, since it’s the number we use to call the emergency services. However, in numerology, the number nine is associated with wisdom, completion and a universal compassion for our fellow earth-dwellers. If you’re repeatedly seeing a 9-based number pattern, you may be drawing close to the end of one particular growth cycle – but fear not, because every ending leads to another beginning. A nine sequence may also be your prompt to get involved with humanitarian causes, or to share the wisdom you have learned thus far. When you see repeated nines, start to clear the decks – and your clutter – so that when this cycle is ended, you can face the future with confidence.
About the author:
Nikki Harper is a spiritualist writer, astrologer, and editor for Wake Up World.
Are you one of over two billion people that use Facebook, the world’s largest social media site?
Facebook has become so deeply ingrained in people’s lives that it has now become the norm to give it access to personal data without much thought, as if this is but a small price to pay for Facebook’s “free” service. But nothing could be further from the truth.
These traceable and sellable data now give Facebook the power to manipulate what we do, how we feel, what we buy and what we believe. The consequences of giving Facebook this much power is only becoming apparent, with mounting lawsuits against their security breaches and lousy privacy settings.
Even CrossFit, the well-established branded fitness regimen, has decided to stop supporting Facebook and its associated services, putting all their activities on Facebook and Instagram to a halt starting May 22, 2019. This decision came in the wake of Facebook’s deletion of the Banting7DayMealPlan user group, which was done without warning or explanation. The group has more than 1.65 million members who post testimonials regarding the efficiency of a low-carb, high-fat diet.
Although the group was later reinstated, Facebook’s action still shows how it acts in the interest of the food and beverage industry. You see, big advertisers on Facebook, like Coca-Cola, don’t want you to have access to this information, and Facebook is more than happy to ban anyone challenging the industrial food system. By doing this, it potentially contributes to the global chronic disease crisis.
Would you continue trusting a company that thinks too little of violating your rights to privacy?
1Facebook’s Primary ‘Product’ Is You
If you think Facebook’s product is the very platform that users interact with, you’re wrong. You are actually Facebook’s primary product. The site makes money off you by meticulously tracking your hobbies, habits and preferences through your “likes,” posts, comments, private messages, friends list, login locations and more. It sells these data, along with your personal information, to whomever wants access to them, potentially facilitating everything from targeted advertising to targeted fraud — this is its entire profit model.
Did you know that it can even access your computer or smartphone’s microphone without your knowledge? So if you’re suddenly receiving ads for products or services that you just spoke out loud about, don’t be surprised — chances are one or more apps linked to your microphone have been eavesdropping on you. These privacy intrusions can continue even after you’ve closed your Facebook account.
Companies can also collect information about the websites you’re visiting or the keywords you’re searching for outside of Facebook’s platform without your permission, and then sell these data to Facebook so it knows which ads to show you. This makes Facebook the most infamous advertising tool ever created, and to increase revenue, it has to continue spying on you.
During Facebook’s early days, its founder, Mark Zuckerberg, assured in an interview that no user information would be sold or shared with anyone the user had not specifically given permission to. However, the site’s blatant disregard for its users’ privacy proves otherwise. In fact, Facebook has been repeatedly caught mishandling user data and lying about their data harvesting, resulting in multiple legal problems.
The origin of Facebook is also far from altruistic, even though it’s said to be created “to make the world more open and connected,” and “give people the power to build community.” A front-runner to Facebook was a site called FaceMash, which was created to rate photos of women — photos that were obtained and used without permission. Some of the women were even compared to farm animals! This speaks volumes about Zuckerberg’s disrespect for privacy. Facebook is basically founded on a misogynistic hate group and it should therefore ban itself.
2Facebook Faces Investigation for Its Lax Security and Privacy Practices
Facebook is currently facing a number of lawsuits regarding its controversial data-sharing practices and poor security measures. Back in 2010, the U.S. Federal Trade Commission (FTC) revealed that Facebook was sharing user data with third-party software developers without the users’ consent, expressing concerns about the potential misuse of personal information, as Facebook does not track how third parties utilized them.
While Facebook agreed by consent order to “identify risk to personal privacy” and eliminate those risks, they did not actually pay attention to their security lapse. Had they done so, they would’ve been able to prevent the Cambridge Analytica scandal, the main focus of FTC’s first criminal probe. This issue involves Facebook’s deal with a British political consulting firm, allowing it access to around 87 million user data, which was used to influence public opinion in the U.S. presidential election.
Another criminal investigation into Facebook’s data sharing practice is underway. This time, it revolves around Facebook’s partnerships with tech companies and device makers, allowing them to override the users’ privacy settings and giving them broad access to its users’ information.
Amid federal criminal investigations, Zuckerberg announced the company’s latest plan to encrypt messages, so only the sender and the receiver will supposedly be able to decipher what they say. This is ironic, considering it was recently discovered that Facebook stored millions of user passwords in readable plaintext format in its internal platform, potentially compromising the security of millions of its users.
Zuckerberg has repeatedly demonstrated a complete lack of integrity when it comes to fulfilling his promises of privacy. In fact, in a 2010 talk given at the Crunchie awards, he stated that “privacy is no longer a social norm,” implying that using social media automatically strips you of the right to privacy, and that is why they do not respect it.
3Facebook Is a Monopoly
Facebook’s plan to integrate Instagram, Messenger and WhatsApp would turn it into a global super-monopoly. This merger has been criticized by tech experts, as it robs users of their ability to choose between messaging services, leaving them virtually no choice but to submit to Facebook’s invasive privacy settings. This also gives Facebook unprecedented data mining capabilities.
German antitrust regulator, Bundeskartellamt, is the first to prohibit Facebook’s unrestricted data mining, banning Facebook’s services in Germany if it integrates the three messaging platforms. If other countries follow suit, the merger would fall through, as it probably should.
One of the outspoken proponents of breaking up monopolies like Facebook, Google and Amazon is U.S. presidential candidate Sen. Elizabeth Warren, D-Mass. Her campaign to break up Facebook was censored by the site, taking down three of her ads with a message that said the ads went “against Facebook’s advertising policies.”
After Warren took to Twitter to comment how the censorship simply proves why her proposal was necessary, Facebook then reinstated her ads with the lame excuse that they were only removed because they included Facebook’s logo, which violates the site’s advertising policy.
I’ve Decided — I Am Leaving Facebook
At present, I have nearly 1.8 million Facebook followers, and I am grateful for the support. But a while back, I have expressed my concerns that perhaps I am doing more harm than good by being a part of Facebook, as I could be contributing to the invasive data mining, an idea that never sat well with me.
For those reasons, I decided that leaving the platform and going back to depending on email is the responsible way forward. If you haven’t subscribed to my newsletter yet, I urge you, your family and your friends to sign up now. I polled my audience and they agreed with my decision to leave.
What do you get when you combine science-inspired wonder and seven miles of desert? An incredible video.
Filmmakers Wylie Overstreet and Alex Gorosh, along with a few helpful friends, set out to make a scale model of the solar system. To do that, they traveled 600 miles to Black Rock Desert (home of the Burning Man Festival) in Nevada. Using various technology, vehicles, a drone, math and perseverance, they created “To Scale: The Solar System,” a seven-minute video that shows the orbits of the eight planets in our solar system. (Sorry, Pluto!)
The video is educational, beautiful and awe-inspiring. It shows off our planet’s place in the solar system, and it offers perspective on just how small Earth is in the grand scheme of things. The entire film is captivating, but perhaps the most poignant moment is at sunrise, when the real sun matches the model’s sun, showing that the representation is accurate.
As the video points out, most depictions of the solar system are inaccurate because to create a true scale rendering, the planets would need to be “microscopic.” Overstreet and Gorosh came up with a solution: build a “simulated model” in the middle of a dry lakebed where there’s plenty of space to show off a model of, well, space.
So, why did these filmmakers decide to take on this complex endeavor? Gorosh, a director with high-end commercials and documentaries to his credit, explains the inspiration for the project in a behind the scenes video: “As for why we made the model? Because it’s never been done before, and we felt like it.” Overstreet, a filmmaker with interests in science and nature, also notes, “There is literally not an image that adequately shows you what it [the solar system] actually looks like from out there. The only way to see a scale model of the solar system is to build one.” So they did. They spent 36 hours in what appears to be a rather cold desert to build the model and to capture the footage required.
The technology needed for this undertaking from conception to final cut ranges from sophisticated cameras to analogue tech, like a good old-fashioned compass. They even created a DIY harrow, a piece of equipment typically used to to break up soil but is apparently also excellent for drawing the orbits of planets in desert sand!
According to Overstreet’s website, he’s working on another “To Scale” video about deep time. If the first “To Scale” video is any indication of what’s possible, we can’t wait.
In books, I find psychological and emotional refuge, education and deep wisdom that I just don’t find elsewhere. My passion is connected to the words and the form they come in — printed pages bound together. So I’m not afraid to admit that when I read an article about how print book sales had risen (modestly) and e-book sales had declined (a bit) and that the number of independent bookstores had increased over the past year, I shed tears of joy.
It wasn’t that long ago that everyone was predicting the end of print and the demise of small bookstores. If people were reading, they were doing it digitally, and if they were buying paper books, they weren’t getting them from independent shops. The future looked grim for small stores.
But more and more, we keep hearing about the resurgence of the independent bookstore and how print is not dying after all. As The New York Times reported, “While analysts once predicted that e-books would overtake print by 2015, digital sales have instead slowed sharply.”
And one wonderful consequence of the changing market is that bookstores are slowly coming back.
“That’s right. The phoenix rises from the ashes. According to the American Booksellers Association, there are now 2,321 independent bookstores in the United States,” reported NPR’s Paddy Hirsch in March 2018. “And there are a couple of things that happened to prepare the grind for this recovery. First, when Amazon came along, the independents were decimated, sure. But the corporates — the big-box stores and the chains — they really got crushed. Borders, for instance, went out of business altogether. So that left a gap for the indies to fill.”
That’s hundreds of new, independent bookstores, which is just plain exciting. (I love to find local booksellers whenever I’m in a new city or town, and I know I’m not alone in that regard.)
The good news started to turn around a few years ago. Plus, sales at independent bookstores were up about 9 percent in 2018 from the year before, according to the American Booksellers Association. Bookstores in the U.K. also are experiencing increased revenue. Nielsen Bookscan statistics show year-on-year growth of 22 billion GBP with 2018 book sales reaching 1.59 billion GBP, reported The Guardian.
“I think the worst days of the independents are behind them,” Jim Milliot, coeditorial director for Publishers Weekly magazine, told the Christian Science Monitor in 2013. “The demise of traditional print books has been a bit overblown. Everybody is a little anxious, but they are starting to think they’ve figured it out for the time being.”
Why people want print
Shakespeare & Company bookstore in Paris has been open since 1919. (Photo: Christian Bertrand/Shutterstock.com)
What media stories don’t delve into are the reasons behind the stagnation in e-books and slight-but-real increase in demand for printed books. I don’t think this is anything like the niche nostalgia that’s driving vinyl record sales, which is still a tiny part of the huge music industry. Print book sales are still 80 percent of the market, the dominant form.
Could it be that, unlike music, there’s a real decline in utility when you choose e-books over printed ones — and only a marginal gain in efficiency? Are printed books simply a superior format, as my friend David Lanphier Jr. commented on Facebook?
Yes, you can carry a number of books with you on an e-book reader, which is an undeniable bonus. But most of us are only reading a couple of books at a time, and it’s not that hard to choose one or two books to carry around. For those who need larger print, e-readers are a definite win. If you live far from your local library, e-books are also a great solution.
And some people like looking up words, which is convenient with an e-reader. But in the days of smartphones, it’s almost as easy to grab your phone to check, so I’d call that one a wash.
The physicality of paper books
But unlike music, printed books are far sturdier and more reliable than e-readers. Many of my books have been dropped into water, partially set on fire by candles or campfires, and I hardly own a book that hasn’t had soup, coffee, tea, or water splashed on it. Printed books suffer all these indignities and more: Dogs chewing on them, toddlers throwing them out the car window, or use as a seat for butt protection against damp grass. All of those books are still readable.
You can take a biography to the seaside or read in the swimming pool as I’m wont to do without concern. You can throw a mystery in your backpack and take it to the top of the mountain and not care if it starts raining or your water bottle spills on it. You can keep reading in an Oregon drizzle and then dry that poetry out next to the fire. You can place a novel over your face and nap in the sunshine, breathing printer’s ink and words. You can even use the pages of a memoir to mop up a bit of blood when you fall off your mountain bike and cut your knee. (What? You’ve never bloodied a book?)
You can’t toss a terrible e-book across the room in frustration (cough, Nicholas Sparks, cough), and of course e-book publishers have made sharing titles nigh-impossible.
Of course, if you don’t like clutter, e-books are great; but if you love books, lots of them stacked up is comforting. And the used book market is still a relatively strong one, so just sell them if you don’t want to keep them around. You can then buy more books, something you can’t do with electronic copies of books. I buy used books for $5-8 each, then sell roughly two-thirds of them back to the bookseller for $3-4 credit. So new used books only end up costing me a few bucks, or I can put my credit towards a new title, cutting the cost below that of an e-book copy. Unless you’re buying new books all the time, I’ve found digital copies to be a significantly more expensive way to go.
Reading text in a digital format isn’t always the best way to get all the information from a story. (Photo: smokingapples.com/Flickr)
Besides being fragile, e-readers make scanning back into a book’s content difficult, because your story memory is not tied to a physical object and “spot” within it. You have to remember a word or phrase from the section you want to find. When I’m writing an article with books as reference, I find e-readers impossible to use; same with looking up a favorite few lines for reference later in my journal. And it’s not just because I didn’t grow up a digital native; even those who have grown up with e-readers and tablets still prefer print, according to a survey by Canon that looked at Millennial habits around reading and even sending written notes.
And as Lanphier added to his Facebook comment about this topic, “…my 6 and 1/2 year old niece has an iPad, and she reads on it, but she will read a book too. And, will choose a book over the iPad reading… because a book has that experience. You don’t see moms and kids and dads and kids gathered around the iPad reading together. But, you see them doing that with books.”
Clearly, I’m thrilled books are here to stay. And it looks like the next generation will love their printed books just as I do.
Editors’s note: This article has been updated since it was originally published in September 2015.
Pharmaceuticals: A market for producing ‘lemons’ and serious harm, analysis finds
Date:
August 17, 2010
Source:
American Sociological Association
The pharmaceutical industry is a “market for lemons,” a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe, according to an analysis that will be presented at the 105th Annual Meeting of the American Sociological Association.
“Sometimes drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs’ benefits,” said Donald Light, the sociologist who authored the study and who is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey. “Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It’s really a two-tier market for lemons.”
Three reasons why the pharmaceutical market produces “lemons” are: Having companies in charge of testing new drugs, providing firewalls of legal protection behind which information about harms or effectiveness can be hidden, and the relatively low bar set for drug efficacy in order for a new drug to be approved, Light said.
According to his study, independent reviewers found that about 85 percent of new drugs offer few if any new benefits. Yet, toxic side effects or misuse of prescription drugs now make prescription drugs a significant cause of death in the United States.
Light’s paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” is an institutional analysis of the pharmaceutical industry and how it works based on a range of independent sources and studies, including the Canadian Patented Medicine Prices Review Board, the Food and Drug Administration, and Prescrire International.
The foundation for the paper is the work Light did for a forthcoming book he edited, titled ‘The Risk of Prescription Drugs,” which is scheduled for publication this fall by Columbia University Press.
In both his paper and his book, Light describes the “Risk Proliferation Syndrome” that is maximizing the number of patients exposed to new drugs that have relatively low efficacy and effectiveness but have greater risk of adverse side effects. Building on clinical trials designed to minimize evidence of harm and published literature that emphasizes a drug’s advantages, companies launch massive campaigns to sell it, when a controlled, limited launch would allow evidence to be gathered about the drug’s effects. Companies recruit leading clinicians to try using the drug for conditions other than those for which it is approved and to promote such off-label or unapproved uses. Physicians inadvertently become “double agents” — promoters of the new drug, yet trusted stewards of patients’ well-being, said Light. When patients complain of adverse reactions, studies show their doctors are likely to discount or dismiss them, according to Light.
Despite the extensive requirements for testing the efficacy and safety of each new drug, companies “swamp the regulator” with large numbers of incomplete, partial, substandard clinical trials, Light said. For example, in one study of 111 final applications for approval, 42% lacked adequately randomized trials, 40% had flawed testing of dosages, 39% lacked evidence of clinical efficacy, and 49% raised concerns about serious adverse side effects, said Light.
“Just recently, major reports have come out about biased, poor trials for Avandia and Avastin,” Light said, who noted that orphan drugs are tested even less well.
“The result is that drugs get approved without anyone being able to know how effective they really are or how much serious harm they will cause,” Light said. The companies control the making of scientific knowledge and then control which findings will go to the FDA or be published.
“A few basic changes could improve the quality of trials and evidence about the real risks and benefits of new drugs,” Light said. “We could also increase the percentage of new drugs that are really better for patients.”
The paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” was presented on Aug. 17 in Atlanta at the American Sociological Association’s 105th Annual Meeting.
American Sociological Association. “Pharmaceuticals: A market for producing ‘lemons’ and serious harm, analysis finds.” ScienceDaily. ScienceDaily, 17 August 2010. <www.sciencedaily.com/releases/2010/08/100817111825.htm>.
Over the past year, the U.S. Senate and TheNew York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices.
But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations.
This epidemic of harm from medications makes our prescription drugs the fourth leading cause of death in the United States. Including hospitalizations and deaths from prescribing errors, overdosing, and self-medication, drugs move up to third place.
Below I describe the biases that appear throughout the drug development process, from initial research to FDA review and approval. I conclude with recommendations that would reduce drug development costs and ensure that drugs are only approved if they are safe and significantly more effective than already existing medications.
A Me-Too Business Model
Every drug has risks, so any drug considered for FDA approval should demonstrate clinical advantages that justify those risks. Yet public, independent advisory teams of physicians and pharmacists in several countries found over 90 percent of new drugs approved by the FDA and the European Medicines Agency (EMA) offer few or no advantages over existing drugs to offset their risks of serious harm.
Figure 1 shows the scorecard for 979 newly approved drugs over a 10-year span, based on detailed assessment of clinical benefits and risks by Prescrire, one of the world’s most distinguished, independent review bodies of physicians and pharmacists. (The exhibit focuses on France, a country whose consumer-oriented drug market features an array of products similar to the U.S.)
Figure 1. Few Clinical Advances in a Decade and Hundreds of Other Drugs Approved for Promotion
Only two were breakthrough advances and fewer than 10 percent offered substantial clinical advantages over existing drugs. Yet approved drugs have a 20 percent risk of producing enough harm for regulators to add a serious warning or have them withdrawn.
Flooding the market with hundreds of minor variations on existing drugs and technically innovative but clinically inconsequential new drugs, appears to be the de facto hidden business model of drug companies. In spite of its primary charge to protect the public, the FDA criteria for approval encourage that business model. The main products of pharmaceutical research are scores of clinically minor drugs that win patent protection for high prices, with only a few clinically important advances like Sovaldi or Gleevec.
This business model works. Despite producing drugs with few clinical advantages and significant health risks, industry sales and profits have grown substantially, at public expense. Companies spend 2-3 times less on research than on marketing to convince physicians to prescribe these minor variations.
Industry figures show the public pays companies about six times R&D costs through high prices on drugs. According to a study by Consumer Reports, high costs to patients lead them to postpone visits to physicians, avoid medical tests, and be able unable to afford other, effective drugs. For society as a whole, a leading health economist found that 80 percent of all new expenditures for drugs was spent on the minor variations, not the major advances.
Institutional Corruption
These startling results reflect studies from the Edmond J. Safra Center for Ethics at Harvard University, where research fellows have investigated “institutional corruption” in the pharmaceutical industry. “Institutional corruption” refers to systemic, legal ways that social institutions such as medical science, the medical profession, and the FDA become compromised by corporate and special-interest funding and influence.
Peer-reviewed studies already demonstrate how pharmaceutical companies manipulate FDA rules to generate evidence that their new drugs are more effective and less harmful than unbiased studies would show. The industry then recruits teams of medical writers, editors, and statisticians to select and repackage trial results into peer-reviewed articles that become accepted as reliable medical knowledge.
Based on his investigations, Marc Rodwin concludes, “Scholarly studies have revealed that drug firms design trials that skew the results and that they distort the evidence by selective reporting or biased interpretation.” This distorted evidence goes into clinical guidelines that become, Lisa Cosgrove and Emily Wheeler note, “essentially marketing tools for drug companies.”
Often Neither Safe Nor Effective
The Center for Drug Evaluation and Research (CDER – pronounced “C-DER”) is the FDA division responsible for determining whether new drugs should be approved. Its funding, however, now largely comes not from taxpayers but from the companies submitting their drugs to CDER for review.
This clear conflict of interest and approving so many new drugs with few clinical benefits serve corporate interests more than public interests, especially given the large risks of serious harm. Direct and indirect costs to society far exceed the cost of funding the FDA as a public, independent review body.
New FDA policies to get more drugs reviewed faster so that they can reach patients sooner result ironically in even more drugs being approved with less evidence that they are either safer or more effective. Faster reviews mean the chance that a drug will generate an FDA warning of serious harm jumps from one in five to one in three.
A systematic study of shortened reviews found that each 10-month reduction in review time produced an 18 percent increase of serious adverse reactions, an 11 percent increase of drug-related hospitalizations, and a 7.2 percent increase of drug-related deaths. Only 72 out of 1,300 CDER staff are charged with investigating drug safety, hard evidence that drug safety is a low priority at the FDA.
A recent review of FDA policies in Health Affairs describes how the FDA creates initiatives that ostensibly demonstrate its concern for safety from faster approvals. But the authors then describe how these initiatives frequently fail or backfire. They report no evidence of reduced harm or improved benefit to patients receiving these expedited drugs.
People imagine the FDA has stringent standards that take months or sometimes years for companies to meet. To a degree, that’s true. But the external independent evidence cited here of few new benefits and substantial risks of harm, calls into question what all this costly, lengthy review process is about.
An anthropologist might conclude it’s an elaborate ritual to make the FDA look like a tough watchdog against unsafe and ineffective drugs while it’s an industry-funded lapdog. Consider the easy ride that the FDA gives cancer drugs, requiring little evidence of improved patient outcomes.
For example, approving that new drugs are better than placebo is a low standard when other effective drugs already exist. Placebo trials are also unethical in these situations because they deny subjects in the control arm the use of an effective drug.
Another FDA standard, to prove that approved drugs are “non-inferior,” or not too much worse than an existing drug, does not allow patients to know if the new drug is better than the one they are taking. Using substitute measures for real benefits to patients makes approved drugs look more effective than they are. Allowing randomized trials to be drawn from biased populations that exclude many people who are likely to take the drug and experience an adverse reaction makes new drugs appear safer than they are.
Why does the FDA allow paymasters to design such trials?
Failure To Warn
The FDA is charged with providing physicians and the public with objective, scientific evidence showing that new drugs are safe and effective. Conveniently for drug companies, it carries out this responsibility narrowly by focusing on the label and not on alerting physicians or the public about biased evidence from those trials in leading medical journals that go into guidelines.
The FDA could alert the profession and public about how end points and other details get switched by industry ghost-writing teams, about unpublished negative results, and about positive results published twice; but it does not. Ghost writing and the ghost management of medical knowledge thrive.
To protect the public from unsafe and ineffective drugs and earn public trust, the FDA and Congress must acknowledge the biases described here that result from pharmaceutical corporations financing the public regulator. They should also require two changes: that new drugs demonstrate patient-based clinical advantages through comparative trials, and that these trials be based on the population that will actually take a drug.
These changes would reduce the flood of minor variations shown in Exhibit 1 and the subsequent billions spent on them.
Consider this fact: In 1995, 81 independent organic processing companies existed in the United States. Ten years later, Big Food had gobbled up all but 15 of them. The newly updated “Who Owns Organic?” infographic, originally published in 2003, provides a snapshot of the structure of the organic industry, showing the acquisitions and alliances of the…
Consider this fact: In 1995, 81 independent organic processing companies existed in the United States. Ten years later, Big Food had gobbled up all but 15 of them.
The newly updated “Who Owns Organic?” infographic, originally published in 2003, provides a snapshot of the structure of the organic industry, showing the acquisitions and alliances of the top 100 food processors in North America.
According to The Cornucopia Institute, this chart — authored by Dr. Phil Howard, an Associate Professor in the Department of Community Sustainability at Michigan State — empowers consumers to see at a glance which companies dominate the organic marketplace.
See the updated version below. (Click on the image to view a larger version,
and then click on it again for even larger detail.) Or see a PDF version here.
If you find the graphic hard to read, you might also wish to check out this graphic created by The Washington Post, which was published in May 2015 and shows 92 organic food brands who are owned by some of the nation’s largest food processors.
Major changes since the last version in May 2013
WhiteWave’s December 2013 acquisition of Earthbound Farm, the nation’s largest organic produce supplier, for $600 million.
Coca-Cola acquired a 10% stake in Green Mountain Coffee for $1.25 billion.
Bimbo Bakeries (Mexico) purchased Canada Bread from Maple Leaf Foods (Canada) for $1.7 billion.
The corporate takeover of organic food
According to a press release from The Cornucopia Institute,
“The chart shows that many iconic organic brands are owned by the titans of junk food, processed food, and sugary beverages—the same corporations that spent millions to defeat GMO labeling initiatives in California and Washington. General Mills (which owns Muir Glen, Cascadian Farm, and LaraBar), Coca-Cola (Honest Tea, Odwalla), J.M. Smucker (R.W. Knudsen, Santa Cruz Organic), and many other corporate owners of organic brands contributed big bucks to deny citizens’ right to know what is in their food.”
“Consumers who want food companies that embody more of the original organic ideals would do well to seek out products from independent organic firms,” Dr. Howard advises. “Given the very uneven playing field they are competing in, independent organic processors are unlikely to survive without such support.”
Nature’s Path: Country Choice Organic, Enviro-Kidz
Organic Valley: Organic Prairie
Pacific Natural Foods
Sno Pac
Springfield Creamery: Nancy’s
Traditional Medicinals
Yogi Tea
Dr. Howard observes, “I expect more deals to occur, since organic foods sales continue to increase faster than sales of conventional foods, and corporations are flush with cash and/or access to cheap credit.”
