Big Pharma’s Toxic Chemical Drugs Don’t Work
At Least 50 Percent of The
Effectiveness of All Drugs Is Due To Placebo
There's no doubt that many medications work in the short-term to suppress symptoms. In fact, that's all they do as they are incapable of addressing the underlying cause of disease. But even when a medication works, half of its impact on a patient is be due to one aspect of the placebo effect: the positive message that a doctor provides when prescribing the treatment, according to a new study.
Much of medicine is based on what is considered the
strongest possible evidence: The placebo-controlled trial. The problem is that
this foundation upon which much of medicine rests, has no standard.
The thinking behind relying on placebo-controlled trials is this: to be sure a treatment itself is effective, one needs to compare people whose only difference is whether or not they are taking the drug. Both groups should equally think they are on the drug -- to protect against effects of factors like expectation. So study participants are allocated "randomly" to the drug or a "placebo" -- a pill that might be mistaken for the active drug but is inert.
But, according toBeatrice Golomb, MD, PhD, associate professor of medicine at the University of California, San Diego School of Medicine, this standard has a fundamental problem, "there isn't anything actually known to be physiologically inert. On top of that, there are no regulations about what goes into placebos, and what is in them is often determined by the makers of the drug being studied, who have a vested interest in the outcome. And there has been no expectation that placebos' composition be disclosed. At least then readers of the study might make up their own mind about whether the ingredients in the placebo might affect the interpretation of the study."
Researchers are just starting to appreciate the power that the mind can have over the body, says Tor Wager, an assistant professor of psychology at Columbia University.
The thinking behind relying on placebo-controlled trials is this: to be sure a treatment itself is effective, one needs to compare people whose only difference is whether or not they are taking the drug. Both groups should equally think they are on the drug -- to protect against effects of factors like expectation. So study participants are allocated "randomly" to the drug or a "placebo" -- a pill that might be mistaken for the active drug but is inert.
But, according toBeatrice Golomb, MD, PhD, associate professor of medicine at the University of California, San Diego School of Medicine, this standard has a fundamental problem, "there isn't anything actually known to be physiologically inert. On top of that, there are no regulations about what goes into placebos, and what is in them is often determined by the makers of the drug being studied, who have a vested interest in the outcome. And there has been no expectation that placebos' composition be disclosed. At least then readers of the study might make up their own mind about whether the ingredients in the placebo might affect the interpretation of the study."
Researchers are just starting to appreciate the power that the mind can have over the body, says Tor Wager, an assistant professor of psychology at Columbia University.
As an example of this, Wager points to the body’s response to perceived threats.
"Say it’s late at night and everything is quiet and then suddenly you see someone outside, near a window," he explains. "Your body starts to respond. Your pupils dilate. Your heart rate goes up. You start to sweat."
The belief that something threatening is out there produces a host of physical responses that you have little control over. If you were told to calm down and turn off these sensations, you couldn’t, Wager says. "But if the belief changes -- say, it turns out that it’s just your husband coming home -- the physical response changes."
A positive or negative effect of the placebo can lead to
the misleading appearance of a negative or positive effect of the drug.
The placebo effect is a consciousness event, and more specifically an event in which consciousness and matter interact to change or transform a disease structure into a healing process or flow. At the level of reality at which this event takes place, it is not even possible to say that it is an interaction. This is a level at which consciousness-matter, or as it is more popularly known, mind-body, are not different but are a 'stuff', for want of a better word, which is not committed to either condition, yet is both.
The placebo effect is a consciousness event, and more specifically an event in which consciousness and matter interact to change or transform a disease structure into a healing process or flow. At the level of reality at which this event takes place, it is not even possible to say that it is an interaction. This is a level at which consciousness-matter, or as it is more popularly known, mind-body, are not different but are a 'stuff', for want of a better word, which is not committed to either condition, yet is both.
Study Details
Researchers designed an elaborate study, in which 66 people suffering from migraine headaches were given either a placebo, or a common migraine drug called Maxalt. However, for each migraine attack the participants had during the study period, they were told something different. For example, they were told they were taking a placebo when they were actually taking Maxalt, or vice versa, and sometimes they were told the pill could be either Maxalt or a placebo.
The pain-relieving benefits of the migraine drug increased when patients were told they were taking an effective drug for the treatment of acute migraine. And when the identities of Maxalt tablets and placebo pills were switched, patients reported similar pain relief from placebo pills labeled as Maxalt as from Maxalt tablets labeled as a placebo, according to the study published today (Jan. 8) in the journal Science Translational Medicine.
"In many conditions, placebo effect is a big part of the effect of the drug," said study researcher, Ted Kaptchuk, a professor of medicine at Harvard Medical School. In the new study, 50 percent of the drug's effect could be attributed to the placebo effect, he said.
This could equally work for any drug including vaccines. The relevance is not related to the drug itself but how it is presented to the patient. If a patient believe they are being protected from something, that belief system alone may a role in the drug's effectivness.
"The more you give a positive message, the more a drug works. In this case, our message was just as important as the pharmacology of the drug," Kaptchuk said.
In other words, patients may benefit from optimistic messages from their doctors, which may enhance the effectiveness of a good pharmaceutical, the researchers said.
"When doctors set patients' expectations high, Maxalt [or, potentially, other migraine drugs] becomes more effective," said study researcher Rami Burstein, a professor of anesthesia at Harvard Medical School. "Increased effectiveness means shorter migraine attacks and shorter migraine attacks mean that less medication is needed," Burstein said.
Placebo
Effect Can Be Activated Outside of Conscious Awareness
Described in an on-line issue of the Proceedings of the National Academy of Sciences (PNAS), new findings demonstrated
that the placebo effect can be activated outside of conscious awareness, and
provide an explanation for how patients can show clinical improvement even when
they receive treatments devoid of active ingredients or of known therapeutic
efficacy.
It has long been believed that placebo responses are related to conscious beliefs or thoughts and that when given an inert pill or therapy, patients get better because they have the expectation that they will get better, or in the case of nocebos, get worse because they anticipate that they will get worse.
However, more recently, scientists have recognized that humans learn to expect either reward or threat quickly and automatically without needing to consciously register the idea in their brains. As the authors write, neuroimaging studies of the human brain have suggested that certain structures, such as the striatum and the amygdala, can process incoming stimuli before they reach conscious awareness, and, as a result, may mediate non-conscious effects on human cognition and behavior.
Bodily
memories
The placebo effect is centered on the idea that a person’s expectations and beliefs drive changes in symptoms, even though they have received a sugar pill or a sham treatment with no effect. Knowing that they have received a placebo changes their expectations, which is expected to alter the placebo effect.
However, people report pain relief even when they know the pill they are receiving is a placebo, compared with no treatment at all.
This finding "contradicts the medical beliefs," Kaptchuk said. "Because in medicine, we think you have to think it's a real drug for placebo to work. But apparently, the body has memories, or an embodied awareness, which operates below the level of consciousness."
One possible mechanism for this effect could be that the body is conditioned to react positively in situations related to addressing our health.
Part of what goes into the brain’s interpretation is expectation. The placebo response, at least in part, is a manipulation of expectancy and by changing the expectancy and placebo response we might be able to ultimately find a way to provide sustained therapy for chronic pain without any medication at all.
Rituals and the words of healing activate the brain to release neurotransmitters that change the experience of illness. They can activate centers in the brain that modulate many symptoms like pain and nausea and fatigue.
Contrary to conventional wisdom that patients respond to a placebo because they think they're getting an active drug, more findings reinforce the idea that placebo treatment alone may have a therapeutic benefit shattering the concept of functional medicine.
Sources:
forskning.se
sciencedaily.com
sciencemag.org
Placebo: The Foundation Upon Which
Medicine Rests Has No Standard
The thinking behind relying on placebo-controlled trials is this: to be sure a treatment itself is effective, one needs to compare people whose only difference is whether or not they are taking the drug. Both groups should equally think they are on the drug -- to protect against effects of factors like expectation. So study participants are allocated "randomly" to the drug or a "placebo" -- a pill that might be mistaken for the active drug but is inert.
But, according to the paper's author, Beatrice Golomb, MD, PhD, associate professor of medicine at the University of California, San Diego School of Medicine, this standard has a fundamental problem, "there isn't anything actually known to be physiologically inert. On top of that, there are no regulations about what goes into placebos, and what is in them is often determined by the makers of the drug being studied, who have a vested interest in the outcome. And there has been no expectation that placebos' composition be disclosed. At least then readers of the study might make up their own mind about whether the ingredients in the placebo might affect the interpretation of the study."
Golomb pointed out these limitations to the placebo in a pair of letters to the journal Nature 15 years ago.
"A positive or negative effect of the placebo can lead to the misleading appearance of a negative or positive effect of the drug," she said. "And an effect in the same direction as the drug can lead a true effect of the drug to be lost. These concerns aren't just theoretical. Where the composition has been disclosed, the ingredients of the placebo have in some instances had a likely impact on the result of the study -- in either direction (obscuring a real effect, or creating a spurious one). In the cases we know about, this is not because of any willful manipulation, but because it can in fact be difficult to come up with a placebo that does not have some kind of problem."
Since 15 years have elapsed, the situation might have improved. Therefore, Golomb and her colleagues analyzed just how often randomized trials published in the past two years in each of the top four general medical journals actually disclosed the makeup of placebos.
The answer is not reassuring, according to the researchers, who found that the placebo ingredients for pills were disclosed in fewer than 10 percent of cases. (The nature of the "control" was significantly more likely to be stated for other types of treatments -- like injections, acupuncture, or surgery -- where people are more likely to question what "placebo" actually means.)
"How often study results are affected by what's in the placebo is hard to say -- because, as this study showed, most of the time we have no idea what the placebo is," Golomb concluded.
The Power of Placebo Goes Beyond
The Mind
by Linda Carroll
Much of medicine is based on what is considered the strongest possible evidence: The placebo-controlled trial. A paper published in the October 19 issue of Annals of Internal Medicine -- entitled "What's In Placebos: Who Knows?" calls into question this foundation upon which much of medicine rests, by showing that there is no standard behind the standard -- no standard for the placebo.
Now, using PET scanners and MRIs to peer into the heads of patients who respond to sugar pills, researchers have discovered that the placebo effect is not "all in patients' heads" but rather, in their brains. New research shows that belief in a dummy treatment leads to changes in brain chemistry.
"There have always been people who have said that we could make ourselves better by positive thinking," says Dr. Michael Selzer, professor of neurology at the University of Pennsylvania School of Medicine. "After pooh-poohing this for years, here are studies that show that our thoughts may actually interact with the brain in a physical way."
New insights into how placebos work may even help scientists figure out how to harness the effect and teach people to train their own brains to help with healing.
Mind over
brain matter
Recent reports show that anticipation of relief from a placebo can lead to an actual easing of aches, when the brain makes more of its own pain-dousing opiates. Brain scans of Parkinson’s patients show increases in a chemical messenger called dopamine, which leads to an improvement in symptoms when patients think -- mistakenly -- that they are receiving real therapy.
And studies in depressed patients like Park have found that almost as many are helped by placebo treatments as by actual medications. In fact, as it turns out, a person’s response to placebo treatment may offer clues as to whether "real" treatments with antidepressants are likely to work.
Researchers are just starting to appreciate the power that the mind can have over the body, says Tor Wager, an assistant professor of psychology at Columbia University.
"An emerging idea right now is that belief in a placebo taps into processes in your brain that produce physical results that really shape how your body responds to things," he says. "The brain has much more control over the body than we can voluntarily exert."
As an example of this, Wager points to the body’s response to perceived threats.
"Say it’s late at night and everything is quiet and then suddenly you see someone outside, near a window," he explains. "Your body starts to respond. Your pupils dilate. Your heart rate goes up. You start to sweat."
The belief that something threatening is out there produces a host of physical responses that you have little control over. If you were told to calm down and turn off these sensations, you couldn’t, Wager says. "But if the belief changes -- say, it turns out that it’s just your husband coming home -- the physical response changes."
The question, now, is how to tap into these powerful, unconscious responses, Wager says.
Brain waves
may hold key
At the University of California at Los Angeles, placebo-treated volunteers were hooked up to an electroencephalograph (EEG), a device that records the brain’s electrical activity. After a week of sugar pills, the volunteers were then given either more placebos or an actual antidepressant. They weren’t told which type of pill they received.
Eight weeks later, researchers scrutinized the brain waves recorded by the EEG back when all the volunteers were taking placebos. The UCLA scientists discovered something intriguing: The people who got the most benefit from the actual medication had a specific pattern of brain waves when they were being treated with placebos.
Those results were described in a study published this month in the American Journal of Psychiatry. Researchers haven’t figured out yet what the specific pattern of brain waves mean, but the study does show how patients might be inexpensively screened with an EEG to show doctors who is most likely to respond to antidepressant medications, says the report’s lead author Aimee M. Hunter, a research associate at the Semel Institute for Neuroscience and Human Behavior at UCLA.
Teaching
patients to soothe themselves
Meanwhile, at Stanford University, scientists figured there must be a way to harness the placebo response to help patients soothe their own pain.Â
The researchers rigged up an MRI so that people could watch real-time images of their brains, while lying in the scanner. The idea was to use the images to teach study volunteers to consciously pump up activity in parts of the brain activated by the placebo effect, says Dr. Sean Mackey, associate director of Stanford’s pain management division and director of its neuroimaging and pain lab.
One of those volunteers, Laura Tibbitts, signed up for the study in hopes that she might be able to find a way to quiet the constant, permanent pain that descended after her right shoulder and arm were smashed in a riding accident eight years earlier.
"Pain is not in the muscles or the arm that may be injured," Mackey says. "The pain is in our brains."
A signal starts out at an injured site and travels up to the brain, Mackey explains. But, until the brain interprets that electrical signal, you don’t actually "feel" pain.
Part of what goes into the brain’s interpretation is expectation, Mackey says. "I think of the placebo response, at least in part, as a manipulation of expectancy. And perhaps by changing the expectancy and bumping up the placebo response we might be able to ultimately find a way to provide sustained therapy for chronic pain."
Lying back in the scanner watching images of her brain, Tibbitts was told to conjure up memories of her pain on the day of the accident. Later, she was instructed to think soothing thoughts. "I imagined little people scooping away the pain, trying to rescue me," the 32-year-old San Francisco resident says. "Or I thought about water or snowflakes putting the fire out."
Empowering
experiment
Through trial and error, Tibbitts determined which kinds of thoughts fired up and turned down the brain regions that Mackey said were linked to her pain. The mental pictures had an impact.
And the newfound control over pain levels was empowering, Tibbitts says.
"I think the most incredible thing was to see that scan of my brain constantly producing pain," she adds. "And then to actually gain control over the pain, to see that I had that power -- even when I was making myself feel worse -- was amazing to me."
From Prevent Disease @ http://preventdisease.com/news/14/010914_50-Percent-Effectiveness-Drugs-Is-Placebo.shtml and http://preventdisease.com/news/10/101910_placebo_medicine_no_standard.shtml and http://preventdisease.com/news/12/032612_The-Power-of-Placebo-Goes-Beyond-The-Mind.shtml
For more information about the daily crimes and errors of Big Pharma see http://nexusilluminati.blogspot.com/search/label/big%20pharma
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