By Dr. Mercola
A placebo is an inactive treatment or substance, such as a sugar pill or sham procedure, that looks and feels just like a regular medical treatment.
Patients receiving a placebo generally believe it is the same as the typical standard of care, and many experience what’s known as the “placebo effect” – an improvement in symptoms – even though they received no actual “active” treatment.
Whether or not these inactive “treatments” have a place in real medicine has been debated, because placebos typically have far fewer side effects (if they have any at all) than prescription drugs, injections or actual surgeries – and they often work just as well as the standard of care.
And as research from numerous experts, including those from Harvard Medical School, has revealed, the placebo effect is not only real... it appears to be stronger than was once believed.
Most Dramatic and Classic Example of Medical Placebo Effect
There are certain modern-day examples that show just how powerful placebos can be... and why exploring them as an alternative to side-effect-ridden medications makes sense.
One such example is the classic New England Journal of Medicine knee surgery study.1 This was, without question, one of the most amazing studies I have ever seen published, as it definitely proves the power of your mind in healing.
This double-blind, placebo-controlled, multi-center trial performed at some of the top U.S. hospitals found that most knee surgery for osteoarthritis results in a $3-billion hoax. It is not actually the surgery itself that is responsible for the improvement, but rather is the placebo effect. More precisely, it's the ability of your brain to produce healing when you believe it should be happening (such as after you receive knee surgery). The researchers concluded:
“In this controlled trial involving patients with osteoarthritis of the knee, the outcomes after arthroscopic lavage or arthroscopic débridement were no better than those after a placebo procedure.”
Another example has to do with antidepressants. Research suggests there is little evidence that antidepressants have any benefit to people with mild to moderate depression, and they work no better than a placebo.2
One meta-analysis published in PLoS Medicine3 concluded that the difference between antidepressants and placebo pills is very small – yet these drugs remain one of the most prescribed drugs in the United States!
In a case like this, where there is little difference in effectiveness, but the sugar pills produce far fewer detrimental side effects, it makes the placebo far preferable to the antidepressants.
Placebos and the “Ritual of Medicine” May Prompt Brain Changes That Reduce Pain
Speaking with NPR, Ted Kaptchuk, a professor of medicine at Harvard Medical School and the director of placebo studies at Beth Israel Deaconness Medical Center, explained that receiving a placebo may work because it’s part of the “ritual of medicine.”4
When you visit a physician, explain your health problem and receive a treatment (whether it’s an active one or not), you have a certain expectation that you’re going to get better – and this is often what happens. Kaptchuk continued:
“We have expectations; we have previous experience; we have non-conscious awareness. And we're in a medical environment, and we're used to that environment producing beneficial results. The ritual of medicine activates particular areas in the brain that actually will reduce pain, or at least reduce the sensations that we have in relation to pain.”
Further, in one study Kaptchuk and colleagues conducted on patients with asthma, the same amount of relief was reported for both the active medication and the placebos, leading them to conclude:5
“Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma.”
Do Placebos Have a Real Place in Medicine?
The problem with actually “prescribing” a placebo is that it would be unethical to let a patient believe they’re receiving a “real” medication if they’re not. So the question is: do placebos have a place in medicine, or would telling patients they’re receiving one simply cancel out its benefits? Researchers are currently looking into this, as Kaptchuk explained:6
“We've done two experiments like that. They're small; they're pilot studies. We're hopeful that maybe this will pan out in the future; that we can actually, instead of putting people on drugs right away, maybe put them on the ritual of medicine, and see if that's enough. So I see there's a place for it, but it's still in infancy whether this is really an option or not.”
In one such study designed to determine if the beneficial effects still exist when a patient knows they're receiving a placebo, nearly 60 percent of the patients given a placebo pill (and, again, told they were receiving a placebo) reported adequate relief from irritable bowel syndrome (IBS) symptoms, compared to only 35 percent of those who received no treatment.7
Even more astonishing, those taking the placebo reported improvements that were virtually the same as those reported from people taking the strongest IBS medications.
The jury is still out on whether the practice of taking a sugar pill or simply going through the ritual of treatment is what's causing the beneficial responses... but either way studies have shown that if you think you're receiving a treatment, and you expect that treatment to work, it often does -- and even if you know you're receiving a placebo, the beneficial effects still hold strong. That is the power of your mind! Interestingly, a survey of Chicago-area physicians revealed that 96 percent believed that placebos could, indeed, have a real therapeutic effect – and 48 percent had actually prescribed placebos or “placebo-like treatment” in regular clinical practice.8
How Does the Placebo Effect Work?
As Scientific American reported:9
“In recent decades reports have confirmed the efficacy of various sham treatments in nearly all areas of medicine. Placebos have helped alleviate pain, depression, anxiety, Parkinson’s disease, inflammatory disorders and even cancer.
Placebo effects can arise not only from a conscious belief in a drug but also from subconscious associations between recovery and the experience of being treated—from the pinch of a shot to a doctor’s white coat. Such subliminal conditioning can control bodily processes of which we are unaware, such as immune responses and the release of hormones. … Researchers have decoded some of the biology of placebo responses, demonstrating that they stem from active processes in the brain.”
In one study, it was shown that simply thinking a placebo will help relieve pain will prompt your brain to release more natural painkillers, known as endorphins.10 It’s also been found that some people may be more susceptible to the placebo effect than others because of varying levels of dopamine activity in the area of the brain known as the nucleus accumbens, a region involved with the ability to experience pleasure and reward.11
So while the exact mechanisms behind the placebo effect are still being explored, there’s no denying that the effect is real. And, most likely, the placebo effect takes on many different forms, impacting brain mechanisms involved in expectation, anxiety and rewards. In short, a placebo really does change your brain, in a number of different ways. Writing in the journal Neuropsychopharmacology,12 researchers noted:
“First, as the placebo effect is basically a psychosocial context effect, these data indicate that different social stimuli, such as words and rituals of the therapeutic act, may change the chemistry and circuitry of the patient's brain. Second, the mechanisms that are activated by placebos are the same as those activated by drugs, which suggests a cognitive/affective interference with drug action. Third, if prefrontal functioning is impaired, placebo responses are reduced or totally lacking, as occurs in dementia of the Alzheimer's type.”
How to Harness the Placebo Effect in Your Own Life
There may be cases in your own life where you can use your mind to help heal your body or reduce your reliance on conventional medical care, including medications. And when I say that, I mean that if you strongly believe you will benefit from something, you radically increase the chances that you will. But there is one caveat: you must resolve any emotional blocks that are standing in your way first.
For example, this could be disbelief that the pain or illness will go away, resentment that you have the pain, or even an unconscious desire to keep the pain or disease because of the extra attention you gain from it. If you look at it in terms of energy -- pain is energy and your mind is also energy -- you can see how one directly influences the other.
The Emotional Freedom Technique (EFT) is an extremely powerful tool that you can use to get to the root of your emotional conflicts, and release them, to help open your mind to the power of the placebo effect. It’s often possible to feel better just because your mind subconsciously believes it's time, or your subconscious alters body processes in response to the placebo treatment without you even being aware of it.
As often as possible, always try to use the placebo option first. This is a new way of thinking about healing for most people, but can be extremely powerful, especially when combined with a healthy outlook and disease-preventive lifestyle.
By Dr. Mercola
Pharmaceutical companies have kept the wool pulled over Americans' eyes for many years, and had many convinced that they were working fervently to develop safe medications that would cure and prevent virtually every disease plaguing the world.
But these modern-day messiahs are not the saints they would have you believe … not even close.
According to Dr. David Healy, who has had the opportunity to investigate the circumstances behind the approval of certain drugs at a level that very few others have been able to, drug companies frequently hide vital information about their drugs in order to get it on the market and keep it there.
The drug companies that manufacture some of the best-selling drugs in the world have committed some of the greatest crimes against human health, and all of them have at one point or another been found guilty of criminal activity—some have been nailed several times.
So much so that several pharmaceutical companies are on the Top Corporate Criminals list. Yet we entrust our health, our very lives, to these same corporate "personages" who cannot be put in jail for cutting lives short, and who view billion dollar fines as nothing more than the cost of doing business.
As recently as July 2, GlaxoSmithKline plead guilty to three counts of criminal misdemeanor and other civil liabilities relating to the prescription drugs Paxil, Wellbutrin and Avandia, and agreed to pay a total of $3 billion in fines.
In 2009 Pfizer was fined $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra and their antipsychotic drug Geodon.
Dr. Healy, a professor of psychiatry in North Wales and Great Britain is a former secretary of the British Association for Psychopharmacology and author of over 175 peer-reviewed articles, 200 other pieces, and 20 books, including Let Them Eat Prozac (one of my favorites), and Pharmageddon, another favorite.
His time is divided between an active psychiatry practice and research.
For example, he has studied the serotonin-uptake theory in depressed patients, and is adamant that there's no evidence indicating that depressed patients have something wrong with their serotonin system, which makes selective serotonin reuptake inhibitors (SSRI's) a dubious treatment for depression. It may even be part of the equation for why some people become suicidal on SSRI's, even if they've never had such tendencies before.
"We've got 30 to 40 years' worth of work, and no evidence has come to light that there's anything wrong with the serotonin system in people who were depressed," he says.
Profits Before Life—The Sad History of Antidepressant Drugs
Dr. Healy's conviction that SSRI's can make people actively suicidal was originally borne directly out of his own clinical experience. Since then, the research demonstrating this link has become quite clear, and this class of drugs now carry a "black box" warning. What's really infuriating though is the evidence that has since emerged showing that pharmaceutical companies knew about it, and hid it, and it wasn't until it became an obvious issue in clinical practice that a warning was finally issued. People literally lost their lives because these companies didn't want to risk sluggish sales.
"I got involved as an expert witness in some legal cases that involved these drugs," Dr. Healy explains. "When you get involved as an expert witness in legal cases, you get to go behind the scenes. You get to go into the company archives, and you get to see what the clinical trials really showed, and what the company personnel really thought about the issues.
Then it was clear that the trials also really showed those problems. It was clear that the companies knew there was a problem, and they were in the business of trying to hush the whole thing up.
... The regulators also clearly knew there was a problem, I would say from very early on. They may well have known there was a problem even before the drugs came to the market. They certainly knew there was a problem shortly after Prozac was launched and a great number of people complained about the fact that they had a problem on this drug.
When they looked at the data – the kinds of data that the FDA, for instance, would have been able to see when they held the first public meeting about whether SSRI drugs, Prozac in particular, could cause people to become suicidal – they had a lot of data that the rest of us didn't have. They had data on the other SSRIs that haven't yet been marketed.... I'm sure it was very clear to them then that the SSRIs can cause people to become suicidal."
Publicly, the FDA argued that putting a warning on the drug might deter people from treatment, so by doing the right thing, we might end up with a detrimental outcome. However, no one addressed the fact that not putting a warning on the drug might make more people use them, hence killing more people, more indiscriminately. This is exactly the situation we're dealing with now. Even with the warning, antidepressants are prescribed more or less willy-nilly, for everything from anxiety to pain, high blood pressure, and insomnia—minor ailments that in NO WAY warrant such a huge risk.
"[The information] the FDA had points very clearly not just to the fact that [SSRI] drugs can cause a problem, but that on balance, they harm more people than they help," Dr. Healy says. "How the FDA squared this, I'm not sure."
SSRI's Likely Harm More People than They Help
In addition to suicidal thoughts and behavior, there also seems to be an association between antidepressants and other violent behaviors, such as homicides and school shootings. Unfortunately, while suicide has become a well-established (yet oft-ignored) side effect, the data on other types of violence is, again, being hidden.
"We haven't had hearings about this issue," Dr. Healy says. "People haven't had access to the data. There's been no publications around it. This is one of the biggest problems on which there's a huge amount of data, but to which we've got little or no access."
Dr. Healy estimates that possibly 1,000 to 2,000 people taking an SSRI drug commits suicide each year in the US who would not have done so were they not on the drug. He also believes there's a comparable number of people who will commit a violent act against others as a result of the drug, who would not have done so otherwise. Then there's the issue of generational harm. Birth defects, miscarriages (as many as 20,000 per year), and voluntary abortions due to the baby being diagnosed with a birth defect are other devastating side effects that get little if any attention.
Why is that?
Why is so little attention given to the very serious nature of the side effects associated with these drugs? Why are antidepressants seemingly handed out like candy to cheer people up, as opposed to treat serious mental conditions?
A major part of the problem is the too-cozy-for-comfort relationship between drug companies and psychiatrists and other prescribers. Adding to that problem is the fact that drug companies are actively hiding and suppressing negative data on their drugs, so psychiatrists prescribe drugs without having the real facts.
Psychiatry is Committing "Professional Suicide"
Dr. Healy was recently featured in Time Magazine1, after giving a speech at the American Psychiatric Association's (APA) second largest annual meeting. The topic of the session was conflicts of interest in psychiatry. Maia Szalavitz writes:
"Arguing that his profession is "committing professional suicide" by failing to address its dangerously close relationship with the pharmaceutical industry, he likened psychiatry's attitude toward its faltering legitimacy to the Vatican's widely derided response to its child-sex-abuse scandal by priests — essentially that psychiatry is brushing off justifiable concerns as hype instead of dealing with the source of the problem.
Few experts believe that psychiatry's relationship with the drug industry is healthy. While several speakers at the session pointed out that other specialties are similarly entangled with industry, "everyone does it" is generally not a valid defense where conflicts of interest are concerned.
... "I'm going to argue that we need you to be biased. We want you to be biased by treatments that work," Healy told his colleagues. "I don't mind if you're my doctor and you've given talks for industry. My concern is not that you've been paid by industry, but that you've been fooled by industry. The key conflict is whether people are hiding data from you."
The article goes on to detail some the more unsavory aspects of conflicts of interest—the kind of suppression activities that lead to demolished careers, and worse. Dr. Healy has been personally targeted by drug companies for speaking out against various drugs and exposing wrongdoing. His presentation at the APA included a document obtained via a Freedom of Information Act request, which reveals Eli Lilly's plan for countering his public discourses on how drug companies hide drug data. One of these strategies includes planting people in the audience of his presentations to argue the industry's view.
What Clinical Trials Do and Do Not Show
According to Dr. Healy, in the clinical trials done to bring antidepressants to market it is virtually impossible to show that they have an overall positive effect. Part of the problem that few consider is the fact that clinical trials are not designed to answer some of the most important questions we have about any given drug, such as: Does this drug save lives?
"From what we know of the data that's there, the answer is no, they [antidepressants] don't save lives," Dr. Healy says. "Clinical trials also aren't designed to answer the question, "Will these drugs get people back to work?" From the data we have, we have no reason to think that these drugs will be more likely to get people back to work than placebo would, for instance.
In terms of what most people understand the word "work" to really mean, which is [in the vein of the questions] "Will my life be saved?" or "Will I be able to get back to being employed?" we have no evidence that these drugs "work." What we've got is clinical trials based on rating scales, where you can show that the drug does marginally better than placebo on these rating scales. But that's all we have."
Fortunately, there are other alternatives, which have been shown to have a more life-enhancing effect than antidepressants, such as niacin (vitamin B3). The renowned and recently deceased Canadian psychiatrist Dr. Abram Hoffer was a strong advocate of the use of niacin in psychiatric illness, specifically for schizophrenia, for which there don't seem to be many really good treatments.
What he discovered was that niacin deficiency is a major contributor to pellagra, the symptoms of which mimic depression.
He believed there's a subgroup of people who have an increased nutritional requirement for niacin, making them not merely deficient per se, but niacin dependent. When they don't get it on a regular basis, and typically in far higher doses than normal, they're predisposed to psychiatric illnesses. Dr. Healy believes there may be significant value in niacin supplementation, adding that one of the mechanisms of niacin is detoxification, especially lead. This makes sense, since it it's a potent vasodilator, which would increase supply to the filtering organs, thereby aiding in the excretion process.
To view the full interview, please click HERE!
What's the Mechanism of SSRI's that Make Them so Pernicious?
According to Dr. Healy, the mechanism of harm has not been clearly established. The most likely mechanism of harm is the fact that they act on your serotonin system.
"Serotonin is the most primitive neurotransmitter there is. Even in a single-celled creature, it's there. When you're acting on it, you're acting on a mechanism that is very primitive and very, very profound," Dr. Healy says. "So, it may be just purely the action on your serotonin system that is the problem.
Now, people who say, "I know SSRIs work" are doing the same kind of thing as saying "I know red wine works." If you have a nice glass of red wine in the evening, you feel mellowed out and chilled out... The SSRIs can work in the same kind of way, and can do a useful thing, which is: chill people out. You can get people who were stressed from work who are now a little less stressed at work because of the SSRI they're on. In that sense, they can clearly work—not for all people, but for a portion of people.
But when you test them out in groups of people who are clinically depressed (just as we would find if we were to test alcohol out in groups of people who are clinically depressed in six- to eight-week trials) it's actually rather hard to show that they do any better than placebo. They have, in fact, much the same rates of improvement compared to placebo, as we would expect to find if the drug we were actually testing was alcohol rather than Prozac, for instance."
... What you've got in the case of the SSRIs is much more like a psychic aspirin.
They numb you slightly. They take the emotional pain away. But they do this only when your serotonin system's working normally. And they make your serotonin system more abnormal after you've been on a course of treatment than it was to begin with."
Do Prescription Drugs Save Lives?
In his book Pharmageddon, Dr. Healy expands on the skewed data and other manipulation techniques employed in drug trials. While we spend a great deal of time discussing antidepressants in this interview (which you can listen to in its entirety by following the hyperlink provided above), the situation in terms of proving benefit is the same for other drugs.
Statins, for example, can indeed lower your cholesterol levels, and many do so quite well. So in that sense, they "work." But as with antidepressants, if you ask the question "Do these drugs save lives?" the answer becomes rather murky.
"If you ask the question "Are people going to be better able to work on these drugs?" then the answer is clear: They're actually going to be LESS able to go to work," Dr. Healy says. "They're going to have a range of problems and other symptoms that they didn't have off the pills.
Now, if you got marginally raised lipid levels, that is not something that interferes with your capacity to work. But if you're on a drug like one of the statins for instance, you are on a drug that may cause muscle aches, pains, cognitive failures, and may seriously interfere with your capacity to work."
Osteoporosis drugs are another good example of drugs that, overall, do more harm than good.
"They say up to a third of women over the age of 50 have osteoporosis," Dr. Healy says. "But they don't. This is an osteoporosis that's created by the DEXA scanners that the pharmaceutical companies gave away for free when they were marketing drugs for osteoporosis. If you scan bones, you'll almost always find little bits of thinning here and thinning there.
So you can create the diagnosis of osteoporosis, and you put these women on pills. Because they're on pills, they think their bones are brittle, so they'll probably do the wrong thing, which is they'll think they shouldn't go out and mow the lawn. They shouldn't jog... because their bones are brittle and they might have a fracture. But in fact, getting out to mow the lawn, jog, and get physically fit is a much better thing for them to be doing than to be taking osteoporosis pills, unless they've got very severe osteoporosis."
Personally, I don't see a reason for ever using an osteoporosis drug. They're extremely poisonous, and they kill your osteoclasts, the cells responsible for destroying old damaged and unnecessary bone cells that set your osteoblasts up to replace it with new bone tissue. This creates a dynamic balance of bone resorption and bone building. They make your bone denser, but at the same time they make them weaker.
Why You Don't Want a Doctor Who Follows All the Latest Guidelines
The sad truth is, there's no easy way to determine what you can trust when it comes to medical research and official treatment guidelines. So much of it has been tainted by economic conflicts of interests. An important point made by Dr. Healy is that a doctor who strictly keeps to the guidelines is going to be far more controlled by the pharmaceutical industry than might be good for your health...
"We're in a world where you want a doctor who, for the sake of giving you good care, is prepared to take the risk of losing their job, because this is the world that good doctors increasingly are being forced into. They're being forced into being the kind of physician that says, "I know the guidelines are wrong. Yes, they based it on the latest evidence. But the industry actually controls the evidence, and as far as they do, they control the guidelines process also. I'm going to go by what seems to be the best thing for me to do for my patients."
Unfortunately, there's no simple way to pick out articles in the literature and say, "We can believe this and not that." In fact, you could almost say that the articles in what we used to think of as the best journals in the field – like the New England Journal of Medicine, JAMA, and other journals like this – are more likely to be compromised than articles in perhaps journals that are less well-known."
A perfect example of this is the article I recently did on a study that was widely promoted in the media, which declared that eggs were associated with as much risk for strokes as smoking. It was a critically flawed study. And when we looked at the funding of the study, we discovered strong ties to the pharmaceutical industry. Two of the three researchers in question, have declared interests in statins. Now do you think the companies that make statins might have a vested interest in getting you to be afraid of eggs and cholesterol? Of course they do. The third researcher helped create the vegan "Portfolio Diet," which only allows egg substitutes and then only sparingly, so he too has a financial stake in scaring people away from eggs.
How Outsourcing Clinical Trials Can Skew or Hide Unsavory Findings
Another significant problem that most people don't have a clue about is how outsourcing clinical trials to other countries can affect their believability. Even trials done in the US have been plagued with fraud, such as enlisting patients that don't actually exist. The matter of potential fraud increases with overseas trials, because the FDA does not have the ability to double-check the veracity of the data even if they wanted to (and even in US trials they rarely do).
"There's a trial recently that brought Abilify® to the market with an indication for maintenance treatment for bipolar disorder. This trial was run in approximately 30 U.S. clinical trial centers and two further clinical trial centers in Mexico. In the trial centers based in the United States, when you added all the patients together, you found that Abilify® didn't do any good.
It couldn't beat placebo as a maintenance treatment for patients who had bipolar disorder.
In the Mexican centers, however, it really did beat placebo. It wonderfully beat it. All of the patients down there who got Abilify® did well, and the patients who got placebo did poorly. When you added the two Mexican centers into the U.S. centers, overall you've got a marginal result, which showed that Abilify® was slightly better than placebo.
But this was caused by the Mexican patients. Now, clearly, the Mexican data looks very dodgy, very shaky. The FDA knew this was happening, but didn't in any way investigate the issues. They noted that it was odd, but they didn't investigate the issues, and they didn't stop the company, later, from publishing the trial without drawing any attention to the fact that, "Well, you know, our results don't look all that good when you leave the Mexican trial centers out of the picture."
Dr. Healy's Take on the Future of Medicine
Dr. Healy doesn't cast too much blame on the FDA though, stating that the agency always has been and probably always will be an agency that contributes to public health, "but does so by regulating the wording of adverts that the pharmaceutical companies put out." He points out that it's not really the FDA's job to evaluate the product or the practice of medicine, stressing that this responsibility really falls on doctors.
"Back 30 to 40 years ago, we were a lot safer not because the FDA were doing their job better, but because doctors were doing their job better," he says.
I think it's medicine that has lost its way. I think the FDA is still doing what it has always been doing, which is a very minimal job. I mean, most people out on the street want someone there to protect them from the risk that drugs or industry may pose. They're hoping that that's the FDA, when, in fact, that has never been FDA's brief. It's been the brief of doctors to do that, and we've been failing at that job more and more in recent years."
When asked what he thinks the solution is, Dr. Healy responds:
"I think my solution is this: the job of the doctors have been like the job of the pilot of a plane. Their job is to get you from Chicago to Houston alive—not to get you there 15 minutes earlier; it's to get you there alive...
Doctors seem to have forgotten this. If they can't get you there alive; if they can't be the people whose professional identity is linked to keeping you safe when you go on treatment, they're going to be replaced by cheaper prescribers – by pharmacists or nurses. Anyone can get you on the pill these days. It takes an expert to keep you safe. I think if doctors don't realize this, they're committing professional suicide."
How You Can Get More Informed, and Be Part of the Solution
Dr. Healy is a strong advocate for doing things to make a difference. And this was the impetus behind a brand new website called www.rxisk.org. His goal for this website is to create a people's movement for safer drugs.
"We want people to go in there and report any of the problems they may be having on the medicines that they're on. They can report this to FDA as well. But if they report to us, we're going to feed their reports through to FDA," Dr. Healy explains.
Potentially one of the most valuable features on the site will allow you to go through a series of questions that will help you determine whether ailments you're having are associated with any of the drugs you're taking. At the end, you will get a report that you can then bring with you to your prescribing doctor, to aid you in making a more comprehensive risk versus benefit analysis. The idea is to try and create better teamwork between you and your doctor. Furthermore, you will get feedback on potential problems with individual drugs long before you'd get it from the FDA.
I feel this could be an excellent tool for anyone currently taking any drug, as well as for anyone considering taking one. Forewarned is forearmed, as they say, and when it comes to drugs, you really need to do your due diligence, as the risks are all on you—not on your doctor, the FDA, or the pharmaceutical company.
Weighing the risks versus the benefits is crucial, but in order to do this, you need reliable, truthful information, and I believe www.rxisk.org can be a valuable resource that will only become more valuable with time, as people begin to use it and file their own reports on side effects. So please, bookmark it on your computer and refer to it whenever needed, and share it on your social networks. Together, as a community, we can help the movement for safer drugs.
How Deeply-Flawed Medical Studies Lie About Drug Safety…
Basis of Many Medical Studies Found to be Proved Fatally Flawed
By Dr. Mercola
Now, as you know, I am not a big fan of using prescription drugs for just about any reason. I don't take them, nor do my parents who are 77 and 83. However, I realize that many reading this are in a transition phase or simply unwilling to get off of them at this time.
The information in this article can save you enormous amounts of money if you are throwing away your medications because you are following the inaccurately listed expirations dates on the prescription bottle.
Prescription drugs typically have an expiration date of one to five years, and if you're like most people, you would probably think twice before taking a medication past its expiration date. Medication turnover based on stated expiration dates also costs the medical industry, such as hospitals, pharmacies, and the US military, billions of dollars.
According to a new study,1 prescription drugs can actually remain sufficiently potent well past their expiration date, as long as it's unopened. (It's important to remember that drugs need to be stored properly, as humidity, temperature and exposure to light can affect the drug's shelf life.)
Prescription Drugs Still Viable Up to 40 Years Past Their Expiration Date, Study Finds
The researchers analyzed eight prescription drugs that expired between 28 and 40 years ago, and found that most were just as potent as when they were made.
The drugs included 14 active ingredients, including aspirin, codeine and hydrocodone, and in 86 percent of the cases, there was still at least 90 percent of the active ingredient left in the drug, which is within the limits allowed by the US Food and Drug Administration (FDA). Any given batch of a drug may contain anywhere between 90-110 percent of the amount of the active ingredient stated on the label.
As reported by CNN Health:2
"It's impossible to say from the study results alone whether the eight drugs would be effective if used today, but 'there's no reason to think that they're not,' says Lee Cantrell, the lead author of the study... Two of the tested ingredients, aspirin and amphetamine, consistently fell below the 90 percent threshold, as did one sample of the painkiller phenacetin...
'All [the expiration date] means from the manufacturers' standpoint is that they're willing to guarantee the potency and efficacy for the drug for that long,' he says. 'It has nothing to do with the actual shelf life.'
The fact that expiration dates appear to be somewhat arbitrary may mean that consumers and pharmacies alike are throwing away perfectly good medicine. And this has important implications for drug shortages and especially health care costs, the researchers say.
'We're spending billions and billions on medications and medication turnover,' Cantrell says. 'If a drug has expired, you've got to throw it away, it goes into a landfill, and you have to get a new prescription. This could potentially have a significant impact on cost.'
Although consistently taking depleted prescription drugs could certainly cause complications, expired drugs are generally safe. In the medical literature there is only one example of an expired drug that became toxic, and that was an isolated incident, says Cantrell, the director of the San Diego division of the California Poison Control System."
This supports previous findings by the US military, which found that 90 percent of the drugs tested were potent far past their original expiration date, at least one drug was still good after 15 years. There are exceptions of course. Nitroglycerin, insulin and liquid antibiotics are three drugs that do NOT tend to keep well past their expiration date.
According to a report by The Wall Street Journal from 2000:
"...Francis Flaherty says he has concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer. Mr. Flaherty notes that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set. The expiration date doesn't mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful.
'Manufacturers put expiration dates on for marketing, rather than scientific, reasons,' says Mr. Flaherty, a pharmacist at the FDA until his retirement last year. 'It's not profitable for them to have products on a shelf for 10 years. They want turnover.'"
Cantrell again suggests expiration dating of drugs might need to be reevaluated, and it sounds like a good idea to me. The pharmaceutical industry can easily bilk extra money out of the medical system by stating a drug will expire after one year, when in fact it can safely last several years – perhaps several decades! Overall, it's a massive waste of money, but what's worse, unnecessary medication turnover also contributes to water contamination, which is becoming an increasingly troublesome concern.
You're Probably Drinking Someone Else's Drugs...
The federal government advises throwing most unused or expired medications into the trash rather than flushing them down the toilet, but water testing across the US shows that no matter how the drugs are disposed, they have a tendency to end up in water. For example, a 2008 Associated Press investigation found that the drinking water of at least 51 million Americans contained minute concentrations of a multitude of drugs:3
- Philadelphia tested positive for 56 pharmaceuticals or byproducts in treated drinking water, including medicines for pain, infection, high cholesterol, asthma, epilepsy, mental illness and heart problems. The city's watersheds tested positive for 63 different medications or byproducts
- Southern California drinking water had detectable levels of anti-epileptic and anti-anxiety medications
- A metabolized angina medicine and the mood-stabilizing carbamazepine was found in drinking water in Northern New Jersey, and
- San Francisco's drinking water was found to be laced with a sex hormone
Flushing expired medications down the toilet is not the only way these drugs enter the water supplies. When you take a drug, you also eliminate a fraction of it and/or its byproducts through your urine. Drugs have also been detected in the water at landfills, confirming suspicions that pharmaceuticals thrown into household trash still end up in our water supplies. Water that drains through landfills, known as leach rate, eventually ends up in rivers. And although not all states source drinking water from rivers, many do.
In addition to the chlorine, fluoride and disinfection byproducts (DBPs) this is yet another powerful reason to avoid drinking tap water unless it is filtered.
The federal government does not require water treatment plants to test for drugs, and there are no safety limits for drugs in water. Making matters worse, standard water treatment does NOT filter out drugs. It's also important to realize that bottled water is oftentimes nothing more than tap water, which may or may not have received additional treatment, and bottlers typically do not screen for pharmaceuticals in the water either. Many home filtration systems are similarly untested in terms of their ability to filter out drugs. According to a comprehensive survey of U.S. drinking water,4 10 of the most frequently detected toxic pharmaceuticals overall were:
Atenolol, a beta-blocker used to treat cardiovascular disease Meprobamate, a tranquilizer used in psychiatric treatment Atrazine, an organic herbicide banned in the European Union which has been implicated in the decline of fish stocks and in changes in animal behavior Naproxen, a painkiller and anti-inflammatory linked to increases in asthma incidence Carbamazepine, a mood-stabilizing drug used to treat bipolar disorder Phenytoin, an anticonvulsant used to treat epilepsy Estrone, an estrogen hormone secreted by the ovaries and blamed for causing gender changes in fish Sulfamethoxazole, an antibiotic Gemfibrozil, an anti-cholesterol drug TCEP, a reducing agent used in molecular biology
Water Quality Matters!
Contamination surveys such as those by the US Geological Survey (USGS)5, 6 can help us realize just how intimately connected we are with our environment, and how everything we do (and don't do) impacts that environment and boomerangs right back at us... We literally live in a sea of chemicals these days, and it is certainly not doing your health any good.
Trace amounts of more than 150 different human and veterinary medicines have been detected in environments.
According to the USGS, 80 percent of the streams in the US, along with nearly 25 percent of the nation's groundwater is contaminated with a variety of pharmaceuticals. The drug industry, while admitting that pharmaceuticals are clearly contaminating water supplies, maintains that the levels are too low to cause any harm. Yet, it's known that drugs in waterways can harm fish and other aquatic species, and laboratory studies show human cells do not grow normally when exposed to even trace amounts of certain drugs.
Other potential concerns include:
- Some people are now exposed to traces of multiple drugs at one time, in addition to other harmful metals and chemicals in their water. Subsequently, people may be exposed to combinations of drugs that should not be combined
- Many drugs in the water supply are known to have dangerous side effects when taken in normal prescription doses
- Drugs that were only intended for external application will now be ingested and vice versa
- Some individuals are allergic to drugs found in the water supply
- Pregnant women are also being exposed to drugs that could potentially harm an unborn child
Besides the health risk to humans, drug-tainted water also has an ecological impact, contributing to mass bird die-offs and promoting antibiotic-resistant pathogens. A previous article in Environment3607 describes just how devastating pharmaceutical contamination of the environment can be:
"The popular anti-inflammatory and arthritis drug, diclofenac... is used in both human and veterinary medicine. In India, farmers started dosing their cows and oxen with the drug in the early 1990s to relieve inflammation that could impair the animals' ability to provide milk or pull plows. Soon, about 10 percent of India's livestock harbored some 300 micrograms of diclofenac in their livers.
When they died, their carcasses were sent to special dumps and picked clean by flocks of vultures. It was an efficient system, for unlike feral dogs and plague-infested rats, South Asia's abundant vulture population – estimated at more than 60 million in the early 1990s – carried no human pathogens and was resistant to livestock diseases such as anthrax. But vultures who fed on the treated carcasses accrued a dose of diclofenac of around 100 micrograms per kilogram. A person with arthritis would need 10 times that amount to feel an effect, but it was enough to devastate the vultures.
Between 2000 and 2007, the South Asian vulture population declined by 40 percent every year; today , 95 percent of India's Gyps vultures and 90 percent of Pakistan's are dead, due primarily to the diclofenac that scientists have found lurking in their tissues.
South Asian and British scientists who experimentally exposed captive vultures to diclofenac-dosed buffalo found that the birds went into renal failure – scientists still don't know why – and died within days of exposure. As the vulture population has declined, the feral dog population has boomed, and the Indian government's attempt to control the rabies they carry has started to flounder."
Safer Ways to Dispose of Unused Drugs
In response to what has become an obvious problem, some states have introduced "take-back" programs, which are, not surprisingly, being opposed by the drug industries. You can learn more about local efforts on takebacknetwork.com.8 To give you an idea of just how many drugs are discarded, the fourth DEA-led National Prescription Drug Take-Back initiative9, 10 held this past summer collected a staggering 276 tons of unwanted or expired medications! The four annual events have, in total, collected over 774 tons of drugs, which might otherwise have been flushed down the toilet or discarded into landfills, or been otherwise misused.
The FDA released new guidelines last year for "safely" disposing of drugs:11
- Follow any specific disposal instructions on the drug label or patient information that accompanies the medication. Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so. [I would recommend never flushing ANY drug down the toilet, to protect your community's water quality]
- Take advantage of community drug take-back programs that allow the public to bring unused drugs to a central location for proper disposal. Call your city or county government's household trash and recycling service (see blue pages in phone book) to see if a take-back program is available in your community. The Drug Enforcement Administration, working with state and local law enforcement agencies, is sponsoring National Prescription Drug Take Back Days throughout the United States.
- If no instructions are given on the drug label and no take-back program is available in your area, throw the drugs in the household trash, but first:
- Take them out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.
- Put them in a sealable bag, empty can, or other container to prevent the medication from leaking or breaking out of a garbage bag.
Remove and destroy any prescription labels before throwing away the containers. In some states, pharmacies can take back medications. When in doubt, you should ask your pharmacist for advice. Most are very well trained and educated professionals who will be glad to assist you in this area
Of course, some of these suggestions merely move the environmental peril from one place to another – such as diluting medicines in water and mixing them in garbage that eventually ends up in a landfill near you anyway. The best way to reduce environmental drug pollution is also the simplest and most obvious – Take Control of Your Health by cutting down the number of drugs you take in the first place.
Of course, to curb the pollution problem drug use will also have to be greatly reduced among livestock and other animals in our food supply, so do your part by supporting organic agriculture, in which animals are not permitted to be treated with antibiotics and other drugs.
Also remember when you are drinking tap water you are consuming drugs that your community has been using in addition to chlorine and fluoride and disinfection by products. This is a very powerful reason to avoid drinking tap water unless it is filtered.
Inappropriate Drug Prescriptions are Wasting Millions and Raising Health Risks
Cancer Drugs Found in Tap Water
By Dr. Mercola
A recent report on causes of death shows that suicide has now overtaken traffic accidents as the leading cause of injury-related death in the US. One reason for that is because car accident occurrences are down. But even so, the rate of suicide rose by an unhealthy 15 percent between 2000 and 2009, and poisoning (the number one cause of which is prescription drugs) rose by a whopping 128 percent.
Fatal prescription drug overdoses surpassed car crashes as the leading cause of accidental death in 2007, according to the Department of Health. Many of the overdoses (36 percent) involve prescription opioid painkillers, which were actually the cause of more overdose deaths than heroin and cocaine combined.
Some authorities believe many of these drug poisonings may actually be intentional suicides, even though they may have been classified as accidental. According to the study's author:
"Suicides are terribly undercounted; I think the problem is much worse than official data would lead us to believe. There may be 20 percent or more unrecognized suicides."
If his estimation is correct, we may be looking at upwards of a 35 percent rise in suicide between the years of 2000-2009... It's estimated that a person commits suicide every 15 minutes in the United States.
For each of these suicide deaths, an estimated 8-25 people made suicide attempts.1 Taken together, the latest preliminary 2010 data from the U.S. Centers for Disease Control and Prevention (CDC) lists intentional self-harm, or suicide, as the 10th leading cause of all death in the United States.
Whatever means they use to commit suicide, the rapid increase of people reaching that level of desperation leave us wondering: Why?
Is a Crumbling Economy to Blame?
There's clearly evidence suggesting that economic recessions and financial hardships can be a significant contributing factor.2 According to the Center for Disease Control and Prevention (CDC), suicide rates tend to rise and fall along with recessions and economic booms. For example, during the 1932 Great Depression, as many as 22 people per 100,000 committed suicide. The current economic collapse has also led to a well-documented rash of suicides across Europe.
According to the New York Times:3
"Especially in the most fragile nations like Greece, Ireland and Italy, small-business owners and entrepreneurs are increasingly taking their own lives in a phenomenon some European newspapers have started calling 'suicide by economic crisis.'
...In Greece, the suicide rate among men increased more than 24 percent from 2007 to 2009, government statistics show. In Ireland during the same period, suicides among men rose more than 16 percent. In Italy, suicides motivated by economic difficulties have increased 52 percent, to 187 in 2010 – the most recent year for which statistics were available – from 123 in 2005.
...In Ireland, the phenomenon has been linked to what some therapists call Celtic Tiger depression, the period after 2008 characterized by an influx of middle-aged male patients who complained about sleeplessness and a lack of appetite in the aftermath of that nation's destructive boom-and-bust real estate market."
Other Contributing Factors to Rising Suicide Rates
As one person is quoted as saying in the New York Times, people don't kill themselves because they have debts, rather it's a combination of factors that lead to desperation. If you have a family history of suicide, have been exposed to suicidal behavior (such as from other family members or friends) or have suffered/witnessed physical or sexual abuse or domestic violence, your risk of suicidal behavior increases.
However, the primary risk factor for suicide is depression in combination with substance abuse, and this could include alcohol, illicit drugs, and prescription drugs. It's estimated that more than 90 percent of those who end up taking their own lives fit into this category.4
Another important factor that cannot be overlooked is poor health, which can stretch already strained finances, family and living conditions to the very limit. And then there's the factor of taking too many different drugs simultaneously. While this certainly increases your risk of accidental overdose, polypharmacy in and of itself can have a devastating effect on both physical and mental health, including increased risk of depression, physical accidents like falls, and/or self-harm, along with symptoms that may otherwise exacerbate depression.
Common signs and symptoms that may be indicative of a detrimental interaction between two or more drugs include:
Tiredness, sleepiness or decreased alertness Confusion (chronic or intermittent) Weakness Anxiety or excitability Constipation, diarrhea or incontinence Dizziness and/or falls Tremors Skin rashes Loss of appetite Depression or lack of interest in your usual activities Hallucinations - seeing or hearing things Decreased or altered sexual behavior
Antidepressants May Be Fueling the Problem
Sadly, the knee-jerk conventional treatment for depression and suicidal tendencies is almost exclusively prescription antidepressants. Every year, more than 253 million prescriptions for antidepressants are filled in the United States, making them the second most prescribed drug class in the United States (second only to cholesterol-lowering drugs).5 But how effective are antidepressants in alleviating the symptoms of depression?
Studies have repeatedly demonstrated that antidepressants are no more effective than a placebo, and in some case less effective. A study published in the January 2010 issue of JAMA concluded there is little evidence that SSRIs (a popular group of antidepressants that includes Prozac, Paxil, and Zoloft) have any benefit to people with mild to moderate depression.6
The researchers stated:
"The magnitude of benefit of antidepressant medication compared with placebo... may be minimal or nonexistent, on average, in patients with mild or moderate symptoms."
SSRIs were found to be 33 percent effective, just like a sugar pill – but with far more adverse effects, including violence and suicidal thoughts and actions. Exercise actually outperforms antidepressants, but many still overlook this option.
Total Video Length: 00:54:26
Download Interview Transcript
There is much evidence that antidepressants intensify violent thoughts and behaviors, both suicidal and homicidal, especially among children. And, since the late 1980s, there have been frequent reports of increased violent behavior, including homicides and suicides, among individuals taking antidepressant drugs.
Add to this a faltering economy and many literally feeling like they're "fighting for their livelihoods" and the safety of their family, and the use of antidepressants may very well be pushing people over the edge rather than keeping them from it... It all depends on how you react to them.
Red Flags: Is Someone You Know Teetering on the Edge?
If someone close to you has recently endured a hardship, or you have noticed a change in their behavior, how can you tell when ordinary stress or sadness has progressed to a potentially suicidal level? Besides straightforward or "sideways" comments about not wanting to live any longer, some of the red flags that a person has a high risk for self-harm include:
Acquiring a weapon Hoarding medication No plan for the future Putting affairs in order Making or changing a will Giving away personal belongings Mending grievances Checking on insurance policies Withdrawing from people
If you think someone is suicidal, do not leave him or her alone. Most suicide attempts are expressions of extreme distress, not harmless bids for attention. A person who appears suicidal needs immediate professional help. Help the person to seek immediate assistance from their doctor or the nearest hospital emergency room, or call 911. Eliminate access to firearms or other potential suicide aids, including unsupervised access to medications.
Are You, or Someone You Know Currently Struggling With Depression or Feeling Suicidal?
If you are feeling desperate or have any thoughts of suicide, call the National Suicide Prevention Lifeline, a toll-free number 1-800-273-TALK (8255), or call 911, or simply go to your nearest Hospital Emergency Department.
I know firsthand that depression and suicide is devastating. It takes a toll on the healthiest of families and can destroy lifelong friendships. Few things are harder in life than losing someone you love, especially to suicide.
It's impossible to impart the will to live to somebody who no longer possesses it. No amount of logic, reasoning, or reminders about all they have to live for will put a smile back on the face of a loved one who is seriously contemplating suicide.
If you are currently the one struggling in a dark place, realize that oftentimes you cannot change your circumstances. You can, however, change your response to them. I encourage you to be balanced in your life. Don't ignore your body's warning signs that something needs to change. Sometimes people are so busy taking care of everybody else that they lose sight of taking care of themselves. Know that it's okay to take care of yourself. Putting yourself last is a serious mistake, as you need to find ways to "refill" and replenish your own energy stores or else you'll eventually burn out.
There really are no easy answers – especially when the troubles are related to crumbling finances, joblessness, or tumultuous family and living situations. So many seem to be suffering these days; emotional and mental pain really is epidemic. Knowing that others are suffering as well can be helpful to a degree, but overall, it may only add to the sum total of ones misery and adding to the feeling that there's no hope... One of the most effective ways of being supportive is perhaps to simply allow yourself to reach out and try to truly connect with the person who is suffering – even if it's a virtual stranger. Sometimes, having someone look you in the eye and asking you how you are, really meaning it, can be the lifeline needed in that moment...
Long-Term Strategies for Improving Your Mental Health
You can't make long-term plans for lifestyle changes when you are in a crisis, so clearly, the following recommendations are not meant to get you out of an acute situation. Rather, I invite you to take these lifestyle recommendations to heart as a preventive measure, before depression and other troubles set in.
Optimizing your health may actually be one of the most important things you can do to help you make it safely through financially hard times, as faltering health in combination with poverty can lead even the most level-headed people to the limit of what they can endure. My top tips to support positive mental health are as follows:
- Energy psychology is one of the most powerful tools for resolving emotional issues – specifically a technique called EFT. For serious problems like depression you do NOT want to perform EFT on yourself, you need to seek guidance from a skilled professional, ideally someone who is also trained in conventional methods. The effectiveness of any energy psychology technique will be significantly improved if you combine it with the tips that follow.
- Dramatically decrease your consumption of sugar (particularly fructose), grains, and processed foods. (In addition to being high in sugar and grains, processed foods also contain a variety of additives that can affect your brain function and mental state, especially artificial sweeteners.)
- Adequate vitamin B12. Vitamin B12 deficiency can contribute to depression and affects one in four people.
- Optimize your vitamin D levels, ideally through regular sun exposure. Vitamin D is very important for your mood. One study found that people with the lowest levels of vitamin D were 11 times more prone to be depressed than those who had normal levels.
The best way to get vitamin D is through exposure to SUNSHINE, not swallowing a capsule. Remember, SAD (Seasonal Affective Disorder) is a type of depression that we know is related to sunshine deficiency, so it would make sense that the perfect way to optimize your vitamin D is through sun exposure, or a safe tanning bed if you don't have regular access to the sun.
- Get plenty of high quality animal-based omega-3 fats. Omega-3 fats are crucial for optimal brain function and mental health, and most people don't get enough from diet alone. So make sure you take a high-quality omega-3 fat, such as krill oil.
- Evaluate your salt intake. Sodium deficiency actually creates symptoms that are very much like those of depression. Make sure you do NOT use processed salt (regular table salt) however. You'll want to use an all natural, unprocessed salt like Himalayan salt, which contains more than 80 different micronutrients.
- Adequate daily exercise. Exercise is one of the best-kept secrets to preventing and treating depression.
- Make sure your cholesterol levels aren't too low for optimal mental health. I have been educating the public about the underreported, adverse effects associated with lowering cholesterol through drugs like statins for many years, but what many still do not know is that low cholesterol is linked to dramatically increased rates of suicide and parasuicide, as well as aggression towards others.
This increased expression of violence towards self and others may be due to the fact that low membrane cholesterol decreases the number of serotonin receptors in the brain (which is approximately 30% cholesterol by weight). Lower serum cholesterol concentrations therefore may contribute to decreasing brain serotonin, which not only contributes to suicidal-associated depression, but prevents the suppression of aggressive behavior and violence towards self and others.7
By Dr. Mercola
Americans are a pill-popping population, taking an average of 13 different prescription drugs per capita as of last year's statistics.1 Children in the US are the most medicated in the world, averaging out at four prescriptions per child. Among seniors, drug use is beyond epidemic, averaging out at a staggering 28 prescriptions per person.
The biggest issue is what all of these drugs are really doing to your health.
The facts simply do not support the idea that massive drug use equates to improved health. On the contrary, we're seeing massive increases in chronic illnesses. As drug use continues to increase, Americans' health continues to decline, and this is no coincidence... Many drugs actually increase your risk of illness and premature death, and Plavix is just one of many examples.
Plavix and Aspirin – A Most Dangerous Heart Disease Prevention Plan
Plavix, manufactured by Bristol-Myers Squibb, is an anti-platelet drug that works by thinning your blood and making it less likely to clot. It is promoted for the prevention of strokes and heart attacks. It's what is commonly known as a "blockbuster" drug, currently ranking second on the list of top selling drugs of 2011.
Sadly, Plavix also has serious side effects you may not be aware of. Six years ago, I warned my readers that when combined with aspirin, the drug nearly doubled the death rate from heart disease among patients who had not had a previous heart attack but were at risk, compared to those taking aspirin alone.
Plavix Health Risks Confirmed Again
Now, research2 investigating the effects of Plavix in combination with aspirin versus using aspirin alone for the prevention of stroke and cognitive decline has confirmed these disturbing results.
In fact, the anti-platelet arm of the study was terminated3 and patients were told to stop taking Plavix and take aspirin only, as it became apparent the Plavix-aspirin regimen significantly increased the risk of death. The combination also doubled the risk of gastrointestinal bleeding, and more than doubled fatal hemorrhaging. Previous studies have also demonstrated that Plavix patients have a higher rate of stomach ulcers. Numerous lawsuits have been filed by patients alleging they were injured by this common drug.
Here's something to consider: An aspirin regimen will cost you around $6 per month (or even less than $1 per month if you split regular generic aspirin into quarters), compared to Plavix, which will set you back around $200 per month (or one-tenth of that price if you get generic Clopidogrel).
How in the world can anyone justify the use of a drug that increases your risk of death, and costs 33 to 200 times more than the most common alternative, and to top it all off, call it prevention? It's really amazing how Bristol-Meyers has managed to pull the wool over everyone's eyes on this one. Even if you take Plavix alone, without aspirin, you're still likely wasting huge amounts of money, and, as the new evidence suggests, taking a higher health risk than you would with low-dose aspirin.
A 1996 Lancet study4 comparing Plavix versus aspirin for the prevention of ischaemic events, involving more than 19,000 people followed from one to three years, found that:
"...an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5.32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5.83% with aspirin."
Note the words "intention-to-treat analysis." Statistically, when a study uses intention-to-treat analysis, chances are exceptionally great that it has been inadequately applied, "potentially leading to a biased treatment effect," according to a study5 assessing the methodological quality of intention-to-treat analysis as reported in randomized controlled trials in large medical journals.
What this means in plain English, is that whenever a study resorts to using intention-to-treat analysis, the data has likely been "massaged" in order to achieve a desired result - in this particular case, showing that Plavix was slightly better than aspirin for reducing your risk of stroke, myocardial infarction and vascular death. According to the authors of the above mentioned investigation into the proper methodology of such analysis:
"The intention to treat approach is often inadequately described and inadequately applied. ...Readers should critically assess the validity of reported intention-to-treat analyses."
A Free and Simple Alternative to Plavix
One of the simplest, most inexpensive (as in free), and effective alternatives to blood thinning drugs like Plavix is "Grounding," also known as "Earthing." The concept of earthing, was initially developed by Clint Ober. Stated in the simplest terms possible, earthing is simply walking barefoot; grounding your body to the Earth. And before you dismiss this concept as some placebo-induced fantasy by tree hugging hippies, know that at least a dozen scientific papers have been published demonstrating the mechanics and measurable physical effects of grounding.
When you're grounded there's a transfer of free electrons from the Earth into your body. And these free electrons are probably the most potent antioxidants known to man. Inflammation is a hallmark of virtually all diseases, so preventing chronic inflammation is key for overall health.
Bare skin in general is a very good conductor. You can connect any part of your skin to the Earth, but if you compare various parts there is one that is especially potent, and that's right in the middle of the ball of your foot, which is precisely where your foot would strike the ground if you were walking. It's a well-known point that conductively connects to all of the acupuncture meridians and essentially connects to every nook and cranny of your body. Any free radicals that leak into the healthy tissue will immediately be electrically neutralized. This occurs because the electrons are negative, while the free radicals are positive, so they cancel each other out.
However, there's more!
Another very important discovery, especially as it relates to grounding as an alternative to blood-thinning drugs, is that grounding thins your blood, making it less viscous – essentially doing the same job that Plavix does, but infinitely safer.
Total Video Length: 32:36
How Grounding Thins Your Blood
Dr. Sinatra has been coaching a team led by Dr. Oschman in how to measure blood viscosity using a method called zeta potential. It measures the potential on your red blood cells by determining how fast they migrate in an electrical field. It turns out that when you ground to the earth, the zeta potential of your red blood cells quickly rises, which means your red blood cells have more charge on their surface, which forces them apart from each other.
This action causes your blood to thin and flow easier. It also causes your blood pressure to drop.
Another obvious implication of this is that by repelling each other, your red blood cells are less inclined to stick together and form a clot. Blood clots don't have to be very big to form like a pulmonary embolus that would kill you instantly, so this is a significant benefit. Additionally, if your red blood cell's zeta potential is high, which grounding can facilitate, you not only decrease your heart disease risk but also your risk of multi-infarct dementias, where you start losing brain tissue due to micro-clotting in your brain.
Published in the peer-reviewed Journal of Alternative and Complementary Medicine,6 a recent study into grounding's effect on blood viscosity found that two hours of grounding increased the surface charge on red blood cells, thereby reducing blood viscosity and clumping. (The full article7 can be viewed for free here.) According to the authors:
"Grounding appears to be one of the simplest and yet most profound interventions for helping reduce cardiovascular risk and cardiovascular events."
The Best Surfaces for Grounding
Clearly, the simplest way to ground is to walk barefoot outside when safe to do so. But what about urban or city dwellers who are surrounded by asphalt and concrete? Can you ground on those? And what about natural surfaces – which ones are the most effective? There are indeed significant differences between various surfaces. The ideal location for walking barefoot is the beach, close to or in the water, as sea water is a great conductor. Your body also contains mostly water, so it creates a good connection.
A close second would be a grassy area, especially if it's covered with dew, which is what you'd find if you walk early in the morning. Concrete is a good conductor as long as it hasn't been sealed. Painted concrete does not allow electrons to pass through very well. Materials like asphalt, wood, and typical insulators like plastic or the soles of your shoes, will not allow electrons to pass through and are not suitable for barefoot grounding.
Chronicle of an Unforetold Death
In 2000, one of the best articles I've ever read documenting the tragedy of the traditional medical paradigm was published in the Journal of the American Medical Association (JAMA). The author was Dr. Barbara Starfield of the Johns Hopkins School of Hygiene and Public Health. Based on her article, I created a headline that has reverberated through the web ever since: Doctors Are The Third Leading Cause of Death in the US. Dr. Starfield's research documented how a staggering 225,000 Americans die from iatrogenic causes, i.e. their death is caused by a physician's activity, manner, or therapy. Her statistics included the following details:
- 12,000 die annually from unnecessary surgery
- 7,000 die annually from medication errors in hospitals
- 20,000 die annually from other errors in hospitals
- 80,000 die from infections in hospitals, and
- 106,000 die from non-error, negative side effects of drugs each year
Her work opened our eyes to the true state of affairs within our medical system, so it is a truly sad irony that she recently became another statistic of Death by Medicine... In the August issue of Archives for Internal Medicine,8 her husband, Dr. Neil A. Holtzman, MD, MPH writes, in part:
"Writing in sorrow and anger, I express up front my potential conflict of interest in interpreting the facts surrounding the death of my wife, Barbara Starfield, MD, MPH. Within hours after her sudden and unexpected death, I notified the dean of the Johns Hopkins Bloomberg School of Public Health, on whose faculty she served, that Barbara had apparently died of a coronary occlusion... Because she died while swimming alone, an autopsy was required. The immediate cause of death was 'pool drowning,' but the underlying condition, 'cerebral hemorrhage,' stunned me...
Barbara started taking low-dose aspirin after coronary insufficiency had been diagnosed 3 years before her death, and clopidogrel bisulfate (Plavix) after her right main coronary artery had been stented 6 months after the diagnosis. She reported to the cardiologist that she bruised more easily while taking clopidogrel and bled longer following minor cuts. She had no personal or family history of bleeding tendency or hypertension.
The autopsy findings and the official lack of feedback prompted me to call attention to deficiencies in medical care and clinical research in the United States reified by Barbara's death and how the deficiencies can be rectified. Ironically, Barbara had written about all of them."
Drug Safety Must Become a Priority, Not an Afterthought
Dr. Holzman goes on to explain that when a patient dies suddenly (and not while in a health care facility), there's no routine procedure to notify their physician, even if the patient is autopsied. Therefore, sudden deaths are only in very rare cases ever linked to adverse effects of medical treatment (most common of which is drugs). In this case, Dr. Starfield's husband personally brought the findings of the autopsy to her doctor's attention, who subsequently submitted an adverse event report to the FDA, stating that she was receiving Plavix, which may have contributed to her cerebral hemorrhage and subsequent death.
"The report may be the critical action that prompts a modification in use or design of the product, improves the understanding of the safety profile of the drug or device and leads to increased patient safety," Dr. Holzman writes.
One of Dr. Starfield's points of contention with the current medical system was the lack of systematic recording and studying of adverse events, and her death highlights this situation, as it is quite possible that it was the Plavix-aspirin combination that killed her, yet if it hadn't been for an autopsy and her husband insisting on an adverse event report, no one would ever have been the wiser about such a connection.
Dr. Starfield herself pointed out that her statistics were likely far lower than the real count, as they only included people who died in the hospital. They did not include (as there's no data) people who suddenly die outside a hospital setting, due to a drug side effect.
What if a sufficient number of adverse event reports had been filed prior to her taking a combination therapy of Plavix and aspirin – would her life have been spared? It's impossible to speculate of course, but what is clear is that someone's life would eventually be spared if adverse event reporting is taken seriously. Plavix sales brought in $4.6 billion in sales during 2010 alone;9 meanwhile, there's no telling how many Dr. Starfield's there are out there, who suddenly collapse and die, and no one is ever made the wiser about their true cause of death...
"As our population ages and morbidities accumulate, the United States needs policies that redirect American medicine to primary care physicians," Dr. Holzman writes. "By providing continuing care over time, primary care physicians can practice person-focused as opposed to disease-centered care. They can get to know their patients as persons and become aware of their multiple morbidities, alert to the presence or possibility of disease and/or drug interactions."
...When a specific adverse event is expected (eg, bleeding with clopidogrel), adverse event reporting to FDA should be mandatory, and the manufacturer should be obliged to conduct postmarket surveillance. When a harmful effect is confirmed, the FDA should issue a warning to physicians and require a warning in the package insert. Risks should be weighed against benefits to decide whether the drug should be removed from the market."
How to Report Adverse Drug Reactions
Only a tiny fraction of all adverse drug reactions are ever reported to the FDA – according to some estimates as little as one percent. In order to truly alert the FDA to a problem with a product they've approved, they must be notified – by as many people as possible who believe they have experienced a side effect. This means you can take action against the manufacturers of drugs that continue to put your optimal health at risk, if you feel you have had a bad reaction.
I urge you, if you believe you have experienced side effects from a drug, let the FDA know about it! Please go to the FDA Consumer Complaint Coordinator page, find the phone number listed for your state, and report your adverse reaction.
What to Do if You're at Risk of Heart Disease
Drugs like Plavix are prescribed as "preventive medicine," but you can be sure that these drugs will not optimize your health. If you're at risk for heart disease, I urge you to get your vitamin D levels checked, and if you are deficient, take steps to increase your levels to the therapeutic range of 50-70 ng/ml.
Then simply go through and systematically apply the lifestyle changes described in my Optimal Health Plan. I recently updated it with all the latest guidelines and recommendations, so it's a really comprehensive health plan, covering everything from diet to stress reduction, exercise and supplements, in a systematic, step-by-step way. Making the proper lifestyle changes will virtually eliminate your risk – sometimes quite rapidly – because it helps to significantly reduce inflammation in your body. And, keeping your inflammation levels low is key if you want to reduce your risk of heart disease. An added boon of applying this program is that it will automatically also help you to prevent and treat type 2 diabetes.