Why Learn about Adverse Drug Reactions (ADR)?
* Over 2 MILLION serious ADRs yearly
* 100,000 DEATHS yearly
* ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths
* Ambulatory patients ADR rate—unknown
* Nursing home patients ADR rate— 350,000 yearly
Institute of Medicine, National Academy Press, 2000
Lazarou J et al. JAMA 1998;279(15):1200–1205
Gurwitz JH et al. Am J Med 2000;109(2):87–94
Feb 3, 2010
ADRs: Prevalence and Incidence
Preventable Adverse Drug Reactions: A Focus on Drug Interactions
This learning module was developed based on a needs survey sent to all third year medicine clerkship directors and all medicine residency program directors in the United States.
The first question healthcare providers should ask themselves is “why is it important to learn about ADRs?” The answer is because ADRs are one of the leading causes of morbidity and mortality in health care. The Institute of Medicine reported in January of 2000 that from 44,000 to 98,000 deaths occur annually from medical errors.1 Of this total, an estimated 7,000 deaths occur due to ADRs. To put this in perspective, consider that 6,000 Americans die each year from workplace injuries.
However, other studies conducted on hospitalized patient populations have placed much higher estimates on the overall incidence of serious ADRs. These studies estimate that 6.7% of hospitalized patients have a serious adverse drug reaction with a fatality rate of 0.32%.2 If these estimates are correct, then there are more than 2,216,000 serious ADRs in hospitalized patients, causing over 106,000 deaths annually. If true, then ADRs are the 4th leading cause of death—ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths.
These statistics do not include the number of ADRs that occur in ambulatory settings. Also, it is estimated that over 350,000 ADRs occur in U.S. nursing homes each year.3 The exact number of ADRs is not certain and is limited by methodological considerations. However, whatever the true number is, ADRs represent a significant public health problem that is, for the most part, preventable.
Committee on Quality of Health Care in America: Institute of Medicine
COSTS ASSOCIATED WITH ADRs
* Drug-related morbidity and mortality is $136 billion
* One out of 5 injuries or deaths per year to hospitalized patients
* 100% increase in length of stay, cost and mortality has been reported for hospitalized patients
What are the health care costs associated with adverse drug reactions?
Again, methodological constraints limit making completely accurate estimates, but one estimate of the cost of drug-related morbidity and mortality is $136 billion annually,1 which is more than the total cost of cardiovascular or diabetic care in the United States. In addition, one out of 5 injuries or deaths per year to hospitalized patients may be as a result of ADRs.2 Finally, a two-fold greater mean length of stay, cost and mortality has been reported for hospitalized patients experiencing an ADR compared to a control group of patients without an adverse drug reaction.
WHY ARE THERE SO MANY ADRs?
* Two thirds of patient visits result in prescriptions
* 2.8 Billion prescriptions (10 per person in the U.S. in 2000
* ADRs increase exponentially with 4 or more medications
Why are there so many ADRs? There are many reasons. Here are just a few.
First, more drugs—and many more combinations of drugs—are being used to treat patients than ever before. To exemplify this point, 64% of all patient visits to physicians result in prescriptions.1
Secondly, 2.8 billion prescriptions were filled in the year 2000. 2 That is about 10 prescriptions for every person in the United States.
Finally, the rate of ADRs increases exponentially after a patient is on 4 or more medications.3
Efforts to reduce polypharmacy are important but for many patients, the number of medications cannot always be reduced without doing harm. That is why it is important to understand the basis for drug interactions. This will allow us to make the most appropriate choices in prescribing and avoiding preventable ADRs.
The complete FDA Learning Module can be found at: SOURCE: http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm110632.htm
Adverse Drug Reactions
How Serious Is the Problem and How Often and Why Does It Occur?
Although some adverse drug reactions (ADR) are not very serious, others cause the death, hospitalization, or serious injury of more than 2 million people in the United States each year, including more than 100,000 fatalities. In fact, adverse drug reactions are one of the leading causes of death in the United States. Most of the time, these dangerous events could and should have been avoided. Even the less drastic reactions, such as change in mood, loss of appetite, and nausea, may seriously diminish the quality of life.
Despite the fact that more adverse reactions occur in patients 60 or older, the odds of suffering an adverse drug reaction really begin to increase even before age 50. Almost half (49.5%) of Food and Drug Administration (FDA) reports of deaths from adverse drug reactions and 61% of hospitalizations from adverse drug reactions were in people younger than 60.2 Many physical changes that affect the way the body can handle drugs actually begin in people in their thirties, but the increased prescribing of drugs does not begin for most people until they enter their fifties. By then, the amount of prescription drug use starts increasing significantly, and therefore the odds of having an adverse drug reaction also increase. The risk of an adverse drug reaction is about 33% higher in people aged 50 to 59 than it is in people aged 40 to 49.3, 4
** Adverse Reactions to Drugs Cause Hospitalization of 1.5 Million Americans Each Year **
An analysis of numerous studies in which the cause of hospitalization was determined found that approximately 1.5 million hospitalizations a year were caused by adverse drug reactions.1 This means that every day more than 4,000 patients have adverse drug reactions so serious that they need to be admitted to American hospitals.
A review of patients admitted to medical wards of a hospital found that although for 3.8% of hospital admissions, adverse drug reactions led directly to hospitalization, 57% of these adverse drug reactions were not recognized by the attending physician at the time of admission. As in numerous other studies, many of these admissions should have been prevented. In fact, 18.6% of all drugs prescribed prior to admission were contraindicated.5
Another review of studies of the percentage of hospital admissions related to adverse drug reactions found that up to 88% of ADR-related hospitalizations in the elderly are preventable. In addition, elderly people were four times more likely to be hospitalized by ADR-related problems than nonelderly.6
Although the rate of drug-induced hospitalization is higher in older adults (an average of about 10% of all hospitalizations for older adults are caused by adverse drug reactions) because they use more drugs, a significant proportion of hospitalizations for children are also caused by adverse drug reactions.
A recent review of all studies concerning the reasons for pediatric hospitalization (children under the age of 19) found that 2.09% of all pediatric hospitalizations were caused by adverse drug reactions and that 39% of these were life-threatening.7 Using the most recent published data on pediatric hospitalizations,8 there were 3.8 million children under the age of 19 hospitalized in the United States in 1997. This means that in one year, there are 79,000 children (2.09% x 3.8 million children) admitted to the hospital because of adverse drug reactions, 31,000 of these children having life-threatening adverse reactions.
** Adverse Reactions as a Major Cause of Emergency Room Visits **
A recent review of studies concerning the causes of people going to hospital emergency rooms found that as many as 28% of all emergency department visits were drug-related, including a large proportion due to adverse drug reactions and inappropriate prescriptions. Of all of the drug-related visits, the authors found that 70% were preventable.9
** Adverse Reactions Occur During Hospitalization to 770,000 People a Year **
In addition to the 1.5 million people a year who are admitted to the hospital because of adverse drug reactions, an additional three-quarters of a million people a year develop an adverse reaction after they are hospitalized. According to national projections based on a study involving adverse drug reactions developing in patients in the hospital, 770,000 additional patients a year—more than 2,000 patients a day—suffer an adverse event caused by drugs once they are admitted. Many of the reactions in the patients studied were serious, even life-threatening, and included cardiac arrhythmias, kidney failure, bleeding, and dangerously low blood pressure. People with these adverse reactions had an almost twofold higher risk of death compared to other otherwise comparable hospitalized patients who did not have a drug reaction. Most important, according to the researchers, almost 50% of these adverse reactions were preventable. Among the kinds of preventable problems were adverse interactions between drugs that should not have been prescribed together (hundreds of these are listed in the Drug-Induced Diseases section of this web site), known allergies to drugs that had not been asked about before the patients got a prescription, and excessively high doses of drugs prescribed without considering the patient’s weight and kidney function.10
Thus, adding the number of people with adverse drug reactions so serious that they require hospitalization to those in which the adverse reaction was “caused” by the hospitalization, more than 2.2 million people a year, or 6,000 patients a day, suffer these adverse reactions. In both situations, many of these drug-induced problems should have been prevented.
** Dangerous Prescribing Outside the Hospital for 6.6 Million Older Adults a Year **
Based on the Do Not Use principle we have advocated concerning certain drugs for more than 16 years in our Worst Pills, Best Pills books, web site, and monthly newsletter, several published studies have examined the extent to which people are prescribed drugs that are contraindicated because there are safer alternatives. One study, whose authors stated that “Worst Pills, Best Pills stimulated this research,” found that almost one out of four older adults living at home—6.6 million people a year—were prescribed a “potentially inappropriate” drug or drugs, placing them at risk of such adverse drug effects as mental impairment and sedation, even though the study only examined the use of a relatively short list of needlessly dangerous drugs (fewer than the number listed as Do Not Use drugs on this site).11
Other researchers looked not only at people for whom a contraindicated drug was prescribed, but also at prescriptions for older people involving two other categories: questionable combinations of drugs and excessive treatment duration. The authors categorized all of this as “high-risk prescribing” and limited their analysis to just the three classes of drugs most commonly causing drug-related illness: cardiovascular drugs, psychotropic drugs (ones that act on the mind) such as tranquilizers and antidepressants, and anti-inflammatory drugs. They found that 52.6% of all people 65 or older were given one or more prescriptions for a high-risk drug.12 Thus, more than twice as many older adults were the victims of high-risk prescribing when these two additional categories were added.
** Nine Reasons Why Older Adults Are More Likely Than Younger Adults to Have Adverse Drug Reactions **
Many of the studies and much of the information concerning the epidemic of drug-induced disease focuses on people 60 and over. As we have mentioned previously, some of the changes that eventually lead to great numbers of adverse reactions in older adults (in combination with increased drug use) really begin to occur in the mid-thirties. In connection with the idea that drug-induced disease begins to get more common before age 60, it is interesting to note that in a number of studies comparing the way “older” people clear drugs out of the body with the way younger people do, the definition of older is above 50, and younger is below 50.3
Smaller Bodies and Different Body Composition: Older adults generally weigh less and have a smaller amount of water and a larger proportion of fat than younger adults. Body weight increases from age 40 to 60, mainly due to increased fat, then decreases from age 60 to 70, with even sharper declines from 70 on. Therefore, the amount of a drug per pound of body weight or per pound of body water will often be much higher in an older adult than it would be if the same amount of the drug were given to a younger person. In addition, drugs that concentrate in fat tissue may stay in the body longer because there is more fat for them to accumulate in.
Decreased Ability of the Liver to Process Drugs: Because the liver does not work as well in older adults, they are less able than younger people to process certain drugs so that they can be excreted from the body. This has important consequences for a large proportion of the drugs used to treat heart conditions and high blood pressure, as well as many other drugs processed by the liver. The ability of the body to rid itself of drugs such as Valium, Librium, and many others is affected by this decrease in liver function.
Decreased Ability of the Kidneys to Clear Drugs Out of the Body: The ability of the kidneys to clear many drugs out of the body decreases steadily from age 35 to 40 on. By age 65, the filtering ability of the kidneys has already decreased by 30%. Other aspects of kidney function also decline progressively as people age. This has an effect on the safety of a large number of drugs.
Increased Sensitivity to Many Drugs: The problems of decreased body size, altered body composition (more fat, less water), and decreased liver and kidney function cause many drugs to accumulate in older people’s bodies at dangerously higher levels and for longer times than in younger people. These age-related problems are further worsened by the fact that even at “normal” blood levels of many drugs, older adults have an increased sensitivity to their effects, often resulting in harm. This is seen most clearly with drugs that act on the central nervous system, such as many sleeping pills, alcohol, tranquilizers, strong painkillers such as morphine or pentazocine (TALWIN), and most drugs that have anticholinergic effects (see Anticholinergic in the Glossary). This latter group includes antidepressants, antipsychotic drugs, antihistamines, drugs used to calm the intestinal tract (for treating ulcers or some kinds of colitis) such as Donnatal, atropine, and Librax, antiparkinsonian drugs, and other drugs such as Norpace. [More…]
Institutional Corruption: Pharmaceuticals and the Drug Safety Myth
November 30, 2013
“Institutional corruption” does not refer to any violation of existing rules or laws. Rather it refers to “a certain kind of influence, within an economy of influence, that has a certain effect”
* An activity is considered institutional corruption if it weakens the effectiveness of an institution, and/or weakens public trust in that institution. Institutional corruption is rife within the pharmaceutical industry and its regulatory agencies.
* The consequences of institutional corruption include millions of adverse reactions each year, and at least 128,000 deaths as a direct result of adverse drug reactions within the hospital setting alone.
* When deaths related to diagnostic errors, errors of omission, and failure to follow guidelines are included, the number skyrockets to an estimated 440,000 preventable hospital deaths each year.
– That makes preventable medical errors the third-leading cause of death in the US, right after heart disease and cancer, and hospital-based lethal adverse drug reactions are the fourth leading cause of death.
I’ve highlighted the fact that the pharmaceutical industry is responsible for nearly 20 percent of corporate crime in a number of previous articles.
Here, I want to draw your attention to an excellent article1, 2 on the institutional corruption of pharmaceuticals, published in the Journal of Law, Medicine and Ethics. It’s well worth reading in its entirety if you have an interest in this topic.
This term, “institutional corruption,” does not refer to any violation of existing rules or laws. Rather it refers to “a certain kind of influence, within an economy of influence, that has a certain effect,” as explained the Cambridge lecture above. As presented in the video, an activity is considered institutional corruption if it:
Weakens the effectiveness of an institution, and/or
Weakens public trust in that institution
The lecture series was sponsored by the Edmond J. Safra Foundation Center for Ethics at Harvard, which also published the featured article on this topic, written by Donald W. Light, Joel Lexchin, and Jonathan J. Darrow. They write:3
“Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission.
An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians.
We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of harms and the paucity of benefits…
If “corruption” is defined as an impairment of integrity or moral principle, then institutional corruption is an institution’s deviation from a baseline of integrity.”
Lack of integrity is indeed different from outright violation of law, which is a punishable crime. Avoidance of “moral principle,” while not illegal per se, is still a very serious concern—if nothing else for the very real harm it produces. This is true in most situations, but it’s particularly heinous when it is the modus operandi of those who wield the greatest power over your health care.
*** The Three Levels of Institutional Corruption ***
* The authors assert that, within the pharmaceutical industry, institutional corruption occurs at three different levels:
1) Lobbying efforts and political contributions. This way, the pharmaceutical industry has influenced the US Congress to enact legislation that has severely undermined the stated mission and function of the Food and Drug Administration (FDA).
2)Through the application of industry pressure, “Congress has underfunded FDA enforcement capacities since 1906, and turning to industry-paid “user fees” since 1992 has biased funding to limit the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages,” according to the authors.
3)Commercializing the role of doctors, undermining their position as “independent, trusted advisers to patients.”
As stated in the featured article, the health care system is founded on the moral principle that a doctor, first, will do no harm. The principle of not harming the patient is explicit in the Hippocratic Oath,4 one of the oldest binding documents in history. Under that moral edict, the duty of any health care worker is, first and foremost, to treat illness using the best medical knowledge and science available, and to carefully assess the risks of harm.
“The institutional corruption of health care consists of deviations from these principles,” the featured article states.
Unfortunately, the system in operation today has strayed quite far from this high moral ground. In fact, it has strayed so far that, today, the medical establishment as a whole is one of the leading causes of death!
According to the most recent research5 into the cost of medical mistakes in terms of lives lost, 210,000 Americans are killed by preventable hospital errors each year. When deaths related to diagnostic errors, errors of omission, and failure to follow guidelines are included, the number skyrockets to an estimated 440,000 preventable hospital deaths each year. That makes medical errors the third-leading cause of death in the US, right after heart disease and cancer.
If we limit it to adverse drug reactions alone, the featured article6 tells us that 2.7 million Americans experience a serious adverse drug reaction while hospitalized each year. Of those, an estimated 128,000 die as a direct result of the adverse reaction. According to those statistics, hospital-based adverse drug reactions alone are the fourth leading cause of death in the US.
Sadly, a majority of healthcare workers observe mistakes made by their peers yet rarely do anything to challenge them. This too falls into the discussion in the featured video. In it, it is argued that if you have the ability to right a wrong, but do not, are you not also responsible for the outcome? In essence, part of the problem of institutional corruption is not simply “bad people doing bad things,” but “good people looking the other way.”
*** Do Pharmaceutical Companies Have a Moral Duty to Do No Harm? ***
According to the featured article:
“The major patent-based research pharmaceutical companies also nominally commit themselves to improving health and relieving suffering… But in fact, these companies are mostly developing drugs that are mostly little better than existing products but have the potential to cause widespread adverse reactions even when appropriately prescribed. This deviation from the principles of health care by institutions allegedly dedicated to health care is institutional corruption.
We present evidence that industry has a hidden business model to maximize profits on scores of drugs with clinically minor additional benefits. Physician commitment to better health is compromised as the industry spends billions to create what Lessig calls a “gift economy” of interdependent reciprocation.”
Contrary to popular belief and corporate sob-stories bewailing the high cost of innovation, pharmaceutical companies devote a miniscule 1.3 percent of their revenues to research and development (R&D) of new drugs. Furthermore, pharmaceutical companies’ revenues have climbed six times faster than their investment in R&D over the past 15 years. Meanwhile, an average of 25 percent of revenues is spent on advertising and promotion of “new” drugs that are no better than their predecessors. So much for the claim that R&D costs are becoming increasingly “unsustainable.”
What’s really unsustainable is the industry’s blatant disregard for patients’ health and well being… Most new drugs offer minor clinical advantages over preexisting drugs at best, and no advantage but greater risks, at worst. For the past 35 years, very few drugs created represent any true advancement in drug therapy. According to the three authors, multiple reviews conducted between the mid-1970’s to the mid-1990’s have found that only 11 to 15.6 percent of new molecular entities (NMEs) created provide any kind of “important therapeutic gain.” According to the featured article:
“The independent drug bulletin, La revue Prescrire, analyzes the clinical value of every new drug product or new indication approved in France. From 1981 to 2001, it found that about 12 percent offered therapeutic advantages. But in the following decade, 2002-2011… only 8 percent offered some advantages and nearly twice that many—15.6 percent—were judged to be more harmful than beneficial. A mere 1.6 percent offered substantial advantages.” [Emphasis mine]
They note that similar findings have also been made by the Canadian advisory panel to the Patented Medicine Prices Review Board, and by a Dutch general practice drug bulletin. Interestingly enough, the US has not conducted any such review. Remarkably, studies have revealed that one in every five new drugs ended up causing such serious harm that they eventually received a severe warning label or were withdrawn from the market.
“Of priority drugs that were reviewed in slightly more than half the normal time, at least one in three of them caused serious harm,” the featured article states… [E]vidence suggests that commercial distortions of the review process and aggressive marketing contribute to both undermining beneficence as health care’s raison d’être and to the epidemic of harm to patients.”
*** Conflicts of Interest and Institutional Corruption Within the FDA ***
Just over two decades ago, in 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), and from that moment on, the FDA was set squarely on the path toward doing more harm than good. The act authorizes the FDA to collect “user fees” from drug companies in order to increase the speed by which it can conduct drug reviews. A standard drug application must now be completed within 12 months of submission, compared to as much as 30 months prior to PDUFA. Priority applications must be completed within six months. Since the FDA began collecting user fees from the very industry it was intended to regulate, approved drugs have become increasingly dangerous. According to the featured article:
“Shortened review times led to substantial increases in serious harms. An in-depth analysis found that each 10-month reduction in review time—which could take up to 30 months—resulted in an 18.1-percent increase in serious adverse reactions, a 10.9-percent increase in hospitalizations, and a 7.2-percent increase in deaths.” [Emphasis mine]
*** Can Institutional Integrity Be Restored to Produce Safer Drugs? ***
There are ways to correct this fatally flawed system. Unfortunately, the pharmaceutical industry is at this point so enmeshed with our political structure, the US government may as well be viewed as a hybrid corporate-run entity, presenting a façade of concern toward the public but being none-too-confused about whom they’re really serving, namely industry. The featured article presents five strategies that would “reduce conflicts of interest and improve the safety and effectiveness of drugs,” should politicians and Americans at large decide that enough is enough:
* Research companies should have no part in testing the drugs they’ve developed. What’s called for is an independent institute to conduct drug studies.
* The FDA must restore public trust by taking a renewed leadership role focused on drug safety. Part of this includes simply enforcing its currently existing rules, which are all-too-frequently ignored.
* User fees must be eliminated. The FDA must be wholly funded by taxpayers-as-consumers, in order to clarify whom it serves and eliminate conflicts of interest with industry.
* Approval criteria for new drugs should include evidence of superiority over existing drugs and be of relevance to the patient
* Congress needs to create a National Drug Safety Board “with adequate powers, funds, and mandates to independently investigate and report on drug safety issues,” and provide open access to all data. This would go a long way toward reestablishing the public’s trust.
*** Proof that “Science-Based” Medicine is Disintegrating ***
If we continue allowing Big Pharma to live and operate on moral low ground, you really don’t need supernatural powers to predict what the future will bring. History is full of examples of how far they will go to make a buck. Criminal corruption has reached pandemic levels within the industry already. In fact, it seems to be more of an unspoken rule than the exception.
Peter Gøtzsche, head of the Nordic Cochrane Centre (which is considered the gold standard in terms of independent research reviews), goes so far as to compare the pharmaceutical industry to an organized crime ring in his book, Deadly Medicines and Organized Crime: How Big Pharma Has Corrupted Healthcare.
“Besides peddling drugs known to be more dangerous than advertised, drug companies are also in large part responsible for the decimation of the very core of medical science, since they fund a great deal of the research. The source of funding has been shown to have a tremendous impact on the results of any study.”
According to data from Thomson Reuters,7 the number of retractions of scientific studies have increased more than 15-fold since 2001, and a review8 published just last year showed that nearly 75 percent of all retracted drug studies were attributed to “scientific misconduct,” which includes:
* Data falsification or fabrication
* Questionable veracity
* Unethical author conduct
Corruption of science is incredibly serious, as health care professionals rely on published studies to make treatment recommendations, and large numbers of patients can be harmed when false findings are published. The average lag time between publication of the study and the issuing of a retraction is 39 months. And that’s if the misconduct is ever caught at all. What’s worse, about 32 percent of retractions are never published,9 leaving the readers completely in the dark about the fallacies in those studies.
Poster Children for Corrupted Science
Corrupt and Criminal Pharmaceutical Companies
One clear example of how deadly corrupted science can be is the painkiller Vioxx. There were many indications that this would be a dangerous drug, despite Merck’s claims, and I warned my readers to avoid it before its FDA approval in 1999. In 2008, four years after the drug was withdrawn from the market, an editorial10 published in the Journal of the American Medical Association (JAMA) suggested Merck might have deliberately manipulated dozens of academic documents published in the medical literature, in order to promote Vioxx under false pretenses.
The diabetes drug Avandia is another potent example. Between 1999 and 2007, Avandia is estimated to have caused over 80,000 unnecessary heart attacks,11 although the actual numbers of people harmed or killed by the drug is still largely unknown. Avandia is a poster child for the lethal paradigm of corrupted science as GlaxoSmithKline (GSK), the manufacturer of Avandia, hid damaging information about the drug for over 10 years, as they knew it would adversely affect sales!
Two years ago, GSK agreed to a $3 billion settlement over the sales and marketing practices of several of its drugs, including Avandia. This was the largest federal drug-company settlement in US history, surpassing the $2.3 billion paid by Pfizer in 2009 for illegally promoting off-label uses of four of its drugs. Most recently, GSK’s crooked ways made international headlines yet again when Chinese authorities arrested four of the company’s senior executives on charges of cash and sexual bribery.
The British Medical Journal’s blog recently featured an article12 by former BMJ editor and director of the United Health Group’s chronic disease initiative, Richard Smith. The piece is also the foreword to the book mentioned earlier, Deadly Medicines and Organized Crime. Smith writes:13
“The drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs…. the industry has bought doctors, academics, journals, professional and patient organizations, university departments, journalists, regulators, and politicians. These are the methods of the mob.
… [D]octors and academics are supposed to have a higher calling. Laws that are requiring companies to declare payments to doctors are showing that very high proportions of doctors are beholden to the drug industry and that many are being paid six figures sums for advising companies or giving talks on their behalf. It’s hard to escape the conclusion that these “key opinion leaders” are being bought. They are the “hired guns” of the industry.
And, as with the mob, woe be to anybody who whistleblows or gives evidence against the industry. Peter tells several stories of whistleblowers being hounded, and John Le Carré’s novel describing drug company ruthlessness became a bestseller and a successful Hollywood film.”
Basic Tenets of Optimal Health:
Any time your doctor suggests a drug for an ailment, I urge you to do your due diligence before taking it. That said, remember that leading a common-sense, healthy lifestyle is your best bet to achieve a healthy body and mind. And while conventional medical science may flip-flop back and forth in its recommendations, there are certain basic tenets of optimal health that remain unchanged. Following these healthy lifestyle guidelines can go a very long way toward keeping you well and prevent chronic disease of all kinds:
* Proper Food Choices: For a comprehensive guide on which foods to eat and which to avoid, see my nutrition plan. Generally speaking, you should be looking to focus your diet on whole, ideally organic, unprocessed foods. For the best nutrition and health benefits, you will want to eat a good portion of your food raw.
* Avoid sugar, and fructose in particular. All forms of sugar have toxic effects when consumed in excess, and drive multiple disease processes in your body, not the least of which is insulin resistance, a major cause of chronic disease and accelerated aging. (Use Natural Honey instead)
* I believe the two primary keys for successful weight management are severely restricting carbohydrates (sugars, fructose, and grains) in your diet, and increasing healthy fat consumption. This will optimize insulin and leptin levels, which is key for maintaining a healthy weight and optimal health.
* Regular exercise: Even if you’re eating the healthiest diet in the world, you still need to exercise to reach the highest levels of health, and you need to be exercising effectively, which means including high-intensity activities into your rotation. High-intensity interval-type training boosts human growth hormone (HGH) production, which is essential for optimal health, strength and vigor. HGH also helps boost weight loss.
* So along with core-strengthening exercises, strength training, and stretching, I highly recommend that two to three times a week you do Peak Fitness exercises, which raise your heart rate up to your anaerobic threshold for 20 to 30 seconds, followed by a 90-second recovery period.
* Stress Reduction: You cannot be optimally healthy if you avoid addressing the emotional component of your health and longevity, as your emotional state plays a role in nearly every physical disease — from heart disease and depression, to arthritis and cancer.
* Meditation, prayer, social support and exercise are all viable options that can help you maintain emotional and mental equilibrium. I also strongly believe in using simple tools such as the Emotional Freedom Technique (EFT) to address deeper, oftentimes hidden, emotional problems.
* Drink plenty of clean water so that your urine is light yellow.
((( Non-Fluoridated Alkaline water only )))
* Maintain a healthy gut: About 80 percent of your immune system resides in your gut, and research is stacking up showing that probiotics—beneficial bacteria—affect your health in a myriad of ways; it can even influence your ability to lose weight. A healthy diet is the ideal way to maintain a healthy gut, and regularly consuming traditionally fermented foods is the easiest, most cost effective way to ensure optimal gut flora.
* Optimize your vitamin D levels: Research has shown that increasing your vitamin D levels can reduce your risk of death from ALL causes. For practical guidelines on how to use natural sun exposure to optimize your vitamin D benefits, please see my previous article on how to determine if enough UVB is able to penetrate the atmosphere to allow for vitamin D production in your skin.
((( Vitamin D3: 20,000 IU-25,000 IU (International Units) Daily)))
* Avoid as many chemicals, toxins, and pollutants as possible: This includes tossing out your toxic household cleaners, soaps, personal hygiene products, air fresheners, bug sprays, lawn pesticides, and insecticides, just to name a few, and replacing them with non-toxic alternatives.
* Get plenty of high quality sleep: Regularly catching only a few hours of sleep can hinder metabolism and hormone production in a way that is similar to the effects of aging and the early stages of diabetes. Chronic sleep loss may speed the onset or increase the severity of age-related conditions such as type 2 diabetes, high blood pressure, obesity, and memory loss.
HIDDEN IN PLAIN VIEW:
FDA-APPROVED DRUGS KILL A MILLION AMERICANS PER DECADE!
The discovery of a page, on the FDA’s own website, proves the FDA is fully aware that:
the drugs it certifies as safe have been killing Americans, at the rate of 100,000 per year.
The FDA website page is currently available under the heading, “Why Learn About Adverse Drug Reactions,” and it can be Googled. (Click here to go directly to the FDA page.)
The implications of this Smoking Gun are hard to grasp in any rational way.
The FDA takes no blame, no responsibility for its actions, and yet it admits the death statistics are accurate.
As an investigative reporter, I have been tracking and writing about pharmaceutically-caused deaths for 10 years. I have, on numerous occasions, cited Dr. Barbara Starfield’s report in the July 26th, 2000, Journal of the American Medical Association, in which she presents the figure of 106,000 deaths per year, in America, as a result of these drugs. I have claimed that the federal government and, in particular, the FDA, are aware of these numbers.
And now the page on the FDA’s own website confirms the death toll. Yet, nowhere do we see the FDA taking one shred of responsibility for this ongoing holocaust.
Holocaust? Add up the figures. Medical drugs cause 100,000 deaths in America every year: that means a million Americans are killed every decade.
Understand this very clearly. No medical drug in America can be released for public use until and unless the FDA states it is safe. The FDA is the agency responsible for every such decision on every drug. The buck stops there.
Yes, the FDA has a “special relationship” with the pharmaceutical industry. Yes, the FDA utilizes doctors on their drug-approval panels that have ties to the pharmaceutical industry. But, in the end, it is the FDA official seal that opens the gate and permits a drug to be prescribed by doctors and sold in the US.
In all my research on this medical-drug holocaust, I have never found a case in which any FDA employee was censured, fired, or criminally prosecuted for the killing effects of these drugs.
That is a track record Organized Crime would be proud of, and the comparison is not frivolous.
On this FDA website page that has just come to light, the FDA also readily admits that deaths from medical drugs are the fourth leading cause of death in America, ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile fatalities.
The FDA website page also states there are 2 million serious adverse reactions (ADRs) from the ingestion of medical drugs, annually, in the US. When the FDA says “serious,” they aren’t talking about headaches or slight dizziness or temporary nausea. “Serious” means stroke, heart attack, neurological damage; destruction of that magnitude. Therefore, per decade, that adds up to 20 million ADRs. 20 million.
Examining these figures for death and debilitation, can you find any comparable crime in the American landscape? And yet the major media have been silent. This is the kind of story that could make Watergate look like a Sunday-school picnic. If a paper like the New York Times let loose their hounds in a relentless exploration of the horror, I can assure you that, in time, doctors and medical bureaucrats and even drug-company employees would come out of the woodwork with confessions, and the resultant explosions and outcries would shake the medical/pharmaceutical foundations of America and the planet.
But these major media outlets are an intrinsic part of the Matrix that protects and sustains the crimes and the criminals. It isn’t just drug-advertising profits that keep the leading newspapers and television networks silent. It’s collusion to protect “a revered institution”—the medical system.
Also at stake is Obamacare. The connection is vivid and unmistakable. If the new national health insurance plan goes into effect, millions more Americans, previously uninsured, will be drawn into the system and subjected to the very drugs are killing and maiming people at such a horrific rate.
Where has the US Department of Justice been all these years? Is there any way, under the sun, that a million deaths per decade can be excused? Is there any way the FDA and the drug companies can float safely in the upper atmosphere of privilege, while the concept of justice has any meaning? Where are criminal prosecutions?
The revelations of ongoing knowledge to be found at the FDA website page stagger the mind. Here is yet another implication: what about all the studies on drugs that are published in prestigious medical journals, month after month? These studies unequivocally claim the drugs are safe. What level of fraud must exist for such peer-reviewed studies to attain the false status of medical fact?
Perhaps this quote from Marcia Angell, former editor of the New England Journal of Medicine, will clarify that aspect of the scandal:
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
(Marcia Angell, MD, The New York Review of Books, January 15, 2009)
by Jon Rappoport
SOURCE: [ More ]
POLIO VACCINE CONTAMINATED
* CDC Admits 98 Million Americans Received Polio Vaccine Contaminated With Cancer Virus
* HIV/AIDS was spread by the hepatitis B vaccine produced by Merck & Co. during the early 1970s
* Facts Listed on The CDC Website about SV40:
* SV40 Is an abbreviation for Simian Vacuolating virus 40 or Simian virus 40
* SV40 Is a virus found in some species of monkey.
* SV40 Was discovered in 1960. Soon afterward, the virus was found in polio vaccine.
* SV40 Virus has been found in certain types of cancer in humans.
The CDC has quickly removed a page from their website, which is now cached, ( but now has been removed) admitting that more than 98 million Americans received one or more doses of polio vaccine within an 8-year span when a proportion of the vaccine was contaminated with a cancer causing polyomavirus called SV40. It has been estimated that 10-30 million Americans could have received an SV40 contaminated dose of the vaccine.
SV40 is an abbreviation for Simian vacuolating virus 40 or Simian virus 40, a polyomavirus that is found in both monkeys and humans. Like other polyomaviruses, SV40 is a DNA virus that has been found to cause tumors and cancer.
SV40 is believed to suppress the transcriptional properties of the tumor-suppressing genes in humans through the SV40 Large T-antigen and SV40 Small T-antigen. Mutated genes may contribute to uncontrolled cellular proliferation, leading to cancer.
Michele Carbone, Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesothelioma. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers, writes Geraldo Fuentes.
Dr. Michele Carbone openly acknowledged HIV/AIDS was spread by the hepatitis B vaccine produced by Merck & Co. during the early 1970s. It was the first time since the initial transmissions took place in 1972-74, that a leading expert in the field of vaccine manufacturing and testing has openly admitted the Merck & Co. liability for AIDS.
The matter-of-fact disclosure came during discussions of polio vaccines contaminated with SV40 virus which caused cancer in nearly every species infected by injection. Many authorities now admit much, possibly most, of the world’s cancers came from the Salk and Sabin polio vaccines, and hepatitis B vaccines, produced in monkeys and chimps.
It is said mesothelioma is a result of asbestos exposure, but research reveals that 50% of the current mesotheliomas being treated no longer occurs due to asbestos but rather the SV-40 virus contained in the polio vaccination. In addition, according to researchers from the Institute of Histology and General Embryology of the University of Ferrara, SV-40 has turned up in a variety other tumors. By the end of 1996, dozens of scientists reported finding SV40 in a variety of bone cancers and a wide range of brain cancers, which had risen 30 percent over the previous 20 years.
The SV-40 virus is now being detected in tumors removed from people never inoculated with the contaminated vaccine, leading some to conclude that those infected by the vaccine might be spreading SV40.
Soon after its discovery, SV40 was identified in the oral form of the polio vaccine produced between 1955 and 1961 produced by American Home Products (dba Lederle).
Both the oral, live virus and injectable inactive virus were affected. It was found later that the technique used to inactivate the polio virus in the injectable vaccine, by means of formaldehyde, did not reliably kill SV40.
Just two years ago, the U.S. government finally added formaldehyde to a list of known carcinogens and and admitted that the chemical styrene might cause cancer. Yet, the substance is still found in almost every vaccine.
According to the Australian National Research Council, fewer than 20% but perhaps more than 10% of the general population may be susceptible to formaldehyde and may react acutely at any exposure level. More hazardous than most chemicals in 5 out of 12 ranking systems, on at least 8 federal regulatory lists, it is ranked as one of the most hazardous compounds (worst 10%) to ecosystems and human health (Environmental Defense Fund).
In the body, formaldehyde can cause proteins to irreversibly bind to DNA. Laboratory animals exposed to doses of inhaled formaldehyde over their lifetimes have developed more cancers of the nose and throat than are usual.
Facts Listed on The CDC Website about SV40
-SV40 is a virus found in some species of monkey.
-SV40 was discovered in 1960. Soon afterward, the virus was found in polio vaccine.
-SV40 virus has been found in certain types of cancer in humans.
-In the 1950s, rhesus monkey kidney cells, which contain SV40 if the animal is infected, were used in preparing polio vaccines.
-Not all doses of IPV were contaminated. It has been estimated that 10-30 million people actually received a vaccine that contained SV40.
-Some evidence suggests that receipt of SV40-contaminated polio vaccine may increase risk of cancer.
A Greater Perspective on Aerial Spraying and SV40
The Defense Sciences Office of the Pathogen Countermeasures Program, in September 23, 1998 funded the University of Michigan’s principal investigator, Dr. James Baker, Jr. Dr. Baker, Director of Michigan Nanotechnology Institute for Medicine and Biological Sciences under several DARPA grants. Dr. Baker developed and focused on preventing pathogens from entering the human body, which is a major goal in the development of counter measures to Biological Warfare. This research project sought to develop a composite material that will serve as a pathogen avoidance barrier and post-exposure therapeutic agent to be applied in a topical manner to the skin and mucous membranes. The composite is modeled after the immune system in that it involves redundant, non-specific and specific forms of pathogen defense and inactivation. This composite material is now utilized in many nasal vaccines and vector control through the use of hydro-gel, nanosilicon gels and actuator materials in vaccines.
Through Dr. Baker’s research at the University of Michigan; he developed dendritic polymers and their application to medical and biological science. He co-developed a new vector system for gene transfer using synthetic polymers. These studies have produced striking results and have the potential to change the basis of gene transfer therapy. Dendrimers are nanometer-sized water soluble polymers that can conjugate to peptides or arbohydrates to act as decoy molecules to inhibit the binding of toxins and viruses to cells. They can act also as complex and stabilize genetic material for prolonged periods of time, as in a “time released or delayed gene transfer”. Through Dr. Baker’s ground breaking research many pharmaceutical and biological pesticide manufacturers can use these principles in DNA vaccines specific applications that incorporate the Simian Monkey Virus SV40.
WEST NILE VIRUS SPRAYING
In 2006 Michael Greenwood wrote an article for the Yale School of Public Health entitled, “Aerial Spraying Effectively Reduces Incidence of West Nile Virus (WNV) in Humans.” The article stated that the incidence of human West Nile virus cases can be significantly reduced through large scale aerial spraying that targets adult mosquitoes, according to research by the Yale School of Public Health and the California Department of Public Health.
Under the mandate for aerial spraying for specific vectors that pose a threat to human health, aerial vaccines known as DNA Vaccine Enhancements and Recombinant Vaccine against WNV may be tested or used to “protect” the people from vector infection exposures. DNA vaccine enhancements specifically use Epstein-Barr viral capside’s with multi human complement class II activators to neutralize antibodies. The recombinant vaccines against WNV use Rabbit Beta-globulin or the poly (A) signal of the SV40 virus. In early studies of DNA vaccines it was found that the negative result studies would go into the category of future developmental research projects in gene therapy. During the studies of poly (A) signaling of the SV40 for WNV vaccines, it was observed that WNV will lie dormant in individuals who were exposed to chicken pox, thus upon exposure to WNV aerial vaccines the potential for the release of chicken pox virus would cause a greater risk to having adult onset Shingles.
CALIFORNIA AERIAL SPRAYING for WNV and SV40
In February 2009 to present date, aerial spraying for the WNV occurred in major cities within the State of California. During spraying of Anaheim, CA a Caucasian female (age 50) was exposed to heavy spraying, while doing her daily exercise of walking several miles. Heavy helicopter activity occurred for several days in this area. After spraying, she experienced light headedness, nausea, muscle aches and increased low back pain. She was evaluated for toxicological mechanisms that were associated with pesticide exposure due to aerial spraying utilizing advanced biological monitoring testing. The test results which included protein band testing utilizing Protein Coupled Response (PCR) methods were positive for KD-45. KD-45 is the protein band for SV-40 Simian Green Monkey virus. Additional tests were performed for Epstein-Barr virus capside and Cytomeglia virus which are used in bio-engineering for gene delivery systems through viral protein envelope and adenoviral protein envelope technology. The individual was positive for both; indicating a highly probable exposure to a DNA vaccination delivery system through nasal inhalation.
The question of the century is how many other viruses and toxins are within current day vaccines that we’ll only find out about in a few decades?
Dave Mihalovic is a Naturopathic Doctor who specializes in vaccine research, cancer prevention and a natural approach to treatment.