May
1
FDA Wants More Money, Claims They Are a “Bargain”
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By Dr. Mercola
The US Food and Drug Administration (FDA) is looking to increase their budget by $821 million next year, which would make their proposed 2014 budget a hefty $4.7 billion.
The additional money would help the FDA improve food safety, monitor imports and create measures to protect against chemical and biological threats, FDA Commissioner Margaret Hamburg told Congress, outrageously noting that:1
“FDA is a true bargain among federal agencies.”
This has to be one of the biggest delusions of the 21st century.This is one “bargain” that is not such a good deal for Americans’ health, as the FDA is also the federal agency responsible for a growing list of policy decisions that favor big industry at the expense of public health.
And if their nearly $1-billion budget increase is approved, they stand to fall even further into the drug companies’ trenches …
94 Percent of the FDA’s Budget Increase Funded by Drug Companies
Out of the extra $821 million the FDA is seeking, 94 percent, or $770 million, would come from user fees paid by the drug industry. While some of the FDA is funded by taxpayers, most of their budget comes from such user fees, which are paid by the drug companies to hasten the review and approval of their products.
Industry user fees were first introduced in the early 1990s in an effort to help speed up the FDA's approval process; prior to that, the FDA had been funded entirely by Congress.
This is one of the main reasons why the FDA’s track record for keeping you safely out of harm’s way has failed so miserably over the years, as user fees allow the drug industry to have major leverage over the FDA, and that control is continuing to increase year after year.
The FDA is even trying to have about $83 million in industry user fees exempted from the sequester (mandatory budget cuts to federal agencies that began in 2013), as these fees are supposed to be withheld due to the sequestration. Yet, with a budget already surpassing the $4-billion mark, the FDA has done little to keep Americans safe from dangerous foods and drugs. Instead, they:
- Quietly withdrew their intent to ban low-dose antibiotics in animal feed, allowing the spread of antibiotic-resistant “super-germs” linked to this practice to continue unabated
- Approved the first genetically modified plant intended for the treatment of a human disease, opening the door for biotech companies such as Monsanto, which also has vested interests in the pharmaceutical industry, to design more drugs created from genetically engineered plants and/or animals
- Is considering allowing the unlabeled use of the artificial sweetener aspartame in dairy products
- Approved a generic version of Actos – the brand name for a drug used to treat type 2 diabetes – even though it is presently embroiled in thousands of lawsuits alleging that the drug causes severe side effects including heart failure, macular edema and bladder cancer
- Attempting to regulate stem cell procedures at a Colorado clinic, even though the stem cells being used in the procedure come from the patient’s own body, which means they are essentially claiming that they can regulate a part of your body
FDA Allows Drugs to Remain on Market Despite Uncovering Fraudulent Safety Data
What do you get when the federal agency in charge of monitoring drug safety is funded largely by the companies producing those very same drugs? A massive conflict of interest and an agency that is more interested in serving the drug industry than the American public.
This is not speculation; it’s been shown to be the truth, time and time again. In 2011, the FDA found out that many studies conducted at Cetero Research, a major drug research lab, from 2005 to 2009 were fraudulent, involving manipulated data and tampered records.2 About 100 drugs were already on the market, approved, at least in part, based on these fraudulent studies.
Yet, the FDA made no warnings to the public, instead allowing the potentially dangerous drugs to remain on the market while it quietly ordered re-testing to be done. In Europe, however, multiple drugs were pulled from the market following the revelation. Even today, the FDA has never released a list of the affected drugs, saying this would reveal trade secrets.
Unfortunately, this wasn’t an isolated case. As Scientific American and ProPublica reported:3
“Turns out that wasn't an anomaly: The agency's slow, secretive response in the Cetero case mirrors how it handled an earlier instance of scientific misconduct at another contract research organization, MDS Pharma Services.”
When the FDA found that four years’ worth of data produced by two MDS facilities were potentially fraudulent, it again refused to post a public list of the 217 affected drugs, some of which were already being sold. Despite requiring re-testing of many of the medications, the FDA assured the public that the drugs were safe – an impossible truth since they were approved, in part, based on faulty research. At least five of MDS’ senior executives later went to work for Cetero Research.
Scientific American continued:4
“In January 2007, three and a half years after first finding problems at MDS, the FDA informed drug makers that studies done by MDS between 2000 and 2004 needed to be reevaluated. FDA officials told the media that 217 generic drugs were potentially implicated, 140 of which were already approved for sale.
The agency was unsure how many new drugs might have relied on studies carried out by MDS, according to news accounts, so it asked the manufacturers of every new drug approved between 2000 and 2004 -- some 900 medicines -- to check to see if MDS had conducted any relevant tests. 2The FDA made no effort to warn doctors or patients that it now had doubts about the data underlying some of the drugs it had approved. Instead, the agency sounded a public 'all clear.'”
The FDA Is Failing at Its Stated Mission
Now, with the FDA requesting even more money from the drug industry, it’s likely that such egregious biases in favor of the industry are only going to continue. They simply cannot risk biting the proverbial hand that feeds them …The FDA's mission statement reads as follows:
"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."
In 2007, a report bearing the revealing title "FDA Science and Mission at Risk" by the Subcommittee on Science and Technology,5 detailed how the FDA cannot fulfill its stated mission because:
- Its scientific base has eroded and its scientific organizational structure is weak
- Its scientific workforce does not have sufficient capacity and capability, and
- Its information technology (IT) infrastructure is inadequate
Furthermore, the report found that "the development of medical products based on 'new science' cannot be adequately regulated by the FDA, and that the agency does not have the capacity to carry out risk assessment and analysis. Additionally, the agency's science agenda "lacks coherent structure and vision, as well as effective coordination and prioritization."
The fact that the FDA does not have its ducks in a row, so to speak, has sorely misplaced its priorities, and is not working to fulfill its mission is clearly evidenced in the numerous cases where hundreds and sometimes thousands of complaints about dangerous drugs (like Vioxx and Avandia), vaccines (like Gardasil), and additives (like aspartame) are stubbornly ignored, while SWAT-style teams armed to the teeth are sent to raid supplement makers, whole food businesses, organic farmers, and raw dairies when oftentimes not a single incidence of harm can be attributed to their products.
Hospitals Make More Money From Surgical Complications
The FDA has little incentive to change its current structure or work harder to uncover drug dangers, lest they put billions of dollars of their funding at risk. Likewise, a revealing new JAMA study found that major surgical complications actually earn hospitals more money on privately insured or Medicare-covered patients.6
This isn’t exactly shocking, of course, since the more complications suffered, the longer the hospital stay and the more associated medications, tests and procedures that will be ordered. Hospitals are a business, after all, and the more “services” used by any one patient, the more money they make.
Where money is concerned, a hospital therefore has no incentive to reduce surgical errors and other medical mishaps, which may actually be a key moneymaker for them. And, as the Health Business Blog astutely reported,7 unlike most businesses, which suffer financially when mistakes occur, hospitals get to charge you even more money to treat you for avoidable complications or mistakes they make. Decreasing surgical complications may therefore have adverse financial consequences for many hospitals, the researchers concluded.
More Reason to Take Control of Your Health
Minor changes to the existing structure will not be enough to change the current medical paradigm, which is designed to profit from your ill health. A complete reform of the system would instead be needed, and there are powerful forces at play that do not want this to happen.
As much as possible, be proactive in using a healthy lifestyle to support and protect your health and, if illness does occur, use natural methods that will allow your body to heal itself without the need for the deadly drugs being pushed on you by the drug companies and the FDA.
Related Articles:
Massive Corruption Revealed to be at the Core of Many Drug Approvals
Shocking Story Reveals How the FDA Is Recklessly Abandoning Drug Safety
War on Health: The FDA's Cult of TyrannyApr
18
How to Address Allergies and Asthma Symptoms as “Worst Allergy Season Ever” Begins
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By Dr. Mercola
Spring allergies affect an estimated 25 million Americans, and according to the American Board of Allergy and Immunology, we’re looking at one of the worst allergy seasons in a long time, thanks to a number of climactic factors.1
The Asthma and Allergy Foundation's annual list of the worst cities for those with spring allergies (based on tree pollen counts) include the following five:2
- Jackson, Mississippi
- Knoxville, Tennessee
- Chattanooga, Tennessee
- McAllen, Texas
- Louisville, Kentucky
Airborne pollen is the most common cause of seasonal allergies, also known as hay fever or allergic rhinitis. Early arrival after a mild winter has spawned high levels of pollen, and means allergy season will linger weeks longer. Both 2011 and 2012 reported record-breaking pollen numbers, and this season will likely break those records.
Needless to say, sales of allergy medications of all kinds are booming. This includes antihistamines, decongestants, nasal sprays and allergy shots—many of which can cause significant side effects.
According to the featured article in Forbes, the US market for allergy drugs is projected to hit or exceed $14.7 billion by 2015:
“The companies named to benefit most include Schering-Plough, Novartis, Teva Pharmaceutical Industries (Vicks), Meda Pharmaceuticals, Collegium Pharmaceutical, McNeil Consumer Healthcare, and others, including companies that make alternative remedies as well.”
One of the better alternatives is sublingual allergy drops, which have been shown to work just as well as inhalers. Sublingual immunotherapy has not been approved by the US Food and Drug Administration (FDA), but is widely used in Europe, and some American doctors prescribe it off label.
There are also a number of other alternatives, including provocation neutralization treatment. The success rate for this approach to treating allergies is about 80 to 90 percent, and you can receive the treatment at home.
How and Why Do Allergies Develop?
Allergies are your body's reaction to allergens (particles your body considers foreign), a sign that your immune system is working overtime. The first time your body encounters an allergen, your plasma cells release IgE (immunoglobulin E), an antibody specific to that allergen. IgE attaches to the surface of your mast cells.
Mast cells are found in great numbers in your surface tissues (i.e., those with close proximity to the external environment, such as in your skin and in the mucous membranes of your nose), where they help mediate inflammatory responses. Mast cells release a number of important chemical mediators, one of which is histamine.
So, the second time your body encounters a particular allergen, within a few minutes, your mast cells become activated and release a powerful cocktail of histamine, leukotrienes, and prostaglandins, which trigger the entire cascade of symptoms you associate with allergies: sneezing, runny nose, sore throat, hacking cough, itchy eyes, etc.
Histamine can cause your airways to constrict, like with asthma, or cause blood vessels to become more permeable, leading to fluid leakage or hives. Leukotrienes cause hypersecretion of mucus, which you commonly experience as a runny nose or increased phlegm.
Pollen is an extremely common mast cell activator, but other agents can trigger these processes as well. Mold spores, dust, airborne contaminants, dust mites, pet dander, cockroaches, environmental chemicals, cleaning products, personal care products and foods can all cause allergic reactions. Every person is different in what he or she reacts to. And, just because you haven't reacted to something in the past doesn't mean you won't react to it in the future—you can become sensitized at any point in time.
Allergies May Also Be Due to Leaky Gut Syndrome
Leaky gut is a condition that occurs due to the development of gaps between the cells (enterocytes) that make up the membrane lining your intestinal wall. These tiny gaps allow substances such as undigested food, bacteria and metabolic wastes that should be confined to your digestive tract to escape into your bloodstream -- hence the term leaky gut syndrome. Once the integrity of your intestinal lining is compromised, and there is a flow of toxic substances "leaking out" into your bloodstream, your body experiences significant increases in inflammation.
Besides being associated with inflammatory bowel diseases like Crohn's and ulcerative colitis, or celiac disease, leaky gut can also be a contributing factor to allergies.
According to a growing number of experts, including Dr. Loren Cordain, a professor at Colorado State University and an expert on Paleolithic lifestyles, humans are NOT designed to eat grains, and doing so may actually be damaging to your gut. The problem isn't only that there are superior sources of nutrients; grains actually contain anti-nutrients that may damage your gut. Cracks in your intestinal wall can then allow undigested proteins to enter your blood stream. These large complex substances are antigenic and allergenic, meaning they stimulate your immune system to produce antibodies against them. This is what sets the stage for the occurrence of allergies and other autoimmune disorders.
“Healing and sealing” your gut has been shown to help alleviate allergy symptoms.The key lies in altering your diet to eliminate the offending foods, such as grains and processed foods, and introduce healthier ones that will support a proper balance of bacteria in your gut. To restore gut health, and prevent leaky gut from occurring, eating traditionally fermented foods is essential.
Alternative Allergy Treatments that Can Work
A recent ABC News report took 10 common “myths and old wives' tales” to allergists to get feedback on what works and what doesn’t. Included in their list were the following. For the remaining, please see the original article.3 In the following sections, I’ll address a number of other drug-free alternatives:
- Eating locally-produced honey: According to ABC News, the feedback was mostly negative on this strategy. But they do acknowledge the positive results gleaned in a 2011 study, which found that patients diagnosed with birch pollen allergy found significant relief when they consumed birch pollen honey daily from November to March. During birch pollen season, compared to the control group, the patients using honey experienced a 60 percent reduction in symptoms; twice as many asymptomatic days; 70 percent fewer days with severe symptoms, and 50 percent decrease in usage of antihistamines.
While I believe there's truth to the anecdotal claims that local honey can help reduce symptoms of asthma, it's important to be aware that honey itself can also trigger in some cases severe allergic reactions, including anaphylactic shock. So clearly you should not attempt to use honey if you've ever experienced an adverse reaction to honey in the past. Also be careful and use it sparingly in the beginning until you've confirmed that you can tolerate it. Another important point to remember is that honey is high in fructose, which, in excessive amounts, can exacerbate pre-existing insulin resistance and wreak havoc on your body.
- Flushing your nasal cavity with a neti pot: This strategy is widely recommended, even by the American Academy of Allergy, Asthma & Immunology. Irrigating your sinuses will help flush out pollen and other irritants, helping you breathe a little easier
- Acupuncture: Perhaps surprisingly to a lot of people, acupuncture has been shown to offer effective relief from allergy symptoms. A study published earlier this year found that those who went for weekly acupuncture treatments had significantly fewer breathing problems compared to those who did not receive acupuncture. However, the effect only lasted as long as they maintained their treatments. Still, this could be a viable option for seasonal allergy sufferers willing to get needled once a week while pollen counts are at their worst
- Eating “right”: Here, the allergists claimed the findings were inconclusive, but I think there’s a lot of wiggle-room when you ask conventionally trained doctors and researchers to define what the “right” diet is. Most are simply clueless about using nutrition for optimal health. For example, genetically engineered (GE) foods, which are pervasive in the American diet, have been shown to cause food allergies. Ditto for various food additives. Recent research has also found that junk food increases a child’s risk of asthma and allergies, so certainly, avoiding such foods can, at the very least, reduce your risk.
To me, addressing your diet if you have allergies is a no-brainer.
An estimated 80 percent of your immune system is located in your gut, so supporting your digestive health is essential to also supporting your immune system, which is your primary defense system against ALL disease. Processed food, GE ingredients and synthetic additives all decimate the beneficial bacteria in your gut, thereby having a negative effect on your immune system. Ideally, you’ll want to avoid processed foods, focusing on organic, locally-grown foods instead (both to optimize your nutrition and avoid pesticides), and include fermented foods in your diet to optimize your gut flora, or use a high-quality probiotics supplement.
Additionally, as it pertains to your diet: about one-third of seasonal allergy sufferers have something called "oral allergy syndrome,"4 in which your immune system is triggered by proteins in some foods that are molecularly similar to pollen. Your immune system looks at the protein molecule and says, "Close enough!" and attacks it. If you are allergic to ragweed, for example, you may have cross-sensitivity to melons, bananas, tomatoes, zucchini, sunflower seeds, dandelions, chamomile, and Echinacea. If you have a grass allergy, you may also react to peaches, celery, tomatoes, melons and oranges. If this applies to you, you’ll want to avoid such foods.
The MOST Important Allergy 'Treatment' You Need to Pay Attention to
While I believe you certainly need to address your diet and could try any of the alternative strategies listed above, if you have asthma, optimizing your vitamin D levels is absolutely crucial. In fact, research suggests that vitamin D deficiency may be a primary underlying cause of asthma. This means that many are needlessly suffering with a potentially life threatening ailment, since vitamin D deficiency is easily remedied.
Ideally, you'll want to get your vitamin D from safe sun exposure. Beware that using sunscreen when outdoors effectively shields your skin from making any vitamin D. Another alternative is using a safe tanning bed, or if neither of those options are available, an oral vitamin D3 supplement. If you opt for a vitamin D supplement you also need to boost your vitamin K2. For more information on this, please see this previous article.
Whichever way you go, make sure to check your vitamin D levels to make sure you’re within the therapeutic levels of 50-70 ng/ml. If you get your levels to about 60 ng/ml there's a strong likelihood -- especially if you combine it with exercise and balancing out your omega-3 and omega-6 fats as described below -- that you will not experience asthma anymore.
Provocation Neutralization Allergy Treatment
Addressing allergies takes a multi-faceted approach that involves optimizing your diet, intestinal health, vitamin D levels, and avoiding potential triggers. Typically, allergy sufferers tend to arm themselves with a variety of antihistamine pills, nose sprays and eye drops in anticipation of allergy season. But these drug treatments come with their own set of side effects, and relief is short lived. And it's been my experience that conventional allergy testing, whether done through the blood or skin, works for only 20 to 30 percent of patients. It is also quite inconvenient, as you need to go to the doctor's office every week for months or perhaps years, and it can take several years to be effective.
Provocation neutralization (PN) allergy testing and treatment offers many allergy sufferers permanent relief without adverse side effects. The success rate for this approach is about 80 to 90 percent, and you can receive the treatment at home. I offered this effective treatment for many years in my office.
The provocation refers to "provoking a change" and neutralization refers to "neutralizing the reaction caused by provocation." During provocation-neutralization, a small amount of allergen is injected under your skin to produce a small bump called a "wheal" on the top layers of your skin, and then it is monitored for a reaction. If you have a positive reaction, such as fatigue, headache, or a growth in the size of the wheal, then the allergen is neutralized with diluted injections or with drops that go in your mouth of the same allergen. If you are interested in pursuing PN, the American Academy of Environmental Medicine5 (AAEM) has a list of physicians and offices that are trained in this highly effective and recommended technique.
Sublingual Immunotherapy for Asthma & Allergies
“Desensitizing a person to allergies usually involves a series of injections of small amounts of allergens, but a large review of studies has found that putting allergens under the tongue in a water solution might work just as well,” the New York Times6 recently reported.
A meta-analysis of 63 randomized controlled trials, involving more than 5,130 patients between the ages of four and 74, found strong evidence that sublingual immunotherapy improved asthma symptoms caused by grass, tree pollen, dust mites, ragweed and other substances. The treatment produced a greater than 40 percent improvement in symptoms compared to a placebo, and led to a significant reduction in the use of asthma medicines. Interestingly, Provocation Neutralization technique, described above, has also utilized sublingual allergy treatments for many decades.
The review, published in The Journal of the American Medical Association,7 also found moderate evidence that the oral treatment reduced runny nose and eye inflammation. Local reactions were common, but no life-threatening side effects, such as anaphylaxis, were reported. According to Dr. Daniel Moore,8 the allergy drops used for sublingual immunotherapy (SLIT) are administered daily, or several times per week, over a period of years.
“The immune system of the gastrointestinal tract tends to 'tolerate' foreign substances, meaning that it does not respond in an over-active way to swallowed material,” he explains. “...When SLIT is administered into the gastrointestinal tract [via your mouth], the immune system tolerates the allergen, instead of the over-reactivity of the immune system, as with allergic disease. This results in less allergy symptoms when the body is exposed to the allergy source, such as airborne pollen or pet dander... SLIT appears to be effective in the treatment of allergic rhinitis, allergic conjunctivitis and, to a lesser degree, allergic asthma.”
Additional Safe and Effective Strategies to Treat Allergies and Asthma
As already mentioned, addressing your diet and optimizing both your gut health and vitamin D levels should be at the top of your list if you’re suffering from allergies and/or asthma. Here are a few other basic strategies that can help treat the root of the problem as well.
- Increase your intake of animal-based omega-3 fats – I can't emphasize enough the importance of getting sufficient amounts of high-quality animal-based omega-3 fats in your diet. The fats DHA and EPA found in fish oil and krill oil are potent anti-inflammatories.
According to Mother Earth News,9 a German study published in the journal Allergy found people who have diets rich in of omega-3 fatty acids suffer from fewer allergy symptoms. A second study10 in Sweden found that children who regularly ate fish prior to age one had much lower allergies by age four. My favorite sources of omega-3 fatty acids are grass fed meat and eggs, and krill oil. (Fish has become too contaminated to rely on as a staple.)
- Reduce your intake of omega-6 fats – In addition to adding omega-3 fats to your diet, you also want to reduce the amount of omega-6 fats you consume because the ratio between these two fats is very important. If you eat processed foods daily, the balance between omega-3 and omega-6 fats will become distorted, which can cause the type of inflammation that leads to asthma.
- Fermented vegetables and/or probiotics: In a 2008 study, researchers discovered that people who took probiotics throughout allergy season had lower levels of an antibody that triggered allergy symptoms. They also had higher levels of a different antibody (IgG), thought to play a protective role against allergic reactions. Other researchers found evidence that giving probiotics to newborns and mothers-to-be may help prevent childhood allergies.
- Avoid pasteurized milk products, which are notorious for increasing phlegm and making asthma worse.
- Get regular exercise – Exercise (especially out in fresh air if you're an asthmatic) is actually crucial, as it helps to moderate insulin levels.
Below are several other foods and herbs you might want to try:
- Hot peppers: Hot chili peppers, horseradish, and hot mustards work as natural decongestants. In fact, a nasal spray containing capsaicin (derived from hot peppers) significantly reduced nasal allergy symptoms in a 2009 study.
- Quercetin: Quercetin is an antioxidant that belongs to a class of water-soluble plant substances called flavonoids. Although research is sketchy, many believe quercetin-rich foods (such as apples, berries, red grapes, red onions, capers and black tea) prevent histamine release—so they are “natural antihistamines.” Quercetin is also available in supplement form—a typical dose for hay fever is between 200 and 400 mg per day.
- Butterbur (Petasites hybridus): Another natural antihistamine, this herb has been used since ancient times to treat a variety of conditions. As far back as the 17th century, butterbur was used to treat coughs, asthma, and skin wounds. Researchers have since identified the compounds in butterbur that help reduce symptoms in asthma by inhibiting leukotrienes and histamines, which are responsible for symptom aggravation in asthma.11 In a German study,12 40 percent of patients taking butterbur root extract were able to reduce their intake of traditional asthma medications. A British study found butterbur as effective as the drug Zyrtec.
A word of caution is needed, however. Butterbur is a member of the ragweed family, so if you are allergic to ragweed, marigold, daisy, or chrysanthemum, you should not use butterbur. Also, the RAW herb should not be used because it contains substances called pyrrolizidine alkaloids that can be toxic to the liver and kidneys and may cause cancer. Commercial butterbur products have had a lot of these alkaloids removed.
- Goldenseal (Hydrastis canadensis): Goldenseal may be helpful for seasonal allergies. Laboratory studies suggest that berberine, the active ingredient in goldenseal, has antibacterial and immune-enhancing properties.
- Eucalyptus oil: This pure essential oil can be healing to mucus membranes. You can apply a drop on a cotton ball and sniff it several times a day, add a few drops to water (or to a nebulizer, if you own one) for a steam treatment, or use a few drops in your bath water.
There is Hope if You Suffer From Allergies
If you’re one of the tens of millions of allergy sufferers in the US, know there is plenty you can do besides lining the pockets of the pharmaceutical industry. Eating a wholesome diet based on unprocessed, ideally organic and/or locally grown foods, including fermented foods, along with optimizing your vitamin D levels and correcting your omega-3 to omega-6 ratio, will form the foundation upon which your immune system can function in an optimal manner.
For short-term relief of symptoms, you could give acupuncture a try, and irrigate your sinuses with a neti pot. There are also a number of foods and herbs you can try to alleviate symptoms, which are listed above. For more long-term relief, you may want to consider provocation neutralization treatment, or sublingual allergy drops, which work just as well as inhalers.
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17
Side Effects of Statins
Filed Under Main Content, Other News | Leave a Comment
By Dr. Mercola
One in four Americans over the age of 45 now takes cholesterol-lowering drugs known as statins, typically for the primary prevention of heart attacks and strokes.
Not only is their benefit for preventing heart disease highly questionable, but these drugs come with an avalanche of potential side effects, so much so that new research showed a staggering number of patients stop taking them entirely.
Half of Those Taking Statins Quit
A recent study of more than 100,000 people who’d been prescribed statins from 2000 to 2008 found that 17 percent of patients reported side effects such as muscle pain, nausea, and liver and nervous system problems.1
Two-thirds of those who reported side effects quit taking the drugs, and, the study found, half of those prescribed statins quit taking them at least temporarily, while 20 percent quit for more than a year.
The researchers noted that many of the side effects are “tolerable” or specific to only one statin, not the entire class, suggesting that people can remain on the drugs or switch to a different statin if problems arise. But the truth is that many statin side effects are quite serious.
Oftentimes statins do not have any immediate side effects, and they are quite effective at lowering cholesterol levels by 50 points or more (which may not actually have any impact on your heart disease risk). This makes it appear as though they're benefiting your health, and health problems that develop later on are frequently misinterpreted as new and unrelated health problems.
Diabetes, Fatal Kidney Damage and Other Possible Statin Side Effects
With well over 30 million Americans now taking statin drugs, we're witnessing a massive ongoing 'live' experiment, and many are putting their health on the line for drugs that offer little in the way of heart protection. Just last year, the US Food and Drug Administration (FDA) announced it would be requiring additional warning labels for statin drugs. Among them are warnings that statins may increase your risk of:
- Liver damage
- Memory loss and confusion
- Type 2 diabetes
- Muscle weakness (for certain statins)
Statins have also been shown to increase your risk of diabetes via a number of different mechanisms. The most important one is that they increase insulin resistance, which can be extremely harmful to your health.
Increased insulin resistance contributes to chronic inflammation in your body, and inflammation is the hallmark of most diseases, including heart disease, which, ironically, is the primary reason for taking a cholesterol-reducing drug in the first place. It can also promote belly fat, high blood pressure, heart attacks, chronic fatigue, thyroid disruption, and diseases like Parkinson's, Alzheimer's and cancer.
Earlier this year new research also found that taking higher doses of the statins simvastatin (Zocor), atorvastatin (Lipitor) or rosuvastatin (Crestor) increases your risk of acute kidney injury by 34 percent, a condition that can be fatal.2 Some experts are now urging that people on statins have an assessment of their kidney risks, similar to what used to be recommended regarding liver function.
Due to statins' potential to increase liver enzymes and cause liver damage, it used to be recommended that patients be monitored for normal liver function.
The FDA removed this long-standing warning in 2012 and ruled that patients taking statins no longer need routine monitoring of liver enzymes, but instead can have liver enzymes tested before starting the drugs, and then only as clinically needed, which seems reprehensibly irresponsible. In all, statin drugs have been directly linked to over 300 side effects,3 which include:
Cognitive loss Neuropathy Anemia Acidosis Frequent fevers Cataracts Sexual dysfunction An increase in cancer risk Pancreatic dysfunction Immune system suppression Muscle problems, polyneuropathy (nerve damage in the hands and feet), and rhabdomyolysis, a serious degenerative muscle tissue condition Hepatic dysfunction. (Due to the potential increase in liver enzymes, patients must be monitored for normal liver function)
Statins Might Make Your Heart Health Worse
The biggest “sham” of all is that statin drugs, which millions are taking as a form of “preventive medicine” to protect their heart health, can have detrimental effects on your heart. Take a study in the journal Atherosclerosis,4 which showed that statin use is associated with a 52 percent increased prevalence and extent of calcified coronary plaque compared to non-users. Coronary artery calcification is the hallmark of potentially lethal heart disease!
One of the primary mechanisms of harm appears to be CoQ10 depletion. If you take statin drugs without supplementing with CoQ10 (or ideally, the reduced form, called ubiquinol, which is far more effective), your health is at serious risk. CoQ10 is used by every cell in your body, but especially your heart cells. Cardiac muscle cells have up to 200 times more mitochondria, and hence 200 times higher CoQ10 requirements, than skeletal muscle.
Premature aging is yet another side effect of statin drugs, and it's also a primary side effect of having too little CoQ10. Deficiency in this nutrient also accelerates DNA damage, and because CoQ10 is beneficial to heart health and muscle function this depletion leads to fatigue, muscle weakness, soreness and heart failure.
Measure Your LDL Particle Number, Not Total Cholesterol, to Gauge Heart Disease Risk
Could it be that all of this focus on lowering cholesterol levels has missed the boat entirely? Certainly, because cholesterol is NOT the cause of heart disease. Your body NEEDS cholesterol -- it is important in the production of cell membranes, hormones, vitamin D and bile acids that help you to digest fat. Cholesterol also helps your brain form memories and is vital to your neurological function.
If your physician is urging you to check your total cholesterol, know that this test will tell you virtually nothing about your risk of heart disease, unless it is 330 or higher. One of the most important tests you can get to determine your real heart disease risk is the NMR LipoProfile, which measures your LDL particle number. This test also has other markers that can help determine if you have insulin resistance, which is a primary cause of elevated LDL particle number and increased heart disease risk.
The NMR LipoProfile test easy to get and all major labs offer it, including LabCorp and Quest. Most insurance policies cover the test as well. Best of all, even if your doctor were to refuse to order it, you can order it yourself via third-party intermediaries like Direct Labs, or you can order the test online, and get blood drawn locally. Two other ratios you should pay attention to:
- HDL/Total Cholesterol Ratio: Should ideally be above 24 percent. If below 10 percent, you have a significantly elevated risk for heart disease.
- Triglyceride/HDL Ratio: Should be below 2.
Four Additional Risk Factors for Heart Disease
You’ll notice that none of these involve your cholesterol levels …
- Your fasting insulin level: Any meal or snack high in carbohydrates like fructose and refined grains generates a rapid rise in blood glucose and then insulin to compensate for the rise in blood sugar. The insulin released from eating too many carbs promotes fat and makes it more difficult for your body to shed excess weight, and excess fat, particularly around your belly, this is one of the major contributors to heart disease.
Your fasting insulin level can be determined by a simple, inexpensive blood test. A normal fasting blood insulin level is below 5, but ideally you'll want it below 3. If your insulin level is higher than 3 to 5, the most effective way to optimize it is to reduce or eliminate all forms of dietary sugar, particularly fructose, from your diet.
- Your fasting blood sugar level: Studies have shown that people with a fasting blood sugar level of 100-125 mg/dl had a nearly 300 percent higher risk of having coronary heart disease than people with a level below 79 mg/dl.
- Your waist circumference: Visceral fat, the type of fat that collects around your internal organs, is a well-recognized risk factor for heart disease. The simplest way to evaluate your risk here is by simply measuring your waist circumference. For further instructions, please see my previous article, Your Waist Size Can Be a Powerful Predictor of Hypertension and Other Chronic Diseases.
- Your iron level: Iron can be a very potent cause of oxidative stress, so if you have excess iron levels you can damage your blood vessels and increase your risk of heart disease. Ideally, you should monitor your ferritin levels and make sure they are not much above 80 ng/ml. The simplest way to lower them if they are elevated is to donate your blood. If that is not possible you can have a therapeutic phlebotomy and that will effectively eliminate the excess iron from your body.
Diet Can Reduce Your Risk of Heart Attacks Better Than Statins
According to Dr. Barbara Roberts, author of The Truth About Statins, studies haven’t shown that statins are beneficial for women who do not have heart disease, even if they have risk factors like obesity or family history.5 Yet, a recent study found heart attacks were reduced by 30 percent among people eating a Mediterranean diet!6
The healthy eating proved to be just as beneficial, if not more so, than statin drugs claim to be. While I don’t recommend a Mediterranean diet, per se, a healthy diet, like the one described in my nutrition plan, is the cornerstone of any heart-protection “plan.” If you want to protect your heart health, I recommend reducing, with the plan of eliminating, grains and sugars (including fructose) in your diet, replacing them with mostly whole, fresh vegetable carbs and healthy fats. Also try to consume a good portion of your food raw. Examples of healthy fats include:
Olives and olive oil Coconut and coconut oil Organic raw dairy products Avocados Raw organic nuts Seeds Pastured eggs (raw, or lightly cooked with yolks intact) Organic, grass-fed meats
To round out your heart-disease prevention program:
- Make sure you are getting enough high-quality, animal-based omega 3 fats, such as krill oil.
- Optimize your vitamin D levels, ideally through appropriate sun exposure as this will allow your body to also create vitamin D sulfate, which may play a crucial role in preventing the formation of arterial plaque
- Exercise daily, especially with Peak Fitness exercises
- Avoid smoking or drinking alcohol excessively
- Be sure to get plenty of good, restorative sleep
Are You Taking a Statin Drug for No Reason?
That these drugs have proliferated the market the way they have is a testimony to the effectiveness of direct-to-consumer marketing, corruption and corporate greed, because the odds are very high — greater than 1000 to 1 — that if you're taking a statin, you don't really need it.
From my review, the ONLY subgroup that might benefit are those born with a genetic defect called familial hypercholesterolemia, as this makes them resistant to traditional measures of normalizing cholesterol.
If you’re currently taking a statin drug and are worried about the excessive side effects they cause, please consult with a knowledgeable health care practitioner who can help you to optimize your heart health naturally, without the use of these dangerous drugs.
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11
Call to Action as Portland, Oregon Readies to Vote on Water Fluoridation
Filed Under Main Content, Other News | Leave a Comment
By Dr. Mercola
Water fluoridation is considered one of the most notable advancements in public health, and cities around the US spend millions adding fluoride to communal water supplies each year.
But, as stated in the video above, 99 percent of that fluoridated water ends up on your lawn and in your toilet, where it’s really nothing but an environmental pollutant. Then there’s the issue of safety when ingested on a daily basis...
An increasing number of dentists and scientists are raising serious concerns about these chemicals, which by the way have never been approved by the Food and Drug Administration (FDA) — the agency responsible for food and drug safety.
Many do not realize that fluoride is a drug that is available only with a prescription. Yet it's added to municipal water supplies used by more than 180 million Americans, including infants and the elderly without any attention to personalized dosing or potential interactions.
This is a significant problem, because once you add it to the water supply, you have no way of determining how much of the drug any particular person will consume on any given day.
Also consider this: It is illegal, medical malpractice, and unethical for a physician to prescribe a drug without specifying dosage, and to fail to monitor your health for side effects from the drug.
Yet, your water authority is not only allowed, but encouraged to add a toxic drug — fluoride — to your drinking water without your consent and without any way of knowing who in your household is drinking it, how much, and the effect it is having.
Worse yet, while scientific studies have been done on pharmaceutical grade fluoride, none have been made on the fluoride that is actually used for water fluoridation. This chemical (hexafluorosilicic acid) is an industrial waste product that is likely to be even more toxic than medical grade fluoride.
It’s illegal to dump it into rivers and lakes or release the parent gases into the atmosphere. In fact, municipalities that decided to stop fluoridating their water had to keep going until all the chemicals were used up because they couldn’t afford the hazardous waste disposal fees!
Dr. William Hirzy from the EPA has even pointed out that if it goes into the air, it's a pollutant. If it goes into the local water, it's pollution. But if the public water utilities buy it and purposely pour it in our drinking water, it's no longer a pollutant. All of a sudden, by some magic sleight of hand, it's a beneficial public health measure...
Concerns About Water Fluoridation Safety Keep Mounting
One of the latest outspoken critics of fluoridation is Daniel M. Merfeld, Ph.D. Professor of Otology and Laryngology at Harvard Medical School, who has stated that:1
"Most European countries do not fluoridate their water, because such mass medication is considered ineffective and unethical."
After reviewing the evidence, Professor Merfeld agrees that water fluoridation is indeed a form of unchecked mass medication. According to Merfeld, there are "three indisputable facts” with regards to fluoridation that makes it a highly questionable practice:
1) Fluoridation provides an uncontrolled fluoride dose.
2) Fluoridation began before research showed that fluoride’s benefits were due to topical application not ingestion.
3) Fluoridation began before all its side effects were known. When water is fluoridated, the dose is uncontrolled as the amount ingested varies with water intake. Can you imagine your health care professional telling you to just put your prescription drugs in your water, ingest the drugged water when you are thirsty, and go ahead and share your drugged water with others? Of course not!
For those who listen to the propaganda that dental health improved after water fluoridation was instituted should take note that dental health actually improved across the board even in areas that did not add fluoride to their water, simply because better dental care and dental hygiene became available around the same time.
"In fact," professor Merfeld says, "research shows no significant difference in the number of cavities for US communities with and without fluoride in the drinking water. As another example, the vast majority of West European countries do not fluoridate; yet the dental health of Western Europe is no worse than for US communities that fluoridate."
The Health Ramifications of Mass Medicating with Fluoride
In the early 1990’s Dr. William Marcus, a senior scientist with the Environmental Protection Agency (EPA), released a memorandum outlining the adverse effects of fluoride in drinking water. For example, tests showed fluoridated drinking water caused bone and liver cancer in animals. Dr. Marcus was subsequently terminated from his position with the EPA. He later won a wrongful termination suit against the agency and was reinstated, as it was determined that “his employment was terminated solely because he questioned and opposed the EPA’s fluoride policy.”
So much for scientific freedom and public safety. According to the Centers for Disease Control and Prevention (CDC), 41 percent of American adolescents now have dental fluorosis — unattractive discoloration and mottling of the teeth that indicate overexposure to fluoride. But that's not all. Evidence suggests that swallowing fluoride can also cause:
Weakened bones, and fatal bone cancer (osteosarcoma) Impaired mental development, lowered IQ, and dementia Gastrointestinal problems Hyperactivity and/or lethargy Arthritic symptoms Kidney issues Lowered thyroid function Chronic fatigue Disrupted immune system
This is what the science is telling us about the ramifications of fluoride use. And yet, rather than taking the precautionary approach and stopping fluoridation until we know more, our policymakers continue to blindly forge ahead; refusing to give the scientific evidence the attention it deserves. Interestingly enough, a toxicology review is actually required by statute to ensure that fluoride-delivery agents, such as Hexafluorosilicic acid, are safe. But no such review exists for Hexafluorosilicic acid... It is a man-made, bioaccumulative toxin, and you cannot use dilution as a defense for adding a contaminant to public drinking water.
And yet, it’s being done...
According to the EPA’s local's president, Bill Hirzy, a chemist in the EPA's Office of Toxic Substances, water fluoridation remains a government policy because of “institutional inertia [and] embarrassment among government agencies that have been promoting this stuff as safe.”
In October last year, the world’s leading expert on fluoride toxicity and author of "The Case Against Fluoride," Dr. Paul Connett, gave the following presentation in Wichita, Kansas. In it, he addresses the dangers of adding fluoride to communal water supplies, and the health risks associated with drinking fluoridated water. To learn more from the foremost expert in this field, I recommend listening to Dr. Connett’s presentation.
Why is the American Dental Association Ignoring the Science?
According to a 2006 report on water fluoridation produced by the US National Research Council, the benefits from fluoride are topical only, and cannot be achieved through ingestion. It also detailed positive associations between fluoride ingestion and bone fractures, cancer, reduced IQ and dementia.
Meanwhile, the American Dental Association (ADA), which is mired in conflicts of interest with the amalgam industry, has had “amalgam safety” and “universal water fluoridation” as their top two highest goals for their National Oral Health Agenda2 as of 2009. Furthermore, the ADA, one of the most influential trade lobbies in the US3, 4 believes that:5
“All communal water supplies containing less than the optimal level of fluoride should be adjusted to an optimum level. Toward this end, the ADA is urging Congress and state legislators to make capacity-building funds readily available to help communities establish, upgrade and maintain an effective public water fluoridation infrastructure.”
The ADA spent $2.56 million on their lobbying efforts last year, and more than half of its lobbyists (11 out of 20) have previously held government jobs,6 again demonstrating the revolving doors between government and industry. This is a key feature found among most highly effective lobbying groups.
The ADA is also one of the most secretive when it comes to its funding. It was one of just a handful of groups that declined to provide information to The Chronicle about their responses to Senator Charles E. Grassley, who in 2009 asked 33 nonprofit health and medical groups to report how much money they received from pharmaceutical, medical-device, and insurance companies, and how they disclose such information to the public.7, 8
The association has also spent much of its time defending the dental profession against lawsuits that charge the mercury used in fillings causes health problems.
The ADA has close ties with the world’s leading supplier of dental mercury (amalgam) fillings, Henry Schein, and has steadfastly refused to admit that placing neurotoxic mercury in your mouth might not be a good idea. In recent years, many dentists have reconsidered this archaic practice and about half of all American dentists are now mercury-free, but the ADA’s dismissal of the evidence has led to low-income children being disproportionately harmed. Amalgam is still the primary filling material used in many underprivileged children due to it being the least expensive alternative. Henry Schein also makes sure uninsured children receive their toxic wares via “charity” programs like the annual Give Kids a Smile program9 to which it donates dental supplies.
Is There a Better Way to Address Tooth Decay?
In a recent opinion piece by Lauen Ayers — a local chapter leader of the Weston A. Price Foundation — commenting on the proposed fluoridation plan for Sonoma County, CA, she writes:10
“Instead of slapping fluorosilicic acid on the problem like a band-aid, we should get to the source of the problem – the tidal wave of sugar that inundates children every day, as UCSF pediatric endocrinologist Robert Lustig, MD, explains in 'The Bitter Truth.'
In the USDA breakfast and lunch program, 50 to 65 percent of the calories are from carbohydrates. Sugar is added to everything from applesauce to taco sauce because sugar hits the opiate receptors in the brain, making children addicts. Posters of veggies can’t make kids 'Just Say No' to the sugar-added foods. It’s up to adults to get rid of sugary non-foods.
...Sugar companies also donate to the ADA and similar groups. In 1949 the Sugar Research Foundation proclaimed their mission: 'to find out how tooth decay may be controlled effectively without restriction of sugar intake.' Coincidentally, a year later the U.S. Public Health Service endorsed fluoridation. ... Even fluoride at 0.2 mg/L can harm salmon; if fluoridation passes, our water would have 0.7 mg/L, three times as much!”
Clearly, this absurd practice of adding Hexafluorosilicic acid to drinking water to prevent tooth decay is based more on politics than science. Why should a water department be given the power to medicate anyone when they don't take a health history, they don't pass out a listing of side effects, monitor the dose or the effect? This is tantamount to gross negligence. In early 2011, the EPA announced11 that 41 percent of American teenagers have dental fluorosis and recommended cutting the parts per million down to 0.7 ppm. At the time, EPA Assistant Administrator for the Office of Water, Peter Silva, stated:
“EPA’s new analysis will help us make sure that people benefit from tooth decay prevention while at the same time avoiding the unwanted health effects from too much fluoride.”
The only safe level when considering the addition of fluoride to drinking/bathing water is ZERO. I predict that water fluoridation will become known as one of the biggest frauds ever perpetrated against the public in the 20th and 21st century. That oft-quoted phrase that water fluoridation is one of the greatest public health achievements of the 20th Century was created by a Public Relations firm, not hard-core facts. It's time to stop quoting that drivel.
In his 2012 article Poison is Treatment—Edward Bernays and the Campaign to Fluoridate America12, James F. Tracy reveals the PR campaign that created this fake public health measure:
“The wide-scale U.S. acceptance of fluoride-related compounds in drinking water and a wide variety of consumer products over the past half century is a textbook case of social engineering orchestrated by Sigmund Freud’s nephew and the “father of public relations” Edward L. Bernays,” he writes. “The episode is instructive, for it suggests the tremendous capacity of powerful interests to reshape the social environment, thereby prompting individuals to unwarily think and act in ways that are often harmful to themselves and their loved ones.”
I highly recommend taking the time to read Tracy’s informative expose on how good PR can trump science and keep you in the dark for decades, lest you dig a bit deeper. In the future, water fluoridation will be compared to tobacco science, DDT science, asbestos science, and thalidomide science — all grossly manipulated to hide an incredibly costly truth.
Water fluoridation was invented by brilliant schemers who needed to get rid of toxic industrial waste that would cost them hundreds of millions of dollars for proper disposal. They duped politicians with fraudulent science and endorsements, which is not science, and sold them on a “public health” idea in which humans are utilized to filter this poison through their bodies, while 99 percent simply goes down the drain. Adding insult to injury, they now MAKE hundreds of millions of dollars selling this hazardous industrial waste, rather than having to pay for its disposal. Hexafluorosilicic acid manufacturers, suppliers, and distributors are laughing all the way to the bank, seeing how they've finagled municipalities across America to pay them for poison.
Children Tend to Suffer the Greatest Health Effects
Water fluoridation came about as the result of a massively successful PR campaign, originally aimed to protect aluminum and steel producers from lawsuits against the fluorine pollution coming from their plants. Fluoride is in fact a toxic substance that accumulates in the human body over time, where it has been shown to wreak havoc with enzymes and produce a number of serious adverse health effects, including neurological and endocrine dysfunction. No less than 25 human studies have also linked fluoride with lowered IQ in children, including recent research from Harvard. Approximately 50 percent of the fluoride that you ingest each day ends up accumulating in your bones over a lifetime.
Making matters worse, water fluoridation disproportionately harms young children, as they tend to suffer the greatest health effects. One important point to remember, which few pediatricians, dentists or other health professionals stress, is that you should NOT use fluoridated water when mixing infant formula.
According to Dr. David Kennedy, who produced and directed the documentary film Fluoridegate — An American Tragedy:
"One of California’s highest paid and most prolific Fluoridation advocate admits that giving an infant a formula made with fluoridated tap water will overdose the baby and cause the teeth to come in spotted and fluorotic. One can only wonder why such insanity persists in our country when it has been banned in so many other more advanced democracies."
Call to Action as Portland Readies to Vote on Water Fluoridation
Portland, Oregon, gets its water from the Bull Run watershed, a 102-square mile protected watershed that is so pristine and pure the city was even granted a waiver from having to build a water treatment plant. In May, Portland residents will vote for or against adding risky fluoridation chemicals to their unusually pristine water supply. Not only will adding fluoride add to environmental chemical pollution and increase residents’ risks of dental fluorosis and other health concerns, it will also raise monthly water bills since adding these industrial waste chemicals costs millions of dollars.
Portland rejected water fluoridation in 1956, 1962, and 1980. But after more than a year of secretive planning, fluoride lobbyists convinced the Portland city council to add this toxic waste for their public's consumption. Luckily, the citizens of Portland stood together by gathering enough signatures to force the decision to a vote on May 21, 2013.
Hopefully, with your help in spreading the message, Portland will once again stop this measure. If you live in Portland and want to sign up as a volunteer or pledge to vote No on water fluoridation on the City of Portland ballot, please do so on the Clean Water Portland Pledge Page.
Remember, these lobbyists are well funded, and we're going to see a campaign similar to Prop 37 in California. The citizens need your help to keep Portland free of this contaminant. So, regardless of where you live, please help by donating to their campaign to ensure Portland's pure water source remains that way.
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27
Zithromax and Januvia: Two Commonly-Prescribed Drugs Now Shown to Be Killing Patients
Filed Under Main Content, Other News | Leave a Comment
By Dr. Mercola
Recent news again highlights why you’d be well advised to heed early warnings about potentially dangerous drugs.
The first featured article reports that the US Food and Drug Administration (FDA) is now investigating a potential link between a commonly used class of diabetes drugs and pancreatic inflammation and pre-cancerous changes to the pancreas.1
The FDA is also adding a heart-risk warning to the antibiotic Zithromax (azithromycin), better known as the Z-Pak.2
I’ve discussed the dangers of Zithromax before, most recently in December last year, and warned of potential dangers of Januvia all the way back in 2006 — the same drug now being investigated by the FDA for a potential link to pancreatic cancer. I also published a strong warning against this class of drugs last year.
In each case, I presented the evidence against the drugs long before any warnings were issued by the FDA, or action was taken to remove the dangerous drugs from the market.
In the case of Vioxx, my warnings preceded the drug’s eventual removal by five years, but it was too late as the drug had already killed over 60,000 people.
I have no doubt that these newer diabetes drugs will kill tens of thousands of people from cancer before action is taken. There is a good chance the death toll will even exceed that from Vioxx. Hopefully, you or someone you love will not be one of the victims, as you will have this potentially life-saving information.
“Want of foresight, unwillingness to act when action would be simple and effective, lack of clear thinking, confusion of counsel until the emergency comes, until self-preservation strikes its jarring gong - these are the features which constitute the endless repetition of history.” ~ Winston Churchill
FDA Investigates Potential Cancer Link to Popular Diabetes Drugs
According to an FDA notice,3 posted on March 14, the agency is:
“Evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.”
This class of diabetes drugs, known as incretin mimetics, includes:
Exenatide (Byetta, Bydureon) Liraglutide (Victoza) Sitagliptin (Januvia, Janumet, Janumet XR, Juvisync) Saxagliptin (Onglyza, Kombiglyze XR) Alogliptin (Nesina, Kazano, Oseni) Linagliptin (Tradjenta, Jentadueto)
Incretin mimetics (also known as glucagon-like peptide-1 receptor agonist, or GLP-1 agonist, and dipeptidyl peptidase-4 inhibitors, or simply DPP-4 inhibitors), work by mimicking incretin hormones, reducing glucagon levels, and inhibiting the enzyme called DPP-4.
Incretins are a group of gut hormones your body produces naturally to stimulate the release of insulin in response to a meal. So, as your blood sugar rises, the drug prompts your pancreas to release insulin. It also prevents your pancreas from putting out too much glucagon, another hormone, which causes your liver to release stored sugar into your bloodstream.
Another mechanism by which it helps control your blood sugar level is by inhibiting DPP-4 — a protease (an enzyme that chops up protein chains) that, among other things, destroys the hormone GLP-1, which may explain why these drugs appear to be linked to increased cancer risk. (I’ll discuss this more below.)The medication also slows the rate at which your stomach empties after you’ve eaten a meal, which may reduce feelings of hunger. This dampens the rate at which your blood sugar rises after eating.
The first drug in this class — Sitagliptin, manufactured by Merck and sold under the name Januvia4, 5 — received FDA approval in 2006.6 It is one of the most commonly prescribed drugs for diabetes, which is why it will have such a devastating effect if it not stopped soon. Saxagliptin (Onglyza), another DPP-4 inhibitor, was approved in July 2009, followed by Linagliptin (Trajenta) in 2011. A number of additional DPP-4 inhibitors are currently under development, including a potentially disastrous once-a-week version.
Other Cancer Links Found, Which are Not Addressed by the FDA
The fact that this class of drugs could have a damaging effect on your pancreas was already known. In fact, one of the known side effects listed on the "Warnings and Precautions" section of the drug label is acute pancreatitis. According to a study7 published on February 25 in the journal JAMA, exenatide or sitagliptin doubled the risk of developing acute pancreatitis.
What’s “new” (at least to the FDA) is that these drugs may also cause pancreatic duct metaplasia (pre-cancerous cellular changes). However, previous research has not only indicated a pancreatic cancer risk with these drugs, they’ve also indicated a connection of thyroid, colon, melanoma, and prostate cancer! Dr. Ron Rosedale first made me aware of this connection. He is a pioneer in the natural cure of diabetes and knew this years ago because he reviewed studies like the following:
- A 2006 study8 found that “the use of DPP-4 inhibitors together with GLP-2 led to increased proliferation as well as elevated migratory activity. Therefore, the use of DPP-4 inhibitors could increase the risk of promoting an already existing intestinal tumor and may support the potential of colon cancer cells to metastasize”
- One 2008 study9 found that DPP-4 inhibitors may proteolytically inactivate local mediators involved in gliomagenesis (the formation and development of brain tumors). Another study published that same year10 linked the drug to prostate cancer
- In 2010,11 researchers concluded that “although the data on the effects of DPP-IV inhibitors in humans are scarce, the increased risk of infections and the tendency towards a higher incidence of some tumors fall in line with experimental evidence suggesting the possibility of their adverse immunological and oncological effects”
- According to a 2011 study in the journal Gastroentorology:12, 13 “data are consistent with case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1 based therapy. The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer, and DPP-4 inhibition to increase risk for all cancers”
- Earlier this year, researchers warned14 DPP-4 “is implicated in regulation of malignant transformation, promotion and further progression of cancer, exerting tumor-suppressing or even completely opposite - tumor-promoting activities”
This study indicates the need for exploring the cause and the importance of the disturbances in the serum DPP-4 activity and in the CD26 expression on immunocompetent cells in complex molecular mechanisms underlying the development and progression of melanoma. Significant decline in serum DPP-4 activity found in melanoma patients compared to healthy controls might indicate its possible role in development and progression of melanoma, but further research needs to be done in order to fully elucidate the cause and the importance of observed changes in DPP-4 activity.
The reason why incretin mimetic drugs appear to be associated with increased risk for a number of different cancers might be due to the following, which you’re unlikely to hear from your doctor: DPP-4 is a tumor suppressor,15 so by inhibiting DPP-4 — which these drugs do — you are continuously inhibiting one of your body’s natural cancer suppressing mechanisms. According to Januvia’s drug information, the drug inhibits the DPP-4 enzyme for 24 hours, and you take it daily. So you are effectively permanently blocking the activity of a tumor suppressor gene.
Yet none of the safety studies on Januvia addressed its impact on tumor growth! What I find interesting is that the FDA’s investigation was launched after pancreatic tissue samples were taken from patients who died from “unspecified causes,” opposed to some identified pancreatic issue. So I guess there’s still room for additional issues associated with these drugs...
Beware — Novel Combo Drug Will Likely Increase Both Cancer AND Heart Failure
Remarkably, Merck has indicated that the once-a-week version of the DPP-4 inhibitor being developed is also being tested in combination with certain statin drugs, such as Lipitor and Simvastatin. The reasoning for these drug combinations is that diabetics fall under the guidelines of being statin candidates because they have a higher cardiovascular risk, but 40 percent of diabetics don't take them. The idea is to create a combination drug containing both a DPP-4 inhibitor and a statin.
So they’re combining two hazardous drugs into one pill that synergistically will radically increase your risk of cancer AND heart failure! These are very common side effects from these drugs when taken individually, but what has not even been studied is the synergistic toxicity of taking these dangerous drugs together.
It’s sheer madness in a pill... What makes it all the more frustrating is that pharmaceutical companies are raking in the profits from these dangerous drugs when type 2 diabetes is one of the easiest diseases to address without ANY drugs. Merck, for example, made an astounding $6 BILLION in combined sales for Januvia and Janumet last year alone, making these drugs the company’s top sellers.
FDA Adds Heart-Risk Warning to Z-Pak
Earlier this month, the FDA also announced it is adding a new warning to the label of Zithromax, a very potent antibiotic used to treat bronchitis, pneumonia and other serious infections, including sexually transmitted diseases. Or at least it should be reserved for serious infections. It’s widely overused, which is troubling for several reasons. First of all, the new warning states that the drug can cause deadly heart arrhythmias. The FDA warns that:
“Doctors should consider prescribing other antibiotics to patients at risk of heart problems, including those with irregular heartbeats or low levels of potassium or magnesium in their blood.”
The popularity of Zithromax is driven by the fact that you don’t have to take it for as many days as other, less potent antibiotics — a regular course is only five days, compared to 10 days for most others. But therein lies another problem. Overuse of potent antibiotics drives the rapid rise in antibiotic-resistant bacteria, and renders the drug useless for more serious infections. According to the FDA, an astounding average of 50 million prescriptions for Zithromax are filled each year.
This is a Flash-based video and may not be viewable on mobile devices.
Risks Associated with Z-Pak You Need to Know
“...[T]he FDA warned it could be dangerous for some people and urged everyone to understand the risks... The new drug label follows a Vanderbilt University study released in May showing a slightly higher chance for deadly heart problems in patients taking the drug. Researchers analyzed health records and data from millions of prescriptions for several antibiotics given to about 540,000 Tennessee Medicaid patients from 1992 to 2006. The highest risks were in Zithromax patients with existing heart problems,” according to MSN News:16
“The results suggested there would be 47 extra heart-related deaths per 1 million courses of treatment with Zithromax, compared with another antibiotic, amoxicillin.”
The study in question, published in the New England Journal of Medicine17 found that azithromycin increases your chances of dying from a cardiovascular event by 250 percent within the first five days of usage, compared to those who took amoxicillin. This is nearly the same as that for Vioxx, which killed 60,000 people and was voluntarily removed from the market nearly eight years ago. When researchers looked at people who already had heart problems, their risk of dying while on this drug were even higher. The risk of cardiovascular death was also significantly greater with azithromycin than with ciprofloxacin, while levofloxacin and azithromycin had comparable risks of cardiovascular death. Other known side effects of the Z-Pak include skin rashes, itching, severe, watery diarrhea, and severe allergic or anaphylactic reactions. If you take a statin drug, you may also experience more severe side effects, such as myopathy―muscle and tendon pain, weakness and cramping.18
The primary problem here though appears to be related to using the drug acutely. So if you took the drugs months or years ago there is nothing to worry about as the increased risk of causing this heart rhythm abnormality has eventually disappeared. However the disruption to your ever important gut flora could last many years or even decades unless you take aggressive efforts to reverse the damage.
While not stated anywhere on the drug label, all antibiotics, and especially the more potent ones like the Z-Pak, decimate your gut flora, which in turn leaves you with a sorely weakened immune system until the beneficial bacteria in your gut has time to repopulate. Ideally it would be wise to eliminate sugars and regularly use fermented foods or a high-quality probiotic supplement to restore your normal gut flora.
Remember, antibiotics should only be taken when absolutely necessary, almost a life and death scenario. If, for whatever reason, you do choose to use them it is crucial to rebalance your intestinal flora to prevent long-term effects to your health. Typically this results in an overgrowth of yeast, fungi and pathogenic organisms, which can persist for years or decades unless you carefully address the damage. Taking probiotics while on an antibiotic can also help reduce diarrhea, which is a common side effect. Saccharomyces boulardii is beneficial yeast that is not killed by antibiotics so it can actually be taken while you are on the antibiotics.
Do You REALLY Need a Drug?
In more recent years, a growing body of research shows that simple lifestyle changes such as diet and exercise are effective remedies for many common health problems. At the same time, we're seeing more and more evidence of the lethal harm being brought by poorly tested drugs.
To me, the choice is clear. But a lot of people still do not realize just how effective lifestyle changes can be in treating their disease. Many diabetics, for example, are convinced they need drugs, and resist the idea that treating or even curing their disease is entirely within their own control. The truth is, type 2 diabetes is virtually 100 percent avoidable and treatable entirely without drugs. If you're still in the dark about how to accomplish this, please see this link.
Similarly, many are quick to ask for an antibiotic, even in cases where antibiotics are useless, such as for viral infections. The temptation is to opt for a potent antibiotic to resolve the infection as quickly as possible, but this can have very serious ramifications, from decreasing your immune function for an extended period of time, to contributing to the rise of antibiotic-resistance. The Z-Pak is a great antibiotic, but if used inappropriately, it may no longer work when you really need it.
If you absolutely need to use an antibiotic, use the least potent one that is appropriate for the infection, and make sure to reseed your gut with beneficial bacteria.
Your best bet is to eat plenty of fermented foods, such as fermented vegetables, each day. Each mouthful of fermented food can provide trillions of beneficial bacteria — far more than you can get from a probiotics supplement, which will typically provide you with colony-forming units in the billions.
Last year, my team started testing fermented vegetables produced with our probiotic starter culture to determine their probiotic potency and we were astounded to discover they had 10 trillion colony-forming units of bacteria. Literally, one serving of vegetables was equal to an entire bottle of a high potency probiotics. Another really novel additional benefit is that it also produces very high levels of vitamin K2, nearly 500 mcg. We are currently in the midst of doing very sophisticated and expensive DNA sequencing analysis to optimize this starter culture formula and hope to be able to launch it later this year.
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