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2013 Statin Guidelines
People with LDL cholesterol levels of ≥130 mg/dL should not take statin drugs if that is their only risk factor for cardiovascular disease, according to new guidelines developed jointly by the American Heart Association, the American College of Cardiology, and the Obesity Society. The expert panels that produced the November 2013 guidelines could not find evidence that lowering LDL levels to a targeted level reduces heart attack or stroke risk, according to a New York Times article by Gina Kolata. Instead of focusing on LDL cholesterol, the new algorithm uses gender, age, race, HDL and total cholesterol levels, diabetes, hypertension, systolic blood pressure, and smoking as the variables to determine cardiovascular risk (See ASCVD Risk Estimator in references, below). In addition, the guidelines have lowered the bar for when to begin statin treatment – a decision that has drawn heavy criticism from practitioners.
Instead of a 10% to 20% risk of a cardiovascular event within 10 years, the new algorithm says, anyone with just a 7.5% to 9.9% risk within 10 years needs statin therapy. "'According to the new risk calculator all African American men aged 65 and up with normal blood pressure and normal cholesterol levels should be on statins," cardiologist Barbara Roberts told the British Medical Journal (BMJ). "That's an outrage and is unsupported by clinical evidence.'"
The risks of statin therapy may outweigh benefits for many patients – a factor that the guidelines panel did not consider, according to David Newman, a physician researcher at Mount Sinai in New York City. Newman told the BMJ: "'For patients without diabetes or a prior heart attack or stroke who are treated with statins for five years, 98% will see no benefit: 1.6% will be spared a heart attack and 0.4% a stroke – and importantly, there will be no difference in overall mortality. At the same time, 2% of individuals treated with statins will develop diabetes and 10% will have muscle damage.'"
Roberts and Newman are not the only critics. John D. Abramson, a Harvard Medical School lecturer, and Rita F. Redberg, cardiologist and editor of JAMA Internal Medicine, wrote a blistering editorial criticizing the new recommendations for "expanding the definition of who should take the drugs – a decision that will benefit the pharmaceutical industry more than anyone else." They point out that the American College of Cardiology and the American Heart Association both receive major funding from drug companies. "Statins are effective for people with known heart disease," they write. "But for people who have less than a 20 percent risk of getting heart disease in the next 10 years, statins not only fail to reduce the risk of death, but also fail even to reduce the risk of serious illness. …"
Moreover, Abramson and Redberg worry that patients will be content to take medication instead of making lifestyle changes that provide true prevention of cardiovascular disease. Smoking, lack of exercise, poor diet, stress, and other lifestyle factors cause 80% of cardiovascular disease. "Statins give the illusion of protection to many people, who would be much better served, for example, by simply walking an extra 10 minutes per day," say the authors.
Eight of the 15 panel members who drew up the guidelines – including the chairman and one of two cochairs – had ties to the pharmaceutical industry, according to a BMJ article by Jeanne Lenzer. Neil J. Stone, the panel's chairman, had financial ties to Abbott, AstraZeneca, Merck, Pfizer, Sanofi-Aventis, and Schering-Plough when asked to lead the panel; all six companies make cholesterol-lowering drugs. He told BMJ, "I immediately severed ties with all industry connections prior to assuming my role as chair." Jerome Hoffman, professor emeritus of medicine at the University of California, Los Angeles, told Lenzer "'… unless the decision to sever financial ties represents a fundamental change of heart – and is accompanied by an absolute pledge not to take money from industry in the future – this type of revolving door relationship between 'public service' and [industry] is about as clear a model of conflict of interest as I can imagine.'" Stone told BMJ that he would not accept industry funding for two years after the guidelines were released.
Abramson JD, Redberg RF. Don't give more patients statins. New York Times. November 13, 2013. Available at www.nytimes.com/2013/11/14/opinion/dont-give-more-patients-statins.html. Accessed February 14, 2014.
ASCVD Risk Estimator. [Web page] http://tools.cardiosource.org/ASCVD-Risk-Estimator. Accessed February 19, 2014.
Kolata G. Experts reshape treatment guide for cholesterol. New York Times. November 12, 2013. Available at www.nytimes.com/2013/11/13/health/new-guidelines-redefine-use-of -statins.html. Accessed February 14, 2014.
Lenzer J. Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers. BMJ. November 21, 2013; 347:f6989. Available at www.davidrasnick.com/Home_files/Lenzer%202013.pdf. Accessed February 14, 2014.
Homeopathy and Asthma
Individualized homeopathic treatment reduced children's asthma severity and need for conventional medications in a small 2012 observational study led by H. F. Shafei. Thirty children with diagnosed asthma, aged 7 to 15, took part in the study. Asthma severity and bronchodilator and/or corticosteroid inhaler use were stable in the year before the children were referred to pediatricians at Egypt's Homeopathic Clinic of the National Research Center (Cairo), according to Christopher Johnson, ND.
In addition to standard medications, children received homeopathic medicine that best matched their individual physical symptoms and mental-emotional expression. They were given a single dose of a polychrest in 200c potency and a "respiratory remedy" for daily use. Because polychrests affect numerous physical, emotional, and mental aspects, they are often used to support a person's overall constitution. In this study, Calcarea carbonicum and Natrum muriaticum were the two most frequently prescribed polychrests. Both are associated with coughing and shortness of breath, but the personality profiles differ. Calcarea carbonicum is appropriate for children who tend to be obstinate and worry about their health and safety. Natrum muriaticum is the remedy for children who are hypersensitive to reprimands and want to be left alone when they don't feel well. In contrast to the constitutional remedy, the respiratory remedy was in a lower potency (up to 30c) and taken daily to address coughing episodes. These remedies were chosen based on symptoms such as coughing triggers, associated pain, sound of the cough, type of mucus (if any), and time that coughing most often occurred.
After 6 months, the researchers assessed the effect of adjunctive homeopathic therapy by comparing asthma medication use and symptom frequency with baseline measures. At baseline, 33% of the children (n = 10) used inhalers more than once a day; 20% (n = 6) used them once a day; 40% (n = 12) used them 2 to 6 times a week; and 7% (n = 2) used them less than twice a week. "After 6 months of treatment," writes Johnson, "not a single child was using their inhaler throughout the day and only 6% used inhalers even once a day." Oral corticosteroid use also fell. Ninety percent of the children (n = 27) needed more than two courses of oral corticosteroid therapy a year before homeopathic treatment, compared with just 10% (n = 3) after treatment.
Symptoms also declined. At baseline, 30% of the children experienced asthma symptoms every day with an addition 23% experiencing symptoms "'throughout the day.'" By study's end, only 7% had daily symptoms. None had symptoms that bothered them all day long. The only adverse event was "'the appearance of transient skin papules which disappeared in 24 hours… after improvement of asthma symptoms.' Most homeopaths would view this as an "aggravation" of symptoms and a positive sign of healing," says Johnson.
The next step, according to the Egyptian authors, is placebo-controlled study. (I hope these controlled studies, like this one, involve experienced homeopathic doctors.) Although they can save lives, conventional asthma medications have adverse affects, such as adrenal insufficiency, decreased growth, weight gain, delayed puberty, and hyperactivity. Competent homeopathic treatment could lessen the need for the drugs and, thereby, reduce children's exposure to these risks.
Johnson C. Asthma on the rise. … Homeopathy Today. Spring 2013;36–37.
Shafei HF, AbdelDayen SM, Mohamed NH. Individualized homeopathy in a group of Egyptian asthmatic children [abstract]. Homeopathy. October 2012; 101(4);224–230. Available at www.ncbi.nlm.nih.gov/pubmed/23089218. Accessed March 3, 2014.
Clogged Plumbing and Heart Stent Overuse
"Although the image of coronary arteries as kitchen pipes clogged with fat is simple, familiar, and evocative, it is also wrong," says Michael B. Rothberg, MD, MPH, in a 2013 commentary. That image, however, has led to the overuse of heart stents, small metal mesh tubes that are inserted in an artery, during angioplasty. Using a heart stent to hold open and strengthen a blocked coronary artery can be lifesaving during a heart attack; but the procedure does not prevent heart attacks in people with stable cardiovascular disease – a fact that most patients and some doctors do not realize.
As Rothberg points out, cardiovascular disease is not a plumbing problem that can be solved with a surgical Roto-Rooter. Angioplasty and heart stents address distinct constrictions or blockages in an artery. These procedures, however, do not address inflammatory damage that is occurring in other parts of the artery, damage that weakens vessels and can lead to rupture. In most cases, cardiac events occur at weakened areas that show little evidence of blockage. "Before rupture," says Rothberg, "these plaques often do not limit flow and may be invisible to angiography and stress tests. They are therefore not amenable to percutaneous coronary intervention [angioplasty]."
Still, 9 out of 10 patients undergoing elective angioplasty believe that the procedure will prevent future cardiac events, according to a small study conducted by Rothberg and colleagues. This erroneous belief is largely cultivated by the "old plumbing analogy" still used in advertisements and educational materials. Rothberg suggests a different analogy to help patients understand cardiovascular disease. He says that cholesterol deposited in arterial walls produces "an inflammatory reaction, like a pimple." "When those pimples pop, they cause the blood in the arteries to clot at the site," he explains. "If the clot closes off the entire artery, that causes a heart attack, and emergent medical attention is required to remove the clot." Sometimes, old plaques, "like scarred old pimples," partially block blood flow, producing pain. If medication does not relieve the pain, angioplasty is the next option for symptom relief.
Reducing inflammation through evidence-based lifestyle changes (smoking cessation, exercise, stress reduction, and a Mediterranean diet) and anti-inflammatory medications are the "only effective measures" for preventing heart attacks, says Rothberg. Nonetheless, he expects the plumbing analogy and angioplasty overuse to continue, "… partly because it is difficult to admit that in the past we got it wrong and performed what now appear to have been unnecessary procedures, but also because our current payment system continues to reward interventions based on the old model and cardiac procedures are an important source of hospital revenue." The average cost of angioplasty is about $30,000, according to New York Times reporter Anahad O'Connor.
Rothberg MB. Coronary artery disease as clogged pipes: a misconceptual model. Circulation. 2013:6:129-132. Available at http://circoutcomes.ahajournals.org/content/6/1/129. Accessed February 14, 2014.
O'Connor A. Heart stents still overused, experts say. New York Times. August 15, 2013. Available at http://well.blogs.nytimes.com/2013/08/15/heart-stents-continue-to-be-overused. Accessed February 6, 2014.
Soil, Microbes, and Allergies
Tiny organisms living in the earth's soil are the linchpin for health in all life forms. For humans, the benefits extend far beyond the hygiene hypothesis, or "farm effect," which posits that exposure to diverse organisms makes our immune systems less likely to overreact and produce allergic responses. Scientists are just beginning to identify microorganisms (bacteria, viruses, fungi) and parasites in the natural environment that interact with larger life forms (including humans) to their mutual benefit. This ecological viewpoint is reflected in the biodiversity hypothesis, an extension of the hygiene hypothesis.
The biodiversity hypothesis says that the less contact people have with a microbially diverse natural environment, the less diverse their own commensal microbiota. Commensal organisms produce molecules that activate health-supporting biochemical responses in their hosts, including immune modulation. Many people in over-developed nations live in microbially poor environments. Urbanization and disruption of soil habitat with chemicals and plowing reduce microbial diversity. Allergies and other inflammatory illnesses are most common in industrialized countries.
Ilkka Hanski and his colleagues at the University of Helsinki (Finland) published a 2012 study that supports the biodiversity hypothesis. The researchers took a random sample of adolescents living within a 100 by 150 km area (62 by 93 miles) and looked at allergy incidence, microbial diversity in the yards around their homes, and microbes living on their skin. They made three discoveries. First, the bacterial classes on the teens' skin reflected the diversity in their yards. Second, healthy teens had greater diversity surrounding their homes and significantly higher generic diversity of gammaproteobacteria on their skin compared with teens who had allergies. Third, gammaproteobacteria, specifically Acinetobacter, "positively correlated" with the expression of interleukin-10 in the teens' blood mononuclear cells. IL-10 is "a key anti-inflammatory cytokine in immunologic tolerance," according to the authors.
Acinetobacter and other organisms may produce the same anti-inflammatory effect when they are inhaled, according to Graham Rook, professor emeritus of medical microbiology at University College London. "'We do not know the relative importance of contact via the skin and via the airways,'" he told Sharon Levy, writing for Environmental Health Perspective, "'but physiologically the airways seem more likely.'"
The Finnish team noticed a direct correlation between the diversity and abundance of bacteria on teens' skin and the presence of native plants in their yards. Native plants have coevolved with indigenous microbes, insects, and other life forms, forming an interdependent community – much like the organisms living in and on our bodies. "[It] is the cooperation between bacteria, fungi, and plants' roots (collectively referred to as the rhizosphere) that is responsible for transferring carbon and nutrients from the soil [and air] to the plant – and eventually to our plates," says Daphne Miller, MD, author of Farmacology: What Innovative Family Farming Can Teach Us About Health and Healing. The key to inflammatory disease may lie in the health of our soil.
Hanski I, von Hertzen L, Fyhrquist N, et al. Environmental biodiversity, human microbiota, and allergy are interrelated [abstract]. PNAS. May 22, 2012;109(21). Available at www.pnas.org/content/109/21/8334. Accessed February 14, 2014.
Levy S. Reduced bacterial biodiversity is associated with increased allergy. Environ Health Perspect. August 2012;120(8):A304. Available at www.ncbi.nlm.nih.gov/pmc/articles/PMC3440091.
Miller D. The surprising healing qualities … of dirt. Yes! Winter 2014. Available at www.yesmagazine.org/issues/how-to-eat-like-our-lives-depend-on-it/how-dirt-heals-us. Accessed February 6, 2014.
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