Friday, January 30, 2009
The paper also helps explain why certain individuals have an increased risk for such adverse effects. "Muscle problems are the best known of statin drugs' adverse side effects," said Golomb. "But cognitive problems and peripheral neuropathy, or pain or numbness in the extremities like fingers and toes, are also widely reported." A spectrum of other problems, ranging from blood glucose elevations to tendon problems, can also occur as side effects from statins. The paper cites clear evidence that higher statin doses or more powerful statins – those with a stronger ability to lower cholesterol – as well as certain genetic conditions, are linked to greater risk of developing side effects.
"Physician awareness of such side effects is reportedly low," Golomb said. "Being vigilant for adverse effects in their patients is necessary in order for doctors to provide informed treatment decisions and improved patient care." The paper also summarizes powerful evidence that statin-induced injury to the function of the body's energy-producing cells, called mitochondria, underlies many of the adverse effects that occur to patients taking statin drugs.
Mitochondria produce most of the oxygen free radicals in the body, harmful compounds that "antioxidants" seek to protect against. When mitochondrial function is impaired, the body produces less energy and more "free radicals" are produced. Coenzyme Q10 ("Q10") is a compound central to the process of making energy within mitochondria and quenching free radicals. However, statins lower Q10 levels because they work by blocking the pathway involved in cholesterol production – the same pathway by which Q10 is produced. Statins also reduce the blood cholesterol that transports Q10 and other fat-soluble antioxidants. "The loss of Q10 leads to loss of cell energy and increased free radicals which, in turn, can further damage mitochondrial DNA," said Golomb, who explained that loss of Q10 may lead to a greater likelihood of symptoms arising from statins in patients with existing mitochondrial damage – since these people especially rely on ample Q10 to help bypass this damage. Because statins may cause more mitochondrial problems over time – and as these energy powerhouses tend to weaken with age—new adverse effects can also develop the longer a patient takes statin drugs. "The risk of adverse effects goes up as age goes up, and this helps explain why," said Golomb. "This also helps explain why statins' benefits have not been found to exceed their risks in those over 70 or 75 years old, even those with heart disease."
High blood pressure and diabetes are linked to higher rates of mitochondrial problems, so these conditions are also clearly linked to a higher risk of statin complications, according to Golomb and co-author Marcella A. Evans, of UC San Diego and UC Irvine Schools of Medicine. The connection between statins' antioxidant properties and mitochondrial risk helps explain a complicated finding that statins can protect against the very same problems, in some people, to which they may predispose others – problems such as muscle and kidney function or heart arrhythmia.
This paper was funded in part by a Robert Wood Johnson Generalist Physician Faculty Scholar award to Dr Golomb.
Bonnie - what more does the cardiology community need to see on this issue? The least they can do is force the drug makers to put CoQ10 back into the drug as a combination. For those who have know us for a while, we slammed the statin drug manufacturers, who wanted to put CoQ10 in the original formula, but decided against it because it was "too expensive." How do we like that decision now?
Doctors studied the chemicals, perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA), in 1,240 women from the Danish National Birth Cohort, which includes nearly 100,000 women and their children. The chemicals also have been found in non-stick cookware, pesticides, clothing and personal care products, as well as industrial surfactants and emulsifiers, according to the study released in Human Reproduction.
Two studies published in 2007 showed that babies exposed to the chemicals in the womb were more likely to be born smaller than other infants. Earlier tests on animals have linked the two chemicals to cancer and developmental problems. Studies show that the chemicals can remain in the environment
The new study is the first to link perfluorinated chemicals to infertility, authors says.
Authors say it's possible that the chemicals interfere with the hormones involved in reproduction. In the study, women with higher chemical exposure had more irregular periods.
Manufacturers say they're already using safer alternatives to these chemicals. 3M has stopped making PFOA and PFOS. DuPont's manufacturing processes now remove more than 97% of PFOA.
Bonnie - isn't that nice of 3M and DuPont. We have know that this has been problematic for a while. Only when pressured by consumer groups did these companies take action. Safer alternatives? I'd like to see the safety studies on the new chemicals.
Thursday, January 29, 2009
While the Obama Administration is haggling over how best to fix these departments, we have a few suggestions as to how you can, to the best of your ability, control what goes into your mouth and onto your body. Some of these sound simple and redundant, but now more than ever, we must be vigilant about adhering to them.
- Drink filtered water
- Eat Locally Grown - less chemicals, less times exchanging hands, less processing, you get the picture
- Certified Organic - while they are not immune to food safety issues, the risk is much lower and certified organic foodstuffs contain less chemicals.
- The least amount of ingredients in the product, the better. In most cases, this indicates that the foodstuff is real food.
- Reduce processed food intake - more ingredients and longer shelf life usually means ingredients that have come from numerous manufacturers all with different food safety practices.
- Purchase food well before the expiration date.
- Avoid consumption of raw fish, meat, poultry, or dairy.
- Use cooked leftovers within two days.
- Avoid consuming samples at grocery stores.
- Whether at home or eating out, make sure your food is cooked through.
- Keep eating areas at home and at wok well sanitized.
- Add spices and other natural ingredients to your food to stave off bacteria (garlic, onion, basil, ginger, curry, clove, cinnamon, oregano, and sage have been studied for their antimicrobial activity); some of these spices may not be well tolerated by all (especially with salicylate sensitivity).
- Keep raw animal food separate from other foods and in sealed bag or container to avoid cross-contamination.
- Don't leave raw meat in the refrigerator longer than 2 days; freeze if not using quickly.
- Wash fruits and vegetables with cold water filtered before eating; cut away bruised or damaged areas
- Never leave food out for over one hour unless it is properly heated/cooled.
- Do not take any medications that have not been in the marketplace for a minimum of two years
- Look at the expiration dates of your meds to see if they are still good. If expired, do not throw in the garbage. Give to proper waste disposal service so it does not go back into the environment/water supply.
- Before taking any medication, ask your doctor and pharmacist about any side effects and contraindications. Then, read the insert of the medication before taking the product. The same goes for any applicable medical device or surgical procedure.
- Take dietary supplements from a trusted source (we've got you covered on this one).
- Take probiotics daily to maintain optimal gut flora balance.
- Consistent hand washing with soap and very warm water.
- Avoid direct hand contact with eyes, ears, nose, and mouth.
- Keep the host healthy (this means you).
- Body should be balanced 60% alkaline/40% acid.
- Use safe household products and cosmetics.
Recent Food Safety Articles from NCI
The 2009 U.S. Government Accountability Office Report can be found at http://www.gao.gov/docsearch/featured/highrisk.html
Wednesday, January 28, 2009
Steve - while a drop in the bucket, this is hopefully the first of many victories for advancing nutrition with this administration!
Texan researchers have identified a pathway to explain how a compound in cruciferous vegetables like broccoli may protect against pancreatic cancer. The tissue of cruciferous vegetables, like broccoli, cauliflower, cabbage and Brussels sprouts, contain high levels of the active plant chemicals glucosinolates. These are metabolized by the body into isothiocyanates, which are known to be powerful anti-carcinogens.
The results, published online ahead of print in the Journal of the National Cancer Institute, study extends out understanding of the potential anti-cancer benefits of such vegetables.
Steve - mmm...learn to love those cruciferous veggies!
Weight loss of five pounds or more predicted worse survival.
The findings should be interpreted cautiously because the study was retrospective and because nutritional supplements and IV fluids were given at physician discretion, he added.
Nutritional support during chemoradiation has been shown to improve outcomes in other types of cancer. Those observations provided the impetus for the retrospective review.
The analysis included 132 patients treated with curative-intent radiotherapy. In 77% of the cases, patients were given oral or enteral nutritional supplements during radiation therapy, and 38% received IV fluids. Median follow-up was 14.1 months, and median survival from the end of radiation therapy was 1.5 years. Compared with nutritional support alone, IV fluids with or without nutritional support doubled the hazard ratio for mortality. Patients who received neither nutritional support nor IV fluids also had a significantly higher mortality risk compared with the patients who received only nutritional support.
Tuesday, January 27, 2009
"There has been a lot of talk in the nutrition world that omega-6 fatty acids might be bad," said William S. Harris, the nutritionist heading the committee that issued the report in the Jan. 26 online issue of Circulation. "We wanted to evaluate it, and if it is not true, we wanted to make sure the American public eats enough of them."
The debate arose because arachidonic acid, a component of omega-6 fatty acids, is a building block for some inflammation-related molecules, and there have been fears that it might increase the risk of heart disease.
Bonnie - the issue is not that omega-6's are bad when eaten in moderation. The issue is that the ratio of omega-6 consumed in the U.S. compared to omega-3 is completely out-of-whack (20:1). This disparity is a main reason why so many Americans are inflamed.
I never said to avoid omega-6 foods. You need to curtail consumption and increase omega-3 consumption to optimize your ratio (3:1).
Researchers have detected traces of mercury in samples of high-fructose corn syrup, a widely used sweetener that has replaced sugar in many processed foods. The study was published in the peer-reviewed journal Environmental Health.
The source of the metal appears to be caustic soda and hydrochloric acid, which manufacturers of corn syrup use to help convert corn kernels into the food additive.
A handful of plants across the nation still make the soda and acid by mixing a briny solution in electrified vats of mercury. Some of the toxic metal ends up in the final product, according to industry documents cited in the study.
Corn syrup manufacturers insisted their products are mercury-free. But the study said at least one maker of caustic soda that has used the mercury-based technology listed the corn syrup industry as a client.
The researchers cautioned that their study was limited. Only 20 samples were analyzed; mercury was detected in nine.
A former EPA scientist who reviewed the paper said more study is needed to establish the risk, if any, posed by contaminated corn syrup.
Proton pump inhibitors, which suppress the production of stomach acid, include the prescription drugs Nexium, Prevacid, Aciphex and Protonix. Prilosec is a proton pump inhibitor largely sold over the counter, and FDA urged patients on Plavix who may take any of these drugs to discuss the combination with their physician.
FDA says it was prompted by published reports that clopidogrel is less effective in reducing cholesterol levels in some patients. Proton pump inhibitors appear to reduce the breakdown of some drugs by the liver. It may also increase the concentration of diazepam (Valium), phenytoin (Dilantin) and warfarin (Coumadin).
Bonnie - this is not a surprise. We knew that PPIs reduced/blocked the absorption of many vitamins and minerals.
Monday, January 26, 2009
Jay S. Cohen MD
If you read a newspaper or watched television news on December 10, 2008, you would have thought that Crestor, a cholesterol-lowering statin medication, was a wonder drug.
Of course, a few years ago you would have thought the same thing after the heavy news coverage for another powerful statin, Lipitor. Yet, my analyses at MedicationSense (2005, 2006) revealed that the Lipitor studies demonstrated limited benefits and worrisome adverse effects.
The new Crestor study, which involved more than 17,000 subjects, examined the drug's effectiveness in reducing elevated blood levels of C-reactive protein (CRP), a marker for cardiovascular inflammation.1 It is currently believed that increased levels of inflammation are associated with a higher incidence of heart attacks and strokes (more on CRP below).
Crestor Study Results -- and What They Really Mean
The authors of the Crestor-CRP study reported that over the 1.9 years of the study, there was a 44% reduction in cardiac events (defined as heart attack, stroke, severe angina, or cardiac death) among the subjects taking Crestor versus those taking a placebo. A 44% reduction sounds very impressive, but it is misleading.
Here on the actual numbers from the study. Over 2 years, 1.36% of subjects in the placebo group experienced a cardiac event; 0.77% of subjects in the Crestor group experienced an event. The difference was 0.59%. That is, less than 1%, a tiny difference.
The difference was so tiny that it will require 120 individuals with elevated CRP to take Crestor every day for two years for just one person to obtain benefit.2 Meanwhile, the other 119 individuals taking and paying for Crestor for two years will obtain no protection from a cardiovascular event.
Why would the results of the Crestor-CRP study be proclaimed so loudly nationwide despite being so tiny? The Crestor-CRP study was underwritten by AstraZeneca, the manufacturer of Crestor. We have seen previously that the marketing departments of drug companies are masters at obtaining maximum media coverage for their studies even if the results are unimpressive. Wide exposure means increased sales and big profits.
One media outlet took a critical stance. ABCNEWS.com boldly offered a dissenting opinion. In "Doctor Urges Caution in Interpreting New Findings on Cholesterol Drug," Dr. Nortin Hadler wrote, "The benefit shown in this study is tiny, and if [the Crestor-CRP study] were repeated, there might be no benefit at all. I never leap to act on the basis of such small effects."3
Serious Side Effects Downplayed
In Crestor-CRP, the drug displayed many of the common adverse effects of other statin medications (Lipitor, Zocor, Pravachol, Mevacor, Lescol). Typical side effects include abdominal pain, muscle pain, serious muscle breakdown (rhabdomyolysis), renal disorders, and liver disorders. More subjects in the Crestor group experienced these side effects than subjects in the placebo group.
A far more serious adverse effect occurred with Crestor: 270 cases of newly diagnosed diabetes were reported among Crestor users, and 216 cases were reported among placebo users. The 54 more cases of diabetes in the Crestor group was a significant and worrisome finding. Diabetes is one of the most destructive, life-shortening disorders of our time. It also is a leading cause of heart attacks and strokes. Imagine, taking Crestor to prevent a heart attack and getting diabetes instead.
When the FDA decides whether to approve a new drug, it makes it decision based on whether the drug will produce significantly more benefit than risk. If Crestor were being evaluated today for approval by the FDA, I believe Crestor would not be approved because its use in the Crestor-CRP study was associated with many new cases of diabetes.
Should I Be Tested for Elevated CRP?
Half of all cardiac deaths occur in people with normal cholesterol levels, so other factors cleary are involved in the development of cardiovascular disease. New studies suggest that an elevated level of CRP may be as important an indicator of cardiac risk as cholesterol levels.4.5
"Forward-thinking cardiologists suspect that internal inflammation is the root cause of many diseases including those of the heart and blood vessels," states cardiologist Stephen Sinatra. "Studies have shown that people with elevated CRP run two times the risk of dying from a cardiovascular-related problem compared with those who have high cholesterol levels. Combine a cholesterol burden with a markedly elevated CRP and your risk of heart attack and stroke increases by a factor of nine."6
Despite this, experts still disagree on whether the entire population should be tested for elevated CRP. I believe that anyone who has cardiovascular disease or is at risk for it should be tested for elevated CRP. Furthermore, I also encourage anyone interested in prevention to have a CRP test.
A CRP level below 1 is low-risk; 1-3 moderate-risk; above 3 high-risk.
Should My Elevated CRP Be Treated?
If your CRP level is elevated, it should not be ignored. Yet this does not mean that your doctor should immediately prescribe you a statin. As Dr. James Ehrlich, a pioneer in cardiovascular disease screening, said, an elevated CRP "is a call for more information, not an invitation to take an automation-like approach to prescribing life-long statins."7
An elevated CRP indicates a higher than normal level of inflammation in the body. Many medical conditions can produce inflammation. Your doctor should examine you for signs of infection: teeth, sinuses, bladder, ovaries or prostate. A recent cold or bout of the flu can also elevate CRP. Inflammatory disorders such as rheumatoid arthritis may cause an elevated CRP.
If no other causes of infection are found, the elevated CRP likely reflects cardiovascular inflammation. Should it be treated? Experts differ on this, but in general I recommend treatment.
Is Crestor the Only Treatment for Elevated CRP?
No. There are many choices, pharmaceutical and natural. This section will discuss statin therapy.
We have known for a decade that the effects of all statins are similar. This means that all statins can reduce elevated CRP.
In the Crestor-CRP study, 20 mg of Crestor was used. This is a powerful dose, and because Crestor is only available as a brand-need drug, it is expensive. At a nationwide discount pharmacy, 100 pills of 20-mg Crestor costs $340. The cost over one year is approximately $1360. Over 20 years, the cost of Crestor 20 mg per day is approximately $27,000.8 An equally powerful dose, 80 mg, of Zocor is available as a generic (simvastatin), and it costs about 90% less.
Just because the Crestor-CRP study used a powerful dose of Crestor does not mean that only a powerful dose will reduce elevated CRP. Some experts believe that it is not necessary to use the same strong statin doses that doctors frequently prescribe to reduce cholesterol levels. Elevated levels of CRP may not require such strong treatment. According to Dr. Uve Ravnskov, "It may be wiser to search for the lowest effective dose instead of the dose with maximal effect on LDL-cholesterol."9
If you are prone to getting side effects with medications, or if you simply want to reduce your risk of side effects, ask your doctor about starting with the lowest dose of simvastatin. If this does not adequately reduce your elevated CRP level, ask your doctor to increase the dose gradually until you arrive at the amount that works. With Zocor (simvastatin), the lowest dose is 10 mg.
Integrative doctors recommend a variety of natural approaches to reduce elevated CRP. Because smoking increases CRP, the first step for any smoker is to stop smoking. Being overweight increases CRP, so weight loss is also important. Healthy eating and exercise can also reduce CRP levels.
Women taking hormone replacement therapy should be aware that the therapy can increase CRP levels.10 Check with your doctor.
There are several natural supplements that have anti-inflammatory qualities. Alternative doctors often include one, such as curcumin or ginger, in their combination treatment for elevated CRP. Some alternative doctors include aspirin because of its proven anti-inflammatory effect.
Vitamin C might also be included in the treatment of elevated CRP. A study in the Journal of the American College of Nutrition demonstrated that 515 mg/day of vitamin C reduced CRP 24%.11 In comparison, in the Crestor-CRP study, Crestor reduced CRP levels by an average up 37%. Vitamin C plus other therapies mentioned in this section might rival or exceed this result.
Vitamin E, with its natural anti-inflammatory effects, might also help reduce elevated CRP.
Omega-3 fatty acids (fish oils) have proven anti-inflammatory effects. Studies have shown that daily intake of omega-3 fatty acids reduce the risk of cardiac death and also reduce the pain of rheumatoid arthritis.12,13 Fish oils should be a standard part of the treatment of elevated CRP. Because fish oils and aspirin taken together can increase the body's tendency for bleeding, check with your doctor before taking these therapies together.
A natural supplement with properties similar to prescription statins is red yeast rice. This fermentation product contains small amounts of several statin-like compounds. It works like a mild statin and, like prescription statins, reduces vascular inflammation and elevated CRP. Red yeast rice can also reduce cholesterol levels. Like prescription statins, red yeast rice can cause adverse effects, but the risk is low and, if side effects occur, they are usually milder than with prescription statins.
Jay S. Cohen M.D. is a nationally recognized expert on medications and side effects. He is an adjunct associate professor of preventive medicine. Dr. Cohen provides consultations to people across America who are interested in statin drugs or natural alternatives for reducing elevated CRP or cholesterol, or who are interested in cardiovascular health and methods of prevention.
1. Ridker PM, Danielson E, Fonseca FAH, et al (for the JUPITER Study Group). Rosuvastatin to prevent vascular events in men and women with elevated C?reactive protein. The New England Journal of Medicine, Nov. 20, 2008;359(21):2195?2207.
2. Hlatky MA. Expanding the Orbit of Primary Prevention ?? Moving beyond JUPITER. New England Journal of Medicine, Nov. 20, 2008;359 (21):2280?82.
3. Hadler NM. Crestor, by Jove... or Not. Doctor urges caution in interpreting new findings on cholesterol drug. ABC News, Nov. 10, 2008:http://abcnews.go.com.
4. Ridker, PM, Rifai, N, Rose, L, et al. R. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. New England Journal of Medicine 2002;347:1557-1565.
5. Albert, MA, Glynn, RJ, Ridker, PM. Plasma concentration of C-reactive protein and the calculated. Framingham Coronary Heart Disease Risk Score. Circulation 2003;108(2):161?5.
6. Sinatra, S. Statins: grossly overprescribed for cholesterol and underprescribed for internal inflammation. The Sinatra Health Report, Sept. 2002;8:1.
7. West A. JUPITER: separating the solid clinical matter from the hot gas. Holistic Primary Care, Winter 2008;9(4):1-2.
8. Crestor costs. Costco pharmacy, Dec. 20, 2008:www.costco.com.
9. Ravnskov, U. Is atherosclerosis caused by high cholesterol? QJM (Quarterly Journal of Medicine) 2002;95:397-403.
10. Walsh, BW, Paul, S, Wild RA, et al. The Effects of Hormone Replacement Therapy and Raloxifene on C?Reactive Protein and Homocysteine in Healthy Postmenopausal Women: A Randomized, Controlled Trial. Journal of Clinical Endocrinology and Metabolism 2004;85:214?218.
11. Block, G, Jensen, C, Dietrich, M, et al. Plasma C-reactive protein concentrations in active and passive smokers: influence of antioxidant supplementation. Journal of the American College of Nutrition 2004;23:141-147.
12. Simopoulos, AP. Essential Fatty Acids in Health and Chronic Disease. American Journal of Clinical Nutrition 1999;70(suppl):560S-569S.13. Simopoulos, AP. The Mediterranean diets: What is so special about the diet of Greece? Journal of Nutrition 2001;131:3065S-3073S.
Friday, January 23, 2009
A new large-scale senior population study has found that a lack of vitamin D in the elderly could be linked to cognitive impairment. The study, conducted on almost 2,000 adults over the age of 65, is the first of its scale to identify this relationship, and prompted researchers to suggest vitamin D supplementation as a possible means of reducing the risk of dementia. The findings from the researchers at the Peninsula Medical School, the University of Cambridge and the University of Michigan revealed that compared to those with optimum levels of vitamin D, those with the lowest levels were more than twice as likely to be cognitively impaired.
The elderly, in particular, are at risk of deficiency as the skin’s capacity to absorb vitamin D from the sun decreases with age. According to the researchers of the new study, which will appear in the forthcoming issue of the Journal of Geriatric Psychology and Neurology, 1,766 participants (708 men and 1,058 women) participated in the Health Survey for England in 2000. Their levels of cognitive function were assessed using the Abbreviated Mental Test (AMT), a common neurocognitive screening instrument. Fasting blood samples were also taken, and levels of serum 25(OH)D were measured.
Their findings revealed that people with normal cognitive function had higher levels of serum 25(OH)D than those who were cognitively impaired. Those with the lowest serum 25(OH)D concentrations were four times more likely to be cognitively impaired.
Bonnie - testing 25(OH)D levels at any age is crucial. The elderly are at particular risk for low levels because of lack of sun exposure and reduced ability to absorb critical nutrients.
Thursday, January 22, 2009
An ex-pub landlady who attributes her longevity to cod liver oil has celebrated her 104th birthday.
Alice Leaf is a former landlady of the Phoenix Pub, in George Street, York. She was born in Heworth on January 21, 1905, and lived with her family in Bromley Street, off Leeman Road.
She started work at Terry’s on her 14th birthday in 1919 and remembers her father returning from serving in the trenches during the First World War.
Mrs Leaf married her policeman husband, Stanley, in 1928 and the couple went to live in Wakefield for his work. They also lived in Whitby before returning to York.
Her son, Raymond, said: “You would not think she was her age. She is laughing and joking and when she was 100 the mayor came to visit and went to the wrong person as my mother didn’t look old enough.”
Wednesday, January 21, 2009
The study was conducted by researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University as well as research centers in Florida and Japan. Another study on green tea, also featured in this issue of the Journal of Nutrition, shows that drinking plentiful amounts of the beverage over many years may have a subtle influence in decreasing the risk of breast cancer. The study examined almost 7,000 women, ages 20 to 74, in China. The women were evaluated for breast cancer incidence and consumption of green tea. Compared with nondrinkers, women who drank green tea had a slightly decreased risk of breast cancer. The benefit was strongest for women who drank the most green tea over longer periods of time.
Tuesday, January 20, 2009
Steve - we blogged this because it is yet another example that genetic predisposition to disease is a multifaceted task that has too many variables that have yet to be discovered. While continued science will most likely decipher the genetic combinations that cause human diseases, we should be focusing our short-term efforts on silencing the expression of their epigenetic triggers, which begins with diet, lifestyle, and environment.
"I can't wait until spring," says author Bill Alexander. "I miss lettuce. I haven't had any decent lettuce for months."
He's not the only one waiting eagerly for the growing season to begin. All signs are that 2009 will be a banner year for vegetable growing, following a spurt last summer.
"We've seen almost double demand," says Tracy Lee, director of horticulture at the seed company W. Atlee Burpee Co. in Warminster, Pa. (burpee.com). "It's amazing."
When the Garden Writers Association in Manassas, Va., surveyed gardeners in spring 2007, they rated vegetables in second place (after lawns) among types of growing they intended to do, after it had wallowed in fourth or fifth place after perennials for years. Polling hasn't started yet this year, says executive director Robert LaGasse, but he expects the trend to continue.
Why the growth in enthusiasm for growing food? The economy surely has a role. An increase in seed sales is "typical when we see an economic downturn," according to Stephanie Turner, director of seed product at Park Seed Co., another venerable catalog house in Greenwood, S.C. (parkseed.com). "People are trying to stay home and beautify what they have and grow their own food."
But there are other factors at work: When tomatoes were pulled from store shelves last summer for fear of salmonella, it was only the latest of a succession of scares that revealed how long the supply chain is for supermarket produce—and how vulnerable to contamination. Sales of organically grown produce have been on the rise for years, and it's natural to go from buying expensive organic heirloom tomatoes at the farmer's market to wondering if you could grow them yourself cheaper.
If you grow your own food, you don't need to wonder what pesticide was sprayed on it or what was in the soil where it was planted or whether the people who picked it washed their hands. You control all that.
There also is a growing awareness that trucking fruits and vegetables long distances from farm to distribution center to supermarket to home uses a lot of gas and emits a lot of greenhouse gases.
The "Locavore" movement—which contends it is most environmentally responsible to eat food grown close to home—leads to a logical conclusion: There's no place more local than your own backyard. "Your produce is fresher and it hasn't traveled a long distance so you haven't contributed to the carbon footprint," Turner says.
Monday, January 19, 2009
Here we go again: The pharmaceutical maker Merck is seeking approval from the FDA for boys as young as 9 to get the Gardasil vaccine, which prevents some strains of the Human Papilloma Virus (or HPV), a virus spread during sex which, in turn, can cause cervical cancer in women.
This is not a case against giving kids of either sex the vaccine for reasons of principle, though such reasons might suffice. The vaccine, targeted to children and very young teens, is new. (We don't even know if it will be effective beyond five years or so.) So, giving it to my child? No.
And doesn't giving kids the vaccine -- hard to do that "secretly," since it takes three separate doses during a time kids are not being routinely vaccinated -- communicate that we expect our kids to behave sexually? Could a child easily think, despite a parent's best efforts to communicate otherwise, that he's protected in ways he is not after having "the vaccine"?
Of course. These are kids.
But what really outrages me is that encouraging the routine vaccination of children and very young teens with Gardasil, a push happening now, makes no sense from a public health standpoint.
There are about 40 different strains of sexually transmitted HPV, and while the Gardasil vaccine protects against some of the most problematic ones, it does not guard against all of them.
Anyway, most sexually active people will get HPV at some point, according to a number of reliable medical Web sites. And the body typically clears the virus on its own. In maybe 10 to 20 percent of cases, that won't happen. And some of those cases in women will go on to become cervical cancer.
BTW, while HPV can, rarely, lead to certain genital cancers in men, circumcision greatly reduces such risks, but that's another column. (Actually "circumcision" goes on the list of "topics I will never write about," which in itself may be a column.)
Cervical cancer is almost always curable when caught early, and an extremely effective, easy, and relatively inexpensive test to detect it, the pap smear, is routine. (BTW, the vaccine protects against less than 80 percent of cervical cancer cases, which is why the pap smear is still a must, even after the vaccine. Do most women know this?)
Still, cervical cancer last year afflicted more than 11,000 American women and almost 4,000 died of it, because the cancer wasn't detected early. Truly a tragedy.
But now let's circle back. For starters, the series of vaccines, which may not give protection over the long term, costs, on average, $360. Very expensive compared to other vaccines. No wonder Merck loves it, and would like insurance companies to pay for it. Last year alone, in targeting only half of a very young population, it generated more than $1.5 billion dollars for Merck.
So, there are billions -- yes, billions -- of dollars to be sucked out of our health care system to pay to help prevent a disease that is relatively rare, easily detected, and almost always curable if found early. And consider that almost certainly the same people "responsible" enough to get the vaccine for themselves or their kids will be the same ones having the annual pap tests to begin with.
Yes, any particular individual may be helped by Gardasil. Yes, young adult women and men might want to consider the vaccine, particularly before becoming sexually active.
But from a public health standpoint, to encourage expensive, widespread vaccination of children with Gardasil, as is currently the case? It makes no sense. Or cents.
How about doing something really helpful, and instead spend a fraction of those billions to get women at greatest risk, who aren't likely to be the ones getting Gardasil anyway -- the poor -- a pap test on a regular basis? Why not spend the balance to perhaps fight childhood and adult obesity, now the second leading cause of preventable death in the United States, claiming some 300,000 lives a year?
In other words, can we please do a public health cost/benefit analysis here?
Apparently not. Too often in recent decades when it comes to public health issues in the United States, and very often when it comes to public health and sex, we simply lose our senses -- and our cents.
Bonnie - I couldn't have said it better myself.
The study found a total of 21,009 pediatric head and neck infections caused by staph germs from 2001 through 2006. The percentage caused by hard-to-treat MRSA bacteria more than doubled during that time from almost 12 percent to 28 percent. The study appears in January's Archives of Otolaryngology.
MRSA infections were once limited mostly to hospitals, nursing homes and other health-care settings but other studies have shown they are increasingly picked up in the community, in otherwise healthy people. This can happen through direct skin-to-skin contact or contact with surfaces contaminated with germs from cuts and other open wounds. But staph germs also normally live or "colonize" on the skin and in other tissues including inside the nose and throat, without causing symptoms. Symptoms that it could be MRSA include ear infections that drain pus, or swollen neck lymph nodes caused by pus draining from a throat or nose abcess. Unlike cold and flu bugs, MRSA germs aren't airborne and don't spread through sneezing. MRSA does not respond to penicillin-based antibiotics and doctors are concerned that it is becoming resistant to others. The study authors said a worrisome 46 percent of MRSA infections studied were resistant to the antibiotic clindamycin, one of the non-penicillin drugs doctors often rely on to treat community-acquired MRSA.
Bonnie - we have been reporting on MRSA for a while now. We only have ourselves to blame for the rise in these cases. The chronic misuse of antibiotics have contributed greatly to the resistant MRSA strains. While there is very little data available, we recommend consulting your health professional about lauric acid (Monolaurin) and GSE (grapefruit seed extract) as natural preventatives. MayoClinic.com has good information about understanding MRSA.
Smaller chains like Hannaford Bros. Co., based in Scarborough, Maine, launched a three-star system of good, better and best called Guiding Stars in September 2006.
Supervalu's approach "sounds helpful and good," said Michael Jacobson, director of the Center for Science in the Public Interest. But it doesn't go far enough, he argued. For example, it's useful to know which ice cream, cookies or other junk food is the best for you, and Supervalu won't be rating those types of foods for its nutrition tags.
The other issue is that there is no continuity among the nutrition groups that are hired by grocers. Jacobson is an advocate of one national system for the supermarket industry that has been tested to make sure it best encourages consumers to choose the most healthful foods.
Bonnie - this just sets the consumer up for more confusion. If the nutrition experts hired to create the labeling systems are all following the USDA guidelines, the effort will be meaningless. In addition, not putting labels on junk food is a joke. The grocers want it both ways: they don't want to be the "food police," yet they want to placate the government officials and public health experts that are calling for more effort in addressing the obesity epidemic.
At least Hannaford created good, better, and best labels, which leaves the consuumer to ponder the purchase items without these ratings.
Chronically overweight people reprogram controls over their DNA and pass on fatness and disease not only to their children, but to future generations.
Melbourne scientists have proved for the first time that damage done by unhealthy eating is "remembered" in genetic controls - epigenetics - and turns off good genes needed to prevent diabetes, heart disease and other complications.
Lead researcher Assoc Prof Assam El-Osta, from the Baker IDI Heart and Diabetes Institute team, said, "It is this idea that you are what you eat, and perhaps that is a reflection of what your parents ate, and perhaps what your grandparents ate," he said.
The scientists proved that a single sugar hit, such as eating a chocolate bar, damaged the controls regulating the genes for two weeks.
But Prof El-Osta warned that regular poor eating meant the damage would last for months or years, and the real problems caused by an unhealthy diet were deferred until later life.
A poor diet could lead to very serious changes that are remembered for many months, or even years.
"You don't see the damage caused that day, that week or that month, but later on in life you see these complications like heart disease or problems with the eyes and your kidneys," Prof El-Osta said.
"This is not all doom and gloom . . . we think there is good epigenetic memory as well for individuals who have a good diet, not only for themselves but potentially for future generations. "If you have had five years of bad control, where good genes are switched off and bad genes switched on, changing that for a couple of months to a good diet may not have a tremendous impact.
"But going back to a good diet would have some effect 10 years later."
The findings were reported in the Journal of Experimental Medicine.
Steve - YES! YES! YES! This is the stuff public health professionals get excited about. Like we have said for the last several years, epigenetics does not just affect us, but one or two generations in the future. The mantra of "You Are What You Eat" is now a bit outdated. It now should be, "You and Your Future Generations Are What You Eat!"
Friday, January 16, 2009
"Detoxification could theoretically work like hemodialysis: the blood is diverted out of the body and into a special chamber containing the biocompatible magnetic particles," they wrote in a statement. "By using magnetic fields, the charged magnetic particles could be fished out. The purified blood is then reintroduced to the patient." Lead is a dangerous heavy metal and is especially toxic to children. Safe and effective detoxification processes are especially important.
The South Korean team, lead by Jong Hwa Jung at the Gyeongsang National University's department of chemistry, managed to remove 96 percent of lead ions from blood samples using these magnetic particles.
Bonnie - we would assume that this would be effective for other heavy metals as well.
Thursday, January 15, 2009
Final U.S. regulations requiring meat and fresh produce to be labeled with country of origin will take effect March 16, the Department of Agriculture said.
The labeling rule, also known as COOL, is a longtime goal of U.S. farmers and ranchers convinced that identifying imported food may encourage manufacturers to use more U.S. products. Meat companies have opposed it and helped delay the requirements for years, saying they will result in additional expenses for labor, labels and changes to facilities needed to separate foreign and domestic products.
The study included data from patients who had participated in health surveys throughout the 1970s and 1980s. The average follow-up rate was 21 years. The researchers decided to study the association between coffee consumption in midlife and the development of late-onset dementia or Alzheimer's "because the long-term impact of caffeine on the central nervous system was still unknown" and because the processes that lead to these conditions may start decades before symptoms appear.
Bonnie - a significant study because the focus was long-term effects. In this case, coffee was found to be preventative. However, coffee loaded with sugar and milk/cream, as seen in other studies, lowers the protective effect greatly.
The 19-point checklist has nothing to do with high technology. Instead, it focuses on basic safety measures, such as ensuring that patients get antibiotics to prevent infection and requiring that all members of the team introduce themselves. "An operation involves hundreds of steps with lots of team members," Gawande says. "We're good at making sure we do most of these things most of the time, but we're not good at doing all of them all of the time."
The study shows that an operation's success depends far more on teamwork and clear communication than the brilliance of individual doctors, says co-author Alex Haynes, also of Harvard. And that's good news, he says, because it means hospitals everywhere can improve. Researchers modeled the checklist, which takes only two minutes to go through, after ones used by the aviation industry, which has dramatically reduced the number of crashes in recent years.
Courtesy of USA Today
Steve - how easy would it be to follow a checklist? The only reason I can come up with for not following the check list is arrogance. A recent study also showed that a nurse checklist for ICU patients saw a dramatic drop in infection-related complications. This is elementary stuff "my dear Watson."
Current law requires supplement manufacturers to disclose limited information about their products, and what information is available is a result of dietary supplement manufacturers touting the use of nanotechnology when marketing their products, according to the report. "While it is not possible to precisely determine the prevalence of dietary supplements using engineered nanoparticles, it is likely that the public's exposure to these products will grow significantly in the next several years," says Lisa Barclay, also a co-author of the report.
Steve - this is another reason why you use a resource such as Nutritional Concepts to do the work for you. We screen any product we carry for nanoparticles. At this point in time, we do not endorse any products with nanomaterials because their is no data ensuring that they are safe.
The Office of Inspector General recommended the department develop an overall control policy for all GMO imports and implement a strategy to monitor GMO crop and livestock development in foreign nations.
The audit found that the USDA needs to develop screening measures to weed out undeclared GMO crops and livestock. The department currently has no measures in place to identify a shipment of unapproved GMO imports unknown to the U.S. regulatory system, the report said.
The report noted that China has pledged $500 million toward biotechnology by 2010 and has developed a new form of GMO rice.
Although the implications associated with Americans consuming unapproved GMO food are unknown, the health and environmental concerns that it poses could threaten commerce.
Steve - we discussed this inevitability when we attended a public comment event held by the USDA. It is coming to fruition as predicted because the USDA and FDA are underfunded, undermanned, and corrupt (as they themselves have stated).
Wednesday, January 14, 2009
If tolerated, try to add one each week to your diet that you've never had before.
- Blueberries (wild)
- Bok choy
- Brazil nut
- Broccoli/Broccoli Sprouts
- Brown Rice
- Cherries (tart)
- Chocolate (70% cocoa or higher)
- Cod Liver Oil
- Coffee (unsweetened)
- Collard Greens
- Black Beans
- Brussels sprouts
- Edamame (boiled soybeans)
- Eggs (organic, DHA infused)
- Flaxseed (pulverized)
- Grapeseed Oil
- Mushrooms (Shiitake)
- Mustard Greens
- Oats (steel-cut only)
- Olives/Olive Oil
- Pumpkin (canned organic)
- Salmon (wild caught)
- Soy Milk (organic unsweetened)
- Sunflower Seeds/Seed Butter
- Sweet Potato
- Tea (unsweetened)
- Tomato sauce
- Turkey Breast (nitrate-free)
- White Potato (baked)
- Yogurt (Greek)
Leave in the comment box and we'll let you know if it belongs.
Doctors focused on 657 babies born before 33 weeks — about seven weeks before the end of the average 40-week pregnancy. Doctors randomly assigned half of newborns to a high-DHA diet and half to a standard one. For the high-DHA diet, breastfeeding mothers took six 500-milligram tuna fish oil capsules and, if needed, babies received infant formula in which DHA made up 1% of the total fatty acids. Mothers of babies on the standard diet got placebo pills, and their babies got regular formula.
Babies underwent standard development tests at 18 months.
Doctors found no difference in mental retardation rates overall or in boys, the study shows.
But premature girls given the high-DHA diet scored about 5 points higher on a 100-point test, which translates to a 55% reduction in the proportion of girls with a "mild mental delay" and an 80% reduction in the proportion of girls with "significant" mental delay, says author Maria Makrides of Women's and Children' Hospital in Adelaide, Australia. She notes that premature girls generally have lower risks of complications than boys.
There were no harmful side effects of taking DHA, which mothers naturally pass on to their babies in the womb. Babies born early miss out on the benefits of DHA, which may help develop their brains during the critical last weeks of pregnancy, Makrides says. She notes that the preemie girls given extra DHA had test scores nearly as high as those of full-term babies.
Based on those findings, her hospital is preparing to offer a DHA-rich diet to its preemies, Makrides says.
By Carolyn Y. Johnson,
With a toddler's aplomb, Ellie Brogan gives a tour of her body's plumbing. The pouch tucked into her diaper is "my ostomy." A hole in her stomach that hooks to a feeding tube is "my button." "My central line" feeds nutrients to a vein near her heart.
But after show and tell, Ellie scampers around the house like any other child, her blond curls bouncing.
You'd never know that when she was just a day old, doctors warned Abby and Gib Brogan that their daughter, born with just a tiny fraction of her small intestine and missing some of her colon, would probably need a liver transplant or die by her first birthday.
Now, 2 1/2 years later, Ellie is one of more than 100 children with rare "short bowel syndrome" who have received a therapy pioneered at Children's Hospital Boston. It uses an old-fashioned substance - fish oil - to keep their livers healthy, and doctors and Ellie's parents say it helped save her life.
Babies like Ellie, who lack the ability to digest food or absorb nutrients, need to be fed intravenously. But the IV nutrition also damages their livers.
Dr. Rusty Jennings, a pediatric surgeon and one of Ellie's doctors, described the double-edged sword physicians faced when treating such patients: "You can't not give it [the IV nutrition] to them or they'll die of malnutrition. You do give it to them, and they die of liver disease."
Then came an unusual leap of medicine from the lab into the clinic.
In experiments in mice, Dr. Mark Puder, a Children's Hospital surgeon, and colleagues found that using a nutritional supplement made with fish oil instead of the standard one, made from soybean oil, did not cause liver damage.
In 2004, a desperately ill baby on IV nutrition in Jennings's care faced liver failure, and he approached Puder.
With approval from the US Food and Drug Administration, the hospital's institutional review board, and the parents, Puder changed the IV nutrition, swapping a fish oil formula for the standard fat supplement.
"At about a month, he started getting better," Jennings said. "It was just freaking amazing - I couldn't believe it."
From that single case came a shift in treatment. So far, 112 children at Children's Hospital - Ellie Brogan among them - have been given the fish oil, called Omegaven. The treatment is now available at 70 hospitals around the world. Parents call it a miracle.
Although the data have not yet been published, Puder said that more than 90 percent of the Children's Hospital patients are alive. He noted that the hospital often sees children who arrive from elsewhere in very bad shape and may be beyond the help of Omegaven because the therapy wasn't started sooner.
"Now we see, the sooner we start, the better we do," Puder said. It is not known whether the patients will now live close to a normal lifespan.
The Brogans are committed to telling their story and giving other parents hope through a blog that chronicles their journey.
Their lives have changed. Abby has switched fields and jobs. They moved from Connecticut to be closer to Boston. The couple, trained as marine biologists, say they have new respect for the oily fish used to make Omegaven - menhaden (also known as the common pogy). They have watched their little girl, whose eyes and skin were once yellowed by liver failure, develop more healthy coloring.
At the beginning of December, as she has improved, Ellie was taken off IV nutrition and the fish oil. She is eating food on her own, and her doctors hope her bowel will continue to adapt and allow her to live a more normal life.
"We think if it hadn't been for this," Gib Brogan said, "she might be post-transplant or she might not be with us."
Bonnie - this is truly amazing stuff. I commend the doctors for thinking out of the box.
By Julie Deardorff
For years, Dr. Ali Keshavarzian ignored "alternative" therapies because his Western-trained brain wanted more evidence that they actually worked.
But Keshavarzian also knew conventional medicine often needed some assistance. And when he learned his patients were seeking out natural products, acupuncture, meditation and massage, he took a deep breath and dived in.
Ten years later, Keshavarzian straddles both worlds, using Western treatments along with a variety of alternative approaches, a combination known as complementary and alternative medicine, or CAM. "CAM is looking at a patient as a human being, rather than a disease," said Keshavarzian, a gastroenterologist at Rush University Medical Center. "Instead of treating 'ulcerative colitis,' I treat 'Mr. Jones.' "
The future success of the holistic CAM movement in the U.S. hinges on the very people who once viewed alternative medicine with cold skepticism: mainstream, conventionally trained doctors. Though many, such as Keshavarzian, still believe medical treatments should be backed by rigorous scientific data, they will not rule out adding into the treatment mix mind-body therapies that have been used for centuries in other cultures. Keshavarzian, for example, might suggest relaxation techniques when he thinks stress is a factor, acupuncture for pain or probiotics for acute diarrhea.
"The public has been on board for some time," said physician Andrew Weil, founder of the University of Arizona's School of Integrative Medicine, which has trained more than 350 physician fellows. "The professionals are harder to win over."
Five chronic conditions—mood disorders, diabetes, heart disease, asthma and high blood pressure—account for more than half of all U.S. health expenditures, according to the Institute of Medicine, part of the National Academy of Sciences, which advises the federal government on health issues. But these are the disorders that conventional medicine struggles to treat, according to the institute.
"Studies show that $2.5 trillion is being spent in a system that is not improving the overall health of our citizens," according to the institute. "Incidents of chronic disease are on a sharp rise and by 2023 will cost our nation $4.3 trillion."
Proponents say CAM, which is also called "integrative medicine," is a cost-effective solution.
Integrative treatments fall into four main categories: natural products (vitamins and supplements), energy medicine (acupuncture), manipulative practices (chiropractic work) and mind-body medicine (meditation or deep breathing).
For instance, if a patient needs bypass surgery, an integrative doctor would recommend it. But afterward, he or she might suggest fish oil, exercise or nutritional changes to aid healing.
Laura Restaino of Wheaton tried an integrative physician, Charles Dumont, a Loyola University pediatric gastroenterologist, after prescription drugs, creams, steroids and lotions prescribed by conventional doctors failed to treat her daughter Alex's severe eczema. After receiving hand acupuncture (using pellets in place of needles) from Dumont, the condition cleared up almost instantly, Restaino said.
Alex, now 12, sees Dumont every six to eight weeks for maintenance acupuncture. "He's kind, he listens and he doesn't rush," her mom said.
Though primarily driven by patient demand, the integrative medicine movement recently has received a boost from the conservative medical establishment, including the American Academy of Pediatrics, which has a CAM task force.
An increasing number of prestigious medical schools are teaching integrative practices. Since 1999, the Consortium of Academic Health Centers for Integrative Medicine, a group that includes Duke University, Harvard and Northwestern, has grown from 8 to 43 members. With more traditional medical schools focusing on health care that addresses the mental, emotional and physical aspects of healing, the use of CAM by the nation's future physicians is expected to grow.
Meanwhile, it's getting easier for practicing physicians to find CAM training. In early December, the University of Chicago and the Mayo Clinic co-sponsored the ninth annual two-day CAM conference for medical professionals. And the 2009 Integrate Chicago Conference on Jan. 17 at Loyola is being organized by, and for, medical students interested in integrative medicine.
Nearly 40 percent of adults used integrative therapies last year, according to a new government report, most often to treat chronic back, neck and joint pain, arthritis, anxiety, high cholesterol and head or chest colds.
And 12 percent of U.S. children have used an alternative therapy.
"Early in my career I felt like we [doctors] were missing the boat because we weren't addressing underlying problems," said integrative physician Steve Devries, a preventive cardiologist at Northwestern Memorial Hospital. "We'd often tell patients after angioplasty that they 'had the heart of a teenager again.' But it was completely untrue. We'd bought them time to correct the underlying problem, but if we didn't fix that then we'd see them again and again."
Now Devries focuses on prevention; his aftercare includes addressing factors that influence heart disease, including stress and nutrition. He'll find a therapy that fits a person—meditation, yoga, biofeedback or talk therapy—as part of an overall treatment plan. "The modality is not as important as the awareness of a mind-body connection," he said.
One of the challenges of integrative medicine, however, is that it requires more of a doctor's time. Critics say it also has a relatively small evidence base, but that, too, is changing. Though research funding pales in comparison to pharmaceutical drug trials, the National Institutes of Health's National Center for Complementary and Alternative Medicine has been increasing its pace of granting funds for CAM research. It has funded more than 2,200 research studies since 1999.
"The difference is that 50 years ago Western medicine began to examine its practice more vigorously; the other methods have begun to do it more recently," said Keshavarzian. "You can't dismiss CAM; it's the result of 1,000 years of experience. But we can vigorously study it."
Bonnie - it is nice to see Dr. Devries interviewed for this piece. I have referred clients to him for years.
The 2007 survey of more than 32,000 Americans, which for the first time included children, found that use of yoga, "probiotics," fish oil and other "complementary and alternative" therapies held steady among adults since the last national survey five years earlier, and that such treatments have become part of health care for many youngsters.
"It's clear that millions of Americans every year are turning to complementary and alternative medicine," said Richard L. Nahin of the National Institutes of Health's National Center for Complementary and Alternative Medicine, which released the survey. "The use of complementary and alternative medicine seems to have stabilized in the United States."
The most commonly used are dietary supplements and herbal products, followed by deep-breathing exercises, meditation, chiropractic therapy, massage and yoga. "I think it's fair to say we can conclude that this is part of the steady state of medical care in the United States," said David Eisenberg, director of the Harvard Medical School's division for research and education in complementary and integrative medical therapies. "I think the news is complementary and alternative medicine use by the U.S. public is here to stay.
Here are the 10 most common CAM treatments among adults, according to NCAAM.
- Natural products: 17.7%
(most common: EPA/DHA fish oil)
- Deep-breathing exercises: 12.7%
- Meditation: 9.4%
- Chiropractic or osteopathic manipulation: 8.6%
- Massage: 8.3%
- Yoga: 6.1%
- Diet-based therapies: 3.6%
- Progressive relaxation: 2.9%
- Guided imagery: 2.2%
- Homeopathic treatment: 1.8%
Almost half of these patients had "bad" cholesterol, or LDL, levels below 100 mg/dL, which is considered optimal under current guidelines from the National Cholesterol Education Program.
The new research -- based on data from nearly 137,000 patients at more than 500 hospitals -- suggests that current LDL guidelines aren't low enough to identify people likely to have a heart attack, said Dr. Gregg C. Fonarow, lead author of the study published in the American Heart journal.
"Falsely, patients and doctors thought they were being well-protected" if LDL levels fell within the recommended range, Fonarow said.
Dr. Sidney Smith Jr., who's on a panel of experts that's revising government guidelines on heart disease and obesity, said the study makes a good case for lowering LDL recommendations. "It certainly gives us an idea on where we need to focus our efforts," Smith said.
Steve - wow are these doctors in denial. How low are they going to go? Until the entire country is on a statin?
They should be changing the guidelines to focus on cardiac inflammation. We have known for years that LDL cholesterol is only one piece of the puzzle. Quelling inflammation is much more important. Diet, nutrients, and other CAM therapies can handle this issue. In tougher cases, red yeast rice or statins may be warranted.
Treating people with high CRP levels dramatically reduced the number of lives lost to heart disease and the number of costly and painful procedures needed to restore heart patients to health.
Tuesday, January 13, 2009
U.S. health officials finalized guidelines that make it easier for pharmaceutical companies to tell doctors about unapproved uses of medicines, a practice opposed by critics of industry marketing.
The Food and Drug Administration (FDA) guidelines explain when manufacturers such as Pfizer Inc and Merck & Co may distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.
The move, announced a week before Republican President George W. Bush leaves office, puts in place a policy that drew objections from congressional Democrats and drug-industry critics when it was proposed last year. Opponents say it will allow promotion of uses without adequate testing.
"In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift," said Rep. Henry Waxman, chairman of the House of Representatives Energy and Commerce Committee.
"This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective. I hope this policy will be carefully re-examined by the new administration," added Waxman, a California Democrat.
By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for any use they see fit, a practice known as "off-label" use.
Distribution of medical literature suggesting a drug may have merit for an unapproved use is a marketing area that has been in dispute for years.
The FDA in its guidelines said "public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses."
Industry critics say distribution of the journal articles promotes untested uses of drugs and may be dangerous. It also may deter manufacturers from doing more tests of the new uses and subjecting them to FDA scrutiny for possible approval.
About one of five prescriptions in the United States was written to treat a condition for which the drug was not approved, according to a 2006 study published in the Archives of Internal Medicine. The researchers said most off-label use occurs without scientific support.
The guidelines also apply to medical device makers.
Steve - what a parting gift, Mr. Bush. Thanks a lot. So I guess now, any drug prescribed for health problems or symptoms NOT identified by the manufacturer should be avoided. Otherwise, you'll be a guiniea pig and Big Pharma will drive our health costs even hiigher.