FDA, dereliction continues

HEART DEVICES AND STENTS

Studies fault FDA approval process

By Carla K. Johnson
ASSOCIATED PRESS

CHICAGO — Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents.    Safety targets often weren’t clearly spelled out in the research submitted by device-makers, and important patient information was missing, according to one study conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center.
A separate analysis by researchers at the University of California, San Francisco, found that heart devices frequently got the FDA’s blessing based on research involving small groups of patients outside the United States. Many studies of devices lacked such standards as randomization and a clear goal.
Dr. Jeffrey Shuren, the FDA’s acting device center director, said the agency is looking closely at its device program and making changes. It wants manufacturers to adhere to tougher research guidelines that will be out in 2010, Shuren said.
The FDA, chief watchdog on device safety, approves products ranging from wrinkle fillers to artificial knees. Heart devices fall into a category of high-risk devices that require the toughest review before they can be marketed. They include implantable defibrillators, valves and stents, which are tiny metal-mesh tubes used to prop open arteries.
The new studies cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of the division resigned, months after scientists under his leadership alleged that they had been pressured to approve certain products. The year began with congressional investigators saying the FDA should quickly make sure the riskiest devices are approved through the most stringent process. The new studies didn’t examine the safety of the devices, nor did they look for differences in the approval process for items that were later recalled.

Global sales of heart and blood-vessel devices were nearly $76.7 billion in 2008, according to market research firm BCC Research.
One of the new studies, published online yesterday in the American Journal of Therapeutics, found that about 40 percent of pivotal studies lacked precise targets for how safety would be measured. Studies also failed to fully account for what happened to all patients enrolled in the research and omitted important information on patients such as how many had heart disease or diabetes.
The second study was in today’s Journal of the American Medical Association. Researchers at the University of California, San Francisco, examined summaries of research behind 78 heart and blood-vessel devices. It found many devices were approved based on small studies — 300 patients on average — and  two-thirds were approved based on just one study.
Both studies looked at devices approved from 2000 to 2007.

7 Foods smart to skip

Shine from Yahoo

Tuesday, December 29, 2009

The 7 foods experts won’t eat

partner

• by Liz Vaccariello, Editor-in-Chief, PREVENTION, on Tue Nov 24, 2009 11:15am PST

How healthy (or not) certain foods are—for us, for the environment—is a hotly debated topic among experts and consumers alike, and there are no easy answers. But when Prevention talked to the people at the forefront of food safety and asked them one simple question—“What foods do you avoid?”—we got some pretty interesting answers. Although these foods don’t necessarily make up a “banned” list, as you head into the holidays—and all the grocery shopping that comes with it—their answers are, well, food for thought:.

1. Canned Tomatoes

The expert: Fredrick vom Saal, PhD, an endocrinologist at the University of Missouri who studies bisphenol-A

The problem: The resin linings of tin cans contain bisphenol-A, a synthetic estrogen that has been linked to ailments ranging from reproductive problems to heart disease, diabetes, and obesity. Unfortunately, acidity (a prominent characteristic of tomatoes) causes BPA to leach into your food. Studies show that the BPA in most people’s body exceeds the amount that suppresses sperm production or causes chromosomal damage to the eggs of animals. “You can get 50 mcg of BPA per liter out of a tomato can, and that’s a level that is going to impact people, particularly the young,” says vom Saal. “I won’t go near canned tomatoes.”

The solution: Choose tomatoes in glass bottles (which do not need resin linings), such as the brands Bionaturae and Coluccio. You can also get several types in Tetra Pak boxes, like Trader Joe’s and Pomi.

2. Corn-Fed Beef

The expert: Joel Salatin, co-owner of Polyface Farms and author of half a dozen books on sustainable farming

The problem: Cattle evolved to eat grass, not grains. But farmers today feed their animals corn and soybeans, which fatten up the animals faster for slaughter. More money for cattle farmers (and lower prices at the grocery store) means a lot less nutrition for us. A recent comprehensive study conducted by the USDA and researchers from Clemson University found that compared with corn-fed beef, grass-fed beef is higher in beta-carotene, vitamin E, omega-3s, conjugated linoleic acid (CLA), calcium, magnesium, and potassium; lower in inflammatory omega-6s; and lower in saturated fats that have been linked to heart disease. “We need to respect the fact that cows are herbivores, and that does not mean feeding them corn and chicken manure,” says Salatin.

The solution: Buy grass-fed beef, which can be found at specialty grocers, farmers’ markets, and nationally at Whole Foods. It’s usually labeled because it demands a premium, but if you don’t see it, ask your butcher.

3. Microwave Popcorn

The expert: Olga Naidenko, PhD, a senior scientist for the Environmental Working Group,

The problem: Chemicals, including perfluorooctanoic acid (PFOA), in the lining of the bag, are part of a class of compounds that may be linked to infertility in humans, according to a recent study from UCLA. In animal testing, the chemicals cause liver, testicular, and pancreatic cancer. Studies show that microwaving causes the chemicals to vaporize—and migrate into your popcorn. “They stay in your body for years and accumulate there,” says Naidenko, which is why researchers worry that levels in humans could approach the amounts causing cancers in laboratory animals. DuPont and other manufacturers have promised to phase out PFOA by 2015 under a voluntary EPA plan, but millions of bags of popcorn will be sold between now and then.

The solution: Pop natural kernels the old-fashioned way: in a skillet. For flavorings, you can add real butter or dried seasonings, such as dillweed, vegetable flakes, or soup mix.

4. Nonorganic Potatoes

The expert: Jeffrey Moyer, chair of the National Organic Standards Board

The problem: Root vegetables absorb herbicides, pesticides, and fungicides that wind up in soil. In the case of potatoes—the nation’s most popular vegetable—they’re treated with fungicides during the growing season, then sprayed with herbicides to kill off the fibrous vines before harvesting. After they’re dug up, the potatoes are treated yet again to prevent them from sprouting. “Try this experiment: Buy a conventional potato in a store, and try to get it to sprout. It won’t,” says Moyer, who is also farm director of the Rodale Institute (also owned by Rodale Inc., the publisher of Prevention). “I’ve talked with potato growers who say point-blank they would never eat the potatoes they sell. They have separate plots where they grow potatoes for themselves without all the chemicals.”

The solution: Buy organic potatoes. Washing isn’t good enough if you’re trying to remove chemicals that have been absorbed into the flesh.

5. Farmed Salmon

The expert: David Carpenter, MD, director of the Institute for Health and the Environment at the University at Albany and publisher of a major study in the journal Science on contamination in fish.

The problem: Nature didn’t intend for salmon to be crammed into pens and fed soy, poultry litter, and hydrolyzed chicken feathers. As a result, farmed salmon is lower in vitamin D and higher in contaminants, including carcinogens, PCBs, brominated flame retardants, and pesticides such as dioxin and DDT. According to Carpenter, the most contaminated fish come from Northern Europe, which can be found on American menus. “You can only safely eat one of these salmon dinners every 5 months without increasing your risk of cancer,” says Carpenter, whose 2004 fish contamination study got broad media attention. “It’s that bad.” Preliminary science has also linked DDT to diabetes and obesity, but some nutritionists believe the benefits of omega-3s outweigh the risks. There is also concern about the high level of antibiotics and pesticides used to treat these fish. When you eat farmed salmon, you get dosed with the same drugs and chemicals.

The solution: Switch to wild-caught Alaska salmon. If the package says fresh Atlantic, it’s farmed. There are no commercial fisheries left for wild Atlantic salmon.

6. Milk Produced with Artificial Hormones

The expert: Rick North, project director of the Campaign for Safe Food at the Oregon Physicians for Social Responsibility and former CEO of the Oregon division of the American Cancer Society

The problem: Milk producers treat their dairy cattle with recombinant bovine growth hormone (rBGH or rBST, as it is also known) to boost milk production. But rBGH also increases udder infections and even pus in the milk. It also leads to higher levels of a hormone called insulin-like growth factor in milk. In people, high levels of IGF-1 may contribute to breast, prostate, and colon cancers. “When the government approved rBGH, it was thought that IGF-1 from milk would be broken down in the human digestive tract,” says North. As it turns out, the casein in milk protects most of it, according to several independent studies. “There’s not 100% proof that this is increasing cancer in humans,” admits North. “However, it’s banned in most industrialized countries.”

The solution: Check labels for rBGH-free, rBST-free, produced without artificial hormones, or organic milk. These phrases indicate rBGH-free products.

7. Conventional Apples

The expert: Mark Kastel, former executive for agribusiness and codirector of the Cornucopia Institute, a farm-policy research group that supports organic foods

The problem: If fall fruits held a “most doused in pesticides contest,” apples would win. Why? They are individually grafted (descended from a single tree) so that each variety maintains its distinctive flavor. As such, apples don’t develop resistance to pests and are sprayed frequently. The industry maintains that these residues are not harmful. But Kastel counters that it’s just common sense to minimize exposure by avoiding the most doused produce, like apples. “Farm workers have higher rates of many cancers,” he says. And increasing numbers of studies are starting to link a higher body burden of pesticides (from all sources) with Parkinson’s disease.

The solution: Buy organic apples. If you can’t afford organic, be sure to wash and peel them first.

Paleo, Root Foods

www.ThePaleoDiet.com Loren Cordain, Ph.D. December 26, 2009 – Volume 2 Issue 3 (Originally published July 15, 2006) Jan, Hello! Welcome to The Paleo Diet Update. For the next several weeks we will be publishing archival issues of The Paleo Diet Update while we work on our new monthly edition of the newsletter. We appreciate your readership, interest, and enthusiasm for The Paleo Diet and hope that you find items of interest from our archival editions of the newsletter. New Products in The Paleo Diet Store I’m pleased to announce that my DVDs Acne Vulgaris: A Disease of Western Civilization and How to Treat Multiple Sclerosis with Diet are now available for purchase as stand-alone products for $19.95. Please visit my web store for more information. In addition, I’m now selling copies of my previously unpublished papers on Paleo Diet-related topics. The first paper to be offered is Nutritional Differences between Grass and Grain Fed Beef: Health Implication. The paper is available for $19.95. Please visit my web store for more information. The Paleo Diet Blog I’m pleased see the continued response from the Paleo Diet community to my new Paleo Diet Blog! My team and I will continue to provide useful nutritional information to our our readers, as well as an interactive format for readers to view past questions submitted from the Paleo Diet community and the answers provided by our team. We encourage you to check out new articles, browse our Q&A, and submit your own questions or comments. Loren Cordain, Ph.D., Professor	Loren Cordain, Ph.D. In This Issue Root Foods in Perspective Recipe of the Month Success Story of the Month
Root Foods in Perspective
Dear Dr. Cordain, I know that potatoes and sweet potatoes are ‘banned’ foods, but what about other root vegetables such as celeriac, turnips and Swedes (rutabagas)? Thanks, Anna W. Design Manager Hi Anna, Let me take a round about approach before I directly answer your question. First off, potatoes and sweet potatoes are not necessarily forever and completely banned from the diet. For overweight individuals and for anyone suffering from chronic diseases of insulin resistance, I highly recommend that potatoes and sweet potatoes be eliminated or severely restricted until body weight normalizes and/or disease symptoms ameliorate. Because both sweet potatoes and potatoes are net base yielding vegetables, they represent superior carbohydrate sources compared to cereal grains. Additionally, when fully cooked, these vegetables contain few or no antinutrients (such as dietary lectins) which can adversely affect health. In contrast fully cooked cereals still contain numerous antinutrients including lectins. In my original book, The Paleo Diet, I spoke of the 85:15 rule – meaning that if one were 85 % compliant with the diet most of the time, significant improvements in health could occur. I still believe this concept, and I believe that minor dietary discretions involving potatoes and sweet potatoes on an occasional basis will have little adverse impact upon health. In fact, for highly fit athletes, or for healthy, normal weight individuals doing significant aerobic exercise on a daily basis, potatoes and sweet potatoes represent a good source of carbohydrate necessary to replenish spent muscle glycogen stores. See (http://www.thepaleodiet.com/paleo_books/) for more information. There are approximately 96 vegetable crops that are grown world wide which fit under the catch all phrase of “roots and tubers”1. Root and tuber vegetables are actually the underground food storage organs of various plants. These edible underground organs are classified into one of five categories: 1) roots, 2) tubers, 3) rhizomes, 4) corms, and 5) bulbs. Commonly consumed roots are carrots, parsnips, radishes, beets, Swedes (rutabagas), sweet potatoes, cassava and celeriac, whereas commonly consumed tubers include potatoes and yams. Examples of edible rhizomes are the arrowroot, ginger and turmeric. Corms include taros and Chinese water chestnuts whereas common edible bulbs take in onions and garlic. Crops with an enlarged stem (leek and kohlrabi), even when located underground, are generally not classified as roots and tubers2. The table below shows worldwide production of the top 11 root and tuber crops. Crop (Metric tons/year) Potato 307,440,446 Beet (sugar) 246,475,609 Cassava 184,852,540 Sweet potato 136,130,396 Onion (dry) 51,914,247 Yam 39,643,170 Carrot 21,020,436 Garlic 12,107,007 Taro 9,220,522 Ginger 988,182 Chicory root 960,700 Source: FAO, 2003. It is interesting to see that the world’s top two tuber crops (potatoes and sugar beets) are major contributors to the ubiquitous high glycemic load in the U.S. diet (see Figure 1 below). Note that 41.4 % of the total calories in the typical US diet come from high glycemic foods: 1) refined grains, 2) refined sugars, 3) potatoes. From previous newsletters, eagle eyed Paleo Diet newsletter subscribers will immediately recognize that a high glycemic load is one of the major dietary factors underlying obesity and numerous chronic health problems in westernized countries3, 4. Figure 1. Per Capita Percentages of Highly Glycemic and Highly Insulinemic Foods in the U.S. Diet (1990-99). OK, now let’s get down to directly answering Anna’s question, “but what about other root vegetables such as celeriac, turnips and Swedes (rutabagas)?” In the table below I have compiled data for the only 9 root and tuber vegetables listed in the International table of glycemic index and glycemic load values5. I have also compiled data for 5 additional root and tubers whose glycemic indices have not yet been determined, including turnips and celeriac. My recommendation for overweight subjects or for people with diseases of insulin resistance (type 2 diabetes, hypertension, dyslipidemia [elevated triglycerides, low HDL, elevated small dense LDL], coronary heart disease, gout, and acne) is to not exceed a glycemic load of 10 for any given meal and to keep the days glycemic load under 40. If you look at the table carefully, you can see that a 100g (~1/4 lb) serving of baked potato would provide you with half your daily glycemic load allotment. A similar serving of sweet potato would be a better choice with a glycemic load of 14.8, but better choices still would be beets, Swedes or carrots, which under normal circumstances you can basically eat until you are full, as it would be quite difficult to consume enough of these foods to exceed a daily glycemic load of 40. Although glycemic index and load values for celeriac have not yet been determined, the amount of carbohydrate per 100g (9.2g) is similar to that for beets, Swedes and carrots. Consequently, it is likely that celeriac has a similar low glycemic load and presents no problems. The same goes for turnips. Enjoy these healthful, net base yielding root and tuber vegetables. One final note for eagle eyed readers. I have calculated the glycemic load using a standardized 100g serving as this procedure will “level the playing field” when making comparisons between and among various food items. In the International Table of Glycemic Index and Glycemic Load Values (5), glycemic loads are calculated by multiplying the glycemic index by the carbohydrate content of a “standard serving.” Although this practice is widely utilized, the problem is that “standard servings” vary from food item to food item, thereby introducing a bias for the greater serving size. International Table of Glycemic Index and Glycemic Load Values 100 g samples kcal CHO g CHO g/kcal Gly Index Std Dev Gly Load/100 g Cassava, Manioc, Tapioca 160 38.1 4.2 70 10 26.6 Potato, Baked 109 25.2 4.3 85 12 21.4 Taro 142 34.6 4.1 55 1 19.0 Parsnips 81 19.5 4.2 97 19 18.9 Sweet Potato, Baked 103 24.3 4.2 61 7 14.8 Yam 116 27.6 4.2 37 8 10.2 Beets 44 10.0 4.4 64 16 6.4 Rutabegas, Swedes 39 8.7 4.5 72 8 6.3 Carrots 45 10.5 4.3 47 16 4.9 Jerusalem Artichoke 76 17.4 4.4 na na na Chicory 73 17.5 4.2 na na na Burdock Root 72 17.4 4.1 na na na Celeriac 42 9.2 4.6 na na na Turnips 27 6.2 4.3 na na na
Recipe of the Month
Baked Walnut-Stuffed Carrots This recipe comes from The Paleo Diet for Athletes. 4 large carrots, washed and pared 1 medium onion, chopped 1/4 cup chopped walnuts 1/2 green bell pepper, chopped 3 tablespoons olive oil Freshly ground black pepper Boil the carrots for 30 minutes, then cut in half lengthwise. Preheat the oven to 350°F. Hollow out the centers and puree the extracted portions. Combine the onion, walnuts, and bell pepper with 1 tablespoon of the oil. Add ground pepper to taste. Mix in the pureed carrots, and stuff the eight carrot halves with the mixture. Bake in a dish coated with the remaining 2 tablespoons of oil. Bake for about 30 minutes. Serves 8.
Success Story of the Month: 90 Days to Better Health
Dear Dr. Cordain, Thank you for your work on Paleolithic eating. Here is my experience with removing virtually all grains and legumes from my diet for the past 90 days. I do continue to drink less than one glass of skim milk per day and eat perhaps 8 oz of sheep and/or goat cheese per week. I eat seafood at least twice per week and eat until satisfaction a good quantity of lean meats, whole fruits, and non-starchy vegetables. In between snacks are a trail mix of walnuts and other assorted nuts (all raw) and chopped fruits. I am a 54 year old male in good overall health except having been on Lisinapril for three years for blood pressure of 130/90 (unmedicated). Height is 67″. Here are before and after statistics: Start: Weight: 178 BMI: 27.9 Chol Tot 182, HDL 48, Tot/HDL 3.79, LDL 109, Tri 128, Gluc 92 (fasting) After 90 days: Weight: 158 BMI: 24.9 Chol Tot 180, HDL 60, Tot/HDL 3.00, LDL 105, Tri 77, Gluc 93 (not fasting) My doctor and I were very pleased with the 20 pound weight loss, reduction in blood pressure (about 10 points) and significant improvement in HDL and Triglycerides after just 90 days. He is reducing the Lisinapril dosage, and I should be off of it in a month. I’m also looking forward to continuing dropping more weight. This is the first time in my adult life that I have felt in control of my weight and blood chemistry. Thank you for your part in researching and publicizing this way of eating. Sincerely, Bob S. References http://www.uga.edu/rootandtubercrops/English/ http://www.mypyramid.gov/ Cordain L, Eades MR, Eades MD. Hyperinsulinemic diseases of civilization: more than just syndrome X. Comp Biochem Physiol Part A 2003;136:95-112. Cordain L, Eaton SB, Sebastian A, Mann N, Lindeberg S, Watkins BA, O’Keefe JH, Brand-Miller J. Origins and evolution of the Western diet: health implications for the 21st century. Am J Clin Nutr. 2005 Feb;81(2):341-54. Foster-Powell K, Holt SH, Brand-Miller JC. International table of glycemic index and glycemic load values: 2002. Am J Clin Nutr. 2002 Jul

Pets and cleaning agents

I like clean, but am not a germ freak and do not use bacterial soap nor am I big on disinfectants.  But I am considered odd by many in that I do make my own colloidal silver, distill my drinking water and delight in making fermented veggies.  Until I read this article which I acquired from the Vitality Science people in the current Dr Clark Newsletter,   it hadn’t occurred to me to use colloidal silver as a cleaning agent.  I use it a lot for so many things which is why I started to make it because it CAN be costly to buy in any quantity.    My little 10# Heidi is so precious to me that I appreciate the advice given here.     Jan

Pet Health and Household Cleaning Agents

Jan & Heidi

Here’s a common complaint we hear: My pet is sick and my vet can’t figure out why. Many times, it is not their fault! They are trained to treat the symptoms that stem from something that is likely to be temporary condition; no way can they effectively treat constant health threats like household cleaners or air fresheners.

Health threats? Yes, the very products you use to clean your home and freshen the air can make your pets sick- really sick! Think about it: Household cleaning products and air-fresheners are made with chemicals, or combinations of chemicals. Most of the labels tell us they are harmful if swallowed, or if they get in your eye, open cuts… Granted that is not likely to happen, but what about constant exposure to their fumes? Illnesses like frequent headaches, loss of energy, dizziness can all be attributed to inhaling toxic chemicals. Individually they “may” be safe, but in most homes pet are being bombarded. “How much exposure is too much?”

Even if you have never experienced any of the afore mentioned symptoms, what about your pets? Their exposure is 5-7 times greater than your own. Keep in mind your pet’s nose is thousands of times more sensitive than yours, and that one of our years is the equivalent of 5-7 of theirs! Unfortunately, they can’t say “Hey, something is burning my eyes, my nose, my mouth, or my paws!” or, “All of a sudden I’m not feeling good!” Their likely reaction is to move to a different resting place, or to sleep more than usual.

Household Cleaners

Household Cleaners can be very toxic, but the tendency is to use a more concentrated cleaner for the areas your pet frequents in an effort to protect your pet and your family. People who are unable to keep pace with pet odor, often place multiple air-fresheners near their pet’s bedding and resting places. When they finally get around to cleaning, they are far more likely to use highly concentrated products.

Imagine you are your pet

You spend most of your home life at floor level, where fumes and germs are the most concentrated. Toxic chemicals used in cleaners, disinfectants, and air-fresheners can burn your lungs, and eyes. They can cause the pads of your feet to burn. In response, your pet licks their pads (often incessantly), not only are they burning his mouth, he (or she) is ingesting them. This is often an unknown cause of diarrhea, vomiting, and numerous misdiagnoses!

The Good News is that you can make your pet areas clean and germ-free without exposing your family or your pet to toxic chemicals. I personally use colloidal silver mixed with 3% hydrogen peroxide to disinfectant everything that comes into my house. Colloidal silver has many scientifically proven medicinal uses, but it is expensive. You can buy a relatively inexpensive colloidal silver generating machines are available that will produce all the colloidal silver any size family needs. But here is an inexpensive technique that will give you the peace of mind that the areas of concern are germ free and smell fresh.

Susan Sumner, a food scientist at Virginia Polytechnic Institute and State University, developed a cleaning and sanitizing combination consisting of 3% hydrogen peroxide (available at the drug store), and white vinegar; each was placed in separate spray bottles.

In tests performed on heavily contaminated food and food surfaces, the combined strength of the two mists killed virtually all Salmonella, Shigella, or E. coli bacteria, making this spray combination more effective at killing these potentially lethal bacteria than chlorine bleach, or any commercially available kitchen cleaner!

The best results came from using one mist right after the other- collectively being ten times more effective than using either spray by itself, or than mixing the vinegar and hydrogen peroxide in one sprayer.

Cleaning Fruits or Vegetables

When cleaning fruit or vegetables, liberally spray with both the vinegar and the hydrogen peroxide, leave for 2 minutes, and then rinse under running water, preferably filtered, alkalinized, or purified. Either the vinegar or the hydrogen peroxide may be applied first. There is no after taste, or toxic residue.

Buying in bulk saves money. Gallon jugs of concentrated hydrogen peroxide are available from beauty supply stores, but must be handled with gloves, and carefully diluted with distilled water. Exact measurements are very important to achieve the proper 3% dilution. If you make a gallon at a time, you can use some to mop floors, put some in a spray bottle to disinfect food and water bowls, litter boxes, the air, bathroom and fixtures, door handles, countertops, sponges, fruits and vegetables, cutting boards, sponges, bedding, walls, remote controls, cell phones… Fill another spray bottle with plain white vinegar to use as a cleaner.

The burning question (no pun intended) is “Why have we gotten away from inexpensive, basic, safe, yet effective cleaners and replaced them with potentially harmful off-the-shelf household cleaners and air-fresheners?” Clearly, Madison Avenue is very good at what they do, but at whose expense?

Author: Robert Hart, Vice President of Vitality Science. His articles have been published in Fido Friendly, Natural Awakenings, plus numerous pet websites and newsletters including; Barkley and Paws, Pet Guardian Angels, Truth About Pet Food, Ani-Med, Professors House, Pet Style, and Mystic Pop.

Vitality Science formulates clinically proven, all-natural, remedies, supplements and treatment resistant programs for cats and dogs. To watch their videos or learn more visit www.vitalityscience.com

Hurts like hell – but stuff happens

Boy says first words since beaning

HOLKO FAMILY PHOTO
A November photo shows Luke Holko, the Warren, Ohio, 4-year-old who was hit in the head by a foul ball at a minor-league game in September, with his mother, Nicole.

4-year-old who nearly died spurs baseball fans to donate $24,000

By Matt Leingang
ASSOCIATED PRESS

WARREN, Ohio — A 4-year-old boy who was hit in the head by a foul ball at a minor-league baseball game in September spoke his first words since the accident this week, a major breakthrough in his recovery from an injury that nearly killed him.
Luke Holko, whose fractured skull and brain injury spurred fans to donate $24,000 at ballparks to help the family with medical bills, told his mother he wanted “more” crackers during snack time Tuesday night, his father said.
The boy also can say “no.”

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Verbal communication is a sign that Luke’s brain is making new nerve connections to overcome tissue that was destroyed by the ball’s impact, said Dr. Micah Baird, a physical medicine specialist overseeing the boy’s rehabilitation at Akron Children’s Hospital.   Though his long-term prognosis remains uncertain, Luke, whose injury initially left him in a coma and unable to move, has reached a series of important milestones this month, Baird said. He can crawl, sit and roll, and he’s able to use a walker with little assistance.    “Little by little, our Luke is coming back,” said his father, Chad Holko.

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Luke and his parents had front-row seats near first base for a Sept. 2 doubleheader at the home of the Mahoning Valley Scrappers, a short-season Class A affiliate of the Cleveland Indians.   The boy was hit in the back of the head as he sat in his father’s lap and immediately fell limp. A horrified crowd watched his father run up the stands to meet paramedics stationed at the ballpark.

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The injury destroyed tissue in Luke’s cerebellum and brain stem, but the front of the brain, which controls thinking, decision-making and personality, was not injured, Baird said.

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Luke’s progress is a comfort to Ben Carlson, who hit the foul ball. Carlson, a first baseman out of Missouri State who was drafted by the Indians in the sixth round of the June draft, said he’s using Luke’s recovery as motivation in his offseason workouts at home in Topeka, Kan.   “I’m working hard for him because I know he’s working hard to get back to where he was,” said Carlson, who cried with the Holko family during hospital visits in the weeks after the accident. He stays in touch with phone calls to the family and reads a daily blog on Luke’s recovery posted by the boy’s mother, Nicole.

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Nicole Holko, who recently left a job as a medical assistant, drives Luke 40 miles from their home near Warren to Akron, where for five days each week he gets six hours of physical, occupational and speech therapy.   The family doesn’t blame Carlson for the accident.    But the family is interested in improving safety at baseball games and would like to see netting extended from home plate to foul territory, Chad Holko said.

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Scrappers general manager Dave Smith said the organization has had discussions about the issue. The debate at all professional levels is whether extended netting would interfere too much with fans’ view, he said. Teams have been unwilling to keep data on fan injuries to further protect themselves against liability, said Robert Gorman, a librarian and baseball historian at Winthrop University in Rock Hill, S.C.    “It’s what I call the ‘ignorance is bliss’ defense: If you don’t know, then it becomes harder to hold you legally accountable,” said Gorman, who co-wrote the 2008 book  Death at the Ballpark.

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Using old newspaper clippings and Internet searches, Gorman documented 52 fan deaths from foul balls from 1867 to 2007 — 49 at amateur games and one each in the major leagues, minor leagues and Negro leagues.    The Scrappers are eager to welcome Luke back to a game, Smith said. The team, along with others in the New York-Penn League, collected the $24,000 in fan donations.    Banks, restaurants, firefighters and community groups have chipped in, too.

Paleo – ancient grain use

(No bells or whistles here, just an intelligent response to a request for his opinion.  Thought it should be shared)

Dr. Cordain was recently asked to comment on the articles
entitled “Mozambican Grass Seed Consumption During the
Middle Stone Age” by Julio Mercader in the journal Science,
and “Humans feasting on grains for at least 100,000 years,”
by Katherine Harmon Scientific American. Both articles cite
evidence that humans consumed grain much earlier than was
previously thought.

Dr. Cordain’s response:

This is an interesting paper ( Mercader J. Mozambican grass
seed consumption during the middle stone age. Science
2009;326:1680-83) as it may push probable (but clearly not
definite) cereal grain consumption by hominins back to at least
105,000 years ago. Prior to this evidence, the earliest
exploitation of wild cereal grains was reported by Piperno
and colleagues at Ohalo II in Israel and dating to ~23,500
years ago (Nature 2004;430:670-73). As opposed to the Ohalo
II data in which a large saddle stone was discovered with
obvious repetitive grinding marks and embedded starch granules
attributed to a variety of grains and seeds that were
concurrently present with the artifact , the data from
Ngalue is less convincing for the use of cereal grains
as seasonal food. No associated intact grass seeds have been
discovered in the cave at Ngalue, nor were anvil stones
with repetitive grinding marks found. Hence, at best,
the data suggests sporadic use (and not necessarily
consumption) of grains at this early date. Clearly, large
scale processing of sorghum for consumption for extended
periods seems unlikely.

Further, It should be pointed out that consumption of wild
grass seeds of any kind requires extensive technology and
processing to yield a digestible and edible food that likely
did not exist 105,000 years ago. Harvesting of wild
grass seeds without some kind of technology (e.g.
sickles and scythes [not present at this time]) is
tedious and difficult at best. Additionally, containers
of some sort (baskets [not present at this time], pottery
[not present] or animal skin containers are needed to
collect the tiny grains. Many grain species require
flailing to separate the seed from the chaff and then
further winnowing ([baskets not present]), or animal
skins] to separate the seeds from the chaff. Intact
grains are not digestible by humans unless they are
first ground into a flour (which breaks down the cell
walls), and then cooked (typically in water – e.g.
boiling [technology not present]) or parched in a
fire which gelatinizes the starch granules, and thereby
makes them available for digestion and absorption. Because
each and every one of these processing steps requires
additional energy on the part of the gatherer, most
contemporary hunter gatherers did not exploit grains
except as starvation foods because they yielded such
little energy relative to the energy obtained (optimal
foraging theory).

If indeed the grinder/core axes with telltale starch
granules were used to make flour from sorghum seeds,
then the flour still had to be cooked to gelatinize the
starch granules to make it digestible. In Neolithic
peoples, grass seed flour most typically is mixed with
water to make a paste (dough) that is then cooked into flat
breads. It is highly unlikely that the technology or the
behavioral sophistication existed 105,000 years ago to
make flat breads. Whole grains can be parched intact
in fires, but this process is less effective than making
flour into a paste and cooking it to gelatinize the starch
granules. Hence, it is difficult to reconcile the chain of
events proposed by the authors (appearance of sorghum starch
granules on cobbles or grinders = pounding or grinding of
sorghum grains = consumption of sorghum). I wouldn’t hang
my hat on this evidence indicating grains were necessarily
consumed by hominins at this early date. To my mind, the
Ohalo II data still represents the best earliest evidence
for grain consumption by hominins.

Cordially,
Loren Cordain, Ph.D., Professor

Paleo Diet Enterprises LLC

TOXIC WOMBS…. my god!

NATURAL HEALTH  usa

Are Mothers-To-Be Unwittingly Passing BPA and other chemicals to their Unborn babies? And When Will the FDA Wake Up To These Dangers?

Consider these sobering facts:

• Children exposed to both tobacco smoke and lead are 800 percent more likely to develop ADHD.

• Childhood exposure to lead can cause permanent brain damage to those genetically susceptible. No region of the brain is spared.

• Adults with an average age of 21 who had been enrolled as infants in the Cincinnati Lead Study had IQ deficiencies as well as histories of juvenile delinquency and criminal arrests.

• Baby boys whose mothers used insect repellants in the first three months of pregnancy were at an increased risk of a birth defect called hypospadias (the urethra, which carries urine from the bladder to the opening of the penis, is shortened).

• A study of pregnant women by the Washington Toxics Coalition learned that:

* Every woman tested had been exposed to Bisphenol A (BPA), which is linked to a number of adverse health effects. BPA has been found in the lining of nearly every kind of food container, baby bottles, dental sealants and composite fillings, among other products.

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* Every woman tested had been exposed to at least two — and in some cases, to as many as four — perfluorinated chemicals. Known as Teflon chemicals, these are used in manufacturing nonstick cookware.

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* Every woman had been exposed to mercury, which is known to harm the development of the brain in the unborn.

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* Every woman had been exposed to at least four phthalates, which are linked to adverse health effects. Phthalates are used to make fragrances last longer and also to soften plastic in personal-care products, shower curtains, baby toys, etc.

The Seattle Post Globe published a story about one mother who took part in the Washington Toxics Coalition study. Trained as a midwife, while pregnant she walked a 3-mile trail twice a week, swam weekly, took prenatal yoga classes, tried to eat mostly organic foods and avoided any scented lotions or other personal-care products. And yet, she rated the worst among the women tested for Teflon chemicals. An advocate of breast-feeding, she now worries that while breast-feeding to insure optimal nutrition for her infant son, she will pass chemicals along to him in her breast milk as she did, unwittingly, through her placenta.

Johns Hopkins University’s study of cord blood samples from 20 newborns revealed hundreds of chemicals, this from cord blood most of us would expect to be uncontaminated. With only about 200 of the 80,000 chemicals in our environment having been tested for their effects on humans, the American population is unknowingly taking part in an experiment. Dr. Phil Landrigan of Mt. Sinai School of Medicine has warned the medical community that 1 in 6 American children is now behavior- or learning-disabled because of exposure to chemicals. To add to this gloomy picture, studies have shown that genes are turned on or off by environmental factors, so future generations will also be impacted.

All children deserve the best protection we can provide, but the government is failing to shield our most vulnerable population — the unborn — from chemicals in the environment.

bottles, deoderant, soap nuts. .

This is meant to be a tie-in to the TOXIC WOMBS…. . . my god!  post of this same day..

I don’t do this, normally, but I have recently used this company I found on-line to purchase my “natural deoderant stone” which is the way I do it and have for maybe 20 years.  It works for me.  Not anti-perspirant of course, but gets the job done with no harm to my body (decided to leave aluminum behind years ago).  I was pleasantly surprised to find they have some pretty  interesting sounding stuff which I want to try.    Specifically,  the SOAP NUTS   and the beautifully priced STAINLESS STEEL  bottles (including baby bottles).   I’m not going to sell them to you – - if you are interested, go to their site and see for yourself:  greenvirginproducts.com.    So if anyone in your house needs a  possible way to lessen your “toxic load” like BPA’s,  this might be something to think about.     Jan  (I love their name!)

Should we worry, or not?

2 risky chemicals in most of us

By Doug Caruso
THE COLUMBUS DISPATCH

Chemicals used to make plastic bottles and Teflon are so widespread that government health officials found them in most Americans it tested.

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For the first time, the Centers for Disease Control and Prevention included tests for the chemicals — called bisphenol A and C8 — in its fourth National Report on Human Exposure to Environmental Chemicals.    The CDC report does not say that the levels of the chemicals found in the tests are dangerous, but a growing body of research says the chemicals are linked to health problems. In all, 212 chemicals were studied in the CDC report.   “We have widespread exposure among the U.S. population,” said Dr. Anila Jacob, senior scientist for the Environmental Working Group, which has conduct ed its own studies on people’s exposure to chemicals.   “We should really be sure they’re tested for health and safety,” Jacob said.

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Bisphenol A, or BPA, has been in the news recently because of reports that it seeps out of baby bottles, water bottles and other plastic containers.   The chemical is the subject of about $8.6 million in research projects at the University of Cincinnati, said Scott Belcher, an associate professor in pharmacology and cell biophysics there.    The CDC said it found the chemical in “more than 90 percent” of the people it tested. The report also said most participants had measurable levels of C8 in their blood.

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Researchers have been studying C8 since high levels were found in water supplies in southern Ohio across the Ohio River from a DuPont plant that makes Teflon in West Virginia.    The U.S. Environmental Protection Agency has labeled C8 a “likely carcinogen.” DuPont has pledged to phase out its use by 2015 while saying the chemical is safe.

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The American Chemistry Council, an industry group, said the CDC report shows that the levels of chemicals found in most Americans are not dangerous.    “Like the previous three studies, the CDC report … reaffirms that levels of manmade and natural compounds detected in Americans remain low,” a council news release said.

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But Belcher said studies in animals show that concentrations of BPA near the levels that the CDC finds in humans cause heart problems in females and delay brain development in the young. Other studies have linked contamination to sexual dysfunction in men.    Belcher and other researchers are seeing effects in animals at concentrations far below the 50 parts per billion the U.S. Food and Drug Administration deems safe in food.

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The CDC found that 95 percent of people had 16 parts per billion or less in their urine. The average amount found was 2.6 parts per billion.    “What people think is a very, very low level has the possibility of not being safe,” Belcher said.
That’s because the chemical affects the body’s hormonal system. “Hormones naturally occurring in the body work at amazingly low levels,” he said.
Although the CDC treats each chemical it studies individually, both Belcher and Jacob said, it’s important to remember that most people are exposed to numerous chemicals, and that these interactions are largely unknown.    Belcher said he is trying to determine the effects of a combination of BPA with another ubiquitous chemical called BDE-47, which is widely used in flame retardants. The CDC found that chemical in the blood of “nearly all” the participants in its study.    “It’s easy to forget that multiple chemicals can be found in one individual,” Jacob said. “Consider the individual who’s being exposed to multiple chemicals at a time.”

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The report had good news, too: Far fewer children have been found with dangerous levels of lead in their blood. In the first such report, which looked at levels for 1976 to 1980, 88.2 percent of children ages 1 to 5 had elevated lead levels. In this report, 1.4 percent of children had elevated lead levels.   Columbus Public Health tests in 2006 found that of 10,407 children screened, 88, or fewer than 1 percent, had a high lead level in their blood.    The CDC noted that children living in older houses with lead paint are still in significant danger of ingesting too much lead.    Lead was removed from paint and gasoline years ago.

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Jacob, with the Environmental Working Group, said the improvement in lead levels shows that efforts to reduce contaminants in the environment can work.    “That’s a really good lesson for all of us to learn,” she said. “It shows that if we take the effort, we can decrease the levels in people.”
dcaruso@dispatch.com

TOXIC WATERS

This article from the NEW YORK TIMES is tied in with the previous article regarding Dr. Clark’ s research on Water.

That Tap Water Is Legal but May Be Unhealthy

Irfan Khan/The Los Angeles Times, via Associated Press

This Los Angeles reservoir contained chemicals that sunlight converted to compounds associated with cancer. The city used plastic balls to block the sun, but nearby homeowners asked why, if the water didn’t violate the law.

By CHARLES DUHIGG

Published: December 16, 2009

The 35-year-old federal law regulating tap water is so out of date that the water Americans drink can pose what scientists say are serious health risks — and still be legal.

Toxic Waters

Outdated Laws: Articles in this series are examining the worsening pollution in American waters, and regulators’ response.

Examine whether contaminants in your water supply met two standards: the legal limits established by the Safe Drinking Water Act, and the typically stricter health guidelines.

What’s in Your Water

The data was collected by an advocacy organization, the Environmental Working Group, who shared it with The Times.

Multimedia

In Los Angeles, a Struggle Over Water Quality

Contaminants in Drinking Water

Only 91 contaminants are regulated by the Safe Drinking Water Act, yet more than 60,000 chemicals are used within the United States, according to Environmental Protection Agency estimates. Government and independent scientists have scrutinized thousands of those chemicals in recent decades, and identified hundreds associated with a risk of cancer and other diseases at small concentrations in drinking water, according to an analysis of government records by The New York Times.

But not one chemical has been added to the list of those regulated by the Safe Drinking Water Act since 2000.

Other recent studies have found that even some chemicals regulated by that law pose risks at much smaller concentrations than previously known. However, many of the act’s standards for those chemicals have not been updated since the 1980s, and some remain essentially unchanged since the law was passed in 1974.

All told, more than 62 million Americans have been exposed since 2004 to drinking water that did not meet at least one commonly used government health guideline intended to help protect people from cancer or serious disease, according to an analysis by The Times of more than 19 million drinking-water test results from the District of Columbia and the 45 states that made data available.

In some cases, people have been exposed for years to water that did not meet those guidelines.

But because such guidelines were never incorporated into the Safe Drinking Water Act, the vast majority of that water never violated the law.

Some officials overseeing local water systems have tried to go above and beyond what is legally required. But they have encountered resistance, sometimes from the very residents they are trying to protect, who say that if their water is legal it must be safe.

Dr. Pankaj Parekh, director of the water quality division for the City of Los Angeles, has faced such criticism. The water in some city reservoirs has contained contaminants that become likely cancer-causing compounds when exposed to sunlight.

To stop the carcinogens from forming, the city covered the surface of reservoirs, including one in the upscale neighborhood of Silver Lake, with a blanket of black plastic balls that blocked the sun.

Then complaints started from owners of expensive houses around the reservoir. “They supposedly discovered these chemicals, and then they ruined the reservoir by putting black pimples all over it,” said Laurie Pepper, whose home overlooks the manmade lake. “If the water is so dangerous, why can’t they tell us what laws it’s violated?”

Dr. Parekh has struggled to make his case. “People don’t understand that just because water is technically legal, it can still present health risks,” he said. “And so we encounter opposition that can become very personal.”

Some federal regulators have tried to help officials like Dr. Parekh by pushing to tighten drinking water standards for chemicals like industrial solvents, as well as a rocket fuel additive that has polluted drinking water sources in Southern California and elsewhere. But those efforts have often been blocked by industry lobbying.

Drinking water that does not meet a federal health guideline will not necessarily make someone ill. Many contaminants are hazardous only if consumed for years. And some researchers argue that even toxic chemicals, when consumed at extremely low doses over long periods, pose few risks. Others argue that the cost of removing minute concentrations of chemicals from drinking water does not equal the benefits.

Moreover, many of the thousands of chemicals that have not been analyzed may be harmless. And researchers caution that such science is complicated, often based on extrapolations from animal studies, and sometimes hard to apply nationwide, particularly given that more than 57,400 water systems in this country each deliver, essentially, a different glass of water every day.

Government scientists now generally agree, however, that many chemicals commonly found in drinking water pose serious risks at low concentrations.

And independent studies in such journals as Reviews of Environmental Contamination and Toxicology; Environmental Health Perspectives; American Journal of Public Health; and Archives of Environmental and Occupational Health, as well as reports published by the National Academy of Sciences, suggest that millions of Americans become sick each year from drinking contaminated water, with maladies from upset stomachs to cancer and birth defects.