Pharmaceutical Manufacturing
Pharmaceutical companies, which develop both over-the-counter and prescription drugs, have been among the biggest political spenders for years. While the industry has traditionally supported Republican candidates, some key players have recently increased donations to Democratic candidates as the GOP’s power in Washington erodes.
The pharmaceutical manufacturing industry will likely fair better this decade now that President Barack Obama’s initial plan to institute a public health insurance did not become a part of sweeping health care reform legislation signed into law in 2010. A government-run plan, because of its size, would have had considerable negotiating power to draw down drug prices. [Read more Background]
Top Contributors, 2011-2012
Contributor Amount Pfizer Inc $702,391
Amgen Inc AstraZeneca PLC Abbott Laboratories Merck & Co GlaxoSmithKline Eli Lilly & Co Novartis AG Bayer Corp Endo Pharmaceuticals Perrigo Co Mutual Pharmaceutical Allergan Inc Teva Pharmaceuticals USA Sanofi-Aventis Bristol-Myers Squibb Pharmaceutical Rsrch & Mfrs of America Nostrum Pharmaceuticals Cephalon Inc Takeda Pharmaceuticals North America
Contribution Trends, 1990-2010
Lobbying Totals, 1998-2010
Party Split, 1990-2010
Top Recipients, 2011-2012
Candidate Office Amount Obama, Barack (D) $129,139
Romney, Mitt (R) $89,300
Upton, Fred (R-MI) House Brown, Scott P (R-MA) Senate Hatch, Orrin G (R-UT) Senate
Average Contributions to Members of Congress, 1990-2010
Data for the current election cycle were released by the Federal Election Commission on Monday, February 13, 2012
Feel free to distribute or cite this material, but please credit the Center for Responsive Politics.
Harvard Medical School found that 1 in 10 premature deaths is caused by eating red meat:
Small quantities of processed meat such as bacon, sausages or salami can increase the likelihood of dying by a fifth, researchers from Harvard School of Medicine found. Eating steak increases the risk of dying by 12%.
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Red meat often contains high amounts of saturated fat, while bacon and salami contain large amounts of salt. Replacing red meat with poultry, fish or vegetables, whole grains and other healthy foods cut the risk of dying by up to one fifth, the study found.
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The study published in the Archives of Internal Medicine followed more than 100,000 people for around 28 years asking them periodically about their diet and lifestyle.
It was found that for every serving of red meat – equivalent to 3 ounces (85 grams) – eaten each day there was an 18 per cent increased risk of dying from heart disease and a 10 per cent increased risk of dying from cancer.
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“The research itself seems solid and is based on two large scale cohort studies monitored over a long period of time.”
Other studies have also found that eating too much meat causes cancer and other health problems.
But how much of the problem isn’t red meat … but the fact that what we’re eating isn’t what our grandparents wouldn’t even recognize as meat at all?
For all of human history – until the last couple of decades – people ate beef from cows (or buffalo or bison) which grazed on grass. The cows were usually strong and healthy. Their meat was lean, with very little saturated fat, as the critters ate well and got outdoor exercise. Their meat was high in good Omega 3 fats. See this and this, and humans evolved to consume a lot of Omega 3 fatty acids in the wild game and fish which they ate (more).
Today, on the other hand, beef is laden with saturated fat and almost entirely lacking healthy fats like Omega 3s, because the cows are force-fed food which makes them sick. Specifically, instead of their natural menu - grass - they are force-fed corn, which makes them sick. Because their diet makes them ill, they are given massive amounts of antibiotics. Even with the antibiotics, the diet and living conditions would kill them pretty quickly if they aren't slaughtered.
They are also given estrogen to fatten them up. And they are fed parts of other animals, which can give them mad cow disease.
Well-known food writer (and meat-lover) Michael Pollan gave a must-read account of modern beef practices in the New York Times in 2002:
Cows raised on grass simply take longer to reach slaughter weight than cows raised on a richer diet, and the modern meat industry has devoted itself to shortening a beef calf’s allotted time on earth. ”In my grandfather’s day, steers were 4 or 5 years old at slaughter” …. now we get there at 14 to 16 months.” Fast food indeed. What gets a beef calf from 80 to 1,200 pounds in 14 months are enormous quantities of corn, protein supplements — and drugs, including growth hormones.
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Calves have no need of regular medication while on grass, but as soon as they’re placed in the backgrounding pen, they’re apt to get sick. Why? The stress of weaning is a factor, but the main culprit is the feed. The shift to a ”hot ration” of grain can so disturb the cow’s digestive process — its rumen, in particular — that it can kill the animal if not managed carefully and accompanied by antibiotics.
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Growing the vast quantities of corn used to feed livestock in this country takes vast quantities of chemical fertilizer, which in turn takes vast quantities of oil — 1.2 gallons for every bushel. So the modern feedlot is really a city floating on a sea of oil.
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Tanker trucks back up to silo-shaped tanks, into which they pump thousands of gallons of liquefied fat and protein supplement. In a shed attached to the mill sit vats of liquid vitamins and synthetic estrogen; next to these are pallets stacked with 50-pound sacks of Rumensin and tylosin, another antibiotic.
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Corn is a mainstay of livestock diets because there is no other feed quite as cheap or plentiful: thanks to federal subsidies and ever-growing surpluses, the price of corn ($2.25 a bushel) is 50 cents less than the cost of growing it. The rise of the modern factory farm is a direct result of these surpluses, which soared in the years following World War II, when petrochemical fertilizers came into widespread use. Ever since, the U.S.D.A.’s policy has been to help farmers dispose of surplus corn by passing as much of it as possible through the digestive tracts of food animals, converting it into protein. Compared with grass or hay, corn is a compact and portable foodstuff, making it possible to feed tens of thousands of animals on small plots of land. Without cheap corn, the modern urbanization of livestock would probably never have occurred.
We have come to think of ”cornfed” as some kind of old-fashioned virtue; we shouldn’t. Granted, a cornfed cow develops well-marbled flesh, giving it a taste and texture American consumers have learned to like. Yet this meat is demonstrably less healthy to eat, since it contains more saturated fat. A recent study in The European Journal of Clinical Nutrition found that the meat of grass-fed livestock not only had substantially less fat than grain-fed meat but that the type of fats found in grass-fed meat were much healthier. (Grass-fed meat has more omega 3 fatty acids and fewer omega 6, which is believed to promote heart disease; it also contains betacarotine and CLA, another ”good” fat.) A growing body of research suggests that many of the health problems associated with eating beef are really problems with cornfed beef. In the same way ruminants have not evolved to eat grain, humans may not be well adapted to eating grain-fed animals. Yet the U.S.D.A.’s grading system continues to reward marbling — that is, intermuscular fat — and thus the feeding of corn to cows.
The economic logic behind corn is unassailable, and on a factory farm, there is no other kind. Calories are calories, and corn is the cheapest, most convenient source of calories. Of course the identical industrial logic — protein is protein — led to the feeding of rendered cow parts back to cows, a practice the F.D.A. banned in 1997 after scientists realized it was spreading mad-cow disease.
Make that mostly banned. The F.D.A.’s rules against feeding ruminant protein to ruminants make exceptions for ”blood products” (even though they contain protein) and fat. Indeed, my steer has probably dined on beef tallow recycled from the very slaughterhouse he’s heading to in June. ”Fat is fat,” the feedlot manager shrugged when I raised an eyebrow.
F.D.A. rules still permit feedlots to feed nonruminant animal protein to cows. (Feather meal is an accepted cattle feed, as are pig and fish protein and chicken manure.) Some public-health advocates worry that since the bovine meat and bone meal that cows used to eat is now being fed to chickens, pigs and fish, infectious prions could find their way back into cattle when they eat the protein of the animals that have been eating them. To close this biological loophole, the F.D.A. is now considering tightening its feed rules.
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”When we buy supplement, the supplier says it’s 40 percent protein, but they don’t specify beyond that.” When I called the supplier, it wouldn’t divulge all its ”proprietary ingredients” but promised that animal parts weren’t among them. Protein is pretty much still protein.
Compared with ground-up cow bones, corn seems positively wholesome. Yet it wreaks considerable havoc on bovine digestion. During my day at Poky, I spent an hour or two driving around the yard with Dr. Mel Metzen, the staff veterinarian. Metzen, a 1997 graduate of Kansas State’s vet school, oversees a team of eight cowboys who spend their days riding the yard, spotting sick cows and bringing them in for treatment. A great many of their health problems can be traced to their diet. ”They’re made to eat forage,” Metzen said, ”and we’re making them eat grain.”
Perhaps the most serious thing that can go wrong with a ruminant on corn is feedlot bloat. The rumen is always producing copious amounts of gas, which is normally expelled by belching during rumination. But when the diet contains too much starch and too little roughage, rumination all but stops, and a layer of foamy slime that can trap gas forms in the rumen. The rumen inflates like a balloon, pressing against the animal’s lungs. Unless action is promptly taken to relieve the pressure (usually by forcing a hose down the animal’s esophagus), the cow suffocates.
A corn diet can also give a cow acidosis. Unlike that in our own highly acidic stomachs, the normal pH of a rumen is neutral. Corn makes it unnaturally acidic, however, causing a kind of bovine heartburn, which in some cases can kill the animal but usually just makes it sick. Acidotic animals go off their feed, pant and salivate excessively, paw at their bellies and eat dirt. The condition can lead to diarrhea, ulcers, bloat, liver disease and a general weakening of the immune system that leaves the animal vulnerable to everything from pneumonia to feedlot polio.
Cows rarely live on feedlot diets for more than six months, which might be about as much as their digestive systems can tolerate. ”I don’t know how long you could feed this ration before you’d see problems,” Metzen said; another vet said that a sustained feedlot diet would eventually ”blow out their livers” and kill them. As the acids eat away at the rumen wall, bacteria enter the bloodstream and collect in the liver. More than 13 percent of feedlot cattle are found at slaughter to have abscessed livers.
What keeps a feedlot animal healthy — or healthy enough — are antibiotics. Rumensin inhibits gas production in the rumen, helping to prevent bloat; tylosin reduces the incidence of liver infection. Most of the antibiotics sold in America end up in animal feed — a practice that, it is now generally acknowledged, leads directly to the evolution of new antibiotic-resistant ”superbugs.” In the debate over the use of antibiotics in agriculture, a distinction is usually made between clinical and nonclinical uses. Public-health advocates don’t object to treating sick animals with antibiotics; they just don’t want to see the drugs lose their efficacy because factory farms are feeding them to healthy animals to promote growth. But the use of antibiotics in feedlot cattle confounds this distinction. Here the drugs are plainly being used to treat sick animals, yet the animals probably wouldn’t be sick if not for what we feed them.
I asked Metzen what would happen if antibiotics were banned from cattle feed. ”We just couldn’t feed them as hard,” he said. ”Or we’d have a higher death loss.” (Less than 3 percent of cattle die on the feedlot.) The price of beef would rise, he said, since the whole system would have to slow down.
”Hell, if you gave them lots of grass and space,” he concluded dryly, ”I wouldn’t have a job.”
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I stopped by the shed where recent arrivals receive their hormone implants. The calves are funneled into a chute, herded along by a ranch hand wielding an electric prod, then clutched in a restrainer just long enough for another hand to inject a slow-release pellet of Revlar, a synthetic estrogen, in the back of the ear. [This] is virtually a universal practice in the cattle industry in the United States. (It has been banned in the European Union.)
American regulators permit hormone implants on the grounds that no risk to human health has been proved, even though measurable hormone residues do turn up in the meat we eat. These contribute to the buildup of estrogenic compounds in the environment, which some scientists believe may explain falling sperm counts and premature maturation in girls. Recent studies have also found elevated levels of synthetic growth hormones in feedlot wastes; these persistent chemicals eventually wind up in the waterways downstream of feedlots, where scientists have found fish exhibiting abnormal sex characteristics.
The F.D.A. is opening an inquiry into the problem, but for now, implanting hormones in beef cattle is legal and financially irresistible: an implant costs $1.50 and adds between 40 and 50 pounds to the weight of a steer at slaughter, for a return of at least $25.
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The unnaturally rich diet of corn that has compromised [the cow's] health is fattening his flesh in a way that in turn may compromise the health of the humans who will eat him. The antibiotics he’s consuming with his corn were at that very moment selecting, in his gut and wherever else in the environment they wind up, for bacteria that could someday infect us and resist the drugs we depend on. We inhabit the same microbial ecosystem as the animals we eat, and whatever happens to it also happens to us.
I thought about the deep pile of manure that [the cows] and I were standing in. We don’t know much about the hormones in it — where they will end up or what they might do once they get there — but we do know something about the bacteria. One particularly lethal bug most probably resided in the manure beneath my feet. Escherichia coli 0157 is a relatively new strain of a common intestinal bacteria (it was first isolated in the 1980′s) that is common in feedlot cattle, more than half of whom carry it in their guts. Ingesting as few as 10 of these microbes can cause a fatal infection.
Most of the microbes that reside in the gut of a cow and find their way into our food get killed off by the acids in our stomachs, since they originally adapted to live in a neutral-pH environment. But the digestive tract of the modern feedlot cow is closer in acidity to our own, and in this new, manmade environment acid-resistant strains of E. coli have developed that can survive our stomach acids — and go on to kill us. By acidifying a cow’s gut with corn, we have broken down one of our food chain’s barriers to infection. Yet this process can be reversed: James Russell, a U.S.D.A. microbiologist, has discovered that switching a cow’s diet from corn to hay in the final days before slaughter reduces the population of E. coli 0157 in its manure by as much as 70 percent. Such a change, however, is considered wildly impractical by the cattle industry.
So much comes back to corn, this cheap feed that turns out in so many ways to be not cheap at all. While I stood in [the] pen, a dump truck pulled up alongside the feed bunk and released a golden stream of feed. The animals stepped up to the bunk for their lunch. The $1.60 a day I’m paying for three giant meals is a bargain only by the narrowest of calculations. It doesn’t take into account, for example, the cost to the public health of antibiotic resistance or food poisoning by E. coli or all the environmental costs associated with industrial corn.
For if you follow the corn from this bunk back to the fields where it grows, you will find an 80-million-acre monoculture that consumes more chemical herbicide and fertilizer than any other crop. Keep going and you can trace the nitrogen runoff from that crop all the way down the Mississippi into the Gulf of Mexico, where it has created (if that is the right word) a 12,000-square-mile ”dead zone.”
But you can go farther still, and follow the fertilizer needed to grow that corn all the way to the oil fields of the Persian Gulf. [The cow] started life as part of a food chain that derived all its energy from the sun; now that corn constitutes such an important link in his food chain, he is the product of an industrial system powered by fossil fuel. (And in turn, defended by the military — another uncounted cost of ”cheap” food.) I asked David Pimentel, a Cornell ecologist who specializes in agriculture and energy, if it might be possible to calculate precisely how much oil it will take to grow my steer to slaughter weight…. roughly 284 gallons of oil. We have succeeded in industrializing the beef calf, transforming what was once a solar-powered ruminant into the very last thing we need: another fossil-fuel machine.
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Much of what happens next — the de-hiding of the animal, the tying off of its rectum before evisceration — is designed to keep the animal’s feces from coming into contact with its meat. This is by no means easy to do, not when the animals enter the kill floor smeared with manure and 390 of them are eviscerated every hour. (Partly for this reason, European plants operate at much slower line speeds.) But since that manure is apt to contain lethal pathogens like E. coli 0157, and since the process of grinding together hamburger from hundreds of different carcasses can easily spread those pathogens across millions of burgers, packing plants now spend millions on ”food safety” — which is to say, on the problem of manure in meat.
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It’s accepted that the animals will enter the kill floor caked with feedlot manure that has been rendered lethal by the feedlot diet. Rather than try to alter that diet or keep the animals from living in their waste or slow the line speed — all changes regarded as impractical — the industry focuses on disinfecting the manure that will inevitably find its way into the meat. This is the purpose of irradiation (which the industry prefers to call ”cold pasteurization”). It is also the reason that carcasses pass through a hot steam cabinet and get sprayed with an antimicrobial solution before being hung in the cooler at the National Beef plant.
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I discovered that grass-fed meat is more expensive than supermarket beef. Whatever else you can say about industrial beef, it is remarkably cheap, and any argument for changing the system runs smack into the industry’s populist arguments. Put the animals back on grass, it is said, and prices will soar; it takes too long to raise beef on grass, and there’s not enough grass to raise them on, since the Western range lands aren’t big enough to sustain America’s 100 million head of cattle. And besides, Americans have learned to love cornfed beef. Feedlot meat is also more consistent in both taste and supply and can be harvested 12 months a year. (Grass-fed cattle tend to be harvested in the fall, since they stop gaining weight over the winter, when the grasses go dormant.)
All of this is true. The economic logic behind the feedlot system is hard to refute. And yet so is the ecological logic behind a ruminant grazing on grass. Think what would happen if we restored a portion of the Corn Belt to the tall grass prairie it once was and grazed cattle on it. No more petrochemical fertilizer, no more herbicide, no more nitrogen runoff. Yes, beef would probably be more expensive than it is now, but would that necessarily be a bad thing? Eating beef every day might not be such a smart idea anyway — for our health, for the environment. And how cheap, really, is cheap feedlot beef? Not cheap at all, when you add in the invisible costs: of antibiotic resistance, environmental degradation, heart disease, E. coli poisoning, corn subsidies, imported oil and so on. All these are costs that grass-fed beef does not incur.
In addition to antibiotics and estrogen, industrial meat operators feed other chemicals to the animals shortly before slaughter … which end up in our bodies.
As Alternet reported in 2010 that chemicals which can cause severe adverse health effects, and which have been banned in China and 159 other nations, are added to the feed of cattle, pigs and turkeys shortly before slaughter – and a lot of the chemicals are contained in the meat we eat:
The FDA approved a livestock drug banned in 160 nations and responsible for hyperactivity, muscle breakdown and 10 percent mortality in pigs, according to angry farmers who phoned the manufacturer.
The beta agonist ractopamine, a repartitioning agent that increases protein synthesis, was recruited for livestock use when researchers found the drug, used in asthma, made mice more muscular says Beef magazine.
But unlike the growth promoting antibiotics and hormones used in livestock which are withdrawn as the animal nears slaughter, ractopamine is started as the animal nears slaughter.
As much as twenty percent of Paylean, given to pigs for their last 28 days, Optaflexx, given to cattle their last 28 to 42 days and Tomax, given to turkeys their last 7 to 14 days, remains in consumer meat says author and well known veterinarian Michael W. Fox.
Though banned in Europe, Taiwan and China–more than 1,700 people were “poisoned” from eating Paylean-fed pigs since 1998 says the Sichuan Pork Trade Chamber of Commerce– ractopamine is used in 45 percent of US pigs and 30 percent of ration-fed cattle says Elanco Animal Health which manufactures all three products.
How does a drug marked, “Not for use in humans. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask” become “safe” in human food? With no washout period?
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In fact, in 2002, three years after Paylean’s approval, the FDA’s Center for Veterinary Medicine’s Office of Surveillance and Compliance accused Elanco of withholding information about “safety and effectiveness” and “adverse animal drug experiences” upon which ractopamine was approved, in a 14-page warning letter.
“Our representatives requested a complete and accurate list of all your GLP [Good Laboratory Practices] studies involving Paylean® (Ractopamine hydrochloride), including their current status as well as the names of the respective study monitors. In response, your firm supplied to our representatives multiple lists which differed in the names of the studies and their status. In addition, your firm could not locate or identify documents pertaining to some of the studies. This situation was somewhat confusing and created unneeded delays for our representatives,” wrote Gloria J. Dunnavan, Director Division of Compliance.
Where was mention of the farmer phone calls to Elanco reporting, “hyperactivity,” “dying animals,” “downer pigs” and “tying up” and “stress” syndromes, asks the FDA letter. Where was the log of phone calls that included farmers saying, “animals are down and shaking,” and “pig vomiting after eating feed with Paylean”?
But, not to worry. Despite ractopamine’s dangers and the falsified approval documents, the FDA approved ractopamine the following year for cattle–and last year for turkeys.
According to Temple Grandin, Professor of Animal Science at Colorado State University, the “indiscriminant use of Paylean (ractopamine) has contributed to an increase in downer non-ambulatory pigs,” and pigs that “are extremely difficult to move and drive.” In Holsteins, ractopamine is known for causing hoof problems, says Grandin and feedlot managers report the “outer shell of the hoof fell off” on a related beta agonist drug, zilpateral.
A[n] article in the 2003 Journal of Animal Science confirms that “ractopamine does affect the behavior, heart rate and catecholamine profile of finishing pigs and making them more difficult to handle and potentially more susceptible to handling and transport stress.”
Nor can we overlook the effects of “adding these drugs to waterways or well water supplies–via contaminated animal feed and manure runoff– when this class of drugs is so important in treating children with asthma,” says David Wallinga, MD of the Institute for Agriculture and Trade Policy.
The FDA’s approval of a drug for food that requires impervious gloves and a mask just to handle is reminiscent of the bovine growth hormone debacle.
Like rBST, ractopamine increases profits despite greater livestock death and disability because a treated animal does the work of two in a macabre version of economies of scale.
Like rBST, food consumers are metabolic, neurological and carcinogen guinea pigs so that agribusiness can make a profit.
As can be seen from the discussion above, our grandparents would not recognize what we’re eating today as meat. (And – on top of that – there are all of the meat additives.)
And yet the government is so protective of the current model of industrial farming that private citizens such as ranchers and meat packers are prohibited from testing for mad cow disease, and even investigating factory farming may get one labeled as a terrorist, even though a paper in the American Society of Microbiology’s newsletter mBio shows that overuse of antibiotics by factory farmers creates “superbugs”.
Healthier Alternatives
If you’re going to eat red meat, make it grass fed beef.
Cows fed grass don’t require massive amounts of antibiotics … the cows stay healthier because they’re eating the food they were designed for. The meat is much lower in saturated fats and higher in good Omega 3 fats (which makes you and your kids smarter). In addition, if they are fed grass, they are much less likely to get mad cow disease.
Grass fed cows also use much less oil – which goes into the industrial fertilizer, pesticides and other parts of growing corn and mixing industrial chemicals for cattle – and so are better for the environment (and reduce the “need” for foreign oil wars). Indeed, grass not only contributes less carbon dioxide to the atmosphere than corn, but may actually be a “carbon sink” for greenhouse gasses – taking more out than they add.
Stores like Trader Joe’s and Whole Foods prominently market grass fed beef.
Ranching cooperatives are popping up. I predict they will grow in popularity, as people learn what’s in their meat.
Backyard chickens are also becoming very popular. You can get chickens and buy or build a chicken coop for eggs and chicken meat.
Indulge in this vodka cooler without feeling the slightest bit guilty. The refreshing cocktail is infused with cool minty flavor, thanks to organic spearmint tea, and each serving clocks in just 83 calories.
Ingredients:
6 spoonfuls Spearmint Tea by DAVIDsTEA
2 1/2 c. water
1/2 c. vodka
1/4 c. lime juice
1/4 c. agave nectar
Directions:
Pour boiling water over tea and infuse 4-7 minutes. Strain tea and pour into a pitcher filled with ice. Stir in vodka, lime juice, and agave nectar. Garnish glasses with mint sprigs and lime wedges.
Makes 6 servings.
While plenty of bars will serve sugar-loaded margaritas during happy hour, you can whip up a healthier version at home with this simple recipe. Plus, the color will definitely put you in a festive mood!
Ingredients:
2 parts refine Margarita Mix
1 part tequila
Directions:
Mix 2 oz. refine Margarita Mix and 1 oz. tequila. Shake and strain, pour into ice-filled, salt-rimmed glass, and garnish with a lime.
Created by James Labe, this tea-based concoction will help you and your friends celebrate St. Patty’s Day like the Irish prefer without costing you too many calories. Bottoms up!
Ingredients:
1 Numi Decaf Ginger Lemon tea bag
3 oz. fresh cucumber juice
1 1/2 oz. tequila
Splash of lemon juice
Directions:
Infuse one tea bag in tequila for 30 minutes, then remove bag, squeezing out excess. Combine and stir ingredients. Serve on the rocks. Garnish with lime wedge.
Skip the green-colored beer this year and try crafting this low-cal martini created by The Cocktail Guru Jonathan Pogash. Fresh lemon juice and peach-flavored vodka lends the drink a fresh, fruity boost.
Ingredients:
1 1/2 oz. Van Gogh Cool Peach Vodka
1/2 oz. fresh lemon juice
1 tsp. agave nectar
8-10 mint leaves
Directions:
Add ingredients to a mixing glass with ice and shake very well. Strain into a chilled cocktail glass. Garnish with mint sprig.
Another take on the healthy margarita, this yummy cocktail has shockingly few calories. A little sweet and a lot boozy, the St. Patty’s Day-themed drink is enhanced by a splash of freshly squeezed lime.
Ingredients:
3 oz. Kiwi Strawberry Sparkling ICE
1 oz. tequila
Splash of triple sec
Fresh squeezed lime
Directions:
Shake and pour into a chilled rocks glass rimmed in salt.
This is the easiest St. Patrick’s Day cocktail you’ll ever make. All you have to do is pour VnC’s Mojito into a glass and serve! Comprised of premium New Zealand vodka, mint, and lime juice, the all-natural bevvie comes ready to serve but tastes like it was made by a professional mixologist.
Ingredients:
VnC’s Mojito
Directions:
Pour into a glass.
This tasty bevvy is even better than finding a pot ‘o gold on St. Patrick’s Day. Thanks to a low-cal mojito mix, you get a guilt-free drink potent enough to get you tipsy without toppling your daily calorie intake!
Ingredients:
1 part vodka
2 parts refine Mojito Mix
Splash of club soda
2 tsp. muddled cucumber
Directions:
Mix 2 oz. vodka and 1 oz. refined Mojito Mix. Shake and strain into glass, then splash with club soda and garnish with lime. For an added fresh taste, muddle 3-4 slices of cucumber and pour into glass.
Greystone Manor Supperclub, a hot new nightclub in Los Angeles, crafted a delectable drink in honor of the holiday. But watch out: This blend of freshly squeezed juices and orange vodka gets an extra spicy kick from a slice of jalapeno!
Ingredients:
2 oz. Grey Goose Orange Vodka
3/4 oz. fresh lemon juice
3/4 oz. simple syrup
1/2 oz. orange juice
1 jalapeno
Directions:
Muddle 1 jalepeno in a mixing glass, then add juices and vodka. Fill mixing glass with ice; shake and serve up in a sugar-rimmed martini glass.
Sure, this beverage looks fancy, but it’s a snap to make! Plus, it’s only fitting to celebrate St. Patty’s Day by mixing up a drink with Jameson Irish Whiskey.
Ingredients:
1 1/2 oz. Jameson Irish Whiskey
3/4 oz. fresh lemon juice
1/2 oz. fresh orange juice
1/2 oz. simple syrup
Orange flag (made with orange wheel and Luxardo Maraschino cherry)
Directions:
Measure Jameson Irish Whiskey, lemon juice, orange juice, and simple syrup into mixing glass. Add ice, close with Boston Shaker, and shake vigorously 20-30 times. Mound ice in rocks glass. Using a Hawthorne Strainer, strain drink into rocks glass. Garnish with orange flag.
No St. Patrick’s Day party is complete without a shamrock shot among friends. Melon liquor infuses each one of these lower-calorie libations with flavor and a festive green hue.
Ingredients:
2 oz. VuQo Vodka
1 oz. DeKuyper® Melon Liqueur
Splash of lemon lime soda
Directions:
Combine in cocktail shaker with ice, shake, pour and serve.
This boozy bevvie hovers at just about 100 calories, allowing you to drink and still shrink! Plus, the addition of green-colored fruit like kiwi and grapes makes it perfectly appropriate for the holiday.
Ingredients:
2 oz. TY KU Liqueur
1 oz. Fresca
Muddled kiwi (1 slice)
Green grapes (1 grape)
Lemon (1 slice)
Directions:
Stir TY KU Liqueur and Fresca together in glass, muddle kiwi in liquid, add sliced green grape, top with squeeze of lemon, and serve.
This lucky, low-cal cocktail gets its bright green color from melon liquor and its refreshing taste from sparkling wine. Every bubbly sip is worth the 206 calories this drink will cost you.
Ingredients:
2 1/2 oz. VOGA Sparkling
1 oz. Midori Melon Liquor
1 oz. vodka
1 1/2 oz. lemonade
Directions:
In a shaker, combine ice, VOGA Sparkling, vodka, and lemonade. Stir gently and strain into a chilled cocktail glass.
Clocking in at an impressive 144 calories with only 4 grams of sugar, this drink is your best bet if you’re looking for something sweet to swig. As a bonus, it only calls for two simple ingredients.
Ingredients:
1/2 oz. Midori Melon Liqueur
Champagne (dry)
Directions:
Pour Midori into a champagne flute, top with champagne.
Natural sparkling water (with zero carbs and calories) helps keep this invigorating cocktail light while lemon and cranberry juice give it plenty of zesty flavor.
Ingredients:
4 oz. Kiwi Strawberry Sparkling ICE
1 oz. Stoli Vodka
Splash of fresh squeezed lemon
Splash of white cranberry juice
Directions:
Stir gently and serve in a chilled champagne flute. Garnish with a slice of kiwi.
St. Patrick’s Day is one of the booziest holidays of the year, often serving as an excuse for people to indulge in high-calorie, sugar-packed cocktails at their local watering holes. Try something new this year and craft one of these 14 low-calorie drinks at home.
Starting in August, the Obama administration's new rules on contraceptive coverage take effect. Photo Illustration by Kevork Djansezian/Getty Images.
Two years after its passage, the sweeping health care overhaul remains deeply controversial, with both political parties trying to use it to their advantage in the upcoming elections. As GOP lawmakers constantly deride "Obamacare" and threaten to repeal it, it's easy to forget that implementation marches on, and a number of notable changes will take effect for consumers this year.
They will, that is, unless the Supreme Court strikes down some or all of the law, including the requirement that nearly everyone have health insurance beginning in 2014. If that happens, all bets are off. Provisions that have already taken effect -- such as allowing adult children to remain on their parents' health plans until age 26 and the 50 percent discount on brand-name drugs for seniors who reach the so-called donut hole in their prescription drug plans -- could be rolled back, and provisions for 2012 cancelled. The court will hear arguments in the case later this month and a decision is expected this summer.
If the law stands, here are the major new provisions that will affect consumers this year:
Free Contraception Coverage
Starting in August, the Obama administration's new rules on contraceptive coverage that have generated such controversy take effect. That means that women in a new health plan or in an existing one that has changed its benefits enough to not be considered grandfathered under the law will be able to receive contraceptives without an out-of-pocket charge. In addition, these plans will have to provide a variety of basic women's health services, including well-woman visits (breast exams, pap smears, etc); screening for gestational diabetes; HPV testing; counseling for sexually transmitted infections; counseling and screening for HIV; and screening and counseling for interpersonal and domestic violence.
Religious employers such as churches are exempt from the new requirement. Colleges, hospitals and other employers that are affiliated with religious institutions are not exempt, but employees at those institutions will receive free contraceptive services from their employer's insurer.
Religiously-affiliated employers have a one-year grace period to implement this change, so some employees may not receive the free benefit until August 2013.
Rebates For Consumers
Under the health-care overhaul, insurers have to spend at least 80 to 85 percent of premium revenues on medical claims and quality improvement or else rebate the difference to policyholders. In most group plans, that would mean the employer.
How much consumers can expect to receive remains an open question. An analysis by the National Association of Insurance Commissioners, based on 2010 data, estimated that insurers would have returned $2 billion to consumers had the provision been in force then. The analysis said rebates would have gone to 53 percent of people in individual plans, 23 percent in small-group plans and 15 percent of large-group plan members.
In December, the Obama administration estimated that 9 million Americans might receive rebates totaling up to $1.4 billion, also based on 2010 data. The administration says some reports show insurers have been moderating their premium increases to avoid having to pay rebates. But other policy experts aren't so sure.
"My guess is that rebates will be higher [than the NAIC estimate] in 2011," says Timothy Jost, a law professor at Washington and Lee University who helped prepare the NAIC report. "Insurers seem to have raised their premiums based on projected increases in utilization that never occurred."
Clearer Descriptions
Beginning in September, at the start of the open enrollment season, all health plans will have to provide concise, consistent plan information aimed at allowing consumers to easily understand their benefits and compare plans.
Every plan will be required to give people a short summary of coverage and a uniform glossary of terms. It will also have to provide examples of how much the plan would cover if someone had a baby or was managing Type 2 diabetes -- two common situations that should make it easier for people to compare plans.
"This is a big deal," says Jennifer Tolbert, director of state health reform at the Kaiser Family Foundation. "Some of the materials people get explaining their health plan benefits are extraordinarily confusing, and this should make it clearer."
Shrinking Doughnut Hole
The health care overhaul is slowly eliminating the 'doughnut hole.' This is the break in Medicare prescription drug benefits that, in a standard plan, begins after total drug spending by the beneficiary and the health plan exceeds $2,930 and continues until the beneficiary has hit the $4,700 out-of-pocket limit.
Last year, Medicare beneficiaries with high drug costs got a 50 percent discount on brand-name drugs once they reached the doughnut hole. This year, they'll see a 14 percent discount on generic drugs as well.
Drug costs will continue to diminish in coming years, until in 2020 the doughnut hole no longer exists and Medicare beneficiaries with drug plans will simply be responsible for 25 percent of their drug costs.
Accountable Care
Last December, the administration announced that 32 health-care organizations would participate in a three-year Pioneer Accountable Care Organization program aimed at providing better, coordinated care for 860,000 Medicare beneficiaries. Providers -- including hospitals, clinics and physician groups -- that work together to improve beneficiaries' health and to bring costs down will share in the savings that they achieve.
Although Medicare beneficiaries may not realize that their health-care provider is participating in the program, they may start to notice changes in their care this year, says Debra Ness, president of the National Partnership for Women and Families. She leads the Campaign for Better Care, a coalition of organizations focusing on improving health-care delivery.
"For some of these folks, it may start to feel like they have a team working with them, or like their primary-care provider is developing an individualized care plan," she says. "Compared to what happens now, it could feel like a pretty big change."
Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.
Introduction
As a follow-up to my March 1 posting, I want to share the findings of our root cause analysis of the service disruption of February 29th. We know that many of our customers were impacted by this event and we want to be transparent about what happened, what issues we found, how we plan to address these issues, and how we are learning from the incident to prevent a similar occurrence in the future.
Again, we sincerely apologize for the disruption, downtime and inconvenience this incident has caused. We will be proactively issuing a service credit to our impacted customers as explained below. Rest assured that we are already hard at work using our learnings to improve Windows Azure.
Overview of Windows Azure and the Service Disruption
Windows Azure comprises many different services, including Compute, Storage, Networking and higher-level services like Service Bus and SQL Azure. This partial service outage impacted Windows Azure Compute and dependent services: Access Control Service (ACS), Windows Azure Service Bus, SQL Azure Portal, and Data Sync Services. It did not impact Windows Azure Storage or SQL Azure.
While the trigger for this incident was a specific software bug, Windows Azure consists of many components and there were other interactions with normal operations that complicated this disruption. There were two phases to this incident. The first phase was focused on the detection, response and fix of the initial software bug. The second phase was focused on the handful of clusters that were impacted due to unanticipated interactions with our normal servicing operations that were underway. Understanding the technical details of the issue requires some background on the functioning of some of the low-level Windows Azure components.
Fabric Controllers, Agents and Certificates
In Windows Azure, cloud applications consist of virtual machines running on physical servers in Microsoft datacenters. Servers are grouped into “clusters” of about 1000 that are each independently managed by a scaled-out and redundant platform software component called the Fabric Controller (FC), as depicted in Figure 1. Each FC manages the lifecycle of applications running in its cluster, provisions and monitors the health of the hardware under its control. It executes both autonomic operations, like reincarnating virtual machine instances on healthy servers when it determines that a server has failed, as well as application-management operations like deploying, updating and scaling out applications. Dividing the datacenter into clusters isolates faults at the FC level, preventing certain classes of errors from affecting servers beyond the cluster in which they occur.
Figure 1. Clusters and Fabric Controllers
Part of Windows Azure’s Platform as a Service (PaaS) functionality requires its tight integration with applications that run in VMs through the use of a “guest agent” (GA) that it deploys into the OS image used by the VMs, shown in Figure 2. Each server has a “host agent” (HA) that the FC leverages to deploy application secrets, like SSL certificates that an application includes in its package for securing HTTPS endpoints, as well as to “heart beat” with the GA to determine whether the VM is healthy or if the FC should take recovery actions.
Figure 2. Host Agent and Guest Agent Initialization
So that the application secrets, like certificates, are always encrypted when transmitted over the physical or logical networks, the GA creates a “transfer certificate” when it initializes. The first step the GA takes during the setup of its connection with the HA is to pass the HA the public key version of the transfer certificate. The HA can then encrypt secrets and because only the GA has the private key, only the GA in the target VM can decrypt those secrets.
There are several cases that require generation of a new transfer certificate. Most of the time that’s only when a new VM is created, which occurs when a user launches a new deployment, when a deployment scales out, or when a deployment updates its VM operating system. The fourth case is when the FC reincarnates a VM that was running on a server it has deemed unhealthy to a different server, a process the platform calls “service healing.”
The Leap Day Bug
When the GA creates the transfer certificate, it gives it a one year validity range. It uses midnight UST of the current day as the valid-from date and one year from that date as the valid-to date. The leap day bug is that the GA calculated the valid-to date by simply taking the current date and adding one to its year. That meant that any GA that tried to create a transfer certificate on leap day set a valid-to date of February 29, 2013, an invalid date that caused the certificate creation to fail.
As mentioned, transfer certificate creation is the first step of the GA initialization and is required before it will connect to the HA. When a GA fails to create its certificates, it terminates. The HA has a 25-minute timeout for hearing from the GA. When a GA doesn’t connect within that timeout, the HA reinitializes the VM’s OS and restarts it.
If a clean VM (one in which no customer code has executed) times out its GA connection three times in a row, the HA decides that a hardware problem must be the cause since the GA would otherwise have reported an error. The HA then reports to the FC that the server is faulty and the FC moves it to a state called Human Investigate (HI). As part of its standard autonomic failure recovery operations for a server in the HI state, the FC will service heal any VMs that were assigned to the failed server by reincarnating them to other servers. In a case like this, when the VMs are moved to available servers the leap day bug will reproduce during GA initialization, resulting in a cascade of servers that move to HI.
To prevent a cascading software bug from causing the outage of an entire cluster, the FC has an HI threshold, that when hit, essentially moves the whole cluster to a similar HI state. At that point the FC stops all internally initiated software updates and automatic service healing is disabled. This state, while degraded, gives operators the opportunity to take control and repair the problem before it progresses further.
The Leap Day Bug in Action
The leap day bug immediately triggered at 4:00PM PST, February 28th (00:00 UST February 29th) when GAs in new VMs tried to generate certificates. Storage clusters were not affected because they don’t run with a GA, but normal application deployment, scale-out and service healing would have resulted in new VM creation. At the same time many clusters were also in the midst of the rollout of a new version of the FC, HA and GA. That ensured that the bug would be hit immediately in those clusters and the server HI threshold hit precisely 75 minutes (3 times 25 minute timeout) later at 5:15PM PST. The bug worked its way more slowly through clusters that were not being updated, but the critical alarms on the updating clusters automatically stopped the updates and alerted operations staff to the problem. They in turn notified on-call FC developers, who researched the cause and at 6:38PM PST our developers identified the bug.
By this time some applications had single VMs offline and some also had multiple VMs offline, but most applications with multiple VMs maintained availability, albeit with some reduced capacity. To prevent customers from inadvertently causing further impact to their running applications, unsuccessfully scaling-out their applications, and fruitlessly trying to deploy new applications, we disabled service management functionality in all clusters worldwide at 6:55PM PST. This is the first time we’ve ever taken this step. Service management allows customers to deploy, update, stop and scale their applications but isn’t necessary for the continued operation of already deployed applications. However stopping service management prevents customers from modifying or updating their currently deployed applications.
We created a test and rollout plan for the updated GA by approximately 10:00PM PST, had the updated GA code ready at 11:20PM PST, and finished testing it in a test cluster at 1:50AM PST, February 29th. In parallel, we successfully tested the fix in production clusters on the VMs of several of our own applications. We next initiated rollout of the GA to one production cluster and that completed successfully at 2:11AM PST, at which time we pushed the fix to all clusters. As clusters were updated we restored service management functionality for them and at 5:23AM PST we announced service management had been restored to the majority of our clusters.
Secondary Outage
When service management was disabled, most of the clusters either were already running the latest FC, GA and HA versions or almost done with their rollouts. Those clusters were completely repaired. Seven clusters, however, had just started their rollouts when the bug affected them. Most servers had the old HA/GA combination and some had the new combination, both of which contained the GA leap day bug, as shown below:
Figure 3. Servers running different versions of the HA and GA
We took a different approach to repair these seven clusters, which were in a partially updated state. We restored to previous versions of the FC, HA, but with a fixed GA, instead of updating them to the new HA with a fixed new GA. The first step we took was to test the solution by putting the older HA on a server that had previously been updated to the new HA to keep version compatibility with the older GA. The VMs on the server started successfully and appeared to be healthy.
Under normal circumstances when we apply HA and GA updates to a cluster, the update takes many hours because we honor deployment availability constraints called Update Domains (UDs). Instead of pushing the older HA out using the standard deployment functionality, we felt confident enough with the tests to opt for a “blast” update, which simultaneously updated to the older version the HA on all servers at the same time.
Unfortunately, in our eagerness to get the fix deployed, we had overlooked the fact that the update package we created with the older HA included the networking plugin that was written for the newer HA, and the two were incompatible. The networking plugin is responsible for configuring a VM’s virtual network and without its functionality a VM has no networking capability. Our test of the single server had not included testing network connectivity to the VMs on the server, which was not working. Figure 4 depicts the incompatible combination.
Figure 4. Servers running the incompatible combination of HA and HA networking plugin
At 2:47 AM PST on the 29th, we pushed the incompatible combination of components to those seven clusters and every VM, including ones that had been healthy previously, causing them to become disconnected from the network. Since major services such as Access Control Service (ACS) and Windows Azure Service Bus deployments were in those clusters, any application using them was now impacted because of the loss of services on which they depended.
We quickly produced a corrected HA package and at 3:40 AM PST tested again, this time verifying VM connectivity and other aspects of VM health. Given the impact on these seven clusters, we chose to blast out the fix starting at 5:40 AM PST. The clusters were largely operational again by 8:00 AM PST, but a number of servers were in corrupted states as a result of the various transitions. Developers and operations staff worked furiously through the rest of the day manually restoring and validating these servers. As clusters and services were brought back online we provided updates to the dashboard, and posted the last incident update to the Windows Azure dashboard that all Windows Azure services were healthy at 2:15 AM PST, March 1st.
Improving the Service
After an incident occurs, we take the time to analyze the incident and ways we can improve our engineering, operations and communications. To learn as much as we can, we do the root cause analysis but also follow this up with an analysis of all aspects of the incident. The three truths of cloud computing are: hardware fails, software has bugs and people make mistakes. Our job is to mitigate all of these unpredictable issues to provide a robust service for our customers. By understanding and addressing these issues we will continue to improve the service we offer to our customers.
The analysis is organized into four major areas, looking at each part of the incident lifecycle as well as the engineering process that preceded it:
- Prevention – how the system can avoid, isolate, and/or recover from failures
- Detection – how to rapidly surface failures and prioritize recovery
- Response – how to support our customers during an incident
- Recovery – how to reduce the recovery time and impact on our customers
Prevention
- Testing. The root cause of the initial outage was a software bug due to the incorrect manipulation of date/time values. We are taking steps that improve our testing to detect time-related bugs. We are also enhancing our code analysis tools to detect this and similar classes of coding issues, and we have already reviewed our code base.
- Fault Isolation. The Fabric Controller moved nodes to a Human Investigate (HI) state when their operations failed due to the Guest Agent (GA) bug. It incorrectly assumed the hardware, not the GA, was faulty. We are taking steps to distinguish these faults and isolate them before they can propagate further into the system.
- Graceful Degradation. We took the step of turning off service management to protect customers’ already running services during this incident, but this also prevented any ongoing management of their services. We are taking steps to have finer granularity controls to allow disabling different aspects of the service while keeping others up and visible.
Detection
- Fail Fast. GA failures were not surfaced until 75 minutes after a long timeout. We are taking steps to better classify errors so that we fail-fast in these cases, alert these failures and start recovery.
Response
- Service Dashboard. The Windows Azure Dashboard is the primary mechanism to communicate individual service health to customers. However the service dashboard experienced intermittent availability issues, didn’t provide a summary of the situation in its entirety, and didn’t provide the granularity of detail and transparency our customers need and expect.
- Intermittent availability: This dashboard is run on two different internal infrastructures, Windows Azure and Microsoft.com, to deal with the catastrophic failure of either system. It is also geo-replicated to deal with geographic specific incidents. However, the dashboard experienced intermittent availability issues due to exceptionally high volume and fail-over/load balancing that was taking place. We have taken steps to correct this and ensure more robust service in the future.
- Situation summary: The service dashboard provides information on the health status of 60+ individual services at the sub-region level. While this is valuable in understanding individual service status, the lack of summary information made it difficult for customers to understand the situation holistically. Customers have asked for a summarized view on the dashboard to quickly gain a comprehensive understanding of the scope and severity of the outage. We are taking steps to make this change.
- Detail and transparency: Although updates are posted on an hourly basis, the status updates were often generic or repeated the information provided in the last couple of hours. Customers have asked that we provide more details and new information on the specific work taking place to resolve the issue. We are committed to providing more detail and transparency on steps we’re taking to resolve an outage as well as details on progress and setbacks along the way.
- Customer Support. During this incident, we had exceptionally high call volumes that led to longer than expected wait times. While we are staffed to handle high call volumes in the event of an outage the intermittent availability of the service dashboard and lack of updates through other communication channels contributed to the increased call volume. We are reevaluating our customer support staffing needs and taking steps to provide more transparent communication through a broader set of channels.
- Other Communication Channels. A significant number of customers are asking us to better use our blog, Facebook page, and Twitter handle to communicate with them in the event of an incident. They are also asking that we provide official communication through email more quickly in the days following the incident. We are taking steps to improve our communication overall and to provide more proactive information through these vehicles. We are also taking steps to provide more granular tools to customers and support to diagnose problems with their specific services.
Recovery
- Internal tooling. We developed and modified some of our internal tooling to address this incident. We will continue to invest in our tools to help speed recovery and make recovery from intermediate states more predictable.
- Dependency priorities. We are also examining our processes to make sure dependencies are factored into recovery to ensure that all Windows Azure infrastructure services, such as ACS and Windows Azure Service Bus, are recovered first to reduce the impact on customers.
- Visibility. We are looking at how we can provide better visibility into recovery steps and provide customers with visibility into the intermediate progress being made.
Service Credits
Microsoft recognizes that this outage had a significant impact on many of our customers. We stand behind the quality of our service and our Service Level Agreement (SLA), and we remain committed to our customers. Due to the extraordinary nature of this event, we have decided to provide a 33% credit to all customers of Windows Azure Compute, Access Control, Service Bus and Caching for the entire affected billing month(s) for these services, regardless of whether their service was impacted. These credits will be applied proactively and will be reflected on a billing period subsequent to the affected billing period. Customers who have additional questions can contact support for more information.
Conclusion
We will continue to spend time to fully understand all of the issues outlined above and over the coming days and weeks we will take steps to address and mitigate the issues to improve our service. We know that our customers depend on Windows Azure for their services and we take our SLA with customers very seriously. We will strive to continue to be transparent with customers when incidents occur and will use the learning to advance our engineering, operations, communications and customer support and improve our service to you.
Sincerely,
Bill Laing and the Windows Azure Team
Heath and Human Services Secretary Kathleen Sebelius, middle, makes her way to a news conference in July to announce a preliminary framework on health insurance exchanges. She issued the final regulations Monday. Photo by Tom Willaims/Roll Call.
Just two weeks before the Supreme Court begins considering whether to strike down the federal health reform law, the Obama administration issued more guidelines for the law's full-scale implementation.
The much-anticipated final regulations for health insurance exchanges -- released Monday in a 644-page document -- emphasized the broad latitude states will have in developing and implementing their own health insurance marketplaces by 2014. The virtual shopping centers will aim to make the process of buying health insurance as easy as navigating a site like Amazon.com and are expected to serve about 21 million Americans by 2017.
According to Health and Human Services Secretary Kathleen Sebelius, the final exchange regulations give states "the flexibility they need to design an exchange that works for them." She also reiterated the administration's belief that the exchanges will boost competition in the individual and small-business marketplace and will give both groups "the same purchasing power big businesses have today."
Critics didn't buy it. Virginia Gov. Bob McDonnell issued a statement saying the "flexibility" claim is a vague attempt by the Obama administration to hide the fact that it has "overpromised, oversold and under-delivered."
"This administration's inability to provide critical guidance to their broken health care reform mandate gives more and more credence to the necessity of the Supreme Court ruling this law unconstitutional," McDonnell said.
At the other extreme, Ron Pollack, founding executive director of the pro-health care reform Families USA, called the rules "a major milestone on the path to consumer empowerment." He praised the initial six-month enrollment window, the fact that each exchange will need to have at least one voting board member who is consumer-interest advocate, and a new rule that will ensure that appropriate "navigators" be available to help consumers sort through expanded coverage options.
Julie Appleby of Kaiser Health News spoke with the NewsHour's Hari Sreenivasan for an Exchange 101 in August. Watch the video for a refresher, then read her updates below.
What exactly is in these new rules?
Appleby: These changes incorporated a couple new things. One of the biggest is that a consumer representative must now sit on every governing panel set up to oversee the exchanges. Up to half of the board can be made up of insurers or other industry representatives, but at least one consumer representative must be present and able to vote. The new rules also include a little bit of information about partnerships. If a state can't run its own exchange by the deadline -- or if they can't run a piece of it -- it can partner with the federal government to do that. Additionally, the rules lay out what type of organization is going to oversee the exchange. It could be a state agency or nonprofit group, which gives the states flexibility. One of the other key things these exchanges will do is determine who qualifies for tax credits and subsidies to help buy insurance and who qualifies for the Medicaid expansion in 2014.
Is there now a clearer timeline for the rollout of these exchanges?
Appleby: States need to be ready to start enrolling people in the exchanges by October of 2013. Even before that, by January of next year, they have to be able to say, 'We're on track to meet that deadline.' The federal government is acknowledging that some states aren't going to make it. So it's now possible for a state to receive conditional approval, where officials can say, 'We think you're going to be ready except in a couple areas, so we can help you fill that gap.'
The administration has repeated often how flexible these exchange will be for states. Is that accurate?
Appleby: The regulations keep things pretty broad, and I think states certainly want that kind of flexibility. Some wanted more of a national standard so things don't vary so much, but the federal government says things will go most smoothly and work best if the states are able to determine the specifics of implementation. So like with many rules associated with health reform, they've tried to keep things flexible.
Since these are the final rules, is there anything that's been left undetermined at this point?
Appleby: This does not include information about the federal fallback exchange for states that can't implement an exchange of their own or the ones that refuse to implement any part of the health care law. That's coming in a future rule. They've also included some interim final rules that now have a 45-day comment period, including the provision about how long it should take to find out if you're eligible for some of these subsidies or for the Medicaid expansion.
Curious about how the exchanges could play out in your state? Last summer, Health Correspondent Betty Ann Bowser traveled to Utah, a state with a big head start, to see how small businesses have fared under the expanded marketplaces. Check out the video below.
March 07, 2012
Drug Company Coupons Are Illegal Bribes Used to Dupe Consumers, Lawsuit Alleges
Three health plans in Community Catalyst's Prescription Access Litigation coalition today filed class action lawsuits in four federal courts against eight major drug companies
BOSTON, MA - Three health plans in Community Catalyst's Prescription Access Litigation coalition today filed class action lawsuits in four federal courts against major drug manufacturers for illegally subsidizing co-payments for expensive brand-name prescription drugs such as Lipitor and Nexium through the promotion of co-pay coupons.
The lawsuit alleges that the payments by eight drug makers -- Abbott, Amgen, AstraZeneca, Bristol-Meyers-Squibb, GlaxoSmithKline, Merck, Novartis, and Pfizer -- are illegal under a federal statute that prohibits commercial bribery because the undisclosed payments to patients and pharmacies are made through a ‘shadow claims system' designed to keep information about the presence or amount of these payments from health plans.
Community Catalyst, a national consumer advocacy organization, warns that while prescription drug coupons appear to save consumers money by reducing or eliminating co-payments, in reality they dramatically increase the cost of health care by driving up health insurance premiums and potentially causing consumers to hit benefit caps or lose coverage altogether.
"Pharmaceutical corporations are duping consumers with misleading coupons that are more about increasing corporate profits than actually reducing the cost of drugs for consumers" said Wells Wilkinson, director of the Prescription Access Litigation project at Community Catalyst. "If not stopped, the use of these deceptive coupons will increase costs for consumers' health plans by billions of dollars, contributing to higher premiums and the increasing loss of coverage and benefits for Americans."
A recent report by the Pharmacy Benefit Manager trade association (PCMA) estimates drug coupons will increase drug costs by $32 billion nationwide by 2021. Federal government health plans like Medicare consider these coupons kickbacks and have banned them; they are also banned in Massachusetts under an anti-kickback law.
The lawsuits were filed in New York, Chicago, Philadelphia and Newark by the AFSCME District Council 37 Health & Security Plan Trust, Sergeants Benevolent Association, the New England Carpenters, and the Plumbers and Pipefitters Local 572 Health and Welfare Fund. These health plans provide drug benefits for civilian and uniformed municipals workers, retirees and their dependents throughout the City of New York, plumbers from Florida to Ohio, and carpenters throughout New England. All of these health plans are struggling to keep up with continually rising drug costs.
"Our members are harmed by these unlawful practices by drug companies because coupons offering discounts off of brand drugs don't save consumers money in the long run." says Lillian Roberts, Executive Director of AFSCME, District Council 37, a plaintiff in the lawsuit.
"By combining direct-to-consumer marketing and supermarket ‘coupon clipping,' pharmaceutical companies are steering consumers to higher priced drugs in the pursuit of greater profits" said Edward Mullins, President of the Sergeants Benevolent Association, also a plaintiff in the lawsuit.
Under most health plans, consumers pay a larger co-payment for expensive brand-name drugs. By subsidizing all or the majority of a consumer's co-payment, drug companies promote the sale of these expensive products over less expensive, equally effective medications. This drives up the cost of care for health plans, employers and, ultimately, consumers. In addition, consumers who stay on expensive brand-name drugs run the risk of reaching their coverage caps sooner, forcing them to either pay out of pocket or forgo important care when they need it.
"Drug company coupons are not coupons. They are high-interest loans. We save money now, but we pay the loan sharks later," said Dr. William Jordan, a practicing physician in New York City serving low-income patients.
In 2009, half of the 109 best-selling U.S. brand-name drugs were promoted by coupons, and the number of coupon subsidy programs has skyrocketed since then, from 86 in July 2009 to 362 in November 2011. Coupons are aggressively marketed to consumers by TV, radio, Internet ads, and through physicians and pharmacists. And consumers are using them up, unaware of the negative impact on their premiums. In 2010 alone, co-pay coupons were used in one-eighth of all brand-name drug purchases, or 100 million prescriptions, according to the PCMA report.
Coupons also threaten anticipated savings from so called "patent cliff drugs," the dozens of brand-name drugs going off-patent between 2010 and 2013 and competing for the first time against generic counterparts.
Aside from cost concerns, consumer advocates and policymakers are also concerned about coupons for safety reasons. For instance, the FDA is currently studying whether drug coupons can mislead consumers concerning the safety and risks of drug products.
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About Community Catalyst
Community Catalyst is a national non-profit consumer advocacy organization dedicated to quality affordable health care for all. Community Catalyst works in partnership with national, state and local consumer organizations, policymakers, and foundations, providing leadership and support to change the health care system so it serves everyone - especially vulnerable members of society. For more information, visit www.communitycatalyst.org. Read or comment on our blog at http://blog.communitycatalyst.org/. Follow us on Twitter @healthpolicyhub.The 130-member Prescription Access Litigation coalition, a project of Community Catalyst, has played a major role in bringing lawsuits challenging illegal pharmaceutical industry pricing or promotional tactics. One lawsuit resulted in over $360 million in settlements with 29 of the country's largest drug makers.
You won’t need the luck o’ the Irish when you’re whipping up this low-cal key lime pie. Thanks to fat-free cream cheese and light yogurt, this no-bake dessert won’t max out your daily calorie intake.
Ingredients:
2 tbsp. cold water
1 tbsp. fresh lime juice
1 1/2 tsp. unflavored gelatin
4 oz. fat-free cream cheese, softened
3 containers (6 oz. each) Yoplait Light Thick & Creamy key lime pie yogurt
1/2 c. frozen (thawed) reduced-fat whipped topping
2 tsp. grated lime peel
1 reduced-fat graham cracker crumb crust (6 oz.)
Directions:
In 1-quart saucepan, mix water and lime juice. Sprinkle gelatin on lime juice mixture; let stand 1 minute. Heat over low heat, stirring constantly, until gelatin is dissolved. Cool slightly, about 2 minutes. In medium bowl, beat cream cheese with electric mixer on medium speed until smooth. Add yogurt and lime juice mixture; beat on low speed until well blended. Fold in whipped topping and lime peel. Pour into crust. Refrigerate until set, about 2 hours.
Makes 8 servings.
Recipe provided by Betty Crocker
Tempted to order McDonald’s seasonal Shamrock Shake? Try whipping up this guilt-free version at home. This icy bevvie blends low-fat cottage cheese with protein powder, and every sip is infused with a hint of cool minty flavor. Plus, you can’t beat the pretty green hue for the perfect St. Patty’s Day delight!
?Ingredients:
?1/2c. low-fat cottage cheese (or vanilla yogurt)
?1 scoop vanilla or plain protein powder
?1/8 tsp. mint extract (or to taste)
?2-3 packets stevia or sweetener of choice (or to taste)
?5-10 ice cubes (more or less depending on how thick you like it)
?4-6 oz. water (alter according to desired thickness)
?A few drops of green food coloring, or a handful of spinach to make it green
?1-2 tbsp. Sugar-Free Instant Pistachio Pudding Mix (optional)
?Pinch of guar of xanthan gum (optional)
?Directions:
?Put all the base ingredients in the blender, and blend away until desired consistency! Swirl in one drop of red food coloring just before serving, and top with whipped cream and crushed candy cane if desired!
Makes 1 serving.
Recipe provided by Dashing Dish
Veggie burgers often get a bad rap, but this wholesome recipe will change your mind. Made with chick peas, veggies, and just the right amount of seasoning, these patties are loaded with both flavor and good-for-you perks.
Ingredients:
1 15-oz. can Progresso chick peas (garbanzo beans), drained, rinsed
1 egg
1 clove garlic, finely chopped
1 tsp. smoked paprika
1/2 tsp. ground coriander
1/2 tsp. ground cumin
1/2 tsp. coarse (kosher or sea) salt
1 c. chopped fresh spinach
1/2 c. shredded carrot
2 tbsp. chopped fresh cilantro
3/4 c. Progresso panko bread crumbs
2 tbsp. canola oil
Toppings, as desired (avocado halves, cilantro leaves, cucumber slices, tomato slices, sweet pepper strips, lettuce leaves)
Sauces, as desired (spicy mustard, Sriracha, ketchup, citrus vinaigrette)
Directions:
In food processor bowl, place chick peas, egg, garlic, smoked paprika, coriander, cumin, and salt. Cover; process with on-and-off pulses about 45 seconds or until nearly smooth. Stir together bean mixture, spinach, carrot, and cilantro until well combined. Stir in bread crumbs. Shape mixture into 4 patties, about 3 1/2 in. in diameter and 1/2 in. thick. In 10-in. nonstick skillet, heat 2 tbsp. canola oil over medium heat until hot. Cook patties in oil 8 to 10 minutes, turning once, until brown and crisp. Serve veggie burgers stacked with toppings and drizzled with sauce.
Makes 4 servings.
Recipe provided by Betty Crocker
These minty green-colored oats make a festive St. Patrick’s Day breakfast. The mint and chocolate flavors go hand in hand to boost the oats with an almost dessert-like flavor, while chia seeds add nutritional value in the form of omega-3s and fiber.
Ingredients:
1/2 c. oats mixed with 1 1/2 c. water
1 tbsp. chia seeds
1 scoop SunWarrior Protein Powder
2-3 tsp. mint extract
1 tsp. cacao powder
Green food coloring
Directions:
Microwave 1/2 c. oats with 1 1/2 c. liquid (water or milk). After oats are cooked add chia seeds, protein powder, mint extract, cacao powder, and food coloring. Mix all together. You could make the oats night before and refrigerate overnight for cold oats or cook in the morning and enjoy hot. For the chocolate frosting, mix 1 scoop SunWarrior Vanilla Protein Powder, 2 tbsp. cocoa powder, stevia, and water.
Makes 1 serving.
Recipe provided by Healthy Diva Eats
You can’t get greener than a bowl of kale! Thanks to a zesty mix of lemon juice, apple cider vinegar, and minced garlic, this recipe yields a salad bursting with flavor. Each serving is low in calories and fat but high in fiber and antioxidants, so dig in!
?Ingredients:
?1/2 bunch raw kale, washed, de-stemmed, and dried
?1 tbsp. tahini
?1 tbsp. apple cider vinegar (or water)
?1 tbsp. lemon juice
?1 tbsp. Bragg’s liquid aminos (tamari or soy sauce would work too)
?2 tbsp. nutritional yeast
?1 tsp. minced garlic (1-2 cloves garlic)
?Sesame seeds to taste as garnish (optional)
?Directions:
Break or cut kale into bite size pieces and place in a large bowl. Puree all ingredients except kale and sesame seeds in a blender or food processor to blend the dressing. Pour dressing over kale and massage into the kale with your hands until all pieces of kale are coated. Let the salad sit in the fridge for an hour or so to marinate. You can skip this step if you need to eat right away, but allowing some time to marinate will wilt the kale a bit and make it a little more palatable, particularly for those who are skeptical of eating raw kale. Sprinkle on some sesame seeds before serving if so desired.
Makes 4 servings.
Recipe provided by Eating Bird Food
While these crunchy cakes are more yellow in color than green, they’re still a perfect St. Patty’s Day treat for your family and friends. Each scrumptious morsel is totally satisfying and packed with vitamin-rich zucchini, yet strikingly low in calories, carbs, and fat.
Ingredients:
1 large zucchini, grated
1 large egg
1 c. panko bread crumbs
Salt and pepper to taste
1 tbsp. Adobo spices
1/2 c. Parmesan cheese, grated
Directions:
Remove excess liquid from freshly grated zucchini by placing them between paper towels and squeezing. In a large bowl, combine all the ingredients. Mix thoroughly. Heat a large pan on medium, and spray with Pam. Shape spoonfuls of the zucchini batter into 2-in. (diameter) patties, and drop onto the sizzling pan. Cook each side for about a minute and a half, or until the outside is golden brown. Finish the cakes off in the oven. Stick them on a baking pan and broil them for 1-2 minutes. Serve hot, alone or with ranch dressing.
Makes about 12 cakes.
Recipe provided by Just Putzing Around the Kitchen
A clever take on Dr. Seuss’ Green Eggs and Ham, this easy-to-make recipe doesn’t even require fake food coloring! Instead, harness the healthy powers of a veggie like fresh kale or spinach to tinge the scrambled eggs with a green hue.
Ingredients:
6 eggs (pastured and/or organic eggs recommended)
1 tbsp. milk (whole milk recommended)
2 tbsp. onion, roughly chopped
1 c. fresh kale or spinach leaves, washed with big stems removed
Salt and pepper to taste
Butter for frying (organic and/or grass-fed butter recommended)
Directions:
Combine first 5 ingredients in a blender (including the salt and pepper) and blend until the greens are pureed into little bits. Heat a big pat of butter in a frying pan over medium-low heat. Once the butter has melted pour the egg mixture into the warm pan. Let it sit for a couple minutes before you begin to stir and scramble with a spatula. Cook until eggs are done all the way through.
Makes 3 servings.
Recipe provided by 100 Days of Real Food
A delectable fusion of healthy vegetables, this green soup is great to serve on St. Patty’s Day (and also ideal for detoxing the next day!). Avocado, broccoli, and arugula not only lend the soup its rich emerald shade, but ensure that every sip is brimming with nutritional benefits too.
Ingredients:
1/2 Haas avocado
8-10 decent-sized broccoli clusters (stems kept at least 1 in. long)
1/3 onion of choice
2 handfuls arugula
1 tbsp. olive oil
Salt (about 1 tsp.) or to taste
1 tbsp. apple cider vinegar
Red pepper flakes (about 1/4 tsp.) or to taste
Drizzle of honey or agave
Juice from half a lemon
1 in. minced ginger root
1 c. water
Directions:
Lightly steam the broccoli. Remove from heat when bright green. Saute onions in olive oil until just soft. Place cooked broccoli and onions and all the other ingredients in a blender, food processor, or use hand immersion blender. Add 1/2 c. water and blend. Keep adding more water until you reach desired consistency. Add any additional salt to taste. Enjoy hot or cold!
Makes 2 servings.
Recipe provided by Honest Fare
For a hearty lunch or dinner idea, look no further than these roasted green peppers. Stuffed with quinoa and other healthy ingredients (like edamame, tomatoes, and mushrooms), these tender peppers offer a vegetarian-friendly meal that’s sure to impress guests.
Ingredients:
1/2 tbsp. olive oil
1 c. frozen edamame, thawed
5 white mushrooms, sliced
1 roma tomato, diced
1 c. fresh spinach
2 organic green bell peppers
1 tbsp. teriyaki stir-fry sauce
1/2 c. uncooked quinoa, rinsed and cooked
1/3 c. water
Directions:
Heat oil in a skillet over medium-high heat. Add edamame, mushrooms, and tomato, stirring until cooked, roughly 5-7 minutes. Add spinach and cook until spinach is wilted. Add in the stir-fry sauce and cook until coated. Remove from heat and place in a medium-sized bowl with cooked quinoa. Toss to combine. Set aside to let the filling cool until just warm. Meanwhile, preheat the oven to 350 degrees. Slice the tops off the peppers, and then core and seed them. Stuff each pepper with the filling, packing it down until each pepper is filled to the top. Place the peppers in a baking dish and replace the tops. Add the water to the bottom of the dish. Cover everything with aluminum foil and bake for 30 minutes. Remove foil, then bake for an additional 20-25 minutes until peppers are soft and juicy. Remove peppers from baking dish and serve.
Makes 2 servings.
Recipe provided by Eating Bender
This delicious soup calls for a lot of ingredients, but the result is well worth rounding them up! The combination of spices and veggies, especially the kick from jalapeno and green chiles, makes this concoction one tasty dish.
Ingredients:
1 tbsp. vegetable oil
1 medium onion, diced
1 red pepper, trimmed and chopped
?1 carrot, coarsely chopped
?1 jalapeno chile, seeded, trimmed, and minced
?1 4-oz. can chopped green chiles, drained
?4 garlic cloves, minced
?1/2 tsp. cumin
?Salt and freshly ground black pepper
?2 tbsp. all-purpose flour
?2 1/4 c. chicken broth
?1 1/2 lbs. boneless, skinless chicken breasts, cut into 1-in. chunks
?1 c. corn kernels (frozen is fine)
?2 tbsp. fresh lime juice
?2 tbsp. chopped fresh cilantro
Directions:
Heat the oil in a Dutch oven over medium heat. Add the onion, bell pepper, carrot, and jalapeno. Cook about 4 minutes, until the vegetables are soft. Stir in the green chiles, garlic, cumin, 1/2 tsp. salt, and 1/4 tsp. pepper, and cook 1 minute, until aromatic. Stir in the flour until incorporated. Stir in the broth and chicken, bring to a simmer, and cook for 5 minutes. If using fresh corn, stir it in and cook for 5-10 minutes. If frozen, cook the chicken 5-10 minutes, until no longer pink, then add the corn and cook 1-2 minutes more. Stir in the lime juice and cilantro and add extra salt and pepper to taste. Serve with corn tortillas, charred over the stove flame.
Makes 4 servings.
Recipe provided by Cara Eisenpress of Big Girls, Small Kitchen
Whether you dress up in green or hit up your local watering hole for a pint of brilliantly colored beer, there’s nothing like ringing in St. Patrick’s Day with some festive cheer. This year, celebrate by cooking up some edible treats that are all SHAPE (and leprechaun)-approved!
When I signed up for this weight-loss journey, I panicked at the thought of never being able to sink my teeth into one of my favorite meals—a cheeseburger and fries again. But along the way, I've learned that alternatives to standard fast food fare do exist.
For example, swap the beef for turkey, lose the bun, bake your fries in the oven and add a side salad! Follow the tips below for a healthy cheeseburger and French fry makeover:
“Small quantities of processed meat such as bacon, sausages or salami can increase the likelihood of dying early by a fifth,” The Daily Telegraph reported today.
The news is based on a large study that looked at the diets and health of over 120,000 people over periods of up to 28 years, assessing their diets every four years and following the development of any heart problems or cancer.
Researchers found that regularly eating red meat, in particular processed meat, was associated with a significantly higher risk of dying prematurely. Each 85g daily serving of unprocessed red meat (equivalent to about three thin slices of roast beef) was associated with a 13% increase in early death, while one daily serving of processed meat (one hot dog or two slices of bacon) was associated with a 20% increased risk.
The researchers then input their data into a theoretical model, which estimated that 9.3% of early deaths in men and 7.6% in women in the study could have been prevented if all the participants had consumed fewer than 0.5 servings a day (about 42g a day) of red meat.
This was a well-conducted study but it could not conclusively prove that red meat raises the risk of premature death, although the results are of key interest and the evidence is mounting on the issue. According to UK dietary surveys, 4 in 10 men and 1 in 10 women eat more than 90g of red and processed meat a day. The Department of Health recommends that people eating more than 90g of red and processed meat a day limit their intake to no more than 70 grams a day in cooked weight. That is about the size of a large beefburger.
Where did the story come from?
The study was carried out by researchers from a number of research institutions, including the Harvard School of Public Health in the US. It was funded by the US National Institutes of Health, and the US National Heart, Lung and Blood Institute.
The study was published in the peer-reviewed medical journal, Archives of Internal Medicine.
This research was widely reported in the media, with several reports including comments from independent experts. The Daily Mail also included some critical comments on the research from the industry funded Meat Advisory Panel. The Sun’s claim that red meat kills was misleading.
What kind of research was this?
This was a prospective cohort study to investigate the association between red meat intake and early death in two large groups of men and women. It looked at both deaths from all causes and deaths from heart disease and cancer.
The researchers point out that red meat consumption has been associated with increased risk of chronic diseases but its association with the risk of mortality (death) remains uncertain.
What did the research involve?
The researchers analysed data from two large US cohort studies of health and lifestyle that took place in the US between 1976 and 2008. One of these studies examined outcomes in a range of healthcare professionals and the other only in nurses. In these studies, health questionnaires were sent to participants every two years to collect health-related information, with food questionnaires sent out every four years.
For the present analysis, researchers assessed the diets of 37,698 men and 83,644 women who were free of both cancer and heart disease at the start of the studies (1986 and 1980 respectively).
Diet was assessed using the validated food frequency questionnaires they had completed, which included detailed questions on both processed and unprocessed meat consumption.
In each questionnaire, participants were asked how often on average they consumed each food of a standard portion size, with nine possible responses ranging from ‘never or less than once a month’ to ‘six or more times a day’. The standard serving size was 85g (3oz) for unprocessed red meat. Processed red meat included bacon (two slices, 13g) hot dogs (one, 45g). The participants were sent these questionnaires every four years until 2006.
The researchers collected information about deaths among participants by reports from next of kin, through postal authorities and by searching a national death index. The cause of death was primarily taken from medical records and death certificates. The researchers used codes from an international classification of diseases to distinguish between deaths due to cancer and cardiovascular disease.
They used appropriate statistical methods to analyse the data, taking account of possible other factors such as bodyweight, smoking status, physical activity level, family history, blood pressure and cholesterol.
In a further analysis the researchers modelled how death rates would be affected if one daily serving of red meat was substituted with an alternative food such as fish, poultry, nuts, legumes, low fat dairy or wholegrain.
What were the basic results?
The 121,342 participants were followed up for up to 28 years, during which time there were 23,926 deaths, including 9,464 deaths due to cancer and 5,910 from heart disease and stroke (collectively classed as cardiovascular disease [CVD]).
The researchers compared the highest consumers of red meat with the lowest consumers of red meat to calculate the increases in risk due to each additional serving per day. This was an average across all groups and it is worth noting that even the people with the lowest consumption of red meat were still eating, on average, ? of a serving a day and so were not vegetarian. The researchers found:
- consuming one serving of unprocessed red meat a day was associated with a 13% increased risk of early death (95% confidence interval [CI], 1.07-1.20), an 18% increase in risk of death from CVD (1.13-1.23) and a 10% increase in the risk of death from cancer (1.06-1.14)
- one serving of processed meat daily was associated with a 20% increased risk of early death (CI 95% 1.15-1.24), 21% increase in risk of death from CVD (1.13-1.31) and a 16% increase in the risk of death from cancer (1.09-1.23)
When the researchers modelled the impact of replacing meat with other foods their model estimated that that:
- Substituting one serving of red meat a day with one serving a day of other foods was associated with between 7% and 19% lower mortality risk.
- 9.3% of early deaths in men and 7.6% in women taking part in the study could be prevented at the end of follow-up if all the individuals consumed fewer than 0.5 servings a day (approximately 42g a day) of red meat.
How did the researchers interpret the results?
They say their study provides evidence that regular consumption of red meat, especially processed meat, is associated with an increased risk of death due to any cause, as well as due to CVD and cancer. Conversely, substitution with other protein sources is associated with a lower risk.
The authors propose that presence of saturated fat and iron in red meat might partly explain this association with higher risk of CVD, while the presence of other constituents such as sodium and nitrites might explain the additional risk associated with processed meats. They also point out that some of the compounds in red meat created by high temperature cooking are potential carcinogens.
Conclusion
This study had several strengths including its size, long follow-up period and detailed and repeated assessments of people’s meat intake. It also adjusted the results for other factors that might affect risk of mortality. However, relying on participants to self-report factors, such as their meat intake through questionnaires, introduces the possibility of error, although the questionnaires were validated. Furthermore, participants were mainly white health professionals, so the results may not be relatable to other populations.
This study cannot prove that regular consumption of red meat ‘kills’, as the Sun put it. Red meat is a good source of protein and certain nutrients such as iron, some vitamins and zinc, but it is already recognised that it is likely to raise the risk of cancer especially bowel cancer. The Department of Health advises adults who eat high levels of red and processed meat should reduce their intake to no more than 70g a day to reduce this risk. For advice on how to cut down, see our guidelines on red meat consumption.
Links To The Headlines
Eating red meat regularly 'dramatically increases the risk of death from heart disease'. Daily Mail, March 13 2012
Bacon sandwiches and fizzy drinks 'take years off your life'. Metro, March 13 2012
Fresh warning on red meat health risks. BBC News, March 13 2012
Eating red meat raises 'substantially' risk of cancer or heart disease death. The Guardian, March 13 2012
Red meat ‘kills’. The Sun, March 13 2012
Links To Science
Pan A, Sun Q, Bernstein AM et al. Red Meat Consumption and Mortality - Results From 2 Prospective Cohort Studies. Archives of Internal Medicine, March 12 2012
I have a great deal of respect for Robert Tauxe, MD, MPH, Deputy Director of the Division of the CDC that is charged with prevention and control of foodborne, waterborne and fungal infections. He has been in the diarrheal trenches for a very long time - from just after E. coli O157:H7 made its quiet entrance in a McDonald's restaurant (unnamed at the time), to the deadliest Listeria outbreak linked to tainted Colorado cantaloupes. Over many years he has had the responsibility for overseeing investigations into the estimated 76 million (or is it 48 million?) sickened, 325,000 (or it is 125,000?) hospitalized, and 5,000 (or is it 3,000?) deaths yearly due to foodborne illness. That is a lot of responsibility. I have had the pleasure over the last two decades to, on occasion, share the food safety stage with him (although I get the sense that the feeling is less than mutual). And I cannot think of anyone who looks better in a bow tie.
It is therefore with mixed emotions, and the knowledge that I likely make my relationship with public health - both federal and state - even more tenuous, that I question his quotes back in January to MSNBC during the dust-up over the disclosure or non-disclosure of "Mexican-style fast food restaurant chain, Restaurant Chain A", which was the source of a Salmonella outbreak that sickened 68 people in 10 states. Here is what he had to say to MSNBC:
Dr. Robert Tauxe, a top CDC official, defended the agency's practice of withholding company identities, which he said aims to protect not only public health, but also the bottom line of businesses that could be hurt by bad publicity. The CDC, the Food and Drug Administration and state health departments often identify companies responsible for outbreaks, but sometimes do not.
"The longstanding policy is we publicly identify a company only when people can use that information to take specific action to protect their health," said Tauxe, the CDC's deputy director of the Division of Foodborne, Waterborne and Environmental Diseases.
"On the other hand, if there's not an important public health reason to use the name publicly, CDC doesn't use the name publicly."
Because companies supply vital information about outbreaks voluntarily, CDC seeks to preserve cordial relationships.
"We don't want to compromise that cooperation we'll need," Tauxe said. ...
Tauxe acknowledged there's no written policy or checklist that governs that decision, only decades of precedent.
"It's a case-by-case thing and all the way back, as far as people can remember, there's discussions of 'hotel X' or 'cruise ship Y," he said.
I, too, was quoted in the article above and was repeatedly asked if I thought that the CDC was bending to company pressure to keep the restaurant chain's name quiet. I said emphatically no! But that did not make it into the article. So, not to put words in Dr. Tauxe's mouth (and, granted, he may have had more to say), but as best as I can tell, these are his arguments for disclosure and non-disclosure and my thoughts, in italics:
A. Although there is no written policy, it is the way we have done things for years;
Why do I hear my mom saying, "just because so and so does that does not mean you should too." For all government policies (and neckwear) - change is good.
B. Since the outbreak has concluded, there is not an immediate public health threat;
Frankly, that is the case in most foodborne illness outbreaks. In nearly every single outbreak investigated by the CDC, the outbreak source is figured out long after the peak occurrence of the illnesses. However, disclosure gives the public important information about which companies have a strong or weak food safety record.
C. Disclosing the name of the company jeopardizes cooperation from the company in this and future outbreaks; and
If a company will only cooperate if they are placed in what amounts to a witness-protection program, with promises of non-disclosure, it does not say much for our government's or the company's commitment to safe food.
D. Bad publicity may cause economic hardship to the restaurant.
True, but not poisoning your customers is a better business practice.
I would also add a couple more reasons for non-disclosure that I received via email (mostly anonymously):
1. The source was an unknown supplier, so naming only the restaurant might place unfair blame on the restaurant;
This one does make some sense. However, is this the unnamed restaurant's first problem with a faulty supplier, or is this a pattern? And even if it is the first time, is there a possibility that some of the unnamed, contaminated product is still in the market? 2. Because the outbreak involves a perishable item, by the time the CDC announces the outbreak, the tainted product has long been consumed or discarded;
This one I have heard a "bunch" of times - especially in relation to leafy green outbreaks. However, why should the public be left in the dark about the type of product that sickens, as well as the likely grower and shipper responsible for the product? Shouldn't consumers have this informations so they can make decisions about who to buy from?
3. Going public with the name of the restaurant compromises the epidemiologic investigation by suggesting the source of the outbreak before the investigation is complete;
I completely agree with this one. This is a tough call, and one that must create the most angst for public health officials - they decide the balance between having enough data to go forward to protect the public health or wait for more data. The point is, do not go public until the investigation is complete.
4. Public health is concerned about making an investigation mistake like, it's the tomatoes, err, I mean peppers; and
See my answer to 3 above. This is why, under the law, public health officials are immune from liability for the decisions they make in good faith to protect the public.
5. Public health - especially surveillance - is under budgetary pressure and there are simply not enough resources to complete investigations.
There is no question that this is true. I have seen it in dropped investigations over the last few years. Labs are not doing genetic fingerprinting to help reveal links between ill people. And many tracebacks are stopped by the lack of people-power to do the research necessary to find the "root cause" of an outbreak.
For me it is easy - the public has a right to know and to use the information as it sees fit, and people - especially government employees - have no right to decide what we should and should not know.
There was an article here on BlogHer yesterday that has me all fired up. It’s about judging parents, and how it’s actually ok.
Except it’s not.
It was written by a new mom, someone whose blog I actually really like. A young mom. A mom who maybe hasn’t weathered the storms of toddler reflux, breastfeeding failure, postpartum depression, child sleep disorders, isolation from friends and family, and plain ol’ active/curious/energetic toddler temperament.
Her solution to having your toddler melt down in the middle of the supermarket? Leave. Leave your groceries, leave your cart, leave your pride, and carry your screaming child outside so that they don’t hurt anyone else’s ears. Or assault their peaceful zen yoga moment. The one that is happening in the produce aisle.
My solution?
But really. Here’s why her article kind of made me cry.
It’s easy to judge other moms, when you haven’t been there. It’s easy to give advice about two year old tantrums, when your child hasn’t had one yet. We judge other moms because it’s easier than helping them. It’s lazy. It’s critical. But you know why we really do it?
Because it makes us feel better about our own parenting.
If you start a sentence with “I would never…”, then your own back gets a little pat of encouragement. You feel like you’re putting another penny in the “Good Mom Bank.” But think on this for a minute. Have you ever wondered WHY a mom might be “letting” her toddler have a meltdown in the supermarket?
Perhaps she’s like me, and the days and the hours and the minutes have started to melt together. Maybe her husband is on a long business trip, and she’s let the refrigerator get low on dinner options. Maybe she’s been feeling really lonely lately, and that feeling, coupled with the dread that she gets when it’s time to take her antsy little boy shopping, is almost too much to bear. Maybe her toddler is transitioning from riding in the shopping cart like a baby to walking through the store like a big boy. Maybe they’ve worked on good behavior all week, leading up to this trip. Maybe he made it through every single aisle, and his mom thinks that the end is finally in sight, and they hit the checkout line, and he loses it. Maybe her child is hungry and she’s pushing the limits of his patience, but she needs to get just a few more things to add to the meal that she promised a new mama she’d make for her.
Sometimes when I’m shopping by myself, I hope that I run into “that mama” in the checkout aisle. So that I can give her a knowing smile, fish a Lightning McQueen car out of the bottom of my purse, and load all of her groceries on the checkout belt so that she has both hands free to soothe her crying boy. Wouldn’t that be helpful? I mean, instead of glaring at her and hoping that she leaves her cart in the middle of the aisle while she banishes her child to the car?
Or maybe helping out is what I secretly wish someone would do for me. That someone would throw a knowing glance my way, at a time when I need it the most.
Parenting is hard. The lessons that we’re required to teach our children can be taught in many ways. I like to think that Max is learning that it’s ok to be upset. It’s ok to be pissed off that you’re in the grocery store with Mom, and because you’re 2, you get to resort to using pure emotion to express your feelings, since you haven’t yet learned the phrase “Mom, I’m exhausted and pretty bored here. Can we please hurry this up and go home?”
My job as Max’s mom, is to love him through his meltdowns. But my job is also to model for him how to interact with the world around him. I used to get embarrassed when he had a tantrum in public. My cheeks would burn with shame, and I’d hustle him out of wherever we were as fast as my legs would carry me. But now? Now that he’s almost three? I quietly bend down to his level, or pick him up in my arms. I acknowledge that he’s upset. I help him find a solution. And I show him that we can both hold our heads up high, even when we feel like shit. And then I shoot a “Fuck you, stop looking at me” stare at anyone who starts to open their mouth.
Of course, I don’t do this in the library. Or the movie theater. Or when his behavior is clearly offending someone else, or ruining their right to have a pleasant outing somewhere. Some drastic times call for drastic measures. I am not a permissive parent who lets my toddler call all the shots. When Max started screaming “I don’t waaaaant to share” during the backyard brunch that Sean’s boss was throwing, I quietly scooped him up and took him out to the car. We had our little talk over a few goldfish crackers, and he was able to return to the party and play nicely. There is a time and a place. There is a nice comfy spot where boundary-setting and rule-breaking meet somewhere in the middle.
The rest of the time? When we’re in a public place that can tolerate a little more toddler energy? Well, you have no idea how hard we’re working on learning how to navigate the world around us. Not just Max, but me.
I’m feeding him macaroni and cheese and french fries in a restaurant because he has serious GI issues that we see a specialist for. I prefer to try out new foods and textures in the safety of our own dining room, so that when he gags on it and vomits everywhere, it’s not three tables down from you. So pay attention to your own food, not mine.
When Max and I flew to Palm Springs a few weeks ago, he sat in his seat like a perfect angel the entire time. He played with toys. He watched a movie. He ate his snacks and called out to me with the things he saw through the window. The grandmother sitting next to us whispered to me “Kudos on your parenting. He is sooo well-behaved!” And I glowed, from the inside out. Until she whispered again “Now if someone would just HOLD that baby a few rows back, maybe she’d stop crying!”
And my heart broke for that mom. Because I had been in her shoes. And I will be again. I didn’t need to look behind me to know that she was holding her baby. And soothing her. And loving on her. And sweating with frustration and probably crying right along with her. And dying a thousand deaths inside, because she thought that every single person on that plane was judging her. How does that help her? How does that give her the encouragement she needs to take a deep breath, and soldier on?
I have been that mom. And if you haven’t, then you haven’t earned the right to judge me. I remember having a new baby, and being afraid to go outside. I remember setting a goal of driving downtown and walking from the Nordstrom’s at one end of the block, to the Starbucks at the other end. I would repeat (in my head) over and over, “It’s ok, you can do this. No one thinks that you’re a bad mom for pushing a crying baby in the stroller. They don’t know that he has reflux and doesn’t sleep. They can’t see the vomit stains on your sweater. Really. OK maybe, but who cares? Keep walking. One foot in front of the other. See? You’re doing it…you are DOING it!” Just writing that makes me cry. Because it was so hard. And I felt so alone. Until one day I realized, I could walk backwards out of Starbucks, open the door with my rear end, pull the stroller through, and still not wake my baby or spill my latte. I got this. This is soooo under control.
Have you ever noticed how many mamas with new babies are sitting on the sofas in the Nordstrom’s ladies room? It is safe in there. They’re all thinking to themselves “I can DO this. In just one more minute…or maybe two.”
And so our babies grow, and our parenting skills grow, and we learn that mothering doesn’t just happen on the playground. It happens in the grocery store, and in the Starbucks line, and on the airplane, and in a crowded restaurant. You can’t always choose your teachable moments folks.
So instead of judging each other, what if we put our brilliant mama minds to good use, and came up with some ways to support each other?
I’ll give you my top 3 helpful “I got your back, Mama” hints, and then you can give me yours, OK?
1. Make it better. Be useful. If you see a mom struggling, pitch in. “Here, let me load your groceries into the trunk while you get your kids loaded in,” or “Can I offer your child one of my son’s toys to play with while we’re stuck here on the runway waiting to take off?” or “I’m coming over to visit tonight and I’m bringing dinner.”
2. Don’t assume. Some children have sensory issues that cause them to get easily overwhelmed. Some kids have autism, or other special needs that look a lot like behavior disorders, though they are purely neurological. The mom feeding her kids McDonald’s may have just worked a double shift, and she may be spending her last 5 dollars to get food into her kids bellies before bed. You don’t know if you just assume.
3. Do some research on child temperament. All children are different. What works for one mom may not work for me. I don’t do time-outs, because they don’t work for Max’s temperament. We never let him cry it out, because of his health issues. I believe that he is a little person who has big emotions and valid needs, and so I let him learn about life at his own pace. I used to think that everything that was right with Max was thanks to our STELLAR parenting methods. While that does help, much of it has to do with his natural temperament. And his propensity to take things apart to discover how they work? That’s not bad parenting…just a curious temperament. It’s all in how you frame it.
As parents, we’d be well-served to remember “First, do no harm.” Take a deep breath, take a step back, and ask yourself if the judgment you’re about to make is really helpful. Could it be hurting someone? Could it be making things worse, when they already feel like they’re failing/outnumbered/hopelessly overwhelmed?
And then go whisper “You’re doing a really great job. This is hard isn’t it?” to the first struggling mama you see. I promise, she won’t be that hard to find.
Over the last few weeks, I have been sicker than sicker than sick. I managed to pick up whooping cough, which, combined with other health issues I already have, made my blood pressure dip to a very scary place, to boot. I had already been having some flare-ups from those other issues, so they made the whooping cough worse, it made them worse. Like plenty of uninsured people do, I tried to hold off on healthcare for as long as I could, but eventually had to cave and suck up the big bill so I could get the big meds and also be sure I wasn't, you know, dying or anything.
This combo of illnesses made it impossible for me to do nearly anything, including most work. When you mostly work from home, you can usually work through almost anything, so when you can't even do that, you know it's bad. They've also put some big cramps in my life. For a week or so, the deepest conversations I had with anyone were something to the effect of "More. Tea. Blanket. Ugh," and the most passionate embrace I had with my partner was the one where I was only grabbing them to say, "Please, I beg of you, just shoot me now." For the next few months, I'm going to be more susceptible to a host of things which could really mess me up, which is going to make most socializing and some of the work I had planned mighty tricky. Also, my partner and I are getting too good at pantomiming kisses; as if being sick wasn't scary enough, the possibility of becoming an expert mime adds a whole new layer of terror.
While I've been on the mend, I've been thinking a lot about that process, especially since thinking about any more than that involves a level of brainpower I haven't had.
When we hear from users who are dealing with infections, like most of what we do, it's usually sexual or reproductive health-related, not about things like whooping cough or the flu. But I've got a few reminders from the front lines of my sickbed that are important no matter what kind of yuck you've got going on.
1. That bit about getting rest? It's serious.
Sleep and rest are so, so, so darn important when we have any kind of infection. Many, if not most, of us are usually sleep-deprived as it is, which is often part of the reason we pick up bugs in the first place: lack of sleep or rest really does a doozy on our immune systems and the way the whole of our bodies function. Getting rest when we're sick is kind of like turning off the TV, radio and facebook when we're trying to study: it lets our bodies put all their focus on healing. Ideally, too, when we're in the space where we rest -- like our bedrooms -- we're not being nonstop assaulted with all kinds of pathogens like we are when we're out and about.
So, do get that rest. You don't have to be sleeping for days (that's not usually so great either: you want to move your body around some a little bit each day, just nothing too taxing), but take it freaking easy. You have absolute permission from your body to be a slacker, and to focus on totally mellow, non-stressful, non-achieving things you enjoy: board games or chill video games, a favorite movie, a puzzle, listening to the same CD a million times, writing in a journal or penning a song, painting your toenails ridiculous colors, organizing your photo albums, cross-stitching political slogans, whatever.
I know that if you're in your teens or twenties, chances are awfully good that other people, especially older adults, might push you to or past your freaking limits and can be really unforgiving about illness or taking the time to rest you need. But seriously, that is their problem. They need to let up with that, rather than you needing to keep yourself sick or get sicker because of their unforgiving standards. This is one of those places where notes from a healthcare provider can really help, so if you can/do see one, always be sure to ask them for a note for whoever you might need one for that's clear about the rest you need. If you have a job, while it's always so tough to deal with the budget hit missing work can have, do remember that the more rest you get when you really need it, the faster you'll get better, and the less likely you'll be to only get half-well and probably miss way more days of work later on than you will right now.
2. Be sure and take any medications properly and completely.
If you're dealing with any kind of an infection, whether it's the kind I got or a UTI or STI, you're likely to be given antibiotics when you get healthcare.
One common mistake a lot of people make with them -- especially if they have side effects they don't like when taking them, and I hear you with that -- is stopping when they start to feel better, or totally feel better, but the whole course of antibiotics isn't done. That's a big no-no, because what can happen is that an infection doesn't wind up totally cleared up. Our symptoms from an illness, remember, don't always tell us sound things about an illness: we can be ill without symptoms, or feel better when we've still got one. Really, there's little point in taking a medication if you're not going to take it properly. So be sure to listen to and read the directions when you get it, and follow them to the letter. (This is also why you can't just use someone else's leftover antibiotics: there shouldn't be any left over in the first place, and the leftovers probably won't be enough to treat you.)
3. Manage your stresses.
I'm a pretty mellow person most of the time, but when it became clear I was sick and wasn't going to get better for a while, the inside of my head went something like this, on a nonstop, escalating loop:
"Oh, gawd, I'm behind already and now I'm going to be eighty-million more times behind. I needed time off, and this doesn't fit the bill, now who knows when I'll get any. How am I going to get all the things done I need to? And oh GAWD, I have events and speaking engagements coming up: what if I'm not better by then? And even if I am, will the hell this made me look like still be around, because UGH if it is. Bargh, people want to talk with me and I keep having to ask more and more people to wait. GARGH, my poor partner, all I'm available for right now is whining. BLEH, I miss my friends and I can't even call them and when will I see them and oh no, I have to call my Dad, he'll be all worried, but CRIPES how can I even think about any of my life-life when I'm so behind with work and BLAHAHHHHHHWAHHHHHH...."
You get the picture. It's freaking stressful to be sick: your body is stressed out by it, and it makes any stress you already had seem or feel even worse. And then the existing stress and the extra stress make it even harder for you to get better, so you get more stressed. You've got to learn to let a lot of things just go. Taking things one day at a time helps too: for instance, there's really nothing I can do about things weeks from now for now, and who knows, my worries about things later may turn out to be needless. We can also ask for help. It's great for all of us to carry our own weight when we can, but sometimes in life we can't, and when you're sick is usually one of those times. Chances are there are people in your life you've helped out when they needed it: now it's time for you to ask them to return the favor.
Think about it this way, perhaps: just like with the rest, in some ways, any kind of illness often has something to do with a memo from our bodies telling us to slow the heck down and do a lot less. Just like most of us don't get enough rest, most of us carry too much stress, overcommit, and don't manage either as well as we could. When we're sick, we can get some practice chilling out that we probably need more of anyway.
4. Don't try and jump back into things too quickly before you're better.
Let "ease on in" be your mantra. Also "all things in good time." Sure, it stinks to be unable to do the things we really want to do, but it usually stinks more to do them and get other people sick, stay sick longer ourselves, or to get sicker. To boot, a lot of things which can be awesome when we're not sick are usually less-than when we are, especially things that ask our body to do anything challenging. Like sex.
With sexual or reproductive illness, or after a sexual or reproductive surgery of any kind, particularly, you'll often be told to hold off on sex for a given amount of time, either to heal from infection, or prevent infection for yourself or others. If you have a genital infection, that also is often about being kind to tissues which are already delicate, but can be even more so with an infection. That's a directive some people aren't always keen about, and one plenty of people play fast and loose with, thinking maybe "just this once," or, "well, what about THIS kind of sex instead of that kind?" Over the years, at Scarleteen and elsewhere I've counseled a lot of folks who've gone ahead and not held off, and made everything worse, or who want to find the magic loophole that isn't. With a cultural trend towards things like "technical" virginity, some folks will go to "Well, oral sex isn't really sex," or "He was only inside for a second," kind of places which may seem like sound rationales to you, but when it comes to sexual health, sex is sex, and when a healthcare provider says to lay off it, there's not usually any nuance: they usually mean any and all kinds of genital sexual activity.
You don't have to tell me twice that it's a bummer not to be able to be intimate or sexual in the ways you want to, especially when you could use some extra comfort, some validation, or hell, figure if you're going to be in bed all day, you might as well do something fun there. But when sex puts your health or that of others at risk, it's just not a smart choice. And sex can always wait until we're feeling better. If a partner can't deal with that, they need to step it up and learn, and probably adjust their mindset about sexual relationships so that there's always room, whatever the reason, for sex they might want to be sex they just can't engage in right then.
Hopefully none of you are in a situation where sex is an "if you must," but you know, sometimes some folks are. So, if you must, and you've been advised not to, then at the very least do safer sex to the letter, using the appropriate barrier for whatever kind of sex it is, be that a condom, dental dam or glove.
An extra tip? We often hear people say that one of the barriers to having conversations about sex or a sexual life with partners is a lack of time to do it, or finding that their time is so limited that talking about sex means not engaging in any. Well, here you are. You're sick, buddy. You need to shelve sex for right now, and that's just that. So, now might be a great time to have some of those talks. They might be serious talks, but they don't have to be. This could also be a time to talk about sexual things you've been wanting to do or explore, or to sit and verbally review all the things you've been loving about your sex life (which can make it even more exciting when you can get back to it).
5. Learn your lessons.
Sometimes illness happens when we could have prevented it or done things differently that might have reduced our risks or made an illness we got no matter what less bad than it was. That sucks when we're in the thick of it, of course, because feeling sick stinks enough without a rousing, relentless chorus of "I should've known better" going round and round in your head.
But the things we might learn by becoming sick can help us out as we recover, or give us valuable takeaways moving forward. For instance, in my case, something like this is always a reminder that I often do way, way too much in a day, a week, a month or a year, and that I need to always do what I can to try and do less and slow the heck down. It was a reminder that both my partner and myself can make some extra efforts to keep our immune systems working better. I also am reminded that I need to make some effort to make more room in my life for things like this happening, so when they do, they won't be such a huge crisis, and to cut myself a darn break for, you know, being human like everyone else.
What might it be for you? Let's say you've picked up an STI. Obviously, it can be a reminder, if you haven't already, to beef up your safer sex practices, or go back to square one with them with a partner if you've ditched them (which is always important any time an infection winds up in the mix). Maybe you've been in denial about exclusivity you want, but which, given the particular STI you have now or keep getting, obviously isn't the reality of your relationship: you may need to make choices around that. Maybe you know you need to get tested more often or draw harder lines about partners getting tested before you're sexual with them. Maybe those UTIs you keep landing are a billboard telling you that your habit of drinking tons of soda, but rarely water, is one you really need to break, like, yesterday. Or maybe you have an existing health issue or illness you need to find out more about so you can manage it better, or maybe you need to find yourself some more sex ed to know more about what your health risks are or can be and how to reduce them.
Whatever your takeaways are, take them, use them as best you can, and focus on what's useful about them and being proactive to improve things, rather than using them as a club to beat yourself up with, or yet one more source of stress that'll only keep you from healing as quickly as you can.
At back to back briefings on Capitol Hill late last week, the Center for Science in the Public Interest and the Center for a Livable Future presented a panel of experts to House and Senate staffers with a straightforward message on whether the overuse of antibiotics in animal agriculture is a human health issue: "the science is clear."
"The science is so clear that the political pressure on the FDA won't be able to keep us from moving forward," said founding director of the Center for a Livable Future, Robert Lawrence, a professor of environmental health at the Bloomberg School of Public Health and a professor of medicine at the Johns Hopkins School of Medicine. "The pharmaceutical and animal industries continue to deny the scientific evidence. We believe that the science is clear."
At the meetings, dozens of staffers were briefed on a new white paper put out by CSPI focused on these so-called superbugs and foodborne illness outbreaks. CSPI reported that in 2011, 167 illnesses, 47 hospitalizations and one death were linked to antibiotic-resistant foodborne pathogens.
Two of the outbreaks were connected to ground turkey -- one contaminated with Salmonella Hadar and one with Salmonella Heidelberg -- and one outbreak was connected to ground beef contaminated with Salmonella Typhimurium. "All of those bacteria were resistant to treatment from several antibiotics that are critically important to human medicine, including drugs in the penicillin, cephalosporin, and tetracycline families," CSPI reported.
The white paper also noted that since 2000, 38 outbreaks tied to resistant pathogens sickened 20,064, hospitalized 3,108 and killed 27 -- a count that includes an "enormous" 1985 outbreak of Salmonella Typhimurium caused by milk, which sickened 16,659, hospitalized 2,777, and killed 18.
"Antibiotics are the crown jewels of modern medicine, and they are critical to treating diseases in both humans and farm animals," said CSPI food safety director Caroline Smith DeWaal. "We must not continue to jeopardize the effectiveness of these drugs by using them recklessly for non-therapeutic uses on farms and in animal factories. Otherwise, consumers may face longer illnesses, more hospitalizations, and more fatalities when exposed to resistant strains of common foodborne pathogens."
CSPI quoted World Health Organization's position on the issue from last year: "WHO has long recognized that antibiotic use in food animals, which seems to outweigh antibiotic use for human therapy in many countries, contributes importantly to the public health problem of antibiotic resistance."
In the United States, around 80 percent of all antibiotics sold are given to food animals each year.
At the briefings, public health advocates called on Congress to pass legislation to limit antibiotic use in agriculture, by passing the Preservation of Antibiotics for Medical Treatment Act (PAMTA), and asked the U.S. Food and Drug Administration to take greater leadership on the issue.
"I would just love to see the United States taking a lead on this issue and show global leadership like we do on so many issues," said Lance Price, an associate professor at the Translational Genomics Research Institute in Arizona. "On this one, we are lagging far behind the rest of the world. All the warning signs are there...and the good science is there and we're doing nothing. It's a shameful thing. I hope that we can turn this and start taking the lead."
The number of teenage pregnancies in Wokingham has fallen by 39% since 1998. Conception rates in Wokingham have gone down from 27.8 per 1,000 girls aged 15 to 17 in 1998, the year against which all targets are being measured nationally; to 16.9 in 2009. The figures issued by the Office of National Statistics reveal that Wokingham has the third lowest teenage conception rate among local authorities in England.
Jane Wells, Assistant Director of Public Health at NHS Berkshire West, said: ‘The decline in teenage pregnancies in Wokingham reflects successful partnership working with Wokingham Borough Council in schools, in the youth service and through a relatively new young people’s health drop-in service - Juice. The Juice service provides advice on an extensive range of health issues from weight, healthy eating, smoking and concerns about drugs and alcohol to sexual health and contraception advice.’
Jane added: ‘This work remains a priority in Berkshire West because children born to teenage mothers have higher rates of infant mortality and are at increased risk of low birth-weight which affects the child’s long-term health. Teenage mothers are more likely to suffer post-natal depression and experience poor mental health after the birth.’
Amanda Smith, Head of Early Intervention & Integration within Wokingham Borough Council’s Children’s Services Department said: ‘We are really pleased to see these further reductions in the teenage pregnancy rate, which reflects the strong partnership that exists between ourselves and health service providers. Providing effective services that promote sexual health and prevent teenage pregnancies remain a priority for Children’s Services. We will continue to commission these services for 2011/12, and will be working to ensure that they are targeted at the most vulnerable young people who live in Wokingham.’
Other NHS Berkshire West and Council initiatives to tackle teenage pregnancy include:
- A Sexual Health Outreach Nurse has been appointed, whose primary responsibility is to provide sexual and reproductive health services to the most vulnerable and at risk young people in Berkshire West
- The C Card scheme was launched in March 2009 and provides young people under-19 better access to sexual health information and free condoms, leading in turn to a greater awareness about safer sex, unplanned pregnancies and sexually transmitted infections.
- A team of specialist nurses in Wokingham who provide advice to young people.
The number of young people using the Juice service at Wokingham hospital totalled 150 up to the end of December, but it is still too early to provide uptake figures for the Bulmershe service.
Humedica
Ethiopia, Somalia
Since October of last year, humedica has been running a health centre at the Melkadida refugee camp in the south of Ethiopia. What had started with makeshift, but nevertheless professional treatment and supply tents, is now taking shape in form of completely new and improved buildings.
Originally, the idea of building a humedica health centre arose from the simple wish to expand medical care at Melkadida also to the more remote areas and parts of the refugee camp.
In the beginning there was only one major health centre that offered medical treatment at one end of the camp. For those who were seriously ill or very weak, the trip through the entire camp was often too long, and hence they had no access to any kind of help.
Since the beginning of October 2010, the so-called “Health Post” of humedica has been under construction, in order to make support for ill and injured persons at the camp more easily accessible. Up to now, examination and treatment rooms, a pharmacy and waiting areas, registration and administration rooms had been accommodated in several tents.
Together with local staff, the humedica doctors and nurses offered their skills and knowledge to those in need of help under the simplest conditions. Nevertheless, the patients receive highly qualified treatment even now.
In order to expand the possibilities of the health post, construction works for a newly built health centre started a few weeks ago. At an impressive pace, the tents were replaced by stable and spacious buildings of corrugate iron, which is the preferred material for so-called “semi-permanent structure”. Therefore, the inauguration of the new health centre is expected to take place at the beginning of March.
Apart from treatment rooms, a pharmacy, and waiting and administration areas, the new building will also contain a small laboratory and a separate area for psycho-social treatment offered by our partner organisation Jesuit Refugee Service (JRS).
Furthermore, a mother-child ward will soon be set up, where birth preparation and follow-up examinations will be offered, and where women will have the opportunity of bearing their children in a hygienic, clean and medical environment.
While so far, ill and injured patients could only be treated as out-patients at the health post, the new building will also dispose of an in-patient ward, where patients can be treated and observed for short periods of a few days.
In order to improve the vaccination situation for the camp inhabitants, in particular for children, an additional vaccination centre will be set up. Epidemic diseases, such as measles or polio are a continuous threat to the health and even the lives of individuals in an environment like a refugee camp, where many people live together in close quarters.
The expansion and alteration of the humedica health centre will provide more space, better hygiene, more stable structures and a larger scope of medical treatment possibilities. However, it does not only mean medical care for the people at the Melkadida refugee camp. For many of them, the health post also is a ray of hope, which shows them that they are not alone in their misery.
Please continue to support our relief measures at the Horn of Africa by means of your donation also in future. Thank you very much.
humedica e. V.
Donation reference “Famine relief Africa”
Account 47 47
Bank code 734 500 00
Sparkasse Kaufbeuren
You can also achieve great results by means of sending a short text message: simply send a text message containing the reference DOC to +49 8 11 90. Your mobile bill will be charged with 5 euros, and 4.83 euros of this amount will be channelled directly into the humedica project work.
Last November, EngageHealth held its first conference in Brussels, ‘The future of healthcare in Europe’. This meeting brought together a broad range of cross-stakeholder organisations and explored healthcare strategies in a time of fiscal crisis. I thought you might like to know a report of that meeting is now available, free for download, and we hope that you will find it both useful and insightful. Patient groups, industry, policymakers, providers were the main contributors. To download please go to
VALUE-BASED RATIONING IN HEALTHCARE
Our next event, ‘What is value in healthcare?’ looks at value from a range of perspectives. Details of the programme can be found on the same web-page, and we very much look forwarding to welcoming many of you to London on the 29th March.
fyi attending patient groups are:
n Beat n Breathe On UK n Deutsche Gesellschaft fur Versicherte und Patienten e.V. (DGVP) [Speaker] n European Federation of Road Traffic Victims n International Alliance of Patients' Organizations [speaker] n Macmillan Cancer Support n MS Society n Nephrotic Syndrome in Children Support Group n Oxfordshire Carers Forum n Parkinson's UK n Patient Concern n Rare Disease UK n Rarer Cancers Foundation [Speaker] n Really learning n Socialist Health Association n Trigeminal Neuralgia Association UK
PatientView is a co-founder of EngageHealth Alliance Europe
Democracy itself is being undermined by publicly funded agencies crawling with conflicts of interest and devoid of scrutiny
'From any single perspective', Bertrand Russell said, "power always seems to be elsewhere". This article is about one of those elsewheres. It is about the network of unelected committees, boards and commissions, operating below the public radar, through which governments pursue the aims that weren't disclosed in their manifestos. The people they appoint are an index to the interests they serve. To list them is to expose the gulf between what a government claims to be and what it is.
It would be misleading to suggest that the process I'm about to discuss is new. Blair and Brown began the abuses that the coalition government is refining: purging countervailing voices from public bodies and stuffing them with the representatives of business.
But Cameron and his ministers are extending this project to serve what seems to me to be their core aims. These are to marketise and covertly privatise what remains of public provision and to create a welfare state for corporations and the ultra-rich, whose income will be sustained by public contracts and captive markets for essential services.
I'll begin with the government's "reform" of the National Health Service. The body charged with breaking an integrated, co-ordinated system into warring kingdoms whose commercial interests discourage collaboration is called Monitor. Its role will be to enforce competition, ensuring that "any qualified provider" can enter the NHS.
The current government has made two new appointments to Monitor's board, including the chair, who is also the body's chief executive. Both were previously senior partners at the consultancy company McKinsey. Of the six members of Monitor's senior management team, two previously worked for McKinsey (including the chief executive) and two at a similar company, KPMG.
As an investigation by Spinwatch, carried in the Mail on Sunday, shows, both board members and executives at Monitor have been lavishly entertained by McKinsey, which, like KPMG, is picking up fat contracts from NHS reforms. The company, the Mail reports, drew up many of the proposals in the health and social care bill, which were "included in the legislation wholesale". Both McKinsey and KPMG have been major beneficiaries of previous privatisations or private finance schemes.
Other health agencies seem similarly unbalanced. MHRA, the medicines and healthcare products regulatory agency, is the body that has been criticised for failing adequately to regulate breast and hip implants, with grim consequences for some patients. While the board contains retired senior executives from AstraZeneca and Merck Sharp & Dohme, it includes no one from a patient group, or any other body representing people whose health could be damaged by its decisions.
The Medical Research Council, which disburses research funds for the preservation of life, is chaired by a man who runs a company specialising in weapons technology. Sir John Chisholm was the civil servant in charge of privatising the government's Defence Evaluation and Research Agency. While doing so, he bought a ?129,000 stake in the company. The value of this stake rose to ?26m when the new defence firm, QinetiQ, was floated. This was described as "obscene" by the former defence minister Lord Gilbert and "greed of the highest order" by the agency's former managing director.
The other council members include executives or directors from Pfizer, Kardia Therapeutics and Microgen Ltd, but no one who makes their primary living working for a medical charity or any other public interest group. It seems to me that the direction of publicly funded medical research is being set by a weird and unbalanced board.
You can see something similar across government. The Office of Rail Regulation, for instance, is supposed to ensure that the railways are safe, efficient and "meet the needs of passengers and freight customers". Yet its board contains no members from passenger groups, unions or transport campaigns. The government did, however, find room for current or former executives of National Express, BAA, Rolls Royce, National Grid and Thames Water.
Soon after this government took office it set up a Farming Regulation Task Force. It was chaired by the ex-director general of the National Farmers Union. His deputy was another NFU official. Other members consisted of two more farmers, three corporate executives, onecounty council official and someone from the Game and Wildlife Conservation Trust, which claims to defend wildlife but gives advice on setting snares and spring traps. There was no one representing groups protecting the environment, landscape or animal welfare.
Its report was titled, with crashing irony, Striking a Balance. It insisted that "government must trust industry". Among its recommendations were that the government should relax the rules on the stocking density of chickens reared for meat, that new pesticides should be approved more quickly, that farmers should be given 24-year water abstraction licences (madness in view of the fluctuating pattern of droughts) and that "industry representatives" should have special, confidential access to the government's draft legislation. The body the government has set up to implement the taskforce's proposals will be chaired by the same man.
This is just a snapshot of the committee-nobbling in which successive governments have engaged. As well as excluding people who represent the wider public interest, David Cameron's government has snuffed out the bodies which might have balanced these one-sided boards, such as the Sustainable Development Commission and the Royal Commission on Environmental Pollution. Its bonfire of the quangos was in fact a bonfire of dissent, as committees which told it what it didn't want to hear were selectively purged.
I am not arguing that there should be no corporate representation on government bodies, but that it should be one strand among many. For every corporate executive on these boards there must be someone who represents an opposing interest; otherwise they become clubs for crony capitalists, feather-bedding their industries, acting against the public good.
The web of unelected bodies functions as a kind of shadow government, drafting and enforcing policies, disbursing money, regulating – or failing to regulate – business, quietly, unobtrusively, without effective public scrutiny or restraint. When it is unbalanced, crawling with conflicts of interest, it makes a nonsense of democracy. This is how governments get what they want, regardless of what the voters might think.
Twitter: @georgemonbiot
A fully referenced version of this article can be found at www.monbiot.com
Scientists are experimenting with modifying foods as a low-cost answer to health problems, including obesity and zinc deficiency
Fond of a full English breakfast? Perhaps you should have a glass of blood orange juice on the side – it might help to reduce the harm from all the fat you are ingesting, and make you less likely to become obese.
But as blood oranges are among the least favoured fruits for consumers, scientists in the UK are hoping to find ways to genetically modify standard oranges to incorporate the beneficial effects of their less popular cousins.
The project is one of several aimed at improving health through the genetic modification of plants – a process that scientists say could be a low-cost answer to harmful nutritional deficiencies.
Another project involves incorporating algae genes into oilseed rape, in order to produce nutritionally vital fish oils without having to kill fish; and grains modified to take up more zinc from the environment, to alleviate the zinc deficiency that blights millions.
The scientists involved believe that the public will be more accepting of GM plants that plug common nutritional gaps, than those crops that benefit big companies. "This isn't about increasing the profits from multinationals – there are big gains to be had," said Prof Dale Sanders, director of the John Innes Centre, an independent centre for plant science and microbiology research.
Although only a handful of GM experiments are licensed in the UK at present, some lab research continues, although scientists are concerned that the science is moving elsewhere. Cathie Martin, also of the John Innes Centre, who is leading the research on blood oranges, said: "There are enormous problems in creating something that can be grown in Europe, and big problems in public funding, because of the regulation."
Unpublished research has suggested that compounds found within blood oranges could help to cut obesity by reducing the accumulation of fats, and so avoid some of the harm from fatty foods. In one human study, people fed a full English breakfast along with the juice of three blood oranges experienced less accumulation of fat, possibly because of substances known as anthocyanins, found in abundance in blood oranges.
The results should be taken with caution – they are unpublished and have not yet been peer-reviewed. Studies on mice have shown a similar effect, preventing obesity in mice fed a high-fat diet, compared to mice given ordinary orange juice, or water, but the human effects are still uncertain.
Overfishing is a severe problem in the world's oceans, but eating fish is one of the few ways in which we can gain enough omega oils to keep the cardiovascular system and the brain in good health. Fish produce these long chain fatty acids by feeding on algae and other sources. Prof Johnathan Napier at Rothamsted Research, an agricultural research organisation, has been working for about a decade on ways to take genes from algae and introduce them into land-based plants such as oilseed rape. In this way, the genetically modified seed can be harvested and turned into oil that will contain the same acids, which are easily absorbed by the body.
Cultivating algae for food will not work, according to Dr Napier, because of the vast quantities of water and space in order to make enough algae. But if the same genes can be expressed in oil-bearing plants, it should be possible to mimic the processes that occur within fishes' bodies, and make an edible form of the long chain Omega 3 fatty acids on a large scale.
Zinc deficiency can cause mental retardation in its extreme forms, but even mild deficiencies can impair the immune system, reducing the body's resistance to common diseases including malaria, pneumonia and diarrhoea. The World Health Organisation estimates that one-third of the world may be suffering from some zinc deficiency, and that it contributes to at least 800,000 deaths a year globally.
By changing the genes in certain grains, it may be possible to induce them to take up more zinc from the ground, in a form that is more easily digestible to human beings.
Prof Sanders said the research could open ways to improve people's diets to remove nutritional deficiencies in key areas, with massive benefits to human health.
Dr. Nancy Kay, author of Speaking for Spot, is back with a handy guide for pet lovers. In this book, clients seeking the best veterinary team approach are presented with "a dozen reasonable things to expect" from their veterinarian. How do your expectations measure up?
Learn more in this review: Your Dog's Best Health
Related Reading:
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With experts predicting one of the worst allergy seasons in ten years, allergy sufferers better be on high alert.
Allergists say there are things you can do to avoid the sneezing, itchy, watery eyes and scratchy throats though before they hit.
"People with spring allergies often don't realize how many things can aggravate their allergy symptoms, so they just muddle along and hope for an early end to the season," said Dr. Myron Zitt, former American Academy of Allergy, Asthma and Immunology (ACAAI) president.. "But there's no reason to suffer. A few simple adjustments in habits and treatment can make springtime much more enjoyable."
Some of the tips experts suggest include keeping your car and house windows closed so that pollen can't drift inside from the outdoors. Pollen tends to be worst early in the morning. Your health care provider can also recommend a variety of medications to help keep your symptoms under control.
Doctors also caution allergy sufferers to use the right air filter. There are many to choose from.
Related: Is it Allergies or Non-Allergic Rhinitis?
Although the FDA has no health-related standards (as far as air filters go), it does consider some portable air filtration systems to be Class II medical devices. The Administration offers the following guidelines when considering an air filter, and questions to consider before purchasing one.
What substances will the cleaner remove from the air in my home? What substances will it not?
What is the efficiency rating of the cleaner in relation to the "true HEPA" standard?
Will the unit clean the air in a room the size of my bedroom?
How easy/difficult is it to change the filter? (Ask for demonstration.) How often does it have to be changed? How much do filters cost? Are they readily available throughout the year?
How much noise does the unit make? Is it quiet enough to run while I sleep? (Turn it on and try it, even though you will probably be in a noisy place.)
In addition, it's important to note the differences between the common cold, influenza and seasonal allergies.
- If symptoms last longer than a week, it might be allergies.
- A cold or flu can cause a fever and achiness. Allergies don’t.
- If your nose is running and it’s clear, odds are good that an allergy is the cause.
Experts caution that if allergies go long untreated they can lead to more serious conditions including ear infections and sinusitis.
Most recommened consulting your physician for a full work-up, including allergy testing, if you are unsure about your symptoms. This will give you the right information and hopefully clear up any questions you might have as to what you might be allergic to and how to avoid those triggers.
More from GalTime:
- Cell Phones: Could Yours Make You Sick?
- Are You Allergic to Kissing?
- Will 1 Lost Hour of Sleep Increase Your Risk for a Heart Attack?
- Using Food as Medicine
Tara Weng is the national editor of parenting and health for GalTime. She is also a media consultant with a focus on medical and consumer topics. Her professional experience includes a stint as a medical/features producer at the NBC affiliate in Boston, MA and a media relations position at a top teaching hospital in Boston. Tara has also done public relations consulting work and has written for several online and print media outlets. She is a wife and a mother to two children (who are fantastic) and an enthusiastic New England sports fan.
Read more: http://galtime.com/profile/38415/3408/tara-weng#ixzz1ojBCEj4O
It is no consolation to the roughly one out of 600 families who lost their homes in the U.S. but Wall Street made a lot of money slicing and dicing mortgages it knew would implode, while hiding risks. Financial giants, like AIG, are still buzzing along and neither penalties or new laws will prevent a future crash, say financial analysts, because the risky business models have not really changed.
A similar Big Pharma bubble, leavened with risky blockbuster drugs that also blew up, is now bursting. Like Wall Street’s bundled high risk loans, the “tide” created by Big Pharma’s high risk drugs raised many ships during the 2000s from advertising, public relations and medical communication agencies to TV and radio stations, medical journals and doctor/pitchmen who shoveled in its marketing budgets. But now the joy ride is over and Pharma is shedding jobs and settling billions in claims without changing its risky business model, like Wall Street.
In Europe, governments are no longer willing to pay the high prices for drugs that they once did say published reports and some countries are drafting laws making drug makers “prove their drugs are effective or risk having them dropped from the coverage list, or covered at a lower rate.” Imagine!
Germany has already saved 1.9 billion euros in 2011 by refusing to pay higher prices for drugs unless they are clearly superior to existing medicines, and Pharma worries that other countries will also get tough and want scientific proof for drug effectiveness instead of marketing and spin. In the U.S. and elsewhere, a drug only needs to be superior to no drug (placebo) to be approved by regulators — yet “new” is conveyed as “better than any drug to date” in advertising. Some clinicians say Haldol, an inexpensive antipsychotic, and lithium, a similar affordable bipolar drug are better than blockbuster antipyschotics and bipolar drugs that created Pharma’s 2000 bubble.
Before the Vioxx scandal and major settlements over blockbuster drugs like Zyprexa, Bextra, Celebrex, Geodon and Seroquel, being a Pharma rep was probably the next best thing to working on Wall Street. Direct-to-consumer advertising did your pre-sell for you, and all you had to do was show up with your snappy Vytorin tote bag and samples case. Some Pharma reps had their own reception room with ice water, swivel chairs, and laptop ports at medical offices, and most waltzed in to see the doctor right in front of waiting and sick patients. (It didn’t hurt that reps were usually “hotties,” both men or women).
But, by 2011, the bloom had fallen off Pharma reps’ roses. The number of prescribers willing to see most reps fell almost 20 percent, the number refusing to see all reps increased by half, and eight million sales calls were “nearly impossible to complete,” reported ZS Associates. Blockbuster drugs that were found to be unsafe after their big sales push or even withdrawn altogether, did not help the reps’ credibility with doctors. After the aggressively marketed hormone therapy was linked to high incidences of cancer, stroke and heart attack, Wyeth (now Pfizer) announced it was eliminating 1,200 jobs and closing its Rouses Point, New York plant where Prempro products were manufactured.
As government and private insurers increasingly say, “You want us to cover what?” about expensive, dangerous drugs that are not even proven effective, Pharma bubble jobs are evaporating. Almost 20,000 jobs have vanished at AstraZeneca, Novartis and Pfizer in the last 12 months alone. (AstraZeneca scrapped 21,600 more since 2007). Meanwhile, Pharma is outsourcing more of its operations to poor countries.
Workers and people willing to be trial subjects are both a bargain in poor countries where many can’t understand drug risks or refuse them if they did (and most can’t afford the very drugs they help sell). In January the Argentinian Federation of Health Professionals accused drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis, reported CNN. In 2010, 10 deaths occurred during Pfizer and AstraZeneca drug trials at the Bhopal Memorial Hospital and Research Centre which was ironically built for survivors of the 1984 Bhopal gas disaster, reports MSNBC. 3,878 workers perished in Bhopal when chemicals leaked at a Union Carbide pesticide plant.
Outsourcing drug manufacturing to cheap venues also contributes to Pharma’s cascade of “quality control” problems in which drugs are mislabeled, contaminated or otherwise made dangerous. It is speculated that Johnson & Johnson’s CEO William Weldon “was pushed to retire because of all of the quality issues at McNeil as well as with the company’s hip implant products, which have resulted in a raft of litigation,” reports FiercePharma.
Like the Wall Street bubble, the Pharma bubble was built on products that industry, but not the public, knew were risky, sold for quick profits. Now regulators are examining some of these “assets” more closely and with disturbing findings. The FDA now warns that bestselling statin drugs like Lipitor and Crestor, even approved for children, are linked to memory loss and diabetes associated with. The equally well selling proton pump inhibitors like Nexium and Prilosec for acid reflux disease (GERD) are now believed to increase the risk of bone fractures by 30 percent.
In March, the FDA even rejected a Merck drug that combines the active drug in Lipitor with the active drug in Zetia and Vytorin, a drug that Forbes calls Son of Vytorin. Vytorin (the father) was advertised to treat both food and family “sources of cholesterol” until results from a study that Merck and Schering-Plough appeared to withhold from regulators showed the drug had no effect on the buildup of plaque in the arteries (believed to correlate with heart attack and stroke). There was such a gap between marketing and science, Sen. Chuck Grassley (R-Iowa) asked the General Accounting Office to investigate why the FDA was approving “drugs that appear to have little to no effect in protecting lives and increasing health.”
Yet even as clouds develop over Pharma’s top-selling drugs, some say the FDA is too hard on new drugs, not too easy. “The FDA is impeding useful innovations in the U.S.,” says former FDA deputy commissioner Scott Gottlieb in the a Wall Street Journal oped and lagging behind other countries. Former FDA commissioner Andrew Von Eschenbach, also writing in the WSJ, agrees. The FDA should improve U.S. drug competitiveness by allowing drugs “to be approved based on safety, with efficacy to be proven in later trials,” while the public is already taking the drugs. Isn’t that what’s happening now?
I live, sleep, eat, and breathe nutrition, so I would rather spend time at a farmer’s market or health food grocery than a department store or mall any day. When I discover brand new, healthy (and delicious) products I feel like a kid in a candy shop. That’s why I was so excited to attend the Natural Products Expo West in Anaheim, California over the weekend, where thousands of natural products were featured.
Chattanooga Police Department
CONTACT: Officer Nathan Hartwig
Public Information Officer
Community Safety Fair
Wednesday, March 07, 2012
The Chattanooga Police Department and Virginia College have teamed together to sponsor a Community Safety Fair which is to be held on March 24, 2012 from 11:00 a.m. until 4:00 p.m. at the Virginia College’s Eastgate Campus. The purpose of the Safety Fair is to provide health and safety information to the public and to create positive interaction with members from all aspects of our community. The Fair is free of charge and is open to the public, including both adults and children.
There will be several classroom seminars such as Crime Prevention, Identity Theft, Gangs, Code Enforcement, Health Wellness, Fire Prevention, Chattanooga Zoo, and Animal Bite Prevention. There will also be numerous displays set up in the parking lot which will include the Chattanooga Police Bomb Squad, S.W.A.T., Beat the Heat Race Car, Big Brothers Big Sisters, Virginia College Blood Pressure Booth, Citizen’s Police Academy Alumni Association, Face Painting (provided by Virginia College Cosmetology students), Parks and Recreation, Safe Internet Surfing (provided by the F.B.I.), READMOBILE, The Chattanooga Aquarium and Zoo, and Child Car Seat Safety Checks. A lunch will be provided consisting of a hotdog,soda, and snacks. There will also be a free raffle for numerous prizes.
Tents will be set up outside, so whether rain or shine, the event will go on. Save the date of Saturday, March 24th, and come enjoy a day of Safety Awareness and community interaction!
We would also like to thank our sponsors: Coca Cola, Home Depot, Target, Walmart, Firehouse Subs, Chattanooga Bakery, and others.
For more information, you can contact any of the following:
Captain Jeannie Snyder
Chattanooga Police Department
Office: 423-643-5334 / Cell: 423-421-4754
Richard A Johnson
Virginia College School of Business and Health
Chattanooga, TN 37411
Office: 423-893-2043 / Cell: 423-544-6033
Officer Wayne Jefferson
Chattanooga Police Department
Office: 423-643-5090 / Cell: 423-421-3722
Officer Nathan Hartwig
Chattanooga Police Department
Office: 423-643-5571 / Cell: 423-208-6212
On March 9, the Drug Enforcement Administration ("DEA") filed its opposition to Cardinal Health, Inc.'s ("Cardinal's") appeal of a recent United States District Court ruling. At issue is the DEA's Immediate Suspension Order ("ISO") revoking Cardinal's Lakeland, Florida facility's registration to ship controlled substances, which has been previously reported here and here. The DEA alleges that Cardinal did not adequately stop diversion of oxycodone, an often-abused pain medication (diversion exists when controlled substances are distributed to an entity that does not have a valid DEA registration). Cardinal is not accused of diversion itself, but instead is accused of not adequately preventing diversion at four pharmacies. Because the ISO was issued prior to an administrative hearing, Cardinal requested that the suspension be halted pending the resolution of this upcoming hearing. The district court denied this request.
Typically, the DEA revokes a distributor's registration after providing the registrant notice of the intent to revoke and a hearing. The DEA may issue an ISO without a hearing, however, when there is an "imminent danger to the public health or safety." Cardinal's appeal argues that the DEA was "arbitrary and capricious" when it issued the ISO because the DEA never met the "heightened standard" Cardinal argues is required to find that the Lakeland facility posed an imminent danger to public health or safety. Additionally, Cardinal argues that it already took remedial measures that obviated any imminent danger, including suspending or sharply curtailing shipments to the four pharmacies specified in the ISO. Consequently, Cardinal argues, issuing the ISO was contrary to law and denied Cardinal its due process right to be heard before the DEA suspended its registration.
The District Court, however, stated that "the DEA's issuance of the ISO easily passes the arbitrary and capricious standard of review." The court noted that the DEA considered the following factors: "(1) the rampant pharmaceutical drug problem in Florida, (2) Cardinal Lakeland's history of inadequate anti-diversion controls, (3) the large and increasing amounts of oxycodone distributed by Cardinal Lakeland to the four pharmacies from 2009 to 2011, (4) the sizeable amounts of oxycodone distributed to 25 other pharmacies in 2011 that exceeded state and national averages, and (5) the evidence of Cardinal Lakeland's failure to monitor its chain pharmacy customers, despite clear warning signs of inadequate anti-diversion controls at those pharmacies . . . ." Based on these factors, the court found that the DEA had a reasonable basis to conclude that the Lakeland facility's continued registration posed an imminent danger to public health or safety. This, combined with the DEA's explanation for the action and consideration of Cardinal's remedial efforts, led the court to conclude Cardinal was unlikely to succeed in proving that the ISO was arbitrary and capricious.
Continue ReadingAsthma inhalers may be linked to birth defects, the Daily Mail has today reported. The newspaper said that new research has linked steroid asthma pumps "to a slightly increased risk of hormonal and metabolic disorders in babies"
The research was from a Danish study that looked at whether the risk of developing a variety of early childhood diseases was linked to their pregnant mother’s use of glucocorticoid steroid inhalers - a standard preventative treatment for asthma.
The national study looked at over 65,000 Danish women who gave birth between 1996 and 2002, 6.3% of whom had asthma, and followed the children to an average of six years. The researchers looked at a wide range of disease types but found the use of inhalers was only linked to an increased risk of developing an endocrine (hormonal) or metabolic disorder during early childhood.
Further research into the long-term effects of inhaled corticosteroids is warranted, and additional research to confirm the finding of this research is needed. In the meantime, recommendations on the use of steroid inhalers are unlikely to change. Pregnant women prescribed inhaled steroids should continue to take these medications as advised as the benefits of using this medication are likely to outweigh the risks, especially in women who have severe asthma.
Where did the story come from?
The study was carried out by researchers from the University of Basel, Ruhr-University Bochum and other medical and research institutions throughout Europe and the US. The research was funded by the Danish National Research Foundation, the Swiss National Science Foundation, the German National Academic Foundation and Research Foundation of the University of Basel.
The study was published in the peer-reviewed American Journal of Respiratory and Critical Care Medicine.
This study was not widely reported in the media; however, the Daily Mail did focus on it in a story about prescription drugs and risk of birth defects. The story mentioned a range of different types of prescription drugs that could be linked to birth defects, although it mainly discussed a possible link between asthma inhalers and birth defects. While the story did mention that the research found only a slightly increased risk in one category of diseases, it did not report that this study found no significant increased risk for most diseases.
Throughout its article the Mail referred to a ‘major inquiry’ and an ‘investigation’ into the use of a variety of medications during pregnancy. The research in question is the EUROmediCAT study, a large ongoing project to look at the use of medication during pregnancy. The way the project was described might lead readers to assume it is some sort of emergency investigation or was set up as the result of a specific health scare. However, it is an ongoing scientific study and does not suggest any kind of health scare or emergency at present.
This Behind the Headlines article focuses on the study looking at inhalers and potential birth defects, rather than the EUROmediCAT study.
What kind of research was this?
This was a national cohort study that aimed to assess the association of women using glucocorticoid inhalers for asthma during pregnancy and their child’s risk of developing several types of disease during the first several years of life.
Previous research into the safety of inhaled glucocorticoids has suggested that they are safe to use during pregnancy, and are not associated with increased risk of birth defects. This research has provided the basis for many policies recommending the continued use of inhalers for the treatment of asthma during pregnancy. The researchers say, however, that these studies only examined the short-term risks, and that research should assess the children for longer to determine if there are any longer-term associations with a wider variety of diseases.
A prospective cohort study is an appropriate design for assessing associations such as long-term outcomes of medicine use, as it collects information on a range of factors before any outcomes develop, and then goes on to see how they might account for any relationship that develops.
What did the research involve?
This study analysed data from the Danish National Birth Cohort, which included births between 1996 and 2003. Women were invited to participate during their first antenatal visit, at around 6 to 12 weeks of pregnancy. Approximately 60% of the invited women decided to participate. Interviews during and after pregnancy were conducted, and researchers assessed the development of disease during early childhood by examining medical registries.
For this substudy looking specifically at the use of certain asthma medications, the researchers extracted data from the Danish National Birth Cohort on women with asthma who gave birth to a single baby (women carry twins or other multiples were not included in the analysis).
Women were considered as having asthma if the condition occurred at any time during the current pregnancy. Researchers recorded information on the type of asthma treatment at several times during the study - at weeks 12 and 30 of pregnancy and at six months after birth.
Researchers also collected information on the child relating to diagnoses in a number of disease types based on the International Classification of Diseases, version 10. They used a statistical technique called regression analysis to assess the association between use of inhaled corticosteroids and the development of these disease types during early childhood:
- infections and parasitic diseases
- neoplasms (cancers)
- diseases of the blood or immune system
- endocrine or metabolic disorders
- mental disorders
- diseases of the nervous system
- diseases of the eye
- diseases of the ear
- diseases of the circulatory system
- diseases of the respiratory system
- diseases of the digestive system
- diseases of the skin
- diseases of the musculoskeletal system
- diseases of the genitourinary system
- any disease
During these analyses the researchers included several measures that have been shown to impact on early childhood health, including socioeconomic status, mother’s occupation, the number of previous pregnancies, child sex, and the use of any non-steroid inhalers during the pregnancy. This allowed them to assess the influence any of these factors might have on the relationship between maternal inhaler use and the risk of early childhood diseases.
What were the basic results?
There were 65,085 mother-child pairs enrolled in the original Danish National Birth Cohort. Of these, 4,083 (6.3%) had asthma during pregnancy and were included in the current analysis. Of women with asthma, 1,231 (30%) used steroid-inhalers during pregnancy, the most common of which was budesonide. The median (average) child age at the end of the study was 6.1 years (range 3.6 to 8.9 years).
In all, 2,443 children developed a disease during early childhood. When the researchers compared the risk of developing diseases between the children of women who used inhaled corticosteroids compared to the children of women who did not, they found there was no significant difference in risk for the following categories:
- infections and parasitic diseases
- neoplasms
- diseases of the blood or immune system
- mental disorders
- diseases of the nervous system
- diseases of the eye
- diseases of the ear
- diseases of the circulatory system
- diseases of the respiratory system
- diseases of the digestive system
- diseases of the skin
- diseases of the musculoskeletal system
- diseases of the genitourinary system
- any disease
A total of 93 children (2.28% of the asthma cohort) developed an endocrine or metabolic disorder during early childhood. The endocrine system is made up of various glands that release hormones into the blood. The metabolism is the system the body uses to turn food into energy.
The researchers calculated that children of women who used inhaled glucocorticoids during pregnancy had 62% increased risk of developing an endocrine or metabolic disorder, compared to children of women who did not use the inhalers (hazard ratio 1.62, 95% confidence interval 1.03 to 2.54, p=0.036).
How did the researchers interpret the results?
The researchers concluded that use of glucocorticoids during pregnancy was not associated with an increased risk of the child developing most diseases during early childhood compared to the children of mothers with asthma who did not use the treatment. The only disease category in which use of inhalers was associated with an increased risk was endocrine and metabolic disorders.
Conclusion
This large cohort study suggests that the use of inhaled glucocorticoids for the treatment of asthma during pregnancy does not increase the risk of developing most types of disease during early childhood. As the researchers say, this data is ‘mostly reassuring’ and supports the use of these inhalers during pregnancy.
The study did find an increased risk of developing endocrine or metabolic disorders in children of mothers with asthma who used steroid inhalers during pregnancy. However, it is important to remember that the increased risk is relative to children of women with asthma who did not use inhaled steroids, and that only 93 children developed an endocrine or metabolic disorder of the 4,083 whose mothers who had asthma during pregnancy.
The study does not give absolute numbers of children with these conditions whose mothers did and did not use steroid inhalers, but the absolute risk for both groups is likely to be quite low.
The researchers say that their results regarding this increased relative risk for endocrine and metabolic diseases should be investigated further. They point to several limitations of their study, including the fact that they relied upon a clinical diagnosis of a disorder and did not consider other potentially more sensitive measures. In addition, the researchers did not have information on diagnoses made by the childrens’ GPs, and therefore may have missed out on a diagnosis of less severe disease.
They also say that some disease categories had very small number of diagnoses (such as cancers and blood and immune system diseases), which may have resulted in an imprecise estimation of the hazard ratios.
An editorial accompanying this study suggested that the results be interpreted with caution, given some of the study limitations, such as the fact that the analysis did not control for asthma severity or patients’ use of other treatments alongside their inhalers. They say that it is unclear whether the findings are the result of women using inhaled steroids for the management of more severe asthma.
Pregnant women who have been prescribed inhaled steroids for asthma should continue to take these medications as advised, as well-controlled asthma is important for the health of both the mother and the baby.
Women who have any concerns about the medical management of their asthma during their pregnancy should speak with their doctor.
Analysis by Bazian
Links To The Headlines
Are asthma inhalers linked to birth defects? Thousands of pregnant women at centre of inquiry into health problems in babies. Daily Mail, March 12 2012
Links To Science
Tegethoff M, Greene N, Olsen J et al. Inhaled Glucocorticoids during Pregnancy and Offspring Pediatric Diseases A National Cohort Study. American Journal of Respiratory and Critical Care Medicine. March 1 2012, vol. 185 no. 5 557-563
Related editorial
George J, Abramson MJ, and Walker SP. Asthma in Pregnancy: Are Inhaled Corticosteroids Safe?. American Journal of Respiratory and Critical Care Medicine. 2012; 185: 476-478.
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