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?
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%.
***
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.
***
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.
***
“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.
***
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
.
***
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.
***
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.
***
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 c
ontains 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.
***
”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.”
***
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.
***
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.
***
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.
***
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.
***
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?
***
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.
A team of researchers at Duke University has determined the structure of a key molecule that can carry chemotherapy and anti-viral drugs into cells, which could help to create more effective drugs with fewer effects to healthy tissue.
"Knowing the structure and properties of the transporter molecule may be the key to changing the way that some chemotherapies, for example, could work in the body to prevent tumor growth," said senior author
Seok-Yong Lee, PhD, assistant professor of biochemistry at Duke.
The article was published in
Nature online on March 11.
The transporter molecule, called a concentrative nucleoside transporter, works by moving nucleosides, the building blocks of DNA and RNA, from the outside to the inside of cells. It also transports nucleoside-like chemo drugs through cell membranes.
Once inside the cells, the nucleoside-like drugs are modified into nucleotides that are incorporated into DNA in ways that prevent tumor cells from dividing and functioning.
"We discovered the structure of the transporter molecule, and now we believe it is possible to improve nucleoside drugs to be better recognized by a particular form of the transporter molecule that resides in certain types of tissue," Lee said. "Now we know the transporter molecule has three forms, which recognize different drugs and reside in different tissues."
The team determined the chemical and physical principles a transporter molecule uses to recognize the nucleosides, "so if you can improve the interactions between the transporter and the drug, you won't need as much of the drug to get it into the tumor cells efficiently," Lee said. "Knowing the shape of the transporters will let scientists design drugs that are recognized well by this transporter."
Because the drugs enter healthy cells as well as tumor cells, giving a lower dose of drug that targets tumor tissue would be the best scenario, said Lee, who is also a member of the
Duke Ion Channel Research Unit. "Healthy cells don't divide as often as tumor cells, so lowering the amount of drug given overall would be an effective approach to killing tumors while protecting patients."
The researchers studied transporter molecules from
Vibrio cholera
, a comma-shaped bacterium. The bacterial transporter serves as a good model system for studying human transporters because they share similar amino acid sequences. They found that both the human and bacterial transporter use a sodium gradient to import nucleosides and drugs into the cells.
The next step will be to try to understand which features of the transporter confer the ability to recognize certain chemo drugs and ultimately to design drugs that can easily enter the cells.
This work won a prize for Dr. Lee, the National Institute of General Medical Sciences Award, which he will receive at the Biophysical Society meeting in February.
The work was funded by the McKnight Endowment Fund for Neuroscience, the Alfred P. Sloan Foundation, the Klingenstein Fund, the Mallinckrodt Foundation, the Basil O'Connor Starter Scholar Research Award from the March of Dimes Foundation, and the NIH Director's New Innovator Award, in addition to start-up funds from the Duke University Medical Center.
Other authors include Zachary Lee Johnson and Cheom-Gil Cheong also of the Department of Biochemistry and the Ion Channel Research Unit.
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."
Last week a consumer advocacy group reported that the leading brown sodas contain levels of 4-methylimidazole (4-MI) - an animal carcinogen - high enough to cause cancer in 7 out of 1 million Americans. Days later, soda companies, including Coca-Cola and Pepsi, announced that they were reducing the amount of 4-MI in their colas to meet the limit set by California - the only state that regulates the substance.
However industry says it did not make this change for public health reasons, since the amount of 4-MI in colas does not actually pose a risk to consumers. Instead, companies want to avoid having to put a cancer warning label on cans in the event that government regulators decide to restrict 4-MI. But this change in policy, requested by the Center for Science in the Public Interest (CSPI) seems unlikely to come about anytime soon, as even the Food and Drug Administration (FDA) refuted the group's claims that the 138 micrograms it found in brown sodas on average poses a cancer risk.
"A person would have to drink more than a thousand cans of soda in a day to match the doses administered in studies that showed links to cancer in rodents," said FDA spokesperson Doug Karas in a now widely-cited statement.
According to Dr. James Coughlin, a toxicologist who studies animal carcinogen, the risk posed by 4-MI is even smaller than this government estimate suggests.
The limit on 4-MI now being adopted by cola companies nationwide was set by California's Proposition 65, which lists all chemicals considered carcinogens by the state.
To set this threshold, rulemakers relied on the results of a 2007 study from the National Toxicology Program which found that 4-MI at high doses caused lung cancer in mice.
But in order for humans to reach the equivalent of even the lowest cancer-causing dose in mice, says Coughlin, a woman would have to drink 37,000 cans (12 oz) a day for the rest of her life. A man, on the other hand, would have to drink a whopping 95,000 cans a day during his lifetime. These figures are taken from a slightly more conservative study of colas done last year that found an average of 130 micrograms of 4-MI per can as opposed to the 138 micrograms found by CSPI.
"It's certainly not a health risk," Coughlin told Food Safety News. "Cola is not causing cancer in humans. It's just not happening."
In fact, he says, in the same study, rats were also given high doses of 4-MI, and none of them developed tumors. The chemical even reduced their risk of 5 other types of cancer (besides the lung cancer it produced in mice).
"I believe this is much ado about nothing," he says.
But Michael Jacobson, executive director of CSPI, says the organization is sticking by its petition to limit 4-MI nationwide. FDA's claim that one would need to drink over 1,000 cans a day to risk cancer is "a ridiculous statement," he says, "and it deserves ridicule."
"It's disappointing to see FDA defending a cancer-causing chemical in the food supply," he said in an interview with Food Safety News.
Jacobson says it's not the dose but the percentage of mice that got tumors in the study that matters. Since about 30 percent of the mice developed cancer, and a can of soda has about 1/1,000 of the amount of 4-MI administered to the mice, that would equate to 30 cancer cases in every 100,000 people.
Coughlin, on the other hand, says you can't apply the number of illnesses in an animal study directly to humans.
"CSPI took these animal numbers and calculated cases of human cancer, but you can't just take those animal statistics and transfer them," he says.
For this reason, adding 4-MI to California's list of toxins was a mistake in the first place, he says, as it was based on the prevalence of cancer in mice and not adjusted properly for the human body.
"There is strong scientific evidence that the chemical never should have been listed by Prop-65."
Nonetheless, Coke and Pepsi - whose products had the most 4-MI in CSPI's study - are changing how they produce caramel coloring (this process is what creates 4-MI) in order to avoid backlash should nationwide policy adapt to California law.
"The companies that make caramel coloring for our members' soft drinks are now producing it to meet California's new standard, and it will be used in products nationwide," said the American Beverage Association in a statement. "Consumers will notice no difference in our products and have no reason at all for any health concerns, as supported by FDA and regulatory agencies around the world."
Editor's note: An earlier version of this article quoted James Coughlin as saying "I believe this is much ado about something," when in fact he said "I believe this is much ado about nothing." The story has been updated to reflect this correction.
Botox injections may help women with urinary incontinence, The Daily Telegraph has today reported. The newspaper said that injecting the muscle-freezing toxin into the wall of the bladder can have a long-lasting impact on overactive bladder syndrome, a major cause of incontinence.
The newspaper’s story is based on a UK medical trial that investigated whether the paralysing properties of botox were effective at reducing the symptoms such as frequently using the toilet, feeling an urgent need to urinate, and leakage in patients with overactive bladder syndrome.
The trial featured 240 women who had not responded to medical treatments for overactive balder syndrome. The researchers found that women who received the botox injection experienced these symptoms significantly less frequently than women who received a dummy injection of saltwater. However, women given botox were more likely to get urinary tract infections.
The results of the study indicate that botox may be effective in treating a common and upsetting health condition. However, if it does get adopted into use in this way there are several other treatment options (including lifestyle measures, bladder training exercises and medication that would be considered first. Botox may be considered as an option only if these treatments fail, and the benefits would have to be considered in relation to its potential harms.
Where did the story come from?
The study was carried out by researchers from the University of Leicester and was funded by the Moulton Charitable Trust and the women’s health charity Wellbeing of Women.
The study was published in the peer-reviewed medical journal European Urology.
The Telegraph covered this study appropriately, covering the study size and design, as well as the treatment benefits and harms.
What kind of research was this?
While it is hard to gauge the true scale of the problem, research suggests that around 13% of women in the UK may have some form of urinary incontinence. Although many conditions and factors can cause urinary incontinence, one major cause is overactive bladder syndrome. The condition is marked by uncontrolled contraction of the bladder that results in an urgent need to pass urine. While this can lead women to need the toilet frequently, some also experience a form of leakage called urge incontinence.
An overactive bladder can be a cause of urge incontinence, which is when urine leaks at the same time or just after you feel an intense urge to pass urine. Urge incontinence differs from stress incontinence, where the pelvic floor muscles are too weak to prevent urination. This causes urine to leak when your bladder is placed under pressure from actions such as coughing or laughing.
This was a placebo-controlled randomised controlled trial that examined the effectiveness and safety of using botulinum toxin (botox) as a treatment for overactive bladder syndrome. A randomised controlled trial is the best way to measure the effectiveness of a treatment, as the randomisation process helps to ensure that any patient characteristics that may influence the outcome have an equal chance of appearing in either treatment group. This allows researchers to be confident that any observed effect is due to the treatment under study.
What did the research involve?
The researchers enrolled 240 women with bladder muscle overactivity, or overactive bladder syndrome, that had not responded to previous treatment. The women were randomly allocated injections of either Botulinum toxin A (botox) or placebo (saltwater) into the wall of the bladder. Women with another common type of incontinence, stress incontinence, were not included in the study.
The participants kept a diary over three days, recording the number of times they:
- emptied their bladder
- felt an urgent need to empty their bladder
- experienced an unintentional passing of urine (or leakage)
The women also completed a questionnaire that assessed their quality of life, as overactive bladder syndrome often has a significant negative impact on patient quality of life.
The researchers conducted follow-up sessions with the women on average at six weeks, three months and six months after treatment. They assessed differences in the frequency of the above three symptoms between the two treatment groups. They also compared quality of life scores, treatment complications and time until troubling symptoms returned between the two groups.
The researchers used appropriate statistical methods to assess differences in frequency of symptoms between the two groups.
What were the basic results?
There were 122 women allocated to the botox treatment group and 118 women allocated to the placebo group.
The researchers compared the outcomes in the botox and placebo groups at the six-month follow-up. They found that in any 24-hour period women in the botox group:
- emptied their bladders less often: 8.33 times versus 9.67 times, a difference of 1.34 (95% confidence interval [CI] 1.00 to 2.33, p=0.0001)
- experienced fewer leakage episodes: 1.67 versus 6.00, a difference of 4.33 episodes (95% CI 3.33 to 5.67, p
<0.0001) - experienced fewer episodes of urgency to urinate: 3.83 versus 6.33, a difference of 2.50 episodes (95% CI 1.33 to 3.33, p
<0.0001)
Almost a one-third of women in the botox group (31.3%) developed bladder control (or continence) following their treatment, compared to 12.0% in the placebo group (Odds Ratio [OR] 3.12, 95% CI 1.49 to 6.52, p=0.002).
However, urinary tract infection was reported at least once during six months by a one-third of women in the botox treatment group, compared to 10% in the placebo group (OR 3.68, 95% CI 1.72 to 8.25, p=0.0003).
Those given botox also reported greater difficulty emptying their bladders, which required self-catheterisation to remove their urine: 16% of the botox group compared to 4% of the placebo group (OR 4.87, 95% CI 1.52 to 20.33, p=0.003).
How did the researchers interpret the results?
The researchers concluded that injections of botulinum toxin A into the bladder wall is an effective and safe treatment for overactive bladder syndrome in women who have not responded to previous treatment.
Conclusion
Urinary incontinence can be a distressing and problematic condition, and although we cannot be sure of the number of people affected, research suggests it is surprisingly common.
While there is a range of potential treatments and ways to manage urinary incontinence (including medication, bladder training, lifestyle changes and surgery) not all people respond to them, and they can have problems. This randomised controlled trial provided good evidence that botox injections may be a useful treatment option for women with incontinence due to overactive bladder syndrome that has proven difficult to treat with other methods.
The researchers say that the relief of symptoms reported by the participants was considerably better than those who used oral anticholinergic drugs. These drugs act on the nerve supply to the bladder and are the standard medical treatment used for this condition. They add that other randomised controlled trials have reported similar effects.
The researchers say that since they designed their trial, other studies have published results that support using a lower recommended dose of botox for this type of treatment. Therefore, it is unclear if the same results would be found at this reduced dose. They also say that their study recruited participants with severe cases of overactive bladder syndrome, and that it is unclear if the treatment would be as effective in less severe cases.
It is important to note that the study participants did not have stress incontinence, which is a common cause of urinary incontinence. Therefore, the results of this study cannot be generalised to all women with symptoms of overactive bladder or incontinence, but can only be applied to those with diagnosed overactive bladder syndrome (or detrusor overactivity).
Botox is not routinely used by the NHS in this way, but if it were then it would probably be considered as an option only among women who have required specialist referral for their condition. This would be given after they had tried other treatment options first, which may include lifestyle measures and bladder training exercises in addition to oral medications. If these treatments fail, the benefits of botox would have to be considered in relation to its potential harms.
Links To The Headlines
Botox 'stops the call of the bathroom'. The Daily Telegraph, March 12 2012
Links To Science
Tincello DG, Kenyon S, Abrams KR et al. Botulinum Toxin A Versus Placebo for Refractory Detrusor Overactivity in Women: A Randomised Blinded Placebo-Controlled Trial of 240 Women (the RELAX Study). European Eurology, Published online 5 January 2012
Asthma 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.
The NACMCF is set to discuss microbiological criteria, pathogen testing methodology, and sampling plans.
The full committee is scheduled to meet by phone conference on Wednesday, March 28, from 2 p.m. to 5 p.m. EST. The meeting is open to the public. Those interested in participating can contact Karen Thomas-Sharp at the FSIS Office of Public Health Science, at 202-690-6620 or email: Karen.thomas-sharp@fsis.usda.gov.
According to the federal register notice, the NACMCF was established in 1988, in response to a recommendation of the National Academy of Sciences for an interagency approach to microbiological criteria for foods, and in response to a recommendation of the U.S. House of Representatives Committee on Appropriations, as expressed in the Rural
Development, Agriculture, and Related Agencies Appropriation Bill for fiscal year 1988. The charter for the NACMCF is available on the FSIS website.
"The NACMCF provides scientific advice and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services on public health issues relative to the safety and wholesomeness of the U.S. food supply, including development of microbiological criteria, as well as the review and evaluation of epidemiological and risk assessment data and methodologies for assessing microbiological hazards in foods," according to the register. "The Committee also provides scientific advice and recommendations to the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Departments of Commerce and Defense."
The petition, filed by nonprofit Center for Food Safety and supported by more than 400 health and consumer organizations and businesses, argues that consumers require more complete labeling in order to make informed decisions. Since October 2011, members of the public have submitted more than 850,000 comments in support of the petition. Genetically engineered foods are foods made from organisms -- mainly plants -- that have had their genes modified to exhibit specific desired traits, such as tomatoes modified to delay ripening or corn with built-in resistances to herbicides and insects. Such foods have been sold on the market since 1996.
Drafting of the bicameral congressional letter was led by Sen. Barbara Boxer (CA) and Rep. Peter DeFazio (OR). It was signed by several members of congress recently tied to food safety issues, including Rep. Louise Slaughter (NY), Sen. Jon Tester (MT) and Rep. Dennis Kucinich (OH).
The letter called the FDA's current policy on labeling inadequate because it only covers foods changed "materially" by taste, smell or other senses.
"The use of novel food technologies like genetic engineering on a commercial scale has so far slipped underneath FDA's limited threshold for 'materiality' because such technologies make silent, genetic, and molecular changes to food that are not capable of being detected by human senses," the letter read.
The 55 congress members argued that the basic issue under debate was the fundamental right of consumers to make informed decision about what they eat. Labeling foods does not imply that they are unsafe, but it does allow consumers to choose whether or not they want to purchase them, they said.
The FDA currently requires labeling for more than 3,000 ingredients, additives and processes, including other processes that similarly do not alter the food materially. The congress members cited the FDA's rule requiring labeling of irradiated foods as an example of the FDA's "reasonable" decision to look beyond sensory changes and label foods based on information consumers find important.
"We urge you to fully review the facts, law, and science, and side with the American public by requiring the labeling of genetically engineered foods as is done in nearly 50 countries around the world," the letter read.
Japan, Australia, China, Russia, Brazil and 15 European countries are among those requiring labeling for GE foods.
Today, the majority of soybeans, corn, cotton, canola, sugar beets and papayas grown in the U.S. are genetically engineered. Along with being modified for resistances to herbicides and insect pests, corn, the most thoroughly engineered crop, has seen some GE varieties become vitamin-fortified with beta carotene and vitamin C.
The FDA and many scientists have declared GE foods to be as safe as their unmodified counterparts. Critics, including other scientists, say that there has not been enough testing or tracking to verify whether or not GE foods present a safe alternative.
The complete list of congress members who signed the letter, provided by the Center for Food Safety's True Food Network, follows below:
House Members: Peter DeFazio (OR-4), Richard Hanna (NY-24), Dennis Kucinich (OH-10), George Miller (CA-7), Louise Slaughter (NY-28), Keith Ellison (MN-5), Raul Grijalva (AZ-7), Peter Welch (VT-At Large), Hansen Clarke (MI-13), Earl Blumenauer (OR-3), Lloyd Doggett (TX-25), Anna Eshoo (CA-14), Sam Farr (CA-17), Maurice Hinchey (NY-22), Rush Holt (NJ-12), Chellie Pingree (ME-1), Jim McDermott (WA-7), Madeleine Bordallo (GU-At Large), James Moran (VA-8), John Olver (MA-1), Jared Polis (CO-2), Charles Rangel (NY-15), Suzanne Bonamici (OR-1), Pete Stark (CA-13), Howard L. Berman (CA-28), Robert Brady (PA-1), David Cicilline (RI-1), Yvette D. Clarke (NY-11), Steve Cohen (TN-9), Dianne DeGette (CO-1), Bob Filner (CA-5), Barney Frank (MA-4), Luis Gutierrez (IL-4), Janice Hahn (CA-36), Michael Honda (CA-15), Barbara Lee (CA-9), Zoe Lofgren (CA-16), James McGovern (MA-3), Jan Schakowsky (IL-9), Jackie Speier (CA-12), John Tierney (MA-6), Melvin L. Watt (NC-12), Lynn Woolsey (CA-6), Maxine Waters (CA-35), and Grace Napolitano (CA-38).
Senators: Barbara Boxer (CA), Patrick Leahy (VT), Bernie Sanders (VT), Daniel Akaka (HI), Dianne Feinstein (CA), Ron Wyden (OR), Mark Begich (AK), Jon Tester (MT), Richard Blumenthal (CT), and Jeff Merkley (OR).
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