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The Frightening Tale Of The Antibiotic Apocalypse

Every time your doctor has prescribed you an antibiotic to treat an existing bacterial infection is a time you could have died of that infection. Maybe much less likely in some cases, more likely in others; but the risk is there. Now imagine that antibiotics stop working, especially for the really dangerous cases, and you and everyone you know has to face future infections with nothing better than hope, rest and tea.

Welcome to the antibiotics apocalypse.

Since it could actually happen, I'm going to rate an antibiotic apocalypse, worried over by the UK's Chief Medical Officer, Professor Dame Sally Davies, as well as World Health Organisation head, Margaret Chan, as much scarier than a zombie apocalypse.

As Davies told the UK Parliament last month, "Antibiotics are losing their effectiveness at a rate that is both alarming and irreversible – similar to global warming ... Bacteria are adapting and finding ways to survive the effects of antibiotics, ultimately becoming resistant so they no longer work."

Why is this more alarming now? Two reasons, and both have to do with corporate greed. (You are shocked, I know.)

The first reason is that pharmaceutical companies have mostly stopped researching new antibiotics because they aren't very profitable. Which makes sense. Of course it's more profitable to come up with new antidepressants and boner pills than the next treatment for staph infection. How often do people get staph?

Well, more often these days, since staph is infecting more people now that it's developed antibiotic-resistant strains, thanks to modern pig farms. In a sane country, we could call for more public research spending to develop new antibiotics if the market won't pick up the slack, but that's just not likely to happen.

Hog confinement barn interior, courtesy EPA.govThough this takes us to the second reason for jumped-up antibiotic resistance, which is modern livestock practices for food animals of all types. Because it turns out that giving animals steady doses of antibiotics in their daily feed helps them put on weight faster, and it has the handy side effect of allowing them to survive incredibly filthy and overcrowded conditions where they're basically walking around ankle-deep in their own waste. (Mmm, bacon!)

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New FDA Rules Proposed To Prevent Food Contamination

Progress! This is the kind of nuts-and-bolts stuff that makes a huge difference in our everyday lives. Not incidentally, this is the kind of thing for which we should be able to count on from our federal government, the sort of thing at which Republican "conservatives" so love to chip away. Food safety seems to be a reasonable thing to expect, don't you think? So thumbs up to the Obama administration for starting the process of getting this done:

The Food and Drug Administration on Friday proposed two sweeping rules aimed at preventing the contamination of produce and processed foods, which has sickened tens of thousands of Americans annually in recent years.

The proposed rules represent a sea change in the way the agency polices food, a process that currently involves taking action after contamination has been identified. It is a long-awaited step toward codifying the food safety law that Congress passed two years ago.

Changes include requirements for better record keeping, contingency plans for handling outbreaks and measures that would prevent the spread of contaminants in the first place. While food producers would have latitude in determining how to execute the rules, farmers would have to ensure that water used in irrigation met certain standards and food processors would need to find ways to keep fresh food that may contain bacteria from coming into contact with food that has been cooked.

New safety measures might include requiring that farm workers wash their hands, installing portable toilets in fields and ensuring that foods are cooked at temperatures high enough to kill bacteria.

The lack of toilets for farm workers is a common reason for produce contamination. Use your imagination -- and then wash your spinach!



Costco Tests Own Meat To Ensure Food Safety for Members

I hate to sound like a commercial, but this is useful to know. If you're like me, you probably didn't need another reason to love Costco. But this adds a level of comfort with their food safety I would be reluctant to assume anywhere else:

Costco’s 250,000-square-foot beef plant in California’s fertile San Joaquin Valley is not your typical meat plant.

It’s relatively new and spotless. There are high-tech, hand-wash sanitation stations scattered throughout the plant connected to counters that allow plant officials to make sure each employee uses them at least four times daily.

The massive meatball cook room is built entirely of stainless steel. Even the loading docks, where trucks deliver raw beef, is sanitized regularly to prevent contamination.

Plant manager Kevin Smith was a pre-med student in college who majored in physics. And Craig Wilson, who is in charge of Costco’s food quality assurance program, has a long history of working to solve pathogen problems in meat.

“We do not have customers,” explained Doug Holbrook, Costco’s vice president for meat sales. “We have members, and we are responsible to those members, our shareholders and employees to do things differently, to take a different approach.”

The plant has a decided advantage over Big Beef’s slaughter plants because they don’t kill cattle here, so there are no manure-covered hides or intestines to contaminate raw beef products.

But just the same, Costco’s approach is different.

All meat arriving at the Tracy plant comes with a certificate from the supplier pledging that pre-shipment tests showed no E. coli contamination, something other companies are also doing now. But Costco tests it anyway, and if it tests positive, it’s shipped back to the supplier. Less than one percent is shipped back.

Then the finished products — hot dogs, hamburger patties, ground beef, Polish sausages and meatballs — are tested again before they leave the plant.

In fact, Costco officials boast that, until recently, they did more E. coli testing in the company’s lab than the USDA does nationwide at all other beef plants combined.

In discussing the federal meat inspection program, Wilson said, “food safety is an oxymoron...we (Costco) are results-driven and more nimble than the government.” He stopped short of claiming that Costco procedures are more effective than those enforced by federal meat inspectors.

Costco did have a recall over mechanically tenderized beef, which is becoming known as a dangerous practice.



FDA Can't Keep Up With Compounding Pharmacies


As I've written before, political pressure is one of the factors that keep us from having a safe drug supply.

This is frightening, is it? (Especially worrisome to me, since my doctor wants me to get injections in my neck.) We have a real problem with the pharmaceutical industry in this country, and we do not have a thorough system of ensuring a reliably safe drug supply. This story spells out some of the problems:

A year before people began dying of meningitis caused by a tainted drug from a compounding pharmacy in Massachusetts, the Food and Drug Administration worried that compounders across the country might be selling another substandard drug, one possibly made with unapproved Chinese ingredients.

But when the F.D.A. began seeking samples to test, the trade group representing compounding pharmacists went on the offensive. Instead of encouraging members to help the agency determine if the injectable drug, used to reduce the risk of premature birth, was substandard, the group tutored pharmacists on how to sidestep requests.

In an e-mail to members, the International Academy of Compounding Pharmacists suggested that they respond to any request for samples by saying: “We do not compound or distribute ‘samples’ of any of our prescription medications to anyone.” And if a compounded drug was on the premises, the trade group added, a pharmacist should say it was awaiting pickup by a patient.

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Growing Meningitis Outbreak Linked to Steroid

A growing outbreak of fungal meningitis has claimed 7 lives and infected up to 64 people across 9 states. The rate that the outbreak is growing is also alarming:

The total number of cases has also grown to 64 people in nine states, the CDC said. That is 17 more cases and two more states than the day before.

Patients contracted the deadly meningitis after being injected in their spine with a preservative-free steroid called methylprednisolone acetate that was contaminated by a fungus. The steroid is used to treat pain and inflammation.

The steroid is manufactured by compound pharmacies. Compounding is used to create special blends of medications that aren't available on the market, as well as to custom tailor drugs to fit a certain patients needs. According to a 2003 GAO report, nearly 10% of all drugs administered in the Untied States are compound manufactured. But how safe are these drugs? Well it depends on the state they are manufactured in:

Drugs manufactured by compound pharmacies do not have to go through FDA-mandated pre-market approval. Instead, oversight and licensing of these pharmacies comes from state health pharmacy boards.

The steroid causing this outbreak was manufactured by The New England Compounding Center, a pharmacy based in Massachusetts. When federal inspectors did come in to the plant last week, they found unopened vials of the steroid that contained foreign particles. After testing one of these vials, the particle was determined to be the fungus causing this meningitis.

Reading about it, I can't help but think back to the healthcare debate. When the Affordable Care Act was being debated in Congress, one of the issues was allowing people to buy their prescriptions from Canada and other countries. The opponents to that argued that those countries don't have the same safety screenings that our country does. Ironically, I don't recall reading about such an outbreak happening in Canada.

So if we are going to prevent our citizens from getting their medications from Canada, simply because our safety standards are higher, then shouldn't we be sure that is the case? Shouldn't these compound pharmacies be regulated by strict federal standards and not just state regulations? It seems that should be the case. Institute tough oversight and regulations on the federal level, coupled with inspections of facilities, and maybe we wouldn't be talking about this deadly outbreak today.



Although when it comes to the specific date of our mass death, Harold Camping might as well be talking Chinese nuclear development with Herman Cain, it seems a little bit harder to doubt his general prognostication of doom in the weeks after 56 exotic animals were released into the countryside by the owner of a "private zoo" in Ohio.

Just before he shot himself to death.

If you don't know the whole story by now, to quickly summarize: In a scene that Director Emeritus of the Columbus, Ohio Zoo and television personality Jack Hanna compared to "Noah's Ark", endangered Bengal tigers, grizzly bears, monkeys, and a variety of other animals - 49 in all - were killed en masse by law enforcement.

Make no mistake - this happened because Ohio is one of a handful of states that does not regulate the sale and ownership of exotic animals, and it has been purposefully made that way. Tea Party-sympathiser-cum-Governor John Kasich, upon his election to that office, began his assault on government by letting an executive order expire that had provided actual restrictions concerning who could own and sell these animals in the Buckeye State.

To Kasich, this kind of crazy Hobbesianism would "hurt small business", which presumably includes the particular lunatic who had done jail time for illegal possession of firearms and was cited multiple times for animal abuse - but still had his Animal Farm up and running in Ohio - until he granted his boarders amnesty. Because of the anti-regulation zealots who have taken control of our political culture and institutions, this was the profile of someone still fit to continue to lord over a coterie of dangerous and endangered species, in his own little Jurassic Park.

As Darth Vader would say, "Impressive. Most impressive."

Now if you were to ask the Don King of pizza, Herman Cain, I'm sure he'd have a simple plan to solve this problem, which would probably include a number of 9s and the assumption that Zanesville, Ohio is somewhere in the vicinity of Chiang Mai. But for those of us with a beyond-Perry intellect, the story is as simple as it is sadly quotidian. What led to the death of these exotic animals is the same insanity that crashed Wall Street and allows drug companies to lie to people while killing them: the mass deregulation of America.

If you think the animals have run wild in eastern Ohio, then take a look at what a-not-quite-as-evolved species did on Wall Street, resulting in thousands of zookeepers finally showing up to occupy this land those on "The Street" thought was theirs to defile and despoil.

From the 1980s onward, when we started to "get government of our backs", as Ronnie liked to say, we created a mess that now has awoken 99 per cent of the people who generally can't spare the pocket change for a $10,000 Tiffany towel rod. The apogee of this idiocy was the Gramm-Leach-Bliley Act, which in 1999 repealed one of the great accomplishments of the New Deal, the Glass-Steagall legislation separating commercial and investment banks.

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Safe food isn't a controversial issue, right? President Obama supports the food safety bill -- even the Republicans support it. So why hasn't it passed? The holdup seems to be that Sen. Dianne Feinstein (D-Calif.) says she'll offer an amendment banning bisphenol-A, the nasty little chemical and known endocrine disruptor found in virtually all food and beverage containers -- which upsets the companies who make the stuff. The container industry is a huge one, and banning the substance so widely used could have major economic effects at a time when we're barely holding on. Hopefully they'll come up with an effective compromise with Feinstein:

A year after House Democrats and Republicans overwhelmingly approved legislation to improve food safety, public health advocates are growing frustrated that the Senate has yet to take up the bill.

A coalition of food safety groups tried to turn up the pressure last week on Senate Majority Leader Harry M. Reid (D-Nev.) and Minority Leader Mitch McConnell (R-Ky.), running newspaper ads in the lawmakers' two states featuring constituents who fell seriously ill from food poisoning. The ads urged Reid and McConnell to move the bill to the Senate floor and pass it.

"Time is short -- there are not a lot of legislative days on the calendar and we're seeing [food] recalls every week," said Erik Olson with the food and consumer product safety programs at Pew Health Group. "There is obviously a lot of interest in making sure folks know this bill has broad public support and that there is really no reason not to move this. It would show that Washington can get something done."

[...] The bill, which would be the first major change to food safety laws in 70 years, is designed to give the Food and Drug Administration vast new regulatory authority over food production. It places greater responsibility on manufacturers and farmers to produce food free from contamination -- a departure from the country's reactive tradition, which has relied on government inspectors to catch tainted food after the fact.

The legislation follows a wave of food-borne illnesses over the past four years, involving products as varied as spinach and cookie dough, which has shaken consumer confidence and made the issue a priority for many lawmakers and the White House. Food illnesses affect one in four Americans and kill 5,000 each year, according to government statistics. Tainted food has cost the food industry billions of dollars in recalls, lost sales and legal expenses.

The measure also would give the FDA authority to order a recall if it suspects contamination -- authority it does not currently have. It would allow the FDA to quarantine a geographic area, blocking the distribution of suspect food to the rest of the country. And the agency would gain access to records at farms and food production facilities.



Pharma_a37b2.jpg

I wish I could say I was surprised, but pharmaceutical companies and medical device manufacturing is very big business in New Jersey and when those companies say jump, elected officials say "How high?" Wouldn't it be nice if they put as much thought into the health and safety of their constituents?

The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner, said he had acted properly.

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters.



Sometimes I'm just rendered speechless, and this is one of those times. Natasha Chart via Sustainable Food at Change.org:

Obama's considering appointing a former Monsanto vice president, Mike Taylor, to head the Food Safety Working Group at the FDA.

As Jill Richardson writes at LaVidaLocavore at the link above, Taylor thinks the FDA wastes too much time on food safety inspections at meat packing plants. Further, he believes that one of their main problems is that they have to slow down their line speed too much.

Everyone who's read anything about the horrendous working conditions at US meatpacking plants knows that incomplete kills before slaughter and worker injuries increase dramatically when line speeds increase.

As also noted at the Ethicurean, Taylor is the reason milk from rBGH/rBST cows doesn't have to be labeled. Bovine growth hormone is perfectly safe, after all. Except for cows, or humans who drink its breakdown products in milk.

So yes, Mike Taylor is the person we have to thank for putting pus from mastitis-infected cows into the milk supply, and exposing milk-drinking Americans by the millions to greater cancer risks.

This guy is heading up a food safety working group.

I'm just swimming in the changeiness.

Kids, if you care about your food, you know what to do:

Comments: 202-456-1111

Switchboard: 202-456-1414

Or click here.



Did You Have Your Bowl of Cholesterol Drugs This Morning?

I guess we have to start getting prescriptions for this stuff, huh?

WASHINGTON (AFP) – Popular US breakfast cereal Cheerios is a drug, at least if the claims made on the label by its manufacturer General Mills are anything to go by, the US Food and Drug Administration (FDA) has said.

"Based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug," the FDA said in a letter to General Mills which was posted on the federal agency's website Tuesday.

Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four percent in six weeks.

Citing a clinical study, the product labels also claim that eating two servings a day of Cheerios helps to reduce bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol, the FDA letter says.

Those claims indicate that Cheerios -- said by General Mills to be the best-selling cereal in the United States -- is intended to be used to lower cholesterol and prevent, lessen or treat the disease hypercholesterolemia, and to treat and prevent coronary heart disease.

"Because of these intended uses, the product is a drug," the FDA concluded in its letter.

Not only that, but Cheerios is a new drug because it has not been "recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease," the FDA said.

That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and that its "lower your cholesterol four percent in six weeks" message has been featured on the box for more than two years.