FDA Finds Food Safety Violations At Two Iowa Farms That Recalled Eggs

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Posted on 1st September 2010 by gjohnson in Uncategorized

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Now that the Food and Drug Administration has inspected the two Iowa egg farms that recalled a half billion eggs, it’s no mystery how these places could be the source of a salmonella outbreak. 

Do you like flies, maggots and rodents around your eggs? Well, that’s what the FDA found at Wright County Egg and Hillandale Farms during the past few weeks. The inspections were done to check if the two egg plants were in compliance with new food safety regulations that just went into effect, according to The New York Times.     

http://www.nytimes.com/2010/08/31/business/31eggs.html?_r=1&scp=1&sq=egg%20recall&st=Search

FDA inspectors will also be headed to 600 egg-producing plants during the next 15 months, presumably to avoid another salmonella outbreak and massive egg recall. There have been about 1,500 reported cases of Salmonella enteritidis traced to bad eggs as part of the current outbreak so far.

The violations that the inspectors found in Iowa were so numerous I can’t list them all, but they included holes made by mice and mice scurrying around the barns, and chickens traipsing around manure that is often “piled four to eight feet high,” according to The Times.      

At Wright County Egg, salmonella bacteria was found in the bone meal that is part of the feed that young chickens have for their meals.

And on Monday, the FDA disclosed that it had detected salmonella at the Hillandale egg farm, in the water that is used to wash eggs, The Times reported.

The newspaper also did some digging, and found out that the owner of Wright County Egg, Jack DeCoster, has a long list of “environmental, labor and immigration violations” at his egg farms in states such as Maine and Iowa.

The next question is whether or not the FDA will put some bite into its bark, and issue any sanctions against DeCoster and Wright County Egg. 

  

 

 

 

Two Years After Heparin Deaths, Ways To Keep Tabs On The Drug Suppy Chain

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Posted on 31st August 2010 by gjohnson in Uncategorized

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I found a thoughtful examination Monday of the problems, and possible solutions, for plugging the holes in the drug supply chain on IndustryWeek.com. The headline for the story was “Controlling Variability and Vulnerability in the Pharmaceutical Supply Chain.” 

http://www.industryweek.com/articles/controlling_variability_and_vulnerability_in_the_pharmaceutical_supply_chain_22634.aspx?ShowAll=1&SectionID=4

The story starts off by citing several incidents that have impacted the U.S. drug supply chain, with the first one being the 2008 tainted heparin disaster that I have written about extensively. While IndustryWeek.com cites the official governnment number of dead from that tragedy at 81 lives, I believe hundreds of innocent people died after getting the contaminated heparin. 

“The popular blood thinner was recalled because a tainted ingredient was used by a contract manufacturer located in a developing region that had lower standards for raw materials,” IndustryWeek.com says. China was the region.

The article suggests that this problem will be exacerbated in the future “as economic pressures mount” and prompt an increase in outsourcing and contract manufacturing.

“The difficulty is that outsourcing presents a new set of problems that challenge supply chain integrity and complicate supply chain visibility,” IndustryWeek.com said.

But the story says there are ways to safeguard the drug supply chain. One way is electronic pedigrees, or e-Pedigrees and RFID, a documented and complete history of a given product’s chain of custody, “from the manufacturer to the point of dispensing.”   

 But governments have been slow to use new technologies such as e-Pedigree, ”increasing the likelihood that counterfeit items can enter the drug supply chain,” according to IndustyWeek.com.

Spectroscopy, which creates a chemical fingerprint of a product, is another tool to analyze raw goods and finished products.

But at least one of these tracking tools present their own issues. RFID tagging — which gathers national drug codes, lot numbers and expiration dates – is costly to use, for example.     

IndustryWeek.com doesn’t expect regulators in the United States or elsewhere to agree on a formula to safeguard the drug supply chain. So it’s up to the private sector to track products from the start of the chain to the end.        

     

 

 

New York Times Editorial Calls For Senate Action On Food Safety Bill

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Posted on 27th August 2010 by gjohnson in Uncategorized

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The recall of a half billion eggs following a salmonella outbreak continues to make headlines, and even prompted an editorial Friday In The New York Times. http://www.nytimes.com/2010/08/27/opinion/27fri2.html?_r=1&ref=opinion

The Times calls for the Senate to pass stalled legislation that would give more power and authority to the Food and Drug Administration to safeguard Americans from outbreaks of food-related illnesses. The House had already passed its version of the bill.

A bipartisan group of six senators has developed an amendment to the food safety bill that The Times said could finally bring it to a vote. But The Times has some reservations about this amendment, because it would only require inspections of certain high-risk facilities every three years, after a five-year transition period. 

The House bill mandates inspections every six to 12 months. The Times suggests that Congress carefully consider how many inspections are necessary and whether there is money to fund them.

“They should err on the side of consumer safety,” the paper says, and I agree.

The Times also has a Page One story on the egg recall, “Heart of Iowa As Fault Line of Egg Recall: Farm Tied to Outbreak Leaves a Town Tense.”  http://www.nytimes.com/2010/08/27/us/27eggs.html?_r=1&ref=todayspaper

The article is about the town of Clarion, Iowa, which is where Wright County Egg is located. On Thursday the FDA announced that they had found salmonella bacteria matching the strain of the recent outbreak in the company’s feed and barns. The salmonella outbreak has sickened 1,500 people so far.

The Wall Street Journal sent two reporters out to Clarion, who like The Times also interviewed townsfolk about what they thought of the egg hubbub and the DeCoster family, which owns Wright County Egg. The Journal pieces is headlined ”In Empire of Eggs, A Dozen Opinions.”      

http://online.wsj.com/article/SB10001424052748704540904575451971858275344.html?mod=WSJ_hpp_sections_news#printMode

 

Egg Recall May Lead To Food Safety Reform

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Posted on 25th August 2010 by gjohnson in Uncategorized

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I’ve been blogging about this topic for months now, but The New York Times Wednesday used the recall of a half billion eggs to write about our nation’s “highly complicated and often dysfunctional food safety system.”

 http://www.nytimes.com/2010/08/25/business/25eggs.html?scp=3&sq=egg%20recall&st=cse

The story notes that whether we are talking about a recall of eggs, peanuts, lettuce or hamburger patties, ”consumer groups say that federal oversight too often falls short.”

One of the problems is that policing food safety is handled by two federal agencies, the Food and Drug Administration and the Agriculture Department, and the way that they divvy out the responsibilities “can seem so illogical that some of the bureaucrats themselves have called for change,” according to The Times.

The egg recall, which followed a salmonella outbreak, offers a case study of the problems. The FDA regulates eggs that are still “in the shells,” while the agriculture department handles liquid eggs used for making food, grades eggs and is responsible for chickens.

The recalled eggs were hatched in Iowa, and the state’s agriculture department monitors what farmers do with the chicken litter that they spread on fields.

But according to The Times, no agency inspected the Iowa farms to check that the eggs were safe for us to eat.

There is a bright note. There are new safety rules for egg production that would likely have prevented the current salmonella outbreak and egg recall. That regulation only became effective last month.

The regulation mandates that egg producers get their chicks and hens from companies that monitor for salmonella; that they set up a system to stop rodents from spreading disease; and that they test their hen houses for salmonella on a regular basis, The Times reported.

And there’s another important point in the story. Consumer groups think that the egg recall and salmonella outbreak may prompt Washington to finally enact a food safety bill that gives the FDA more authority and resources. 

That bill would also give the FDA the power to do what you probably think it can do already: Recall foods. Right now, the FDA doesn’t have the authority to make companies recall potentially dangerous foodstuffs. The FDA can only try to convince food makers to voluntarily recall contaminated food.

The comprehensive food safety bill has been passed by the House but is stuck in the Senate, according to The Times. Let’s hope that it gets some traction after this egg scare.

     

  

    

With 550 Millions Eggs Recalled, FDA Head Calls For Help

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Posted on 23rd August 2010 by gjohnson in Uncategorized

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 It took the recall of half a billion eggs tied to a salmonella outbreak,  but the Food and Drug Administration Monday finally called out for help.

FDA Commissioner Margaret Hamburg made the rounds of the morning network news shows to warn Americans about eating eggs and to plead for more authority for her agency to safeguard the public.   

http://www.aolnews.com/nation/article/amid-massive-egg-recall-fda-chief-margaret-hamburg-calls-for-more-authority/19603999

Hamburg’s TV appearances came in the wake of the recall of eggs by two major suppliers in the past week, with 380 million recalled by Wright County Egg Aug. 13 and 170 million eggs by Hillandale Farms a week later. The eggs have been linked to about 1,300 salmonella cases since May.

This week Hamburg warned the public not to eat their eggs “runny,” to cook them thoroughly and to keep them refrigerated.

And on “The Today” Show, Hamburg said of the FDA, “We need greater abilities to trace back products to their source.  We neeed better abilities and authorities to put in place these preventive controls and hold companies acccountable.”

AOL News pointed out that it’s been a year since a large peanut butter recall, and yet the FDA’s authority remains limited. The FDA is fairly powerless in this egg recall, for example. It doesn’t have the power to recall eggs, only the egg industry can announce a recall.   

The agency is still trying to track down the source of the salmonella, with this outbreak prompting the biggest egg recall in history. 

Baxter Tries To Keep Some Information About 2008 Heparin Tragedy Under Seal

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Posted on 20th August 2010 by gjohnson in Uncategorized

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Baxter International wants to keep secrets from the public regarding the 2008 contaminated heparin disaster, where many people needlessly died. But someone is challenging the drug maker in court to have the informaton released.

Baxter and Scientific Protein Laboratories are mounting a defense against a civil mass tort suit stemming from deaths and injuries caused by tainted heparin, a blood thinner, imported from China from 2007 to 2008. It’s believed that contaminants were mixed in with unrefined heparin “by lower-level suppliers,” according to The Journal.

Now a company that isn’t part of the litigation, Amphastar Pharmaceuticals, wants depositions that were taken for the cases unsealed, The Wall Street Journal reported Friday. 

http://online.wsj.com/article/SB10001424052748704868604575433960537183170.html?mod=googlenews_wsj

Baxter and Scientific Protein argue that the depositions, related to Momenta Pharmaceuticals, need to remain confidential because they reveal proprietary information. Momenta, which is not named in the heparin suit, assisted the U.S. government in its investigation of the heparin contamination.

But Amphastar claims that the documents contain information regarding what part of Chinese supply chain the tainted heparin came in on. Therefore, Amphastar maintains that the depositions relate to an issue regarding public health and safety, and that they need to be unsealed.

Baxter and Scientic Protein deny any wrongdoing or negligence in the herparin deaths, which I believe were far more than the 81 the government has linked to it.

Baxter told The Journal that the materials it wants to remain sealed relate to suits where the plantiffs’ symptoms were not the same as those who had gotten the bad heparin.    

Earlier this month a federal judge in Toledo, Ohio, granted Baxter and Scientific Protein their confidentiality request. But a week ago Amphastar moved to have the materials unsealed.

Amphastar may be more concerned about getting an edge on Momenta than its stated reason, which is getting information to a congressional probe of the Food and Drug Administration’s handing of the heparin tragedy. 

Amphastar is competing against Momenta for approval to manufacture a new, and pricier, version of heparin, The Journal reported. In July Momenta got FDA approval for its heparin, named enoxaparin, while Amphastar’s application is pending.

The Journal reported that in court papers Amphastar argues that worries about heparin safety are relevant “to enoxaparin because heparin is the starting material of exoxaparin’s active ingredient.” The United States gets most its heparin from China.

The FDA never cited or named the Chinese companies that supplied the lethal heparin un 2008.

 

  

FDA Expresses Doubts About Approving Cymbalta To Treat Pain

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Posted on 18th August 2010 by gjohnson in Uncategorized

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The Food and Drug Administration appears to have serious reservations about approving the antidepressant Cymbalta for use as a pain killer, according to the Associated Press.  

http://www.google.com/hostednews/ap/article/ALeqM5imhQxoC38eZsccOCB3oRHh0vjfzgD9HLBLSO0

On Tuesday the FDA made public its review of Eli Lilly’s bid for approval to market Cymbalta for chronic pain, including back pain. But the federal agency seemed wary of widening the use of the drug, which an estimated 15 million people are taking now.

AP reported that Thursday the FDA will ask several outside experts whether they believe Cymbalta should get the go-ahead to treat pain.

Currently Cymbalta has FDA approval to treat depression, fibromyalgia and diabetic nerve pain. But the drug’s side effects, including it’s toxic impact on the liver, are among the reasons why the FDA hasn’t given Cymbalta the go-ahead as a pain killer, acording to AP.

The FDA is also questioning Eli Lilly’s methodology for trials last summer that tested Cymbalta’s use to control pain caused by osteoarthritis.  

Cymbalta is a serotonin-norepinephrine reuptake inhibitor, and researchers don’t exactly undertand how it eases pain. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Jerry Brown To ‘Bounce House’ Makers: Get The Lead Out

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Posted on 12th August 2010 by gjohnson in Uncategorized

So-called “bounce houses”  may be dangerous for your kids, according to California Attorney General Jerry Brown.

The Golden State’s AG office filed suit Wednesday alleging that the inflatable playhouses have dangerous levels of lead, “sometimes dozens of times the federal limit,” The New York Times reported Thursday.

 http://www.nytimes.com/2010/08/12/us/12bounce.html?_r=1&ref=todayspaper

The Center for Environmental Health, an advocacy group, tested bounce houses, especially their vinyl surfaces. That investigation, which lead to the lawsuit, determined that lead levels in the vinyl ranged from 5,000 parts per million to 29,000, which is much higher than the federal guidelines of 90 to 300 parts per millions, according to The Times.

One of the companies named in the suit, Cutting Edge Creations Inc., told The Times that the case was “a witchhunt” that threatened to shutter small business owners, people who run children’s party centers.

The environmental health center responded, saying that kids don’t have to stop bouncing around in the inflatable houses, but that they should wash their hands afterward.

Exposure to lead can lead to learning disabilities, behavior problems, seizures, coma and death.

 

American’s Mistrust Drugs Made Outside The U.S., But Most Have Ingredients That Are

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Posted on 2nd August 2010 by gjohnson in Uncategorized

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Americans don’t trust medications made outside of the United States, yet roughly 80 percent of the ingredients used to make or package drugs sold here are manufactured in other countries, according to a new poll cited by USA Today.

http://www.usatoday.com/news/health/2010-08-03-recall03_ST_N.htm

More than three out of four people were confident in the safety of prescription drugs made in the United States, according to a poll released Monday by the Pew Charitable Trust’s Prescription Project. But less than 10 percent were confident in pharmaceuticals made in China or India.    

It’s no wonder that Americans are skittish about pharmaceuticals made outside of the states. In 2007 and 2008, there were what I believe to be hundreds of deaths of those who took contaminated heparin, a tragedy that made national headlines. That deadly blood thinner was made with a tainted active ingredient from China.

But what most Americans don’t know is that about 80 percent of the materials used to manufacture drugs that are sold in the United States are made in other countries, Allan Coukell, a pharmacist for the Pew Health Group, told USA Today.

He stated what many of us know: That the Food and Drug Administration doesn’t have the resources to inspect and keep its eye on drug factories around the globe.

Monday Sen. Michael Bennet, D-Colo., was expected to intoduce a bill that wouild permit the FDA to order recalls of dangerous lots of drugs, USA Today reported.

In Pew’s poll, in which 802 registered voters were questioned, 55 percent said that the government should take more steps to make sure that drugs made in other countries are safe. The survey also found that almost 90 percent of those polled approved of new laws on drug safety.       

Millions Of Frozen Mice, Dinner For Snakes, Recalled After Salmonella Outbreak

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Posted on 1st August 2010 by gjohnson in Uncategorized

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There have been a lot of recalls of food items because of salmonella, but this is the most unusual that I can recall: frozen mice.

 The frozen mice make a tasty meal for snakes and reptiles. But some pet owners are apparently risking exposure to disease when they feed their exotic pets the rodents. 

More than 400 people, including snake owners in the United States and Great Britain, have become sick as part of a salmonella outbreak that’s being blamed on the frozen mice.    

http://www.nytimes.com/2010/07/30/business/global/30mice.html?ref=todayspaper

The outbreak has been traced to pet food sole online by MiceDirect, which is in Georgia, according to The New York Times. The company last week recalled millions of frozen mice, and plans to irradiate future batches of frozen mice.

MiceDirect also recalled some of the other meals it provides for pet reptiles: frozen rats and baby chickens. That’s a precaution, because salmonella hasn’t been detected in those yet.

The frozen-mice salmonella outbreak was first discovered in Great Britain two years ago, and the first U.S. case popped up this January. The Centers for Disease Control has found 30 cases in 17 states, The Times reported . 

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