News and Events - 27 Feb 2012

Trio Of Anti-Obesity Drugs Pursuing Second Attempt At FDA Approval

2012-02-25 06:30:59

The makers of three previously rejected weight loss drugs have resubmitted their products to the Food and Drug Administration (FDA for approval, with each hoping to become the first new prescription anti-obesity drug to be approved in the U.S. in 13 years. As
previously reported here on RedOrbit.com, one of those three drugs, Qnexa, received approval from a panel of FDA advisors on Thursday by a 20-2 margin. That verdict placed Qnexa, a combination of the appetite suppressant phentermine and the anti-seizure and migraine drug topiramate that is manufactured by Vivus, one step closer to reaching the market. According to the Associated Press (AP , "topiramate is believed to make patients feel more satiated." When the medication was rejected previously, the FDA asked Vivus for additional clinical data on the drug's potential impact on major cardiovascular events and birth defects. Studies have also shown that topiramate use during pregnancy can increase the risk of birth defects, including oral clefts. One question the advisory committee considered is whether or not Vivus should be required to conduct a large new clinical trial before the medicine receives final approval, in order to determine whether the drug can increase a person's risk of heart attack. Vivus is requesting permission to conduct the study after receiving approval, in the hopes of avoiding additional delays which could last several years. "Many experts view the combination pill as the most promising of the new weight loss drugs, due to studies showing most patients lost nearly 10 percent of their weight -- the highest reduction reported with any recent diet pill," the AP wrote. A second ruling on the drug is expected by April 17, the news agency added. The other two medications up for approval are Orexigen Therapeutics' Contrave, a combination of an antidepressant and an anti-smoking drug believed to curb appetite, and Arena Pharmaceutical's lorcaserin, which stimulates serotonin receptors in the brain in order to make people feel fuller. The AP describes Contrave's results as "lackluster." Approximately 40% of those taking the medication losing 5% of their body weight -- barely allowing the medication to qualify as an effective weight loss pill under the FDA's minimum requirements, according to the wire service. There are also cardiovascular concerns surrounding Contrave, leading the FDA to order a 10,000-patient heart health study scheduled to be completed in two years' time. "Lorcaserin has faced the most severe safety questions from FDA, which rejected the drug in 2010 after raising concerns about cancerous tumors seen in rats who received the drug," the AP said. "Early this year Arena submitted new information evaluating the link between its drug and cancer. The FDA is scheduled to make a new ruling on the drug by June 27." --- On the Net:

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Qnexa Anti-Obesity Drug a Poor Substitute for Diet, Exercise (ContributorNetwork

26.02.2012 19:25:57

ContributorNetwork - COMMENTARY | The Food and Drug Administration has approved the anti-obesity drug Qnexa for weight loss. Qnexa, an anticonvulsant plus appetite suppressant cocktail, has risks, says the LA Times. The FDA says being fat is a bigger threat to health than those issues, though.

Antipsychotics For Seniors With Dementia - Death Risk

25.02.2012 11:00:00

The largest Harvard Medical study, thus far, of nursing homes in the U.S., indicates in bmj.com that nursing home residents above the age of 65, who take certain antipsychotic medication for dementia, have a higher risk of mortality. In 2005, the US Food and Drug Administration (FDA issued a warning that atypical antipsychotic drugs are linked to a higher risk of mortality in elderly patients with dementia. However, questions still remain on whether the risks vary according to which drugs are taken. In 2008, the warning was extended to also include conventional antipsychotics...

News and Events - 25 Feb 2012

A Budget Cut Only the Produce Industry Could Love

michele@informedeating.org (Michele Simon

24.02.2012 12:59:06

You've probably never heard of the Microbiological Data Program (MDP but if you eat fresh produce, you should, because it's currently on President Obama's budgetary chopping block. The MDP is a small ($5 million annually pathogen monitoring program tucked away in the U.S. Department of Agriculture. It tests fruits and vegetables for deadly bugs like E. coli, salmonella, and listeria.
While the testing program may be inexpensive, it's critical because no other federal mechanism currently exists to conduct regular testing of fresh produce. (The Food and Drug Administration--which technically has jurisdiction over produce safety--conducts only limited inspections.
To date, the MDP has
tested high-risk produce such as alfalfa sprouts, cilantro, green onions, peppers, tomatoes, spinach, and other leafy greens. Every one of these vegetables has caused a food-borne illness outbreak or recall over the years, some of them lethal thanks in part to an industrialized food system that transports bugs nationwide. You might recall, a shocking
34 people (and counting died from a listeria outbreak last year in cantaloupe in 26 states (yes, melon - also on USDA's tested produce list . That tragedy alone should cause the Obama Administration to rethink this thoughtless budget cut.
It's not like this is some wasteful government program. It's a relatively cheap way to help save lives, so what's going on? Here is how food safety attorney Bill Marler
explains who just might be behind the idea:
The produce industry hates this program as it has found pathogens in domestic and imported samples and FDA has responded to the information and recalled products. The produce industry--via the fruit and vegetable advisory committee--recommended to USDA and Congress that the program be terminated.
The produce industry hates the program? Now we're getting somewhere.


According to this AP
story, lobbyists with the United Fresh Produce Association and other major trade associations "have repeatedly pushed the government in recent years to get rid of the comprehensive testing program, saying it has cost growers millions in produce recalls." (Isn't that the idea--to get tainted food off the market? Instead, industry suggests more private sector testing.
More private sector testing? Like the
third-party "audit" that missed the deadly listeria in the cantaloupe at Jensen's Farms? According to a
Congressional report on the matter released in January, FDA called it "an inherent conflict of interest" for a private auditor to provide safe handling advice in exchange for payment. Moreover, such auditors don't have to adhere to scientific standards, are not regulated by the FDA, and cannot enforce FDA rules.
This is also the same United Fresh Produce Association that
claims to care about food safety but
does not want to pay the fees necessary to fully implement the Food Safety Modernization Act, the new law intended to improve inspection and oversight by the Food and Drug Administration.
According to the
Center for Responsive Politics, the United Fresh Produce Association has spent more than a million dollars a year on lobbying in each of the past three years. Of course only some of that money was spent lobbying on food safety but the trade group must expect a good return on its investment.
For its part, USDA claims the program doesn't belong there but is better suited to FDA, raising once again, the challenges caused by our currently fragmented oversight system and lack of a single, effective food safety agency.
The Food Safety Modernization Act may help fix some of these problems, but we still have to find the funding. Obama's budget also
seeks a 17 percent increase for FDA, but almost all of the new money would come from industry fees, which again, industry is dead set against. Moreover, it's not at all clear that FDA will pick up the slack from USDA's testing of fresh produce.
In sum, Obama is proposing to cut a nominal food safety program that's working fine, while suggesting new funds come from fees that industry will fight. Of course, testing won't solve all problems either. Not with an industrialized food system that consistently externalizes costs in favor of profits. Maybe if we examined how massive consolidation of produce growers, processors, and distributors contributes to these nasty outbreaks in the first place, and considered better prevention through smaller-scale production models, we wouldn't have to haggle over this testing program. But meantime, can't we find somewhere else to cut $5 million that doesn't make our problems even worse?
-----------------------------
Michele Simon, a public health lawyer, recently joined the Center for Food Safety as a Policy Consultant, where she will help CFS expand into issues related to food safety and nutrition. This commentary was first posted Feb. 22, 2012 on the
Center for Food Safety website.  

The Fight Over the Microbiological Data Program

hbottemiller@foodsafetynews.com (Helena Bottemiller

23.02.2012 12:59:01

A "tiny" program at USDA, which does the lion's share of public produce testing in the U.S., is on the chopping block.

Depending on who you ask, the U.S. Department of Agriculture's Microbiological Data Program (MDP , which randomly tests produce for dangerous pathogens, is either an unnecessary, slow-moving program housed in the wrong agency, or a critical public health initiative that fills a big, alarming gap in domestic produce testing.

The debate over MDP, which falls under the Agriculture Marketing Service, intensified last week with the news that the Obama administration's budget eliminates the $5 million program in Fiscal Year 2013.

Launched under President Bush's 2001 Food Safety Initiative, MDP now tests about 15,000 samples of fruits and vegetables each year, far more than any other federal or state program. Public health officials pull samples of alfalfa sprouts, cantaloupe, cilantro, hot peppers, bagged lettuce and spinach and tomatoes to gather data on E. coli (STEC , E. coli O157:H7 and other pathogens that can contaminate these products. 

Samples are collected from produce distribution centers in 11 states, which, according to MDP, represent about 50 percent of the United States population. Any isolated pathogens are then sent for pulsed field gel electrophoresis (PFGE testing and the resulting pattern is uploaded into the Centers for Disease Control PulseNet database so that it can be matched against human isolates or outbreak patterns.

In its budget request for FY 2013, the Obama administration justified cutting MDP, calling it a "lower-priority program because it is has a low impact and is not central to the core mission of AMS, which is to facilitate the competitive and efficient marketing of agricultural products."

On Monday, The New York Times ran an
editorial boosting the obscure program into the limelight. In "A Tiny Program That Matters," the editors call the proposed cut "an alarming setback in the fight to keep the food supply safe."

"Keeping food safe requires consistent monitoring by the federal government," read the editorial. "Ending this small program would harm those efforts."

The produce industry has long argued that MDP is ineffective and does nothing for food safety.

"By the time they detect something and notify FDA the product has already been eaten," said David Gombas, senior vice president for food safety and technology at United Fresh, in an interview with Food Safety News last summer, adding that it could be several weeks before a recall is initiated after a positive test. "They're not preventing anything. That produce is gone."

United Fresh, which represents the majority of the produce industry, has lobbied for eliminating the program, arguing that the MDP has strayed from its original mission, data collection, to regulatory and enforcement activities that are slow and unnecessary.  

"Growers, processors are not notified at the time samples are taken. Most results are well past shelf-life," read the minutes of a United Fresh Food Safety & Technology Council meeting in January 2011. "Does a single sample positive make any sense to cause a recall without reported illnesses? We do not believe this program is adding to public safety. There must be other alternatives."

Tiny Program, Broad Impact 

According a r
eport in the Chicago Tribune, which first flagged that the program was on the chopping block last summer, MDP tests have triggered at least 19 produce recalls in the past two years.

In the past couple of months, for example, MDP tests conducted by the Washington State Department of Agriculture sparked recalls of
bagged spinach and
jalapeno and serrano chili peppers, both for Salmonella.     

Washington state's capacity for produce testing is a prime example of the impact MDP can have on the ground. In 2010, the WSDA's microbiology laboratory received $400,000 to implement produce testing for MDP, resources that state officials say also help boost local food safety oversight.

"It is unlikely that we would be able to continue the activity using existing state resources," said Kirk Robinson, Assistant Director at the Food Safety and Consumer Services Division, in July, adding that the lab would likely have to cut staff that are currently funded by the program. "This loss of staff could impact the timelines of work in response to foodborne illnesses outbreaks."

Robinson noted that the MDP funding helps WSDA improve testing infrastructure and laboratory equipment.

"Besides testing MDP samples, this equipment has been utilized for testing food and dairy products for regulatory purposes, and has successfully identified human pathogens in higher-risk foods on several occasions in the last few years," he said.

One state official estimated there is generally about a week of lag time between when a produce sample is collected from a distribution facility and when FDA might recall product that is confirmed positive.

According to an MDP document obtained by Food Safety News, between 2002 to 2011, MDP-participating laboratories analyzed approximately 121,000 fresh fruit and vegetable samples.

During this same time period, numerous pathogens were isolated from the produce samples tested by MDP:  (128 Salmonella, (42 non-O157 ETEC, (97 non-O157 STEC, (2 E. coli O157:H7, and (4 Listeria monocytogenes, and throughout the decade of testing, MDP significantly improved the turnaround time on samples. 

"Constantly refining procedures and adding technologies such as automated DNA extraction and real-time PCR has allowed MDP laboratories to reduce the time it takes from sample receipt to pathogen isolation from 14 days to as little as 5 days," according to the document, which outlined the program's accomplishments.

According to MDP, the program provides close to 90 percent of all available bacterial pathogen data for fruit and vegetables and is a "significant contributor" to CDC's PulseNet Database.

Vilsack in the Hot Seat
  
Last Friday, the debate over zeroing out MDP came to a head at a four-hour agriculture appropriations hearing, during which U.S Rep. Rosa DeLauro (D-CT grilled Agriculture Secretary Tom Vilsack over the cut.

"I think it's a critical program, I've always believed that, I've always advocated for it," said DeLauro, who pressed Vilsack to defend USDA's decision.

"It's a question of where it's appropriately funded," said Vilsack. "We don't think it's consistent with the mission of [the Agricultural Marketing Service]. That's the question. As we take a look at our budget, we've got to take a look at our core competencies and what is directly linked to our mission."

Citing the "disgrace" of the proposed food safety budget for the U.S. Food and Drug Administration, DeLauro continued to press Vilsack on the issue during two rounds of questioning. She said she believes the administration's budget showed their focus on food safety was "questionable."

DeLauro pointed out that, in the scheme of things, the MDP's budget is "not a lot of money" -- it "winds up being budget dust." The congresswoman also lambasted the idea that state and local governments pick up the slack on produce testing.

"Talk about resources! Go to any state effort. There are no resources there," she said. "We're not talking billions of dollars - like the numbers that get thrown around this institution for things that don't have the same kind of ability to save lives. Is this a program that's going to fall through the cracks and no one is going to pick it up?"

"I wish we would figure out how to take programs that work and provide a real difference and say that that's worth saving."

Vilsack responded saying he'd like to see FDA's budget increase by $4 million to absorb the program, but the austere fiscal situation means making tough choices. DeLauro promised to give USDA some suggestions for alternative cuts because, she said: "I am telling you, it's not going to happen at FDA."

"I will work with you. I will go through your budget. I will find a place where we can get $4.3 million to potentially save lives," added DeLauro. "That's what this piece does."

FDA Issues Interim Rule on Record Access

info@foodsafetynews.com (News Desk

24.02.2012 12:59:05

The U.S. Food and Drug Administration issued an
interim final rule on record-keeping by food firms to make current regulation consistent with FDA's expanded access to records, which was granted by the FDA Food Safety Modernization Act in January 2011.

According to FDA, the new interim rule makes "the reference to records access in the food-firm record-keeping requirements under FSMA consistent with the current statutory language in the Federal Food, Drug, and Cosmetic Act." The agency's records access authority and the record-keeping requirements were first established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

"This new interim final rule is FDA's latest step in implementing the FSMA. The expanded records-access authority is expected to improve FDA's ability to respond to and contain safety problems with the human and animal food supply," said the agency Thursday.

A
new draft guidance, "Draft Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act," was published to provide more detailed information on the updated record-availability requirement.

FDA also published an update to its Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4 , to ensure the guidance is consistent with the new FSMA requirements. See
Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5 .
The new interim final rule is effective March 1, 2012.

Public comments on the interim final rule may be submitted electronically to the docket through
http://www.regulations.gov. In addition, public comments to the guidance mentioned above may also be submitted electronically to
http://www.regulations.gov.

Comments may be submitted by mail to:

Division of Dockets Management (HFA-305 ?Food and Drug Administration
?5630 Fishers Lane, Rm. 1061?
Rockville, MD 20852

FDA Panel Votes Approves Weight Loss Pill

2012-02-23 10:04:16

Another review by the Food and Drug Administration (FDA for a new drug yesterday resulted in a 20-2 judgment in favor of allowing Qnexa to be placed on the market to combat obesity, reports Rita Rubin for WebMD Health News. Qnexa is a combination of two drugs that have long been on the market -- appetite suppressant phentermine and topiramate, which is used to treat seizures and migraines. Obesity specialists and patient advocates agree there is a huge need for obesity drugs to bridge a treatment gap between diet and exercise, which do not work for many people, and bariatric surgery, which is expensive and not suitable for those with specialized medical conditions. The FDA, however, has been cautious with approving diet drugs, in part because with two-thirds of American adults overweight or obese, such drugs might be used for a long time by millions of people. When the FDA previously turned Qnexa down, it asked Vivus for more clinical data on the medication’s potential impact on major adverse cardiovascular events and birth defects. One question the advisory committee considered is whether Vivus should be required to conduct a large new clinical trial before the final approval is given to assess whether the drug increases the risk of heart attack. Facing more delays, possibly by several years, Vivus has proposed doing the study after approval. Studies also show that the use of topiramate during pregnancy increases the risk of oral clefts, such as cleft lip, by a factor of two to five, according to the FDA staff review released last week. That is a concern, the reviewers said, because “the major consumers of weight-loss drugs are women of childbearing potential,” leading to “the potential for large numbers of pregnancy exposures.” Qnexa was picked as the most suitable weight loss drug because of the high level of weight loss reported in company studies, with an average of more than 10 percent total body mass reduced among participants of the study, USA Today is reporting. Reviewers for the FDA were still guarded in their approval. “Overall, the long-term clinical impact of the observed modest improvements in comorbidity outcomes is uncertain, particularly in a population with higher risk of CV adverse events,” the FDA wrote, referring to cardiovascular events such as heart attacks. The main cardiovascular concern is that Qnexa increases heart rate. Still, the reviewers did say that the effect of the drug in lowering blood pressure was “somewhat reassuring.” Vivus proposes to market Qnexa only to those who meet the government’s definition of obesity: a BMI of 30 or greater. The labeling would advise people who lose less than 3 percent of their body weight in three months on the drug to stop taking it. The company will also put a plan in place to try and make sure pregnant women do not take the drug. The FDA has faced complaints from the public and drug companies for several years for acting too cautiously in its drug approvals. Perhaps this is a sign that the agency is allowing some leeway in its approval process. --- On the Net:

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Lawmakers Urge FDA to Act on Arsenic Standards

hbottemiller@foodsafetynews.com (Helena Bottemiller

24.02.2012 12:59:01

Reps. Frank Pallone (D-NJ and Rosa DeLauro (D-CT are continuing to press the U.S. Food and Drug Administration to respond to reports of arsenic in juices and other foods.

On Wednesday, Pallone held a press conference at a preschool in New Brunswick, NJ to drum up support for his bill, "Arsenic Prevention and Protection from Lead Exposure in Juice Act of 2012'' otherwise known as the "APPLE Juice Act of 2012." The legislation, which DeLauro has cosponsored, would require that FDA establish lead and arsenic standards for fruit juices within two years.

Both arsenic and lead are known to affect brain development in children. Both toxins are pervasive in the environment -- both naturally occurring and the result of pesticide use, emissions and other industrial and agricultural chemicals. In both cases, the federal government has set a safety threshold for drinking water but not for juice.

Both lawmakers sent a letter to FDA this week to "strongly urge" the implementation of enforceable standards for heavily metals, including arsenic, in FDA-regulated products.

"There are no regulations for this toxin in other food products, including juices or infant formula, though China has a standard for arsenic in food," read the letter to FDA Commissioner Margaret Hamburg.

Pallone and DeLauro pointed to a
recent study published in Environmental Health Perspectives which found that food products sampled in the study "may introduce significant concentrations of [inorganic arsenic] to an individual's diet," which included infant milk formula and cereal bars." They also cited a January Consumer Reports investigation which found concerning levels of arsenic and other heavy metals in juice products from Connecticut, New Jersey, and New York.

Consumer Reports tested 88 samples of apple juice and grape juice purchased in three states and found that 10 percent had total arsenic levels exceeding the federal standards of 10 parts per billion (ppb for arsenic in drinking water, and that most of the arsenic "was the type called inorganic, which is a human carcinogen." The tests also found that 25 percent of the juice tested had lead levels higher than the 5 ppb limit for bottled water.

The FDA says its "level of concern" for heavy metals in juices is anything above 23 ppb. The agency maintains that there is no threat to public health but testing has been stepped up.

"Young children are the most vulnerable to the harmful health effects of chronic arsenic exposure, such as brain damage, so the high levels of arsenic and lead found in fruit juices and infant formula are absolutely unacceptable," said Pallone at the press event. "That is why I intend to put significant pressure on the FDA, starting today with a letter to the Commissioner, to act now and go even further beyond the specifications in my bill. FDA has a public health duty to protect babies and children from arsenic exposure - whether its fruit juice or baby formula."  

In their letter, Pallone and DeLauro tout their bill, which targets apple juice, and ask FDA to move on a wider variety of FDA-regulated products: "Given that bill and the recent research on the threat that arsenic in fruit juices and food products pose, we urge you to implement maximum standards for all food products, including juices and infant formula, in a timely manner."

Norovirus, Oysters and Reporting Foodborne Illness

mrothschild@foodsafetynews.com (Mary Rothschild

23.02.2012 12:59:07

On Nov. 4, 2011 the U.S. Food and Drug Administration
announced a recall of ASSI branch frozen oysters from South Korea, which has been linked to an outbreak of norovirus in the Pacific Northwest.
Now the Centers for Disease Control and Prevention (CDC reveals the story behind that recall in the February 17 edition of its Morbidity and Mortality Weekly Report (MMWR . It's a cautionary tale about a batch of contaminated oysters that could have made many more people sick had public health officials not been able to crack the case quickly.
On Oct. 19, 2011, the CDC relates, a woman in Washington state contacted Public Health - Seattle & King County and said she began suffering from acute gastroenteritis after dining at a local restaurant.
Staff members interviewed the woman and her companions and learned that three of the seven in the dinner party had eaten a raw oyster dish, and from 18 to 36 hours later experienced aches, nausea and diarrhea. One of the three also reported vomiting.
The four diners who did not eat the raw oysters did not become ill.
A stool specimen from one of the ill diners, collected 17 days after onset of symptoms, tested positive for norovirus.
Health department investigators collected eight 3-lb. bags of frozen raw oysters in the restaurant's walk-in freezer and sent them off to the Food and Drug Administration's Gulf Coast Seafood Laboratory for testing. They were positive for norovirus.
The frozen oysters, which had been distributed in seven states, had a two-year shelf life and could have made many other people ill -- freezing does not kill norovirus -- had they not been removed from circulation.
"Such contamination has potential for exposing persons widely dispersed in space and time, making cases difficult to identify or link through traditional complaint-based surveillance," the CDC authors wrote in the MMWR.
The CDC noted that it has recently launched a national electronic norovirus outbreak surveillance network, called CaliciNet, and recommends the collection of stool specimens to confirm a diagnosis, characterize the norovirus strain and upload the sequence results into CaliciNet.
"Additionally, all suspected and confirmed norovirus outbreaks should be reported to CDC by state and local health departments through the National Outbreak Reporting System," the authors advise.
Noroviruses are the most common cause of epidemic gastroenteritis, responsible for at least half  of all gastroenteritis outbreaks worldwide, and a major cause of foodborne illness. In the United States, norovirus is estimated to cause about 21 million illnesses each year.

Children Now Eligible for Screening Test for Bacterium (HealthDay

25.02.2012 0:02:37

HealthDay - FRIDAY, Feb. 24 (HealthDay News -- The U.S. Food and Drug Administration has expanded approval for a breath test that screens for a common ulcer-causing germ, to include children aged 3 years to 17.

FDA takes stand for public health, resists industry pressures to increase allowable levels of toxic fungicide carbendazim in orange juice product imports

23.02.2012 9:00:00

In an unusual turn of events, the U.S. Food and Drug Administration (FDA has actually decided to aggressively protect public health rather than shield corporate profits by denying a recent request made by the Juice Products Association (JPA , a juice industry trade...

FDA Weighs Fate of Qnexa for Weight Loss, Again

22.02.2012 11:00:00

WEDNESDAY, Feb. 22 (HealthDay News -- The U.S. Food and Drug Administration plans to take a second look at the weight loss pill Qnexa on Wednesday, after initially rejecting it because of concerns about heart problems and possible birth defects. ...

FDA officer advises on live case demonstrations of devices

24.02.2012 16:18:33

Dr Andrew Farb, a medical officer at the U.S. Food and Drug Administration (FDA has advised clinicians on live case demonstrations of devices.

A study in the Journal of the American College of Cardiology: Cardiovascular Interventions suggests that broadcasting heart procedures live to doctors at medical meetings may not present a risk to the patient on the table. Doctors at Rambam Medical Center in Haifa, Israel reviewed 101 patients treated during live transmissions from a single center in 15 invasive-cardiology conferences between 1998 and 2010.  The study found that procedural and 30-day clinical outcomes were similar to those found in daily practice and to those that have been reported in the contemporary published data, and concludes that these results suggest that broadcasting live case demonstrations in selected patients from selected centers may be safe.

Such demonstrations must first be approved by the FDA. In an interview with Reuters Health, Dr Andrew Farb,  who co-wrote an editorial published with the findings said the main goal of these demonstrations is to increase awareness of a clinical trial, and possibly get more doctors to enroll patients in it. This, he stated, is part of the FDA's "mission" to help get clinical trials done in a timely manner and get effective treatments into practice. 

Dr Farb also noted that the demonstrations must clearly state that the procedure involves an "investigational device," and the operators cannot try to commercially promote the device.

The full article from the Journal of the American College of Cardiology can be found
here. 

Read the Reuters Health interview with Dr Andrew Farb
here. 

News and Events - 23 Feb 2012

Drug-Resistant Staph Linked to Animal Antibiotics

ggoetz@foodsafetynews.com (Gretchen Goetz

21.02.2012 18:53:00

A study published today in MiBio lends further weight to the growing theory that using animal antibiotics in livestock contributes to drug resistance among human bacteria.
Methicillin-resistant Staphylococcus aureus, or MRSA, is a strain of Staph that's resistant to methicillin - the drug most commonly used to treat Staph infections.  
Using a detailed DNA mapping technique, researchers at the Translational Genomics Research Institute (TGen in Arizona were able to trace one of these superbugs - MRSA CC398 - to its origins, discovering that the human strain of this bacteria developed its drug resistance in animals rather than in people.
Often referred to as "pig-MRSA" or "livestock-associated MRSA," the strain is known to affect humans who have been exposed to live animals, such as farmers or veterinarians. But this study found that CC398 was originally a human bacteria, susceptible to antibiotics, before it spread to animals and then back to people. By the time it returned to humans it had picked up two souvenirs: resistance to methicillin and resistance to tetracycline - a drug often used to treat Staph infections in patients allergic to the penicillin class of antibiotics, which includes methicillin.   
Because both tetracycline and penicillins are commonly administered to food animals, the study finds that it is likely that the use of these drugs in livestock gave this Staph bacteria the exposure it needed to develop resistance to these drugs. 
In 2010, Tetracycline - used to promote growth and prevent the spread of disease - comprised over 42 percent of all
antibiotics administered to food-producing animals in the United States. That year 12,328,520 pounds of the drug were given to animals, while just over 100,000 pounds of the drug are sold for human use. And while over 1.9 million pounds of penicillin were sold for animal use in 2010, approximately 1.5 million pounds are distributed for
human use.  
Both of these drugs are crucial for treating human Staph infections, says Dr. Lance Price, lead author of the study and Director of TGen's Center for Food Microbiology and Environmental Health.
"Methacyline's a really good antibiotic for treating these kinds of infections," he told Food Safety News in an interview. "But a substantial portion of the population is allergic to penicillin and they need alternative drugs like tetracycline. But 69% of the staph we see is resistant to tetracycline."
Price says that animal feeding operation provide the perfect setting for the growth of antibiotic-resistant bacteria. According to the
Centers for Disease Control and Prevention, MRSA is easily transmitted in settings where factors it calls the "5 Cs" are present: crowding, frequent skin-to-skin contact, compromised skin (cuts or abrasions , contamination or lack of cleanliness. 
"A CAFO (Concentrated Animal Feeding Operation is the place where these 5 Cs are most prevalent," says Price. "And the single worst thing you could do is add antibiotics to that environment. It's the cocktail for creating superbugs."
Once these superbugs are created, there's no telling where they can go, Price says. While most cases of CC398 come from direct contact with livestock, some human cases cannot be traced to live animals, raising the question of where they came from. Other humans? Contaminated meat?
Several studies have shown MRSA to be prevalent on our meat and poultry. A study published in the
Journal of Food Protection in October of last year found Staph bacteria in 29 percent of grocery store ground meats. And a study led by Price released earlier that year discovered Staph on almost one half of grocery store meats and poultry after putting samples in a bacteria enrichment broth to make Staph more detectable. Half of these contaminated meats were carrying a multi-drug resistant strain of Staph.

Price says the transmission of MRSA from meat to humans is an area that needs more research.
"There is definitely drug-resistant Staph in our food supply and probably in high concentrations. We still don't know whether it's a good route of exposure for people," he explains. "I think that's something we've really got to dedicate some research to." 
For now though, Price says the upshot of his research is that antibiotics should be saved for treatment, not growth or prevention.  
"We should be using antibiotics prudently, both in human antibiotics and animal production," he notes. "We should only be using them to treat infections - and it should be a last resort - because we're heading towards a time when our antibiotics won't work anymore, and we have to do everything we can to preserve the ones we have."

Food Safety & Consumer Leaders Come To Taylor's Defense

dflynn@foodsafetynews.com (Dan Flynn

21.02.2012 12:59:03

Michael Taylor, with major accomplishments in food safety for two Democratic Presidents, is nevertheless finding himself the target of a petition seeking his removal.
And as if the old adage needed more proof that political movements always end up eating their own, Mr. Taylor's nemesis is MoveOn, the left-of-center group that got its start trying to retain President Clinton after his sexual liaison with Monica Lewinsky.
Taylor, currently deputy commissioner for foods at the U.S. Food and Drug Administration (FDA , did not get on MoveOn's bad side for anything as nefarious as that.
He did however do a 15-month stint as vice president for public policy for Monsanto, leaving the corporation that has been called one of America's ten most innovative companies, in January 2000. If Taylor's obituary were written now, it's not his short time at Monsanto that would get much attention.  It would be his two longer periods of public service.  At USDA during the Clinton Administration, he was the top administrator  for the Food Safety and Inspection Service that first banned E. coli O157:H7 from beef.
And at FDA, he put his skills with Congress to work to get the Food Safety Modernization Act passed by Congress and he now in charge of implementation.  
Still, a loose coalition of genetic engineering (GE opponents, raw milk advocates, organic farmers and the like has voiced objections to Taylor since he joined the Obama Administration.  They point to other stints in
Taylor's resume where they claim he had ties to Monsanto.
A petition went up months ago, but only after MoveOn adopted Taylor's removal as a pet cause has the effort "gone viral."   It has so far collected about 420,000 signatures.
Now,  however, some of the nation's best known food safety and consumer advocates are trying to see if they can get MoveOn to back down.
 "We acknowledge that Monsanto symbolizes a lot of things that many people (including some of us don't like about modern, industrial agriculture. But Mr. Taylor's resume is not reducible to his work at that company," the signers wrote MoveOn.
"It is far more relevant that in the Clinton Administration he headed the Food Safety and Inspection Service at the U.S. Department of Agriculture, where he stood up to the meat industry and fought for strict controls that help keep E. coli and other pathogens out of meat and poultry. Since joining the Obama Administration, Taylor has been working extraordinarily hard to transform the FDA from a reactive agency that chases down foodborne?illness outbreaks after people fall ill, to a proactive public?health?based agency focused on preventing foods from becoming contaminated in the first place."
"We are confident that his leadership, formerly at USDA and now at FDA, has and will continue to reduce the number of Americans sickened, hospitalized, and killed by foodborne pathogens."
Signing on to the
public letter are:
-Michael F. Jacobson, Ph.D., Executive Director Center for Science in the Public Interest
-Shaun Kennedy, Director, National Center for Food Protection and Defense Director, Partnerships and Programs, College of Veterinary Medicine Assistant Professor, Veterinary Population Medicine University of Minnesota
-William D. Marler, Esq. Marler Clark, The Food Safety Law Firm
-J. Glenn Morris, M.D., Director, Emerging Pathogens Institute University of Florida
-Michael Rodemeyer, Lecturer, Department of Science, Technology and Society University of Virginia, Former Executive Director, Pew Initiative on Food and Biotechnology
-Donald W. Schaffner, Ph.D., Extension Specialist in Food Science and Professor Director of the Center for Advanced Food Technology Rutgers University
-Deirdre Schlunegger Chief Executive Officer STOP Foodborne Illness
-Carol L. Tucker?Foreman, Distinguished Fellow, The Food Policy Institute Consumer Federation of America, Former Assistant Secretary of Agriculture
On the other side, Atlanta' s Frederick Ravid is the author of the petition calling for Taylor's removal.  He posted it on
SignOn.org in August.  MoveOn sent it out on Feb. 6 to its five million members, spiking sign-ups.
Taylor's supporters have pointed out that Ravid 's claims that biotech foods contribute to various types of cancers are without scientific merit.
Taylor has removed himself from making any policies having to do with GE foods.

FDA Addresses US Cancer Drug Shortage

Pharma International's US Correspondent

22.02.2012 11:10:51

The US Food and Drug Administration has moved to address a US cancer treatment drug shortage. Not only will it permit one drug to be imported, it's also fast-tracking the approval process for another.

Both measures are intended to ensure US cancer patients have access to the drugs they need after data showed that supply issues hampered the distribution of a good 200 drugs last year.

According to doctors and other health officials, the situation has forced suppliers into putting off cancer treatment programmes or drawing on other, less-effective or more expensive drugs to plug the gap.

The imported cancer drug is Lipodox, which is used in ovarian cancer and multiple myeloma treatment when other medications have been ineffective. It shares an ingredient, doxorubicin, with Johnson & Johnson's Doxil, supplies of which are now scarce.

FDA Cancer Drug Approval

Meanwhile, the FDA has also acted against the US drug shortage by approving APP Pharmaceuticals' production of methotrexate - a cancer drug used alongside other treatments to fight childhood leukaemia.

"A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration", Doctor Margaret Hamburg - administration commissioner - confirmed in a statement. She added: "Through the collaborative work of FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.

"We are making progress. There were 195 drug shortages prevented in 2011 and 114 drug shortages prevented since October 2011 when we made the call for early notification."

US Drug Shortages

The US drug shortages have been attributed to multiple causes including manufacturing plant closures.

Lipodox is produced by Sun Pharma Global FZE which, in a statement, described the unusual circumstances under which it had been contracted. ‘[The] temporary importation of unapproved foreign drugs is considered only in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs', it wrote.

Slaughter Asks 60 Top Food Companies for Details on Antibiotic Use

hbottemiller@foodsafetynews.com (Helena Bottemiller

21.02.2012 12:59:02

Continuing her charge against the subtherapeutic use of antibiotics in food animal production, Congresswoman Louise Slaughter (D-NY sent a letter late last week to more than 60 of the leading fast food companies, meat producers, and grocery stories asking them to release details on their antibiotic use policies.

Slaughter specically asked the companies to breakdown what percentage of the food they sell is raised "without any antibiotics," raised with antibiotics only for "therapeutic reasons," or raised with "routine use of antibiotics" -- information that consumers often have no way of knowing. The list of companies that received the letter was varied, including: Burger King, Cargill, YUM! Brands, Costco, Bon Appetit Management Company, Kraft, McDonald's and Whole Foods.
 
"Very simply, consumers have a right to know what's in their food," said Slaughter. "It's like that old commercial, 'where's the beef?' We just want to know, 'what's in the beef?' The US is facing a growing public health crisis in the form of antibiotic-resistant bacteria, and information about how these companies are contributing to its rise or resolution should be available to consumers."

Antibiotic-resistance is not just an issue that rallies sustainable agriculture advocates -- who have long argued against drug use in food animal production -- the issue is increasingly tied to foodborne illness outbreak headlines.

Last year, the United States had the most outbreaks ever of antibiotic-resistant Salmonella tied to meat and poultry, according to Slaughter's office. Last summer, the largest Class I meat recall on record was initiated after Cargill ground turkey was linked to a nationwide drug-resistant Salmonella Heidelberg outbreak tied to 136 illnesses and one death. 

"Decades of research has shown that the practice of routinely feeding antibiotics to swine, cows, and chickens harms human health by contributing to diseases that fail drug treatment," the letter continued. "A National Academy of Sciences report stated that 'a decrease in the inappropriate use of antimicrobials in human medicine is not enough [to slow the increase in antibiotic resistance]. Substantial efforts must be made to decrease inappropriate misuse in animals and agriculture as well."

The most recent estimates show around 80 percent of all antibiotics sold annually are used in food animal production.

The only microbiologist serving in Congress, Slaughter challenged companies to tout examples of lessening antibiotic use.

"There are some who would have us believe that we must pump our food up with antibiotics to keep prices low and affordable," she said. "But the food industry has proven success stories and leaders who understand the benefits that come from raising and serving antibiotic-free meat. It is not incompatible for us to have healthy and affordable food."

The
letter asks companies to respond in detail to Congresswoman Slaughter's office by June 15.

Friday Recall Announcements Revisited

msmith@foodsafetynews.com (Marijke Schwarz Smith

21.02.2012 12:59:01

In a story last summer for Food Safety News, I looked to see if the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS recalls were biased toward any one day of the week. This inquiry followed what seemed to be several late Friday recall announcements, including a nationwide recall of contaminated ground turkey implicated in a multistate outbreak of Salmonella infection.
That Friday recall and others raised questions about whether the timing of recall notices could potentially leave consumers uninformed about unsafe food over a weekend.
That
preliminary look did not show any significant differences in the daily publication of recall notices, but with the close of 2011, I decided to take a longer look.

This more comprehensive look included recalls going back to 2005 for USDA and Food and Drug Administration (FDA monitored foods.  The USDA data also detailed whether there was a specific pathogen found in the foods (or epidemiologically linked to an outbreak , if any illnesses were associated with the recalled item, and the class of the recall as designated by the USDA's Food Safety and Inspection Service (FSIS .  The FDA does not specify classes in its recall notices, so only the first two categories could be assessed.

The conclusions of this more detailed analysis show a different story from the earlier one.  

USDA-FSIS Recalls

On the USDA front; from 2005-2011 there were more recalls announced on Fridays than would be expected by random chance (p
<.001 .  Indeed, 2006, 2007, 2009, 2010 and 2011 all had significantly higher numbers of recalls on Fridays (p<.05 .
The total number of Class I recalls on Fridays were also higher from 2005-2011 (p=.003 . Class I recalls, by definition, are for dangerous or defective products that could cause serious health problems or deaths.
While on a per year basis, only 2006 and 2011 have significantly higher number of Class I recalls on Fridays than expected, 2007 and 2009 are very nearly significantly higher (p=.055 and p=.062, respectively .  


 The red line indicates the expected number of recalls if equally distributed throughout the week.  A proportion significantly higher than expected of p
<.01 indicated by *.

In addition, if weekend recall dates are excluded, the pattern holds for total recalls with a greater number on Fridays than other weekdays (p=.002 .  For Class I recalls, there was no significant difference in the number of Friday recalls compared with the number expected for weekdays, but there were still more alerts published on that day than any other day of the week (p=.086 .


The red line indicates the expected number of recalls if equally distributed throughout the week.  A proportion significantly higher than expected of p
<.01 indicated by *.

There was no trend in any day of the week having more pathogen or illness related recalls than any other day in the seven years analyzed.  This was true when only weekdays were analyzed, as well.  This indicates that recall notices related to outbreaks of foodborne illness and due to specific pathogens found in food have been evenly spaced throughout the week.

While this is the case, when taken as a whole there were more Class I and Class II recalls on Fridays than would be expected. The significance of this difference for Class I recalls was eliminated when analyzing only weekdays, but held true for Class II notices, perhaps showing a propensity for putting out more urgent recalls on Fridays.

One particularly interesting finding was an observable pattern in an increasing number of Class II and Class III recalls during the time period studied, while Class I recall numbers remained relatively static.  There was a significant difference in the number of Class II recalls starting in 2008 the percentage that Class II recalls make of the total number of recalls has continued to increase (P
<.05 .  Class III recalls remain rare and, as such, there is little statistical power in any observations made.

 

The increasing number of Class II and slightly Class III with the stagnant number of Class I led to an overall increase in the number of recalls per year by the USDA from 56 in 2005 to 108 in 2011.

FDA Recalls

The previous article on this topic did not evaluate FDA recalls.  This oversight has been amended this time around, and the findings are similar to those for FSIS recalls.

A glance at the total recalls per day chart shows that between 2005 and 2011 a significantly higher number of recalls were issued on Fridays than would be expected (P
<.01 . 

 
The red line indicates the expected number of recalls if equally distributed throughout the week.  A proportion significantly higher than expected of p
<.01 indicated by *.

This holds when excluding the weekends that had so few recalls. 

 
The red line indicates the expected number of recalls if equally distributed throughout the week.  A proportion significantly higher than expected of p
<.01 indicated by *.

The FDA data again points to a bias toward publishing recall notices on Fridays over other days of the week and, if anything, the tendency is more pronounced with this agency than with the FSIS.  Indeed, recall announcements related to foods testing positive for pathogens and those associated with illnesses were also more common on Fridays, compared to the whole week or just the work week, a trend not seen in FSIS recalls.





Fridays have consistently seen significantly more than an expected number of recall notices for both the whole week and weekdays only for the entire seven years examined.  However, due to the low number of recalls related to illnesses in all the years, statistical tests cannot be performed on a per year basis.  This is also true of pathogen-related recalls prior to 2009.

There was again a pattern of certain types of recalls increasing over the years, as well as the overall number of FDA recalls increasing.  The total number of recalls in 2005 was 145 and this reached a max of more than 800 because of multiple peanut butter-related recalls in 2009.  Excluding that outlier, there was still a steady increase in the number of FDA recalls from 2005 to the end of 2011.

Why Fridays?

This tendency toward releasing recall statements on Fridays, more than on other days of the week, is likely not intentional but could be problematic, because people who do not consume media over the weekend might be less likely to be informed in a timely manner and, as a result, could eat recalled food. On the other hand, Friday recall notices may be the result of a sense of urgency to get make the information public before the work week ends.
Indeed, processes within the regulatory agencies may be causing an inordinate number of recall notices to be issued on Fridays. Such factors could include laboratory procedures to find contamination in samples, communication delays between the lab, regulators and the companies voluntarily recalling their products, and the general timeline of work in the offices. These, along with other processes, including political pressures, could lead to significantly more recalls on Fridays.

Importantly, recalls are initiated by private companies once the potential for hazard is found.  The company distributing or producing the food recalls the products in coordination with the regulatory agency, but the company is ultimately responsible for when the recall is initiated.
It could take days before information regarding potential hazards makes it from a lab or other area of initial discovery, through the regulatory agency to the producer, and then for a recall alert to be issued. Thus, the high number of Friday recalls could be seen as an attempt to get the information out before the weekend, while people are still likely to be tuned into the news.

While the causes leading to the high number of Friday recalls cannot be determined with this small look into the past few years, what can be seen is a potential for lack of communication between the consumer and the food regulators.  Easy access to information regarding potentially dangerous foods should be an issue of primary importance for both the USDA and FDA, and these agencies can work to ensure that the information is not going out when people are less likely to get it.
 

FDA Rushes To Fix Shortage Of Cancer Drugs

2012-02-21 15:03:31

The Food and Drug Administration (FDA announced plans on Tuesday to help resupply the U.S. with two leading cancer drugs. The agency said they will address shortages of two leading cancer drugs by allowing one of them to be imported from abroard, and rush approval for a new manufacturer to make the second. "We're not out of the woods," Dr Sandra L Kweder of the Food and Drug Administration's drug center told the New York Times. "But these two particular shortages have been very, very upsetting to patients and to us." The FDA said it will allow imports of a version of the cancer drug Doxil in the next few weeks, satisfying doctors and patients who have been forced to postpone care or to use alternatives. The imported drug is called Lipodox and has the same active ingredient as Doxil, which is doxorubicin. The agency announced it will also approve APP Pharmaceuticals to make methotrexate, which is a drug used to treat childhood leukemia, ovarian cancer and multiple myeloma. The FDA said it reached a limited, temporary arrangement for importing Lipodox from Sun Pharmaceutical Industries. Doxil has been in short supply since manufacturing problems surfaced at the plant Ben Venue, a unit of Boehringer Ingelheim. Problems at the plant also contributed to a shortage of methotrexate, which lead the FDA to take action so medical practices would not run out of the drug entirely. Ben Venue said last week that it would release reserves of methotrexate that were made before it shut down the plant last November. According to analysis from the IMS Institute for Healthcare Informatics, over half a million cancer patients were affected by a short supply of drugs last year. Doxil is one of 287 drugs that have been in short supply in the past year, according to the University of Utah's Drug Information Service. --- On the Net:

• 
  Food and Drug Administration (FDA
  

News Wrap: Supreme Court to Consider Affirmative Action Challenge

22.02.2012 0:12:00

Watch Video |
Listen to the Audio

KWAME HOLMAN: The U.S. Supreme Court will revisit the issue of affirmative action in college admissions in arguments this fall. The court agreed today to hear a case filed by a white student who was denied entry at the University of Texas in 2008.

She contends the school's race-conscious policy is unconstitutional. The high court last ruled on the issue in 2003, when it upheld the use of race in admissions at the University of Michigan Law School.

Federal regulators moved today to ease critical shortages of two cancer drugs. The Food and Drug Administration announced it's allowing temporary imports of a replacement drug for Doxil, used to treat ovarian cancer. The agency also approved new suppliers of methotrexate, a drug to treat children with leukemia.

An official at the American Cancer Society said patients need the relief.

DR. LEONARD LICHTENFELD, American Cancer Society: The current drug shortage has become a daily nightmare for cancer patients, their families, and those who treat them, with no clear understanding of when drugs currently in shortage will become available and an uncertainty of when additional drugs may go into shortage.

KWAME HOLMAN: FDA officials said there currently are 283 prescription drugs in scarce supply or simply unavailable in the U.S.

On Wall Street, the Dow Jones industrial average broke 13000 for the first time since May of 2008, but it could not hold. Instead, the Dow ended with a gain of just 15 points to close at 12,965. The Nasdaq fell three points to close at 2,948.

A team from the U.N.'s nuclear watchdog agency held new talks in Iran today on the country's nuclear program. The group is supposed to gauge whether Iran is getting closer to developing a nuclear weapon, but the Foreign Ministry said the U.N. team will not be visiting any nuclear facilities.

RAMIN MEHMANPARAST, Iranian Foreign Ministry spokesman (through translator : The titles of the members of the visiting delegation are not inspectors. This is an expert delegation from the International Atomic Energy Agency, led by the vice president of the director general of IAEA. The purpose of the visit is not inspection. The goal is negotiation and talks on cooperation between Iran and IAEA to create a framework for further talks and cooperation.

KWAME HOLMAN: Also today, the head -- the deputy head of Iran's armed forces warned the regime could launch a preemptive strike if it feels threatened. He did not name a target.

In Syria, opposition groups claimed up to 100 people were killed in fighting across the country. Many of the deaths, they said, were in the opposition stronghold of Homs. There, the neighborhood of Baba Amr came under a heavy new artillery barrage by the Syrian military. Rebel sources said shells rained down at a rate of 10 per minute, but activists said President Bashar Assad's troops had been stymied in efforts to launch a ground attack.

In Washington, State Department spokeswoman Victoria Nuland appeared to open the door slightly to arming the opposition.

VICTORIA NULAND, State Department spokeswoman: We don't believe that it makes sense to contribute now to the further militarization of Syria. What we don't want to see is the spiral of violence increase. That said, if we can't get Assad to yield to the pressure that we are all bringing to bear, we may have to consider additional measures.

KWAME HOLMAN: U.S. officials also supported a call by the International Red Cross for a daily cease-fire to allow deliveries of humanitarian aid.

Protests erupted in Afghanistan today after Korans inadvertently were burned last night at a U.S. military base. More than 2,000 Afghans demonstrated outside the facility. Some in the crowd shouted "Die, foreigners" as they set tires ablaze and threw stones at the main gate.

A Western military official said the Muslim holy books were removed from a nearby jail because detainees wrote extremist messages in them.

The NATO commander in Afghanistan said emphatically they shouldn't have been added to trash meant for incineration.

LT. GEN. JOHN ALLEN, International Security Assistance Forces: We are thoroughly investigating the incident. We are taking steps to ensure this doesn't ever happen again. I assure you, I promise you, this wasn't intentional in any way. And I offer my sincere apologies for any offense this may have caused.

KWAME HOLMAN: Afghan President Hamid Karzai denounced the burning, and he ordered a separate inquiry into the incident.
Separately, three NATO soldiers were killed today in a roadside bombing in Southern Afghanistan; 47 NATO service members have died in Afghanistan so far this year.

Those are some of the day's major stories.

CDC: Raw Milk Much More Likely to Cause Illness

jandrews@foodsafetynews.com (James Andrews

22.02.2012 12:59:01

Raw milk and raw milk products are 150 times more likely than their pasteurized counterparts to sicken those who consume them, according to a 13-year review published by the Centers for Disease Control and Prevention on Tuesday. States that permit raw milk sales also have more than twice as many illness outbreaks as states where raw milk is not sold.
The CDC study,
published online in Emerging Infectious Diseases, reviewed dairy-related outbreaks between 1993 and 2006 in all 50 states, during which time the authors counted 121 dairy-related illness outbreaks resulting in 4,413 illnesses, 239 hospitalizations and three deaths. 
Despite raw milk products accounting for approximately one percent of dairy production in the U.S., raw milk dairies were linked to 60 percent of those dairy-related outbreaks. In addition, 202 of the 239 hospitalizations (85 percent resulted from raw milk outbreaks. Thirteen percent of patients from raw milk outbreaks were hospitalized, versus one percent of patients from pasteurized milk outbreaks.
Seventy-five percent of the raw milk outbreaks occurred in the 21 states where the sale of raw milk was legal at the study's onset in 1993. Today, 30 states permit the sale of raw milk, while another seven are considering raw milk legislation changes this year.
The study found that individuals under the age of 20 accounted for 60 percent of those affected by raw milk outbreaks, compared with 23 percent associated with pasteurized products. Children were also more likely than adults to become seriously ill from pathogenic bacteria in raw milk.
The differences in illness severity between raw and pasteurized milk are largely due to the pathogens present in each: People sickened from raw milk typically ingest injurious bacteria -- most commonly Salmonella or Campylobacter -- whereas pasteurized milk outbreaks more often result from "relatively mild" pathogens such as norovirus, according to the CDC.
This is the first comprehensive federal-level update to raw milk statistics of this kind since 1998, when the Center for Food Safety and Applied Nutrition released
a similar review of raw milk outbreaks spanning from 1973 to 1992. That study found that 46 raw milk outbreaks  occurred during the review window, with 40 of them in states with legal raw milk sales.
At the time, the 1998 study concluded that "consumption of raw milk remains a preventable cause of foodborne illness." Similarly, Tuesday's CDC study suggested that "stronger restrictions and enforcement should be considered."
"It's really helpful to have these numbers updated as interest in raw milk increases through activist groups," said Michele Jay-Russell, Ph.D., program manager of the Western Center for Food Safety at University of California Davis.
"I wouldn't say the statistics are surprising, but it's helpful to know that, unfortunately, things have not really changed since the last report," she added. "Despite being in the 21st century, raw milk continues to make people sick."
The study comes on the heels of one of the largest raw milk outbreaks in U.S. history. As of Tuesday, 77 people in four states been sickened in a Campylobacter outbreak linked to raw milk from Your Family Cow dairy in Pennsylvania that began in late January. At least nine of the victims from that outbreak have been hospitalized.
Many of those who are ill in that outbreak are children.  "Parents who have lived through the experience of watching their child fight for their life after drinking raw milk now say that it's just not worth the risk," said Dr. Barbara Mahon, co-author of the CDC study, in a news release.
Since January 2007, the end of the study's review window, there have been
at least 56 additional foodborne illness outbreaks associated with raw milk. Between 2010 and 2011, raw dairy products
were linked to 21 outbreaks and 201 illnesses, while pasteurized dairy products caused two outbreaks and 39 illnesses. 
According to Jay-Russell, nearly all instances of outbreaks from pasteurized dairy occur because of contamination after the pasteurization process.
This year, Indiana, New Jersey, Iowa, Idaho, New Hampshire, Kentucky and Wisconsin have all considered changes to their raw milk sales laws. The majority of the bills under review would either permit the sale of raw milk where currently illegal, or remove certain restrictions on its sale in states where it's already permitted.
Federal law restricts the transport of raw milk across state lines for sale, though consumers are free to travel across state lines to purchase milk and take it home, and there is no law against consuming unpasteurized milk.
The push for loosened raw milk sales rules across many states runs counter to the best scientific recommendations the CDC and Food and Drug Administration can make based on the available data, Jay-Russell said. Many raw milk proponents argue that raw milk provides nutrients and numerous health benefits negated by the pasteurization process, while many food scientists say there's no credible scientific evidence for any of those claims.
"It's [the CDC and FDA's] charge to look at the health statistics and inform the public and help policy makers create policy that makes sense," Jay-Russell said. "But there's a push-back. Some groups don't want government influence over food, so it makes it a much more political debate than a scientific one."

FDA: New suppliers to ease 2 cancer drug shortages (AP

22.02.2012 8:00:02

AP - Federal regulators said Tuesday that they've approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments.

Another Cantaloupe Outbreak Victim Dies

mrothschild@foodsafetynews.com (Mary Rothschild

22.02.2012 12:59:03

After a five-month battle with listeriosis from eating contaminated cantaloupe, 68-year-old Mike Hauser of Colorado died Tuesday morning,
the Denver Post reported.
Hauser's death brings the number of adult fatalities to 34 in the outbreak traced to Listeria-tainted cantaloupes grown and packed by Jensen Farms and distributed by Frontera Produce. The outbreak, which sickened at least 146 people in 28 states, was the deadliest involving foodborne infection in nearly 100 years.
Four more outbreak victims have died since the
final investigation update from the Centers for Disease Control and Prevention, which attributed 30 deaths and one miscarriage to listeriosis infections caused by the Colorado cantaloupes.
In addition to Mike Hauser, 
fatalities not included in the CDC's count are Paul Schwarz of Missouri, Sharon Jones of Colorado, and Dale Braddock of Nebraska. 
Hauser was a retired podiatrist.
Investigators from the Food and Drug Administration and Colorado public health officials have said hard-to-clean equipment and pooled water in the packing plant, in addition to condensation on cantaloupes moved to cold storage, were among the factors contributing to the lethal outbreak.

FDA Moves to Head Off Shortages of 2 Cancer Drugs (HealthDay

22.02.2012 7:47:11

HealthDay - TUESDAY, Feb. 21 (HealthDay News -- The U.S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer drugs that have been in dangerously short supply.

FDA Weighs Fate of Qnexa for Weight Loss, Again (HealthDay

22.02.2012 20:02:13

HealthDay - WEDNESDAY, Feb. 22 (HealthDay News -- The U.S. Food and Drug Administration plans to take a second look at the weight loss pill Qnexa on Wednesday, after initially rejecting it because of concerns about heart problems and possible birth defects.

Newly enacted abortion laws taking personal toll. Texas requires invasive sonograms, too.

rss@dailykos.com (Meteor Blades

20.02.2012 23:14:42

While the effort to impose religious dogma on the secular matter of birth control failed last week in great part because of an outpouring of citizen opposition, the victories of last year's anti-abortion juggernaut are starting to take their toll.

As we've pointed out here several times in the past nine months, the anti-choice forces
made major strides in making legal abortions harder to get in 2011. They did their work at the state level where they have achieved steady, damaging victories for a number of years, but were especially emboldened by the Republican success at the polls in 2010.

To condense, 135 provisions were enacted in 36 states during 2011 relating to reproductive health or rights. Eighty-nine of those provisions restricted abortion, 50 more than in 2005, the previous record year for such legislation. Dry statistics. But as Carole Joffe
reports, they are causing personal pain. Both for women seeking abortions and for providers.

First consider Jennie McCormick. She ordered abortion medication over the internet and now faces criminal charges that could put her away for five years. Joffe writes: "She has also been stigmatized in her own community to a degree to which the fictional Hester Prynne of
The Scarlet Letter
fame could relate." From the
Independent:

When Jennie Linn McCormack walks the streets of Pocatello, the town in southern Idaho where she was born, raised, and still lives, she attempts to disguise her face by covering it with a thick woollen scarf.

It doesn't really work. In the supermarket, people stop and point. At fast-food outlets, they hiss "it's her!" In the local church, that supposed bastion of forgiveness, fire-and-brimstone preachers devote entire sermons to accusing her of mortal sin. [...]

Unmarried, impoverished and pregnant with her fourth child, McCormack faced the problem so many American women do because nearly 90 percent of the nation's counties have no clinics or hospitals that will perform abortions. That is an outcome of nearly four decades of attacks by anti-choice forces. For her, the closest clinic was in Salt Lake City, a 150-mile drive. Because Utah requires a waiting period, she would have had to make the five-hour round-trip twice. The expense of the trip, the procedure and follow-up medical care also worried her.

Then she found out from her sister about RU-486, the abortion-inducing drug. Her sister ordered it, and McCormack took the pill as soon as it arrived. It worked. But there were complications that brought the fact of her abortion to the notice of authorities. In Idaho, self-induced abortions are outlawed. Although the original charges against McCormack were dismissed last summer, they could be reinstated. The whole affair has put the issue of the constitutionality of the ban in Idaho, and by extrapolation similar bans in six other states, into the hands of the Ninth Circuit Court of Appeals.

Then there is the provider. Joffe relates the example of Amy Hagstrom Miller, who oversees abortion clinics in Texas under the name Whole Women's Health. She and her clients now have to contend with new obstacles from a state law that requires a woman seeking an abortion to obtain an ultrasound from a physician who must describe to her in detail the development of the fetus. The same physician must perform the abortion, which presents a huge scheduling problem.

But, more importantly, the vast majority of abortions are performed at 12 weeks of pregnancy or less. The fetus is quite small at this phase. That means that physicians who want to avoid running afoul of a law that is intended by its sponsors to reduce abortions must use a transvaginal probe. That requires penetrating a woman's vagina, "state rape," as opponents have so rightly called it. If she refuses, no abortion.

From Idaho to Texas and other states across the nation, it's all part of the long-running effort to end legal abortions. There is nothing the anti-choice forces will not stoop to in their relentless war on reproductive freedom.  

Cholesterol scam: Disinformation slowly unraveling among health professionals

22.02.2012 9:00:00

The idea of cholesterol creating cardiac problems has caused obsessive cholesterol count blood testing for decades. Another outcome of this scare was obsessively avoiding fat, especially saturated fats. The food industry responded with low and no fat foods from milk...