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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  FDA
  
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  Vivus
  
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  Orexigen Therapeutics
  
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  Arena Pharmaceutical
  

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...

Worth Repeating: Marijuana and the Psychology of Optimal Experience

25.02.2012 4:20:00

??Worth Repeating?By Ron Marczyk, R.N.Health Education Teacher (Retired The reductionist, "group think," cold, dogmatic drug warriors of the National Institute of Drug Abuse, the DEA, and the FDA have been digesting their own misinformation for so long they have lost their humanity. As counterintuitive as it sounds, the" high" or "feel good" buzz from marijuana is an actual "therapeutic effect" that heals the brain, produces homeostasis and prevents many neurodegenerative conditions.Brain homeostasis is restored by the direct action of THC/CBD-activating CB1 receptors in the amygdala which regulate our "happiness / emotional salience module." This pathway is dedicated to seeking for "meaningfulness" in our existence.This innate drive is the need for self-actualization. THC increases the probability of these events occurring, through inducing metaphysical "flow states" and "peak experiences." We live near the edge, where the view is better. 
Continue reading "Worth Repeating: Marijuana and the Psychology of Optimal Experience" >

CDER World

25.02.2012 0:19:00

"CDER World" Web-based training explains FDA drug regulatory work.

J&J's Alex Gorsky takes on consumer trust. By David Sell

26.02.2012 11:49:00

"The transition to new management will hopefully help J&J focus on rectifying its manufacturing problems," said George Sillup, professor of pharmaceutical marketing at St. Joseph's University and a former J&J executive. But, Sillup notes, J&J is a huge operation with $65 billion in revenue, and reputations - good or bad - don't change quickly. "The concern with that is, once you start going wrong, you can't turn the battleship. That is very difficult to recoup."

The challenge is not only in the more well-known consumer divisions. J&J has issues in pharmaceuticals and medical devices.

One example is the antipsychotic drug Risperdal, J&J's third-best-selling prescription medication, which had sales of $1.6 billion in fiscal 2011.

J&J's subsidiary Janssen makes Risperdal. Gorsky, who started as a Janssen sales rep, was leading the company in the early 2000s when problems with the drug first came to light.

In January, the company paid $158 million to settle allegations - first made in Pennsylvania by whistle-blower Allen Jones - that the company illegally promoted Risperdal for unapproved use in children and adolescents, in part by paying Texas Medicaid officials to give it preferential treatment.

Such episodes would run counter to J&J's official credo that says the company's "first responsibility is to the doctors, nurses, and patients, to mothers and fathers and all others who use our products and services." After mentioning employees and communities, "our final responsibility" is to shareholders.

"After settlement was announced in the Austin courtroom, I had a brief, congenial conversation with J&J's corporate representative," Jones said last week when asked about the CEO change. "I asked him to please go back to his company and fix things - to try to make the J&J Credo mean something again. I sincerely hope that J&J has the same desire and that this is a step in that direction."

The litigation is not over, not by a long shot. J&J said last week in a filing with the Securities and Exchange Commission that the company started 2012 with 10,415 lawsuits pending, including 420 involving Risperdal. Besides other state battles, J&J said in the SEC filing, it is negotiating with the federal government to settle civil and criminal allegations of improper marketing. That bill might run beyond $1 billion. Then there are individual suits, 63 of which are being argued by Philadelphia lawyer Stephen Sheller's firm.

In court filings, Sheller has argued - unsuccessfully so far - that evidence of negative clinical data provided by J&J in discovery should be forwarded to the FDA with the idea that Risperdal would be pulled from the market because of negative side effects.

"I hope they've had an epiphany and will do the right thing," Sheller said of paying the plaintiffs, some of whom rely on taxpayer-funded Medicaid to provide health care, including for diabetes and gynecomastia (enlarged breasts in boys , which are some of the possible side effects of Risperdal.

Gorsky got the job in part because he was in charge of J&J's DePuy medical-device unit and was intimately involved in J&J's pending $21.3 billion acquisition of Synthes Inc., another device-maker, with several facilities in Chester County. Before J&J made the largest purchase in its history, Gorsky met several times with Synthes chairman Hansjorg Wyss in 2010 when Wyss was looking to sell his company. At the same time, Synthes was preparing to settle criminal and civil charges involving illegal human testing of one of its products, a bone cement.

DePuy is facing lawsuits over recalled replacement hips. Now, integrating Synthes with DePuy will not be easy, and the device market has been hurt by the recession in the United States and Europe.

J&J's challenges were the subject of a recent article in the online periodical
Knowledge@Wharton from the Wharton School of the University of Pennsylvania. The article's title: "Patients Versus Profits at Johnson & Johnson: Has the Company Lost Its Way?"

Gorsky holds an M.B.A. from Wharton.

In the article, a Wharton professor of legal studies and business ethics, Thomas Donaldson, gave J&J credit for taking steps to fix manufacturing plants, but said J&J managers were having to juggle a lot of balls.

via
philly.com

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News and Events - 25 Feb 2012

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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Healthy People Co. Recalls Dietary Products Bought on or Before October 25, 2011

23.02.2012 17:19:15

The Missouri Department of Health and Senior Services received the following recall regarding the expansion of Healthy People Co. dietary supplements to include all lot numbers sold on or before October 25, 2011.  The original recall was initiated on Feb. 2, 2012.

FDA lab analysis confirmed the presence of Sibutramine and Tadalafil in the products identified herein, making the following products unapproved new drugs:

MINCE BELLE (Dietary Supplement, 30 Capsules
LOT: HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021, HPCMB/10-016; UPC7503013203305

EVERLAX (Dietary Supplement, 30 Capsules
LOT: HPCEX/074, HPCEX/076, HPCEX/072, HPCEX/032; UPC7503013203046

EVER SLIM (Dietary Supplement, 30 Capsules
LOT: HPCES-079, HPCES-070, HPCES-071, HPCES/038; UPC7503013203053

EVER SLIM Shake Mix (Dietary Supplement Strawberry Contents17.6 oz.
LOT: HPESSF/168: UPC7503013203084

EVER SLIM Shake Mix (Dietary Supplement Chocolate Contents17.6 oz.
LOT: HPESSC/061: UPC7503013203077

ACAI-MAN MANGOSTEEN Herbal Drink (Dietary Supplement Contents 16.6 oz.
LOT: HPJAC/004: UPC7503013203015

PERFECT MEN (Dietary Supplement, 10 Capsules
LOT: HPCPM/002; UPC7503013203190

Sibutramine is an FDA-approved drug for appetite suppressant for the treatment of obesity, making dietary supplements: Mince Belle, Everlax, Ever Slim, Ever Slim Shake Mix Dietary Supplement Strawberry, and Ever Slim Shake Mix Dietary Supplement Chocolate unapproved drugs.  It is a Schedule IV controlled substance and because of the risks associated with its use, it should be taken only under the direct supervision of a qualified health care professional.  Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  Sibutramine has been withdrawn from the U.S. marketplace. The active drug ingredient is not listed on the label for the products listed above.

Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED , making Perfect Men Dietary Supplement and Acai-man Mangosteen Herbal Drink Dietary Supplement unapproved drugs.  FDA advises that this poses a threat to consumers because Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

These products were distributed nationwide.

The full recall announcement can be found at: 
http://www.fda.gov/Safety/Recalls/ucm292796.htm?source=govdelivery.

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

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."

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.  

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. 

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."

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.

Stand Strong, GlaxoSmithKline! - Brainstorm - The Chronicle of Higher Education

23.02.2012 12:24:00

By
Carl Elliott

We Love Pharma, courtesy of CDM Worldwide

The pharmaceutical industry gets a bad rap.  To listen to the critics you’d think pharmaceutical companies are in the same sleazy category as oil, finance and tobacco companies.  But pharmaceutical companies invent life-saving medications, not to mention countless other psychoactive products that many of us enjoy on a recreational basis.  Pharmaceutical companies get blamed for fraud, kickbacks, and research deaths, but they never get the credit for oxycontin.

That is why I was thrilled to see that GlaxoSmithKline is sponsoring the prize for the
British Medical Journal
‘s annual
Research Paper of the Year. Sure, the pharma-bashers will whine like infants at the
BMJ’
s decision to brand a medical research prize with the name of multinational drug company, just as they’re whining about an American editor’s decision to re-locate a leading bioethics journal to the Texas headquarters of a
stem cell tourism clinic. These people just don’t get it.  This is not about propaganda or corruption.  It is about developing innovative medications for diseases that we didn’t even know existed.

In that spirit, my nomination for the GlaxoSmithKline (GSK Research Paper of the Year goes to a ground-breaking article about GSK’s very own antidepressant, Paxil, which was published in the
Journal of the American Academy of Child and Adolescent Psychiatry
.  The title of the article is “Efficacy of Paroxetine in the Treatment of Adolescent Major Depression,” but seasoned pharma-watchers know it better as
Study 329. The data behind Study 329 showed that Paxil didn’t actually work in adolescents – that, in fact, it was
no better than a sugar pill. However, as any marketer understands, bad data cannot be allowed to interfere with a good paper.  By the time Study 329 appeared in print, GSK had used the magic of biostatistics to transform the raw data into a gleaming advertisement for Paxil.  As a result, when FDA eventually decided that Paxil had a few minor side-effects,
such as suicide, Study 329 had already done its work: getting a GSK product into the hands of troubled teenagers.  And wait, here’s the beauty part: although the published version of Study 329 was “authored” by leading academic psychiatrists, it was actually
written by a GSK ghostwriter.

Of course, the pharma-bashers have been complaining about Study 329 for years.  Some of them even want the journal to retract it.  The lead “author” who signed the paper, Martin Keller of Brown University, has been
beaten up by the Senate Finance Committee,
harassed by the New York attorney general, and vilified in the press, all because he put his name on a ghosted article and forgot to report
half a million dollars in pharmaceutical income.  To which I say: stand strong, GSK.  Ignore the naysayers and the nitpickers.  It’s about time you gave these good people some public recognition.  Yes, it’s true that Study 329 is eleven years old, but you’re paying the BMJ over $47,000 to
sponsor this prize. Surely they can bend the rules, just this once.

via
chronicle.com

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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. ...

U.S. consumers tell insurers to cover experimental drugs

24.02.2012 18:07:45

[IMGCAP(1 ] NEW YORK | Mon Jan 23, 2012 9:42am EST (Reuters - When your health insurance provider denies an experimental treatment or a high-cost drug, how much are you willing to pay for the care you believe you need? Barby Ingle, a former cheerleading and dance coach at Washington University who now lives in a Phoenix suburb, has been forced to face this question. …

FDA Moves to Head Off Shortages of 2 Cancer Drugs

22.02.2012 10:00:00

Title: FDA Moves to Head Off Shortages of 2 Cancer Drugs


Category: Health News


Created: 2/21/2012 2:05:00 PM


Last Editorial Review: 2/22/2012

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...

Diet Drug Qnexa Gets Thumbs-Up From FDA Panel

23.02.2012 0:53:00

In a reversal, a panel of experts is advising the Food and Drug Administration to approve Qnexa, a weight-loss pill, that was rejected in 2010. The potential benefits for overweight people exceed the risks, such as birth defects and increased heart rates, the panel determined.

American Regent Recalls Phenylephrine HCl Injection Due To Visible Particles

24.02.2012 0:51:11

The Missouri Department of Health and Senior Services received the following recall regarding Phenylephrine HCl Injection, USP, Lot 0693 due to potential safety concerns.

The product recall includes:

• Phenylephrine HCl Injection, USP, 1% (10mg/mL , 5 mL Vial NDC # 0517-0405-25, Lot # 0693, Exp Date: October, 2012.
  

Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness , and granuloma formation.

Phenylephrine HCl Injection, USP is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anesthesia and for the treatment of vascular failure in shock, shock like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anesthesia, and as a vasoconstrictor in regional analgesia.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, emergency rooms, clinics, and other healthcare facilities and providers should not use this product for patient care and should immediately quarantine any product for return.

The full recall announcement can be found at: 
www.fda.gov/Safety/Recalls/ucm292951.htm?source=govdelivery.

3 weight loss drugs make 2nd bid for approval

24.02.2012 21:26:24

The FDA has rejected three prescription diet pills in the last three years, raising questions of whether any weight loss drug can win approval in the U.S. Despite the latest rejections, all three drugmakers are resubmitting their products for a second review.

Vivus Shares Surge After FDA Panel Backs Diet Drug

23.02.2012 23:12:37

Vivus shares doubled after a federal advisory panel overwhelmingly backed the weight-loss drug Qnexa, clearing the way for U.S. approval of the first prescription diet drug in more than a decade.

FDA panel backs previously rejected obesity pill

23.02.2012 16:30:06

A previously rejected weight loss pill won an overwhelming endorsement from public health advisers Wednesday, raising hopes that the drug from Vivus Inc. could become the first new anti-obesity medication to reach the U.S. market in more than a decade.

CDER World

24.02.2012 23:14:00

"CDER World" Web-based training explains FDA drug regulatory work.

News and Events - 23 Feb 2012

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.

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
  

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."

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.

FDA to review safety of caffeine powder

22.02.2012 18:01:38

Food and Drug Administration officials plan to investigate whether a form of caffeine sold in lipstick-shaped containers is safe for consumers.

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.

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.
 

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.

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 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.

Cancer drug shortages in U.S. eased by new suppliers

22.02.2012 0:34:43

FDA head Margaret Hamburg announces approval of new suppliers for two crucial cancer drugs, easing critical shortages in the U.S.

FDA approves new suppliers for cancer drugs to ease shortage

21.02.2012 19:36:53

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 patients worried about missing life-saving treatments.

Healthy People Co. is Expanding its Voluntary Recall Initiated on February 02, 2012 to Include Dietary Products Bought on or Before October 25, 2011

22.02.2012 6:29:00

Healthy People Co. announced today that is expanding its voluntary nationwide recall of the company’s dietary supplements sold under the brand names described below, regardless of the lot numbers referenced herein, and to the extent these products were bought on or before October 25, 2011. On February 02, 2011, Healthy People Co. conducted a voluntary recall because FDA lab analysis confirmed the presence of Sibutramine and Tadalafil in the products identified herein, making the following products unapproved new drugs:

FDA to Boost Supply of Cancer Drugs

22.02.2012 3:33:50

The FDA approved two new suppliers of two cancer drugs that are currently in short supply.

The Accidental Vegetarian

22.02.2012 19:04:40

A mid-February show of hands, please: how many of us are still sticking with our New Year's resolutions?

 

Honestly, I'm not sure I made any resolutions this year. If I did, well, they were fleeting and of the altruistic, yet unquantifiable variety, such as
“Be a kinder person.”
You know, the types of resolutions that were intended to elicit similar responses from our kids:
“I'll be nicer to my brother,”
or
“I'll help Mommy more around the house.”

 

Yep, we're not great about sticking with resolutions here.

 

Of course, because I'm a woman of a certain age whose metabolism flew the coop about five years ago, I always privately resolve to eat better and exercise more. I just don't speak those words out loud, because I know that the likelihood of me hitting the gym during the insanely busy spring growing season for my business is nil.

 

And, frankly, I refuse to deprive myself of red wine and chocolate.

 

So, imagine my shock when I became—inadvertently--a vegetarian.

This is a startling development for several reasons:

 

I grew up in a meat and potatoes family. Truly. Dinner centered around a roast beast, potatoes, white, squishy bread rolls, and maybe a salad. The overriding focus on meat was, I believe, a generational, socioeconomic attribute. Both of my parents grew up during the Depression. Our father often told stories of his life on the family farm, where the family celebrated the demise of a ill-fated chicken crossing the road with a rare fried-chicken dinner. He also raised a pet pig.

 

Trust me. You don't want to know what became of his pet.

 

I rarely ate a vegetable during my entire childhood. There's something to be said about being the baby of the family, particularly if you're a late-in-life, surprise baby. My siblings regaled me with dinner-table horror stories: gagging down ice cold, mushy peas until 10 p.m., eating a ketchup-covered banana that someone thought would be a creative way to avoid eating her fruit...

 

By the time I made an appearance, my parents were tired. It was easier to cater to my picky palate than deal with dinner drama. Thus, I became the pickiest eater in the Midwest. Not only did my mother make separate meals for me, I was never force-fed broccoli. Or peas. Or squash. My childhood vegetable consumption included:

• 
  

  Iceburg lettuce—plain, thank you. No dressing or weird additions to my crunchy pale green leaves, please.
  

• 
  

  Corn. With lots of butter and salt.
  

• 
  

  Potatoes. Honestly, I don't think potatoes even count. And all of the GMOs in the corn probably negates any health benefits the corn theoretically provided.
  

Embarrassingly, my vegetable phobia continued well into my adulthood. Yes, I added a few bits of green to my repertoire—cucumbers, real lettuce, asparagus, spinach salad—but until five years ago, I didn't even eat tomatoes.

Ironically, I now own an organic, heirloom plant nursery, specializing in 160 varieties of tomatoes.

 

As a mother, I created my family's meals much like my mother did—meat, starch, and occasional side of quickly microwaved peas. Yes, I added more veggies, but meat took center stage at every meal. Granted—our meat was pristine, raised humanely by local farmers, some of whom are now friends. Our meat originated from happy, healthy animals living happy, healthy lives. Free-range chicken, grass-fed beef, heritage turkeys—delicious, star quality dinner showpieces.

 

Then, a strange twist of fate.

 

A raccoon attacked our own backyard flock of hens. (You can read about it
here and
here.

 

It was traumatic. These girls are my daughter's pets. With names. And personalities. Fortunately, the raccoon only severely injured one hen, Salt, and after extensive consultation with our wonderful veterinarian, she sadly couldn't be saved.

 

In those moments of holding Salt, trying to assess her wounds and comfort her, something shifted.

 

My perception about food changed.

 

I suddenly found myself unable to eat meat.

I thought my aversion was temporary. After all, our daughter, who loves her chickens as if they are her children, still relishes Zaxby's even after the demise of her pet.

 

But as days passed, I found myself reading Alice Waters' books, heading to Whole Foods, leaving with a cart full of stunning produce, and then trying to figure out how to cook it. And you know what?

 

It. Was. Good.

 

Fresh eggs and Swiss Chard frittata. Mushroom risotto. Ratatouille.

 

Who knew? (Actually, I think many people knew. It was like discovering an amazing secret club, and I'd finally earned admittance.

 

Even the kids ate more vegetables. Put an asparagus spear on the plate of a six year old boy, and listen to the whines ensue...until you share the “stinky pee” secret.

It was amazing how much more appealing the asparagus became after divulging that crucial bit of info.

 

My husband joked that I shouldn't write about my emerging vegetarianism, because he knows my carnivorous ways too well. And who knows? Will it stick? Right now, after six weeks without meat, I'm optimistic. And I feel good. I'm not vegan—I eat seafood, dairy products, and eggs, so meal planning is fairly easy. Plus, it's not like I banned chocolate and wine from my life—that would never stick. Actually, eating my veggies and forgoing meat is surprisingly simple.

 

Last fall, our oldest son brought his new girlfriend home for dinner. Prior to their arrival, he informed me that she was—gasp!--a vegetarian. Panic! What could I cook? If I made risotto, could I use chicken stock, or should I run to the store for vegetable broth? Would she be offended by the steak I already prepared for the family? How much salad does a vegetarian eat? I made more, just in case...

 

And honestly, I worried. How could this relationship work? Our son is a serious carnivore, like me. He even owns this t-shirt to taunt his vegetarian friends:

 

 

 

 

Funny thing. Our son is now on his third meat-free week...and he likes it.

 

Love makes college boys do some crazy things, huh?

 

I'm not advocating vegetarianism. It's not my place to tell anyone what or how to eat. (Although I do hope you'll support your local farmers as much as possible, please. I still eat crap occasionally. I'm—shamefully--addicted to Diet Coke. (I know, I know...it's really bad for me. I promise, I'll work on it.

 

But this vegetarian thing? Well. It's pretty delicious.

 

My parents should have made me eat my peas, after all.

 

Bon appetit!

 

~Julie

 

 

Julie is the owner of
Garden Delights, an organic heirloom plant nursery specializing in edibles. She writes about growing gardens, growing green, growing locavores, growing kids, and growing one day at a time at
Growing Days.

All vegetable image credits: Julie Thompson-Adolf.

FDA to ease shortages of 2 cancer drugs

21.02.2012 17:05:36

Ovarian cancer patients whose treatment was interrupted or even stopped entirely because they couldn’t get supplies of the critical chemotherapy drug Doxil applauded news early Tuesday that federal health officials have found a solution to the shortage.

Johnson & Johnson: Another example of big company with small morals

21.02.2012 16:17:00

via
blog.nj.com

In 2009, the FDA told Johnson & Johnson it could no longer sell an unsafe hip replacement in the United States. That didn’t stop the New Jersey health care giant from selling the device in other countries.
Now, the New Brunswick company faces up to $3 billion in legal and medical costs over the device, which J&J finally recalled in 2010 after evidence was revealed that it was leaving tiny, painful slivers of metal in many of those overseas patients.
Inside J&J, workers take pride in the corporation’s famous credo. Summarized, it says: Act ethically and responsibly, no matter the cost, and profits will follow.
J&J is proof that profits follow bad corporate behavior, too.
In 2010, the company earned a record $13 billion. At the same time, it paid roughly $750 million in government fines and settlements for a laundry list of wrongs. It was fined $70 million for overseas bribery, shut down a children’s drug factory for safety violations and was investigated for a “phantom” recall of tainted Motrin.
Defenders of the 1 percent insist corporations and their executives have every right to amass whatever fortunes they can in America’s free market.
But the headlines reveal that many big businesses are raking in billions without conscience. What we’re seeing is a grotesque shift in corporate values that undermines Corporate America’s image as the benevolent job creator.
Occupy Wall Street zeroed in on the enormous gap in pay between corporate executives and the so-called 99 percent. But not enough was said about the erosion of corporate citizenship and the lengths to which Big Banking, Big Pharma and Big Oil, just to name a few, will go to increase profits at the expense — even the victimization — of humanity. (See accompanying chart for some awful offenses.
We see deadly accidents in coal mines and on oil rigs as owners cut corners on worker and environmental protections; patients put at risk when pharmaceutical companies take already successful drugs and try to drive profits even higher by selling them for diseases the FDA never studied nor approved; taxpayers footing fraudulent bills as contractors look at government like a blank check, overcharging millions or more.
It is understandable for companies to pull back on their charitable works in tough times, or even trim the workforce. In the throes of the Great Recession, even companies with a social conscience often did that. Who could justify million-dollar gifts for charity when employees are being laid off?
But this is different. This is despicable behavior, and it’s widespread. If the same acts were committed by an individual, that person would likely find himself in prison. Corporations typically face only the loss of cash. Don’t worry, they’ll make more.
The U.S. Supreme Court is inching toward full personhood for corporations — see Citizens United vs. FEC, which granted them freedom of speech. Perhaps it’s time they were punished like people, too.

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