Pistachio company: Raw nuts may be bacteria source

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Posted on 31st March 2009 by Gordon Johnson in Uncategorized

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Date: 3/31/2009

GARANCE BURKE
Associated Press Writer

TERRA BELLA, Calif. (AP) — The salmonella scare that prompted a blanket federal warning against eating pistachios may have erupted because contaminated raw nuts got mixed with roasted nuts during processing, the company at the center of the nationwide recall said Tuesday.

Lee Cohen, the production manager for Setton International Foods Inc., said the company does not believe pistachios were contaminated by a human or animal source in its plant. He said the company suspects that roasted pistachios sold to Kraft Foods Inc. may have become mixed at Setton’s plant with raw nuts that could have contained traces of the bacteria.

The pistachios were processed at central California-based Setton Pistachio of Terra Bella Inc., which is in the corporate family of Commack, N.Y.-based Setton International Foods Inc. Cohen is in California to help as the Food and Drug Administration inspects the nation’s second-largest pistachio processor.

Kraft spokeswoman Laurie Guzzinati said her company’s auditors “observed employee practices where raw and roasted nuts were not adequately segregated and that could explain the sporadic contamination.”

She said she didn’t know what they saw specifically, but “that’s how the auditors shared the information with us.”

Federal health officials warned people on Monday not to eat any products containing pistachios while they investigate.

The FDA said Setton Pistachio, the nation’s second-largest pistachio processor, was voluntarily recalling more than 2 million pounds of its roasted nuts shipped since last fall. Some of those nuts were shipped to Norway and Mexico, officials said Tuesday.

“We know that the farm in California shipped its products to 36 wholesalers,” said Dr. David Acheson, assistant commissioner for food safety. “But what we don’t know yet is what those wholesalers did with them — whether they were repackaged for consumers, or whether they were sold to manufacturers making ice cream or cookies or candies.”

Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn’t been confirmed, Acheson said. Still, Setton decided to shut down the Terra Bella plant late last week, officials said.

The FDA learned about the problem March 24, when Kraft Foods Inc. notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day.

Kraft expanded its recall this Tuesday to include any Planters and Back to Nature products that contain pistachios supplied by Setton Pistachio since Sept. 1.

“Safety is our top priority,” Guzzinati said. “We’re proud of our quality and the procedures we have in place. This is always a place we look for continuous improvement. In this instance when it was brought to our attention we were able to act and respond.”

The recalled nuts are a small fraction of the 55 million pounds of pistachios that the company’s plant processed last year and an even smaller portion of the 278 million pounds produced in the state in the 2008 season, according to the Fresno-based Administrative Committee for Pistachios.

California is the second-largest producer of pistachios in the world.

The latest recall is not related to the nationwide recall of peanuts.

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Associated Press reporter Tracie Cone in Fresno contributed to this report.

Copyright 2009 The Associated Press.

FDA says to avoid pistachios amid salmonella scare

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Posted on 31st March 2009 by Gordon Johnson in Uncategorized

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Date: 3/31/2009 1:59 PM

GARANCE BURKE
Associated Press Writer

FRESNO, Calif. (AP) — Federal food officials are warning people not to eat any food containing pistachios because of possible contamination by salmonella, in another food scare sure to rattle consumers already upset by the contamination of peanuts with the same bacteria.

The Food and Drug Administration said central California-based Setton Pistachio of Terra Bella Inc., the nation’s second-largest pistachio processor, was voluntarily recalling more than 2 million pounds of its roasted nuts shipped since last fall.

“Our advice to consumers is that they avoid eating pistachio products, and that they hold onto those products,” said Dr. David Acheson, assistant commissioner for food safety. “The number of products that are going to be recalled over the coming days will grow, simply because these pistachio nuts have then been repackaged into consumer-level containers.”

Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn’t been confirmed, Acheson said. Still, the plant decided to shut down late last week, officials said.

The recalled nuts are a small fraction of the 55 million pounds of pistachios that the company’s plant processed last year and an even smaller portion of the 278 million pounds produced in the state in the 2008 season, according to the Fresno-based Administrative Committee for Pistachios.

California is the second-largest producer of pistachios in the world.

According to the company’s Web site, Setton Pistachio is in the corporate family of Commack, N.Y.-based Setton International Foods Inc. The company sells nuts, dried fruit, edible seeds, chocolate and yogurt-coated candies.

The FDA learned about the problem last Tuesday, when Kraft Foods Inc. notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day.

The FDA contacted Setton Pistachio and California health officials shortly afterward, in what Acheson called a “proactive move.”

By Friday, Cincinnati-based grocery operator Kroger Co. recalled one of its lines of bagged pistachios because of possible salmonella contamination, saying the California plant also supplied its nuts. Those nuts were sold in 31 states.

Fabia D’Arienzo, a spokeswoman for Tulare County-based Setton Pistachio, said the company was only recalling certain bulk roasted in-shell and roasted shelled pistachios that were shipped on or after September 1.

Because Setton Pistachio shipped bags of nuts weighing up to 2,000 pounds to 36 wholesalers across the country, it will take weeks to figure out how many products could be affected, said Jeff Farrar, chief of the Food and Drug Branch of the California Department of Public Health.

“It will be safe to assume based on the volume that this will be an ingredient in a lot of different products, and that may possibly include things like ice cream and cake mixes,” Farrar said. “The firm is already turning around trucks in transit to bring those back to the facility.”

Salmonella, the most common cause of food-borne illness, causes diarrhea, fever and cramping. Most people recover, but the infection can be life-threatening for children, the elderly and people with weakened immune systems.

Roasting is supposed to kill the bacteria in nuts. But problems can occur if the roasting is not done correctly or if roasted nuts are re-contaminated. That can happen if mice, rats or birds get into the facility.

The national peanut salmonella outbreak was blamed on a Georgia company under federal investigation for flouting safety procedures and knowingly shipping contaminated peanuts.

That outbreak is still ongoing. More than 690 people in 46 states have gotten sick. Nearly 3,900 products made with peanut ingredients from Peanut Corp. of America have been recalled.

California public health authorities have taken hundreds of samples at Setton’s processing facility, but lab results have not yet determined whether salmonella was found at the plant, Farrar said. The food companies’ own tests of the contaminated products isolated four different types of salmonella, but none were the same strain as the one found in the peanuts, Acheson said.

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Associated Press writers Ricardo Alonso-Zaldivar in Washington and Tracie Cone in Fresno contributed to this report.

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On the Net:

http://www.settonfarms.com

http://www.fda.gov

Copyright 2009 The Associated Press.

NOTE: The Seattle Post Intelligencer has posted an article which reports:

“The company at the center of a nationwide pistachio recall says the salmonella contamination could have come from raw nuts during processing but not a human or animal source in its plant.”

Read their entire article at:
http://www.seattlepi.com/national/1110ap_salmonella_pistachios.html

VA: 16 patients of problem clinics infected

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Posted on 27th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/27/2009

BILL POOVEY
Associated Press Writer

CHATTANOOGA, Tenn. (AP) — Viral infections, including hepatitis, have been found in 16 patients exposed to contaminated equipment at Veterans Affairs medical facilities, a department spokeswoman said Friday.

So far, 10 colonoscopy patients from the VA medical center in Murfreesboro, Tenn., have tested positive for hepatitis, VA spokeswoman Katie Roberts told The Associated Press. In a later e-mail, she reported six patients at the VA’s ear, nose and throat clinic in Augusta, Ga, tested positive for unspecified viral infections.

The number of reported infections could rise.

More than 10,000 veterans were warned to get blood tests because they could have been exposed to contamination at those two facilities plus a medical center in Miami. All three sites failed to properly sterilize equipment between treatments, and the problems dated back for more than five years at the Murfreesboro and Miami hospitals.

Roberts said the department doesn’t yet have results from most of the veterans it warned.

A VA alert to patients said they “could have been exposed to body fluids from a previous patient.”

Roberts said four Tennessee patients have tested positive for hepatitis B and six have tested positive for hepatitis C. No one has tested positive for HIV, she said.

Hepatitis is a viral infection of the liver. The most common form, hepatitis C, is potentially life-threatening and can cause permanent liver damage. Both the B and C forms are spread by contact with the blood or other body fluid of an infected person, according to the Centers for Disease Control and Prevention.

Roberts stressed that the source of the infections isn’t known and may never be identified.

“There’s no way to scientifically, conclusively prove they contracted this due to treatment at our facility,” Roberts said.

But the VA will make sure those who tested positive “get the best possible treatment,” she said.

The VA’s inspector general office has started a review, spokeswoman Joanne Moffett said Friday.

According to a VA e-mail, only about half of the Murfreesboro and Augusta patients notified by letter of a mistake that exposed them to “potentially infectious fluids” have requested department blood tests.

Some veterans said they decided to seek tests from their private physicians, rather than the VA.

The public first became aware of problems in February, when the agency announced it had sent letters to about 6,400 patients who had colonoscopies between April 23, 2003, and Dec. 1, 2008, at Murfreesboro and to about 1,800 patients treated over 11 months last year at Augusta.

Roberts said the problem in Tennessee was discovered in December and an internal alert was issued.

This week the VA announced it sent letters advising 3,260 patients who had colonoscopies between May 2004 and March 12 at the Miami Veterans Affairs Healthcare System that they also should get tests for HIV, hepatitis and other infectious diseases.

“We feel that the risk of cross-contamination among patients is small, and many patients are at no risk whatsoever,” Dr. William E. Duncan of the VA Health Administration said in an e-mail. “Since we cannot know which patients are at risk, we are notifying everyone we feel may possibly have been placed at risk.”

Two weeks after a review of procedures and training at VA facilities nationwide, Roberts said the VA cannot yet say if patients at other locations were exposed to equipment that was not properly sterilized.

U.S. Rep Ileana Ros-Lehtinen, R-Fla., said VA officials told her and other members of Congress on Thursday that the Miami facility initially reported it was free from problems only to later backtrack.

Ros-Lehtinen said the details were disclosed by the VA in a closed-door meeting convened by U.S. Rep. Steve Buyer, R-Ind., the top Republican on the House Committee on Veterans’ Affairs.

Joe Davis, a spokesman for the Veterans of Foreign Wars in Washington, said he has notified his 20,000 newsletter subscribers about the situation.

“We are obviously very concerned anytime anybody’s health is at risk from going to see the doctor,” he said Friday. “We believe the VA has done an adequate job in quickly notifying those veterans who might be affected.”

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Associated Press writer Matt Sedensky in Miami contributed to this report.

Copyright 2009 The Associated Press.

FDA Takes Action Against KV Pharmaceutical Company

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Posted on 20th March 2009 by Gordon Johnson in Uncategorized

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The below story is from the FDA website. It is one more example of the broken American pharmaceutical industry.

Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2009

FDA News
FOR IMMEDIATE RELEASE
March 2, 2009

FDA Takes Action Against KV Pharmaceutical Company
Company Making, Marketing and Distributing Adulterated and Unapproved Drugs
The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA’s current Good Manufacturing Practice (cGMP) and new drug approval requirements for six years.

The Consent Decree also enjoins KV’s officers David A. Van Vliet, president and chief executive officer; Rita E. Bleser, president of the pharmaceutical division; Jay S. Sawardeker, vice president of corporate quality, and Marc S. Hermelin, former chief executive officer and a member of KV’s Board of Directors, from manufacturing and distributing any drug at or from KV’s facilities until the company’s procedures and products are brought into compliance with the law.

KV Pharmaceutical manufactures, processes, packages, labels, holds, and distributes drugs from various locations in St. Louis, Mo., and the surrounding area. FDA inspected KV between December 2008 and February 2009, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of those inspections, which led to this action, KV recalled all products manufactured and distributed from its facilities.

“The FDA requires companies to manufacture drugs in accordance with the current good manufacturing practice standards and to comply with FDA approval requirements,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy.”

Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections of their facilities and certify that they are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the decree. The Consent Decree also requires the defendants to destroy all drugs they recalled between May 2008 and Feb. 3, 2009. Those drugs are currently in their possession.

If the defendants fail to comply with any provision of the Consent Decree, the Act, or FDA regulations, FDA may order the firm to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions.

“The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”

The Consent Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and the payment of an additional $15,000 for each violation, up to $5 million per year.

For more information:

FDA/CDER Web page on Compliance with Current Good Manufacturing Practices
http://www.fda.gov/cder/dmpq/

FDA’s ongoing efforts against marketed unapproved drugs
http://www.fda.gov/cder/drug/unapproved_drugs/

Federal Agents Seize more than $24M in Unapproved New Drugs
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01868.html

Ethex Corporation Initiates Nationwide Recall
http://www.fda.gov/oc/po/firmrecalls/ethex12_08.html

KV Voluntarily Suspends Shipments of all its Approved Tablet Drugs
http://www.fda.gov/oc/po/firmrecalls/kv12_08.html

Link to CPG guidance, http://www.fda.gov/cder/Guidance/6911fnl.htm

Private inspections of food companies seen as weak

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Posted on 20th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/20/2009

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — The mortgage meltdown exposed the weakness of self-regulation in financial markets. Now the salmonella outbreak is doing the same for the food industry.

A House subcommittee Thursday released new documents that showed how private inspectors contracted by Peanut Corp. of America failed to find long-standing sanitary problems at company facilities. Peanut Corp. is at the center of a nationwide outbreak that has sickened nearly 700 people and is blamed for at least nine deaths.

Lawmakers said the food industry’s private inspection system failed to catch filthy conditions because the company itself hired the inspectors.

“There is an obvious and inherent conflict of interest when an auditor works for the same supplier it is evaluating,” said Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce investigations subcommittee. He termed it a “cozy relationship.”

Last summer, Peanut Corp.’s private inspector, a company called AIB, awarded the peanut processor a certificate in 2008 for “superior” quality at its Plainview, Texas, plant. This year, salmonella was discovered there.

The outbreak was initially traced to a Peanut Corp. facility in Blakely, Ga. Later, contamination was found at the Texas plant. Peanut Corp. is under criminal investigation for allegedly shipping products it knew to be tainted.

Owner Stewart Parnell has refused to answer questions from lawmakers, citing constitutional protections against self-incrimination. On Thursday, Parnell told The Associated Press he couldn’t comment on the allegations and referred questions to his attorney, who was not immediately available.

Federal law does not require food companies to pay for their own inspections of suppliers. Nor are industry labs and inspectors required to tell the government about any problems they find.

At least one food company that used its own inspectors, Nestle USA, ultimately decided not to do business with Peanut Corp. Nestle USA had no recalls. But a Nestle affiliate in Puerto Rico recalled some ice cream products, and Nestle HealthCare Nutrition — another affiliate — recalled a nutritional bar.

The committee released a 2002 Nestle USA inspection report of Peanut Corp.’s Blakely plant. “They found that the place was filthy,” said Rep. Henry Waxman, D-Calif.

A second audit by Nestle USA of Peanut Corp.’s Texas facility in 2006 also found major pest control and other problems. The audit said that would disqualify the plant from supplying chopped peanut pieces to sprinkle atop Drumstick ice-cream cones.

Auditors found at least 50 mouse carcasses in and around the plant and also a dead pigeon “lying on the ground near the peanut-receiving door.”

The audit also said the plant had no pathogen-monitoring plan and noted that one needed to be developed for the plant to be in compliance with audit standards.

Companies that bought ingredients from Peanut Corp. said they had no way of defending themselves against a supplier they accuse of deliberately breaking the rules and covering up.

“I think we did everything we could do,” Kellogg Co. chief executive David Mackay told the committee.

“The issue was that (Peanut Corp.) acted in a dishonest and unethical way,” he added.

Lawmakers and the Obama administration say the problem goes beyond a rogue company, and major reforms are needed. Legislation has been introduced in Congress to take food safety oversight away from the Food and Drug Administration and give it to a new agency with stronger legal powers and more funding.

Peanut Corp. produced not only peanut butter, but peanut paste, an ingredient found in foods from granola bars and dog biscuits to ice cream and cake. More than 3,490 products have been recalled, including some millions of Kellogg’s Austin and Keebler peanut butter sandwich crackers.

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On the Net:

FDA salmonella page: http://tinyurl.com/8srctw

Copyright 2009 The Associated Press.

China punishes more officials in milk scandal

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Posted on 20th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/20/2009

BEIJING (AP) — China’s Communist Party has punished eight more senior government officials for their roles in last year’s tainted infant formula scandal, a state news agency reported Friday.

Milk laced with the industrial chemical melamine was blamed for the deaths of at least six babies and the sickening of nearly 300,000 others. The scandal forced the head of China’s quality watchdog to resign, and courts have sentenced two men to death for producing the chemical and supplying dairies with toxic milk.

The crisis also highlighted the need for major overhauls in China’s food safety system, and led to a law enacted this month that consolidates hundreds of separate regulations covering the country’s 500,000 food processing companies.

The official Xinhua News Agency said the Communist Party’s disciplinary body removed Wang Bubu, chief of the law enforcement and supervision department at China’s quality watchdog, from his official and party posts. A deputy chief of food circulation supervision at the State Administration for Industry and Commerce was also fired, it said.

Six others — from agencies including the State Food and Drug Administration and the Ministries of Agriculture and Health — received penalties including demotions and having their misdeeds recorded, Xinhua said. Xinhua said all were punished for their failures in supervising.

Several senior city officials were fired last year in Shijiazhuang, the northern Chinese city where the dairy at the heart of the scandal was based. The chairwoman of the company has been sentenced to life in prison.

The scandal has been blamed on middlemen who added melamine, which is high in nitrogen, to watered-down milk to fool quality tests for protein content. Melamine can cause kidney stones and kidney failure.

Copyright 2009 The Associated Press.

Kellogg's CEO calls for major food safety reforms

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Posted on 18th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/18/2009

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — The top official at Kellogg’s, the giant food-maker who lost $70 million worth of peanut products in the recent salmonella outbreak, is urging lawmakers to overhaul the nation’s food safety system.

Kellogg Company CEO David Mackay wants food safety placed under a new leader in the Health and Human Services department. He also called for new requirements that all food companies have written safety plans, annual federal inspections of facilities that make high-risk foods, and other reforms.

Mackay’s strong endorsement of major changes could boost President Barack Obama’s efforts to overhaul the system. Last week Obama launched a special review of food safety programs, which are split among several departments and agencies, and rely in some cases on decades-old laws. Critics say more funding is needed for inspections and basic research.

“The recent outbreak illustrated that the U.S. food safety system must be strengthened,” Mackay said in prepared remarks for a hearing Thursday. “We believe the key is to focus on prevention, so that potential sources of contamination are identified and properly addressed before they become actual food safety problems.”

A copy of his statement for the House Energy and Commerce Committee was obtained by The Associated Press.

The salmonella outbreak has sickened at least 691 people, and is being blamed for nine deaths. The source was a small Georgia peanut processing plant, which allegedly shipped products that managers knew were contaminated with salmonella.

The plant produced not only peanut butter, but peanut paste, an ingredient in foods from granola bars and dog biscuits, to ice cream and cake. More than 3,490 products have been recalled, including some Kellogg’s Austin and Keebler peanut butter sandwich crackers. The Georgia plant has been shut down and its owner, Peanut Corp. of America, is under criminal investigation by the Justice Department.

Mackay said Kellogg’s had to recall more than 7 million cases of crackers and cookies, at a cost of $65 million to $70 million. Kellogg’s began purchasing peanut paste from Peanut Corp. in July, 2007, after the supplier passed quality checks and audits.

“Audit findings reported no concerns that the facility may have had any pathogen-related issues or any potential contamination,” Mackay said in his statement. “None of the salmonella or hygiene issues that have been reported by regulators over the past several months were noted in any of the audit reports provided to Kellogg.”

FDA inspectors swooped down on the Georgia plant in January and found multiple sanitary violations. The problems included moisture leaks, improper storage and openings that could allow rodents into the facility. FDA tests found salmonella contamination within the plant. After invoking bioterrorism laws, the FDA obtained Peanut Corp. records that showed the company’s own tests repeatedly found salmonella in finished products.

How persistent problems at the Georgia plant managed to escape the attention of state inspectors and independent private auditors is one of the main unanswered questions in the investigation.

Mackay’s call for a food safety “authority” within the HHS department appears similar to legislation from Rep. Rosa DeLauro, D-Conn. Her plan would take food safety away from FDA and give it to a new agency within the department. The FDA is responsible for most foods, while the Agriculture Department inspects meat and poultry. DeLauro’s plan would not affect the USDA.

Copyright 2009 The Associated Press.

FDA cites bleeding risk with experimental J&J drug

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Posted on 17th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/17/2009

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — Federal health officials say a Johnson & Johnson drug helps prevent deadly blood clots in patients getting hip or knee replacement, but it also carries a risk of serious internal bleeding.

Johnson & Johnson and partner Bayer have asked the Food and Drug Administration to approve their once-daily pill, rivaroxaban, as an anticlotting drug to stop blood clots in legs and those that can travel to the lungs. More than 800,000 U.S. patients receive hip or knee replacements each year, and an estimated 40 to 60 percent are at risk of blood clots.

But FDA regulators said in documents posted online Tuesday that the drug carries nearly twice the risk of bleeding of Sanofi-Aventis’ Lovenox, the top-selling blood thinner used by patients receiving orthopedic implants.

On Thursday the agency will ask a panel of cardiology experts to weigh in on the drug’s risks and benefits. The FDA is not required to follow the advice of its panel, though it usually does.

After reviewing four studies with more than 12,000 patients, the FDA said major bleeding occurred in 0.4 percent of patients on the J&J; drug, compared with 0.2 percent of those taking Sanofi’s drug, known chemically as enoxaparin. The drug was Paris-based Sanofi’s biggest product last year, with sales of $3.5 billion.

“The evidence that administration of rivaroxaban could lead to bleeding events in significantly more patients relative to enoxaparin amplifies this safety concern,” states the FDA’s review, posted online Tuesday.

Regulators also voiced concerns about potential risks of liver injury or toxicity, a common side effect with blood-thinning drugs. Bayer and J&J; have proposed that the drug would be used for only two weeks by knee surgery patients and five weeks by hip surgery patients.

But the FDA is concerned doctors could use it for longer periods. The agency will ask its panelists whether there is enough information to gauge the risks of the drug over the long term.

The agency said it asked the companies to develop a lower-dose version of rivaroxaban that could be used by patients with liver or kidney problems. According to the agency, the companies “regarded this modification as unnecessary.”

But a J&J; spokesman said the company “is actively working with the FDA on this issue to assure the best balance of benefit and risk.”

The FDA also said the companies declined to design a risk minimization strategy for their drug, or a plan to help doctors and patients use the drug safely. But the company said it has submitted a number of plans to reduce the drug’s risks, including education and outreach programs.

The agency will have to weigh rivaroxaban’s risks against its promise as a lifesaving medication.

In four studies of knee and hip replacement patients, rivaroxaban cut the risk of blood clots or death in half, to 0.6 percent, compared with 1.3 percent for patients taking Lovenox.

Rivaroxaban is one of several new anticlotting drugs designed to be safer and more effective than older treatments. One mainstay of anticlotting treatment, Coumadin or warfarin, requires patients to undergo frequent blood tests because a too-high or too-low dose can lead to strokes or dangerous bleeding.

“If we look at our program, we believe we have a very effective drug with a very positive benefit risk profile,” J&J; Vice President Peter Wildgoose said in an interview last week.

J&J; is studying the drug in more than 60,000 patients for additional uses, including stroke prevention and treatment of coronary artery disease.

If the drug is approved, Johnson & Johnson’s Ortho-McNeil business will sell the drug in U.S., while Bayer HealthCare AG will have marketing rights in other countries.

Shares of New Brunswick, N.J.-based J&J; fell $1.18, or 2.3 percent, to $49.56 in morning trading.

Copyright 2009 The Associated Press.

Recalls: State Farm bears, bicycles, girl's shoes

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Posted on 17th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/17/2009

By The Associated Press

The following recalls have been announced:

— About 827,000 State Farm Good Neigh Bears in the U.S. and Canada, made in China and distributed by State Farm of Bloomington, Ill., because the bears’ eyes can come off, posing a choking hazard to young children. The company has received one report of a bear’s plastic eye detaching and a child placing it in her mouth. No injuries have been reported. The stuffed bears are brown and wear a white and red State Farm shirt. They were given away free through State Farm agents and at State Farm sponsored events from September 2005 through March 2007. Details: by phone at 877-226-8079; by Web at http://tinyurl.com/c2mroj or http://www.cpsc.gov.

— About 1,300 2009 Six 5, Six 6, Six Carbon 5 and Six Carbon 6 bicycles, made in Taiwan and imported by Cannondale Bicycle Corp. of Bethel, Conn., because they don’t have spoke protector discs. This poses a risk of falls. No incidents have been reported. The bicycles were sold by authorized Cannondale dealers around the country between October 2008 and February 2009. Details: by phone at 800-245-3872; by Web at http://www.cannondale.com or http://www.cpsc.gov.

— About 31,000 Nordstrom girl’s shoes, made in China and imported by Nordstrom Inc. of Seattle because surface paint on the outer sole of the shoes contains high levels of lead, which is toxic if ingested by young children. No injuries or incidents have been reported. The recall involves six styles of Nordstrom-brand shoes for girls. They were sold at Nordstrom stores nationwide from September 2006 through last month. Details: by phone at 800-804-0806; by Web at http://www.cpsc.gov.

Copyright 2009 The Associated Press.

China's milk victims complain of intimidation

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Posted on 17th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/17/2009

By ANITA CHANG
Associated Press Writer

BEIJING (AP) — Families whose children fell ill from tainted milk have come under pressure to drop compensation lawsuits, victims’ advocates said Tuesday, showing the government’s lingering uneasiness over one of China’s worst contamination scandals.

Local officials were calling and visiting at least a half-dozen families, urging them to drop their cases against the dairies and accept a government-sanctioned compensation plan giving 2,000 yuan ($290) to most victims, said Zhao Lianhai, the father of a child sickened by the milk.

At least one family has decided to back out of their lawsuit, said Zhao, who has rallied other families through a Web site he created.

“One parent told me, ‘I’m more than 30 years old but I’ve never before seen the county and village officials. Everyone in the family is really scared,’” said Lu Jun, an AIDS activist who has been working with families of tainted milk victims in central China’s Henan province.

Infant formula contaminated with the industrial chemical melamine was blamed for killing at least six babies and sickening nearly 300,000 across China in the scandal that began in September.

Unscrupulous middlemen are accused of adding melamine, which is high in nitrogen, to watered-down milk to fool quality tests for protein content. When ingested, melamine can cause kidney stones and kidney failure.

The scandal rocked the country, culminating in a law enacted in recent weeks that consolidates hundreds of disparate regulations covering the country’s 500,000 food processing companies.

The accusations that local officials are trying to intimidate victim’s families come despite this month’s announcement by the executive vice president of China’s highest court, Shen Deyong, that parents who rejected the government’s compensation plan were welcome to file lawsuits against the dairies.

It was not clear why local officials would try to stop the families after Shen’s announcement. But different levels of government in China often disagree on how to handle matters, and local officials may see lawsuits as a threat to their authority with the potential to upset stability in their community.

More than 600 families have demanded higher compensation than the government plan offers — one-time payouts using money from dairies named in the scandal. Families that take the money can’t sue for more unless they can prove they were forced to agree to the compensation plan, lawyers have said.

Wang Zhenping, whose 1 1/2-year-old son became ill after drinking contaminated infant formula, said he has received four phone calls from health bureau officials in Henan’s Zhoukou city in the last two weeks. They also have visited his mother’s house twice.

“The last time they called me, I told them to call my lawyer,” he said, planning to continue his legal fight against Sanlu, the dairy at the center of the crisis.

Phones at the Zhoukou city health bureau rang unanswered Tuesday.

Lawyers representing the victims’ families have also run into obstacles in recent days.

Li Jinglin, an attorney who was representing parents of children sickened by Shengyuan brand infant formula, said the Beijing city justice bureau called his law firm last Friday and told his superiors he should not be working on the case. Li said he withdrew from the case but hoped another lawyer could take his spot.

A coalition of lawyers working to sue the 22 dairies named in the scandal is focused primarily on getting at least one case involving the key dairy Sanlu to be accepted by a court in the northern city of Shijiazhuang.

“We just want the courts to accept at least one case as an example,” lawyer Lin Zheng said.

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Associated Press researcher Xi Yue in Beijing contributed to this report.

Copyright 2009 The Associated Press.

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