FDA investigates import seafood claims
Thu, 09 Aug 2007 04:36:24 GMTBy JUSTIN PRITCHARD, Associated Press Writer
LOS ANGELES - The Food and Drug Administration said Wednesday it is checking whether shipments of Chinese seafood on an agency watch list were properly cleared for public consumption without being tested for banned drugs or chemicals.
Agency officials said that while they believe the shipments were screened correctly, they wanted more details. That review comes in response to findings The Associated Press published Tuesday that at least 1 million pounds of frozen shrimp, catfish or eel raised in Chinese ponds were on an agency watch list but were not diverted to a lab.
The 28 shipments the AP identified arrived under an FDA "import alert," which is supposed to trigger the tough screening requirement.
The seafood, equal to the amount 66,000 Americans eat in a year, did not pose an immediate public health risk; the FDA has worried that long-term exposure to substances fed to some Chinese seafood could increase the risk of cancer or make antibiotics less potent.
A leading Democrat in the House of Representatives said the AP's report raises serious questions about FDA's inspection system and his committee's investigators want the FDA to explain what percentage of all import alert shipments from China — not just seafood — are being stopped and tested.
"The discovery that suspect seafood from China has reached dining room tables in America without being tested is disturbing," said Rep. John Dingell, D-Mich., whose Energy and Commerce Committee has been investigating the FDA's imported-food safety record. "Apparently, the 'import alert' system used by the FDA to test high risk foods cannot be trusted."
The agency said it has about 450 budgeted positions for screening all the imports it oversees — approximately 20 million shipments of everything from fish to vegetables to pharmaceuticals. Funding for inspectors has not kept pace with the surge in imports over the past decade and FDA employees have told Dingell's committee they're too stretched to guarantee food safety.
For its investigation, the AP reviewed 4,300 seafood shipments from China and found 211 that arrived under import alert between October and May. It was during that period the FDA was putting specific Chinese companies with seafood that had flunked lab tests on its watch list, leading up to a June announcement that all farm-raised shrimp, catfish and eel had to be inspected.
The AP was able to reach importers that brought in 112 of the shipments. They said that 28 of the 112 shipments had not been detained and tested.
The FDA did not verify the AP's numbers.
Agency officials said their initial research showed that from an AP-provided list of more than 200 shipments that arrived under an import alert, 19 were flagged by FDA's computer system and reviewed by a person who determined they didn't need to be tested. Agency officials said they needed to talk to local offices that processed the cargo to find out why those shipments, as well as four others, were allowed through.
The AP gave the FDA its list weeks before publication; the agency did not comment on the specific shipments until after Tuesday's story ran.
"What we're saying is that based on the electronic 30,000-foot view, we can't determine why they were released and we're going to look into those further," said Michael Chappell, the official responsible for field inspections and labs.
"There is no evidence to say they were released ... incorrectly," said Domenic Veneziano, who oversees FDA's import operations.
The agency would not provide details on the total 23 shipments without a Freedom of Information Act request.
China penalizes firms in US toys scare
Thu, 09 Aug 2007 09:20:55 GMTBy AUDRA ANG, Associated Press Writer
BEIJING - China banned exports by two toy manufacturers whose products were subject to major recalls in the United States because they were decorated with lead-tainted paint, the government said Thursday.
The General Administration for Quality Supervision, Inspection and Quarantine said the restrictions on Lee Der Industrial Co. Ltd. and Hansheng Wood Products were temporary, but did not give any details.
"They have been asked to evaluate and change their business practices," the administration said in a notice on its Web site.
The quality control watchdog also suggested that foreign companies who contract Chinese factories to make their products should take more responsibility.
"To prevent loopholes in quality control, overseas brand owners should improve their product design and supervision over product quality," the administration said.
The agency said police were investigating two companies' use of "fake plastic pigment" but did not elaborate. Such pigments are a type of industrial latex usually used to increase surface gloss and smoothness.
Chinese companies often have long supply chains, making it difficult to trace the exact origin of components, chemicals, and food additives.
Lead poisoning can cause vomiting, anemia and learning difficulties. In extreme cases, it can cause severe neurological damage and death.
Officials at Lee Der and Hansheng, both located in the southern province of Guangdong, said Thursday they had not heard about the export ban and refused to comment further.
It was not immediately clear how long the ban would last, or whether any further action was planned. The watchdog last month revoked the business licenses of two other Chinese companies that made a tainted pet food ingredient blamed for causing the deaths of cats and dogs in North America.
Lee Der made 967,000 toys recalled last week by Mattel Inc. because they were coated with paint found to have excessive amounts of lead. The plastic preschool toys, sold under the Fisher-Price brand in the U.S., included the popular Big Bird, Elmo, Dora and Diego characters.
In June, RC2 Corp. recalled 1.5 million wooden railroad toys and set parts made by Hansheng from its Thomas & Friends Wooden Railway product line because of lead paint.
The Chinese watchdog also warned that other toy manufacturers whose products do not meet safety standards overseas will not be allowed to sell their goods abroad until they rectify problems. But it said the majority of toys made in China were manufactured strictly according to foreign specifications.
China has come under fire in recent months after potentially dangerous levels of chemicals and toxins were found in some of its exports. A long list of products, from seafood to toothpaste, have been recalled or rejected by a number of countries worried about safety, and Beijing has been fighting to regain consumer confidence.
On Thursday, a New Jersey-based tire importer said it would recall 255,000 Chinese-made tires it claims were defective because they lack a safety feature that prevents tread separation.
The company had been ordered by the National Highway Traffic Safety Administration in June to recall as many as 450,000 tires that it bought from Hangzhou Zhongce Rubber Co. since 2002.
Chinese officials have vowed to tighten monitoring and the State Council, China's Cabinet, approved a new regulation on food safety with unusual speed.
On Wednesday, the State Food and Drug Administration announced for the first time that the government was spending $1.1 billion on improving the country's infrastructure for food and drug safety. That plan was approved in 2005, but construction of new safety testing labs and other facilities have only just begun, the administration said.
Meanwhile, the official Xinhua News Agency said five people were on trial in the southern city of Guangzhou in connection with the 2006 deaths of 13 consumers who took a drug to treat inflamed gallbladders and stomach linings.
The five were employees at the Qiqihar No. 2 Pharmaceutical Co. of Heilongjiang province, which allegedly used a chemical, diglycol, that can cause kidney failure. A vendor passed it off as a normal ingredient and quality inspectors failed to detect the diglycol.
China's pharmaceutical industry is highly lucrative but poorly regulated. Companies frequently cash in by substituting fake or substandard ingredients.
IBM launches system to track medications
Thu, 09 Aug 2007 04:18:49 GMTBy BARBARA ORTUTAY, AP Business Writer
NEW YORK - To help the pharmaceutical industry combat drug counterfeiting, IBM is launching an electronic pedigree system Thursday that tracks medications through the supply chain until they reach consumers.
The system employs radio-frequency identification, or RFID tags, which are already used to track packages of drugs, especially ones popular with counterfeiters. Pfizer, for example, uses RFID chips to track packs of its erectile dysfunction drug Viagra, and Purdue Pharma LP has been using them since 2004 to track its pain reliever OxyContin.
IBM's ePedigree system helps drug companies create electronic certificates of authenticity for medications — down to the individual bottle — as they move from manufacturers and distributors to pharmacies and hospitals.
"The whole time, the system is watching what's happening, it records life history," said Chris Clauss, director of sensor information management at IBM Software.
While there is no guarantee that RFID tags will get rid of all counterfeits, he added, "what we can do is raise the bar," and make it substantially more difficult.
Drug companies' prior attempts at fighting fakes — such as holograms, watermarks and the like — were often reproduced within months, to the point where even their brand managers could not tell the difference between the counterfeit and the real thing.
IBM, which first worked with RFID more than 10 years ago, said its ePedigree system will help companies comply with a slew of new regulations, such as ones going into effect in California in 2009.
California's ePedigree law will require that any medication distributed in the state have its life history attached to it — starting at the drug manufacturer until it ends up in the pharmacy.
In recent years, much of the market has focused on the hardware of RFID — how the data is scanned and collected in the chips — said Michael Liard, research director of RFID and Contactless at ABI Research. IBM's ePedigree system, however, focuses on how that information is distributed along the supply chain.
The ePedigree system is useful not just for battling fakes, Clauss said, but for keeping track of expiration dates, batch numbers in case a drug is recalled, and so on.
International Business Machines Corp. is based in Armonk, N.Y.
Panel No strong signs of plastic hazard
Thu, 09 Aug 2007 05:09:22 GMTWASHINGTON - A federal advisory panel on Wednesday found no strong evidence of health hazards from a chemical commonly found in plastics, but left the door open for further investigation.
At issue is a chemical called bisphenol A, which is in products ranging from baby bottles to the coatings inside food cans. Some research links the chemical to reproductive abnormalities and other health problems in animals. That and widespread exposure to the plastic prompted the National Toxicology Program to appoint an expert panel to review the science.
The panel found little if any reason for concern for the general population.
But when it came to exposure for fetuses or young children, the panel found what it called "some concern" about links to neural or behavioral problems, ranking the evidence midway on a five-step scale, said Michael Shelby, the toxicology program's risk-evaluation chief.
The National Toxicology Program, a division of the National Institutes of Health, will review the findings and open them for public comment before making a final determination. That scientific review then is used by regulatory agencies in setting safety standards.
The plastics industry has long defended bisphenol A. Critics have contended the review was skewed toward industry, and denounced the findings Wednesday.
Fat hormone sheds new light on obesity study
Thu, 09 Aug 2007 18:34:26 GMTBy Michael Kahn
LONDON - The hormone that tells us we are full also regulates our desire for certain foods, researchers said on Thursday, in a finding that sheds light on why people gain weight and could lead to new treatments for obesity.
The study showed that patients with a rare genetic disorder who lacked the hormone called leptin ate less after receiving injections of the hormone, said I.S. Farooqi, a researcher at Cambridge University who led the study.
Previous research has shown the hormone does not help people with normal leptin levels lose weight, but scientists still do not completely understand how it works, Farooqi said.
&;By studying patients who have no leptin and then treating them with leptin, we can tell what it is doing,&; Farooqi said in a telephone interview. &;It gives a clear look at how leptin operates in the brain.&;
In the study, published in the journal Science, researchers searched for &;circuits&; in the brain that signal when a person is hungry or full and found that they were linked to areas involved in determining the enjoyment of food.
To see how the hormone worked, the researchers showed the patients pictures of different types of food, ranging from tasty fare like chocolate cake and pizza to blander choices such as cauliflower and broccoli.
The patients with the genetic disorder -- of which there are about a dozen known cases in the world -- liked all types of food, ate excessively and were obese, the researchers said.
Using magnetic resonance imaging technology, the researchers tracked the patients' brain activity as they responded to the pictures and pinpointed several key areas that play an important role when it comes to a desire for food.
After the patients received leptin injections, the areas that had previously shown activity all the time at the sight of food were only active if the people had not eaten the night before, which was a normal response, Farooqi said.
It showed desire for food is driven by biology -- not greed -- which causes overeating and obesity, Farooqi said.
Knowing how leptin, which is produced by fat cells, triggers different parts of the brain could lead to new drugs that target obesity and help dangerously overweight people take pounds off.
&;If you find those molecules that leptin triggers then you can manipulate or target them with drugs to treat obesity,&; Farooqi said. &;The first step is to work out what leptin does and how it does it.&;
(Reporting by Michael Kahn; editing by Maggie Fox and Michael Winfrey; email: michael.kahn@reuters.com; Reuters Messaging; michael.kahn.reuters.com@reuters.net))
Prenatal stress may affect babies39 sleep
Thu, 09 Aug 2007 15:01:15 GMTBy Amy Norton
NEW YORK - A mother's anxiety or depression during pregnancy may affect her child's sleep patterns early in life, a new study suggests.
Researchers found that babies and toddlers whose mothers had such symptoms during pregnancy tended to have more sleep problems than other young children.
The investigators suspect that elevated stress hormones that mark depression and anxiety may shape fetal brain development in a way that disturbs early-life sleep patterns.
It's important for young children to develop healthy sleep habits not only for the sake of their tired parents, according to lead study author Dr. Thomas O'Connor, an associate professor of psychiatry at the University of Rochester in Rochester, New York.
Sleep problems have, for instance, been linked to a higher risk of behavioral problems in childhood, he said. &;Quality of sleep early on may be a good indicator of healthy development,&; O'Connor told Reuters Health.
The implication, he said, is that taking care of mothers' stress during pregnancy could help not only them but also their children.
&;I think the message is, let's take stress and anxiety during pregnancy seriously,&; O'Connor said.
He and his colleagues report their findings in the journal Early Human Development.
The results are based on a survey of more than 14,000 British women who answered questions about anxiety and depression symptoms during and after pregnancy. They were also surveyed about their children's sleep habits at ages 6 months, 18 months and 30 months.
In general, mothers with greater symptoms during pregnancy reported more sleep problems with their children -- such as frequent nighttime awakenings, difficulty falling asleep and, with older children, regularly refusing to go to bed.
Mothers' symptoms of depression and anxiety after giving birth did not explain the link between prenatal symptoms and child sleep problems. &;This supports the notion that there's something special about the prenatal period,&; O'Connor said.
It's not clear yet how to best alleviate stress and anxiety in pregnancy, or whether this would lessen children's sleep problems.
More study is needed, O'Connor said, but potential options include relaxation therapy and other non-drug approaches that would not carry a risk of adverse effects on the fetus.
It's also important to remember that some worries and emotional ups and downs are to be expected with pregnancy, O'Connor noted. It's when symptoms begin to impair a woman's daily life, such as her ability to work or get along normally in her relationships, that there may be a problem.
SOURCE: Early Human Development, July 2007.
Thu, 09 Aug 2007 14:57:59 GMT
NEW YORK - Elderly people who display &;self-neglect&; behavior often suffer from common age-related ailments like depression, heart problems, and dementia, a new study shows.
&;These disorders render the senior unable to perform the tasks necessary for daily living&; such as eating and bathing, Dr. Carmel Bitondo Dyer, a researcher from the University of Texas Health Science Center, Houston, told Reuters Health.
Some elderly persons who neglect themselves simply lack access to support services, whereas others either refuse help, or when provided access to services cannot complete the tasks necessary to obtain these services, Dyer and colleagues note in the September issue of the American Journal of Public Health.
The researchers sought to identify factors associated with self-neglect by studying 538 people who were referred to an adult protective service agency because they weren't taking care of themselves. Their average age was 75.6 years and 70 percent were women.
The team found that two-thirds of these subjects had physical problems that prevented them from functioning normally, half scored poorly on mental health tests, and virtually all of them had inadequate social support networks.
Patients in the study had a range of illnesses, yet 46 percent were not on any medication. For example, 52 percent had high blood pressure but only 24 percent were taking blood pressure-lowering medication; and 25 percent had diabetes yet only 15 percent were taking an anti-diabetes medication. Other common disorders, which often went untreated, were arthritis, stroke, dementia and depression.
Self-neglect is a very common problem among the aged, Dyer and colleagues note in their report.
&;We have a theory,&; she told Reuters Health, &;that if social or medical support is not available or declined by these elders, they may manifest self-neglecting behaviors, such as living in very dirty homes or suffering the consequences of otherwise treatable diseases like hypertension or diabetes.&;
&;Lack of family or social support was the most common finding in this study, which supports our theory,&; she added.
SOURCE: American Journal of Public Health, September 2007.
