Thursday, May 3, 2007

Blog Roundup

Fallout from Pet Food Contamination Affects Whole Industry

Article in the Washington Post -- Crisis Over Pet Food Extracting Healthy Cost: Owners, Manufacturers, Suppliers All Feel Fallout, by Rick Weiss and Nancy Trejos.  Here's an excerpt:

While the Food and Drug Administration pursues what is sure to be a long investigation into how pet food became contaminated with an ingredient for making plastics, and while Congress begins the months-long process of haggling over food-safety amendments, pet food companies, their suppliers and their customers do not have the luxury of waiting.

They have to cope with the crisis immediately, and for most, that is already proving expensive.

Stephen S. Miller, chief executive of ChemNutra of Las Vegas, was sued last week by a pet food company to which it had sold tainted Chinese wheat gluten. He now faces legal fees and the costs of extra on-site inspections he plans to impose on his Chinese suppliers.

Producers of brand-name pet foods, several of which were revealed by the recall to use the same ingredients that economy chow makers use, stand to lose once-loyal customers, many of whom are saying they would not return to their former brands.

And some pet owners like Mitzner, fed up with worrying about poisoning their animals, can expect to pay up to three times as much for organic or other specialty chows.

If there is one player that may benefit from the still-spreading disaster -- federal officials said yesterday that millions of chickens that ate the contaminated food were sold for human consumption -- it is the U.S. wheat gluten industry, which has been struggling for years to compete against cheaper Chinese imports.

BGS

May 3, 2007 in FDA, Food Poisoning | Permalink | Comments (2) | TrackBack (0)

Wednesday, May 2, 2007

Medicare Won't Cover Stents for Neck Arteries

Article in the New York Times -- In a Reversal, U.S. Says Medicare Won’t Cover Stents for Neck Arteries, by Barnaby J. Feder.  Here's an excerpt:

Responding to criticism from surgeons, the government has dropped its previously announced plans to expand Medicare coverage for the use of stents to prop open neck arteries to prevent strokes.

Instead, Medicare will stick with definitions that restrict eligibility for such stents to fewer than 10 percent of the 150,000 to 200,000 Americans who annually undergo surgery to clear blockages that restrict blood flow to the brain and raise stroke risks.

That is a far more conservative stance on stenting than has been taken by the Food and Drug Administration, which determines when a device is safe and effective enough to be sold commercially. And it is likely to slow the expansion of coverage among private insurers.

The decision, which Medicare regulators published online on Monday night, was an unexpected reversal for stent makers and many doctors who have promoted stenting as a less invasive alternative to neck surgery.

BGS

May 2, 2007 in FDA, Medical Devices - Misc. | Permalink | Comments (0) | TrackBack (0)

Vaccines for Humans and Cattle as Way to Battle E.Coli

Article in the New York Times -- Scientists Look to Vaccines in the War on E. Coli, by Andrew Pollack.  Here's an excerpt:

Shousun C. Szu, a scientist at the National Institutes of Health, says the best way to prevent people from being poisoned by deadly E. coli would be to vaccinate all infants against the bacteria.

Graeme McRae, a Canadian biotechnology executive, says it would be more practical to inoculate cows instead.

Vaccines for people and for cattle are just two approaches under development to prevent or treat food poisoning by the strain E. coli O157:H7.

Right now, scientists can do little medically to fight the pathogen, which was responsible for two severe outbreaks last fall, one from contaminated bagged spinach and a second from tainted lettuce served in chain taco restaurants.

The main approach has been to try to prevent contamination through careful handling, rigorous inspections and government regulation.

BGS

May 2, 2007 in E Coli, FDA | Permalink | Comments (0) | TrackBack (0)

Melamine Found in Pet Food Unlikely to Pose Threat to Humans

Article in the New York Times -- Pet Food Chemical Unlikely to Pose Threat to Humans, Experts Say, as U.S. Continues Inquiry, by Donald G. McNeil, Jr.  Here's an excerpt:

Toxicologists monitoring the American food supply for traces of melamine after it was found in imported ingredients in the contaminated pet food that has killed at least 16 dogs and cats and sickened thousands of others said yesterday that even if there were small amounts of it in the American food supply, it would be unlikely to pose much of a threat to humans.

Sampling thus far by the Food and Drug Administration for melamine, which has also been detected in chicken feed on some farms in Indiana, has not turned up the chemical in food meant for humans, and the trace amounts found in some poultry feed — and hog feed — would presumably be excreted or broken down by the animals before they were slaughtered, scientists and federal officials said.

Also, a survey of poison control centers, veterans’ hospitals and a sample of private hospitals across the country by the federal Centers for Disease Control and Prevention has found no increase in reports of kidney diseases, the most likely indicator of melamine poisoning, said Bernadette Burden, a C.D.C. spokeswoman.

Here's a link to a related article in the Washington Post -- Millions Of Chickens Fed Tainted Pet Food: Risk to Consumers Minimal, FDA Says, by Rick Weiss.

BGS

May 2, 2007 in FDA, Food Poisoning | Permalink | Comments (0) | TrackBack (0)

Restyled Federal Rules of Civil Procedure

Today the Supreme Court sent the package of "restyled" Federal Rules of Civil Procedure to Congress, which means that the new rules will go into effect December 1, 2007 unless Congress affirmatively acts to reject them.  Here's the link to the notice on the federal courts rulemaking page.  The Advisory Committee on Civil Rules worked on the restyling project for several years, with the goal of making the rules clearer and more readable without changing their substantive meaning.  That last point has been a subject of controversy, with some civil procedure scholars arguing that changing the language of the rules inevitably will change how those rules are interpreted and used.  In any event, it appears likely that come Dec. 1, we'll be using the new improved FRCPs.

HME

May 2, 2007 in Procedure | Permalink | Comments (1) | TrackBack (0)

FDA Proposes Expanded Suicide Warning for Antidepressants for Young Adults

Article in the New York Times -- FDA Seeks Antidepressant Warning, by the Associated Press.  Here's an excerpt:

Young adults beginning treatment with antidepressants should be warned about an increased risk of suicidal thoughts and behavior, federal health officials said Wednesday.

The Food and Drug Administration proposed labeling changes that would expand a warning now on all antidepressants. The current language applies only to children and adolescents. The expanded warning would apply to adults 18-24 during the first month or two of treatment with the drugs, the FDA said.

The proposed labeling changes also would note that studies have not shown this increased risk in adults older than 24, and that adults 65 and older taking antidepressants have a decreased risk of suicidal thoughts and behavior, it said.

The proposed expanded warnings emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

Here's a link to the related article in the Wall Street Journal -- FDA Asks Antidepressant Makers To Warn Adults About Suicide Risks, by Jennifer Corbett Dooren.

BGS

May 2, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 1, 2007

Calls for More FDA Screening Based on Adulterated Pet Food from China

Article in the Washingon Post -- Pet Deaths Spur Call for Better FDA Screening:Imports Raise Concern About Human Foods, by Rick Weiss and Ariana Eunjung Cha.  Here's an excerpt:

Amid growing revelations that suppliers in China frequently spike pet food and other food ingredients with contaminants to boost profits, momentum is building in Washington to bolster the Food and Drug Administration's capacity to detect and screen out adulterated imports.

Several Chinese suppliers conceded over the weekend that adding melamine to pet food ingredients -- now blamed for the deaths of many animals in the United States and possible contamination of the human food supply -- is but the latest technique for fooling U.S. companies into thinking they are purchasing a high-quality product.

Before melamine there was urea, Chinese traders said -- another nitrogen-rich chemical that was used to give false high scores on tests of protein content but was abandoned after it made animals ill.

The task of guarding against contaminants in imports has become far more complicated because an increasing portion of the tens of billions of dollars in Chinese food and agricultural imports involves powders and concentrates for the processed-food industry -- including the wheat gluten and rice protein at the center of the pet food scandal. Animal feed imports alone grew sevenfold from 2001 to 2006, the Commerce Department says.

BGS

May 1, 2007 in FDA, Food Poisoning | Permalink | Comments (0) | TrackBack (0)

Monday, April 30, 2007

Use of Deceptive Pet Food Filler in China

Article in the New York Times -- Filler in Animal Feed Is Open Secret in China, by David Barboza and Alexei Barrionuevo.  Here's an excerpt:

As American food safety regulators head to China to investigate how a chemical made from coal found its way into pet food that killed dogs and cats in the United States, workers in this heavily polluted northern city openly admit that the substance is routinely added to animal feed as a fake protein.

For years, producers of animal feed all over China have secretly supplemented their feed with the substance, called melamine, a cheap additive that looks like protein in tests, even though it does not provide any nutritional benefits, according to melamine scrap traders and agricultural workers here.

“Many companies buy melamine scrap to make animal feed, such as fish feed,” said Ji Denghui, general manager of the Fujian Sanming Dinghui Chemical Company, which sells melamine. “I don’t know if there’s a regulation on it. Probably not. No law or regulation says ‘don’t do it,’ so everyone’s doing it. The laws in China are like that, aren’t they? If there’s no accident, there won’t be any regulation.”

BGS

April 30, 2007 in Food Poisoning | Permalink | Comments (0) | TrackBack (0)