The Obfuscation Report

January 15th, 2008 2:37 pm
Drug Has No Benefit in Trial, Makers Say

By Alex Berenson / New York Times

A clinical trial of Zetia, a cholesterol-lowering drug prescribed to about 1 million people a week, failed to show that the drug has any medical benefits, Merck and Schering-Plough said on Monday.

The results will add to the growing concern over Zetia and Vytorin, a drug that combines Zetia with another cholesterol medicine in a single pill. About 60 percent of patients who take Zetia do so in the form of Vytorin, which combines Zetia with the cholesterol drug Zocor.

While Zetia lowers cholesterol by 15 percent to 20 percent in most patients, no trial has ever shown that it can reduce heart attacks and strokes — or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems.

This trial was designed to show that Zetia could reduce the growth of those plaques. Instead, the plaques actually grew almost twice as fast in patients taking Zetia along with Zocor than in those taking Zocor alone.

Patients in the trial who took the combination of Zetia and Zocor were receiving it in the form of Vytorin pills. The trial, called Enhance, lasted two years and covered about 720 patients with extremely high cholesterol, mostly in the Netherlands.

Dr. Steven Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were “shocking.” Patients should not be prescribed Zetia unless all other cholesterol drugs have failed, he said.

“This is as bad a result for the drug as anybody could have feared,” Dr. Nissen said. Millions of patients may be taking a drug that has no benefits for them, raising their risk of heart attacks and exposing them to potential side effects, he said.

Still, patients who are taking Vytorin or Zetia should talk to their doctors if they are concerned and not discontinue taking the medicines on their own, Dr. Nissen said.

Dr. Howard Hodis, a cardiologist at the University of Southern California, also said he was concerned by the trial’s results. Growth in fatty plaques — called atherosclerosis — is highly correlated with heart attacks and strokes, Dr. Hodis said.

“Clearly, progression of atherosclerosis is the only way you get events,” Dr. Hodis said. “If you don’t treat progression, then you get events.”

The results of the trial “necessitate further investigation — that just can’t be ignored,” Dr. Hodis said.

Both companies’ stocks fell on Monday, with Merck’s share price down a bit more than 1 percent. Shares of Schering-Plough, whose profits are much more dependent on the drugs, were down nearly 8 percent.

The results will also add to the controversy surrounding a long delay in releasing the results of the trial. Merck and Schering-Plough completed the trial in April 2006 and had initially planned to release the findings no later than March 2007. But the companies then missed several self-imposed deadlines, citing the complexity of the data analysis from the study and saying they did not know when or if the data would be ready for publication.

Last month, after several news articles highlighted the delay, they finally agreed to release the results soon.

For Merck and Schering-Plough, which jointly market Zetia and Vytorin and share profits from the drugs, the trial’s results are a serious setback. Zetia and Vytorin are important contributors to both companies’ profits, especially to Schering, which is smaller and less profitable than Merck.

Analysts estimate that about 70 percent of Schering’s earnings depend on the drugs. The controversy over the trial is also a problem for Merck, which is trying to repair its reputation after withdrawing the painkiller Vioxx from the market in September 2004.

In the United States, Zetia and Vytorin combined account for about 20 percent of the overall cholesterol-lowering market. More than 100 million prescriptions have been filled in the United States for Zetia and Vytorin since the Food and Drug Administration approved them in November 2002 and August 2004 respectively. Both drugs cost about $3 a day.

Because Zetia reduces cholesterol differently from statins like Lipitor and Zocor, doctors often prescribed it as an additional therapy for patients whose cholesterol remains high even after they are already taking statins. But even before Zetia was introduced in 2002, some cardiologists argued that statins had positive cardiovascular effects that go beyond their ability to reduce cholesterol, and that Zetia lacks those effects.

The Enhance trial covered patients with a gene that causes them to produce very high levels of low-density lipoprotein cholesterol, commonly called L.D.L., or bad cholesterol. Patients in the trial had L.D.L. levels of about 320 milligrams per deciliter at the beginning of the trial, about three times the level cardiologists recommend.

Over the two years of the trial, patients who took Zocor alone reduced their L.D.L. by 41 percent on average, while patients who took Vytorin reduced their cholesterol by 58 percent. Yet despite the larger cholesterol reduction, patients taking Vytorin actually had more growth in fatty plaques in their carotid arteries than those on Zocor. The carotid artery runs through the neck and delivers oxygenated blood to the brain.

Labels: American Corporate Republic, Corporate Criminals, Corporate Malfeasance.

I get it. Appoint someone from the industry to regulate the industry and let the "Market" regulate products safety. In laymans terms, that means if your child dies from a dangerous product, the "market" will correct it. And then when you go to sue for the death of your child, you'll find that the Party of Family Values has also limited the liability of companies, meaning suing them won't do you any good and won't protect anyone else's child from facing the same fate.

Jesus, I hate Republicans. Here's the story:
________________________________________________
Industries Paid for Top Regulators' Travel
Two Heads of Product Safety Agency Accepted Trips From Manufacturer Groups
By Elizabeth Williamson
Washington Post Staff Writer
Friday, November 2, 2007; A01

The chief of the Consumer Product Safety Commission and her predecessor have taken dozens of trips at the expense of the toy, appliance and children's furniture industries and others they regulate, according to internal records obtained by The Washington Post. Some of the trips were sponsored by lobbying groups and lawyers representing the makers of products linked to consumer hazards.

The records document nearly 30 trips since 2002 by the agency's acting chairman, Nancy Nord, and the previous chairman, Hal Stratton, that were paid for in full or in part by trade associations or manufacturers of products ranging from space heaters to disinfectants. The airfares, hotels and meals totaled nearly $60,000, and the destinations included China, Spain, San Francisco, New Orleans and a golf resort on Hilton Head Island, S.C.

Notable among the trips -- commonly described by officials as "gift travel" -- was an 11-day visit to China and Hong Kong in 2004 by Stratton, then chairman. The $11,000 trip was paid for by the American Fireworks Standards Laboratory, an industry group based in an office suite in Bethesda whose only laboratories are in Asia.

The CPSC says that at the time, the group had no pending regulatory requests. But since then the fireworks group has urged the commission to adopt its safety standards, an idea that is still pending, according to an organization newsletter.

Consumer groups and lawmakers intensified their criticism of the CPSC this summer after several highly publicized recalls of Chinese-made toys that contained hazardous levels of lead. Critics have long charged that the agency has become too close to regulated industries, opting for "voluntary" standards and repeatedly choosing not to take legal action against businesses that refuse to recall dangerous products.

Government-wide travel regulations state that officials from agencies such as the CPSC should not accept money for travel from nonfederal sources if the payments "would cause a reasonable person . . . to question the integrity of agency programs or operations."

But CPSC officials defend the industry-paid trips as a way for the agency to be in contact with manufacturing officials and hear their concerns despite a limited travel budget. Commission spokeswoman Julie Vallese said the agency's counsel and its ethics officers conducted "a full conflict-of-interest analysis" of the trips and stand behind their decisions.

"The mission of the agency and the benefits to consumer safety are two factors that are taken into consideration in approving gift travel," she said. Reports of the trips are submitted to the Office of Government Ethics, she added.

Several ethics experts and lawyers say the two administrators' travel records, some of which they reviewed at the request of The Post, suggest a conflict of interest.

"This is a blatant violation of the ethics code," said Craig Holman, an expert on governmental ethics law for the nonprofit consumer advocacy group Public Citizen. The rules allow nonfederal sources to pay for trips, "but not if you're a private party with business pending before the agency," he said.

The agency's travel patterns during the Bush administration, detailed in internal agency documents, differ from those of the Clinton era. Ann Brown, who served as chairman from 1994 to 2001, traveled only at the expense of the agency or of media organizations that sponsored appearances where she announced product recalls, according to the documents provided.

"We hated to have an industry pay for our staff for anything," said Pam Gilbert, a lawyer who was executive director of the agency under Brown.

The records show that Nord and Stratton repeatedly accepted gift travel for events from industries subject to CPSC enforcement. In February 2006, the Toy Industry Association provided Nord with rail fare, two nights in a hotel, meals -- and even $51 to pay her Union Station parking bill -- to attend the American International Toy Fair in New York, one of the industry's biggest product exhibitions.

Joan Lawrence, the association's vice president who oversees toy safety, said that "I have heard some enforcement officials say that they consider attending vital" because "they are able to see new products before they hit retail shelves" and suggest safety improvements. She added that "approximately 50 percent of the CPSC budget is used for children's products."

But Lawrence could not say why, given the importance of the event and the industry, the agency did not pay for its own travel. "If they came up with the money, that's okay," she said. "The educational component, of course, is our priority, and that's why we pay for the chairman."

Vallese, the CPSC spokeswoman, said Nord gave two speeches at the meeting, toured "new toy exhibits," watched "product demonstrations" and participated in "product safety discussions."

In a presentation to a trade group of product regulators and manufacturers last year, Nord said the agency was "working aggressively" to limit deaths from residential fires and carbon monoxide poisoning, according to an account published on the group's Web site. She noted that "fuel-fired heating equipment" is linked to more than 300 deaths a year.

Makers of that equipment are represented by the Gas Appliance Manufacturers Association, for which Stratton, Nord's predecessor, was a guest speaker at two annual meetings. In 2003 Stratton spoke at the group's meeting on Hilton Head Island in South Carolina. In 2005, he spoke at its annual meeting in Orlando.

The meetings drew more than 300 manufacturers' representatives and spouses for seminars, a dinner dance and golf. While the association's manufacturers are regulated by three other government agencies, its vice president, Joseph Mattingly, said he could not recall paying for any attendees from those agencies.

Stratton said: "My view was we needed to engage industries and not only tell them what we expected but also to learn what they were thinking. . . . You can't do that sitting in the ivory tower at the CPSC."

The records also detail several trips that were paid for by lawyers who represent manufacturers in product liability lawsuits.

In February, for example, Nord accepted more than $2,000 in travel and accommodations from the Defense Research Institute to attend its meeting in New Orleans on "product litigation trends," according to her report. The institute is made up of more than 20,000 corporate defense lawyers. In 2004, Stratton attended the group's meeting in Barcelona, at a cost to the group of $915 for his hotel room.

"They are the biggest government agency that would have impact on the stuff that we do," said Steve Coronado, a former chairman of the group's product liability committee, which has 3,000 members. "They've been very cordial and accommodating and gracious," he said of the agency's past three chiefs.

Coronado said that Nord was the group's main presenter in New Orleans and that she briefed 1,000 lawyers about "what their processes and procedures are, rules and regulations changes." He added: "I don't think it was a very politically oriented presentation." A CPSC spokesman did not respond to a request for direct comment by Nord on this trip and others.

Coronado said Brown, the Clinton-era agency chairman, also spoke to the group. But agency records of her non-CPSC-financed travel do not list that trip, suggesting that it was not paid for by the lawyers group. Gilbert, the former CPSC executive director, called DRI's contribution toward Stratton's hotel bill in Spain "amazing."

Stratton said the group "wanted to know where the CPSC was going on various product issues, and they wanted to know what the companies [the lawyers represented] could expect, what the government was thinking in regard to their issues." He said lawyers who sue companies over product-related injuries never invited him to speak.

Stratton gave a general defense of his more than 25 trips, which included a trip to China that the Toy Industry Association paid $8,000 to help finance. "Everybody wants to see the chairman," he said. The fireworks group that paid for a separate China trip did not respond to an e-mailed request for comment about its contacts with the CPSC.

Some say the commission's approach to gift travel points to a Bush administration philosophy that favors engaging corporations in policymaking that affects them. "This administration apparently has taken the position that speaking and appearing before the regulated community, even where there are enforcement matters pending, does not create the appearance of a conflict," said Kenneth Gross, an ethics lawyer at Skadden, Arps.

"These are difficult and subjective lines to be drawn," he said. "Prior administrations have drawn that line in a different place."

Nord was a corporate lawyer at Eastman Kodak before her appointment. Stratton led Lawyers for Bush in his home state of New Mexico during the president's 2000 campaign and co-founded the Rio Grande Foundation, which advocates limited government and supports free-market economic principles.

The CPSC did not immediately agree to a request to review copies of internal documents related to several trips or its internal gift-travel regulations. But the records document a pattern of travel that varies from the stated habits of top officials at four other regulatory agencies.

The Securities and Exchange Commission, for example, "does not accept host-paid travel reimbursements or in-kind payments from any organization regulated by the agency," said spokesman John Heine. Food and Drug Administration rules likewise do not permit outside travel payments from regulated companies, organizations "engaged in any lobbying activities" or those that receive "more than ten percent of their income from a corporate source," among other restrictions.

The Federal Communications Commission bans travel paid for by regulated companies or others with business before the agency, for officials from division heads upward, according to spokesman Clyde Ensslin.

F. Gary Davis, who helped establish the Office of Government Ethics in 1978 and served as its general counsel and deputy director until 2000, said the government-wide regulations were imposed "to ensure that there is no appearance of impropriety when you're dealing with a prohibited source." He said that it is conceivable that some of the CPSC's industry-sponsored trips were justified but that in those cases, the agency should be prepared to make its decision-making records available.

Labels: Corporate Malfeasance., Corporate Republic

Marvel recalls 5 styles of Curious George dolls

WASHINGTON, Nov 8 (Reuters) - Marvel Toys recalled about 175,000 Curious George plush dolls because the surface paint on the toy's plastic face and hat contain excessive levels of lead, the U.S. Consumer Protection Agency said on Thursday.

Marvel Entertainment Inc (MVL.N: Quote, Profile, Research), which licenses comic-book characters, said earlier on Thursday that it was voluntarily recalling about 110,000 units. Those units are included in the CPSC's recall.

The CPSC recall involves 12-inch plush dolls with five themes: birthday, fireman, sweet dreams, tool time and tool time with a soft face.

The agency said consumers should immediately take away the recalled toysy from children and contact Marvel Toys at (800) 352-2064 to receive a full refund. (Reporting by Karey Wutkowski, editing by Leslie Gevirtz)

Labels: Corporate Malfeasance., Corporate Republic

Of course they also oppose your right to sue, if a company kills your child. And this is the party of "Family Values" and the "Culture of Life." More like "Corporate Values" and a "Culture of Death."
_________________________________________________________
Strengthening of Consumer Agency Opposed by Its Boss
By STEPHEN LABATON
October 30, 2007

WASHINGTON, Oct. 29 — The top official for consumer product safety has asked Congress in recent days to reject legislation that would strengthen the agency that polices thousands of consumer goods, from toys to tools.

On the eve of an important Senate committee meeting to consider the legislation, Nancy A. Nord, the acting chairman of the Consumer Product Safety Commission, has asked lawmakers in two letters not to approve the bulk of legislation that would increase the agency’s authority, double its budget and sharply increase its dwindling staff.

Ms. Nord opposes provisions that would increase the maximum penalties for safety violations and make it easier for the government to make public reports of faulty products, protect industry whistleblowers and prosecute executives of companies that willfully violate laws.

The measure is an effort to buttress an agency that has been under siege because of a raft of tainted and dangerous products manufactured both domestically and abroad. In the last two months alone, more than 13 million toys have been recalled after tests indicated lead levels of almost 200 times the safety ceiling.

Ms. Nord’s opposition to key elements of the legislation is consistent with the broadly deregulatory approach of the Bush administration. In a variety of areas, from antitrust to trucking and worker safety, officials appointed by President Bush have sought to reduce the role of regulation and government in the marketplace.

Tony Fratto, a White House spokesman, said that Ms. Nord had not coordinated with the administration to kill the legislation. But he said that the White House shared many of her concerns and that Allan Hubbard, President Bush’s top economic adviser at the White House, was preparing to send a letter to Congress “that is probably even more forceful than Ms. Nord’s.”

The Senate Commerce Committee is set to vote on Tuesday on the legislation, which is sponsored by Senator Daniel K. Inouye, the Hawaii Democrat who heads the committee, and Senator Mark Pryor, the Arkansas Democrat who heads the consumer affairs subcommittee.

It would more than double the agency’s budget, to $141 million, over the next seven years, raise staffing levels by about 20 percent, and give the commission broad new powers to police the marketplace. It would raise the cap on the maximum penalties, to $100 million, from $1.8 million.

Ms. Nord, who before joining the agency had been a lawyer at Eastman Kodak and an official at the United States Chamber of Commerce, criticized the measure in letters sent late last week and this afternoon to the Democratic leaders of the committee. She was critical, for instance, of a provision to ban lead from all toys. She said that the proposal to raise the potential penalty to $100 million “may have the undesired consequence of firms, as a precautionary measure, flooding the agency with virtually every consumer complaint and incident.”

She opposed making it easier to bring criminal prosecutions of companies that knowingly sell defective products and also criticized a measure that would make it easier for the commission to publicly disclose reports of faulty products.

While manufacturers had agreed on another provision that would give independent company laboratories the authority to test products and certify their safety, Ms. Nord said she objected to the provision and preferred that the legislation give the commission the authority to defer to the work of the laboratories, should it choose to.

Some of Ms. Nord’s complaints were similar to the ones that business groups and manufacturers have raised, including that the legislation would be unnecessarily burdensome. But in other areas, such as whistleblower protection for company employees, her complaints went beyond those of industry.

While companies generally have not objected to giving protection to whistleblowers in the industries regulated by the commission, for example, she said it would “dramatically drain the limited resources of the commission, to the direct detriment of public safety.”

While Ms. Nord said she supports the committee’s efforts in general, she issued a more modest proposal than the one under consideration in the Senate. It would, among other things, increase the maximum amount of civil penalties to $10 million, create incentives for companies to quickly halt sales of recalled products, and give the government the authority to seize assets of a company found to have violated criminal safety laws.

Senator Pryor said Ms. Nord’s objections to the measure surprised him.

“It’s hard for me to know if it’s just ideological or she is just expressing the wishes of the administration,” Mr. Pryor said. “Either way it comes to the same conclusion and that is that they say they want more resources, but they are very reluctant to accept those resources.”

Consumer advocates also said they were stunned by Ms. Nord’s letter.

“It was remarkable to send a letter like that to a committee, when you’re in dire straits and you need increased funding and you’ve acknowledged that,” said Ellen Bloom, director of federal policy at Consumers Union.

The agency has suffered from a steady decline in its budget and staffing in recent years. Its staff is about 420, about half its size in the 1980s. It has only one fulltime employee to test toys. And 15 inspectors are assigned to police all foreign imports of consumer products under the agency’s supervision, a marketplace that last year was valued at $614 billion.

Through an agency spokesman, Ms. Nord declined to discuss her opposition to the legislation.

Ms. Nord’s letter was challenged by the sole Democrat at the commission, Thomas H. Moore. In a letter last week, Mr. Moore told the lawmakers that he generally supported the legislation for being “strongly pro-consumer.”

Labels: Corporate Malfeasance., Corporate Republic

DEAR REPUBLICANS - HERE'S WHY WE NEED INDEPENDENT OVERSEERS NOT INDUSTRY HACKS TO PROTECT CONSUMERS
_________________________________________________________
Toys linked to a date-rape drug recalled
Mom describes 48 hours of 'horror' after her toddler ingested Aqua Dots
The Associated Press
updated 1:25 p.m. ET, Thurs., Nov. 8, 2007

WASHINGTON - A mother said Thursday she knew something was terribly wrong when her 20-month-old son began to stumble and started vomiting. He had just ingested a popular toy that contains a chemical that turns into a powerful “date rape” drug when eaten.

It was the latest Chinese-made toy pulled from shelves in North America.

Shelby Esses, 30, said her son Jacob fell and went limp after getting into his older sister’s Aqua Dots set, which was recalled Wednesday by the Consumer Product Safety Commission.

“That’s when we knew what he had eaten and that things were pretty bad,” she told ABC’s “Good Morning America.”

Aqua Dots, a highly popular holiday toy sold by Australia-based Moose Enterprises, are beads that can be arranged into designs and fused when sprayed with water. The toy was pulled from shelves in North American and Australia after scientists found they contain a chemical that converts into the so-called date rape drug when eaten. Two children in the U.S. and three in Australia were hospitalized after swallowing the beads.

Scientists say a chemical coating on the beads can metabolize into the drug gamma hydroxy butyrate. When eaten, the compound — made from common and easily available ingredients — can induce unconsciousness, seizures, drowsiness, coma and death.

Dr. Matt Jaeger, of Arkansas Children’s Hospital, treated Jacob and said he was very worried when he saw him.

“It was pretty dramatic,” he told ABC. “He was unconscious in this coma for about six hours. And then over the course of just a few minutes, went from being completely asleep to wide awake and playing like nothing ever happened.”

Before the toddler was released from the hospital, his military pilot father crawled around his Jacksonville home, near Little Rock, making sure every Aqua Dot was gone. Buying the toy, popular this Christmas season, turned into a 48-hour “horror” for the toddler and his family, they said.

Meanwhile, toy sets seized in Hong Kong were being tested Thursday, a customs official said, speaking on condition of anonymity because of policy. If the tests come back positive for the chemical, suppliers in Hong Kong could face a year in jail and fines of $12,877, she said.

A spokeswoman for the CPSC said Thursday that parents should keep the toy out of children’s’ hands.

“If a child ingests them the glue turns into a toxic substance and it’s very serious,” Julie Vallese, a spokeswoman for the CPSC, said on CBS’ “Early Show.” “We want parents very much to heed this warning.”

Vallese said two U.S. children had fallen into “comatose” conditions from the Aqua Dots. The children have since recovered, she said.

In Australia, the toys were ordered off store shelves Tuesday when officials learned that a 2-year-old boy and a 10-year-old girl were hospitalized after swallowing the beads. A 19-month-old toddler also was being treated.

China’s toy industry came under closer scrutiny earlier this year when Mattel Inc. recalled more than 21 million Chinese-made toys worldwide. Products including Barbie doll accessories and toy cars were pulled off shelves because of concerns about lead paint or tiny detachable magnets that could be swallowed.

Aqua Dots, which are called Bindeez in Australia, were named toy of the year at an industry function in that country.

Retailer Toys “R” Us Inc. said it issued a “stop sale” on the entire Spin Master Aqua Dots product line Tuesday in its North American stores and on its Web site. “We understand that Spin Master and U.S. regulatory authorities are investigating this product and we have asked Spin Master to fully explain what it believes happened,” it said.

Toys “R” Us also pulled the toys in Hong Kong, Singapore and Malaysia after officials in Australia ordered them off shelves.

A company spokeswoman for Moose Enterprises’ Hong Kong office said the production of the toy was outsourced to a mainland Chinese factory. She refused to elaborate and referred all further requests for comment to the company’s head office in Australia.

“Our Hong Kong office is only responsible for operations such as logistics and shipping arrangements, we don’t have any firsthand information,” the employee, who would only give her surname, Lo, told The Associated Press.

Moose Enterprises said Bindeez and Aqua Dots are made at the same factory, which is in Shenzhen in southern Guangdong province. Last week, the government announced an export ban on more than 700 toy factories in the region because of shoddy products.

The company said the product is distributed in 40 countries.

The toys were supposed to use 1,5-pentanediol, a nontoxic compound found in glue, but instead contained the harmful 1,4-butanediol, which is widely used in cleaners and plastics.

The Food and Drug Administration in 1999 declared the chemical a Class I Health Hazard, meaning it can cause life-threatening harm.

Both chemicals are manufactured in China and elsewhere, including by major multinational companies, and are also marketed over the Internet.

It’s not clear why 1,4-butanediol was substituted. However, there is a significant difference in price between the two chemicals. The Chinese online trading platform ChemNet China lists the price of 1,4 butanediol at between about $1,350-$2,800 per metric ton, while the price for 1,5-pentanediol is about $9,700 per metric ton.

Labels: Corporate Malfeasance.

June 19, 2007
As More Toys Are Recalled, Trail Ends in China
By ERIC S. LIPTON and DAVID BARBOZA New York Times

WASHINGTON, June 18 — China manufactured every one of the 24 kinds of toys recalled for safety reasons in the United States so far this year, including the enormously popular Thomas & Friends wooden train sets, a record that is causing alarm among consumer advocates, parents and regulators.

The latest recall, announced last week, involves 1.5 million Thomas & Friends trains and rail components — about 4 percent of all those sold in the United States over the last two years by RC2 Corporation of Oak Brook, Ill. The toys were coated at a factory in China with lead paint, which can damage brain cells, especially in children.

Just in the last month, a ghoulish fake eyeball toy made in China was recalled after it was found to be filled with kerosene. Sets of toy drums and a toy bear were also recalled because of lead paint, and an infant wrist rattle was recalled because of a choking hazard.

Over all, the number of products made in China that are being recalled in the United States by the federal Consumer Product Safety Commission has doubled in the last five years, driving the total number of recalls in the country to 467 last year, an annual record.

It also means that China today is responsible for about 60 percent of all product recalls, compared with 36 percent in 2000.

Much of the rise in China’s ranking on the recall list has to do with its corresponding surge as the world’s toy chest: toys made in China make up 70 to 80 percent of the toys sold in the country, according to the Toy Industry Association.

Combined with the recent scares in the United States of Chinese-made pet food, and globally of Chinese-made pharmaceuticals and toothpaste, the string of toy recalls is inspiring new demands for stepped-up enforcement of safety by United States regulators and importers, as well as by the government and industry in China.

“These are items that children are supposed to be playing with,” said Prescott Carlson, co-founder of a Web site called the Imperfect Parent, which includes a section that tracks recalls of toys and other baby products. “It should be at a point where companies in the United States that are importing these items are held liable.”

The toy trains and railroad pieces are made directly for RC2 at plants it oversees in China, presumably giving it some control over the quality and safety of the toys made there. Staci Rubinstein, a spokeswoman for RC2, declined on Monday to comment on safety control measures at company plants in China.

The Toy Industry Association, which represents most American toy companies and importers, also declined to comment.

Julie Vallese, a spokeswoman for the Consumer Product Safety Commission, said the agency recognizes that more must be done to prevent the importation of hazardous toys and other products from China. “It is a big concern. And the agency is taking steps to try to address that as quickly as possible,” Ms. Vallese said. “Their businesses will suffer if they don’t meet safety standards.”

Scott J. Wolfson, a second Consumer Product Safety Commission spokesman, would not say how long ago RC2 discovered the problem or when it first reported it to federal authorities.

In the last two years, the staff of the consumer product commission has been cut by more than 10 percent, leaving fewer regulators to monitor the safety of the growing flood of imports.

Some consumer advocates say that such staff cuts under the Bush administration have made the commission a lax regulator. The commission, for example, acknowledged in a recent budget document that “because of resource limitations,” it was planning next year to curtail its efforts aimed at preventing children from drowning in swimming pools and bathtubs.

The toy industry in the United States is largely self-policed. The Consumer Product Safety Commission has safety standards, but it has only about 100 field investigators and compliance personnel nationwide to conduct inspections at ports, warehouses and stores of $22 billion worth of toys and tens of billions of dollars’ worth of other consumer products sold in the country each year. “They don’t have the staff that they need to try to get ahead of this problem,” said Janell Mayo Duncan, senior counsel at the Consumers Union, which publishes Consumer Reports. “They need more money and resources to do more checks.”

Most recalls are done voluntarily, as was the case with Thomas & Friends, after companies discover problems or receive complaints.

Among the toy recalls, the problem is most acute with low-price, no-brand-name toys that are often sold at dollar stores and other deep discounters, which are manufactured and sent to the United States often without the involvement of major American toy importers. Last year, China also was the source of 81 percent of the counterfeit goods seized by Customs officials at ports of entry in the United States — products that typically are not made according to the standards on the labels they are copying.

At one of the RC2 factories in Dongguan, China, on Sunday, a pair of workers who were paid about $150 a month to spray paint on mostly metal toy trains six days a week said they did not know whether the paint they used contained lead. The factory produces metal toys as well as the wooden toys listed in the Thomas recall.

“We’re just doing the painting,” says Li Hong, a 22-year-old factory worker who was sitting out in front of the factory dormitories.

Exactly who operates the factories making the Thomas & Friends trains in Dongguan is unclear. While the zone is run by a group of Chinese or Hong Kong suppliers, it also houses an office building that bears the RC2 corporate logo.

China’s own government auditing agency reported last month that 20 percent of the toys made and sold in China had safety hazards such as small parts that could be swallowed or sharp edges that could cut a child, according to a report in China Daily. Officials in China, of course, are fighting back, insisting that its food and other exports are safe and valuable, that new regulations are being put into place and that problem goods account for a tiny portion of all exports.

The Toy Industry Association urges its members to routinely test products it is importing to make sure they comply with federal safety standards, which prohibit, for example, surface paint that contains lead in toys or items that could cause a choking hazard.

Other major retailers or toy industry companies hit by recalls for products made in China this year include Easy-Bake Ovens, made by Hasbro, which could trap children’s fingers in the oven and burn them, and Target stores, which the consumer product commission said was importing and selling Anima Bamboo collection games, some of which were coated with lead paint.

The 22 models of the Thomas & Friends toys that are being recalled include some of the most popular items in the line’s collection, such as the red James engine and the fire brigade truck. The toy line, based on the children’s book and television series, has an almost fanatical following among some families, who own dozens of models, which can cost $6.50 to $70 each.

The string of lead paint cases has drawn the most attention from consumer watchdogs and parenting advice columnists.

“Do I have to look at every toy that has paint on it that comes from China as perhaps suspect?” said Mr. Carlson, of Imperfect Parent.

Ms. Duncan, of Consumers Union, urged parents to sign up for the Consumer Product Safety Commission’s automated notification system at the commission’s Web site (www.cpsc.gov), so they can stay on top of which toys are being recalled.

Ms. Vallese, the spokeswoman for the product safety commission, said the agency’s acting chairwoman, Nancy A. Nord, went to China in May for a meeting with her counterparts there, focusing in particular on toys, lighters, electronics and fireworks.

“Is there a concern that there are more products coming in from China and making sure they live up to the standards we expect?” Ms. Vallese said. “Yes, there is, and we understand our authority and obligation and we will make sure we enforce it.”

But parents shopping at for toys in New York over the weekend said the whole episode left them uneasy.

“I think it’s terrible,” said Chris Gunster, 41, while perusing the Thomas & Friends display area in Toys “R” Us at Times Square with his wife and 4-year-old son, James, a big fan of the toy trains. “Lead paint in this day and age?”

Labels: Avoiding Environmental and Minimum Wages, Corporate Malfeasance., Outsourcing, U.S. Corporatism