http://www.washingtonpost.com/wp-dyn/content/article/2009/11/24/AR2009112401601.html

Lead, chemicals found in toys despite stricter law

Group's tests discover that some products still 'slip through the cracks'

By Lyndsey Layton

Washington Post Staff Writer
Wednesday, November 25, 2009

Despite a new law that bans six chemicals from children's products and lowers the lead limit for them, a public interest group has found a number of toys at major retailers that contain the chemicals and illegal amounts of lead.

In a report released Tuesday called "Trouble in Toyland," the U.S. Public Interest Research Group (U.S. PIRG) found that while many manufacturers and retailers are complying with the new law, a handful are not, and it is hard for consumers to tell the difference.

"We have seen substantial progress over the last year because of the new law and new leadership at the Consumer Product Safety Commission," said Elizabeth Hitchcock, public health advocate at U.S. PIRG. "At the same time, we are seeing some products that slip through the cracks."

For 24 years, U.S. PIRG has released a report about toy safety at the start of the holiday season. This is the first report since Congress approved broad changes to consumer safety laws in 2008, in response to dangerously high levels of lead in thousands of toys imported from China in the past several years.

Concerns have also been growing about a family of chemicals known as phthalates, which are widely found in plastic toys and have been linked to reproductive disorders and other health problems. Congress overwhelmingly voted to outlaw phthalates from children's products, as well as to significantly reduce the amount of lead allowed in them.

U.S. PIRG sent 15 children's products to an independent laboratory for testing. Four were found to have excessive lead levels, and two contained phthalates. For example, a charm made by Claire's boutiques was 71 percent lead by weight, when the legal limit is .03 percent. A cloth book for toddlers, "Big Rex and Friends," which was purchased at Toys R Us, contained 0.19 percent lead. After being notified by U.S. PIRG, Toys R Us stopped selling the book, but it is still available through other retailers.

A Pretty Princess Puppy Purse from Claire's boutiques had a level of 5.4 percent of one of the banned phthalates, while an Elmo lunch bag made by Fast Forward New York had a level of 7.2 percent of another banned phthalate.

On Monday, Inez Tenenbaum, chairman of the Consumer Product Safety Commission, told reporters that "parents and grandparents can have more confidence this year than ever before" because of the new law. Toy recalls have dropped from 162 last year to 38 so far this year, she said. Recalls of children's products with excessive lead levels have decreased from 85 last year to 15 this year, she said.

Since she became chairman of the commission in June, Tenenbaum has traveled twice to China and Southeast Asia to discuss with her Asian counterparts "how to build safety into toys." The Chinese government shuttered several toy factories because of concerns about product safety, she said, adding: "The Chinese are taking toy safety very seriously."

Still, shoppers have no way of telling whether the products on store shelves comply with the law, Hitchcock said. "To take a product that you buy and send it off to a laboratory costs some money and is not something that parents can or should have to do with a product," she said.

U.S. PIRG is launching a tool with toy safety tips that consumers can access via cellphone, Hitchcock said.

The new law requires manufacturers to send their products to independent laboratories to verify that they meet the standards, but that provision will not take effect until February. Still, the statute makes it illegal for manufacturers to create children's products that violate the standards and for retailers to sell them.

The group's report also examined toys that pose a choking hazard to young children and those that make excessive noise, which can cause hearing loss. The report and the mobile site are available on the U.S. PIRG Web site.

Novartis builds a $1 billion vaccine factory in North Carolina, and nearly 49 percent of that cost was borne by you, the taxpayer. Sweet deal for Novartis, eh? Are Swiss pharmaceutical firms also "too big to fail"?

http://www.reuters.com/article/GCA-SwineFlu/idUSTRE5AM2XR20091124

Novartis opens new flu vaccine plant in U.S.

http://online.wsj.com/article/SB10001424052748704779704574555481034996654.html?mod=dist_smartbrief

NOVEMBER 24, 2009, 9:11 A.M. ET

Glaxo Warns on Batch of Swine-Flu Vaccine

LONDON -- Pharmaceuticals company GlaxoSmithKline PLC said Tuesday it has advised medical staff in Canada to not use one batch of swine-flu vaccines in case they trigger life-threatening allergies.

Company spokeswoman Gwenan White said that they issued the advice after reports that one batch of the swine-flu vaccine might have caused more allergic reactions than normal.

"We have advised health care professionals not to use that batch while health authorities and GlaxoSmithKline investigate," she said.

Ms. White said the batch at issue, which has been distributed across Canada, contains 172,000 doses of the vaccine. She declined to say how many doses had been administered before the advice to stop using them was given.

Ms. White said U.K.-based GlaxoSmithKline wrote to Canadian health-care professionals advising them to stop using the batch on Nov. 18. She says a total of 7.5 million doses of the vaccine have been distributed in Canada.

GlaxoSmithKline is the world's second-largest drug maker by revenue. Its shares were down 0.08% on the London stock exchange.

http://www.reuters.com/article/marketsNews/idUSN2326694820091123?rpc=77&pageNumber=2&virtualBrandChannel=11604

Vioxx risks could have been detected earlier-study
Mon Nov 23, 2009 4:00pm EST

 * Risks arose more than 3 years before drug was pulled

* Study argues for quicker access to drug safety data

By Julie Steenhuysen

CHICAGO, Nov 23 (Reuters) - Heart risks from taking Merck & Co Inc's
(MRK.N) painkiller Vioxx could have been detected more than three
years before the company withdrew the drug from the market in
September 2004, had the data been openly available, U.S. researchers
said on Monday.

They said their analysis illustrates the need for quick, public
disclosure of drug safety data.

"You could have known there were marked safety problems with Vioxx as
early as 2000 and the signal only grew stronger," said Dr. Harlan
Krumholz of Yale University School of Medicine, who worked on the
study published in the Archives of Internal Medicine.

Merck voluntarily withdrew Vioxx from the market in September 2004
after a clinical trial found the blockbuster drug increased the risk
of heart attacks and strokes in long-term users of the medicine.

In November 2007, Merck signed a $4.85 billion deal to settle
thousands of claims for heart attacks, strokes and deaths allegedly
caused by the drug.

The study draws on company data from more than 30 clinical trials
conducted by Merck between 1996 and 2004 comparing Vioxx, or
rofecoxib, to a placebo or dummy pill.

Krumholz gained access to the data through his role as a paid witness
for plaintiffs in lawsuits involving heart attacks or strokes that
occurred after taking the drug.

"Most of the information we are using in this study was never
published, or if it was published, they never included the key safety
data," he said.

Of the 30 studies, 18 were published before September 2004, when the
drug was withdrawn, six were published after that, and six were never
published.

"We're suggesting this has to change," Krumholz said.

The team pooled data from randomized clinical trials that compared
Vioxx to a placebo.

They pooled the trials in the order the studies were done, and after
each one, they analyzed the data to see if they could detect any
signal that would suggest the drug was raising the risk of heart
attacks and strokes.

They found a trend toward increased heart risks compared with placebo
as early as December 2000, and a statistically significant signal by
June 2001, nearly three and a half years before the company pulled the
drug from the market.

 Merck rejects the conclusions of the study, saying its own analysis
of the data done while the drug was on the market did not show an
increased risk of blood clots.

"There is nothing new here. We studied Vioxx before and after it was
on the market. We studied it extensively using more rigorous methods
than these authors used and we didn't see any cardiovascular risk,"
Ron Rogers, a Merck spokesman, said in a telephone interview.

He said the first time they saw a risk was in September 2004, and the
company voluntarily pulled the drug from the market within a week of
those results.

He rejects the methodology used by Krumholz and colleagues, which
counted heart problems reported by doctors, and not those that were
confirmed by outside experts.

Krumholz said the methods used by the team "represent a well-accepted
approach" that passed a tough peer review process.

He said the purpose of the study was not to point a finger at Merck,
but to argue for better ways of tracking the safety of drugs once they
are approved by the U.S. Food and Drug Administration.

(Editing by Vicki Allen)

((julie.steenhuysen@thomsonreuters.com ; +1 312 408 8131)

Chinese-made toys are slightly less likely to kill your kid this season, according to the US government. That's nice to hear... I guess. It's too bad Chinese drywall can still kill you.

http://www.google.com/hostednews/afp/article/ALeqM5j_p4v8Agv2ocyHdnC1JZ8ghohIQA

(AFP) – 1 day ago

WASHINGTON — The United States Monday praised Beijing for "taking toy safety seriously" two years after millions of made-in-China toys had to be recalled amid fears they were dangerous.

"The Chinese government closed down numerous toy factories after the wave of US recalls and they are educating toy makers about our new rules," Inez Tanenbaum, head of the Consumer Product Safety Commission (CPSC), told reporters.

Americans will be able to "shop for children this holiday season with a little more confidence than ever before," she said, just days before the US Christmas holiday shopping season officially begins.

More than 21 million toys and kids' products made in China were recalled in three months in 2007 because they contained dangerous levels of lead, according to US officials.

Tough US laws on toy safety were phased in last year and toy makers are now required to have certain products tested and certified in independent, accredited laboratories.

The new rules imposed by the Consumer Products Safety Improvement Act allow only 90 parts per million (ppm) of lead paint in toys and an overall lead content of 300 ppm, Tenenbaum said.

"Before this, there has never been a total lead limit in toys," she said.

Certain phthalates -- chemicals that make plastic malleable -- have been banned from toys and accessories that children are likely to put in their mouths.

"The rules that parents were calling for in 2007 when all the recalls were happening are now in place," said Tenenbaum, adding China has been "responsive" to US requests to improve toy safety.

Recalls for lead violations have become more infrequent and smaller in size than in 2007 and 2008, she said.

There were around 150 toy recalls in both 2007 and 2008, and only 38 so far this year, Tenenbaum said.

Of this year's toy recalls, 15 involved violations of lead levels. Last year, 85 toy recalls involved lead, while in 2007 the number was 63.

China is the world's top toy exporter. In 2006, the country sold 22 billion toys overseas, or 60 percent of the globe's total.

* * *

http://www.google.com/hostednews/ap/article/ALeqM5gD4avarflIqeq856bkEM8jMJRR_wD9C5HGRO0

By BRIAN SKOLOFF (AP) – 1 day ago

WEST PALM BEACH, Fla. — The federal government said Monday that it has found a "strong association" between problematic imported Chinese drywall and corrosion of pipes and wires, a conclusion that supports complaints by thousands of homeowners over the last year.

In its second report on the potentially defective building materials, the U.S. Consumer Product Safety Commission said its investigation also has found a "possible" link between health problems reported by homeowners and higher-than-normal levels of hydrogen sulfide gas emitted from the wallboard coupled with formaldehyde, which is commonly found in new houses.

The commission, along with the Environmental Protection Agency and the Centers for Disease Control and Prevention, continues to study the potential health effects, and the long-term implications of the corrosion.

"We can say that we believe that there's a number of different chemicals that when brought together can be related to some of these irritant health effects that we've been getting reports of," said CPSC spokesman Scott Wolfson. "But we're still working toward that exact nexus."

The commission said it can now move forward with additional studies to identify effective remediation of the problem and potential assistance from the federal government. However, Warren Friedman of the U.S. Department of Housing and Urban Development said it's too soon to discuss specifics of any financial assistance homeowners could get.

The Formaldehyde Council, a trade group, said there is no scientific evidence to support the theory that the two chemicals can combine to sicken people.

Betsy Natz, the group's executive director, called it "irresponsible to speculate that formaldehyde and hydrogen sulfide can act in a synergistic ... manner to cause irritant effects in human beings at the low levels found in the CPSC study."

The CPSC has spent more than $3.5 million on the studies, and has received more than 2,000 homeowner complaints from 32 states, Washington, D.C., and Puerto Rico, in what is now the largest consumer product investigation in U.S. history. Most of the complaints have come from Florida, Louisiana, and Virginia. Wolfson said the CPSC has committed nearly 15 percent of its staff to the issue.

The results released Monday came, in part, from a 51-home indoor air quality study.

However, officials cautioned that not all Chinese drywall is necessarily problematic and that homes with American-made drywall also are being studied.

"Not all drywall is alike," said Jack McCarthy, president of Environmental Health & Engineering Inc., the firm hired by the government to perform the air quality tests. "It depends on what it's made of, not necessarily the country where it came from."

Added Wolfson: "We are not limited in the scope of our investigation to just Chinese drywall."

The commission released its first report on the drywall last month, noting further studies were needed before it could consider a recall, ban or other action.

Thousands of homeowners who bought new houses built with the imported Chinese building product are finding their lives in limbo as hundreds of lawsuits against builders, contractors, suppliers and manufacturers wind through the courts.

During the height of the U.S. housing boom, with building materials in short supply, American construction companies imported millions of pounds of Chinese-made drywall because it was abundant and cheap. An Associated Press analysis of shipping records found that more than 500 million pounds of Chinese gypsum board was imported between 2004 and 2008 — enough to have built tens of thousands of homes.

They are heavily concentrated in the Southeast, especially Florida and areas of Louisiana and Mississippi hit hard by Hurricane Katrina.

The suspect building materials have previously been found by state and federal agencies to emit "volatile sulfur compounds" and produce a rotten-egg odor. Homeowners complain the fumes are corroding copper pipes, destroying TVs and air conditioners, blackening jewelry and silverware, and making them sick.

The federal government says China is assisting with the investigation.

___

On The Net:

http://www.cpsc.gov/info/drywall/index.html