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

Because a "research" tax credit that gives huge companies $7 billion in tax savings leaves me scratching my head.

http://www.bloomberg.com/apps/news?pid=20603037&sid=aibLRu6QCZlA

Rangel Says House Democrats Will Renew Tax Breaks (Update1)

Nov. 20 (Bloomberg) -- House Democrats plan to move next month to renew about $30 billion in tax breaks before they expire at year’s end, including a research credit promoted by companies such as Dow Chemical Co.

Representative Charles Rangel of New York, the Democratic chairman of the Ways and Means Committee, said yesterday the panel will send a measure containing the extensions directly to the House floor for consideration, bypassing a committee debate.

The committee is moving to renew 45 provisions, including deductions for college tuition and for state and local sales tax payments, which will save individuals $1.5 billion and $1.8 billion, respectively. Other breaks include benefits for films and television shows produced in the U.S., and an incentive for producing rum in Puerto Rico and the U.S. Virgin Islands.

The biggest is a research credit for businesses, worth $7 billion in tax savings. The R&D Credit Coalition, a Washington- based trade group, estimates the credit is equal to a federal subsidy of 6 cents for every dollar a company spends on research in the U.S. The group has more than 500 members including Dow, the largest U.S. chemical maker, CA Inc., the second-largest maker of software for mainframe computers, and Microsoft Corp., the world’s biggest software maker.

House Democrats also plan to renew a $4 billion benefit allowing U.S.-based companies like General Electric Co. to defer tax on income from their overseas lending activities.

Offshore Tax Evasion

Massachusetts Representative Richard Neal, a Democrat, said the tax break extensions are likely to be funded, in part, by legislation introduced Oct. 27 by Rangel and Senate Finance Committee Chairman Max Baucus that is designed to help the Internal Revenue Service fight offshore tax evasion.

Neal said the Ways and Means panel likely will defer extending a so-called “patch” of the alternative minimum tax that spares about 30 million households from paying about $70 billion in higher income taxes this year. Congress would have to extend the patch in 2010 to keep the higher taxes from taking effect then.

Committee member Chris Van Hollen of Maryland said the panel also is leaning toward passing a new, permanent estate tax instead of a one-year measure to keep the current levy from expiring next year.

“That would be the prevailing view,” Van Hollen said. Another option, he said, would be to enact a multiyear extension of current law to ensure there is consistent tax treatment of large estates over the next several years.

The current tax imposes a top levy of 45 percent on couples’ estates valued at more than $7 million. In 2010 the tax is scheduled to vanish under a phase-out Congress approved in 2001. It is due to return in 2011 with a top rate of 55 percent on estates worth more than $1 million.

To contact the reporter on this story: Ryan J. Donmoyer in Washington at rdonmoyer@bloomberg.net

Last Updated: November 20, 2009 11:21 EST

Typical mega-farms pack animals so close to each other (and each other's sh*t) that they have to dose the animals with antibiotics to prevent infections. What does this mean to you, the consumer? Well, you are what what you eat eats, as Michael Pollan would say.

Here is an alternative to the crap sold by typical agribusiness.

http://www.startribune.com/local/70678072.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aUUsA

Drug misuse on Minnesota dairy cows prompts federal warning

Two state farms were reprimanded for unsafe levels of antibiotics in animals. The 2 animals were pulled from slaughter lines after testing.

http://www.reuters.com/article/rbssHealthcareNews/idUSN2024658320091121

Pfizer to pay $6.3 mln to patient in Prempro lawsuit

Consumers are virtually forced to get them, and manufacturers can't be sued if anything goes wrong. What's not to like?

http://www.google.com/hostednews/ap/article/ALeqM5jcCGUacLKnh4fvRr0oo4ulxVjz_AD9C1NUP01

By LINDA A. JOHNSON (AP) – 2 days ago

MARIETTA, Pa. — Malaria. Tuberculosis. Alzheimer's disease. AIDS. Pandemic flu. Genital herpes. Urinary tract infections. Grass allergies. Traveler's diarrhea. You name it, the pharmaceutical industry is working on a vaccine to prevent it.

Many could be on the market in five years or less.

Contrast that with five years ago, when so many companies had abandoned the vaccine business that half the U.S. supply of flu shots was lost because of factory contamination at one of the two manufacturers left.

Vaccines are no longer a sleepy, low-profit niche in a booming drug industry. Today, they're starting to give ailing pharmaceutical makers a shot in the arm.

The lure of big profits, advances in technology and growing government support has been drawing in new companies, from nascent biotechs to Johnson & Johnson. That means recent remarkable strides in overcoming dreaded diseases and annoying afflictions likely will continue.

"Even if a small portion of everything that's going on now is successful in the next 10 years, you put that together with the last 10 years (and) it's going to be characterized as a golden era," says Emilio Emini, Pfizer Inc.'s head of vaccine research.

Vaccines now are viewed as a crucial path to growth, as drugmakers look for ways to bolster slowing prescription medicine sales amid intensifying generic competition and government pressure to cut down prices under the federal health overhaul.

Unlike medicines that treat diseases, vaccines help prevent infections by revving up the body's natural immune defenses against invaders. They are made from viruses, bacteria or parts of them that have been killed or weakened so they generally can't cause an infection.

Investment in partnerships and other deals to develop and manufacture vaccines has been on a tear — and accelerating since the swine flu pandemic began. Billions in government grants are bringing better, faster ways to develop and manufacture vaccines. Rising worldwide emphasis on preventive health care, plus the advent of the first multibillion-dollar vaccines, have further boosted their appeal.

While prescription drug sales are forecast to rise by a third in five years, vaccine sales should double, from $19 billion last year to $39 billion in 2013, according to market research firm Kalorama Information. That's five times the $8 billion in vaccine sales in 2004.

"What was essentially 25 years ago a rounding error now has become real money," says Robin Robertson, director of the U.S. Biomedical Advanced Research Development Authority.

That jump is due to a couple of new blockbuster vaccines and rising use of existing ones. The government's list of recommended vaccines for children since has more than doubled since 1985 to 17. It now also calls for a half-dozen vaccines for everyone over 18 and up to four more for some adults.

The last decade brought breakthrough vaccines against pneumococcal disease and rotavirus — two of the world's top killers — meningitis, cervical cancer and more.

Better technology to create and mass produce vaccines is bringing progress in preventing tropical dengue fever and new threats like superbugs MRSA and C. difficile, even ending addiction to cocaine and nicotine. Success on some vaccines in development, particularly for Alzheimer's and AIDS, likely would bring billions a year in sales.

Just this fall and early next year, the swine flu vaccines are expected to bring their makers at least a couple billion extra dollars.

That's despite the five manufacturers for the U.S. not being able to meet an optimistic plan to first make seasonal flu shots and then produce 120 million doses of swine flu vaccine by mid-October — an unprecedented task. But they are steadily catching up with demand.

Unlike most vaccines now "manufactured" in mammal, yeast or other cells — quickly, purely and at high yields — flu vaccines are still grown over many weeks in chicken eggs because it's economical and those newer, faster methods aren't U.S.-approved yet. Because swine flu vaccine grew slower than expected, there have been shortages — and lines of anxious consumers.

But a horde of biotech companies, many using multimillion-dollar government grants, already are testing state-of-the-art technology for the next pandemic.

Scientists — including some at J&J's new vaccine partner, Holland's Crucell NV — even are working to develop the holy grail: a universal flu vaccine targeting a part of the virus that doesn't change year to year.

And some future vaccines will come in patches, pills and nasal sprays, rather than painful shots.

In the last century, vaccines dramatically lengthened lifespans by stopping diseases that killed or disabled millions, from smallpox to polio.

After all those successes, many pharmaceutical companies instead focused on lucrative daily pills for chronic diseases. By the middle of this decade, only a handful were still making vaccines, which are harder to produce than chemical-based pills, making yields unpredictable.

That led to the 2004 fiasco when half the U.S. flu shot supply was lost overnight, plus continuing periodic shortages of some kids' vaccines.

Today, five companies supply flu vaccine: GlaxoSmithKline, Switzerland's Novartis AG, Australia's CSL Biotherapies, MedImmune, part of Britain's AstraZeneca PLC, and France's Sanofi-Aventis SA.

There's been more research on flu vaccines in the last five years than in the previous 20, notes Dr. William Schaffner, Vanderbilt University's head of preventive medicine and a spokesman for the Infectious Diseases Society of America.

Now many drugmakers are rethinking vaccines.

Britain's GlaxoSmithKline is gunning to become the world's top vaccine manufacturer by revenue, unseating pioneer Merck & Co. This spring, Glaxo opened a state-of-the-art vaccine packaging plant in Marietta, Pa., west of Philadelphia, so it can expand in the U.S. market.

Glaxo, which sold only one vaccine in the U.S. 13 years ago, now sells 12 here — and 30 worldwide. It has 20 more in human testing, including ones for meningitis and malaria.

J&J, which previously avoided vaccines, plans to build a full vaccine portfolio, starting with universal flu and Alzheimer's vaccines, says research head Dr. Paul Stoffels.

Even Pfizer Inc.'s $68 billion acquisition of Wyeth in October was partly about getting its vaccine expertise, now being put to work against Alzheimer's. Wyeth makes the most successful vaccine ever, Prevnar, which protects children from ear infections and potentially deadly pneumonia and blood infections. Prevnar brought in $2.7 billion in 2008 sales, and with approval of an improved version pending, billions more a year are expected.

Experts call Prevnar the "game changer." It was the first vaccine to exceed $1 billion in annual sales, followed by Merck's cervical cancer shot Gardasil, with $2.3 billion in 2008 sales.

"Vaccines are now perhaps seen to be more attractive than drugs," says Dr. Stanley Plotkin, a former University of Pennsylvania professor and industry researcher who helped develop the German measles and rotavirus vaccines.

Vaccines command higher prices — roughly $375 for the three-shot Gardasil series — and so are more profitable than in the past. With only one or two makers of most vaccine types, price competition is rare in wealthy countries. Plus, they rarely face generic competition.

For flu shot makers, the risk of having to throw out millions of unused doses here come spring has plunged as U.S. guidelines have steadily widened to include 83 percent of Americans. Use has jumped from 20 million doses in 1990 to 113 million last year.

And many companies are partnering with promising biotechs, the World Health Organization and global charities, or setting up deals with local drugmakers abroad, to inexpensively manufacture vaccines in developing and middle-tier countries that increasingly want them to prevent much-higher health care costs.

"What you had was, everybody out of the water," says analyst Steve Brozak of WBB Securities. "Now, everybody's back in the water."

Never underestimate the skankiness of industry lobbying groups. People hear about the ill health effects of PVC (polyvinyl chloride)--stuff like reproductive defects in people exposed in utero and in infancy--and they think about scaling back their personal use of vinyl. Not a bad thing--unless you're the guy who makes the stuff. Then you have to get your troops moving to convince people that plastic is good for them, nothing to worry about...

http://www.plasticsnews.com/headlines2.html?id=17169&channel=83

New group focusing on flexible vinyl issues

WASHINGTON (Nov. 19, 1 p.m. ET) -- In response to increased attacks on flexible vinyl products, as well as the phthalates used to soften vinyl to make a variety of plastic products, the industry has formed the Flexible Vinyl Alliance in an effort to respond more quickly to initiatives at the state and local levels.

“We want to activate a grassroots network,” said Kevin Ott, coordinator of the FVA. “We want to get more ears to the ground and add more voices to the debate.” Ott is former executive director of the Film and Bag Federation of the Society of the Plastics Industry Inc., where he was involved in the industry’s efforts to defeat plastic bag bans. He now heads his own consulting firm in McLean, Va.

The Phthalate Esters Panel of the American Chemistry Council in Arlington, Va., is providing funding for FVA for its first 18 months, Ott said. The announcement of the formation of FVA was made Nov, 17, but the alliance has been in operation since Sept. 1 and its first steering committee meeting was earlier this month.

Sources said phthalates manufacturer ExxonMobil Chemical Co. was the driving force behind the creation of FVA and that phthalates manufacturers and compounders felt that they needed to develop their own network at the state and local level to address specific issues involving flexible vinyl and phthalates.

“They felt that they weren’t getting enough help defending products that use phthalates as a plasticizer,” said one source.

ExxonMobil is a member of both the Phthalate Esters Panel of ACC and the Vinyl Institute in Alexandria, Va.

The 11-member FVA steering committee includes representatives from PVC compounders, molders fabricators and manufacturers and all three major U.S. phthalate manufacturers. There are also representatives from SPI and the Resilient Floor Covering Institute and Canadian pipe manufacturer Ipex Inc., whose representative, Veso Sebot, is also a member of the 3-year-old Vinyl Promotion Network, an informal group of companies and organizations in the vinyl supply chain with a similar mission of promoting the benefits of vinyl.

The addition of new alliance to help the industry advocate the benefits and sustainability of vinyl was welcomed by VI president Greg Bocchi.

“We look forward to working with them as they address issues of advocacy related to flexible vinyl,” he said, “We have been involved with the FVA since its inception, taking part in all of its organizational meetings.”

Allen Blakey, vice president of industry and government affairs at VI, agreed. “We welcome anyone who wants to promote the benefits of vinyl. We are glad to have another group of people, additional resources and manpower supporting us.”

Ott said one of FVA’s goals is “to create a grassroots network of people at the local and state levels to talk about the benefits of flexible plastic.”

“There is no lack of cogent messages and we are not in competition with other trade groups,” said Ott. “We just want to drill the messages about the benefits of flexible vinyl products to a level that is more local. We are here to assist and coordinate on advocacy” and provide information and messages to manufacturers, retailers and brand owners to enable them to speak out in communities when challenges to flexible vinyl products occur.

Flexible vinyl products, in particular toys and items intended for children, have been the targets of activists who seek to have retailers take those products off their shelves. In addition, earlier this year, a permanent ban on the use of three types of phthalates in products intended for children went into effect in the U.S.

“The FVA wants to provide information to their members so those members can get out and advocate at local and state levels,” which makes sense, said Bocchi. “They want to have a grassroots network specific to flexible vinyl they can call on quickly whenever their products come under attack.”

Ott said the FVA has three main goals.

“We want to inform consumers about what’s happening and the benefits of flexible vinyl products. We want to make sure the value chain of brand owners, retailers and manufacturers have the information they need to discuss those issues with decision-makers and legislators at the grassroots level. And we want to coordinate those activities,” he said.

“We want to help get those messages out to a more diversified audience and down to where they need to be so people in companies can go forward and advocate for the sustainability and about the benefits of flexible vinyl products,” said Ott. “We want companies to have a comfort zone when talking about the benefits of vinyl and get them the information they need to be advocates for their own products.

“We are trying to fill a gap,” he said. “When we see things coming down the pike whether it’s at the state, local or federal level, we want to weigh in and encourage local folks to get involved.”

The 11 members of the FVAS steering committee are:

* Lou Cappucci, head of the vinyl division of Teknor Apex.

* William Carroll, vice president of Occidental Chemical Corp.

* Steve Cullen, global business manager for the plasticizers business unit at Eastman Chemical Co.

* Bill Dominick, vice president of automotive and industrial R&D for Rutland Plastic Technologies Inc.

* Paul Galasso, commercial manager of intermediates for the Americas for ExxonMobil Chemical Co.

* Patrick Harmon, industry manager of oxo-alcohols and plasticizers for BASF Corp.

* Brenda Hollo, technical manager for plastic additives for Ferro Corp.

* David Kiddoo, global business manager for AlphaGary Corp.

* Terry Peters, executive director of SPI’s fluoropolymers division.

* Dean Thompson, president of the Resilient Floor Covering Institute.

* Veso Sobot, director of corporate affairs at Ipex Inc. and a member of the Vinyl Promotion Network.

http://www.bloomberg.com/apps/news?pid=20601124&sid=ahgs1cipLGGY

Flu Shot Made From Caterpillars Fails Safety Vote (Update3)

Nov. 19 (Bloomberg) -- Protein Sciences Corp. failed to prove its experimental flu vaccine is safe enough to be approved and more study is needed, a U.S. advisory panel said.

The shot, called FluBlok, is produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells. Members of the advisory panel to the U.S. Food and Drug Administration voted 6-to-5 that the company hadn’t proven the vaccine safe, saying clinical trials weren’t large enough to support mass production. Nine of the 11 panelists said the shot was as effective as licensed vaccines in adults ages 18 to 49.

Closely held Protein Sciences, based in Meriden, Connecticut, and backed by $147 million in U.S. contracts, is seeking to become the country’s first supplier to break from the 50-year-old technique of growing the vaccine in chicken eggs. The egg-based process has been blamed for delays in this year’s pandemic swine flu vaccine, and U.S. health officials have pledged to increase production times.

“The reason we’re struggling so much is the safety database isn’t very large,” said Pamela McInnes, director of the Division of Extramural Research at the National Institutes of Health and one of the panelists. “The company has clearly done some nice work, and there’s been a lot of progress made. There’s not a signal in my mind that I’m very worried, but we are missing information.”

Patient Hospitalized

There were several examples of face swelling reported in clinical trials, and one person was hospitalized for a condition called pleuropericarditis, characterized by swelling around the heart and lungs. While the hospitalized patient had reported fever, shortness of breath and chest pain a week before he was vaccinated, the shot couldn’t be ruled out as a contributor to his illness, panelists said.

Staff documents released by the FDA ahead of today’s panel hearing said the vaccine was found to be as safe and effective as other flu shots in four human trials covering 3,231 adults ages 18 and older. Panelists today said that because the vaccine wasn’t significantly more effective than competitors, the company needed to prove safety in larger trials in order to justify approval.

While the FDA usually follows its panels’ recommendations, the agency isn’t required to do so.

The new swine flu strain identified in April has infected 22 million Americans and killed about 3,900, according to the Atlanta-based CDC. More people with flu symptoms sought treatment from doctors in October and November than at the February peak of a normal flu season, according to data on the CDC Web site. The U.S. flu season runs from November to March.

Vaccine Delays

Vaccine to combat the swine flu, known as H1N1, began arriving in October, and about 50 million doses are available for shipment, health officials said yesterday. That’s less than half what officials projected in July for the end of October.

Novavax Inc., which has enrolled 1,000 recipients in clinical trials of a competing technology, rebounded in Nasdaq Stock Market composite trading on the panel’s decision. The shares fell 4 cents, or 1 percent, to $3.77 at 4 p.m., after declining as much as 6.6 percent during the meeting. The Rockville, Maryland-based company makes a vaccine from virus- like particles, structures that mimic the flu without causing infection.

Early Bets

Novartis AG, based in Basel, Switzerland, London-based GlaxoSmithKline Plc and Baxter International Inc. based in Deerfield, Illinois, made early bets on a method of growing the live vaccine in cultured animal cells. Novartis, which sells vaccine using the cell-based technique in Europe, received U.S. contracts for $487 million to build a production plant in North Carolina.

The animal-cell process, which relies on growing the live virus in cells, may prove less dependable than Protein Sciences’ technique, said William Schaffner, chairman of the department of preventive medicine at Vanderbilt University in Nashville, Tennessee, before today’s meeting.

“Variability is gone, the egg allergy is gone, purity increases so it can be much more refined -- that’s exciting to us,” Schaffner, who is a consultant for the U.S. Centers for Disease Control and Prevention’s advisory committee on vaccines, said in a telephone interview. “We are at the beginning of some major changes in influenza vaccine technology.”

Not Necessarily Faster

Animal cell-based technology isn’t necessarily faster than egg-based, Philip Hosbach, vice president of immunization policy and government relations for the vaccine unit of Paris-based Sanofi-Aventis SA, said yesterday at a congressional oversight hearing in Washington. Vas Narasimhan, president of Novartis’s U.S. vaccine unit, said the cell-based method may save six to eight weeks of production time.

“The big companies are going with mammalian cells, which really doesn’t make any sense,” said Daniel Adams, chief executive officer of Protein Sciences, in a telephone interview before the panel met. “You’re substituting mammalian cells for eggs, but you still have to use a live virus. You still have to wait for a seed strain from the CDC.

“People for a long time thought you could deal with a pandemic using eggs,” Adams said. “My gut reaction is that change comes slowly, but I certainly expect our technology to be a major player in the flu.”

Adams didn’t immediately return a phone call for comment after the panel vote.

Cell-Based Shots

Novartis’s cell-based vaccines for seasonal flu and swine flu, approved for use in Europe, show the safety and effectiveness of the production method, company spokesman Eric Althoff said in an e-mail. The drugmaker’s technique produced the first batch of swine flu vaccine, he said.

“Existing technologies are here now; they’re tried and true,” Donna Cary, a spokeswoman for Sanofi, said today in a telephone interview. She said Sanofi is evaluating new vaccine technologies including cell-based production and a so-called universal vaccine that would cover all strains and wouldn’t need to be re-administered each year.

A Glaxo representative couldn’t be reached.

Most seasonal flu vaccines are made by taking versions of the three most-commonly circulating influenza strains and growing the virus in millions of chicken eggs. The virus is then removed from the eggs and damaged so it can’t cause infections. Some strains grow faster than others, and a poorly performing seed virus such as the pandemic swine flu, can delay production, which typically take 5 to 6 months.

Caterpillar Virus

Protein Sciences extracts genes from the dead flu virus and inserts it in a virus that feeds on a tropical caterpillar known as an armyworm. The virus is then exposed to ovary cells harvested from a single caterpillar and reproduced in large quantities. Ovary cells are used because they remain stable as they are cultured in a laboratory.

The caterpillar virus feeds on the ovary cells in vessels similar to those used to ferment beer, and there isn’t the variability of trying to grow a live flu virus that isn’t well adapted for chicken eggs, said Adams of Protein Sciences. The consistency of the caterpillar virus growth cuts down on the manufacturing time.

The end result is a vaccine made of protein and salt water, he said. Because the vaccine is pure, preservatives such as thimerosal aren’t necessary.

Protein Sciences fought off an involuntary bankruptcy suit by creditor Emergent BioSolutions Inc. in September. In addition to its government contracts, the company is funded by private investors including Wyeth, which was acquired by New York-based Pfizer Inc. for $68 billion in October.

To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net

Last Updated: November 19, 2009 18:00 EST

Better than its predecessor, that is. Better than the old vaccine that caused the "need" for the new vaccine. Pfizer is a winner no matter what happens, it seems.

http://www.reuters.com/article/euRegulatoryNews/idUSN1651571220091116

UPDATE 2-US FDA wants panel to probe Pfizer vaccine efficacy

This is beyond bizarre. Some chlorine plants have decided to go to mercury-free technology, and legislation is pending that will force all chlorine plants to do the same. The American Chemistry Council and its flunkies at the Washington Post have decided that this is a bad thing. Not only will it be more expensive for the chlorine manufacturers to do their work without using a highly toxic heavy metal, but it will also create a glut of mercury on the market--a glut that apparently has no choice but to be spread around by South African gold miners.

First off, I have to say, Boo hoo! about the chlorine manufacturers griping about making their (also toxic) product in a cleaner way. I mean, damn! I'm not allowed to spill toxic crap all over my neighborhood. I'm not even allowed to dump my grass clippings in the street. Why should life be any different for Erco et al?

Second, it's clear that many countries need to take serious action to curb mercury emissions by their industries. It's not just South African gold miners. Think about mercury-emitting coal-fired power plants in China. The net effect of this particular limit on mercury is positive for people living near the chlorine plants. The next step is up to the government in South Africa. Maybe if we weren't so busy trying to convince people that carbon dioxide is toxic, we could put some pressure on other countries to curb their emissions of truly toxic chemicals, like mercury.

http://www.washingtonpost.com/wp-dyn/content/article/2009/11/16/AR2009111602846.html

A glut of mercury raises fears

Cleaner chlorine plants may indirectly be creating an excess of toxic metal

By Kari Lydersen

Washington Post Staff Writer
Tuesday, November 17, 2009

Over the past decade, environmental groups have pressured U.S. chlorine plants to stop spewing mercury, the toxic heavy metal that settles in water and makes its way into the food chain by contaminating fish and shellfish. In the past four years, five such plants converted to mercury-free technology, cutting the industry's mercury emissions by 88 percent, according to the Environmental Protection Agency.

But this success has created a new environmental problem. Hundreds of tons of mercury acquired for use by the plants may be on the global market, where it could ultimately be used in small-scale unregulated "artisanal" gold mining. Such activity might create environmental and health hazards in developing countries.

Environmental stewardship is often a complicated balancing act, with solutions to one problem creating new and sometimes unforeseen issues -- for example, the planting of kudzu to control soil erosion and the introduction of voracious Asian carp to clean up aquaculture operations. In both cases, the invasive species wreaked havoc of their own.

Removing mercury from U.S. chlorine production could be another such example.

When the Erco Worldwide chlorine plant in Port Edwards, Wis., converted to mercury-free membrane technology this year, it sold 200 tons of mercury to a broker. Peter Maxson, a Brussels-based consultant who advises the European Commission on mercury, said it is likely some of that mercury ended up in a Dutch warehouse that distributes the metal worldwide. According to Maxson and various watchdog groups, significant amounts of globally traded mercury end up in artisanal gold mining in South America, Africa and Asia.

Erco President Paul Timmons and a spokeswoman for Olin Chemicals, which converted plants in Niagara Falls, N.Y., and Louisiana in recent years, say their brokers signed contracts that the mercury would not be sold for any use that emits the metal into the atmosphere. But critics say it is hard to track where globally traded mercury goes. "It's kind of like money laundering," Maxson said. "They can say they are doing the right thing and then wash their hands of it."

Four remaining plants

Mercury has been phased out of many industrial processes and products in the United States and Europe, though it is still used in fluorescent light bulbs and various scientific and manufacturing devices. The remaining four chlorine plants that use mercury account for only 2.5 percent of U.S. emissions, though they are major sources in their states: West Virginia, Ohio, Georgia and Tennessee.

Officially called chlor-alkali plants, they use cells full of mercury as cathodes in a reaction where salt brine is turned into chlorine gas and caustic soda, or lye. Chlorine is used to purify water in pools and municipal drinking systems, and to manufacture a wide range of products including paper, textiles and medicines. Caustic soda (potassium hydroxide or sodium hydroxide) also has many uses, such as titanium refining and cleaning products.

Mercury is also a convenient tool for extracting gold from sediment or rock, used by both large corporate gold mines and Third World miners selling lumps of gold for dollars a day.

The individual miners add mercury to silt or soil; after it binds with flecks of gold, this amalgamated ore can be sifted out. Heating evaporates the mercury, leaving only gold. The miner is directly exposed to mercury, and the metal is also usually released into the atmosphere in high concentrations.

"Many of them do it in a really wasteful, dirty processes, usually because they don't know better," said Glenn Wiser, a lawyer hired by the United Nations to give advice on ongoing treaty negotiations meant to curb the global mercury trade. "It has devastating health impacts on the miners and their families, and can get into water and have global impacts."

Bans on the horizon

U.S. and European policymakers are trying to limit the amount of mercury available to those miners. A European Union ban on mercury exports takes effect in 2011, and U.S. exports will be banned in 2013. The bans, affecting up to a third of the world trade, will probably mean rising mercury prices; that would make it less attractive for artisanal miners to use the toxic metal, or at least make them more likely to recapture and reuse mercury instead of releasing it. Until the ban takes effect, environmentalists have demanded that Erco and other companies store their mercury rather than sell it.

"The problem with the export ban is that it's pushed back so much [to 2013], you get situations like Erco," said Jackie Savitz, senior campaign director at the environmental group Oceana.

Companies claim they cannot store their mercury. But according to the EPA, mercury storage is possible but is highly regulated and requires special permits. By 2013 the Energy Department is slated to open a long-term mercury storage site, which for a fee will accept mercury from chlorine plants, Nevada gold mines and other industries. Maxson said Erco's 200 tons of mercury would probably fetch about a million dollars from a broker.

"This was a drop in the bucket compared" with the $121 million that Erco spent on the of the conversion, said Eric Uram, director of the coalition Mercury Free Wisconsin. "They should have taken the opportunity to lead not only as a local business and member of the [local] community but also as a global business and member of the global community."

The House Energy and Commerce Committee passed a bill in October that would force the remaining plants to close or go mercury-free within five years and prohibit them from exporting mercury.

Plant owners say conversion isn't economically feasible in today's economic climate. "If you can't get the financing, that's a huge factor -- it's not like Congress is offering incentives or support," said Rob Simon, a spokesman for the American Chemistry Council's chlorine division.

Reginald "Barney" Baxter, owner of the Ashta Chemicals plant in Ohio near Lake Erie, thinks the legislation mandating conversion is unfair, considering mercury emissions from coal-burning power plants dwarf those of chlorine plants. He plans a conversion by 2018 but says a tighter deadline would force the plant to close, costing hundreds of jobs.

"I don't know why they're picking on us," Baxter said. "Mother Nature through a perverted sense of humor put mercury in coal, and China's putting up two new coal-burning plants a week. There's nothing you can do in the U.S. that will make a difference."